Page:United States Statutes at Large Volume 117.djvu/2259

 117 STAT. 2240

PUBLIC LAW 108–173—DEC. 8, 2003 milligram of molecules, or grams) of the drug or biological that is dispensed, exclusive of any diluent without reference to volume measures pertaining to liquids. For years after 2004, the Secretary may establish the unit for a manufacturer to report and methods for counting units as the Secretary determines appropriate to implement this section. ‘‘(3) MULTIPLE SOURCE DRUG.—For all drug products included within the same multiple source drug billing and payment code, the amount specified in this paragraph is the volume-weighted average of the average sales prices reported under section 1927(b)(3)(A)(iii) determined by— ‘‘(A) computing the sum of the products (for each National Drug Code assigned to such drug products) of— ‘‘(i) the manufacturer’s average sales price (as defined in subsection (c)); and ‘‘(ii) the total number of units specified under paragraph (2) sold; and ‘‘(B) dividing the sum determined under subparagraph (A) by the sum of the total number of units under subparagraph (A)(ii) for all National Drug Codes assigned to such drug products. ‘‘(4) SINGLE SOURCE DRUG OR BIOLOGICAL.—The amount specified in this paragraph for a single source drug or biological is the lesser of the following: ‘‘(A) AVERAGE SALES PRICE.—The average sales price as determined using the methodology applied under paragraph (3) for all National Drug Codes assigned to such drug or biological product. ‘‘(B) WHOLESALE ACQUISITION COST (WAC).—The wholesale acquisition cost (as defined in subsection (c)(6)(B)) using the methodology applied under paragraph (3) for all National Drug Codes assigned to such drug or biological product. ‘‘(5) BASIS FOR PAYMENT AMOUNT.—The payment amount shall be determined under this subsection based on information reported under subsection (f) and without regard to any special packaging, labeling, or identifiers on the dosage form or product or package. ‘‘(c) MANUFACTURER’S AVERAGE SALES PRICE.— ‘‘(1) IN GENERAL.—For purposes of this section, subject to paragraphs (2) and (3), the manufacturer’s ‘average sales price’ means, of a drug or biological for a National Drug Code for a calendar quarter for a manufacturer for a unit— ‘‘(A) the manufacturer’s sales to all purchasers (excluding sales exempted in paragraph (2)) in the United States for such drug or biological in the calendar quarter; divided by ‘‘(B) the total number of such units of such drug or biological sold by the manufacturer in such quarter. ‘‘(2) CERTAIN SALES EXEMPTED FROM COMPUTATION.—In calculating the manufacturer’s average sales price under this subsection, the following sales shall be excluded: ‘‘(A) SALES EXEMPT FROM BEST PRICE.—Sales exempt from the inclusion in the determination of ‘best price’ under section 1927(c)(1)(C)(i).

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