Sec. 302. Applying the Medicaid additional rebate requirement to generic drugs

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Section 1927(c)(3) of the Social Security Act ( 42 U.S.C. 1396r–8(c)(3) ) is amended— in subparagraph (A), by striking The amount and inserting Except as provided in subparagraph (C), the amount ; and by adding at the end the following new subparagraph: The amount of the rebate specified in this paragraph for a rebate period, with respect to each dosage form and strength of a covered outpatient drug other than a single source drug or an innovator multiple source drug, shall be increased in the manner that the rebate for a dosage form and strength of a single source drug or an innovator multiple source drug is increased under subparagraphs

(A)and

(D)of paragraph (2), except as provided in clause (ii). In applying subparagraphs

(A)and

(D)of paragraph

(2)under clause (i)— the reference in subparagraph (A)(i) of such paragraph to 1990 shall be deemed a reference to 2014 ; subject to clause (iii), the reference in subparagraph (A)(ii) of such paragraph to calendar quarter beginning July 1, 1990 shall be deemed a reference to the calendar quarter in which the average manufacturer price for the drug is the lowest during the 12-calendar quarter period ending on September 30, 2014 ; subject to clause (iii), the reference in subparagraph (A)(ii) of such paragraph to September 1990 shall be deemed a reference to the last month of such calendar quarter ; the references in subparagraph

(D)of such paragraph to paragraph (1)(A)(ii) , this paragraph , and December 31, 2009 shall be deemed references to subparagraph

(A), this subparagraph , and December 31, 2014 , respectively; and any reference in such paragraph to a single source drug or an innovator multiple source drug shall be deemed to be a reference to a drug to which clause

(i)applies. In applying paragraph (2)(A)(ii)(II) under clause

(i)with respect to a covered outpatient drug that is first sold as a drug other than a single source drug or an innovator multiple source drug after the date that is 3 years before the date of the enactment of this subparagraph, such paragraph shall be applied— by substituting the applicable quarter for the calendar quarter beginning July 1, 1990 ; and by substituting the last month in such applicable quarter for September 1990 . In this subsection, the term applicable quarter means, with respect to a drug described in clause (iii), the fifth full calendar quarter in which the drug is sold as a drug other than a single source drug or an innovator multiple source drug. . The amendments made by subsection

(a)shall apply to rebate periods beginning after December 31, 2014.

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42 USC 1396r–8(c)(3)

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Sec. 302

Applying the Medicaid additional rebate requirement to generic drugs

Cite42 USC 1396r–8(c)(3)

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