I

103D CONGRESS

2D SESSION H. R. 4028

To empower the Department of Health and Human Services to issue advisory

opinions on whether certain arrangements for the delivery of health

care services and supplies are in compliance with statutes and rules

establishing acceptable health care billing and payment practices and

with statutes and rules defining health care fraud and abuse.

IN THE HOUSE OF REPRESENTATIVES

MARCH 11, 1994

Mr. HOAGLAND (for himself, Mr. PORTER, Mr. BREWSTER, and Mr. THOMAS

of California) introduced the following bill; which was referred jointly to

the Committees on Ways and Means and Energy and Commerce

A BILL

To empower the Department of Health and Human Services

to issue advisory opinions on whether certain arrangements for the delivery of health care services and supplies are in compliance with statutes and rules establishing acceptable health care billing and payment practices

and with statutes and rules defining health care fraud

and abuse.

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled,
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1 SECTION 1. SHORT TITLE; REFERENCES IN ACT.

2 (a) SHORT TITLE.—This Act may be cited as the

3 ‘‘Health Care Fraud and Abuse Advisory Opinion Act of

4 1994’’.

5 (b) REFERENCES IN ACT.—Except as otherwise spe6 cifically provided, whenever an amendment herein is ex7 pressed in terms of an amendment to, or repeal of a sec8 tion or other provision, the reference shall be considered

9 to be made to that section or other provision of the Social

10 Security Act.

11 SEC. 2. AUTHORIZING THE SECRETARY OF HEALTH AND

12 HUMAN SERVICES TO ISSUE ADVISORY OPIN13 IONS UNDER TITLE XI.

14 (a) AUTHORIZATION.—Title XI, section 1128 (42

15 U.S.C. 1320a–7) is amended by the addition of the follow16 ing new paragraph:

17 ‘‘(j) The Secretary shall issue advisory opinions as

18 provided in this section.

19 ‘‘(1) MATTERS SUBJECT TO ADVISORY OPIN20 IONS.—The Secretary shall issue advisory opinions

21 as to the following matters:

22 ‘‘(i) What constitutes prohibited remunera23 tion within the meaning of section 1320a–7b(b)

24 of title 42, United States Code.

25 ‘‘(ii) Whether an arrangement or proposed

26 arrangement satisfies the criteria set forth in
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1 section 1320a–7b(b)(3) of title 42, United

2 States Code as amended for activities which do

3 not result in prohibited remuneration.

4 ‘‘(iii) Whether an arrangement or proposed

5 arrangement satisfies the criteria which the

6 Secretary has established, or shall establish by

7 regulation for activities which do not result in

8 prohibited remuneration.

9 ‘‘(iv) What constitutes an inducement to

10 reduce or limit services to individuals entitled to

11 benefits under part A or part B of title XVIII

12 or title XIX within the meaning of section

13 1320a–7a(b) of title 42, United States Code.

14 ‘‘(v) Whether an arrangement, activity or

15 proposed arrangement or proposed activity vio16 lates any other provision of the Act.

17 ‘‘(2) MATTERS NOT SUBJECT TO ADVISORY

18 OPINIONS.—Such advisory opinions shall not address

19 the following matters:

20 ‘‘(i) Whether the fair market value shall

21 be, or was paid or received for any goods, serv22 ices or property.

23 ‘‘(ii) Whether an individual is a bona fide

24 employee within the requirements of section

25 3121(d)(2) of title 26, United States Code.
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1 ‘‘(3) EFFECT OF ADVISORY OPINIONS.—

2 ‘‘(i) Each advisory opinion issued by the

3 Secretary shall be binding as to the Secretary

4 and the party or parties requesting the opinion.

5 ‘‘(ii) The failure of a party to seek an advi6 sory opinion may not be introduced into evi7 dence to prove that the party intended to vio8 late the provisions of sections 1320a–7, 1320a–

9 7(a), or 1320a–7(b) of title 42, United States

10 Code.

11 ‘‘(4) REGULATIONS.—The Secretary within one

12 hundred and eighty days of the date of enactment,

13 shall issue regulations establishing a system for the

14 issuance of advisory opinions. Such regulations shall

15 provide for—

16 ‘‘(i) the procedure to be followed by a

17 party applying for an advisory opinion;

18 ‘‘(ii) the procedure to be followed by the

19 Secretary in responding to a request for an ad20 visory opinion;

21 ‘‘(iii) the interval in which the Secretary

22 shall respond;

23 ‘‘(iv) the reasonable fee to be charged to

24 the party requesting an advisory opinion; and
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1 ‘‘(v) the manner in which advisory opinions

2 will be made available to the public.

3 ‘‘(5) INTERVAL FOR ISSUANCE OF ADVISORY

4 OPINIONS.—Under no circumstances shall the inter5 val in which the Secretary shall respond to a party

6 requesting an advisory opinion exceed 30 days.’’.

7 SEC. 3. AUTHORIZING THE SECRETARY OF HEALTH AND

8 HUMAN SERVICES TO ISSUE ADVISORY OPIN9 IONS UNDER TITLE XVIII.

10 (a) AUTHORIZATION.—Title XVIII, section 1877 (42

11 U.S.C. 1395nn) is amended by the addition of the follow12 ing new paragraph:

13 ‘‘(i)(1) ADVISORY OPINIONS.—The Secretary shall

14 issue advisory opinions on whether an arrangement or pro15 posed arrangement will result in a prohibited referral

16 within the meaning of section 1395nn of title 42, United

17 States Code, as amended.

18 ‘‘(2) EFFECT OF ADVISORY OPINIONS.—

19 ‘‘(i) Each advisory opinion issued by the Sec20 retary shall be binding as to the Secretary and the

21 party or parties requesting the opinion.

22 ‘‘(ii) The failure of a party to seek an advisory

23 opinion may not be introduced into evidence to prove

24 that the party intended to violate the provisions of

25 section 1395nn of title 42, United States Code.
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1 ‘‘(3) REGULATIONS.—The Secretary within one hun2 dred and eighty days of the date of enactment, shall issue

3 regulations establishing a system for the issuance of advi4 sory opinions. Such regulations shall provide for—

5 ‘‘(i) the procedure to be followed by a party ap6 plying for an advisory opinion;

7 ‘‘(ii) the procedure to be followed by the Sec8 retary in responding to a request for an advisory

9 opinion;

10 ‘‘(iii) the interval in which the Secretary shall

11 respond;

12 ‘‘(iv) the reasonable fee to be charged to the

13 party requesting an advisory opinion; and

14 ‘‘(v) the manner in which advisory opinions will

15 be made available to the public.

16 ‘‘(4) INTERVAL FOR ISSUANCE OF ADVISORY OPIN17 IONS.—Under no circumstances shall the interval in which

18 the Secretary shall respond to a party requesting an advi19 sory opinion exceed thirty days.’’.

20 SEC. 4. EFFECTIVE DATE.

21 Unless otherwise specified herein, the Health Care

22 Fraud and Abuse Advisory Opinion Act of 1994 shall be

23 effective upon enactment.

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