
From the U.S. Code Online via GPO Access
[wais.access.gpo.gov]
[Laws in effect as of January 23, 2000]
[Document affected by Public Law 106-554 Section 1(a)(6)[543]]
[CITE: 42USC1320a-7d]

 
                 TITLE 42--THE PUBLIC HEALTH AND WELFARE
 
                       CHAPTER 7--SOCIAL SECURITY
 
   SUBCHAPTER XI--GENERAL PROVISIONS, PEER REVIEW, AND ADMINISTRATIVE 
                             SIMPLIFICATION
 
                       Part A--General Provisions
 
Sec. 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.
---------------------------------------------------------------------------
    \1\ So in original. Probably should be ``section''.
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                           (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, 
    and before the date which is 4 years 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.

(Aug. 14, 1935, ch. 531, title XI, Sec. 1128D, as added Pub. L. 104-191, 
title II, Sec. 205, Aug. 21, 1996, 110 Stat. 2000; amended Pub. L. 105-
33, title IV, Sec. 4331(a)(1), Aug. 5, 1997, 111 Stat. 395; Pub. L. 105-
277, div. J, title V, Sec. 5201(c), Oct. 21, 1998, 112 Stat. 2681-917.)

                       References in Text

    Section 14(a) of the Medicare and Medicaid Patient and Program 
Protection Act of 1987, referred to in subsec. (a)(1)(A)(i), is section 
14(a) of Pub. L. 100-93, which is set out as a note under section 1320a-
7b of this title.
    Section 5 of the Inspector General Act of 1978, referred to in 
subsec. (a)(1)(C), is section 5 of Pub. L. 95-452, Oct. 12, 1978, 92 
Stat. 1103, as amended, which is set out in the Appendix to Title 5, 
Government Organization and Employees.
    The Internal Revenue Code of 1986, referred to in subsec. (b)(3)(B), 
is classified generally to Title 26, Internal Revenue Code.


                               Amendments

    1998--Subsec. (b)(2)(A). Pub. L. 105-277 inserted ``or section 
1320a-7a(i)(6) of this title'' before period at end.
    1997--Subsec. (b)(2)(D). Pub. L. 105-33 substituted ``section 1320a-
7a(b)'' for ``section 1320a-7b(b)''.


                    Effective Date of 1997 Amendment

    Amendment by Pub. L. 105-33 effective as if included in the 
enactment of the Health Insurance Portability and Accountability Act of 
1996, Pub. L. 104-191, see section 4331(f) of Pub. L. 105-33, set out as 
a note under section 1320a-7e of this title.

                  Section Referred to in Other Sections

    This section is referred to in sections 1320a-7c, 1395nn of this 
title.
