117 STAT. 2376
PUBLIC LAW 108–173—DEC. 8, 2003 (2) EFFECTIVE DATE.—The amendment made by paragraph (1) shall apply to final regulations published on or after the date of the enactment of this Act.
42 USC 1395hh note.
SEC. 903. COMPLIANCE WITH CHANGES IN REGULATIONS AND POLICIES.
42 USC 1395hh note.
42 USC 1395hh note.
VerDate 11-MAY-2000
13:59 Aug 30, 2004
(a) NO RETROACTIVE APPLICATION OF SUBSTANTIVE CHANGES.— (1) IN GENERAL.—Section 1871 (42 U.S.C. 1395hh), as amended by section 902(a), is amended by adding at the end the following new subsection: ‘‘(e)(1)(A) A substantive change in regulations, manual instructions, interpretative rules, statements of policy, or guidelines of general applicability under this title shall not be applied (by extrapolation or otherwise) retroactively to items and services furnished before the effective date of the change, unless the Secretary determines that— ‘‘(i) such retroactive application is necessary to comply with statutory requirements; or ‘‘(ii) failure to apply the change retroactively would be contrary to the public interest.’’. (2) EFFECTIVE DATE.—The amendment made by paragraph (1) shall apply to substantive changes issued on or after the date of the enactment of this Act. (b) TIMELINE FOR COMPLIANCE WITH SUBSTANTIVE CHANGES AFTER NOTICE.— (1) IN GENERAL.—Section 1871(e)(1), as added by subsection (a), is amended by adding at the end the following: ‘‘(B)(i) Except as provided in clause (ii), a substantive change referred to in subparagraph (A) shall not become effective before the end of the 30-day period that begins on the date that the Secretary has issued or published, as the case may be, the substantive change. ‘‘(ii) The Secretary may provide for such a substantive change to take effect on a date that precedes the end of the 30-day period under clause (i) if the Secretary finds that waiver of such 30day period is necessary to comply with statutory requirements or that the application of such 30-day period is contrary to the public interest. If the Secretary provides for an earlier effective date pursuant to this clause, the Secretary shall include in the issuance or publication of the substantive change a finding described in the first sentence, and a brief statement of the reasons for such finding. ‘‘(C) No action shall be taken against a provider of services or supplier with respect to noncompliance with such a substantive change for items and services furnished before the effective date of such a change.’’. (2) EFFECTIVE DATE.—The amendment made by paragraph (1) shall apply to compliance actions undertaken on or after the date of the enactment of this Act. (c) RELIANCE ON GUIDANCE.— (1) IN GENERAL.—Section 1871(e), as added by subsection (a), is further amended by adding at the end the following new paragraph: ‘‘(2)(A) If— ‘‘(i) a provider of services or supplier follows the written guidance (which may be transmitted electronically) provided by the Secretary or by a medicare contractor (as defined in
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