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 arrange-
ments for the delivery of health care services and sup-
plies are in compliance with statutes and rules establish-
ing acceptable health care billing and payment practices
and with statutes and rules defining health care fraud
and abuse.
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled,
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SECTION 1. SHORT TITLE; REFERENCES IN ACT.
(a) SHORT TITLE.—This Act may be cited as the
‘‘Health Care Fraud and Abuse Advisory Opinion Act of
1994’’.
(b) REFERENCES IN ACT.—Except as otherwise spe-
cifically provided, whenever an amendment herein is ex-
pressed in terms of an amendment to, or repeal of a sec-
tion or other provision, the reference shall be considered
to be made to that section or other provision of the Social
Security Act.
SEC. 2. AUTHORIZING THE SECRETARY OF HEALTH AND
HUMAN SERVICES TO ISSUE ADVISORY OPIN-
IONS UNDER TITLE XI.
(a) AUTHORIZATION.—Title XI, section 1128 (42
U.S.C. 1320a–7) is amended by the addition of the follow-
ing new paragraph:
‘‘(j) The Secretary shall issue advisory opinions as
provided in this section.
‘‘(1) MATTERS
SUBJECT
TO
ADVISORY
OPIN-
IONS.—The Secretary shall issue advisory opinions
as to the following matters:
‘‘(i) What constitutes prohibited remunera-
tion within the meaning of section 1320a–7b(b)
of title 42, United States Code.
‘‘(ii) Whether an arrangement or proposed
arrangement satisfies the criteria set forth in
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section 1320a–7b(b)(3) of title 42, United
States Code as amended for activities which do
not result in prohibited remuneration.
‘‘(iii) Whether an arrangement or proposed
arrangement satisfies the criteria which the
Secretary has established, or shall establish by
regulation for activities which do not result in
prohibited remuneration.
‘‘(iv) What constitutes an inducement to
reduce or limit services to individuals entitled to
benefits under part A or part B of title XVIII
or title XIX within the meaning of section
1320a–7a(b) of title 42, United States Code.
‘‘(v) Whether an arrangement, activity or
proposed arrangement or proposed activity vio-
lates any other provision of the Act.
‘‘(2) MATTERS
NOT
SUBJECT
TO
ADVISORY
OPINIONS.—Such advisory opinions shall not address
the following matters:
‘‘(i) Whether the fair market value shall
be, or was paid or received for any goods, serv-
ices or property.
‘‘(ii) Whether an individual is a bona fide
employee within the requirements of section
3121(d)(2) of title 26, United States Code.
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‘‘(3) EFFECT OF ADVISORY OPINIONS.—
‘‘(i) Each advisory opinion issued by the
Secretary shall be binding as to the Secretary
and the party or parties requesting the opinion.
‘‘(ii) The failure of a party to seek an advi-
sory opinion may not be introduced into evi-
dence to prove that the party intended to vio-
late the provisions of sections 1320a–7, 1320a–
7(a), or 1320a–7(b) of title 42, United States
Code.
‘‘(4) REGULATIONS.—The Secretary within one
hundred and eighty days of the date of enactment,
shall issue regulations establishing a system for the
issuance of advisory opinions. Such regulations shall
provide for—
‘‘(i) the procedure to be followed by a
party applying for an advisory opinion;
‘‘(ii) the procedure to be followed by the
Secretary in responding to a request for an ad-
visory opinion;
‘‘(iii) the interval in which the Secretary
shall respond;
‘‘(iv) the reasonable fee to be charged to
the party requesting an advisory opinion; and
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‘‘(v) the manner in which advisory opinions
will be made available to the public.
‘‘(5) INTERVAL
FOR
ISSUANCE
OF
ADVISORY
OPINIONS.—Under no circumstances shall the inter-
val in which the Secretary shall respond to a party
requesting an advisory opinion exceed 30 days.’’.
SEC. 3. AUTHORIZING THE SECRETARY OF HEALTH AND
HUMAN SERVICES TO ISSUE ADVISORY OPIN-
IONS UNDER TITLE XVIII.
(a) AUTHORIZATION.—Title XVIII, section 1877 (42
U.S.C. 1395nn) is amended by the addition of the follow-
ing new paragraph:
‘‘(i)(1) ADVISORY OPINIONS.—The Secretary shall
issue advisory opinions on whether an arrangement or pro-
posed arrangement will result in a prohibited referral
within the meaning of section 1395nn of title 42, United
States Code, as amended.
‘‘(2) EFFECT OF ADVISORY OPINIONS.—
‘‘(i) Each advisory opinion issued by the Sec-
retary shall be binding as to the Secretary and the
party or parties requesting the opinion.
‘‘(ii) The failure of a party to seek an advisory
opinion may not be introduced into evidence to prove
that the party intended to violate the provisions of
section 1395nn of title 42, United States Code.