Sec. 53104. REBATE OBLIGATION WITH RESPECT TO LINE EXTENSION DRUGS

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## SEC. 53104 REBATE OBLIGATION WITH RESPECT TO LINE EXTENSION DRUGS ###

(a)In General Section 1927(c)(2)(C) of the Social Security Act (42 U.S.C. 1396r–8(c)(2)(C)) is amended by striking “

(C)treatment of new formulations.—In the case ” and all that follows through the period at the end of the first sentence and inserting the following: > > ##### “(C) Treatment of new formulations > > > ###### “(i) In general > > In the case of a drug that is a line extension of a single source drug or an innovator multiple source drug that is an oral solid dosage form, the rebate obligation for a rebate period with respect to such drug under this subsection shall be the greater of the amount described in clause

(ii)for such drug or the amount described in clause

(iii)for such drug. > > > ###### “(ii) Amount 1 > > For purposes of clause (i), the amount described in this clause with respect to a drug described in clause

(i)and rebate period is the amount computed under paragraph

(1)for such drug, increased by the amount computed under subparagraph

(A)and, as applicable, subparagraph

(B)for such drug and rebate period. > > > ###### “(iii) Amount 2 > > For purposes of clause (i), the amount described in this clause with respect to a drug described in clause

(i)and rebate period is the amount computed under paragraph

(1)for such drug, increased by the product of— > > > ###### “(I) > > the average manufacturer price for the rebate period of the line extension of a single source drug or an innovator multiple source drug that is an oral solid dosage form; > > > ###### “(II) > > the highest additional rebate (calculated as a percentage of average manufacturer price) under this paragraph for the rebate period 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 line extension product paid for under the State plan in the rebate period (as reported by the State).” > . ###

(b)Effective Date **[**[42 U.S.C. 1396r–8 note](/us/usc/t42/s1396r–8)**]** The amendments made subsection

(a)shall apply with respect to rebate periods beginning on or after October 1, 2018.

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42 USC 1396r–8(c)(2)(C)
42 USC 1396r–8

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Sec. 53104

REBATE OBLIGATION WITH RESPECT TO LINE EXTENSION DRUGS

Cite42 USC 1396r–8(c)(2)(C)

Cite42 USC 1396r–8

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