II

103D CONGRESS

2D SESSION S. 2381

To require the Secretary of Health and Human Services to provide health

care fraud and abuse guidance, and for other purposes.

IN THE SENATE OF THE UNITED STATES

AUGUST 11, 1994

Mr. COHEN introduced the following bill; which was read the first time

A BILL

To require the Secretary of Health and Human Services

to provide health care fraud and abuse guidance, and

for other purposes.

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled,

3 SECTION 1. HEALTH CARE FRAUD AND ABUSE GUIDANCE.

4 (a) SOLICITATION AND PUBLICATION OF MODIFICA5 TIONS TO EXISTING SAFE HARBORS AND NEW SAFE

6 HARBORS.—

7 (1) IN GENERAL.—

8 (A) SOLICITATION OF PROPOSALS FOR

9 SAFE HARBORS.—Not later than January 1,

10 1995, and not less than annually thereafter, the
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1 Secretary of Health and Human Services (here2 after in this section referred to as the ‘‘Sec3 retary’’) shall publish a notice in the Federal

4 Register soliciting proposals, which will be ac5 cepted during a 60-day period, for—

6 (i) modifications to existing safe har7 bors issued pursuant to section 14(a) of

8 the Medicare and Medicaid Patient and

9 Program Protection Act of 1987 (42

10 U.S.C. 1320a–7b note);

11 (ii) additional safe harbors specifying

12 payment practices that shall not be treated

13 as a criminal offense under section

14 1128B(b) of the Social Security Act the

15 (42 U.S.C. 1320a–7b(b)) and shall not

16 serve as the basis for an exclusion under

17 section 1128(b)(7) of such Act (42 U.S.C.

18 1320a–7(b)(7));

19 (iii) interpretive rulings to be issued

20 pursuant to subsection (b); and

21 (iv) special fraud alerts to be issued

22 pursuant to subsection (c).

23 (B) PUBLICATION OF PROPOSED MODI24 FICATIONS AND PROPOSED ADDITIONAL STATE

25 HARBORS.—After considering the proposals de-
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1 scribed in clauses (i) and (ii) of subparagraph

2 (A), the Secretary, in consultation with the At3 torney General, shall publish in the Federal

4 Register proposed modifications to existing safe

5 harbors and proposed additional safe harbors, if

6 appropriate, with a 60-day comment period.

7 After considering any public comments received

8 during this period, the Secretary shall issue

9 final rules modifying the existing safe harbors

10 and establishing new safe harbors, as appro11 priate.

12 (C) REPORT.—The Inspector General of

13 the Department of Health and Human Services

14 (hereafter in this section referred to as the ‘‘In15 spector General’’) shall, in an annual report to

16 Congress or as part of the year-end semiannual

17 report required by section 5 of the Inspector

18 General Act of 1978 (5 U.S.C. App.), describe

19 the proposals received under clauses (i) and (ii)

20 of subparagraph (A) and explain which propos21 als were included in the publication described in

22 subparagraph (B), which proposals were not in23 cluded in that publication, and the reasons for

24 the rejection of the proposals that were not in25 cluded.
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1 (2) CRITERIA FOR MODIFYING AND ESTABLISH2 ING SAFE HARBORS.—In modifying and establishing

3 safe harbors under paragraph (1)(B), the Secretary

4 may consider the extent to which providing a safe

5 harbor for the specified payment practice may result

6 in any of the following:

7 (A) An increase or decrease in access to

8 health care services.

9 (B) An increase or decrease in the quality

10 of health care services.

11 (C) An increase or decrease in patient free12 dom of choice among health care providers.

13 (D) An increase or decrease in competition

14 among health care providers.

15 (E) An increase or decrease in the ability

16 of health care facilities to provide services in

17 medically underserved areas or to medically un18 derserved populations.

19 (F) An increase or decrease in the cost to

20 Government health care programs.

21 (G) An increase or decrease in the poten22 tial overutilization of health care services.

23 (H) The existence or nonexistence of any

24 potential financial benefit to a health care pro-
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1 fessional or provider which may vary based on

2 their decisions of—

3 (i) whether to order a health care

4 item or service; or

5 (ii) whether to arrange for a referral

6 of health care items or services to a par7 ticular practitioner or provider.

8 (I) Any other factors the Secretary deems

9 appropriate in the interest of preventing fraud

10 and abuse in Government health care programs.

11 (b) INTERPRETIVE RULINGS.—

12 (1) IN GENERAL.—

13 (A) REQUEST FOR INTERPRETIVE RUL14 ING.—Any person may present, at any time, a

15 request to the Inspector General for a state16 ment of the Inspector General’s current inter17 pretation of the meaning of a specific aspect of

18 the application of sections 1128A and 1128B of

19 the Social Security Act (hereafter in this sec20 tion referred to as an ‘‘interpretive ruling’’).

21 (B) ISSUANCE AND EFFECT OF INTERPRE22 TIVE RULING.—

23 (i) IN GENERAL.—If appropriate, the

24 Inspector General shall in consultation

25 with the Attorney General, issue an inter-
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1 pretive ruling in response to a request de2 scribed in subparagraph (A). Interpretive

3 rulings shall not have the force of law and

4 shall be treated as an interpretive rule

5 within the meaning of section 553(b) of

6 title 5, United States Code. All interpretive

7 rulings issued pursuant to this provision

8 shall be published in the Federal Register

9 or otherwise made available for public in10 spection.

11 (ii) REASONS FOR DENIAL.—If the In12 spector General does not issue an interpre13 tive ruling in response to a request de14 scribed in subparagraph (A), the Inspector

15 General shall notify the requesting party of

16 such decision and shall identify the reasons

17 for such decision.

18 (2) CRITERIA FOR INTERPRETIVE RULINGS.—

19 (A) IN GENERAL.—In determining whether

20 to issue an interpretive ruling under paragraph

21 (1)(B), the Inspector General may consider—

22 (i) whether and to what extent the re23 quest identifies an ambiguity within the

24 language of the statute, the existing safe
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1 harbors, or previous interpretive rulings;

2 and

3 (ii) whether the subject of the re4 quested interpretive ruling can be ade5 quately addressed by interpretation of the

6 language of the statute, the existing safe

7 harbor rules, or previous interpretive rul8 ings, or whether the request would require

9 a substantive ruling not authorized under

10 this subsection.

11 (B) NO RULINGS ON FACTUAL ISSUES.—

12 The Inspector General shall not give an inter13 pretive ruling on any factual issue, including

14 the intent of the parties or the fair market

15 value of particular leased space or equipment.

16 (c) SPECIAL FRAUD ALERTS.—

17 (1) IN GENERAL.—

18 (A) REQUEST FOR SPECIAL FRAUD

19 ALERTS.—Any person may present, at any

20 time, a request to the Inspector General for a

21 notice which informs the public of practices

22 which the Inspector General considers to be

23 suspect or of particular concern under section

24 1128B(b) of the Social Security Act (42 U.S.C.
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1 1320a–7b(b)) (hereafter in this subsection re2 ferred to as a ‘‘special fraud alert’’).

3 (B) ISSUANCE AND PUBLICATION OF SPE4 CIAL FRAUD ALERTS.—Upon receipt of a re5 quest described in subparagraph (A), the In6 spector General shall investigate the subject

7 matter of the request to determine whether a

8 special fraud alert should be issued. If appro9 priate, the Inspector General shall in consulta10 tion with the Attorney General, issue a special

11 fraud alert in response to the request. All spe12 cial fraud alerts issued pursuant to this sub13 paragraph shall be published in the Federal

14 Register.

15 (2) CRITERIA FOR SPECIAL FRAUD ALERTS.—

16 In determining whether to issue a special fraud alert

17 upon a request described in paragraph (1), the In18 spector General may consider—

19 (A) whether and to what extent the prac20 tices that would be identified in the special

21 fraud alert may result in any of the con22 sequences described in subsection (a)(2); and
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1 (B) the volume and frequency of the con2 duct that would be identified in the special

3 fraud alert.

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