Page:United States Statutes at Large Volume 124.djvu/335

124 STAT. 309 PUBLIC LAW 111–148—MAR. 23, 2010 (d) ADDITIONAL REBATE FOR NEW FORMULATIONS OF EXISTING DRUGS.— (1) IN GENERAL.—Section 1927(c)(2) of the Social Security Act (42 U.S.C. 1396r–8(c)(2)) is amended by adding at the end the following new subparagraph: ‘‘(C) TREATMENT OF NEW FORMULATIONS.— ‘‘(i) IN GENERAL.—Except as provided in clause (ii), in the case of a drug that is a new formulation, such as an extended-release formulation, of a single source drug or an innovator multiple source drug, the rebate obligation with respect to the drug under this section shall be the amount computed under this sec- tion for the new formulation of the drug or, if greater, the product of— ‘‘(I) the average manufacturer price for each dosage form and strength of the new formulation of the single source drug or innovator multiple source drug; ‘‘(II) the highest additional rebate (calculated as a percentage of average manufacturer price) under this section for any strength of the original single source drug or innovator multiple source drug; and ‘‘(III) the total number of units of each dosage form and strength of the new formulation paid for under the State plan in the rebate period (as reported by the State). ‘‘(ii) NO APPLICATION TO NEW FORMULATIONS OF ORPHAN DRUGS.—Clause (i) shall not apply to a new formulation of a covered outpatient drug that is or has been designated under section 526 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bb) for a rare disease or condition, without regard to whether the period of market exclusivity for the drug under section 527 of such Act has expired or the specific indication for use of the drug.’’. (2) EFFECTIVE DATE.—The amendment made by paragraph (1) shall apply to drugs that are paid for by a State after December 31, 2009. (e) MAXIMUM REBATE AMOUNT.—Section 1927(c)(2) of such Act (42 U.S.C. 1396r–8(c)(2)), as amended by subsection (d), is amended by adding at the end the following new subparagraph: ‘‘(D) MAXIMUM REBATE AMOUNT.—In no case shall the sum of the amounts applied under paragraph (1)(A)(ii) and this paragraph with respect to each dosage form and strength of a single source drug or an innovator multiple source drug for a rebate period beginning after December 31, 2009, exceed 100 percent of the average manufacturer price of the drug.’’. (f) CONFORMING AMENDMENTS.— (1) IN GENERAL.—Section 340B of the Public Health Service Act (42 U.S.C. 256b) is amended— (A) in subsection (a)(2)(B)(i), by striking ‘‘1927(c)(4)’’ and inserting ‘‘1927(c)(3)’’; and (B) by striking subsection (c); and (C) redesignating subsection (d) as subsection (c). 42 USC 1396r–8 note.