PUBLIC LAW 108–173—DEC. 8, 2003
117 STAT. 2307
Subtitle C—Other Provisions SEC. 621. HOSPITAL OUTPATIENT DEPARTMENT (HOPD) PAYMENT REFORM.
(a) PAYMENT FOR DRUGS.— (1) SPECIAL RULES FOR CERTAIN DRUGS AND BIOLOGICALS.— Section 1833(t) (42 U.S.C. 1395l(t)), as amended by section 411(b), is amended by inserting after paragraph (13) the following new paragraphs: ‘‘(14) DRUG APC PAYMENT RATES.— ‘‘(A) IN GENERAL.—The amount of payment under this subsection for a specified covered outpatient drug (defined in subparagraph (B)) that is furnished as part of a covered OPD service (or group of services)— ‘‘(i) in 2004, in the case of— ‘‘(I) a sole source drug shall in no case be less than 88 percent, or exceed 95 percent, of the reference average wholesale price for the drug; ‘‘(II) an innovator multiple source drug shall in no case exceed 68 percent of the reference average wholesale price for the drug; or ‘‘(III) a noninnovator multiple source drug shall in no case exceed 46 percent of the reference average wholesale price for the drug; ‘‘(ii) in 2005, in the case of— ‘‘(I) a sole source drug shall in no case be less than 83 percent, or exceed 95 percent, of the reference average wholesale price for the drug; ‘‘(II) an innovator multiple source drug shall in no case exceed 68 percent of the reference average wholesale price for the drug; or ‘‘(III) a noninnovator multiple source drug shall in no case exceed 46 percent of the reference average wholesale price for the drug; or ‘‘(iii) in a subsequent year, shall be equal, subject to subparagraph (E)— ‘‘(I) to the average acquisition cost for the drug for that year (which, at the option of the Secretary, may vary by hospital group (as defined by the Secretary based on volume of covered OPD services or other relevant characteristics)), as determined by the Secretary taking into account the hospital acquisition cost survey data under subparagraph (D); or ‘‘(II) if hospital acquisition cost data are not available, the average price for the drug in the year established under section 1842(o), section 1847A, or section 1847B, as the case may be, as calculated and adjusted by the Secretary as necessary for purposes of this paragraph. ‘‘(B) SPECIFIED COVERED OUTPATIENT DRUG DEFINED.— ‘‘(i) IN GENERAL.—In this paragraph, the term ‘specified covered outpatient drug’ means, subject to clause (ii), a covered outpatient drug (as defined in section 1927(k)(2)) for which a separate ambulatory
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