Richard W. Deotte, Yvette Deotte, John Kelley, Alison Kelley, On Behalf

Case 4:18-cv-00825-O Document 1 Filed 10/06/18 Page 1 of 10 PageID 1
UNITED STATES DISTRICT COURT

FOR THE NORTHERN DISTRICT OF TEXAS
FORT WORTH DIVISION
Richard W. DeOtte, Yvette DeOtte,

John Kelley, Alison Kelley, on behalf
of themselves and others similarly
situated; Hotze Health & Wellness
Center, on behalf of itself and others
similarly situated,
Plaintiffs,
Case No. 4:18-cv-825
v.
Alex M. Azar II, in his official capacity

as Secretary of Health and Human
Services; Steven T. Mnuchin, in his
official capacity as Secretary of the
Treasury; R. Alexander Acosta, in his
official capacity as Secretary of Labor;
United States of America,
Defendants.
PLAINTIFFS’ CLASS-ACTION COMPLAINT

Federal regulations require health insurance to cover all FDA-approved contra-
ceptive methods. See 45 C.F.R. § 147.130(a)(1)(iv); 29 C.F.R. § 2590.715–
2713(a)(1)(iv); 26 C.F.R. § 54.9815-2713T. These agency rules violate the Religious
Freedom Restoration Act because they substantially burden those who object to con-
traception and abortifacients on religious grounds.
JURISDICTION AND VENUE

1. The Court has subject-matter jurisdiction under 28 U.S.C. § 1331 and 28
U.S.C. § 1343.
2. Venue is proper because a substantial part of the events giving rise to the
claims occurred in this judicial district. See 28 U.S.C. § 1391(b)(2).
plaintiffs’ class-action complaint Page 1 of 10

PARTIES
3. Plaintiff Richard W. DeOtte resides in Tarrant County, Texas.
4. Plaintiff Yvette DeOtte resides in Tarrant County, Texas.
5. Plaintiff John Kelley resides in Tarrant County, Texas.

6. Plaintiff Alison Kelley resides in Tarrant County, Texas.
7. Plaintiff Hotze Health & Wellness Center is a for-profit business incorpo-
rated under the laws of Texas.
8. Defendant Alex M. Azar II is the U.S. Secretary of Health and Human Ser-
vices. His office is located at 200 Independence Avenue SW, Washington, D.C.
20201. Secretary Azar is sued in his official capacity.
9. Defendant Steven T. Mnuchin is the U.S. Secretary of the Treasury. His of-
fice is located at 1500 Pennsylvania Avenue, NW, Washington, D.C. 20220. Secretary
Mnuchin is sued in his official capacity.
10. Defendant R. Alexander Acosta is the U.S. Secretary of Labor. His office is
located at 200 Constitution Avenue, NW, Washington, D.C. 20210. Secretary Acosta
is sued in his official capacity.
11. Defendant United States of America is the federal government of the United
States of America.
THE CONTRACEPTIVE MANDATE

12. The Affordable Care Act requires group health plans and health insurance
issuers to cover “preventive care” for women without any cost-sharing requirements
such as deductibles or co-pays. See 42 U.S.C. § 300gg–13(a)(4) (attached as Exhibit
1). The statute empowers the Health Resources and Services Administration to de-
termine the “preventive care” that health insurance plans must cover. See id.
13. In 2011, the Health Resources and Services Administration decided that all
FDA-approved contraceptive methods must be covered as “preventive care” under the
Affordable Care Act. This “Contraceptive Mandate” is codified at 45 C.F.R.

§ 147.130(a)(1)(iv), 29 C.F.R. § 2590.715–2713(a)(1)(iv), and 26 C.F.R.

§ 54.9815–2713T(a)(1)(iv) (attached as Exhibits 2–4).
14. The Contraceptive Mandate exempts church employers. See 78 Fed. Reg.
39870, 39,896 (July 2, 2013) (attached as Exhibit 5).
15. The Contraceptive Mandate also exempts the “grandfathered” plans that
are protected under section 1251 of the Affordable Care Act. See 29 C.F.R.
§ 2590.715–1251.
16. The Contraceptive Mandate also offers an accommodation to religious
non-profits who object to covering contraception for sincere religious reasons.
See 78 Fed. Reg. 39870, 39896–97 (July 2, 2013) (describing provisions that were
formerly codified at 45 CFR § 147.131(c)) (attached as Exhibit 5). An entity of this
sort must first certify that it is a religious non-profit that objects to covering some or
all methods of contraception on religious grounds. See id. at 39896 (describing pro-
visions that were formerly codified at 45 CFR § 147.131(b)). Then the issuer of the
group health insurance used by the religious non-profit must exclude contraceptive
coverage from that employer’s plan, but the issuer must pay for any contraception
used by the non-profit’s employees. See id. (describing provisions that were formerly
codified at 45 CFR § 147.131(c)). The issuer may not shift any of those costs on to
the religious non-profit, its insurance plan, or its employee beneficiaries. See id.
17. If a religious non-profit is self-insured, then its third-party administrator
must pay for the employees’ contraception, without shifting any costs on to the reli-
gious non-profit, its insurance plan, or its employee beneficiaries. See 78 Fed. Reg.
39870, 39893 (July 2, 2013) (describing provisions that were formerly codified at 26
CFR § 54.9815– 2713A(b)(2)) (attached as Exhibit 5).
18. In Burwell v. Hobby Lobby Stores, Inc., 134 S. Ct. 2751, 2798 (2014), the
Supreme Court held that the Contraceptive Mandate violated the Religious Freedom

Restoration as applied to closely held, for-profit corporations that oppose the cover-
age of contraception for sincere religious reasons.
19. In Wheaton College v. Burwell, 134 S. Ct. 2806 (2014), the Supreme Court
enjoined federal officials from requiring a religious non-profit to directly notify its
health insurance issuers or third-party administrators about its religious objections to
the Contraceptive Mandate.
20. In response to Hobby Lobby and Wheaton College, the Obama Administration
amended the Contraceptive Mandate in two ways. First, it allowed closely held for-
profit corporations to use the accommodation offered to religious non-profits. See
80 Fed. Reg. 41318, 41346 (July 14, 2015) (describing provisions formerly codified
at 45 C.F.R. § 147.131(b)) (attached as Exhibit 6); id. at 41345 (describing provi-
sions formerly codified at 29 C.F.R. § 2590.715–2713A(a)); id. at 41343 (describing
provisions formerly codified at 26 C.F.R. § 54.9815–2713A(a)). Second, it allowed
employers seeking this accommodation to choose whether to directly notify their
health insurance issuers or third-party administrators — or whether to notify the Sec-
retary of Health or Human Services, who would then inform the health insurance
issuers or third-party administrators of the employer’s religious objections and of their
need to pay for the contraception of the affected employees. See 80 Fed. Reg. 41318,
41346 (July 14, 2015) (describing provisions formerly codified at 45 C.F.R.
§ 147.131(b)(3)); id. at 41345 (describing provisions formerly codified at 29 C.F.R.
§ 2590.715–2713A(a)(3)); id. at 41344 (describing provisions formerly codified at
26 C.F.R. § 54.9815–2713A(b)(ii)). Under the previous version of Contraceptive

Mandate, objecting religious non-profits were compelled to directly notify their health
insurance issuers or third-party administrators, and some objected to this requirement
on the ground that it made them complicit in the eventual provision of abortifacient
contraception. See, e.g., Wheaton College, 134 S. Ct. 2806.

21. On May 4, 2017, President Trump issued an executive order instructing the
Secretary of the Treasury, the Secretary of Labor, and the Secretary of Health and
Human Services to amend the Contraceptive Mandate to address conscience-based

objections. See Executive Order 13798 (attached as Exhibit 7).
22. In response to this order, the Department of the Treasury, the Department
of Labor, and the Department of Health and Human Services issued an interim final
rule that exempts any non-profit or for-profit entity from the Contraceptive Mandate
if it opposes the coverage of contraception for sincere religious reasons. See 82 Fed.
Reg. 47792 (October 13, 2017) (attached as Exhibit 8).
23. Under the Trump Administration’s interim final rule, religious objectors are
no longer required to use the accommodation process that requires an objector’s
health insurance issuer or third-party administrator to pay for employees’ contracep-
tion. Id. at 47835 (codified at 45 C.F.R. § 147.132(a)). And there is no longer any
requirement that religious objectors notify the government or take any steps that
would make them complicit in the provision of abortifacient contraception. Id. at
47835 (codified at 45 C.F.R. § 147.132(a)(2)).
24. The interim final rule also accommodated individuals who object to the cov-
erage of contraception in their health insurance. See id. at 47835 (creating a new
provision in 45 C.F.R. § 147.132(b)). Under the Obama-era Contraceptive Mandate,
individual religious objectors were forced to choose between purchasing health insur-
ance that covers contraception or forgoing health insurance entirely — unless they ob-
tained insurance through a religious employer that was exempt from Contraceptive
Mandate. The interim final rule ensured that individual religious objectors would have
the option to purchase health insurance that excludes contraception from any willing
health insurance issuer.

25. The Departments also issued a separate interim final rule that provides sim-
ilar accommodations for entities and individuals who oppose the coverage of contra-
ception for non-religious moral reasons. See 82 Fed. Reg. 47838 (October 13, 2017)
(attached as Exhibit 9).
26. Several states challenged the Trump Administration’s accommodation of re-
ligious objectors. In Pennsylvania v. Trump, 281 F. Supp. 3d 553 (E.D. Pa. 2017), a
federal district court issued a nationwide preliminary injunction against each of the
interim final rules. In California v. Health and Human Services, 281 F. Supp. 3d 806
(N.D. Cal. 2017), a different federal district issued a second nationwide preliminary
injunction against the interim final rules.
27. As a result of these injunctions, the Obama-era Contraceptive Mandate re-
mains in place, which compels religious employers and individual insurance benefi-
ciaries to become complicit in the provision of abortifacient contraception.
STATEMENT OF THE CLAIM — INDIVIDUAL PLAINTIFFS

28. Plaintiffs Richard and Yvette DeOtte and plaintiffs John and Alison Kelley
are Christians who believe that life begins at conception, and that all human life is
sacred from conception until natural death.
29. Because of their religious beliefs, the DeOttes and the Kelleys regard the use
of abortifacient contraception as morally equivalent to abortion.
30. Although neither the DeOttes nor the Kelleys oppose the use of non-abor-
tifacient contraception by married couples to prevent pregnancy, they object to the
Contraceptive Mandate’s requirement that insurers pay for non-abortifacient contra-
ception because it encourages illicit sexual activity outside of marriage and forces other
insurance beneficiaries to subsidize it.
31. Mr. Kelley and Mr. DeOtte are self-employed and responsible for purchas-
ing their own health insurance for themselves and their families.

32. The Contraceptive Mandate violates the Religious Freedom Restoration

Act, because it forces religious believers to choose between purchasing health insur-
ance that makes them complicit in abortifacient contraception and sexual activity out-
side of marriage, or forgoing health insurance entirely. That is a substantial burden
on the exercise of their religion. Cf. Burwell v. Hobby Lobby Stores, Inc., 134 S. Ct.
2751, 2770 (2014).
33. There is no compelling governmental interest in requiring religious believers
to subsidize other people’s contraception as a condition of purchasing health insur-
ance.
34. Even if one were to assume that the government has a compelling interest
in ensuring that women can access contraception at zero marginal cost, there are other
ways for the government to achieve that goal without burdening the religious freedom
of those who object to abortifacient contraception and sexual activity outside of mar-
riage on religious grounds.
35. The plaintiffs sue as representatives of a class of all religious believers in the
United States who object to abortifacient contraception and sexual activity outside of
marriage on religious grounds.
STATEMENT OF THE CLAIM —

HOTZE HEALTH & WELLNESS CENTER
36. The Hotze Health & Wellness Center is a Christian-owned business incor-
porated under the laws of Texas. It has approximately 75 employees. The Hotze
Health & Wellness Center is self-insured and provides health insurance to its employ-
ees.
37. Dr. Steven F. Hotze is the founder and CEO of the Hotze Health & Well-
ness Center.
38. Dr. Hotze is a Christian, and he operates his business according to Christian
principles and teaching.

39. Dr. Hotze believes that life begins at conception, and that the use of abor-
tifacient contraception is tantamount to abortion. Dr. Hotze’s beliefs on this matter
are rooted in his Christian faith, which teaches that all human life is sacred from con-
ception until natural death.
40. Dr. Hotze also believes that the Bible is the Word of God, and the Bible
teaches that any form of sexual relations outside of marriage between a man and a
woman is sinful.
41. Although Dr. Hotze’s Christian beliefs do not oppose the use of non-abor-
tifacient contraception by married couples to prevent pregnancy, Dr. Hotze never-
theless objects to the Contraceptive Mandate’s requirement that he provide non-abor-
tifacient contraception to his employees at zero marginal cost because it encourages
illicit sexual activity outside of marriage.
42. The Contraceptive Mandate violates the Religious Freedom Restoration
Act, because it forces the Hotze Health and Wellness Center to become complicit in
the provision of abortifacient contraception. It also forces the company to become
complicit in the provision of non-abortifacient contraception which is often (though
not always) used to facilitate illicit sexual activity outside of marriage. Under the Con-
traceptive Mandate, the Hotze Health and Wellness Center must either provide con-
traception to its employees, or become complicit in the provision of contraception by
others. That is a substantial burden on the exercise of its religion. See Burwell v. Hobby
Lobby Stores, Inc., 134 S. Ct. 2751, 2775–79 (2014).
43. There is no compelling governmental interest in forcing the Hotze Health

& Wellness Center and other Christian businesses to become complicit in the provi-
sion of contraception.
44. The Hotze Health & Wellness Center sues as representative of a class of all
closely held for-profit corporations in the United States that oppose the Contraceptive
Mandate for sincere religious reasons.

CAUSES OF ACTION
45. The plaintiffs are suing under the Religious Freedom Restoration Act and
the Administrative Procedure Act, each of which supplies a cause of action for the
claims that they are asserting. See 42 U.S.C. 2000bb-1(c); 5 U.S.C. § 702.
DEMAND FOR RELIEF

46. The plaintiffs respectfully request that the court:
a. certify a class of all individuals in the United States who oppose the
Contraceptive Mandate for sincere religious reasons;
b. certify a separate class of all businesses in the United States that op-
pose the Contraceptive Mandate for sincere religious reasons;
c. declare that the Contraceptive Mandate violates the plaintiffs’ rights
under the Religious Freedom Restoration Act;
d. hold unlawful and set aside any agency action that seeks to enforce
the Contraceptive Mandate without adequately accommodating the
rights of religious objectors under the Religious Freedom Restoration
Act;
e. permanently enjoin the defendants from enforcing the Contraceptive
Mandate;
f. award costs and attorneys’ fees under 42 U.S.C. § 1988;
g. award all other relief that the Court may deem just, proper, or equi-
table.

Respectfully submitted.
/s/ Jonathan F. Mitchell

Charles W. Fillmore Jonathan F. Mitchell
H. Dustin Fillmore Texas Bar No. 24075463
The Fillmore Law Firm, L.L.P. Mitchell Law PLLC
1200 Summit Avenue, Suite 860 106 East Sixth Street, Suite 900
Fort Worth, Texas 76102 Austin, Texas 78701
(817) 332-2351 (phone) (512) 686-3940 (phone)
(817) 870-1859 (fax) (512) 686-3941 (fax)
chad@fillmorefirm.com jonathan@mitchell.law
dusty@fillmorefirm.com
Counsel for Plaintiffs and
Dated: October 6, 2018 the Proposed Classes

Case 4:18-cv-00825-O Document 1-1 Filed 10/06/18 Page 1 of 2 PageID 11
Page 1331 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 300gg–13
I of Pub. L. 111–148, enacting this section and sections § 300gg–13. Coverage of preventive health serv-
300gg–12 to 300gg–15, 300gg–16 to 300gg–19, 300gg–93, and ices
300gg–94 of this title, amending former sections 300gg–11
and 300gg–12 of this title and sections 300gg–21 to (a) In general
300gg–23 of this title, and transferring section 300gg–13 A group health plan and a health insurance is-
of this title to section 300gg–9 of this title and sections
suer offering group or individual health insur-
300gg–4 to 300gg–7 of this title to sections 300gg–25 to
300gg–28 of this title, respectively] (and the amend- ance coverage shall, at a minimum provide cov-
ments made by this subtitle) shall become effective for erage for and shall not impose any cost sharing
plan years beginning on or after the date that is 6 requirements for—
months after the date of enactment of this Act [Mar. (1) evidence-based items or services that
23, 2010], except that the amendments made by sections have in effect a rating of ‘‘A’’ or ‘‘B’’ in the
1002 and 1003 [enacting sections 300gg–93 and 300gg–94 of current recommendations of the United States
this title] shall become effective for fiscal years begin- Preventive Services Task Force;
ning with fiscal year 2010.
‘‘(b) SPECIAL RULE.—The amendments made by sec-
(2) immunizations that have in effect a rec-
tions 1002 and 1003 [enacting sections 300gg–93 and ommendation from the Advisory Committee
300gg–94 of this title] shall take effect on the date of en- on Immunization Practices of the Centers for
actment of this Act [Mar. 23, 2010].’’ Disease Control and Prevention with respect
to the individual involved; and 1
§ 300gg–12. Prohibition on rescissions (3) with respect to infants, children, and ado-
A group health plan and a health insurance is- lescents, evidence-informed preventive care
suer offering group or individual health insur- and screenings provided for in the comprehen-
ance coverage shall not rescind such plan or cov- sive guidelines supported by the Health Re-
erage with respect to an enrollee once the en- sources and Services Administration.2
rollee is covered under such plan or coverage in- (4) with respect to women, such additional
volved, except that this section shall not apply preventive care and screenings not described
to a covered individual who has performed an in paragraph (1) as provided for in comprehen-
act or practice that constitutes fraud or makes sive guidelines supported by the Health Re-
an intentional misrepresentation of material sources and Services Administration for pur-
fact as prohibited by the terms of the plan or poses of this paragraph.2
coverage. Such plan or coverage may not be can- (5) for the purposes of this chapter, and for
celled except with prior notice to the enrollee, the purposes of any other provision of law, the
and only as permitted under section 300gg–2(b) 1 current recommendations of the United States
or 300gg–42(b) of this title. Preventive Service Task Force regarding
breast cancer screening, mammography, and
(July 1, 1944, ch. 373, title XXVII, § 2712, as added prevention shall be considered the most cur-
Pub. L. 111–148, title I, § 1001(5), Mar. 23, 2010, 124 rent other than those issued in or around No-
Stat. 131.) vember 2009.
REFERENCES IN TEXT
Nothing in this subsection shall be construed to
Section 300gg–2(b) of this title, referred to in text, prohibit a plan or issuer from providing cov-
was in the original a reference to section ‘‘2702(c)’’ of erage for services in addition to those rec-
act July 1, 1944, which was translated as meaning sec- ommended by United States Preventive Services
tion 2703(b) of act July 1, 1944, to reflect the probable
intent of Congress. Section 2702(c), which is classified
Task Force or to deny coverage for services that
to section 300gg–1 of this title, relates to special rules are not recommended by such Task Force.
for network plans, while section 2703(b) specifies the (b) Interval
reasons for which a health insurance issuer may (1) In general
nonrenew or discontinue health insurance coverage of-
fered in connection with a health insurance coverage The Secretary shall establish a minimum in-
offering in the group or individual market. Section terval between the date on which a recom-
300gg–2(b) also parallels section 300gg–42(b) which ap- mendation described in subsection (a)(1) or
pears in the same context in this section as the ref- (a)(2) or a guideline under subsection (a)(3) is
erence to section 300gg–2(b). issued and the plan year with respect to which
PRIOR PROVISIONS the requirement described in subsection (a) is
A prior section 300gg–12, act July 1, 1944, ch. 373, title effective with respect to the service described
XXVII, § 2712, as added Pub. L. 104–191, title I, § 102(a), in such recommendation or guideline.
Aug. 21, 1996, 110 Stat. 1964, which related to guaranteed (2) Minimum
renewability of coverage for employers in a group mar-
ket, was renumbered section 2732 of act July 1, 1944, The interval described in paragraph (1) shall
amended, and transferred to subsecs. (b) to (e) of sec- not be less than 1 year.
tion 300gg–2 of this title, by Pub. L. 111–148, title I, (c) Value-based insurance design
§§ 1001(3), 1563(c)(9), formerly § 1562(c)(9), title X,
§ 10107(b)(1), Mar. 23, 2010, 124 Stat. 130, 267, 911. The Secretary may develop guidelines to per-
Another prior section 2712 of act July 1, 1944, was suc- mit a group health plan and a health insurance
cessively renumbered by subsequent acts and trans- issuer offering group or individual health insur-
ferred, see section 238k of this title. ance coverage to utilize value-based insurance
EFFECTIVE DATE designs.
Section effective for plan years beginning on or after (July 1, 1944, ch. 373, title XXVII, § 2713, as added
the date that is 6 months after Mar. 23, 2010, see section Pub. L. 111–148, title I, § 1001(5), Mar. 23, 2010, 124
1004 of Pub. L. 111–148, set out as a note under section Stat. 131.)
300gg–11 of this title.
1 So in original. The word ‘‘and’’ probably should not appear.
1 See References in Text note below. 2 So in original. The period probably should be a semicolon.
§ 300gg–14 TITLE 42—THE PUBLIC HEALTH AND WELFARE Page 1332
PRIOR PROVISIONS explanation that accurately describes the bene-

A prior section 300gg–13, act July 1, 1944, ch. 373, title fits and coverage under the applicable plan or
XXVII, § 2713, as added Pub. L. 104–191, title I, § 102(a), coverage. In developing such standards, the Sec-
Aug. 21, 1996, 110 Stat. 1966, was renumbered section retary shall consult with the National Associa-
2709 of act July 1, 1944, and transferred to section tion of Insurance Commissioners (referred to in
300gg–9 of this title by Pub. L. 111–148, title I, §§ 1001(3), this section as the ‘‘NAIC’’), a working group
1563(c)(10)(C), formerly § 1562(c)(10)(C), title X, composed of representatives of health insurance-
§ 10107(b)(1), Mar. 23, 2010, 124 Stat. 130, 268, 911.
related consumer advocacy organizations,
Another prior section 2713 of act July 1, 1944, was suc-
cessively renumbered by subsequent acts and trans- health insurance issuers, health care profes-
ferred, see section 238l of this title. sionals, patient advocates including those rep-
resenting individuals with limited English pro-
EFFECTIVE DATE ficiency, and other qualified individuals.
Section effective for plan years beginning on or after (b) Requirements
the date that is 6 months after Mar. 23, 2010, see section
The standards for the summary of benefits and
1004 of Pub. L. 111–148, set out as a note under section
300gg–11 of this title. coverage developed under subsection (a) shall
provide for the following:
§ 300gg–14. Extension of dependent coverage (1) Appearance
(a) In general The standards shall ensure that the sum-
mary of benefits and coverage is presented in
A group health plan and a health insurance is-
a uniform format that does not exceed 4 pages
suer offering group or individual health insur-
in length and does not include print smaller
ance coverage that provides dependent coverage
than 12-point font.
of children shall continue to make such cov-
erage available for an adult child until the child (2) Language
turns 26 years of age. Nothing in this section The standards shall ensure that the sum-
shall require a health plan or a health insurance mary is presented in a culturally and linguis-
issuer described in the preceding sentence to tically appropriate manner and utilizes termi-
make coverage available for a child of a child re- nology understandable by the average plan en-
ceiving dependent coverage. rollee.
(b) Regulations (3) Contents
The Secretary shall promulgate regulations to The standards shall ensure that the sum-
define the dependents to which coverage shall be mary of benefits and coverage includes—
(A) uniform definitions of standard insur-
made available under subsection (a).
ance terms and medical terms (consistent
(c) Rule of construction with subsection (g)) so that consumers may
Nothing in this section shall be construed to compare health insurance coverage and un-
modify the definition of ‘‘dependent’’ as used in derstand the terms of coverage (or exception
title 26 with respect to the tax treatment of the to such coverage);
cost of coverage. (B) a description of the coverage, including
cost sharing for—
(July 1, 1944, ch. 373, title XXVII, § 2714, as added (i) each of the categories of the essential
Pub. L. 111–148, title I, § 1001(5), Mar. 23, 2010, 124 health benefits described in subparagraphs
Stat. 132; amended Pub. L. 111–152, title II, (A) through (J) of section 18022(b)(1) of this
§ 2301(b), Mar. 30, 2010, 124 Stat. 1082.) title; and
PRIOR PROVISIONS (ii) other benefits, as identified by the
Secretary;
A prior section 2714 of act July 1, 1944, was succes-
sively renumbered by subsequent acts and transferred, (C) the exceptions, reductions, and limita-
see section 238m of this title. tions on coverage;
(D) the cost-sharing provisions, including
AMENDMENTS deductible, coinsurance, and co-payment ob-
2010—Subsec. (a). Pub. L. 111–152 struck out ‘‘(who is ligations;
not married)’’ after ‘‘adult child’’. (E) the renewability and continuation of
coverage provisions;
EFFECTIVE DATE
(F) a coverage facts label that includes ex-
Section effective for plan years beginning on or after amples to illustrate common benefits sce-
the date that is 6 months after Mar. 23, 2010, see section narios, including pregnancy and serious or
1004 of Pub. L. 111–148, set out as a note under section chronic medical conditions and related cost
300gg–11 of this title.
sharing, such scenarios to be based on recog-
§ 300gg–15. Development and utilization of uni- nized clinical practice guidelines;
form explanation of coverage documents and (G) a statement of whether the plan or
standardized definitions coverage—
(i) provides minimum essential coverage
(a) In general (as defined under section 5000A(f) of title
Not later than 12 months after March 23, 2010, 26); and
the Secretary shall develop standards for use by (ii) ensures that the plan or coverage
a group health plan and a health insurance is- share of the total allowed costs of benefits
suer offering group or individual health insur- provided under the plan or coverage is not
ance coverage, in compiling and providing to ap- less than 60 percent of such costs;
plicants, enrollees, and policyholders or certifi- (H) a statement that the outline is a sum-
cate holders a summary of benefits and coverage mary of the policy or certificate and that
45 C.F.R. § 147.130 (a)

Coverage of preventive health services.
(a) Services —
(1) In general. Beginning at the time described in paragraph (b) of this section and subject
to §§ 147.131, 147.132, and 147.133, a group health plan, or a health insurance issuer
offering group or individual health insurance coverage, must provide coverage for and must
not impose any cost-sharing requirements (such as a copayment, coinsurance, or a
deductible) for —
(i) Evidence-based items or services that have in effect a rating of A or B in the current
recommendations of the United States Preventive Services Task Force with respect to the
individual involved (except as otherwise provided in paragraph (c) of this section);
(ii) Immunizations for routine use in children, adolescents, and adults that have in effect a
recommendation from the Advisory Committee on Immunization Practices of the Centers
for Disease Control and Prevention with respect to the individual involved (for this
purpose, a recommendation from the Advisory Committee on Immunization Practices of
the Centers for Disease Control and Prevention is considered in effect after it has been
adopted by the Director of the Centers for Disease Control and Prevention, and a
recommendation is considered to be for routine use if it is listed on the Immunization
Schedules of the Centers for Disease Control and Prevention);
(iii) With respect to infants, children, and adolescents, evidence-informed preventive care
and screenings provided for in comprehensive guidelines supported by the Health
Resources and Services Administration; and
(iv) With respect to women, such additional preventive care and screenings not described in
paragraph (a)(1)(i) of this section as provided for in comprehensive guidelines supported by
the Health Resources and Services Administration for purposes of section 2713(a)(4) of the
Public Health Service Act, subject to §§ 147.131, 147.132, and 147.133.
45 C.F.R. § 147.131
Accommodations in connection with coverage of certain preventive health services.
(a)–(b) [Reserved]
(c) Eligible organizations for optional accommodation. An eligible organization is an

organization that meets the criteria of paragraphs (c)(1) through (3) of this section.
(1) The organization is an objecting entity described in § 147.132(a)(1)(i) or (ii), or 45

CFR 147.133(a)(1)(i) or (ii).
(2) Notwithstanding its exempt status under § 147.132(a) or 147.133, the organization
voluntarily seeks to be considered an eligible organization to invoke the optional
accommodation under paragraph (d) of this section; and
(3) The organization self-certifies in the form and manner specified by the Secretary or
provides notice to the Secretary as described in paragraph (d) of this section. To qualify as
an eligible organization, the organization must make such self-certification or notice
available for examination upon request by the first day of the first plan year to which the
accommodation in paragraph (d) of this section applies. The self-certification or notice
must be executed by a person authorized to make the certification or provide the notice on
behalf of the organization, and must be maintained in a manner consistent with the record
retention requirements under section 107 of ERISA.
(4) An eligible organization may revoke its use of the accommodation process, and its
issuer must provide participants and beneficiaries written notice of such revocation as
specified in guidance issued by the Secretary of the Department of Health and Human
Services. If contraceptive coverage is currently being offered by an issuer through the
accommodation process, the revocation will be effective on the first day of the first plan
year that begins on or after 30 days after the date of the revocation (to allow for the
provision of notice to plan participants in cases where contraceptive benefits will no longer
be provided). Alternatively, an eligible organization may give 60–days notice pursuant to
section 2715(d)(4) of the PHS Act and § 147.200(b), if applicable, to revoke its use of the
accommodation process.
(d) Optional accommodation — insured group health plans —

(1) General rule. A group health plan established or maintained by an eligible organization
that provides benefits through one or more group health insurance issuers may voluntarily
elect an optional accommodation under which its health insurance issuer(s) will provide
payments for all or a subset of contraceptive services for one or more plan years. To invoke
the optional accommodation process:
(i) The eligible organization or its plan must contract with one or more health insurance
issuers.
(ii) The eligible organization must provide either a copy of the self-certification to each
issuer providing coverage in connection with the plan or a notice to the Secretary of the
Department of Health and Human Services that it is an eligible organization and of its
objection as described in § 147.132 or 147.133 to coverage for all or a subset of
contraceptive services.
(A) When a self-certification is provided directly to an issuer, the issuer has sole
responsibility for providing such coverage in accordance with § 147.130(a)(iv).
(B) When a notice is provided to the Secretary of the Department of Health and Human
Services, the notice must include the name of the eligible organization; a statement that it
objects as described in § 147.132 or 147.133 to coverage of some or all contraceptive
services (including an identification of the subset of contraceptive services to which
coverage the eligible organization objects, if applicable) but that it would like to elect the
optional accommodation process; the plan name and type (that is, whether it is a student
health insurance plan within the meaning of § 147.145(a) or a church plan within the
meaning of section 3(33) of ERISA); and the name and contact information for any of the
plan’s health insurance issuers. If there is a change in any of the information required to be
included in the notice, the eligible organization must provide updated information to the
Secretary of the Department of Health and Human Services for the optional
accommodation to remain in effect. The Department of Health and Human Services will
send a separate notification to each of the plan’s health insurance issuers informing the
issuer that the Secretary of the Deparement of Health and Human Services has received a
notice under paragraph (d)(1)(ii) of this section and describing the obligations of the issuer
under this section.
(2) If an issuer receives a copy of the self-certification from an eligible organization or the
notification from the Department of Health and Human Services as described in paragraph
(d)(1)(ii) of this section and does not have an objection as described in § 147.132 or
147.133 to providing the contraceptive services identified in the self-certification or the
notification from the Department of Health and Human Services, then the issuer will
provide payments for contraceptive services as follows —
(i) The issuer must expressly exclude contraceptive coverage from the group health
insurance coverage provided in connection with the group health plan and provide separate
payments for any contraceptive services required to be covered under § 141.130(a)(1)(iv)
for plan participants and beneficiaries for so long as they remain enrolled in the plan.
(ii) With respect to payments for contraceptive services, the issuer may not impose any cost-
sharing requirements (such as a copayment, coinsurance, or a deductible), premium, fee, or
other charge, or any portion thereof, directly or indirectly, on the eligible organization, the
group health plan, or plan participants or beneficiaries. The issuer must segregate premium
revenue collected from the eligible organization from the monies used to provide payments
for contraceptive services. The issuer must provide payments for contraceptive services in a
manner that is consistent with the requirements under sections 2706, 2709, 2711, 2713,
2719, and 2719A of the PHS Act. If the group health plan of the eligible organization
provides coverage for some but not all of any contraceptive services required to be covered
under § 147.130(a)(1)(iv), the issuer is required to provide payments only for those
contraceptive services for which the group health plan does not provide coverage.
However, the issuer may provide payments for all contraceptive services, at the issuer’s
option.
(3) A health insurance issuer may not require any documentation other than a copy of the
self-certification from the eligible organization or the notification from the Department of
Health and Human Services described in paragraph (d)(1)(ii) of this section.
(e) Notice of availability of separate payments for contraceptive services — insured group
health plans and student health insurance coverage. For each plan year to which the
optional accommodation in paragraph (d) of this section is to apply, an issuer required to
provide payments for contraceptive services pursuant to paragraph (d) of this section must
provide to plan participants and beneficiaries written notice of the availability of separate
payments for contraceptive services contemporaneous with (to the extent possible), but
separate from, any application materials distributed in connection with enrollment (or re-
enrollment) in group health coverage that is effective beginning on the first day of each
applicable plan year. The notice must specify that the eligible organization does not
administer or fund contraceptive benefits, but that the issuer provides separate payments for
contraceptive services, and must provide contact information for questions and complaints.
The following model language, or substantially similar language, may be used to satisfy the
notice requirement of this paragraph (e) “Your [employer/institution of higher education]
has certified that your [group health plan/student health insurance coverage] qualifies for
an accommodation with respect to the Federal requirement to cover all Food and Drug
Administration-approved contraceptive services for women, as prescribed by a health care
provider, without cost sharing. This means that your [employer/institution of higher
education] will not contract, arrange, pay, or refer for contraceptive coverage. Instead,
[name of health insurance issuer] will provide separate payments for contraceptive services
that you use, without cost sharing and at no other cost, for so long as you are enrolled in
your [group health plan/student health insurance coverage]. Your [employer/institution of
higher education] will not administer or fund these payments . If you have any questions
about this notice, contact [contact information for health insurance issuer].”
(f) Definition. For the purposes of this section, reference to “contraceptive” services,
benefits, or coverage includes contraceptive or sterilization items, procedures, or services,
or related patient education or counseling, to the extent specified for purposes of
§ 147.130(a)(1)(iv).
(g) Severability. Any provision of this section held to be invalid or unenforceable by its
terms, or as applied to any person or circumstance, shall be construed so as to continue to
give maximum effect to the provision permitted by law, unless such holding shall be one of
utter invalidity or unenforceability, in which event the provision shall be severable from this
section and shall not affect the remainder thereof or the application of the provision to
persons not similarly situated or to dissimilar circumstances.
45 C.F.R. § 147.132
Religious exemptions in connection with coverage of certain preventive health services.
(a) Objecting entities.
(1) Guidelines issued under § 147.130(a)(1)(iv) by the Health Resources and Services
Administration must not provide for or support the requirement of coverage or payments
for contraceptive services with respect to a group health plan established or maintained by
an objecting organization, or health insurance coverage offered or arranged by an objecting
organization, and thus the Health Resources and Service Administration will exempt from
any guidelines’ requirements that relate to the provision of contraceptive services:
(i) A group health plan and health insurance coverage provided in connection with a group
health plan to the extent the non-governmental plan sponsor objects as specified in
paragraph (a)(2) of this section. Such non-governmental plan sponsors include, but are not
limited to, the following entities —
(A) A church, an integrated auxiliary of a church, a convention or association of churches,

or a religious order.
(B) A nonprofit organization.
(C) A closely held for-profit entity.
(D) A for-profit entity that is not closely held.
(E) Any other non-governmental employer.
(ii) An institution of higher education as defined in 20 U.S.C. 1002 in its arrangement of

student health insurance coverage, to the extent that institution objects as specified in
paragraph (a)(2) of this section. In the case of student health insurance coverage, this
section is applicable in a manner comparable to its applicability to group health insurance
coverage provided in connection with a group health plan established or maintained by a
plan sponsor that is an employer, and references to “plan participants and beneficiaries” will
be interpreted as references to student enrollees and their covered dependents; and
(iii) A health insurance issuer offering group or individual insurance coverage to the extent
the issuer objects as specified in paragraph (a)(2) of this section. Where a health insurance
issuer providing group health insurance coverage is exempt under this paragraph (a)(1)(iii),
the plan remains subject to any requirement to provide coverage for contraceptive services
under Guidelines issued under § 147.130(a)(1)(iv) unless it is also exempt from that
requirement.
(2) The exemption of this paragraph (a) will apply to the extent that an entity described in
paragraph (a)(1) of this section objects to its establishing, maintaining, providing, offering,
or arranging (as applicable) coverage, payments, or a plan that provides coverage or
payments for some or all contraceptive services, based on its sincerely held religious beliefs.
(b) Objecting individuals. Guidelines issued under § 147.130(a)(1)(iv) by the Health

Resources and Services Administration must not provide for or support the requirement of
coverage or payments for contraceptive services with respect to individuals who object as
specified in this paragraph (b), and nothing in § 147.130(a)(1)(iv), 26 CFR 54.9815–
2713(a)(1)(iv), or 29 CFR 2590.715–2713(a)(1)(iv) may be construed to prevent a willing
health insurance issuer offering group or individual health insurance coverage, and as
applicable, a willing plan sponsor of a group health plan, from offering a separate benefit
package option, or a separate policy, certificate or contract of insurance, to any individual
who objects to coverage or payments for some or all contraceptive services based on
sincerely held religious beliefs.
(c) Definition. For the purposes of this section, reference to “contraceptive” services,
§ 147.130(a)(1)(iv).
(d) Severability. Any provision of this section held to be invalid or unenforceable by its
45 C.F.R. § 147.133
Moral exemptions in connection with coverage of certain preventive health services.
(a) Objecting entities.
(1) Guidelines issued under § 147.130(a)(1)(iv) by the Health Resources and Services
Administration must not provide for or support the requirement of coverage or payments
for contraceptive services with respect to a group health plan established or maintained by
an objecting organization, or health insurance coverage offered or arranged by an objecting
organization, and thus the Health Resources and Service Administration will exempt from
any guidelines’ requirements that relate to the provision of contraceptive services:
(i) A group health plan and health insurance coverage provided in connection with a group
health plan to the extent one of the following non-governmental plan sponsors object as
specified in paragraph (a)(2) of this section:
(A) A nonprofit organization; or
(B) A for-profit entity that has no publicly traded ownership interests (for this purpose, a
publicly traded ownership interest is any class of common equity securities required to be
registered under section 12 of the Securities Exchange Act of 1934);
(ii) An institution of higher education as defined in 20 U.S.C. 1002 in its arrangement of

student health insurance coverage, to the extent that institution objects as specified in
paragraph (a)(2) of this section. In the case of student health insurance coverage, this
section is applicable in a manner comparable to its applicability to group health insurance
coverage provided in connection with a group health plan established or maintained by a
plan sponsor that is an employer, and references to “plan participants and beneficiaries” will
be interpreted as references to student enrollees and their covered dependents; and
(iii) A health insurance issuer offering group or individual insurance coverage to the extent
the issuer objects as specified in paragraph (a)(2) of this section. Where a health insurance
issuer providing group health insurance coverage is exempt under paragraph (a)(1)(iii) of
this section, the group health plan established or maintained by the plan sponsor with
which the health insurance issuer contracts remains subject to any requirement to provide
coverage for contraceptive services under Guidelines issued under § 147.130(a)(1)(iv)
unless it is also exempt from that requirement.
(2) The exemption of this paragraph (a) will apply to the extent that an entity described in
paragraph (a)(1) of this section objects to its establishing, maintaining, providing, offering,
or arranging (as applicable) coverage or payments for some or all contraceptive services, or
for a plan, issuer, or third party administrator that provides or arranges such coverage or
payments, based on its sincerely held moral convictions.
(b) Objecting individuals. Guidelines issued under § 147.130(a)(1)(iv) by the Health

Resources and Services Administration must not provide for or support the requirement of
coverage or payments for contraceptive services with respect to individuals who object as
specified in this paragraph (b), and nothing in § 147.130(a)(1)(iv), 26 CFR 54.9815–
2713(a)(1)(iv), or 29 CFR 2590.715–2713(a)(1)(iv) may be construed to prevent a willing
health insurance issuer offering group or individual health insurance coverage, and as
applicable, a willing plan sponsor of a group health plan, from offering a separate policy,
certificate or contract of insurance or a separate group health plan or benefit package
option, to any individual who objects to coverage or payments for some or all contraceptive
services based on sincerely held moral convictions.
(c) Definition. For the purposes of this section, reference to “contraceptive” services,
§ 147.130(a)(1)(iv).
(d) Severability. Any provision of this section held to be invalid or unenforceable by its
29 C.F.R. § 2590.715–2713(a)
Coverage of preventive health services.
(a) Services —
(1) In general. Beginning at the time described in paragraph (b) of this section and subject
to § 2590.715–2713A, a group health plan, or a health insurance issuer offering group
health insurance coverage, must provide coverage for and must not impose any cost-sharing
requirements (such as a copayment, coinsurance, or a deductible) for —
(i) Evidence-based items or services that have in effect a rating of A or B in the current
recommendations of the United States Preventive Services Task Force with respect to the
individual involved (except as otherwise provided in paragraph (c) of this section);
(ii) Immunizations for routine use in children, adolescents, and adults that have in effect a
recommendation from the Advisory Committee on Immunization Practices of the Centers
for Disease Control and Prevention with respect to the individual involved (for this
purpose, a recommendation from the Advisory Committee on Immunization Practices of
the Centers for Disease Control and Prevention is considered in effect after it has been
adopted by the Director of the Centers for Disease Control and Prevention, and a
recommendation is considered to be for routine use if it is listed on the Immunization
Schedules of the Centers for Disease Control and Prevention);
(iii) With respect to infants, children, and adolescents, evidence-informed preventive care
and screenings provided for in comprehensive guidelines supported by the Health
Resources and Services Administration; and
paragraph (a)(1)(i) of this section as provided for in comprehensive guidelines supported by
the Health Resources and Services Administration for purposes of section 2713(a)(4) of the
Public Health Service Act, subject to 45 CFR 147.131, 147.132, and 147.133.
26 C.F.R. § 54.9815–2713T
Coverage of preventive health services (temporary).
(a) Services — (1) In general. Beginning at the time described in paragraph (b) of
§ 54.9815–2713 and subject to § 54.9815–2713A, a group health plan, or a health
insurance issuer offering group health insurance coverage, must provide coverage for and
must not impose any cost-sharing requirements (such as a copayment, coinsurance, or a
deductible) for —
(i)–(iii) [Reserved]. For further guidance, see § 54.9815–2713(a)(1)(i) through (iii).
paragraph (a)(1)(i) of § 54.9815–2713 as provided for in comprehensive guidelines
supported by the Health Resources and Services Administration for purposes of section
2713(a)(4) of the Public Health Service Act, subject to 45 CFR 147.131, 147.132, and
147.133.
Vol. 78 Tuesday,
No. 127 July 2, 2013
Part III
Department of the Treasury
Internal Revenue Service
26 CFR Part 54
Department of Labor
Employee Benefits Security Administration
29 CFR Parts 2510 and 2590
Department of Health and Human Services

45 CFR Parts 147 and 156
Coverage of Certain Preventive Services Under the Affordable Care Act;
Final Rules
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Rules and 31 PageID 25
DEPARTMENT OF THE TREASURY accommodations with respect to the part A of title XXVII of the Public
contraceptive coverage requirement for Health Service Act (PHS Act) relating to
Internal Revenue Service group health plans established or group health plans and health insurance
maintained by eligible organizations issuers in the group and individual
26 CFR Part 54 (and group health insurance coverage markets. The Affordable Care Act adds
[TD–9624] provided in connection with such section 715(a)(1) to the Employee
plans), as well as student health Retirement Income Security Act of 1974
RIN 1545–BJ60 insurance coverage arranged by eligible (ERISA) and section 9815(a)(1) to the
organizations that are institutions of Internal Revenue Code (Code) to
DEPARTMENT OF LABOR higher education. These regulations also incorporate the provisions of part A of
finalize related amendments to title XXVII of the PHS Act into ERISA
Employee Benefits Security regulations concerning Affordable and the Code, and to make them
Administration Insurance Exchanges. applicable to group health plans and
DATES: Effective date: These final health insurance issuers providing
29 CFR Parts 2510 and 2590 health insurance coverage in connection
regulations are effective on August 1,
RIN 1210–AB44 2013. Applicability date: With the with group health plans. The sections of
exception of the amendments to the the PHS Act incorporated into ERISA
DEPARTMENT OF HEALTH AND religious employer exemption, which and the Code are sections 2701 through
HUMAN SERVICES apply to group health plans and health 2728.
insurance issuers for plan years Section 2713(a)(4) of the PHS Act, as
45 CFR Parts 147 and 156 beginning on or after August 1, 2013, added by the Affordable Care Act and
these final regulations apply to group incorporated into ERISA and the Code,
[CMS–9968–F] requires that non-grandfathered group
health plans and health insurance
RIN 0938–AR42 health plans and health insurance
issuers for plan years beginning on or
issuers offering non-grandfathered
after January 1, 2014.
Coverage of Certain Preventive group or individual health insurance
Services Under the Affordable Care FOR FURTHER INFORMATION CONTACT: For coverage provide benefits for certain
Act inquiries related to the religious women’s preventive health services
employer exemption and eligible without cost sharing, as provided for in
AGENCIES: Internal Revenue Service, organization accommodations: Jacob comprehensive guidelines supported by
Department of the Treasury; Employee Ackerman, Centers for Medicare & the Health Resources and Services
Benefits Security Administration, Medicaid Services (CMS), Department Administration (HRSA). On August 1,
Department of Labor; Centers for of Health and Human Services (HHS), at 2011, HRSA adopted and released
Medicare & Medicaid Services, (410) 786–1565; Amy Turner or Beth guidelines for women’s preventive
Department of Health and Human Baum, Employee Benefits Security health services (HRSA Guidelines)
Services. Administration (EBSA), Department of based on recommendations of the
ACTION: Final rules. Labor, at (202) 693–8335; Karen Levin, independent Institute of Medicine. As
Internal Revenue Service (IRS), relevant here, the HRSA Guidelines
SUMMARY: This document contains final Department of the Treasury, at (202) include all Food and Drug
regulations regarding coverage of certain 927–9639. Administration (FDA)-approved
preventive services under section 2713 For matters related to the Federally- contraceptive methods, sterilization
of the Public Health Service Act (PHS facilitated Exchange user fee procedures, and patient education and
Act), added by the Patient Protection adjustment: Ariel Novick, CMS, HHS, at counseling for women with
and Affordable Care Act, as amended, (301) 492–4309. reproductive capacity, as prescribed by
and incorporated into the Employee Customer Service Information: a health care provider (collectively,
Retirement Income Security Act of 1974 Individuals interested in obtaining contraceptive services).1 Except as
and the Internal Revenue Code. Section information from the Department of discussed later in this section, non-
2713 of the PHS Act requires coverage Labor concerning employment-based grandfathered group health plans and
without cost sharing of certain health coverage laws may call the EBSA health insurance coverage are required
preventive health services by non- Toll-Free Hotline at 1–866–444–EBSA to provide coverage consistent with the
grandfathered group health plans and (3272) or visit the Department of Labor’s HRSA Guidelines without cost sharing
health insurance coverage. Among these Web site (www.dol.gov/ebsa). for plan years (in the individual market,
services are women’s preventive health Information from HHS on private health policy years) beginning on or after
services, as specified in guidelines insurance coverage can be found on August 1, 2012.2
supported by the Health Resources and CMS’s Web site (www.cms.gov/cciio), Interim final regulations
Services Administration (HRSA). As and information on health care reform implementing section 2713 of the PHS
authorized by the current regulations, can be found at www.HealthCare.gov. Act were published on July 19, 2010 (75
and consistent with the HRSA SUPPLEMENTARY INFORMATION: FR 41726) (2010 interim final
guidelines, group health plans
established or maintained by certain I. Background 1 The HRSA Guidelines exclude services relating
religious employers (and group health The Patient Protection and Affordable to a man’s reproductive capacity, such as
insurance coverage provided in Care Act (Pub. L. 111–148) was enacted vasectomies and condoms.
2 Interim final regulations published by the

connection with such plans) are exempt on March 23, 2010. The Health Care and Departments on July 19, 2010, generally provide
from the otherwise applicable Education Reconciliation Act of 2010 that plans and issuers must cover a newly
requirement to cover certain (Pub. L. 111–152) was enacted on March recommended preventive service starting with the
contraceptive services. These final 30, 2010. These statutes are collectively first plan year (in the individual market, policy
year) that begins on or after the date that is one year
regulations simplify and clarify the known as the Affordable Care Act. The after the date on which the new recommendation
religious employer exemption. These Affordable Care Act reorganizes, is issued. 26 CFR 54.9815–2713T(b)(1); 29 CFR
final regulations also establish amends, and adds to the provisions of 2590.715–2713(b)(1); 45 CFR 147.130(b)(1).
CaseFederal
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regulations). On August 1, 2011, the temporary enforcement safe harbor student health insurance coverage
Departments of Health and Human would remain in effect until the first arranged by eligible organizations that
Services (HHS), Labor, and the Treasury plan year beginning on or after August are institutions of higher education.
(collectively, the Departments) amended 1, 2013. The Departments committed to In the case of a self-insured group
the 2010 interim final regulations to rulemaking during the 1-year safe health plan established or maintained
provide HRSA with authority that harbor period to ensure more women by an eligible organization, the
would effectively exempt group health broad access to recommended proposed regulations presented
plans established or maintained by preventive services, including potential approaches under which the
certain religious employers (and group contraceptive services, without cost third party administrator of the plan
health insurance coverage provided in sharing, while simultaneously would arrange for a health insurance
connection with such plans) from the protecting certain additional nonprofit issuer to provide contraceptive coverage
requirement to cover contraceptive religious organizations with religious to plan participants and beneficiaries
services consistent with the HRSA objections to contraceptive coverage without cost sharing, premium, fee, or
Guidelines (76 FR 46621) (2011 from having to contract, arrange, pay, or other charge to plan participants or
amended interim final regulations), and, refer for such coverage. beneficiaries or to the eligible
on the same date, HRSA exercised this On March 21, 2012, the Departments organization or its plan. An issuer (or its
authority in the HRSA Guidelines such published an advance notice of affiliate) would be able to offset the
that group health plans established or proposed rulemaking (ANPRM) that costs incurred by the third party
maintained by these religious employers described and solicited comments on administrator and the issuer in the
(and group health insurance coverage possible approaches to achieve these course of arranging and providing such
provided in connection with such goals (77 FR 16501). coverage by claiming an adjustment in
plans) are exempt from the requirement On February 6, 2013, following the Federally-facilitated Exchange (FFE)
to cover contraceptive services.3 The review of the comments on the ANPRM, user fee.
2011 amended interim final regulations the Departments published proposed The Departments received over
specified that, for purposes of this regulations at 78 FR 8456 (proposed 400,000 comments (many of them
exemption, a religious employer is one regulations). The regulations proposed standardized form letters) in response to
that: (1) Has the inculcation of religious to simplify and clarify the definition of the proposed regulations. After
values as its purpose; (2) primarily religious employer for purposes of the consideration of the comments, the
employs persons who share its religious religious employer exemption. The Departments are publishing these final
tenets; (3) primarily serves persons who regulations also proposed regulations. With the exception of the
share its religious tenets; and (4) is a accommodations for health coverage amendments to the religious employer
nonprofit organization described in established or maintained or arranged exemption, which apply to group health
section 6033(a)(1) and (a)(3)(A)(i) or (iii) by certain nonprofit religious
plans and group health insurance
of the Code. Section 6033(a)(3)(A)(i) and organizations with religious objections
issuers for plan years beginning on or
(iii) of the Code refers to churches, their to contraceptive coverage. These
after August 1, 2013, these final
integrated auxiliaries, and conventions organizations were referred to as eligible
regulations apply to group health plans
or associations of churches, as well as organizations.
and health insurance issuers for plan
to the exclusively religious activities of The regulations proposed that, in the
years beginning on or after January 1,
any religious order. Final regulations case of an insured group health plan
2014, which is when the majority of
issued on February 10, 2012, adopted established or maintained by an eligible
plan years begin.6 7 Contemporaneously
the definition of religious employer in organization, the health insurance issuer
providing group health insurance issued amendments to the HRSA
the 2011 amended interim final Guidelines implementing the simplified
regulations without modification (2012 coverage in connection with the plan
would be required to assume sole and clarified religious employer
final regulations).4 exemption authorized by 45 CFR
Contemporaneous with the issuance responsibility, independent of the
eligible organization and its plan, for 147.131(a) of these final regulations will
of the 2012 final regulations, HHS, with
providing contraceptive coverage to be effective on August 1, 2013.
the agreement of the Departments of
Labor and the Treasury, issued guidance plan participants and beneficiaries
6 Section 2713(b) of the PHS Act and the
establishing a temporary safe harbor without cost sharing, premium, fee, or companion provisions of ERISA and the Code
from enforcement of the contraceptive other charge to plan participants or provide that the Secretary shall establish an interval
coverage requirement by the beneficiaries or to the eligible of not less than one year between when new
Departments for group health plans organization or its plan. The recommendations or guidelines under PHS Act
established or maintained by certain section 2713(a) are issued and the first plan year (in
Departments proposed a comparable the individual market, policy year) for which
nonprofit organizations with religious accommodation with respect to insured coverage of services addressed in such
objections to contraceptive coverage recommendations or guidelines must be in effect.
(and group health insurance coverage Section 9815(a)(1) of the Internal Revenue Code, Under the 2010 interim final regulations, the
provided in connection with such issued on February 10, 2012, and reissued on requirement on a non-exempt, non-grandfathered
August 15, 2012. Available at: http://www.cms.gov/ group health plan or group or individual health
plans).5 The guidance provided that the CCIIO/Resources/Files/Downloads/prev-services- insurance policy to cover a newly recommended
guidance-08152012.pdf. The guidance, as reissued preventive service without cost sharing takes effect
3 The 2011 amended interim final regulations
on August 15, 2012, clarifies, among other things, starting with the first plan year (in the individual
were issued and effective on August 1, 2011, and that plans that took some action before February 10, market, policy year) that begins on or after the date
published on August 3, 2011(76 FR 46621). 2012, to try, without success, to exclude or limit that is one year after the new recommendation is
4 The 2012 final regulations were published on contraceptive coverage are not precluded from issued. 26 CFR 54.9815–2713T(b)(1); 29 CFR
February 15, 2012 (77 FR 8725). eligibility for the safe harbor. The temporary 2590.715–2713(b)(1); 45 CFR 147.130(b)(1). In the
5 Guidance on the Temporary Enforcement Safe enforcement safe harbor is also available to insured case of contraceptive services, this 1-year period
Harbor for Certain Employers, Group Health Plans, student health insurance coverage arranged by ended on August 1, 2012, because the HRSA
and Group Health Insurance Issuers with Respect to nonprofit institutions of higher education with Guidelines including such services were issued on
the Requirement to Cover Contraceptive Services religious objections to contraceptive coverage that August 1, 2011. These final regulations do not alter
Without Cost Sharing Under Section 2713 of the meet the conditions set forth in the guidance. See this effective date.
Public Health Service Act, Section 715(a)(1) of the final rule entitled ‘‘Student Health Insurance 7 This estimate is based on the Department of
Employee Retirement Income Security Act, and Coverage’’ published March 21, 2012 (77 FR 16457). Labor’s analysis of Form 5500 data.
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Two additional guidance documents treatment earlier.8 Further, Congress, by also have medical benefits for women
are being issued contemporaneously amending the Affordable Care Act who are contraindicated for pregnancy,
with these final regulations. First, HHS during Senate consideration of the bill and there are demonstrated preventive
is issuing guidance extending the to ensure that recommended preventive health benefits from contraceptives
temporary safe harbor from enforcement services for women would be covered relating to conditions other than
of the contraceptive coverage adequately by non-grandfathered group pregnancy (for example, prevention of
requirement by the Departments to health plans and health insurance certain cancers, menstrual disorders,
encompass plan years beginning on or coverage, recognized that women have and acne).13 In addition, by reducing the
after August 1, 2013, and before January unique health care needs.9 Such needs number of unintended pregnancies,
1, 2014. This guidance continues to include contraceptive services.10 contraceptives reduce the number of
include a form to be used by an Some commenters asserted that women seeking abortions.14 It is for a
organization during this temporary contraceptive services should not be woman and her health care provider in
period to self-certify that its plan considered preventive health services, each particular case to weigh any risks
qualifies for the temporary enforcement arguing that they do not prevent disease against the benefits in deciding whether
safe harbor. Second, as described in and have been shown by some studies to use contraceptive services in general
more detail later in this preamble, HHS to be harmful to women’s health. The or any particular contraceptive service.
and DOL are also issuing a self- HRSA Guidelines are based on Covering contraceptives also yields
certification form to be executed by an recommendations of the independent significant cost savings. A 2000 study
organization seeking to be treated as an Institute of Medicine (IOM), which estimated that it would cost 15 to 17
eligible organization for purposes of an undertook a review of the scientific and percent more not to provide
medical evidence on women’s contraceptive coverage in employee
accommodation under these final
preventive services. As documented in health plans than to provide such
regulations. This self-certification form
the IOM report, ‘‘Clinical Preventive coverage, after accounting for both the
is applicable in conjunction with the
Services for Women: Closing the Gaps,’’ direct medical costs of pregnancy and
accommodations under these final
women experiencing an unintended the indirect costs, such as employee
regulations (that is, for plan years pregnancy may not immediately be absence.15 Consistent with this finding,
beginning on or after January 1, 2014), aware that they are pregnant, and thus when contraceptive coverage was added
after the expiration of the temporary delay prenatal care. They also may be to the Federal Employees Health
enforcement safe harbor. less motivated to cease behaviors during Benefits Program, premiums did not
II. Overview of the Final Regulations pregnancy, such as smoking and increase because there was no resulting
consumption of alcohol, that pose net health care cost increase.16 Specific
These final regulations promote two pregnancy-related risks. Studies show a to public financing of contraceptive
important policy goals. First, the greater risk of preterm birth and low services, a 2010 analysis projected that
regulations provide women with access birth weight among unintended expanding access to family planning
to contraceptive coverage without cost pregnancies.11 In addition, services under Medicaid saves $4.26 for
sharing, thereby advancing the contraceptive use helps women improve every $1 spent.17 Additional research
compelling government interests in birth spacing and therefore avoid the
safeguarding public health and ensuring increased risk of adverse pregnancy 89:S25–S33 (2005); Fuentes-Afflick, E., & Hessol,
that women have equal access to health outcomes that comes with pregnancies N., Interpregnancy Interval and the Risk of
Premature Infants, Obstetrics & Gynecology,
care. Second, the regulations advance that are too closely spaced. Short 95(3):383–390 (2000).
these interests in a narrowly tailored interpregnancy intervals in particular 13 Institute of Medicine, Clinical Preventive
fashion that protects certain nonprofit have been associated with low birth Services for Women: Closing the Gaps, Washington,
religious organizations with religious weight, prematurity, and small-for- DC: National Academy Press, 2011, at p. 107.
14 Institute of Medicine, Clinical Preventive
objections to providing contraceptive gestational age births.12 Contraceptives
Services for Women: Closing the Gaps, Washington,
coverage from having to contract, DC: National Academy Press, 2011, at p. 105. See
8 Institute of Medicine, Clinical Preventive
arrange, pay, or refer for such coverage. also, Peipert, J., et al., Preventing Unintended
Services for Women: Closing the Gaps, Washington, Pregnancies by Providing No-Cost Contraception,
The regulations finalize the general DC: National Academy Press, 2011, at p. 16. Obstetrics & Gynecology, 120(6): 1291–1297 (2012);
approach described in the proposed 9 S.Amdt. 2791 to S.Amdt. 2786 to H.R. 3590
see also Bongaarts, J., & Westoff, C., The Potential
regulations, with modifications in (Service Members Home Ownership Tax Act of Role of Contraception in Reducing Abortion,
response to comments that are intended 2009), December 3, 2009. Studies in Family Planning, 31(3): 193–202 (2000).
10 Institute of Medicine, Clinical Preventive 15 Testimony of Guttmacher Inst., submitted to
primarily to simplify administration of
Services for Women: Closing the Gaps, Washington. the Comm. on Preventive Servs. for Women,
the policy. DC: National Academy. Press, 2011, at p. 9; see also Institute of Medicine, January 12, 2012, p. 11, citing
Section 2713 of the PHS Act reflects Sonfield, A., The Case for Insurance Coverage of Bonoan, R. & Gonen, J.S., Promoting Healthy
Contraceptive Services and Supplies Without Cost Pregnancies: Counseling and Contraception as the
a determination by Congress that Sharing, 14 Guttmacher Policy Review. 10 (2011), First Step, Washington Business Group on Health,
coverage of recommended preventive available at www.guttmacher.org/pubs/gpr/14/1/ Family Health in Brief, Issue No. 3. August 2000;
services without cost sharing by non- gpr140107.html. See also Congressional Record, see also Sonfield, A., The Case for Insurance
grandfathered group health plans and S12025 (Dec. 1, 2009), S12114, S12271, S12277 Coverage of Contraceptive Services and Supplies
(December 3, 2009) (statements of Senators B. Without Cost Sharing, 14 Guttmacher Pol’y Rev. 10
health insurance coverage is necessary Boxer, D. Feinstein, A. Franken, and B. Nelson, (2011); Mavranezouli, I., Health Economics of
to achieve access to basic health care for respectively). Contraception, 23 Best Practice & Res. Clinical
more Americans. Individuals are more 11 Gipson, J.D., et al., The Effects of Unintended Obstetrics & Gynecology 187–198 (2009); Trussell,
likely to use preventive services if they Pregnancy on Infant, Child and Parental Health: A J., et al., Cost Effectiveness of Contraceptives in the
Review of the Literature, Studies on Family United States, 79 Contraception 5–14 (2009);
do not have to satisfy cost-sharing Trussell, J., The Cost of Unintended Pregnancy in
Planning, 2008, 39(1):18–38.
requirements (such as a copayment, 12 Conde-Aguledo, A., et al., Birth Spacing and the United States, 75 Contraception 168–170 (2007).
coinsurance, or a deductible). Use of Risk of Adverse Perinatal Outcomes—A Meta- 16 Dailard, C., Special Analysis: The Cost of
preventive services results in a healthier Analysis, Journal of the American Medical Contraceptive Insurance Coverage, Guttmacher Rep.
population and reduces health care Association, 295(15):1809–1823 (2006); see also on Public Policy (March 2003).
Zhu, B., Effect of Interpregnancy Interval on Birth 17 Sawhill, R., et al., An Ounce of Prevention:
costs by helping individuals avoid Outcomes: Findings from Recent U.S. Studies, Policy Prescriptions to Reduce the Prevalence of
preventable conditions and receive International Journal of Gynecology & Obstetrics, Fragile Families, Future of Children, 20(2):133–155.
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arrived at a similar conclusion and Research also shows that cost sharing coverage for recommended preventive
found that, in total, services provided at can be a significant barrier to access to services without cost sharing.
publicly funded family planning centers contraception.23 As IOM noted, women Accordingly, consistent with the general
saved $5.1 billion in 2008.18 use preventive services more than men, rules for the provision of coverage for
Further, the importance of covering generating significant out-of-pocket recommended preventive services
contraceptive services has been expenses for women.24 Thus, without cost sharing set forth in the
recognized by many states, issuers, and eliminating cost sharing is particularly 2010 interim final regulations, nothing
employers. Twenty-eight states now critical to addressing the gender prevents a plan or issuer from using
have laws requiring health insurance disparity of concern here. reasonable medical management
issuers to cover contraceptives.19 A The Departments aim to advance techniques to determine the frequency,
2002 study found that more than 89 these compelling public health and method, treatment, or setting for an item
percent of insured plans covered gender equity interests by providing or service to the extent not specified in
contraceptives.20 And a 2010 survey of more women broad access to a recommendation or guideline and
employers revealed that 85 percent of recommended preventive services, nothing requires a plan or issuer that
large employers and 62 percent of small including contraceptive services, has a network of health care providers
employers offered coverage of FDA- without cost sharing, while to provide benefits or eliminate cost
approved contraceptives, with another simultaneously protecting certain sharing for items or services that are
32 percent of small employers reporting nonprofit religious organizations with delivered out-of-network.25
that they did not know whether they did religious objections to contraceptive
so.21 B. Religious Employer Exemption and
coverage from having to contract, Accommodations for Health Coverage
Furthermore, in directing non- arrange, pay, or refer for such coverage,
grandfathered group health plans and Established or Maintained or Arranged
as described in these final regulations. by Eligible Organizations—26 CFR
health insurance coverage to cover Moreover, through these final
preventive services and screenings for 54.9815–2713A, 29 CFR 2590.715–
regulations, the Departments seek to 2713A, 45 CFR 147.131
women described in HRSA Guidelines achieve these goals in ways that take
without cost sharing, the statute into account the responsibilities These sections of the final regulations
acknowledges that both existing health imposed on health insurance issuers simplify and clarify the criteria for the
coverage and existing preventive and third party administrators. religious employer exemption from the
services recommendations often did not contraceptive coverage requirement.
adequately serve the unique health A. Amendments to Coverage of These sections also establish
needs of women. This disparity placed Recommended Preventive Health accommodations with respect to the
women in the workforce at a Services—26 CFR 54.9815–2713, 29 CFR contraceptive coverage requirement for
disadvantage compared to their male 2590.715–2713, 45 CFR 147.130 group health plans established or
coworkers. Research shows that access These sections of the final regulations maintained by eligible organizations
to contraception improves the social finalize technical amendments to the (and group health insurance coverage
and economic status of women.22 existing preventive services coverage provided in connection with such
regulations as proposed. The final plans), as well as student health
18 Frost, J., et al., Contraceptive Needs and
regulations amend paragraph (a) of the insurance coverage arranged by eligible
Services, National and State Data, 2008 Update,
New York: Guttmacher Institute (2010). existing regulations so that the general organizations that are institutions of
19 Sonfield, A., et al., U.S. Insurance Coverage of requirement to provide coverage for higher education.
Contraceptives and the Impact of Contraceptive recommended preventive services
Coverage Mandates, Perspectives on Sexual and
1. Religious Employer Exemption
Reproductive Health 36(2):72–79, 2002.
without cost sharing is subject to the
religious employer exemption and Under the 2012 final regulations,
20 Sonfield, A., et al., U.S. Insurance Coverage of
eligible organization accommodations HRSA has the authority to issue
Contraceptives and the Impact of Contraceptive
Coverage Mandates, Perspectives on Sexual and discussed later in this section. guidelines in a manner that exempts
Reproductive Health 36(2):72–79, 2002. The regulations also finalize proposed group health plans established or
21 Claxton, G., et al., Employer Health Benefits:
amendments to paragraph (a)(1)(iv) of maintained by religious employers (and
2010 Annual Survey, Menlo Park, Cal.: Kaiser group health insurance coverage
Family Found. & Chicago, Illinois: Health Research the existing regulations. As amended,
& Education Trust, 2010. While many employers the authorization for HRSA to exempt provided in connection with such
included contraceptive coverage in their group religious employers from the plans) from any requirement to cover
health plans prior to the Affordable Care Act, the
contraceptive coverage requirement and contraceptive services consistent with
Departments note that the contraceptive coverage the HRSA Guidelines that would
requirement promotes the government’s interests the definition of religious employer are
with respect to even these plans’ participants and now located in new 45 CFR 147.131(a) otherwise apply. A religious employer
beneficiaries by ensuring that these plans cover of the HHS regulation and incorporated was defined for this purpose as one that:
contraceptive services without cost sharing, a
by reference in the regulations of the (1) Has the inculcation of religious
significant financial barrier to such services that values as its purpose; (2) primarily
was prevalent before the contraceptive coverage Departments of Labor and the Treasury.
requirement. Institute of Medicine, Clinical There are no other changes to the employs persons who share its religious
Preventive Services for Women: Closing the Gaps, provisions of the 2010 interim final tenets; (3) primarily serves persons who
Washington, DC: National Academy Press, 2011, at
p. 107. See also Postlethwaite, D., et al., A
regulations related to providing 25 See 26 CFR 54.9815–2713T(a)(3) and (4); 29
Comparison of Contraceptive Procurement Pre- and CFR 2590.715–2713(a)(3) and (4); 45 CFR
Post-Benefit Change, 76 Contraception 360 (2007). Power to the Pill: The Impact of Contraceptive 147.130(a)(3) and (4). Note, however, if a plan or
22 Testimony of Guttmacher Institute, submitted Freedom on Women’s Life Cycle Labor Supply, issuer does not have in its network a provider who
to the Comm. on Preventive Services for Women, Quarterly Journal of Economics, 2006, 121(1):289– can provide the particular service, then the plan or
Institute of Medicine, January 12, 2012, p. 6, citing 320. issuer must cover the item or service when
23 Postlethwaite, D., et al., A Comparison of
Goldin, C. & Katz, L., Career and Marriage in the performed by an out-of-network provider and not
Age of the Pill, American Economic Review, 2000, Contraceptive Procurement Pre- and Post-Benefit impose cost sharing with respect to the item or
90(2):461–465; Goldin, C. & Katz, L.F., The Power Change, 76 Contraception 360 (2007). service. See FAQs About Affordable Care Act
of the Pill: Oral Contraceptives and Women’s Career 24 Institute of Medicine, Clinical Preventive Implementation (Part XII), Q3 (February 20, 2013),
and Marriage Decisions, Journal of Political Services for Women: Closing the Gaps, Washington, available at: http://www.dol.gov/ebsa/faqs/faq-
Economy, 2002, 110(4):730–770; Bailey, M.J., More DC: National Academy Press, 2011, p. 19. aca12.html.
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share its religious tenets; and (4) is a commenters recommended that the guidelines will become effective
nonprofit organization described in requirement to cover contraceptive beginning August 1, 2013.
section 6033(a)(1) and 6033(a)(3)(A)(i) services be rescinded altogether.
2. Accommodations for Health Coverage
or (iii) of the Code. Section Some commenters stated that the Established or Maintained or Arranged
6033(a)(3)(A)(i) and (iii) of the Code exemption for religious employers by Eligible Organizations
refers to churches, their integrated should be eliminated and that religious
auxiliaries, and conventions or employers should instead be subject to In addition to simplifying and
associations of churches, as well as to the accommodations for eligible clarifying the definition of religious
the exclusively religious activities of organizations so that their employees employer, these final regulations
any religious order. may also receive alternative establish accommodations with respect
The Departments proposed to contraceptive coverage without cost to the contraceptive coverage
simplify and clarify the definition of sharing. Other commenters opposed requirement for health coverage
religious employer by eliminating the eliminating the first three prongs of the established or maintained or arranged
first three prongs and clarifying the definition of religious employer, stating by eligible organizations, as defined in
fourth prong of the definition. Under that only churches and other houses of these final regulations. After meeting a
this proposal, an employer that is worship that meet the criteria of all of self-certification standard, as described
organized and operates as a nonprofit the prongs should be subject to the in more detail in this preamble,
entity and is referred to in section exemption. Many commenters agreed nonprofit religious organizations that
6033(a)(3)(A)(i) or (iii) of the Code with the Departments that the proposed qualify for these accommodations are
would be considered a religious definition of religious employer would not required to contract, arrange, pay, or
employer for purposes of the religious not materially expand the universe of refer for contraceptive coverage;
employer exemption. These proposed however, plan participants and
religious employers, but others felt that
amendments were intended to eliminate beneficiaries (or student enrollees and
the proposed definition would unduly
any question as to whether group health their covered dependents) will still
broaden it.
plans of houses of worship that provide benefit from separate payments for
Based on their review of these contraceptive services without cost
educational, charitable, or social comments, the Departments are
services to their communities qualify for sharing or other charge in accordance
finalizing without change the definition with section 2713 of the PHS Act and
the exemption. Specifically, they were of religious employer in the proposed
intended to ensure that an otherwise the companion provisions of ERISA and
regulations. As indicated in the the Code. As discussed later in this
exempt plan is not disqualified because preamble to the proposed regulations
the employer’s purposes extend beyond section, the accommodations
(78 FR 8461), the simplified and established under these final regulations
the inculcation of religious values or clarified definition of religious
because the employer hires or serves do not require the issuance of a separate
employer does not expand the universe excepted benefits individual health
people of different religious faiths. The of religious employers that qualify for
Departments also proposed to clarify insurance policy covering contraceptive
the exemption beyond that which was services, as set forth in the proposed
that, for purposes of the religious intended in the 2012 final regulations,
employer exemption, an employer that regulations, but instead require a
but only eliminates any perceived simpler method of providing direct
is organized and operates as a nonprofit potential disincentive for religious
entity is not limited to any particular payments for contraceptive services.
employers to provide educational,
form of entity under state law. The charitable, and social services to their a. Definition of Eligible Organization
Departments reiterate that, under this communities. The Departments believe The final regulations retain the
standard, it is not necessary to that the simplified and clarified definition of eligible organization set
determine the federal tax-exempt status definition of religious employer forth in the proposed regulations.
of the nonprofit entity in determining continues to respect the religious Accordingly, under these final
whether the religious employer interests of houses of worship and their regulations, an eligible organization is
exemption applies.26 integrated auxiliaries in a way that does an organization that: (1) Opposes
The Departments received numerous not undermine the governmental providing coverage for some or all of the
comments addressing the definition of interests furthered by the contraceptive contraceptive services required to be
religious employer. Some commenters coverage requirement. Houses of covered under section 2713 of the PHS
stated that the proposed definition of worship and their integrated auxiliaries Act and the companion provisions of
religious employer was too narrow and that object to contraceptive coverage on ERISA and the Code on account of
should be broadened to include all religious grounds are more likely than religious objections; (2) is organized and
employers, both nonprofit and for- other employers to employ people of the operates as a nonprofit entity; (3) holds
profit, that have a religious objection to same faith who share the same itself out as a religious organization; and
providing contraceptive coverage in objection, and who would therefore be (4) self-certifies that it satisfies the first
their group health plan. Some less likely than other people to use three criteria (as discussed in more
commenters requested that the contraceptive services even if such detail later in this section).
definition of religious employer be services were covered under their plan. Some commenters requested that the
expanded to exempt not only churches Contemporaneous with the issuance definition of eligible organization be
and other houses of worship, but also of these final regulations, HRSA is broadened to include nonprofit secular
religiously affiliated hospitals and other issuing amended guidelines employers and for-profit employers with
health care organizations and other implementing the simplified and religious objections to contraceptive
religiously affiliated ministries using the clarified religious employer exemption coverage. Other commenters urged that
concepts of Code section 414(e). Other authorized by 45 CFR 147.131(a) of the definition not be extended to for-
26 Similarly, whether a nonprofit entity is a
these final regulations (and incorporated profit employers, arguing that for-profit
religious employer is determined under this
by reference in 26 CFR 54.9815– employers should not be accommodated
definition without regard to whether the entity files 2713(a)(1)(iv) and 29 CFR 2590.715– because their purposes are commercial,
Form 990 with the IRS. 2713(a)(1)(iv)). The amendments to the not religious. Additionally, several
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commenters recommended clarifying making such records available to the enforcement safe harbor, which is also
how an eligible organization would public. Other commenters argued that being issued contemporaneously with
show that it holds itself out as a the act of self-certification would these final regulations.
religious organization. Specifically, infringe on the First Amendment right
c. Separate Payments for Contraceptive
commenters suggested clarifying that of free speech.
The final regulations do not require Services for Participants and
only organizations that prominently and
the self-certification to be submitted to Beneficiaries in Insured Group Health
consistently hold themselves out to the
any of the Departments. An eligible Plans
public as religious organizations may
qualify for an accommodation. organization must simply maintain the The proposed regulations provided, in
The Departments decline to adopt self-certification (executed by an the case of an insured group health plan
these suggestions. The definition of authorized representative of the established or maintained by an eligible
eligible organization in these final organization) in its records, in a manner organization, that the health insurance
regulations is the same as that in the consistent with the record retention issuer providing group coverage in
proposed regulations, and is intended to requirements under section 107 of connection with the plan be required to
allow health coverage established or ERISA, and make the self-certification assume sole responsibility, independent
maintained or arranged by various types available for examination upon request. of the eligible organization and its plan,
of nonprofit religious organizations with The Departments believe that the for providing separate individual health
religious objections to contraceptive requirement to make the self- insurance policies covering
coverage to qualify for an certification available for examination contraceptive services for plan
accommodation. Consistent with upon request appropriately balances participants and beneficiaries without
religious accommodations in related regulators’, issuers’, third party cost sharing, premium, fee, or other
areas of federal law, such as the administrators’, and plan participants charge to plan participants or
exemption for religious organizations and beneficiaries’ (and student enrollees beneficiaries or to the eligible
under Title VII of the Civil Rights Act and their covered dependents’) interest organization or its plan. Under this
of 1964, the definition of eligible in verifying compliance and eligible proposal, an organization seeking to be
organization in these final regulations organizations’ interest in avoiding treated as an eligible organization would
does not extend to for-profit undue inquiry into their character, need only to meet the self-certification
organizations. The Departments are mission, or practices. Further, the standard. The issuer, in turn, would
unaware of any court granting a Departments do not believe that the self- automatically enroll plan participants
religious exemption to a for-profit certification standard infringes on and beneficiaries in separate individual
organization, and decline to expand the freedom of speech. health insurance policies that cover
definition of eligible organization to The proposed regulations provided contraceptive services (and notify them
include for-profit organizations. that the self-certification would specify of such enrollment) without the
b. Self-Certification the contraceptive services for which the imposition of any cost-sharing
Each organization seeking to be organization will not establish, requirement (such as a copayment,
treated as an eligible organization under maintain, administer, or fund coverage. coinsurance, or a deductible), premium,
the final regulations, to avoid The final regulations eliminate this fee, or other charge on plan participants
contracting, arranging, paying, or requirement, pursuant to the standard or beneficiaries or on the eligible
referring for contraceptive coverage, is exclusion policy discussed later in this organization or its plan.
required to self-certify, prior to the section. Further, the final regulations Some commenters stated that the
beginning of the first plan year to which provide that, if an organization seeks to Departments should not provide a
an accommodation is to apply, that it be treated as an eligible organization tailored accommodation for an eligible
meets the definition of an eligible under the final regulations, an issuer or organization that objects to only some
organization.27 The self-certification (as third party administrator may not types of contraceptive services. These
described in these final regulations) require any documentation from the commenters said that customizing
needs to be executed once. A copy of organization beyond its self-certification individual contraceptive policies for
the self-certification needs to be as to its status as an eligible participants and beneficiaries (or
provided to a new health insurance organization. The form to be used for students enrollees and their covered
issuer or a new third party administrator the self-certification is being finalized dependents) in plans of eligible
if the eligible organization changes contemporaneous with the issuance of organizations based on the differing
issuers or third party administrators. these final regulations through the religious objections to contraceptive
Comments addressing this topic process provided for under the coverage of each eligible organization
generally approved of the approach Paperwork Reduction Act of 1995. would create an administrative burden
proposed by the Departments, but some As discussed previously, the self- for issuers and confuse plan participants
commenters suggested that stronger certification form is applicable in and beneficiaries (or student enrollees
protections were needed to promote conjunction with the accommodations and their covered dependents). Some
oversight, enforcement, and under these final regulations (that is, for commenters also noted that requiring
transparency and to prevent abuse. For plan years beginning on or after January coordination of benefits might not be
example, some commenters 1, 2014), after the expiration of the feasible, because many states prohibit
recommended requiring eligible temporary enforcement safe harbor. The coordination between individual and
organizations to file their self- self-certification standard referenced in group health insurance coverage.
these final regulations (and the form to In response to these comments, the
certifications with the Departments and

be executed by an eligible organization final regulations provide that an issuer
27 Although not required to do so by these final to make such self-certification, which is providing payments for contraceptive
regulations, nothing in these final regulations being issued contemporaneously with services in accordance with these final
prevents a religious employer from drafting and these final regulations) are different regulations may use a standard
executing a self-certification regarding its status as
a religious employer and sharing the self-
from the standard (and the form) exclusion from a group health insurance
certification with issuers, plan service providers, associated with the guidance regarding policy that encompasses all
plan participants or beneficiaries, or others. the extension of the temporary recommended contraceptive services
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and not violate PHS Act section 2713 policies that cover contraceptive administrative complexity for issuers.
and the companion provisions of ERISA services, represents a simpler approach At the same time, because the payments
and the Code with respect to the and responds to concerns raised by for contraceptive services are not a
requirement to cover contraceptive commenters, while still ensuring that group health plan benefit under this
services. While issuers may, at their eligible organizations and their plans do approach, this policy ensures that
option, choose to offer customized not contract, arrange, pay, or refer for eligible organizations and their plans do
exclusions from group health insurance such coverage, and that contraceptive not contract, arrange, pay, or refer for
policies based on the differing religious coverage is expressly excluded from the contraceptive coverage, and that such
objections to contraceptive coverage of group health insurance coverage. coverage is expressly excluded from
each eligible organization (or offer Under these final regulations, as their group health insurance policies.
several different but standardized under the proposed regulations, the This approach also minimizes barriers
exclusions from group health insurance eligible organization need only meet the in access to care because plan
policies from which eligible self-certification standard and provide participants and beneficiaries (and their
organizations may choose), they are not to the issuer a copy of its self- health care providers) do not have to
required to do so under these final certification. The issuer that receives the have two separate health insurance
regulations. Regardless of whether an copy of the self-certification from the policies (that is, the group health
issuer uses a standard or customized eligible organization must expressly insurance policy and the individual
exclusion from a group health insurance exclude contraceptive coverage—either contraceptive coverage policy).
policy, plan participants and all contraceptive coverage or coverage of Furthermore, Small Business Health
beneficiaries (and student enrollees and specific contraceptive services if the Insurance Options Programs (SHOPs)
their covered dependents) are assured issuer chooses to customize the (the small group market Exchanges) do
that the issuer will make payments for exclusion—from the group health not need to make operational changes as
any recommended contraceptive insurance coverage of the eligible a result of the accommodation. Small
services excluded from the group health organization. The issuer must also employers that are eligible organizations
insurance policy (or student health notify plan participants and purchasing coverage through a SHOP
insurance coverage). beneficiaries, contemporaneous with (to can simply provide a copy of their self-
Some commenters noted that the the extent possible) but separate from certification to the issuer (rather than
proposed individual health insurance any application materials distributed in provide it to the SHOP) to ensure that
policies covering contraceptive services connection with enrollment (or re- their small group market policy is
might not be viewed as enforceable enrollment) in group health coverage provided in a manner consistent with
contracts under state contract law that is effective beginning on the first these final regulations.
because there would be no premium day of each applicable plan year, that Although these payments for
associated with the coverage and no the issuer provides payments for contraceptive services are not benefits
ability for an individual to decline contraceptive services at no cost under a health insurance policy, to
coverage. Commenters suggested that separate from the group health plan for fulfill an issuer’s responsibilities under
states would need to develop new so long as the participant or beneficiary section 2713 of the PHS Act and the
regulatory processes for reviewing forms remains enrolled in the plan, as companion provisions of ERISA and the
and rates for such policies, and noted discussed later in this section. Unlike Code and consistent with the proposed
that the inability to charge a premium under the proposed regulations, the regulations, an issuer must make them
for such policies could raise actuarial issuer is not required to issue to plan available in a way that meets minimum
soundness and financial reserve participants and beneficiaries standards for consumer protection,
concerns. Commenters also noted that individual health insurance policies which would ordinarily accompany
state laws would prevent issuers covering contraceptive services, and, coverage of recommended preventive
licensed to issue group health insurance thus, there is no need to consider such health services without cost sharing
policies in one state from issuing coverage excepted benefits, as proposed. under section 2713 of the PHS Act and
individual health insurance policies to Instead, under these final regulations, the companion provisions of ERISA and
employees of an eligible organization the issuer must, as a federal regulatory the Code. Thus, issuers, in order to
residing in other states, and expressed requirement, provide payments for satisfy their regulatory obligations under
concern about the cost and contraceptive services for plan these final regulations, must make these
administrative complexity of issuing participants and beneficiaries, separate payments for contraceptive services in a
and administering individual from the group health plan, without the manner consistent with the
contraceptive coverage policies. imposition of cost sharing, premium, requirements under the following
These final regulations achieve the fee, or other charge on plan participants provisions of the PHS Act and the
same end by requiring that a health or beneficiaries or on the eligible companion provisions of ERISA and the
insurance issuer providing group health organization or its plan. Under this Code (and their implementing
insurance coverage in connection with a simplified approach, issuers will not regulations): PHS Act sections 2706
group health plan established or incur the associated administrative costs (non-discrimination in health care),
maintained by an eligible organization of issuing individual contraceptive 2709 (coverage for individuals
assume sole responsibility for providing coverage policies. participating in approved clinical trials),
separate payments for contraceptive This simpler approach to the 2711 (no lifetime or annual limits), 2713
services directly for plan participants accommodation for insured coverage (coverage of preventive health services),
and beneficiaries, without cost sharing, does not trigger certain aspects of state
2719 (appeals process), and 2719A

premium, fee, or other charge to plan insurance law. As the payments at issue
(patient protections), as incorporated by
participants or beneficiaries or to the derive solely from a federal regulatory
reference into ERISA section 715 and
eligible organization or its plan. The requirement, not a health insurance
Code section 9815.28 Consistent with
requirement that, for plan participants policy, they do not implicate issues
and beneficiaries, issuers provide such as issuer licensing and product 28 With respect to the accommodation for self-
payments for contraceptive services, in approval requirements under state law, insured coverage of eligible organizations under
lieu of individual health insurance and they minimize cost and these final regulations, a comparable requirement to
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these standards and as described in the health.30 31 The Departments are One commenter suggested that it
2010 interim final regulations, an issuer unaware of any studies to the would be possible to view the provision
may apply reasonable medical contrary.32 of contraceptive coverage as cost neutral
management techniques and may Some commenters raised specific if an issuer were to set the premium
require that contraceptive services be premium rating and accounting issues otherwise charged to an eligible
obtained in-network (if an issuer has a related to the proposed regulations’ organization as though plan participants
network of providers) in order for plan approach to the cost neutrality of issuers and beneficiaries did not have separate
participants and beneficiaries to obtain providing contraceptive coverage. These contraceptive coverage. Other
such services without cost sharing.29 commenters generally asserted that the commenters argued that the rationale for
cost savings due to lower pregnancy- providing Federally-facilitated
Issuers are prohibited from charging related costs and improvements in Exchange (FFE) user fee adjustments in
any premium, fee, or other charge to women’s health would flow to connection with the accommodation for
eligible organizations or their plans, or employers through reduced premiums, self-insured group health plans of
to plan participants or beneficiaries, for thereby leaving issuers uncompensated eligible organizations was equally
making payments for contraceptive for the cost of providing contraceptive applicable in the context of insured
services, and must segregate the coverage. Further, commenters stated group health plans of eligible
premium revenue collected from that, in the case of a group health organizations and recommended that
eligible organizations from the monies insurance policy in the small group issuers be permitted to charge a
they use to make such payments. In market, the small employer’s reduced premium or otherwise be compensated
making such payments, the issuer must claims experience attributable to for providing contraceptive coverage.
ensure that it does not use any contraceptive coverage (not including In response to these comments, the
premiums collected from eligible the issuer’s direct costs of contraceptive Departments continue to believe that
organizations. Issuers have flexibility in coverage) would be spread across the issuers have various options for
how to structure these payments, issuer’s single risk pool for the entire achieving cost neutrality,
provided that the payments in no way small group market in a state and result notwithstanding that they must make
involve the eligible organization, and in a lower index rate for pricing all of payments for contraceptive services
provided that issuers are able to account the issuer’s small group market without cost sharing, premium, fee, or
for this segregation of funds in products. Thus, according to these other charge to the eligible organization,
accordance with applicable, generally commenters, in both the large and small the group health plan, or plan
accepted accounting and auditing group markets, issuers would not reap participants or beneficiaries.
standards. the cost savings attributable to Issuers of large group insured
The Departments stated in the contraceptive coverage, and would need products have an option by which they
preamble of the proposed regulations to fund the costs of a free-standing can ensure that they accrue the cost
that issuers would find that providing contraceptive coverage policy from savings from reduced pregnancy-related
contraceptive coverage is at least cost some other source. expenses and other health care costs.
neutral because they would be insuring For large group market products, issuers
30 Bertko, J., Glied, S., et al. The Cost of Covering
the same set of individuals under both base premiums on an employer’s prior
Contraceptives Through Health Insurance (February
the group health insurance policies and 9, 2012), http://aspe.hhs.gov/health/reports/2012/
year claims cost (that is, experience
the separate individual contraceptive contraceptives/ib.shtml; Washington Business rating) and other factors.33 Some
coverage policies and, as a result, would Group on Health, Promoting Healthy Pregnancies: commenters asserted that this rating
Counseling and Contraception as the First Step, practice means that any cost savings
experience lower costs from Report of a Consultation with Business and Health
improvements in women’s health, Leader (September 20, 2000), http://
from fewer pregnancies and childbirths
healthier timing and spacing of www.businessgrouphealth.org/pdfs/ and improvements in women’s health
pregnancies, and fewer unplanned healthypregnancy.pdf; Campbell, K.P., Investing in will be passed to the employer in the
Maternal and Child Health: An Employer’s Toolkit, large group insured market. Given that
pregnancies. The Departments continue National Business Group on Health http://
to believe, and have evidence to www.businessgrouphealth.org/healthtopics/
there appears to be no legal requirement
support, that, with respect to the maternalchild/investing/docs/mch_toolkit.pdf; that issuers use this particular rating
accommodation for insured coverage Trussell, J., et al. The Economic Value of practice, and that this practice often
Contraception: A Comparison of 15 Methods, entails adding costs to premiums that
established under these final American Journal Public Health, 1995; 85(4):494–
regulations, providing payments for 503, Revenues of H.R. 3162, the Children’s Health
are not based solely on the experience
contraceptive services is cost neutral for and Medicare Protection Act, for the Rules of the employer’s group,34 issuers
issuers. Several studies have estimated Committee (August 1, 2007) http://www.cbo.gov/ reasonably could set the premium for an
ftpdocs/85xx/doc8519/HR3162.pdf. eligible organization’s large group
that the costs of providing contraceptive 31 The Departments believe that these same cost
coverage are balanced by cost savings policy as if no payments for
savings found by issuers of group health insurance
from lower pregnancy-related costs and would also be found by issuers of student health contraceptive services had been
from improvements in women’s insurance coverage. provided to plan participants and
32 One commenter cited two studies disputing the beneficiaries—reflecting the actual
cost effectiveness of preventive health services, but terms of the group policy, which
provide separate payments for contraceptive these studies are not specific to contraceptive
services consistent with these consumer protections services. Further, these studies find that preventive
expressly excludes contraceptive
is not explicitly placed on the third party care is not cost effective when a large population coverage. This approach would be
administrator. This is because, as the plan receives the preventive service but only a small consistent with pricing methodologies
administrator for contraceptive coverage, the third fraction of that population would have developed currently used in the health insurance
party administrator is already required to comply the condition being prevented, a circumstance not
with these consumer protections, as well as all presented here. See Cohen, J., et al., New England
industry.
other provisions of ERISA that are applicable to Journal of Medicine. 2008, 358:661–663 (February
group health plans, including ERISA sections 104 14, 2008) http://www.nejm.org/toc/nejm/358/7; 33 http://www.nahu.org/consumer/Group
and 503, and the requirements of Part 7 of ERISA. CBO Letter to Congressman Nathan Deal, (August Insurance.cfm.
29 See 26 CFR 54.9815–2713T(a)(3) and (4); 29 7, 2009). http://www.cbo.gov/sites/default/files/ 34 http://www.actuary.org/files/Draft_Large_
CFR 2590.715–2713(a)(3) and (4); 45 CFR cbofiles/ftpdocs/104xx/doc10492/08-07- Group_Medical_Business_Practice_Note_Jan_

147.130(a)(3) and (4). prevention.pdf. 2013.pdf.
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Another option is to treat the cost of corridor program calculations.38 This eligible organization and its plan would
payments for contraceptive services for adjustment compensates for any be held harmless if the issuer were to
women enrolled in insured group health increase in incurred claims associated fail to comply with the requirement to
plans established or maintained by with making payments for contraceptive provide separate payments for
eligible organizations as an services. contraceptive services for plan
administrative cost that is spread across Several commenters expressed participants and beneficiaries at no cost.
the issuer’s entire risk pool, excluding concern that participants and Some commenters requested that the
plans established or maintained by beneficiaries in plans of eligible Departments codify this policy in
eligible organizations given that issuers organizations would be automatically regulation text. Accordingly, this policy
are prohibited from charging any enrolled in individual contraceptive is now codified in paragraph (e) of 26
coverage policies and recommended CFR 54.9815–2713A, 29 CFR 2590.715–
premium, fee, or other charge to eligible
providing an opt-out for plan 2713A, and 45 CFR 147.131 of these
organizations or their plans for
participants and beneficiaries who final regulations.
providing payments for contraceptive
object to contraceptive coverage on To summarize, the following are the
services. In the small group market, religious grounds. Other commenters
issuers are required beginning in 2014 key elements of the accommodation that
stated that allowing participants and is being made for eligible organizations
to treat all of their non-grandfathered beneficiaries to opt out of such
business within a state as a single risk with insured group health plans:
contraceptive coverage would create an
pool, and administrative costs may be administrative burden on issuers and • An organization seeking to be
spread evenly across all plans in the privacy concerns for individuals treated as an eligible organization needs
single risk pool (although issuers are because the issuers would know which only to self-certify that it is an eligible
permitted to apply them on a plan individuals opted in or opted out of organization, provide the issuer with a
basis). In the large group market, while such coverage. The simplified approach copy of the self-certification, and satisfy
there is no single risk pool requirement, described in these final regulations the recordkeeping and inspection
issuers generally spread administrative eliminates this issue altogether, because requirements of the self-certification
costs across their entire book of issuers are not required to issue standard.
business.35 In 2011, health insurance individual contraceptive coverage • The issuer that receives a self-
issuers earned approximately $290 policies at all.39 Rather, they are certification must then expressly
billion in premiums in the insured required only to provide payments for exclude contraceptive coverage from the
small and large group markets.36 If the contraceptive services for those plan eligible organization’s group health
cost of providing payments for participants and beneficiaries who opt insurance coverage.
contraceptive services for participants to use such services. Nothing in these • The issuer must, contemporaneous
and beneficiaries in insured group final regulations compels any plan with (to the extent possible), but
health plans established or maintained participant or beneficiary to use such separate from, any application materials
by eligible organizations were treated as services, and nothing causes distributed in connection with
an administrative cost spread across an participants or beneficiaries to be enrollment (or re-enrollment) in group
issuer’s entire book of business automatically enrolled in contraceptive health coverage that is effective
(excluding plans established or coverage; therefore, these concerns are beginning on the first day of each
maintained by eligible organizations), addressed without the need for an opt- applicable plan year, notify plan
the cost of providing such payments out mechanism. Moreover, nothing in participants and beneficiaries that the
would result in an imperceptible these final regulations precludes issuer provides separate payments for
increase in administrative load.37 These employers or others from expressing any contraceptive services at no cost for so
changes in premiums would be opposition to the use of contraceptives long as the participant or beneficiary
negligible and effectively cost neutral to or requires health care providers to remains enrolled in the plan.
prescribe or provide contraceptives, if • The issuer must segregate premium
issuers, even before considering any
doing so is against their religious revenue collected from the eligible
reductions in claims costs that accrue to
beliefs. organization from the monies used to
the issuer. The Departments explained in the make payments for contraceptive
Under either option, after meeting the preamble of the proposed regulations services. When it makes payments for
self-certification standard, the eligible that a health insurance issuer providing contraceptive services used by plan
organization would not contract, group health insurance coverage in participants and beneficiaries, the issuer
arrange, pay, or refer for contraceptive connection with a group health plan must do so without imposing any
coverage. established or maintained by an eligible premium, fee, or other charge, or any
HHS intends to clarify in guidance organization would be held harmless if portion thereof, directly or indirectly,
that an issuer of group health insurance the issuer relied in good faith on a on the eligible organization, its group
coverage that makes payments for representation by the organization as to health plan, or its plan participants or
its eligibility for the accommodation beneficiaries. In making such payments,
contraceptive services under these final
and such representation was later the issuer must ensure that it does not
regulations may treat those payments as
determined to be incorrect. The use any premiums collected from
an adjustment to claims costs for
Departments also explained that an eligible organizations. Issuers have
purposes of medical loss ratio and risk
flexibility in how to structure these
38 See 45 CFR Part 158 for standards related to the

35 Bluhm, W., ed., Group Insurance, 5th Ed. medical loss ratio and 45 CFR Part 153 Subpart F payments, but must be able to account
2007), 459–460. for standards related to the risk corridor program. for this segregation of funds, subject to
36 2011 MLR–A data, submitted to CMS in July 39 The same is true with respect to the applicable, generally accepted
2012. accommodation for self-insured coverage of eligible accounting and auditing standards.
37 Office of Assistant Secretary for Planning and organizations under these final regulations, given
Evaluation, U.S. Department of Health and Human that third party administrators similarly are not
Thus, an eligible organization need not
Services, ‘‘Cost-Neutrality of Contraceptive required to arrange for individual contraceptive contract, arrange, pay or refer for
Coverage.’’ coverage policies at all. contraceptive coverage.
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• Plan participants and beneficiaries sole purpose of arranging contraceptive must: (1) State that the eligible
may refuse to use contraceptive coverage. These commenters suggested organization will not act as the plan
services. that requiring third party administrators administrator or claims administrator
• An eligible organization and its to serve as fiduciaries would increase with respect to contraceptive services or
group health plan are considered to their exposure to legal liability and also contribute to the funding of
comply with the contraceptive coverage create conflicts of interest with their contraceptive services; and (2) cite 29
requirement even if the issuer fails to plan sponsor clients given that many CFR 2510.3–16 and 26 CFR 54.9815–
comply with the requirement to provide agreements between third party 2713A and 29 CFR 2590.715–2713A,
separate payments for contraceptive administrators and plan sponsors which explain the obligations of the
services for plan participants and prohibit third party administrators from
third party administrator. Upon receipt
beneficiaries at no cost. serving as fiduciaries.
A number of commenters questioned of the copy of the self-certification, the
d. Separate Payments for Contraceptive third party administrator may decide
the Department of Labor’s legal
Services for Participants and not to enter into, or remain in, a
authority to designate a third party
Beneficiaries in Self-Insured Group contractual relationship with the
administrator as the plan administrator
Health Plans eligible organization to provide
for contraceptive coverage by virtue of
Comments varied as to which of the the eligible organization providing a administrative services for the plan.
three proposed approaches to providing copy of its self-certification to the third As relevant here, a plan administrator
separate contraceptive coverage without party administrator. These commenters is defined in ERISA section 3(16)(A)(i)
cost sharing for participants and suggested that the self-certification of as ‘‘the person specifically so designated
beneficiaries in self-insured plans of the eligibility of the organization for the by the terms of the instrument under
eligible organizations should be accommodation would be insufficient to which the plan is operated.’’ As a
finalized. Some commenters suggested act as a designation under ERISA
that none of the proposed approaches document notifying the third party
section 3(16)(A)(i), and questioned
would enable objecting employers to administrator(s) that the eligible
whether the self-certification could be
separate themselves completely from organization will not provide, fund, or
defined as an instrument under which
the administration of contraceptive the plan is operated. administer payments for contraceptive
coverage. These commenters requested After reviewing the comments on the services, the self-certification is one of
an unqualified exemption from the three proposed approaches, the the instruments under which the
contraceptive coverage requirement for Departments are finalizing the third employer’s plan is operated under
such employers. Other commenters approach under which the third party ERISA section 3(16)(A)(i). The self-
stated that none of the proposed administrator becomes an ERISA section certification will afford the third party
approaches would sufficiently ensure 3(16) plan administrator and claims administrator notice of obligations set
that participants and beneficiaries in administrator solely for the purpose of forth in these final regulations, and will
self-insured plans of eligible providing payments for contraceptive be treated as a designation of the third
organizations would receive separate services for participants and party administrator(s) as plan
contraceptive coverage without cost beneficiaries in a self-insured plan of an administrator and claims administrator
sharing. These commenters requested eligible organization at no cost to plan for contraceptive benefits pursuant to
that the final regulations require that participants or beneficiaries or to the section 3(16) of ERISA. Additional
objecting employers retain legal eligible organization. The Departments conditions the eligible organization
responsibility for any failure on the part have determined that the ERISA section must meet in order to be considered to
of issuers or third party administrators 3(16) approach most effectively enables comply with PHS Act section 2713 and
to provide such coverage. eligible organizations to avoid
A number of commenters expressed the companion provisions in ERISA and
contracting, arranging, paying, or the Code include prohibitions on:
concern about the responsibilities that referring for contraceptive coverage after
one or more of the proposed approaches (1) Directly or indirectly interfering with
meeting the self-certification standard, a third party administrator’s efforts to
would impose on third party while also creating the fewest barriers to
administrators. Some of these provide or arrange separate payments
or delays in plan participants and
commenters suggested that the proposed for contraceptive services for
beneficiaries obtaining contraceptive
requirement that third party services without cost sharing. participants or beneficiaries in the plan
administrators arrange for separate Under this approach, as set forth in and (2) directly or indirectly seeking to
contraceptive-only coverage through an these final regulations, with respect to influence a third party administrator’s
issuer would convert third party the contraceptive coverage requirement,
administrators into health insurance an eligible organization is considered to (PBM) to handle claims administration for
brokers. Others suggested that third comply with section 2713 of the PHS prescription drugs and another third party
party administrators would not be administrator to handle claims for inpatient and
Act and the companion provisions in outpatient medical/surgical benefits.) To the extent
willing to assume the responsibility of ERISA and the Code if it provides to all the plan hires more than one third party
arranging for separate contraceptive- third party administrators with which it administrator, each third party administrator would
only coverage. These commenters also or its plan has contracted a copy of its become the section 3(16) plan administrator with
suggested that, even if a third party self-certification, consistent with the respect to the types of claims it normally processes
administrator were willing to assume requirements of these final (that is, the PBM would continue to handle claims
such responsibility, it would pass along
regulations.40 The self-certification for prescription drugs and the other third party
the resultant increase in its administrator would continue to handle claims for
administrative costs to the employer. 40 Third party administrators are hired by plan
inpatient and outpatient medical/surgical benefits);
each would do so in accordance with section 2713
Other commenters expressed concern sponsors to process claims and administer other
administrative aspects of employee benefit plans. In of the PHS Act and the companion provisions of
about an approach that would require ERISA and the Code (even if plan terms might
some cases, a plan hires different third party
third party administrators to become administrator to administer claims for different otherwise provide differently) as plan
plan administrators and fiduciaries classifications of benefits. (For example, one plan administration that may be funded in accordance
under section 3(16) of ERISA for the may contract with a pharmacy benefit manager with 45 CFR 156.50(d).
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decision to provide or arrange such ERISA section 503, providing plan the ability to interpret the definition of
payments.41 participants and beneficiaries with plan administrator under ERISA section
A third party administrator that disclosures required under ERISA 3(16)(A)(i). The Department of Labor’s
receives a copy of the self-certification section 104, and complying with the interpretation of the self-certification
and that agrees to enter into or remain requirements of Part 7 of ERISA. The described herein as one of the
in a contractual relationship with the Departments note that there is no ‘‘instruments under which the plan is
eligible organization to provide obligation for a third party administrator operated’’ is consistent with the plain
administrative services for the plan to enter into or remain in a contract meaning of the term because it identifies
must provide or arrange separate with the eligible organization if it the limited set of plan benefits (that is,
payments for contraceptive services for objects to any of these responsibilities. contraceptive coverage) that the
participants and beneficiaries in the The Departments believe that this employer refuses to provide and that the
plan without cost sharing, premium, fee, approach most successfully addresses third party administrator must therefore
or other charge to plan participants or both the desire of some commenters for provide or arrange for an issuer or
beneficiaries, or to the eligible plan participants and beneficiaries to another entity to provide.
organization or its plan. The third party receive contraceptive coverage without
administrator can provide such cost sharing without delays or other e. Self-Insured Group Health Plans
payments on its own, or it can arrange barriers, and the desire of other Without Third Party Administrators
for an issuer or other entity to provide commenters for objecting employers to Although some commenters
such payments. In either case, like the be separated from contracting, addressed the solicitation for comments
payments for contraceptive services arranging, paying, or referring for on whether and how to provide an
under the accommodation for insured contraceptive coverage. The third party accommodation for self-insured group
plans of eligible organizations discussed administrator serving as the plan health plans established or maintained
previously, the payments are not health administrator for contraceptive benefits by eligible organizations that do not use
insurance policies. Moreover, in either ensures that there is a party with legal the services of a third party
case, the third party administrator can authority to arrange for payments for administrator, no comments indicated
make arrangements with an issuer contraceptive services and administer that such plans actually exist.
offering coverage through an FFE to claims in accordance with ERISA’s Accordingly, the Departments continue
obtain reimbursement for its costs protections for plan participants and to believe that there are no self-insured
(including an allowance for beneficiaries. At the same time, the group health plans in this circumstance.
administrative costs and margin). As approach enables objecting employers, However, to allow for the possibility
discussed later in this section, the issuer after providing third party that such a self-insured group health
offering coverage through the FFE can administrators with a copy of the self- plan does exist, the Departments will
receive an adjustment to the FFE user certification (as described previously), provide any such plan with a safe
fee, and the issuer is required to pass on to separate themselves from contracting, harbor from enforcement of the
a portion of that adjustment to the third arranging, paying, or referring for contraceptive coverage requirement,
party administrator to account for the contraceptive coverage. Additionally, by contingent on: (1) the plan submitting to
costs of providing or arranging substituting payments for contraceptive HHS information (as described later in
payments for contraceptive services. A services for health insurance policies, this section) showing that it does not
third party administrator that provides this approach avoids the complications use the services of a third party
or arranges the payments is entitled to that would be presented by requiring administrator; and (2) if HHS agrees that
retain reimbursement for its costs for the the creation of a contraceptive-only the plan does not use the services of a
period during which it reasonably and health insurance product, and allows third party administrator, the plan
in good faith relied on a representation third party administrators to avoid providing notice to plan participants
by the eligible organization that it was potentially becoming health insurance and beneficiaries in any application
eligible for the accommodation. This is brokers. Accordingly, while the materials distributed in connection with
so even if the organization’s Departments appreciate commenters’ enrollment (or re-enrollment) in
representation was later determined to concerns about the responsibilities that coverage that is effective beginning on
be incorrect. third party administrators must assume the first day of each applicable plan
The third party administrator must under this accommodation, they believe year, indicating that it does not provide
provide plan participants and that this approach best ensures that plan benefits for contraceptive services.
beneficiaries with notice of the participants and beneficiaries receive Such plans must submit to HHS at
availability of the separate payments for contraceptive coverage without cost least 60 days prior to the first day of the
contraceptive services contemporaneous sharing, and without the objecting first applicable plan year all of the
with (to the extent possible), but employers paying for or administering following information:
separate from, any application materials such coverage. • Identifying information for the plan,
distributed in connection with Moreover, none of the comments the eligible organization that acts as the
enrollment (or re-enrollment) in changed the Department of Labor’s view plan sponsor, and an authorized
coverage that is effective beginning on that it has legal authority to require the representative of the organization, along
the first day of each applicable plan year third party administrator to become the with the authorized representative’s
(as discussed in more detail later in this plan administrator under ERISA section telephone number and email address.
3(16) for the sole purpose of providing • A listing of the five most highly
section). Third party administrators
payments for contraceptive services if compensated non-clinical plan service
must also take on the statutory

the third party administrator agrees to providers (other than employees of the
responsibilities of a plan administrator
enter into or remain in a contractual plan or plan sponsor), including contact
under ERISA, including setting up and
relationship with the eligible information for each plan service
operating a claims procedure under
organization to provide administrative provider, a concise description of the
41 Nothing in these final regulations prohibits an services for the plan. The Department of nature of the services provided by each
eligible organization from expressing its opposition Labor has broad rulemaking authority service provider to the plan, and the
to the use of contraceptives. under Title I of ERISA, which includes annual amount of compensation paid to
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each plan service provider (examples of notice contemporaneous with plan written information concerning how to
plan services include claims processing enrollment (or re-enrollment) materials obtain reimbursement for contraceptive
and adjudication, appeals management, would not be possible because issuers services, appeals procedures, provider
provider network development, and typically do not receive enrollee and pharmacy networks, prescription
pharmacy benefit management). information prior to enrollment. drug formularies, medical management
• An attestation (executed by an Consistent with the simplified procedures, and similar issues.42
authorized representative of the approach described previously, these
organization) that the plan is established final regulations provide that this notice g. Student Health Insurance Coverage
or maintained by an eligible must be provided by either the issuer Consistent with the HHS proposed
organization, and is operated in providing separate payments for regulation, paragraph (f) of the HHS
compliance with all applicable contraceptive services under the final regulation provides that an
requirements of part A of title XXVII of accommodation, or a third party accommodation applies to student
the PHS Act, as incorporated into ERISA administrator arranging or providing health insurance coverage arranged by
and the Code. such payments (or its agent). The notice an eligible organization that is an
Such information must be submitted must be provided contemporaneous institution of higher education in a
electronically to with (to the extent possible), but manner comparable to that in which it
marketreform@cms.hhs.gov. separate from, any application materials applies to group health insurance
If any such submission demonstrates distributed in connection with coverage provided in connection with a
that a self-insured group health plan enrollment (or re-enrollment) in group health plan established or
established or maintained by an eligible coverage that is effective beginning on maintained by an eligible organization
organization does not use the services of the first day of each plan year to which that is an employer. For this purpose,
a third party administrator, the the accommodation applies, and it must any reference to plan participants and
Departments will provide a safe harbor indicate that the eligible organization beneficiaries is a reference to student
from enforcement of the contraceptive does not fund or administer enrollees and their covered dependents.
coverage requirement while an contraceptive benefits, but that the Several commenters supported
additional accommodation is issuer or third party administrator will treating student health insurance like
considered. If the Departments discover provide separate payments for employer-sponsored group health
through any such submission that a self- contraceptive services at no cost. The insurance for purposes of these final
insured group health plan established or Departments believe that the direction regulations. Other commenters
maintained by an eligible organization that the notice be provided suggested that an accommodation
does in fact use the services of a third contemporaneous with application should not extend to institutions of
party administrator, the eligible materials ‘‘to the extent possible’’ higher education that arrange student
organization must either follow the provides sufficient flexibility to address health insurance coverage, because
procedures described in these final the concerns raised by commenters student health insurance coverage is
regulations to obtain an accommodation about the timing of the notice. considered a type of individual rather
or otherwise comply with the The final regulations continue to than group health insurance coverage
contraceptive coverage requirement. provide model language that may be under federal law.43 One commenter
used to satisfy this notice requirement. recommended that issuers offering
f. Notice of Availability of Separate
Substantially similar language may also coverage through the Exchanges be
Payments for Contraceptive Services
be used to satisfy the notice required to provide separate
Consistent with the proposed requirement. Some commenters contraceptive coverage at no cost to
regulations, the final regulations direct suggested additions or modifications to students enrolled in nonprofit religious
that, for any plan year to which an the model language. Other commenters institutions of higher education with
accommodation is to apply, a health stated that the Departments should not religious objections to contraceptive
insurance issuer providing separate allow the use of substantially similar coverage (and their dependents).
payments for contraceptive services language. Additionally, some Student health insurance coverage is
pursuant to the accommodation, or a commenters recommended the administered differently than other
third party administrator arranging or Departments set standards to ensure that individual health insurance coverage.
providing such payments (or its agent), the notice is accessible to persons with Whereas most individual health
must provide timely written notice limited English proficiency and person insurance coverage is issued under a
about this fact to plan participants and with disabilities. The Departments contract between an individual
beneficiaries in insured or self-insured believe that the model language in the policyholder and a health insurance
group health plans (or student enrollees final regulations, along with existing issuer, student health insurance
and their covered dependents in student guidance concerning civil rights coverage is available to student
health insurance coverage) of eligible obligations, provide sufficient notice. enrollees and their covered dependents
organizations. The Departments also believe that the pursuant to a written agreement
Under the proposed regulations, this flexibility afforded by the final between an institution of higher
notice would be provided by the issuer regulations to use substantially similar education and a health insurance issuer.
contemporaneous with (to the extent language is generally consistent with Some religiously affiliated colleges and
possible) but separate from any other federal notice requirements. universities object to signing a written
application materials distributed in The notice must include contact agreement or providing financial
connection with enrollment (or re- information for the issuer or third party
enrollment) in health coverage administrator in the event plan 42 Furthermore, as discussed previously, with
established or maintained or arranged participants and beneficiaries (or respect to self-insured coverage, third party
by the eligible organization. student enrollees and their covered administrators that are plan administrators must
Commenters noted that employers, not dependents) have questions or operate in accordance with Part 1 of ERISA,
including ERISA section 104, which generally
issuers, typically distribute plan complaints. The Departments note that requires certain disclosures regarding plan benefits
enrollment (or re-enrollment) materials issuers and third party administrators and limitations.
to employees and that providing this may find it useful to provide additional 43 45 CFR 147.147 (77 FR 16453).
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assistance for student health insurance Commenters further stated that the FFE coverage to participants and
coverage that provides benefits for user fee adjustment must be adequate to beneficiaries in self-insured plans of
contraceptive services. For these provide financial incentives to ensure eligible organizations at no cost, and the
reasons, HHS believes that it is that women in self-insured plans of issuer offers coverage through an FFE,
appropriate to take into account eligible organizations receive the issuer would be able to seek an
religious objections to contraceptive contraceptive coverage at no cost. adjustment to the FFE user fee for the
coverage of eligible organizations that Commenters suggested that the FFE user estimated cost of the contraceptive
are institutions of higher education and fee adjustment may not be an adequate coverage. Moreover, HHS proposed that,
is finalizing the provision applicable to long-term funding source as more states if the issuer providing the contraceptive
student health insurance coverage as establish Exchanges over time, reducing coverage did not offer coverage through
proposed. HHS notes that it does not the number of FFEs and therefore an FFE—either because it was not a
have the authority to require issuers available FFE user fee revenue. QHP issuer, or because it was a QHP
offering coverage through the Exchanges Office of Management and Budget issuer but operated in a state without an
to provide separate contraceptive (OMB) Circular No. A–25R establishes FFE—an issuer in the same issuer group
coverage at no cost to students (and federal policy regarding these types of that offered coverage through an FFE
their dependents). user fees. Consistent with that Circular, would have been able to seek an
The Departments note that any the revised FFE user fee calculation adjustment to the FFE user fee on behalf
accommodation specific to a nonprofit (which will result in an adjustment of of the issuer providing the contraceptive
religious institution of higher education the FFE user fee) will facilitate the coverage. HHS proposed to use the
is intended to accommodate the accommodation of self-insured plans definition of issuer group in 45 CFR
nonprofit religious institution of higher established or maintained by eligible 156.20, that is, all entities treated under
education only with respect to its organizations by ensuring that plan subsection (a) or (b) of section 52 of the
arrangement of student health insurance participants and beneficiaries are Code as a member of the same
coverage for its students and their provided contraceptive coverage at no controlled group of corporations as (or
covered dependents. With respect to the cost so that eligible organizations are under common control with) a health
establishment or maintenance of a group not required to administer or fund such insurance issuer, or issuers affiliated by
health plan by a nonprofit religious coverage. By financing the the common use of a nationally licensed
institution of higher education for its accommodation for self-insured plans of service mark. Several commenters
employees and their dependents, the eligible organizations through the FFE expressed concern that not every issuer
nonprofit religious institution of higher user fee adjustment, participants and seeking to provide contraceptive
education is intended to be beneficiaries in such plans can retain coverage to participants and
accommodated in the same manner as their existing coverage, while gaining beneficiaries in self-insured plans of
that in which any other eligible access to separate payments for eligible organizations would be in the
organization that has established or contraceptive services at no cost. HHS same issuer group as an issuer that
maintained a group health plan for its does not believe that the adjustment to offers coverage through an FFE.
employees and their dependents is to be FFE user fee collections, as Commenters further noted that, even if
accommodated. contemplated under this final the issuer providing the contraceptive
regulation, will materially undermine coverage and the issuer offering
C. Adjustments of Federally-Facilitated
FFE operations. coverage through an FFE were in the
Exchange User Fees—45 CFR 156.50(d) HHS notes that it is not raising the
and 156.80(d) same issuer group, the issuers might
FFE user fee finalized in the 2014 incur significant administrative costs in
These sections of the final HHS Payment Notice to offset the FFE user establishing the necessary arrangements.
regulation set forth processes and fee adjustments, and estimates that In response to these comments, and to
standards to fund the payments for the payments for contraceptive services will account for the payments for
contraceptive services that are provided represent only a small portion of total contraceptive services for participants
for participants and beneficiaries in self- FFE user fees. and beneficiaries in self-insured group
insured plans of eligible organizations The FFE user fee adjustments support health plans of eligible organizations
under the accommodation described many of the goals of the Affordable Care under the accommodation described
previously, at no cost to plan Act, including improving the health of previously, HHS is finalizing a
participants or beneficiaries, eligible the population, reducing health care modification of the proposed policy. In
organizations, third party costs, providing access to health § 156.50(d)(1), a participating issuer
administrators, or issuers, through an coverage, encouraging eligible (defined at 45 CFR 156.50(a) 45) offering
adjustment in the FFE user fee payable organizations to continue to offer health a plan through an FFE may qualify for
by an issuer participating in an FFE.44 coverage, and ensuring access to an adjustment to the FFE user fee to the
In response to the proposed affordable qualified health plans (QHPs) extent that the participating issuer
regulations, some commenters via efficiently operated Exchanges. either: (i) made payments for
questioned HHS’s authority to establish Moreover, as described earlier in these contraceptive services on behalf of a
the FFE user fee adjustment. final regulations, there are significant third party administrator pursuant to 26
Commenters also recommended that benefits associated with contraceptive CFR 54.9815–2713A(b)(2)(ii) or 29 CFR
HHS ensure that the adjustments to user coverage without cost sharing. Such 2590.715–2713A(b)(2)(ii); or (ii) seeks
fee collections not undermine FFE coverage significantly furthers the an adjustment to the FFE user fee with
operations. Commenters stated that the governmental interests in promoting
respect to a third party administrator

FFE user fee should not be increased to public health and gender equality, and
offset the user fee adjustment. promotes the underlying goals of the 45 Under 45 CFR 156.50(a), a participating issuer
Exchanges and the Affordable Care Act includes QHP issuers, issuers of multi-state plans,
44 The FFE user fee was established in the March
more generally. and issuers of stand-alone dental plans. We note
11, 2013 final rule entitled ‘‘Patient Protection and that an issuer of a Consumer Operated and Oriented
Affordable Care Act; HHS Notice of Benefit and
In § 156.50(d) of the proposed Plan (CO–OP) offered on an FFE is also considered
Payment Parameters for 2014’’ (78 FR 15410) (2014 regulations, HHS specified that, if an to be a participating issuer for the purpose of the
Payment Notice). issuer were to provide contraceptive FFE user fee adjustment.
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that, following receipt of a copy of the reduce the administrative burden. or the 60th calendar day following the
self-certification referenced in 26 CFR Commenters also noted that it would date on which the third party
54.9815–2713A(a)(4) or 29 CFR likely be difficult to estimate the cost of administrator receives a copy of a self-
2590.715–2713A(a)(4), made or arranged the contraceptive coverage accurately, certification from an eligible
for payments for contraceptive services particularly in the initial years, given organization. The notification must be
pursuant to 26 CFR 54.9815– that the prohibition on cost sharing provided whether it is intended that the
2713A(b)(2)(i) or (ii) or 29 CFR could affect utilization. In addition, participating issuer will provide
2590.715–2713A(b)(2)(i) or (ii). Under commenters noted that costs would payments for contraceptive services on
the final regulation, neither the third likely vary considerably based on behalf of the third party administrator,
party administrator, nor the differences in utilization patterns and or whether it is intended that the
participating issuer, nor any entity administrative processes. participating issuer will seek an
providing payments for contraceptive In response to these comments, HHS adjustment to the FFE user fee with
services (if neither the third party is making certain modifications to the respect to such payments made or
administrator nor the participating process described previously. Rather arranged for by the third party
issuer is providing such payments) is than using a monthly process, the final administrator. HHS will provide
required to be part of the same issuer regulation at § 156.50(d)(2) requires a guidance on the manner of submission
group or otherwise affiliated. This participating issuer seeking an FFE user of the notification, as well as guidance
modification allows greater flexibility in fee adjustment to submit to HHS, in the on the application for the FFE user fee
the arrangements among third party year following the calendar year in adjustment, through the process
administrators, issuers, and other which the contraceptive services for provided for under the Paperwork
entities, while still ensuring that eligible which payments were made under the Reduction Act of 1995.
organizations are not required to accommodation described previously HHS is also modifying the standards
contract, arrange, pay, or refer for were provided, for each self-insured proposed at § 156.50(d) to align with the
contraceptive coverage. Consistent with plan, the total dollar amount of the final regulations regarding the
the proposed regulations, an allowance payments for contraceptive services that accommodation for self-insured group
for administrative costs and margin in were provided during the applicable health plans of eligible organizations.
the FFE user fee adjustment accounts for calendar year. The issuer will then As discussed previously, under these
the costs of arrangements among the receive an adjustment to its obligation to final regulations, the third party
third party administrator, the pay the FFE user fee equal to the cost administrator may make the payments
participating issuer, and any other of the contraceptive services that were for contraceptive services itself, or it
entity providing payments for provided during the previous year, plus may arrange for an issuer (including an
contraceptive services (if neither the an allowance, as specified by HHS, for issuer that does not offer coverage
third party administrator nor the administrative costs and margin. For through an FFE) or another entity to
participating issuer is providing such example, HHS expects that issuers make the payments on its behalf. Under
payments). seeking an FFE user fee adjustment for either scenario, a third party
In § 156.50(d)(1) through (4) of the payments for contraceptive services that administrator that seeks to offset the
proposed regulations, HHS set forth a were provided in calendar year 2014 costs of such payments through an FFE
process through which an issuer seeking will be required to submit to HHS by user fee adjustment must enter into an
an FFE user fee adjustment would July 15, 2015, the total dollar amount of arrangement with a participating issuer
submit information to HHS to the payments. This timing will allow offering coverage through an FFE. The
demonstrate the provision of adequate time for claims run-out and participating issuer and the third party
contraceptive coverage and estimate the data collection. The FFE user fee administrator must each submit
cost of such coverage. HHS further adjustment will be applied starting in information to HHS, as described in
proposed that it would review this October 2015. Although this approach § 156.50(d)(2) of the final regulation, to
information and provide an adjustment delays the application of the FFE user verify that the payments for
to the issuer’s monthly obligation to pay fee adjustment, it significantly reduces contraceptive services were provided in
the FFE user fee in an amount equal to the administrative burden on issuers, accordance with these final regulations.
the approved estimated cost of the third party administrators, and HHS. Specifically, in § 156.50(d)(2)(i), HHS
contraceptive coverage. HHS suggested HHS believes that tying the FFE user fee finalizes submission standards for a
that the cost of the contraceptive adjustment to the actual costs of participating issuer to receive the FFE
coverage, including administrative costs payments for contraceptive services, user fee adjustment. The participating
and margin, could be estimated on a per plus an allowance for administrative issuer must submit to HHS, in the
capita basis by either the issuer or HHS costs and margin, will provide manner and timeframe specified by
using either actuarial principles and reasonable assurance that the HHS, in the year following the calendar
methodologies or, for 2016 and beyond, adjustment is adequate to cover the full year in which the contraceptive services
previous experience. The per capita rate costs of the payments for contraceptive were provided: (A) Identifying
would then be multiplied by the services, furthering the goal of providing information for the participating issuer
monthly enrollment in the contraceptive contraceptive coverage without cost and each third party administrator that
coverage in order to calculate the total sharing, as required by PHS Act section received a copy of the self-certification
FFE user fee adjustment. 2713 and the companion provisions in with respect to which the participating
HHS sought comments on this ERISA and the Code. issuer seeks an adjustment in the FFE
proposed process for collecting As discussed later in this section, user fee (whether or not the
information, calculating the cost of the HHS is also directing third party participating issuer was the entity that
contraceptive coverage, and applying administrators to submit to HHS a made the payments for contraceptive
the FFE user fee adjustment. HHS notification that the third party services); (B) identifying information for
received several comments suggesting administrator intends for a participating each self-insured group health plan with
that issuers should be required to issuer to seek an FFE user fee respect to which a copy of the self-
submit information only on an annual adjustment. This notification must be certification was received by a third
basis, rather than a monthly basis, to provided by the later of January 1, 2014, party administrator and with respect to
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which the participating issuer seeks an were made by the participating issuer costs and margin, which will be
adjustment in the FFE user fee; and (C) directly, the total dollar amount should incorporated into the FFE user fee
for each such self-insured group health reflect the amount reported to the third adjustment, rather than request the third
plan, the total dollar amount of the party administrator by the participating party administrator or the participating
payments for contraceptive services that issuer; if the third party administrator issuer to submit to HHS an estimate of
were provided during the applicable made or arranged for such payments, the third party administrator and the
calendar year under the accommodation the total dollar amount should reflect participating issuer’s administrative
described previously. If such payments the amount of the payments made by or costs. This approach is consistent with
were made by the participating issuer on behalf of the third party the general approach in these final
directly, the total dollar amount should administrator); and (E) an attestation regulations to simplify administration of
reflect the amount of the payments that the payments for contraceptive the accommodations for eligible
made by the participating issuer; if the services were made in compliance with organizations, while still ensuring that
third party administrator made or 26 CFR 54.9815–2713A(b)(2) or 29 CFR no eligible organization is required to
arranged for such payments, the total 2590.715–2713A(b)(2). If the third party contract, arrange, pay, or refer for
dollar amount should reflect the amount administrator does not meet these contraceptive coverage. HHS notes that
reported to the participating issuer by standards, the participating issuer may it intends to review the methodology for
the third party administrator. Similarly, not receive an FFE user fee adjustment determining reimbursement for
in § 156.50(d)(2)(ii) and (iii), HHS to offset the costs of the payments for administrative costs and margin in
finalizes submission standards for the contraceptive services incurred by or on future years to ensure that HHS is
third party administrator with respect to behalf of the third party administrator. accurately capturing these costs. HHS
which the participating issuer seeks an HHS believes that it is necessary to will establish the allowance as a
adjustment in the FFE user fee. In collect this information directly from percentage of the cost of the payments
paragraph (d)(2)(ii), HHS finalizes a the third party administrator that has for contraceptive services because HHS
standard under which the third party the duty to ensure that the payments for believes that the majority of
administrator must notify HHS, by the contraceptive services are made to administrative costs will be related to
later of January 1, 2014, or the 60th ensure the accuracy of the data processing of payments to providers for
calendar day following the date on provided, without requiring the contraceptive services, and because
which it receives the applicable copy of participating issuer to attest to HHS believes that it is reasonable to
the self-certification, that it intends to information to which it may not have measure margin on this business as a
arrange for a participating issuer to seek access or over which it has little control. percentage of the cost of the
an FFE user fee adjustment. HHS will In § 156.50(d)(3), HHS establishes the contraceptive services. HHS will
provide guidance on the manner of this process by which a participating issuer establish the allowance at no less than
submission through the process will be provided a reduction in its ten percent of such cost, and will
provided for under the Paperwork obligation to pay the FFE user fee. As specify the allowance for a particular
Reduction Act of 1995. This notification long as an authorizing exception under calendar year in the annual HHS notice
is necessary to allow HHS to coordinate OMB Circular No. A–25R is in effect, of benefit and payment parameters. The
the development of the systems for the reduction will be calculated as the specific allowance for the 2014 calendar
administering the FFE user fee sum of the total dollar amount of the year will be proposed for public
adjustment. In paragraphs (d)(2)(iii)(A) payments for contraceptive services comment in the HHS Notice of Payment
through (E), HHS specifies several other submitted by the applicable third party
and Benefit Parameters for 2015 (which
standards under which the third party administrators, as described in
is scheduled to be published in the fall
administrator must submit to HHS, in paragraph (d)(2)(iii)(D), and an
of 2013). This approach will allow HHS
the year following the calendar year in allowance, specified by HHS, for
to provide for a reasonable allowance
which the contraceptive services for administrative costs and margin. In the
for administrative expenses for the third
which payments were made under the proposed regulations, HHS requested
party administrator, the participating
accommodation described previously comments on the appropriate method
issuer, and any other entity providing
were provided, the following for determining the administrative costs
the payments for contraceptive services
information: (A) Identifying information associated with providing the
on behalf of the third party
for the third party administrator and the contraceptive coverage, as well as a
margin to ensure that issuers receive administrator, as well as a margin for
participating issuer; (B) identifying each entity. HHS welcomes feedback
information for each self-insured group appropriate compensation for providing
the contraceptive coverage. Commenters from third party administrators,
health plan with respect to which the participating issuers, and other relevant
participating issuer seeks an adjustment agreed with the proposal to reimburse
for administrative costs and to provide stakeholders on the allowance for
in the FFE user fee; (C) the total number administrative costs and margin,
of participants and beneficiaries in each a margin. Commenters noted that
administrative costs would be incurred including the appropriate percentage
self-insured group health plan during and alternative methods for future
the applicable calendar year; 46 (D) for because of the complexities inherent in
arrangements between entities seeking determination of the allowance for
each self-insured group health plan with administrative costs and margin.
respect to which the third party the FFE user fee adjustment and entities
providing the contraceptive coverage, Section 156.50(d)(4) is similar to the
administrator made payments for
particularly when the entities operate in corresponding proposed provision, and
contraceptive services, the total dollar
specifies that, as long as an exception
amount of such payments that were different states. In addition, commenters

stated that administrative costs incurred under OMB Circular No. A–25R is in
provided during the applicable calendar
by the third party administrators could effect, if the amount of the reduction
year under the accommodation
vary because of variations in billing under paragraph (d)(3) is greater than
described previously (if such payments
processes. the amount of the obligation to pay the
46 No personally identifiable information will be As finalized in this regulation, for the FFE user fee in a particular month, the
collected from participating issuers or third party initial years of this policy, HHS will participating issuer will be provided a
administrators pursuant to § 156.50(d)(2). specify an allowance for administrative credit in succeeding months in the
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amount of the excess. HHS notes that similar to those proposed in payments for the contraceptive services
the likelihood of this occurring will § 156.50(d)(5), but modified slightly to under the accommodation on behalf of
depend on the relative magnitudes of align with the other changes in this final the third party administrator, or if it
the cost of payments for contraceptive regulation. In paragraph (d)(6), HHS seeks the adjustment with respect to
services and the FFE user fee, the specifies that a participating issuer such payments made or arranged for by
number of participants and beneficiaries receiving an adjustment in the FFE user the third party administrator.
in self-insured plans with respect to fee under this section for a particular • A third party administrator must
which the participating issuer seeks an calendar year must maintain for 10 notify HHS that it intends for a
adjustment in the FFE user fee, and the years following that year, and make participating issuer to seek the
number of individuals enrolled in available upon request to HHS, the HHS adjustment by the later of January 1,
coverage offered by the issuer through Office of the Inspector General, the 2014, or the 60th calendar day following
the FFE. HHS also notes that it intends Comptroller General, and their the date on which it received the copy
to provide a monthly report, for the designees, documentation of the applicable self-certification.
initial month in which the FFE user fee demonstrating that it timely paid each • For the participating issuer to
adjustment for a particular calendar year third party administrator, with respect receive the adjustment, the third party
is applied, and for succeeding months to which it received such adjustment, administrator and the participating
until the credit is fully applied, to any amount required under paragraph issuer must notify HHS of the total
issuers that receive an FFE user fee (d)(5). In paragraph (d)(7), HHS specifies amount of the payments made for the
adjustment. HHS contemplates that this documentation standards for third party contraceptive services under the
monthly report will include information administrators with respect to which an accommodation, and provide certain
on the issuer’s user fee obligation for the FFE user fee adjustment is received other information and documentation,
month, its total adjustment for the under this section for a particular including an attestation by the third
applicable calendar year, the user fee calendar year. Third party party administrator that the payments
adjustment applied to date, and the administrators must maintain for 10 for the contraceptive services were
value of the adjustment to be credited to years following the applicable calendar provided in compliance with 26 CFR
future months (so long as the exception year, and make available upon request 54.9815–2713A(b)(2) or 29 CFR
under OMB Circular No. A–25R is in to HHS, the HHS Office of the Inspector 2590.715–2713A(b)(2), by July 15 of the
effect). Additionally, HHS intends to General, the Comptroller General, and year following the calendar year in
provide a monthly report to each their designees, all of the following: (i) which the contraceptive services were
applicable third party administrator A copy of the self-certification provided provided.
detailing any FFE user fee adjustment by the eligible organization for each self- • If the necessary conditions are met,
that will be provided to a participating insured plan with respect to which an and if an exception under OMB Circular
issuer with respect to the costs for adjustment is received; (ii) No. A–25R is in effect, the participating
contraceptive services incurred by or on documentation demonstrating that the issuer will receive an adjustment to its
behalf of the third party administrator, payments for contraceptive services FFE user fee obligation equal to the total
as well as the portion of the user fee were made in compliance with 26 CFR amount of the payments for the
adjustment applied to date. 54.9815–2713A(b)(2) or 29 CFR contraceptive services provided under
Section 156.50(d)(5) specifies that, 2590.715–2713A(b)(2); and (iii) the accommodation, plus an allowance
within 60 calendar days of receipt of documentation supporting the total for administrative costs and margin. If
any adjustment in the FFE user fee, a dollar amount of the payments for the adjustment exceeds the FFE user
participating issuer must pay each third contraceptive services submitted by the fees owed in the month of the initial
party administrator with respect to third party administrator, as described adjustment, any excess adjustment will
which it received any portion of such in paragraph (d)(2)(iii)(D). Although a be carried over to later months, for so
adjustment an amount no less than the commenter argued that the long as the exception under OMB
portion of the adjustment attributable to documentation retention standards Circular No. A–25R is in effect.
the total dollar amount of the payments should be shortened from 10 years to 6 • The allowance, which will be at
for contraceptive services submitted by years, to align with ERISA standards, we least ten percent of the costs of the
the third party administrator, as believe that the finalized standard is payments for the contraceptive services
described in paragraph (d)(2)(iii)(D). appropriate as it aligns with timeframes under the accommodation, will be
HHS expects that the participating under the False Claims Act, 31 U.S.C. specified by HHS in the annual HHS
issuer will also agree to pay each third 3729–3733, and standards used for other notice of benefit and payment
party administrator a portion of such Exchange programs. HHS notes that a parameters.
allowance (and that the apportionment participating issuer or a third party • Within 60 days of receipt of any
will be negotiated between the entities); administrator may satisfy these adjustment, the participating issuer
HHS does not specify such payment in standards by archiving these records must pay the third party administrator
this final regulation, as HHS expects the and ensuring that they are accessible if the portion of the adjustment
entities to work out an arrangement that needed in the event of an investigation, attributable to payments for
best fits their situation. Finally, HHS audit, or other review. contraceptive services made by the third
notes that this provision does not apply To summarize, costs of payments party administrator. No payment is
if the participating issuer made the made for contraceptive services for required with respect to the allowance
payments for contraceptive services on participants and beneficiaries in self- for administrative costs and margin,
although it is expected that the
behalf of the third party administrator, insured group health plans of eligible
as described in paragraph (d)(1)(i), or is organizations under the accommodation participating issuer will agree to pay
in the same issuer group (as defined in described previously will be reimbursed each third party administrator a portion
45 CFR 156.20) as the third party through an adjustment in FFE user fees of such allowance. In addition, no
administrator. as follows: payment is required if the participating
In § 156.50(d)(6) and (7), HHS • The adjustment will be made to the issuer made the payments for the
establishes standards relating to FFE user fees of a participating issuer, contraceptive services under the
documentation and program integrity, if that participating issuer made the accommodation on behalf of the third
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party administrator, or if the provided under 45 CFR 156.50(d)(3)(ii), and therefore qualified for the
participating issuer and third party as licensing and regulatory fees exemption or an accommodation.47
administrator are in the same issuer referenced in 45 CFR 158.161(a), or The final regulations continue to
group. taxes and regulatory fees in the case of provide that the availability of the
Lastly, in response to comments the risk corridors program. For similar exemption or an accommodation be
received, HHS is finalizing a provision reasons, HHS is modifying the provision determined on an employer-by-
clarifying that participating issuers may at 45 CFR 156.80(d) to clarify that, for employer basis, which the Departments
add any amounts paid out to a third the purpose of establishing a single risk continue to believe best balances the
party administrator or incurred by or for pool index rate for a state market, any interests of religious employers and
the participating issuer in contraceptive market-wide adjustments to the index eligible organizations and those of
claims costs under the accommodation rate for expected Exchange user fees employees and their dependents. The
for self-insured group health plans of should include: (1) The expected net Departments are clarifying that, for
eligible organizations provided in these FFE user fee to be paid to HHS; (2) any purposes of these final regulations, any
final regulations, plus the allowance for amounts paid out to a third party nonprofit organization with religious
administrative costs and margin administrator or incurred by or for the objections to contraceptive coverage that
provided under 45 CFR 156.50(d)(3)(ii), participating issuer in contraceptive is part of the same controlled group of
to their net FFE user fee paid to HHS, claims costs under the accommodation corporations or part of the same group
in calculations relating to the index rate for self-insured group health plans of of trades or businesses under common
for the single risk pool under 45 CFR eligible organizations expected to be control (each within the meaning of
156.80(d), the medical loss ratio under credited against user fees payable for section 52(a) or (b) of the Code) with a
45 CFR part 158, and the risk corridors that state market; and (3) the allowance religious employer and/or an eligible
program under 45 CFR 153 subpart F. for administrative costs and margin organization, and that offers coverage
Several commenters noted that provided under 45 CFR 156.50(d)(3)(ii) through the same group health plan as
improperly incorporating the FFE user expected to be credited against user fees such religious employer and/or eligible
fee adjustment provided for under the payable for that state market. organization, is considered to hold itself
final regulation into these calculations HHS clarifies that, if an issuer out as a religious organization and
could lead to unintended consequences. provides payments for contraceptive therefore qualifies for an
For example, if a participating issuer services on behalf of a third party accommodation under these final
were required to incorporate the FFE administrator, such payments are not regulations. Each such organization
user fee adjustment into the calculation directly linked to any of the health must independently satisfy the self-
of the medical loss ratio, but not insurance coverage provided by the certification standard.
allowed to incorporate the cost of the issuer, and the issuer should not E. Religious Freedom Restoration Act
accommodation for self-insured group incorporate the cost of such payments and Other Federal Law
health plans of eligible organizations, into their calculations for the numerator
Some commenters expressed concerns
the adjustment would reduce the with respect to the medical loss ratio or
about the proposed accommodations for
amount reported as licensing and the risk corridors program.
eligible organizations under the
regulatory fees (as described in 45 CFR D. Treatment of Multiple Employer Religious Freedom Restoration Act
158.161(a)). This would result in a Group Health Plans (RFRA) (Pub. L. 103–141) 107 Stat. 1488
lower medical loss ratio. HHS agrees (1993) (codified at 42 U.S.C. 2000bb-
that such a result would not accurately In the case of several employers
offering coverage through a single group 1).48 All such concerns were considered.
reflect the ratio of claims to premiums, But the accommodations for group
as estimated by the medical loss ratio, health plan, the Departments proposed
that each employer be required to health plans established or maintained
for the participating issuer’s insurance by eligible organizations (and group
business, because the FFE user fee independently meet the definition of
religious employer or eligible health insurance coverage provided in
adjustment occurs due to activity not connection with such plans), or student
directly related to the participating organization in order to avail itself of
the exemption or an accommodation health insurance coverage arranged by
issuer’s insurance business. Indeed, eligible organizations that are
under § 156.50(d)(5), the participating with respect to its employees and their
covered dependents. Several institutions of higher education, are not
issuer is required in many required under RFRA. In addition, the
circumstances to pay out the greater commenters supported the proposed
approach of applying the exemption and accommodations for eligible
share of the FFE user fee adjustments to organizations under these final
third party administrators responsible the accommodation on an employer-by-
employer basis. Other commenters regulations do not violate RFRA because
for making (or arranging for another
entity to make) the payments for favored a plan-based approach, allowing 47 Code section 52(a) generally provides that all
contraceptive services. Therefore, HHS any employer offering coverage through employees of all corporations that are members of
clarifies that, for purposes of the the same group health plan as a the same controlled group of corporations,
medical loss ratio and the risk corridors religious employer or eligible including corporations that are at least 50 percent
organization to qualify for the controlled by a common parent corporation, are
program, participating issuers should treated as employed by a single employer. Code
report the sum of: (1) The net FFE user exemption or the accommodation, citing section 52(b) generally provides that all employees
fee paid to HHS; (2) any amounts paid administrative challenges to an of trades or businesses (whether or not
out to a third party administrator or employer-by-employer approach. A few incorporated) that are under common control are
commenters recommended criteria for treated as employed by a single employer.

incurred by or for the participating 48 RFRA provides that the federal government
issuer in contraceptive claims costs determining whether an employer is generally may not ‘‘substantially burden a person’s
under the accommodation for self- affiliated with a religious employer or exercise of religion, even if the burden results from
insured group health plans of eligible eligible organization with which it a rule of general applicability,’’ unless the burden:
offers coverage through a single group ‘‘(1) Is in furtherance of a compelling governmental
organizations provided in these final interest; and (2) is the least restrictive means of
regulations; and (3) the allowance for health plan, such as the control furthering that compelling governmental interest,’’
administrative costs and margin standards in Code section 52(a) and (b), 42 U.S.C. 2000bb–1.
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they do not substantially burden independent choices by employees or result, helping women contribute to
religious exercise, and they serve students and their dependents, who society to the same degree as men.
compelling government interests and have distinct interests and may have Fourth, some commenters suggested
moreover are the least restrictive means their own religious views that differ that certain provisions of the Affordable
to achieve those interests. from those of the eligible organization. Care Act that, in their view, leave some
First, some commenters asserted that Second, some commenters claimed women without contraceptive coverage
the proposed accommodations would that the proposed accommodations with no cost sharing demonstrate that
substantially burden their exercise of would force them to fund or subsidize the government interests in providing
religion by requiring their involvement contraceptive coverage because issuers such coverage cannot be truly
in providing coverage of medical or third party administrators would pass compelling. But these commenters
services to which they object on on the costs of such coverage to eligible misunderstand the effect of these
religious grounds. These final organizations. Again, however, these provisions.49
regulations do not require eligible final regulations specifically prohibit an Nor do the exemption for religious
organizations that provide self- issuer or third party administrator from employers and the accommodations for
certifications to their issuers or third charging any premium, or otherwise eligible organizations undermine the
party administrators to provide health passing on any cost, to an eligible government’s compelling interests. With
coverage that includes benefits for organization with respect to the respect to the religious employer
contraceptive services, or to contract, payments for contraceptive services. exemption, houses of worship and their
arrange, pay, or refer for such coverage Third, some commenters asserted that integrated auxiliaries that object to
or services. Issuers and third party the contraceptive coverage requirement contraceptive coverage on religious
administrators cannot pass along the fails to serve any compelling grounds are more likely than other
costs because these final regulations government interest. As noted employers to employ people who are of
specifically prohibit an issuer or third previously, however, the contraceptive the same faith and/or adhere to the same
party administrator from charging any coverage requirement serves two objection, and who would therefore be
premium or otherwise passing on any compelling governmental interests. The less likely than other people to use
cost relating to payments for contraceptive coverage requirement contraceptive services even if such
contraceptive services to an eligible furthers the government’s compelling services were covered under their plan.
organization. Thus, there is no burden interest in safeguarding public health by Under the eligible organization
on any religious exercise of the eligible expanding access to and utilization of accommodations, individuals in plans
organization. And even if the recommended preventive services for of eligible organizations, who are less
accommodations were found to impose women. HHS tasked IOM with likely than individuals in plans of
some minimal burden on eligible conducting an independent, science- religious employers to share their
organizations, any such burden would based review of the available literature employer’s (or institution of higher
not be substantial for the purposes of to determine what preventive services education’s) faith and objection to
RFRA because a third party pays for the are necessary for women’s health and contraceptive coverage on religious
contraceptive services and there are well-being. IOM included in its grounds, will still benefit from
multiple degrees of separation between recommendations for comprehensive payments for contraceptive services,
the eligible organization and any guidelines for women’s preventive even though such payments will not be
individual’s choice to use contraceptive services all FDA-approved contraceptive provided, funded, or subsidized by their
services. methods, sterilization procedures, and employer (or institution of higher
One commenter contended that the patient education and counseling for education).
mere act of self-certification would women with reproductive capacity. IOM
facilitate access to contraception, determined that lack of access to 49 For example, the Affordable Care Act’s
resulting in violation of its religious contraceptive services has proven in grandfathering provision is only transitional in
beliefs. But the self-certification under many cases to have serious negative effect, and it is expected that a majority of plans
will lose their grandfathered status by the end of
these final regulations simply confirms health consequences for women and 2013. (75 FR 34552; June 17, 2010); see also Kaiser
that an eligible organization is a newborn children. Family Found. & Health Res. & Ed. Trust, Employer
nonprofit religious organization with The government also has a compelling Health Benefits 2012 Annual Survey at 7–8, 190,
religious objections to contraceptive interest in assuring that women have available at http://ehbs.kff.org/pdf/2012/8345.pdf.
equal access to health care services. Moreover, small employers that elect to offer non-
coverage and so informs the issuer or grandfathered health coverage to their employees
third party administrator. Even prior to Women would be denied the full are not exempt from the requirement under the
the proposed regulations, because benefits of preventive care if their preventive health services coverage regulations to
contraceptive benefits are typically in unique health care needs were not provide coverage for recommended preventive
standard product designs, many eligible considered and addressed. For example, health services, including contraceptive services,
without cost sharing (subject to the religious
organizations directed their issuers and prior to the implementation of the employer exemption and eligible organization
third party administrators not to make preventive services coverage provision, accommodations in these final regulations). While
payments for claims for medical women of childbearing age spent 68 the Affordable Care Act excludes small employers
services to which they object on percent more on out-of-pocket health from the possibility of tax liability under the
employer shared responsibility provision at Code
religious grounds. In any event, in order care costs than men, and these costs section 4980H, it encourages such employers to
for a burden on religious exercise to be resulted in women often forgoing offer health coverage to their employees by
‘‘substantial’’ under RFRA, its effects on preventive care. The IOM found that establishing new group health insurance options
the objecting person cannot be as this disproportionate burden on women through the SHOPs, as well as new tax incentives
to exercise such options. With respect to employees

indirect and attenuated as they are here. imposed financial barriers that of small employers that do not offer health coverage
Under these final regulations, third prevented women from achieving health to their employees, the Affordable Care Act
parties, not eligible organizations, outcomes on an equal basis with men. establishes new individual health insurance options
provide the payments for contraceptive The contraceptive coverage requirement through the Exchanges, as well as new tax credits
to assist the purchase of such insurance; such
services, at no cost to eligible helps remedy this problem by helping to insurance will cover recommended preventive
organizations. And whether such equalize the provision of preventive services, including contraceptive services, without
services will be utilized is the result of health care services to women and, as a cost sharing.
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Fifth, some commenters asserted that Exercise Clause because they are neutral eligible organization in these final
the contraceptive coverage requirement and generally applicable. The regulations should not be construed to
is not the least restrictive means of regulations do not target religiously apply with respect to, or relied upon for
advancing these compelling interests, motivated conduct, but rather, are the interpretation of, any other
and proposed various alternatives to intended to improve women’s access to provision of the PHS Act, ERISA, the
these regulations. All of these proposals preventive health care and lessen the Code, or any other provision of federal
were considered, and it was determined disparity between men’s and women’s law, nor is it intended to set a precedent
that they were not feasible and/or would health care costs. And the regulations for any other purpose. For example,
not advance the government’s are generally applicable because they do nothing in these final regulations should
compelling interests as effectively as the not pursue their purpose only against
be construed as affecting the
mechanisms established in these final conduct motivated by religious belief.
interpretation of federal or state civil
regulations and the preventive services The exemption and accommodations set
coverage regulations more generally. For forth in the regulations serve to rights statutes, such as Title VII of the
example, some commenters suggested accommodate religion, not to disfavor it. Civil Rights Act of 1964 or Title IX of
that the government could provide The final regulations also do not the Education Amendments of 1972.
contraceptive services to all women free violate the Establishment Clause. The Furthermore, nothing in these final
of charge (through Medicaid or another exemption and accommodations set regulations precludes employers or
program), establish a government- forth in the regulations are not restricted others from expressing any opposition
funded health benefits program for to organizations of a particular to the use of contraceptives; requires
contraceptive services, or force drug and denomination or denominations. anyone to use contraceptives; or
device manufacturers to provide Instead, they are available on an equal requires health care providers to
contraceptive drugs and devices to basis to religious organizations affiliated prescribe or provide contraceptives if
women for free. The Departments lack with any and all religions. doing so is against their religious
the statutory authority and funding to Finally, the regulations do not violate
beliefs.
implement these proposals. Moreover, federal restrictions relating to abortion
the Affordable Care Act contemplates because FDA-approved contraceptive The Departments received several
providing coverage of recommended methods, including Plan B, Ella, and comments requesting clarification about
preventive services through the existing IUDs, are not abortifacients within the whether the religious employer
employer-based system of health meaning of federal law. (62 FR 8611; exemption and eligible organization
coverage so that women face minimal February 25, 1997) (‘‘Emergency accommodations in these final
logistical and administrative obstacles. contraceptive pills are not effective if regulations supersede state laws that
Imposing additional barriers to women the woman is pregnant[.]’’); 45 CFR require health insurance issuers to
receiving the intended coverage (and its 46.202(f) (‘‘Pregnancy encompasses the provide contraceptive coverage. The
attendant benefits), by requiring them to period of time from implantation until preemption provisions of section 731 of
take steps to learn about, and to sign up delivery.’’). Further, these regulations ERISA and section 2724 of the PHS Act
for, a new health benefit, would make do not require nonprofit religious (implemented at 29 CFR 2590.731(a)
that coverage accessible to fewer organizations that object to such and 45 CFR 146.143(a)) apply such that
women. The same concern undermines contraceptive methods to contract,
the requirements of part 7 of ERISA and
the effectiveness of other commenters’ arrange, pay, or refer for such services.
title XXVII of the PHS Act are not to be
suggestion that the government require F. No Effect on Other Law ‘‘construed to supersede any provision
the multi-state plans on the Exchanges
The religious employer exemption of state law which establishes,
to offer a stand-alone, contraceptive-
only benefit to all women without and eligible organization implements, or continues in effect any
charge. accommodations under these final standard or requirement solely relating
For another example, some regulations are intended to have to health insurance issuers in
commenters suggested that the meaning solely with respect to the connection with group or individual
government should establish tax contraceptive coverage requirement health insurance coverage except to the
incentives for women to use under section 2713 of the PHS Act and extent that such standard or
contraceptive services. Again, the the companion provisions of ERISA and requirement prevents the application of
Departments lack the statutory authority the Code. Whether an employer or a requirement’’ of federal law. With
to implement such proposal. Reliance organization (including an institution of respect to issuers subject to state law,
only on tax incentives would also higher education) is designated as insurance laws that provide greater
depart from the existing employer-based religious for this purpose is not access to contraceptive coverage than
system of health coverage, would intended as a judgment about the federal standards are unlikely to
require women to pay out of pocket for mission, sincerity, or commitment of the ‘‘prevent the application of’’ the
their care in the first instance, and employer or organization (including an
preventive services coverage provision,
would not benefit women who do not institution of higher education), or
and therefore are unlikely to be
have sufficient income to be required to intended to differentiate among the
preempted by these final regulations.
file a tax return. Such barriers would religious merits, mission, sincerity,
commitment, or public or private On the other hand, in states with
make a tax incentive structure less
standing of religious entities. The use of broader religious exemptions and
effective than the employer-based
such designation is limited solely to accommodations with respect to health
system of health coverage in advancing

the government’s compelling interests. defining the class of employers or insurance issuers than those in the final
Finally, some commenters expressed organizations (including institutions of regulations, the exemptions and
concern that the final regulations violate higher education) that qualify for the accommodations will be narrowed to
the Religion Clauses of the First religious employer exemption and align with those in the final regulations.
Amendment or certain federal eligible organization accommodations This is consistent with the application
restrictions relating to abortion. The under these final regulations. The of other federal health insurance
regulations do not violate the Free definition of religious employer or standards.
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G. Applicability Dates and Transitional quantifying both costs and benefits, 6033(a)(3)(A)(i) or (iii) of the Code is a
Enforcement Safe Harbor reducing costs, harmonizing rules, and religious employer, and its group health
These final regulations generally promoting flexibility. plan qualifies for the exemption from
apply to group health plans and health Section 3(f) of Executive Order 12866 the requirement to cover contraceptive
insurance issuers for plan years defines a ‘‘significant regulatory action’’ services. In addition, the final
beginning on or after January 1, 2014, as an action that is likely to result in a regulations establish accommodations
except the amendments to the religious regulation: (1) Having an annual effect that provide women with access to such
employer exemption apply to group on the economy of $100 million or more services, without cost sharing, while
health plans and health insurance in any one year, or adversely and simultaneously protecting certain
issuers for plan years beginning on or materially affecting a sector of the nonprofit religious organizations with
after August 1, 2013. economy, productivity, competition, religious objections to contraceptive
The Departments are extending the jobs, the environment, public health or coverage from having to contract,
current safe harbor from enforcement of safety, or state, local, or tribal arrange, pay, or refer for such coverage
the contraceptive coverage requirement governments or communities (also (as detailed herein).
by the Departments to encompass plan referred to as ‘‘economically
significant’’); (2) creating a serious 2. Anticipated Effects
years beginning on or after August 1,
2013, and before January 1, 2014. This inconsistency or otherwise interfering The Departments expect that these
transitional enforcement safe harbor is with an action taken or planned by final regulations will not result in any
intended to maintain the status quo another agency; (3) materially altering additional significant burden on or costs
with respect to organizations that the budgetary impacts of entitlement to the affected entities.
qualify for the current safe harbor grants, user fees, or loan programs or the B. Special Analyses—Department of the
during the period that exists between rights and obligations of recipients Treasury
the expiration of the current safe thereof; or (4) raising novel legal or
policy issues arising out of legal For purposes of the Department of the
harbor 50 and the applicability date of Treasury, it has been determined that
the accommodations under these final mandates, the President’s priorities, or
the principles set forth in the Executive this Treasury decision is not a
regulations. This period is designed to significant regulatory action as defined
provide issuers and third party Order.
A regulatory impact analysis must be in Executive Order 12866, as amended
administrators with sufficient time to by Executive Order 13563. Therefore, a
prepare to implement the prepared for major rules with
economically significant effects ($100 regulatory assessment is not required. It
accommodations under these final has also been determined that section
regulations. Organizations that qualify million or more in any one year), and
an ‘‘economically significant’’ 553(b) of the Administrative Procedure
under the current safe harbor are not Act (5 U.S.C. chapter 5) does not apply
required to execute another self- regulatory action is subject to review by
the Office of Management and Budget to this final regulation. It is hereby
certification if one has already been certified that the collections of
executed, but are required to provide (OMB). The Departments have
concluded that these final regulations information contained in this final
another notice to plan participants and regulation do not have a significant
beneficiaries in connection with plan are not likely to have economic impacts
of $100 million or more in any one year, impact on a substantial number of small
years beginning on or after August 1, entities. Accordingly, a regulatory
2013, and before January 1, 2014. The and therefore do not meet the definition
of ‘‘economically significant’’ under flexibility analysis under the Regulatory
guidance extending the current safe Flexibility Act (5 U.S.C. chapter 6) is
harbor can be found at: www.cms.gov/ Executive Order 12866.
not required.
cciio and www.dol.gov/healthreform. 1. Need for Regulatory Action These final regulations require each
IV. Economic Impact and Paperwork As stated earlier in this preamble, the organization seeking to be treated as an
Burden Departments previously issued eligible organization under the final
amended interim final regulations regulations to self-certify that it meets
A. Executive Orders 12866 and 13563— authorizing an exemption for group the definition of eligible organization in
Department of Health and Human health plans established or maintained the final regulations. The self-
Services and Department of Labor by religious employers (and group certification must be executed by an
Executive Orders 12866 and 13563 health insurance coverage provided in authorized representative of the
direct agencies to assess all costs and connection with such plans) from organization. The organization must
benefits of available regulatory certain coverage requirements under maintain the self-certification in its
alternatives and, if regulation is section 2713 of the PHS Act (76 FR records in a manner consistent with
necessary, to select regulatory 46621, August 3, 2011). The amended ERISA section 107 and make it available
approaches that maximize net benefits interim final regulations were finalized for examination upon request. The final
(including potential economic, on February 15, 2012 (77 FR 8725). In regulations also direct each eligible
environmental, and public health and these final regulations, the Departments organization to provide a copy of its
safety effects; distributive impacts; and are amending the definition of religious self-certification to the group health
equity). Executive Order 13563 employer in the HHS regulation at 45 insurance issuer or third party
emphasizes the importance of CFR 147.131(a) (incorporated by administrator (as applicable) to avail
reference in the regulations of the itself of an accommodation. The
50 See Guidance on the Temporary Enforcement
Departments of Labor and the Treasury) Departments are unable to estimate the
Safe Harbor for Certain Employers, Group Health

Plans, and Group Health Insurance Issuers with
by eliminating the first three prongs of number of organizations that will seek
Respect to the Requirement to Cover Contraceptive the definition of religious employer that to be treated as eligible organizations. Of
Services Without Cost Sharing Under Section 2713 was established in the 2012 final the eligible organizations, some will
of the Public Health Service Act, Section 715(a)(1) regulations and clarifying the fourth likely be small entities. It is estimated
of the Employee Retirement Income Security Act,
and Section 9815(a)(1) of the Internal Revenue
prong. Accordingly, an employer that is that each eligible organization will need
Code, issued on February 10, 2012, and reissued on organized and operates as a nonprofit only approximately 50 minutes of labor
August 15, 2012. entity and is referred to in section to prepare and provide the information
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in the self-certification. This will not be (including fringe benefits) used to that an organization will need
a significant economic impact. For these estimate the costs are calculated using approximately 50 minutes (30 minutes
reasons, this information collection data available from the Bureau of Labor of clerical labor at a cost of $30.64 per
requirement will not have a significant Statistics. hour, 10 minutes for a manager at a cost
impact on a substantial number of small HHS sought comments in the of $55.22 per hour, 5 minutes for legal
entities. proposed regulations, but did not counsel at a cost of $83.10 per hour, and
These final regulations also require receive any information that would 5 minutes for a senior executive at a cost
health insurance issuers providing allow for an estimate of the number of of $112.43 per hour) to execute the self-
payments for contraceptive services, or organizations that would seek to be certification. The certification may be
third party administrators arranging or treated as eligible organizations, or an electronically transmitted to the issuer
providing such payments (or their estimate of the number of health at minimal cost. Therefore, the total
agents), to provide written notice to insurance issuers that would provide annual burden for preparing and
plan participants and beneficiaries separate payments for contraceptive providing the information in the self-
regarding the availability of such services. HHS is, nevertheless, seeking certification is estimated to be
payments. The notice will be provided OMB approval for the following ICRs approximately $41 for each eligible
contemporaneous with (to the extent consistent with the Paperwork organization.
possible) but separate from any Reduction Act of 1995. The burden
application materials distributed in estimates will be updated in the future 2. Notice of Availability of Separate
connection with enrollment (or re- when more information is available. Payments for Contraceptive Services
enrollment) in health coverage (§ 147.131(d))
1. Self-Certification (§§ 147.131(b)(4) The proposed regulations sought
established, maintained, or arranged by
and 147.131(c)(1)) comment on a notice of availability of
the eligible organization in any plan
year to which the accommodation is to Each organization seeking to be contraceptive coverage. The final
apply. The final regulations contain treated as an eligible organization under regulations instead direct a health
model language for issuers and third the final regulations must self-certify insurance issuer providing payments for
party administrators to use to satisfy the that it meets the definition of an eligible contraceptive services for participants
notice requirement. It is unknown how organization. The self-certification must and beneficiaries in insured plans (or
many issuers provide health insurance be executed by an authorized student enrollees and covered
coverage in connection with insured representative of the organization. The dependents in student health insurance
plans of eligible organizations or how self-certification will not be submitted coverage) of eligible organizations to
many third party administrators provide to any of the Departments. The form that provide a written notice to such plan
plan services to self-insured plans of will be used by organizations for their participants and beneficiaries (or such
eligible organizations. However, the cost self-certification was made available student enrollees and covered
of preparation and distribution of the during the comment period for the dependents) informing them of the
notices will not be significant. It is proposed regulations at http:// availability of such payments. The
estimated that each issuer or third party www.cms.gov/Regulations-and- notice must be provided
administrator will need approximately 1 Guidance/Legislation/ contemporaneous with (to the extent
hour of clerical labor (at $31.64 per PaperworkReductionActof1995/PRA- possible) but separate from any
hour) and 15 minutes of management Listing.html. HHS is finalizing this form application materials distributed in
review (at $55.22 per hour) to prepare with updated instructions and notes, connection with enrollment (or re-
the notices for a total cost of and eliminating the proposed field for enrollment) in group health coverage
approximately $44. It is estimated that listing the contraceptive services for that is effective on the first day of each
each notice will require $0.46 in postage which the organization will not applicable plan year, and must specify
and $0.05 in materials cost (paper and establish, maintain, administer, or fund that contraceptive coverage will not be
ink) and the total postage and materials coverage. The organization must funded or administered by the eligible
cost for each notice sent via mail will be maintain the self-certification in its organization but that the issuer provides
$0.51. For these reasons, these records in a manner consistent with separate payments for contraceptive
information collection requirements ERISA section 107 and make it available services. The notice must also provide
will not have a significant impact on a for examination upon request. The contact information for the issuer for
substantial number of small entities. eligible organization must provide a questions and complaints. To satisfy the
Pursuant to section 7805(f) of the copy of its self-certification to a health notice requirement, issuers may use the
Code, the notice of proposed rulemaking insurance issuer for insured group model language set forth in the final
preceding this final regulation was health plans or student health insurance regulations or substantially similar
submitted to the Chief Counsel for coverage. language.
Advocacy of the Small Business HHS is unable to estimate the number It is unknown how many issuers
Administration for comment on its of organizations that will seek to be provide health insurance coverage in
impact on small businesses. treated as eligible organizations under connection with insured plans of
the final regulations. Therefore, the eligible organizations. In the proposed
C. Paperwork Reduction Act— burden for only one eligible regulations, HHS estimated that each
Department of Health and Human organization, as opposed to all eligible issuer would need approximately 1 hour
Services organizations in total, is estimated. It is of clerical labor (at $31.64 per hour) and
These final regulations contain assumed that, for each eligible 15 minutes of management review (at
information collection requirements organization, clerical staff will gather $55.22 per hour) to prepare the notices
(ICRs) that are subject to review by the and enter the necessary information, for a total cost of approximately $44. It
Office of Management and Budget send the self-certification electronically was estimated that each notice would
(OMB). A description of these to the issuer, and retain a copy for require $0.46 in postage and $0.05 in
provisions is given in the following record-keeping; a manager and legal materials cost (paper and ink) and the
paragraphs with an estimate of the counsel will review it; and a senior total postage and materials cost for each
annual burden. Average labor costs executive will execute it. HHS estimates notice sent via mail would be $0.51.
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One commenter stated that the cost of beneficiaries in self-insured group covered employee benefit plan, and
preparing and sending these notices health plans of eligible organizations, preserves state laws that regulate
may be greater than estimated, but did instead of applying to health insurance insurance, banking, or securities. ERISA
not provide an estimate. HHS believes issuers in connection with disclosures also prohibits states from regulating a
that using the model language provided to participants and beneficiaries in covered plan as an insurance or
in the final regulations will help insured group health plans of eligible investment company or bank. The
minimize costs and declines to revise organizations. Therefore, we are seeking Health Insurance Portability and
the estimate. OMB approval for this notice, relying on Accountability Act of 1996 (HIPAA)
3. Collections for FFE User Fee the same estimates noted previously. added a new preemption provision to
Adjustment (§ 156.50(d)) ERISA (as well as to the PHS Act)
V. Unfunded Mandates Reform Act
narrowly preempting state requirements
The final HHS regulation describes For purposes of the Unfunded on group health insurance coverage.
information collections with respect to Mandates Reform Act of 1995 (Pub. L. States may continue to apply state law
the FFE user fee adjustment under 104–4), as well as Executive Order requirements but not to the extent that
§ 156.50(d). The information collection 12875, these final regulations do not such requirements prevent the
instruments are under development, include any federal mandate that may application of the federal requirement
and HHS will seek public comments result in expenditures by state, local, or that group health insurance coverage
and OMB approval on the instruments tribal governments, nor do they include provided in connection with group
at a later date, consistent with the any federal mandates that may impose health plans provide coverage for
Paperwork Reduction Act of 1995. an annual burden of $100 million, specified preventive services without
4. Collections for Self-Insured Group adjusted for inflation, or more on the cost sharing. HIPAA’s Conference
Health Plans Without Third Party private sector.51 Report states that the conferees intended
Administrators VI. Federalism—Department of Health the narrowest preemption of state laws
and Human Services and Department of with regard to health insurance issuers
The final regulations provide that a
Labor (H.R. Conf. Rep. No. 104–736, 104th
self-insured group health plan
Cong. 2d Session 205, 1996). State
established or maintained by an eligible Executive Order 13132 outlines insurance laws that are more stringent
organization that does not use the fundamental principles of federalism, than the federal requirement are
services of a third party administrator and requires the adherence to specific unlikely to ‘‘prevent the application of’’
will be provided a safe harbor from criteria by federal agencies in the the preventive services coverage
enforcement of the contraceptive process of their formulation and provision, and therefore are unlikely to
coverage requirement by the implementation of policies that have be preempted. Accordingly, states have
Departments contingent on, among ‘‘substantial direct effects’’ on states, the significant latitude to impose
other things: (1) the plan providing relationship between the federal requirements on health insurance
certain information to HHS; and (2) the government and states, or the issuers that are more restrictive than
plan providing participants and distribution of power and those in federal law.
beneficiaries with notice that it does not responsibilities among the various Guidance conveying this
provide benefits for contraceptive levels of government. Federal agencies interpretation was published in the
services. As noted earlier in these final promulgating regulations that have Federal Register on April 8, 1997 (62 FR
regulations, the Departments believe these federalism implications must 16904) and December 30, 2004 (69 FR
that there are no self-insured group consult with state and local officials, 78720), and these final regulations
health plans in this circumstance. and describe the extent of their implement the preventive services
Therefore, because the number of consultation and the nature of the coverage provision’s minimum
respondents is likely to be fewer than concerns of state and local officials in standards and do not significantly
10, HHS is not seeking OMB approval the preamble to the regulation. reduce the discretion given to states
for this collection. In the Departments’ view, these final under the statutory scheme.
D. Paperwork Reduction Act— regulations have federalism The PHS Act provides that states may
Department of Labor and Department of implications, but the federal enforce the provisions of title XXVII of
the Treasury implications are substantially mitigated the PHS Act as they pertain to issuers,
because, with respect to health but that the Secretary of HHS will
As noted previously, as under the insurance issuers, 15 states have
proposed regulations, each organization enforce any provisions that a state does
enacted specific laws, regulations, or not have authority to enforce or that a
seeking to be treated as an eligible bulletins that meet or exceed the federal
organization under the final regulations state has failed to substantially enforce.
standards requiring coverage of When exercising its responsibility to
must self-certify that it meets the specified preventive services without
definition of an eligible organization. enforce provisions of the PHS Act, HHS
cost sharing. The remaining states, works cooperatively with the state to
This requirement is set out at 26 CFR which provide oversight for these
54.9815–2713A(a)(4) and 29 CFR address the state’s concerns and avoid
federal law requirements, do so using conflicts with the state’s exercise of its
2590.715–2713A(a)(4) of the final their general authority to enforce these
regulations of the Departments of Labor authority.52 HHS has developed
federal standards. Therefore, the final procedures to implement its
and the Treasury. regulations are not likely to require
In addition, the final regulations
substantial additional oversight of states 52 This authority applies to insurance issued with
include a notice of availability of by HHS. respect to group health plans generally, including
separate payments for contraceptive In general, section 514 of ERISA plans covering employees of church organizations.
services. This notice requirement is provides that state laws are superseded Thus, this discussion of federalism applies to all
identical to that set forth in 45 CFR group health insurance coverage that is subject to
to the extent that they relate to any the PHS Act, including those church plans that
147.131(d), but it applies to third party provide coverage through a health insurance issuer
administrators in connection with 51 In 2013, that threshold level is approximately (but not to church plans that do not provide
disclosures to participants and $141 million. coverage through a health insurance issuer).
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enforcement responsibilities, and to 29 CFR Part 2590 provided for in binding comprehensive
afford states the maximum opportunity Continuation coverage, Disclosure, health plan coverage guidelines
to enforce the PHS Act’s requirements Employee benefit plans, Group health supported by the Health Resources and
in the first instance. In compliance with plans, Health care, Health insurance, Services Administration, in accordance
Executive Order 13132’s requirement Medical child support, Reporting and with 45 CFR 147.131(a).
that agencies examine closely any recordkeeping requirements. * * * * *
policies that may have federalism ■ Par. 3. Section 54.9815–2713A is
implications or limit the policymaking 45 CFR Part 147
added to read as follows:
discretion of states, the Departments Health care, Health insurance,
have engaged in numerous efforts to Reporting and recordkeeping § 54.9815–2713A Accommodations in
consult and work cooperatively with requirements, and State regulation of connection with coverage of preventive
affected state and local officials. health services.
health insurance.
In conclusion, throughout the process (a) Eligible organizations. An eligible
of developing these final regulations, to 45 CFR Part 156 organization is an organization that
the extent feasible within the specific Administrative practice and satisfies all of the following
preemption provisions of ERISA and the procedure, Advertising, Advisory requirements:
PHS Act, the Departments have committees, Brokers, Conflict of (1) The organization opposes
attempted to balance states’ interests in interest, Consumer protection, Grant providing coverage for some or all of
regulating health coverage and health programs—health, Grants any contraceptive services required to
insurance issuers, and the rights of administration, Health care, Health be covered under § 54.9815–
those individuals whom Congress insurance, Health maintenance 2713(a)(1)(iv) on account of religious
intended to protect in the PHS Act, organization (HMO), Health records, objections.
ERISA, and the Code. Hospitals, American Indian/Alaska (2) The organization is organized and
Natives, Individuals with disabilities, operates as a nonprofit entity.
VII. Statutory Authority (3) The organization holds itself out as
Loan programs—health, Organization
The Department of the Treasury a religious organization.
and functions (Government agencies),
regulations are adopted pursuant to the (4) The organization self-certifies, in a
Medicaid, Public assistance programs,
authority contained in sections 7805 form and manner specified by the
Reporting and recordkeeping
and 9833 of the Code. Secretaries of Health and Human
The Department of Labor regulations requirements, State and local
Services and Labor, that it satisfies the
are adopted pursuant to the authority governments, Sunshine Act, Technical
criteria in paragraphs (a)(1) through (3)
contained in 29 U.S.C. 1002(16), 1027, assistance, Women, and Youth.
of this section, and makes such self-
1059, 1135, 1161–1168, 1169, 1181– DEPARTMENT OF THE TREASURY certification available for examination
1183, 1181 note, 1185, 1185a, 1185b, upon request by the first day of the first
1185d, 1191, 1191a, 1191b, and 1191c; Internal Revenue Service
plan year to which the accommodation
sec. 101(g), Public Law 104–191, 110 Accordingly, 26 CFR part 54 is in paragraph (b) or (c) of this section
Stat. 1936; sec. 401(b), Public Law 105– amended as follows: applies. The self-certification must be
200, 112 Stat. 645 (42 U.S.C. 651 note); executed by a person authorized to
sec. 512(d), Public Law 110–343, 122 PART 54—PENSION EXCISE TAXES
make the certification on behalf of the
Stat. 3881; sec. 1001, 1201, and 1562(e), organization, and must be maintained in
■ Paragraph 1. The authority citation
Public Law 111–148, 124 Stat. 119, as a manner consistent with the record
for part 54 continues to read, in part, as
amended by Public Law 111–152, 124 retention requirements under section
follows:
Stat. 1029; Secretary of Labor’s Order 3– 107 of ERISA.
2010, 75 FR 55354 (September 10, Authority: 26 U.S.C. 7805. * * * (b) Contraceptive coverage—self-
2010). ■ Par. 2. Section 54.9815–2713 is insured group health plans—(1) A group
The Department of Health and Human amended by revising paragraphs (a)(1) health plan established or maintained
Services regulations are adopted introductory text and (a)(1)(iv) to read as by an eligible organization that provides
pursuant to the authority contained in follows: benefits on a self-insured basis complies
sections 2701 through 2763, 2791, and for one or more plan years with any
2792 of the PHS Act (42 U.S.C. 300gg § 54.9815–2713 Coverage of preventive requirement under § 54.9815–
through 300gg–63, 300gg–91, and health services.
2713(a)(1)(iv) to provide contraceptive
300gg–92), as amended; and Title I of (a) * * * coverage if all of the requirements of
the Affordable Care Act, sections 1301– (1) In general. Beginning at the time this paragraph (b)(1) of this section are
1304, 1311–1312, 1321–1322, 1324, described in paragraph (b) of this satisfied:
1334, 1342–1343, 1401–1402, and 1412, section and subject to § 54.9815–2713A, (i) The eligible organization or its plan
Pub. L. 111–148, 124 Stat. 119 (42 a group health plan, or a health contracts with one or more third party
U.S.C. 18021–18024, 18031–18032, insurance issuer offering group health administrators.
18041–18042, 18044, 18054, 18061, insurance coverage, must provide (ii) The eligible organization provides
18063, 18071, 18082, 26 U.S.C. 36B, and coverage for all of the following items each third party administrator that will
31 U.S.C. 9701). and services, and may not impose any process claims for any contraceptive
cost-sharing requirements (such as a services required to be covered under
List of Subjects
copayment, coinsurance, or a § 54.9815–2713(a)(1)(iv) with a copy of
26 CFR Part 54 deductible) with respect to those items the self-certification described in
Excise taxes, Health care, Health and services: paragraph (a)(4) of this section, which
insurance, Pensions, Reporting and * * * * * shall include notice that—
recordkeeping requirements. (iv) With respect to women, to the (A) The eligible organization will not
extent not described in paragraph act as the plan administrator or claims
29 CFR Part 2510 (a)(1)(i) of this section, evidence- administrator with respect to claims for
Employee benefit plans, Pensions. informed preventive care and screenings contraceptive services, or contribute to
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the funding of contraceptive services; more group health insurance issuers (d) Notice of availability of separate
and complies for one or more plan years payments for contraceptive services—
(B) Obligations of the third party with any requirement under § 54.9815– self-insured and insured group health
administrator are set forth in 29 CFR 2713(a)(1)(iv) to provide contraceptive plans. For each plan year to which the
2510.3–16 and 26 CFR 54.9815–2713A. coverage if the eligible organization or accommodation in paragraph (b) or (c)
(iii) The eligible organization must group health plan furnishes a copy of of this section is to apply, a third party
not, directly or indirectly, seek to the self-certification described in administrator required to provide or
interfere with a third party paragraph (a)(4) of this section to each arrange payments for contraceptive
administrator’s arrangements to provide issuer that would otherwise provide services pursuant to paragraph (b) of
or arrange separate payments for such coverage in connection with the this section, and an issuer required to
contraceptive services for participants group health plan. An issuer may not provide payments for contraceptive
or beneficiaries, and must not, directly require any documentation other than services pursuant to paragraph (c) of
or indirectly, seek to influence the third the copy of the self-certification from this section, must provide to plan
party administrator’s decision to make the eligible organization regarding its participants and beneficiaries written
any such arrangements. status as such. notice of the availability of separate
(2) If a third party administrator (2) Payments for contraceptive payments for contraceptive services
receives a copy of the self-certification services—(i) A group health insurance contemporaneous with (to the extent
described in paragraph (a)(4) of this issuer that receives a copy of the self- possible), but separate from, any
section, and agrees to enter into or certification described in paragraph application materials distributed in
remain in a contractual relationship (a)(4) of this section with respect to a connection with enrollment (or re-
with the eligible organization or its plan group health plan established or enrollment) in group health coverage
to provide administrative services for maintained by an eligible organization that is effective beginning on the first
the plan, the third party administrator in connection with which the issuer day of each applicable plan year. The
shall provide or arrange payments for would otherwise provide contraceptive notice must specify that the eligible
contraceptive services using one of the coverage under § 54.9815–2713(a)(1)(iv) organization does not administer or
following methods— must— fund contraceptive benefits, but that the
(i) Provide payments for contraceptive
(A) Expressly exclude contraceptive third party administrator or issuer, as
services for plan participants and
coverage from the group health applicable, provides separate payments
beneficiaries without imposing any cost-
insurance coverage provided in for contraceptive services, and must
sharing requirements (such as a
connection with the group health plan; provide contact information for
copayment, coinsurance, or a
and questions and complaints. The
deductible), or imposing a premium,
(B) Provide separate payments for any following model language, or
fee, or other charge, or any portion
contraceptive services required to be substantially similar language, may be
thereof, directly or indirectly, on the
covered under § 54.9815–2713(a)(1)(iv) used to satisfy the notice requirement of
eligible organization, the group health
for plan participants and beneficiaries this paragraph (d): ‘‘Your employer has
plan, or plan participants or
for so long as they remain enrolled in certified that your group health plan
beneficiaries; or
the plan. qualifies for an accommodation with
(ii) Arrange for an issuer or other
(ii) With respect to payments for respect to the federal requirement to
entity to provide payments for
contraceptive services, the issuer may cover all Food and Drug
contraceptive services for plan
not impose any cost-sharing Administration-approved contraceptive
participants and beneficiaries without
requirements (such as a copayment, services for women, as prescribed by a
imposing any cost-sharing requirements
coinsurance, or a deductible), or impose health care provider, without cost
(such as a copayment, coinsurance, or a
any premium, fee, or other charge, or sharing. This means that your employer
deductible), or imposing a premium,
any portion thereof, directly or will not contract, arrange, pay, or refer
fee, or other charge, or any portion
indirectly, on the eligible organization, for contraceptive coverage. Instead,
thereof, directly or indirectly, on the
the group health plan, or plan [name of third party administrator/
eligible organization, the group health
participants or beneficiaries. The issuer health insurance issuer] will provide or
plan, or plan participants or
must segregate premium revenue arrange separate payments for
beneficiaries.
(3) If a third party administrator collected from the eligible organization contraceptive services that you use,
provides or arranges payments for from the monies used to provide without cost sharing and at no other
contraceptive services in accordance payments for contraceptive services. cost, for so long as you are enrolled in
with either paragraph (b)(2)(i) or (ii) of The issuer must provide payments for your group health plan. Your employer
this section, the costs of providing or contraceptive services in a manner that will not administer or fund these
arranging such payments may be is consistent with the requirements payments. If you have any questions
reimbursed through an adjustment to under sections 2706, 2709, 2711, 2713, about this notice, contact [contact
the Federally-facilitated Exchange user 2719, and 2719A of the PHS Act, as information for third party
fee for a participating issuer pursuant to incorporated into section 9815. If the administrator/health insurance issuer].’’
45 CFR 156.50(d). group health plan of the eligible (e) Reliance—insured group health
(4) A third party administrator may organization provides coverage for some plans—(1) If an issuer relies reasonably
not require any documentation other but not all of any contraceptive services and in good faith on a representation by
than the copy of the self-certification required to be covered under § 54.9815– the eligible organization as to its
from the eligible organization regarding 2713(a)(1)(iv), the issuer is required to eligibility for the accommodation in
its status as such. provide payments only for those paragraph (c) of this section, and the
(c) Contraceptive coverage—insured contraceptive services for which the representation is later determined to be
group health plans—(1) General rule. A group health plan does not provide incorrect, the issuer is considered to
group health plan established or coverage. However, the issuer may comply with any requirement under
maintained by an eligible organization provide payments for all contraceptive § 54.9815–2713(a)(1)(iv) to provide
that provides benefits through one or services, at the issuer’s option. contraceptive coverage if the issuer
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complies with the obligations under this ERISA for any contraceptive services coverage for all of the following items
section applicable to such issuer. required to be covered under and services, and may not impose any
(2) A group health plan is considered § 2590.715–2713(a)(1)(iv) of this chapter cost-sharing requirements (such as a
to comply with any requirement under to which the eligible organization copayment, coinsurance, or a
§ 54.9815–2713(a)(1)(iv) to provide objects on religious grounds, and shall deductible) with respect to those items
contraceptive coverage if the plan supersede any earlier designation. A and services:
complies with its obligations under third party administrator that becomes a * * * * *
paragraph (c) of this section, without plan administrator pursuant to this (iv) With respect to women, to the
regard to whether the issuer complies section shall be responsible for— extent not described in paragraph
with the obligations under this section (1) The plan’s compliance with (a)(1)(i) of this section, evidence-
applicable to such issuer. section 2713 of the Public Health informed preventive care and screenings
Service Act (42 U.S.C. 300gg–13) (as provided for in binding comprehensive
DEPARTMENT OF LABOR
incorporated into section 715 of ERISA) health plan coverage guidelines
Employee Benefits Security and § 2590.715–2713 of this chapter supported by the Health Resources and
Administration with respect to coverage of Services Administration, in accordance
For the reasons stated in the contraceptive services. To the extent with 45 CFR 147.131(a).
preamble, the Department of Labor that the plan contracts with different
* * * * *
amends 29 CFR parts 2510 and 2590 as third party administrators for different
classifications of benefits (such as ■ 5. Section 2590.715–2713A is added
follows:
prescription drug benefits versus to read as follows:
PART 2510—DEFINITION OF TERMS inpatient and outpatient benefits), each § 2590.715–2713A Accommodations in
USED IN SUBCHAPTERS C, D, E, F, G third party administrator is responsible connection with coverage of preventive
AND L OF THIS CHAPTER for providing contraceptive coverage health services.
that complies with section 2713 of the (a) Eligible organizations. An eligible
■ 1. The authority citation for part 2510 Public Health Service Act (as
is revised to read as follows: organization is an organization that
incorporated into section 715 of ERISA) satisfies all of the following
Authority: 29 U.S.C. 1002(2), 1002(16), and § 2590.715–2713 of this chapter requirements:
1002(21),1002(37), 1002(38), 1002(40), 1031, with respect to the classification or
and 1135; Secretary of Labor’s Order 1–2003,
(1) The organization opposes
classifications of benefits subject to its providing coverage for some or all of
68 FR 5374; Sec. 2510.3–101 also issued contract.
under sec. 102 of Reorganization Plan No. 4 any contraceptive services required to
of 1978, 43 FR 47713, 3 CFR, 1978 Comp.,
(2) Establishing and operating a be covered under § 2590.715–
p. 332 and E.O. 12108, 44 FR 1065, 3 CFR, procedure for determining such claims 2713(a)(1)(iv) on account of religious
1978 Comp., p. 275, and 29 U.S.C. 1135 note. for contraceptive services in accordance objections.
Sec. 2510.3–102 also issued under sec. 102 with § 2560.503–1 of this chapter. (2) The organization is organized and
of Reorganization Plan No. 4 of 1978, 43 FR (3) Complying with disclosure and operates as a nonprofit entity.
47713, 3 CFR, 1978 Comp., p. 332 and E.O. other requirements applicable to group (3) The organization holds itself out as
12108, 44 FR 1065, 3 CFR, 1978 Comp., p. health plans under Title I of ERISA with
275. Sec. 2510.3–38 is also issued under sec. a religious organization.
respect to such benefits. (4) The organization self-certifies, in a
1, Pub. L. 105–72, 111 Stat. 1457.
PART 2590—RULES AND form and manner specified by the
■ 2. Section 2510.3–16 is added to read
REGULATIONS FOR GROUP HEALTH Secretary, that it satisfies the criteria in
as follows:
PLANS paragraphs (a)(1) through (3) of this
§ 2510.3–16 Definition of ‘‘plan section, and makes such self-
administrator.’’ ■ 3. The authority citation for part 2590 certification available for examination
(a) In general. The term ‘‘plan is revised to read as follows: upon request by the first day of the first
administrator’’ or ‘‘administrator’’ Authority: 29 U.S.C. 1027, 1059, 1135, plan year to which the accommodation
means the person specifically so 1161–1168, 1169, 1181–1183, 1181 note, in paragraph (b) or (c) of this section
designated by the terms of the 1185, 1185a, 1185b, 1185d, 1191, 1191a, applies. The self-certification must be
instrument under which the plan is 1191b, and 1191c; sec. 101(g), Pub. L. 104– executed by a person authorized to
operated. If an administrator is not so 191, 110 Stat. 1936; sec. 401(b), Pub. L. 105– make the certification on behalf of the
designated, the plan administrator is the 200, 112 Stat. 645 (42 U.S.C. 651 note); sec. organization, and must be maintained in
12(d), Pub. L. 110–343, 122 Stat. 3881; sec. a manner consistent with the record
plan sponsor, as defined in section 1001, 1201, and 1562(e), Pub. L. 111–148,
3(16)(B) of ERISA. 124 Stat. 119, as amended by Pub. L. 111– retention requirements under section
(b) In the case of a self-insured group 152, 124 Stat. 1029; Secretary of Labor’s 107 of ERISA.
health plan established or maintained Order 1–2011, 77 FR 1088 (January 9, 2012). (b) Contraceptive coverage—self-
by an eligible organization, as defined in insured group health plans—(1) A group
■ 4. Section 2590.715–2713 is amended
§ 2590.715–2713A(a) of this chapter, the health plan established or maintained
by revising paragraphs (a)(1)
copy of the self-certification provided by an eligible organization that provides
introductory text and (a)(1)(iv) to read as
by the eligible organization to a third benefits on a self-insured basis complies
follows:
party administrator (including notice of for one or more plan years with any
the eligible organization’s refusal to § 2590.715–2713 Coverage of preventive requirement under § 2590.715–
administer or fund contraceptive health services. 2713(a)(1)(iv) to provide contraceptive
benefits) in accordance with (a) * * * coverage if all of the requirements of

§ 2590.715–2713A(b)(1)(ii) of this (1) In general. Beginning at the time this paragraph (b)(1) are satisfied:
chapter shall be an instrument under described in paragraph (b) of this (i) The eligible organization or its plan
which the plan is operated, shall be section and subject to § 2590.715– contracts with one or more third party
treated as a designation of the third 2713A, a group health plan, or a health administrators.
party administrator as the plan insurance issuer offering group health (ii) The eligible organization provides
administrator under section 3(16) of insurance coverage, must provide each third party administrator that will
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process claims for any contraceptive fee for a participating issuer pursuant to If the group health plan of the eligible
services required to be covered under 45 CFR 156.50(d). organization provides coverage for some
§ 2590.715–2713(a)(1)(iv) with a copy of (4) A third party administrator may but not all of any contraceptive services
the self-certification described in not require any documentation other required to be covered under
paragraph (a)(4) of this section, which than the copy of the self-certification § 2590.715–2713(a)(1)(iv), the issuer is
shall include notice that— from the eligible organization regarding required to provide payments only for
(A) The eligible organization will not its status as such. those contraceptive services for which
act as the plan administrator or claims (c) Contraceptive coverage—insured the group health plan does not provide
administrator with respect to claims for group health plans—(1) General rule. A coverage. However, the issuer may
contraceptive services, or contribute to group health plan established or provide payments for all contraceptive
the funding of contraceptive services; maintained by an eligible organization services, at the issuer’s option.
and that provides benefits through one or (d) Notice of availability of separate
(B) Obligations of the third party more group health insurance issuers
payments for contraceptive services—
administrator are set forth in § 2510.3– complies for one or more plan years
self-insured and insured group health
16 of this chapter and § 2590.715– with any requirement under § 2590.715–
plans. For each plan year to which the
2713A. 2713(a)(1)(iv) to provide contraceptive
accommodation in paragraph (b) or (c)
(iii) The eligible organization must coverage if the eligible organization or
of this section is to apply, a third party
not, directly or indirectly, seek to group health plan furnishes a copy of
administrator required to provide or
interfere with a third party the self-certification described in
arrange payments for contraceptive
administrator’s arrangements to provide paragraph (a)(4) of this section to each
services pursuant to paragraph (b) of
or arrange separate payments for issuer that would otherwise provide
this section, and an issuer required to
contraceptive services for participants such coverage in connection with the
group health plan. An issuer may not provide payments for contraceptive
or beneficiaries, and must not, directly services pursuant to paragraph (c) of
require any documentation other than
or indirectly, seek to influence the third this section, must provide to plan
the copy of the self-certification from
party administrator’s decision to make participants and beneficiaries written
the eligible organization regarding its
any such arrangements. notice of the availability of separate
status as such.
(2) If a third party administrator (2) Payments for contraceptive payments for contraceptive services
receives a copy of the self-certification services—(i) A group health insurance contemporaneous with (to the extent
described in paragraph (a)(4) of this issuer that receives a copy of the self- possible), but separate from, any
section, and agrees to enter into or certification described in paragraph application materials distributed in
remain in a contractual relationship (a)(4) of this section with respect to a connection with enrollment (or re-
with the eligible organization or its plan group health plan established or enrollment) in group health coverage
to provide administrative services for maintained by an eligible organization that is effective beginning on the first
the plan, the third party administrator in connection with which the issuer day of each applicable plan year. The
shall provide or arrange payments for would otherwise provide contraceptive notice must specify that the eligible
contraceptive services using one of the coverage under § 2590.715– organization does not administer or
following methods— 2713(a)(1)(iv) must— fund contraceptive benefits, but that the
(i) Provide payments for contraceptive (A) Expressly exclude contraceptive third party administrator or issuer, as
services for plan participants and coverage from the group health applicable, provides separate payments
beneficiaries without imposing any cost- insurance coverage provided in for contraceptive services, and must
sharing requirements (such as a connection with the group health plan; provide contact information for
copayment, coinsurance, or a and questions and complaints. The
deductible), or imposing a premium, (B) Provide separate payments for any following model language, or
fee, or other charge, or any portion contraceptive services required to be substantially similar language, may be
thereof, directly or indirectly, on the covered under § 2590.715–2713(a)(1)(iv) used to satisfy the notice requirement of
eligible organization, the group health for plan participants and beneficiaries this paragraph (d): ‘‘Your employer has
plan, or plan participants or for so long as they remain enrolled in certified that your group health plan
beneficiaries; or the plan. qualifies for an accommodation with
(ii) Arrange for an issuer or other (ii) With respect to payments for respect to the federal requirement to
entity to provide payments for contraceptive services, the issuer may cover all Food and Drug
contraceptive services for plan not impose any cost-sharing Administration-approved contraceptive
participants and beneficiaries without requirements (such as a copayment, services for women, as prescribed by a
imposing any cost-sharing requirements coinsurance, or a deductible), or impose health care provider, without cost
(such as a copayment, coinsurance, or a any premium, fee, or other charge, or sharing. This means that your employer
deductible), or imposing a premium, any portion thereof, directly or will not contract, arrange, pay, or refer
fee, or other charge, or any portion indirectly, on the eligible organization, for contraceptive coverage. Instead,
thereof, directly or indirectly, on the the group health plan, or plan [name of third party administrator/
eligible organization, the group health participants or beneficiaries. The issuer health insurance issuer] will provide or
plan, or plan participants or must segregate premium revenue arrange separate payments for
beneficiaries. collected from the eligible organization contraceptive services that you use,
(3) If a third party administrator from the monies used to provide without cost sharing and at no other
provides or arranges payments for payments for contraceptive services. cost, for so long as you are enrolled in
contraceptive services in accordance The issuer must provide payments for your group health plan. Your employer
with either paragraph (b)(2)(i) or (ii) of contraceptive services in a manner that will not administer or fund these
this section, the costs of providing or is consistent with the requirements payments. If you have any questions
arranging such payments may be under sections 2706, 2709, 2711, 2713, about this notice, contact [contact
reimbursed through an adjustment to 2719, and 2719A of the PHS Act, as information for third party
the Federally-facilitated Exchange user incorporated into section 715 of ERISA. administrator/health insurance issuer].’’
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(e) Reliance—insured group health supported by the Health Resources and organization or group health plan
plans—(1) If an issuer relies reasonably Services Administration. furnishes a copy of the self-certification
and in good faith on a representation by * * * * * described in paragraph (b)(4) of this
the eligible organization as to its ■ 3. Section 147.131 is added to read as section to each issuer that would
eligibility for the accommodation in follows: otherwise provide such coverage in
paragraph (c) of this section, and the connection with the group health plan.
representation is later determined to be § 147.131 Exemption and accommodations An issuer may not require any
incorrect, the issuer is considered to in connection with coverage of preventive documentation other than the copy of
comply with any requirement under health services. the self-certification from the eligible
§ 2590.715–2713(a)(1)(iv) to provide (a) Religious employers. In issuing organization regarding its status as such.
contraceptive coverage if the issuer guidelines under § 147.130(a)(1)(iv), the (2) Payments for contraceptive
complies with the obligations under this Health Resources and Services services—(i) A group health insurance
section applicable to such issuer. Administration may establish an issuer that receives a copy of the self-
exemption from such guidelines with certification described in paragraph
(2) A group health plan is considered
respect to a group health plan (b)(4) of this section with respect to a
to comply with any requirement under
established or maintained by a religious group health plan established or
§ 2590.715–2713(a)(1)(iv) to provide
employer (and health insurance maintained by an eligible organization
contraceptive coverage if the plan
coverage provided in connection with a in connection with which the issuer
complies with its obligations under
group health plan established or would otherwise provide contraceptive
paragraph (c) of this section, without
maintained by a religious employer) coverage under § 147.130(a)(1)(iv)
regard to whether the issuer complies
with respect to any requirement to cover must—
with the obligations under this section (A) Expressly exclude contraceptive
contraceptive services under such
applicable to such issuer. coverage from the group health
guidelines. For purposes of this
DEPARTMENT OF HEALTH AND paragraph (a), a ‘‘religious employer’’ is insurance coverage provided in
HUMAN SERVICES an organization that is organized and connection with the group health plan;
operates as a nonprofit entity and is and
For the reasons stated in the referred to in section 6033(a)(3)(A)(i) or (B) Provide separate payments for any
preamble, the Department of Health and (iii) of the Internal Revenue Code of contraceptive services required to be
Human Services amends 45 CFR 1986, as amended. covered under § 147.130(a)(1)(iv) for
Subtitle A parts 147 and 156 as follows: (b) Eligible organizations. An eligible plan participants and beneficiaries for
organization is an organization that so long as they remain enrolled in the
PART 147—HEALTH INSURANCE plan.
satisfies all of the following
REFORM REQUIREMENTS FOR THE (ii) With respect to payments for
requirements:
GROUP AND INDIVIDUAL HEALTH (1) The organization opposes contraceptive services, the issuer may
INSURANCE MARKETS providing coverage for some or all of not impose any cost-sharing
any contraceptive services required to requirements (such as a copayment,
■ 1. The authority citation for part 147 be covered under § 147.130(a)(1)(iv) on coinsurance, or a deductible), or impose
continues to read as follows: account of religious objections. any premium, fee, or other charge, or
Authority: Secs. 2701 through 2763, 2791, (2) The organization is organized and any portion thereof, directly or
and 2792 of the Public Health Service Act (42 operates as a nonprofit entity. indirectly, on the eligible organization,
U.S.C. 300gg through 300gg–63, 300gg–91, (3) The organization holds itself out as the group health plan, or plan
and 300gg–92), as amended. a religious organization. participants or beneficiaries. The issuer
■ 2. Section 147.130 is amended by (4) The organization self-certifies, in a must segregate premium revenue
revising paragraphs (a)(1) introductory form and manner specified by the collected from the eligible organization
text and (a)(1)(iv) to read as follows: Secretary, that it satisfies the criteria in from the monies used to provide
paragraphs (b)(1) through (3) of this payments for contraceptive services.
§ 147.130 Coverage of preventive health section, and makes such self- The issuer must provide payments for
services. certification available for examination contraceptive services in a manner that
(a) * * * upon request by the first day of the first is consistent with the requirements
plan year to which the accommodation under sections 2706, 2709, 2711, 2713,
(1) In general. Beginning at the time
in paragraph (c) of this section applies. 2719, and 2719A of the PHS Act. If the
described in paragraph (b) of this
The self-certification must be executed group health plan of the eligible
section and subject to § 147.131, a group
by a person authorized to make the organization provides coverage for some
health plan, or a health insurance issuer
certification on behalf of the but not all of any contraceptive services
offering group or individual health
organization, and must be maintained in required to be covered under
insurance coverage, must provide
a manner consistent with the record § 147.130(a)(1)(iv), the issuer is required
coverage for all of the following items
retention requirements under section to provide payments only for those
and services, and may not impose any
107 of the Employee Retirement Income contraceptive services for which the
cost-sharing requirements (such as a
Security Act of 1974. group health plan does not provide
copayment, coinsurance, or a (c) Contraceptive coverage—insured coverage. However, the issuer may
deductible) with respect to those items group health plans—(1) General rule. A provide payments for all contraceptive
and services: group health plan established or services, at the issuer’s option.
* * * * * maintained by an eligible organization (d) Notice of availability of separate

(iv) With respect to women, to the that provides benefits through one or payments for contraceptive services—
extent not described in paragraph more group health insurance issuers insured group health plans and student
(a)(1)(i) of this section, evidence- complies for one or more plan years health insurance coverage. For each
informed preventive care and screenings with any requirement under plan year to which the accommodation
provided for in binding comprehensive § 147.130(a)(1)(iv) to provide in paragraph (c) of this section is to
health plan coverage guidelines contraceptive coverage if the eligible apply, an issuer required to provide
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payments for contraceptive services with the obligations under this section facilitated Exchange user fee
pursuant to paragraph (c) of this section applicable to such issuer. adjustment—
must provide to plan participants and (f) Application to student health (i) The participating issuer must
beneficiaries written notice of the insurance coverage. The provisions of submit to HHS, in the manner and
availability of separate payments for this section apply to student health timeframe specified by HHS, in the year
contraceptive services contemporaneous insurance coverage arranged by an following the calendar year in which the
with (to the extent possible), but eligible organization that is an contraceptive services for which
separate from, any application materials institution of higher education in a payments were made pursuant to 26
distributed in connection with manner comparable to that in which CFR 54.9815–2713A(b)(2) or 29 CFR
enrollment (or re-enrollment) in group they apply to group health insurance 2590.715–2713A(b)(2) were provided —
health coverage that is effective coverage provided in connection with a (A) Identifying information for the
beginning on the first day of each group health plan established or participating issuer and each third party
applicable plan year. The notice must maintained by an eligible organization administrator that received a copy of the
specify that the eligible organization that is an employer. In applying this self-certification referenced in 26 CFR
does not administer or fund section in the case of student health 54.9815–2713A(a)(4) or 29 CFR
contraceptive benefits, but that the insurance coverage, a reference to ‘‘plan 2590.715–2713A(a)(4) with respect to
issuer provides separate payments for participants and beneficiaries’’ is a which the participating issuer seeks an
contraceptive services, and must reference to student enrollees and their adjustment in the Federally-facilitated
provide contact information for covered dependents. Exchange user fee, whether or not the
questions and complaints. The participating issuer was the entity that
following model language, or PART 156—HEALTH INSURANCE made the payments for contraceptive
substantially similar language, may be ISSUER STANDARDS UNDER THE services;
used to satisfy the notice requirement of AFFORDABLE CARE ACT, INCLUDING (B) Identifying information for each
this paragraph (d): ‘‘Your [employer/ STANDARDS RELATED TO self-insured group health plan with
institution of higher education] has EXCHANGES respect to which a copy of the self-
certified that your [group health plan/ certification referenced in 26 CFR
student health insurance coverage] ■ 4. The authority citation for part 156 54.9815–2713A(a)(4) or 29 CFR
qualifies for an accommodation with continues to read as follows: 2590.715–2713A(a)(4) was received by a
respect to the federal requirement to Authority: Title I of the Affordable Care third party administrator and with
cover all Food and Drug Act, sections 1301–1304, 1311–1312, 1321– respect to which the participating issuer
Administration-approved contraceptive 1322, 1324, 1334, 1342–1343, 1401–1402, seeks an adjustment in the Federally-
services for women, as prescribed by a and 1412, Pub. L. 111–148, 124 Stat. 119 (42 facilitated Exchange user fee; and
health care provider, without cost U.S.C. 18021–18024, 18031–18032, 18041– (C) For each such self-insured group
sharing. This means that your 18042, 18044, 18054, 18061, 18063, 18071, health plan, the total dollar amount of
18082, 26 U.S.C. 36B, and 31 U.S.C. 9701). the payments that were made pursuant
[employer/institution of higher
education] will not contract, arrange, ■ 5. Section 156.50 is amended by to 26 CFR 54.9815–2713A(b)(2) or 29
pay, or refer for contraceptive coverage. adding paragraph (d) to read as follows: CFR 2590.715–2713A(b)(2) for
Instead, [name of health insurance contraceptive services that were
§ 156.50 Financial support. provided during the applicable calendar
issuer] will provide separate payments
for contraceptive services that you use, * * * * * year. If such payments were made by
without cost sharing and at no other (d) Adjustment of Federally-facilitated the participating issuer directly as
cost, for so long as you are enrolled in Exchange user fee—(1) A participating described in paragraph (d)(1)(i) of this
your [group health plan/student health issuer offering a plan through a section, the total dollar amount should
insurance coverage]. Your [employer/ Federally-facilitated Exchange may reflect the amount of the payments
institution of higher education] will not qualify for an adjustment in the made by the participating issuer; if the
administer or fund these payments. If Federally-facilitated Exchange user fee third party administrator made or
you have any questions about this specified in paragraph (c) of this section arranged for such payments, as
notice, contact [contact information for to the extent that the participating described in paragraph (d)(1)(ii) of this
health insurance issuer].’’ issuer— section, the total dollar amount should
(e) Reliance—(1) If an issuer relies (i) Made payments for contraceptive reflect the amount reported to the
reasonably and in good faith on a services on behalf of a third party participating issuer by the third party
representation by the eligible administrator pursuant to 26 CFR administrator.
organization as to its eligibility for the 54.9815–2713A(b)(2)(ii) or 29 CFR (ii) Each third party administrator that
accommodation in paragraph (c) of this 2590.715–2713A(b)(2)(ii); or intends for a participating issuer to seek
section, and the representation is later (ii) Seeks an adjustment in the an adjustment in the Federally-
determined to be incorrect, the issuer is Federally-facilitated Exchange user fee facilitated Exchange user fee with
considered to comply with any with respect to a third party respect to the third party administrator
requirement under § 147.130(a)(1)(iv) to administrator that, following receipt of for payments for contraceptive services
provide contraceptive coverage if the a copy of the self-certification must submit to HHS a notification of
issuer complies with the obligations referenced in 26 CFR 54.9815– such intent, in a manner specified by
under this section applicable to such 2713A(a)(4) or 29 CFR 2590.715– HHS, by the later of January 1, 2014, or
2713A(a)(4), made or arranged for the 60th calendar day following the date
issuer.
(2) A group health plan is considered payments for contraceptive services on which the third party administrator
to comply with any requirement under pursuant to 26 CFR 54.9815– receives the applicable copy of the self-
§ 147.130(a)(1)(iv) to provide 2713A(b)(2)(i) or (ii) or 29 CFR certification referenced in 26 CFR
contraceptive coverage if the plan 2590.715–2713A(b)(2)(i) or (ii). 54.9815–2713A(a)(4) or 29 CFR
complies with its obligations under (2) For a participating issuer 2590.715–2713A(a)(4).
paragraph (c) of this section, without described in paragraph (d)(1) of this (iii) Each third party administrator
regard to whether the issuer complies section to receive the Federally- identified in paragraph (d)(2)(i)(A) of
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this section must submit to HHS, in the no less than 10 percent of the total (i) A copy of the self-certification
manner and timeframe specified by dollar amount of the payments for referenced in 26 CFR 54.9815–
HHS, in the year following the calendar contraceptive services specified in 2713A(a)(4) or 29 CFR 2590.715–
year in which the contraceptive services paragraph (d)(3)(i) of this section. HHS 2713A(a)(4) for each self-insured plan
for which payments were made will specify the allowance for a with respect to which an adjustment is
pursuant to 26 CFR 54.9815– particular calendar year in the annual received.
2713A(b)(2) or 29 CFR 2590.715– HHS notice of benefit and payment
2713A(b)(2) were provided— (ii) Documentation demonstrating that
parameters.
(A) Identifying information for the the payments for contraceptive services
(4) As long as an exception under
third party administrator and the were made in compliance with 26 CFR
OMB Circular No. A–25R is in effect, if
participating issuer; the amount of the adjustment under 54.9815–2713A(b)(2) or 29 CFR
(B) Identifying information for each paragraph (d)(3) of this section is greater 2590.715–2713A(b)(2).
self-insured group health plan with than the amount of the participating (iii) Documentation supporting the
respect to which a copy of the self- issuer’s obligation to pay the Federally- total dollar amount of the payments for
certification referenced in 26 CFR facilitated Exchange user fee in a contraceptive services submitted by the
54.9815–2713A(a)(4) or 29 CFR particular month, the participating third party administrator, as described
2590.715–2713A(a)(4) was received by issuer will be provided a credit in in paragraph (d)(2)(iii)(D) of this section.
the third party administrator and with succeeding months in the amount of the
respect to which the participating issuer excess. ■ 6. Section 156.80 is amended by
seeks an adjustment in the Federally- (5) Within 60 days of receipt of any revising paragraph (d)(1) to read as
facilitated Exchange user fee; adjustment in the Federally-facilitated follows:
(C) The total number of participants
Exchange user fee under this section, a § 156.80 Single risk pool.
and beneficiaries in each such self-
participating issuer must pay each third
insured group health plan during the * * * * *
party administrator with respect to
applicable calendar year; (d) * * *
(D) For each such self-insured group which it received any portion of such
health plan with respect to which the adjustment an amount no less than the (1) In general. Each plan year or
third party administrator made portion of the adjustment attributable to policy year, as applicable, a health
payments pursuant to 26 CFR 54.9815– the total dollar amount of the payments insurance issuer must establish an index
2713A(b)(2) or 29 CFR 2590.715– for contraceptive services submitted by rate for a state market described in
2713A(b)(2) for contraceptive services, the third party administrator, as paragraphs (a) through (c) of this section
the total dollar amount of such described in paragraph (d)(2)(iii)(D) of
based on the total combined claims
payments that were provided during the this section. No such payment is
costs for providing essential health
applicable calendar year. If such required with respect to the allowance
for administrative costs and margin benefits within the single risk pool of
payments were made by the that state market. The index rate must
participating issuer directly as described described in paragraph (d)(3)(ii) of this
section. This paragraph does not apply be adjusted on a market-wide basis for
in paragraph (d)(1)(i) of this section, the the state based on the total expected
total dollar amount should reflect the if the participating issuer made the
payments for contraceptive services on market-wide payments and charges
amount reported to the third party under the risk adjustment and
administrator by the participating behalf of the third party administrator,
as described in paragraph (d)(1)(i) of reinsurance programs, and Exchange
issuer; if the third party administrator user fees (expected to be remitted under
made or arranged for such payments, as this section, or is in the same issuer
group as the third party administrator. § 156.50(b) or § 156.50(c) and (d) of this
described in paragraph (d)(1)(ii) of this
(6) A participating issuer receiving an subchapter as applicable plus the dollar
section, the total dollar amount should
adjustment in the Federally-facilitated amount under § 156.50(d)(3)(i) and (ii)
reflect the amount of the payments
made by or on behalf of the third party Exchange user fee under this section for of this subchapter expected to be
administrator; and a particular calendar year must maintain credited against user fees payable for
(E) An attestation that the payments for 10 years following that year, and that state market). The premium rate for
for contraceptive services were made in make available upon request to HHS, all of the health insurance issuer’s plans
compliance with 26 CFR 54.9815– the Office of the Inspector General, the in the relevant state market must use the
2713A(b)(2) or 29 CFR 2590.715– Comptroller General, and their applicable market-wide adjusted index
2713A(b)(2). designees, documentation rate, subject only to the plan-level
(3) If the requirements set forth in demonstrating that it timely paid each adjustments permitted in paragraph
paragraph (d)(2) of this section are met, third party administrator with respect to (d)(2) of this section.
and as long as an authorizing exception which it received any such adjustment
any amount required to be paid to the * * * * *
under OMB Circular No. A–25R is in
effect, the participating issuer will be third party administrator under
provided a reduction in its obligation to paragraph (d)(5) of this section.
pay the Federally-facilitated Exchange (7) A third party administrator with
user fee specified in paragraph (c) of respect to which an adjustment in the
this section equal in value to the sum of Federally-facilitated Exchange user fee
is received under this section for a
the following:
(i) The total dollar amount of the particular calendar year must maintain
payments for contraceptive services for 10 years following that year, and
submitted by the applicable third party make available upon request to HHS,
administrators, as described in the Office of the Inspector General, the
paragraph (d)(2)(iii)(D) of this section. Comptroller General, and their
(ii) An allowance for administrative designees, all of the following
costs and margin. The allowance will be documentation:
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Signed this 27th day of June 2013.

Beth Tucker,
Deputy Commissioner for Operations
Support, Internal Revenue Service.
Mark J. Mazur,
Assistant Secretary of the Treasury (Tax
Policy).
Signed this 26th day of June 2013.
Phyllis C. Borzi,
Assistant Secretary, Employee Benefits
Security Administration, Department of
Labor.
Dated: June 20, 2013
Marilyn Tavenner,
Administrator, Centers for Medicare &
Medicaid Services.
Approved: June 25, 2013.
Kathleen Sebelius,
Secretary, Department of Health and Human
Services.
[FR Doc. 2013–15866 Filed 6–28–13; 11:15 am]
BILLING CODE 4830–01–P; 4510–029–P; 4120–01–P;
6325–64–P
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Regulations
DEPARTMENT OF THE TREASURY DATES: Effective Date: These final health plans and health insurance
regulations are effective on September issuers offering non-grandfathered
Internal Revenue Service 14, 2015. group or individual health insurance
Applicability Date: These final coverage provide coverage of certain
26 CFR Part 54 regulations are applicable beginning on specified preventive services without
the first day of the first plan year (or, for cost sharing. These preventive services
[TD–9726] individual health insurance coverage, include:
RIN 1545–BJ58, 1545–BM37, 1545–BM39 the first day of the first policy year) that • Evidence-based items or services
begins on or after September 14, 2015. that have in effect a rating of ‘‘A’’ or ‘‘B’’
DEPARTMENT OF LABOR FOR FURTHER INFORMATION CONTACT: in the current recommendations of the
David Mlawsky, Centers for Medicare & United States Preventive Services Task
Employee Benefits Security Medicaid Services (CMS), Department Force (Task Force) with respect to the
Administration of Health and Human Services (HHS), at individual involved.
(410) 786–1565; Amy Turner or • Immunizations for routine use in
29 CFR Parts 2510 and 2590 Elizabeth Schumacher, Employee children, adolescents, and adults that
Benefits Security Administration have in effect a recommendation from
RIN 1210–AB67 the Advisory Committee on
(EBSA), Department of Labor, at (202)
693–8335; or Karen Levin, Internal Immunization Practices of the Centers
DEPARTMENT OF HEALTH AND
Revenue Service (IRS), Department of for Disease Control and Prevention
HUMAN SERVICES
the Treasury, at (202) 927–9639. (Advisory Committee) with respect to
Customer Service Information: the individual involved. A
45 CFR Part 147
Individuals interested in obtaining recommendation of the Advisory
[CMS–9940–F] information from the Department of Committee is considered to be ‘‘in
Labor concerning employment-based effect’’ after it has been adopted by the
RIN 0938–AS50 health coverage laws may call the EBSA Director of the Centers for Disease
Toll-Free Hotline at 1–866–444–EBSA Control and Prevention (CDC). A
Coverage of Certain Preventive recommendation is considered to be for
(3272) or visit the Department of Labor’s
Services Under the Affordable Care ‘‘routine use’’ if it appears on the
Web site (www.dol.gov/ebsa).
Act Immunization Schedules of the CDC.
Information from HHS on private health
AGENCY: Internal Revenue Service, insurance coverage can be found on • With respect to infants, children,
Department of the Treasury; Employee CMS’s Web site (www.cms.gov/cciio), and adolescents, evidence-informed
Benefits Security Administration, and information on health care reform preventive care and screenings provided
Department of Labor; Centers for can be found at www.HealthCare.gov. for in the comprehensive guidelines
Medicare & Medicaid Services, SUPPLEMENTARY INFORMATION: supported by the Health Resources and
Department of Health and Human Services Administration (HRSA).
Services. I. Background • With respect to women, preventive
ACTION: Final rules. The Patient Protection and Affordable care and screenings provided for in
Care Act (Pub. L. 111–148) was enacted comprehensive guidelines supported by
SUMMARY: This document contains final on March 23, 2010. The Health Care and HRSA (not otherwise addressed by the
regulations regarding coverage of certain Education Reconciliation Act of 2010 recommendations of the Task Force),
preventive services under section 2713 (Pub. L. 111–152) was enacted on March including all Food and Drug
of the Public Health Service Act (PHS 30, 2010. These statutes are collectively Administration (FDA)-approved
Act), added by the Patient Protection known as the Affordable Care Act. The contraceptives, sterilization procedures,
and Affordable Care Act, as amended, Affordable Care Act reorganizes, and patient education and counseling
and incorporated into the Employee amends, and adds to the provisions of for women with reproductive capacity,
Retirement Income Security Act of 1974 part A of title XXVII of the Public as prescribed by a health care provider
and the Internal Revenue Code. Section Health Service Act (PHS Act) relating to (collectively, contraceptive services).1
2713 of the PHS Act requires coverage group health plans and health insurance The complete list of recommendations
without cost sharing of certain issuers in the group and individual and guidelines that are required to be
preventive health services by non- markets. The Affordable Care Act adds covered under these final regulations
grandfathered group health plans and section 715(a)(1) to the Employee can be found at: https://www.
health insurance coverage. These Retirement Income Security Act of 1974 healthcare.gov/preventive-care-benefits.
regulations finalize provisions from (ERISA) and section 9815(a)(1) to the Together, the items and services
three rulemaking actions: Interim final Internal Revenue Code (Code) to described in these recommendations
regulations issued in July 2010 related incorporate the provisions of part A of and guidelines are referred to in this
to coverage of preventive services, title XXVII of the PHS Act into ERISA preamble as ‘‘recommended preventive
interim final regulations issued in and the Code, and to make them services.’’
August 2014 related to the process an applicable to group health plans and The Departments of Labor, Health and
eligible organization uses to provide health insurance issuers providing Human Services, and the Treasury (the
notice of its religious objection to the health insurance coverage in connection Departments) 2 have issued rulemaking
asabaliauskas on DSK5VPTVN1PROD with RULES
coverage of contraceptive services, and with group health plans. The sections of to implement these requirements:
proposed regulations issued in August the PHS Act incorporated into ERISA
2014 related to the definition of and the Code are sections 2701 through 1 The HRSA Guidelines exclude services relating
‘‘eligible organization,’’ which would 2728. to a man’s reproductive capacity, such as

expand the set of entities that may avail Section 2713 of the PHS Act, as added vasectomies and condoms.
2 Note, however, that in sections under headings
themselves of an accommodation with by the Affordable Care Act and listing only two of the three Departments, the term
respect to the coverage of contraceptive incorporated into ERISA and the Code, ‘‘Departments’’ generally refers only to the two
services. requires that non-grandfathered group Departments listed in the heading.
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• Interim final regulations on July 19, by certain nonprofit religious preventive services. These FAQs
2010, at 75 FR 41726 (July 2010 interim organizations with religious objections provided guidance related to
final regulations), implemented the to contraceptive coverage (and group compliance with the 2010 and 2014
preventive services requirements of PHS health insurance coverage provided in interim final regulations, and addressed
Act section 2713; connection with those plans) and for issues related to specific services
• Interim final regulations amending insured student plans arranged by required to be covered without cost
the July 2010 interim final regulations certain nonprofit religious organizations sharing, subject to reasonable medical
on August 3, 2011, at 76 FR 46621, that are institutions of higher education management, under recommendations
provided HRSA with the authority to with religious objections to and guidelines specified in section 2713
exempt group health plans established contraceptive coverage; of the PHS Act. Information on related
or maintained by certain religious • Final regulations on July 2, 2013, at safe harbors, forms, and model notices
employers (and group health insurance 78 FR 39870 (July 2013 final is available at http://www.dol.gov/ebsa/
coverage provided in connection with regulations), simplified and clarified the healthreform and http://www.cms.gov/
those plans) from the requirement to definition of religious employer for cciio/resources/regulations-and-
cover contraceptive services consistent purposes of the religious employer guidance/index.html.
with the HRSA Guidelines; 3 exemption and established After consideration of the comments
• Final regulations on February 15, accommodations for health coverage and feedback received from
2012, at 77 FR 8725 (2012 final established or maintained or arranged stakeholders, the Departments are
regulations), finalized the definition of by eligible organizations; 5 publishing these final regulations,8
religious employer in the 2011 amended • Interim final regulations on August which finalize the July 2010 interim
interim final regulations without 27, 2014, at 79 FR 51092 (August 2014 final regulations related to coverage of
modification; 4 interim final regulations), amended the recommended preventive services, the
• An advance notice of proposed July 2013 final regulations in light of the August 2014 interim final regulations
rulemaking (ANPRM) on March 21, United States Supreme Court’s interim related to the process an eligible
2012, at 77 FR 16501, solicited order in connection with an application organization uses to provide notice of its
comments on how to provide for for an injunction in Wheaton College v. religious objection to the coverage of
coverage of recommended preventive Burwell (Wheaton interim order),6 and contraceptive services, and the August
services, including contraceptive provided an alternative process that an 2014 proposed regulations related to the
services, without cost sharing, while eligible organization may use to provide definition of eligible organization.
simultaneously ensuring that certain notice of its religious objection to the II. Overview of the Final Regulations
nonprofit organizations with religious coverage of contraceptive services; and
objections to contraceptive coverage • Proposed regulations on August 27, A. Coverage of Recommended
would not be required to contract, 2014, at 79 FR 51118 (August 2014 Preventive Services Under 26 CFR
arrange, pay, or refer for that coverage; proposed regulations), proposed 54.9815–2713, 29 CFR 2590.715–2713,
• Proposed regulations on February 6, potential changes to the definition of and 45 CFR 147.130
2013, at 78 FR 8456, proposed to ‘‘eligible organization’’ in light of the (i) Scope of Recommended Preventive
simplify and clarify the definition of United States Supreme Court’s decision Services
‘‘religious employer’’ for purposes of the in Burwell v. Hobby Lobby Stores, Inc.7
religious employer exemption, and In addition to these regulations, the Section 2713 of the PHS Act, as added
proposed accommodations for group Departments released six sets of by the Affordable Care Act, requires that
health plans established or maintained Frequently Asked Questions (FAQs) a non-grandfathered group health plan
regarding the preventive services or a health insurance issuer offering
3 On the same date, HRSA exercised this
coverage requirements. The non-grandfathered group or individual
authority in the HRSA Guidelines to exempt group
Departments released FAQs about health insurance coverage provide,
health plans established or maintained by these without cost sharing, coverage for
religious employers (and group health insurance Affordable Care Act Implementation
coverage provided in connection with such plans) Parts II, V, XII, XIX, XX, and XXVI to recommended preventive services, as
from the HRSA Guidelines with respect to answer outstanding questions, including outlined above. The July 2013 final
contraceptive services.
questions related to the coverage of regulations finalized the requirement to
4 Contemporaneous with the issuance of the 2012
provide coverage without cost sharing
final regulations, HHS, with the agreement of the with respect to those preventive services
5 A contemporaneously re-issued HHS guidance
Departments of Labor and the Treasury, issued
guidance establishing a temporary safe harbor from document extended the temporary safe harbor from provided for in the HRSA Guidelines for
enforcement of the contraceptive coverage enforcement of the contraceptive coverage women. These regulations finalize the
requirement by the Departments for group health requirement by the Departments to encompass plan requirement to provide coverage
plans established or maintained by certain years beginning on or after August 1, 2013, and
before January 1, 2014. This guidance included a without cost sharing with respect to the
nonprofit organizations with religious objections to
contraceptive coverage (and group health insurance form to be used by an organization during this other three categories of
coverage provided in connection with such plans) temporary period to self-certify that its plan recommendations and guidelines
originally issued on February 10, 2012, and qualified for the temporary enforcement safe harbor. specified in section 2713 of the PHS
reissued on August 15, 2012, and June 28, 2013; In addition, HHS and the Department of Labor
(DOL) issued a self-certification form, EBSA Form Act: Evidence-based items or services
available at: http://www.cms.gov/CCIIO/Resources/
Regulations-and-Guidance/Downloads/preventive- 700, to be executed by an organization seeking to that have in effect a rating of ‘‘A’’ or ‘‘B’’
services-guidance-6-28-2013.pdf. The guidance be treated as an eligible organization for purposes
clarified, among other things, that plans that took of an accommodation under the July 2013 final 8 The Department of the Treasury/Internal
some action before February 10, 2012, to try, regulations. This self-certification form was Revenue Service published temporary regulations
without success, to exclude or limit contraceptive provided for use with the accommodation under the and proposed regulations with the text of the
coverage were not precluded from eligibility for the July 2013 final regulations, after the expiration of temporary regulations serving as the text of the
safe harbor. The temporary enforcement safe harbor the temporary enforcement safe harbor (that is, for proposed regulations as part of each of the joint
was also available to student health insurance plan years beginning on or after January 1, 2014). rulemaking interim final rules listed above. The
coverage arranged by nonprofit institutions of See http://www.cms.gov/CCIIO/Resources/ Departments of Labor and HHS published their
higher education with religious objections to Regulations-and-Guidance/Downloads/preventive- rules as interim final rules and are finalizing their
contraceptive coverage that met the conditions set services-guidance-6-28-2013.pdf. interim final rules. The Department of the
6 134 S. Ct. 2806 (2014).
forth in the guidance. See Student Health Insurance Treasury/Internal Revenue Service is finalizing its
Coverage, 77 FR 16457 (Mar. 21, 2012). 7 134 S. Ct. 2751 (2014). proposed rules.
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in the current recommendations of the office visit. Second, if a recommended Departments may issue additional
Task Force, immunizations for routine preventive service is not billed subregulatory guidance.
use that have in effect a separately (or is not tracked as
recommendation from the Advisory (iii) Out-of-Network Providers
individual encounter data separately)
Committee, and evidence-informed from an office visit and the primary With respect to a plan or health
preventive care and screenings for purpose of the office visit is the delivery insurance coverage that maintains a
infants, children, and adolescents, of the recommended preventive service, network of providers, the July 2010
provided for in guidelines supported by a plan or issuer may not impose cost interim final regulations provided that
HRSA. The complete list of sharing with respect to the office visit. the plan or issuer is not required to
recommendations and guidelines can be Finally, if a recommended preventive provide coverage for recommended
found at: https://www.healthcare.gov/ service is not billed separately (or is not preventive services delivered by an out-
preventive-care-benefits. tracked as individual encounter data of-network provider. The plan or issuer
Commenters requested additional separately) from an office visit and the may also impose cost sharing for
clarity on the specific items and services primary purpose of the office visit is not recommended preventive services
required to be covered without cost the delivery of the recommended delivered by an out-of-network
sharing. The Departments previously preventive service, a plan or issuer may provider.
released FAQs about Affordable Care impose cost sharing with respect to the
Act Implementation Parts XII 9 and office visit. The reference to tracking Several commenters requested the
XIX 10 to provide guidance related to the individual encounter data was included rule be amended to require that
scope of coverage required under the to provide guidance with respect to preventive services be provided without
recommendations and guidelines, plans and issuers that use capitation or cost sharing when services are provided
including coverage of aspirin and other similar payment arrangements that do out-of-network in all instances. Other
over-the-counter medication, not bill individually for items and commenters suggested that the rule be
colonoscopies, BRCA testing, well- services. amended to require out-of-network
woman visits, screening and counseling coverage if an in-network provider is
Several commenters supported the
for interpersonal and domestic violence, not available to the individual, or if the
primary purpose test, while other
HIV and HPV testing, contraception, services are not available to a material
commenters were concerned that the
breastfeeding and lactation counseling, segment of the plan’s population. One
test provides too much discretion to
and tobacco cessation interventions. commenter asked that, in a situation
providers or issuers to determine the
Moreover, on May 11, 2015, the where preventive services are obtained
primary purpose of the visit. Some
Departments issued FAQs about from a network provider with the
commenters stated that many
Affordable Care Act Implementation 11 assistance of medical professionals who
individuals only seek medical care from
to address specific coverage questions are out-of-network, all of the services be
their physician when they are sick, and
related to BRCA testing, contraception, treated as in-network services, and thus
physicians must be able to provide
sex-specific recommended preventive not subject to cost sharing. Several
preventive services, along with other
services, services for dependents commenters stated that cost sharing for
treatment, in a single office visit. Other
covered under the plan or policy, and recommended preventive services
commenters recommended that the
colonoscopies. If additional questions received from out-of-network providers
Departments eliminate the primary
arise regarding the application of the should not be higher than cost sharing
preventive services coverage purpose test. Some of these commenters
for other ambulatory health services
requirements, the Departments may recommended that cost sharing be
provided on an out-of-network basis.
issue additional subregulatory guidance. prohibited if any recommended
preventive service is provided during In response to comments, the
(ii) Office Visits the visit. Departments issued an FAQ clarifying
The July 2010 interim final These final regulations continue to that, if a plan or issuer does not have in
regulations clarified the cost-sharing provide that when a recommended its network a provider who can provide
requirements applicable when a preventive service is not billed a particular recommended preventive
recommended preventive service is separately (or is not tracked as service, then, consistent with the statute
provided during an office visit through individual encounter data separately) and July 2010 interim final regulations,
the use of the ‘‘primary purpose’’ test: from an office visit, plans and issuers the plan or issuer must cover, without
First, if a recommended preventive must look to the primary purpose of the cost sharing, the item or service when
service is billed separately (or is tracked office visit when determining whether performed by an out-of-network
as individual encounter data separately) they may impose cost sharing with provider.12 These final regulations
from an office visit, a plan or issuer may respect to the office visit. Nothing in adopt the rule of the July 2010 interim
impose cost sharing with respect to the these requirements precludes a health final regulations with respect to out-of-
care provider from providing preventive network providers, with one
9 See FAQs about Affordable Care Act services, along with other treatment, in clarification. These final regulations
Implementation Part XII, available at http://www. a single office visit. These rules only incorporate the clarification that a plan
dol.gov/ebsa/faqs/faq-aca12.html and http://www. or issuer that does not have in its
cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/ establish the circumstances under
aca_implementation_faqs12.html. which an office visit that includes a network a provider who can provide a
10 See FAQs about Affordable Care Act recommended preventive service may particular recommended preventive
Implementation Part XIX, available at http://www. be subject to cost sharing. The service is required to cover the
dol.gov/ebsa/faqs/faq-aca19.html and http://www.
Departments anticipate that the preventive service when performed by
cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/ an out-of-network provider, and may
aca_implementation_faqs19.html. determination of the primary purpose of
11 See FAQs about Affordable Care Act the visit will be resolved through
Implementation Part XXVI, available at 12 See FAQ about Affordable Care Act
normal billing and coding activities, as
www.dol.gov/ebsa/faqs/faq-FAQs/Downloads/aca_ Implementation Part XII, Q3 at http://www.dol.gov/
implementaton_faqs26.pdf. and http://www.cms.
they are for other services. If questions ebsa/faqs/faq-aca12.html and http://www.cms.gov/
gov/CCIIO/Resources/Fact-Sheets-and-FAQs/ arise regarding the application of this CCIIO/Resources/Fact-Sheets-and-FAQs/aca_
Downloads/aca_implementation_faqs26.pdf. rule to common medical scenarios, the implementation_faqs12.html.
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not impose cost sharing with respect to with high-quality providers at reduced (applicable to all non-grandfathered
the preventive service. costs, and reduce fraud and abuse. group health plans and health insurance
Commenters requested guidance on how issuers in the group and individual
(iv) Reasonable Medical Management
plans and issuers may employ value- markets),20 set forth rules regarding
The July 2010 interim final based insurance designs (VBID) in a claims and appeals, including the right
regulations included a provision on manner that complies with the of claimants (or their authorized
reasonable medical management. preventive services coverage representatives), upon appeal of an
Specifically, if a recommendation or requirements.15 Some commenters adverse benefit determination (or a final
guideline for a recommended preventive requested that the final regulations internal adverse benefit determination),
service does not specify the frequency, permit plans and issuers to impose cost to be provided by the plan or issuer,
method, treatment, or setting for the sharing on non-preferred network tiers upon request and free of charge,
provision of that service, the plan or for VBIDs. Another commenter reasonable access to and copies of all
issuer may use reasonable medical requested the Departments permit cost documents, records, and other
management techniques to determine sharing for preventive care delivered at
any coverage limitations. information relevant to the claimant’s
centers of excellence. On December 22, claim for benefits. Other Federal and
The Departments received a number 2010, the Departments issued an FAQ to
of comments related to the use of State law requirements may also apply,
provide guidance regarding VBID as applicable.
reasonable medical management related to the coverage of preventive
techniques. Some commenters were services.16 If questions arise regarding (v) Services Not Described
concerned that the July 2010 interim VBID and the preventive services
final regulations did not clearly outline coverage requirements, the Departments The July 2010 interim final
what constitutes reasonable medical may issue additional subregulatory regulations clarified that a plan or issuer
management techniques, and requested guidance. Several commenters stated may cover preventive services in
that the Departments provide greater that plans and issuers should be addition to those required to be covered
clarity, particularly with respect to a required to use and identify credible by PHS Act section 2713. These final
situation where a patient’s attending references or sources supporting their regulations continue to provide that for
provider determines that the frequency, medical management techniques. The the additional preventive services, a
method, treatment, or setting of a Departments recognize the importance plan or issuer may impose cost sharing
particular item or service is medically of having access to information relating at its discretion, consistent with
appropriate for a particular patient. The to medical management techniques that applicable law. Moreover, a plan or
Departments issued an FAQ clarifying a plan or issuer may apply. Several issuer may impose cost sharing for a
that, under the July 2010 interim final provisions applicable to plans and treatment that is not a recommended
regulations, to the extent not specified issuers address these concerns. ERISA preventive service, even if the treatment
in a recommendation or guideline, a section 104 and the Department of results from a recommended preventive
plan or issuer may rely on the relevant Labor’s implementing regulations 17 service.
evidence base and established provide that, for plans subject to ERISA,
reasonable medical management the plan documents and other (vi) Timing
techniques to determine the frequency, instruments under which the plan is
method, treatment, or setting for the The July 2010 interim final
established or operated must generally regulations provided that plans and
provision of a recommended preventive be furnished by the plan administrator
service.13 These final regulations issuers must provide coverage for new
to plan participants 18 upon request. In recommended preventive services for
incorporate the clarification of the July addition, the Department of Labor’s
2010 interim final regulations set forth plan years (in the individual market,
claims procedure regulations 19 policy years) beginning on or after the
in the FAQ. (applicable to ERISA plans), as well as
On May 11, 2015, the Departments date that is one year after the date the
the Departments’ internal claims and relevant recommendation or guideline
issued FAQs to provide further appeals and external review regulations
guidance on the extent to which plans under PHS Act section 2713 is issued.
under the Affordable Care Act
and issuers may utilize reasonable Some commenters encouraged the
medical management when providing 15 The Departments first solicited comments on
Departments to adopt a shorter
coverage for recommended women’s value-based insurance designs in the July 2010 implementation timeframe. With respect
contraception services in the HRSA interim final regulations. 75 FR 41726, 41729. to the Advisory Committee
guidelines.14 If further questions arise Subsequently, the Departments published a request recommendations, one commenter
for information (RFI) related to value-based
regarding the permissible application of insurance design on December 28, 2010. 75 FR
requested that the effective date for any
reasonable medical management 81544. new recommendation be either the
techniques, the Departments may issue 16 See FAQs about Affordable Care Act publication of the committee’s
additional subregulatory guidance. Implementation Part V, Q1, available at http://www. provisional recommendations or the
Other commenters cited the dol.gov/ebsa/faqs/faq-aca5.html and http://www. publication of the official CDC
cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/
importance of flexibility to permit plans aca_implementation_faqs5.html. immunization schedules, whichever
and issuers to maintain programs that 17 29 CFR 2520.104b–1. occurs first. Other commenters
are cost-effective, negotiate treatments 18 ERISA section 3(7) defines a ‘‘participant’’ to expressed support for the
include any employee or former employee who is implementation timeframe set forth in
13 See FAQs about Affordable Care Act or may become eligible to receive a benefit of any
type from an employee benefit plan or whose
the July 2010 interim final regulations.
Implementation Part II, Q8 available at http://www.
dol.gov/ebsa/faqs/faq-aca2.html and http://www. beneficiaries may be eligible to receive any such The statute requires the Departments to
cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/ benefit. Accordingly, employees who are not establish an interval of not less than one
aca_implementation_faqs2.html. enrolled but are, for example, in a waiting period year between when recommendations or
14 See FAQs about Affordable Care Act for coverage, or who are otherwise shopping among
benefit package options during open season,
guidelines under PHS Act section
Implementation Part XXVI, available at
www.dol.gov/ebsa/faqs/faq-aca26.html and http:// generally are considered plan participants for this
www.cms.gov/CCIIO/Resources/Fact-Sheets-and- purpose. 20 29 CFR 2590.715–2719(b)(2)(i) and 45 CFR
FAQs/Downloads/aca_implementation_faqs26.pdf. 19 29 CFR 2560.503–1(h)(2)(iii). 147.136(b)(2)(i).
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2713(a) 21 are issued, and the plan year applicable federal and state law. We that item or service, there is no
(in the individual market, policy year) agree with those commenters who stated requirement under this section to cover
for which coverage of the services that changes in coverage should not these items and services through the last
addressed in the recommendations or occur during the plan or policy year, day of the plan or policy year. Should
guidelines must be in effect. and are implementing an approach with such circumstances arise, the
To provide plans and issuers adequate respect to changes in recommendations Departments expect to issue
time to incorporate changes or updates or guidelines that narrow or eliminate subregulatory guidance to this effect
to recommendations and guidelines, as coverage requirements for previously with respect to such preventive item or
provided in the July 2010 interim final recommended services that is similar to service.
regulations, these final regulations the one adopted in the July 2010 interim Other requirements of federal or state
continue to provide that a final regulations for new law may apply in connection with
recommendation or guideline of the recommendations or guidelines. ceasing to provide coverage or changing
Task Force is considered to be issued on Furthermore, participants and cost-sharing requirements for any item
the last day of the month on which the beneficiaries of group health plans (and or service. For example, PHS Act
Task Force publishes or otherwise enrollees and dependents in individual section 2715(d)(4) and its implementing
releases the recommendation; a market coverage) may make coverage regulations state that if a group health
recommendation or guideline of the choices based on the benefits offered at plan or health insurance issuer makes
Advisory Committee is considered to be the beginning of the plan or policy year. any material modification in any of the
issued on the date on which it is Plan years (and individual market terms of the plan or coverage involved
adopted by the Director of the CDC; and policy years) vary and recommendations that would affect the content of the
a recommendation or guideline in the and guidelines may be issued at any Summary of Benefits and Coverage
comprehensive guidelines supported by time during a plan or policy year. These (SBC), that is not reflected in the most
HRSA is considered to be issued on the final regulations protect against recently provided SBC, and that occurs
date on which it is accepted by the disruption and provide certainty in other than in connection with a renewal
Administrator of HRSA or, if applicable, coverage (including cost-sharing or reissuance of coverage, the plan or
adopted by the Secretary of HHS. requirements) for the duration of the issuer must provide notice of the
Several commenters supported the plan or policy year. Accordingly, these modification to enrollees not later than
policy that plans and issuers should not final regulations state that a plan or 60 days prior to the date on which the
need to check the recommendations or issuer that is required to provide notification will become effective.
guidelines for changes during the plan coverage for any recommended A list of the recommended preventive
or policy year in order to determine preventive service on the first day of a services is available at https://www.
coverage requirements and should not plan or policy year under a particular healthcare.gov/preventive-care-benefits.
be required to implement changes We intend to update this list to include
recommendation or guideline must
during the plan or policy year. The the date on which the recommendation
generally provide that coverage through
Departments adopted this approach in or guideline was accepted or adopted.
the last day of the plan or policy year,
the July 2010 interim final regulations New recommendations and guidelines
even if the recommendation or
with respect to new recommendations will also be reflected on this site. Plans
guideline changes or is eliminated
or guidelines that impose additional and issuers need not make changes to
during the plan or policy year.
preventive services coverage coverage and cost-sharing requirements
requirements, but adopted a different However, there are limited
circumstances under which it may be based on a new recommendation or
standard for changes in guideline until the first plan year (in the
recommendations or guidelines, inadvisable for a plan or issuer to
continue to cover preventive items or individual market, policy year)
allowing plans and issuers to eliminate beginning on or after the date that is one
coverage for preventive services that are services associated with a
recommendation or guideline that was year after the new recommendation or
no longer recommended during the plan guideline goes into effect. Therefore, by
or policy year, consistent with other in effect on the first day of a plan year
or policy year (for example, due to visiting this site once per year, plans or
21 Section 2713(b)(1) refers to an interval between safety concerns). Therefore, these final issuers should have access to all the
‘‘the date on which a recommendation described in regulations establish that if, during a information necessary to identify any
subsection (a)(1) or (a)(2) or a guideline under plan or policy year, (1) an ‘‘A’’ or ‘‘B’’ additional items or services that must be
subsection (a)(3) is issued and the plan year with
recommendation or guideline of the covered without cost sharing, or to
respect to which the requirement described in identify any items or services that are no
subsection (a) is effective with respect to the service Task Force that was in effect on the first
described in such recommendation or guideline.’’ day of a plan or policy year is longer required to be covered.
While the first part of this statement does not downgraded to a ‘‘D’’ rating (meaning
mention guidelines under subsection (a)(4), it is the
B. Accommodations in Connection With
Departments’ view that it would not be reasonable
that the Task Force has determined that Coverage of Preventive Health
to treat the services covered under subsection (a)(4) there is strong evidence that there is no Services—26 CFR 54.9815–2713A, 29
any differently than those in subsections (a)(1), net benefit, or that the harms outweigh CFR 2510.3–16 and 2590.715–2713A,
(a)(2), and (a)(3). First, the statement refers to ‘‘the the benefits, and therefore discourages
requirement described in subsection (a),’’ which
and 45 CFR 147.131.
would include a requirement under subsection
the use of this service), or (2) any item
or service associated with any (i) The Process an Eligible Organization
(a)(4). Secondly, the guidelines under (a)(4) are
from the same source as those under (a)(3), except preventive service recommendation or Uses To Provide Notice of Its Religious
with respect to women, rather than infants, children guideline specified in 26 CFR 54.9815– Objection to the Coverage of
and adolescents; and other preventive services
2713(a)(1) or 29 CFR. 2590.715– Contraceptive Services
involving women are addressed in subsection (a)(1),
so it is reasonable to treat the guidelines under 2713(a)(1) or 45 CFR 147.130(a)(1) that After issuing the July 2013 final
subsection (a)(4) similarly. Third, without this was in effect on the first day of a plan regulations, the Departments issued
clarification, it would be unclear when such or policy year is the subject of a safety August 2014 interim final regulations in
services would have to be covered. The July 2010
interim final regulations and these final regulations
recall or is otherwise determined to light of the Supreme Court’s Wheaton
accordingly apply the intervals established therein pose a significant safety concern by a interim order concerning notice to the
to services under section 2713(a)(4). federal agency authorized to regulate federal government that an eligible
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organization has a religious objection to 2014 interim final regulations did not funding or administering some or all
providing contraceptive coverage, as an identify any way to administer the contraceptive coverage, will list the
alternative to the EBSA Form 700 accommodation without this contraceptive services to which the
method of self-certification, and to information, or any alternative means organization objects, and will describe
preserve participants’ and beneficiaries’ the Departments can use to obtain the the obligations of the issuer(s) under 26
(and, in the case of student health required information. Nothing in this CFR 54.9815–2713A, 29 CFR 2590.715–
insurance coverage, enrollees’ and alternative notice process (or in the 2713A, and 45 CFR 147.131. Issuers
dependents’) access to coverage for the EBSA Form 700 notice process) remain responsible for compliance with
full range of FDA-approved provides for a government assessment of the statutory and regulatory requirement
contraceptives, as prescribed by a health the sincerity of the religious belief to provide coverage for contraceptive
care provider, without cost sharing. underlying the eligible organization’s services without cost sharing to
These final regulations continue to objection. The notice to HHS, and any participants and beneficiaries of insured
allow eligible organizations to choose subsequent updates, should be sent group health plans, and to enrollees and
between using EBSA Form 700 or the electronically to: marketreform@ dependents of insured student health
alternative process consistent with the cms.hhs.gov, or by regular mail to: plans, notwithstanding that the
Wheaton interim order. The alternative Centers for Medicare & Medicaid policyholder is an eligible organization
process provides that an eligible Services, Center for Consumer with a religious objection to
organization may notify HHS in writing Information and Insurance Oversight, contraceptive coverage that will not
of its religious objection to covering all 200 Independence Avenue SW., have to contract, arrange, pay, or refer
or a subset of contraceptive services. Washington, DC 20201, Room 739H. for the coverage.
The notice must include the name of the When an eligible organization that Several comments addressed
eligible organization and the basis on establishes or maintains a self-insured oversight and enforcement to monitor
which it qualifies for an plan subject to ERISA provides a notice the accommodation. The Departments
accommodation; its objection based on to HHS, the Department of Labor (DOL) will use their established oversight
sincerely held religious beliefs to (working with HHS) will send a separate processes, applicable to all the
covering some or all contraceptive notification to each third party Affordable Care Act market reforms of
services, as applicable (including an administrator of the ERISA plan. The PHS Act title XXVII, part A to monitor
identification of the subset of DOL notification will inform each third compliance with the requirement to
contraceptive services to which party administrator of the eligible arrange for or provide separate
coverage the eligible organization organization’s religious objection to payments for contraceptive services
objects, if applicable); the plan name funding or administering some or all without cost sharing.24
and type (that is, whether it is a student contraceptive coverage, will list the
health insurance plan within the contraceptive services to which the (ii) Definition of a Closely Held for-
meaning of 45 CFR 147.145(a) or a employer objects, will describe the Profit Entity
church plan within the meaning of obligations of the third party (a) General Structure of a Closely Held
ERISA section 3(33)); and the name and administrator(s) under 29 CFR for-Profit Entity
contact information for any of the plan’s 2590.715–2713A and 26 CFR 54.9815–
third party administrators and health 2713A, and will designate the relevant After issuing the July 2013 final
insurance issuers.22 A model notice to third party administrator(s) as plan regulations, the Departments issued
HHS that eligible organizations may, but administrator under section 3(16) of August 2014 proposed regulations in
are not required to, use is available at: ERISA for those contraceptive benefits light of the Supreme Court’s ruling in
http://www.cms.gov/cciio/resources/ that the third party administrator would Hobby Lobby, that, under the Religious
Regulations-and-Guidance/ otherwise manage on behalf of the Freedom Restoration Act of 1993
index.html#Prevention. If there is a eligible organization. The DOL (RFRA),25 the requirement to provide
change in any of the information notification will be an instrument under contraceptive coverage could not be
required to be included, the which the plan is operated, and will applied to certain closely held for-profit
organization must provide updated supersede any earlier designation. In entities that had a religious objection to
information to HHS. establishing and implementing this providing coverage for some or all the
The content required for the notice alternative process, DOL is exercising its FDA-approved contraceptive methods.
represents the minimum information broad rulemaking authority under title I The proposed regulations solicited
necessary for the Departments to of ERISA, which includes the ability to comments on a number of different
determine which entities are covered by interpret and apply the definition of a approaches for defining a closely held
the accommodation, to administer the plan administrator under ERISA section for-profit entity for purposes of
accommodation, and to implement the 3(16)(A). qualifying as an eligible organization
policies in the July 2013 final If an eligible organization that that can avail itself of an
regulations.23 Comments on the August establishes or maintains an insured accommodation, and solicited
group health plan or insured student comments on a number of other related
22 Church plans are exempt from ERISA pursuant
health plan provides a notice to HHS issues.
to ERISA section 4(b)(2). As such, a third party
administrator of a self-insured church plan
under this alternative process, HHS will
established or maintained by an eligible send a separate notification to each 24 The Departments’ oversight and enforcement
organization does not become the plan health insurance issuer of the plan. role with respect to the market reforms under the
administrator by operation of 29 CFR 2510.3–16, HHS’s notification will inform each Affordable Care Act builds upon their respective
although such third party administrators may roles with respect to the market reforms under title
voluntarily provide or arrange separate payments
health insurance issuer of the eligible I of HIPAA. For a description of the latter, see
for contraceptive services and seek reimbursement organization’s religious objection to Notice of Signing of a Memorandum of
for associated expenses under the process set forth Understanding among the Department of the
in 45 CFR 156.50. the required information, HHS will attempt to Treasury, the Department of Labor, and the
23 An accommodation cannot be effectuated until notify the organization of the incompleteness, so Department of Health and Human Services at 64 FR
all of the necessary information is submitted. If the organization can submit additional information 70165 (Dec. 15, 1999).
HHS receives a notice that does not include all of to make its notice complete. 25 42 U.S.C. 2000bb et. seq.
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The Departments received more than which the ownership interests are not required by RFRA and Hobby Lobby.
75,000 comments in response to the publicly traded, and in which a The Departments have extended the
August 2014 proposed regulations. specified fraction of the ownership accommodations to the specified class
Numerous comments addressed matters interest is concentrated in a limited and of for-profit entities in order to provide
outside the scope of the proposed specified number of owners (the additional protection to entities that
regulations (for example, many Departments did not propose a specific may have religious objections to
comments expressed support for or level of ownership concentration but providing contraceptive coverage, and
disagreement with the Supreme Court’s solicited comment on what that level because the Departments believe that
Hobby Lobby decision, contraception in should be). As explained in the eligibility for the accommodations
general, or different methods of preamble to the August 2014 proposed should be based on a rule that has
contraception), and are not addressed in regulations, this approach also has origins in existing law.
this preamble. To the extent comments precedent in federal law, which limits Under the August 2014 proposed
addressed matters that were within the certain tax treatment to entities that are regulations and these final regulations,
scope of the proposed regulations, those more than 50 percent owned by or for the first prong that an eligible
portions of the comments were not more than five individuals.27 The organization (whether it be a nonprofit
considered, and all significant Departments invited comments on the entity or a closely held for-profit entity)
comments related to matters within the appropriate scope of the definition of a must meet in order to avail itself of the
scope of the proposed regulations are qualifying closely held for-profit entity. accommodation is that the entity must
discussed in this preamble. Many As explained in more detail below, oppose providing coverage for some or
commenters expressed support for or these final regulations extend the all of any contraceptive item or service
disagreement with the general accommodation to a for-profit entity required to be covered, on account of
requirement to provide coverage for that is not publicly traded, is majority- religious objections. This requirement
contraceptive services without cost owned by a relatively small number of remains unchanged in these final
sharing. Some commenters expressed individuals, and objects to providing regulations. (In the case of a for-profit
support for the notion that any contraceptive coverage based on its entity, the entity must be opposed to
employer that has religious objections to owners’ religious beliefs. This definition providing these services on account of
covering contraceptive services should includes for-profit entities that are its owners’ religious objections).
either be exempt from doing so, or controlled and operated by individual Many commenters supported
should be able to avail itself of the owners who are likely to have excluding publicly traded entities from
accommodation. Other commenters associational ties, are personally the definition of a closely held for-profit
stated that women should have access to identified with the entity, and can be entity. However, a few commenters
contraceptive services without cost regarded as conducting personal stated that a publicly traded entity
sharing, regardless of where they work, business affairs through the entity. should not be disqualified from the
and that employers should not be Those entities appear to be the types of accommodation. Although the entities
permitted to deny them coverage, closely held for-profit entities in Hobby Lobby were not publicly
whether the employer’s decision is for contemplated by Hobby Lobby, which traded, one commenter noted that the
religious or other reasons. Many involved two family-owned Court did not expressly preclude
commenters suggested that the set of corporations that were operated in publicly traded corporations from the
closely held for-profit entities eligible accordance with their owners’ shared protections of RFRA. Another
for the accommodation be defined as religious beliefs.28 The Departments commenter stated that if a publicly
narrowly as possible. also believe that the definition adopted traded corporation could provide
The August 2014 proposed in these regulations includes the for- evidence of a sincere religious objection
regulations would extend the profit entities that are likely to have to providing contraceptive coverage, it
availability of the accommodation to religious objections to providing should not be precluded from the
closely held for-profit entities. The contraceptive coverage. That assessment accommodation.
preamble proposed two possible is supported by the comments received These final regulations exclude
approaches to defining a closely held on the proposed regulation. As publicly traded entities from the
for-profit entity. Under the first explained below, the Departments definition of an eligible organization.
proposed approach, a qualifying closely sought comment on a definition similar Hobby Lobby did not involve RFRA’s
held for-profit entity would be a for- to the one adopted here, and we believe application to publicly traded
profit entity where none of the that no commenter identified an entity companies, and the Supreme Court
ownership interests in the entity are that would want to avail itself of the emphasized that ‘‘the idea that
publicly traded, and where the entity accommodation but that would be unrelated shareholders—including
has fewer than a specified number of excluded by the definition. In addition, institutional investors with their own
shareholders or owners (the based on the available information, it sets of stakeholders—would agree to run
Departments did not propose a specific appears that the definition adopted in a corporation under the same religious
number, but solicited comment on what these final regulations includes all of beliefs seems improbable.’’ 29
the number should be). As explained in Many commenters favored limiting
the for-profit entities that have as of the
the preamble to the August 2014 the number of owners to ‘‘a handful,’’
date of issuance of these regulations
proposed regulations, there is precedent without specifying a maximum number.
challenged the contraceptive coverage
in other areas of federal law for limiting One commenter urged the Departments
requirement in court.
the definition of closely held entities to The Departments believe that the to establish a limit on the maximum
those with a relatively small number of definition adopted in these regulations number of shareholders for closely held
owners.26 Under the second proposed complies with and goes beyond what is entities of 999.
approach, a qualifying closely held One commenter favored limiting the
entity would be a for-profit entity in 27 See discussion of several Tax code provisions,
number of owners, but stated that any
including 26 U.S.C. 856(h), 542(a)(2), and 469(j)(1), particular limit could lead to anomalous
26 See discussion of definition of S corporations at 79 FR 51122.
under section 1361 of the Tax Code, at 79 FR 51122. 28 See 134 S. Ct. at 2764–2768. 29 134 S. Ct. at 2744.
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results for entities with more than the individuals, who might comprise fewer backdrop of the longstanding
permitted number of owners that seek than half of the total number of owners, governmental recognition of a particular
the accommodation. The commenter would be able to direct the corporation sphere of autonomy for houses of
noted, for example, that if the maximum to seek the accommodation, potentially worship, such as the special treatment
number of shareholders or owners is against the wishes of the minority given to those organizations in the
ten, non-publicly traded companies shareholders. Code.31 This exemption for churches
with eleven shareholders would have to Several commenters suggested that and houses of worship is consistent
provide contraceptive coverage, no basing the definition either on the with their special status under
matter how sincerely held the religious number of owners, or upon a longstanding tradition in our society
objections of the owners. Another concentration of ownership, would be and under federal law, and is not a mere
commenter who favored the approach inappropriate. One commenter stated product of the likelihood that these
stated that the definition should be that there is no basis in the Hobby Lobby institutions hire coreligionists. Hiring
limited to entities that have ten or fewer decision to restrict the definition based coreligionists is not itself a
shareholders, and that shareholders on measures such as shareholder determinative factor as to whether an
should be counted based upon the numbers, fractions of ownership, or tax organization should be accommodated
definitions under subchapter S—that is, rules. Another commenter stated that or exempted from the contraceptive
individuals should be counted along each of the proposed definitions of a requirements.
with certain trusts and estates. This ‘‘closely held corporation’’ is based on Another commenter stated that
would account for Qualified Subchapter an arbitrary metric unrelated to the ownership of the entity should be
S Trusts, but would not allow for other religious beliefs of the owners of the limited to family members. The
partnerships or corporations to be corporation. Another commenter stated Departments do not believe that
shareholders. This commenter also that any rule that defines ‘‘closely held’’ ownership of a closely held for-profit
urged that members of the same family in a narrow manner, such as by limiting entity eligible for the accommodation
be counted as separate shareholders. the number, kind, or percentage control should be limited to members of one
Another commenter explained that a of a share of its owners, or by adopting family. Although many closely held
closely held company is commonly definitions used in the Code, will corporations are family-owned, existing
understood to be one that chooses S- violate RFRA and the Hobby Lobby state and federal definitions of closely
corporation status or has fewer than 100 decision. One commenter stated that a held or close corporations do not
shareholders, and that many are numerical test of shareholders will be typically include this requirement. As
privately held and owned by family both under- and over-inclusive, stated below, however, for purposes of
members. Beyond these characteristics, capturing corporations that meet the these final regulations, an individual is
the commenter urged, the size of the numerical test but whose shareholders considered to own the ownership
company should not matter. One are not expressing a religious belief interests owned, directly or indirectly,
commenter suggested following the through the corporation, and failing to by or for his or her family, meaning
close corporation definition from the capture corporations with a relatively brothers and sisters (including half-
applicable state or, in the absence of a large number of shareholders united in brothers and half-sisters), spouses,
corporate form, following the definition their religious interests. Another ancestors, and lineal descendants. The
of a close corporation under Delaware commenter believed that basing the Departments agree with the commenters
law. definition of ‘‘closely held entity’’ solely who urged us to define a closely held
A few commenters supported a test on the number of owners would not entity, for purposes of these regulations,
that would be aligned with one of the limit eligibility to those types of entities based on an existing federal definition.
federal tax law’s definitions of a addressed in the Hobby Lobby case. The Departments believe that this
‘‘closely held corporation.’’ For One commenter believed that, for approach will minimize confusion for
example, commenters supported a purposes of qualifying for the entities seeking the accommodation.
definition that provides that the accommodation, an entity should only At the same time, the Departments
corporation may not have ownership employ individuals who adhere to the also recognize the need for flexibility in
interests that are publicly traded, that owners’ religious beliefs. The the definition for purposes of the
more than 50 percent of the outstanding Departments do not believe this is a accommodation. Therefore, the
ownership interests in the corporation necessary characteristic for an entity to Departments are adopting in these
must be owned (directly or indirectly) qualify as an eligible organization that regulations a definition that is generally
by five or fewer individuals at any time can avail itself of the accommodation, based on—but is more flexible than—
during the last half of the tax year, and and in Hobby Lobby the court granted the definition of a closely held
that the corporation may not be a relief to companies that did not possess corporation found in the Code 32 (which
personal service corporation. The this feature. Additionally, while the we refer to as the tax-law definition).
commenters favored identifying closely Departments have noted that exempting Under the tax-law definition, a closely
held entities through an approach based churches and their integrated auxiliaries
on this definition because such an (which the regulations refer to as 31 26 U.S.C. 6033(a)(3)(A).
approach would be easy to apply and ‘‘religious employers’’) from the 32 Code section 469(j)(1) states the ‘‘term ‘closely
held C corporation’ means any C corporation
already familiar to corporations that requirement to provide contraceptive described in section 465(a)(1)(B).’’ Section
apply similar concepts under the Code. coverage does not impermissibly 465(a)(1)(B) provides ‘‘a C corporation with respect
Other commenters were generally undermine the government’s compelling to which the stock ownership requirement of
opposed to a limited ownership- interests in promoting public health and paragraph (2) of section 542(a) is met.’’ Section
542(a)(2) provides that the applicable stock
concentration test. One commenter ensuring that women have equal access ownership requirement is met if ‘‘[a]t any time
observed that under this approach, a to health care because churches are during the last half of the taxable year more than
corporation would be able to more likely to hire co-religionists,30 the 50 percent in value of its outstanding stock is
concentrate a fraction of ownership, for exemption to the contraceptive coverage owned, directly or indirectly, by or for not more
than 5 individuals.’’ Similarly, section 856(h)(1)(A)
example 50 percent, in a specified requirement was provided against the provides ‘‘a corporation, trust, or association is
number of owners, such as ten people. closely held if the stock ownership requirement of
The commenter observed that those ten 30 78 FR 39887. section 542(a)(2) is met.’’
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held corporation is a corporation that owners, who collectively own 45 and sisters (including half-brothers and
has more than 50 percent of the value percent of the outstanding ownership half-sisters), a spouse, ancestors, and
of its outstanding stock owned (directly interests, also has a substantially similar lineal descendants. Accordingly, the
or indirectly) by five or fewer ownership structure. family members count as a single owner
individuals at any time during the last We note, however, that a publicly for purposes of these final regulations.
half of the tax year, and is not a personal traded entity would not qualify as
• If a person holds an option to
service corporation.33 The definitions having a substantially similar
ownership structure. purchase ownership interests, he or she
for closely held corporation in various is considered to be the owner of those
Code provisions reference the For purposes of the accommodation,
the value of the ownership interests in ownership interests.
ownership test for personal holding
companies contained in Code section the entity, whether the total ownership To assist potentially eligible for-profit
542(a)(2), which generally has the effect interests or those owned by five or fewer entities seeking further information
of identifying those corporations that individuals, should be calculated based regarding whether they qualify for the
are controlled by a small group of on all ownership interests, regardless of accommodation, an entity may send a
individuals and closely affiliated with whether they have associated voting letter describing its ownership structure
their owners. rights or any other privileges. This is to HHS at accommodation@
Drawing on the tax-law definition, consistent with how the tax-law cms.hhs.gov. If the entity does not
with appropriate modifications to reflect definition of a closely held corporation receive a response from HHS to a
the context here, these regulations is applied. properly submitted letter describing the
establish that to be eligible for the Because the accommodation will be entity’s current ownership structure
accommodation, a closely held, for- sought on a prospective basis, the within 60 calendar days, as long as the
profit entity must, among other criteria, Departments do not believe it entity maintains that structure, it will be
be an entity that is not a nonprofit appropriate to incorporate, from the tax- considered to meet the requirement set
entity, and have more than 50 percent law definition, the time interval over
forth in 26 CFR 54.9815–
of the value of its ownership interests which the test is measured—that the
2713A(a)(4)(iii), 29 U.S.C. 2590.715–
owned directly or indirectly by five or given ownership structure be in place
2713A(a)(4)(iii), and 45 CFR
fewer individuals, or must have an during the last half of the tax year—and
instead adopt a test that is measured as 147.131(b)(4)(iii). However, an entity is
ownership structure that is substantially not required to avail itself of this
similar. of the date of the entity’s self-
certification or notice of its objection to process in order to qualify as a closely
As previously stated, for purposes of held for-profit entity.
defining a closely held for-profit entity provide contraceptive services on
account of religious objections. Based on the information available, it
in these regulations, the Departments
The tax-law definition of ‘‘closely appears that the definition of closely
are using a definition that is more
held corporation’’ excludes certain held for-profit entity set forth in these
flexible than the tax-law definition of
‘‘personal services corporations,’’ such final regulations includes all the for-
closely held corporation. Because the
as accounting firms, actuarial science profit corporations that have filed
Departments believe that the tax-law
firms, architecture firms, and law firms. lawsuits alleging that the contraceptive
definition might exclude some entities
Although there are legitimate reasons coverage requirement, absent an
that should be considered to be closely
for excluding personal service firms accommodation, violates RFRA.
held for purposes of the
from the definition of ‘‘closely held One commenter stated that the
accommodation, and because some for-
corporation’’ for purposes of taxation, definition should include any for-profit
profit entities may have unusual or non-
the Departments do not believe the entity that is controlled directly or
traditional ownership structures not
distinction is necessary in this context. indirectly by a nonprofit eligible
readily analyzed under the 5/50 test, the
Therefore, a personal services organization. The Departments agree,
definition under these final regulations
corporation may qualify as a closely because in this case the nonprofit entity
also includes, as stated above, entities
held for-profit entity under these final will represent one shareholder that
with ownership structures that are
regulations, provided it satisfies the
‘‘substantially similar’’ to structures that owns more than 50 percent of the
other criteria.
satisfy the 5-owner/50-percent ownership interests in the for-profit
Following the tax-law definition, to
requirement. determine if more than 50 percent of the entity.34 The same facts and
For example, an entity where 49 circumstances that are considered in
value of the ownership interests is
percent of the value of the outstanding determining whether a given for-profit
owned by five or fewer individuals, the
ownership interests are owned directly entity qualifies as an eligible for-profit
following rules apply:
by six individuals could also qualify as • Ownership interests owned by or organization under these final
a closely held for-profit entity because for a corporation, partnership, estate, or regulations will also apply when one or
it has an ownership structure that is trust are considered owned more of its owners is a nonprofit
substantially similar to one in which proportionately by the entity’s organization. For purposes of the
five or fewer individuals hold at least 50 shareholders, partners, or beneficiaries. ownership concentration test set forth in
percent of the value of the outstanding For example, if a for-profit entity is 100 these final regulations that applies to
ownership interests. percent owned by a partnership, and the for-profit entities, a nonprofit
As another example, an entity owned partnership is owned 100 percent by organization that has an ownership
by a series of corporate parents, where four individuals, the for-profit entity, for interest in a for-profit entity will be
among the ultimate stockholders are a purposes of these regulations, is considered one individual owner of the
nonprofit entity and a for-profit considered to be owned 100 percent by for-profit entity, and the non-profit
corporation with three individual those four individuals. organization’s percentage ownership in
33 See http://www.irs.gov/Help-&-Resources/
• An individual is considered to own the for-profit entity will be attributed to
the ownership interests owned, directly that nonprofit organization.
Tools-&-FAQs/FAQs-for-Individuals/Frequently-
Asked-Tax-Questions-&-Answers/Small-Business,- or indirectly, by or for his or her family.
Self-Employed,-Other-Business/Entities/Entities-5. The ‘‘family’’ includes only brothers 34 See EBSA Form 700.
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(b) The Process for Making the Decision that it made such a decision). Many must be made aware of their employer’s
To Object To Covering Contraceptive comments supported a requirement that (or educational institution’s) refusal to
Services the decision-making process be offer contraceptive coverage. One
The August 2014 proposed documented, and that the entity submit, commenter stated that a closely held
regulations proposed that a closely held to its third party administrator or health for-profit entity should disclose the
for-profit entity’s objection to covering insurance issuer, as applicable, and to following to its shareholders and
some or all of the contraceptive services the federal government, documentation employees: (A) The reasons the decision
otherwise required to be covered on of the entity’s decision. These final was made, (B) the changes that will take
account of its owners’ sincerely held regulations require that a for-profit place as a result of the decision, and (C)
entity seeking the accommodation must the number of people that will be
religious beliefs must be made in
make the decision pursuant to a affected by the decision. Another
accordance with the organization’s
resolution (or other similar action), as commenter stated that entities availing
applicable rules of governance,
described above. However, the themselves of the accommodation
consistent with state law. Some
Departments are not requiring that this should be required to publicize their
comments proposed alternative or
resolution be provided as a matter of justifications for denying women access
additional criteria for how the decision
course to the federal government or any to coverage of medications that serve
must be made. One criterion suggested
other party. Generally, the Departments purposes other than contraception. One
by many commenters was unanimity
believe it is sufficient that the fact of the commenter noted the need of employees
among all owners regarding opposition
decision itself, as opposed to to know by the employer’s annual open
to contraception. However, one documentation of the decision, be enrollment period whether the
commenter objected to this requirement, communicated as set forth in August employer is availing itself of the
stating that the regulations should not 2014 interim final regulations and these accommodation.
require unanimous shareholder consent final regulations. However, with respect These final regulations do not
because neither the Hobby Lobby to documentation of the decision, record establish any additional requirements to
decision nor state corporate law retention requirements under section disclose the decision. The Departments
imposes such a requirement. 107 of ERISA apply directly to ERISA- believe that the current notice and
Some commenters favored requiring covered plans and, with respect to other disclosure standards afford individuals
each equity holder to certify, under plans or coverage subject to these final eligible for or enrolled in group health
penalty of perjury, that he or she has a regulations, by operation of these final plans (and students eligible for or
religious objection to the entity regulations, which incorporate the enrolled in student health insurance)
providing contraceptive coverage. These record retention requirements under with an accommodation adequate
final regulations do not adopt a ERISA section 107 by reference. This opportunity to know that the employer
requirement that the owners approach is consistent with document (or educational institution) has elected
unanimously decide that the entity will standards for nonprofit entities seeking the accommodation for its group health
not offer contraceptive coverage based the accommodation. plan (or insurance coverage), and that
on a religious objection, or that any they are entitled to separate payment for
equity holder certify under penalty of (d) Disclosure of the Decision To Assert contraceptive services from another
perjury that he or she has a religious a Religious Objection to Contraceptive source without cost sharing. Those
objection to the entity providing the Services standards require that, for each plan
coverage. The Departments believe that In the August 2014 proposed year to which the accommodation
either requirement would be unduly regulations, the Departments sought applies, a third party administrator that
restrictive, and would unnecessarily comments on whether a for-profit entity is required to provide or arrange
interfere with for-profit entities’ seeking the accommodation should be payments for contraceptive services,
decision-making processes. Instead, required to disclose publicly or to its and a health insurance issuer required
these final regulations provide that the employees its decision not to cover to provide payment for these services,
organization’s highest governing body some or all contraceptive services on provide to plan participants and
(such as its board of directors, board of account of religious objections. This beneficiaries (or student enrollees and
trustees, or owners, if managed directly requirement would be in addition to the their covered dependents) written
by the owners) must adopt a resolution requirement that an eligible notice of the availability of separate
(or take other similar action consistent organization that is a for-profit entity payments for these services
with the organization’s applicable rules that seeks the accommodation make its contemporaneous with (to the extent
of governance and with state law) self-certification or notice of objection to possible), but separate from, any
establishing that the organization providing contraceptive coverage on application materials distributed in
objects to covering some or all of the account of religious objections available connection with enrollment or re-
contraceptive services on account of its for examination upon request by the enrollment in health coverage. Model
owners’ sincerely held religious beliefs. first day of the plan year to which the language for this notice is provided in
accommodation applies, and be the regulations.
(c) Documentation of the Decision To maintained in a manner consistent with
Assert a Religious Objection to the record retention requirements under (e) Sincerity of the Owners’ Religious
Contraceptive Coverage section 107 of ERISA. Beliefs
In the August 2014 proposed Many commenters suggested that the Many commenters suggested that, for
regulations, the Departments sought entity should be required to notify HHS a closely held for-profit entity to be
comments on whether a for-profit entity of its decision to object (even if it eligible for an accommodation, it should
seeking the accommodation should be chooses to self-certify and send the self- not be sufficient that the entity’s owners
required to document its decision- certification to its issuer or third party object to providing contraceptive
making process for objecting to coverage administrator). A few commenters coverage. Rather, the commenters
for some or all contraceptive services on stated that all employees and proposed that owners should also be
account of religious objections (as prospective employees (or student required to agree to operate the entity in
opposed to merely disclosing the fact enrollees and their covered dependents) a manner consistent with religious
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principles, and in fact to so operate the Other commenters stated that the Specifically, the third party
entity. Some commenters pointed out federal government should ensure that administrator must provide or arrange
that the July 2013 final regulations no barriers to contraceptive coverage the payments, and the third party
require non-profit religious exist due to an enrollee’s cultural administrator can seek reimbursement
organizations that avail themselves of background, English proficiency, for the costs (including an allowance for
the accommodation to ‘‘hold themselves disability, or sexual orientation. The administrative costs and margin) by
out’’ as religious organizations. Departments agree that no barriers making an arrangement with a
The Departments have not adopted should exist. The same federal and participating issuer—that is, an issuer
such a criterion for for-profit entities. applicable state laws that would offering coverage through a Federally-
The Supreme Court’s decision in Hobby prohibit discrimination by employers, facilitated Exchange (FFE). The
Lobby discussed the application of group health plans, third party participating issuer can receive an
RFRA in connection with the religious administrators, and health insurance adjustment to its FFE user fees to
beliefs of the owners of a closely held issuers generally would also apply with finance these costs.
corporation.35 These final regulations respect to the entities arranging for or One commenter suggested that the
similarly focus on the religious exercise providing separate payments for federal government set up a program to
of the owners of the closely held entity contraceptive services for women in dispense these services using
and provide that the entity, in group health plans and student health contractors. Another commenter
advancing the religious objection, insurance subject to an accommodation. suggested that pharmaceutical
represent that it does so on the basis of Other commenters urged that the companies could provide certain
the religious beliefs of the owners. The separate payments for contraceptive contraceptives directly by mail to
Departments do not believe it is also services be provided in the same persons who are told at a dispensing
necessary that the entity itself manner in which the group health plan pharmacy that their plan has denied
demonstrate by its bylaws, mission or student health insurance would have coverage. Additionally, the
statement, or other documents or otherwise covered these services had pharmaceutical companies could
practices that it has a religious they not had an accommodation, or in directly supply doctors who prescribe
character. Non-profit entities ordinarily the same manner in which the plan or birth control, who in turn could
do not have owners in the same way as coverage subject to an accommodation dispense directly to patients who are
do for-profit entities, and thus the covers other, non-contraceptive benefits. not covered under their employer-
The Departments, however, maintain sponsored group health plan or student
religious character of a non-profit entity
the view that reasonable differences in health insurance coverage. One
would be reflected in how it holds itself
the way services are paid for or commenter suggested making
out.
provided would not necessarily be contraception available for any woman
(f) Other Steps the Departments Should inappropriate, provided those free of charge through a doctor. One
Take To Ensure Contraceptive Coverage differences do not create barriers to commenter suggested providing
With No Cost Sharing accessing payments for contraceptive contraceptive care through Medicaid.
services. Another commenter stated that The Departments have not adopted
The August 2014 proposed the proposals advanced by these
health insurance issuers of plans subject
regulations solicited comments on other comments for two reasons. First, the
to an accommodation should not be
steps the Departments should take to permitted to require enrollees to have Departments do not have the legal
help ensure that participants and two insurance cards, one for authority to require pharmaceutical
beneficiaries (in the case of student contraceptive benefits, and one for other companies or doctors to provide
health insurance coverage, enrollees and benefits. The Departments do not contraceptives directly, nor do they
dependents) in plans subject to an believe that this practice, in of itself, have the authority to implement the
accommodation are able to obtain, would constitute a barrier to accessing other alternative arrangements proposed
without cost, the full range of FDA- separate payments for contraceptive by these commenters. Second, these
approved contraceptives without cost services. alternatives raise obstacles to access to
sharing. Many commenters stated that a seamless coverage. Consistent with the
government enforcement body should (g) Other Comments That Relate to the statutory objective of promoting access
be established to monitor compliance by July 2013 Final Regulations to contraceptive coverage and other
plan sponsors, third party In the August 2014 proposed preventive services without cost
administrators, and health insurance regulations and interim final sharing, plan beneficiaries and enrollees
issuers, of their respective obligations regulations, the Departments sought should not be required to incur
associated with the accommodation. At comment on other potential changes to additional costs—financial or
this time, the Departments do not the July 2013 final regulations in light otherwise—to receive access and thus
believe that an independent body need of the proposed change to the definition should not be required to enroll in new
be established, although as stated above, of eligible organization. In particular, programs or to surmount other hurdles
the Departments will use their the Departments sought comment on to receive access to coverage. The
established oversight processes, applying the approach set forth in the Departments believe that the third party
applicable to all the Affordable Care Act July 2013 final regulations in the administrators and health insurance
market reforms of title XXVII of the PHS context of the expanded definition of issuers already paying for other medical
Act to monitor compliance with the eligible organization. The July 2013 and pharmacy services on behalf of the
requirement to provide contraceptive final regulations provide for separate women seeking the contraceptive
services without cost sharing. As part of payments for contraceptive services for services are better placed to provide
those processes, the Departments will participants and beneficiaries in self- seamless coverage of the contraceptive
work with non-compliant parties to insured group health plans of eligible services, than are other providers that
bring them into compliance, and will organizations in a manner that enables may not be in the insurance coverage
take enforcement action as appropriate. these organizations to completely network, and that lack the coverage
separate themselves from administration administration infrastructure to verify
35 See 134 S. Ct. at 2768. and payment for contraceptive coverage. the identity of women in accommodated
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health plans and provide formatted payments for contraceptive services, the to comply with the federal standard.
claims data for government commenter recommended a broadening These principles continue to apply.
reimbursement. of the pool available for reimbursement One commenter stated that the Hobby
Some commenters suggested other beyond individually negotiated Lobby decision applies to every form of
changes to the July 2013 regulations, arrangements with issuers participating medical care, not just contraception,
with respect to how separate payments in the FFE, including potentially and that the regulations should reflect
for contraceptive services provided establishing a single pool for that. However, in Hobby Lobby, the
under the accommodation are funded. reimbursement or finding an alternative, Court stated:
One commenter expressed concern that simpler financing mechanism for third In any event, our decision in these cases
the August 2014 proposed regulations party administrators, including offsets is concerned solely with the contraceptive
are silent as to possible funds for from federal income taxes, and offsets to mandate. Our decision should not be
reimbursement of costs incurred for amounts due from other lines of understood to hold that an insurance-
contraception services where there is no business operated by the third party coverage mandate must necessarily fail if it
FFE operating in the state. This conflicts with an employer’s religious beliefs.
administrator.
commenter also noted that the Other coverage requirements, such as
regulations do not consider the At this time, the Departments are not immunizations, may be supported by
possibility that the cost for adopting an alternative approach to different interests (for example, the need to
funding separate payments for combat the spread of infectious diseases) and
contraceptive services may exceed the may involve different arguments about the
issuer’s FFE user fee, nor do they contraceptive services with respect to
costs incurred for women in plans least restrictive means of providing them.39
address how a third party administrator
would be reimbursed if the issuer is no subject to an accommodation, although Regarding fully insured plans, one
longer a participating issuer in the FFE. the Departments will continue to commenter noted that the July 2013
The commenter suggested the explore the feasibility of different ideas, final regulations permit issuers that are
Departments consider several different including those proposed in the providing separate payments for
financing options: The user fee for the comments. contraceptive services under the
risk adjustment program; the CMS One commenter suggested that issuers accommodation, to pay for all FDA-
program management fund; the user fee should be permitted to treat the cost of approved contraceptive services, or only
for the Medicare Part D program; the providing separate payments for for those services to which the eligible
Prevention and Public Health Fund; contraceptive services for women in organization objects to covering on
medical loss ratio rebates; CMS plans subject to an accommodation as religious grounds. The commenter noted
innovation funding; and the health an adjustment to claims costs for that this approach simplifies the
insurance provider fee. purposes of calculating their medical operational issues associated with
Another commenter recommended loss ratios, while still being allowed to implementing the accommodation
that HHS provide for an expedited treat such payments as an across multiple employers, and sought
process of adjusting FFE user fees in administrative cost spread across the clarification that this approach is
case the volume of contraceptive claims issuer’s entire risk pool.36 With respect available to third party administrators as
is greater than expected. This to calculating medical loss ratios, HHS well. The Departments clarify that this
commenter also suggested that the has previously stated in rulemaking that option is available to third party
Departments also consider alternative an insurer of an accommodated insured administrators with respect to self-
means of generating funding for this group health or student plan may insured plans.
purpose, such as allowing an issuer to One commenter requested that notices
include the cost of the actual payments
charge a premium of at least an amount of objection to covering contraceptive
it makes for contraceptive services in
equal to the pro rata share of the rate the services on religious grounds be
the numerator of its medical loss ratio.37
eligible organization would have paid provided with at least 60 days’ advance
had it not elected the accommodation, Several commenters asked whether, notice, and that any change in objection
or directly subsidize the cost of in light of the fact that the status based on change of ownership of
contraception using funding provided accommodation was proposed to be the employer not be implemented until
by the Prevention and Public Health expanded to a new set of entities, if the the next plan year or policy year. The
Fund. Department’s discussion in the Departments do not adopt this
One commenter stated that the preamble to the July 2013 final suggestion. Instead, the Departments are
Departments should evaluate the regulations about the extent to which extending, to closely held for-profit
limitations of current funding the accommodation has an effect on entities, the same timeframes that have
arrangements with respect to the current other laws, continues to apply.38 The been in effect for non-profit eligible
accommodation for eligible non-profit Departments explained in that organizations, that is, a plan sponsor
entities, given the additional demands discussion that state insurance laws that can provide such notice, and implement
of the proposal to expand the provide greater access to contraceptive plan benefit changes associated with the
accommodation to certain for-profit coverage than federal standards are accommodation, at any time. For group
entities. The commenter suggested unlikely to be preempted, and that, in health plans subject to ERISA, existing
allowing a separate government funded states with broader religious exemptions notice and timeframe requirements
reimbursement mechanism for enrollees and accommodations with respect to under ERISA apply.
in both insured and self-funded plans as health insurance issuers than those in Another commenter stated that health
an alternative approach to funding the the regulations, plans are still required insurance issuers and third party
program. If the current funding administrators should only be required
approach is continued, the commenter 36 See Discussion of how an issuer may achieve
to provide or arrange for separate
recommended a reassessment of the cost neutrality in the preamble to the July 2013 final payments for contraceptive services for
regulations, at 78 FR 39878.
limitations of the approach for third 37 See Patient Protection and Affordable Care Act;
eligible organizations that have invoked
party administrators. If third party HHS Notice of Benefit and Payment Parameters for an accommodation no earlier than the
administrators remain responsible for 2015 (Mar. 11, 2014), at 79 FR 13809.
providing or arranging separate 38 78 FR 39888. 39 134 S. Ct. at 2783.
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first day of the first plan year that regulations finalize a clarification one year, and therefore meet the
follows publication of these final proposed in the August 2014 proposed definition of ‘‘significant rule’’ under
regulations. To provide employers, regulations under which a reference to Executive Order 12866. Therefore, the
institutions of higher education, third the definition of ‘‘institution of higher Departments have provided an
party administrators, and health education’’ found in 20 U.S.C. 1002 is assessment of the potential costs,
insurance issuers adequate time to added to 45 CFR 147.131(f), to clarify benefits, and transfers associated with
comply, these final regulations apply that both nonprofit and closely held for- these final regulations. In accordance
beginning on the first day of the first profit institutions of higher education, with the provisions of Executive Order
plan year (or, in the individual market, with respect to their insured student 12866, these final regulations were
the first policy year) after these health plans, may qualify as eligible reviewed by the OMB.
regulations are effective. Accordingly organizations.
these final regulations are effective 1. Need for Regulatory Action
beginning on the first day of the first III. Economic Impact and Paperwork
Burden These final regulations finalize the
plan year (or, in the individual market, July 2010 interim final regulations
the first policy year) that begins on or A. Executive Orders 12866 and 13563— related to coverage of recommended
after September 14, 2015. Department of Health and Human preventive services, the August 2014
Several commenters stated that the Services and Department of Labor interim final regulations related to the
decision to not cover some or all
Executive Order 12866 (58 FR 51735) process an eligible organization uses to
contraceptives on religious grounds
directs agencies to assess all costs and provide notice of its religious objections
should be made annually. The
benefits of available regulatory to the coverage of contraceptive
Departments do not believe such a
requirement is appropriate or necessary. alternatives and, if regulation is services, and the August 2014 proposed
One commenter asked for clarification necessary, to select regulatory regulations related to the definition of
as to how a notice of objection would approaches that maximize net benefits eligible organization.
be provided by employers purchasing (including potential economic, As discussed later in the RIA,
coverage through the Small Business environmental, public health and safety historically there has been an
Health Options Program (SHOP) and effects; distributive impacts; and underutilization of preventive services,
whether there will be a mechanism in equity). Executive Order 13563 (76 FR as health insurance issuers have had
place that permits an eligible 3821, January 21, 2011) is supplemental little incentive to cover these services.
organization to select a small group plan to and reaffirms the principles, Currently, there is still an
and provide a notice of objection. With structures, and definitions governing underutilization of some preventive
respect to employers purchasing regulatory review as established in services due to a number of barriers,
coverage through the SHOP, health Executive Order 12866. including costs, ethnic/gender
insurance issuers selling policies Section 3(f) of Executive Order 12866 disparities,40 and a general lack of
through it, and participants and defines a ‘‘significant regulatory action’’ knowledge by those with medical
beneficiaries in such plans, all of the as an action that is likely to result in a coverage.41 While many of these factors
rights and obligations that are associated proposed rule—(1) having an annual are being addressed through the
with these regulations apply no effect on the economy of $100 million Affordable Care Act and these final
differently than if the employer were to or more in any one year, or adversely regulations, the current underutilization
purchase coverage outside of the SHOP. and materially affecting a sector of the of preventive services stems from three
One commenter stated that providing economy, productivity, competition, main factors. First, due to turnover in
separate payments for contraceptive jobs, the environment, public health or the health insurance market, health
services is not cost-neutral for an issuer, safety, or state, local or tribal insurance issuers have historically
and that it is not appropriate for an governments or communities (also lacked incentives to cover preventive
issuer of a student health insurance plan referred to as ‘‘economically services, whose benefits may only be
to be required to make separate significant’’); (2) creating a serious realized in the future when an
payments for contraceptive services for inconsistency or otherwise interfering individual may no longer be enrolled
enrollees in student health plans subject with an action taken or planned by with that issuer. Second, many
to an accommodation, and suggested another agency; (3) materially altering preventive services generate benefits
that the Marketplaces should instead the budgetary impacts of entitlement that do not accrue immediately to the
offer free individual market policies grants, user fees, or loan programs or the individual that receives the services,
covering contraception to those who rights and obligations of recipients making the individual less likely to
desire such coverage, or that such thereof; or (4) raising novel legal or avail themselves of the services,
individuals get such services through policy issues arising out of legal especially in the face of direct,
existing clinics. In the alternative, the mandates, the President’s priorities, or immediate costs. Third, some of the
commenter proposed an ‘‘above the the principles set forth in the Executive benefits of preventive services accrue to
line’’ deduction on their federal income Order. society as a whole, and thus do not get
taxes for all costs incurred for separate A regulatory impact analysis (RIA) factored into an individual’s decision
payments made for contraceptive must be prepared for major rules with making over whether to obtain such
services for enrollees in a student health economically significant effects ($100 services.
plan subject to an accommodation. The million or more in any 1 year), and a
Departments do not adopt the comment. ‘‘significant’’ regulatory action is subject 40 Call, K. T., McAlpine, D. D., Garcia, C. M.,
For the reasons stated in the July 2013 to review by the Office of Management Shippee, N., Beebe, T., Adeniyi, T. C., & Shippee,
final regulations, the Departments and Budget (OMB). As discussed below, T. (2014). Barriers to Care in an Ethnically Diverse
believe that covering contraceptive the Departments anticipate that these Publicly Insured Population. Medical Care.
41 Reed, M. E., Graetz, I., Fung, V., Newhouse,
services is cost-neutral for an issuer at regulations—most notably the policies
J. P., & Hsu, J. (2012). In consumer-driven health
risk for the enrollees in a plan subject first established in the 2010 interim plans, a majority of patients were unaware of free
to an accommodation. With respect to final rule—are likely to have economic or low-cost preventive care. Health Affairs, 31(12),
student health insurance plans, these impacts of $100 million or more in any 2641–2648.
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The July 2010 interim final Form 700 to the issuers or third party organizations with respect to their
regulations and these final regulations administrators of their group health objection to covering contraceptive
address these market failures through plan. The provisions of those interim services.
two avenues. First, the regulations final regulations are being finalized
without any changes. 2. Summary of Impacts
require coverage of recommended
preventive services by non- These final regulations also amend
In accordance with OMB Circular A–
grandfathered group health plans and the definition of an eligible organization
4, Table III.1 below depicts an
health insurance issuers in the group to include a closely held for-profit entity
accounting statement summarizing the
and individual markets, thereby that has a religious objection to
providing coverage for some or all of the Departments’ assessment of the benefits,
overcoming plans’ lack of incentive to costs, and transfers associated with this
invest in these services. Second, the contraceptive services otherwise
required to be covered by the group regulatory action. It is expected that all
regulations eliminate cost-sharing non-grandfathered plans are already
requirements, thereby removing a health plan or student health insurance
plan established, maintained, or complying with the provisions of the
barrier that could otherwise lead an July 2010 and August 2014 interim final
individual to not obtain such services, arranged by the organization.
These final regulations are necessary regulations. Therefore, benefits related
given the long-term and partially to those regulations have been
in order to provide rules that plan
external nature of these benefits. sponsors and issuers can continue to experienced and costs have already
The August 2014 interim final use to determine how to provide been incurred. The Departments are
regulations provided an alternate coverage for certain recommended providing an assessment of the impacts
process that eligible organizations can preventive services without the of existing provisions already
use to provide notice of their religious imposition of cost sharing, to ensure experienced and expected in the future,
objections to providing coverage for women’s ability to receive those in addition to the anticipated impacts of
some or all of the contraceptive services services, and to respect the religious new provisions in these final
to HHS, instead of providing the EBSA beliefs of qualifying eligible regulations.
TABLE III.1—ACCOUNTING TABLE

Benefits:
Qualitative:
* Increased access to and utilization of recommended preventive services, leading to the following benefits:
(1) Prevention and reduction in transmission of illnesses as a result of immunization and screening of transmissible diseases;
(2) delayed onset, earlier treatment, and reduction in morbidity and mortality as a result of early detection, screening, and coun-
seling;
(3) increased productivity and reduced absenteeism; and
(4) savings from lower health care costs.
* Benefits to eligible for-profit entities from not being required to facilitate access to or pay for services that contradict their owners’ reli-
gious beliefs.
Costs:
Qualitative:
* New costs to the health care system when individuals increase their use of preventive services in response to the changes in cov-
erage and cost-sharing requirements of preventive services. The magnitude of this effect on utilization depends on the price elasticity
of demand and the percentage change in prices facing those with reduced cost sharing or newly gaining coverage.
* Administrative cost to eligible for-profit entities to provide self-certification to issuers or third party administrators or notice to HHS.
* Administrative cost to issuers and third party administrators for plans sponsored by eligible closely held for-profit entities to provide
notice to enrollees.
Transfers:
* Costs previously paid out-of-pocket for certain preventive services are now covered by group health plans and issuers.
* Risk pooling in the group market will result in sharing expected cost increases across an entire plan or employee group as higher av-
erage premiums for all enrollee. However, not all of those covered will utilize preventive services to an equivalent extent. As a result,
these final regulations create a small transfer from those paying premiums in the group market utilizing less than the average volume
of preventive services in their risk pool to those whose utilization is greater than average. To the extent there is risk pooling in the in-
dividual market, a similar transfer will occur.
* Transfer of costs related to certain preventive services from eligible self-funded closely held for-profit entities to third party adminis-
trators and issuers that provide (or arrange) separate payments for contraceptive services. Third party administrators can make ar-
rangements with an issuer offering coverage through an FFE to obtain reimbursement for its costs, and the issuer offering coverage
through the FFE can receive an adjustment to the FFE user fee.
3. Estimated Number of Affected 100 workers. The Departments estimate approximately 128,000 governmental
Entities that there are approximately 140,000 plans with 39 million participants in
large and 2.2 million small ERISA- large plans and 2.8 million participants
For purposes of this analysis, the covered group health plans with an in small plans.42 In 2013, approximately
Departments have defined a large group estimated 93.2 million participants in
health plan as an employer plan with large group plans and 36 million 42 All participant counts and the estimates of
100 or more workers and a small group participants in small group plans. The individual policies are from the U.S. Department of
plan as an employer plan with less than Departments estimate that there are Continued
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12.26 million participants were covered profit eligible organizations will seek colonoscopy).48 In 2012, the median
by individual health insurance the religious accommodation provided percentage of women over the age of 18
policies.43 in these final regulations. Health that have not had a pap test in the past
Group health plans and health insurance issuers (or third party 3 years was 22 percent.49 The CDC
insurance issuers offering group and administrators for self-insured plans) for recently found that in adults over 50,
individual health insurance coverage the group health plans established or fewer than 30 percent are up-to-date
that are not grandfathered health plans maintained by these eligible with core preventive services.50
will be affected by these regulations. organizations (and health insurance As explained in the July 2010 interim
There are an estimated 500 issuers issuers of closely held for-profit final regulations, numerous studies have
offering group and individual health institutions of higher education) will shown that improved coverage, or
insurance coverage.44 The number of assume sole responsibility for providing reduced costs, of preventive services
employer-sponsored grandfathered (or arranging) separate payments for results in higher utilization of these
plans has been decreasing steadily since contraceptive services directly for plan services 51 leading to potentially
2010. Thirty-seven percent of employers participants and beneficiaries (and for substantial benefits. Research suggests
offering health benefits offered at least student enrollees and dependents), there are significant health benefits
one grandfathered health plan in 2014, without cost sharing, premium, fee, or associated with a number of newly
compared to 54 percent in 2013 and 72 other charge to plan participants or covered preventive services required
percent in 2011. Therefore, more and beneficiaries (or student enrollees and under the statute and these final
more enrollees in employer-sponsored dependents) or to the eligible regulations. The National Council on
plans have gained access to preventive organization or its plan. In addition, Preventive Priorities (NCPP) has
services without cost sharing. Twenty- based on litigation, the Departments estimated that achieving a utilization
six percent of covered workers were estimate that at least 122 non-profit rate of 90 percent for eight clinical
enrolled in a grandfathered health plan eligible organizations will have the preventive services would save more
in 2014, as compared to 36 percent in option to provide notice of their than 150,000 lives each year in the U.S.,
2013 and 56 percent in 2011.45 In the religious objections to HHS, instead of including 42,000 if smokers were
individual market, it is expected that a providing the EBSA Form 700 to the offered medication or other cessation
large proportion of individual policies issuer or third party administrator of assistance (Table III.2).52 From an
are not grandfathered. In addition, their group health plan. These numbers economic viewpoint, many preventive
enrollees in qualified health plans are likely to underestimate the number services offer high economic value 53
purchased through the Marketplaces of eligible organizations that will seek resulting in an estimated savings of $3.7
have non-grandfathered policies. At the the accommodation. However, these are billion.54 Even if a rate of 90 percent
end of the second enrollment period, the best estimates available to the utilization is not achieved due to a
nearly 11.7 million individuals selected Departments at this time. variety of barriers, including financial,
or were automatically reenrolled into a service accessibility, and socioeconomic
2015 health insurance plan through the 4. Benefits disparities, the Departments expect that
Marketplaces.46 In the July 2010 interim final utilization will increase among those
It is uncertain how many closely held regulations, the Departments anticipated individuals in plans subject to the
for-profit entities have religious several types of benefits that will result regulations because the provisions
objections to providing coverage for from expanding coverage and eliminate cost sharing and require
some or all of the contraceptive services eliminating cost sharing for coverage for these services. It is
otherwise required to be covered. Based recommended preventive services. First, expected that the increased utilization
on litigation and communication individuals will experience improved
received by HHS, the Departments health as a result of reduced 48 CDC. Vital Signs: colorectal cancer screening
estimate that at least 87 closely held for- transmission, prevention or delayed test use—United States, 2012. MMWR 2013;62:881–
888.
onset, and earlier treatment of disease. 49 Behavioral Risk Factor Surveillance System
Labor, EBSA calculations using the March 2013 Second, healthier workers and children Numbers (2012), http://apps.nccd.cdc.gov/BRFSS/
Current Population Survey Annual Social and will be more productive with fewer page.asp?cat=CC&yr=2012&state=All#CC.
Economic Supplement and the 2012 Medical
Expenditure Panel Survey and the 2012 Census of
missed days of work or school. Third, 50 CDC Focuses on Need for Older Adults To
some of the recommended preventive Receive Clinical Preventive Services, brief released
Government. by CDC (2012), http://www.cdc.gov/aging/pdf/cps-
43 This estimate includes enrollment in student services will result in savings due to clinical-preventive-services.pdf.
health insurance plans. Source: Data from Medical lower health care costs. 51 See e.g., Meeker D, Joyce GF, Malkin J, et al.
Loss Ratio submissions for 2013 reporting year, As stated in the July 2010 interim Coverage and preventive screening. Health Serv
available at http://www.cms.gov/CCIIO/Resources/ final regulations, preventive service Res. 2011; 46:173–184. Study found that patients
Data-Resources/mlr.html. responded to the exclusion of preventive services
44 Source: Data from Medical Loss Ratio coverage is limited to those
from deductibles and reducing cost sharing resulted
submissions for 2013 reporting year. recommended by the Task Force (grade in increased utilization of lipid screening, pap
45 See Kaiser Family Foundation and Health of A or B), an applicable Advisory smears, and other services. See e.g., Jill Bernstein,
Research and Education Trust, Employer Health Committee, and HRSA.47 These final Deborah Chollet, and G. Gregory Peterson,
Benefits 2014 Annual Survey (2014), available at Encouraging Appropriate Use of Preventive Health
regulations can be expected to continue Services, Issue Brief Mathematica Policy Research
http://kff.org/private-insurance/report/2014-
employer-health-benefits-survey/; and Employer to increase access to and utilization of Inc., Princeton, NJ (May 2010) Number 2.
Health Benefits 2011 Annual Survey (2011) these services, which have been 52 National Commission on Prevention Priorities.
available at http://kff.org/health-costs/report/ historically underutilized. For example, Preventive Care: A National Profile on Use,
employer-health-benefits-annual-survey-archives/. 27.7 percent of adults aged 50 to 75 Disparities, and Health Benefits. Partnership for
46 This estimate represents the number of Prevention, August 2007. http://www.prevent.org/
have never been screened for colorectal data/files/initiatives/ncpppreventivecarereport.pdf.
individuals who have selected, or been
automatically reenrolled into a 2015 plan through cancer (such as sigmoidoscopy and/or 53 Woolf, Steven. A Closer Look at the Economic
the Marketplaces, with or without payment of Argument for Disease Prevention. JAMA 2009;
premium. See ASPE, Health Insurance 47 See http://www.ahrq.gov/research/findings/ 301(5):536–538.
Marketplaces 2015 Open Enrollment Period: March final-reports/uspstf/uspstfeval.pdf for details of the 54 Maciosek, Michael V., Coffield, Ashley B.,
Enrollment Report, available at http://aspe.hhs.gov/ Task Force grading and http://www.uspreventive Flottemesch, et al., Use of Preventive Services In
health/reports/2015/MarketPlaceEnrollment/ servicestaskforce.org/Page/Name/uspstf-a-and-b- U.S. Health Care Could Save Lives At Little Or No
Mar2015/ib_2015mar_enrollment.pdf. recommendations/ for current recommendations. Cost. Health Affairs 2010, 29(9) 1656–1660.
CaseFederal
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of these services will lead providers to knowing that they will be covered
increase their use of these services without cost sharing.
TABLE III.2—LIVES SAVED FROM INCREASING UTILIZATION OF SELECTED PREVENTIVE SERVICES

Lives saved
Percent annually if
Preventive service Population group utilization 90 percent
(2005) utilization
Regular aspirin use .................................................... Men 40+/Women 50+ ................................................ 40 45,000

Smoking cessation (medication and advice) ............. All adult smokers ....................................................... 28 42,000
Colorectal cancer screening ...................................... Adults 50+ ................................................................. 48 14,000
Influenza vaccination ................................................. Adults 50+ ................................................................. 37 12,000
Cervical cancer screening (in past 3 years) .............. Women 18–64 ........................................................... 83 620
Cholesterol screening ................................................ Men 35+/Women 45+ ................................................ 79 2,450
Breast cancer screening (in past 2 years) ................ Women 40+ ............................................................... 67 3,700
Chlamydia screening ................................................. Women 16–25 ........................................................... 40 30,000
Source: National Commission on Prevention Priorities, 2007.
Studies comparing the utilization of Maintaining high levels of being have been positively linked to
preventive services among adults show immunization in the general population students’ academic outcomes, including
utilization rates range from as high as 89 protects the un-immunized from attendance, grades, test scores, and high
percent for blood pressure checks to exposure so that individuals who school graduation.62 As discussed in the
only 40 percent for annual flu cannot receive, or who do not have a July 2010 interim final rules, studies
vaccinations.55 Under the Affordable sufficient immune response to the show that reduced cost sharing and
Care Act, there have been significantly vaccine, are indirectly protected.58 increased access to care can improve
higher usage rates of several preventive A second type of benefit of these final productivity in both schools and the
services in young adults and women, regulations is improved workplace labor market. Thus, it is expected that
including blood pressure tests, productivity and decreased absenteeism these final regulations can have a
cholesterol screening, and contraceptive for school children. A study by Gallup substantial benefit to the children in the
services.56 Numerous studies have has found that among workers working nation’s education system and the labor
shown that improved coverage, or at least 30 hours a week, those market, both current and future.
reduced costs, of preventive services considered overweight or obese with A third type of benefit from some
results in higher utilization of these one or more chronic condition will miss preventive services is cost savings.
services 57 leading to potentially one to 3.5 days of work a month.59 With Increasing the provision of preventive
substantial benefits. The Departments an estimated 450 million days lost to services is expected to reduce the
expect that utilization of preventive absenteeism, the cost of lost incidence or severity of illness, and, as
services will continue to increase over productivity due to personal health or a result, reduce expenditures on
time among those individuals in plans the inability to concentrate due to their treatment of illness. As discussed in the
affected by these regulations because the own or a family member’s illness is July 2010 interim final regulations and
provisions eliminate cost sharing and estimated to be between $153 and $260 elsewhere,63 childhood vaccinations
require coverage for these services. billion annually.60 have been found to generate
Some recommended preventive Illness and poorly controlled chronic considerable benefit and savings to both
services have both individual and disease also contribute to increased individuals and society. Employing a
public health value. Vaccines have absenteeism among school children. decision analysis cohort model of U.S.
reduced or eliminated serious diseases Recent data indicates that in the 2011– children born during 1994–2013,
that, prior to vaccination, routinely 2012 academic year, 6.2 percent of researchers at CDC analyzed the
caused serious illnesses or deaths. children aged 6 through 17 missed 11 or economic impact of DTaP (diphtheria
more days of school.61 Studies have and tetanus toxoids and acellular
55 The Commonwealth Fund. ‘‘Current Trends in shown that student health and well- Pertussis), Hib (Haemophilus influenza
Health Coverage and the Effects of Implementing type b), Polio (OPV then IPV), MMR
the Affordable Care Act’’ (2013). http://www.
commonwealthfund.org/∼/media/files/publications/
58 See Modern Infectious Disease Epidemiology
(measles, mumps and rubella), Hepatitis
by Johan Giesecke 1994, Chapter 18, The B, varicella, pneumococcal disease
fund-report/2013/apr/1681_collins_insuring_
Epidemiology of Vaccination.
future_biennial_survey_2012_final.pdf.
59 Unhealthy U.S. Workers’ Absenteeism Costs
(PCV, 7-valent and 13-valent), and
56 See. e.g., Lau JS, Adams SH, Park MJ, Boscardin
$153 Billion. Well-Being, Gallop October 17, 2011 rotavirus vaccines in children aged ≤6
WJ, Irwin CE. Improvement in preventive care of
young adults after the affordable care act: the at http://www.gallup.com/poll/150026/Unhealthy-
affordable care act is helping. JAMA Pediatr. 2014; Workers-Absenteeism-Costs-153-Billion.aspx. 62 Vaughn, B., Princiotta, D., Barry, M., Fish, H.,
60 Ibid, see e.g., Health and Productivity Among & Schmitz, H. (2013). Safe Supportive Living Brief:
168(12):1101–1106. See e.g., Sonfield, A., Tapales,
A., Jones RK., Finer, LB. Impact of the federal U.S. Workers, Karen Davis, Ph.D., Sara R. Collins, Schools and The Affordable Care Act. https://safe
contraceptive coverage guarantee on out-of-pocket Ph.D., Michelle M. Doty, Ph.D., Alice Ho, and supportivelearning.ed.gov/sites/default/files/1953_
payments for contraceptives: 2014 update. Alyssa L. Holmgren, The Commonwealth Fund, Schools%20Affordable%20Care%20Brief_
Contraception, 2015: 91(1): 44–48. August 2005. http://www.commonwealthfund.org/ d3%20lvr.pdf.

57 See e.g., Meeker D, Joyce GF, Malkin J, et al. publications/issue-briefs/2005/aug/health-and- 63 See e.g. Maciosek, Michael V., Coffield, Ashley
Coverage and preventive screening. Health Serv productivity-among-u-s-workers. B., Flottemesch, et al., Use of Preventive Services
61 Children Who Missed 11 or More Days of In U.S. Health Care Could Save Lives At Little Or
Res. 2011; 46:173–184. Study found exclusion of
deductibles from, and reduced cost sharing of School per Year Due to Illness or Injury, Kids Count No Cost. Health Affairs 2010 29(9) 1656–1660. See
preventive services resulted in increased utilization Data Center at http://datacenter.kidscount.org/data/ eg. Zhou F, Santoli J, Messonnier ML, et al.
of lipid screening, pap smears, and other services. tables/5202-children-who-missed-11-or-more-days- Economic Evaluation of the 7-Vaccine Routine
See e.g., Jill Bernstein, Deborah Chollet, and G. of-school-per-year-due-to-illness-or-injury?loc=1& Childhood Immunization Schedule in the United
Gregory Peterson, Issue Brief Mathematica Research loct=2#detailed/1/any/false/1021,18,14/691,30,18/ States, 2001. Arch Pediatr Adolesc Med. 2005;
Policy Inc., Princeton, NJ (May 2010) Number 2. 11683. 159(12):1136–1144.
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years. The study estimates that among final regulations are expected to immunizations for privately insured
the 78.6 million children born during increase the take-up rate of preventative children up to age 5 (in families in
this period, these routine services counseling for obesity and Georgia in 2003) found that a one
immunizations will prevent 322 million other conditions among patients, and percent increase in out-of-pocket costs
illnesses and 21 million lead physicians to increase appropriate for routine immunizations (DTaP, IPV,
hospitalizations, averting 732,000 referrals for such services. The effect of MMR, Hib, and Hep B) was associated
premature deaths over their lifetime. these final regulations is expected to be with a 0.07 percent decrease in
Furthermore, it was estimated that these magnified due to the numerous public utilization.70
routine vaccinations will potentially and private sector initiatives dedicated Eligible closely held for-profit entities
avert $402 billion in direct costs and to combating the obesity epidemic and that seek the accommodation for
$1.5 trillion in societal costs and a net smoking cessation. contraceptive services will incur
savings of $295 billion and $1.38 trillion Eligible closely held for-profit entities administrative costs to provide self-
for payers and society, respectively (in that seek the accommodation to exclude certifications to issuers or third party
2013 dollars).64 coverage for contraceptive services from administrators or notices to HHS.
As with immunizations, other health coverage offered to their Issuers and third party administrators
preventive services have been estimated employees and students, and eligible for health plans sponsored by these
to have cost-savings benefits. As organizations that opt to provide notice eligible organizations will also incur
discussed in the July 2010 interim final to HHS, will benefit from not being administrative costs to provide
regulations, aspirin use with high risk required to facilitate access to or pay for notifications to enrollees. The costs
adults and tobacco cessation and coverage that are contrary to their related to these information collection
screening can both yield net savings. owners’ religious beliefs. Women requirements are estimated in section D
For example, in Massachusetts, the enrolled in plans under this below.
availability of tobacco cessation accommodation will have continued Along with new costs of induced
treatments combined with promotional access to contraceptive services without utilization, there are transfers associated
campaigns resulted in a ten percent cost sharing. with these final regulations. A transfer
decline in Medicaid enrolled smokers, a is a change in who pays for the services,
$3.12 savings for every dollar spent on 5. Costs and Transfers where there is not an actual change in
the benefit.65 As discussed in more The changes in how plans and issuers the level of resources used. For
detail in the July 2010 interim final continue to cover the recommended example, costs that were previously
regulations, another area where preventive services resulting from these paid out-of-pocket for certain preventive
prevention can achieve savings is final regulations will result in changes services will now be covered by plans
obesity prevention and reduction. Based in covered benefits and premiums for and issuers under these final
on recent guidelines, up to 116.1 individuals in plans and health regulations. Such a transfer of costs
million American adults are candidates insurance coverage subject to these final could be expected to lead to an increase
for both pharmaceutical and behavioral regulations. New costs to the health in premiums.
treatments for weight loss, and up to 32 system result when individuals increase In the July 2010 interim final
million are eligible for bariatric their use of preventive services in regulations, the Departments analyzed
surgery.66 According to the CDC, from response to the changes in coverage of the impact of eliminating cost sharing,
2011–2012, 16.9 percent of children 2 those services. Cost sharing, including increases in services covered, and
through 19 years of age and 34.9 percent coinsurance, deductibles, and induced utilization on the average
of adults aged 20 and over were obese copayments, divides the costs of health insurance premium using a model to
(defined as having a body mass index services between the plan or issuer and evaluate private health insurance plans
(BMI) greater than or equal to the age the enrollees. The removal of cost against a nationally representative
and sex-specific 95th percentiles of the sharing increases the quantity of population. In the July 2010 interim
200 CDC growth charts).67 One study services demanded by lowering the final regulations, the Departments
used the number of obese and direct cost of the service to consumers. analyzed Medical Expenditure Panel
overweight twelve-year olds in 2005 to Therefore, the Departments expect that Survey (MEPS) data and determined the
simulate a cohort over their lifetimes, the statute and these final regulations average person with employer-
indicating that a sustained one- will continue to increase utilization of sponsored insurance (ESI) would have
percentage-point decrease in the the covered preventive services. The $264 in covered preventive service
prevalence of obesity over the lifetime magnitude of this effect on utilization expenses, of which $240 would be paid
of this cohort would result in an depends on the price elasticity of by insurance and $24 paid out-of-
estimated savings of $260.4 million in demand. pocket.71 When preventive services are
total medical expenditures.68 These Several studies have found that covered with zero copayment, the
individuals are sensitive to prices for Departments estimated the average
64 Whitney, CG., Zhou, F., Singleton, J., Schuchat,
A. Benefits from Immunization During the Vaccines

health services.69 CDC researchers who preventive benefit (holding utilization
of Children Program Era—United States, 1994– studied out-of pocket costs of constant) would increase by $24, or a
2013. MMWR 2014;63(16):352–355. 0.6 percent increase in insurance
65 McAfee, T., Babb, S., McNabb, S., Fiore, MC. 69 Liu, S., and Chollet, D., Price and Income
benefits and premiums for plans that
N Engl J Med 2015; 372:5–7. Elasticity of the Demand for Health Insurance and
66 Stevens, J., Oakkar, EE., Cui, Z., Cai, J., Health Care Services: A Critical Review of the
have relinquished their grandfather
Truesdale, KP. US adults recommended for weight Literature, Mathematica Policy Research Inc.,
70 See e.g., Noelle-Angelique Molinari et al., ‘‘Out-
reduction by 1998 and 2013 obesity guidelines, (March 2006) http://www.mathematica-mpr.com/∼/
NHANES 2007–2012, 2015 Obesity 23(3) 527–531. media/publications/PDFs/priceincome.pdf. See e.g., of-Pocket Costs of Childhood Immunizations: A
67 Ogden CL, Carroll MD, Kit BK, Flegal KM. Ringel, JS., Hosek, SD., Vollaard, BA., and S. Comparison by Type of Insurance Plan,’’ Pediatrics,
Prevalence of Childhood and Adult Obesity in the Mahnovski (2002), The elasticity of demand for 120(5) pp. e1148–e1156 (2007).
United States, 2011–2012. JAMA. 2014; 311(8):806– health care; A review of the literature and its 71 The model does not distinguish between
814. application to the military health system, National recommended and non-recommended preventive
68 Trasande, L., 2010, How Much Should We Defense Research Institute, RAND Health. http:// services, and so this likely represents an
Invest in Preventing Childhood Obesity? Health www.rand.org/content/dam/rand/pubs/ overestimate of the insurance benefits for
Affairs, 29, no. 3:372–378. monograph_reports/2005/MR1355.pdf. preventive services.
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status. Furthermore, in the July 2010 contraceptive coverage is at least cost separately (or is not tracked as
interim final regulations, the neutral because they will be insuring individual encounter data separately)
Departments estimated that additional the same set of individuals under both from the office visit, whether these final
coverage for genetic screening, the group or student health insurance regulations should prohibit cost sharing
depression screening, lead testing, policies for whom they will also be for any office visit in which any
autism testing, and oral health screening making the separate payments for recommended preventive service was
would result in a total average increase contraceptive services and, as a result, administered, or whether cost sharing
in insurance benefits on these services will experience lower costs from should be prohibited only when the
to be 0.12 percent, or just over $4 per improvements in women’s health, preventive service is the primary
insured person. This increase healthier timing and spacing of purpose of the office visit. Prohibiting
represented a mixture of new costs and pregnancies, and fewer unplanned cost sharing for office visits when any
transfers, dependent on whether pregnancies. Several studies have recommended preventive service is
beneficiaries previously purchased estimated that the costs of providing provided, regardless of the primary
these services on their own. Impacts contraceptive coverage are balanced by purpose of the visit, could lead to an
were expected to vary depending on cost savings from lower pregnancy- overly broad application of these final
baseline benefit levels, and related costs and from improvements in regulations; for example, a person who
grandfathered health plans were not women’s health.73 A third party sees a specialist for a particular
expected to experience any impact from administrator can make arrangements condition could end up with a zero
those interim final regulations. with an issuer offering coverage through copayment simply because his or her
As discussed in the July 2010 interim an FFE to obtain reimbursement for its blood pressure was taken as part of the
final regulations, the Departments used costs (including an allowance for office visit. This could create financial
the standard actuarial ‘‘induction administrative costs and margin). The incentives for consumers to request
formula’’ 1/(1+alpha*P), where alpha is issuer offering coverage through the FFE preventive services at office visits that
the ‘‘induction parameter’’ and P is the can receive an adjustment to the FFE are intended for other purposes in order
average fraction of the cost of services user fee, and the issuer is expected to to avoid copayments and deductibles.
paid by consumers to estimate pass on a portion of that adjustment to The increased prevalence of the
behavioral changes to estimate the the third party administrator to account application of zero cost sharing would
induced demand for preventive for the costs of providing or arranging lead to increased premiums compared
services.72 Removing cost sharing for payments for contraceptive services. with the chosen option, without a
preventive services lowers the direct meaningful additional gain in access to
cost to consumers of using preventive B. Regulatory Alternatives
preventive services.
services, which induces additional Several provisions in these final
utilization, estimated with the model A third issue involves health plans
regulations involved policy choices.
above to increase covered expenses and that have differential cost sharing for
One was whether to allow a plan or
benefits by approximately $17, or 0.44 services provided by in-network vs. out-
issuer to impose cost sharing for an
percent in insurance benefits in group of-network providers. These final
office visit when a recommended
health plans. A similar, but larger, effect regulations provide that a plan or issuer
preventive service is provided in that
was anticipated in the individual generally is not required to provide
visit. Sometimes a recommended
market because individual health coverage for recommended preventive
preventive service is billed separately
insurance policies generally had less services delivered by an out-of-network
from the office visit; sometimes it is not.
generous benefits for preventive services provider. The plan or issuer generally
The Departments decided that the cost-
than group health plans. may also impose cost sharing for
sharing prohibition of these final
When eligible closely held for-profit recommended preventive services
regulations applies to the specific
entities seek the accommodation, health delivered by an out-of-network
preventive service as recommended by
insurance issuers (or third party provider. However, if the plan or issuer
the guidelines. Therefore, if the
administrators for self-insured plans) for does not have in its network a provider
preventive service is billed separately
the group health plans established or who can provide the recommended
(or is tracked as individual encounter
maintained by the eligible organizations preventive service, the plan or issuer
data separately) from the office visit, it
(and health insurance issuers of student must cover the item or service when
is the preventive service that has cost
health plans arranged by eligible performed by an out-of-network
sharing waived, not the entire office
organizations that are institutions of provider, and may not impose cost
visit.
higher education) will assume sole sharing with respect to the item or
A second policy choice was, if the
responsibility for providing (or service. The Departments considered
preventive service is not billed
arranging) separate payments for that requiring coverage by out-of-
contraceptive services directly for plan 73 Bertko, J., Glied, S., et al. The Cost of Covering network providers with no cost sharing
participants and beneficiaries (or Contraceptives Through Health Insurance (February would result in higher premiums. Plans
student enrollees and dependents), 9, 2012), http://aspe.hhs.gov/health/reports/2012/ and issuers negotiate allowed charges
without cost sharing, premium, fee, or contraceptives/ib.shtml; Washington Business with in-network providers as a way to
Group on Health, Promoting Healthy Pregnancies:
other charge to plan participants or Counseling and Contraception as the First Step,
promote effective, efficient health care,
beneficiaries (or student enrollees and Report of a Consultation with Business and Health and allowing differences in cost sharing
dependents) or to the eligible Leader (September 20, 2000), Campbell, K.P., in- and out-of-network enables plans to
organization or its plan. The Investing in Maternal and Child Health: An encourage use of in-network providers.
Employer’s Toolkit, National Business Group on
Departments continue to believe that Health (2007) http://www.businessgrouphealth.org/
Allowing zero cost sharing for out-of-
issuers will find that providing healthtopics/maternalchild/investing/docs/mch_ network providers could reduce
toolkit.pdf; Trussell, J., et al. The Economic Value providers’ incentives to participate in
72 Standard formula best described in ‘‘Quantity- of Contraception: A Comparison of 15 Methods, insurer networks. The Departments
Price Relationships in Health Insurance’’, Charles L American Journal Public Health, 1995; 85(4):494–
Trowbridge, Chief Actuary, Social Security 503, Revenues of H.R. 3162, the Children’s Health
decided that permitting cost sharing for
Administration (DHEW Publication No. (SSA) 73– and Medicare Protection Act, for the Rules recommended preventive services
11507, November 1972). Committee (August 1, 2007). provided by out-of-network providers
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(except in cases where the section 7805(f) of the Code, the services. These final regulations
recommended service is only available proposed rule preceding these continue to allow eligible organizations
from an out-of-network provider) is the regulations was submitted to the Chief to use EBSA Form 700 to notify their
appropriate option to preserve a choice Counsel for Advocacy of the Small third party administrators and issuers,
of providers for individuals, while Business Administration for comment as set forth in the July 2013 final
avoiding potentially larger increases in on their impact on small business and regulations and guidance.
costs and transfers as well as potentially no comments were received. The Departments received comments
lower quality care. that HHS underestimated the number of
As discussed previously in the D. Paperwork Reduction Act— closely held for-profit eligible
preamble, the Departments also Department of Health and Human organizations that may seek the
considered different ways to define a Services accommodation. Some commenters
closely held for-profit entity. Under one These final regulations contain noted that it would be difficult to
approach, a qualifying closely held for- information collection requirements that estimate this number. One commenter
profit entity would have been defined as are subject to review by OMB. A estimated that about 1.3 million S-
a for-profit entity where none of the description of these provisions is given corporations offer health insurance to
ownership interests in the entity is in the following paragraphs with an their employees and, based on this data,
publicly traded and where the entity has estimate of the annual burden. In order objection rates of 1 percent of S-
fewer than a specified number of to fairly evaluate whether an corporations would result in 13,000
shareholders or owners. information collection should be objecting firms, an objection rate of 2
Under the second approach, a approved by OMB, section 3506(c)(2)(A) percent would result in 26,000 objecting
qualifying closely held for-profit entity of the Paperwork Reduction Act of 1995 firms and an objection rate of 5 percent
would have been defined as a for-profit requires that we solicit comment on the would result in 65,000 objecting firms.
entity in which the ownership interests following issues: However, the Departments have no
are not publicly traded, and in which a • The need for the information indication that such large numbers of
specified fraction of the ownership collection and its usefulness in carrying closely held for-profit entities would
interest is concentrated in a limited and out the proper functions of our agency. seek the accommodation. The
specified number of owners. Within the • The accuracy of our estimate of the Departments also note that the
second approach, the Departments information collection burden. definition of a qualifying closely held
considered adopting the IRS test to • The quality, utility, and clarity of for-profit entity adopted in these final
define a closely held corporation. The the information to be collected. regulations differs from the definition of
definition adopted in these final rules, • Recommendations to minimize the an S-corporation. In the proposed rules,
although based on the IRS test, is more information collection burden on the based on the number of plaintiffs that
flexible and ensures that it does not affected public, including automated are for-profit employers in recent
exclude some entities that should be collection techniques. litigation objecting on religious grounds
considered to be closely held for the 1. Wage Estimates to the provision of contraceptive
purposes of these final regulations. services, HHS estimated that 71 closely
Under a third approach, the To derive average costs, we used data
held for-profit entities would seek the
Departments considered a test under from the U.S. Bureau of Labor Statistics’
accommodation. In the final regulations,
which none of the ownership interests May 2014 National Occupational based on updated information, HHS is
in the entity is publicly traded, without Employment and Wage Estimates for all revising the estimate to 87. Even though
any other restrictions on the number of salary estimates (http://www.bls.gov/ this may underestimate the number of
owners or on ownership concentration. oes/current/oes_nat.htm). eligible closely held for-profit entities
The Departments believe, however, that 2. Information Collection Requirements that will seek the accommodation, this
such a test would be excessively broad. (ICRs) is the best estimate available to the
C. Special Analyses—Department of Departments at this time.
a. ICRs Regarding Self-Certification For each eligible organization, it is
Treasury (§ 147.131(b)(3)) assumed that clerical staff will gather
For purposes of the Department of the All eligible organizations will have and enter the necessary information,
Treasury, it has been determined that the option of either providing a self- send the self-certification to its issuer(s)
this rule is not a significant regulatory certification (EBSA Form 700) to the or third party administrator(s) or the
action as defined in Executive Order issuers or third party administrators of notice to HHS, and retain a copy for
12866, as supplemented by Executive the plans that would otherwise arrange recordkeeping. A manager and legal
Order 13563. Therefore, a regulatory for or provide coverage for the counsel will subsequently review the
assessment is not required. It also has contraceptive services, or providing a information, and a senior executive will
been determined that section 553(b) of notice to HHS. For the purpose of execute it. It is estimated that an
the Administrative Procedure Act (5 estimating burdens, HHS is assigning organization will need approximately 50
U.S.C. chapter 5) does not apply to this the burden of the self-certification to minutes (30 minutes of clerical labor at
rule. Pursuant to the Regulatory eligible for-profit entities and the a cost of $30 per hour, 10 minutes for
Flexibility Act (5 U.S.C. chapter 6), it is burden of notice to HHS to eligible non- a manager at a cost of $102 per hour, 5
hereby certified that this rule will not profit organizations. minutes for legal counsel at a cost of
have a significant economic impact on The July 2013 final regulations $127 per hour, and 5 minutes for a
a substantial number of small entities. require an eligible organization that senior executive at a cost of $121 per
This certification is based on the fact seeks an accommodation to self-certify hour) to execute the self-certification.
that the regulations merely modify the that it meets the definition of an eligible Therefore, the total one-time burden for
definition of eligible organization to organization using the EBSA Form 700 preparing and providing the information
include certain closely held for-profit and provide it directly to each third in the self-certification is estimated to
entities. This modification, as adopted, party administrator or issuer of the plan be approximately $53 for each eligible
will not increase costs to or burdens on that would otherwise arrange for or organization. The certification may be
the affected organizations. Pursuant to provide coverage for the contraceptive electronically transmitted to the issuer
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or third party administrator at minimal hour, 10 minutes for a compensation regulations or substantially similar
cost or mailed. For purposes of this and benefits manager at a cost of $102 language.
analysis, HHS assumes that all notices per hour, 5 minutes for legal counsel at As mentioned, HHS is anticipating
will be mailed. It is estimated that a cost of $127 per hour, and 5 minutes that at least 122 non-profit and 87
mailing each notice will require $0.49 in by a senior executive at a cost of $121 closely held for-profit entities will seek
postage and $0.05 in materials cost per hour) preparing and sending the an accommodation. It is unknown how
(paper and ink) and the total postage notice and filing it to meet the many issuers or third party
and materials cost for each notice sent recordkeeping requirement. Therefore, administrators provide health insurance
via mail will be $0.54. the total annual burden for preparing coverage or services in connection with
Based on this estimate of 87 affected and providing the notice to HHS will health plans of eligible organizations,
entities and the individual burden require approximately 50 minutes for but HHS will assume at least 209. It is
estimates of 50 minutes and a cost of each eligible organization with an estimated that each issuer or third party
$53, we estimate the total hour burden equivalent cost burden of approximately administrator will need approximately 1
to be 72.5 hours with an equivalent cost $53 for a total hour burden of 102 hours hour of clerical labor (at $30 per hour)
of $4,611. The total paper filing cost with an equivalent cost of $6,425. As and 15 minutes of management review
burden for the notices is approximately HHS and DOL share jurisdiction, they (at $102 per hour) to prepare the
$47. As DOL and HHS share are splitting the hour burden so each notices. The total burden for each issuer
jurisdiction, they are splitting the hour will account for 51 burden hours with or third party administrator to prepare
burden so each will account for 36.25 an equivalent cost of $3,213, with a total notices will be 1.25 hours with an
burden hours at an equivalent cost of of 61 respondents. equivalent cost of approximately $56.
approximately $2,306 and a paper filing Notices to HHS may be sent The total burden for all issuers or third
cost burden of approximately $23, with electronically at minimal cost or by party administrators will be 261.25
approximately 44 respondents. mail. For purposes of this analysis, HHS hours, with an equivalent cost of
assumes that all notices will be mailed. $11,600. As DOL and HHS share
b. ICRs Regarding Notice to HHS
It is estimated that mailing each notice jurisdiction, they are splitting the hour
(§ 147.131(b)(3))
will require $0.49 in postage and $0.05 burden so each will account for 130.63
These final regulations provide an in materials cost (paper and ink) with a burden hours with an equivalent cost of
organization seeking to be treated as an total postage and materials cost for each $5,800, with approximately 105
eligible organization under the August notice sent via mail of $0.54. The total respondents.
2014 interim final regulations an cost burden for the notices is
alternative process, consistent with the approximately $66. As DOL and HHS d. Letter to HHS Regarding Ownership
Supreme Court’s interim order in share jurisdiction, they are splitting the Structure (§ 147.131(b)(4)(v))
Wheaton College, under which an cost burden so each will account for $33 To assist potentially eligible for-profit
eligible organization may notify HHS of of the cost burden. entities seeking further information
its religious objection to coverage of all regarding whether they qualify for the
or a subset of contraceptive services. c. Notice of Availability of Separate
Payments for Contraceptive Services accommodation, an entity may send a
The eligible organization must maintain letter describing its ownership structure
the notice to HHS in its records. The (§ 147.131(d))
to HHS at accommodation@cms.
burden related to this alternate notice is As required by the July 2013 final hhs.gov. However, an entity is not
currently approved under OMB Control regulations, a health insurance issuer or required to avail itself of this process in
Number 0938–1248. third party administrator providing or order to qualify as a closely held for-
Based on litigation, HHS believes that arranging separate payments for profit entity.
at least 122 eligible non-profit contraceptive services for participants
As stated earlier in the preamble, the
organizations will have the option to and beneficiaries in insured plans (or
Departments believe that the definition
provide the alternative notice to HHS student enrollees and covered
adopted in these regulations includes
rather than their third party dependents in student health insurance
the for-profit entities that are likely to
administrators or issuers. Even though coverage) of eligible organizations is
have religious objections to providing
this likely underestimates the number of required to provide a written notice to
contraceptive coverage. In addition, it
eligible non-profit organizations that plan participants and beneficiaries (or
appears based on available information
will seek the accommodation, this is the student enrollees and covered
that the definition adopted in these final
best estimate available to the dependents) informing them of the
regulations includes all of the for-profit
Departments at this time. In order to availability of such payments. The
entities that have, as of the date of
complete this task, HHS assumes that notice must be separate from but
issuance of these regulations,
clerical staff for each eligible contemporaneous with (to the extent
organization will gather and enter the possible) any application materials
requirement in court. Therefore, the
necessary information and send the distributed in connection with
Departments anticipate that fewer than
notice. HHS assumes that a enrollment (or re-enrollment) in group
10 entities will submit a letter to HHS.
compensation and benefits manager and or student coverage of the eligible
Under 5 CFR 1320.3(c)(4), this provision
inside legal counsel will review the organization in any plan year to which
is not subject to the PRA as it will affect
notice and a senior executive will the accommodation is to apply and will
fewer than 10 entities in a 12-month
execute it. HHS estimates that an be provided annually. To satisfy the
period.
eligible organization will spend notice requirement, issuers may, but are
approximately 50 minutes (30 minutes not required to, use the model language 3. Summary of Proposed Annual Burden
of clerical labor at a cost of $30 per set forth in the July 2013 final Estimates
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TABLE III.3—ANNUAL RECORDKEEPING AND REPORTING REQUIREMENTS

Total Total
Burden Total Burden
OMB labor capital/ Total
Total per annual cost per
Regulation section(s) Control Respondents cost of maintenance cost
responses response burden respondent
No. reporting costs ($)
(hours) (hours) ($) ($) ($)
Self-Certification New ......... 44 44 0.83 36.25 $53 $2,306 $23 $2,329

(§ 147.131(b)(3)).
Notice to HHS 0938–1248 61 61 0.83 51 53 3,213 33 3,246
(§ 147.131(b)(3)).
Notice of Availability of New ......... 105 105 1.25 130.63 56 5,800 0 5,800
Separate Payments
for Contraceptive
Services
(§ 147.131(d)).
Total ...................... .................. 210 210 ................ 217.88 .................. $11,319 $56 $11,375
4. Submission of PRA-Related associated with the proposed rule at the 1. ICRs Regarding Self-Certification (29
Comments proposed rule stage and requesting the CFR 2590.2713A(b) or (c))
We have submitted a copy of this rule Department to resubmit the ICR at the Under these final regulations, all
to OMB for its review of the rule’s final rule stage after taking into account eligible organizations will have the
information collection and public comments. OMB assigned OMB option of either providing (1) a self-
recordkeeping requirements. These Control Number 1210–0152 to the certification (EBSA Form 700) to the
requirements are not effective until they proposed ICR. issuers or third party administrators of
have been approved by OMB. Although no public comments were the plans that would otherwise arrange
received in response to the ICRs for or provide coverage for the
E. Paperwork Reduction Act— contraceptive services or (2) a notice to
Department of Labor contained in the August 2014 interim
final and proposed regulations that HHS. For the purpose of estimating
In accordance with the requirements burdens, the Department is assigning
specifically addressed the paperwork
of the Paperwork Reduction Act of 1995 the burden of the self-certification to
burden analysis of the information
(PRA) (44 U.S.C. 3506(c)(2)), the eligible for-profit entities and the
Department submitted an information collections, the comments that were burden of notice to HHS to eligible non-
collection request (ICR) to OMB in submitted, and which are described profit organizations.
accordance with 44 U.S.C. 3507(d), earlier in this preamble, contained The July 2013 final regulations
contemporaneously with the information relevant to the costs and require an eligible organization that
publication of the interim final administrative burdens attendant to the seeks an accommodation to self-certify
regulation, for OMB’s review under the proposals. The Department took into that it meets the definition of an eligible
emergency PRA procedures.74 OMB account the public comments in organization using the EBSA Form 700
approved the ICR on August 27, 2014 connection with making changes to the and provide it directly to each third
under OMB Control Number 1210–0150 proposal, analyzing the economic party administrator or issuer of the plan
through February 28, 2015. impact of the proposals, and developing that would otherwise arrange for or
Contemporaneously with the the revised paperwork burden analysis provide coverage for the contraceptive
publication of the emergency ICR, the summarized below. services. These final regulations
Department published a separate In connection with publication of this continue to allow eligible organizations
Federal Register notice informing the to use EBSA Form 700 to notify their
final rule, the Department submitted
public that it intends to request OMB to third party administrators and issuers,
ICRs to OMB as a revision to OMB
extend the approval for 3 years and as set forth in the July 2013 final
Control Number 1210–0150 for eligible regulations and guidance.
soliciting comments on the ICR.75 The
non-profit organizations and under new In response to the public comment
Department submitted the extension
request to OMB on February 27, 2015. OMB Control Number 1210–0152 for solicitation for the ICRs in the August
OMB approved the ICR extension on eligible for-profit organizations and 2014 proposed regulations, the
April 14, 2015, which currently is received OMB approval for both ICRs. Departments received comments that
scheduled to expire on April 30, 2018. A copy of the ICRs may be obtained they underestimated the number of
The Department also submitted an by contacting the PRA addressee shown closely held for-profit eligible
ICR to OMB in accordance with 44 below or at http://www.RegInfo.gov. organizations that may seek the
U.S.C. 3507(d), for the ICR contained in PRA ADDRESSEE: G. Christopher accommodation. Some commenters
the August 2014 proposed regulations Cosby, Office of Policy and Research, noted that it would be difficult to
contemporaneously with the U.S. Department of Labor, Employee estimate this number. One commenter
publication of the proposal that Benefits Security Administration, 200 estimated that about 1.3 million S-
solicited public comments on the ICR. Constitution Avenue NW., Room N– corporations offer health insurance to
OMB filed a comment regarding the 5718, Washington, DC 20210. their employees and, based on this data,
proposed ICR on October 16, 2014, objection rates of 1 percent of S-
Telephone: 202–693–8410; Fax: 202–
stating that it was not approving the ICR corporations would result in 13,000
219–4745. These are not toll-free
objecting firms, an objection rate of 2
74 5
numbers. percent would result in 26,000 objecting
CFR 1320.13.
75 79 FR 51197 (Aug. 27, 2014). firms and an objection rate of 5 percent
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would result in 65,000 objecting firms. all notices will be mailed. The legal counsel at a cost of $127 per hour,
However, the Departments have no Departments estimate that mailing each and 5 minutes by a senior executive at
indication that such large numbers of notice will require $0.49 in postage and a cost of $121 per hour) preparing and
closely held for-profit entities would $0.05 in materials cost (paper and ink) sending the notice and filing it to meet
seek the accommodation. The and the total postage and materials cost the recordkeeping requirement.
Departments also note that the for each notice sent via mail will be Therefore, the total annual burden for
definition of a qualifying closely held $0.54. preparing and providing the notice to
for-profit entity adopted in these final Based on this estimate of 87 affected HHS will require approximately 50
regulations differs from the definition of entities and the individual burden minutes for each eligible organization
an S-corporation. In the proposed rules, estimates of 50 minutes and a cost of with an equivalent cost burden of
based on the number of plaintiffs that $53, the Departments estimate the total approximately $53 for a total hour
are for-profit employers in recent hour burden associated with the ICR to burden of 102 hours with an equivalent
litigation objecting on religious grounds be 72.5 hours with an equivalent cost of cost of $6,425. As HHS and DOL share
to the provision of contraceptive $4,611. The total paper filing cost jurisdiction, they are splitting the hour
services, the Departments estimated that burden for the notices is approximately burden so each will account for 51
71 closely held for-profit entities would $47. The hour burden associated with burden hours with an equivalent cost of
seek the accommodation. In these final the ICR is allocated equally between $3,213, with a total of 61 respondents.
regulations, based on updated DOL and HHS, because the agencies Notices to HHS may be sent
information, the Departments are share jurisdiction of preventive health electronically at minimal cost or by
revising the estimate to 87. Even though services resulting in an hour burden for mail. For purposes of this analysis, the
this may underestimate of the number of each agency of 36.25 burden hours at an Departments assume that all notices will
eligible closely held for-profit entities equivalent cost of approximately $2,306 be mailed. It is estimated that mailing
that will seek the accommodation, this and a paper filing cost burden of each notice will require $0.49 in postage
is the best estimate available to the approximately $23, with approximately and $0.05 in materials cost (paper and
Departments at this time. 44 respondents. ink) with a total postage and materials
For each eligible organization, the cost for each notice sent via mail of
2. ICRs Regarding Notice to HHS (29
Departments assume that clerical staff $0.54. The total cost burden for the
CFR 2590.2713A(b) or (c))
will gather and enter the necessary notices is approximately $66. As DOL
information, send the self-certification These final regulations provide an and HHS share jurisdiction, they are
to its issuer(s) or third party organization seeking to be treated as an sharing the cost burden equally and
administrator(s) or the notice to HHS, eligible organization under the August each is attributed $33 of the cost
and retain a copy for recordkeeping. A 2014 interim final regulations with an burden.
manager and legal counsel will alternative process, consistent with the
Supreme Court’s interim order in 3. Notice of Availability of Separate
subsequently review the information,
Wheaton College, under which an Payments for Contraceptive Services (29
and a senior executive will execute it.
eligible organization may notify HHS of CFR 2590.2713A(d))
It is estimated that an organization will
need approximately 50 minutes (30 its religious objection to coverage of all As required by the July 2013 final
minutes of clerical labor at a cost of $30 or a subset of contraceptive services. regulations, a health insurance issuer or
per hour,76 10 minutes for a manager at The eligible organization must maintain third party administrator providing or
a cost of $102 per hour,77 5 minutes for the notice to HHS in its records. The arranging separate payments for
legal counsel at a cost of $127 per burden related to this alternate notice is contraceptive services for participants
hour,78 and 5 minutes for a senior currently approved under OMB Control and beneficiaries (or student enrollees
executive at a cost of $121 per hour 79) Number 1210–0150. and covered dependents) in insured
to execute the self-certification. Based on litigation, the Departments plans of eligible organizations is
Therefore, the Departments estimate estimate that at least 122 eligible non- required to provide a written notice to
that the total one-time burden for profit organizations will have the option plan participants and beneficiaries (or
preparing and providing the information to provide the alternative notice to HHS student enrollees and covered
in the self-certification is estimated to rather than their third party dependents) informing them of the
be approximately $53 for each eligible administrators or issuers. Even though availability of such payments. The
organization. The certification may be this may underestimate the number of notice must be separate from but
electronically transmitted to the issuer eligible non-profit organizations that contemporaneous with (to the extent
or third party administrator at minimal will seek the accommodation, it is the possible) any application materials
cost or mailed. For purposes of this best estimate available to the distributed in connection with
analysis, the Departments assume that Departments at this time. In order to enrollment (or re-enrollment) in group
complete this task, the Departments or student coverage of the eligible
76 Secretaries, Except Legal, Medical, and assume that clerical staff for each organization in any plan year to which
Executive (43–6014): $16.13(2012 BLS Wage rate)/ eligible organization will gather and the accommodation is to apply and will
0.679(ECEC ratio) *1.2(Overhead Load Factor) enter the necessary information and
*1.019(Inflation rate) ¥2(Inflated 2 years from base
be provided annually. To satisfy the
year) = $29.60 send the notice. The Departments notice requirement, issuers may, but are
77 Compensation and Benefits Manager (11–3041): assume that a compensation and not required to, use the model language
$50.92(2012 BLS Wage rate)/0.697(ECEC ratio) benefits manager and inside legal set forth in the July 2013 final
*1.35(Overhead Load Factor) *1.019(Inflation rate) counsel will review the notice and a
¥2(Inflated 2 years from base year) = $102.41
regulations or substantially similar
78 Legal Professional (23–1011): $62.93(2012 BLS senior executive will execute it. The language.
Wage rate)/0.697(ECEC ratio) *1.35(Overhead Load Departments estimate that an eligible As mentioned, the Departments
Factor) *1.019(Inflation rate) ¥2(Inflated 2 years organization will spend approximately anticipate that at least 122 non-profit
from base year) = $126.56 50 minutes (30 minutes of clerical labor and 87 closely held for-profit entities
79 Financial Managers (11–3031): $59.26(2012
BLS Wage rate)/0.689(ECEC ratio) *1.35(Overhead

at a cost of $30 per hour, 10 minutes for will seek an accommodation. It is
Load Factor) *1.019(Inflation rate) ¥2(Inflated 2 a compensation and benefits manager at unknown how many issuers or third
years from base year) = $120.57 a cost of $102 per hour, 5 minutes for party administrators provide health
41340 CaseFederal
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insurance coverage or services in (1) a proprietary firm meeting the size large employers; only about 13.3 percent
connection with health plans of eligible standards of the Small Business of employers with less than 100
organizations, but that for the purposes Administration (SBA), (2) a non-profit employees that offer a group health plan
of the analysis, the Departments assume organization that is not dominant in its have a self-funded plan.81
at least 209 do. The Departments field, or (3) a small government With respect to contraceptive
assume that each issuer or third party jurisdiction with a population of less coverage, some eligible organizations
administrator will need approximately than 50,000 (states and individuals are that seek the accommodation may be
one hour of clerical labor (at $30 per not included in the definition of ‘‘small small entities and will incur costs to
hour) and 15 minutes of management entity’’). The Departments use as their provide the self-certification to issuers
review (at $102 per hour) to prepare the measure of significant economic impact or third party administrators or notice to
notices. Therefore, the Departments on a substantial number of small entities HHS. However, the related
estimate that the total burden for each a change in revenues of more than 3 administrative costs are expected to be
issuer or third party administrator to percent to 5 percent. minimal.
prepare notices will be 1.25 hours with As discussed in the Web Portal Third party administrators for self-
an equivalent cost of approximately $56. interim final rule with comment period insured group health plans established
The total burden for all issuers or third published on May 5, 2010 (75 FR or maintained by eligible organizations
party administrators will be 261.25 24481), HHS examined the health will incur administrative costs to send
hours, with an equivalent cost of insurance industry in depth in the notices to enrollees and arrange for
$11,600. The cost burden associated Regulatory Impact Analysis we prepared separate payments for contraceptive
with this ICR is allocated equally for the proposed rule on establishment services. It is unknown how many third
between DOL and HHS, because the of the Medicare Advantage program (69 party administrators impacted by this
agencies share jurisdiction under the FR 46866, August 3, 2004). In that requirement have revenues below the
provision. Therefore, the hour burden analysis it was determined that there size thresholds for ‘‘small’’ business
for each is 130.63 burden hours with an were few, if any, insurance firms established by the SBA (currently $32.5
equivalent cost of $5,800 for underwriting comprehensive health million for third party administrators).
approximately 105 respondents. insurance policies (in contrast, for However, a third party administrator
example, to travel insurance policies or can make arrangements with an issuer
4. Letter to HHS Regarding Ownership dental discount policies) that fell below
Structure (29 CFR 2590.2713A(a)(4)(v)) offering coverage through an FFE to
the size thresholds for ‘‘small’’ business obtain reimbursement for the third party
To assist potentially eligible for-profit established by the SBA (currently $38.5 administrator’s costs.
entities seeking further information million in annual receipts for health
regarding whether they qualify for the insurance issuers).80 In addition, G. Federalism Statement—Department
accommodation, an entity may send a analysis of data from Medical Loss Ratio of Labor and Department of Health and
letter describing its ownership structure annual report submissions for the 2013 Human Services
to HHS at accommodation@ reporting year was used to develop an Executive Order 13132 outlines
cms.hhs.gov. However, an entity is not estimate of the number of small entities fundamental principles of federalism,
required to avail itself of this process in that offer comprehensive major medical and requires the adherence to specific
order to qualify as a closely held for- coverage. It is estimated that 141 out of criteria by federal agencies in the
profit entity. 500 issuers of health insurance coverage process of their formulation and
As stated earlier in the preamble, the nationwide had total premium revenue implementation of policies that have
Departments believe that the definition of $38.5 million or less. This estimate ‘‘substantial direct effects’’ on the states,
adopted in these regulations includes may overstate the actual number of the relationship between the national
the for-profit entities that are likely to small health insurance companies that government and states, or on the
have religious objections to providing would be affected, since 77 percent of distribution of power and
contraceptive coverage. In addition, it these small companies belong to larger responsibilities among the various
appears based on available information holding groups, and many if not all of levels of government. In the
that the definition adopted in these final these small companies are likely to have Departments’ view, these final
regulations includes all of the for-profit non-health lines of business that would regulations have federalism
entities that have, as of the date of result in their revenues exceeding $38.5 implications, but the federalism
issuance of these regulations, million. For these reasons, the
implications are substantially mitigated
challenged the contraceptive coverage Departments expect that these final
because, with respect to health
requirement in court. Therefore, the regulations will not affect a significant
insurance issuers, 45 states are either
Departments anticipate that fewer than number of small issuers.
The provisions of these final enforcing the requirements related to
10 entities will submit a letter to HHS.
regulations affect small employers with coverage of specified preventive
Under 5 CFR 1320.3(c)(4), this provision
self-insured group health plans by services (including contraception)
is not subject to the PRA as it will affect
requiring them to include coverage without cost sharing pursuant to state
fewer than 10 entities in a 12-month
under their group health plans for law or otherwise are working
period.
recommended preventive services collaboratively with HHS to ensure that
F. Regulatory Flexibility Act— without cost sharing. However, small issuers meet these standards. In five
Department of Labor and Department of employers also benefit from having states, HHS ensures that issuers comply
Health and Human Services healthier employees and reduced with these requirements. Therefore, the
The Regulatory Flexibility Act (RFA) absenteeism. Small employers are less final regulations are not likely to require
requires agencies that issue a rule to likely to be self-insured compared to substantial additional oversight of states
analyze options for regulatory relief of by HHS.
small businesses if a rule has a 80 ‘‘Table of Small Business Size Standards
81 Source: Agency for Healthcare Research and
significant impact on a substantial Matched To North American Industry Classification
System Codes,’’ effective July 14, 2014, U.S. Small Quality, Center for Financing, Access and Cost
number of small entities. The RFA Business Administration, available at http:// Trends. 2013 Medical Expenditure Panel Survey-
generally defines a ‘‘small entity’’ as— www.sba.gov. Insurance Component.
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In general, section 514 of ERISA that agencies examine closely any been transmitted to Congress and the
provides that state laws are superseded policies that may have federalism Comptroller General for review.
to the extent that they relate to any implications or limit the policymaking
covered employee benefit plan, and discretion of states, the Departments IV. Statutory Authority
preserves state laws that regulate have engaged in numerous efforts to The Department of the Treasury
insurance, banking, or securities. ERISA consult and work cooperatively with regulations are adopted pursuant to the
also prohibits states from regulating a affected state and local officials. authority contained in sections 7805
covered plan as an insurance or In conclusion, throughout the process and 9833 of the Code.
investment company or bank. The of developing these final regulations, to
Health Insurance Portability and the extent feasible within the specific The Department of Labor regulations
Accountability Act of 1996 (HIPAA) preemption provisions of ERISA and the are adopted pursuant to the authority
added a new preemption provision to PHS Act, the Departments have contained in 29 U.S.C. 1002(16), 1027,
ERISA (as well as to the PHS Act) attempted to balance states’ interests in 1059, 1135, 1161–1168, 1169, 1181–
narrowly preempting state requirements regulating health insurance coverage 1183, 1181 note, 1185, 1185a, 1185b,
on group health insurance coverage. and health insurance issuers, and the 1185d, 1191, 1191a, 1191b, and 1191c;
States may continue to apply state law rights of individuals intended to be sec. 101(g), Public Law 104–191, 110
requirements but not to the extent that protected in the PHS Act, ERISA, and Stat. 1936; sec. 401(b), Public Law 105–
such requirements prevent the the Code. 200, 112 Stat. 645 (42 U.S.C. 651 note);
application of the federal requirement sec. 512(d), Public Law 110–343, 122
that group health insurance coverage H. Unfunded Mandates Reform Act
Stat. 3881; sec. 1001, 1201, and 1562(e),
provided in connection with certain Section 202 of the Unfunded Public Law 111–148, 124 Stat. 119, as
group health plans (or student health Mandates Reform Act (UMRA) of 1995 amended by Public Law 111–152, 124
insurance issuers) provide coverage for requires that agencies assess anticipated Stat. 1029; Secretary of Labor’s Order 1–
specified preventive services without costs and benefits before issuing any
cost sharing. HIPAA’s Conference 2011, 77 FR 1088 (Jan. 9, 2012).
final rule that includes a Federal
Report states that the conferees intended mandate that could result in The Department of Health and Human
the narrowest preemption of state laws expenditure in any one year by state, Services regulations are adopted
with regard to health insurance issuers local or tribal governments, in the pursuant to the authority contained in
(H.R. Conf. Rep. No. 104–736, 104th aggregate, or by the private sector, of sections 2701 through 2763, 2791, and
Cong. 2d Session 205, 1996). State $100 million in 1995 dollars, updated 2792 of the PHS Act (42 U.S.C. 300gg
insurance laws that are more stringent annually for inflation. In 2015, that through 300gg-63, 300gg-91, and 300gg-
than the federal requirement are threshold level is approximately $144 92), as amended; and Title I of the
unlikely to ‘‘prevent the application of’’ million. Affordable Care Act, sections 1301–
the preventive services coverage 1304, 1311–1312, 1321–1322, 1324,
UMRA does not address the total cost
provision, and therefore are unlikely to 1334, 1342–1343, 1401–1402, and 1412,
of a regulatory action. Rather, it focuses
be preempted. Accordingly, states have Public Law 111–148, 124 Stat. 119 (42
significant latitude to impose on certain categories of cost, mainly
those ‘‘Federal mandate’’ costs resulting U.S.C. 18021–18024, 18031–18032,
requirements on health insurance
from—(1) imposing enforceable duties 18041–18042, 18044, 18054, 18061,
issuers that are more restrictive than
those in federal law. on state, local, or tribal governments, or 18063, 18071, 18082, 26 U.S.C. 36B, and
Guidance conveying this on the private sector; or (2) increasing 31 U.S.C. 9701).
interpretation was published in the the stringency of conditions in, or
decreasing the funding of, state, local, or List of Subjects
Federal Register on April 8, 1997 (62 FR
16904) and December 30, 2004 (69 FR tribal governments under entitlement 26 CFR Part 54
78720), and these final regulations programs. These final regulations
implement the preventive services include no mandates on state, local, or Excise taxes, Health care, Health
coverage provision’s minimum tribal governments. Health insurance insurance, Pensions, Reporting and
standards and do not significantly issuers, third party administrators and recordkeeping requirements.
reduce the discretion given to states eligible organizations would incur costs
to comply with the provisions of these 29 CFR Part 2510
under the statutory scheme.
The PHS Act provides that states may final regulations. However, consistent Employee benefit plans, Pensions.
enforce the provisions of title XXVII of with policy embodied in UMRA, these
the PHS Act as they pertain to issuers, final regulations have been designed to 29 CFR Part 2590
but that the Secretary of HHS will be the least burdensome alternative
while achieving the objectives of the Continuation coverage, Disclosure,
enforce any provisions that a state does
Affordable Care Act. Employee benefit plans, Group health
not have authority to enforce or that a
state has failed to substantially enforce. plans, Health care, Health insurance,
I. Congressional Review Act Medical child support, Reporting and
When exercising its responsibility to
enforce provisions of the PHS Act, HHS These final rules are subject to the recordkeeping requirements.
works cooperatively with the state to Congressional Review Act provisions of 45 CFR Part 147
address the state’s concerns and avoid the Small Business Regulatory
conflicts with the state’s exercise of its Enforcement Fairness Act of 1996 (5 Health care, Health insurance,
authority. HHS has developed U.S.C. 801 et seq.), which specifies that Reporting and recordkeeping
procedures to implement its before a rule can take effect, the federal requirements, State regulation of health
enforcement responsibilities, and to agency promulgating the rule shall insurance.
afford states the maximum opportunity submit to each House of the Congress
to enforce the PHS Act’s requirements and to the Comptroller General a report
in the first instance. In compliance with containing a copy of the rule along with
Executive Order 13132’s requirement other specified information, and have
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Approved: July 8, 2015. for Disease Control and Prevention, and recommendations under paragraph (a)(1) of
John Dalrymple, a recommendation is considered to be this section, the plan is not prohibited from
for routine use if it is listed on the imposing cost-sharing requirements with
Deputy Commissioner for Services and
respect to the treatment.
Enforcement, Internal Revenue Service. Immunization Schedules of the Centers Example 3. (i) Facts. An individual
Approved: July 8, 2015. for Disease Control and Prevention); covered by a group health plan visits an in-
Mark J. Mazur, (iii) With respect to infants, children, network health care provider to discuss
Assistant Secretary of the Treasury (Tax and adolescents, evidence-informed recurring abdominal pain. During the visit,
Policy). preventive care and screenings provided the individual has a blood pressure
Signed this 7th day of May 2015. for in comprehensive guidelines screening, which has in effect a rating of A
supported by the Health Resources and or B in the current recommendations of the
Phyllis C. Borzi, United States Preventive Services Task Force
Services Administration; and
Assistant Secretary, Employee Benefits with respect to the individual. The provider
Security Administration, Department of * * * * * bills the plan for an office visit.
Labor. (2) Office visits—(i) If an item or (ii) Conclusion. In this Example 3, the
Dated: May 7, 2015. service described in paragraph (a)(1) of blood pressure screening is provided as part
this section is billed separately (or is of an office visit for which the primary
Andrew M. Slavitt,
tracked as individual encounter data purpose was not to deliver items or services
Acting Administrator, Centers for Medicare described in paragraph (a)(1) of this section.
separately) from an office visit, then a
& Medicaid Services. Therefore, the plan may impose a cost-
plan or issuer may impose cost-sharing
Approved: May 20, 2015. sharing requirement for the office visit
requirements with respect to the office
Sylvia M. Burwell, charge.
visit. Example 4. (i) Facts. A child covered by
Secretary, Department of Health and Human (ii) If an item or service described in
Services. a group health plan visits an in-network
paragraph (a)(1) of this section is not pediatrician to receive an annual physical
DEPARTMENT OF THE TREASURY billed separately (or is not tracked as exam described as part of the comprehensive
individual encounter data separately) guidelines supported by the Health
Internal Revenue Service from an office visit and the primary Resources and Services Administration.
26 CFR Chapter I purpose of the office visit is the delivery During the office visit, the child receives
of such an item or service, then a plan additional items and services that are not
Accordingly, 26 CFR part 54 is described in the comprehensive guidelines
amended as follows: or issuer may not impose cost-sharing
supported by the Health Resources and
requirements with respect to the office Services Administration, nor otherwise
PART 54—PENSION EXCISE TAXES visit. described in paragraph (a)(1) of this section.
(iii) If an item or service described in The provider bills the plan for an office visit.
■ Paragraph 1. The authority citation paragraph (a)(1) of this section is not (ii) Conclusion. In this Example 4, the
for part 54 continues to read in part as billed separately (or is not tracked as service was not billed as a separate charge
follows: individual encounter data separately) and was billed as part of an office visit.
from an office visit and the primary Moreover, the primary purpose for the visit
Authority: 26 U.S.C. 7805 * * * was to deliver items and services described
purpose of the office visit is not the
* * * * * delivery of such an item or service, then as part of the comprehensive guidelines
Section 54.9815–2713 also issued supported by the Health Resources and
a plan or issuer may impose cost- Services Administration. Therefore, the plan
under 26 U.S.C. 9833;
sharing requirements with respect to the may not impose a cost-sharing requirement
■ Par.2. Section 54.9815–2713 is office visit. with respect to the office visit.
amended by adding paragraphs (a)(1)(i), (iv) The rules of this paragraph (a)(2)
(ii), and (iii), and revising paragraphs are illustrated by the following (3) Out-of-network providers. (i)
(a)(2), (3), (4), and (5), (b), and (c) to read examples: Subject to paragraph (a)(3)(ii) of this
as follows: section, nothing in this section requires
Example 1. (i) Facts. An individual a plan or issuer that has a network of
§ 54.9815–2713 Coverage of preventive covered by a group health plan visits an in- providers to provide benefits for items
health services. network health care provider. While visiting
the provider, the individual is screened for or services described in paragraph (a)(1)
(a) * * * cholesterol abnormalities, which has in effect of this section that are delivered by an
(1) * * * a rating of A or B in the current out-of-network provider. Moreover,
(i) Evidence-based items or services recommendations of the United States nothing in this section precludes a plan
that have in effect a rating of A or B in Preventive Services Task Force with respect or issuer that has a network of providers
the current recommendations of the to the individual. The provider bills the plan from imposing cost-sharing
United States Preventive Services Task for an office visit and for the laboratory work requirements for items or services
Force with respect to the individual of the cholesterol screening test. described in paragraph (a)(1) of this
involved (except as otherwise provided (ii) Conclusion. In this Example 1, the plan
may not impose any cost-sharing section that are delivered by an out-of-
in paragraph (c) of this section); requirements with respect to the separately- network provider.
(ii) Immunizations for routine use in billed laboratory work of the cholesterol (ii) If a plan or issuer does not have
children, adolescents, and adults that screening test. Because the office visit is in its network a provider who can
have in effect a recommendation from billed separately from the cholesterol provide an item or service described in
the Advisory Committee on screening test, the plan may impose cost- paragraph (a)(1) of this section, the plan
Immunization Practices of the Centers sharing requirements for the office visit. or issuer must cover the item or service
for Disease Control and Prevention with Example 2. (i) Facts. Same facts as when performed by an out-of-network
respect to the individual involved (for Example 1 of this section. As the result of the provider, and may not impose cost-
screening, the individual is diagnosed with
this purpose, a recommendation from sharing with respect to the item or
hyperlipidemia and is prescribed a course of
the Advisory Committee on treatment that is not included in the service.
Immunization Practices of the Centers recommendations under paragraph (a)(1) of (4) Reasonable medical management.
for Disease Control and Prevention is this section. Nothing prevents a plan or issuer from
considered in effect after it has been (ii) Conclusion. In this Example 2, because using reasonable medical management
adopted by the Director of the Centers the treatment is not included in the techniques to determine the frequency,
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method, treatment, or setting for an item services through the last day of the plan (4) A closely held for-profit entity is
or service described in paragraph (a)(1) year. an entity that—
of this section to the extent not specified (c) Recommendations not current. For (i) Is not a nonprofit entity;
in the relevant recommendation or purposes of paragraph (a)(1)(i) of this (ii) Has no publicly traded ownership
guideline. To the extent not specified in section, and for purposes of any other interests, (for this purpose, a publicly
a recommendation or guideline, a plan provision of law, recommendations of traded ownership interest is any class of
or issuer may rely on the relevant the United States Preventive Services common equity securities required to be
clinical evidence base and established Task Force regarding breast cancer registered under section 12 of the
reasonable medical management screening, mammography, and Securities Exchange Act of 1934); and
techniques to determine the frequency, prevention issued in or around (iii) Has more than 50 percent of the
method, treatment, or setting for November 2009 are not considered to be value of its ownership interest owned
coverage of a recommended preventive current. directly or indirectly by five or fewer
health service. ■ Par. 3. Section 54.9815–2713A is
(5) Services not described. Nothing in individuals, or has an ownership
amended by revising paragraphs (a), (b), structure that is substantially similar
this section prohibits a plan or issuer
(c)(1), and (c)(2)(i) introductory text to thereto, as of the date of the entity’s self-
from providing coverage for items and
read as follows: certification or notice described in
services in addition to those
recommended by the United States paragraph (b) or (c) of this section.
§ 54.9815–2713A Accommodations in
Preventive Services Task Force or the connection with coverage of preventive (iv) For the purpose of the calculation
Advisory Committee on Immunization health services. in paragraph (a)(4)(iii) of this section,
Practices of the Centers for Disease (a) Eligible organizations. An eligible the following rules apply:
Control and Prevention, or provided for organization is an organization that (A) Ownership interests owned by a
by guidelines supported by the Health meets the criteria of paragraphs (a)(1) corporation, partnership, estate, or trust
Resources and Services Administration, through (3) of this section. are considered owned proportionately
or from denying coverage for items and (1) The organization opposes by such entity’s shareholders, partners,
services that are not recommended by providing coverage for some or all of or beneficiaries. Ownership interests
that task force or that advisory any contraceptive items or services owned by a nonprofit entity are
committee, or under those guidelines. A required to be covered under § 54.9815– considered owned by a single owner.
plan or issuer may impose cost-sharing 2713(a)(1)(iv) on account of religious (B) An individual is considered to
requirements for a treatment not objections. own the ownership interests owned,
described in paragraph (a)(1) of this directly or indirectly, by or for his or her
(2)(i) The organization is organized
section, even if the treatment results family. Family includes only brothers
and operates as a nonprofit entity and
from an item or service described in and sisters (including half-brothers and
holds itself out as a religious
paragraph (a)(1) of this section. half-sisters), a spouse, ancestors, and
(b) Timing—(1) In general. A plan or organization; or
(ii) The organization is organized and lineal descendants.
issuer must provide coverage pursuant (C) If a person holds an option to
to paragraph (a)(1) of this section for operates as a closely held for-profit
entity, as defined in paragraph (a)(4) of purchase ownership interests, he or she
plan years that begin on or after is considered to be the owner of those
September 23, 2010, or, if later, for plan this section, and the organization’s
highest governing body (such as its ownership interests.
years that begin on or after the date that
is one year after the date the board of directors, board of trustees, or (v) A for profit entity that seeks
recommendation or guideline is issued. owners, if managed directly by its further information regarding whether it
(2) Changes in recommendations or owners) has adopted a resolution or qualifies for the accommodation
guidelines. (i) A plan or issuer that is similar action, under the organization’s described in this section may send a
required to provide coverage for any applicable rules of governance and letter describing its ownership structure
items and services specified in any consistent with state law, establishing to the Department of Health and Human
recommendation or guideline described that it objects to covering some or all of Services. An entity must submit the
in paragraph (a)(1) of this section on the the contraceptive services on account of letter in the manner described by the
first day of a plan year must provide the owner’s sincerely held religious Department of Health and Human
coverage through the last day of the plan beliefs. Services. If the entity does not receive
year, even if the recommendation or (3) The organization must self-certify a response from the Department of
guideline changes is or is no longer in the form and manner specified by the Health and Human Services to a
described in paragraph (a)(1) of this Secretary of Labor or provide notice to properly submitted letter describing the
section, during the plan year. the Secretary of Health and Human entity’s current ownership structure
(ii) Notwithstanding paragraph Services as described in paragraph (b) or within 60 calendar days, as long as the
(b)(2)(i) of this section, to the extent a (c) of this section. The organization entity maintains that structure it will be
recommendation or guideline described must make such self-certification or considered to meet the requirement set
in paragraph (a)(1)(i) of this section that notice available for examination upon forth in paragraph (a)(4)(iii) of this
was in effect on the first day of a plan request by the first day of the first plan section.
year is downgraded to a ‘‘D’’ rating, or year to which the accommodation in (b) Contraceptive coverage—self-
any item or service associated with any paragraph (b) or (c) of this section insured group health plans. (1) A group
recommendation or guideline specified applies. The self-certification or notice health plan established or maintained
in paragraph (a)(1) of this section is must be executed by a person by an eligible organization that provides
subject to a safety recall or is otherwise authorized to make the certification or benefits on a self-insured basis complies
determined to pose a significant safety notice on behalf of the organization, and for one or more plan years with any
concern by a federal agency authorized must be maintained in a manner requirement under § 54.9815–
to regulate the item or service during a consistent with the record retention 2713(a)(1)(iv) to provide contraceptive
plan year, there is no requirement under requirements under section 107 of coverage if all of the requirements of
this section to cover these items and ERISA. this paragraph (b)(1) are satisfied:
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(i) The eligible organization or its plan (i) Provide payments for contraceptive the basis on which it qualifies for an
contracts with one or more third party services for plan participants and accommodation; its objection based on
administrators. beneficiaries without imposing any cost- its sincerely held religious beliefs to
(ii) The eligible organization provides sharing requirements (such as a coverage of some or all contraceptive
either a copy of the self-certification to copayment, coinsurance, or a services, as applicable (including an
each third party administrator or a deductible), or imposing a premium, identification of the subset of
notice to the Secretary of Health and fee, or other charge, or any portion contraceptive services to which
Human Services that it is an eligible thereof, directly or indirectly, on the coverage the eligible organization
organization and of its religious eligible organization, the group health objects, if applicable); the plan name
objection to coverage of all or a subset plan, or plan participants or and type (that is, whether it is a student
of contraceptive services. beneficiaries; or health insurance plan within the
(A) When a copy of the self- (ii) Arrange for an issuer or other meaning of 45 CFR 147.145(a) or a
certification is provided directly to a entity to provide payments for church plan within the meaning of
third party administrator, such self- contraceptive services for plan ERISA section 3(33)); and the name and
certification must include notice that participants and beneficiaries without contact information for any of the plan’s
obligations of the third party imposing any cost-sharing requirements third party administrators and health
administrator are set forth in 29 CFR (such as a copayment, coinsurance, or a insurance issuers. If there is a change in
2510.3–16 and this section. deductible), or imposing a premium, any of the information required to be
(B) When a notice is provided to the fee, or other charge, or any portion included in the notice, the organization
Secretary of Health and Human thereof, directly or indirectly, on the must provide updated information to
Services, the notice must include the eligible organization, the group health the Secretary of Health and Human
name of the eligible organization and plan, or plan participants or Services. The Department of Health and
the basis on which it qualifies for an beneficiaries. Human Services will send a separate
(3) If a third party administrator notification to each of the plan’s health
accommodation; its objection based on
provides or arranges payments for insurance issuers informing the issuer
sincerely held religious beliefs to
contraceptive services in accordance that the Secretary of Health and Human
coverage of some or all contraceptive with either paragraph (b)(2)(i) or (ii) of
services (including an identification of Services has received a notice under
this section, the costs of providing or paragraph (c)(1) of this section and
the subset of contraceptive services to arranging such payments may be
which coverage the eligible organization describing the obligations of the issuer
reimbursed through an adjustment to under this section.
objects, if applicable); the plan name the Federally-facilitated Exchange user
and type (that is, whether it is a student (2) * * *
fee for a participating issuer pursuant to (i) A group health insurance issuer
health insurance plan within the 45 CFR 156.50(d).
meaning of 45 CFR 147.145(a) or a that receives a copy of the self-
(4) A third party administrator may certification or notification described in
church plan within the meaning of not require any documentation other
ERISA section 3(33)); and the name and paragraph (c)(1)(ii) of this section with
than a copy of the self-certification from respect to a group health plan
contact information for any of the plan’s the eligible organization or notification
third party administrators and health established or maintained by an eligible
from the Department of Labor described organization in connection with which
insurance issuers. If there is a change in in paragraph (b)(1)(ii) of this section.
any of the information required to be the issuer would otherwise provide
(c) * * * contraceptive coverage under § 54.9815–
included in the notice, the organization (1) General rule. A group health plan
must provide updated information to 2713(a)(1)(iv) must—
established or maintained by an eligible
the Secretary of Health and Human organization that provides benefits * * * * *
Services. The Department of Labor through one or more group health § 54.9815–2713AT [REMOVED]
(working with the Department of Health insurance issuers complies for one or
and Human Services), will send a more plan years with any requirement ■ Par. 4. Section 54.9815–2713AT is
separate notification to each of the under § 54.9815–2713(a)(1)(iv) to removed.
plan’s third party administrators provide contraceptive coverage if the § 54.9815–2713T [REMOVED]
informing the third party administrator eligible organization or group health
that the Secretary of Health and Human plan provides either a copy of the self- ■ Par. 5. Section 54.9815–2713T is
Services has received a notice under certification to each issuer providing removed.
paragraph (b)(1)(ii) of this section and coverage in connection with the plan or DEPARTMENT OF LABOR
describing the obligations of the third a notice to the Secretary of Health and
party administrator under 29 CFR Employee Benefits Security
Human Services that it is an eligible
2510.3–16 and this section. Administration
organization and of its religious
(2) If a third party administrator objection to coverage for all or a subset For the reasons stated in the
receives a copy of the self-certification of contraceptive services. preamble, under the authority contained
from an eligible organization or a (i) When a copy of the self- in 29 U.S.C. 1002(16), 1027, 1059, 1135,
notification from the Department of certification is provided directly to an 1161–1168, 1169, 1181–1183, 1181 note,
Labor, as described in paragraph issuer, the issuer has sole responsibility 1185, 1185a, 1185b, 1185d, 1191, 1191a,
(b)(1)(ii) of this section, and agrees to for providing such coverage in 1191b, and 1191c; sec. 101(g), Pub. L.
enter into or remain in a contractual accordance with § 54.9815–2713. An 104–191, 110 Stat. 1936; sec. 401(b),
relationship with the eligible issuer may not require any further Pub. L. 105–200, 112 Stat. 645 (42
organization or its plan to provide documentation from the eligible U.S.C. 651 note); sec. 512(d), Pub. L.
administrative services for the plan, the organization regarding its status as such. 110–343, 122 Stat. 3881; sec. 1001,
third party administrator shall provide (ii) When a notice is provided to the 1201, and 1562(e), Pub. L. 111–148, 124
or arrange payments for contraceptive Secretary of Health and Human Stat. 119, as amended by Pub. L. 111–
services using one of the following Services, the notice must include the 152, 124 Stat. 1029; Secretary of Labor’s
methods— name of the eligible organization and Order 1–2011, 77 FR 1088 (Jan. 9, 2012)
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the Department of Labor adopts as final method, treatment, or setting for the contraceptive services on account of
the interim rules amending 29 CFR part coverage of a recommended preventive the owners’ sincerely held religious
2590 published on July 19, 2010 (75 FR health service. beliefs.
41726) and amending 29 CFR parts 2510 * * * * * (3) The organization must self-certify
and 2590 published August 27, 2014 (79 (b) * * * in the form and manner specified by the
FR 51092) and further amends 29 CFR (2) Changes in recommendations or Secretary or provide notice to the
part 2590 as follows: guidelines. (i) A plan or issuer that is Secretary of Health and Human Services
required to provide coverage for any as described in paragraph (b) or (c) of
PART 2590—RULES AND items and services specified in any this section. The organization must
REGULATIONS FOR GROUP HEALTH recommendation or guideline described make such self-certification or notice
PLANS in paragraph (a)(1) of this section on the available for examination upon request
first day of a plan year must provide by the first day of the first plan year to
■ 6. The authority citation for part 2590 which the accommodation in paragraph
continues to read as follows: coverage through the last day of the plan
year, even if the recommendation or (b) or (c) of this section applies. The
Authority: 29 U.S.C. 1027, 1059, 1135, guideline changes or is no longer self-certification or notice must be
1161–1168, 1169, 1181–1183, 1181 note, executed by a person authorized to
1185, 1185a, 1185b, 1185d, 1191, 1191a, described in paragraph (a)(1) of this
section, during the plan year. make the certification or notice on
1191b, and 1191c; sec. 101(g), Pub. L. 104–
191, 110 Stat. 1936; sec. 401(b), Pub. L. 105– (ii) Notwithstanding paragraph behalf of the organization, and must be
200, 112 Stat. 645 (42 U.S.C. 651 note); sec. (b)(2)(i) of this section, to the extent a maintained in a manner consistent with
12(d), Pub. L. 110–343, 122 Stat. 3881; sec. recommendation or guideline described the record retention requirements under
1001, 1201, and 1562(e), Pub. L. 111–148, in paragraph (a)(1)(i) of this section that section 107 of ERISA.
124 Stat. 119, as amended by Pub. L. 111– was in effect on the first day of a plan (4) A closely held for-profit entity is
152, 124 Stat. 1029; Secretary of Labor’s year is downgraded to a ‘‘D’’ rating, or an entity that—
Order 1–2011, 77 FR 1088 (January 9, 2012).
any item or service associated with any (i) Is not a nonprofit entity;
■ 7. Section 2590.715–2713 is amended (ii) Has no publicly traded ownership
recommendation or guideline specified
by revising paragraphs (a)(3) and (4) and interests (for this purpose, a publicly
in paragraph (a)(1) of this section is
(b)(2) to read as follows: traded ownership interest is any class of
subject to a safety recall or is otherwise
common equity securities required to be
§ 2590.715–2713 Coverage of preventive determined to pose a significant safety
registered under section 12 of the
health services concern by a federal agency authorized
Securities Exchange Act of 1934); and
(a) * * * to regulate the item or service during a (iii) Has more than 50 percent of the
(3) Out-of-network providers—(i) plan year, there is no requirement under value of its ownership interest owned
Subject to paragraph (a)(3)(ii) of this this section to cover these items and directly or indirectly by five or fewer
section, nothing in this section requires services through the last day of the plan individuals, or has an ownership
a plan or issuer that has a network of year. structure that is substantially similar
providers to provide benefits for items * * * * * thereto, as of the date of the entity’s self-
or services described in paragraph (a)(1) ■ 8. Section 2590.715–2713A is certification or notice described in
of this section that are delivered by an amended by revising paragraph (a) to paragraph (b) or (c) of this section.
out-of-network provider. Moreover, read as follows: (iv) For the purpose of the calculation
nothing in this section precludes a plan in paragraph (a)(4)(iii) of this section,
or issuer that has a network of providers § 2590.715–2713A Accommodations in the following rules apply:
from imposing cost-sharing connection with coverage of preventive (A) Ownership interests owned by a
requirements for items or services health services.
corporation, partnership, estate, or trust
described in paragraph (a)(1) of this (a) Eligible organizations. An eligible are considered owned proportionately
section that are delivered by an out-of- organization is an organization that by such entity’s shareholders, partners,
network provider. meets the criteria of paragraphs (a)(1) or beneficiaries. Ownership interests
(ii) If a plan or issuer does not have through (3) of this section. owned by a nonprofit entity are
in its network a provider who can (1) The organization opposes considered owned by a single owner.
provide an item or service described in providing coverage for some or all of (B) An individual is considered to
paragraph (a)(1) of this section, the plan any contraceptive items or services own the ownership interests owned,
or issuer must cover the item or service required to be covered under directly or indirectly, by or for his or her
when performed by an out-of-network § 2590.715–2713(a)(1)(iv) on account of family. Family includes only brothers
provider, and may not impose cost religious objections. and sisters (including half-brothers and
sharing with respect to the item or (2)(i) The organization is organized half-sisters), a spouse, ancestors, and
service. and operates as a nonprofit entity and lineal descendants.
(4) Reasonable medical management. holds itself out as a religious (C) If a person holds an option to
Nothing prevents a plan or issuer from organization; or purchase ownership interests, he or she
using reasonable medical management (ii) The organization is organized and is considered to be the owner of those
techniques to determine the frequency, operates as a closely held for-profit ownership interests.
method, treatment, or setting for an item entity, as defined in paragraph (a)(4) of (v) A for-profit entity that seeks
or service described in paragraph (a)(1) this section, and the organization’s further information regarding whether it
of this section to the extent not specified highest governing body (such as its qualifies for the accommodation
in the relevant recommendation or board of directors, board of trustees, or described in this section may send a
guideline. To the extent not specified in owners, if managed directly by its letter describing its ownership structure
a recommendation or guideline, a plan owners) has adopted a resolution or to the Department of Health and Human
or issuer may rely on the relevant similar action, under the organization’s Services. An entity must submit the
clinical evidence base and established applicable rules of governance and letter in the manner described by the
reasonable medical management consistent with state law, establishing Department of Health and Human
techniques to determine the frequency, that it objects to covering some or all of Services. If the entity does not receive
41346 CaseFederal
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a response from the Department of sharing with respect to the item or any contraceptive items or services
Health and Human Services to a service. required to be covered under
properly submitted letter describing the (4) Reasonable medical management. § 147.130(a)(1)(iv) on account of
entity’s current ownership structure Nothing prevents a plan or issuer from religious objections.
within 60 calendar days, as long as the using reasonable medical management (2)(i) The organization is organized
entity maintains that structure it will be techniques to determine the frequency, and operates as a nonprofit entity and
considered to meet the requirement set method, treatment, or setting for an item holds itself out as a religious
forth in paragraph (a)(4)(iii) of this or service described in paragraph (a)(1) organization; or
section. of this section to the extent not specified (ii) The organization is organized and
* * * * * in the relevant recommendation or operates as a closely held for-profit
guideline. To the extent not specified in entity, as defined in paragraph (b)(4) of
DEPARTMENT OF HEALTH AND a recommendation or guideline, a plan this section, and the organization’s
HUMAN SERVICES or issuer may rely on the relevant highest governing body (such as its
For the reasons stated in the clinical evidence base and established board of directors, board of trustees, or
preamble, under the authority contained reasonable medical management owners, if managed directly by its
in Secs. 2701 through 2763, 2791, and techniques to determine the frequency, owners) has adopted a resolution or
2792 of the Public Health Service Act method, treatment, or setting for similar action, under the organization’s
(42 U.S.C. 300gg through 300gg–63, coverage of a recommended preventive applicable rules of governance and
300gg–91, and 300gg–92, as amended), health service. consistent with state law, establishing
the Department of Health and Human * * * * * that it objects to covering some or all of
Services adopts as final the interim (b) * * * the contraceptive services on account of
rules amending 45 CFR part 147 (2) Changes in recommendations or the owners’ sincerely held religious
published on July 19, 2010 (75 FR guidelines. (i) A plan or issuer that is beliefs.
41726) and amending 45 CFR part 147 required to provide coverage for any (3) The organization must self-certify
published August 27, 2014 (79 FR items and services specified in any in the form and manner specified by the
51092) and further amends 45 CFR part recommendation or guideline described Secretary of Labor or provide notice to
147 as follows: in paragraph (a)(1) of this section on the the Secretary of Health and Human
first day of a plan year (in the individual Services as described in paragraph (c) of
PART 147—HEALTH INSURANCE market, policy year) must provide this section. The organization must
REFORM REQUIREMENTS FOR THE coverage through the last day of the plan make such self-certification or notice
GROUP AND INDIVIDUAL HEALTH or policy year, even if the available for examination upon request
INSURANCE MARKETS recommendation or guideline changes by the first day of the first plan year to
or is no longer described in paragraph which the accommodation in paragraph
■ 9. The authority citation for part 147 (a)(1) of this section, during the plan or (c) of this section applies. The self-
continues to read as follows: policy year. certification or notice must be executed
Authority: Secs. 2701 through 2763, 2791, (ii) Notwithstanding paragraph by a person authorized to make the
and 2792 of the Public Health Service Act (42 (b)(2)(i) of this section, to the extent a certification or notice on behalf of the
U.S.C. 300gg through 300gg–63, 300gg–91, recommendation or guideline described organization, and must be maintained in
and 300gg–92), as amended. in paragraph (a)(1)(i) of this section that a manner consistent with the record
■ 10. Section 147.130 is amended by was in effect on the first day of a plan retention requirements under section
revising paragraphs (a)(3) and (4) and year (in the individual market, policy 107 of ERISA.
(b)(2) to read as follows: year) is downgraded to a ‘‘D’’ rating, or (4) A closely held for-profit entity is
any item or service associated with any an entity that—
§ 147.130 Coverage of preventive health recommendation or guideline specified (i) Is not a nonprofit entity;
services
in paragraph (a)(1) of this section is (ii) Has no publicly traded ownership
(a) * * * subject to a safety recall or is otherwise interests (for this purpose, a publicly
(3) Out-of-network providers—(i) determined to pose a significant safety traded ownership interest is any class of
Subject to paragraph (a)(3)(ii) of this concern by a federal agency authorized common equity securities required to be
section, nothing in this section requires to regulate the item or service during a registered under section 12 of the
a plan or issuer that has a network of plan or policy year, there is no Securities Exchange Act of 1934); and
providers to provide benefits for items requirement under this section to cover (iii) Has more than 50 percent of the
or services described in paragraph (a)(1) these items and services through the last value of its ownership interest owned
of this section that are delivered by an day of the plan or policy year. directly or indirectly by five or fewer
out-of-network provider. Moreover, * * * * * individuals, or has an ownership
nothing in this section precludes a plan structure that is substantially similar
■ 11. Section 147.131 is amended by
or issuer that has a network of providers thereto, as of the date of the entity’s self-
revising paragraphs (b) and (f) to read as
from imposing cost-sharing certification or notice described in
follows:
requirements for items or services paragraph (b) or (c) of this section.
described in paragraph (a)(1) of this § 147.131 Exemption and accommodations (iv) For the purpose of the calculation
section that are delivered by an out-of- in connection with coverage of preventive in paragraph (b)(4)(iii) of this section,
network provider. health services. the following rules apply:

(ii) If a plan or issuer does not have * * * * * (A) Ownership interests owned by a
in its network a provider who can (b) Eligible organizations. An eligible corporation, partnership, estate, or trust
provide an item or service described in organization is an organization that are considered owned proportionately
paragraph (a)(1) of this section, the plan meets the criteria of paragraphs (b)(1) by such entity’s shareholders, partners,
or issuer must cover the item or service through (3) of this section. or beneficiaries. Ownership interests
when performed by an out-of-network (1) The organization opposes owned by a nonprofit entity are
provider, and may not impose cost providing coverage for some or all of considered owned by a single owner.
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(B) An individual is considered to Services. An entity must submit the insurance coverage arranged by an
own the ownership interests owned, letter in the manner described by the eligible organization that is an
directly or indirectly, by or for his or her Department of Health and Human institution of higher education as
family. Family includes only brothers Services. If the entity does not receive defined in 20 U.S.C. 1002 in a manner
and sisters (including half-brothers and a response from the Department of comparable to that in which they apply
half-sisters), a spouse, ancestors, and Health and Human Services to a to group health insurance coverage
lineal descendants. properly submitted letter describing the provided in connection with a group
(C) If a person holds an option to entity’s current ownership structure health plan established or maintained
purchase ownership interests, he or she within 60 calendar days, as long as the by an eligible organization that is an
is considered to be the owner of those entity maintains that structure it will be employer. In applying this section in the
ownership interests. considered to meet the requirement set case of student health insurance
(v) A for-profit entity that seeks forth in paragraph (b)(4)(iii) of this coverage, a reference to ‘‘plan
further information regarding whether it section. participants and beneficiaries’’ is a
qualifies for the accommodation * * * * * reference to student enrollees and their
described in this section may send a (f) Application to student health covered dependents.
letter describing its ownership structure insurance coverage. The provisions of [FR Doc. 2015–17076 Filed 7–10–15; 11:15 am]
to the Department of Health and Human this section apply to student health BILLING CODE 6325–64–P; 4150–28–P; 4120–01–P
EXECUTIVE ORDERS
Presidential Executive Order

Promoting Free Speech and
Religious Liberty
LAW & JUSTICE Issued on: May 4, 2017
★ ★ ★
By the authority vested in me

as President by the
Constitution and the laws of
the United States of America,
in order to guide the executive
branch in formulating and
implementing policies with
implications for the religious
liberty of persons and
organizations in America, and
to further compliance with the
Constitution and with
applicable
Case 4:18-cv-00825-O Document 1-7 statutes Page
Filed 10/06/18 and 2 of 7 PageID 86
Presidential Directives, it is
hereby ordered as follows:
Section 1. Policy. It shall be

the policy of the executive
branch to vigorously enforce
Federal law’s robust
protections for religious
freedom. The Founders
envisioned a Nation in which
religious voices and views
were integral to a vibrant
public square, and in which
religious people and
institutions were free to
practice their faith without
fear of discrimination or
retaliation by the Federal
Government. For that reason,
the United States Constitution
enshrines and protects the
fundamental right to religious
liberty as Americans’ first
freedom. Federal law protects
the freedom of Americans and
their organizations to exercise
religion and participate fully in
civic life without undue
interference by the Federal
Government.
Case 4:18-cv-00825-O Document 1-7 The executive
Filed 10/06/18 Page 3 of 7 PageID 87
branch will honor and enforce
those protections.
Sec. 2. Respecting Religious

and Political Speech. All
executive departments and
agencies (agencies) shall, to
the greatest extent practicable
and to the extent permitted by
law, respect and protect the
freedom of persons and
organizations to engage in
religious and political speech.
In particular, the Secretary of
the Treasury shall ensure, to
the extent permitted by law,
that the Department of the
Treasury does not take any
adverse action against any
individual, house of worship,
or other religious organization
on the basis that such
individual or organization
speaks or has spoken about
moral or political issues from a
religious perspective, where
speech of similar character
has, consistent with law, not
ordinarily been treated as
participation
Case 4:18-cv-00825-O Document 1-7 or intervention
in a political campaign on
behalf of (or in opposition to)
a candidate for public o!ice by
the Department of the
Treasury. As used in this
section, the term “adverse
action” means the imposition
of any tax or tax penalty; the
delay or denial of tax-exempt
status; the disallowance of tax
deductions for contributions
made to entities exempted
from taxation under section
501(c)(3) of title 26, United
States Code; or any other
action that makes unavailable
or denies any tax deduction,
exemption, credit, or benefit.
Sec. 3. Conscience
Protections with Respect to
Preventive-Care Mandate. The
Secretary of the Treasury, the
Secretary of Labor, and the
Secretary of Health and
Human Services shall consider
issuing amended regulations,
consistent with applicable
law, to address conscience-
based
Case 4:18-cv-00825-O Document 1-7 objections
Filed 10/06/18 toPage
the 5 of 7 PageID 89
preventive-care mandate
promulgated under section
300gg-13(a)(4) of title 42,
United States Code.
Sec. 4. Religious Liberty

Guidance. In order to guide all
agencies in complying with
relevant Federal law, the
Attorney General shall, as
appropriate, issue guidance
interpreting religious liberty
protections in Federal law.
Sec. 5. Severability. If any

provision of this order, or the
application of any provision to
any individual or
circumstance, is held to be
invalid, the remainder of this
order and the application of
its other provisions to any
other individuals or
circumstances shall not be
a!ected thereby.
Sec. 6. General Provisions. (a)

Nothing in this order shall be
construed to impair or
otherwise
Case 4:18-cv-00825-O Document 1-7 a!ect:
(i) the authority granted

by law to an executive
department or agency, or
the head thereof; or
(ii) the functions of the

Director of the O!ice of
Management and Budget
relating to budgetary,
administrative, or
legislative proposals.
(b) This order shall be

implemented consistent with
applicable law and subject to
the availability of
appropriations.
(c) This order is not intended

to, and does not, create any
right or benefit, substantive or
procedural, enforceable at law
or in equity by any party
against the United States, its
departments, agencies, or
entities, its o!icers,
employees, or agents, or any
other person.
DONALD
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THE WHITE HOUSE,

May 4, 2017.
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DEPARTMENT OF THE TREASURY DATES: Effective date: These interim building. A stamp-in clock is available
final rules and temporary regulations for persons wishing to retain a proof of
Internal Revenue Service are effective on October 6, 2017. filing by stamping in and retaining an
Comment date: Written comments on extra copy of the comments being filed.)
26 CFR Part 54 these interim final rules are invited and b. For delivery in Baltimore, MD—
must be received by December 5, 2017. Centers for Medicare & Medicaid
[TD–9827]
ADDRESSES: Written comments may be Services, Department of Health and
RIN 1545–BN92 submitted to the Department of Health Human Services, 7500 Security
and Human Services as specified below. Boulevard, Baltimore, MD 21244–1850.
DEPARTMENT OF LABOR If you intend to deliver your
Any comment that is submitted will be
shared with the Department of Labor comments to the Baltimore address, call
Employee Benefits Security telephone number (410) 786–9994 in
and the Department of the Treasury, and
Administration advance to schedule your arrival with
will also be made available to the
public. one of our staff members.
29 CFR Part 2590 Comments erroneously mailed to the
Warning: Do not include any personally addresses indicated as appropriate for
RIN 1210–AB83 identifiable information (such as name,
address, or other contact information) or
hand or courier delivery may be delayed
DEPARTMENT OF HEALTH AND confidential business information that you do and received after the comment period.
HUMAN SERVICES not want publicly disclosed. All comments Comments received will be posted
may be posted on the Internet and can be without change to www.regulations.gov.
45 CFR Part 147 retrieved by most Internet search engines. No FOR FURTHER INFORMATION CONTACT: Jeff
deletions, modifications, or redactions will Wu (310) 492–4305 or marketreform@
[CMS–9940–IFC] be made to the comments received, as they cms.hhs.gov for Centers for Medicare &
RIN 0938–AT20 are public records. Comments may be Medicaid Services (CMS), Department
submitted anonymously. Comments,
of Health and Human Services (HHS),
Religious Exemptions and identified by ‘‘Preventive Services,’’ may be
submitted one of four ways (please choose Amber Rivers or Matthew Litton,
Accommodations for Coverage of only one of the ways listed) Employee Benefits Security
Certain Preventive Services Under the Administration (EBSA), Department of
Affordable Care Act 1. Electronically. You may submit Labor, at (202) 693–8335; Karen Levin,
electronic comments on this regulation Internal Revenue Service, Department of
AGENCY: Internal Revenue Service, to http://www.regulations.gov. Follow the Treasury, at (202) 317–5500.
Department of the Treasury; Employee the ‘‘Submit a comment’’ instructions. Customer Service Information:
Benefits Security Administration, 2. By regular mail. You may mail Individuals interested in obtaining
Department of Labor; and Centers for written comments to the following information from the Department of
Medicare & Medicaid Services, address ONLY: Centers for Medicare & Labor concerning employment-based
Department of Health and Human Medicaid Services, Department of health coverage laws may call the EBSA
Services. Health and Human Services, Attention: Toll-Free Hotline at 1–866–444–EBSA
ACTION: Interim final rules with request CMS–9940–IFC, P.O. Box 8016, (3272) or visit the Department of Labor’s
for comments. Baltimore, MD 21244–8016. Web site (www.dol.gov/ebsa).
Please allow sufficient time for mailed Information from HHS on private health
SUMMARY: The United States has a long comments to be received before the insurance coverage can be found on
history of providing conscience close of the comment period. CMS’s Web site (www.cms.gov/cciio),
protections in the regulation of health 3. By express or overnight mail. You and information on health care reform
care for entities and individuals with may send written comments to the can be found at www.HealthCare.gov.
objections based on religious beliefs and following address ONLY: Centers for
moral convictions. These interim final SUPPLEMENTARY INFORMATION:
Medicare & Medicaid Services,
rules expand exemptions to protect Department of Health and Human I. Background
religious beliefs for certain entities and Services, Attention: CMS–9940–IFC, Congress has consistently sought to
individuals whose health plans are Mail Stop C4–26–05, 7500 Security protect religious beliefs in the context of
subject to a mandate of contraceptive Boulevard, Baltimore, MD 21244–1850. health care and human services,
coverage through guidance issued 4. By hand or courier. Alternatively, including health insurance, even as it
pursuant to the Patient Protection and you may deliver (by hand or courier) has sought to promote access to health
Affordable Care Act. These rules do not your written comments ONLY to the services.1 Against that backdrop,
alter the discretion of the Health following addresses prior to the close of
Resources and Services Administration the comment period: 1 See, for example, 42 U.S.C. 300a–7 (protecting
(HRSA), a component of the United a. For delivery in Washington, DC— individuals and health care entities from being
States Department of Health and Human Centers for Medicare & Medicaid required to provide or assist sterilizations,
Services (HHS), to maintain the Services, Department of Health and abortions, or other lawful health services if it would
violate their ‘‘religious beliefs or moral
guidelines requiring contraceptive Human Services, Room 445–G, Hubert convictions’’); 42 U.S.C. 238n (protecting
coverage where no regulatorily H. Humphrey Building, 200 individuals and entities that object to abortion);
recognized objection exists. These rules Independence Avenue SW., Consolidated Appropriations Act of 2017, Div. H,
asabaliauskas on DSKBBXCHB2PROD with RULES
also leave the ‘‘accommodation’’ process Washington, DC 20201. Title V, Sec. 507(d) (Departments of Labor, HHS,
and Education, and Related Agencies
in place as an optional process for (Because access to the interior of the Appropriations Act), Public Law 115–31 (protecting
certain exempt entities that wish to use Hubert H. Humphrey Building is not any ‘‘health care professional, a hospital, a
it voluntarily. These rules do not alter readily available to persons without provider-sponsored organization, a health
multiple other Federal programs that Federal government identification, maintenance organization, a health insurance plan,
or any other kind of health care facility,
provide free or subsidized commenters are encouraged to leave organization, or plan’’ in objecting to abortion for
contraceptives for women at risk of their comments in the CMS drop slots any reason); Id. at Div. C, Title VIII, Sec. 808
unintended pregnancy. located in the main lobby of the (regarding any requirement of ‘‘the provision of
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Congress granted the Health Resources HRSA exercised that discretion under final rules to better balance the
and Services Administration (HRSA), a the last Administration to require health Government’s interest in ensuring
component of the United States coverage for, among other things, certain coverage for contraceptive and
Department of Health and Human contraceptive services,2 while the sterilization services in relation to the
Services (HHS), discretion under the administering agencies—the Government’s interests, including as
Patient Protection and Affordable Care Departments of Health and Human reflected throughout Federal law, to
Act to specify that certain group health Services, Labor, and the Treasury provide conscience protections for
plans and health insurance issuers shall (collectively, ‘‘the Departments’’ 3)— individuals and entities with sincerely
cover, ‘‘with respect to women, such exercised the same discretion to allow held religious beliefs in certain health
additional preventive care and exemptions to those requirements. care contexts, and to minimize burdens
screenings . . . as provided for in Through rulemaking, including three in our regulation of the health insurance
comprehensive guidelines supported interim final rules, the Departments market.
by’’ by HRSA (the ‘‘Guidelines’’). Public allowed exemptions and
A. The Affordable Care Act
Health Service Act section 2713(a)(4). accommodations for certain religious
objectors where the Guidelines require Collectively, the Patient Protection
contraceptive coverage by health insurance plans’’ coverage of contraceptive services. and Affordable Care Act (Pub. L. 111–
in the District of Columbia, ‘‘it is the intent of Many individuals and entities 148), enacted on March 23, 2010, and
Congress that any legislation enacted on such issue the Health Care and Education
should include a ‘conscience clause’ which
provides exceptions for religious beliefs and moral requirement and regulations Reconciliation Act of 2010 (Pub. L. 111–
convictions.’’); Id. at Div. C, Title VII, Sec. 726(c) (hereinafter, the ‘‘contraceptive 152), enacted on March 30, 2010, are
(Financial Services and General Government Mandate,’’ or the ‘‘Mandate’’) as being known as the Affordable Care Act. In
Appropriations Act) (protecting individuals who signing the Affordable Care Act,
object to prescribing or providing contraceptives inconsistent with various legal
contrary to their ‘‘religious beliefs or moral protections, including the Religious President Obama issued Executive
convictions’’); Id. at Div. I, Title III (Department of Freedom Restoration Act, 42 U.S.C. Order 13535 (March 24, 2010), which
State, Foreign Operations, and Related Programs 2000bb–1. Much of that litigation declared that, ‘‘[u]nder the Act,
Appropriations Act) (protecting applicants for longstanding Federal laws to protect
family planning funds based on their ‘‘religious or continues to this day.
conscientious commitment to offer only natural The Departments have recently conscience (such as the Church
family planning’’); 42 U.S.C. 290bb–36 (prohibiting exercised our discretion to reevaluate Amendment, 42 U.S.C. 300a–7, and the
the statutory section from being construed to these exemptions and accommodations. Weldon Amendment, section 508(d)(1)
require suicide related treatment services for youth of Pub. L. 111–8) remain intact’’ and
where the parents or legal guardians object based
This evaluation includes consideration
on ‘‘religious beliefs or moral objections’’); 42 of various factors, such as the interests that ‘‘[n]umerous executive agencies
U.S.C. 290kk–1 (protecting the religious character of served by the existing Guidelines, have a role in ensuring that these
organizations participating in certain programs and regulations, and accommodation restrictions are enforced, including the
the religious freedom of beneficiaries of the HHS.’’
programs); 42 U.S.C. 300x–65 (protecting the
process; 4 the extensive litigation;
religious character of organizations and the Executive Order 13798, ‘‘Promoting Free The Affordable Care Act reorganizes,
religious freedom of individuals involved in the use Speech and Religious Liberty’’ (May 4, amends, and adds to the provisions of
of government funds to provide substance abuse 2017); protection of the free exercise of part A of title XXVII of the Public
services); 42 U.S.C. 604a (protecting the religious Health Service Act (PHS Act) relating to
character of organizations and the religious freedom
religion in the First Amendment and by
of beneficiaries involved in the use of government Congress in the Religious Freedom group health plans and health insurance
assistance to needy families); 42 U.S.C. 1395w– Restoration Act of 1993; Congress’ issuers in the group and individual
22(j)(3)(B) (protecting against forced counseling or history of providing protections for markets. In addition, the Affordable
referrals in Medicare Choice, now Medicare Care Act adds section 715(a)(1) to the
Advantage, managed care plans with respect to
religious beliefs regarding certain health
objections based on ‘‘moral or religious grounds’’); services (including contraception, Employee Retirement Income Security
42 U.S.C. 1396a(w)(3) (ensuring particular Federal sterilization, and items or services Act of 1974 (ERISA) and section
law does not infringe on ‘‘conscience’’ as protected believed to involve abortion); the 9815(a)(1) to the Internal Revenue Code
in State law concerning advance directives); 42 (Code) to incorporate the provisions of
U.S.C. 1396u–2(b)(3) (protecting against forced discretion afforded under section
counseling or referrals in Medicaid managed care 2713(a)(4) of the PHS Act; the structure part A of title XXVII of the PHS Act into
plans with respect to objections based on ‘‘moral or and intent of that provision in the ERISA and the Code, and thereby make
religious grounds’’); 42 U.S.C. 5106i (prohibiting broader context of section 2713 and the them applicable to certain group health
certain Federal statutes from being construed to plans regulated under ERISA or the
require that a parent or legal guardian provide a Patient Protection and Affordable Care
child any medical service or treatment against the Act; the regulatory process and Code. The sections of the PHS Act
religious beliefs of the parent or legal guardian); 42 comments submitted in various requests incorporated into ERISA and the Code
U.S.C. 2996f(b) (protecting objection to abortion for public comments (including in the are sections 2701 through 2728 of the
funding in legal services assistance grants based on PHS Act.
‘‘religious beliefs or moral convictions’’); 42 U.S.C. Departments’ 2016 Request for
14406 (protecting organizations and health Information). These interim final rules concern
providers from being required to inform or counsel In light of these factors, the section 2713 of the PHS Act. Where it
persons pertaining to assisted suicide); 42 U.S.C. Departments issue these new interim applies, section 2713(a)(4) of the PHS
18023 (blocking any requirement that issuers or Act requires coverage without cost
exchanges must cover abortion); 42 U.S.C. 18113
(protecting health plans or health providers from
2 This document’s references to ‘‘contraception,’’ sharing for ‘‘such additional’’ women’s
being required to provide an item or service that ‘‘contraceptive,’’ ‘‘contraceptive coverage,’’ or preventive care and screenings ‘‘as
helps cause assisted suicide); also, see 8 U.S.C. ‘‘contraceptive services’’ generally includes provided for’’ and ‘‘supported by’’
1182(g) (protecting vaccination objections by contraceptives, sterilization, and related patient

education and counseling, unless otherwise
guidelines developed by HRSA/HHS.
‘‘aliens’’ due to ‘‘religious beliefs or moral
convictions’’); 18 U.S.C. 3597 (protecting objectors indicated. The Congress did not specify any
to participation in Federal executions based on 3 Note, however, that in sections under headings particular additional preventive care
‘‘moral or religious convictions’’); 20 U.S.C. 1688 listing only two of the three Departments, the term and screenings with respect to women
(prohibiting sex discrimination law to be used to ‘‘Departments’’ generally refers only to the two that HRSA could or should include in
require assistance in abortion for any reason); 22 Departments listed in the heading.
U.S.C. 7631(d) (protecting entities from being 4 In this document, we generally use its Guidelines, nor did Congress
required to use HIV/AIDS funds contrary to their ‘‘accommodation’’ and ‘‘accommodation process’’ indicate whether the Guidelines should
‘‘religious or moral objection’’). interchangeably. include contraception and sterilization.
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The Departments have consistently preventive services (76 FR 46623). To regarding certain health matters, and are
interpreted section 2714(a)(4) PHS Act’s the contrary, Congress carved out an consistent with the intent that the
grant of authority to include broad exemption from section 2713 of the PHS Affordable Care Act would be
discretion to decide the extent to which Act for grandfathered plans. In contrast, implemented in accordance with the
HRSA will provide for and support the this exemption is not applicable to protections set forth in those laws.
coverage of additional women’s many of the other provisions in Title I
preventive care and screenings in the of the Affordable Care Act—provisions B. The Regulations Concerning
Guidelines. In turn, the Departments previously referred to by the Women’s Preventive Services
have interpreted that discretion to Departments as providing ‘‘particularly On July 19, 2010, the Departments
include the ability to exempt entities significant protections.’’ (75 FR 34540). issued interim final rules implementing
from coverage requirements announced Those provisions include: Section 2704 section 2713 of the PHS Act (75 FR
in HRSA’s Guidelines. That of the PHS Act, which prohibits 41726). Those interim final rules
interpretation is rooted in the text of preexisting condition exclusions or charged HRSA with developing the
section 2713(a)(4) of the PHS Act, which other discrimination based on health Guidelines authorized by section
allows HRSA to decide the extent to status in group health coverage; section 2713(a)(4) of the PHS.
which the Guidelines will provide for 2708 of the PHS Act, which prohibits
and support the coverage of additional excessive waiting periods (as of January 1. The Institute of Medicine Report
women’s preventive care and 1, 2014); section 2711 of the PHS Act,
screenings. which relates to lifetime limits; section In developing the Guidelines, HRSA
Accordingly, the Departments have 2712 of the PHS Act, which prohibits relied on an independent report from
consistently interpreted section rescission of health insurance coverage; the Institute of Medicine (IOM, now
2713(a)(4) of the PHS Act’s reference to section 2714 of the PHS Act, which known as the National Academy of
‘‘comprehensive guidelines supported extends dependent coverage until age Medicine) on women’s preventive
by HRSA for purposes of this 26; and section 2718 of the PHS Act, services, issued on July 19, 2011,
paragraph’’ to grant HRSA authority to which imposes a medical loss ratio on ‘‘Clinical Preventive Services for
develop such Guidelines. And because health insurance issuers in the Women, Closing the Gaps’’ (IOM 2011).
the text refers to Guidelines ‘‘supported individual and group markets (for The IOM’s report was funded by the
by HRSA for purposes of this insured coverage), or requires them to HHS Office of the Assistant Secretary
paragraph,’’ the Departments have provide rebates to policyholders. (75 FR for Planning and Evaluation (ASPE),
consistently interpreted that authority to 34538, 34540, 34542). Consequently, of pursuant to a funding opportunity that
afford HRSA broad discretion to the 150 million nonelderly people in charged the IOM to conduct a review of
consider the requirements of coverage America with employer-sponsored effective preventive services to ensure
and cost-sharing in determining the health coverage, approximately 25.5 women’s health and well-being.6
nature and extent of preventive care and million are estimated to be enrolled in The IOM made a number of
screenings recommended in the grandfathered plans not subject to recommendations with respect to
guidelines. (76 FR 46623). As the section 2713 of the PHS Act.5 As the women’s preventive services. As
Departments have noted, these Supreme Court observed, ‘‘there is no relevant here, the IOM recommended
Guidelines are different from ‘‘the other legal requirement that grandfathered that the Guidelines cover the full range
guidelines referenced in section 2713(a) plans ever be phased out.’’ Burwell v. of Food and Drug Administration
of the PHS Act, which pre-dated the
Hobby Lobby Stores, Inc., 134 S. Ct. (FDA)-approved contraceptive methods,
Affordable Care Act and were originally
2751, 2764 n.10 (2014). sterilization procedures, and patient
issued for purposes of identifying the
The Departments’ interpretation of education and counseling for women
non-binding recommended care that
section 2713(a)(4) of the PHS Act to with reproductive capacity. Because
providers should provide to patients.’’
permit HRSA to establish exemptions FDA includes in the category of
Id. Guidelines developed as nonbinding
from the Guidelines, and of the ‘‘contraceptives’’ certain drugs and
recommendations for care implicate
Departments’ own authority as devices that may not only prevent
significantly different legal and policy
administering agencies to guide HRSA conception (fertilization), but may also
concerns than guidelines developed for
in establishing such exemptions, is also prevent implantation of an embryo,7 the
a mandatory coverage requirement. To
guide HRSA in exercising the discretion consistent with Executive Order 13535. IOM’s recommendation included
afforded to it in section 2713(a)(4) of the That order, issued upon the signing of several contraceptive methods that
PHS Act, the Departments have the Affordable Care Act, specified that many persons and organizations believe
previously promulgated regulations ‘‘longstanding Federal laws to protect are abortifacient—that is, as causing
defining the scope of permissible conscience * * * remain intact,’’ early abortion—and which they
exemptions and accommodations for including laws that protect religious conscientiously oppose for that reason
such guidelines. (45 CFR 147.131). The beliefs (and moral convictions) from
interim final rules set forth herein are a certain requirements in the health care 6 Because section 2713(a)(4) of the PHS Act
necessary and appropriate exercise of context. While the text of Executive specifies that the HRSA Guidelines shall include
Order 13535 does not require the preventive care and screenings ‘‘with respect to
the authority of HHS, of which HRSA is women,’’ the Guidelines exclude services relating to
a component, and of the authority expanded exemptions issued in these a man’s reproductive capacity, such as vasectomies
delegated to the Departments interim final rules, the expanded and condoms.
collectively as administrators of the exemptions are, as explained below, 7 FDA’s guide ‘‘Birth Control: Medicines To Help
consistent with longstanding Federal You,’’ specifies that various approved

statutes. (26 U.S.C. 9833; 29 U.S.C. contraceptives, including Levonorgestrel, Ulipristal
1191c; 42 U.S.C. 300gg–92) laws to protect religious beliefs Acetate, and IUDs, work mainly by preventing
Our interpretation of section fertilization and ‘‘may also work * * * by
5 Kaiser Family Foundation & Health Research & preventing attachment (implantation) to the womb
2713(a)(4) of the PHS Act is confirmed
Educational Trust, ‘‘Employer Health Benefits, 2017 (uterus)’’ of a human embryo after fertilization.
by the Affordable Care Act’s statutory Annual Survey,’’ available at http://files.kff.org/ Available at https://www.fda.gov/forconsumers/
structure. Congress did not intend to attachment/Report-Employer-Health-Benefits- byaudience/forwomen/freepublications/
require entirely uniform coverage of Annual-Survey-2017. ucm313215.htm.
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distinct from whether they also oppose In administering this Mandate, on employers to file any certification form
contraception or sterilization. August 1, 2011, the Departments or comply with any other information
One of the 16 members of the IOM promulgated interim final rules collection process.
committee, Dr. Anthony LoSasso, a amending our 2010 interim final rules Contemporaneous with the issuance
Professor at the University of Illinois at (76 FR 46621) (2011 interim final rules). of the 2012 final regulations, HHS—
Chicago School of Public Health, wrote The 2011 interim final rules specify that with the agreement of the Department of
a formal dissenting opinion. He argued HRSA has the authority to establish Labor (DOL) and the Department of the
that the IOM committee did not have exemptions from the contraceptive Treasury—issued guidance establishing
sufficient time to evaluate fully the coverage requirement for certain group a temporary safe harbor from
evidence on whether the use of health plans established or maintained enforcement of the contraceptive
preventive services beyond those by certain religious employers and for coverage requirement by the
encompassed by the United States health insurance coverage provided in Departments with respect to group
Preventive Services Task Force connection with such plans.9 The 2011 health plans established or maintained
(USPSTF), HRSA’s Bright Futures interim final rules defined an exempt by certain nonprofit organizations with
Project, and the Advisory Committee on ‘‘religious employer’’ narrowly as one religious objections to contraceptive
Immunization Practices (ACIP) leads to that: (1) Had the inculcation of religious coverage (and the group health
lower rates of disability or disease and values as its purpose; (2) primarily insurance coverage provided in
increased rates of well-being. He further employed persons who shared its connection with such plans).12 The
argued that ‘‘the recommendations were religious tenets; (3) primarily served guidance provided that the temporary
made without high quality, systematic persons who shared its religious tenets; safe harbor would remain in effect until
evidence of the preventive nature of the and (4) was a nonprofit organization, as the first plan year beginning on or after
services considered,’’ and that ‘‘the described in section 6033(a)(1) and August 1, 2013. The temporary safe
committee process for evaluation of the (a)(3)(A)(i) or (iii) of the Code. Those harbor did not apply to for-profit
evidence lacked transparency and was relevant sections of the Code include entities. The Departments stated that,
largely subject to the preferences of the only churches, their integrated during the temporary safe harbor, the
committee’s composition. Troublingly, auxiliaries, conventions or associations Departments would engage in
the process tended to result in a mix of of churches, and the exclusively rulemaking to achieve ‘‘two goals—
objective and subjective determinations religious activities of a religious order. providing contraceptive coverage
filtered through a lens of advocacy.’’ Dr. The practical effect of the rules’ without cost-sharing to individuals who
LoSasso also raised concerns that the definition of ‘‘religious employer’’ was want it and accommodating non-
committee did not have time to develop to create potential uncertainty about exempted, nonprofit organizations’
a framework for determining whether whether employers, including many of religious objections to covering
coverage of any given preventive service those houses of worship or their contraceptive services.’’ (77 FR 8727).
leads to a reduction in healthcare integrated auxiliaries, would fail to On March 21, 2012, the Departments
expenditure.8 (IOM 2011 at 231–32). In qualify for the exemption if they published an advance notice of
its response to Dr. LoSasso, the other 15 engaged in outreach activities toward proposed rulemaking (ANPRM) that
committee members stated, in part, that persons who did not share their described possible approaches to
‘‘At the first committee meeting, it was religious tenets.10 As the basis for achieve those goals with respect to
agreed that cost considerations were adopting that limited definition of religious nonprofit organizations, and
outside the scope of the charge, and that solicited public comments on the same.
religious employer, the 2011 interim
the committee should not attempt to (77 FR 16501). Following review of the
final rules stated that they relied on the
duplicate the disparate review processes comments on the ANPRM, the
laws of some ‘‘States that exempt certain
used by other bodies, such as the Departments published proposed
religious employers from having to
USPSTF, ACIP, and Bright Futures. regulations on February 6, 2013 (2013
comply with State law requirements to
HHS, with input from this committee, NPRM) (78 FR 8456).
cover contraceptive services.’’ (76 FR
may consider other factors including The 2013 NPRM proposed to expand
46623). That same day, HRSA exercised
cost in its development of coverage the definition of ‘‘religious employer’’
the discretion described in the 2011
decisions.’’ for purposes of the religious employer
interim final rules to provide the
2. HRSA’s 2011 Guidelines and the exemption.
Departments’ Second Interim Final 12 Guidance on the Temporary Enforcement Safe
Rules 3. The Departments’ Subsequent Harbor for Certain Employers, Group Health Plans,
Rulemaking on the Accommodation and and Group Health Insurance Issuers with Respect to
On August 1, 2011, HRSA released Third Interim Final Rules the Requirement to Cover Contraceptive Services
onto its Web site its Guidelines for Without Cost Sharing Under section 2713 of the
women’s preventive services, adopting Final regulations issued on February Public Health Service Act, Section 715(a)(1) of the
10, 2012, adopted the definition of Employee Retirement Income Security Act, and
the recommendations of the IOM Section 9815(a)(1) of the Internal Revenue Code,
https://www.hrsa.gov/ ‘‘religious employer’’ in the 2011 issued on February 10, 2012, and reissued on
womensguidelines/. The Guidelines interim final rules without modification August 15, 2012. Available at: http://
included coverage for all FDA-approved (2012 final regulations).11 (77 FR 8725). www.lb7.uscourts.gov/documents/12cv3932.pdf.
The exemption did not require religious The guidance, as reissued on August 15, 2012,
contraceptives, sterilization procedures, clarified, among other things, that plans that took
and related patient education and some action before February 10, 2012, to try,
9 The 2011 amended interim final rules were

counseling for women with without success, to exclude or limit contraceptive
issued and effective on August 1, 2011, and coverage were not precluded from eligibility for the
reproductive capacity, as prescribed by published in the Federal Register on August 3, safe harbor. The temporary enforcement safe harbor
a health care provider. 2011 (76 FR 46621). was also available to insured student health
10 See, for example, Comments of the United
insurance coverage arranged by nonprofit
8 The Departments do not relay these dissenting States Conference of Catholic Bishops on Interim institutions of higher education with religious
remarks as an endorsement of the remarks, but to Final Rules on Preventive Services, File Code CMS– objections to contraceptive coverage that met the
describe the history of the Guidelines, which 9992–IFC2 (Aug. 31, 2011). conditions set forth in the guidance. See final rule
includes this part of the report that IOM provided 11 The 2012 final regulations were published on entitled ‘‘Student Health Insurance Coverage’’
to HRSA. February 15, 2012 (77 FR 8725). published March 21, 2012 (77 FR 16457).
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exemption. Specifically, it proposed to The Departments published final bear the cost of such payments,15 and
require only that the religious employer regulations on July 2, 2013 (July 2013 HHS intended to clarify in guidance that
be organized and operate as a nonprofit final regulations) (78 FR 39869). The the issuer could treat those payments as
entity and be referred to in section July 2013 final regulations finalized the an adjustment to claims costs for
6033(a)(3)(A)(i) or (iii) of the Code, expansion of the exemption for houses purposes of medical loss ratio and risk
eliminating the requirements that a of worship and their integrated corridor program calculations.
religious employer (1) have the auxiliaries. Although some commenters With respect to self-insured group
inculcation of religious values as its had suggested that the exemption be health plans, the July 2013 final
purpose, (2) primarily employ persons further expanded, the Departments regulations specified that the self-
who share its religious tenets, and (3) declined to adopt that approach. The certification was an instrument under
primarily serve persons who share its July 2013 regulations stated that, which the plan was operated and that it
religious tenets. because employees of objecting houses obligated the third party administrator
of worship and integrated auxiliaries are to provide or arrange for contraceptive
The 2013 NPRM also proposed to coverage by operation of section 3(16) of
create a compliance process, which it relatively likely to oppose
contraception, exempting those ERISA. The regulations stated that, by
called an accommodation, for group submitting the self-certification form,
health plans established, maintained, or organizations ‘‘does not undermine the
governmental interests furthered by the the eligible organization ‘‘complies’’
arranged by certain eligible religious with the contraceptive coverage
nonprofit organizations that fell outside contraceptive coverage requirement.’’
(78 FR 39874). But, like the 2013 NPRM, requirement and does not have to
the houses of worship and integrated contract, arrange, pay, or refer for
auxiliaries covered by section the July 2013 regulations assumed that
‘‘[h]ouses of worship and their contraceptive coverage. See, for
6033(a)(3)(A)(i) or (iii) of the Code (and, example, Id. at 39874, 39896. Consistent
thus, outside of the religious employer integrated auxiliaries that object to
contraceptive coverage on religious with these statements, the Departments,
exemption). The 2013 NPRM proposed through the Department of Labor, issued
to define such eligible organizations as grounds are more likely than other
employers to employ people of the same a self-certification form, EBSA Form
nonprofit entities that hold themselves 700. The form stated, in indented text
out as religious, oppose providing faith who share the same objection’’ to
contraceptives (Id.). labeled as a ‘‘Notice to Third Party
coverage for certain contraceptive items Administrators of Self-Insured Health
on account of religious objections, and The July 2013 regulations also Plans,’’ that ‘‘[t]he obligations of the
maintain a certification to this effect in finalized an accommodation for eligible third party administrator are set forth in
their records. The 2013 NPRM stated, organizations. Under the 26 CFR 54.9815–2713A, 29 CFR 2510.3–
without citing a supporting source, that accommodation, an eligible organization 16, and 29 CFR 2590.715–2713A’’ and
employees of eligible organizations was required to submit a self- concluded, in unindented text, that
‘‘may be less likely than’’ employees of certification to its group health ‘‘[t]his form is an instrument under
exempt houses of worship and insurance issuer or third party which the plan is operated.’’
integrated auxiliaries to share their administrator, as applicable. Upon The Departments extended the
employer’s faith and opposition to receiving that self-certification, the temporary safe harbor again on June 20,
contraception on religious grounds. (78 issuer or third party administrator 2013, to encompass plan years
FR 8461). The 2013 NPRM therefore would provide or arrange for payments beginning on or after August 1, 2013,
proposed that, in the case of an insured for the contraceptive services to the plan and before January 1, 2014. The
group health plan established or participants and beneficiaries enrolled guidance extending the safe harbor
maintained by an eligible organization, in the eligible organization’s plan, included a form to be used by an
the health insurance issuer providing without requiring any cost sharing on organization during this temporary
group health insurance coverage in the part of plan participants and period to self-certify that its plan
connection with the plan would provide beneficiaries and without cost to the qualified for the temporary safe harbor
contraceptive coverage to plan eligible organization. With respect to if no prior form had been submitted.
participants and beneficiaries without self-insured plans, the third party
cost sharing, premium, fee, or other administrators (or issuers they 4. Litigation Over the Mandate and the
charge to plan participants or contracted with) could receive Accommodation Process
beneficiaries enrolled in the eligible reimbursements by reducing user fee During the period when the
organization’s plan—and without any payments (to Federally facilitated Departments were publishing and
cost to the eligible organization.13 In the Exchanges) by the amounts paid out for modifying our regulations, organizations
case of a self-insured group health plan contraceptive services under the and individuals filed dozens of lawsuits
established or maintained by an eligible accommodation, plus an allowance for challenging the Mandate. Plaintiffs
organization, the 2013 NPRM presented certain administrative costs, as long as included religious nonprofit
potential approaches under which the the Secretary of the Department of organizations, businesses run by
third party administrator of the plan Health and Human Services requests religious families, individuals, and
would provide or arrange for and an authorizing exception under others. Religious plaintiffs principally
contraceptive coverage to plan OMB Circular No. A–25R is in effect.14 argued that the Mandate violated the
participants and beneficiaries. With respect to fully insured group Religious Freedom Restoration Act of
On August 15, 2012, the Departments health plans, the issuer was expected to 1993 (RFRA) by forcing them to provide
also extended our temporary safe harbor coverage or payments for sterilization
until the first plan year beginning on or 14 See also 45 CFR 156.50. Under the regulations, and contraceptive services, including
after August 1, 2013. if the third party administrator does not participate what they viewed as early abortifacient
in a Federally facilitated Exchange as an issuer, it items, contrary to their religious beliefs.
is permitted to contract with an insurer which does
13 The NPRM proposed to treat student health so participate, in order to obtain such Based on this claim, in July 2012 a
insurance coverage arranged by eligible reimbursement. The total contraceptive user fee
organizations that are institutions of higher adjustment for the 2015 benefit year was $33 15 ‘‘[P]roviding payments for contraceptive
education in a similar manner. million. services is cost neutral for issuers.’’ (78 FR 39877).
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Federal district court issued a the compelling interest test of RFRA, the appeal from the Unites States Supreme
preliminary injunction barring the Departments could not rely on interests Court on June 30, 2014. On July 3, 2014,
Departments from enforcing the ‘‘couched in very broad terms, such as the Supreme Court issued an interim
Mandate against a family-owned promoting ‘public health’ and ‘gender order in favor of the College, stating
business. Newland v. Sebelius, 881 F. equality,’ but rather, had to demonstrate that, ‘‘[i]f the [plaintiff] informs the
Supp. 2d. 1287 (D. Colo. 2012). Multiple that a compelling interest was served by Secretary of Health and Human Services
other courts proceeded to issue similar refusing an exemption to the ‘‘particular in writing that it is a nonprofit
injunctions against the Mandate, claimant[s]’’ seeking an exemption. Id. organization that holds itself out as
although a minority of courts ruled in at 2779. Assuming without deciding religious and has religious objections to
the Departments’ favor. Compare that a compelling interest existed, the providing coverage for contraceptive
Tyndale House Publishers, Inc. v. Court held that the Government’s goal of services, the [Departments of Labor,
Sebelius, 904 F. Supp. 2d 106 (D.D.C. guaranteeing coverage for contraceptive Health and Human Services, and the
2012), and The Seneca Hardwood methods without cost sharing could be Treasury] are enjoined from enforcing
Lumber Company, Inc. v. Sebelius (sub achieved in a less restrictive manner. [the Mandate] against the [plaintiff] . . .
nom Geneva Coll. v. Sebelius), 941 F. The Court observed that ‘‘[t]he most pending final disposition of appellate
Supp. 2d 672 (W.D. Pa. 2013), with straightforward way of doing this would review.’’ Wheaton College v. Burwell.
O’Brien v. U.S. Dep’t of Health & be for the Government to assume the 134 S. Ct. 2806, 2807 (2014). The order
Human Servs., 894 F. Supp. 2d 1149 cost of providing the four contraceptives stated that Wheaton College did not
(E.D. Mo. 2012). at issue to any women who are unable need to use EBSA Form 700 or send a
A circuit split swiftly developed in to obtain them under their health- copy of the executed form to its health
cases filed by religiously motivated for- insurance policies due to their insurance issuers or third party
profit businesses, to which neither the employers’ religious objections.’’ Id. at administrators to meet the condition for
religious employer exemption nor the 2780. The Court also observed that the injunctive relief. Id.
eligible organization accommodation (as Departments had ‘‘not provided any In response to this litigation, on
then promulgated) applied. Several for- estimate of the average cost per August 27, 2014, the Departments
profit businesses won rulings against employee of providing access to these simultaneously issued a third set of
the Mandate before the Unites States contraceptives,’’ nor ‘‘any statistics interim final rules (August 2014 interim
Court of Appeals for the Tenth Circuit, regarding the number of employees who final rules) (79 FR 51092), and a notice
sitting en banc, while similar rulings might be affected because they work for of proposed rulemaking (August 2014
against the Departments were issued by corporations like Hobby Lobby, proposed rules) (79 FR 51118). The
the Seventh and District of Columbia Conestoga, and Mardel’’. Id. at 2780–81. August 2014 interim final rules changed
(DC) Circuits. Hobby Lobby Stores, Inc. But the Court ultimately concluded that the accommodation process so that it
v. Sebelius, 723 F.3d 1114 (10th Cir. it ‘‘need not rely on the option of a new, could be initiated either by self-
2013); Korte v. Sebelius, 735 F.3d 654 government-funded program in order to certification using EBSA Form 700 or
(7th Cir. 2013); Gilardi v. U.S. Dep’t of conclude that the HHS regulations fail through a notice informing the Secretary
Health & Human Servs., 733 F.3d 1208 the least-restrictive means test’’ because of the Department of Health and Human
(D.C. Cir. 2013). The Third and Sixth ‘‘HHS itself ha[d] demonstrated that it Services that an eligible organization
Circuits disagreed with similar ha[d] at its disposal an approach that is had religious objections to coverage of
plaintiffs, and in November 2013 the all or a subset of contraceptive services.
less restrictive than requiring employers
U.S. Supreme Court granted certiorari in (79 FR 51092). In response to Hobby
to fund contraceptive methods that
Hobby Lobby and Conestoga Wood Lobby, the August 2014 proposed rules
violate their religious beliefs.’’ Id. at
Specialties Corp. v. Secretary of U.S. extended the accommodation process to
2781–82. The Court explained that the
Department of Health & Human closely held for-profit entities with
‘‘already established’’ accommodation
Services, 724 F.3d 377 (3d Cir. 2013), to religious objections to contraceptive
process available to nonprofit
resolve the circuit split. coverage, by including them in the
organizations was a less-restrictive
On June 30, 2014, the Supreme Court definition of eligible organizations. (79
alternative that ‘‘serve[d] HHS’s stated
ruled against the Departments and held FR 51118). Neither the August 2014
interests equally well,’’ although the
that, under RFRA, the Mandate could interim final rules nor the August 2014
Court emphasized that its ruling did not proposed rules extended the exemption,
not be applied to the closely held for- decide whether the accommodation
profit corporations before the Court and neither added a certification
process ‘‘complie[d] with RFRA for requirement for exempt entities.
because their owners had religious purposes of all religious claims’’. Id. at
objections to providing such In October 2014, based on an
2788–82. interpretation of the Supreme Court’s
coverage.16 Burwell v. Hobby Lobby
Meanwhile, another plaintiff obtained interim order, HHS deemed Wheaton
Stores, Inc. 134 S. Ct. 2751 (2014). The
temporary relief from the Supreme College as having submitted a sufficient
Court held that the ‘‘contraceptive
Court in a case challenging the notice to HHS. HHS conveyed that
mandate ‘substantially burdens’ the
accommodation under RFRA. Wheaton interpretation to the DOL, so as to
exercise of religion’’ as applied to
College, a Christian liberal arts college trigger the accommodation process.
employers that object to providing
in Illinois, objected that the On July 14, 2015, the Departments
contraceptive coverage on religious
accommodation was a compliance finalized both the August 2014 interim
grounds, and that the plaintiffs were
process that rendered it complicit in final rules and the August 2014
therefore entitled to an exemption
delivering payments for abortifacient proposed rules in a set of final

unless the Mandate was the least
contraceptive services to its employees. regulations (the July 2015 final
restrictive means of furthering a
Wheaton College refused to execute the regulations) (80 FR 41318). (The July
compelling governmental interest. Id. at
EBSA Form 700 required under the July 2015 final regulations also encompassed
2775. The Court observed that, under
2013 final regulations. It was denied a issues related to other preventive
16 The Supreme Court did not decide whether preliminary injunction in the Federal services coverage.) The preamble to the
RFRA would apply to publicly traded for-profit district and appellate courts, and sought July 2015 final regulations stated that,
corporations. See 134 S. Ct. at 2774. an emergency injunction pending through the accommodation, payments
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for contraceptives and sterilization religious grounds. They objected to the After remand, as indicated by the
would be provided in a way that is self-certification requirement on the Departments in court filings, some
‘‘seamless’’ with the coverage that same basis. Federal district courts split meetings were held between attorneys
eligible employers provide to their plan in the cases, granting preliminary for the Government and for the plaintiffs
participants and beneficiaries. Id. at injunction motions to religious groups in those cases. Separately, at various
41328. The July 2015 final regulations in the majority of cases, but denying times after the Supreme Court’s remand
allowed eligible organizations to submit them to others. In most appellate cases, order, HHS and DOL sent letters to the
a notice to HHS as an alternative to religious nonprofit organizations lost issuers and third party administrators of
submitting the EBSA Form 700, but their challenges, where the courts often certain plaintiffs in Zubik and other
specified that such notice must include concluded that the accommodation pending cases, directing the issuers and
the eligible organization’s name and an imposed no substantial burden on their third party administrators to provide
expression of its religious objection, religious exercise under RFRA. For contraceptive coverage for participants
along with the plan name, plan type, example, Priests for Life v. U.S. Dep’t of in those plaintiffs’ group health plans
and name and contact information for Health and Human Servs., 772 F. 3d 229 under the accommodation. The
any of the plan’s third party (D.C. Cir. 2014); Little Sisters of the Poor Departments also issued a Request for
administrators or health insurance Home for the Aged v. Burwell, 794 F.3d Information (RFI) on July 26, 2016,
issuers. The Departments indicated that 1151 (10th Cir. 2015); Geneva Coll. v. seeking public comment on options for
such information represents the Sec’y U.S. Dep’t of Health & Human modifying the accommodation process
minimum information necessary for us Servs., 778 F.3d 422 (3d Cir. 2015). But in light of the supplemental briefing in
to administer the accommodation the Eighth Circuit disagreed and ruled Zubik and the Supreme Court’s remand
process. in favor of religious nonprofit order. (81 FR 47741). Public comments
When an eligible organization employers. Dordt College v. Burwell, were submitted in response to the RFI,
maintains an insured group health plan 801 F.3d 946, 949–50 (8th Cir. 2015) during a comment period that closed on
or student health plan and provides the (relying on Sharpe Holdings, Inc. v. U.S. September 20, 2016.
alternative notice, the July 2015 final Dep’t of Health & Human Servs., 801 On December 20, 2016, HRSA
regulations provide that HHS will F.3d 927 (8th Cir. 2015)). updated the Guidelines via its Web site,
inform the health insurance issuer of its On November 6, 2015, the U.S. https://www.hrsa.gov/
obligations to cover contraceptive Supreme Court granted certiorari in womensguidelines2016/index.html.
services to which the eligible seven similar cases under the title of a HRSA announced that, for plans subject
organization objects. Where an eligible to the Guidelines, the updated
filing from the Third Circuit, Zubik v.
organization maintains a self-insured Guidelines would apply to the first plan
Burwell. The Court held oral argument
plan under ERISA and provides the year beginning after December 20, 2017.
on March 23, 2016, and, after the
alternative notice, the regulations Among other changes, the updated
argument, asked the parties to submit
provide that DOL will work with HHS Guidelines specified that the required
supplemental briefs addressing
to send a separate notification to the contraceptive coverage includes follow-
‘‘whether and how contraceptive
self-insured plan’s third party up care (for example, management and
coverage may be obtained by
administrator(s). The regulations further evaluation, as well as changes to, and
petitioners’ employees through
provide that such notification is an removal or discontinuation of, the
petitioners’ insurance companies, but in
instrument under which the plan is contraceptive method). They also
operated for the purposes of section a way that does not require any
involvement of petitioners beyond their specified that coverage should include
3(16) of ERISA, and the instrument
own decision to provide health instruction in fertility awareness-based
would designate the third party
insurance without contraceptive methods for women desiring an
administrator as the entity obligated to
coverage to their employees’’. In a brief alternative method of family planning.
provide or arrange for payments for
filed with the Supreme Court on April HRSA stated that, with the input of a
contraceptives to which the eligible
12, 2016, the Government stated on committee operating under a
organization objects. The July 2015 final
behalf of the Departments that the cooperative agreement, HRSA would
regulations continue to apply the
accommodation process for eligible review and periodically update the
amended notice requirement to eligible
organizations with insured plans could Women’s Preventive Services’
organizations that sponsor church plans
operate without any self-certification or Guidelines. The updated Guidelines did
exempt from ERISA pursuant to section
4(b)(2) of ERISA, but acknowledge that, written notice being submitted by not alter the religious employer
with respect to the operation of the eligible organizations. exemption or accommodation process.
accommodation process, section 3(16) of On May 16, 2016, the Supreme Court On January 9, 2017, the Departments
ERISA does not provide a mechanism to issued a per curiam opinion in Zubik, issued a document entitled, ‘‘FAQs
impose an obligation to provide vacating the judgments of the Courts of About Affordable Care Act
contraceptive coverage as a plan Appeals and remanding the cases ‘‘in Implementation Part 36’’ (FAQ).17 The
administrator on those eligible light of the substantial clarification and FAQ stated that, after reviewing
organizations’ third party refinement in the positions of the comments submitted in response to the
administrators. (80 FR 41323). parties’’ in their supplemental briefs. 2016 RFI and considering various
Meanwhile, a second split among (136 S. Ct. 1557, 1560 (2016).) The Court options, the Departments could not find
Federal appeals courts had developed stated that it anticipated that, on a way at that time to amend the
involving challenges to the Mandate’s remand, the Courts of Appeals would accommodation so as to satisfy objecting
accommodation. Many religious ‘‘allow the parties sufficient time to eligible organizations while pursuing
nonprofit organizations argued that the resolve any outstanding issues between the Departments’ policy goals. Thus, the
accommodation impermissibly them.’’ Id. The Court also specified that
17 Available at: https://www.dol.gov/sites/default/
burdened their religious beliefs because ‘‘the Government may not impose taxes
files/ebsa/about-ebsa/our-activities/resource-center/
it utilized the plans the organizations or penalties on petitioners for failure to faqs/aca-part-36.pdf and https://www.cms.gov/
themselves sponsored to provide provide the relevant notice’’ while the CCIIO/Resources/Fact-Sheets-and-FAQs/
services to which they objected on cases remained pending. Id. at 1561. Downloads/ACA-FAQs-Part36_1-9-17-Final.pdf.
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litigation on remand from the Supreme furtherance of a compelling under section 2713(a)(4) of the PHS to
Court remains unresolved. governmental interest; and (2) is the provide an exemption from the Mandate
A separate category of unresolved least restrictive means of furthering that to a broader range of entities and
litigation involved religious employees compelling governmental interest.’’ 42 individuals that object to contraceptive
as plaintiffs. For example, in two cases, U.S.C. 2000bb–1(a) and (b). In Hobby coverage on religious grounds, while
the plaintiff-employees work for a Lobby, the Supreme Court had ‘‘little continuing to offer the existing
nonprofit organization that agrees with trouble concluding’’ that, in the absence accommodation as an optional
the employees (on moral grounds) in of an accommodation or exemption, alternative. The Departments have also
opposing coverage of certain ‘‘the HHS contraceptive mandate decided to create a process by which a
contraceptives they believe to be ‘substantially burden[s]’ the exercise of willing employer and issuer may allow
abortifacient, and that is willing to offer religion. 42 U.S.C. 2000bb–1(a).’’ 134 S. an objecting individual employee to
them insurance coverage that omits Ct. at 2775. And although the Supreme obtain health coverage without
such services. See March for Life v. Court did not resolve the RFRA claims contraceptive coverage. These interim
Burwell, 128 F. Supp. 3d 116 (D.D.C. presented in Zubik on their merits, it final rules leave unchanged HRSA’s
2015); Real Alternatives, 150 F. Supp. instructed the parties to consider authority to decide whether to include
3d 419, affirmed by 867 F.3d 338 (3d alternative accommodations for the contraceptives in the women’s
Cir. 2017). In another case, the plaintiff- objecting plaintiffs, after the preventive services Guidelines for
employees work for a State government Government suggested that such entities that are not exempted by law,
entity that the employees claim is alternatives might be possible. regulation, or the Guidelines. These
willing, under State law, to provide a Despite multiple rounds of rules also do not change the many other
plan omitting contraception consistent rulemaking, however, the Departments mechanisms by which the Government
with the employees’ religious beliefs. have not assuaged the sincere religious advances contraceptive coverage,
See Wieland v. HHS, 196 F. Supp. 3d objections to contraceptive coverage of particularly for low-income women.
1010 (E.D. Mo. 2016). Those and similar numerous organizations, nor have we In addition to relying on the text of
employee-plaintiffs generally contend resolved the pending litigation. To the section 2713(a)(4) of the PHS Act and
that the Mandate violates their rights contrary, the Departments have been the Departments’ discretion to
under RFRA by making it impossible for litigating RFRA challenges to the promulgate rules to carry out the
them to obtain health insurance Mandate and related regulations for provisions of the PHS Act, the
consistent with their religious beliefs, more than 5 years, and dozens of those Departments also draw on Congress’
either from their willing employer or in challenges remain pending today. That decision in the Affordable Care Act
the individual market, because the litigation, and the related modifications neither to specify that contraception
Departments offer no exemptions to the accommodation, have consumed must be covered nor to require
encompassing either circumstance. substantial governmental resources inflexible across-the-board application
Such challenges have seen mixed while creating uncertainty for objecting of section 2713 of the PHS Act. The
success. Compare, for example, organizations, issuers, third party Departments further consider Congress’
Wieland, 196 F. Supp. 3d at 1020 administrators, employees, and extensive history of protecting religious
(concluding that the Mandate violates beneficiaries. Consistent with the objections when certain matters in
the employee plaintiffs’ rights under President’s Executive Order and the health care are specifically regulated—
RFRA and permanently enjoining the Government’s desire to resolve the often specifically with respect to
Departments) and March for Life, 128 F. pending litigation and prevent future contraception, sterilization, abortion,
Supp. 3d at 133–34 (same), with Real litigation from similar plaintiffs, the and activities connected to abortion.
Alternatives, 2017 WL 3324690 at *18 Departments have concluded that it is Notable among the many statutes
(affirming dismissal of employee appropriate to reexamine the exemption (listed in footnote 1 in Section I-
plaintiffs’ RFRA claim). and accommodation scheme currently Background) that include protections for
On May 4, 2017, the President issued in place for the Mandate. religious beliefs are, not only the
an ‘‘Executive Order Promoting Free These interim final rules (and the Church Amendments, but also
Speech and Religious Liberty.’’ companion interim final rules published protections for health plans or health
Regarding ‘‘Conscience Protections with elsewhere in this Federal Register) are care organizations in Medicaid or
Respect to Preventive-Care Mandate,’’ the result of that reexamination. The Medicare Advantage to object ‘‘on moral
that order instructs ‘‘[t]he Secretary of Departments acknowledge that coverage or religious grounds’’ to providing
the Treasury, the Secretary of Labor, and of contraception is an important and coverage of certain counseling or
the Secretary of Health and Human highly sensitive issue, implicating many referral services. (42 U.S.C. 1395w–
Services [to] consider issuing amended different views, as reflected in the 22(j)(3)(B); 42 U.S.C. 1396u–2(b)(3)). In
regulations, consistent with applicable comments received on multiple addition, Congress has protected
law, to address conscience-based rulemakings over the course of individuals who object to prescribing or
objections to the preventive-care implementation of section 2713(a)(4) of providing contraceptives contrary to
mandate promulgated under section the PHS Act. After reconsidering the their religious beliefs. Consolidated
300gg–13(a)(4) of title 42, United States interests served by the Mandate in this Appropriations Act of 2017, Division C,
Code.’’ particular context, the objections raised, Title VII, Sec. 726(c) (Financial Services
and the applicable Federal law, the and General Government
II. RFRA and Government Interests Departments have determined that an Appropriations Act), Public Law 115–31
Underlying the Mandate expanded exemption, rather than the (May 5, 2017). Congress likewise
RFRA provides that the Government existing accommodation, is the most provided that, if the District of
‘‘shall not substantially burden a appropriate administrative response to Columbia requires ‘‘the provision of
person’s exercise of religion even if the the religious objections raised by certain contraceptive coverage by health
burden results from a rule of general entities and organizations concerning insurance plans,’’ ‘‘it is the intent of
applicability’’ unless the Government the Mandate. The Departments have Congress that any legislation enacted on
‘‘demonstrates that application of the accordingly decided to revise the such issue should include a ‘conscience
burden to the person—(1) is in regulations channeling HRSA authority clause’ which provides exceptions for
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religious beliefs and moral convictions’’. choose between the Mandate, the relevant interests, as well as by our
Id. at Division C, Title VIII, Sec. 808. In accommodation, or penalties for desire to bring to a close the more than
light of the fact that Congress did not noncompliance imposes a substantial 5 years of litigation over RFRA
require HRSA to include contraception burden on religious exercise under challenges to the Mandate, the
in Guidelines issued under section 2713 RFRA. We believe that the Court’s Departments have determined that the
of the PHS Act, we consider it analysis in Hobby Lobby extends, for the appropriate administrative response is
significant, in support of the purposes of analyzing a substantial to create a broader exemption, rather
implementation of those Guidelines by burden, to the burdens that an entity than simply adjusting the
the expanded exemption in these faces when it religiously opposes accommodation process.
interim final rules, that Congress’ most participating in the accommodation RFRA requires the Government to
recent statement on the prospect of process or the straightforward Mandate, respect religious beliefs under ‘‘the most
Government mandated contraceptive and is subject to penalties or demanding test known to constitutional
coverage was to express the specific disadvantages that apply in this context law’’: Where the Government imposes a
intent that a conscience clause be if it chooses neither. As the Eighth substantial burden on religious exercise,
provided and that it should protect Circuit stated in Sharpe Holdings, ‘‘[i]n it must demonstrate a compelling
religious beliefs. light of [nonprofit religious governmental interest and show that the
The Departments’ authority to guide organizations’] sincerely held religious law or requirement is the least
HRSA’s discretion in determining the beliefs, we conclude that compelling restrictive means of furthering that
scope of any contraceptive coverage their participation in the interest. City of Boerne v. Flores, 521
requirement under section 2713(a)(4) of accommodation process by threat of U.S. 507, 534 (1997). For an interest to
the PHS Act includes the authority to severe monetary penalty is a substantial be compelling, its rank must be of the
provide exemptions and independently burden on their exercise of religion. . . . ‘‘highest order’’. Church of the Lukumi
justifies this rulemaking. The That they themselves do not have to Babalu Aye, Inc. v. City of Hialeah, 508
Departments have also determined that arrange or pay for objectionable U.S. 520, 546 (1993); see also Sherbert
requiring certain objecting entities or contraceptive coverage is not v. Verner, 374 U.S. 398, 406–09 (1963);
individuals to choose between the determinative of whether the required Wisconsin v. Yoder, 406 U.S. 205, 221–
Mandate, the accommodation, or or forbidden act is or is not religiously 29 (1972). In applying RFRA, the
penalties for noncompliance violates offensive’’. (801 F.3d at 942.) Supreme Court has ‘‘looked beyond
their rights under RFRA. Our reconsideration of these issues broadly formulated interests justifying
has also led us to conclude, consistent the general applicability of government
A. Elements of RFRA with the rulings in favor of religious mandates and scrutinized the asserted
1. Substantial Burden employee plaintiffs in Wieland and harm of granting specific exemptions to
March for Life cited above, that the particular religious claimants.’’
The Departments believe that agencies Mandate imposes a substantial burden Gonzales v. O Centro Espirita
charged with administering a statute or on the religious beliefs of individual Beneficente Uniao do Vegetal, 546 U.S.
associated regulations or guidance that employees who oppose contraceptive 418, 431 (2006). To justify a substantial
imposes a substantial burden on the coverage and would be able to obtain a burden on religious exercise under
exercise of religion under RFRA have plan that omits contraception from a RFRA, the Government must show it
discretion in determining how to avoid willing employer or issuer (as has a compelling interest in applying
the imposition of such burden. The applicable), but cannot obtain one solely the requirement to the ‘‘particular
Departments have previously contended because of the Mandate’s prohibition on claimant[s] whose sincere exercise of
that the Mandate does not impose a that employer and/or issuer providing religion is being substantially
substantial burden on entities and them with such a plan. burdened.’’ Id. at 430–31. Moreover, the
individuals. With respect to the Consistent with our conclusion earlier Government must meet the
coverage Mandate itself, apart from the this year after the remand of cases in ‘‘exceptionally demanding’’ least-
accommodation, and as applied to Zubik and our reviewing of comments restrictive-means standard. Hobby
entities with religious objections, our submitted in response to the 2016 RFI, Lobby, 134 S. Ct. at 2780. Under that
argument was rejected in Hobby Lobby, the Departments believe there is not a standard, the Government must
which held that the Mandate imposes a way to satisfy all religious objections by establish that ‘‘it lacks other means of
substantial burden. (134 S. Ct. at 2775– amending the accommodation. achieving its desired goal without
79.) With respect to whether the Accordingly, the Departments have imposing a substantial burden on the
Mandate imposes a substantial burden decided it is necessary and appropriate exercise of religion by the objecting
on entities that may choose the to provide the expanded exemptions set parties.’’ Id.
accommodation, but must choose forth herein. Upon further examination of the
between the accommodation, the relevant provisions of the Affordable
Mandate, or penalties for 2. Compelling Interest Care Act and the administrative record
noncompliance, a majority of Federal Although the Departments previously on which the Mandate was based, the
appeals courts have held that the took the position that the application of Departments have concluded that the
accommodation does not impose a the Mandate to certain objecting application of the Mandate to entities
substantial burden on such entities employers was necessary to serve a with sincerely held religious objections
(mostly religious nonprofit entities). compelling governmental interest, the to it does not serve a compelling
The Departments have reevaluated Departments have now concluded, after governmental interest. The Departments
our position on this question, however, reassessing the relevant interests and for have reached that conclusion for
in light of all the arguments made in the reasons stated below, that it does multiple reasons, no one of which is
various cases, public comments that not. Under such circumstances, the dispositive.
have been submitted, and the concerns Departments are required by law to First, Congress did not mandate that
discussed throughout these rules. We alleviate the substantial burden created contraception be covered at all under
have concluded that requiring certain by the Mandate. Here, informed by the the Affordable Care Act. Instead,
objecting entities or individuals to Departments’ reassessment of the Congress merely provided for coverage
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of ‘‘such additional preventive care and Third, various entities that brought but not as they pertain to church plans
screenings’’ for women ‘‘provided for in legal challenges to the Mandate that do not provide coverage through a
comprehensive guidelines supported by (including some of the largest policy issued by a health insurance
[HRSA].’’ Congress, thus, left the employers) have been willing to provide issuer. The combined result of PHS Act
identification of any additional required coverage of some, though not all, section 2713’s authority to remove
preventive services for women to contraceptives. For example, the contraceptive coverage obligations from
administrative discretion. The fact that plaintiffs in Hobby Lobby were willing self-insured church plans, and HHS’s
Congress granted the Departments the to provide coverage with no cost sharing and DOL’s lack of authority under the
authority to promulgate all rules of 14 of 18 FDA-approved women’s PHS Act or ERISA to require TPAs to
appropriate and necessary for the contraceptive and sterilization methods. become administrators of those plans to
administration of the relevant (134 S. Ct. at 2766.) With respect to provide such coverage, has led to
provisions of the Code, ERISA, and the organizations and entities holding those significant incongruity in the
PHS Act, including by channeling the beliefs, the fact that they are willing to requirement to provide contraceptive
discretion Congress afforded to HRSA to provide coverage for various coverage among nonprofit organizations
decide whether to require contraceptive contraceptive methods significantly with religious objections to the
coverage, indicates that the detracts from the government interest in coverage.
Departments’ judgment should carry requiring that they provide coverage for More specifically, issuers and third
particular weight in considering the other contraceptive methods to which party administrators for some, but not
relative importance of the Government’s they object. all, religious nonprofit organizations are
interest in applying the Mandate to the subject to enforcement for failure to
Fourth, the case for a compelling
narrow population of entities exempted provide contraceptive coverage under
interest is undermined by the existing
in these rules. the accommodation, depending on
accommodation process, and how it
whether they participate in a self-
Second, while Congress specified that applies to certain similarly situated
insured church plan. Notably, many of
many health insurance requirements entities based on whether or not they
those nonprofit organizations are not
added by the Affordable Care Act— participate in certain self-insured group
houses of worship or integrated
including provisions adjacent to section health plans, known as church plans,
auxiliaries. Under section 3(33)(C)(iv) of
2713 of the PHS Act—were so important under applicable law. The Departments
ERISA, many organizations in self-
that they needed to be applied to all previously exempted eligible insured church plans need not be
health plans immediately, the organizations from the contraceptive churches, but can merely ‘‘share[]
preventive services requirement in coverage requirement, and created an common religious bonds and
section 2713 of the PHS Act was not accommodation under which those convictions with [a] church or
made applicable to ‘‘grandfathered organizations bore no obligation to convention or association of churches’’.
plans.’’ That feature of the Affordable provide for such coverage after The effect is that many similar religious
Care Act is significant: As cited above, submitting a self-certification or notice. organizations are being treated very
seven years after the Affordable Care Where a non-exempt religious differently with respect to their
Act’s enactment, approximately 25.5 organization uses an insured group employees receiving contraceptive
million people are estimated to be health plan instead of a self-insured coverage—depending on whether the
enrolled in grandfathered plans not church plan, the health insurance issuer organization is part of a church plan—
subject to section 2713 of the PHS Act. would be obliged to provide even though the Departments claimed a
We do not suggest that a requirement contraceptive coverage or payments to compelling interest to deny exemptions
that is inapplicable to grandfathered the plan’s participants under the to all such organizations. In this context,
plans or otherwise subject to exceptions accommodation. Even in a self-insured the fact that the Mandate and the
could never qualify as a serving a church plan context, the preventive Departments’ application thereof
compelling interest under RFRA. For services requirement in section ‘‘leaves appreciable damage to [their]
example, ‘‘[e]ven a compelling interest 2713(a)(4) of the PHS Act applies to the supposedly vital interest unprohibited’’
may be outweighed in some plan, and through the Code, to the is strong evidence that the Mandate
circumstances by another even religious organization that sponsors the ‘‘cannot be regarded as protecting an
weightier consideration.’’ Hobby Lobby, plan. But under the accommodation, interest ‘of the highest order.’ ’’ Lukumi,
134 S. Ct. at 2780. But Congress’ once a self-insured church plan files a 508 U.S. at 520 (citation and quotation
decision not to apply section 2713 of the self-certification or notice, the marks omitted).
PHS Act to grandfathered plans, while accommodation relieves it of any further Fifth, the Departments’ previous
deeming other requirements closely obligation with respect to contraceptive assertion that the exemption for houses
associated in the same statute as services coverage. Having done so, the of worship was offered to respect a
sufficiently important to impose accommodation process would certain sphere of church autonomy (80
immediately, is relevant to our normally transfer the obligation to FR 41325) does not adequately explain
assessment of the importance of the provide or arrange for contraceptive some of the disparate results of the
Government interests served by the coverage to a self-insured plan’s third existing rules. And the desire to respect
Mandate. As the Departments observed party administrator (TPA). But the church autonomy is not grounds to
in 2010, those immediately applicable Departments lack authority to compel prevent the Departments from
requirements were ‘‘particularly church plan TPAs to provide expanding the exemption to other
significant.’’ (75 FR 34540). Congress’ contraceptive coverage or levy fines religious entities. The Departments
decision to leave section 2713 out of against those TPAs for failing to provide previously treated religious
that category informs the Departments’ it. This is because church plans are organizations that operate in a similar
assessment of the weight of the exempt from ERISA pursuant to section fashion very differently for the purposes
Government’s interest in applying the 4(b)(2) of ERISA. Section 2761(a) of the of the Mandate. For example, the
Guidelines issued pursuant to section PHS Act provides that States may Departments exempted houses of
2713 of the PHS Act to religious enforce the provisions of title XXVII of worship and integrated auxiliaries that
objectors. the PHS Act as they pertain to issuers, may conduct activities, such as the
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operating of schools, that are also requirement that they provide items.19 The Departments recognize, of
conducted by non-exempt religious contraceptive coverage to their plan course, that not all of the plaintiffs
nonprofit organizations. Likewise, participants and beneficiaries. challenging the accommodation require
among religious nonprofit groups that After considering the differential all of their employees (or covered
were not exempt as houses of worship treatment of various religious nonprofit students) to share their religious
or integrated auxiliaries, many operate organizations under the previous objections to contraceptives. At the
their religious activities similarly even if accommodation, the Departments same time, it has become apparent from
they differ in whether they participate conclude that it is appropriate to public comments and from court filings
in self-insured church plans. As another expand the exemption to other religious in dozens of cases—encompassing
example, two religious colleges might nonprofit organizations with sincerely hundreds of organizations—that many
have the same level of religiosity and held religious beliefs opposed to religious nonprofit organizations
commitment to defined ideals, but one contraceptive coverage. We also express their beliefs publicly and hold
might identify with a specific large conclude that it is not appropriate to themselves out as organizations for
denomination and choose to be in a self- limit the scope of a religious exemption whom their religious beliefs are vitally
insured church plan offered by that by relying upon a small minority of important. Employees of such
denomination, while another might not State laws that contain narrow organizations, even if not required to
be so associated or might not have as exemptions that focus on houses of sign a statement of faith, often have
ready access to a church plan and so worship and integrated auxiliaries. (76 access to, and knowledge of, the views
might offer its employees a fully insured FR 46623.) of their employers on contraceptive
health plan. Under the accommodation, Sixth, the Government’s interest in coverage, whether through the
employees of the college using a fully ensuring contraceptive coverage for organization’s published mission
insured plan (or a self-insured plan that employees of particular objecting statement or statement of beliefs,
is not a church plan) would receive employers is undermined by the through employee benefits disclosures
coverage of contraceptive services characteristics of many of those and other communications with
without cost sharing, while employees employers, especially nonprofit employees and prospective employees,
of the college participating in the self- employers. The plaintiffs challenging or through publicly filed lawsuits
insured church plan would not receive the existing accommodation include, objecting to providing such coverage
the coverage where that plan required among other organizations, religious and attendant media coverage. In many
its third party administrator to not offer colleges and universities, and religious cases, the employees of religious
the coverage. orders that provide health care or other organizations will have chosen to work
As the Supreme Court recently charitable services. Based in part on our for those organizations with an
confirmed, a self-insured church plan experience litigating against such understanding—explicit or implicit—
exempt from ERISA through ERISA organizations, the Departments now that they were being employed to
3(33) can include a plan that is not disagree with our previous assertion advance the organization’s goals and to
actually established or maintained by a that ‘‘[h]ouses of worship and their be respectful of the organization’s
church or by a convention or association integrated auxiliaries that object to beliefs even if they do not share all of
of churches, but is maintained by ‘‘an contraceptive coverage on religious those beliefs. Religious nonprofit
organization . . . the principal purpose grounds are more likely than other organizations that engage in expressive
or function of which is the employers to employ people of the same activity generally have a First
administration or funding of a plan or faith who share the same objection.’’ 18 Amendment right of expressive
program for the provision of retirement (78 FR 39874.) Although empirical data association and religious free exercise to
benefits or welfare benefits, or both, for was not required to reach our previous choose to hire persons (or, in the case
the employees of a church or a conclusion, we note that the conclusion of students, to admit them) based on
convention or association of churches, if was not supported by any specific data whether they share, or at least will be
such organization is controlled by or or other source, but instead was respectful of, their beliefs.20
associated with a church or a intended to be a reasonable assumption. Given the sincerely held religious
convention or association of churches’’ Nevertheless, in the litigation and in beliefs of many religious organizations,
(a so-called ‘‘principal-purpose numerous public comments submitted imposing the contraceptive-coverage
organization’’). See Advocate Health throughout the regulatory processes requirement on those that object based
Care Network v. Stapleton, 137 S. Ct. described above, many religious on such beliefs might undermine the
1652, 1656–57 (U.S. June 5, 2017); nonprofit organizations have indicated Government’s broader interests in
ERISA 3(33)(C). While the Departments that they possess deep religious ensuring health coverage by causing the
take no view on the status of these commitments even if they are not entities to stop providing health
particular plans, the Departments houses of worship or their integrated coverage. For example, because the
acknowledge that the church plan auxiliaries. Some of the religious Affordable Care Act does not require
exemption not only includes some non- nonprofit groups challenging the
houses-of-worship as organizations accommodation claim that their 19 See, for example, Geneva College v. Sebelius,
employees are required to adhere to a 929 F. Supp. 2d 402, 411 (W.D. Pa. 2013); Grace
whose employees can be covered by the Schools v. Sebelius, 988 F. Supp. 2d 935, 943 (N.D.
plan, but also, in certain circumstances, statement of faith which includes the Ind. 2013); Comments of the Council for Christian
may include plans that are not entities’ views on certain contraceptive Colleges & Universities, re: CMS–9968–P (filed Apr.
themselves established and maintained 8, 2013) (‘‘On behalf of [] 172 higher education
18 In changing its position, an agency ‘‘need not institutions . . . a requirement for membership in
by houses of worship. Yet, such entities demonstrate to a court’s satisfaction that the reasons the CCCU is that full-time administrators and
and plans—if they file a self- for the new policy are better than the reasons for faculty at our institutions share the Christian faith
certification or notice through the the old one; it suffices that the new policy is of the institution.’’).
existing accommodation—are relieved permissible under the statute, that there are good 20 Notably, ‘‘the First Amendment simply does
reasons for it, and that the agency believes it to be not require that every member of a group agree on
of obligations under the contraceptive better, which the conscious change of course every issue in order for the group’s policy to be
Mandate and their third party adequately indicates.’’ FCC v. Fox Television ‘expressive association.’’’ Boy Scouts of America v.
administrators are not subject to a Stations, Inc., 556 U.S. 502, 515 (2009). Dale, 530 U.S. 640, 655 (2000).
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institutions of higher education to (OPA), provides a wide variety of insurance at private colleges and
arrange student coverage, some voluntary family planning information universities. It is not clear that applying
institutions of higher education that and services for clients based on their the Mandate among those objecting
object to the Mandate appear to have ability to pay, through a network that entities is a narrowly tailored way to
chosen to stop arranging student plans includes nearly 4,000 family planning benefit the most at-risk population. The
rather than comply with the Mandate or centers. http://www.hhs.gov/opa/title-x- entities appear to encompass some such
be subject to the accommodation with family-planning/ Individuals with women, but also appear to omit many of
respect to such populations.21 family incomes at or below the HHS them and to include a significantly
Seventh, we now believe the poverty guideline (for 2017, $24,600 for larger cross-section of women as
administrative record on which the a family of four in the 48 contiguous employees or plan participants. At the
Mandate rests is insufficient to meet the States and the District of Columbia) same time, the Mandate as applied to
high threshold to establish a compelling receive services at no charge unless a objecting employers appears to
governmental interest in ensuring that third party (governmental or private) is encompass a relatively small percentage
women covered by plans of objecting authorized or obligated to pay for these of the number of women impacted by
organizations receive cost-free services. Individuals with incomes in the Mandate overall, since most
contraceptive coverage through those excess of 100 percent up to 250 percent employers do not appear to have
plans. To begin, in support of the IOM’s of the poverty guideline are charged for conscientious objections to the
recommendations, which HRSA services using a sliding fee scale based Mandate.26 The Guttmacher Institute,
adopted, the IOM identified several on family size and income. on which the IOM relied, further
studies showing a preventive services Unemancipated minors seeking reported that 89 percent of women who
gap because women require more confidential services are assessed fees are at risk of unintended pregnancy and
preventive care than men. (IOM 2011 at based on their own income level rather are living at 0 through 149 percent of
19–21). Those studies did not identify than their family’s income. The the poverty line are already using
contraceptives or sterilization as availability of such programs to serve contraceptives, as are 92 percent of
composing a specific portion of that gap, the most at-risk women (as defined in those with incomes of 300 percent or
and the IOM did not consider or the IOM report) diminishes the more of the Federal poverty level.27
establish in the report whether any cost Government’s interest in applying the The rates of—and reasons for—
associated with that gap remains after Mandate to objecting employers. Many unintended pregnancy are notoriously
all other women’s preventive services forms of contraception are available for difficult to measure.28 In particular,
are covered without cost-sharing. Id. around $50 per month, including long- association and causality can be hard to
Even without knowing what the acting methods such as the birth control disentangle, and the studies referred to
empirical data would show about that shot and intrauterine devices (IUDs).24 by the 2011 IOM Report speak more to
gap, the coverage of the other women’s Other, more permanent forms of association than causality. For example,
preventive services required under both contraception like implantables bear a IOM 2011 references Boonstra, et al.
the HRSA Guidelines and throughout higher one-time cost, but when
section 2713(a) of the PHS Act— calculated over the duration of use, cost
26 Prior to the implementation of the Affordable
including annual well-woman visits and Care Act approximately 6 percent of employer
a similar amount.25 Various State survey respondents did not offer contraceptive
a variety of tests, screenings, and programs supplement the Federal coverage, with 31 percent of respondents not
counseling services—serves at a programs referenced above, and 28 knowing whether they offered such coverage Kaiser
minimum to diminish the cost gap States have their own mandates of Family Foundation & Health Research &
identified by IOM for women whose Educational Trust, ‘‘Employer Health Benefits, 2010
contraceptive coverage as a matter of Annual Survey’’ at 196, available at https://kaiser
employers decline to cover some or all State law. This existing inter- familyfoundation.files.wordpress.com/2013/04/
contraceptives on religious grounds.22 governmental structure for obtaining 8085.pdf. It is not clear whether the minority of
Moreover, there are multiple Federal, contraceptives significantly diminishes employers who did not cover contraception
State, and local programs that provide refrained from doing so for conscientious reasons or
the Government’s interest in applying for other reasons. Estimates of the number of
free or subsidized contraceptives for the Mandate to employers over their women who might be impacted by the exemptions
low-income women. Such Federal sincerely held religious objections. offered in these rules, as compared to the total
programs include, among others, The record also does not reflect that number of women who will likely continue to
Medicaid (with a 90 percent Federal receive contraceptive coverage, is discussed in more
the Mandate is tailored to the women detail below.
match for family planning services), most likely to experience unintended 27 ‘‘Contraceptive Use in the United States,’’
Title X, community health center grants, pregnancy, identified by the 2011 IOM September 2016.
and Temporary Assistance for Needy report as ‘‘women who are aged 18 to 24 28 The IOM 2011 Report reflected this when it
Families. According to the Guttmacher years and unmarried, who have a low cited the IOM’s own 1995 report on unintended
Institute, government-subsidized family pregnancy, ‘‘The Best Intentions’’ (IOM 1995). IOM
income, who are not high school 1995 identifies various methodological difficulties
planning services are provided at 8,409 graduates, and who are members of a in demonstrating the interest in reducing
health centers overall.23 The Title X racial or ethnic minority’’. (IOM 2011 at unintended pregnancies by means of a coverage
program, for example, administered by 102). For example, with respect to
mandate in employer plans. These include: The
the HHS Office of Population Affairs ambiguity of intent as an evidence-based measure
religiously objecting organizations, the (does it refer to mistimed pregnancy or unwanted
21 See, for example, Manya Brachear Pashman,
Mandate applies in employer-based pregnancy, and do studies make that distinction?);
group health plans and student ‘‘the problem of determining parental attitudes at
‘‘Wheaton College ends coverage amid fight against conception’’ and inaccurate methods often used for
birth control mandate,’’ Chicago Tribune (July 29, that assessment, such as ‘‘to use the request for an
2015); Laura Bassett, ‘‘Franciscan University Drops 24 See, for example, Caroline Cunningham, ‘‘How
abortion as a marker’’; and the overarching problem
Entire Student Health Insurance Plan Over Birth Much Will Your Birth Control Cost Once the of ‘‘association versus causality,’’ that is, whether
Control Mandate,’’ HuffPost (May 15, 2012). Affordable Care Act Is Repealed?’’ Washingtonian intent causes certain negative outcomes or is merely
22 The Departments are not aware of any objectors (Jan. 17, 2017), available at https:// correlated with them. IOM 1995 at 64–66. See also
to the contraceptive Mandate that are unwilling to www.washingtonian.com/2017/01/17/how-much- IOM 1995 at 222 (‘‘the largest public sector funding
cover any of the other preventive services without will-your-birth-control-cost-once-the-affordable- efforts, Title X and Medicaid, have not been well
cost sharing as required by PHS Act section 2713. care-act-is-repealed/; also, see https://www.planned evaluated in terms of their net effectiveness,
23 ‘‘Facts on Publicly Funded Contraceptive parenthood.org/learn/birth-control. including their precise impact on unintended
Services in the United States,’’ March 2016. 25 Id. pregnancy’’).
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(2006), as finding that, ‘‘as the rate of In the longer term—from 1972 through thrombosis.’’ 39 In addition, IOM 2011
contraceptive use by unmarried women 2002—while the percentage of sexually stated that ‘‘[l]ong-term use of oral
increased in the United States between experienced women who had ever used contraceptives has been shown to
1982 and 2002, rates of unintended some form of contraception rose to 98 reduce a woman’s risk of endometrial
pregnancy and abortion for unmarried percent,35 unintended pregnancy rates cancer, as well as protect against pelvic
women also declined,’’ 29 and Santelli in the Unites States rose from 35.4 inflammatory disease and some benign
and Melnikas as finding that ‘‘increased percent36 to 49 percent.’’37 The breast diseases (PRB, 1998). The Agency
rates of contraceptive use by adolescents Departments note these and other for Healthcare Research and Quality
from the early 1990s to the early 2000s studies38 to observe the complexity and (AHRQ) is currently undertaking a
was associated with a decline in teen uncertainty in the relationship between systematic evidence review to evaluate
pregnancies and that periodic increases contraceptive access, contraceptive use, the effectiveness of oral contraceptives
in the teen pregnancy rate are associated and unintended pregnancy. as primary prevention for ovarian
with lower rates of contraceptive use’’. cancer (AHRQ, 2011).’’ (IOM 2011 at
IOM 2011 at 105.30 In this respect, the Contraception’s association with 107). However, after IOM 2011 made
report does not show that access to positive health effects might also be this statement, AHRQ (a component of
contraception causes decreased partially offset by an association with HHS) completed its systematic evidence
incidents of unintended pregnancy, negative health effects. In 2013 the review.40 Based on its review, AHRQ
because both of the assertions rely on National Institutes of Health indicated, stated that: ‘‘[o]varian cancer incidence
association rather than causation, and in funding opportunity announcement was significantly reduced in OC [oral
they associate reduction in unintended for the development of new clinically contraceptive] users’’; ‘‘[b]reast cancer
pregnancy with increased use of useful female contraceptive products, incidence was slightly but significantly
contraception, not merely with that ‘‘hormonal contraceptives have the increased in OC users’’; ‘‘[t]he risk of
increased access to such contraceptives. disadvantage of having many cervical cancer was significantly
Similarly, in a study involving over undesirable side effects[,] are associated increased in women with persistent
8,000 women between 2012 and 2015, with adverse events, and obese women human papillomavirus infection who
conducted to determine whether are at higher risk for serious used OCs, but heterogeneity prevented a
contraceptive coverage under the complications such as deep venous formal meta-analysis’’; ‘‘[i]ncidences of
Mandate changed contraceptive use both colorectal cancer [] and
patterns, the Guttmacher Institute a systematic review,’’ 109 Obstet. Gynecol. 181 endometrial cancer [] were significantly
concluded that ‘‘[w]e observed no (2007). reduced by OC use’’; ‘‘[t]he risk of
35 William D. Mosher & Jo Jones, U.S. Dep’t of
changes in contraceptive use patterns vascular events was increased in current
HHS, CDC, National Center for Health Statistics,
among sexually active women.’’ 31 With ‘‘Use of Contraception in the United States: 1982– OC users compared with nonusers,
respect to teens, the Santelli and 2008’’ at 5 fig. 1, 23 Vital and Health Statistics 29 although the increase in myocardial
Melnikas study cited by IOM 2011 (Aug. 2010), available at https://www.cdc.gov/nchs/ infarction was not statistically
observes that, between 1960 and 1990, data/series/sr_23/sr23_029.pdf.
36 Helen M. Alvaré, ‘‘No Compelling Interest: The
significant’’; ‘‘[t]he overall strength of
as contraceptive use increased, teen ‘Birth Control’ Mandate and Religious Freedom,’’ 58 evidence for ovarian cancer prevention
sexual activity outside of marriage Vill. L. Rev. 379, 404–05 & n.128 (2013), available was moderate to low’’; and ‘‘[t]he
likewise increased (although the study at http://digitalcommons.law.villanova.edu/vlr/ simulation model predicted that the
does not assert a causal relationship).32 vol58/iss3/2 (quoting Christopher Tietze, combined increase in risk of breast and
‘‘Unintended Pregnancies in the United States,
Another study, which proposed an 1970–1972,’’ 11 Fam. Plan. Persp. 186, 186 n.*
cervical cancers and vascular events
economic model for the decision to (1979) (‘‘in 1972, 35.4 percent percent of all U.S. was likely to be equivalent to or greater
engage in sexual activity, stated that pregnancies were ‘unwanted’ or ‘wanted later’’’)). than the decreased risk in ovarian
‘‘[p]rograms that increase access to 37 Id. (citing Lawrence B. Finer & Stanley K.
cancer.’’41 Based on these findings,
contraception are found to decrease teen Henshaw, ‘‘Disparities in Rates of Unintended AHRQ concluded that ‘‘[t]here is
Pregnancy in the United States, 1994 and 2001’’ 38
pregnancies in the short run but Persp. on Sexual Reprod. Health 90 (2006) (‘‘In insufficient evidence to recommend for
increase teen pregnancies in the long 2001, 49 percent of pregnancies in the United States or against the use of OCs solely for the
run.’’ 33 Regarding emergency were unintended’’)). primary prevention of ovarian
contraception in particular, ‘‘[i]ncreased 38 See, for example, J.L Dueñas, et al., ‘‘Trends in
cancer . . . . the harm/benefit ratio for
the Use of Contraceptive Methods and Voluntary ovarian cancer prevention alone is
access to emergency contraceptive pills Interruption of Pregnancy in the Spanish
enhances use but has not been shown to Population during 1997–2007,’’ 83 Contraception uncertain, particularly when the
reduce unintended pregnancy rates.’’34 82 (2011) (as use of contraceptives increased from
49 percent to 80 percent, the elective abortion rate 39 NIH, ‘‘Female Contraceptive Development
29 H. Boonstra, et al., ‘‘Abortion in Women’s more than doubled); D. Paton, ‘‘The economics of Program (U01)’’ (Nov. 5, 2013), available at https://
Lives’’ at 18, Guttmacher Inst. (2006). family planning and underage conceptions,’’ 21 J. grants.nih.gov/grants/guide/rfa-files/RFA-HD-14-
30 Citing John S. Santelli & Andrea J. Melnikas, Health Econ. 207 (2002) (data from the UK confirms 024.html. Thirty six percent of women in the
an economic model which suggests improved United States are obese. https://www.niddk.nih.gov/
‘‘Teen Fertility in Transition: Recent and Historic
family planning access for females under 16 health-information/health-statistics/overweight-
Trends in the United States,’’ 31 Ann. Rev. Pub. obesity. Also see ‘‘Does birth control raise my risk
increases underage sexual activity and has an
Health 371 (2010). for health problems?’’ and ‘‘What are the health
31 Bearak, J.M. and Jones, R.K., ‘‘Did
ambiguous impact on underage conception rates);
T. Raine et al., ‘‘Emergency contraception: advance risks for smokers who use birth control?’’ HHS
Contraceptive Use Patterns Change after the provision in a young, high-risk clinic population,’’ Office on Women’s Health, available at https://
Affordable Care Act? A Descriptive Analysis,’’ 27 96 Obstet. Gynecol. 1 (2000) (providing advance www.womenshealth.gov/a-z-topics/birth-control-
Women’s Health Issues 316 (Guttmacher Inst. May– provision of emergency contraception at family methods; Skovlund, CW, ‘‘Association of Hormonal
June 2017), available at http://www.whijournal. planning clinics to women aged 16–24 was Contraception with Depression,’’ 73 JAMA
com/article/S1049-3867(17)30029-4/fulltext. associated with the usage of less effective and less Psychiatry 1154 (Nov. 1, 2016), available at https://
32 31 Ann. Rev. Pub. Health at 375–76.
consistently used contraception by other methods); www.ncbi.nlm.nih.gov/pubmed/27680324.
33 Peter Arcidiacono, et al., ‘‘Habit Persistence 40 Havrilesky, L.J, et al., ‘‘Oral Contraceptive User
M. Belzer et al., ‘‘Advance supply of emergency
and Teen Sex: Could Increased Access to contraception: a randomized trial in adolescent for the Primary Prevention of Ovarian Cancer,’’
Contraception Have Unintended Consequences for mothers,’’ 18 J. Pediatr. Adolesc. Gynecol. 347 Agency for Healthcare Research and Quality, Report
Teen Pregnancies?’’ (2005), available at http:// (2005) (advance provision of emergency No.: 13–E002–EF (June 2013), available at https://
public.econ.duke.edu/∼psarcidi/teensex.pdf. contraception to mothers aged 13–20 was associated archive.ahrq.gov/research/findings/evidence-based-
34 G. Raymond et al., ‘‘Population effect of with increased unprotected sex at the 12-month reports/ocusetp.html.
increased access to emergency contraceptive pills: follow up). 41 Id.
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potential quality-of-life impact of breast As discussed above and based on the Our review is sufficient to lead us to
cancer and vascular events are Departments’ knowledge of litigation conclude that significantly more
considered.’’42 challenging the Mandate, during the uncertainty and ambiguity exists in the
In addition, in relation to several time ASPE estimated the scope of record than the Departments previously
studies cited above, imposing a coverage preventive services coverage (2011– acknowledged when we declined to
Mandate on objecting entities whose 2013), houses of worship and integrated extend the exemption to certain
plans cover many enrollee families who auxiliaries were exempt from the objecting organizations and individuals
may share objections to contraception Mandate, other objecting religious as set forth herein, and that no
could, among some populations, affect nonprofit organizations were protected compelling interest exists to counsel
risky sexual behavior in a negative way. by the temporary safe harbor, and against us extending the exemption.
For example, it may not be a narrowly hundreds of accommodated self-insured During public comment periods, some
tailored way to advance the Government church plan entities were not subject to commenters noted that some drugs
interests identified here to mandate enforcement of the Mandate through included in the preventive services
contraceptive access to teenagers and their third party administrators. In contraceptive Mandate can also be
young adults who are not already addition, dozens of for-profit entities useful for treating certain existing health
sexually active and at significant risk of that had filed lawsuits challenging the conditions. The IOM similarly stated
unintended pregnancy.43 Mandate were protected by court orders that ‘‘the non-contraceptive benefits of
Finally, evidence from studies that pending the Supreme Court’s resolution hormonal contraception include
post-date the Mandate is not of Hobby Lobby in June 2014. It would treatment of menstrual disorders, acne
inconsistent with the observations the therefore appear that the benefits or hirsutism, and pelvic pain.’’ IOM
Departments make here. In 2016, HRSA recorded by the report occurred even 2011 at 107. Consequently, some
awarded a 5-year cooperative agreement though most objecting entities were not commenters suggested that religious
to the American College of Obstetricians in compliance.46 Additional data objections to the Mandate should not be
and Gynecologists to develop indicates that, in 28 States where permitted in cases where such methods
recommendations for updated Women’s contraceptive coverage mandates have are used to treat such conditions, even
Preventive Services Guidelines. The been imposed statewide, those if those methods can also be used for
awardee formed an expert panel called mandates have not necessarily lowered contraceptive purposes. Section
the Women’s Preventive Services rates of unintended pregnancy (or 2713(a)(4) of the PHS Act does not,
Initiative that issued a report (the WPSI abortion) overall.47 however, apply to non-preventive care
report).44 After observing that ‘‘[p]rivate The Departments need not take a provided solely for treatment of an
companies are increasingly challenging position on these empirical questions. existing condition. It applies only to
the contraception provisions in the ‘‘such additional preventive care and
Affordable Care Act,’’ the WPSI report health.org/wp-content/uploads/2017/01/WPSI_ screenings . . . as provided for’’ by
cited studies through 2013 stating that 2016AbridgedReport.pdf. HRSA (Section 2713(a)(4) of the PHS
46 In addition, as in IOM 2011, the WPSI report
application of HRSA Guidelines had Act). HRSA’s Guidelines implementing
bases its evidentiary conclusions relating to
applied preventive services coverage to contraceptive coverage, use, unintended pregnancy,
this section state repeatedly that they
55.6 million women and had led to a 70 and health benefits, on conclusions that the apply to ‘‘preventive’’ services or care,
percent decrease in out-of-pocket phenomena are ‘‘associated’’ with the intended and with respect to the coverage of
outcomes, without showing there is a causal contraception specifically, they declare
expenses for contraceptive services relationship. For example, the WPSI report states
among commercially insured women. that the methods covered are
that ‘‘[c]ontraceptive counseling in primary care
Id. at 57–58. The WPSI report relied on may increase the uptake of hormonal methods and ‘‘contraceptive’’ methods as a ‘‘Type of
a 2015 report of the HHS Office of the [long-acting reversible contraceptives], although Preventive Service,’’ and that they are to
Assistant Secretary for Planning and data on structured counseling in specialized be covered only ‘‘[a]s prescribed’’ by a
reproductive health settings demonstrated no such physician or other health care provider.
Evaluation (ASPE), ‘‘The Affordable effect.’’ Id. at 63. The WPSI report also
Care Act Is Improving Access to acknowledges that a large-scale study evaluating the https://www.hrsa.gov/womens
Preventive Services for Millions of effects of providing no-cost contraception had ‘‘no guidelines/ The contraceptive coverage
Americans,’’ which estimated that randomization or control group.’’ Id. at 63. requirement in the Guidelines also only
The WPSI report also identifies the at-risk applies for ‘‘women with reproductive
persons who have private insurance population as young, low-income, and/or minority
coverage of preventive services without women: ‘‘[u]nintended pregnancies
capacity.’’ https://www.hrsa.gov/
cost sharing includes 55.6 million disproportionately occur in women age 18 to 24 womensguidelines/; (80 FR 40318).
women.45 years, especially among those with low incomes or Therefore, the Guidelines’ inclusion of
from racial/ethnic minorities.’’ Id. at 58. The WPSI contraceptive services requires coverage
report acknowledges that many in this population of contraceptive methods as a type of
42 Id. Also, see Kelli Miller, ‘‘Birth Control &
are already served by Title X programs, which
Cancer: Which Methods Raise, Lower Risk,’’ The provide family planning services to ‘‘approximately preventive service only when a drug
Am. Cancer Society, (Jan. 21, 2016), available at 1 million teens each year.’’ Id. at 58. The WPSI that the FDA has approved for
http://www.cancer.org/cancer/news/features/birth- report observes that between 2008 and 2011—before contraceptive use is prescribed in whole
control-cancer-which-methods-raise-lower-risk. the contraceptive coverage requirement was
43 For further discussion, see Alvaré, 58 Vill. L.
or in part for such use. The Guidelines
implemented—unintended pregnancy decreased to
Rev. at 400–02 (discussing the Santelli & Melnikas the lowest rate in 30 years. Id. at 58. The WPSI and section 2713(a)(4) of the PHS Act do
study and the Arcidiacono study cited above, and report does not address how to balance not require coverage of such drugs
other research that considers the extent to which contraceptive coverage interests with religious where they are prescribed exclusively
reduction in teen pregnancy is attributable to sexual objections, nor does it specify the extent to which for a non-contraceptive and non-
risk avoidance rather than to contraception access). applying the Mandate among commercially insured
44 ‘‘WPSI 2016 Recommendations: Evidence at objecting entities serves to deliver contraceptive
preventive use to treat an existing
Summaries and Appendices,’’ at 54–64, available at coverage to women most at risk of unintended condition.48 As discussed above, the last
https://www.womenspreventivehealth.org/wp- pregnancy.
content/uploads/2016/12/Evidence-Summaries- 47 See Michael J. New, ‘‘Analyzing the Impact of 48 The Departments previously cited the IOM’s
and-Appendices.pdf. State Level Contraception Mandates on Public listing of existing conditions that contraceptive
45 Available at https://aspe.hhs.gov/pdf-report/ Health Outcomes,’’ 13 Ave Maria L. Rev. 345 (2015), drugs can be used to treat (menstrual disorders,
affordable-care-act-improving-access-preventive- available at http://avemarialaw-law- acne, and pelvic pain), and said of those uses that
services-millions-americans; also, see Abridged review.avemarialaw.edu/Content/articles/vXIII.i2. ‘‘there are demonstrated preventive health benefits
Report, available at https://www.womenspreventive new.final.0809.pdf. Continued
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Administration decided to exempt student health coverage, and not required by RFRA, they would
houses of worship and their integrated individuals enrolled in plans where exercise their discretion to address the
auxiliaries from the Mandate, and to their employers or issuers (as substantial burden identified in Hobby
relieve hundreds of religious nonprofit applicable) are willing to offer them a Lobby by expanding the exemptions
organizations of their obligations under religiously acceptable plan, hold from the Mandate instead of revising
the Mandate and not further require sincerely held religious beliefs against accommodations previously offered. In
contraceptive coverage to their (respectively) providing, arranging, or the Departments’ view, a broader
employees. In several of the lawsuits participating in plans that comply with exemption is a more direct, effective
challenging the Mandate, some religious the Mandate either by providing means of satisfying all bona fide
plaintiffs stated that they do not object contraceptive coverage or by using the religious objectors. This view is
and are willing to cover drugs accommodation. Because we have informed by the fact that the
prescribed for the treatment of an concluded that requiring such Departments’ previous attempt to
existing condition and not for compliance through the Mandate or develop an appropriate accommodation
contraceptive purposes—even if those accommodation has constituted a did not satisfy all objectors. That
drugs are also approved by the FDA for substantial burden on the religious previous accommodation consumed
contraceptive uses. Therefore, the exercise of many such entities or Departmental resources not only
Departments conclude that the fact that individuals, and because we conclude through the regulatory process, but in
some drugs that are approved for requiring such compliance did not serve persistent litigation and negotiations.
preventive contraceptive purposes can a compelling interest and was not the Offering exemptions as described in
also be used for exclusively non- least restrictive means of serving a these interim final rules is a more
preventive purposes to treat existing compelling interest, we now believe that workable way to respond to the
conditions is not a sufficient reason to requiring such compliance led to the substantial burden identified in Hobby
refrain from expanding the exemption to violation of RFRA in many instances. Lobby and bring years of litigation
the Mandate. We recognize that this is a change of concerning the Mandate to a close.
An additional consideration position on this issue, and we make that
supporting the Departments’ present change based on all the matters C. General Scope of Expanded Religious
view is that alternative approaches can discussed in this preamble. Exemptions
further the interests the Departments 1. Exemption and Accommodation for
previously identified behind the B. Discretion To Provide Religious
Exemptions Religious Employers, Plan Sponsors,
Mandate. As noted above, the and Institutions of Higher Education
Government already engages in dozens Even if RFRA does not compel the
of programs that subsidize religious exemptions provided in these For all of these reasons, and as further
contraception for the low-income interim final rules, the Departments explained below, the Departments now
women identified by the IOM as the believe they are the most appropriate believe it is appropriate to modify the
most at risk for unintended pregnancy. administrative response to the religious scope of the discretion afforded to
The Departments have also objections that have been raised. RFRA HRSA in the July 2015 final regulations
acknowledged in legal briefing that identifies certain circumstance under to direct HRSA to provide the expanded
contraception access can be provided which government must accommodate exemptions and change the
through means other than coverage religious exercise-when a government accommodation to an optional process if
offered by religious objectors, for action imposes a substantial burden on HRSA continues to otherwise provide
example, through ‘‘a family member’s the religious exercise of an adherent and for contraceptive coverage in the
employer,’’ ‘‘an Exchange,’’ or ‘‘another imposition of that burden is not the Guidelines. As set forth below, the
government program.’’ 49 least restrictive means of achieving a expanded exemption encompasses non-
Many employer plan sponsors, compelling government interest. RFRA governmental plan sponsors that object
institutions of education arranging does not, however, prescribe the based on sincerely held religious beliefs,
accommodation that the government and institutions of higher education in
from contraceptives relating to conditions other must adopt. Rather, agencies have their arrangement of student health
than pregnancy.’’ 77 FR 8727 & n.7. This was not, discretion to fashion an appropriate and plans. The accommodation is also
however, an assertion that PHS Act section administrable response to respect maintained as an optional process for
2713(a)(4) or the Guidelines require coverage of
‘‘contraceptive’’ methods when prescribed for an
religious liberty interests implicated by exempt employers, and will provide
exclusively non-contraceptive, non-preventive use. their own regulations. We know from contraceptive availability for persons
Instead it was an observation that such drugs— Hobby Lobby that, in the absence of any covered by the plans of entities that use
generally referred to as ‘‘contraceptives’’—also have accommodation, the contraceptive- it (a legitimate program purpose).
some alternate beneficial uses to treat existing The Departments believe this
conditions. For the purposes of these interim final
coverage requirement imposes a
rules, the Departments clarify here that our substantial burden on certain objecting approach is sufficiently respectful of
previous reference to the benefits of using employers. We know from other religious objections while still allowing
contraceptive drugs exclusively for some non- lawsuits and public comments that the Government to advance other
contraceptive and non-preventive uses to treat interests. Even with the expanded
existing conditions did not mean that the
many religious entities have objections
Guidelines require coverage of such uses, and to complying with the accommodation exemption, HRSA maintains the
consequently is not a reason to refrain from offering based on their sincerely held religious discretion to require contraceptive
the expanded exemptions provided here. Where a beliefs. Previously, the Departments coverage for nearly all entities to which
drug approved by the FDA for contraceptive use is the Mandate previously applied (since
prescribed for both a contraceptive use and a non-
attempted to develop an
contraceptive use, the Guidelines (to the extent they accommodation that would either most plan sponsors do not appear to
apply) would require its coverage. Where a drug alleviate the substantial burden imposed possess the requisite religious
approved by the FDA for contraceptive use is on religious exercise or satisfy RFRA’s objections), and to reconsider those
prescribed exclusively for a non-contraceptive and interests in the future where no covered
non-preventive use to treat an existing condition, it
requirements for imposing that burden.
would be outside the scope of the Guidelines. Now, however, the Departments have objection exists. Other Government
49 Brief for the Respondents at 65, Zubik v. reassessed the relevant interests and subsidies of contraception are likewise
Burwell, 136 S. Ct. 1557 (2016) (No. 14–1418). determined that, even if exemptions are not affected by this rule.
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2. Exemption for Objecting Individuals the insurance market because such other avenues for obtaining
Covered by Willing Employers and burdens may be factored into the contraception, including the various
Issuers willingness of an employer or issuer to governmental programs discussed
As noted above, some individuals offer such coverage. At the level of plan above. As the Government is under no
have brought suit objecting to being offerings, the extent to which plans constitutional obligation to fund
covered under an insurance policy that cover contraception under the prior contraception, cf. Harris v. McRae, 448
includes coverage for contraceptives. rules is already far from uniform. United States 297 (1980), even more so
See, for example, Wieland v. HHS, 196 Congress did not require compliance may the Government refrain from
F. Supp. 3d 1010 (E.D. Mo. 2016); Soda with section 2713 of the PHS Act by all requiring private citizens to cover
v. McGettigan, No. 15–cv–00898 (D. entities—in particular by grandfathered contraception for other citizens in
Md.). Just as the Departments have plans. The Departments’ previous violation of their religious beliefs. Cf.
determined that the Government does exemption for houses of worship and Rust v. Sullivan, 500 U.S. 173, 192–93
not have a compelling interest in integrated auxiliaries, and our lack of (1991) (‘‘A refusal to fund protected
applying the Mandate to employers that authority to enforce the accommodation activity, without more, cannot be
object to contraceptive coverage on with respect to self-insured church equated with the imposition of a
religious grounds, we have also plans, show that the importance of a ‘penalty’ on that activity.’’).52
concluded that the Government does uniform health insurance system is not That conclusion is consistent with the
not have a compelling interest in significantly harmed by allowing plans Supreme Court’s observation that RFRA
requiring individuals to be covered by to omit contraception in many may require exemptions even from laws
policies that include contraceptive contexts.51 Furthermore, granting requiring claimants ‘‘to confer benefits
coverage when the individuals have exemptions to individuals who do not on third parties.’’ Hobby Lobby, 134 S.
sincerely held religious objections to wish to receive contraceptive coverage Ct. at 2781 n.37. The burdens imposed
that coverage. The Government does not where the plan and, as applicable, on such third parties may be relevant to
have an interest in ensuring the issuer and plan sponsor are willing, the RFRA analysis, but they cannot be
provision of contraceptive coverage to does not undermine the Government’s dispositive. ‘‘Otherwise, for example,
individuals who do not wish to have interest in ensuring the provision of the Government could decide that all
such coverage. Especially relevant to such coverage to other individuals who supermarkets must sell alcohol for the
this conclusion is the fact that the wish to receive it. Nor do such convenience of customers (and thereby
Departments have described their exemptions undermine the operation of exclude Muslims with religious
interests of health and gender equality the many other programs subsidizing objections from owning supermarkets),
as being advanced among women who contraception. Rather, such exemptions or it could decide that all restaurants
‘‘want’’ the coverage so as to prevent serve the Government’s interest in must remain open on Saturdays to give
‘‘unintended’’ pregnancy. (77 FR accommodating religious exercise. employees an opportunity to earn tips
8727).50 No asserted interest is served Accordingly, as further explained (and thereby exclude Jews with
by denying an exemption to individuals below, the Departments have provided religious objections from owning
who object to it. No unintended an exemption to address the concerns of restaurants).’’ Id. Where, as here,
pregnancies will be avoided or costs objecting individuals. contraceptives are readily accessible
reduced by imposing the coverage on and, for many low income persons, are
D. Effects on Third Parties of available at reduced cost or for free
those individuals. Exemptions
Although the Departments previously through various governmental programs,
took the position that allowing The Departments note that the and contraceptive coverage may be
individual religious exemptions would exemptions created here, like the available through State sources or
undermine the workability of the exemptions created by the last family plans obtained through non-
insurance system, the Departments now Administration, do not burden third objecting employers, the Departments
agree with those district courts that have parties to a degree that counsels against have determined that the expanded
concluded that an exemption that providing the exemptions. Congress did exemptions rather than
allows—but does not require—issuers not create a right to receive accommodations are the appropriate
and employers to omit contraceptives contraceptive coverage, and Congress response to the substantial burden that
from coverage provided to objecting explicitly chose not to impose the the Mandate has placed upon the
individuals does not undermine any section 2713 of the PHS Act religious exercise of many religious
compelling interest. See Wieland, 196 F. requirements on grandfathered plans employers.
Supp. 3d at 1019–20; March for Life, that cover millions of people.
III. Provisions of the Interim Final
128 F. Supp. 3d at 132. The individual Individuals who are unable to obtain
Rules With Comment Period
exemption will only apply where the contraceptive coverage through their
employer-sponsored health plans The Departments are issuing these
employer and issuer (or, in the
because of the exemptions created in interim final rules in light of the full
individual market, the issuer) are
these interim final rules, or because of history of relevant rulemaking
willing to offer a policy accommodating
the objecting individual. As a result, the other exemptions to the Mandate, have (including prior interim final rules),
Departments consider it likely that public comments, and litigation
where an individual exemption is
51 Also, see Real Alternatives, 2017 WL 3324690 throughout the Federal court system.
invoked, it will impose no burdens on
at *36 (3d Cir. Aug. 4, 2017) (Jordan, J., concurring The interim final rules seek to resolve
in part and dissenting in part) (‘‘Because insurance this matter and the long-running
companies would offer such plans as a result of
50 In this respect, the Government’s interest in market forces, doing so would not undermine the litigation with respect to religious
contraceptive coverage is different than its interest government’s interest in a sustainable and
in persons receiving some other kinds of health functioning market. . . . Because the government 52 Cf. also Planned Parenthood Ariz., Inc. v. Am.
coverage or coverage in general, which can lead to has failed to demonstrate why allowing such a Ass’n of Pro-Life Obstetricians & Gynecologists, 257
important benefits that are not necessarily system (not unlike the one that allowed wider P.3d 181, 196 (Ariz. Ct. App. 2011) (‘‘a woman’s
conditional on the recipient’s desire to use the choice before the Affordable Care Act) would be right to an abortion or to contraception does not
coverage and the specific benefits that may result unworkable, it has not satisfied strict scrutiny.’’ compel a private person or entity to facilitate
from their choice to use it. (citation and internal quotation marks omitted)). either.’’).
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objections by extending the exemption the process optional for eligible For avoidance of doubt, the
under the HRSA Guidelines to organizations. HRSA is simultaneously Departments wish to make clear that the
encompass entities, and individuals, updating its Guidelines to reflect the expanded exemption created in
with sincerely held religious beliefs requirements of these interim final § 147.132(a) applies to several distinct
objecting to contraceptive or rules.53 entities involved in the provision of
sterilization coverage, and by making coverage to the objecting employer’s
the accommodation process optional for A. Regulatory Restatements of Section employees. This explanation is
eligible organizations. 2713(a) and (a)(4) of the PHS Act consistent with how prior rules have
The Departments acknowledge that These interim final rules modify the worked by means of similar language.
the foregoing analysis represents a restatements of the requirements of Section 147.132(a)(1) introductory text
change from the policies and section 2713(a) and (a)(4) of the PHS and (a)(1)(i), by specifying that ‘‘[a]
interpretations we previously adopted Act, contained in 26 CFR 54.9815– group health plan and health insurance
with respect to the Mandate and the 2713(a)(1) introductory text and coverage provided in connection with a
governmental interests that underlie the (a)(1)(iv), 29 CFR 2590.715–2713(a)(1) group health plan’’ is exempt ‘‘to the
Mandate. These changes in policy are introductory text and (a)(1)(iv), and 45 extent the plan sponsor objects as
within the Departments’ authority. As CFR 147.130(a)(1) introductory text and specified in paragraph (a)(2),’’ exempt
the Supreme Court has acknowledged, (a)(1)(iv), so that they conform to the the group health plans the sponsors of
‘‘[a]gencies are free to change their statutory text of section 2713 of the PHS which object, and exempt their health
existing policies as long as they provide Act. insurance issuers from providing the
a reasoned explanation for the change.’’ coverage in those plans (whether or not
Encino Motorcars, LLC v. Navarro, 136 B. Prefatory Language of the Exemption the issuers have their own objections).
S. Ct. 2117, 2125 (2016). This ‘‘reasoned in 45 CFR 147.132 Consequently, with respect to
analysis’’ requirement does not demand These interim final rules move the Guidelines issued under
that an agency ‘‘demonstrate to a court’s religious exemption from 45 CFR § 147.130(a)(1)(iv), or the parallel
satisfaction that the reasons for the new 147.131 to a new § 147.132 and expand provisions in 26 CFR 54.9815–
policy are better than the reasons for the it as follows. In the prefatory language 2713(a)(1)(iv) and 29 CFR 2590.715–
old one; it suffices that the new policy of § 147.132, these interim final rules 2713(a)(1)(iv), the plan sponsor, issuer,
is permissible under the statute, that specify that not only are certain entities and plan covered in the exemption of
there are good reasons for it, and that ‘‘exempt,’’ but the Guidelines shall not that paragraph would face no penalty as
the agency believes it to be better, which support or provide for an imposition of a result of omitting contraceptive
the conscious change of course the contraceptive coverage requirement coverage from the benefits of the plan
adequately indicates’’. United Student to such entities. This is an participants and beneficiaries.
Aid Funds, Inc. v. King, 200 F. Supp. 3d acknowledgement that section Consistent with the restated
163, 169–70 (D.D.C. 2016) (citing FCC v. 2713(a)(4) of the PHS Act requires exemption, exempt entities will not be
Fox Television Stations, Inc., 556 U.S. women’s preventive services coverage required to comply with a self-
502, 515 (2009)); also, see New Edge only ‘‘as provided for in comprehensive certification process. Although exempt
Network, Inc. v. FCC, 461 F.3d 1105, guidelines supported by the Health entities do not need to file notices or
1112–13 (9th Cir. 2006) (rejecting an Resources and Services certifications of their exemption, and
argument that ‘‘an agency changing its Administration.’’ To the extent the these interim final rules do not impose
course by rescinding a rule is obligated HRSA Guidelines do not provide for or any new notice requirements on them,
to supply a reasoned analysis for the support the application of such coverage existing ERISA rules governing group
change beyond that which may be to exempt entities, the Affordable Care health plans require that, with respect to
required when an agency does not act in Act does not require the coverage. plans subject to ERISA, a plan
the first instance’’). Section 147.132 not only describes the document must include a
Here, for all of the reasons discussed exemption of certain entities and plans, comprehensive summary of the benefits
above, the Departments have but does so by specifying that the HRSA covered by the plan and a statement of
determined that the Government’s Guidelines do not provide for, or the conditions for eligibility to receive
interest in the application of support the application of, such benefits. Under ERISA, the plan
contraceptive coverage requirements in coverage to exempt entities and plans. document provides what benefits are
this specific context to the plans of provided to participants and
certain entities and individuals does not C. General Scope of Exemption for beneficiaries under the plan and,
outweigh the sincerely held religious Objecting Entities therefore, if an objecting employer
objections of those entities and In the new 45 CFR 147.132 as created would like to exclude all or a subset of
individuals based on the analyses set by these interim final rules, these rules contraceptive services, it must ensure
forth above. Thus, these interim final expand the exemption that was that the exclusion is clear in the plan
rules amend the Departments’ July 2015 previously located in § 147.131(a). With document. Moreover, if there is a
final regulations to expand the respect to employers that sponsor group reduction in a covered service or
exemption to include additional entities health plans, the new language of benefit, the plan has to disclose that
and persons that object based on § 147.132(a)(1) introductory text and change to plan participants.54 Thus,
sincerely held religious beliefs. These (a)(1)(i) provides exemptions for where an exemption applies and all or
rules leave in place HRSA’s discretion employers that object to coverage of all a subset of contraceptive services are
to continue to require contraceptive and or a subset of contraceptives or omitted from a plan’s coverage,
sterilization coverage where no such
sterilization and related patient
objection exists, and to the extent that 54 See, for example, 29 U.S.C. 1022, 1024(b), 29
education and counseling based on
section 2713 of the PHS Act applies. CFR 2520.102–2, 2520.102–3, & 2520.104b–3(d),
sincerely held religious beliefs. and 29 CFR 2590.715–2715. Also, see 45 CFR
These interim final rules also maintain
147.200 (requiring disclosure of the ‘‘exceptions,
the existence of an accommodation 53 See https://www.hrsa.gov/womensguidelines/ reductions, and limitations of the coverage,’’
process, but consistent with our and https://www.hrsa.gov/womensguidelines2016/ including group health plans and group &
expansion of the exemption, we make index.html. individual issuers).
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otherwise applicable ERISA disclosures Congress’ intent in the Affordable Care sponsor with the requisite objections
must reflect the omission of coverage in Act and throughout other Federal health but, for the sake of clarity, they include
ERISA plans. These existing disclosure care laws. As discussed above, many an illustrative, non-exhaustive list of
requirements serve to help provide Federal health care laws and regulations employers whose objections qualify the
notice to participants and beneficiaries provide exemptions for objections based plans they sponsor for an exemption.
of what ERISA plans do and do not on religious beliefs, and RFRA applies Under these interim final rules, the
cover. The Departments invite public to the Affordable Care Act. Expanding Departments do not limit the Guidelines
comment on whether exempt entities, or the exemption removes religious exemption with reference to nonprofit
others, would find value either in being obstacles that entities and certain status or to sections 6033(a)(3)(A)(i) or
able to maintain or submit a specific individuals may face when they (iii) of the Code, as previous rules have
form of certification to claim their otherwise wish to participate in the done. A significant majority of States
exemption, or in otherwise receiving health care market. This advances the either impose no contraceptive coverage
guidance on a way to document their Affordable Care Acts goal of expanding requirement or offer broader exemptions
exemption. health coverage among entities and than the exemption contained in the
The exemptions in § 147.132(a) apply individuals that might otherwise be July 2015 final regulations.57 Although
‘‘to the extent’’ of the objecting entities’ reluctant to participate. These rules also the practice of States is by no means a
sincerely held religious beliefs. Thus, leave in place many Federal programs limit on the discretion delegated to
entities that hold a requisite objection to that subsidize contraceptives for women HRSA by the Affordable Care Act, nor
covering some, but not all, contraceptive who are most at risk of unintended a statement about what the Federal
items would be exempt with respect to pregnancy and who may have more Government may do consistent with
the items to which they object, but not limited access to contraceptives.56 RFRA or other limitations in federal
with respect to the items to which they These interim final rules achieve greater law, such State practice can be
do not object. Likewise, the requisite uniformity and simplicity in the informative as to the viability of broad
objection of a plan sponsor or regulation of health insurance by protections for religious liberty. In this
institution of higher education in expanding the exemptions to include case, such practice supports the
§ 147.132(a)(1)(i) and (ii) exempts its entities that object to the Mandate based Departments’ decision to expand the
group health plan, health insurance on their sincerely held religious beliefs. federal exemption, bringing the Federal
coverage offered by a health insurance The Departments further conclude Government’s practice into greater
issuer in connection with such plan, that it would be inadequate to merely alignment with the practices of the
and its issuer in its offering of such attempt to amend the accommodation majority of the States.
coverage, but that exemption does not process instead of expand the
extend to coverage provided by that 2. Section 147.132(a)(1)(i)(A)
exemption. The Departments have
issuer to other group health plans where stated in our regulations and court Despite not limiting the exemption to
the plan sponsor has no qualifying briefings that the existing certain organizations referred to in
objection. The objection of a health accommodation with respect to self- section 6033(a)(3)(A)(i) or (iii) of the
insurance issuer in § 147.132(a)(1)(iii) insured plans requires contraceptive Code, the exemption in these rules
similarly operates only to the extent of coverage as part of the same plan as the includes such organizations. Section
its objection, and as otherwise limited coverage provided by the employer, and 147.132(a)(1)(i)(A) specifies, as under
as described below. operates in a way ‘‘seamless’’ to those the prior exemption, that the exemption
D. Exemption of Employers and plans. As a result, in significant covers ‘‘a group health plan established
Institutions of Higher Education respects, the accommodation process or maintained by . . . [a] church, the
does not actually accommodate the integrated auxiliary of a church, a
The scope of the exemption is convention or association of churches,
objections of many entities. The
expanded for non-governmental plan or a religious order.’’ In the preamble to
Departments have engaged in an effort
sponsors and certain entities that rules setting forth the prior exemption at
to attempt to identify an
arrange health coverage under these § 147.132(a), the Departments
accommodation that would eliminate
interim final rules. The Departments interpreted this same language used in
the plaintiffs’ religious objections,
have consistently taken the position that those rules by declaring that ‘‘[t]he final
including seeking public comment
section 2713(a)(4) of the PHS Act grants regulations continue to provide that the
through an RFI, but we stated in January
HRSA authority to issue Guidelines that availability of the exemption or
2017 that we were unable to develop
provide for and support exemptions accommodation be determined on an
such an approach at that time.
from a contraceptive coverage employer by employer basis, which the
requirement. Since the beginning of 1. Plan Sponsors Generally Departments continue to believe best
rulemaking concerning the Mandate, The expanded exemptions in these balances the interests of religious
HRSA and the Departments have interim final rules cover any kind of employers and eligible organizations
repeatedly exercised their discretion to non-governmental employer plan and those of employees and their
create and modify various exemptions dependents.’’ (78 FR 39886). Therefore,
within the Guidelines.55 56 See, for example, Family Planning grants in 42
under the prior exemption, if an
The Departments believe the U.S.C. 300, et seq.; the Teenage Pregnancy employer participated in a house of
approach of these interim final rules Prevention Program, Public Law 112–74 (125 Stat
worship’s plan—perhaps because it was
better aligns our implementation of 786, 1080); the Healthy Start Program, 42 U.S.C.
254c–8; the Maternal, Infant, and Early Childhood affiliated with a house of worship—but
section 2713(a)(4) of the PHS Act with Home Visiting Program, 42 U.S.C. 711; Maternal was not an integrated auxiliary or a
and Child Health Block Grants, 42 U.S.C. 703; 42 house of worship itself, that employer
55 ‘‘The fact that the agency has adopted different U.S.C. 247b–12; Title XIX of the Social Security
definitions in different contexts adds force to the Act, 42 U.S.C. 1396, et seq.; the Indian Health was not considered to be covered by the
argument that the definition itself is flexible, Service, 25 U.S.C. 13, 42 U.S.C. 2001(a), & 25 U.S.C.
particularly since Congress has never indicated any 1601, et seq.; Health center grants, 42 U.S.C. 57 See Guttmacher Institute, ‘‘Insurance Coverage
disapproval of a flexible reading of the statute.’’ 254b(e), (g), (h), & (i); the NIH Clinical Center, 42 of Contraceptives’’ available at https://
Chevron, U.S.A., Inc. v. Natural Resources Defense U.S.C. 248; and the Personal Responsibility www.guttmacher.org/state-policy/explore/
Council, Inc., 467 U.S. 837, 863–64 (1984). Education Program, 42 U.S.C. 713. insurance-coverage-contraceptives.
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exemption, even though it was, in the Sebelius, 987 F. Supp. 2d 232, 242 The mechanisms for determining
ordinary meaning of the text of the prior (E.D.N.Y. 2013). Therefore the whether a company has adopted and
regulation, participating in a ‘‘plan Departments believe it is most holds such principles or views is a
established or maintained by a [house of appropriate to use a plan basis, not an matter of well-established State law
worship].’’ employer by employer basis, to with respect to corporate decision-
Under these interim final rules, determine the scope of an exemption for making,60 and the Departments expect
however, the Departments intend that, a group health plan established or that application of such laws would
when this regulation text exempts a maintained by a house of worship or cabin the scope of this exemption.
plan ‘‘established or maintained by’’ a integrated auxiliary. In including entities in the exemption
house of worship or integrated that are not closely held, these interim
auxiliary, such exemption will no 3. Section 147.132(a)(1)(i)(B) final rules provide for the possibility
longer ‘‘be determined on an employer Section 147.132(a)(1)(i)(B) of the rules that some publicly traded entities may
by employer basis,’’ but will be specifies that the exemption includes use the exemption. Even though the
determined on a plan basis—that is, by the plans of plan sponsors that are Supreme Court did not extend its
whether the plan is a ‘‘plan established nonprofit organizations. holding in Hobby Lobby to publicly
or maintained by’’ a house of worship traded corporations (the matter could be
4. Section 147.132(a)(1)(i)(C)
or integrated auxiliary. This resolved without deciding that
interpretation better conforms to the text Under § 147.132(a)(1)(i)(C), the rules question), the Court did instruct that
of the regulation setting forth the extend the exemption to the plans of RFRA applies to corporations because
exemption—in both the prior regulation closely held for-profit entities. This is they are ‘‘persons’’ as that term is
and in the text set forth in these interim consistent with the Supreme Court’s defined in 1 U.S.C. 1. Given that the
final rules. It also offers appropriate ruling in Hobby Lobby, which declared definition under 1 U.S.C. 1 applies to
respect to houses of worship and their that a corporate entity is capable of any corporation, the Departments
integrated auxiliaries not only in their possessing and pursuing non-pecuniary consider it appropriate to extend the
internal employment practices but in goals (in Hobby Lobby, religion), exemption set forth in these interim
their choice of organizational form and/ regardless of whether the entity operates final rules to for-profit corporations
or in their activity of establishing or as a nonprofit organization, and whether or not they are closely held.
maintaining health plans for employees rejecting the Departments’ argument to The Departments are generally aware
of associated employers that do not the contrary. (134 S. Ct. 2768–75) Some that in a country as large as America
meet the threshold of being integrated reports and industry experts have comprised of a supermajority of
auxiliaries. Moreover, under this indicated that not many for-profit religious persons, some publicly traded
interpretation, houses of worship would entities beyond those that had originally entities might claim a religious
not be faced with the potential prospect brought suit have sought relief from the character for their company, or that the
of services to which they have a Mandate after Hobby Lobby.58 majority of shares (or voting shares) of
religious objection being covered for some publicly traded companies might
5. Section 147.132(a)(1)(i)(D)
employees of an associated employer be controlled by a small group of
participating in a plan they have Under § 147.132(a)(1)(i)(D), the rules religiously devout persons so as to set
established and maintain. extend the exemption to the plans of forth such a religious character.61 The
The Departments do not believe there for-profit entities that are not closely fact that such a company is religious
is a sufficient factual basis to exclude held. The July 2015 final regulations does not mean that it will have an
from this part of the exemption entities extended the accommodation to for- objection to contraceptive coverage, and
that are so closely associated with a profit entities only if they are closely there are many fewer publicly traded
house of worship or integrated auxiliary held, by positively defining what companies than there are closely held
that they are permitted participation in constitutes a closely held entity. The ones. But our experience with closely
its health plan, but are not themselves Departments implicitly recognized the held companies is that some, albeit a
integrated auxiliaries. Additionally, this difficulty of providing an affirmative small minority, do have religious
interpretation is not inconsistent with definition of closely held entities in the objections to contraceptive coverage.
the operation of the accommodation July 2015 final regulations when we Thus we consider it possible, though
under the prior rule, to the extent that, adopted a definition that included very unlikely, that a religious publicly
in practice and as discussed elsewhere entities that are merely ‘‘substantially
herein, it does not force contraceptive similar’’ to certain specified parameters, provide an exemption on an interim final basis to
coverage to be provided on behalf of the and we allowed entities that were not closely held entities by using a negative definition:
plan participants of many religious entities that do not have publicly traded ownership
sure if they met the definition to inquire interests as defined by certain securities required to
organizations in a self-insured church with HHS; HHS was permitted to be registered under section 12 of the Securities
plan exempt from ERISA—which are decline to answer the inquiry, at which Exchange Act of 1934. Although this is a more
exempt in part because the plans are time the entity would be deemed to workable definition than set forth in our previous
established and maintained by a church. rules, we have determined that it is appropriate to
qualify as an eligible organization. The offer the expanded religious exemptions to certain
(Section 3(33)(A) of ERISA) In several exemptions in these interim final rules entities whether or not they have publicly traded
lawsuits challenging the Mandate, the do not need to address this difficulty ownership interests.
Departments took the position that some because they include both for-profit 60 Although the Departments do not prescribe any
plans established and maintained by entities that are closely held and for- form or notification, they would expect that such
principles or views would have been adopted and

houses of worship, but that included profit entities that are not closely held.59 documented in accordance with the laws of the
entities that were not integrated jurisdiction under which they are incorporated or
auxiliaries, were church plans under 58 See Jennifer Haberkorn, ‘‘Two years later, few organized.
section 3(33) of ERISA and, thus, the Hobby Lobby copycats emerge,’’ Politico (Oct. 11, 61 See, e.g., Nasdaq.com, ‘‘4 Publicly Traded
Government ‘‘has no authority to 2016), available at http://www.politico.com/story/ Religious Companies if You’re Looking to Invest in
2016/10/obamacare-birth-control-mandate- Faith’’ (Feb. 7, 2014), available at http://
require the plaintiffs’ TPAs to provide employers-229627. www.nasdaq.com/article/4-publicly-traded-
contraceptive coverage at this time.’’ 59 In the companion interim final rules published religious-companies-if-youre-looking-to-invest-in-
Roman Catholic Archdiocese of N.Y. v. elsewhere in this Federal Register, the Departments faith-cm324665.
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traded company might have objections extended, in the case of institutions of with respect to providing coverage in
to contraceptive coverage. At the same higher education (as defined in 20 those plans. The issuer exemption in
time, we are not aware of any publicly U.S.C. 1002), to their arrangement of § 147.132(a)(1)(iii) adds to that
traded entities that challenged the student health insurance coverage, in a protection, but the additional protection
Mandate specifically either publicly or manner comparable to the applicability operates in a different way than the plan
in court. The Departments agree with of the exemption for group health sponsor exemption operates. As set
the Supreme Court that it is improbable insurance coverage provided in forth in these interim final rules, the
that many publicly traded companies connection with a group health plan only plan sponsors, or in the case of
with numerous ‘‘unrelated established or maintained by a plan individual insurance coverage,
shareholders—including institutional sponsor. As mentioned above, because individuals, who are eligible to
investors with their own set of the Affordable Care Act does not require purchase or enroll in health insurance
stakeholders—would agree to run a institutions of higher education to coverage offered by an exempt issuer
corporation under the same religious arrange student coverage, some that does not cover some or all
beliefs’’ and thereby qualify for the institutions of higher education that contraceptive services are plan sponsors
exemption. (134 S. Ct. at 2774) object to the Mandate appear to have or individuals who themselves object
chosen to stop arranging student plans and are otherwise exempt based on their
6. Section 147.132(a)(1)(i)(E)
rather than comply with the Mandate or objection. Thus, the issuer exemption
Under § 147.132(a)(1)(i)(E), the rules use the accommodation. Extending the specifies that where a health insurance
extend the exemption to the plans of exemption in these interim final rules issuer providing group health insurance
any other non-governmental employer. may remove an obstacle to such entities coverage is exempt under paragraph
The plans of governmental employers deciding to offer student plans, thereby (a)(1)(iii), the plan remains subject to
are not covered by the plan sponsor giving students another health any requirement to provide coverage for
exemption of § 147.132(a)(1)(i). The insurance option. contraceptive services under Guidelines
Departments are not aware of reasons issued under 42 CFR 147.130(a)(1)(iv)
why it would be appropriate or E. Exemption for Issuers
unless the plan is otherwise exempt
necessary to offer religious exemptions These interim final rules extend the from that requirement. Accordingly, the
to governmental employer plan exemption, in § 147.132(a)(1)(iii), to only plan sponsors, or in the case of
sponsors in the United States with health insurance issuers offering group individual insurance coverage,
respect to the contraceptive Mandate. or individual health insurance coverage individuals, who are eligible to
But, as discussed below, governmental that sincerely hold their own religious
purchase or enroll in health insurance
employers are permitted to respect an objections to providing coverage for
coverage offered by an issuer that is
individual’s objection under contraceptive services.
The Departments are not currently exempt under this paragraph (a)(1)(iii)
§ 147.132(b) and thus to provide health
aware of health insurance issuers that that does not include coverage for some
insurance coverage without the
possess their own religious objections to or all contraceptive services are plan
objected-to contraceptive coverage to
offering contraceptive coverage. sponsors or individuals who themselves
such individual. Where that exemption
Nevertheless, many Federal health care object and are exempt. Issuers that hold
is operative, the Guidelines may not be
conscience laws and regulations protect religious objections should identify to
construed to prevent a willing
issuers or plans specifically. For plan sponsors the lack of contraceptive
governmental plan sponsor of a group
example, 42 U.S.C. 1395w–22(j)(3)(B) coverage in any health insurance
health plan from offering a separate
and 1396u–2(b)(3) protect plans or coverage being offered that is based on
benefit package option, or a separate
managed care organizations in Medicaid the issuer’s exemption, and
policy, certificate or contract of
or Medicare Advantage. The Weldon communicate the group health plan’s
insurance, to any individual who
Amendment protects HMOs, health independent obligation to provide
objects to coverage or payments for
insurance plans, and any other health contraceptive coverage, unless the group
some or all contraceptive services based
care organizations are protected from health plan itself is exempt under
on sincerely held religious beliefs.
By the general extension of the being required to provide coverage or regulations governing the Mandate.
exemption to the plans of plan sponsors pay for abortions. See, for example, In this way, the issuer exemption
in § 147.132(a)(1)(i), these interim final Consolidated Appropriations Act of serves to protect objecting issuers both
rules also exempt group health plans 2017, Public Law 115–31, Div. H, Title from being asked or required to issue
sponsored by an entity other than an V, Sec. 507(d). Congress also declared policies that cover contraception in
employer (for example, a union) that this year that ‘‘it is the intent of violation of the issuers’ sincerely held
objects based on sincerely held religious Congress’’ to include a ‘‘conscience religious beliefs, and from being asked
beliefs to coverage of contraceptives or clause’’ which provides exceptions for or required to issue policies that omit
sterilization. religious beliefs if the District of contraceptive coverage to non-exempt
Columbia requires ‘‘the provision of entities or individuals, thus subjecting
7. Section 147.132(a)(1)(ii) contraceptive coverage by health the issuers to potential liability if those
As in the previous rules, the plans of insurance plans.’’ See Id. at Div. C, Title plans are not exempt from the
institutions of higher education that VIII, Sec. 808. In light of the clearly Guidelines. At the same time, the issuer
arrange student health insurance expressed intent of Congress to protect exemption will not serve to remove
coverage will continue to be treated religious liberty, particularly in certain contraceptive coverage obligations from
similarly to the way in which the plans health care contexts, along with the any plan or plan sponsor that is not also
of employers are treated, but for the specific efforts to protect issuers, the exempt, nor will it prevent other issuers
purposes of such plans being exempt or Departments have concluded that an from being required to provide
electing the optional accommodation, exemption for issuers is appropriate. contraceptive coverage in individual
rather than merely being eligible for the As discussed above, where the insurance coverage. Permitting issuers
accommodation as in the previous rule. exemption for plan sponsors or to object to offering contraceptive
These interim final rules specify, in institutions of higher education applies, coverage based on sincerely held
§ 147.132(a)(1)(ii), that the exemption is issuers are exempt under those sections religious beliefs will allow issuers to
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continue to offer coverage to plan establishing, maintaining, providing, contraceptive coverage, even if those
sponsors and individuals, without offering, or arranging (as applicable) governmental entities do not object to
subjecting them to liability under coverage, payments, or a plan that offering contraceptive coverage in
section 2713(a)(4) of the PHS Act or provides coverage or payments for some general.
related provisions for their failure to or all contraceptive services, based on This ‘‘individual exemption’’ cannot
provide contraceptive coverage. its sincerely held religious beliefs. be used to force a plan (or its sponsor)
The issuer exemption does not or an issuer to provide coverage
specifically include third party G. Individual Exemption omitting contraception, or, with respect
administrators, although the optional These interim final rules include a to health insurance coverage, to prevent
accommodation process provided under special rule pertaining to individuals the application of State law that requires
these interim final rules specifies that (referred to here as the ‘‘individual coverage of such contraceptives or
third party administrators cannot be exemption’’). Section 147.132(b) sterilization. Nor can the individual
required to contract with an entity that provides that nothing in exemption be construed to require the
invokes that process. Some religious § 147.130(a)(1)(iv), 26 CFR 54.9815– guaranteed availability of coverage
third party administrators have brought 2713(a) (1)(iv), or 29 CFR 2590.715– omitting contraception to a plan sponsor
suit in conjunction with suits brought 2713(a)(1)(iv), may be construed to or individual who does not have a
by organizations enrolled in ERISA- prevent a willing plan sponsor of a sincerely held religious objection. This
exempt church plans. Such plans are group health plan or a willing health individual exemption is limited to the
now exempt under these interim final insurance issuer offering group or requirement to provide contraceptive
rules, and their third party individual health insurance coverage, coverage under section 2713(a)(4) of the
administrators, as claims processors, are from offering a separate benefit package PHS Act, and does not affect any other
under no obligation under section option, or a separate policy, certificate, Federal or State law governing the plan
2713(a)(4) of the PHS Act to provide or contract of insurance, to any or coverage. Thus, if there are other
benefits for contraceptive services, as individual who objects to coverage or applicable laws or plan terms governing
that section applies only to plans and payments for some or all contraceptive the benefits, these interim final rules do
issuers. In the case of ERISA-covered services based on the individual’s not affect such other laws or terms.
plans, plan administrators are obligated sincerely held religious beliefs. The The Departments believe the
under ERISA to follow the plan terms, individual exemption extends to the individual exemption will help to meet
but it is the Departments’ understanding coverage unit in which the plan the Affordable Care Act’s goal of
that third party administrators are not participant, or subscriber in the increasing health coverage because it
typically designated as plan individual market, is enrolled (for will reduce the incidence of certain
administrators under section 3(16) of instance, to family coverage covering individuals choosing to forego health
ERISA and, therefore, would not the participant and his or her coverage because the only coverage
normally act as plan administrators beneficiaries enrolled under the plan), available would violate their sincerely
under section 3(16) of ERISA. Therefore, but does not relieve the plan’s or held religious beliefs.62 At the same
to the Departments’ knowledge, it is issuer’s obligation to comply with the time, this individual exemption ‘‘does
only under the existing accommodation Mandate with respect to the group not undermine the governmental
process that third party administrators health plan at large or, as applicable, to interests furthered by the contraceptive
are required to undertake any any other individual policies the issuer coverage requirement,’’ 63 because,
obligations to provide or arrange for offers. when the exemption is applicable, the
contraceptive coverage to which they This individual exemption allows individual does not want the coverage,
might object. These interim final rules plan sponsors and issuers that do not and therefore would not use the
make the accommodation process specifically object to contraceptive objectionable items even if they were
optional for employers and other plan coverage to offer religiously acceptable covered.
sponsors, and specify that third party coverage to their participants or
subscribers who do object, while H. Optional Accommodation
administrators that have their own
objection to complying with the offering coverage that includes Despite expanding the scope of the
accommodation process may decline to contraception to participants or exemption, these rules also keep the
enter into, or continue, contracts as subscribers who do not object. This accommodation process, but revise it so
third party administrators of such plans. individual exemption can apply with as to make it optional. In this way,
For these reasons, these interim final respect to individuals in plans objecting employers are no longer
rules do not otherwise exempt third sponsored by private employers or required to choose between direct
party administrators. The Departments governmental employers. For example, compliance or compliance through the
solicit public comment, however, on in one case brought against the accommodation. These rules maintain
whether there are situations where there Departments, the State of Missouri the location of the accommodation
may be an additional need to provide enacted a law under which the State is process in the Code of Federal
distinct protections for third party not permitted to discriminate against Regulations at 45 CFR 147.131, 26 CFR
administrators that may have religious insurance issuers that offer health plans 54.9815–2713A, and 29 CFR 2590.715–
beliefs implicated by the Mandate. without coverage for contraception 2713A. These rules, by virtue of
based on employees’ religious beliefs, or expanding the plan sponsor exemption
F. Scope of Objections Needed for the against the individual employees who beyond houses of worship and
Objecting Entity Exemption accept such offers. See Wieland, 196 F. integrated auxiliaries that were
Exemptions for objecting entities Supp. 3d at 1015–16 (quoting Mo. Rev.
specify that they apply where the Stat. 191.724). Under the individual 62 See, for example, Wieland, 196 F. Supp. 3d at
entities object as specified in exemption of these interim final rules, 1017, and March for Life, 128 F. Supp. 3d at 130,
§ 147.132(a)(2). That paragraph specifies employers sponsoring governmental where the courts noted that the individual
employee plaintiffs indicated that they viewed the
that exemptions for objecting entities plans would be free to honor the Mandate as pressuring them to ‘‘forgo health
will apply to the extent that an entity objections of individual employees by insurance altogether.’’
described in § 147.132(a)(1) objects to its offering them plans that omit 63 78 FR 39874.
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previously exempt, and beyond will be effective on the 1st day of the 1st discretion to decide whether to continue
religious nonprofit groups that were plan year that begins on or after 30 days to require contraceptive coverage under
previously accommodated, and by after the date of the revocation (to allow the Guidelines (in plans where Congress
defining eligible organizations for the for the provision of notice to plan applied section 2713 of the PHS Act) if
accommodation with reference to those participants in cases where no objection exists. The Departments
covered by the exemption, likewise contraceptive benefits will no longer be believe this array of programs and
expand the kinds of entities that may provided). Alternatively, an eligible requirements better serves the interest of
use the optional accommodation. This organization may give 60-days notice providing contraceptive coverage while
includes plan sponsors with sincerely pursuant to section 2715(d)(4) of the protecting the conscience rights of
held religious beliefs for the reasons PHS Act,64 if applicable, to revoke its entities that have sincerely held
described above. Consequently, under use of the accommodation process. religious objections to some or all
these interim final rules, objecting The Departments have eliminated the contraceptive or sterilization services.
employers may make use of the provision in the previous The Departments request and
exemption, or may choose to pursue the accommodation under which an issuer encourage public comments on all
optional accommodation process. If an is deemed to have complied with the matters addressed in these interim final
eligible organization pursues the Mandate where the issuer relied rules.
optional accommodation process reasonably and in good faith on a V. Interim Final Rules, Request for
through the EBSA Form 700 or other representation by an eligible Comments and Waiver of Delay of
specified notice to HHS, it voluntarily organization as to its eligibility for the Effective Date
shifts an obligation to provide separate accommodation, even if that
but seamless contraceptive coverage to representation was later determined to Section 9833 of the Code, section 734
its issuer or third party administrator. be incorrect. Because any organization of ERISA, and section 2792 of the PHS
The fees adjustment process for with a sincerely held religious objection Act authorize the Secretaries of the
qualifying health issuers or third party to contraceptive coverage is now eligible Treasury, Labor, and HHS (collectively,
administrators pursuant to 45 CFR for the optional accommodation under the Secretaries) to promulgate any
156.50 is not modified, and (as specified these interim final rules and is also interim final rules that they determine
therein) requires for its applicability exempt, the Departments believe there are appropriate to carry out the
that an exception under OMB Circular is minimal opportunity for mistake or provisions of chapter 100 of the Code,
No. A–25R be in effect as the Secretary misrepresentation by the organization, part 7 of subtitle B of title I of ERISA,
of the Department of Health and Human and the reliance provision is no longer and part A of title XXVII of the PHS Act,
Services requests. necessary. which include sections 2701 through
If an eligible organization wishes to 2728 of the PHS Act and the
revoke its use of the accommodation, it I. Definition of Contraceptive Services incorporation of those sections into
can do so under these interim final rules for the Purpose of These Rules section 715 of ERISA and section 9815
and operate under its exempt status. As The interim final rules specify that of the Code. These interim final rules
part of its revocation, the issuer or third when the rules refer to ‘‘contraceptive’’ fall under those statutory authorized
party administrator of the eligible services, benefits, or coverage, such justifications, as did previous rules on
organization must provide participants terms include contraceptive or this matter (75 FR 41726; 76 FR 46621;
and beneficiaries written notice of such sterilization items, services, or related 79 FR 51092).
revocation as specified in guidance patient education or counseling, to the Section 553(b) of the Administrative
issued by the Secretary of the extent specified for purposes of Procedure Act (APA) requires notice
Department of Health and Human § 147.130(a)(1)(iv). This was the case and comment rulemaking, involving a
Services. This revocation process under the previous rules, as expressed notice of proposed rulemaking and a
applies both prospectively to eligible in the preamble text of the various comment period prior to finalization of
organizations who decide at a later date iterations of the regulations, but the regulatory requirements—except when
to avail themselves of the optional Departments wish to make the scope an agency, for good cause, finds that
accommodation and then decide to clear by specifying it in the regulatory notice and public comment thereon are
revoke that accommodation, as well as text. impracticable, unnecessary, or contrary
to organizations that were included in to the public interest. These provisions
the accommodation prior to the effective J. Conclusion of the APA do not apply here because
date of these interim final rules either The Departments believe that the of the specific authority granted to the
by their submission of an EBSA Form Guidelines and the exemptions Secretaries by section 9833 of the Code,
700 or notification, or by some other expanded herein will advance the section 734 of ERISA, and section 2792
means under which their third party limited purposes for which Congress of the PHS Act.
administrator or issuer was notified by imposed section 2713 of the PHS Act, Even if these provisions of the APA
DOL or HHS that the accommodation while acting consistently with Congress’ applied, they would be satisfied: The
applies. Consistent with other well-established record of allowing for Departments have determined that it
applicable laws, the issuer or third party religious exemptions with respect to would be impracticable and contrary to
administrator of an eligible organization especially sensitive health care and the public interest to delay putting these
must promptly notify plan participants health insurance requirements. These provisions in place until a full public
and beneficiaries of the change of status interim final rules leave fully in place notice-and-comment process is
to the extent such participants and over a dozen Federal programs that completed. As discussed earlier, the
beneficiaries are currently being offered provide, or subsidize, contraceptives for Departments have issued three interim
contraceptive coverage at the time the women, including for low income final rules implementing this section of
accommodated organization invokes its women based on financial need. These the PHS Act because of the immediate
exemption. If contraceptive coverage is interim final rules also maintain HRSA’s needs of covered entities and the
being offered by an issuer or third party weighty matters implicated by the
administrator through the 64 See also 26 CFR 54.9815–2715(b); 29 CFR HRSA Guidelines. As recently as
accommodation process, the revocation 2590.715–2715(b); 45 CFR 147.200(b). December 20, 2016, HRSA updated
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those Guidelines without engaging in violated RFRA. Good cause exists to have been waiting to receive from the
the regulatory process (because doing so issue the expanded exemption in these Departments for more than a year. If the
is not a legal requirement), and interim final rules in order to cure such Departments were to publish a notice of
announced that it plans to continue to violations (whether among litigants or proposed rulemaking instead of these
update the Guidelines. among similarly situated parties that interim final rules, many more months
Dozens of lawsuits over the Mandate have not litigated), to help settle or could pass before the current Mandate
have been pending for nearly 5 years. resolve cases, and to ensure, moving is lifted from the entities receiving the
The Supreme Court remanded several of forward, that our regulations are expanded exemption, during which
those cases more than a year ago, stating consistent with any approach we have time those entities would be deprived of
that on remand ‘‘[w]e anticipate that the taken in resolving certain litigation the relief clearly set forth in these
Courts of Appeals will allow the parties matters. interim final rules. In response to
sufficient time to resolve any The Departments have also been several of the previous rules on this
outstanding issues between them’’. subject to temporary injunctions issue—including three issued as interim
Zubik, 136 S. Ct. at 1560. During that protecting many religious nonprofit final rules under the statutory authority
time, Courts of Appeals have been organizations from being subject to the cited above—the Departments received
asking the parties in those cases to accommodation process against their more than 100,000 public comments on
submit status reports every 30 through wishes, while many other organizations multiple occasions. Those comments
90 days. Those status reports have are fully exempt, have permanent court included extensive discussion about
informed the courts that the parties orders blocking the contraceptive whether and by what extent to expand
were in discussions, and about the RFI coverage requirement, or are not subject the exemption. Most recently, on July
issued in late 2016 and its subsequent to section 2713 of the PHS Act and its 26, 2016, the Departments issued a
comment process and the FAQ the enforcement due to Congress’ limited request for information (81 FR 47741)
Departments issued indicating that we application of that requirement. Good and received over 54,000 public
could not find a way at that time to cause exists to change the Departments’ comments about different possible ways
amend the accommodation process so as previous rules to direct HRSA to bring to resolve these issues. In connection
to satisfy objecting eligible organizations its Guidelines in accord with the legal with past regulations, the Departments
while pursuing the Departments’ policy realities and remove the threat of a have offered or expanded a temporary
goals. Since then, several courts have future violation of religious beliefs, safe harbor allowing organizations that
issued orders setting more pressing including where such violations are were not exempt from the HRSA
deadlines. For example, on March 10, contrary to Federal law. Guidelines to operate out of compliance
2017, the United States Court of Other objecting entities similarly have with the Guidelines. The Departments
Appeals for the Seventh Circuit ordered not had the protection of court will fully consider comments submitted
that, by May 1, 2017, ‘‘the court expects injunctions. This includes some in response to these interim final rules,
to see either a report of an agreement to nonprofit entities that have sued the but believe that good cause exists to
resolve the case or detailed reports on Departments, but it also includes some issue the rules on an interim final basis
the parties’ respective positions. In the organizations that do not have lawsuits before the comments are submitted and
event no agreement is reported on or pending against us. For example, many reviewed.
before May 1, 2017, the court will plan of the closely held for-profit companies As the United States Court of Appeals
to schedule oral argument on the merits that brought the array of lawsuits for the D.C. Circuit stated with respect
of the case on short notice after that challenging the Mandate leading up to to an earlier interim final rule
date’’. The Departments submitted a the decision in Hobby Lobby are not promulgated with respect to this issue
status report but were unable to set forth protected by injunctions from the in Priests for Life v. U.S. Department of
their specific position because this current rules, including the requirement Health and Human Services, 772 F.3d
interim final rule was not yet on public that they either fully comply with the 229, 276 (D.C. Cir. 2014), vacated on
display. Instead, the Departments Mandate or subject themselves to the other grounds, Zubik v. Burwell, 136 S.
informed the Court that we ‘‘are now accommodation. Continuing to apply Ct. 1557 (2016), ‘‘[S]everal reasons
considering whether further the Mandate’s regulatory burden on support HHS’s decision not to engage in
administrative action would be individuals and organizations with notice and comment here’’. Among
appropriate’’. In response, the court religious beliefs against it could serve as other things, the Court noted that ‘‘the
extended the deadline to June 1, 2017, a deterrent for citizens who might agency made a good cause finding in the
again declaring the court expected ‘‘to consider forming new entities— rule it issued’’; that ‘‘the regulations the
see either a report of an agreement to nonprofit or for-profit—and to offering interim final rule modifies were recently
resolve the case or detailed reports on health insurance in employer-sponsored enacted pursuant to notice and
the parties’ respective positions’’. The plans or plans arranged by institutions comment rulemaking, and presented
Departments were again unable to set of higher education. Delaying the virtually identical issues’’; that ‘‘HHS
forth their position in that status report, protection afforded by these interim will expose its interim rule to notice
but were able to state that the final rules would be contrary to the and comment before its permanent
‘‘Departments of Health and Human public interest because it would serve to implementation’’; and that ‘‘delay in
Services, Labor, and the Treasury are extend for many months the harm implementation of the rule would
engaged in rulemaking to reconsider the caused to all entities and individuals interfere with the prompt availability of
regulations at issue here,’’ citing https:// with religious objections to the contraceptive coverage and delay the
www.reginfo.gov/public/do/ Mandate. Good cause exists to provide implementation of the alternative opt-
eoDetails?rrid=127381. immediate resolution to this myriad of out for religious objectors’’. Id. at 277.
As discussed above, the Departments situations rather than leaving them to Delaying the availability of the
have concluded that, in many instances, continued uncertainty, inconsistency, expanded exemption would delay the
requiring certain objecting entities or and cost during litigation challenging ability of those organizations and
individuals to choose between the the previous rules. individuals to avail themselves of the
Mandate, the accommodation, or These interim final rules provide a relief afforded by these interim final
penalties for noncomplaince has specific policy resolution that courts rules. Good cause is supported by
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providing relief for entities and interim final rules effective immediately economically significant effects ($100
individuals for whom the Mandate upon filing at the Office of the Federal million or more in any one year), and
operates in violation of their sincerely Register. an ‘‘economically significant’’
held religious beliefs, but who would regulatory action is subject to review by
VI. Economic Impact and Paperwork
have to experience that burden for many the Office of Management and Budget
Burden
more months under the prior (OMB). As discussed below regarding
regulations if these rules are not issued We have examined the impacts of the anticipated effects of these rules and the
on an interim final basis. Good cause is interim final rules as required by Paperwork Reduction Act, these interim
also supported by the effect of these Executive Order 12866 on Regulatory final rules are not likely to have
interim final rules in bringing to a close Planning and Review (September 30, economic impacts of $100 million or
the uncertainty caused by years of 1993), Executive Order 13563 on more in any 1 year, and therefore do not
litigation and regulatory changes made Improving Regulation and Regulatory meet the definition of ‘‘economically
under section 2713(a)(4) of the PHS Act. Review (January 18, 2011), the significant’’ under Executive Order
Issuing interim final rules with a Regulatory Flexibility Act (RFA) 12866. However, OMB has determined
comment period provides the public (September 19, 1980, Pub. L. 96 354), that the actions are significant within
with an opportunity to comment on section 1102(b) of the Social Security the meaning of section 3(f)(4) of the
whether these regulations expanding the Act, section 202 of the Unfunded Executive Order. Therefore, OMB has
exemption should be made permanent Mandates Reform Act of 1995 (March reviewed these final regulations, and the
or subject to modification without 22, 1995; Pub. L. 104–4), Executive Departments have provided the
delaying the effective date of the Order 13132 on Federalism (August 4, following assessment of their impact.
regulations. 1999), the Congressional Review Act (5
Delaying the availability of the U.S.C. 804(2) and Executive Order 1. Need for Regulatory Action
expanded exemption would also 13771 on Reducing Regulation and These interim final rules amend the
increase the costs of health insurance. Controlling Regulatory Costs (January Departments’ July 2015 final regulations
As reflected in litigation pertaining to 30, 2017). to expand the exemption from the
the Mandate, some entities are in requirement to provide coverage for
A. Executive Orders 12866 and 13563—
grandfathered health plans that do not contraceptives and sterilization,
Department of HHS and Department of
cover contraception. They wish to make established under the HRSA Guidelines,
Labor
changes to their health plans that will promulgated under section 2713(a)(4) of
reduce the costs of insurance coverage Executive Orders 12866 and 13563 the PHS Act, section 715(a)(1) of the
for their beneficiaries or policyholders, direct agencies to assess all costs and ERISA, and section 9815(a)(1) of the
but which would cause the plans to lose benefits of available regulatory Code, and to revise the accommodation
grandfathered status. They are refraining alternatives and, if regulation is process to make it optional for eligible
from making those changes—and necessary, to select regulatory organizations. The expanded exemption
therefore are continuing to incur and approaches that maximize net benefits would apply to individuals and entities
pass on higher insurance costs—to (including potential economic, that have religious objections to some
prevent the Mandate from applying to environmental, and public health and (or all) of the contraceptive and/or
their plans in violation of their safety effects; distributive impacts; and sterilization services that would be
consciences. Issuing these rules on an equity). Executive Order 13563 covered under the Guidelines. Such
interim final basis is necessary in order emphasizes the importance of action is taken, among other reasons, to
to help reduce the costs of health quantifying both costs and benefits, provide for participation in the health
insurance for such entities and their reducing costs, harmonizing rules, and insurance market by certain entities or
plan participants. promoting flexibility. individuals free from penalties for
These interim final rules also set forth Section 3(f) of Executive Order 12866 violating sincerely held religious beliefs
an optional accommodation process, defines a ‘‘significant regulatory action’’ opposed to providing or receiving
and expand eligibility for that process to as an action that is likely to result in a coverage of contraceptive services, and
a broader category of entities. Delaying regulation: (1) Having an annual effect to resolve many of the lawsuits that
the availability of the optional on the economy of $100 million or more have been filed against the Departments.
accommodation process would delay in any one year, or adversely and
materially affecting a sector of the 2. Anticipated Effects
the ability of organizations that do not
now qualify for the accommodation, but economy, productivity, competition, The Departments assess this interim
wish to opt into it, to be able to do so jobs, the environment, public health or final rule together with a companion
and therefore to provide a mechanism safety, or State, local, or tribal interim final rule concerning moral but
for contraceptive coverage to be governments or communities (also non-religious conscientious objections
provided to their employees while the referred to as ‘‘economically to contraception, published elsewhere
organization’s religious objections are significant’’); (2) creating a serious in this Federal Register. Regarding
accommodated. inconsistency or otherwise interfering entities that are extended an exemption,
For the foregoing reasons, the with an action taken or planned by absent expansion of the exemption the
Departments have determined that it another agency; (3) materially altering Guidelines would require many of these
would be impracticable and contrary to the budgetary impacts of entitlement entities and individuals to either: Pay
the public interest to engage in full grants, user fees, or loan programs or the for coverage of contraceptive services
notice and comment rulemaking before rights and obligations of recipients that they find religiously objectionable;
putting these interim final rules into thereof; or (4) raising novel legal or submit self-certifications that would
effect, and that it is in the public interest policy issues arising out of legal result in their issuer or third party
to promulgate interim final rules. For mandates, the President’s priorities, or administrator paying for such services
the same reasons, the Departments have the principles set forth in the Executive for their employees, which some entities
determined, consistent with section Order. also believe entangles them in the
553(d) of the APA (5 U.S.C. 553(d)), that A regulatory impact analysis must be provision of such objectionable
there is good cause to make these prepared for major rules with coverage; or, pay tax penalties or be
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subject to other adverse consequences administrators, who will no longer have contraceptive access, such as through a
for non-compliance with these continuing obligations imposed on them parent’s or spouse’s plan, or through
requirements. These interim final rules by the accommodation. one of the many governmental programs
remove certain associated burdens These interim final rules will result in that subsidize contraceptive coverage to
imposed on these entities and some persons covered in plans of newly supplement their access.
individuals—that is, by recognizing exempt entities not receiving coverage The Departments have access to
their religious objections and exempting or payments for contraceptive services. sources of information discussed in the
them—on the basis of such objections— The Departments do not have sufficient following paragraphs that are relevant to
from the contraceptive and/or data to determine the actual effect of this issue, but those sources do not
sterilization coverage requirement of the these rules on plan participants and provide a full picture of the impact of
HRSA Guidelines and making the beneficiaries, including for costs they these interim final rules.
accommodation process optional for may incur for contraceptive coverage, First, the prior rules already exempted
eligible organizations. nor of unintended pregnancies that may certain houses of worship and their
To the extent that entities choose to occur. As discussed above and for integrated auxiliaries. Further, as
revoke their accommodated status to reasons explained here, there are discussed above, the prior
make use of the expanded exemption multiple levels of uncertainty involved accommodation process allows
immediately, a notice will need to be in measuring the effect of the expanded hundreds of additional religious
sent to enrollees (either by the entity or exemption, including but not limited nonprofit organizations in self-insured
by the issuer or third party to— church plans that are exempt from
administrator) that their contraceptive • How many entities will make use of ERISA to file a self-certification or
coverage is changing, and guidance will their newly exempt status. notice that relieves not only themselves
reflect that such a notice requirement is • how many entities will opt into the but, in effect, their third party
imposed no more than is already accommodation maintained by these administrators of any obligation to
required by preexisting rules that rules, under which their plan provide contraceptive coverage or
require notices to be sent to enrollees of participants will continue receiving payments. Although in the latter case,
changes to coverage during a plan year. contraceptive coverage. third party administrators are legally
If the entities wait until the start of their • which contraceptive methods some permitted to provide the coverage,
next plan year to change to exempt newly exempt entities will continue to several self-insured church plans
status, instead of doing so during a plan provide without cost-sharing despite the themselves have expressed an objection
year, those entities generally will also be entity objecting to other methods (for in litigation to allowing such
able to avoid sending any example, as reflected in Hobby Lobby, contraceptive coverage to be provided,
supplementary notices in addition to several objecting entities still provide and according to information received
what they would otherwise normally coverage for 14 of the 18 women’s during litigation, it appears that such
send prior to the start of a new plan contraceptive or sterilization methods, contraceptive coverage has not been
year. Additionally, these interim final 134 S. Ct. at 2766). provided. In addition, a significant
rules provide such entities with an • how many women will be covered portion of the lawsuits challenging the
offsetting regulatory benefit by the by plans of entities using their newly Mandate were brought by a single firm
exemption itself and its relief of burdens exempt status. representing Catholic dioceses and
on their religious beliefs. As discussed • which of the women covered by related entities covered by their diocese-
below, assuming that more than half of those plans want and would have used sponsored plans. In that litigation, the
entities that have been using the contraceptive coverage or payments for Departments took the position that,
previous accommodation will seek contraceptive methods that are no where those diocese-sponsored plans
immediate revocation of their longer covered by such plans. are self-insured, those plans are likely
accommodated status and notices will • whether, given the broad church plans exempt from ERISA.65 For
be sent to all their enrollees, the total availability of contraceptives and their the purposes of considering whether the
estimated cost of sending those notices relatively low cost, such women will expanded exemption in these rules
will be $51,990. obtain and use contraception even if it affects the persons covered by such
The Departments estimate that these is not covered. diocese-sponsored plans, the
interim final rules will not result in any • the degree to which such women Departments continue to assume that
additional burdens or costs on issuers or are in the category of women identified such plans are similar to other objecting
third party administrators. As discussed by IOM as most at risk of unintended entities using self-insured church plans
below, the Departments believe that 109 pregnancy. with respect to their third party
of the 209 entities making use of the • the degree to which unintended
administrators being unlikely to provide
accommodation process will instead pregnancies may result among those
contraceptive coverage to plan
make use of their newly exempt status. women, which would be attributable as
participants and beneficiaries under the
In contrast, the Departments expect that an effect of these rules only if the
previous rule. Therefore the
a much smaller number (which we women did not otherwise use
assume to be 9) will make use of the contraception or a particular 65 See, for example, Brief in Opp. To Pls.’ Mot.
accommodation that were not provided contraceptive method due to their plan for Prelim. Inj., Brandt v. Burwell, No. 2:14–cv–
access to it previously. Reduced making use of its newly exempt status. 681–AJS, doc. #23 (W.D. Pa. filed June 10, 2014)
burdens for issuers and third party • the degree to which such (arguing that ‘‘plaintiffs have not established an
administrators due to reductions in use unintended pregnancies may be injury in fact to the degree plaintiffs have a self-
insured church plan,’’ based on the fact that ‘‘the
of the accommodation will more than associated with negative health effects, same law firm representing the plaintiffs here has
offset increased obligations on issuers or whether such effects may be offset by suggested in another similar case that all ‘Catholic
and third party administrators serving other factors, such as the fact that those entities like the Archdiocese participate in ‘‘church
the fewer number of entities that will women will be otherwise enrolled in plans.’’ ’); Roman Catholic Archdiocese of N.Y. v.
Sebelius, 987 F. Supp. 2d 232, 242 (E.D.N.Y. 2013)
newly opt into the accommodation. This insurance coverage. (‘‘because plaintiffs’ self-insured plans are church
will lead to a net decrease in burdens • the extent to which such women plans, their third party administrators would not be
and costs on issuers and third party will qualify for alternative sources of required to provide contraceptive coverage’’).
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Departments estimate that these interim fervency. For the reasons discussed filed lawsuits challenging the Mandate.
final rules have no significant effect on above, the Departments no longer The Departments agree with the
the contraceptive coverage of women believe we can distinguish many of the Supreme Court’s expectation in this
covered by plans of houses of worship women covered in the plans of religious regard: ‘‘it seems unlikely that the sort
and their integrated auxiliaries, entities nonprofit entities from the women of corporate giants to which HHS refers
using a self-insured church plan, or covered in the plans of houses of will often assert RFRA claims. HHS has
church dioceses sponsoring self-insured worship and integrated auxiliaries not pointed to any example of a publicly
plans. regarding which the Departments traded corporation asserting RFRA
It is possible that an even greater assumed share their employers’ rights, and numerous practical restraints
number of litigating or accommodated objection to contraception, nor from would likely prevent that from
plans might have made use of self- women covered in the plans of religious occurring. For example, the idea that
insured church plan status under the entities using self-insured church plans unrelated shareholders—including
previous accommodation. Notably, one regarding which we chose not to institutional investors with their own
of the largest nonprofit employers that calculate any anticipated effect even set of stakeholders—would agree to run
had filed suit challenging the Mandate though we conceded we were not a corporation under the same religious
had, under these prior rules, shifted requiring their third party beliefs seems improbable’’. Hobby
most of their employees into self- administrators to provide contraceptive Lobby, 134 S. Ct. at 2774. Therefore,
insured church plans, and the coverage. In the estimates and although publicly traded entities could
Departments have taken the position assumptions below, we include the make use of exempt status under these
that various other employers that filed potential effect of these interim rules on interim final rules, the Departments do
suit were eligible to assume self-insured women covered by such entities, in not expect that very many will do so, as
church plan status.66 The Supreme order to capture all of the anticipated compared to the 87 religious closely
Court’s recent decision in Advocate effects of these rules. held for-profit entities that brought
Health Care Network, while not Third, these interim final rules extend litigation challenging the Mandate
involving this Mandate, also clarifies the exemption to for-profit entities. (some of which might be content with
certain circumstances under which Among the for-profit employers that the accommodation).
religious hospitals may be eligible for filed suit challenging the Mandate, the Fourth, the Departments have a
self-insured church plan status. See 137 one with the most employees was limited amount of information about
S. Ct. at 1656–57, 1663 (holding that a Hobby Lobby.67 As noted above, and entities that have made use of the
church plan under ERISA can be a plan like some similar entities, the plaintiffs accommodation process as set forth in
not established and maintained by a in Hobby Lobby were willing to provide the previous rules. HHS previously
church, if it is maintained by a coverage with no cost sharing of various estimated that 209 entities would make
principal-purpose organization). contraceptive services: 14 of 18 FDA- use of the accommodation process. That
Second, when the Departments approved women’s contraceptive and estimate was based on HHS’s
previously created the exemption, sterilization methods.68 (134 S. Ct. at observation in its August 2014 interim
expanded its application, and provided 2766.) The effect of expanding the final rules and July 2015 final
an accommodation (which, as exemption to for-profit entities is regulations that there were 122 eligible
mentioned, can lift obligations on self- therefore mitigated to the extent many entities that had filed litigation
insured church plans for hundreds of of the persons covered by such entities’ challenging the accommodation process,
nonprofit organizations), we concluded plans may receive coverage for at least and 87 closely held for-profit entities
that no significant burden or costs some contraceptive services. No that had filed suit challenging the
would result at all. (76 FR 46625; 78 FR publicly traded for-profit entities have Mandate in general. (79 FR 51096; 80 FR
39889.) We reached this conclusion 41336). The Departments acknowledged
despite the impact, just described, 67 Verified Complaint ¶ 34, Hobby Lobby Stores, that entities that had not litigated might
whereby the previous rule apparently Inc., et al. v. Sebelius, No. 5:12–cv–01000–HE (Sept. make use of the accommodation, but we
12, 2012 W.D. Okla.) (13,240 employees).
lead to women not receiving 68 By reference to the FDA Birth Control Guide’s
stated we did not have better data to
contraceptive coverage through list of 18 birth control methods for women and 2 estimate how many might use the
hundreds of nonprofit entities using for men, https://www.fda.gov/downloads/ accommodation overall.
self-insured church plans. We also forconsumers/byaudience/forwomen/ After issuing those rules, the
reached this conclusion without freepublications/ucm517406.pdf, Hobby Lobby and Departments have not received
entities with similar beliefs were not willing to
counting any significant burden or cost cover: IUD copper; IUD with progestin; emergency complete data on the number of entities
to some women covered in the plans of contraceptive (Levonorgestrel); and emergency actually using the accommodation,
houses of worship or integrated contraceptive (Ulipristal Acetate). See 134 S. Ct. at because the accommodation does not
auxiliaries that might want 2765–66. Hobby Lobby was willing to cover: require many accommodated entities to
Sterilization surgery for women; sterilization
contraceptive coverage. This conclusion implant for women; implantable rod; shot/injection; submit information to us. Our limited
was based in part on the assertion, set oral contraceptives (‘‘the Pill’’—combined pill); oral records indicate that approximately 63
forth in previous regulations, that contraceptives (‘‘the Pill’’—extended/continuous entities have affirmatively submitted
employees of houses of worship and use/combined pill); oral contraceptives (‘‘the Mini notices to HHS to use the
Pill’’—progestin only); patch; vaginal contraceptive
integrated auxiliaries likely share their ring; diaphragm with spermicide; sponge with accommodation. This includes some
employers’ opposition to contraception. spermicide; cervical cap with spermicide; female fully insured and some self-insured
Many other religious nonprofit entities, condom; spermicide alone. Id. Among women using plans, but it does not include entities
however, both adopt and implement these 18 female contraceptive methods, 85 percent that may have used the accommodation
use the 14 methods that Hobby Lobby and entities
religious principles with similar with similar beliefs were willing to cover
by submitting an EBSA form 700 self-
(22,446,000 out of 26,436,000), and ‘‘[t]he pill and certification directly to their issuer or
66 See https://www.franciscanhealth.org/sites/ female sterilization have been the two most third party administrator. We have
default/files/ commonly used methods since 1982.’’ See deemed some other entities as being
2015%20employee%20benefit%20booklet.pdf.; see, Guttmacher Institute, ‘‘Contraceptive Use in the
for example, Roman Catholic Archdiocese of N.Y. United States’’ (Sept. 2016), available at https://
subject to the accommodation through
v. Sebelius, 987 F. Supp. 2d 232, 242 (E.D.N.Y. www.guttmacher.org/fact-sheet/contraceptive-use- their litigation filings, but that might not
2013). united-states. have led to contraceptive coverage being
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provided to persons covered in some of there are or how many will choose into the accommodation is not caused
those plans, either because they are either option. by these rules.
exempt as houses of worship or Overall, therefore, without sufficient Without any data to estimate how
integrated auxiliaries, they are in self- data to estimate what the estimated 209 many of any entities newly eligible for
insured church plans, or we were not previously accommodated entities will and interested in using the
aware of their issuers or third party do under these interim final rules, we accommodation might exist, HHS
administrators so as to send them letters assume that just over half of them will assumes for the purposes of estimating
obligating them to provide such use the expanded exemption, and just the anticipated effect of these rules that
coverage. Our records also indicate that under half will continue their less than 10 entities (9) will do so.
60 plans used the contraceptive user accommodated status under the Therefore, we estimate that 109 entities
fees adjustments in the 2015 plan year, voluntary process set forth in these will use the voluntary accommodation
the last year for which we have data. rules. Specifically, we assume that 109 moving forward, 100 of which were
This includes only self-insured plans, previously accommodated entities will already using the previous
and it includes some plans that self- make use of their exempt status, and accommodation, and that 109 entities
certified through submitting notices and 100 will continue using the that have been using the previous
other plans that, presumably, self- accommodation. This estimate is based accommodation will use the expanded
certified through the EBSA form 700. in part on our view that most litigating exemption instead.
These sets of data are not inconsistent nonprofit entities would prefer the Fifth, in attempting to estimate the
with our previous estimate that 209 exemption to the accommodation, but anticipated effect of these interim final
entities would use the accommodation, that many of either have not been using rules on women receiving contraceptive
but they indicate that some non- the accommodation or, if they have been coverage, the Departments have limited
using it, it is not providing information about the entities that have
litigating entities used the
contraceptive coverage for women in filed suit challenging the Mandate.
accommodation, and some litigating
their plans where they participate in Approximately 209 entities have
entities did not, possibly amounting to
self-insured church plans. This estimate brought suit challenging the Mandate
a similar number. For this reason, and
is also consistent with our lack of over more than 5 years. They have
because we do not have more complete
knowledge of how many for-profit included a broad range of nonprofit
data available, we believe the previous
entities were using the accommodation entities and closely held for-profit
estimate of 209 accommodated entities
and will choose the exemption or the entities. We discuss a number of
is still the best estimate available for
accommodation, given that many of potentially relevant points:
how many entities have used the First, the Departments do not believe
them did not bring legal challenges
accommodation under the previous that out-of-pocket litigation costs have
against the accommodation after Hobby
rule. This assumes that the number of been a significant barrier to entities
Lobby. This estimate is further
litigating entities that did not use the choosing to file suit. Based on the
consistent with our view, explained in
accommodation is approximately the Departments’ knowledge of these cases
more detail below, that some entities
same as the number of non-litigating through public sources and litigation,
that are using the accommodation and
entities that did use it. nearly all the entities were represented
did not bring litigation will use the
In considering how many entities will exemption, but many accommodated, pro bono and were subject to little or no
use the voluntary accommodation non-litigating entities—including the discovery during the cases, and multiple
moving forward—and how many will ones with the largest relative workforces public interest law firms publicly
use the expanded exemption—we also among accommodated entities—will provided legal services for entities
do not have specific data. We expect the continue using the accommodation. The willing to challenge the Mandate.69 (It is
122 nonprofit entities that specifically Departments recognize that we do not noteworthy, however, that such pro
challenged the accommodation in court have better data to estimate the effects bono arrangements and minimization of
to use the expanded exemption. But, as of these interim final rules on such discovery do not eliminate 100 percent
noted above, we believe a significant entities. of the time costs of participating in
number of them are not presently In addition to these factors, we litigation or, as discussed in more detail
participating in the accommodation, recognize that the expanded exemption below, the potential for negative
and that some nonprofit entities in self- and accommodation are newly available
insured church plans are not providing to religious for-profit entities that are 69 See, for example, Catholic Diocese of
contraceptive coverage through their not closely held and some other plan Pittsburgh, ‘‘Award-winning attorney ‘humbled’ by
recognition,’’ Pittsburgh Catholic (‘‘Jones Day is
third party administrators even if they sponsors. As explained above, the doing the cases ‘pro bono,’ or voluntarily and
are using the accommodation. Among Departments believe religious for-profit without payment.’’) (quoting Paul M. Pohl, Partner,
the 87 for-profit entities that filed suit entities that are not closely held may Jones Day), available at http://diopitt.org/
challenging the Mandate in general, few exist, or may wish to come into being. pittsburgh-catholic/award-winning-attorney-
humbled-recognition; ‘‘Little Sisters Fight for
if any filed suit challenging the HHS does not anticipate that there will Religious Freedom,’’ National Review (Oct. 2, 2013)
accommodation. We do not know how be significant number of such entities, (‘‘the Becket Fund for Religious Liberty is
many of those entities are using the and among those, we believe that very representing us pro bono, as they do all their
accommodation, how many may be clients.’’) (quoting Sister Constance Veit, L.S.P.,
few if any will use the accommodation. communications director for the Little Sisters of the
complying with the Mandate fully, how All of the for-profit entities that have Poor), available at http://www.nationalreview.com/
many may be relying on court challenged the Mandate have been article/360103/little-sisters-fight-religious-freedom-
injunctions to do neither, or how many religious closely held entities. interview; Suzanne Cassidy, ‘‘Meet the major legal
will use the expanded exemption It is also possible that religious players in the Conestoga Wood Specialties Supreme
Court case,’’ LancasterOnline (Mar. 25, 2014)
moving forward. Among entities that nonprofit or closely held for-profit (‘‘Cortman and the other lawyers arguing on behalf
never litigated but used the entities that were already eligible for the of Conestoga Wood Specialties and Hobby Lobby
accommodation, we expect many but accommodation but did not previously are offering their services pro bono.’’), available at
http://lancasteronline.com/news/local/meet-the-
not all of them to continue using the use it will opt into it moving forward, major-legal-players-in-the-conestoga-wood-
accommodation, and we do not have but because they could have done so specialties/article_302bc8e2-b379-11e3-b669-
data to estimate how many such entities under the previous rules, their opting 001a4bcf6878.html.
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publicity. Both concerns could have provide some information, albeit approximately 44.3 percent of women of
dissuaded participation in lawsuits, and incomplete, about how many people are childbearing age use women’s
the potential for negative publicity may employed by these entities. As noted contraceptive methods covered by the
also dissuade participation in the above, however, contraceptive coverage Guidelines.75 Therefore, we estimate
expanded exemptions.) among the employees of many litigating that approximately 7,221 women of
Second, prior to the Affordable Care entities will not be affected by these childbearing age that use contraception
Act, the vast majority of entities already rules because some litigating entities covered by the Guidelines are covered
covered contraception, albeit not always were exempt under the prior rule, while by employer sponsored plans of entities
without cost-sharing The Departments others were or appeared to be in self- that have filed lawsuits challenging the
do not have data to indicate why insured church plans so that women Mandate, where those plans are neither
entities that did not cover contraception covered in their plans were already not exempt under the prior rule nor are self-
prior to the Affordable Care Act chose receiving contraceptive coverage. insured church plans.
not to cover it. As noted above, Among litigating entities that were We also estimate that for the
however, the Departments have neither exempt nor likely using self- educational institutions objecting to the
maintained that compliance with the insured church plans, our best estimate Mandate as applied to student coverage
contraceptive Mandate is cost-neutral to based on court documents and public that they arranged, where the entities
issuers, which indicates that no sources is that such entities employed were neither exempt under the prior
significant financial incentive exists to approximately 65,000 persons, male and rule nor were their student plans self-
omit contraceptive coverage. As female.71 The average number of insured, such student plans likely
indicated by the report by HHS ASPE workers at firms offering health benefits covered approximately 3,300 students.
discussed above, we have assumed that that are actually covered by those On average, we expect that
millions of women received preventive benefits is 62 percent.72 This amounts to approximately half of those students
services after the Mandate went into approximately 34,000 employees (1,650) are female. For the purposes of
effect because nearly all entities covered under those plans. DOL this estimate, we also assume that
complied with the Guidelines. We are estimates that for each employee female policyholders covered by plans
not aware of expressions from most of policyholder, there is approximately arranged by institutions of higher
those entities indicating that they would one dependent.73 This amounts to education are women of childbearing
have sincerely held religious objections approximately 68,000 covered persons. age. We expect that they would have
to complying with the Mandate, and Census data indicate that women of less than the average number of
therefore that they would make use of childbearing age—that is, women aged dependents per policyholder than exists
the expanded exemption provided here. 15–44—compose 20.2 percent of the in standard plans, but for the purposes
Third, omitting contraceptive general population.74 In addition, of providing an upper bound to this
coverage has subjected some entities to estimate, we assume that they would
serious public criticism and in some number of employees that work for an entity, and have an average of one dependent per
cases organized boycotts or opposition that entity was not apparently exempt as a house policyholder, thus bringing the number
of worship or integrated auxiliary, and it was not
campaigns that have been reported in using the kind of plan that we have stated in of policyholders and dependents back
various media and online outlets litigation qualifies for self-insured church plan up to 3,300. Many of those dependents
regarding entities that have filed suit. status (see, for example, Roman Catholic are likely not to be women of
Archdiocese of N.Y. v. Sebelius, 987 F. Supp. 2d
The Departments expect that even if 232, 242 (E.D.N.Y. 2013)), we examined
childbearing age, but in order to provide
some entities might not receive such employment data contained in some IRS form an upper bound to this estimate, we
criticism, many entities will be reluctant W–3’s that are publicly available online for certain assume they are. Therefore, for the
to use the expanded exemption unless nonprofit groups, and looked at other Web sites purposes of this estimate, we assume
discussing the number of people employed at
they are committed to their views to a certain entities. that the effect of these expanded
significant degree. 71 In a small number of lawsuits, named plaintiffs exemptions on student plans of
Overall, the Departments do not know include organizations claiming to have members litigating entities includes 3,300
how many entities will use the that seek an exemption. We have very little women. Assuming that 44.3 perecent of
expanded exemption. We expect that information about the number, size, and types of
entities those members. Based on limited
such women use contraception covered
some non-litigating entities will use it, information from those cases, however, their by the Guidelines,76 we estimate that
but given the aforementioned membership appears to consist mainly, although
considerations, we believe it might not not entirely, of houses of worship, integrated c2010br-03.pdf. The Guidelines’ requirement of
be very many more. Moreover, many auxiliaries, and participants in self-insured plans of contraceptive coverage only applies ‘‘for all women
churches. As explained above, the contraceptive with reproductive capacity.’’ https://www.hrsa.gov/
litigating entities are already exempt or coverage of women covered by such plans is not womensguidelines/; also, see 80 FR 40318. In
are not providing contraceptive likely to be affected by the expanded exemption in addition, studies commonly consider the 15–44 age
coverage to women in their plans due to these rules. However, to account for plans subject range to assess contraceptive use by women of
their participating in self-insured to contraceptive coverage obligations among those childbearing age. See, for example, Guttmacher
members we have added 10,000 to our estimate of Institute, ‘‘Contraceptive Use in the United States’’
church plans, so the effect of the the number of persons among litigants that may be (Sept. 2016), available at https://
expanded exemption among litigating impacted by these rules. www.guttmacher.org/fact-sheet/contraceptive-use-
entities is significantly lower than it 72 See Kaiser Family Foundation and Health united-states.
would be if all the women in their plans Research and Educational Trust, ‘‘Employer Health 75 See https://www.guttmacher.org/fact-sheet/
Benefits: 2017 Annual Survey’’ at 57, available at contraceptive-use-united-states (reporting that of
were already receiving the coverage. http://files.kff.org/attachment/Report-Employer- 60,877,000 women aged 15–44, 26,945,000 use
To calculate the anticipated effects of
Health-Benefits-Annual-Survey-2017. women’s contraceptive methods covered by the

this rule on contraceptive coverage 73 ‘‘Health Insurance Coverage Bulletin’’ Table 4, Guidelines).
among women covered by plans page 21. Using March 2015 Annual Social and 76 It would appear that a smaller percentage of
provided by litigating entities, we start Economic Supplement to the Current Population college-aged women use contraception—and use
Survey. https://www.dol.gov/sites/default/files/ more expensive methods such as long acting
by examining court documents and ebsa/researchers/data/health-and-welfare/health- methods or sterilization—than among other women
other public sources.70 These sources insurance-coverage-bulletin-2015.pdf. of childbearing age. See NCHS Data Brief, ‘‘Current
74 United States Census Bureau, ‘‘Age and Sex Contraceptive Status Among Women Aged 15–44:
70 Where complaints, affidavits, or other Composition: 2010’’ (May 2011), available at United States, 2011–2013’’ (Dec. 2014), available at
documents filed in court did not indicate the https://www.census.gov/prod/cen2010/briefs/ Continued
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1,462 of those women would be affected plans provided by religious nonprofit anticipated effect on the contraceptive
by these rules. hospitals or health systems may not be coverage of women in those plans.
Together, this leads the Departments affected by the expanded exemption. A Considering all these data points and
to estimate that approximately 8,700 broad range of religious hospitals or limitations, the Departments offer the
women of childbearing age may have health systems have publicly indicated following estimate of the number of
their contraception costs affected by that they do not conscientiously oppose women who will be impacted by the
plans of litigating entities using these participating in the accommodation.78 expanded exemption in these interim
expanded exemptions. As noted above, Of course, some of these religious final rules. The Departments begin with
the Departments do not have data hospitals or health systems may opt for the 8,700 women of childbearing age
indicating how many of those women the expanded exemption under these that use contraception who we estimate
agree with their employers’ or interim final rules, but others might not. will be affected by use of the expanded
educational institutions’ opposition to In addition, among plans of religious exemption among litigating entities. In
contraception (so that fewer of them nonprofit hospitals or health systems, addition to that number, we calculate
than the national average might actually some have indicated that they might be the following number of women affected
use contraception). Nor do we know eligible for status as a self-insured by accommodated entities using the
how many would have alternative church plan.79 As discussed above, expanded exemption. As noted above,
contraceptive access from a parent’s or some litigants challenging the Mandate approximately 576,000 plan participants
spouse’s plan, or from Federal, State, or have appeared, after their complaints and beneficiaries were covered by self-
local governmental programs, nor how were filed, to make use of self-insured insured plans that received
many of those women would fall in the contraceptive user fee adjustments in
church plan status.80 (The Departments
category of being most at risk of 2014. Although additional self-insured
take no view on the status of these
unintended pregnancy, nor how many entities may have participated in the
particular plans under ERISA, but
of those entities would provide some accommodation without making use of
simply make this observation for the
contraception in their plans while only contraceptive user fees adjustments, we
purpose of seeking to estimate the
objecting to certain contraceptives. do not know what number of entities
impact of these interim final rules.) did so. We consider it likely that self-
Sixth, in a brief filed in the Zubik Nevertheless, overall it seems likely that
litigation, the Departments stated that insured entities with relatively larger
many of the remaining religious hospital numbers of covered persons had
‘‘in 2014, [HHS] provided user-fee or health systems plans previously
reductions to compensate TPAs for sufficient financial incentive to make
using the accommodation will continue use of the contraceptive user fees
making contraceptive coverage available to opt into the voluntary
to more than 600,000 employees and adjustments. Therefore, without better
accommodation under these interim data available, we assume that the
beneficiaries,’’ and that ‘‘[t]hat figure final rules, under which their
includes both men and women covered number of persons covered by self-
employees will still receive insured plans using contraceptive user
under the relevant plans.’’ 77 HHS has contraceptive coverage. To the extent
reviewed the information giving rise to fees adjustments approximates the
that plans of religious hospitals or number of persons covered by all self-
that estimate, and has received updated health systems are able to make use of
information for 2015. In 2014, 612,000 insured plans using the accommodation.
self-insured church plan status, the An additional but unknown number
persons were covered by plans claiming previous accommodation rule would of persons were likely covered in fully
contraceptive user fees adjustments, and already have allowed them to relieve insured plans using the accommodation.
in 2015, 576,000 persons were covered themselves and their third party The Departments do not have data on
by such plans. These numbers include administrators of obligations to provide how many fully insured plans have
all persons in such plans, not just contraceptive coverage or payments. been using the accommodation, nor on
women of childbearing age. Therefore, in such situations these how many persons were covered by
HHS’s information indicates that interim final rules would not have an those plans. DOL estimates that, among
religious nonprofit hospitals or health persons covered by employer sponsored
systems sponsored a significant 78 See, for example, https://www.chausa.org/ insurance, 56.1 percent are covered by
minority of the accommodated self- newsroom/women%27s-preventive-health-services- self-insured plans and 43.9 percent are
insured plans that were using final-rule (‘‘HHS has now established an
covered by fully insured plans.81
contraceptive user fees adjustments, yet accommodation that will allow our ministries to
continue offering health insurance plans for their Therefore, corresponding to the 576,000
those plans covered more than 80 employees as they have always done. . . . We are persons covered by self-insured plans
percent of the persons covered in all pleased that our members now have an using user fee adjustments, we estimate
plans using contraceptive user fees accommodation that will not require them to an additional 451,000 persons were
adjustments. Some of those plans cover contract, provide, pay or refer for contraceptive
coverage. . . . We will work with our members to covered by fully insured plans using the
nearly 100,000 persons each, and implement this accommodation.’’) In comments accommodation. This yields an estimate
several others cover approximately submitted in previous rules concerning this of 1,027,000 covered persons of all ages
40,000 persons each. In other words, Mandate, the Catholic Health Association has stated and sexes in plans using the previous
these plans were proportionately much it ‘‘is the national leadership organization for the
Catholic health ministry, consisting of more than accommodation.
larger than the plans provided by other 2,000 Catholic health care sponsors, systems, As discussed below, and recognizing
entities using the contraceptive user fees hospitals, long-term care facilities, and related the limited data available for our
adjustments. organizations. Our ministry is represented in all 50 estimates, the Departments estimate that
There are two reasons to believe that states and the District of Columbia.’’ Comments on
CMS–9968–ANPRM (dated June 15, 2012). 100 of the 209 entities that were using
a significant fraction of the persons 79 See, for example, Brief of the Catholic Health the accommodation under the prior rule
covered by previously accommodated Association of the United States as Amicus Curiae
in Support of Petitioners, Advocate Health Care 81 ‘‘Health Insurance Coverage Bulletin’’ Table
https://www.cdc.gov/nchs/data/databriefs/ Network, Nos. 16–74, 16–86, 16–258, 2017 WL 3A, page 15. Using March 2015 Annual Social and
db173.pdf. 371934 at *1 (U.S. filed Jan. 24, 2017) (‘‘CHA Economic Supplement to the Current Population
77 Brief of Respondents at 18–19 & n.7, Zubik v. members have relied for decades that the ‘church Survey. https://www.dol.gov/sites/default/files/
Burwell, No. 14–1418, et al. (U.S. filed Feb. 10, plan’ exemption contained in’’ ERISA.). ebsa/researchers/data/health-and-welfare/health-
2016). The actual number is 612,487. 80 See supra note 66. insurance-coverage-bulletin-2015.pdf.
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will continue to opt into it under these to be affected by accommodated entities approximately $584 per year per woman
interim final rules. Notably, however, using the expanded exemption. of childbearing age that use
the data concerning accommodated self- It is not clear the extent to which this contraception covered by the Guidelines
insured plans indicates that plans number overlaps with the number and are covered in their plans.
sponsored by religious hospitals and estimated above of 8,700 women in As discussed above, the Departments
health systems encompass more than 80 plans of litigating entities that may be estimate that the expanded exemptions
percent of the persons covered in such affected by these rules. Based on our will impact the contraceptive costs of
plans. In other words, plans sponsored limited information from the litigation approximately 31,700 women of
by such entities have a proportionately and accommodation notices, we expect childbearing age that use contraception
larger number of covered persons than that the overlap is significant. covered by the Guidelines. At an
do plans sponsored by other Nevertheless, in order to estimate the average of $584 per year, the financial
accommodated entities, which have possible effects of these rules, we transfer effects attributable to the
smaller numbers of covered persons. As assume there is no overlap between interim final rules on those women
these two numbers, and therefore that would be approximately $18.5
also cited above, many religious
these interim final rules would affect million.83 84
hospitals and health systems have
the contraceptive costs of approximately To account for uncertainty in the
indicated that they do not object to the
31,700 women. estimate, we conducted a second
accommodation, and some of those Under the assumptions just discussed,
entities might also qualify as self- analysis using an alternative framework,
the number of women whose in order to thoroughly consider the
insured church plans, so that these contraceptive costs will be impacted by
interim final rules would not impact the possible upper bound economic impact
the expanded exemption in these of these interim final rules.
contraceptive coverage their employees interim final rules is less than 0.1
receive. We do not have specific data on As noted above, the HHS ASPE report
percent of the 55.6 million women in estimated that 55.6 million women aged
which plans of which sizes will actually private plans that HHS ASPE 15 to 64 and covered by private
continue to opt into the estimated 82 receive preventive services insurance had preventive services
accommodation, nor how many will coverage under the Guidelines. coverage under the Affordable Care Act.
make use of self-insured church plan In order to estimate the cost of
Approximately 16.2 percent of those
status. We assume that the proportions contraception to women affected by the
women were enrolled in plans on
of covered persons in self-insured plans expanded exemption, the Departments
exchanges or were otherwise not
using contraceptive user fees are aware that, under the prior
covered by employer sponsored
adjustments also apply in fully insured accommodation process, the total user
insurance, so only 46.6 million women
plans, for which we lack representative fee adjustment amount for self-insured
aged 15 to 64 received the coverage
data. Based on these assumptions and plans for the 2015 benefit year was $33
through employer sponsored private
without better data available, we assume million. These adjustments covered the
insurance plans.85 In addition, some of
that the 100 accommodated entities that cost of contraceptive coverage provided
to women participants and beneficiaries those private insurance plans were
will remain in the accommodation will offered by government employers,
account for 75 percent of all the persons in self-insured plans where the
employer objected and made use of the encompassing approximately 10.5
previously covered in accommodated million of those women aged 15 to 64.86
plans. In comparison, we assume the accommodation, and where an
109 accommodated entities that will authorizing exception under OMB 83 As noted above, the Departments have taken
make use of the expanded exemption Circular No. A–25R was in effect as the the position that providing contraceptive coverage
will encompass 25 percent of persons Secretary of the Department of Health is cost neutral to issuers. (78 FR 39877). At the same
previously covered in accommodated and Human Services requests. Nine time, because of the up-front costs of some
percent of that amount was attributable contraceptive or sterilization methods, and because
plans. some entities did not cover contraception prior to
to administrative costs and margin, the Affordable Care Act, premiums may be expected
Applying these percentages to the according to the provisions of 45 CFR to adjust to reflect changes in coverage, thus
total number of 1,027,000 persons we 156.50(d)(3)(ii). Thus the amount of the partially offsetting the transfer experienced by
estimate are covered in accommodated adjustments attributable to the cost of women who use the affected contraceptives. As
plans, we estimate that approximately contraceptive services was about $30 discussed elsewhere in this analysis, such women
257,000 persons previously covered in may make up approximately 8.9 percent (= 20.2
million. As discussed above, in 2015 percent × 44.3 percent) of the covered population,
accommodated plans will be covered in that amount corresponded to 576,000 in which case the offset would also be
the 109 plans that use the expanded persons covered by such plans. Among approximately 8.9 percent.
exemption, and 770,000 persons will be those persons, as cited above,
84 Describing this impact as a transfer reflects an
covered in the estimated 100 plans that implicit assumption that the same products and
approximately 20.2 percent on average services would be used with or without the rule.
continue to use the accommodation. were women of childbearing age—that Such an assumption is somewhat oversimplified
According to the Census data cited is, approximately 116,000 women. As because the interim final rules shift cost burden to
above, 20.2 percent of these persons are noted above, approximately 44.3 consumption decision-makers (that is, the women
women of childbearing age, which who choose whether or not to use the relevant
percent of women of childbearing age contraceptives) and thus can be expected to lead to
amounts to approximately 51,900 use women’s contraceptive methods some decrease in use of the affected drugs and
women of childbearing age in covered by the Guidelines, which devices and a potential increase in pregnancy—thus
previously accommodated plans that we includes 51,400 women in those plans. leading to a decrease and an increase, respectively,
estimate will use the expanded in medical expenditures.

Therefore, entities using contraceptive 85 Available at https://aspe.hhs.gov/system/files/
exemption. As noted above, user fees adjustments received pdf/139221/The%20Affordable%20Care%20
approximately 44.3 percent of women of Act%20is%20Improving%20Access%20to%20
childbearing age use women’s 82 Available at https://aspe.hhs.gov/pdf-report/ Preventive%20Services%20for%20
contraceptive methods covered by the affordable-care-act-improving-access-preventive- Millions%20of%20Americans.pdf.
services-millions-americans; also, see Abridged 86 The ASPE study relied on Census data of
Guidelines, so that we expect Report, available at https://www.womenspreventive private health insurance plans, which included
approximately 23,000 women that use health.org/wp-content/uploads/2017/01/WPSI_ plans sponsored by either private or public sector
contraception covered by the Guidelines 2016AbridgedReport.pdf. Continued
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The expanded exemption in these use women’s contraceptive methods a corporation under the same religious
interim final rules does not apply to covered by the Guidelines. Therefore we beliefs seems improbable’’. 134 S. Ct. at
government plan sponsors. Thus we estimate that 574,000 women of 2774. The Departments are aware of
estimate that the number of women aged childbearing age that use contraceptives several Federal health care conscience
15 to 64 covered by private sector covered by the Guidelines were covered laws 89 that in some cases have existed
employer sponsored insurance who by plans that omitted contraceptive for decades and that protect companies,
receive preventive services coverage coverage prior to the Affordable Care including publicly traded companies,
under the Affordable Care Act is Act.88 from discrimination if, for example,
approximately 36 million. It is unknown what motivated those
they decline to facilitate abortion, but
Prior to the implementation of the employers to omit contraceptive
we are not aware of examples where
Affordable Care Act, approximately 6 coverage—whether they did so for
percent of employer survey respondents conscientious reasons, or for other publicly traded companies have made
did not offer contraceptive coverage, reasons. Despite our lack of information use of these exemptions. Thus, while we
with 31 percent of respondents not about their motives, we attempt to make consider it important to include
knowing whether they offered such a reasonable estimate of the upper publicly traded companies in the scope
coverage.87 The 6 percent may have bound of the number of those employers of these expanded exemptions for
included approximately 2.16 million of that omitted contraception before the reasons similar to those used by the
the women aged 15–64 covered by Affordable Care Act and that would Congress in RFRA and some health care
employer sponsored insurance plans in make use of these expanded exemptions conscience laws, in estimating the
the private sector. According to Census based on sincerely held religious beliefs. anticipated effects of the expanded
data, 59.9 percent of women aged 15 to To begin, we estimate that publicly exemptions we agree with the Supreme
64 are of childbearing age (aged 15 to traded companies would not likely Court that it is improbable any will do
44), in this case, 1.3 million. And as make use of these expanded so.
noted above, approximately 44.3 exemptions. Even though the rule does
This assumption is significant
percent of women of childbearing age not preclude publicly traded companies
from dropping coverage based on a because 31.3 percent of employees in
employers. See Table 2, notes 2 & 3 (explaining the sincerely held religious belief, it is the private sector work for publicly
scope of private plans and government plans for likely that attempts to object on traded companies.90 That means that
purposes of Table 2), available at https://
religious grounds by publicly traded only approximately 394,000 women
www.census.gov/content/dam/Census/library/
publications/2014/demo/p60-250.pdf. companies would be rare. The aged 15 to 44 that use contraceptives
According to data tables from the Medical Departments take note of the Supreme covered by the Guidelines were covered
Expenditure Panel Survey (MEPS) of the Agency for Court’s decision in Hobby Lobby, where by plans of non-publicly traded
Healthcare Research and Quality of HHS (https:// companies that did not provide
meps.ahrq.gov/mepsweb/), State and local
the Court observed that ‘‘HHS has not
governments employ 19,297,960 persons; 99.2 pointed to any example of a publicly contraceptive coverage pre-Affordable
percent of those employers offer health insurance; traded corporation asserting RFRA Care Act.
and 67.4 percent of employees that work at such rights, and numerous practical restraints
entities where insurance is offered are enrolled in Moreover, these interim final rules
those plans, amounting to 12.9 million persons
would likely prevent that from build on existing rules that already
enrolled. DOL estimates that in the public sector, occurring. For example, the idea that exempt houses of worship and
for each policyholder there is an average of slightly unrelated shareholders—including integrated auxiliaries and, as explained
less than one dependent. ‘‘Health Insurance institutional investors with their own
Coverage Bulletin’’ Table 4, page 21. https:// above, effectively remove obligations to
www.dol.gov/sites/default/files/ebsa/researchers/ set of stakeholders—would agree to run provide contraceptive coverage within
data/health-and-welfare/health-insurance-
coverage-bulletin-2015.pdf. Therefore, State and 88 Some of the 31 percent of survey respondents
objecting self-insured church plans.
local government employer plans cover that did not know about contraceptive coverage These rules will therefore not effect
approximately 24.8 million persons of all ages. may not have offered such coverage. If it were transfers to women in the plans of such
Census data indicates that on average, 12 percent possible to account for this non-coverage, the employers. In attempting to estimate the
of persons covered by private insurance plans are estimate of potentially affected covered women
aged 65 and older. Using these numbers, we could increase. On the other hand, these employers’ number of such employers, we consider
estimate that State and local government employer lack of knowledge about contraceptive coverage the following information. Many
plans cover approximately 21.9 million persons suggests that they lacked sincerely held religious Catholic dioceses have litigated or filed
under age 65. beliefs specifically objecting to such coverage—
The Federal Government has approximately 8.2 beliefs without which they would not qualify for
public comments opposing the
million persons covered in its employee health the expanded exemptions offered by these rules. In Mandate, representing to the
plans. According to information we received from that case, omission of such employers and covered Departments and to courts around the
the Office of Personnel Management, this includes women from this estimation approach would be
2.1 million employees having 3.2 million
country that official Catholic Church
appropriate. Correspondingly, the 6 percent of
dependents, and 1.9 million retirees (annuitants) employers that had direct knowledge about the teaching opposes contraception. There
having 1 million dependents. We do not have absence of coverage may be more likely to have are 17,651 Catholic parishes in the
information about the ages of these policyholders omitted such coverage on the basis of religious
and dependents, but for the purposes of this beliefs than were the 31 percent of survey 89 For example, 42 U.S.C. 300a–7(b), 42 U.S.C.
estimate we assume the annuitants and their respondents who did not know whether the
dependents are aged 65 or older and the employees coverage was offered. Yet an entity’s mere 238n, and Consolidated Appropriations Act of
and their dependents are under age 65, so that the knowledge about its coverage status does not itself 2017, Div. H, Title V, Sec. 507(d), Public Law 115–
Federal Government’s employee health plans cover reflect its motive for omitting coverage. In 31.
5.3 million persons under age 65. responding to the survey, the entity may have 90 John Asker, et al., ‘‘Corporate Investment and
Thus, overall we estimate there are 27.2 million simply examined its plan document to determine Stock Market Listing: A Puzzle?’’ 28 Review of
persons under age 65 enrolled in private health whether or not contraceptive coverage was offered. Financial Studies Issue 2, at 342–390 (Oct. 7, 2014),
insurance sponsored by government employers. Of As will be relevant in a later portion of the analysis, available at https://doi.org/10.1093/rfs/hhu077.
those, 38.3 percent are women aged 15–64, that is, we have no data indicating what portion of the This is true even though there are only about 4,300
10.5 million. entities that omitted contraceptive coverage pre- publicly traded companies in the U.S. See Rayhanul
87 Kaiser Family Foundation & Health Research & Affordable Care Act did so on the basis of sincerely Ibrahim, ‘‘The number of publicly-traded US
Educational Trust, ‘‘Employer Health Benefits, 2010 held religious beliefs, as opposed to doing so for companies is down 46% in the past two decades,’’
Annual Survey’’ at 196, available at https://kaiser other reasons that would not qualify them for the Yahoo! Finance (Aug. 8, 2016), available at https://
familyfoundation.files.wordpress.com/2013/04/ expanded exemption offered in these interim final finance.yahoo.com/news/jp-startup-public-
8085.pdf. rules. companies-fewer-000000709.html.
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United States,91 197 Catholic dioceses,92 contraceptive coverage, covered 362,100 as many as 14 of 18 of the contraceptive
5,224 Catholic elementary schools, and women aged 15 to 44 that use methods included in the Guidelines.
1,205 Catholic secondary schools.93 Not contraceptives covered by the This will reduce, and potentially
all Catholic schools are integrated Guidelines. As noted above, we estimate eliminate, the contraceptive cost
auxiliaries of Catholic churches, but an average annual expenditure on transfer for women covered in their
there are other Catholic entities that are contraceptive products and services of plans.95 Furthermore, among nonprofit
integrated auxiliaries that are not $584 per user. That would amount to entities that object to the Mandate, it is
schools, so we use the number of $211.5 million in potential transfer possible that a greater share of their
schools to estimate of the number of impact among entities that did not cover employees oppose contraception than
integrated auxiliaries. Among self- contraception pre- Affordable Care Act among the general population, which
insured church plans that oppose the for any reason. should lead to a reduction in the
Mandate, the Department has been sued We do not have data indicating how estimate of how many women in those
by two—Guidestone and Christian many of the entities that omitted plans actually use contraception.
Brothers. Guidestone is a plan organized coverage of contraception pre- In addition, not all sincerely held
by the Southern Baptist convention. It Affordable Care Act did so on the basis conscientious objections to
covers 38,000 employers, some of which of sincerely held religious beliefs that contraceptive coverage are likely to be
are exempt as churches or integrated might qualify them for exempt status held by persons with religious beliefs as
auxiliaries, and some of which are not.94 under these interim final rules, as distinct from persons with sincerely
Christian Brothers is a plan that covers opposed to having done so for other held non-religious moral convictions,
Catholic organizations. It covers reasons. Besides the entities that filed whose objections would not be
Catholic churches and integrated lawsuits or submitted public comments encompassed by these interim final
auxiliaries, which are estimated above, concerning previous rules on this rules.96 We do not have data to indicate,
but also it has said in litigation that it matter, we are not aware of entities that among entities that did not cover
also covers about 500 additional entities omitted contraception pre-Affordable contraception pre-Affordable Care Act
that are not exempt as churches. In total, Care Act and then opposed the based on sincerely held conscientious
therefore, we estimate that contraceptive coverage requirement objections as opposed to other reasons,
approximately 62,000 employers among after it was imposed by the Guidelines. which ones did so based on religious
houses of worship, integrated For the following reasons, however, we beliefs and which ones did so instead
auxiliaries, and church plans, were believe that a reasonable estimate is that based on non-religious moral
exempt or relieved of contraceptive no more than approximately one third convictions. Among the general public,
coverage obligations under the previous of the persons covered by relevant polls vary about religious beliefs but one
rules. We do not know how many entities—that is, no more than prominent poll shows that 89 percent of
persons are covered in the plans of approximately 120,000 affected Americans say they believe in God,
those employers. Guidestone reports women—would likely be subject to while 11 percent say they do not or are
that among its 38,000 employers, its potential transfer impacts under the agnostic.97 Therefore, we estimate that
plan covers approximately 220,000 expanded religious exemptions offered for every ten entities that omitted
persons, and its employers include in these interim final rules. contraception pre-Affordable Care Act
‘‘churches, mission-sending agencies, Consequently, as explained below, we based on sincerely held conscientious
hospitals, educational institutions and believe that the potential impact of objections as opposed to other reasons,
other related ministries.’’ Using that these interim final rules falls one did so based on sincerely held non-
ratio, we estimate that the 62,000 substantially below the $100 million religious moral convictions, and
church and church plan employers threshold for economically significant therefore are not affected by the
among Guidestone, Christian Brothers, and major rules. expanded exemption provided by these
and Catholic churches would include First, as mentioned, we are not aware
interim final rules for religious beliefs.
359,000 persons. Among them, as of information that would lead us to Based on our estimate of an average
referenced above, 72,500 would be of estimate that all or most entities that annual expenditure on contraceptive
childbearing age, and 32,100 would use omitted coverage of contraception pre-
products and services of $584 per user,
contraceptives covered by the Affordable Care Act did so on the basis
Guidelines. Therefore, we estimate that of sincerely held conscientious 95 On the other hand, a key input in the approach
the private, non-publicly traded objections in general or religious beliefs that generated the one third threshold estimate was
employers that did not cover specifically, as opposed to having done a survey indicating that six percent of employers
so for other reasons. Moreover, as did not provide contraceptive coverage pre-
contraception pre-Affordable Care Act, Affordable Care Act. Employers that covered some
and that were not exempt by the suggested by the Guidestone data
contraceptives pre-Affordable Care Act may have
previous rules nor were participants in mentioned previously, employers with answered ‘‘yes’’ or ‘‘don’t know’’ to the survey. In
self-insured church plans that oppose conscientious objections may tend to such cases, the potential transfer estimate has a
have relatively few employees. Also, tendency toward underestimation because the rule’s
avoiding negative publicity, the effects on such women—causing their contraceptive
91 Roman Catholic Diocese of Reno, ‘‘Diocese of
coverage to be reduced from all 18 methods to some
Reno Directory: 2016–2017,’’ available at http:// difficulty of taking away a fringe benefit smaller subset—have been omitted from the
www.renodiocese.org/documents/2016/9/ that employees have become calculation.
2016%202017%20directory.pdf. accustomed to having, and avoiding the 96 Such objections may be encompassed by
92 Wikipedia, ‘‘List of Catholic dioceses in the
administrative cost of renegotiating companion interim final rules published elsewhere
United States,’’ available at https:// in this Federal Register. Those rules, however, as
en.wikipedia.org/wiki/List_of_Catholic_dioceses_ insurance contracts, all provide reasons an interim final matter, are more narrow in scope
in_the_United_States. for some employers not to return to pre- than these rules. For example, in providing
93 National Catholic Educational Association, Affordable Care Act lack of expanded exemptions for plan sponsors, they do
‘‘Catholic School Data,’’ available at http:// contraceptive coverage. Additionally, as not encompass companies with certain publicly
www.ncea.org/NCEA/Proclaim/Catholic_School_ discussed above, many employers with traded ownership interests.
Data/Catholic_School_Data.aspx. 97 Gallup, ‘‘Most Americans Still Believe in God’’
94 Guidestone Financial Resources, ‘‘Who We objections to contraception, including (June 14–23, 2016), available at http://
Serve,’’ available at https://www.guidestone.org/ several of the largest litigants, only www.gallup.com/poll/193271/americans-believe-
AboutUs/WhoWeServe. object to some contraceptives and cover god.aspx.
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the effect of the expanded exemptions general notice of proposed rulemaking minimize the information collection
on 120,000 women would give rise to is not required when an agency, for burden.
approximately $70.1 million in good cause, finds that notice and public However, we are requesting an
potential transfer impact. This falls comment thereon are impracticable, emergency review of the information
substantially below the $100 million unnecessary, or contrary to the public collection referenced later in this
threshold for economically significant interest. The interim final rules are section. In compliance with the
and major rules. In addition, as noted exempt from the APA, both because the requirement of section 3506(c)(2)(A) of
above, premiums may be expected to PHS Act, ERISA, and the Code contain the PRA, we have submitted the
adjust to reflect changes in coverage, specific provisions under which the following for emergency review to the
thus partially offsetting the transfer Secretaries may adopt regulations by Office of Management and Budget
experienced by women who use the interim final rule and because the (OMB). We are requesting an emergency
affected contraceptives. As discussed Departments have made a good cause review and approval under both 5 CFR
elsewhere in this analysis, such women finding that a general notice of proposed 1320.13(a)(2)(i) and (iii) of the
may make up approximately 8.9 percent rulemaking is not necessary earlier in implementing regulations of the PRA in
(= 20.2 percent × 44.3 percent) of the this preamble. Therefore, the RFA does order to implement provisions regarding
covered population, in which case the not apply and the Departments are not self-certification or notices to HHS from
offset would also be approximately 8.9 required to either certify that the eligible organizations (§ 147.131(c)(3)),
percent, yielding a potential transfer of regulations or this amendment would notice of availability of separate
$63.8 million. not have a significant economic impact payments for contraceptive services
We request comment on all aspects of on a substantial number of small entities (§ 147.131(f)), and notice of revocation
the preceding regulatory impact or conduct a regulatory flexibility of accommodation (§ 147.131(c)(4)). In
analysis, as well as on how to attribute analysis. accordance with 5 CFR 1320.13(a)(2)(i),
impacts to this interim final rule and the Nevertheless, the Departments we believe public harm is reasonably
companion interim final rule carefully considered the likely impact of likely to ensue if the normal clearance
concerning exemptions provided based procedures are followed. The use of
the rule on small entities in connection
on sincerely held (non-religious) moral normal clearance procedures is
with their assessment under Executive
convictions published elsewhere in this reasonably likely to prevent or disrupt
Order 12866. The Departments do not
Federal Register. the collection of information. Similarly,
expect that these interim final rules will
B. Special Analyses—Department of the have a significant economic effect on a in accordance with 5 CFR
Treasury substantial number of small entities, 1320.13(a)(2)(iii), we believe the use of
because they will not result in any normal clearance procedures is
For purposes of the Department of the
additional costs to affected entities, and reasonably likely to cause a statutory or
Treasury, certain Internal Revenue
in many cases will relieve burdens and court ordered deadline to be missed.
Service (IRS) regulations, including this
costs from such entities. By exempting Many cases have been on remand for
one, are exempt from the requirements
from the Mandate small businesses and over a year from the Supreme Court,
in Executive Order 12866, as
nonprofit organizations with religious asking the Departments and the parties
supplemented by Executive Order
objections to some (or all) to resolve this matter. These interim
13563. The Departments anticipate that
contraceptives and/or sterilization, the final rules extend exemptions to
there will be more entities reluctantly
Departments have reduced regulatory entities, which involves no collection of
using the existing accommodation that
burden on such small entities. Pursuant information and which the Departments
will choose to operate under the newly
to section 7805(f) of the Code, these have statutory authority to do by the use
expanded exemption, than entities that
regulations have been submitted to the of interim final rules. If the information
are not currently eligible to use the
Chief Counsel for Advocacy of the Small collection involved in the amended
accommodation that will opt into it. The
Business Administration for comment accommodation process is not approved
effect of this rule will therefore be that
on their impact on small business. on an emergency basis, newly exempt
fewer overall adjustments are made to
entities that wish to opt into the
the Federally facilitated Exchange user D. Paperwork Reduction Act— amended accommodation process might
fees for entities using the Department of Health and Human not be able to do so until normal
accommodation process, as long as the Services clearance procedures are completed.
Secretary of the Department of Health A description of the information
and Human Services requests and an Under the Paperwork Reduction Act
of 1995 (the PRA), Federal agencies are collection provisions implicated in
authorizing exception under OMB these interim final rules is given in the
Circular No. A–25R is in effect, than required to publish notice in the
Federal Register concerning each following section with an estimate of
would have occurred under the the annual burden. Average labor costs
previous rule if this rule were not proposed collection of information.
Interested persons are invited to send (including 100 percent fringe benefits)
finalized. Therefore, a regulatory used to estimate the costs are calculated
assessment is not required. comments regarding our burden
estimates or any other aspect of this using data available from the Bureau of
C. Regulatory Flexibility Act collection of information, including any Labor Statistics.98
The Regulatory Flexibility Act (5 of the following subjects: (1) The a. ICRs Regarding Self-Certification or
U.S.C. 601 et seq.) (RFA) imposes necessity and utility of the proposed Notices to HHS (§ 147.131(c)(3))
certain requirements with respect to information collection for the proper

Each organization seeking to be
Federal rules that are subject to the performance of the agency’s functions;
treated as an eligible organization that
notice and comment requirements of (2) the accuracy of the estimated
wishes to use the optional
section 553(b) of the APA (5 U.S.C. 551 burden; (3) ways to enhance the quality,
accommodation process offered under
et seq.) and that are likely to have a utility, and clarity of the information to
significant economic impact on a be collected; and (4) the use of 98 May 2016 National Occupational Employment
substantial number of small entities. automated collection techniques or and Wage Estimates United States found at https://
Under Section 553(b) of the APA, a other forms of information technology to www.bls.gov/oes/current/oes_nat.htm.
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these interim final rules must either use compensation and benefits manager at a contemporaneous with (to the extent
the EBSA Form 700 method of self- cost of $122.02 per hour,101 5 minutes possible), any application materials
certification or provide notice to HHS of for legal counsel at a cost of $134.50 per distributed in connection with
its religious objection to coverage of all hour,102 and 5 minutes by a senior enrollment (or re-enrollment) in group
or a subset of contraceptive services. executive at a cost of $186.88 per or student coverage of the eligible
Specifically, these interim final rules hour 103) preparing and sending the self- organization in any plan year to which
continue to allow eligible organizations certification or notice to HHS and filing the accommodation is to apply and will
to notify an issuer or third party it to meet the recordkeeping be provided annually. To satisfy the
administrator using EBSA Form 700, or requirement. Therefore, the total annual notice requirement, issuers and third
to notify HHS, of their religious burden for preparing and providing the party administrators may, but are not
objection to coverage of all or a subset information in the self-certification or required to, use the model language set
of contraceptive services, as set forth in notice to HHS will require forth previously by HHS or substantially
the July 2015 final regulations. The approximately 50 minutes for each similar language. The burden for this
burden related to the notice to HHS is eligible organization with an equivalent ICR is currently approved under OMB
currently approved under OMB Control cost burden of approximately $74.96 for control number 0938–1292.
Number 0938–1248 and the burden a total hour burden of approximately 7.5 As mentioned, HHS is anticipating
related to the self-certification (EBSA hours with an equivalent cost of that approximately 109 entities will use
Form 700) is currently approved under approximately $675 for 9 entities. As the optional accommodation (100 that
OMB control number 0938–1292. DOL and HHS share jurisdiction, they used it previously, and 9 that will newly
Notably, however, entities that are are splitting the hour burden so each opt into it). It is unknown how many
participating in the previous will account for approximately 3.75 issuers or third party administrators
accommodation process, where a self- burden hours with an equivalent cost of provide health insurance coverage or
certification or notice has already been approximately $337. services in connection with health plans
submitted, and where the entities HHS estimates that each self- of eligible organizations, but HHS will
choose to continue their accommodated certification or notice to HHS will assume at least 109. It is estimated that
status under these interim final rules, require $0.49 in postage and $0.05 in each issuer or third party administrator
generally do not need to file a new self- materials cost (paper and ink) and the will need approximately 1 hour of
certification or notice (unless they total postage and materials cost for each clerical labor (at $55.68 per hour) 104
change their issuer or third party self-certification or notice sent via mail and 15 minutes of management review
administrator). As explained above, will be $0.54. For purposes of this (at $117.40 per hour) 105 to prepare the
HHS assumes that, among the 209 analysis, HHS assumes that 50 percent notices. The total burden for each issuer
entities we estimated are using the of self-certifications or notices to HHS or third party administrator to prepare
previous accommodation, 109 will use will be mailed. The total cost for notices will be 1.25 hours with an
the expanded exemption and 100 will sending the self-certifications or notices equivalent cost of approximately $85.03.
continue under the voluntary to HHS by mail is approximately $2.70 The total burden for all issuers or third
accommodation. Those 100 entities will for 5 entities. As DOL and HHS share party administrators will be 136 hours,
not need to file additional self- jurisdiction they are splitting the cost with an equivalent cost of $9,268. As
certifications or notices. HHS also burden so each will account for $1.35 of DOL and HHS share jurisdiction, they
assumes that an additional 9 entities the cost burden. are splitting the hour burden so each
that were not using the previous will account for 68 burden hours with
accommodation will opt into it. Those b. ICRs Regarding Notice of Availability an equivalent cost of $4,634, with
entities will be subject to the self- of Separate Payments for Contraceptive approximately 55 respondents.
certification or notice requirement. Services (§ 147.131(e)) As discussed above, the Departments
In order to estimate the cost for an estimate that 770,000 persons will be
As required by the July 2015 final
entity that chooses to opt into the covered in the plans of the 100 entities
regulations, a health insurance issuer or
accommodation process, HHS assumes, that previously used the
third party administrator providing or
as it did in its August 2014 interim final accommodation and will continue doing
arranging separate payments for
rules, that clerical staff for each eligible so, and that an additional 9 entities will
contraceptive services for participants
organization will gather and enter the newly opt into the accommodation. It is
and beneficiaries in insured or self-
necessary information and send the self- not known how many persons will be
insured group health plans (or student
certification to the issuer or third party covered in the plans of the 9 entities
enrollees and covered dependents in
administrator as appropriate, or send newly using the accommodation.
student health insurance coverage) of Assuming that those 9 entities will have
the notice to HHS.99 HHS assumes that eligible organizations is required to
a compensation and benefits manager a similar number of covered persons per
provide a written notice to plan entity, we estimate that all 109
and inside legal counsel will review the participants and beneficiaries (or
self-certification or notice to HHS and a accommodated entities will encompass
student enrollees and covered 839,300 covered persons. We assume
senior executive would execute it. HHS dependents) informing them of the
estimates that an eligible organization that sending one notice to each
availability of such payments. The participant will satisfy the need to send
would spend approximately 50 minutes notice must be separate from, but
(30 minutes of clerical labor at a cost of the notices to all participants and
$55.68 per hour,100 10 minutes for a dependents. Among persons covered by
101 Occupation code 11–3111 for Compensation
and Benefits Managers with mean hourly wage plans, approximately 50.1 percent are
99 For purposes of this analysis, the Department $61.01, https://www.bls.gov/oes/current/ participants and 49.9 percent are
assumes that the same amount of time will be oes113111.htm.
required to prepare the self-certification and the 102 Occupation code 23–1011 for Lawyers with 104 Occupation code 43–6011 for Executive
notice to HHS. mean hourly wage $67.25, https://www.bls.gov/oes/ Secretaries and Executive Administrative Assistants
100 Occupation code 43–6011 for Executive current/oes231011.htm. with mean hourly wage $27.84.
Secretaries and Executive Administrative Assistants 103 Occupation code11–1011 for Chief Executives 105 Occupation code 11–1021 General and
with mean hourly wage $27.84, https:// with mean hourly wage $93.44, https:// Operations Managers with mean hourly wage
www.bls.gov/oes/current/oes436011.htm. www.bls.gov/oes/current/oes111011.htm. $58.70.
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dependents.106 For 109 entities, the total their use of the accommodation, and approximately $19,798. As DOL and
number of notices will be 420,490. For will therefore be required to cause the HHS share jurisdiction, they are
purposes of this analysis, the notification to be sent (the issuer or splitting the hour burden so each will
Departments also assume that 53.7 third party administrator can send the account for 109 burden hours with an
percent of notices will be sent notice on behalf of the entity). For the equivalent cost of approximately $9,899.
electronically, and 46.3 percent will be purpose of calculating ICRs associated As discussed above, HHS estimates
mailed.107 Therefore, approximately with revocations of the accommodation, that there are 257,000 covered persons
194,687 notices will be mailed. HHS and for various reasons discussed above, in accommodated plans that will revoke
estimates that each notice will require HHS assumes that litigating entities that their accommodated status and use the
$0.49 in postage and $0.05 in materials were previously using the expanded exemption.111 As before, we
cost (paper and ink) and the total accommodation and that will revoke it use the average of 50.1 percent of
postage and materials cost for each fall within the estimated 109 entities covered persons who are policyholders,
notice sent via mail will be $0.54. The that will revoke the accommodation
total cost for sending approximately and estimate that an average of 53.7
overall. percent of notices will be sent
194,687 notices by mail is
approximately $105,131. As DOL and As before, HHS assumes that, for each electronically and 46.3 percent by mail.
HHS share jurisdiction, they are issuer or third party administrator, a Therefore, approximately 128,757
splitting the cost burden so each will manager and inside legal counsel and notices will be sent, of which 59,615
account for $52,565 of the cost burden. clerical staff will need approximately 2 notices will be mailed. HHS estimates
hours to prepare and send the that each notice will require $0.49 in
c. ICRs Regarding Notice of Revocation notification to participants and postage and $0.05 in materials cost
of Accommodation (§ 147.131(c)(4)) beneficiaries and maintain records (30 (paper and ink) and the total postage
An eligible organization may revoke minutes for a manager at a cost of and materials cost for each notice sent
its use of the accommodation process; $117.40 per hour,108 30 minutes for via mail will be $0.54. The total cost for
its issuer or third party administrator legal counsel at a cost of $134.50 per sending approximately 59,615 notices
must provide written notice of such hour 109, 1 hour for clerical labor at a by mail is approximately $32,192. As
revocation to participants and cost of $55.68 per hour 110). The burden DOL and HHS share jurisdiction, they
beneficiaries as soon as practicable. As per respondent will be 2 hours with an are splitting the hour burden so each
discussed above, HHS estimates that equivalent cost of $181.63; for 109 will account for 64,379 notices, with an
109 entities that are using the entities, the total burden will be 218 equivalent cost of approximately
accommodation process will revoke hours with an equivalent cost of $16,096.
TABLE 1—SUMMARY OF INFORMATION COLLECTION BURDENS
Hourly labor Total labor
Burden per Total annual
OMB Number of cost of cost of Total cost
Regulation section Responses respondent burden
control No. respondents reporting reporting ($)
(hours) (hours) ($) ($)
Self-Certification or Notices to HHS ....... 0938—NEW ... *5 5 0.83 3.75 $89.95 $337.31 $338.66
Notice of Availability of Separate Pay- 0938—NEW ... *55 210,245 1.25 68.13 68.02 4,634.14 57,199.59
ments for Contraceptive Services.
Notice of Revocation of Accommodation 0938—NEW ... *55 64,379 2.00 109 90.82 9,898.84 25,994.75
Total ................................................ ........................ *115 274,629 4.08 180.88 ...................... 14,870.29 83,533.00
* The total number of respondents is 227 (= 9+109+109) for both HHS and DOL, but the summaries here and below exceed that total because of rounding up that
occurs when sharing the burden between HHS and DOL.
Note: There are no capital/maintenance costs associated with the ICRs contained in this rule; therefore, we have removed the associated column from Table 1.
Postage and material costs are included in Total Cost.
We are soliciting comments on all of comments on all of the related new OMB control number that will
the information collection requirements information collection requirements ultimately contain the approval for the
contained in these interim final rules. In currently approved under 0938–1292 new information collection
addition, we are also soliciting and 0938–1248. HHS is requesting a requirements contained in these interim
106 ‘‘Health Insurance Coverage Bulletin’’ Table 4, percent of Internet users use online banking, which 111 In estimating the number of women that might
page 21. Using March 2015 Annual Social and is used as the proxy for the number of Internet users have their contraceptive coverage affected by the
Economic Supplement to the Current Population who will opt in for electronic disclosure (for a total expanded exemption, we indicated that we do not
Survey. https://www.dol.gov/sites/default/files/ of 23.5 percent receiving electronic disclosure know the extent to which the number of women in
ebsa/researchers/data/health-and-welfare/health- outside of work). Combining the 30.2 percent who accommodated plans affected by these rules overlap
insurance-coverage-bulletin-2015.pdf. receive electronic disclosure at work with the 23.5 with the number of women in plans offered by
107 According to data from the National percent who receive electronic disclosure outside of
litigating entities that will be affected by these
Telecommunications and Information Agency work produces a total of 53.7 percent who will
receive electronic disclosure overall. rules, though we assume there is significant
(NTIA), 36.0 percent of individuals age 25 and over
108 Occupation code 11–1021 for General and overlap. That uncertainty should not affect the
have access to the Internet at work. According to
Operations Managers with mean hourly wage calculation of the ICRs for revocation notices,
a Greenwald & Associates survey, 84 percent of
plan participants find it acceptable to make $58.70, https://www.bls.gov/oes/current/ however. If the two numbers overlap, the estimates
electronic delivery the default option, which is oes111021.htm. of plans revoking the accommodation and
used as the proxy for the number of participants 109 Occupation code 23–1011 for Lawyers with policyholders covered in those plans would already
who will not opt out that are automatically enrolled mean hourly wage $67.25, https://www.bls.gov/oes/ include plans and policyholders of litigating
(for a total of 30.2 percent receiving electronic current/oes231011.htm. entities. If the numbers do not overlap, those
disclosure at work). Additionally, the NTIA reports 110 Occupation code 43–6011 for Executive litigating entity plans would not presently be
that 38.5 percent of individuals age 25 and over Secretaries and Executive Administrative Assistants enrolled in the accommodation, and therefore
have access to the Internet outside of work. with mean hourly wage $27.84, https:// would not need to send notices concerning
According to a Pew Research Center survey, 61 www.bls.gov/oes/current/oes436011.htm. revocation of accommodated status.
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final rules as well as the related revision. The request was made under OMB Numbers: 1210–0150.
requirements currently approved under emergency clearance procedures Affected Public: Private Sector—Not
0938–1292 and 0938–1248. In an effort specified in regulations at 5 CFR for profit and religious organizations;
to consolidate the number of 1320.13. In an effort to consolidate the businesses or other for-profits.
information collection requests, we will number of information collection Total Respondents: 114 112 (combined
formally discontinue the control requests, DOL will combine the ICR with HHS total is 227).
numbers 0938–1292 and 0938–1248 related to the OMB control number Total Responses: 274,628 (combined
once the new information collection 1210–0152 with the ICR related to the with HHS total is 549,255).
request associated with these interim OMB control number 1210–0150. Once Frequency of Response: On occasion.
final rules is approved. the ICR is approved DOL will
To obtain copies of a supporting Estimated Total Annual Burden
discontinue 1210–0152. A copy of the
statement and any related forms for the Hours: 181 (combined with HHS total is
information collection request may be
proposed collection(s) summarized in 362 hours).
obtained free of charge on the
this notice, you may make your request RegInfo.gov Web site at http:// Estimated Total Annual Burden Cost:
using one of following: www.reginfo.gov/public/do/ $68,662 (combined with HHS total is
1. Access CMS’ Web site address at PRAViewICR?ref_nbr=201705-1210-001. $137,325).
https://www.cms.gov/Regulations-and- This approval will allow respondents to Type of Review: Revised Collection.
Guidance/Legislation/ temporarily utilize the additional Agency: DOL–EBSA.
PaperworkReductionActof1995/PRA- flexibility these interim final regulations F. Regulatory Reform Executive Orders
Listing.html. provide, while DOL seeks public 13765, 13771 and 13777
2. Email your request, including your comment on the collection methods—
address, phone number, OMB number, including their utility and burden. Executive Order 13765 (January 20,
and CMS document identifier, to Consistent with the analysis in the 2017) directs that, ‘‘[t]o the maximum
Paperwork@cms.hhs.gov. HHS PRA section above, the extent permitted by law, the Secretary of
3. Call the Reports Clearance Office at Departments expect that each of the the Department of Health and Human
(410) 786–1326. estimated 9 eligible organizations newly Services and the heads of all other
If you comment on these information opting into the accommodation will executive departments and agencies
collections, that is, reporting, spend approximately 50 minutes in (agencies) with authorities and
recordkeeping or third-party disclosure preparation time and incur $0.54 responsibilities under the Act shall
requirements, please submit your mailing cost to self-certify or notify exercise all authority and discretion
comments electronically as specified in HHS. Each of the 109 issuers or third available to them to waive, defer, grant
the ADDRESSES section of these interim party administrators for the 109 eligible exemptions from, or delay the
final rules with comment period. organizations that make use of the implementation of any provision or
E. Paperwork Reduction Act— accommodation overall will distribute requirement of the Act that would
Department of Labor Notices of Availability of Separate impose a fiscal burden on any State or
Payments for Contraceptive Services. a cost, fee, tax, penalty, or regulatory
Under the Paperwork Reduction Act, These issuers and third party burden on individuals, families,
an agency may not conduct or sponsor, administrators will spend healthcare providers, health insurers,
and an individual is not required to approximately 1.25 hours in preparation patients, recipients of healthcare
respond to, a collection of information time and incur $0.54 cost per mailed services, purchasers of health insurance,
unless it displays a valid OMB control notice. Notices of Availability of or makers of medical devices, products,
number. In accordance with the Separate Payments for Contraceptive or medications.’’ In addition, agencies
requirements of the PRA, the ICR for the Services will need to be sent to 420,489 are directed to ‘‘take all actions
EBSA Form 700 and alternative notice policyholders, and 53.7 percent of the consistent with law to minimize the
have previously been approved by OMB notices will be sent electronically, while unwarranted economic and regulatory
under control numbers 1210–0150 and 46.3 percent will be mailed. Finally, 109 burdens of the [Affordable Care Act],
1210–0152. A copy of the ICR may be entities using the previous and prepare to afford the States more
obtained by contacting the PRA accommodation process will revoke its flexibility and control to create a more
addressee shown below or at http:// use and will therefore be required to free and open healthcare market.’’ These
www.RegInfo.gov. PRA ADDRESSEE: G. cause the Notice of Revocation of interim final rules exercise the
Christopher Cosby, Office of Policy and Accommodation to be sent (the issuer or discretion provided to the Departments
Research, U.S. Department of Labor, third party administrator can send the under the Affordable Care Act, RFRA,
Employee Benefits Security notice on behalf of the entity). These and other laws to grant exemptions and
Administration, 200 Constitution entities will spend approximately two thereby minimize regulatory burdens of
Avenue NW., Room N–5718, hours in preparation time and incur the Affordable Care Act on the affected
Washington, DC 20210. Telephone: $0.54 cost per mailed notice. Notice of entities and recipients of health care
202–693–8410; Fax: 202–219–4745. Revocation of Accommodation will services.
These are not toll-free numbers. need to be sent to an average of 128,757 Consistent with Executive Order
These interim final rules amend the policyholders and 53.7 percent of the 13771 (82 FR 9339, February 3, 2017),
ICR by changing the accommodation notices will be sent electronically. The we have estimated the costs and cost
process to an optional process for DOL information collections in this rule savings attributable to this interim final
exempt organizations and requiring a are found in 29 CFR 2510.3–16 and rule. As discussed in more detail in the
notice of revocation to be sent by the 2590.715–2713A and are summarized as preceding analysis, this interim final
issuer or third party administrator to follows: rule lessens incremental reporting
participants and beneficiaries in plans Type of Review: Revised Collection.
whose employer who revokes their Agency: DOL–EBSA. 112 Denotes that there is an overlap between
accommodation. DOL submitted the Title: Coverage of Certain Preventive jurisdiction shared by HHS and DOL over these
ICRs in order to obtain OMB approval Services under the Affordable Care respondents and therefore they are included only
under the PRA for the regulatory Act—Private Sector. once in the total.
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costs.113 Therefore, this interim final and describe the extent of their requirements, State regulation of health
rule is considered an Executive Order consultation and the nature of the insurance.
13771 deregulatory action. concerns of State and local officials in Kirsten B. Wielobob,
F. Unfunded Mandates Reform Act the preamble to the regulation.
Deputy Commissioner for Services and
The Unfunded Mandates Reform Act These interim final rules do not have Enforcement.
of 1995 (section 202(a) of Pub. L. 104– any Federalism implications, since they Approved: October 2, 2017.
4), requires the Departments to prepare only provide exemptions from the David J. Kautter,
a written statement, which includes an contraceptive and sterilization coverage Assistant Secretary for Tax Policy.
assessment of anticipated costs and requirement in HRSA Guidelines Signed this 4th day of October, 2017.
benefits, before issuing ‘‘any rule that supplied under section 2713 of the PHS Timothy D. Hauser,
includes any Federal mandate that may Act.
Deputy Assistant Secretary for Program
result in the expenditure by State, local, Operations, Employee Benefits Security
VII. Statutory Authority
and tribal governments, in the aggregate, Administration, Department of Labor.
or by the private sector, of $100,000,000 The Department of the Treasury Dated: October 4, 2017.
or more (adjusted annually for inflation) temporary regulations are adopted Seema Verma,
in any one year.’’ The current threshold pursuant to the authority contained in Administrator, Centers for Medicare &
after adjustment for inflation is $148 sections 7805 and 9833 of the Code. Medicaid Services.
million, using the most current (2016)
The Department of Labor regulations Approved: October 4, 2017.
Implicit Price Deflater for the Gross
Domestic Product. For purposes of the are adopted pursuant to the authority Donald Wright,
Unfunded Mandates Reform Act, these contained in 29 U.S.C. 1002(16), 1027, Acting Secretary, Department of Health and
interim final rules do not include any 1059, 1135, 1161–1168, 1169, 1181– Human Services.
Federal mandate that may result in 1183, 1181 note, 1185, 1185a, 1185b,
1185d, 1191, 1191a, 1191b, and 1191c; DEPARTMENT OF THE TREASURY
expenditures by State, local, or tribal
governments, nor do they include any sec. 101(g), Public Law 104–191, 110 Internal Revenue Service
Federal mandates that may impose an Stat. 1936; sec. 401(b), Public Law 105– For the reasons set forth in this
annual burden of $100 million, adjusted 200, 112 Stat. 645 (42 U.S.C. 651 note); preamble, 26 CFR part 54 is amended as
for inflation, or more on the private sec. 512(d), Public Law 110–343, 122 follows:
sector. Stat. 3881; sec. 1001, 1201, and 1562(e),
G. Federalism Public Law 111–148, 124 Stat. 119, as PART 54—PENSION EXCISE TAXES
amended by Public Law 111–152, 124
Executive Order 13132 outlines Stat. 1029; Secretary of Labor’s Order 1– ■ 1. The authority citation for part 54
fundamental principles of federalism, 2011, 77 FR 1088 (Jan. 9, 2012). continues to read in part as follows:
and requires the adherence to specific Authority: 26 U.S.C. 7805 * * *
criteria by Federal agencies in the The Department of Health and Human
process of their formulation and Services regulations are adopted ■ 2. Section 54.9815–2713 is amended
implementation of policies that have pursuant to the authority contained in by revising paragraphs (a)(1)
‘‘substantial direct effects’’ on States, sections 2701 through 2763, 2791, and introductory text and (a)(1)(iv) to read as
the relationship between the Federal 2792 of the PHS Act (42 U.S.C. 300gg follows:
Government and States, or the through 300gg–63, 300gg–91, and
§ 54.9815–2713 Coverage of preventive
distribution of power and 300gg–92), as amended; and Title I of health services.
responsibilities among the various the Affordable Care Act, sections 1301–
levels of Government. Federal agencies (a) * * *
1304, 1311–1312, 1321–1322, 1324,
(1) In general. [Reserved]. For further
promulgating regulations that have 1334, 1342–1343, 1401–1402, and 1412, guidance, see § 54.9815–2713T(a)(1)
these federalism implications must Public Law 111–148, 124 Stat. 119 (42 introductory text.
consult with State and local officials, U.S.C. 18021–18024, 18031–18032,
* * * * *
18041–18042, 18044, 18054, 18061,
113 Other noteworthy potential impacts (iv) [Reserved]. For further guidance,
18063, 18071, 18082, 26 U.S.C. 36B, and
encompass potential changes in medical see § 54.9815–2713T(a)(1)(iv).
expenditures, including potential decreased 31 U.S.C. 9701).
expenditures on contraceptive devices and drugs
* * * * *
and potential increased expenditures on pregnancy- List of Subjects
■ 3. Section 54.9815–2713T is added to
related medical services. OMB’s guidance on E.O. read as follows:
13771 implementation (https:// 26 CFR Part 54
www.whitehouse.gov/the-press-office/2017/04/05/ § 54.9815–2713T Coverage of preventive
memorandum-implementing-executive-order- Excise taxes, Health care, Health
13771-titled-reducing-regulation) states that impacts insurance, Pensions, Reporting and health services (temporary).
should be categorized as consistently as possible recordkeeping requirements. (a) Services—(1) In general. Beginning
within Departments. The Food and Drug at the time described in paragraph (b) of
Administration, within HHS, and the Occupational 29 CFR Part 2590
Safety and Health Administration (OSHA) and
§ 54.9815–2713 and subject to
Mine Safety and Health Administration (MSHA), § 54.9815–2713A, a group health plan,
Continuation coverage, Disclosure,
within DOL, regularly estimate medical expenditure or a health insurance issuer offering
impacts in the analyses that accompany their Employee benefit plans, Group health
group health insurance coverage, must
regulations, with the results being categorized as plans, Health care, Health insurance, provide coverage for and must not
benefits (positive benefits if expenditures are Medical child support, Reporting and
reduced, negative benefits if expenditures are impose any cost-sharing requirements
raised). Following the FDA, OSHA and MSHA recordkeeping requirements. (such as a copayment, coinsurance, or a
accounting convention leads to this interim final deductible) for—
rule’s medical expenditure impacts being
45 CFR Part 147
categorized as (positive or negative) benefits, rather
(i)–(iii) [Reserved]. For further
than as costs, thus placing them outside of Health care, Health insurance, guidance, see § 54.9815–2713(a)(1)(i)
consideration for E.O. 13771 designation purposes. Reporting and recordkeeping through (iii).
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(iv) With respect to women, such make the certification or provide the identification of the subset of
additional preventive care and notice on behalf of the organization, and contraceptive services to which
screenings not described in paragraph must be maintained in a manner coverage the eligible organization
(a)(1)(i) of § 54.9815–2713 as provided consistent with the record retention objects, if applicable), but that it would
for in comprehensive guidelines requirements under section 107 of like to elect the optional
supported by the Health Resources and ERISA. accommodation process; the plan name
Services Administration for purposes of (5) An eligible organization may and type (that is, whether it is a student
section 2713(a)(4) of the Public Health revoke its use of the accommodation health insurance plan within the
Service Act, subject to 45 CFR 147.131 process, and its issuer or third party meaning of 45 CFR 147.145(a) or a
and 147.132. administrator must provide participants church plan within the meaning of
(2)–(c) [Reserved]. For further and beneficiaries written notice of such section 3(33) of ERISA); and the name
guidance, see § 54.9815–2713(a)(2) revocation as specified in guidance and contact information for any of the
through (c). issued by the Secretary of the plan’s third party administrators. If
(d) Effective/Applicability date. (1) Department of Health and Human there is a change in any of the
Paragraphs (a) through (c) of this section Services. If contraceptive coverage is information required to be included in
are applicable beginning on April 16, currently being offered by an issuer or the notice, the eligible organization
2012, except— third party administrator through the must provide updated information to
(2) Paragraphs (a)(1) introductory text accommodation process, the revocation the Secretary of the Department of
and (a)(1)(iv) of this section are effective will be effective on the first day of the Health and Human Services for the
on October 6, 2017. first plan year that begins on or after 30 optional accommodation process to
(e) Expiration date. This section days after the date of the revocation (to remain in effect. The Department of
expires on October 6, 2020. allow for the provision of notice to plan Labor (working with the Department of
■ 4. Section 54.9815–2713A is revised
participants in cases where Health and Human Services), will send
to read as follows: contraceptive benefits will no longer be a separate notification to each of the
provided). Alternatively, an eligible plan’s third party administrators
§ 54.9815–2713A Accommodations in organization may give sixty-days notice informing the third party administrator
connection with coverage of preventive pursuant to section 2715(d)(4) of the that the Secretary of the Department of
health services. PHS Act and § 54.9815–2715(b), if Health and Human Services has
(a) through (f) [Reserved]. For further applicable, to revoke its use of the received a notice under paragraph
guidance, see § 54.9815–2713AT. accommodation process. (b)(1)(ii) of this section and describing
(b) (b) Optional accommodation—self- the obligations of the third party
■ 5. Section 54.9815–2713AT is added
insured group health plans. (1) A group administrator under 29 CFR 2510.3–16
to read as follows: health plan established or maintained
and this section.
by an eligible organization that provides
(2) If a third party administrator
§ 54.9815–2713AT Accommodations in benefits on a self-insured basis may
connection with coverage of preventive receives a copy of the self-certification
voluntarily elect an optional
health services (temporary). from an eligible organization or a
accommodation under which its third
(a) Eligible organizations for optional notification from the Department of
party administrator(s) will provide or
accommodation. An eligible Labor, as described in paragraph
arrange payments for all or a subset of
organization is an organization that (b)(1)(ii) of this section, and is willing
contraceptive services for one or more
meets the criteria of paragraphs (a)(1) to enter into or remain in a contractual
plan years. To invoke the optional
through (4) of this section. relationship with the eligible
accommodation process:
(1) The organization is an objecting (i) The eligible organization or its plan organization or its plan to provide
entity described in 45 CFR must contract with one or more third administrative services for the plan,
147.132(a)(1)(i) or (ii); party administrators. then the third party administrator will
(2) Notwithstanding its status under (ii) The eligible organization must provide or arrange payments for
paragraph (a)(1) of this section and provide either a copy of the self- contraceptive services, using one of the
under 45 CFR 147.132(a), the certification to each third party following methods—
organization voluntarily seeks to be administrator or a notice to the (i) Provide payments for the
considered an eligible organization to Secretary of the Department of Health contraceptive services for plan
invoke the optional accommodation and Human Services that it is an eligible participants and beneficiaries without
under paragraph (b) or (c) of this section organization and of its objection as imposing any cost-sharing requirements
as applicable; and described in 45 CFR 147.132 to coverage (such as a copayment, coinsurance, or a
(3) [Reserved] of all or a subset of contraceptive deductible), premium, fee, or other
(4) The organization self-certifies in services. charge, or any portion thereof, directly
the form and manner specified by the (A) When a copy of the self- or indirectly, on the eligible
Secretary of Labor or provides notice to certification is provided directly to a organization, the group health plan, or
the Secretary of the Department of third party administrator, such self- plan participants or beneficiaries; or
Health and Human Services as certification must include notice that (ii) Arrange for an issuer or other
described in paragraph (b) or (c) of this obligations of the third party entity to provide payments for the
section. To qualify as an eligible administrator are set forth in 29 CFR contraceptive services for plan
organization, the organization must 2510.3–16 and this section. participants and beneficiaries without
make such self-certification or notice (B) When a notice is provided to the imposing any cost-sharing requirements
available for examination upon request Secretary of Health and Human (such as a copayment, coinsurance, or a
by the first day of the first plan year to Services, the notice must include the deductible), premium, fee, or other
which the accommodation in paragraph name of the eligible organization; a charge, or any portion thereof, directly
(b) or (c) of this section applies. The statement that it objects as described in or indirectly, on the eligible
self-certification or notice must be 45 CFR 147.132 to coverage of some or organization, the group health plan, or
executed by a person authorized to all contraceptive services (including an plan participants or beneficiaries.
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(3) If a third party administrator (i) The eligible organization or its plan (i) The issuer must expressly exclude
provides or arranges payments for must contract with one or more health contraceptive coverage from the group
contraceptive services in accordance insurance issuers. health insurance coverage provided in
with either paragraph (b)(2)(i) or (ii) of (ii) The eligible organization must connection with the group health plan
this section, the costs of providing or provide either a copy of the self- and provide separate payments for any
arranging such payments may be certification to each issuer providing contraceptive services required to be
reimbursed through an adjustment to coverage in connection with the plan or covered under § 54.9815–2713(a)(1)(iv)
the Federally facilitated Exchange user a notice to the Secretary of the for plan participants and beneficiaries
fee for a participating issuer pursuant to Department of Health and Human for so long as they remain enrolled in
45 CFR 156.50(d). Services that it is an eligible the plan.
(4) A third party administrator may organization and of its objection as (ii) With respect to payments for
not require any documentation other described in 45 CFR 147.132 to coverage contraceptive services, the issuer may
than a copy of the self-certification from for all or a subset of contraceptive not impose any cost-sharing
the eligible organization or notification services. requirements (such as a copayment,
from the Department of Labor described (A) When a self-certification is coinsurance, or a deductible), or impose
in paragraph (b)(1)(ii) of this section. provided directly to an issuer, the issuer any premium, fee, or other charge, or
(5) Where an otherwise eligible has sole responsibility for providing any portion thereof, directly or
organization does not contract with a such coverage in accordance with indirectly, on the eligible organization,
third party administrator and files a self- § 54.9815–2713. the group health plan, or plan
certification or notice under paragraph participants or beneficiaries. The issuer
(B) When a notice is provided to the
(b)(1)(ii) of this section, the obligations must segregate premium revenue
Secretary of the Department Health and
under paragraph (b)(2) of this section do collected from the eligible organization
Human Services, the notice must
not apply, and the otherwise eligible from the monies used to provide
include the name of the eligible
organization is under no requirement to payments for contraceptive services.
organization; a statement that it objects
provide coverage or payments for The issuer must provide payments for
as described in 45 CFR 147.132 to
contraceptive services to which it contraceptive services in a manner that
coverage of some or all contraceptive
objects. The plan administrator for that is consistent with the requirements
otherwise eligible organization may, if it services (including an identification of
under sections 2706, 2709, 2711, 2713,
and the otherwise eligible organization the subset of contraceptive services to
2719, and 2719A of the PHS Act, as
choose, arrange for payments for which coverage the eligible organization
incorporated into section 9815 of the
contraceptive services from an issuer or objects, if applicable) but that it would
PHS Act. If the group health plan of the
other entity in accordance with like to elect the optional
eligible organization provides coverage
paragraph (b)(2)(ii) of this section, and accommodation process; the plan name
for some but not all of any contraceptive
such issuer or other entity may receive and type (that is, whether it is a student services required to be covered under
reimbursements in accordance with health insurance plan within the § 54.9815–2713(a)(1)(iv), the issuer is
paragraph (b)(3) of this section. meaning of 45 CFR 147.145(a) or a required to provide payments only for
(6) Where an otherwise eligible church plan within the meaning of those contraceptive services for which
organization is an ERISA-exempt church section 3(33) of ERISA); and the name the group health plan does not provide
plan within the meaning of section 3(33) and contact information for any of the coverage. However, the issuer may
of ERISA and it files a self-certification plan’s health insurance issuers. If there provide payments for all contraceptive
or notice under paragraph (b)(1)(ii) of is a change in any of the information services, at the issuer’s option.
this section, the obligations under required to be included in the notice, (3) A health insurance issuer may not
paragraph (b)(2) of this section do not the eligible organization must provide require any documentation other than a
apply, and the otherwise eligible updated information to the Secretary of copy of the self-certification from the
organization is under no requirement to Department of Health and Human eligible organization or the notification
provide coverage or payments for Services for the optional from the Department of Health and
contraceptive services to which it accommodation process to remain in Human Services described in paragraph
objects. The third party administrator effect. The Department of Health and (c)(1)(ii) of this section.
for that otherwise eligible organization Human Services will send a separate (d) Notice of availability of separate
may, if it and the otherwise eligible notification to each of the plan’s health payments for contraceptive services—
organization choose, provide or arrange insurance issuers informing the issuer self-insured and insured group health
payments for contraceptive services in that the Secretary of the Department plans. For each plan year to which the
accordance with paragraphs (b)(2)(i) or Health and Human Services has optional accommodation in paragraph
(ii) of this section, and receive received a notice under paragraph (b) or (c) of this section is to apply, a
reimbursements in accordance with (c)(2)(ii) of this section and describing third party administrator required to
paragraph (b)(3) of this section. the obligations of the issuer under this provide or arrange payments for
(c) Optional accommodation— section. contraceptive services pursuant to
insured group health plans—(1) General (2) If an issuer receives a copy of the paragraph (b) of this section, and an
rule. A group health plan established or self-certification from an eligible issuer required to provide payments for
maintained by an eligible organization organization or the notification from the contraceptive services pursuant to
that provides benefits through one or Department of Health and Human paragraph (c) of this section, must
more group health insurance issuers Services as described in paragraph provide to plan participants and
may voluntarily elect an optional (c)(2)(ii) of this section and does not beneficiaries written notice of the
accommodation under which its health have its own objection as described in availability of separate payments for
insurance issuer(s) will provide 45 CFR 147.132 to providing the contraceptive services contemporaneous
payments for all or a subset of contraceptive services to which the with (to the extent possible), but
contraceptive services for one or more eligible organization objects, then the separate from, any application materials
plan years. To invoke the optional issuer will provide payments for distributed in connection with
accommodation process— contraceptive services as follows— enrollment (or re-enrollment) in group
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health coverage that is effective PART 2590—RULES AND (4) The organization self-certifies in
beginning on the first day of each REGULATIONS FOR GROUP HEALTH the form and manner specified by the
applicable plan year. The notice must PLANS Secretary or provides notice to the
specify that the eligible organization Secretary of the Department of Health
does not administer or fund ■ 6. The authority citation for part 2590 and Human Services as described in
contraceptive benefits, but that the third continues to read as follows: paragraph (b) or (c) of this section. To
party administrator or issuer, as Authority: 29 U.S.C. 1027, 1059, 1135, qualify as an eligible organization, the
applicable, provides or arranges 1161–1168, 1169, 1181–1183, 1181 note, organization must make such self-
separate payments for contraceptive 1185, 1185a, 1185b, 1191, 1191a, 1191b, and certification or notice available for
services, and must provide contact 1191c; sec. 101(g), Pub. L. 104–191, 110 Stat. examination upon request by the first
information for questions and 1936; sec. 401(b), Pub. L. 105–200, 112 Stat. day of the first plan year to which the
complaints. The following model 645 (42 U.S.C. 651 note); sec. 512(d), Pub. L. accommodation in paragraph (b) or (c)
110–343, 122 Stat. 3881; sec. 1001, 1201, and of this section applies. The self-
language, or substantially similar
1562(e), Pub. L. 111–148, 124 Stat. 119, as
language, may be used to satisfy the certification or notice must be executed
amended by Pub. L. 111–152, 124 Stat. 1029;
notice requirement of this paragraph (d): Division M, Pub. L. 113–235, 128 Stat. 2130; by a person authorized to make the
‘‘Your employer has certified that your Secretary of Labor’s Order 1–2011, 77 FR certification or provide the notice on
group health plan qualifies for an 1088 (Jan. 9, 2012). behalf of the organization, and must be
accommodation with respect to the maintained in a manner consistent with
■ 7. Section 2590.715–2713 is amended the record retention requirements under
Federal requirement to cover all Food by revising paragraphs (a)(1)
and Drug Administration-approved section 107 of ERISA.
introductory text and (a)(1)(iv) to read as (5) An eligible organization may
contraceptive services for women, as follows:
prescribed by a health care provider, revoke its use of the accommodation
without cost sharing. This means that § 2590.715–2713 Coverage of preventive process, and its issuer or third party
your employer will not contract, health services. administrator must provide participants
arrange, pay, or refer for contraceptive (a) Services—(1) In general. Beginning and beneficiaries written notice of such
coverage. Instead, [name of third party at the time described in paragraph (b) of revocation as specified in guidance
administrator/health insurance issuer] this section and subject to § 2590.715– issued by the Secretary of the
will provide or arrange separate 2713A, a group health plan, or a health Department of Health and Human
payments for contraceptive services that insurance issuer offering group health Services. If contraceptive coverage is
you use, without cost sharing and at no insurance coverage, must provide currently being offered by an issuer or
other cost, for so long as you are coverage for and must not impose any third party administrator through the
enrolled in your group health plan. cost-sharing requirements (such as a accommodation process, the revocation
Your employer will not administer or copayment, coinsurance, or a will be effective on the first day of the
fund these payments. If you have any deductible) for— first plan year that begins on or after 30
questions about this notice, contact days after the date of the revocation (to
* * * * * allow for the provision of notice to plan
[contact information for third party (iv) With respect to women, such
administrator/health insurance issuer].’’ participants in cases where
additional preventive care and contraceptive benefits will no longer be
(e) Definition. For the purposes of this screenings not described in paragraph
section, reference to ‘‘contraceptive’’ provided). Alternatively, an eligible
(a)(1)(i) of this section as provided for in organization may give 60-days notice
services, benefits, or coverage includes comprehensive guidelines supported by
contraceptive or sterilization items, pursuant to PHS Act section 2715(d)(4)
the Health Resources and Services and § 2590.715–2715(b), if applicable, to
procedures, or services, or related Administration for purposes of section revoke its use of the accommodation
patient education or counseling, to the 2713(a)(4) of the Public Health Service process.
extent specified for purposes of Act, subject to 45 CFR 147.131 and (b) Optional accommodation—self-
§ 54.9815–2713(a)(1)(iv). 147.132. insured group health plans. (1) A group
(f) Severability. Any provision of this
* * * * * health plan established or maintained
section held to be invalid or
■ 8. Section 2590.715–2713A is revised by an eligible organization that provides
unenforceable by its terms, or as applied benefits on a self-insured basis may
to any person or circumstance, shall be to read as follows:
voluntarily elect an optional
construed so as to continue to give § 2590.715–2713A Accommodations in accommodation under which its third
maximum effect to the provision connection with coverage of preventive party administrator(s) will provide or
permitted by law, unless such holding health services. arrange payments for all or a subset of
shall be one of utter invalidity or (a) Eligible organizations for optional contraceptive services for one or more
unenforceability, in which event the accommodation. An eligible plan years. To invoke the optional
provision shall be severable from this organization is an organization that accommodation process:
section and shall not affect the meets the criteria of paragraphs (a)(1) (i) The eligible organization or its plan
remainder thereof or the application of through (4) of this section. must contract with one or more third
the provision to persons not similarly (1) The organization is an objecting party administrators.
situated or to dissimilar circumstances. entity described in 45 CFR (ii) The eligible organization must
(g) Expiration date. This section 147.132(a)(1)(i) or (ii); provide either a copy of the self-
expires on October 6, 2020. (2) Notwithstanding its exempt status certification to each third party
DEPARTMENT OF LABOR under 45 CFR 147.132(a), the administrator or a notice to the
organization voluntarily seeks to be Secretary of the Department of Health
Employee Benefits Security considered an eligible organization to and Human Services that it is an eligible
Administration invoke the optional accommodation organization and of its objection as
For the reasons set forth in the under paragraph (b) or (c) of this section described in 45 CFR 147.132 to coverage
preamble, the Department of Labor as applicable; and of all or a subset of contraceptive
amends 29 CFR part 2590 as follows: (3) [Reserved] services.
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(A) When a copy of the self- organization, the group health plan, or coverage in connection with the plan or
certification is provided directly to a plan participants or beneficiaries; or a notice to the Secretary of the
third party administrator, such self- (ii) Arrange for an issuer or other Department of Health and Human
certification must include notice that entity to provide payments for Services that it is an eligible
obligations of the third party contraceptive services for plan organization and of its objection as
administrator are set forth in § 2510.3– participants and beneficiaries without described in 45 CFR 147.132 to coverage
16 of this chapter and this section. imposing any cost-sharing requirements for all or a subset of contraceptive
(B) When a notice is provided to the (such as a copayment, coinsurance, or a services.
Secretary of Health and Human deductible), premium, fee, or other (A) When a self-certification is
Services, the notice must include the charge, or any portion thereof, directly provided directly to an issuer, the issuer
name of the eligible organization; a or indirectly, on the eligible has sole responsibility for providing
statement that it objects as described in organization, the group health plan, or such coverage in accordance with
45 CFR 147.132 to coverage of some or plan participants or beneficiaries. § 2590.715–2713.
all contraceptive services (including an (3) If a third party administrator (B) When a notice is provided to the
identification of the subset of provides or arranges payments for Secretary of the Department of Health
contraceptive services to which contraceptive services in accordance and Human Services, the notice must
coverage the eligible organization with either paragraph (b)(2)(i) or (ii) of include the name of the eligible
objects, if applicable), but that it would this section, the costs of providing or organization; a statement that it objects
like to elect the optional arranging such payments may be as described in 45 CFR 147.132 to
accommodation process; the plan name reimbursed through an adjustment to coverage of some or all contraceptive
and type (that is, whether it is a student the Federally facilitated Exchange user services (including an identification of
health insurance plan within the fee for a participating issuer pursuant to the subset of contraceptive services to
meaning of 45 CFR 147.145(a) or a 45 CFR 156.50(d). which coverage the eligible organization
church plan within the meaning of (4) A third party administrator may objects, if applicable) but that it would
section 3(33) of ERISA); and the name not require any documentation other like to elect the optional
and contact information for any of the than a copy of the self-certification from accommodation process; the plan name
plan’s third party administrators. If the eligible organization or notification and type (that is, whether it is a student
there is a change in any of the from the Department of Labor described health insurance plan within the
information required to be included in in paragraph (b)(1)(ii) of this section. meaning of 45 CFR 147.145(a) or a
the notice, the eligible organization (5) Where an otherwise eligible church plan within the meaning of
must provide updated information to organization does not contract with a section 3(33) of ERISA); and the name
the Secretary of the Department of third party administrator and it files a and contact information for any of the
Health and Human Services for the self-certification or notice under plan’s health insurance issuers. If there
optional accommodation process to paragraph (b)(1)(ii) of this section, the is a change in any of the information
remain in effect. The Department of obligations under paragraph (b)(2) of required to be included in the notice,
Labor (working with the Department of this section do not apply, and the the eligible organization must provide
Health and Human Services), will send otherwise eligible organization is under updated information to the Secretary of
a separate notification to each of the no requirement to provide coverage or Department Health and Human Services
plan’s third party administrators payments for contraceptive services to for the optional accommodation process
informing the third party administrator which it objects. The plan administrator to remain in effect. The Department of
that the Secretary of the Department of for that otherwise eligible organization Health and Human Services will send a
Health and Human Services has may, if it and the otherwise eligible separate notification to each of the
received a notice under paragraph organization choose, arrange for plan’s health insurance issuers
(b)(1)(ii) of this section and describing payments for contraceptive services informing the issuer that the Secretary
the obligations of the third party from an issuer or other entity in of Health and Human Services has
administrator under § 2510.3–16 of this accordance with paragraph (b)(2)(ii) of received a notice under paragraph
chapter and this section. this section, and such issuer or other (c)(2)(ii) of this section and describing
(2) If a third party administrator entity may receive reimbursements in the obligations of the issuer under this
receives a copy of the self-certification accordance with paragraph (b)(3) of this section.
from an eligible organization or a section. (2) If an issuer receives a copy of the
notification from the Department of (c) Optional accommodation— self-certification from an eligible
Labor, as described in paragraph insured group health plans—(1) General organization or the notification from the
(b)(1)(ii) of this section, and is willing rule. A group health plan established or Department of Health and Human
to enter into or remain in a contractual maintained by an eligible organization Services as described in paragraph
relationship with the eligible that provides benefits through one or (c)(2)(ii) of this section and does not
organization or its plan to provide more group health insurance issuers have its own objection as described in
administrative services for the plan, may voluntarily elect an optional 45 CFR 147.132 to providing the
then the third party administrator will accommodation under which its health contraceptive services to which the
provide or arrange payments for insurance issuer(s) will provide eligible organization objects, then the
contraceptive services, using one of the payments for all or a subset of issuer will provide payments for
following methods— contraceptive services for one or more contraceptive services as follows—
(i) Provide payments for the plan years. To invoke the optional (i) The issuer must expressly exclude
contraceptive services for plan accommodation process: contraceptive coverage from the group
participants and beneficiaries without (i) The eligible organization or its plan health insurance coverage provided in
imposing any cost-sharing requirements must contract with one or more health connection with the group health plan
(such as a copayment, coinsurance, or a insurance issuers. and provide separate payments for any
deductible), premium, fee, or other (ii) The eligible organization must contraceptive services required to be
charge, or any portion thereof, directly provide either a copy of the self- covered under § 2590.715–2713(a)(1)(iv)
or indirectly, on the eligible certification to each issuer providing for plan participants and beneficiaries
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for so long as they remain enrolled in separate payments for contraceptive U.S.C. 300gg through 300gg–63, 300gg–91,
the plan. services, and must provide contact and 300gg–92), as amended.
(ii) With respect to payments for information for questions and ■ 10. Section 147.130 is amended by
contraceptive services, the issuer may complaints. The following model revising paragraphs (a)(1) introductory
not impose any cost-sharing language, or substantially similar text and (a)(1)(iv) to read as follows:
requirements (such as a copayment, language, may be used to satisfy the
coinsurance, or a deductible), or impose § 147.130 Coverage of preventive health
notice requirement of this paragraph (d): services.
any premium, fee, or other charge, or ‘‘Your employer has certified that your
any portion thereof, directly or group health plan qualifies for an (a) * * *
indirectly, on the eligible organization, (1) In general. Beginning at the time
accommodation with respect to the
the group health plan, or plan described in paragraph (b) of this
Federal requirement to cover all Food
participants or beneficiaries. The issuer section and subject to §§ 147.131 and
and Drug Administration-approved
must segregate premium revenue 147.132, a group health plan, or a health
contraceptive services for women, as
collected from the eligible organization insurance issuer offering group or
prescribed by a health care provider,
from the monies used to provide individual health insurance coverage,
without cost sharing. This means that
payments for contraceptive services. must provide coverage for and must not
your employer will not contract,
The issuer must provide payments for impose any cost-sharing requirements
arrange, pay, or refer for contraceptive
contraceptive services in a manner that (such as a copayment, coinsurance, or a
coverage. Instead, [name of third party
is consistent with the requirements deductible) for—
administrator/health insurance issuer]
under sections 2706, 2709, 2711, 2713, will provide or arrange separate * * * * *
2719, and 2719A of the PHS Act, as payments for contraceptive services that (iv) With respect to women, such
incorporated into section 715 of ERISA. you use, without cost sharing and at no additional preventive care and
If the group health plan of the eligible other cost, for so long as you are screenings not described in paragraph
organization provides coverage for some enrolled in your group health plan. (a)(1)(i) of this section as provided for in
but not all of any contraceptive services Your employer will not administer or comprehensive guidelines supported by
required to be covered under fund these payments. If you have any the Health Resources and Services
§ 2590.715–2713(a)(1)(iv), the issuer is questions about this notice, contact Administration for purposes of section
required to provide payments only for [contact information for third party 2713(a)(4) of the Public Health Service
those contraceptive services for which administrator/health insurance issuer].’’ Act, subject to §§ 147.131 and 147.132.
the group health plan does not provide * * * * *
(e) Definition. For the purposes of this
coverage. However, the issuer may ■ 11. Section 147.131 is revised to read
section, reference to ‘‘contraceptive’’
provide payments for all contraceptive as follows:
services, benefits, or coverage includes
services, at the issuer’s option.
(3) A health insurance issuer may not contraceptive or sterilization items, § 147.131 Accommodations in connection
require any documentation other than a procedures, or services, or related with coverage of certain preventive health
copy of the self-certification from the patient education or counseling, to the services.
eligible organization or the notification extent specified for purposes of (a)–(b) [Reserved]
from the Department of Health and § 2590.715–2713(a)(1)(iv). (c) Eligible organizations for optional
Human Services described in paragraph (f) Severability. Any provision of this accommodation. An eligible
(c)(1)(ii) of this section. section held to be invalid or organization is an organization that
(d) Notice of availability of separate unenforceable by its terms, or as applied meets the criteria of paragraphs (c)(1)
payments for contraceptive services— to any person or circumstance, shall be through (3) of this section.
self-insured and insured group health construed so as to continue to give (1) The organization is an objecting
plans. For each plan year to which the maximum effect to the provision entity described in § 147.132(a)(1)(i) or
optional accommodation in paragraph permitted by law, unless such holding (ii).
(b) or (c) of this section is to apply, a shall be one of utter invalidity or (2) Notwithstanding its exempt status
third party administrator required to unenforceability, in which event the under § 147.132(a), the organization
provide or arrange payments for provision shall be severable from this voluntarily seeks to be considered an
contraceptive services pursuant to section and shall not affect the eligible organization to invoke the
paragraph (b) of this section, and an remainder thereof or the application of optional accommodation under
issuer required to provide payments for the provision to persons not similarly paragraph (d) of this section; and
contraceptive services pursuant to situated or to dissimilar circumstances. (3) The organization self-certifies in
paragraph (c) of this section, must the form and manner specified by the
DEPARTMENT OF HEALTH AND Secretary or provides notice to the
provide to plan participants and
HUMAN SERVICES Secretary as described in paragraph (d)
beneficiaries written notice of the
availability of separate payments for For the reasons set forth in the of this section. To qualify as an eligible
contraceptive services contemporaneous preamble, the Department of Health and organization, the organization must
with (to the extent possible), but Human Services amends 45 CFR part make such self-certification or notice
separate from, any application materials 147 as follows: available for examination upon request
distributed in connection with by the first day of the first plan year to
enrollment (or re-enrollment) in group PART 147—HEALTH INSURANCE which the accommodation in paragraph
health coverage that is effective REFORM REQUIREMENTS FOR THE (d) of this section applies. The self-
beginning on the first day of each GROUP AND INDIVIDUAL HEALTH certification or notice must be executed
applicable plan year. The notice must INSURANCE MARKETS by a person authorized to make the
specify that the eligible organization certification or provide the notice on
does not administer or fund ■ 9. The authority citation for part 147 behalf of the organization, and must be
contraceptive benefits, but that the third continues to read as follows: maintained in a manner consistent with
party administrator or issuer, as Authority: Secs 2701 through 2763, 2791, the record retention requirements under
applicable, provides or arranges and 2792 of the Public Health Service Act (42 section 107 of ERISA.
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(4) An eligible organization may plan within the meaning of section 3(33) only for those contraceptive services for
revoke its use of the accommodation of ERISA); and the name and contact which the group health plan does not
process, and its issuer must provide information for any of the plan’s health provide coverage. However, the issuer
participants and beneficiaries written insurance issuers. If there is a change in may provide payments for all
notice of such revocation as specified in any of the information required to be contraceptive services, at the issuer’s
guidance issued by the Secretary of the included in the notice, the eligible option.
Department of Health and Human organization must provide updated (3) A health insurance issuer may not
Services. If contraceptive coverage is information to the Secretary of the require any documentation other than a
currently being offered by an issuer Department of Health and Human copy of the self-certification from the
through the accommodation process, the Services for the optional eligible organization or the notification
revocation will be effective on the first accommodation to remain in effect. The from the Department of Health and
day of the first plan year that begins on Department of Health and Human Human Services described in paragraph
or after 30 days after the date of the Services will send a separate (d)(1)(ii) of this section.
revocation (to allow for the provision of notification to each of the plan’s health (e) Notice of availability of separate
notice to plan participants in cases insurance issuers informing the issuer payments for contraceptive services—
where contraceptive benefits will no that the Secretary of the Deparement of insured group health plans and student
longer be provided). Alternatively, an Health and Human Services has health insurance coverage. For each
eligible organization may give 60-days received a notice under paragraph plan year to which the optional
notice pursuant to section 2715(d)(4) of (d)(1)(ii) of this section and describing accommodation in paragraph (d) of this
the PHS Act and § 147.200(b), if the obligations of the issuer under this section is to apply, an issuer required to
applicable, to revoke its use of the section. provide payments for contraceptive
accommodation process. (2) If an issuer receives a copy of the services pursuant to paragraph (d) of
(d) Optional accommodation— self-certification from an eligible this section must provide to plan
insured group health plans—(1) General organization or the notification from the participants and beneficiaries written
rule. A group health plan established or Department of Health and Human notice of the availability of separate
maintained by an eligible organization Services as described in paragraph payments for contraceptive services
that provides benefits through one or (d)(1)(ii) of this section and does not contemporaneous with (to the extent
more group health insurance issuers have an objection as described in possible), but separate from, any
may voluntarily elect an optional § 147.132 to providing the contraceptive application materials distributed in
accommodation under which its health services identified in the self- connection with enrollment (or re-
insurance issuer(s) will provide certification or the notification from the enrollment) in group health coverage
payments for all or a subset of Department of Health and Human that is effective beginning on the first
contraceptive services for one or more Services, then the issuer will provide day of each applicable plan year. The
plan years. To invoke the optional payments for contraceptive services as notice must specify that the eligible
accommodation process: follows— organization does not administer or
(i) The eligible organization or its plan (i) The issuer must expressly exclude fund contraceptive benefits, but that the
must contract with one or more health contraceptive coverage from the group issuer provides separate payments for
insurance issuers. health insurance coverage provided in contraceptive services, and must
(ii) The eligible organization must connection with the group health plan provide contact information for
provide either a copy of the self- and provide separate payments for any questions and complaints. The
certification to each issuer providing contraceptive services required to be following model language, or
coverage in connection with the plan or covered under § 141.130(a)(1)(iv) for substantially similar language, may be
a notice to the Secretary of the plan participants and beneficiaries for used to satisfy the notice requirement of
Department of Health and Human so long as they remain enrolled in the this paragraph (e) ‘‘Your [employer/
Services that it is an eligible plan. institution of higher education] has
organization and of its objection as (ii) With respect to payments for certified that your [group health plan/
described in § 147.132 to coverage for contraceptive services, the issuer may student health insurance coverage]
all or a subset of contraceptive services. not impose any cost-sharing qualifies for an accommodation with
(A) When a self-certification is requirements (such as a copayment, respect to the Federal requirement to
provided directly to an issuer, the issuer coinsurance, or a deductible), premium, cover all Food and Drug
has sole responsibility for providing fee, or other charge, or any portion Administration-approved contraceptive
such coverage in accordance with thereof, directly or indirectly, on the services for women, as prescribed by a
§ 147.130(a)(iv). eligible organization, the group health health care provider, without cost
(B) When a notice is provided to the plan, or plan participants or sharing. This means that your
Secretary of the Department of Health beneficiaries. The issuer must segregate [employer/institution of higher
and Human Services, the notice must premium revenue collected from the education] will not contract, arrange,
include the name of the eligible eligible organization from the monies pay, or refer for contraceptive coverage.
organization; a statement that it objects used to provide payments for Instead, [name of health insurance
as described in § 147.132 to coverage of contraceptive services. The issuer must issuer] will provide separate payments
some or all contraceptive services provide payments for contraceptive for contraceptive services that you use,
(including an identification of the services in a manner that is consistent without cost sharing and at no other
subset of contraceptive services to with the requirements under sections cost, for so long as you are enrolled in
which coverage the eligible organization 2706, 2709, 2711, 2713, 2719, and your [group health plan/student health
objects, if applicable) but that it would 2719A of the PHS Act. If the group insurance coverage]. Your [employer/
like to elect the optional health plan of the eligible organization institution of higher education] will not
accommodation process; the plan name provides coverage for some but not all administer or fund these payments . If
and type (that is, whether it is a student of any contraceptive services required to you have any questions about this
health insurance plan within the be covered under § 147.130(a)(1)(iv), the notice, contact [contact information for
meaning of § 147.145(a) or a church issuer is required to provide payments health insurance issuer].’’
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(f) Definition. For the purposes of this include, but are not limited to, the (b) Objecting individuals. Guidelines
section, reference to ‘‘contraceptive’’ following entities— issued under § 147.130(a)(1)(iv) by the
services, benefits, or coverage includes (A) A church, an integrated auxiliary Health Resources and Services
contraceptive or sterilization items, of a church, a convention or association Administration must not provide for or
procedures, or services, or related of churches, or a religious order. support the requirement of coverage or
patient education or counseling, to the (B) A nonprofit organization. payments for contraceptive services
extent specified for purposes of (C) A closely held for-profit entity. with respect to individuals who object
§ 147.130(a)(1)(iv). (D) A for-profit entity that is not as specified in this paragraph (b), and
(g) Severability. Any provision of this closely held. nothing in § 147.130(a)(1)(iv), 26 CFR
section held to be invalid or (E) Any other non-governmental
54.9815–2713(a)(1)(iv), or 29 CFR
employer.
unenforceable by its terms, or as applied 2590.715–2713(a)(1)(iv) may be
(ii) An institution of higher education
to any person or circumstance, shall be construed to prevent a willing health
as defined in 20 U.S.C. 1002 in its
construed so as to continue to give arrangement of student health insurance insurance issuer offering group or
maximum effect to the provision coverage, to the extent that institution individual health insurance coverage,
permitted by law, unless such holding objects as specified in paragraph (a)(2) and as applicable, a willing plan
shall be one of utter invalidity or of this section. In the case of student sponsor of a group health plan, from
unenforceability, in which event the health insurance coverage, this section offering a separate benefit package
provision shall be severable from this is applicable in a manner comparable to option, or a separate policy, certificate
section and shall not affect the its applicability to group health or contract of insurance, to any
remainder thereof or the application of insurance coverage provided in individual who objects to coverage or
the provision to persons not similarly connection with a group health plan payments for some or all contraceptive
situated or to dissimilar circumstances. established or maintained by a plan services based on sincerely held
■ 12. Add § 147.132 to read as follows: sponsor that is an employer, and religious beliefs.
references to ‘‘plan participants and (c) Definition. For the purposes of this
§ 147.132 Religious exemptions in beneficiaries’’ will be interpreted as
connection with coverage of certain section, reference to ‘‘contraceptive’’
references to student enrollees and their services, benefits, or coverage includes
preventive health services.
covered dependents; and contraceptive or sterilization items,
(a) Objecting entities. (1) Guidelines (iii) A health insurance issuer offering
issued under § 147.130(a)(1)(iv) by the procedures, or services, or related
group or individual insurance coverage patient education or counseling, to the
Health Resources and Services to the extent the issuer objects as
Administration must not provide for or extent specified for purposes of
specified in paragraph (a)(2) of this § 147.130(a)(1)(iv).
support the requirement of coverage or section. Where a health insurance issuer
payments for contraceptive services providing group health insurance (d) Severability. Any provision of this
with respect to a group health plan coverage is exempt under this paragraph section held to be invalid or
established or maintained by an (a)(1)(iii), the plan remains subject to unenforceable by its terms, or as applied
objecting organization, or health any requirement to provide coverage for to any person or circumstance, shall be
insurance coverage offered or arranged contraceptive services under Guidelines construed so as to continue to give
by an objecting organization, and thus issued under § 147.130(a)(1)(iv) unless it maximum effect to the provision
the Health Resources and Service is also exempt from that requirement. permitted by law, unless such holding
Administration will exempt from any (2) The exemption of this paragraph shall be one of utter invalidity or
guidelines’ requirements that relate to (a) will apply to the extent that an entity unenforceability, in which event the
the provision of contraceptive services: described in paragraph (a)(1) of this provision shall be severable from this
(i) A group health plan and health section objects to its establishing, section and shall not affect the
insurance coverage provided in maintaining, providing, offering, or remainder thereof or the application of
connection with a group health plan to arranging (as applicable) coverage, the provision to persons not similarly
the extent the non-governmental plan payments, or a plan that provides situated or to dissimilar circumstances.
sponsor objects as specified in coverage or payments for some or all [FR Doc. 2017–21851 Filed 10–6–17; 11:15 am]
paragraph (a)(2) of this section. Such contraceptive services, based on its BILLING CODE 4830–01–P; 4510–29–P; 4120–01–P;
non-governmental plan sponsors sincerely held religious beliefs. 6325–64–P
47838 Case 4:18-cv-00825-O
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DEPARTMENT OF THE TREASURY Effective date: These interim final their comments in the CMS drop slots
rules are effective on October 6, 2017. located in the main lobby of the
Internal Revenue Service Comment date: Written comments on building. A stamp-in clock is available
these interim final rules are invited and for persons wishing to retain a proof of
26 CFR Part 54 must be received by December 5, 2017. filing by stamping in and retaining an
[TD–9828] ADDRESSES: Written comments may be extra copy of the comments being filed.)
submitted to the Department of Health b. For delivery in Baltimore, MD—
RIN 1545–BN91 Centers for Medicare & Medicaid
and Human Services as specified below.
Any comment that is submitted will be Services, Department of Health and
DEPARTMENT OF LABOR Human Services, 7500 Security
shared with the Department of Labor
and the Department of the Treasury, and Boulevard, Baltimore, MD 21244–1850.
Employee Benefits Security If you intend to deliver your
Administration will also be made available to the
public. comments to the Baltimore address, call
Warning: Do not include any telephone number (410) 786–9994 in
29 CFR Part 2590 advance to schedule your arrival with
personally identifiable information
RIN 1210–AB84 (such as name, address, or other contact one of our staff members.
information) or confidential business Comments erroneously mailed to the
DEPARTMENT OF HEALTH AND information that you do not want addresses indicated as appropriate for
HUMAN SERVICES publicly disclosed. All comments may hand or courier delivery may be delayed
be posted on the Internet and can be and received after the comment period.
45 CFR Part 147 retrieved by most Internet search Comments received will be posted
engines. No deletions, modifications, or without change to www.regulations.gov.
[CMS–9925–IFC]
redactions will be made to the FOR FURTHER INFORMATION CONTACT: Jeff
RIN 0938–AT46 Wu (310) 492–4305 or
comments received, as they are public
records. Comments may be submitted marketreform@cms.hhs.gov for Centers
Moral Exemptions and for Medicare & Medicaid Services
Accommodations for Coverage of anonymously. Comments, identified by
‘‘Preventive Services,’’ may be (CMS), Department of Health and
Certain Preventive Services Under the Human Services (HHS), Amber Rivers or
Affordable Care Act submitted one of four ways (please
choose only one of the ways listed) Matthew Litton, Employee Benefits
AGENCY: Internal Revenue Service, 1. Electronically. You may submit Security Administration (EBSA),
Department of the Treasury; Employee electronic comments on this regulation Department of Labor, at (202) 693–8335;
Benefits Security Administration, to http://www.regulations.gov. Follow Karen Levin, Internal Revenue Service,
Department of Labor; and Centers for the ‘‘Submit a comment’’ instructions. Department of the Treasury, at (202)
Medicare & Medicaid Services, 2. By regular mail. You may mail 317–5500.
Department of Health and Human written comments to the following Customer Service Information:
Services. address ONLY: Centers for Medicare & Individuals interested in obtaining
ACTION: Interim final rules with request Medicaid Services, Department of information from the Department of
for comments. Health and Human Services, Attention: Labor concerning employment-based
CMS–9925–IFC, P.O. Box 8016, health coverage laws may call the EBSA
SUMMARY: The United States has a long Baltimore, MD 21244–8016. Toll-Free Hotline at 1–866–444–EBSA
history of providing conscience Please allow sufficient time for mailed (3272) or visit the Department of Labor’s
protections in the regulation of health comments to be received before the Web site (www.dol.gov/ebsa).
care for entities and individuals with close of the comment period. Information from HHS on private health
objections based on religious beliefs or 3. By express or overnight mail. You insurance coverage can be found on
moral convictions. These interim final may send written comments to the CMS’s Web site (www.cms.gov/cciio),
rules expand exemptions to protect following address ONLY: Centers for and information on health care reform
moral convictions for certain entities Medicare & Medicaid Services, can be found at www.HealthCare.gov.
and individuals whose health plans are Department of Health and Human SUPPLEMENTARY INFORMATION:
subject to a mandate of contraceptive Services, Attention: CMS–9925–IFC,
coverage through guidance issued I. Background
Mail Stop C4–26–05, 7500 Security
pursuant to the Patient Protection and Boulevard, Baltimore, MD 21244–1850. In the context of legal requirements
Affordable Care Act. These rules do not 4. By hand or courier. Alternatively, touching on certain sensitive health care
alter the discretion of the Health you may deliver (by hand or courier) issues—including health coverage of
Resources and Services Administration, your written comments ONLY to the contraceptives—Congress has a
a component of the United States following addresses prior to the close of consistent history of supporting
Department of Health and Human the comment period: conscience protections for moral
Services, to maintain the guidelines a. For delivery in Washington, DC— convictions alongside protections for
requiring contraceptive coverage where Centers for Medicare & Medicaid religious beliefs, including as part of its
no regulatorily recognized objection Services, Department of Health and efforts to promote access to health
exists. These rules also provide certain Human Services, Room 445–G, Hubert services.1 Against that backdrop,
morally objecting entities access to the H. Humphrey Building, 200 1 See, for example, 42 U.S.C. 300a–7 (protecting
voluntary ‘‘accommodation’’ process Independence Avenue SW., individuals and health care entities from being
regarding such coverage. These rules do Washington, DC 20201. required to provide or assist sterilizations,
not alter multiple other Federal (Because access to the interior of the abortions, or other lawful health services if it would
programs that provide free or subsidized Hubert H. Humphrey Building is not violate their ‘‘religious beliefs or moral
contraceptives for women at risk of convictions’’); 42 U.S.C. 238n (protecting
readily available to persons without individuals and entities that object to abortion);
unintended pregnancy. Federal government identification, Consolidated Appropriations Act of 2017, Div. H,
DATES: commenters are encouraged to leave Title V, Sec. 507(d) (Departments of Labor, HHS,
CaseFederal
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Congress granted the Health Resources administering agencies—the Departments’ 2016 Request for
and Services Administration (HRSA), a Departments of Health and Human Information). Elsewhere in this issue of
component of the United States Services, Labor, and the Treasury the Federal Register, the Departments
Department of Health and Human (collectively, ‘‘the Departments’’),3 published, contemporaneously with
Services (HHS), discretion under the exercised both the discretion granted to these interim final rules, companion
Patient Protection and Affordable Care HHS through HRSA, its component, in interim final rules expanding
Act to specify that certain group health PHS Act section 2713(a)(4), and the exemptions to protect sincerely held
plans and health insurance issuers shall authority granted to the Departments as religious beliefs in the context of the
cover, ‘‘with respect to women, such administering agencies (26 U.S.C. 9833; contraceptive Mandate.
additional preventive care and 29 U.S.C. 1191c; 42 U.S.C. 300gg–92) to In light of these considerations, the
screenings . . . as provided for in issue regulations to guide HRSA in Departments issue these interim final
comprehensive guidelines supported carrying out that provision. Through rules to better balance the Government’s
by’’ HRSA (the ‘‘Guidelines’’). Public rulemaking, including three interim interest in promoting coverage for
Health Service Act section 2713(a)(4). final rules, the Departments exempted contraceptive and sterilization services
HRSA exercised that discretion under and accommodated certain religious with the Government’s interests in
the last Administration to require health objectors, but did not offer an providing conscience protections for
coverage for, among other things, certain exemption or accommodation to any individuals and entities with sincerely
contraceptive services,2 while the group possessing non-religious moral held moral convictions in certain health
objections to providing coverage for care contexts, and in minimizing
and Education, and Related Agencies some or all contraceptives. Many burdens imposed by our regulation of
Appropriations Act), Public Law 115–31 (protecting the health insurance market.
any ‘‘health care professional, a hospital, a
individuals and entities challenged the
provider-sponsored organization, a health contraceptive coverage requirement and A. The Affordable Care Act
maintenance organization, a health insurance plan, regulations (hereinafter, the
or any other kind of health care facility, ‘‘contraceptive Mandate,’’ or the Collectively, the Patient Protection
organization, or plan’’ in objecting to abortion for
‘‘Mandate’’) as being inconsistent with and Affordable Care Act (Pub. L. 111–
any reason); Id. at Div. C, Title VIII, Sec. 808 148), enacted on March 23, 2010, and
(regarding any requirement of ‘‘the provision of various legal protections. These
contraceptive coverage by health insurance plans’’ challenges included lawsuits brought by the Health Care and Education
in the District of Columbia, ‘‘it is the intent of
some non-religious organizations with Reconciliation Act of 2010 (Pub. L. 111–
Congress that any legislation enacted on such issue 152), enacted on March 30, 2010, are
should include a ‘conscience clause’ which sincerely held moral convictions
known as the Affordable Care Act. In
provides exceptions for religious beliefs and moral inconsistent with providing coverage for
convictions.’’); Id. at Div. C, Title VII, Sec. 726(c) signing the Affordable Care Act,
some or all contraceptive services, and
(Financial Services and General Government President Obama issued Executive
Appropriations Act) (protecting individuals who those cases continue to this day. Various
Order 13535 (March 24, 2010), which
object to prescribing or providing contraceptives public comments were also submitted
contrary to their ‘‘religious beliefs or moral declared that, ‘‘[u]nder the Act,
asking the Departments to protect
convictions’’); Id. at Div. I, Title III (Department of longstanding Federal laws to protect
objections based on moral convictions.
State, Foreign Operations, and Related Programs
The Departments have recently conscience (such as the Church
Appropriations Act) (protecting applicants for Amendment, 42 U.S.C. 300a–7, and the
family planning funds based on their ‘‘religious or exercised our discretion to reevaluate
conscientious commitment to offer only natural Weldon Amendment, section 508(d)(1)
these exemptions and accommodations.
family planning’’); 42 U.S.C. 290bb–36 (prohibiting of Pub. L. 111–8) remain intact’’ and
This evaluation includes consideration
the statutory section from being construed to that ‘‘[n]umerous executive agencies
require suicide related treatment services for youth of various factors, such as: The interests
have a role in ensuring that these
where the parents or legal guardians object based served by the existing Guidelines,
on ‘‘religious beliefs or moral objections’’); 42 restrictions are enforced, including the
regulations, and accommodation
U.S.C. 1395w–22(j)(3)(B) (protecting against forced Department of Health and Human
counseling or referrals in Medicare Choice, now process; 4 the extensive litigation;
Services (HHS).’’ Those laws protect
Medicare Advantage, managed care plans with Executive Order 13798, ‘‘Promoting Free
respect to objections based on ‘‘moral or religious objections based on moral convictions
Speech and Religious Liberty’’ (May 4,
grounds’’); 42 U.S.C. 1396a(w)(3) (ensuring in addition to religious beliefs.
particular Federal law does not infringe on
2017); Congress’ history of providing The Affordable Care Act reorganizes,
‘‘conscience’’ as protected in State law concerning protections for moral convictions amends, and adds to the provisions of
advance directives); 42 U.S.C. 1396u–2(b)(3) alongside religious beliefs regarding part A of title XXVII of the Public
(protecting against forced counseling or referrals in certain health services (including
Medicaid managed care plans with respect to Health Service Act (PHS Act) relating to
objections based on ‘‘moral or religious grounds’’); contraception, sterilization, and items or group health plans and health insurance
42 U.S.C. 2996f(b) (protecting objection to abortion services believed to involve abortion); issuers in the group and individual
funding in legal services assistance grants based on the discretion afforded under PHS Act markets. In addition, the Affordable
‘‘religious beliefs or moral convictions’’); 42 U.S.C.
14406 (protecting organizations and health
section 2713(a)(4); the structure and Care Act adds section 715(a)(1) to the
providers from being required to inform or counsel intent of that provision in the broader Employee Retirement Income Security
persons pertaining to assisted suicide); 42 U.S.C. context of section 2713 and the Patient Act of 1974 (ERISA) and section
18023 (blocking any requirement that issuers or Protection and Affordable Care Act; and
exchanges must cover abortion); 42 U.S.C. 18113 9815(a)(1) to the Internal Revenue Code
(protecting health plans or health providers from the history of the regulatory process and (Code) to incorporate the provisions of
being required to provide an item or service that comments submitted in various requests part A of title XXVII of the PHS Act into
helps cause assisted suicide); see also 8 U.S.C. for public comments (including in the ERISA and the Code, and thereby make
1182(g) (protecting vaccination objections by
‘‘aliens’’ due to ‘‘religious beliefs or moral them applicable to certain group health
convictions’’); 18 U.S.C. 3597 (protecting objectors ‘‘contraceptive services’’ generally includes

contraceptives, sterilization, and related patient plans regulated under ERISA or the
to participation in Federal executions based on
‘‘moral or religious convictions’’); 20 U.S.C. 1688 education and counseling, unless otherwise Code. The sections of the PHS Act
(prohibiting sex discrimination law to be used to indicated. incorporated into ERISA and the Code
3 Note, however, that in sections under headings
require assistance in abortion for any reason); 22 are sections 2701 through 2728 of the
U.S.C. 7631(d) (protecting entities from being listing only two of the three Departments, the term
‘‘Departments’’ generally refers only to the two
PHS Act.
required to use HIV/AIDS funds contrary to their
‘‘religious or moral objection’’). Departments listed in the heading. These interim final rules concern
2 This document’s references to ‘‘contraception,’’ 4 In this IFR, we generally use ‘‘accommodation’’ section 2713 of the PHS Act. Where it
‘‘contraceptive,’’ ‘‘contraceptive coverage,’’ or and ‘‘accommodation process’’ interchangeably. applies, section 2713(a)(4) of the PHS
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Act requires coverage without cost such guidelines. (45 CFR 147.131). The certain requirements in the health care
sharing for ‘‘such additional’’ women’s interim final rules set forth herein are a context. Although the text of Executive
preventive care and screenings ‘‘as necessary and appropriate exercise of Order 13535 does not require the
provided for’’ and ‘‘supported by’’ the authority delegated to the expanded exemptions issued in these
guidelines developed by HRSA/HHS. Departments as administrators of the interim final rules, the expanded
The Congress did not specify any statutes. (26 U.S.C. 9833; 29 U.S.C. exemptions are, as explained below,
particular additional preventive care 1191c; 42 U.S.C. 300gg–92). consistent with longstanding Federal
and screenings with respect to women Our interpretation of section laws to protect conscience regarding
that HRSA could or should include in 2713(a)(4) of the PHS Act is confirmed certain health matters, and are
its Guidelines, nor did Congress by the Affordable Care Act’s statutory consistent with the intent that the
indicate whether the Guidelines should structure. The Congress did not intend Affordable Care Act would be
include contraception and sterilization. to require entirely uniform coverage of implemented in consideration of the
The Departments have consistently preventive services. (76 FR 46623). To protections set forth in those laws.
interpreted section 2713(a)(4)’s of the the contrary, Congress carved out an
PHS Act grant of authority to include exemption from section 2713 for B. The Regulations Concerning
broad discretion to decide the extent to grandfathered plans. This exemption is Women’s Preventive Services
which HRSA will provide for and not applicable to many of the other On July 19, 2010, the Departments
support the coverage of additional provisions in Title I of the Affordable issued interim final rules implementing
women’s preventive care and screenings Care Act—provisions previously section 2713 of the PHS Act (75 FR
in the Guidelines. In turn, the referred to by the Departments as 41726). Those interim final rules
Departments have interpreted that providing ‘‘particularly significant charged HRSA with developing the
discretion to include the ability to protections.’’ (75 FR 34540). Those Guidelines authorized by section
exempt entities from coverage provisions include: Section 2704, which 2713(a)(4) of the PHS Act.
requirements announced in HRSA’s prohibits preexisting condition 1. The Institute of Medicine Report
Guidelines. That interpretation is rooted exclusions or other discrimination
in the text of section 2713(a)(4) of the based on health status in group health In developing the Guidelines, HRSA
PHS Act, which allows HRSA to decide coverage; section 2708, which prohibits relied on an independent report from
the extent to which the Guidelines will excessive waiting periods (as of January the Institute of Medicine (IOM, now
provide for and support the coverage of 1, 2014); section 2711, which relates to known as the National Academy of
additional women’s preventive care and lifetime limits; section 2712, which Medicine) on women’s preventive
screenings. prohibits rescissions of health insurance services, issued on July 19, 2011,
Accordingly, the Departments have coverage; section 2714, which extends ‘‘Clinical Preventive Services for
consistently interpreted section dependent coverage until age 26; and Women, Closing the Gaps’’ (IOM 2011).
2713(a)(4) of the PHS Act reference to section 2718, which imposes a medical The IOM’s report was funded by the
‘‘comprehensive guidelines supported loss ratio on health insurance issuers in HHS Office of the Assistant Secretary
by the Health Resources and Services the individual and group markets (for for Planning and Evaluation, pursuant
Administration for purposes of this insured coverage), or requires them to to a funding opportunity that charged
paragraph’’ to grant HRSA authority to provide rebates to policyholders. (75 FR the IOM to conduct a review of effective
develop such Guidelines. And because 34538, 34540, 34542). Consequently, of preventive services to ensure women’s
the text refers to Guidelines ‘‘supported the 150 million nonelderly people in health and well-being.6
by the Health Resources and Services America with employer-sponsored The IOM made a number of
Administration for purposes of this health coverage, approximately 25.5 recommendations with respect to
paragraph,’’ the Departments have million are estimated to be enrolled in women’s preventive services. As
consistently interpreted that authority to grandfathered plans not subject to relevant here, the IOM recommended
afford HRSA broad discretion to section 2713 of the PHS Act.5 As the that the Guidelines cover the full range
consider the requirements of coverage Supreme Court observed, ‘‘there is no of Food and Drug Administration
and cost-sharing in determining the legal requirement that grandfathered (FDA)-approved contraceptive methods,
nature and extent of preventive care and plans ever be phased out.’’ Burwell v. sterilization procedures, and patient
screenings recommended in the Hobby Lobby Stores, Inc., 134 S. Ct. education and counseling for women
guidelines. (76 FR 46623). As the 2751, 2764 n.10 (2014). with reproductive capacity. Because
Departments have noted, these The Departments’ interpretation of FDA includes in the category of
Guidelines are different from ‘‘the other section 2713(a)(4) of the PHS Act to ‘‘contraceptives’’ certain drugs and
guidelines referenced in section 2713(a), permit HRSA to establish exemptions devices that may not only prevent
which pre-dated the Affordable Care Act from the Guidelines, and of the conception (fertilization), but may also
and were originally issued for purposes Departments’ own authority as prevent implantation of an embryo,7 the
of identifying the non-binding administering agencies to guide HRSA IOM’s recommendation included
recommended care that providers in establishing such exemptions, is also
6 Because section 2713(a)(4) of the PHS Act
should provide to patients.’’ Id. consistent with Executive Order 13535.
specifies that the HRSA Guidelines shall include
Guidelines developed as nonbinding That order, issued upon the signing of preventive care and screenings ‘‘with respect to
recommendations for care implicate the Affordable Care Act, specified that women,’’ the Guidelines exclude services relating to
significantly different legal and policy ‘‘longstanding Federal laws to protect a man’s reproductive capacity, such as vasectomies
concerns than guidelines developed for conscience . . . remain intact,’’ and condoms.
7 FDA’s guide ‘‘Birth Control: Medicines To Help
a mandatory coverage requirement. To including laws that protect religious You,’’ specifies that various approved
guide HRSA in exercising the discretion beliefs and moral convictions from contraceptives, including Levonorgestrel, Ulipristal
afforded to it in section 2713(a)(4), the Acetate, and IUDs, work mainly by preventing
Departments have previously 5 Kaiser Family Foundation & Health Research & fertilization and ‘‘may also work . . . by preventing
Educational Trust, ‘‘Employer Health Benefits, 2017 attachment (implantation) to the womb (uterus)’’ of
promulgated regulations defining the Annual Survey,’’ available at http://files.kff.org/ a human embryo after fertilization. Available at
scope of permissible religious attachment/Report-Employer-Health-Benefits- https://www.fda.gov/forconsumers/byaudience/
exemptions and accommodations for Annual-Survey-2017. forwomen/freepublications/ucm313215.htm.
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several contraceptive methods that included coverage for all FDA-approved health plans established or maintained
many persons and organizations believe contraceptives, sterilization procedures, by certain nonprofit organizations with
are abortifacient—that is, as causing and related patient education and religious objections to contraceptive
early abortion—and which they counseling for women with coverage (and the group health
conscientiously oppose for that reason reproductive capacity, as prescribed by insurance coverage provided in
distinct from whether they also oppose a health care provider (hereinafter ‘‘the connection with such plans).12 The
contraception or sterilization. One of the Mandate’’). temporary safe harbor did not include
16 members of the IOM committee, Dr. In administering this Mandate, on nonprofit organizations that had an
Anthony LoSasso, a Professor at the August 1, 2011, the Departments objection to contraceptives based on
University of Illinois at Chicago School promulgated interim final rules moral convictions but not religious
of Public Health, wrote a formal amending our 2010 interim final rules. beliefs, nor did it include for-profit
dissenting opinion. He stated that the (76 FR 46621) (2011 interim final rules). entities of any kind. The Departments
IOM committee did not have sufficient The 2011 interim final rules specified stated that, during the temporary safe
time to evaluate fully the evidence on that HRSA has the authority to establish harbor, the Departments would engage
whether the use of preventive services exemptions from the contraceptive in rulemaking to achieve ‘‘two goals—
beyond those encompassed by section coverage requirement for certain group providing contraceptive coverage
2713(a)(1) through (3) of the PHS Act health plans established or maintained without cost-sharing to individuals who
leads to lower rates of disability or by certain religious employers and for want it and accommodating non-
disease and increased rates of well- health insurance coverage provided in exempted, nonprofit organizations’
being, such that the IOM should connection with such plans.9 The 2011 religious objections to covering
recommend additional services to be interim final rules only offered the contraceptive services.’’ (77 FR 8727).
included under Guidelines issued under exemption to a narrow scope of On March 21, 2012, the Departments
section 2713(a)(4) of the PHS Act. He employers, and only if they were published an advance notice of
further stated that ‘‘the religious. As the basis for adopting that proposed rulemaking (ANPRM) that
recommendations were made without limited definition of religious employer, described possible approaches to
high quality, systematic evidence of the the 2011 interim final rules stated that achieve those goals with respect to
preventive nature of the services they relied on the laws of some ‘‘States religious nonprofit organizations, and
considered,’’ and that ‘‘the committee that exempt certain religious employers solicited public comments on the same.
process for evaluation of the evidence from having to comply with State law (77 FR 16501). Following review of the
lacked transparency and was largely requirements to cover contraceptive comments on the ANPRM, the
subject to the preferences of the services.’’ (76 FR 46623). Several Departments published proposed
committee’s composition. Troublingly, comments were submitted asking that regulations on February 6, 2013 (2013
the process tended to result in a mix of the exemption include those who object NPRM) (78 FR 8456).
objective and subjective determinations to contraceptive coverage based on non- The 2013 NPRM proposed to expand
filtered through a lens of advocacy.’’ He religious moral convictions, including the definition of ‘‘religious employer’’
also raised concerns that the committee pro-life, non-profit advocacy for purposes of the religious employer
did not have time to develop a organizations.10 exemption. Specifically, it proposed to
framework for determining whether require only that the religious employer
coverage of any given preventive service 3. The Departments’ Subsequent be organized and operate as a nonprofit
leads to a reduction in healthcare Rulemaking on the Accommodation and entity and be referred to in section
expenditure.8 IOM 2011 at 231–32. In Third Interim Final Rules 6033(a)(3)(A)(i) or (iii) of the Code,
its response to Dr. LoSasso, the other 15 Final regulations issued on February eliminating the requirements that a
committee members stated in part that 10, 2012, adopted the definition of religious employer—(1) have the
‘‘At the first committee meeting, it was ‘‘religious employer’’ in the 2011 inculcation of religious values as its
agreed that cost considerations were interim final rules without modification purpose; (2) primarily employ persons
outside the scope of the charge, and that (2012 final regulations).11 (77 FR 8725). who share its religious tenets; and (3)
the committee should not attempt to The exemption did not require exempt primarily serve persons who share its
duplicate the disparate review processes employers to file any certification form religious tenets. The proposed expanded
used by other bodies, such as the or comply with any other information
USPSTF, ACIP, and Bright Futures. collection process. 12 Guidance on the Temporary Enforcement Safe
HHS, with input from this committee, Contemporaneously with the issuance Harbor for Certain Employers, Group Health Plans,
may consider other factors including of the 2012 final regulations, HHS—
and Group Health Insurance Issuers with Respect to
cost in its development of coverage the Requirement to Cover Contraceptive Services
with the agreement of the Department of Without Cost Sharing Under section 2713 of the
decisions.’’ Labor (DOL) and the Department of the Public Health Service Act, Section 715(a)(1) of the
Treasury—issued guidance establishing Employee Retirement Income Security Act, and
2. HRSA’s 2011 Guidelines and the Section 9815(a)(1) of the Internal Revenue Code,
Departments’ Second Interim Final a temporary safe harbor from issued on February 10, 2012, and reissued on
Rules enforcement of the contraceptive August 15, 2012. Available at: http://
On August 1, 2011, HRSA released coverage requirement by the www.lb7.uscourts.gov/documents/12cv3932.pdf.
Departments with respect to group The guidance, as reissued on August 15, 2012,
onto its Web site its Guidelines for clarified, among other things, that plans that took
women’s preventive services, adopting some action before February 10, 2012, to try,
9 The 2011 amended interim final rules were

the recommendations of the IOM. without success, to exclude or limit contraceptive
issued and effective on August 1, 2011, and coverage were not precluded from eligibility for the
https://www.hrsa.gov/ published in the Federal Register on August 3, safe harbor. The temporary enforcement safe harbor
womensguidelines/ The Guidelines 2011. (76 FR 46621). was also available to insured student health
10 See, for example, Americans United for Life
insurance coverage arranged by nonprofit
8 The Departments do not relay these dissenting (‘‘AUL’’) Comment on CMA–9992–IFC2 at 10 (Nov. institutions of higher education with religious
remarks as an endorsement of the remarks, but to 1, 2011), available at http://www.regulations.gov/ objections to contraceptive coverage that met the
describe the history of the Guidelines, which #!documentDetail;D=HHS-OS-2011-0023-59496. conditions set forth in the guidance. See final rule
includes this part of the report that IOM provided 11 The 2012 final regulations were published on entitled ‘‘Student Health Insurance Coverage’’
to HRSA. February 15, 2012 (77 FR 8725). published March 21, 2012 (77 FR 16457).
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definition still encompassed only until the first plan year beginning on or plans, the issuer was expected to bear
religious entities. after August 1, 2013. the cost of such payments,16 and HHS
The 2013 NPRM also proposed to The Departments published final intended to clarify in guidance that the
regulations on July 2, 2013 (July 2013 issuer could treat those payments as an
create a compliance process, which it
final regulations) (78 FR 39869). The adjustment to claims costs for purposes
called an accommodation, for group
July 2013 final regulations finalized the of medical loss ratio and risk corridor
health plans established, maintained, or
expansion of the exemption for houses program calculations. The Departments
arranged by certain eligible nonprofit of worship and their integrated extended the temporary safe harbor
organizations that fell outside the auxiliaries. Although some commenters again on June 20, 2013, to encompass
houses of worship and integrated had suggested that the exemption be plan years beginning on or after August
auxiliaries covered by section further expanded, the Departments 1, 2013, and before January 1, 2014.
6033(a)(3)(A)(i) or (iii) of the Code (and, declined to adopt that approach. The
thus, outside of the religious employer July 2013 regulations stated that, 4. Litigation Over the Mandate and the
exemption). The 2013 NPRM proposed because employees of objecting houses Accommodation Process
to define such eligible organizations as of worship and integrated auxiliaries are During the period when the
nonprofit entities that hold themselves relatively likely to oppose Departments were publishing and
out as religious, oppose providing contraception, exempting those modifying our regulations, organizations
coverage for certain contraceptive items organizations ‘‘does not undermine the and individuals filed dozens of lawsuits
on account of religious objections, and governmental interests furthered by the challenging the Mandate. Plaintiffs
maintain a certification to this effect in contraceptive coverage requirement.’’ included religious nonprofit
their records. The 2013 NPRM stated, (78 FR 39874). However, like the 2013 organizations, businesses run by
without citing a supporting source, that NPRM, the July 2013 regulations religious families, individuals, and
employees of eligible organizations assumed that ‘‘[h]ouses of worship and others, including several non-religious
‘‘may be less likely than’’ employees of their integrated auxiliaries that object to organizations that opposed coverage of
exempt houses of worship and contraceptive coverage on religious certain contraceptives under the
integrated auxiliaries to share their grounds are more likely than other Mandate on the basis of non-religious
employer’s faith and opposition to employers to employ people of the same moral convictions. Religious for-profit
contraception on religious grounds. (78 faith who share the same objection’’ to entities won various court decisions
FR 8461). The 2013 NPRM therefore contraceptives. Id. leading to the Supreme Court’s ruling in
proposed that, in the case of an insured The July 2013 regulation also Burwell v. Hobby Lobby Stores, Inc. 134
group health plan established or finalized an accommodation for eligible S. Ct. 2751 (2014). The Supreme Court
maintained by an eligible organization, organizations, which were then defined ruled against the Departments and held
the health insurance issuer providing to include solely organizations that are that, under the Religious Freedom
group health insurance coverage in religious. Under the accommodation, an Restoration Act of 1993 (RFRA), the
eligible organization was required to Mandate could not be applied to the
connection with the plan would provide
submit a self-certification to its group closely held for-profit corporations
contraceptive coverage to plan
health insurance issuer or third party before the Court because their owners
participants and beneficiaries without
administrator, as applicable. Upon had religious objections to providing
cost sharing, premium, fee, or other such coverage.17
charge to plan participants or receiving that self-certification, the
issuer or third party administrator On August 27, 2014, the Departments
beneficiaries enrolled in the eligible simultaneously issued a third set of
organization’s plan—and without any would provide or arrange for payments
for the contraceptive services to the plan interim final rules (August 2014 interim
cost to the eligible organization.13 In the final rules) (79 FR 51092), and a notice
participants and beneficiaries enrolled
case of a self-insured group health plan of proposed rulemaking (August 2014
in the eligible organization’s plan,
established or maintained by an eligible proposed rules) (79 FR 51118). The
without requiring any cost sharing on
organization, the 2013 NPRM presented August 2014 interim final rules changed
the part of plan participants and
potential approaches under which the the accommodation process so that it
beneficiaries and without cost to the
third party administrator of the plan eligible organization. With respect to could be initiated either by self-
would provide or arrange for self-insured plans, the third party certification using EBSA Form 700 or
contraceptive coverage to plan administrators (or issuers they through a notice informing the Secretary
participants and beneficiaries. The contracted with) could receive of HHS that an eligible organization had
proposed accommodation process was reimbursements by reducing user fee religious objections to coverage of all or
not to be offered to non-religious payments (to Federally facilitated a subset of contraceptive services (79 FR
nonprofit organizations, nor to any for- Exchanges) by the amounts paid out for 51092). In response to Hobby Lobby, the
profit entities. Public comments again contraceptive services under the August 2014 proposed rules extended
included the request that exemptions accommodation, plus an allowance for the accommodation process to closely
encompass objections to contraceptive certain administrative costs, as long as held for-profit entities with religious
coverage based on moral convictions objections to contraceptive coverage, by
the HHS Secretary requests and an
and not just based on religious beliefs.14 including them in the definition of
authorizing exception under OMB
On August 15, 2012, the Departments eligible organizations (79 FR 51118).
Circular No. A–25R is in effect.15 With
extended our temporary safe harbor Neither the August 2014 interim final
respect to fully insured group health
rules nor the August 2014 proposed

13 The NPRM proposed to treat student health 15 See also 45 CFR 156.50. Under the regulations,
rules extended the exemption; neither
insurance coverage arranged by eligible if the third party administrator does not participate added a certification requirement for
organizations that are institutions of higher in a Federally-facilitated Exchange as an issuer, it
education in a similar manner. is permitted to contract with an insurer which does 16 ‘‘[P]roviding payments for contraceptive
14 See,for example, AUL Comment on CMS– so participate, in order to obtain such services is cost neutral for issuers.’’ (78 FR 39877).
9968–P at 5 (Apr. 8, 2013), available at http:// reimbursement. The total contraceptive user fee 17 The Supreme Court did not decide whether
www.regulations.gov/#!documentDetail;D=CMS- adjustment for the 2015 benefit year was $33 RFRA would apply to publicly traded for-profit
2012-0031-79115. million. corporations. See 134 S. Ct. at 2774.
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exempt entities; and neither Supreme Court’s remand order. (81 FR contraception), applying the Mandate to
encompassed objections based on non- 47741). Public comments were March for Life or similar organizations
religious moral convictions. submitted in response to the RFI, during that definitively hire only employees
On July 14, 2015, the Departments a comment period that closed on who oppose certain contraceptives
finalized both the August 2014 interim September 20, 2016. Those comments lacked a rational basis and therefore
final rules and the August 2014 included the request that the exemption violated their right of equal protection
proposed rules in a set of final be expanded to include those who under the Due Process Clause.
regulations (the July 2015 final oppose the Mandate for either religious March for Life’s employees, who
regulations) (80 FR 41318). (The July ‘‘or moral’’ reasons, consistent with stated they were personally religious
2015 final regulations also encompassed various state laws (such as in (although personal religiosity was not a
issues related to other preventive Connecticut or Missouri) that protect condition of their employment), also
services coverage.) The July 2015 final objections to contraceptive coverage sued as co-plaintiffs. They contended
regulations allowed eligible based on moral convictions.18 that the Mandate violates their rights
organizations to submit a notice to HHS Beginning in 2015, lawsuits under RFRA by making it impossible for
as an alternative to submitting the EBSA challenging the Mandate were also filed them to obtain health insurance
Form 700, but specified that such notice by various non-religious organizations consistent with their religious beliefs,
must include the eligible organization’s with moral objections to contraceptive either from the plan March for Life
name and an expression of its religious coverage. These organizations asserted wanted to offer them, or in the
objection, along with the plan name, that they believe some methods individual market, because the
plan type, and name and contact classified by FDA as contraceptives may Departments offered no exemptions in
information for any of the plan’s third have an abortifacient effect and either circumstance. Another non-
party administrators or health insurance therefore, in their view, are morally religious nonprofit organization that
issuers. The Departments indicated that equivalent to abortion. These opposed the Mandate’s requirement to
such information represents the organizations have neither received an provide certain contraceptive coverage
minimum information necessary for us exemption from the Mandate nor do on moral grounds also filed a lawsuit
to administer the accommodation they qualify for the accommodation. For challenging the Mandate. Real
process. example, the organization that since Alternatives, Inc. v. Burwell, 150 F.
Meanwhile, a second series of legal 1974 has sponsored the annual March Supp. 3d 419 (M.D. Pa. 2015).
challenges were filed by religious for Life in Washington, DC (March for Challenges by non-religious nonprofit
nonprofit organizations that stated the Life), filed a complaint claiming that the organizations led to conflicting opinions
accommodation impermissibly Mandate violated the equal protection among the Federal courts. A district
burdened their religious beliefs because court agreed with the March for Life
component of the Due Process Clause of
it utilized their health plans to provide plaintiffs on the organization’s equal
the Fifth Amendment, and was arbitrary
services to which they objected on protection claim and the employees’
and capricious under the
religious grounds, and it required them RFRA claims (not specifically ruling on
Administrative Procedure Act (APA).
to submit a self-certification or notice. the APA claim), and issued a permanent
Citing, for example, (77 FR 8727), March
On November 6, 2015, the U.S. Supreme injunction against the Departments that
for Life argued that the Departments’
Court granted certiorari in seven similar is still in place. March for Life v.
stated interests behind the Mandate
cases under the title of a filing from the Burwell, 128 F. Supp. 3d 116 (D.D.C.
were only advanced among women who
Third Circuit, Zubik v. Burwell. On May 2015). The appeal in March for Life is
‘‘want’’ the coverage so as to prevent
16, 2016, the Supreme Court issued a pending and has been stayed since early
‘‘unintended’’ pregnancy. March for Life 2016. In another case, Federal district
per curiam opinion in Zubik, vacating
the judgments of the Courts of contended that because it only hires and appellate courts in Pennsylvania
Appeals—most of which had ruled in employees who publicly advocate disagreed with the reasoning from
the Departments’ favor—and remanding against abortion, including what they March for Life and ruled against claims
the cases ‘‘in light of the substantial regard as abortifacient contraceptive brought by a similarly non-religious
clarification and refinement in the items, the Departments’ interests were nonprofit employer and its religious
positions of the parties’’ that had been not rationally advanced by imposing the employees. Real Alternatives, 150 F.
filed in supplemental briefs. 136 S. Ct. Mandate upon it and its employees. Supp. 3d 419, affirmed by 867 F.3d 338
1557, 1560 (2016). The Court stated that Accordingly, March for Life contended (3d Cir. 2017). One member of the
it anticipated that, on remand, the that applying the Mandate to it (and appeals court panel in Real Alternatives
Courts of Appeals would ‘‘allow the other similarly situated organizations) dissented in part, stating he would have
parties sufficient time to resolve any lacked a rational basis and therefore ruled in favor of the individual
outstanding issues between them.’’ Id. doing so was arbitrary and capricious in employee plaintiffs under RFRA. Id. at
The Court also specified that ‘‘the violation of the APA. March for Life *18.
Government may not impose taxes or further contended that because the On December 20, 2016, HRSA
penalties on petitioners for failure to Departments concluded the updated the Guidelines via its Web site,
provide the relevant notice’’ while the government’s interests were not https://www.hrsa.gov/
cases remained pending. Id. at 1561. undermined by exempting houses of womensguidelines2016/index.html.
After remand, as indicated by the worship and integrated auxiliaries HRSA announced that, for plans subject
Departments in court filings, meetings (based on our assumption that such to the Guidelines, the updated
were held between attorneys for the entities are relatively more likely than Guidelines would apply to the first plan
Government and for the plaintiffs in other religious nonprofits to have year beginning after December 20, 2017.
those cases. The Departments also employees that share their views against Among other changes, the updated
issued a Request for Information (‘‘RFI’’) Guidelines specified that the required
18 See, for example, https://www.regulations.gov/
on July 26, 2016, seeking public contraceptive coverage includes follow-
document?D=CMS-2016-0123-54142; see also
comment on options for modifying the https://www.regulations.gov/document?D=CMS-
up care (for example, management and
accommodation process in light of the 2016-0123-54218 and https://www.regulations.gov/ evaluation, as well as changes to, and
supplemental briefing in Zubik and the document?D=CMS-2016-0123-46220. removal or discontinuation of, the
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contraceptive method). They also conscience protections if they did so. below, of protecting moral convictions
specified, for the first time, that Specifically, these interim final rules in particular health care contexts. The
coverage should include instruction in expand exemptions to the contraceptive Departments’ implementation of section
fertility awareness-based methods for Mandate to protect certain entities and 2713(a)(4) of the PHS Act with respect
women desiring an alternative method individuals that object to coverage of to contraceptive coverage is a context
of family planning. HRSA stated that, some or all contraceptives based on similar to those encompassed by many
with the input of a committee operating sincerely held moral convictions but not other health care conscience protections
under a cooperative agreement, HRSA religious beliefs, and these rules make provided or supported by Congress.
would review and periodically update those exempt entities eligible for This Mandate concerns contraception
the Women’s Preventive Services’ accommodations concerning the same and sterilization services, including
Guidelines. The updated Guidelines did Mandate. items believed by some citizens to have
not alter the religious employer an abortifacient effect—that is, to cause
A. Discretion To Provide Exemptions
exemption or accommodation process, the destruction of a human life at an
Under Section 2713(a)(4) of the PHS Act
nor did they extend the exemption or early stage of embryonic development.
and the Affordable Care Act
accommodation process to organizations These are highly sensitive issues in the
or individuals that oppose certain forms The Departments have consistently history of health care regulation and
of contraception (and coverage thereof) interpreted HRSA’s authority under have long been shielded by conscience
on moral grounds. section 2713(a)(4) of the PHS Act to protections in the laws of the United
On January 9, 2017, the Departments allow for exemptions and States.
issued a document entitled, ‘‘FAQs accommodations to the contraceptive
About Affordable Care Act Mandate for certain objecting B. Congress’ History of Providing
Implementation Part 36.’’ 19 The FAQ organizations. Section 2713(a)(4) of the Exemptions for Moral Convictions
stated that, after reviewing comments PHS Act gives HRSA discretion to In deciding the most appropriate way
submitted in response to the 2016 RFI decide whether and in what to exercise our discretion in this
and considering various options, the circumstances it will support context, the Departments draw on
Departments could not find a way at Guidelines providing for additional nearly 50 years of statutory law and
that time to amend the accommodation women’s preventive services coverage. Supreme Court precedent discussing the
so as to satisfy objecting eligible That authority includes HRSA’s protection of moral convictions in
organizations while pursuing the discretion to include contraceptive certain circumstances—particularly in
Departments’ policy goals. The coverage in those Guidelines, but the the context of health care and health
Departments did not adopt the approach Congress did not specify whether or to insurance coverage. Congress very
requested by certain commenters, cited what extent HRSA should do so. recently expressed its intent on the
above, to expand the exemption to Therefore, section 2713(a)(4) of the PHS matter of Government-mandated
include those who oppose the Mandate Act allows HRSA to not apply the contraceptive coverage when it
for moral reasons. Guidelines to certain plans of entities or declared, with respect to the possibility
On May 4, 2017, the President issued individuals with religious or moral that the District of Columbia would
Executive Order 13798, ‘‘Promoting Free objections to contraceptive coverage, require contraceptive coverage, that ‘‘it
Speech and Religious Liberty.’’ Section and by not applying the Guidelines to is the intent of Congress that any
3 of that order declares, ‘‘Conscience them, to exempt those entities from the legislation enacted on such issue should
Protections with Respect to Preventive- Mandate. These rules are a necessary include a ‘conscience clause’ which
Care Mandate. The Secretary of the and appropriate exercise of the provides exceptions for religious beliefs
Treasury, the Secretary of Labor, and the authority of HHS, of which HRSA is a and moral convictions.’’ Consolidated
Secretary of Health and Human Services component, and of the authority Appropriations Act of 2017, Division C,
shall consider issuing amended delegated to the Departments Title VIII, Sec. 808, Public Law 115–31
regulations, consistent with applicable collectively as administrators of the (May 5, 2017). In support of these
law, to address conscience-based statutes. (26 U.S.C. 9833; 29 U.S.C. interim final rules, we consider it
objections to the preventive-care 1191c; 42 U.S.C. 300gg–92). significant that Congress’ most recent
mandate promulgated under section Our protection of conscience in these statement on the prospect of
300gg–13(a)(4) of title 42, United States interim final rules is consistent with the Government mandated contraceptive
Code.’’ structure and intent of the Affordable coverage specifically intends that a
Care Act. The Affordable Care Act conscience clause be included to protect
II. Expanded Exemptions and refrains from applying section moral convictions.
Accommodations for Moral Convictions 2713(a)(4) of the PHS Act to millions of The many statutes listed in Section I-
These interim final rules incorporate women in grandfathered plans. In Background under footnote 1, which
conscience protections into the contrast, we anticipate that show Congress’ consistent protection of
contraceptive Mandate. They do so in conscientious exemptions to the moral convictions alongside religious
part to bring the Mandate into Mandate will impact a much smaller beliefs in the Federal regulation of
conformity with Congress’s long history number of women. President Obama health care, includes laws such as the
of providing or supporting conscience emphasized in signing the Affordable 1973 Church Amendments, which we
protections in the regulation of sensitive Care Act that ‘‘longstanding Federal law discuss at length below, all the way to
health-care issues, cognizant that to protect conscience’’—laws with the 2017 Consolidated Appropriations
Congress neither required the conscience protections encompassing Act discussed above. Notably among
Departments to impose the Mandate nor moral (as well as religious) objections— those laws, the Congress has enacted
prohibited them from providing specifically including (but not limited protections for health plans or health
to) the Church Amendments (42 U.S.C. care organizations in Medicaid or
19 Available at: https://www.dol.gov/sites/default/
300a–7), ‘‘remain intact.’’ Executive Medicare Advantage to object ‘‘on moral
files/ebsa/about-ebsa/our-activities/resource-center/
faqs/aca-part-36.pdf and https://www.cms.gov/
Order 13535. Nothing in the Affordable or religious grounds’’ to providing
CCIIO/Resources/Fact-Sheets-and-FAQs/ Care Act suggests Congress’ intent to coverage of certain counseling or
Downloads/ACA-FAQs-Part36_1-9-17-Final.pdf. deviate from its long history, discussed referral services. 42 U.S.C. 1395w–
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22(j)(3)(B) (protecting against forced protections provided by those participating in the performance of certain
counseling or referrals in Medicare provisions of the Church Amendments medical procedures; others, for moral
Choice, now Medicare Advantage, would encompass moral objections to reasons, not necessarily for any religious
belief, can feel equally as strong about human
managed care plans with respect to contraceptive services or coverage.
life. They too can revere human life.
objections based on ‘‘moral or religious The Church Amendments were As mortals, we cannot with confidence say,
grounds’’); 42 U.S.C. 1396u–2(b)(3) enacted in the wake of the Supreme when life begins. But whether it is life, or the
(protecting against forced counseling or Court’s decision in Roe v. Wade, 410 potentiality of life, our moral convictions as
referrals in Medicaid managed care U.S. 113 (1973). Even though the Court well as our religious beliefs, warrant
plans with respect to objections based in Roe required abortion to be legal in protection from this intrusion by the
on ‘‘moral or religious grounds’’). The certain circumstances, Roe did not Government. Would, therefore, the Senator
Congress has also protected individuals include, within that right, the include moral convictions?
who object to prescribing or providing requirement that other citizens must Would the Senator consider an amendment
on page 2, line 18 which would add to
contraceptives contrary to their facilitate its exercise. Thus, Roe religious beliefs, the words ‘‘or moral’’?
‘‘religious beliefs or moral convictions.’’ favorably quoted the proceedings of the Mr. CHURCH. I would suggest to the
Consolidated Appropriations Act of American Medical Association House of Senator that perhaps his objective could be
2017, Division C, Title VII, Sec. 726(c) Delegates 220 (June 1970), which more clearly stated if the words ‘‘or moral
(Financial Services and General declared ‘‘Neither physician, hospital, conviction’’ were added after ‘‘religious
Government Appropriations Act), nor hospital personnel shall be required belief.’’ I think that the Supreme Court in
Public Law 115–31. to perform any act violative of considering the protection we give religious
personally-held moral principles.’’ 410 beliefs has given comparable treatment to
C. The Church Amendments’ Protection deeply held moral convictions. I would not
of Moral Convictions U.S. at 144 & n.38 (1973). Likewise in be averse to amending the language of the
Roe’s companion case, Doe v. Bolton, amendment in such a manner. It is consistent
One of the most important and well- the Court observed that, under State with the general purpose. I see no reason
established federal statutes respecting law, ‘‘a physician or any other employee why a deeply held moral conviction ought
conscientious objections in specific has the right to refrain, for moral or not be given the same treatment as a religious
health care contexts was enacted over religious reasons, from participating in belief.
the course of several years beginning in the abortion procedure.’’ 410 U.S. 179, Mr. STEVENSON. The Senator’s suggestion
1973, initially as a response to court 197–98 (1973). The Court said that these is well taken. I thank him.
decisions raising the prospect that conscience provisions ‘‘obviously . . .
entities or individuals might be required afford appropriate protection.’’ Id. at 119 Congr. Rec. S5717–18.
to facilitate abortions or sterilizations. 198. As an Arizona court later put it, ‘‘a As the debate proceeded, Senator
These sections of the United States Code woman’s right to an abortion or to Church went on to quote Doe v. Bolton’s
are known as the Church Amendments, contraception does not compel a private reliance on a Georgia statute that stated
named after their primary sponsor person or entity to facilitate either.’’ ‘‘a physician or any other employee has
Senator Frank Church (D–Idaho). The Planned Parenthood Ariz., Inc. v. Am. the right to refrain, for moral or religious
Church Amendments specifically Ass’n of Pro-Life Obstetricians & reasons, from participating in the
provide conscience protections based on Gynecologists, 257 P.3d 181, 196 (Ariz. abortion procedure.’’ 119 Congr. Rec. at
sincerely held moral convictions. S5722 (quoting 410 U.S. at 197–98).
Ct. App. 2011).
Among other things, the amendments The Congressional Record contains Senator Church added, ‘‘I see no reason
protect the recipients of certain Federal relevant discussions that occurred when why the amendment ought not also to
health funds from being required to the protection for moral convictions was cover doctors and nurses who have
perform, assist, or make their facilities first proposed in the Church strong moral convictions against these
available for abortions or sterilizations if Amendments. When Senator Church particular operations.’’ Id. Considering
they object ‘‘on the basis of religious introduced the first of those the scope of the protections, Senator
beliefs or moral convictions,’’ and they amendments in 1973, he cited not only Gaylord Nelson (D–WI) asked whether,
prohibit recipients of certain Federal ‘‘if a hospital board, or whatever the
Roe v. Wade but also an instance where
health funds from discriminating ruling agency for the hospital was, a
a Federal court had ordered a Catholic
against any personnel ‘‘because he governing agency or otherwise, just
hospital to perform sterilizations. 119
refused to perform or assist in the
Congr. Rec. S5717–18 (Mar. 27, 1973). capriciously—and not upon the
performance of such a procedure or
After his opening remarks, Senator religious or moral questions at all—
abortion on the grounds that his
Adlai Stevenson III (D–IL) rose to ask simply said, ‘We are not going to bother
performance or assistance in the
that the amendment be changed to with this kind of procedure in this
performance of the procedure or
specify that it also protects objections to hospital,’ would the pending
abortion would be contrary to his
abortion and sterilization based on amendment permit that?’’ 119 Congr.
religious beliefs or moral convictions’’
moral convictions on the same terms as Rec. at S5723. Senator Church
(42 U.S.C. 300a–7(b), (c)(1)). Later
it protects objections based on religious responded that the amendment would
additions to the Church Amendments
beliefs. The following excerpt of the not encompass such an objection. Id.
protect other conscientious objections,
Congressional Record is particularly Senator James L. Buckley (C–NY),
including some objections on the basis
relevant to this discussion: speaking in support of the amendment,
of moral conviction to ‘‘any lawful
Mr. STEVENSON. Mr. President, first of all
added the following perspective:
health service,’’ or to ‘‘any part of a
health service program.’’ (42 U.S.C. I commend the Senator from Idaho for Mr. BUCKLEY. Mr. President, I
300a–7(c)(2), (d)). In contexts covered bringing this matter to the attention of the compliment the Senator from Idaho for
Senate. I ask the Senator a question. proposing this most important and timely
by those sections of the Church
One need not be of the Catholic faith or amendment. It is timely in the first instance
Amendments, the provision or coverage any other religious faith to feel deeply about because the attempt has already been made
of certain contraceptives, depending on the worth of human life. The protections to compel the performance of abortion and
the circumstances, could constitute afforded by this amendment run only to sterilization operations on the part of those
‘‘any lawful health service’’ or a ‘‘part of those whose religious beliefs would be who are fundamentally opposed to such
a health service program.’’ As such, the offended by the necessity of performing or procedures. And it is timely also because the
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recent Supreme Court decisions will likely moral objections in many other nevertheless impose upon him a duty of
unleash a series of court actions across the situations. These include, for example: conscience to refrain from participating
United States to try to impose the personal • Protections for individuals and in any war at any time, those beliefs
preferences of the majority of the Supreme entities that object to abortion: See 42 certainly occupy in the life of that
Court on the totality of the Nation.
I believe it is ironic that we should have
U.S.C. 238n; 42 U.S.C. 18023; 42 U.S.C. individual ‘a place parallel to that filled
this debate at all. Who would have predicted 2996f(b); and Consolidated by . . . God’ in traditionally religious
a year or two ago that we would have to Appropriations Act of 2017, Div. H, persons. Because his beliefs function as
guard against even the possibility that Title V, Sec. 507(d), Public Law 115–31; a religion in his life, such an individual
someone might be free [sic] 20 to participate • Protections for entities and is as much entitled to a ‘religious’
in an abortion or sterilization against his individuals that object to providing or conscientious objector exemption . . .
will? Such an idea is repugnant to our covering contraceptives: See id. at Div. as is someone who derives his
political tradition. This is a Nation which has C, Title VIII, Sec. 808; id. at Div. C, Title conscientious opposition to war from
always been concerned with the right of VII, Sec. 726(c) (Financial Services and
conscience. It is the right of conscience traditional religious convictions.’’
which is protected in our draft laws. It is the General Government Appropriations The Departments look to the
right of conscience which the Supreme Court Act); and id. at Div. I, Title III; and description of moral convictions in
has quite properly expanded not only to • Protections for entities and Welsh to help explain the scope of the
embrace those young men who, because of individuals that object to performing, protection provided in these interim
the tenets of a particular faith, believe they assisting, counseling, or referring as final rules. Neither these interim final
cannot kill another man, but also those who pertains to suicide, assisted suicide, or rules, nor the Church Amendments or
because of their own deepest moral advance directives: See 42 U.S.C. other Federal health care conscience
convictions are so persuaded. 290bb–36; 42 U.S.C. 14406; 42 U.S.C.
I am delighted that the Senator from Idaho
statutes, define ‘‘moral convictions’’
has amended his language to include the
18113; and 42 U.S.C. 1396a(w)(3). (nor do they define ‘‘religious beliefs’’).
words ‘‘moral conviction,’’ because, of
The Departments believe that the But in issuing these interim final rules,
course, we know that this is not a matter of intent behind Congress’ protection of we seek to use the same background
concern to any one religious body to the moral convictions in certain health care understanding of that term that is
exclusion of all others, or even to men who contexts, especially to protect entities reflected in the Congressional Record in
believe in a God to the exclusion of all and individuals from governmental 1973, in which legislators referenced
others. It has been a traditional concept in coercion, supports our decision in these cases such as Welsh to support the
our society from the earliest times that the interim final rules to protect sincerely addition of language protecting moral
right of conscience, like the paramount right held moral convictions from
to life from which it is derived, is sacred. convictions. In protecting moral
governmental compulsion threatened by convictions parallel to religious beliefs,
119 Congr. Rec. at S5723. the contraceptive Mandate. Welsh describes moral convictions
In support of the same protections D. Court Precedents Relevant to These warranting such protection as ones: (1)
when they were debated in the U.S. Expanded Exemptions That the ‘‘individual deeply and
House, Representative Margaret Heckler sincerely holds’’; (2) ‘‘that are purely
The legislative history of the ethical or moral in source and content;
(R–MA) 21 likewise observed that ‘‘the protection of moral convictions in the
right of conscience has long been (3) ‘‘but that nevertheless impose upon
first Church Amendments shows that him a duty’’; (4) and that ‘‘certainly
recognized in the parallel situation in Members of Congress saw the protection
which the individual’s right to occupy in the life of that individual a
as being consistent with Supreme Court place parallel to that filled by . . . God’
conscientious objector status in our decisions. Not only did Senator Church
selective service system has been in traditionally religious persons,’’ such
cite the abortion case Doe v. Bolton as that one could say ‘‘his beliefs function
protected’’ and ‘‘expanded by the a parallel instance of conscience
Supreme Court to include moral as a religion in his life.’’ (398 U.S. at
protection, but he also spoke of the 339–40). As recited above, Senators
conviction as well as formal religious Supreme Court generally giving
belief.’’ 119 Congr. Rec. H4148–49 (May Church and Nelson agreed that
‘‘comparable treatment to deeply held protections for such moral convictions
31, 1973). Rep. Heckler added, ‘‘We are moral convictions.’’ Both Senator
concerned here only with the right of would not encompass an objection that
Buckley and Rep. Heckler specifically an individual or entity raises
moral conscience, which has always cited the Supreme Court’s protection of
been a part of our national tradition.’’ ‘‘capriciously.’’ Instead, along with the
moral convictions in laws governing requirement that protected moral
Id. at 4149. military service. Those legislators
These first of the Church convictions must be ‘‘sincerely held,’’
appear to have been referencing cases this understanding cabins the protection
Amendments, codified at 42 U.S.C.
such as Welsh v. United States, 398 U.S. of moral convictions in contexts where
300a–7(b) and (c)(1), passed the House
333 (1970), which the Supreme Court they occupy a place parallel to that
372–1, and were approved by the Senate
decided just 3 years earlier. filled by sincerely held religious beliefs
94–0. 119 Congr. Rec. at H4149; 119 Welsh involved what is perhaps the
Congr. Rec. S10405 (June 5, 1973). The in religious persons and organizations.
Government’s paradigmatic compelling In the context of this particular
subsequently adopted provisions that interest—the need to defend the nation Mandate, it is also worth noting that, in
comprise the Church Amendments by military force. The Court stated that, Hobby Lobby, Justice Ginsburg (joined,
similarly extend protection to those where the Government protects in this part of the opinion, by Justices
organizations and individuals who objections to military service based on Breyer, Kagan, and Sotomayor), cited
object to the provision of certain ‘‘religious training and belief,’’ that Justice Harlan’s opinion in Welsh, 398
services on the basis of their moral protection would also extend to U.S. at 357–58, in support of her
convictions. And, as noted above, avowedly non-religious objections to statement that ‘‘[s]eparating moral
subsequent statutes add protections for war held with the same moral strength. convictions from religious beliefs would
20 The Senator might have meant ‘‘[forced] . . .
Id. at 343. The Court declared, ‘‘[i]f an be of questionable legitimacy.’’ 134 S.
against his will.’’ individual deeply and sincerely holds Ct. at 2789 n.6. In quoting this passage,
21 Rep. Heckler later served as the 15th Secretary beliefs that are purely ethical or moral the Departments do not mean to suggest
of HHS, from March 1983 to December 1985. in source and content but that that all laws protecting only religious
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beliefs constitute an illegitimate participation or attendance contrary to respect for conscience in the laws and
‘‘separat[ion]’’ of moral convictions, nor medical ethics.’’ (28 CFR 26.5).23 founding principles of the United
do we assert that moral convictions Forty-five States have health care States. Members of Congress specifically
must always be protected alongside conscience protections covering relied on the American tradition of
religious beliefs; we also do not agree objections to abortion, and several of respect for conscience when they
with Justice Harlan that distinguishing those also cover sterilization or decided to protect moral convictions in
between religious and moral objections contraception.24 Most of those State health care. As quoted above, in
would violate the Establishment Clause. laws protect objections based on supporting protecting conscience based
Instead, the Departments believe that, in ‘‘moral,’’ ‘‘ethical,’’ or ‘‘conscientious’’ on non-religious moral convictions,
the specific health care context grounds in addition to ‘‘religious’’ Senator Buckley declared ‘‘[i]t has been
implicated here, providing respect for grounds. Particularly in the case of a traditional concept in our society from
moral convictions parallel to the respect abortion, some Federal and State the earliest times that the right of
afforded to religious beliefs is conscience laws do not require any conscience, like the paramount right to
appropriate, draws from long-standing specified motive for the objection. (42 life from which it is derived, is sacred.’’
Federal Government practice, and U.S.C. 238n). These various statutes and Rep. Heckler similarly stated that ‘‘the
shares common ground with Congress’ regulations reflect an important right of moral conscience . . . has
intent in the Church Amendments and governmental interest in protecting always been a part of our national
in later Federal conscience statutes that moral convictions in appropriate health tradition.’’ This tradition is reflected, for
provide protections for moral contexts. example, in a letter President George
convictions alongside religious beliefs The contraceptive Mandate implicates Washington wrote saying that ‘‘[t]he
in other health care contexts. that governmental interest. Many Citizens of the United States of America
persons and entities object to this have a right to applaud themselves for
E. Conscience Protections in Regulations Mandate in part because they consider having given to mankind examples of an
and Among the States some forms of FDA-approved enlarged and liberal policy: A policy
The tradition of protecting moral contraceptives to be abortifacients and worthy of imitation. All possess alike
convictions in certain health contexts is morally equivalent to abortion due to liberty of conscience and immunities of
not limited to Congress. Multiple federal the possibility that some of the items citizenship.’’ 25 Thomas Jefferson
regulations protect objections based on may have the effect of preventing the similarly declared that ‘‘[n]o provision
moral convictions in such contexts.22 implantation of a human embryo after in our Constitution ought to be dearer to
Other federal regulations have also fertilization. Based on our knowledge man than that which protects the rights
applied the principle of respecting from the litigation, all of the current of conscience against the enterprises of
moral convictions alongside religious litigants asserting purely non-religious the civil authority.’’ 26 Although these
beliefs when they have determined that objections share this view, and most of statements by Presidents Washington
it is appropriate to do so in particular the religious litigants do as well. The and Jefferson were spoken to religious
circumstances. The Equal Employment Supreme Court, in describing family congregations, and although religious
Opportunity Commission has business owners with religious and moral conscience were tightly
consistently protected ‘‘moral or ethical objections, explained that ‘‘[t]he owners intertwined for the Founders, they both
beliefs as to what is right and wrong of the businesses have religious reflect a broad principle of respect for
which are sincerely held with the objections to abortion, and according to conscience against government
strength of traditional religious views’’ their religious beliefs the four coercion. James Madison likewise called
alongside religious views under the contraceptive methods at issue are conscience ‘‘the most sacred of all
‘‘standard [] developed in United States abortifacients. If the owners comply property,’’ and proposed that the Bill of
with the HHS mandate, they believe Rights should guarantee, in addition to
v. Seeger, 380 U.S. 163 (1965) and
they will be facilitating abortions.’’ protecting religious belief and worship,
[Welsh].’’ (29 CFR 1605.1). The
Hobby Lobby, 134 S. Ct. at 2751. that ‘‘the full and equal rights of
Department of Justice has declared that,
Outside of the context of abortion, as conscience [shall not] be in any manner,
in cases of capital punishment, no
cited above, Congress has also provided or on any pretext infringed.’’ 27
officer or employee may be required to
health care conscience protections These Founding Era statements of
attend or participate if doing so ‘‘is
pertaining to sterilization, general principle do not specify how
contrary to the moral or religious
contraception, and other health care they would be applied in a particular
convictions of the officer or employee,
services and practices. health care context. We do not suggest
or if the employee is a medical
F. Founding Principles that the specific protections offered in
professional who considers such
this rule would also be required or
22 See, for example, 42 CFR 422.206 (declaring
The Departments also look to necessarily appropriate in any other
that the general Medicare Advantage rule ‘‘does not
guidance from the broader history of context that does not raise the specific
require the MA plan to cover, furnish, or pay for concerns implicated by this Mandate.
23 See also 18 CFR 214.11 (where a law
a particular counseling or referral service if the MA These interim final rules do not address
organization that offers the plan—(1) Objects to the enforcement agency (LEA) seeks assistance in the
provision of that service on moral or religious investigation or prosecution of trafficking of in any way how the Government would
grounds.’’); 42 CFR 438.102 (declaring that persons, the reasonableness of the LEA’s request balance its interests with respect to
information requirements do not apply ‘‘if the will depend in part on ‘‘[c]ultural, religious, or
MCO, PIHP, or PAHP objects to the service on moral objections to the request’’). 25 From George Washington to the Hebrew
moral or religious grounds’’); 48 CFR 1609.7001 24 According to the Guttmacher Institute, 45 states Congregation in Newport, Rhode Island (Aug. 18,
(‘‘health plan sponsoring organizations are not have conscience statutes pertaining to abortion (43 1790), available at https://founders.archives.gov/
required to discuss treatment options that they of which cover institutions), 18 have conscience documents/Washington/05-06-02-0135.
would not ordinarily discuss in their customary statutes pertaining to sterilization (16 of which 26 Letter to the Society of the Methodist Episcopal
course of practice because such options are cover institutions), and 12 have conscience statutes Church at New London, Connecticut (February 4,
inconsistent with their professional judgment or pertaining to contraception (8 of which cover 1809), available at https://founders.archives.gov/
ethical, moral or religious beliefs.’’); 48 CFR institutions). ‘‘Refusing to Provide Health Services’’ documents/Jefferson/99-01-02-9714.
352.270–9 (‘‘Non-Discrimination for Conscience’’ (June 1, 2017), available at https:// 27 James Madison, ‘‘Essay on Property’’ (March
clause for organizations receiving HIV or Malaria www.guttmacher.org/state-policy/explore/refusing- 29, 1792); First draft of the First Amendment, 1
relief funds). provide-health-services. Annals of Congress 434 (June 8, 1789).
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other health services not encompassed H. Litigation Concerning the Mandate organizations that have sued seeking a
by the contraceptive Mandate.28 Instead The sensitivity of certain health care moral exemption have all adopted moral
we highlight this tradition of respect for matters makes it particularly important tenets opposed to contraception and
conscience from our Founding Era to for the Government to tread carefully hire only employees who share this
provide background support for the when engaging in regulation concerning view. It is reasonable to conclude that
Departments’ decision to implement those areas, and to respect individuals employees of these organizations would
section 2713(a)(4) of the PHS Act, while and organizations whose moral therefore not benefit from the Mandate.
protecting conscience in the exercise of convictions are burdened by As a result, subjecting this subset of
moral convictions. We believe that these Government regulations. Providing organizations to the Mandate does not
interim final rules are consistent both conscience protections advances the advance any governmental interest. The
with the American tradition of respect Affordable Care Act’s goal of expanding need to resolve this litigation and the
for conscience and with Congress’ health coverage among entities and potential concerns of similar entities,
history of providing conscience individuals that might otherwise be and our requirement to comply with
protections in the kinds of health care reluctant to participate in the market. permanent injunctive relief currently
matters involved in this Mandate. For example, the Supreme Court in imposed in March for Life, provide
Hobby Lobby declared that, if HHS substantial reasons for the Departments
G. Executive Orders Relevant to These
requires owners of businesses to cover to protect moral convictions through
Expanded Exemptions
these interim final rules. Even though,
Protecting moral convictions, as set procedures that the owners ‘‘could not
as discussed below, we assume the
forth in the expanded exemptions and in good conscience’’ cover, such as
number of entities and individuals that
accommodations of these rules, is abortion, ‘‘HHS would effectively
may seek exemption from the Mandate
consistent with recent executive orders. exclude these people from full
on the basis of moral convictions, as
President Trump’s Executive Order participation in the economic life of the
these two sets of litigants did, will be
concerning this Mandate directed the Nation.’’ 134 S. Ct. at 2783. That would
small, we know from the litigation that
Departments to consider providing be a serious outcome. As demonstrated
it will not be zero. As a result, the
protections, not specifically for by litigation and public comments,
Departments have taken these types of
‘‘religious’’ beliefs, but for various citizens sincerely hold moral
objections into consideration in
‘‘conscience.’’ We interpret that term to convictions, which are not necessarily reviewing our regulations. Having done
include moral convictions and not just religious, against providing or so, we consider it appropriate to issue
religious beliefs. Likewise, President participating in coverage of the protections set forth in these interim
Trump’s first Executive Order, EO contraceptive items included in the final rules. Just as Congress, in adopting
13765, declared that ‘‘the Secretary of Mandate, and some believe that some of the early provisions of the Church
Health and Human Services (Secretary) those items may cause early abortions. Amendments, viewed it as necessary
and the heads of all other executive The Departments wish to implement the and appropriate to protect those
departments and agencies (agencies) contraceptive coverage Guidelines organizations and individuals with
with authorities and responsibilities issued under section 2713(a)(4) of the objections to certain health care services
under the [ACA] shall exercise all PHS Act in a way that respects the on the basis of moral convictions, so we,
authority and discretion available to moral convictions of our citizens so that too, believe that ‘‘our moral convictions
them to waive, defer, grant exemptions they are more free to engage in ‘‘full as well as our religious beliefs, warrant
from, or delay the implementation of participation in the economic life of the protection from this intrusion by the
any provision or requirement of the Act Nation.’’ These expanded exemptions Government’’ in this situation.
that would impose a fiscal burden on do so by removing an obstacle that
any State or a cost, fee, tax, penalty, or might otherwise lead entities or I. The Departments’ Rebalancing of
regulatory burden on individuals, individuals with moral objections to Government Interests
families, healthcare providers, health contraceptive coverage to choose not to For additional discussion of the
insurers, patients, recipients of sponsor or participate in health plans if Government’s balance of interests
healthcare services, purchasers of health they include such coverage. concerning religious beliefs issued
insurance, or makers of medical devices, Among the lawsuits challenging the contemporaneously with these interim
products, or medications.’’ This Mandate, two have been filed based in final rules, see the related document
Mandate imposes both a cost, fee, tax, part on non-religious moral convictions. published by the Department elsewhere
or penalty, and a regulatory burden, on In one case, the Departments are subject in this issue of the Federal Register.
individuals and purchasers of health to a permanent injunction requiring us There, we acknowledge that the
insurance that have moral convictions to respect the non-religious moral Departments have changed the policies
opposed to providing contraceptive objections of an employer. See March and interpretations we previously
coverage. These interim final rules for Life v. Burwell, 128 F. Supp. 3d 116 adopted with respect to the Mandate
exercise the Departments’ discretion to (D.D.C. 2015). In the other case, an and the governmental interests that
grant exemptions from the Mandate to appeals court recently affirmed a district underlying it, and we assert that we
reduce and relieve regulatory burdens court ruling that allows the previous now believe the Government’s
and promote freedom in the health care regulations to be imposed in a way that legitimate interests in providing for
market. violates the moral convictions of a small contraceptive coverage do not require us
nonprofit pro-life organization and its to violate sincerely held religious beliefs
28 As the Supreme Court stated in Hobby Lobby, employees. See Real Alternatives, 2017 while implementing the Guidelines. For
the Court’s decision concerns only the WL 3324690. Our litigation of these parallel reasons, the Departments
contraceptive Mandate, and should not be
understood to hold that all insurance-coverage cases has led to inconsistent court believe Congress did not set forth—and
mandates, for example, for vaccinations or blood rulings, consumed substantial we do not possess—interests that
transfusions, must necessarily fail if they conflict governmental resources, and created require us to violate sincerely held
with an employer’s religious beliefs. Nor does the uncertainty for objecting organizations, moral convictions in the course of
Court’s opinion provide a shield for employers who
might cloak illegal discrimination as a religious (or issuers, third party administrators, and generally requiring contraceptive
moral) practice. 134 S. Ct. at 2783. employees and beneficiaries. The coverage. These changes in policy are
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within the Departments’ authority. As Government is under no constitutional III. Provisions of the Interim Final
the Supreme Court has acknowledged, obligation to fund contraception, cf. Rules With Comment Period
‘‘[a]gencies are free to change their Harris v. McRae, 448 U.S. 297 (1980), The Departments are issuing these
existing policies as long as they provide even more so may the Government interim final rules in light of the full
a reasoned explanation for the change.’’ refrain from requiring private citizens to history of relevant rulemaking
Encino Motorcars, LLC v. Navarro, 136 cover contraception for other citizens in (including 3 previous interim final
S. Ct. 2117, 2125 (2016). This ‘‘reasoned violation of their moral convictions. Cf. rules), public comments, and the long-
analysis’’ requirement does not demand Rust v. Sullivan, 500 U.S. 173, 192–93 running litigation from non-religious
that an agency ‘‘demonstrate to a court’s (1991) (‘‘A refusal to fund protected moral objectors to the Mandate, as well
satisfaction that the reasons for the new activity, without more, cannot be as the information contained in the
policy are better than the reasons for the equated with the imposition of a companion interim final rules issued
old one; it suffices that the new policy ‘penalty’ on that activity.’’).
is permissible under the statute, that elsewhere in this issue of the Federal
there are good reasons for it, and that The Departments acknowledge that Register. These interim final rules seek
the agency believes it to be better, which coverage of contraception is an to resolve these matters by directing
the conscious change of course important and highly controversial HRSA, to the extent it requires coverage
adequately indicates.’’ United Student issue, implicating many different views, for certain contraceptive services in its
Aid Funds, Inc. v. King, 200 F. Supp. 3d as reflected for example in the public Guidelines, to afford an exemption to
163, 169–70 (D.D.C. 2016) (citing FCC v. comments received on multiple certain entities and individuals with
Fox Television Stations, Inc., 556 U.S. rulemakings over the course of sincerely held moral convictions by
502, 515 (2009)); see also New Edge implementation of section 2713(a)(4) of which they object to contraceptive or
Network, Inc. v. FCC, 461 F.3d 1105, the PHS Act. Our expansion of sterilization coverage, and by making
1112–13 (9th Cir. 2006) (rejecting an conscience protections for moral the accommodation process available
argument that ‘‘an agency changing its convictions, similar to protections for certain organizations with such
course by rescinding a rule is obligated contained in numerous statutes convictions.
to supply a reasoned analysis for the governing health care regulation, is not For all of the reasons discussed and
change beyond that which may be taken lightly. However, after referenced above, the Departments have
required when an agency does not act in reconsidering the interests served by the determined that the Government’s
the first instance’’).29 Mandate in this particular context, the interest in applying contraceptive
The Departments note that the objections raised, and the relevant coverage requirements to the plans of
exemptions created here, like the Federal law, the Departments have certain entities and individuals does not
exemptions created by the last determined that expanding the outweigh the sincerely held moral
Administration, do not burden third exemptions to include protections for objections of those entities and
parties to a degree that counsels against moral convictions is a more appropriate individuals. Thus, these interim final
providing the exemptions. In addition to administrative response than continuing rules amend the regulations amended in
the apparent fact that many entities with to refuse to extend the exemptions and both the Departments’ July 2015 final
non-religious moral objections to the accommodations to certain entities and regulations and in the companion
Mandate appear to only hire persons individuals for whom the Mandate interim final rules concerning religious
that share those objections, Congress did violates their sincerely held moral beliefs issued contemporaneously with
not create a right to receive convictions. Although the number of these interim final rules and published
contraceptive coverage, and Congress organizations and individuals that may elsewhere in this issue of the Federal
explicitly chose not to impose the seek to take advantage of these Register.
section 2713 requirements on exemptions and accommodations may These interim final rules expand
grandfathered plans benefitting millions be small, we believe that it is important those exemptions to include additional
of people. Individuals who are unable to formally to codify such protections for entities and persons that object based on
obtain contraceptive coverage through objections based on moral conviction, sincerely held moral convictions. These
their employer-sponsored health plans given the long-standing recognition of rules leave in place HRSA’s discretion
because of the exemptions created in such protections in health care and to continue to require contraceptive and
these interim final rules, or because of health insurance context in law and sterilization coverage where no
other exemptions to the Mandate, have regulation and the particularly sensitive objection specified in the regulations
other avenues for obtaining nature of these issues in the health care exists, and if section 2713 of the PHS
contraception, including through context. These interim final rules leave Act otherwise applies. These interim
various other mechanisms by which the unchanged HRSA’s authority to decide final rules also maintain the existence of
Government advances contraceptive whether to include contraceptives in the an accommodation process as a
coverage, particularly for low-income women’s preventive services Guidelines voluntary option for organizations with
women, and which these interim final for entities that are not exempted by moral objections to contraceptive
rules leave unchanged.30 As the law, regulation, or the Guidelines. These coverage, but consistent with our
rules also do not change the many other expansion of the exemption, we expand
29 See also Chevron, U.S.A., Inc. v. Natural mechanisms by which the Government eligibility for the accommodation to
Resources Defense Council, Inc., 467 U.S. 837, 863– advances contraceptive coverage, include organizations with sincerely
64 (1984) (‘‘The fact that the agency has adopted
particularly for low-income women. held moral convictions concerning
different definitions in different contexts adds force

to the argument that the definition itself is flexible, contraceptive coverage. HRSA is
particularly since Congress has never indicated any and Child Health Block Grants, 42 U.S.C. 703; 42 simultaneously updating its Guidelines
disapproval of a flexible reading of the statute.’’) U.S.C. 247b–12; Title XIX of the Social Security to reflect the requirements of these
30 See, for example, Family Planning grants in 42 Act, 42 U.S.C. 1396, et seq.; the Indian Health interim final rules.31
U.S.C. 300, et seq.; the Teenage Pregnancy Service, 25 U.S.C. 13, 42 U.S.C. 2001(a), & 25 U.S.C.
Prevention Program, Public Law 112–74 (125 Stat 1601, et seq.; Health center grants, 42 U.S.C.
786, 1080); the Healthy Start Program, 42 U.S.C. 254b(e), (g), (h), & (i); the NIH Clinical Center, 42 31 See https://www.hrsa.gov/womensguidelines/
254c–8; the Maternal, Infant, and Early Childhood U.S.C. 248; and the Personal Responsibility and https://www.hrsa.gov/womensguidelines2016/
Home Visiting Program, 42 U.S.C. 711; Maternal Education Program, 42 U.S.C. 713. index.html.
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1. Exemption for Objecting Entities document provides what benefits are with reference to nonprofit status as
Based on Moral Convictions provided to participants and previous rules have done. Many of the
In the new 45 CFR 147.133 as created beneficiaries under the plan and, federal health care conscience statutes
by these interim final rules, we expand therefore, if an objecting employer cited above offer protections for the
the exemption that was previously would like to exclude all or a subset of moral convictions of entities without
located in § 147.131(a), and that was contraceptive services, it must ensure regard to whether they operate as
expanded in § 147.132 by the that the exclusion is clear in the plan nonprofits or for-profit entities. In
companion interim final rules document. Moreover, if there is a addition, a significant majority of states
concerning religious beliefs issued reduction in a covered service or either impose no contraceptive coverage
contemporaneously with these interim benefit, the plan has to disclose that requirement, or offer broader
change to plan participants.32 Thus, exemptions than the exemption
final rules and published elsewhere in
where an exemption applies and all or contained in the July 2015 final
this issue of the Federal Register.
With respect to employers that a subset of contraceptive services are regulations.33 States also generally
sponsor group health plans, omitted from a plan’s coverage, protect moral convictions in health care
§ 147.133(a)(1) and (a)(1)(i) provide otherwise applicable ERISA disclosures conscience laws, and they often offer
exemptions for certain employers that should reflect the omission of coverage those protections whether or not an
in ERISA plans. These existing entity operates as a nonprofit.34
object to coverage of all or a subset of
disclosure requirements serve to help Although the practice of states is by no
contraceptives or sterilization and
provide notice to participants and means a limit on the discretion
related patient education and
beneficiaries of what ERISA plans do delegated to HRSA by the Affordable
counseling based on sincerely held
and do not cover. The Departments Care Act, nor is it a statement about
moral convictions.
For avoidance of doubt, the invite public comment on whether what the Federal Government may do
Departments wish to make clear that the exempt entities, or others, would find consistent with other protections or
expanded exemption in § 147.133(a) value either in being able to maintain or limitations in federal law, such state
applies to several distinct entities submit a specific form of certification to practice can be informative as to the
involved in the provision of coverage to claim their exemption, or in otherwise viability of offering protections for
the objecting employer’s employees. receiving guidance on a way to conscientious objections in particularly
This explanation is consistent with how document their exemption. sensitive health care contexts. In this
The exemptions in § 147.133(a) apply case, the existence of many instances
prior rules have worked by means of
‘‘to the extent’’ of the objecting entities’ where conscience protections are
similar language. Section 147.133(a)(1)
sincerely held moral convictions. Thus, offered, or no underlying mandate of
and (a)(1)(i), by specifying that ‘‘[a]
entities that hold a requisite objection to this kind exists that could violate moral
group health plan and health insurance
covering some, but not all, contraceptive convictions, supports the Departments’
coverage provided in connection with a
items would be exempt with respect to decision to expand the Federal
group health plan’’ is exempt ‘‘to the
the items to which they object, but not exemption concerning this Mandate as
extent the plan sponsor objects as
with respect to the items to which they set forth in these interim final rules.
specified in paragraph (a)(2),’’ exempt
do not object. Likewise, the requisite Section 147.133(a)(1)(i)(A) of the rules
the group health plans the sponsors of
objection of a plan sponsor or specifies that the exemption includes
which object, and exempt their health
institution of higher education in the plans of a plan sponsor that is a
insurance issuers in providing the
§ 147.133(a)(1)(i) and (ii) exempts its nonprofit organization with sincerely
coverage in those plans (whether or not
group health plan, health insurance held moral convictions.
the issuers have their own objections).
coverage offered by a health insurance Section 147.133(a)(1)(i)(B) of the rules
Consequently, with respect to
issuer in connection with such plan, specifies that the exemption includes
Guidelines issued under
and its issuer in its offering of such the plans of a plan sponsor that is a for-
§ 147.130(a)(1)(iv), or the parallel
coverage, but that exemption does not profit entity that has no publicly traded
provisions in 26 CFR 54.9815–
extend to coverage provided by that ownership interests (for this purpose, a
2713T(a)(1)(iv) and 29 CFR 2590.715–
issuer to other group health plans where publicly traded ownership interest is
2713(a)(1)(iv), the plan sponsor, issuer,
the plan sponsors have no qualifying any class of common equity securities
and plan covered in the exemption of
objection. The objection of a health required to be registered under section
that paragraph would face no penalty as
insurance issuer in § 147.133(a)(1)(iii) 12 of the Securities Exchange Act of
a result of omitting contraceptive
similarly operates only to the extent of 1934).
coverage from the benefits of the plan
its objection, and as otherwise limited Extending the exemption to certain
participants and beneficiaries.
as described below. for-profit entities is consistent with the
Consistent with the restated
Supreme Court’s ruling in Hobby Lobby,
exemption, exempt entities will not be 2. Exemption of Certain Plan Sponsors
which declared that a corporate entity is
required to comply with a self- The rules cover certain kinds of non- capable of possessing and pursuing non-
certification process. Although exempt governmental employer plan sponsors pecuniary goals (in Hobby Lobby,
entities do not need to file notices or with the requisite objections, and the religion), regardless of whether the
certifications of their exemption, and rules specify which kinds of entities entity operates as a nonprofit
these interim final rules do not impose qualify for the exemption. organization, and rejecting the
any new notice requirements on them, Under these interim final rules, the
existing ERISA rules governing group Departments do not limit the exemption 33 See Guttmacher Institute, ‘‘Insurance Coverage
health plans require that, with respect to of Contraceptives’’ (Aug. 1, 2017), available at
plans subject to ERISA, a plan 32 See, for example, 29 U.S.C. 1022, 1024(b), 29 https://www.guttmacher.org/state-policy/explore/
document must include a CFR 2520.102–2, 2520.102–3, & 2520.104b–3(d), insurance-coverage-contraceptives.
comprehensive summary of the benefits and 29 CFR 2590.715–2715. See also 45 CFR 34 See, for example, Guttmacher Institute,
147.200 (requiring disclosure of the ‘‘exceptions, ‘‘Refusing to Provide Health Services’’ (Aug. 1,
covered by the plan and a statement of reductions, and limitations of the coverage,’’ 2017), available at https://www.guttmacher.org/
the conditions for eligibility to receive including group health plans and group & state-policy/explore/refusing-provide-health-
benefits. Under ERISA, the plan individual issuers). services.
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Departments’ argument to the contrary. whether the exemption in furnished for the purpose of causing or
134 S. Ct. 2768–75. Some reports and § 147.133(a)(1)(i) for plan sponsors with assisting in causing assisted suicide,
industry experts have indicated that not moral objections to the Mandate should euthanasia, or mercy killing, and the
many for-profit entities beyond those be finalized to encompass all of the statute similarly does not limit those
that had originally brought suit have types of plan sponsors covered by protections based on whether the entity
sought relief from the Mandate after § 147.132(a)(1)(i), including publicly is publicly traded or governmental. (42
Hobby Lobby.35 The mechanisms for traded corporations with objections U.S.C. 18113).38
determining whether a company has based on sincerely held moral Sections 1395w–22(j)(3)(B) and
adopted and holds certain principles or convictions, and also non-federal 1396u–2(b)(3) of 42 U.S.C. protect
views, such as sincerely held moral governmental plan sponsors that may organizations that offer Medicaid and
convictions, is a matter of well- have objections based on sincerely held Medicare Advantage managed care
established State law with respect to moral convictions. plans from being required to provide,
corporate decision-making,36 and the In the case of particularly sensitive reimburse for, or provide coverage of a
Departments expect that application of health care matters, several significant counseling or referral service if they
such laws would cabin the scope of this federal health care conscience statutes object to doing so on moral grounds,
exemption. protect entities’ moral objections and those paragraphs do not further
The July 2015 final regulations without precluding publicly traded and specify that publicly traded entities do
extended the accommodation to for- governmental entities from using those not qualify for the protections. Congress’
profit entities only if they are closely protections. For example, the first most recent statement on Government
held, by positively defining what paragraph of the Church Amendments requirements of contraceptive coverage
constitutes a closely held entity. Any provides certain protections for entities specified that, if the District of
such positive definition runs up against that object based on moral convictions Columbia requires ‘‘the provision of
the myriad state differences in defining to making their facilities or personnel contraceptive coverage by health
such entities, and potentially intrudes available to assist in the performance of insurance plans,’’ ‘‘it is the intent of
into a traditional area of state regulation abortions or sterilizations, and the Congress that any legislation enacted on
of business organizations. The statute does not limit those protections such issue should include a ‘conscience
Departments implicitly recognized the based on whether the entities are clause’ which provides exceptions for
difficulty of defining closely held publicly traded or governmental. (42 religious beliefs and moral convictions.’’
entities in the July 2015 final U.S.C. 300a–7(b)). Thus, under section Consolidated Appropriations Act of
regulations when we adopted a 300a–7(b), a hospital in a publicly 2017, Division C, Title VIII, Sec. 808.
definition that included entities that are traded health system, or a local Congress expressed no intent that such
merely ‘‘substantially similar’’ to certain governmental hospital, could adopt a conscience should be limited based on
specified parameters, and we allowed sincerely held moral convictions by whether the entity is publicly traded.
entities that were not sure if they met which it objects to providing facilities or At the same time, the Departments
the definition to inquire with HHS; HHS personnel for abortions or sterilizations, lack significant information about the
was permitted to decline to answer the and if the entity receives relevant funds need to extend the expanded exemption
inquiry, at which time the entity would from HHS specified by section 300a– further. We have been subjected to
be deemed to qualify as an eligible 7(b), the protections of that section litigation by nonprofit entities
organization. Instead of attempting to would apply. The Coats-Snowe expressing objections to the Mandate
positively define closely held Amendment likewise provides certain based on non-religious moral
businesses for the purpose of this rule, protections for health care entities and convictions, and we have been sued by
the Departments consider it much more postgraduate physician training closely held for-profit entities
clear, effective, and preferable to define programs that choose not to perform, expressing religious objections. This
the category negatively by reference to refer for, or provide training for combination of different types of
one element of our previous definition, abortions, and the statute does not limit plaintiffs leads us to believe that there
namely, that the entity has no publicly those protections based on whether the may be a small number of closely held
traded ownership interest (that is, any entities are publicly traded or for-profit entities that would seek to use
class of common equity securities governmental. (42 U.S.C. 238n). an exemption to the contraceptive
required to be registered under section The Weldon Amendment 37 provides Mandate based on moral convictions.
12 of the Securities Exchange Act of certain protections for health care The fact that many closely held for-
1934). entities, hospitals, provider-sponsored profit entities brought challenges to the
In this way, these interim final rules organizations, health maintenance Mandate has led us to offer protections
differ from the exemption provided to organizations, and health insurance that would include publicly traded
plan sponsors with objections based on plans that do not provide, pay for, entities with religious objections to the
sincerely held religious beliefs set forth provide coverage of, or refer for Mandate if such entities exist. But the
in § 147.132(a)(1)—those extend to for- abortions, and the statute does not limit combined lack of any lawsuits
profit entities whether or not they are those protections based on whether the challenging the Mandate by for-profit
closely held or publicly traded. The entity is publicly traded or entities with non-religious moral
Departments seek public comment on governmental. The Affordable Care Act convictions, and of any lawsuits by any
provides certain protections for any kind of publicly traded entity, leads us
35 See Jennifer Haberkorn, ‘‘Two years later, few
institutional health care entity, hospital, to not extend the expanded exemption
Hobby Lobby copycats emerge,’’ Politico (Oct. 11, in these interim final rules to publicly
2016), available at http://www.politico.com/story/ provider-sponsored organization, health
2016/10/obamacare-birth-control-mandate- maintenance organization, health traded entities, but rather to invite
employers-229627. insurance plan, or any other kind of public comment on whether to do so in
36 Although the Departments do not prescribe any
health care facility, that does not
form or notification, they would expect that such 38 The lack of the limitation in this provision may
principles or views would have been adopted and

provide any health care item or service be particularly relevant since it is contained in the
documented in accordance with the laws of the same statute, the ACA, as the provision under
jurisdiction under which they are incorporated or 37 Consolidated Appropriations Act of 2017, Div. which the Mandate—and these exemptions to the
organized. H, Title V, Sec. 507(d), Pub. L. 115–31. Mandate—are promulgated.
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a way parallel to the protections set accommodation process does not 4. Exemption for Issuers
forth in § 147.132(a)(1)(i). We agree with actually accommodate the objections of These interim final rules extend the
the Supreme Court that it is improbable many entities. This has led many exemption, in § 147.133(a)(1)(iii), to
that many publicly traded companies religious groups to challenge the health insurance issuers offering group
with numerous ‘‘unrelated accommodation in court, and we expect or individual health insurance coverage
shareholders—including institutional similar challenges would come from that sincerely hold their own moral
investors with their own set of organizations objecting to the convictions opposed to providing
stakeholders—would agree to run a accommodation based on moral coverage for contraceptive services.
corporation under the same religious convictions if we offered them the As discussed above, where the
beliefs’’ (or moral convictions) and accommodation but not an exemption. exemption for plan sponsors or
thereby qualify for the exemption. When we took that narrow approach institutions of higher education applies,
Hobby Lobby, 134 S. Ct. at 2774. We are with religious nonprofit entities it led to issuers are exempt under those sections
also not aware of other types of plan with respect to providing coverage in
multiple cases in many courts that we
sponsors (such as non-Federal those plans. The issuer exemption in
needed to litigate to the Supreme Court
governmental entities) that might § 147.133(a)(1)(iii) adds to that
possess moral objections to compliance various times. Although objections to
the accommodation were not protection, but the additional protection
with the Mandate, including whether operates in a different way than the plan
some might consider certain specifically litigated in the two cases
brought by nonprofit non-religious sponsor exemption operates. The only
contraceptive methods as having a
organizations (because we have not even plan sponsors, or in the case of
possible abortifacient effect.
made them eligible for the individual insurance coverage,
Nevertheless, we would welcome any
accommodation), those organizations individuals, who are eligible to
comments on whether such
made it clear that they and their purchase or enroll in health insurance
corporations or other plan sponsors
employees strongly oppose coverage of coverage offered by an exempt issuer
exist and would benefit from such an
certain contraceptives in their plans and that does not cover some or all
exemption.
Despite our a lack of complete in connection with their plans. contraceptive services are plan sponsors
information, the Departments know that or individuals who themselves object
nonprofit entities have challenged the 3. Exemption for Institutions of Higher and are otherwise exempt based on their
Mandate, and we assume that a closely Education objection (whether the objection is
held business might wish to assert non- based on moral convictions, as set forth
The plans of institutions of higher in these rules, or on religious beliefs, as
religious moral convictions in objecting education that arrange student health
to the Mandate (although we anticipate set forth in exemptions created by the
insurance coverage will be treated companion interim final rules published
very few if any will do so). Thus we
similarly to the way that plans of elsewhere in this issue of the Federal
have chosen in these interim final rules
to include them in the expanded employers are treated for the purposes Register). Thus, the issuer exemption
exemption and thereby remove an of such plans being exempt or specifies that where a health insurance
obstacle preventing such entities from accommodated based on moral issuer providing group health insurance
claiming an exemption based on non- convictions. These interim final rules coverage is exempt under paragraph
religious moral convictions. But we are specify, in § 147.133(a)(1)(ii), that the (a)(1)(iii), the plan remains subject to
less certain that we need to use these exemption is extended, in the case of any requirement to provide coverage for
interim final rules to extend the institutions of higher education (as contraceptive services under Guidelines
expanded exemption for moral defined in 20 U.S.C. 1002), to their issued under § 147.130(a)(1)(iv) unless
convictions to encompass other kinds of arrangement of student health insurance the plan is otherwise exempt from that
plan sponsors not included in the coverage, in a manner comparable to the requirement. Accordingly, the only plan
protections of these interim final rules. applicability of the exemption for group sponsors, or in the case of individual
Therefore, with respect to plan sponsors health insurance coverage provided in insurance coverage, individuals, who
not included in the expanded connection with a group health plan are eligible to purchase or enroll in
exemptions of § 147.133(a)(1)(i), and established or maintained by a plan health insurance coverage offered by an
non-federal governmental plan sponsors sponsor. issuer that is exempt under this
that might have moral objections to the paragraph (a)(1)(iii) that does not
The Departments are not aware of include some or all contraceptive
Mandate, we invite public comment on institutions of higher education that
whether to include such entities when services are plan sponsors or
arrange student coverage and object to individuals who themselves object and
we finalize these rules at a later date.
The Departments further conclude the Mandate based on non-religious are exempt.
that it would be inadequate to merely moral convictions. We have been sued Under the rules as amended, issuers
provide entities access to the by several institutions of higher with objections based on sincerely held
accommodation process instead of to education that arrange student coverage moral convictions could issue policies
the exemption where those entities and object to the Mandate based on that omit contraception to plan sponsors
object to the Mandate based on sincerely religious beliefs. We believe the or individuals that are otherwise exempt
held moral convictions. The existence of such entities with non- based on either their religious beliefs or
Departments have stated in our religious moral objections, or the their moral convictions, and issuers
regulations and court briefings that the possible formation of such entities in with sincerely held religious beliefs
existing accommodation with respect to the future, is sufficiently possible so could likewise issue policies that omit
self-insured plans requires that we should provide protections for contraception to plan sponsors or
contraceptive coverage as part of the them in these interim final rules. But individuals that are otherwise exempt
same plan as the coverage provided by based on a lack of information about based on either their religious beliefs or
the employer, and operates in a way such entities, we assume that none will their moral convictions.
‘‘seamless’’ to those plans. As a result, use the exemption concerning student Issuers that hold moral objections
in significant respects, the coverage at this time. should identify to plan sponsors the
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lack of contraceptive coverage in any elsewhere in this issue of the Federal This individual exemption allows
health insurance coverage being offered Register. The Departments solicit public plan sponsors and issuers that do not
that is based on the issuer’s exemption, comment; however, on whether there specifically object to contraceptive
and communicate the group health are situations where there may be an coverage to offer morally acceptable
plan’s independent obligation to additional need to provide distinct coverage to their participants or
provide contraceptive coverage, unless protections for third party subscribers who do object, while
the group health plan itself is exempt administrators that may have moral offering coverage that includes
under regulations governing the convictions implicated by the contraception to participants or
Mandate. Mandate.39 subscribers who do not object. This
In this way, the issuer exemption individual exemption can apply with
serves to protect objecting issuers both 5. Scope of Objections Needed for the respect to individuals in plans
from being asked or required to issue Objecting Entity Exemption sponsored by private employers or
policies that cover contraception in Exemptions for objecting entities governmental employers. For example,
violation of the issuers’ sincerely held specify that they apply where the in one case brought against the
moral convictions, and from being asked entities object as specified in Departments, the State of Missouri
or required to issue policies that omit § 147.133(a)(2). That section specifies enacted a law under which the State is
contraceptive coverage to non-exempt that exemptions for objecting entities not permitted to discriminate against
entities or individuals, thus subjecting will apply to the extent that an entity insurance issuers that offer health plans
the issuers to potential liability if those described in § 147.133(a)(1) objects to its without coverage for contraception
plans are not exempt from the establishing, maintaining, providing, based on employees’ moral convictions,
Guidelines. At the same time, the issuer offering, or arranging (as applicable) for or against the individual employees
exemption will not serve to remove coverage, payments, or a plan that who accept such offers. See Wieland,
contraceptive coverage obligations from provides coverage or payments for some 196 F. Supp. 3d at 1015–16 (quoting
any plan or plan sponsor that is not also or all contraceptive services, based on Mo. Rev. Stat. 191.724). Under the
exempt, nor will it prevent other issuers its sincerely held moral convictions. individual exemption of these interim
from being required to provide final rules, employers sponsoring
contraceptive coverage in individual 6. Individual Exemption governmental plans would be free to
insurance coverage. Protecting issuers These interim final rules include a honor the sincerely held moral
that object to offering contraceptive special rule pertaining to individuals objections of individual employees by
coverage based on sincerely held moral (referred to here as the ‘‘individual offering them plans that omit
convictions will help preserve space in exemption’’). Section 147.133(b) contraception, even if those
the health insurance market for certain provides that nothing in governmental entities do not object to
issuers so that exempt plan sponsors § 147.130(a)(1)(iv), 26 CFR 54.9815– offering contraceptive coverage in
and individuals will be able to obtain 2713T(a)(1)(iv) and 29 CFR 2590.715– general.
coverage. 2713(a)(1)(iv), may be construed to This ‘‘individual exemption’’ cannot
The Departments are not currently prevent a willing plan sponsor of a be used to force a plan (or its sponsor)
aware of health insurance issuers that group health plan and/or a willing or an issuer to provide coverage
possess their own religious or moral health insurance issuer offering group or omitting contraception, or, with respect
objections to offering contraceptive individual health insurance coverage, to health insurance coverage, to prevent
coverage. Nevertheless, many Federal from offering a separate benefit package the application of state law that requires
health care conscience laws and option, or a separate policy, certificate, coverage of such contraceptives or
regulations protect issuers or plans or contract of insurance, to any sterilization. Nor can the individual
specifically. For example, as discussed exemption be construed to require the
individual who objects to coverage or
above, 42 U.S.C. 1395w–22(j)(3)(B) and guaranteed availability of coverage
payments for some or all contraceptive
1396u–2(b)(3) protect plans or managed omitting contraception to a plan sponsor
services based on the individual’s
care organizations in Medicaid or or individual who does not have a
sincerely held moral convictions. The
Medicare Advantage. The Weldon sincerely held moral objection. This
individual exemption extends to the
Amendment protects HMOs, health individual exemption is limited to the
coverage unit in which the plan
insurance plans, and any other health requirement to provide contraceptive
participant, or subscriber in the
care organizations from being required coverage under section 2713(a)(4) of the
individual market, is enrolled (for
to provide coverage or pay for abortions. PHS Act, and does not affect any other
instance, to family coverage covering
See, for example, Consolidated federal or state law governing the plan
Appropriations Act of 2017, Div. H, the participant and his or her
beneficiaries enrolled under the plan), or coverage. Thus, if there are other
Title V, Sec. 507(d), Public Law 115–31. applicable laws or plan terms governing
The most recently enacted Consolidated but does not relieve the plan’s or
issuer’s obligation to comply with the the benefits, these interim final rules do
Appropriations Act declares that
Mandate with respect to the group not affect such other laws or terms.
Congress supports a ‘‘conscience The Departments believe the
clause’’ to protect moral convictions health plan at large or, as applicable, to
any other individual policies the issuer individual exemption will help to meet
concerning ‘‘the provision of the Affordable Care Act’s goal of
contraceptive coverage by health offers.
increasing health coverage because it
insurance plans.’’ See id. at Div. C, Title will reduce the incidence of certain
39 The exemption for issuers, as outlined here,

VIII, Sec. 808. individuals choosing to forego health
does not make a distinction among issuers based on
The issuer exemption does not whether they are publicly traded, unlike the plan coverage because the only coverage
specifically include third party sponsor exemption for business entities. Because available would violate their sincerely
administrators, for the reasons the issuer exemption operates more narrowly than
the exemption for business plan sponsors operates, held moral convictions.40 At the same
discussed in the companion interim
in the ways described here, and exists in part to
final rules concerning religious beliefs help preserve market options for objecting plan 40 This prospect has been raised in cases of
issued contemporaneously with these sponsors, the Departments consider it appropriate religious individuals—see, for example, Wieland,
interim final rules and published to not draw such a distinction among issuers. Continued
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time, this individual exemption ‘‘does on moral bases from those who object section 2713(a) and (a)(4) of the PHS
not undermine the governmental on religious bases. That is, a willing Act, contained in 26 CFR 54.9815–
interests furthered by the contraceptive employer or issuer may offer the same 2713T(a)(1) introductory text and
coverage requirement,’’ 41 because, benefit package option or policy, (a)(1)(iv), 29 CFR 2590.715–2713(a)(1)
when the exemption is applicable, the certificate, or contract of insurance— introductory text and (a)(1)(iv), and 45
individual does not want the coverage, which excludes the same scope of some CFR 147.130(a)(1) and (a)(1)(iv).
and therefore would not use the or all contraceptive coverage—to
9. Conclusion
objectionable items even if they were individuals who are exempt from the
covered. In addition, because the Mandate because of their moral The Departments believe that the
individual exemption only operates convictions (under these rules) or their Guidelines, and the expanded
when the employer and/or issuer, as religious beliefs (under the regulations exemptions and accommodations set
applicable, are willing, the exemption as amended by the interim final rules forth in these interim final rules, will
will not undermine any governmental pertaining to religious beliefs). advance the legitimate but limited
interest in the workability of the purposes for which Congress imposed
7. Optional Accommodation section 2713 of the PHS Act, while
insurance market, because we expect
that any workability concerns will be In addition to expanding the acting consistently with Congress’ well-
taken into account in the decision of exemption to those with sincerely held established record of allowing for moral
whether to be willing to offer the moral convictions, these rules also exemptions with respect to various
individual morally acceptable coverage. expand eligibility for the optional health care matters. These interim final
For similar reasons, we have changed accommodation process to include rules maintain HRSA’s discretion to
our position and now believe the employers with objections based on decide whether to continue to require
individual exemption will not sincerely held moral convictions. This contraceptive coverage under the
undermine any Government interest in is accomplished by inserting references Guidelines if no regulatorily recognized
uniformity in the health insurance to the newly added exemption for moral exemption exists (and in plans where
market. At the level of plan offerings, convictions, 45 CFR 147.133, into the Congress applied section 2713 of the
the extent to which plans cover regulatory sections where the PHS Act). As cited above, these interim
contraception under the prior rules is accommodation process is codified, 45 final rules also leave fully in place over
already far from uniform. The Congress CFR 147.131, 26 CFR 54.9815–2713AT, a dozen Federal programs that provide,
did not require compliance with section and 29 CFR 2590.715–2713A. In all or subsidize, contraceptives for women,
2713 of the PHS Act by all entities—in other respects the accommodation including for low income women based
particular by grandfathered plans. The process works the same as it does for on financial need. The Departments
Departments’ previous exemption for entities with objections based on believe this array of programs and
houses of worship and integrated sincerely held religious beliefs, as requirements better serves the interests
auxiliaries, and our accommodation of described in the companion interim of providing contraceptive coverage
self-insured church plans, show that the final rules concerning religious beliefs while protecting the moral convictions
importance of a uniform health issued contemporaneously with these of entities and individuals concerning
insurance system is not significantly interim final rules and published coverage of some or all contraceptive or
harmed by allowing plans to omit elsewhere in this issue of the Federal sterilization services.
contraception in many contexts.42 Register. The Departments request and
With respect to operationalizing this The Departments are not aware of encourage public comments on all
provision of these rules, as well as the entities with objections to the Mandate matters addressed in these interim final
similar provision protecting individuals based on sincerely held moral rules.
with religious objections to purchasing convictions that wish to make use of the
optional accommodation, and our IV. Interim Final Rules, Request for
insurance that covers some or all
present assumption is that no such Comments and Waiver of Delay of
contraceptives, in the interim final rules
entities will seek to use the Effective Date
published elsewhere in this issue of the
Federal Register, the Departments note accommodation rather than the Section 9833 of the Code, section 734
that a plan sponsor or health insurance exemption. But if such entities do wish of ERISA, and section 2792 of the PHS
issuer is not required to offer separate to use the accommodation, making it Act authorize the Secretaries of the
and different benefit package options, or available to them will both provide Treasury, Labor, and HHS (collectively,
separate and different forms of policy, contraceptive coverage to their plan the Secretaries) to promulgate any
certificate, or contract of insurance with participants and respect those entities’ interim final rules that they determine
respect to those individuals who object objections. Because entities with are appropriate to carry out the
objections to the Mandate based on provisions of chapter 100 of the Code,
196 F. Supp. 3d at 1017, and March for Life, 128 sincerely held non-religious moral part 7 of subtitle B of title I of ERISA,
F. Supp. 3d at 130—where the courts noted that the convictions have not previously had and part A of title XXVII of the PHS Act,
individual employee plaintiffs indicated that they which include sections 2701 through
viewed the Mandate as pressuring them to ‘‘forgo
access to the accommodation, they
health insurance altogether.’’ would not be in a position to revoke 2728 of the PHS Act and the
41 78 FR 39874. their use of the accommodation at the incorporation of those sections into
42 See also Real Alternatives, 2017 WL 3324690 time these interim final rules are issued, section 715 of ERISA and section 9815
at *36 (3d Cir. Aug. 4, 2017) (Jordan, J., concurring but could do so in the future under the of the Code. These interim final rules
in part and dissenting in part) (‘‘Because insurance fall under those statutory authorized
companies would offer such plans as a result of
same parameters set forth in the
market forces, doing so would not undermine the accommodation regulations. justifications, as did previous rules on
government’s interest in a sustainable and this matter (75 FR 41726; 76 FR 46621;
functioning market. . . . Because the government 8. Regulatory Restatements of Section and 79 FR 51092).
has failed to demonstrate why allowing such a 2713(a) and (a)(4) of the PHS Act Section 553(b) of the APA requires
system (not unlike the one that allowed wider
choice before the ACA) would be unworkable, it has
These interim final rules insert notice and comment rulemaking,
not satisfied strict scrutiny.’’ (citation and internal references to 45 CFR 147.133 into the involving a notice of proposed
quotation marks omitted)). restatements of the requirements of rulemaking and a comment period prior
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to finalization of regulatory serious disincentive—indeed a crisis of that the exemptions be expanded to

requirements—except when an agency, conscience—between participating in or include those who oppose the Mandate
for good cause, finds that notice and providing quality and affordable health for either religious or ‘‘moral’’ reasons.45
public comment thereon are insurance coverage and being forced to In connection with past regulations, the
impracticable, unnecessary, or contrary violate their sincerely held moral Departments have offered or expanded a
to the public interest. These provisions convictions. The existence of temporary safe harbor allowing
of the APA do not apply here because inconsistent court rulings in multiple organizations that were not exempt from
of the specific authority granted to the proceedings has also caused confusion the HRSA Guidelines to operate out of
Secretaries by section 9833 of the Code, and uncertainty that has extended for compliance with the Guidelines. The
section 734 of ERISA, and section 2792 several years, with different federal Departments will fully consider
of the PHS Act. courts taking different positions on comments submitted in response to
Even if these provisions of the APA whether entities with moral objections these interim final rules, but believe that
applied, they would be satisfied: The are entitled to relief from the Mandate. good cause exists to issue the rules on
Departments have determined that it Delaying the availability of the an interim final basis before the
would be impracticable and contrary to expanded exemption would require comments are submitted and reviewed.
the public interest to delay putting these entities to bear these burdens for many Issuing interim final rules with a
provisions in place until a full public more months. Continuing to apply the comment period provides the public
notice-and-comment process is Mandate’s regulatory burden on with an opportunity to comment on
completed. As discussed earlier, the individuals and organizations with whether these regulations expanding the
Departments have issued three interim moral convictions objecting to exemption should be made permanent
final rules implementing this section of compliance with the Mandate also or subject to modification without
the PHS Act because of the immediate serves as a deterrent for citizens who delaying the effective date of the
needs of covered entities and the might consider forming new entities regulations.
weighty matters implicated by the consistent with their moral convictions As the U.S. Court of Appeals for the
HRSA Guidelines. As recently as and offering health insurance through D.C. Circuit stated with respect to an
December 20, 2016, HRSA updated those entities. earlier IFR promulgated with respect to
those Guidelines without engaging in Moreover, we separately expanded this issue in Priests for Life v. U.S.
the regulatory process (because doing so exemptions to protect religious beliefs Department of Health and Human
is not a legal requirement), and in the companion interim final rules Services, 772 F.3d 229, 276 (D.C. Cir.
announced that it plans to so continue issued contemporaneously with these 2014), vacated on other grounds, Zubik
to update the Guidelines. interim final rules and published v. Burwell, 136 S. Ct. 1557 (2016),
Two lawsuits have been pending for elsewhere in this issue of the Federal ‘‘[S]everal reasons support HHS’s
several years by entities raising non- Register. Because Congress has decision not to engage in notice and
religious moral objections to the provided many statutes that protect comment here.’’ Among other things,
Mandate.43 In one of those cases, the religious beliefs and moral convictions the Court noted that ‘‘the agency made
Departments are subject to a permanent similarly in certain health care contexts, a good cause finding in the rule it
injunction and the appeal of that case it is important not to delay the issued’’; that ‘‘the regulations the
has been stayed since February 2016. In expansion of exemptions for moral interim final rule modifies were recently
the other case, Federal district and convictions set forth in these rules, enacted pursuant to notice and
appeals courts ruled in favor of the since the companion rules provide comment rulemaking, and presented
Departments, denying injunctive relief protections for religious beliefs on an virtually identical issues’’; that ‘‘HHS
to the plaintiffs, and that case is also interim final basis. Otherwise, our will expose its interim rule to notice
still pending. Based on the public regulations would simultaneously and comment before its permanent
comments the Departments have provide and deny relief to entities and implementation’’; and that not
received, we have reason to believe that individuals that are, in the Departments’ proceeding under interim final rules
some similar nonprofit entities might view, similarly deserving of exemptions would ‘‘delay the implementation of the
exist, even if it is likely a small and accommodations consistent, with alternative opt-out for religious
number.44 similar protections in other federal laws.
objectors.’’ Id. at 277. Similarly, not
For entities and individuals facing a This could cause similarly situated
proceeding with exemptions and
burden on their sincerely held moral entities and individuals to be burdened
accommodations for moral objectors
convictions, providing them relief from unequally.
In response to several of the previous here would delay the implementation of
Government regulations that impose those alternative opt-outs for moral
such a burden is an important and rules on this issue—including three
issued as interim final rules under the objectors.
urgent matter, and delay in doing so Delaying the availability of the
injures those entities in ways that statutory authority cited above—the
expanded exemption could also
cannot be repaired retroactively. The Departments received more than
increase the costs of health insurance
100,000 public comments on multiple
burdens of the existing rules undermine for some entities. As reflected in
occasions. Those comments included
these entities’ and individuals’ litigation pertaining to the Mandate,
extensive discussion about whether and
participation in the health care market some entities are in grandfathered
to what extent to expand the exemption.
because they provide them with a health plans that do not cover
Most recently, on July 26, 2016, the
43 March for Life, 128 F. Supp. 3d 116; Real

Departments issued a request for 45 See, for example, http://www.regulations.gov/
Alternatives, 867 F.3d 338. information (81 FR 47741) and received #!documentDetail;D=HHS-OS-2011-0023-59496,
44 See, for example, Americans United for Life over 54,000 public comments about http://www.regulations.gov/
(‘‘AUL’’) Comment on CMA–9992–IFC2 at 10 (Nov. different possible ways to resolve these #!documentDetail;D=CMS-2012-0031-79115,
1, 2011), available at http://www.regulations.gov/ issues. As noted above, the public https://www.regulations.gov/document?D=CMS-
#!documentDetail;D=HHS-OS-2011-0023-59496, 2016-0123-54142, https://www.regulations.gov/
and AUL Comment on CMS–9968–P at 5 (Apr. 8,
comments in response to both the RFI document?D=CMS-2016-0123-54218, and https://
2013), available at http://www.regulations.gov/ and various prior rulemaking www.regulations.gov/document?D=CMS-2016-0123-
#!documentDetail;D=CMS-2012-0031-79115. proceedings included specific requests 46220.
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contraception. As such, they may wish Regulatory Flexibility Act (RFA) Executive Order 12866. However, OMB
to make changes to their health plans (September 19, 1980, Pub. L. 96–354, has determined that the actions are
that will reduce the costs of insurance section 1102(b) of the Social Security significant within the meaning of
coverage for their beneficiaries or Act, section 202 of the Unfunded section 3(f)(4) of the Executive Order.
policyholders, but which would cause Mandates Reform Act of 1995 (March Therefore, OMB has reviewed these
the plans to lose grandfathered status. 22, 1995; Pub. L. 104–4), Executive final regulations and the Departments
To the extent that entities with Order 13132 on Federalism (August 4, have provided the following assessment
objections to the Mandate based on 1999), the Congressional Review Act (5 of their impact.
moral convictions but not religious U.S.C. 804(2) and Executive Order
1. Need for Regulatory Action
beliefs fall into this category, they may 13771 on Reducing Regulation and
be refraining from making those Controlling Regulatory Costs (January These interim final rules amend the
changes—and therefore may be 30, 2017). Departments’ July 2015 final regulations
continuing to incur and pass on higher and do so in conjunction with the
A. Executive Orders 12866 and 13563— amendments made in the companion
insurance costs—to prevent the
Department of HHS and Department of interim final rules concerning religious
Mandate from applying to their plans in
Labor beliefs issued contemporaneously with
violation of their consciences. We are
not aware of the extent to which such Executive Orders 12866 and 13563 these interim final rules and published
entities exist, but 17 percent of all direct agencies to assess all costs and elsewhere in this issue of the Federal
covered workers are in grandfathered benefits of available regulatory Register. These interim final rules
health plans, encompassing tens of alternatives and, if regulation is expand the exemption from the
millions of people.46 Issuing these rules necessary, to select regulatory requirement to provide coverage for
on an interim final basis reduces the approaches that maximize net benefits contraceptives and sterilization,
costs of health insurance and regulatory (including potential economic, established under the HRSA Guidelines,
burdens for such entities and their plan environmental, and public health and promulgated under section 2713(a)(4) of
participants. safety effects; distributive impacts; and the PHS Act, section 715(a)(1) of the
These interim final rules also expand equity). Executive Order 13563 ERISA, and section 9815(a)(1) of the
access to the optional accommodation emphasizes the importance of Code, to include certain entities and
process for certain entities with quantifying both costs and benefits, individuals with objections to
objections to the Mandate based on reducing costs, harmonizing rules, and compliance with the Mandate based on
moral convictions. If entities exist that promoting flexibility. sincerely held moral convictions, and
wish to use that process, the Section 3(f) of Executive Order 12866 they revise the accommodation process
Departments believe they should be able defines a ‘‘significant regulatory action’’ to make entities with such convictions
to do so without the delay that would as an action that is likely to result in a eligible to use it. The expanded
be involved by not offering them the regulation: (1) Having an annual effect exemption would apply to certain
optional accommodation process by use on the economy of $100 million or more individuals, nonprofit entities,
of interim final rules. Proceeding in any 1 year, or adversely and institutions of higher education, issuers,
otherwise could delay the provision of materially affecting a sector of the and for-profit entities that do not have
contraceptive coverage to those entities’ economy, productivity, competition, publicly traded ownership interests,
employees. jobs, the environment, public health or that have a moral objection to providing
For the foregoing reasons, the safety, or State, local, or tribal coverage for some (or all) of the
Departments have determined that it governments or communities (also contraceptive and/or sterilization
would be impracticable and contrary to referred to as ‘‘economically services covered by the Guidelines.
the public interest to engage in full significant’’); (2) creating a serious Such action is taken, among other
notice and comment rulemaking before inconsistency or otherwise interfering reasons, to provide for conscientious
putting these interim final rules into with an action taken or planned by participation in the health insurance
effect, and that it is in the public interest another agency; (3) materially altering market free from penalties for violating
to promulgate interim final rules. For the budgetary impacts of entitlement sincerely held moral convictions
the same reasons, the Departments have grants, user fees, or loan programs or the opposed to providing or receiving
determined, consistent with section rights and obligations of recipients coverage of contraceptive services, to
553(d) of the APA (5 U.S.C. 553(d)), that thereof; or (4) raising novel legal or resolve lawsuits that have been filed
there is good cause to make these policy issues arising out of legal against the Departments by some such
interim final rules effective immediately mandates, the President’s priorities, or entities, and to avoid similar legal
upon filing for public inspection at the the principles set forth in the Executive challenges.
Office of the Federal Register. Order.
A regulatory impact analysis must be 2. Anticipated Effects
V. Economic Impact and Paperwork prepared for major rules with The Departments acknowledge that
Burden economically significant effects ($100 expanding the exemption to include
We have examined the impacts of the million or more in any one year), and objections based on moral convictions
interim final rules as required by an ‘‘economically significant’’ might result in less insurance coverage
Executive Order 12866 on Regulatory regulatory action is subject to review by of contraception for some women who
Planning and Review (September 30, the Office of Management and Budget may want the coverage. Although the
1993), Executive Order 13563 on (OMB). As discussed below regarding Departments do not know the exact
Improving Regulation and Regulatory anticipated effects of these rules and the scope of that effect attributable to the
Review (January 18, 2011), the Paperwork Reduction Act, these interim moral exemption in these interim final
final rules are not likely to have rules, they believe it to be small.
46 Kaiser Family Foundation & Health Research &
economic impacts of $100 million or With respect to the expanded
Educational Trust, ‘‘Employer Health Benefits, 2017
Annual Survey,’’ available at http://files.kff.org/
more in any one year, and therefore do exemption for nonprofit organizations,
attachment/Report-Employer-Health-Benefits- not meet the definition of as noted above the Departments are
Annual-Survey-2017. ‘‘economically significant’’ under aware of two small nonprofit
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organizations that have filed lawsuits is possible that the exemption for come into existence, based on similar
raising non-religious moral objections to nonprofit organizations with moral reasons to those given above for why the
coverage of some contraceptives. Both of convictions in these interim final rules exemptions and accommodations are
those entities have fewer than five could be used by a nonprofit extended to other entities. We invite
employees enrolled in health coverage, organization that employs persons who public comment on whether and how
and both require all of their employees do not share the organization’s views on many such entities will make use of
to agree with their opposition to the contraception, but it was also possible these interim final rules.
coverage.47 Based on comments under our previous rules that a house of The expanded exemption for issuers
submitted in response to prior worship or integrated auxiliary could will not result in a distinct effect on
rulemakings on this subject, we believe employ persons who do not share their contraceptive coverage for women who
that at least one other similar entity views on contraception.48 Although we wish to receive it because that
exists. However, we do not know how are unable to find sufficient data on this exemption only applies in cases where
many similar entities exist. Lacking issue, we believe that there are far fewer plan sponsors or individuals are also
other information we assume that the non-religious moral nonprofit otherwise exempt, and the effect of
number is small. Without data to organizations opposed to contraceptive those exemptions is discussed
estimate the number of such entities, we coverage than there are churches with elsewhere herein. The expanded
believe it to be less than 10, and assume religious objections to such coverage. exemption for individuals that oppose
the exemption will be used by nine Based on our limited data, we believe contraceptive coverage based on
nonprofit entities. the most likely effect of the expanded sincerely held moral convictions will
We also assume that those nine exemption for nonprofit entities is that provide coverage that omits
entities will operate in a fashion similar it will be used by entities similar to the contraception for individuals that object
to the two similar entities of which we two entities that have sought an to contraceptive coverage.
are aware, so that their employees will exemption through litigation, and The expanded moral exemption
likely share their views against coverage whose employees also oppose the would also cover for-profit entities that
of certain contraceptives. This is coverage. Therefore, we expect that the do not have publicly traded ownership
consistent with our conclusion in expanded exemption for nonprofit interests, and that have non-religious
previous rules that no significant entities will have no effect of reducing moral objections to the Mandate. The
burden or costs would result from contraceptive coverage to employees Departments are not aware of any for-
exempting houses of worship and who want that coverage. profit entities that possess non-religious
integrated auxiliaries. (See 76 FR 46625 These interim final rules expand the moral objections to the Mandate.
and 78 FR 39889). We reached that exemption to include institutions of However, scores of for-profit entities
conclusion without ultimately requiring higher education that arrange student have filed suit challenging the Mandate.
that houses of worship and integrated coverage and have non-religious moral Among the over 200 entities that
auxiliaries only hire persons who agree objections to the Mandate, and they brought legal challenges, only two
with their views against contraception, make exempt entities with moral entities (less than 1 percent) raised non-
and without even requiring that such objections eligible to use the religious moral objections—both were
entities actually oppose contraception accommodation. The Departments are nonprofit. Among the general public
in order to be exempt (in contrast, the not aware of either kind of entity. We polls vary about religious beliefs, but
expanded exemption here requires the believe the number of entities that one prominent poll shows that 89
exempt entity to actually possess object to the Mandate based on non- percent of Americans say they believe in
sincerely held moral convictions religious moral convictions is already God.49 Among non-religious persons,
objecting to the coverage). In concluding very small. The only entities of which only a very small percentage appears to
that the exemption for houses of we are aware that have raised such hold moral objections to contraception.
worship and integrated auxiliaries objections are not institutions of higher A recent study found that only 2 percent
would result in no significant burden or education, and appear to hold of religiously unaffiliated persons
costs, we relied on our assumption that objections that we assume would likely believed using contraceptives is morally
the employees of exempt houses of lead them to reject the accommodation wrong.50 Combined, this suggests that
worship and integrated auxiliaries likely process. Therefore, for the purposes of 0.2 percent of Americans at most 51
share their employers’ opposition to estimating the anticipated effect of these might believe contraceptives are morally
contraceptive coverage. interim final rules on contraceptive wrong based on moral convictions but
A similar assumption is supported coverage of women who wish to receive not religious beliefs. We have no
with respect to the expanded exemption such coverage, we assume that—at this information about how many of those
for nonprofit organizations. To our time—no entities with non-religious persons run closely held businesses,
knowledge, the vast majority of moral objections to the Mandate will be offer employer sponsored health
organizations objecting to the Mandate institutions of higher education that insurance, and would make use of the
assert religious beliefs. The only arrange student coverage, and no expanded exemption for moral
nonprofit organizations of which we are entities with non-religious moral
aware that possess non-religious moral objections will opt into the 49 Gallup, ‘‘Most Americans Still Believe in God’’
convictions against some or all accommodation. We wish to make the (June 14–23, 2016), available at http://
expanded exemption and www.gallup.com/poll/193271/americans-believe-
contraceptive methods only hire god.aspx.
persons who share their convictions. It accommodation available to such
50 Pew Research Center, ‘‘Where the Public

entities in case they do exist or might Stands on Religious Liberty vs. Nondiscrimination’’
47 Non-religious nonprofit organizations that at page 26 (Sept. 28, 2016), available at http://
engage in expressive activity generally have a First 48 Cf., for example, Gallup, ‘‘Americans, assets.pewresearch.org/wp-content/uploads/sites/
Amendment right to hire only people who share Including Catholics, Say Birth Control Is Morally 11/2016/09/Religious-Liberty-full-for-web.pdf.
their moral convictions or will be respectful of OK,’’ (May 22, 2012) (‘‘Eighty-two percent of U.S. 51 The study defined religiously ‘‘unaffiliated’’ as
them—including their convictions on whether the Catholics say birth control is morally acceptable’’), agnostic, atheist or ‘‘nothing in particular’’ (id. at 8),
organization or others provide health coverage of available at http://www.gallup.com/poll/154799/ as distinct from several versions of Protestants, or
contraception, or of certain items they view as being americans-including-catholics-say-birth-control- Catholics. ‘‘Nothing in particular’’ might have
abortifacient. morally.aspx. included some theists.
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convictions set forth in these interim covered persons. Census data indicate its plan participants and beneficiaries.
final rules. Given the large number of that women of childbearing age—that is, Finally, because the accommodation
closely held entities that challenged the women aged 15–44—comprise 20.2 process was not previously available to
Mandate based on religious objections, percent of the general population.54 entities that possess non-religious moral
we assume that some similar for-profit This amounts to approximately 33 objections to the Mandate, we do not
entities with non-religious moral women of childbearing age for this anticipate that these interim final rules
objections exist. But we expect that it group of individuals covered by group will result in any burden from such
will be a comparatively small number of plans sponsored by for-profit moral entities revoking their accommodated
entities, since among the nonprofit objectors. Approximately 44.3 percent status.
litigants, only two were non-religious. of women currently use contraceptives The Departments believe the
Without data available to estimate the covered by the Guidelines.55 Thus we foregoing analysis represents a
actual number of entities that will make estimate that 15 women may incur reasonable estimate of the likely impact
use of the expanded exemption for for- contraceptive costs due to for-profit under the rules expanded exemptions.
profit entities that do not have publicly entities using the expanded exemption The Departments acknowledge
traded ownership interests and that provided in these interim final rules.56 uncertainty in the estimate and
have objections to the Mandate based on In the companion interim final rules therefore conducted a second analysis
sincerely held moral convictions, we concerning religious beliefs issued using an alternative framework, which
expect that fewer than 10 entities, if contemporaneously with these interim is set forth in the companion interim
any, will do so—we assume nine for- final rules and published elsewhere in final rule concerning religious beliefs
profit entities will use the exemption in this issue of the Federal Register, we issued contemporaneously with this
these interim final rules. estimate that the average cost of interim final rule and published
The expanded exemption contraception per year per woman of elsewhere in this issue of the Federal
encompassing certain for-profit entities childbearing age that use contraception Register. Under either estimate, this
could result in the removal of covered by the Guidelines, within interim final rule is not economically
contraceptive coverage from women health plans that cover contraception, is significant.
who do not share their employers’ $584. Consequently, we estimate that We reiterate the rareness of instances
views. The Departments used data from the anticipated effects attributable to the in which we are aware that employers
the Current Population Survey (CPS) cost of contraception from for-profit assert non-religious objections to
and the Medical Expenditure Panel entities using the expanded exemption contraceptive coverage based on
Survey-Insurance Component (MEPS– in these interim final rules is sincerely held moral convictions, as
IC) to obtain an estimate of the number approximately $8,760. discussed above, and also that in the
of policyholders that will be covered by The Departments estimate that these few instances where such an objection
the plans of the nine for-profit entities interim final rules will not result in any has been raised, employees of such
we assume may make use of these additional burden or costs on issuers or employers also opposed contraception.
expanded exemptions.52 The average third party administrators. As discussed We request comment on all aspects of
number of policyholders (9) in plans above, we assume that no entities with the preceding regulatory impact
with under 100 employees was non-religious moral convictions will use analysis.
obtained. It is not known what size the the accommodation, although we wish
B. Special Analyses—Department of the
for-profit employers will be that might to make it available in case an entity
Treasury
claim this exemption, but as discussed voluntarily opts into it in order to allow
above these interim final rules do not contraceptive coverage to be provided to For purposes of the Department of the
include publicly traded companies (and Treasury, certain Internal Revenue
we invite public comments on whether
54 U.S. Census Bureau, ‘‘Age and Sex Service (IRS) regulations, including this
to do so in the final rules), and both of
Composition: 2010’’ (May 2011), available at one, are exempt from the requirements
https://www.census.gov/prod/cen2010/briefs/ in Executive Order 12866, as
the two nonprofit entities that c2010br-03.pdf. The Guidelines’ requirement of
challenged the Mandate included fewer contraceptive coverage only applies ‘‘for all women supplemented by Executive Order
than five policyholders in each entity. with reproductive capacity.’’ https://www.hrsa.gov/ 13563. The Departments estimate that
womensguidelines/; see also 80 FR 40318. In the likely effect of these interim final
Therefore we assume the for-profit addition, studies commonly consider the 15–44 age
entities that may claim this expanded range to assess contraceptive use by women of
rules will be that entities will use the
exemption will have fewer than 100 childbearing age. See, Guttmacher Institute, exemption and not the accommodation.
employees and an average of 9 ‘‘Contraceptive Use in the United States’’ (Sept. Therefore, a regulatory assessment is not
2016), available at https://www.guttmacher.org/fact- required.
policyholders. For nine entities, the sheet/contraceptive-use-united-states.
total number of policyholders would be 55 See https://www.guttmacher.org/fact-sheet/ C. Regulatory Flexibility Act
81. DOL estimates that for each contraceptive-use-united-states.
The Regulatory Flexibility Act (5
56 We note that many non-religious for-profit
policyholder, there is approximately U.S.C. 601 et seq.) (RFA) imposes
entities which sued the Departments challenging
one dependent.53 This amounts to 162 the Mandate, including some of the largest certain requirements with respect to
employers, only objected to coverage of 4 of the 18 Federal rules that are subject to the
52 ‘‘Health Insurance Coverage Bulletin’’ Table 4,
types of contraceptives required to be covered by
page 21. Using March 2015 Annual Social and the Mandate—namely, those contraceptives which
notice and comment requirements of
Economic Supplement to the Current Population they viewed as abortifacients, and akin to abortion section 553(b) of the APA (5 U.S.C. 551
Survey. https://www.dol.gov/sites/default/files/ —and they were willing to provide coverage for et seq.) and that are likely to have a
ebsa/researchers/data/health-and-welfare/health- other types of contraception. It is reasonable to significant economic impact on a

insurance-coverage-bulletin-2015.pdfEstimates of assume that this would also be the case with respect
the number of ERISA Plans based on 2015 Medical to some for-profits that object to the Mandate on the
substantial number of small entities.
Expenditure Survey—Insurance basis of sincerely held moral convictions. Under Section 553(b) of the APA, a
53 ‘‘Health Insurance Coverage Bulletin’’ Table 4, Accordingly, it is possible that even fewer women general notice of proposed rulemaking
page 21. Using March 2015 Annual Social and beneficiaries under such plans would bear out-of- is not required when an agency, for
Economic Supplement to the Current Population pocket expenses in order to obtain contraceptives,
Survey. https://www.dol.gov/sites/default/files/ and that those who might do so would bear lower
good cause, finds that notice and public
ebsa/researchers/data/health-and-welfare/health- costs due to many contraceptive items being comment thereon are impracticable,
insurance-coverage-bulletin-2015.pdf. covered. unnecessary, or contrary to the public
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interest. The interim final rules are contemporaneously with these interim 3. Call the Reports Clearance Office at
exempt from the APA, both because the final rules and published elsewhere in (410) 786–1326.
PHS Act, ERISA, and the Code contain this issue of the Federal Register. As If you comment on these information
specific provisions under which the discussed there, regulations covering collections, that is, reporting,
Secretaries may adopt regulations by the accommodation include provisions recordkeeping or third-party disclosure
interim final rule and because the regarding self-certification or notices to requirements, please submit your
Departments have made a good cause HHS from eligible organizations comments electronically as specified in
finding that a general notice of proposed (§ 147.131(c)(3)), notice of availability of the ADDRESSES section of these interim
rulemaking is not necessary earlier in separate payments for contraceptive final rules with comment period.
this preamble. Therefore, the RFA does services (§ 147.131(f)), and notice of E. Paperwork Reduction Act—
not apply and the Departments are not revocation of accommodation Department of Labor
required to either certify that the (§ 147.131(c)(4)). The burdens related to
regulations or this amendment would those ICRs are currently approved under Under the Paperwork Reduction Act,
not have a significant economic impact OMB Control Numbers 0938–1248 and an agency may not conduct or sponsor,
on a substantial number of small entities 0938–1292. These interim final rules and an individual is not required to
or conduct a regulatory flexibility amend the accommodation regulations respond to, a collection of information
analysis. to make entities with moral objections unless it displays a valid OMB control
Nevertheless, the Departments to the Mandate eligible to use the same number. In accordance with the
carefully considered the likely impact of accommodation processes. The requirements of the PRA, the ICR for the
the rule on small entities in connection Departments will update the forms and EBSA Form 700 and alternative notice
with their assessment under Executive model notices regarding these processes have previously been approved by OMB
Order 12866. The Departments do not to reflect that entities with sincerely under control numbers 1210–0150 and
expect that these interim final rules will held moral convictions are eligible 1210–0152. A copy of the ICR may be
have a significant economic effect on a organizations. obtained by contacting the PRA
substantial number of small entities, As discussed above, however, we addressee shown below or at http://
because they will not result in any assume that no entities with non- www.RegInfo.gov. PRA ADDRESSEE: G.
additional costs to affected entities. religious moral objections to the Christopher Cosby, Office of Policy and
Instead, by exempting from the Mandate Mandate will use the accommodation, Research, U.S. Department of Labor,
small businesses and nonprofit and we know that no such entities were Employee Benefits Security
organizations with moral objections to eligible for it until now, so that they do Administration, 200 Constitution
some or all contraceptives and/or not possess accommodated status to Avenue NW., Room N–5718,
sterilization, the Departments have revoke. Therefore we believe that the Washington, DC 20210. Telephone:
reduced regulatory burden on small burden for these ICRs is accounted for 202–693–8410; Fax: 202–219–4745.
entities. Pursuant to section 7805(f) of in the collection approved under OMB These are not toll-free numbers.
the Code, these regulations have been Control Numbers 0938–1248 and 0938– Consistent with the analysis in the
submitted to the Chief Counsel for 1292, as described in the interim final HHS PRA section above, although these
Advocacy of the Small Business rules concerning religious beliefs issued interim final rules make entities with
Administration for comment on their contemporaneously with these interim certain moral convictions eligible for the
impact on small business. final rules. accommodation, we assume that no
We are soliciting comments on all of entities will use it rather than the
D. Paperwork Reduction Act— the possible information collection exemption, and such entities were not
Department of Health and Human requirements contained in these interim previously eligible for the
Services final rules, including those discussed in accommodation so as to revoke it.
Under the Paperwork Reduction Act the companion interim final rules Therefore we believe these interim final
of 1995 (the PRA), federal agencies are concerning religious beliefs issued rules do not involve additional burden
required to publish notice in the contemporaneously with these interim not accounted for under OMB control
Federal Register concerning each final rules and published elsewhere in number 1210–0150.
proposed collection of information. this issue of the Federal Register, for Regarding the ICRs discussed in the
Interested persons are invited to send which these interim final rules provide companion interim final rules
comments regarding our burden eligibility to entities with objections concerning religious beliefs issued
estimates or any other aspect of this based on moral convictions. In addition, contemporaneously with these interim
collection of information, including any we are also soliciting comments on all final rules and published elsewhere in
of the following subjects: (1) The of the related information collection this issue of the Federal Register, the
necessity and utility of the proposed requirements currently approved under forms for which would be used if any
information collection for the proper 0938–1292 and 0938–1248. entities with moral objections used the
performance of the agency’s functions; To obtain copies of a supporting accommodation process in the future,
(2) the accuracy of the estimated statement and any related forms for the DOL submitted those ICRs in order to
burden; (3) ways to enhance the quality, proposed collection(s) summarized in obtain OMB approval under the PRA for
utility, and clarity of the information to this notice, you may make your request the regulatory revision. The request was
be collected; and (4) the use of using one of following: made under emergency clearance
automated collection techniques or 1. Access CMS’ Web site address at procedures specified in regulations at 5
other forms of information technology to https://www.cms.gov/Regulations-and- CFR 1320.13. OMB approved the ICRs
minimize the information collection Guidance/Legislation/ under the emergency clearance process.
burden. PaperworkReductionActof1995/PRA- In an effort to consolidate the number of
We estimate that these interim final Listing.html. information collection requests, DOL
rules will not result in additional 2. Email your request, including your indicated it will combine the ICR
burdens not accounted for as set forth in address, phone number, OMB number, related to the OMB control number
the companion interim final rules and CMS document identifier, to 1210–0152 with the ICR related to the
concerning religious beliefs issued Paperwork@cms.hhs.gov. OMB control number 1210–0150. Once
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the ICR is approved, DOL indicated it is considered an EO 13771 deregulatory concerns of state and local officials in
will discontinue 1210–0152. OMB action. the preamble to the regulation.
approved the ICR under control number These interim final rules do not have
G. Unfunded Mandates Reform Act
1210–0150 through [DATE]. A copy of any Federalism implications, since they
the information collection request may The Unfunded Mandates Reform Act
only provide exemptions from the
be obtained free of charge on the of 1995 (section 202(a) of Pub. L. 104–
4), requires the Departments to prepare contraceptive and sterilization coverage
RegInfo.gov Web site at http://
www.reginfo.gov/public/do/ a written statement, which includes an requirement in HRSA Guidelines
PRAViewICR?ref_nbr=201705-1210-001. assessment of anticipated costs and supplied under section 2713 of the PHS
This approval allows respondents benefits, before issuing ‘‘any rule that Act.
temporarily to utilize the additional includes any Federal mandate that may VI. Statutory Authority
flexibility these interim final regulations result in the expenditure by State, local,
provide, while DOL seeks public and tribal governments, in the aggregate, The Department of the Treasury
comment on the collection methods— or by the private sector, of $100,000,000 temporary regulations are adopted
including their utility and burden. or more (adjusted annually for inflation) pursuant to the authority contained in
Contemporaneously with the in any one year.’’ The current threshold sections 7805 and 9833 of the Code.
publication of these interim final rules, after adjustment for inflation is $148 The Department of Labor regulations
DOL will publish a notice in the Federal million, using the most current (2016)
Register informing the public of its are adopted pursuant to the authority
Implicit Price Deflator for the Gross
intention to extend the OMB approval. contained in 29 U.S.C. 1002(16), 1027,
Domestic Product. For purposes of the
Unfunded Mandates Reform Act, these 1059, 1135, 1161–1168, 1169, 1181–
F. Regulatory Reform Executive Orders 1183, 1181 note, 1185, 1185a, 1185b,
13765, 13771 and 13777 interim final rules do not include any
Federal mandate that may result in 1185d, 1191, 1191a, 1191b, and 1191c;
Executive Order 13765 (January 20, expenditures by State, local, or tribal sec. 101(g), Public Law 104–191, 110
2017) directs that, ‘‘[t]o the maximum governments, nor do they include any Stat. 1936; sec. 401(b), Public Law 105–
extent permitted by law, the Secretary of Federal mandates that may impose an 200, 112 Stat. 645 (42 U.S.C. 651 note);
Health and Human Services (Secretary) annual burden of $100 million, adjusted sec. 512(d), Public Law 110–343, 122
and the heads of all other executive for inflation, or more on the private Stat. 3881; sec. 1001, 1201, and 1562(e),
departments and agencies (agencies) sector. Public Law 111–148, 124 Stat. 119, as
with authorities and responsibilities amended by Public Law 111–152, 124
under the Act shall exercise all H. Federalism
Stat. 1029; Secretary of Labor’s Order 1–
authority and discretion available to Executive Order 13132 outlines 2011, 77 FR 1088 (Jan. 9, 2012).
them to waive, defer, grant exemptions fundamental principles of federalism,
from, or delay the implementation of The Department of Health and Human
and requires the adherence to specific
any provision or requirement of the Act Services regulations are adopted
criteria by Federal agencies in the
that would impose a fiscal burden on pursuant to the authority contained in
process of their formulation and
any State or a cost, fee, tax, penalty, or sections 2701 through 2763, 2791, and
implementation of policies that have
regulatory burden on individuals, ‘‘substantial direct effects’’ on States, 2792 of the PHS Act (42 U.S.C. 300gg
families, healthcare providers, health the relationship between the Federal through 300gg–63, 300gg–91, and
insurers, patients, recipients of Government and States, or the 300gg–92), as amended; and Title I of
healthcare services, purchasers of health distribution of power and the Affordable Care Act, sections 1301–
insurance, or makers of medical devices, responsibilities among the various 1304, 1311–1312, 1321–1322, 1324,
products, or medications.’’ In addition, levels of Government. Federal agencies 1334, 1342–1343, 1401–1402, and 1412,
agencies are directed to ‘‘take all actions promulgating regulations that have Pub. L. 111–148, 124 Stat. 119 (42
consistent with law to minimize the these federalism implications must U.S.C. 18021–18024, 18031–18032,
unwarranted economic and regulatory consult with state and local officials, 18041–18042, 18044, 18054, 18061,
burdens of the [Affordable Care Act], and describe the extent of their 18063, 18071, 18082, 26 U.S.C. 36B, and
and prepare to afford the States more consultation and the nature of the 31 U.S.C. 9701).
flexibility and control to create a more
free and open healthcare market.’’ These including potential decreased expenditures on
List of Subjects
interim final rules exercise the contraceptive devices and drugs and potential 26 CFR Part 54
discretion provided to the Departments increased expenditures on pregnancy-related
medical services. OMB’s guidance on E.O. 13771
under the Affordable Care Act and other implementation (https://www.whitehouse.gov/the- Excise taxes, Health care, Health
laws to grant exemptions and thereby press-office/2017/04/05/memorandum- insurance, Pensions, Reporting and
minimize regulatory burdens of the implementing-executive-order-13771-titled- recordkeeping requirements.
Affordable Care Act on the affected reducing-regulation) states that impacts should be
entities and recipients of health care categorized as consistently as possible within 29 CFR Part 2590
Departments. The Food and Drug Administration,
services. within HHS, and the Occupational Safety and Continuation coverage, Disclosure,
Consistent with Executive Order Health Administration (OSHA) and Mine Safety
13771 (82 FR 9339, February 3, 2017), and Health Administration (MSHA), within DOL, Employee benefit plans, Group health
we have estimated the costs and cost regularly estimate medical expenditure impacts in plans, Health care, Health insurance,
the analyses that accompany their regulations, with Medical child support, Reporting and
savings attributable to this interim final the results being categorized as benefits (positive
rule. As discussed in more detail in the benefits if expenditures are reduced, negative
recordkeeping requirements.
preceding analysis, this interim final benefits if expenditures are raised). Following the
45 CFR Part 147
rule lessens incremental reporting FDA, OSHA and MSHA accounting convention
leads to this interim final rule’s medical
costs.57 Therefore, this interim final rule expenditure impacts being categorized as (positive Health care, Health insurance,
or negative) benefits, rather than as costs, thus Reporting and recordkeeping
57 Other noteworthy potential impacts encompass placing them outside of consideration for E.O.
potential changes in medical expenditures, 13771 designation purposes.
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requirements, State regulation of health ■ f. In paragraph (c)(1)(ii)(B) by adding in its place the reference
insurance. removing the reference ‘‘147.132’’ and ‘‘147.132 or 147.133’’; and
adding in its place the reference ■ g. In paragraph (c)(2) introductory text
Kirsten B. Wielobob,
‘‘147.132 or 147.133’’; and by removing the reference ‘‘147.132’’
Deputy Commissioner for Services and and adding in its place the reference
■ g. In paragraph (c)(2) introductory text
Enforcement.
by removing the reference ‘‘147.132’’ ‘‘147.132 or 147.133’’.
Approved: October 2, 2017.
and adding in its place the reference
David J. Kautter, DEPARTMENT OF HEALTH AND
‘‘147.132 or 147.133’’.
Assistant Secretary for Tax Policy. HUMAN SERVICES
DEPARTMENT OF LABOR For the reasons set forth in the
Signed this 4th day of October, 2017.
Timothy D. Hauser, Employee Benefits Security preamble, the Department of Health and
Deputy Assistant Secretary for Program Administration Human Services amends 45 CFR part
Operations, Employee Benefits Security For the reasons set forth in the 147 as follows:
Administration, Department of Labor. preamble, the Department of Labor PART 147—HEALTH INSURANCE
Dated: October 4, 2017. amends 29 CFR part 2590 as follows: REFORM REQUIREMENTS FOR THE
Seema Verma, GROUP AND INDIVIDUAL HEALTH
PART 2590—RULES AND
Administrator, Centers for Medicare & INSURANCE MARKETS
Medicaid Services. REGULATIONS FOR GROUP HEALTH
PLANS ■ 6. The authority citation for part 147
Approved: October 4, 2017.
continues to read as follows:
Donald Wright, ■ 3. The authority citation for part 2590
Acting Secretary, Department of Health and continues to read as follows: Authority: Secs 2701 through 2763, 2791,
Human Services. and 2792 of the Public Health Service Act (42
Authority: 29 U.S.C. 1027, 1059, 1135, U.S.C. 300gg through 300gg–63, 300gg–91,
DEPARTMENT OF THE TREASURY 1161–1168, 1169, 1181–1183, 1181 note, and 300gg–92), as amended.
1185, 1185a, 1185b, 1191, 1191a, 1191b, and
Internal Revenue Service 1191c; sec. 101(g), Pub. L. 104–191, 110 Stat. § 147.130 [Amended]
For the reasons set forth in this 1936; sec. 401(b), Pub. L. 105–200, 112 Stat.
645 (42 U.S.C. 651 note); sec. 512(d), Pub. L. ■ 7. Section 147.130, as amended
preamble, 26 CFR part 54 is amended as 110–343, 122 Stat. 3881; sec. 1001, 1201, and elsewhere in this issue of the Federal
follows: 1562(e), Pub. L. 111–148, 124 Stat. 119, as Register, is further amended in
amended by Pub. L. 111–152, 124 Stat. 1029; paragraphs (a)(1) introductory text and
PART 54—PENSION EXCISE TAXES Division M, Pub. L. 113–235, 128 Stat. 2130; (a)(1)(iv) by removing the reference
Secretary of Labor’s Order 1–2011, 77 FR ‘‘§§ 147.131 and 147.132’’ and adding in
■ 1. The authority citation for part 54 1088 (Jan. 9, 2012).
continues to read, in part, as follows: its place the reference ‘‘§§ 147.131,
§ 2590.715–2713 [Amended] 147.132, and 147.133’’.
Authority: 26 U.S.C. 7805. * * *
■ 4. Section 2590.715–2713, as § 147.131 [Amended]
§ 54.9815–2713T [Amended]
amended elsewhere in this issue of the ■ 8. Section 147.131, as revised
■ 2. Section 54.9815–2713T, as added Federal Register], is further amended in elsewhere in this issue of the Federal
elsewhere in this issue of the Federal paragraph (a)(1)(iv) by removing the Register, is further amended—
Register, is amended in paragraph reference ‘‘147.131 and 147.132’’ and ■ a. In paragraph (c)(1) by removing the
(a)(1)(iv) by removing the reference adding in its place the reference reference ‘‘(ii)’’ and adding in its place
‘‘147.131 and 147.132’’ and adding in its ‘‘147.131, 147.132, and 147.133’’. the reference ‘‘(ii), or 45 CFR
place the reference ‘‘147.131, 147.132, 147.133(a)(1)(i) or (ii)’’.
and 147.133’’. § 2590.715–2713A [Amended]
■ b. In paragraph (c)(2) by removing the
■ 5. Section 2590.715–2713A, as revised reference ‘‘§ 147.132(a)’’ and adding in
§ 54.9815–2713AT [Amended]
elsewhere in this issue of the Federal its place the reference ‘‘§ 147.132(a) or
■ 3. Section 54.9815–2713AT, as added Register], is further amended— 147.133’’; and
elsewhere in this issue of the Federal ■ a. In paragraph (a)(1) by removing ■ c. In paragraphs (d)(1)(ii) introductory
Register], is amended— ‘‘(ii)’’ and adding in its place ‘‘(ii), or 45 text, (d)(1)(ii)(B) and (d)(2) by removing
■ a. In paragraph (a)(1) by removing ‘‘or CFR 147.133(a)(1)(i) or (ii)’’; the reference ‘‘§ 147.132’’ and to adding
(ii)’’ and adding in its place ‘‘or (ii), or ■ b. In paragraph (a)(2) by removing the in its place the reference ‘‘§ 147.132 or
45 CFR 147.133(a)(1)(i) or (ii)’’; reference ‘‘147.132(a)’’ and adding in its 147.133’’.
■ b. In paragraph (a)(2) by removing the place the reference ‘‘147.132(a) or ■ 9. Add § 147.133 to read as follows:
reference ‘‘147.132(a)’’ and adding in its 147.133(a)’’;
place the reference ‘‘147.132(a) or ■ c. In paragraph (b)(1)(ii) introductory § 147.133 Moral exemptions in connection
147.133(a)’’; text by removing the reference with coverage of certain preventive health
■ c. In paragraph (b)(1)(ii) introductory ‘‘147.132’’ and adding in its place the services.
text by removing the reference reference ‘‘147.132 or 147.133’’; (a) Objecting entities. (1) Guidelines
‘‘147.132’’ and adding in its place the ■ d. In paragraph (b)(1)(ii)(B) by issued under § 147.130(a)(1)(iv) by the
reference ‘‘147.132 or 147.133’’; removing the reference ‘‘147.132’’ and Health Resources and Services
■ d. In paragraph (b)(1)(ii)(B) by adding in its place the reference Administration must not provide for or
removing the reference ‘‘147.132’’ and ‘‘147.132 or 147.133’’; support the requirement of coverage or
adding in its place the reference ■ e. In paragraph (c)(1)(ii) introductory payments for contraceptive services
‘‘147.132 or 147.133’’; text by removing the reference with respect to a group health plan
■ e. In paragraph (c)(1)(ii) introductory ‘‘147.132’’ and adding in its place the established or maintained by an
text by removing the reference reference ‘‘147.132 or 147.133’’; objecting organization, or health
‘‘147.132’’ and adding in its place the ■ f. In paragraph (c)(1)(ii)(B) by insurance coverage offered or arranged
reference ‘‘147.132 or 147.133’’; removing the reference ‘‘147.132’’ and by an objecting organization, and thus
47862 CaseFederal
4:18-cv-00825-O
82, No. 197 1-9 Filed
/ Friday, 10/06/18
October Page
13, 2017 25and
Regulations
the Health Resources and Service to the extent the issuer objects as construed to prevent a willing health
Administration will exempt from any specified in paragraph (a)(2) of this insurance issuer offering group or
guidelines’ requirements that relate to section. Where a health insurance issuer individual health insurance coverage,
the provision of contraceptive services: providing group health insurance and as applicable, a willing plan
(i) A group health plan and health coverage is exempt under paragraph sponsor of a group health plan, from
insurance coverage provided in (a)(1)(iii) of this section, the group offering a separate policy, certificate or
connection with a group health plan to health plan established or maintained contract of insurance or a separate group
the extent one of the following non- by the plan sponsor with which the health plan or benefit package option, to
governmental plan sponsors object as health insurance issuer contracts any individual who objects to coverage
specified in paragraph (a)(2) of this remains subject to any requirement to or payments for some or all
section: provide coverage for contraceptive contraceptive services based on
(A) A nonprofit organization; or services under Guidelines issued under sincerely held moral convictions.
(B) A for-profit entity that has no § 147.130(a)(1)(iv) unless it is also (c) Definition. For the purposes of this
publicly traded ownership interests (for exempt from that requirement. section, reference to ‘‘contraceptive’’
this purpose, a publicly traded
(2) The exemption of this paragraph services, benefits, or coverage includes
ownership interest is any class of
(a) will apply to the extent that an entity contraceptive or sterilization items,
common equity securities required to be
registered under section 12 of the described in paragraph (a)(1) of this procedures, or services, or related
Securities Exchange Act of 1934); section objects to its establishing, patient education or counseling, to the
(ii) An institution of higher education maintaining, providing, offering, or extent specified for purposes of
as defined in 20 U.S.C. 1002 in its arranging (as applicable) coverage or § 147.130(a)(1)(iv).
arrangement of student health insurance payments for some or all contraceptive (d) Severability. Any provision of this
coverage, to the extent that institution services, or for a plan, issuer, or third section held to be invalid or
objects as specified in paragraph (a)(2) party administrator that provides or unenforceable by its terms, or as applied
of this section. In the case of student arranges such coverage or payments, to any person or circumstance, shall be
health insurance coverage, this section based on its sincerely held moral construed so as to continue to give
is applicable in a manner comparable to convictions. maximum effect to the provision
its applicability to group health (b) Objecting individuals. Guidelines permitted by law, unless such holding
insurance coverage provided in issued under § 147.130(a)(1)(iv) by the shall be one of utter invalidity or
connection with a group health plan Health Resources and Services unenforceability, in which event the
established or maintained by a plan Administration must not provide for or provision shall be severable from this
sponsor that is an employer, and support the requirement of coverage or section and shall not affect the
references to ‘‘plan participants and payments for contraceptive services remainder thereof or the application of
beneficiaries’’ will be interpreted as with respect to individuals who object the provision to persons not similarly
references to student enrollees and their as specified in this paragraph (b), and situated or to dissimilar circumstances.
covered dependents; and nothing in § 147.130(a)(1)(iv), 26 CFR [FR Doc. 2017–21852 Filed 10–6–17; 11:15 am]
(iii) A health insurance issuer offering 54.9815–2713(a)(1)(iv), or 29 CFR BILLING CODE 4830–01–P; 4510–029–P; 4120–01–P;
group or individual insurance coverage 2590.715–2713(a)(1)(iv) may be 6325–64–P
JS 44 (Rev. 08/18) CIVIL COVER
Case 4:18-cv-00825-O Document SHEET
1-10 Filed 10/06/18 Page 1 of 2 PageID 161
The JS 44 civil cover sheet and the information contained herein neither replace nor supplement the filing and service of pleadings or other papers as required by law, except as
provided by local rules of court. This form, approved by the Judicial Conference of the United States in September 1974, is required for the use of the Clerk of Court for the
purpose of initiating the civil docket sheet. (SEE INSTRUCTIONS ON NEXT PAGE OF THIS FORM.)
I. (a) PLAINTIFFS DEFENDANTS

Richard W. DeOtte, Yvette DeOtte, John Kelley, Alison Kelley;
Alex M. Azar II; Steven T. Mnuchin; R. Alexander Acosta;
Hotze Health & Wellness Center
United States of America
(b) County of Residence of First Listed Plaintiff Harris County of Residence of First Listed Defendant
(EXCEPT IN U.S. PLAINTIFF CASES) (IN U.S. PLAINTIFF CASES ONLY)
NOTE: IN LAND CONDEMNATION CASES, USE THE LOCATION OF
THE TRACT OF LAND INVOLVED.
(c) Attorneys (Firm Name, Address, and Telephone Number) Attorneys (If Known)
Jonathan F. Mitchell, Mitchell Law PLLC
106 East Sixth Street, Suite 900, Austin, Texas 78701
(512) 686-3940
II. BASIS OF JURISDICTION (Place an “X” in One Box Only) III. CITIZENSHIP OF PRINCIPAL PARTIES (Place an “X” in One Box for Plaintiff
(For Diversity Cases Only) and One Box for Defendant)
’ 1 U.S. Government ’ 3 Federal Question PTF DEF PTF DEF
Plaintiff (U.S. Government Not a Party) Citizen of This State ’ 1 ’ 1 Incorporated or Principal Place ’ 4 ’ 4
of Business In This State
’ 2 U.S. Government ’ 4 Diversity Citizen of Another State ’ 2 ’ 2 Incorporated and Principal Place ’ 5 ’ 5
Defendant (Indicate Citizenship of Parties in Item III) of Business In Another State
Citizen or Subject of a ’ 3 ’ 3 Foreign Nation ’ 6 ’ 6

Foreign Country
IV. NATURE OF SUIT (Place an “X” in One Box Only) Click here for: Nature of Suit Code Descriptions.
CONTRACT TORTS FORFEITURE/PENALTY BANKRUPTCY OTHER STATUTES
’ 110 Insurance PERSONAL INJURY PERSONAL INJURY ’ 625 Drug Related Seizure ’ 422 Appeal 28 USC 158 ’ 375 False Claims Act
’ 120 Marine ’ 310 Airplane ’ 365 Personal Injury - of Property 21 USC 881 ’ 423 Withdrawal ’ 376 Qui Tam (31 USC
’ 130 Miller Act ’ 315 Airplane Product Product Liability ’ 690 Other 28 USC 157 3729(a))
’ 140 Negotiable Instrument Liability ’ 367 Health Care/ ’ 400 State Reapportionment
’ 150 Recovery of Overpayment ’ 320 Assault, Libel & Pharmaceutical PROPERTY RIGHTS ’ 410 Antitrust
& Enforcement of Judgment Slander Personal Injury ’ 820 Copyrights ’ 430 Banks and Banking
’ 151 Medicare Act ’ 330 Federal Employers’ Product Liability ’ 830 Patent ’ 450 Commerce
’ 152 Recovery of Defaulted Liability ’ 368 Asbestos Personal ’ 835 Patent - Abbreviated ’ 460 Deportation
Student Loans ’ 340 Marine Injury Product New Drug Application ’ 470 Racketeer Influenced and
(Excludes Veterans) ’ 345 Marine Product Liability ’ 840 Trademark Corrupt Organizations
’ 153 Recovery of Overpayment Liability PERSONAL PROPERTY LABOR SOCIAL SECURITY ’ 480 Consumer Credit
of Veteran’s Benefits ’ 350 Motor Vehicle ’ 370 Other Fraud ’ 710 Fair Labor Standards ’ 861 HIA (1395ff) ’ 485 Telephone Consumer
’ 160 Stockholders’ Suits ’ 355 Motor Vehicle ’ 371 Truth in Lending Act ’ 862 Black Lung (923) Protection Act
’ 190 Other Contract Product Liability ’ 380 Other Personal ’ 720 Labor/Management ’ 863 DIWC/DIWW (405(g)) ’ 490 Cable/Sat TV
’ 195 Contract Product Liability ’ 360 Other Personal Property Damage Relations ’ 864 SSID Title XVI ’ 850 Securities/Commodities/
’ 196 Franchise Injury ’ 385 Property Damage ’ 740 Railway Labor Act ’ 865 RSI (405(g)) Exchange
’ 362 Personal Injury - Product Liability ’ 751 Family and Medical ’ 890 Other Statutory Actions
Medical Malpractice Leave Act ’ 891 Agricultural Acts
REAL PROPERTY CIVIL RIGHTS PRISONER PETITIONS ’ 790 Other Labor Litigation FEDERAL TAX SUITS ’ 893 Environmental Matters
’ 210 Land Condemnation ’ 440 Other Civil Rights Habeas Corpus: ’ 791 Employee Retirement ’ 870 Taxes (U.S. Plaintiff ’ 895 Freedom of Information
’ 220 Foreclosure ’ 441 Voting ’ 463 Alien Detainee Income Security Act or Defendant) Act
’ 230 Rent Lease & Ejectment ’ 442 Employment ’ 510 Motions to Vacate ’ 871 IRS—Third Party ’ 896 Arbitration
’ 240 Torts to Land ’ 443 Housing/ Sentence 26 USC 7609 ’ 899 Administrative Procedure
’ 245 Tort Product Liability Accommodations ’ 530 General Act/Review or Appeal of
’ 290 All Other Real Property ’ 445 Amer. w/Disabilities - ’ 535 Death Penalty IMMIGRATION Agency Decision
Employment Other: ’ 462 Naturalization Application ’ 950 Constitutionality of
’ 446 Amer. w/Disabilities - ’ 540 Mandamus & Other ’ 465 Other Immigration State Statutes
Other ’ 550 Civil Rights Actions
’ 448 Education ’ 555 Prison Condition
’ 560 Civil Detainee -
Conditions of
Confinement
V. ORIGIN (Place an “X” in One Box Only)
’ 1 Original ’ 2 Removed from ’ 3 Remanded from ’ 4 Reinstated or ’ 5 Transferred from ’ 6 Multidistrict ’ 8 Multidistrict
Proceeding State Court Appellate Court Reopened Another District Litigation - Litigation -
(specify) Transfer Direct File
Cite the U.S. Civil Statute under which you are filing (Do not cite jurisdictional statutes unless diversity):
42 U.S.C. 2000bb-1(c); 5 U.S.C. § 702
VI. CAUSE OF ACTION Brief description of cause:
Federal constitutional and RFRA challenge to the Contraceptive Mandate
VII. REQUESTED IN ’ CHECK IF THIS IS A CLASS ACTION DEMAND $ CHECK YES only if demanded in complaint:
COMPLAINT: UNDER RULE 23, F.R.Cv.P. JURY DEMAND: ’ Yes ’ No
VIII. RELATED CASE(S)
(See instructions):
IF ANY JUDGE DOCKET NUMBER
DATE SIGNATURE OF ATTORNEY OF RECORD
October 6, 2018
FOR OFFICE USE ONLY
RECEIPT # AMOUNT APPLYING IFP JUDGE MAG. JUDGE

JS 44 Reverse (Rev. 08/18)
INSTRUCTIONS FOR ATTORNEYS COMPLETING CIVIL COVER SHEET FORM JS 44
Authority For Civil Cover Sheet
The JS 44 civil cover sheet and the information contained herein neither replaces nor supplements the filings and service of pleading or other papers as
required by law, except as provided by local rules of court. This form, approved by the Judicial Conference of the United States in September 1974, is
required for the use of the Clerk of Court for the purpose of initiating the civil docket sheet. Consequently, a civil cover sheet is submitted to the Clerk of
Court for each civil complaint filed. The attorney filing a case should complete the form as follows:
I.(a) Plaintiffs-Defendants. Enter names (last, first, middle initial) of plaintiff and defendant. If the plaintiff or defendant is a government agency, use
only the full name or standard abbreviations. If the plaintiff or defendant is an official within a government agency, identify first the agency and
then the official, giving both name and title.
(b) County of Residence. For each civil case filed, except U.S. plaintiff cases, enter the name of the county where the first listed plaintiff resides at the
time of filing. In U.S. plaintiff cases, enter the name of the county in which the first listed defendant resides at the time of filing. (NOTE: In land
condemnation cases, the county of residence of the "defendant" is the location of the tract of land involved.)
(c) Attorneys. Enter the firm name, address, telephone number, and attorney of record. If there are several attorneys, list them on an attachment, noting
in this section "(see attachment)".
II. Jurisdiction. The basis of jurisdiction is set forth under Rule 8(a), F.R.Cv.P., which requires that jurisdictions be shown in pleadings. Place an "X"
in one of the boxes. If there is more than one basis of jurisdiction, precedence is given in the order shown below.
United States plaintiff. (1) Jurisdiction based on 28 U.S.C. 1345 and 1348. Suits by agencies and officers of the United States are included here.
United States defendant. (2) When the plaintiff is suing the United States, its officers or agencies, place an "X" in this box.
Federal question. (3) This refers to suits under 28 U.S.C. 1331, where jurisdiction arises under the Constitution of the United States, an amendment
to the Constitution, an act of Congress or a treaty of the United States. In cases where the U.S. is a party, the U.S. plaintiff or defendant code takes
precedence, and box 1 or 2 should be marked.
Diversity of citizenship. (4) This refers to suits under 28 U.S.C. 1332, where parties are citizens of different states. When Box 4 is checked, the
citizenship of the different parties must be checked. (See Section III below; NOTE: federal question actions take precedence over diversity
cases.)
III. Residence (citizenship) of Principal Parties. This section of the JS 44 is to be completed if diversity of citizenship was indicated above. Mark this
section for each principal party.
IV. Nature of Suit. Place an "X" in the appropriate box. If there are multiple nature of suit codes associated with the case, pick the nature of suit code
that is most applicable. Click here for: Nature of Suit Code Descriptions.
V. Origin. Place an "X" in one of the seven boxes.

Original Proceedings. (1) Cases which originate in the United States district courts.
Removed from State Court. (2) Proceedings initiated in state courts may be removed to the district courts under Title 28 U.S.C., Section 1441.
When the petition for removal is granted, check this box.
Remanded from Appellate Court. (3) Check this box for cases remanded to the district court for further action. Use the date of remand as the filing
date.
Reinstated or Reopened. (4) Check this box for cases reinstated or reopened in the district court. Use the reopening date as the filing date.
Transferred from Another District. (5) For cases transferred under Title 28 U.S.C. Section 1404(a). Do not use this for within district transfers or
multidistrict litigation transfers.
Multidistrict Litigation – Transfer. (6) Check this box when a multidistrict case is transferred into the district under authority of Title 28 U.S.C.
Section 1407.
Multidistrict Litigation – Direct File. (8) Check this box when a multidistrict case is filed in the same district as the Master MDL docket.
PLEASE NOTE THAT THERE IS NOT AN ORIGIN CODE 7. Origin Code 7 was used for historical records and is no longer relevant due to
changes in statue.
VI. Cause of Action. Report the civil statute directly related to the cause of action and give a brief description of the cause. Do not cite jurisdictional
statutes unless diversity. Example: U.S. Civil Statute: 47 USC 553 Brief Description: Unauthorized reception of cable service
VII. Requested in Complaint. Class Action. Place an "X" in this box if you are filing a class action under Rule 23, F.R.Cv.P.
Demand. In this space enter the actual dollar amount being demanded or indicate other demand, such as a preliminary injunction.
Jury Demand. Check the appropriate box to indicate whether or not a jury is being demanded.
VIII. Related Cases. This section of the JS 44 is used to reference related pending cases, if any. If there are related pending cases, insert the docket
numbers and the corresponding judge names for such cases.
Date and Attorney Signature. Date and sign the civil cover sheet.

Richard W. Deotte, Yvette Deotte, John Kelley, Alison Kelley, On Behalf

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Case 4:18-cv-00825-O Document 1 Filed 10/06/18 Page 1 of 10 PageID 1

UNITED STATES DISTRICT COURT

Richard W. DeOtte, Yvette DeOtte,

Alex M. Azar II, in his official capacity

PLAINTIFFS’ CLASS-ACTION COMPLAINT

JURISDICTION AND VENUE

plaintiffs’ class-action complaint Page 1 of 10

5. Plaintiff John Kelley resides in Tarrant County, Texas.

THE CONTRACEPTIVE MANDATE

plaintiffs’ class-action complaint Page 2 of 10

§ 147.130(a)(1)(iv), 29 C.F.R. § 2590.715–2713(a)(1)(iv), and 26 C.F.R.

plaintiffs’ class-action complaint Page 3 of 10

26 C.F.R. § 54.9815–2713A(b)(ii)). Under the previous version of Contraceptive

plaintiffs’ class-action complaint Page 4 of 10

Human Services to amend the Contraceptive Mandate to address conscience-based

plaintiffs’ class-action complaint Page 5 of 10

STATEMENT OF THE CLAIM — INDIVIDUAL PLAINTIFFS

plaintiffs’ class-action complaint Page 6 of 10

32. The Contraceptive Mandate violates the Religious Freedom Restoration

STATEMENT OF THE CLAIM —

plaintiffs’ class-action complaint Page 7 of 10

43. There is no compelling governmental interest in forcing the Hotze Health

plaintiffs’ class-action complaint Page 8 of 10

DEMAND FOR RELIEF

plaintiffs’ class-action complaint Page 9 of 10

/s/ Jonathan F. Mitchell

plaintiffs’ class-action complaint Page 10 of 10

PRIOR PROVISIONS explanation that accurately describes the bene-

45 C.F.R. § 147.130 (a)

(c) Eligible organizations for optional accommodation. An eligible organization is an

(1) The organization is an objecting entity described in § 147.132(a)(1)(i) or (ii), or 45

(d) Optional accommodation — insured group health plans —

(a) Objecting entities.

(A) A church, an integrated auxiliary of a church, a convention or association of churches,

(B) A nonprofit organization.

(C) A closely held for-profit entity.

(D) A for-profit entity that is not closely held.

(E) Any other non-governmental employer.

(ii) An institution of higher education as defined in 20 U.S.C. 1002 in its arrangement of

(b) Objecting individuals. Guidelines issued under § 147.130(a)(1)(iv) by the Health

(a) Objecting entities.

(A) A nonprofit organization; or

(ii) An institution of higher education as defined in 20 U.S.C. 1002 in its arrangement of

(b) Objecting individuals. Guidelines issued under § 147.130(a)(1)(iv) by the Health

(i)–(iii) [Reserved]. For further guidance, see § 54.9815–2713(a)(1)(i) through (iii).

Department of Health and Human Services

2 Interim final regulations published by the

certifications with the Departments and

2719 (appeals process), and 2719A

CFR 2590.715–2713(a)(3) and (4); 45 CFR cbofiles/ftpdocs/104xx/doc10492/08-07- Group_Medical_Business_Practice_Note_Jan_

38 See 45 CFR Part 158 for standards related to the

must also take on the statutory

respect to a third party administrator

amount of such payments that were different states. In addition, commenters

commenters recommended criteria for treated as employed by a single employer.

to exercise such options. With respect to employees

system of health coverage in advancing

Safe Harbor for Certain Employers, Group Health

benefits) in accordance with (a) * * * coverage if all of the requirements of

* * * * * maintained by an eligible organization (d) Notice of availability of separate

Signed this 27th day of June 2013.

‘‘eligible organization,’’ which would 2728. to a man’s reproductive capacity, such as

FAQs/Downloads/aca_implementation_faqs26.pdf. 19 29 CFR 2560.503–1(h)(2)(iii). 147.136(b)(2)(i).