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1 ‘‘(I) has been reasonably de-
2 signed, implemented, and enforced so
3 that it generally will be effective in
4 preventing and detecting criminal,
5 civil, and administrative violations
6 under this Act and in promoting qual-
7 ity of care; and
8 ‘‘(II) includes at least the re-
9 quired components specified in clause
10 (iv).
11 ‘‘(iv) REQUIRED COMPONENTS OF

12 PROGRAM.—The required components of a

13 compliance and ethics program of an orga-
14 nization are the following:
15 ‘‘(I) The organization must have
16 established compliance standards and
17 procedures to be followed by its em-
18 ployees, contractors, and other agents
19 that are reasonably capable of reduc-
20 ing the prospect of criminal, civil, and
21 administrative violations under this
22 Act.
23 ‘‘(II) Specific individuals within
24 high-level personnel of the organiza-
25 tion must have been assigned overall

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538
1 responsibility to oversee compliance
2 with such standards and procedures
3 and have sufficient resources and au-
4 thority to assure such compliance.
5 ‘‘(III) The organization must
6 have used due care not to delegate
7 substantial discretionary authority to
8 individuals whom the organization
9 knew, or should have known through
10 the exercise of due diligence, had a
11 propensity to engage in criminal, civil,
12 and administrative violations under
13 this Act.
14 ‘‘(IV) The organization must
15 have taken steps to communicate ef-
16 fectively its standards and procedures
17 to all employees and other agents,
18 such as by requiring participation in
19 training programs or by disseminating
20 publications that explain in a practical
21 manner what is required.
22 ‘‘(V) The organization must have
23 taken reasonable steps to achieve com-
24 pliance with its standards, such as by
25 utilizing monitoring and auditing sys-

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539
1 tems reasonably designed to detect
2 criminal, civil, and administrative vio-
3 lations under this Act by its employ-
4 ees and other agents and by having in
5 place and publicizing a reporting sys-
6 tem whereby employees and other
7 agents could report violations by oth-
8 ers within the organization without
9 fear of retribution.
10 ‘‘(VI) The standards must have
11 been consistently enforced through ap-
12 propriate disciplinary mechanisms, in-
13 cluding, as appropriate, discipline of
14 individuals responsible for the failure
15 to detect an offense.
16 ‘‘(VII) After an offense has been
17 detected, the organization must have
18 taken all reasonable steps to respond
19 appropriately to the offense and to
20 prevent further similar offenses, in-
21 cluding repayment of any funds to
22 which it was not entitled and any nec-
23 essary modification to its program to
24 prevent and detect criminal, civil, and

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540
1 administrative violations under this
2 Act.
3 ‘‘(VIII) The organization must
4 periodically undertake reassessment of
5 its compliance program to identify
6 changes necessary to reflect changes
7 within the organization and its facili-
8 ties.
9 ‘‘(v) COORDINATION.—The provisions
10 of this subparagraph shall apply with re-
11 spect to a skilled nursing facility in lieu of
12 section 1874(d).’’.
13 (2) NURSING FACILITIES.—Section 1919(d)(1)
14 of the Social Security Act (42 U.S.C. 1396r(d)(1)),
15 as amended by section 1411(c)(2), is amended by
16 adding at the end the following new subparagraph:
17 ‘‘(C) COMPLIANCE AND ETHICS PRO-

18 GRAM.—

19 ‘‘(i) REQUIREMENT.—On or after the

20 date that is 36 months after the date of
21 the enactment of this subparagraph, a
22 nursing facility shall, with respect to the
23 entity that operates the facility (in this
24 subparagraph referred to as the ‘operating
25 organization’ or ‘organization’), have in op-

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1 eration a compliance and ethics program
2 that is effective in preventing and detect-
3 ing criminal, civil, and administrative viola-
4 tions under this Act and in promoting
5 quality of care consistent with regulations
6 developed under clause (ii).
7 ‘‘(ii) DEVELOPMENT OF REGULA-

8 TIONS.—

9 ‘‘(I) IN GENERAL.—Not later

10 than the date that is 2 years after
11 such date of the enactment, the Sec-
12 retary, in consultation with the In-
13 spector General of the Department of
14 Health and Human Services, shall de-
15 velop regulations for an effective com-
16 pliance and ethics program for oper-
17 ating organizations, which may in-
18 clude a model compliance program.
19 ‘‘(II) DESIGN OF REGULA-

20 TIONS.—Such regulations with respect

21 to specific elements or formality of a
22 program may vary with the size of the
23 organization, such that larger organi-
24 zations should have a more formal
25 and rigorous program and include es-

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542
1 tablished written policies defining the
2 standards and procedures to be fol-
3 lowed by its employees. Such require-
4 ments may specifically apply to the
5 corporate level management of multi-
6 unit nursing home chains.
7 ‘‘(III) EVALUATION.—Not later
8 than 3 years after the date of promul-
9 gation of regulations under this clause
10 the Secretary shall complete an eval-
11 uation of the compliance and ethics
12 programs required to be established
13 under this subparagraph. Such eval-
14 uation shall determine if such pro-
15 grams led to changes in deficiency ci-
16 tations, changes in quality perform-
17 ance, or changes in other metrics of
18 resident quality of care. The Secretary
19 shall submit to Congress a report on
20 such evaluation and shall include in
21 such report such recommendations re-
22 garding changes in the requirements
23 for such programs as the Secretary
24 determines appropriate.

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1 ‘‘(iii) REQUIREMENTS FOR COMPLI-

2 ANCE AND ETHICS PROGRAMS.—In this

3 subparagraph, the term ‘compliance and
4 ethics program’ means, with respect to a
5 nursing facility, a program of the oper-
6 ating organization that—
7 ‘‘(I) has been reasonably de-
8 signed, implemented, and enforced so
9 that it generally will be effective in
10 preventing and detecting criminal,
11 civil, and administrative violations
12 under this Act and in promoting qual-
13 ity of care; and
14 ‘‘(II) includes at least the re-
15 quired components specified in clause
16 (iv).
17 ‘‘(iv) REQUIRED COMPONENTS OF

18 PROGRAM.—The required components of a

19 compliance and ethics program of an orga-
20 nization are the following:
21 ‘‘(I) The organization must have
22 established compliance standards and
23 procedures to be followed by its em-
24 ployees and other agents that are rea-
25 sonably capable of reducing the pros-

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544
1 pect of criminal, civil, and administra-
2 tive violations under this Act.
3 ‘‘(II) Specific individuals within
4 high-level personnel of the organiza-
5 tion must have been assigned overall
6 responsibility to oversee compliance
7 with such standards and procedures
8 and has sufficient resources and au-
9 thority to assure such compliance.
10 ‘‘(III) The organization must
11 have used due care not to delegate
12 substantial discretionary authority to
13 individuals whom the organization
14 knew, or should have known through
15 the exercise of due diligence, had a
16 propensity to engage in criminal, civil,
17 and administrative violations under
18 this Act.
19 ‘‘(IV) The organization must
20 have taken steps to communicate ef-
21 fectively its standards and procedures
22 to all employees and other agents,
23 such as by requiring participation in
24 training programs or by disseminating

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