117 STAT. 2238
PUBLIC LAW 108–173—DEC. 8, 2003
(b) APPLICATION OF MARKET-BASED PAYMENT SYSTEMS.—Section 1842(o) (42 U.S.C. 1395u(o)) is amended— (1) in paragraph (1), by striking ‘‘equal to 95 percent of the average wholesale price.’’ and inserting ‘‘equal to the following: ‘‘(A) In the case of any of the following drugs or biologicals, 95 percent of the average wholesale price: ‘‘(i) A drug or biological furnished before January 1, 2004. ‘‘(ii) Blood clotting factors furnished during 2004. ‘‘(iii) A drug or biological furnished during 2004 that was not available for payment under this part as of April 1, 2003. ‘‘(iv) A vaccine described in subparagraph (A) or (B) of section 1861(s)(10) furnished on or after January 1, 2004. ‘‘(v) A drug or biological furnished during 2004 in connection with the furnishing of renal dialysis services if separately billed by renal dialysis facilities. ‘‘(B) In the case of a drug or biological furnished during 2004 that is not described in— ‘‘(i) clause (ii), (iii), (iv), or (v) of subparagraph (A), ‘‘(ii) subparagraph (D)(i), or ‘‘(iii) subparagraph (F), the amount determined under paragraph (4). ‘‘(C) In the case of a drug or biological that is not described in subparagraph (A)(iv), (D)(i), or (F) furnished on or after January 1, 2005, the amount provided under section 1847, section 1847A, section 1847B, or section 1881(b)(13), as the case may be for the drug or biological. ‘‘(D)(i) Except as provided in clause (ii), in the case of infusion drugs furnished through an item of durable medical equipment covered under section 1861(n) on or after January 1, 2004, 95 percent of the average wholesale price for such drug in effect on October 1, 2003. ‘‘(ii) In the case of such infusion drugs furnished in a competitive acquisition area under section 1847 on or after January 1, 2007, the amount provided under section 1847. ‘‘(E) In the case of a drug or biological, consisting of intravenous immune globulin, furnished— ‘‘(i) in 2004, the amount of payment provided under paragraph (4); and ‘‘(ii) in 2005 and subsequent years, the amount of payment provided under section 1847A. ‘‘(F) In the case of blood and blood products (other than blood clotting factors), the amount of payment shall be determined in the same manner as such amount of payment was determined on October 1, 2003. ‘‘(G) The provisions of subparagraphs (A) through (F) of this paragraph shall not apply to an inhalation drug or biological furnished through durable medical equipment covered under section 1861(n).’’; and (2) by adding at the end the following new paragraph: ‘‘(4)(A) Subject to the succeeding provisions of this paragraph, the amount of payment for a drug or biological under this paragraph furnished in 2004 is equal to 85 percent of the average wholesale price (determined as of April 1, 2003) for the drug or biological.
VerDate 11-MAY-2000
13:59 Aug 30, 2004
Jkt 019194
PO 00000
Frm 00174
Fmt 6580
Sfmt 6581
D:\STATUTES\2003\19194PT3.001
APPS10
PsN: 19194PT3
�
