§ 1320a–7d.
(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);
(iii)
advisory opinions to be issued pursuant to subsection (b); and
(iv)
special fraud alerts to be issued pursuant to subsection (c).
(B)
Publication of proposed modifications and proposed additional safe harbors
(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.
(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).
(3)
Consideration of safe harbor for certain contingency management interventions
(b)
Advisory opinions
(1)
Issuance of advisory opinions
(2)
Matters subject to advisory opinions
The Secretary shall issue advisory opinions as to the following matters:
(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 or subchapter XIX 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
(B)
Failure to seek opinion
(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
([Aug. 14, 1935, ch. 531], title XI, § 1128D, as added [Pub. L. 104–191, title II, § 205], Aug. 21, 1996, [110 Stat. 2000]; amended [Pub. L. 105–33, title IV, § 4331(a)(1)], Aug. 5, 1997, [111 Stat. 395]; [Pub. L. 105–277, div. J, title V, § 5201(c)], Oct. 21, 1998, [112 Stat. 2681–917]; [Pub. L. 106–554, § 1(a)(6) [title V, § 543]], Dec. 21, 2000, [114 Stat. 2763], 2763A–551; [Pub. L. 117–286, § 4(b)(79)], Dec. 27, 2022, [136 Stat. 4351]; [Pub. L. 117–328, div. FF, title IV, § 4127], Dec. 29, 2022, [136 Stat. 5915].)