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1 ‘‘(II) under a State Pharma-
2 ceutical Assistance Program;
3 ‘‘(III) by the Indian Health Serv-
4 ice, an Indian tribe or tribal organiza-
5 tion, or an urban Indian organization
6 (as defined in section 4 of the Indian
7 Health Care Improvement Act); or
8 ‘‘(IV) under an AIDS Drug As-
9 sistance Program under part B of
10 title XXVI of the Public Health Serv-
11 ice Act.’’.
12 (b) EFFECTIVE DATE.—The amendments made by
13 subsection (a) shall apply to costs incurred on or after
14 January 1, 2011.
15 SEC. 1185. PERMITTING MID-YEAR CHANGES IN ENROLL-

16 MENT FOR FORMULARY CHANGES THAT AD-

17 VERSELY IMPACT AN ENROLLEE.

18 (a) IN GENERAL.—Section 1860D–1(b)(3) of the So-

19 cial Security Act (42 U.S.C. 1395w–101(b)(3)) is amend-
20 ed by adding at the end the following new subparagraph:
21 ‘‘(F) CHANGE IN FORMULARY RESULTING

22 IN INCREASE IN COST-SHARING.—

23 ‘‘(i) IN GENERAL.—Except as pro-

24 vided in clause (ii), in the case of an indi-
25 vidual enrolled in a prescription drug plan

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378
1 (or MA–PD plan) who has been prescribed
2 and is using a covered part D drug while
3 so enrolled, if the formulary of the plan is
4 materially changed (other than at the end
5 of a contract year) so to reduce the cov-
6 erage (or increase the cost-sharing) of the
7 drug under the plan.
8 ‘‘(ii) EXCEPTION.—Clause (i) shall
9 not apply in the case that a drug is re-
10 moved from the formulary of a plan be-
11 cause of a recall or withdrawal of the drug
12 issued by the Food and Drug Administra-
13 tion, because the drug is replaced with a
14 generic drug that is a therapeutic equiva-
15 lent, or because of utilization management
16 applied to—
17 ‘‘(I) a drug whose labeling in-
18 cludes a boxed warning required by
19 the Food and Drug Administration
20 under section 210.57(c)(1) of title 21,
21 Code of Federal Regulations (or a
22 successor regulation); or
23 ‘‘(II) a drug required under sub-
24 section (c)(2) of section 505–1 of the
25 Federal Food, Drug, and Cosmetic

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379
1 Act to have a Risk Evaluation and
2 Management Strategy that includes
3 elements under subsection (f) of such
4 section.’’.
5 (b) EFFECTIVE DATE.—The amendment made by
6 subsection (a) shall apply to contract years beginning on
7 or after January 1, 2011.
8 Subtitle F—Medicare Rural Access
9 Protections
10 SEC. 1191. TELEHEALTH EXPANSION AND ENHANCEMENTS.

11 .

12 (a) ADDITIONAL TELEHEALTH SITE.——

13 (1) IN GENERAL.—Paragraph (4)(C)(ii) of sec-
14 tion 1834(m) of the Social Security Act (42 U.S.C.
15 1395m(m)) is amended by adding at the end the fol-
16 lowing new subclause:
17 ‘‘(IX) A renal dialysis facility.’’
18 (2) EFFECTIVE DATE.—The amendment made
19 by paragraph (1) shall apply to services furnished on
20 or after January 1, 2011.
21 (b) TELEHEALTH ADVISORY COMMITTEE.—
22 (1) ESTABLISHMENT.—Section 1868 of the So-
23 cial Security Act (42 U.S.C. 1395ee) is amended—

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380
1 (A) in the heading, by adding at the end
2 the following: ‘‘TELEHEALTH ADVISORY COM-

3 MITTEE’’; and
4 (B) by adding at the end the following new
5 subsection:
6 ‘‘(c) TELEHEALTH ADVISORY COMMITTEE.—
7 ‘‘(1) IN GENERAL.—The Secretary shall appoint
8 a Telehealth Advisory Committee (in this subsection
9 referred to as the ‘Advisory Committee’) to make
10 recommendations to the Secretary on policies of the
11 Centers for Medicare & Medicaid Services regarding
12 telehealth services as established under section
13 1834(m), including the appropriate addition or dele-
14 tion of services (and HCPCS codes) to those speci-
15 fied in paragraphs (4)(F)(i) and (4)(F)(ii) of such
16 section and for authorized payment under paragraph
17 (1) of such section.
18 ‘‘(2) MEMBERSHIP; TERMS.—

19 ‘‘(A) MEMBERSHIP.—
20 ‘‘(i) IN GENERAL.—The Advisory
21 Committee shall be composed of 9 mem-
22 bers, to be appointed by the Secretary, of
23 whom—
24 ‘‘(I) 5 shall be practicing physi-
25 cians;

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381
1 ‘‘(II) 2 shall be practicing non-
2 physician health care practitioners;
3 and
4 ‘‘(III) 2 shall be administrators
5 of telehealth programs.
6 ‘‘(ii) REQUIREMENTS FOR APPOINT-

7 ING MEMBERS.—In appointing members of

8 the Advisory Committee, the Secretary
9 shall—
10 ‘‘(I) ensure that each member
11 has prior experience with the practice
12 of telemedicine or telehealth;
13 ‘‘(II) give preference to individ-
14 uals who are currently providing tele-
15 medicine or telehealth services or who
16 are involved in telemedicine or tele-
17 health programs;
18 ‘‘(III) ensure that the member-
19 ship of the Advisory Committee rep-
20 resents a balance of specialties and
21 geographic regions; and
22 ‘‘(IV) take into account the rec-
23 ommendations of stakeholders.

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1 ‘‘(B) TERMS.—The members of the Advi-
2 sory Committee shall serve for such term as the
3 Secretary may specify.
4 ‘‘(C) CONFLICTS OF INTEREST.—An advi-
5 sory committee member may not participate
6 with respect to a particular matter considered
7 in an advisory committee meeting if such mem-
8 ber (or an immediate family member of such
9 member) has a financial interest that could be
10 affected by the advice given to the Secretary
11 with respect to such matter.
12 ‘‘(3) MEETINGS.—The Advisory Committee
13 shall meet twice each calendar year and at such
14 other times as the Secretary may provide.
15 ‘‘(4) PERMANENT COMMITTEE.—Section 14 of
16 the Federal Advisory Committee Act (5 U.S.C.
17 App.) shall not apply to the Advisory Committee.’’
18 (2) FOLLOWING RECOMMENDATIONS.—Section

19 1834(m)(4)(F) of such Act (42 U.S.C.

20 1395m(m)(4)(F)) is amended by adding at the end
21 the following new clause:
22 ‘‘(iii) RECOMMENDATIONS OF THE

23 TELEHEALTH ADVISORY COMMITTEE.—In

24 making determinations under clauses (i)

25 and (ii), the Secretary shall take into ac-

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383
1 count the recommendations of the Tele-
2 health Advisory Committee (established
3 under section 1868(c)) when adding or de-
4 leting services (and HCPCS codes) and in
5 establishing policies of the Centers for
6 Medicare & Medicaid Services regarding
7 the delivery of telehealth services. If the
8 Secretary does not implement such a rec-
9 ommendation, the Secretary shall publish
10 in the Federal Register a statement re-
11 garding the reason such recommendation
12 was not implemented.’’
13 (3) WAIVER OF ADMINISTRATIVE LIMITA-

14 TION.—The Secretary of Health and Human Serv-

15 ices shall establish the Telehealth Advisory Com-
16 mittee under the amendment made by paragraph (1)
17 notwithstanding any limitation that may apply to
18 the number of advisory committees that may be es-
19 tablished (within the Department of Health and
20 Human Services or otherwise).
21 SEC. 1192. EXTENSION OF OUTPATIENT HOLD HARMLESS

22 PROVISION.

23 Section 1833(t)(7)(D)(i) of the Social Security Act

24 (42 U.S.C. 1395l(t)(7)(D)(i)) is amended—
25 (1) in subclause (II)—

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384
1 (A) in the first sentence, by striking
2 ‘‘‘2010’’and inserting ‘‘2012’’; and
3 (B) in the second sentence, by striking ‘‘or
4 2009’’ and inserting ‘‘, 2009, 2010, or 2011’’;
5 and
6 (2) in subclause (III), by striking ‘‘January 1,
7 2010’’ and inserting ‘‘January 1, 2012’’.
8 SEC. 1193. EXTENSION OF SECTION 508 HOSPITAL RECLAS-

9 SIFICATIONS.

10 Subsection (a) of section 106 of division B of the Tax

11 Relief and Health Care Act of 2006 (42 U.S.C. 1395
12 note), as amended by section 117 of the Medicare, Med-
13 icaid, and SCHIP Extension Act of 2007 (Public Law
14 110–173) and section 124 of the Medicare Improvements
15 for Patients and Providers Act of 2008 (Public Law 110–
16 275), is amended by striking ‘‘September 30, 2009’’ and
17 inserting ‘‘September 30, 2011’’.
18 SEC. 1194. EXTENSION OF GEOGRAPHIC FLOOR FOR WORK.

19 Section 1848(e)(1)(E) of the Social Security Act (42

20 U.S.C. 1395w–4(e)(1)(E)) is amended by striking ‘‘before
21 January 1, 2010’’ and inserting ‘‘before January 1,
22 2012’’.

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