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U.S. Code as of:
01/19/04
Section 1320a-7d. Guidance regarding application of health care fraud and abuse sanctions
(a) Solicitation and publication of modifications to existing safe
harbors and new safe harbors
(1) In general
(A) Solicitation of proposals for safe harbors
Not later than January 1, 1997, and not less than annually
thereafter, the Secretary shall publish a notice in the Federal
Register soliciting proposals, which will be accepted during a
60-day period, for -
(i) modifications to existing safe harbors issued pursuant
to section 14(a) of the Medicare and Medicaid Patient and
Program Protection Act of 1987 (42 U.S.C. 1320a-7b note);
(ii) additional safe harbors specifying payment practices
that shall not be treated as a criminal offense under section
1320a-7b(b) of this title and shall not serve as the basis
for an exclusion under section 1320a-7(b)(7) of this title;
(iii) advisory opinions to be issued pursuant to subsection
(b) of this section; and
(iv) special fraud alerts to be issued pursuant to
subsection (c) of this section.
(B) Publication of proposed modifications and proposed
additional safe harbors
After considering the proposals described in clauses (i) and
(ii) of subparagraph (A), the Secretary, in consultation with
the Attorney General, shall publish in the Federal Register
proposed modifications to existing safe harbors and proposed
additional safe harbors, if appropriate, with a 60-day comment
period. After considering any public comments received during
this period, the Secretary shall issue final rules modifying
the existing safe harbors and establishing new safe harbors, as
appropriate.
(C) Report
The Inspector General of the Department of Health and Human
Services (in this section referred to as the "Inspector
General") shall, in an annual report to Congress or as part of
the year-end semiannual report required by section 5 of the
Inspector General Act of 1978 (5 U.S.C. App.), describe the
proposals received under clauses (i) and (ii) of subparagraph
(A) and explain which proposals were included in the
publication described in subparagraph (B), which proposals were
not included in that publication, and the reasons for the
rejection of the proposals that were not included.
(2) Criteria for modifying and establishing safe harbors
In modifying and establishing safe harbors under paragraph
(1)(B), the Secretary may consider the extent to which providing
a safe harbor for the specified payment practice may result in
any of the following:
(A) An increase or decrease in access to health care
services.
(B) An increase or decrease in the quality of health care
services.
(C) An increase or decrease in patient freedom of choice
among health care providers.
(D) An increase or decrease in competition among health care
providers.
(E) An increase or decrease in the ability of health care
facilities to provide services in medically underserved areas
or to medically underserved populations.
(F) An increase or decrease in the cost to Federal health
care programs (as defined in section 1320a-7b(f) of this
title).
(G) An increase or decrease in the potential overutilization
of health care services.
(H) The existence or nonexistence of any potential financial
benefit to a health care professional or provider which may
vary based on their decisions of -
(i) whether to order a health care item or service; or
(ii) whether to arrange for a referral of health care items
or services to a particular practitioner or provider.
(I) Any other factors the Secretary deems appropriate in the
interest of preventing fraud and abuse in Federal health care
programs (as so defined).
(b) Advisory opinions
(1) Issuance of advisory opinions
The Secretary, in consultation with the Attorney General, shall
issue written advisory opinions as provided in this subsection.
(2) Matters subject to advisory opinions
The Secretary shall issue advisory opinions as to the following
matters:
(A) What constitutes prohibited remuneration within the
meaning of section 1320a-7b(b) of this title or section
1320a-7a(i)(6) of this title.
(B) Whether an arrangement or proposed arrangement satisfies
the criteria set forth in section 1320a-7b(b)(3) of this title
for activities which do not result in prohibited remuneration.
(C) 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.
(D) What constitutes an inducement to reduce or limit
services to individuals entitled to benefits under subchapter
XVIII of this chapter or subchapter XIX of this chapter within
the meaning of section 1320a-7a(b) of this title.
(E) Whether any activity or proposed activity constitutes
grounds for the imposition of a sanction under section 1320a-7,
1320a-7a, or 1320a-7b of this title.
(3) Matters not subject to advisory opinions
Such advisory opinions shall not address the following matters:
(A) Whether the fair market value shall be, or was paid or
received for any goods, services or property.
(B) Whether an individual is a bona fide employee within the
requirements of section 3121(d)(2) of the Internal Revenue Code
of 1986.
(4) Effect of advisory opinions
(A) Binding as to Secretary and parties involved
Each advisory opinion issued by the Secretary shall be
binding as to the Secretary and the party or parties requesting
the opinion.
(B) Failure to seek opinion
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 sections (!1) 1320a-7, 1320a-7a, or
1320a-7b of this title.
(5) Regulations
(A) In general
Not later than 180 days after August 21, 1996, the Secretary
shall issue regulations to carry out this section. 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 advisory 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
(v) the manner in which advisory opinions will be made
available to the public.
(B) Specific contents
Under the regulations promulgated pursuant to subparagraph
(A) -
(i) the Secretary shall be required to issue to a party
requesting an advisory opinion by not later than 60 days
after the request is received; and
(ii) the fee charged to the party requesting an advisory
opinion shall be equal to the costs incurred by the Secretary
in responding to the request.
(6) Application of subsection
This subsection shall apply to requests for advisory opinions
made on or after the date which is 6 months after August 21,
1996.
(c) Special fraud alerts
(1) In general
(A) Request for special fraud alerts
Any person may present, at any time, a request to the
Inspector General for a notice which informs the public of
practices which the Inspector General considers to be suspect
or of particular concern under the Medicare program under
subchapter XVIII of this chapter or a State health care
program, as defined in section 1320a-7(h) of this title (in
this subsection referred to as a "special fraud alert").
(B) Issuance and publication of special fraud alerts
Upon receipt of a request described in subparagraph (A), the
Inspector General shall investigate the subject matter of the
request to determine whether a special fraud alert should be
issued. If appropriate, the Inspector General shall issue a
special fraud alert in response to the request. All special
fraud alerts issued pursuant to this subparagraph shall be
published in the Federal Register.
(2) Criteria for special fraud alerts
In determining whether to issue a special fraud alert upon a
request described in paragraph (1), the Inspector General may
consider -
(A) whether and to what extent the practices that would be
identified in the special fraud alert may result in any of the
consequences described in subsection (a)(2) of this section;
and
(B) the volume and frequency of the conduct that would be
identified in the special fraud alert.
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