117 STAT. 2254
PUBLIC LAW 108–173—DEC. 8, 2003
part B of title XVIII of the Social Security Act for radiopharmaceuticals, including the use by carriers of invoice pricing methodology. (i) CONFORMING AMENDMENTS.— (1) APPLICATION OF ASP AND COMPETITIVE BIDDING.—Section 1842(o)(2) (42 U.S.C. 1395u(o)(2)) is amended by adding at the end the following: ‘‘This paragraph shall not apply in the case of payment under paragraph (1)(C).’’. (2) NO CHANGE IN COVERAGE BASIS.—Section 1861(s)(2)(A) (42 U.S.C. 1395x(s)(2)(A)) is amended by inserting ‘‘(or would have been so included but for the application of section 1847B)’’ after ‘‘included in the physicians’ bills’’. (3) PAYMENT.—(A) Section 1833(a)(1)(S) (42 U.S.C. 1395l(a)(1)(S)) is amended by inserting ‘‘(or, if applicable, under section 1847, 1847A, or 1847B)’’ after ‘‘1842(o)’’. (B) Section 1862(a)(1) (42 U.S.C. 1395y(a)(1)) is amended— (i) by striking ‘‘and’’ at the end of subparagraph (H); (ii) by striking the semicolon at the end of subparagraph (I) and inserting ‘‘, and’’; and (iii) by adding at the end the following new subparagraph: ‘‘(J) in the case of a drug or biological specified in section 1847A(c)(6)(C) for which payment is made under part B that is furnished in a competitive area under section 1847B, that is not furnished by an entity under a contract under such section;’’. (4) CONSOLIDATED REPORTING OF PRICING INFORMATION.— Section 1927 (42 U.S.C. 1396r–8) is amended— (A) in subsection (a)(1), by inserting ‘‘or under part B of title XVIII’’ after ‘‘section 1903(a)’’; (B) in subsection (b)(3)(A)— (i) in clause (i), by striking ‘‘and’’ at the end and inserting a semicolon; (ii) in clause (ii), by striking the period and inserting ‘‘; and’’; and (iii) by adding at the end the following: ‘‘(iii) for calendar quarters beginning on or after January 1, 2004, in conjunction with reporting required under clause (i) and by National Drug Code (including package size)— ‘‘(I) the manufacturer’s average sales price (as defined in section 1847A(c)) and the total number of units specified under section 1847A(b)(2)(A); ‘‘(II) if required to make payment under section 1847A, the manufacturer’s wholesale acquisition cost, as defined in subsection (c)(6) of such section; and ‘‘(III) information on those sales that were made at a nominal price or otherwise described in section 1847A(c)(2)(B); for a drug or biological described in subparagraph (C), (D), (E), or (G) of section 1842(o)(1) or section 1881(b)(13)(A)(ii). Information reported under this subparagraph is subject to audit by the Inspector General of the Department of Health and Human Services.’’; (C) in subsection (b)(3)(B)—
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