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136 STAT. 1871 PUBLIC LAW 117–169—AUG. 16, 2022 in each of fiscal years 2023 through 2031, to remain available until expended. SEC. 11102. MEDICARE PART D REBATE BY MANUFACTURERS. (a) IN GENERAL.—Part D of title XVIII of the Social Security Act is amended by inserting after section 1860D–14A (42 U.S.C. 1395w–114a) the following new section: ‘‘SEC. 1860D–14B. MANUFACTURER REBATE FOR CERTAIN DRUGS WITH PRICES INCREASING FASTER THAN INFLATION. ‘‘(a) REQUIREMENTS.— ‘‘(1) SECRETARIAL PROVISION OF INFORMATION.—Not later than 9 months after the end of each applicable period (as defined in subsection (g)(7)), subject to paragraph (3), the Sec- retary shall, for each part D rebatable drug, report to each manufacturer of such part D rebatable drug the following for such period: ‘‘(A) The amount (if any) of the excess annual manufac- turer price increase described in subsection (b)(1)(A)(ii) for each dosage form and strength with respect to such drug and period. ‘‘(B) The rebate amount specified under subsection (b) for each dosage form and strength with respect to such drug and period. ‘‘(2) MANUFACTURER REQUIREMENTS.—For each applicable period, the manufacturer of a part D rebatable drug, for each dosage form and strength with respect to such drug, not later than 30 days after the date of receipt from the Secretary of the information described in paragraph (1) for such period, shall provide to the Secretary a rebate that is equal to the amount specified in subsection (b) for such dosage form and strength with respect to such drug for such period. ‘‘(3) TRANSITION RULE FOR REPORTING.—The Secretary may, for each rebatable covered part D drug, delay the timeframe for reporting the information and rebate amount described in subparagraphs (A) and (B) of such paragraph for the applicable periods beginning October 1, 2022, and October 1, 2023, until not later than December 31, 2025. ‘‘(b) REBATE AMOUNT.— ‘‘(1) IN GENERAL.— ‘‘(A) CALCULATION.—For purposes of this section, the amount specified in this subsection for a dosage form and strength with respect to a part D rebatable drug and applicable period is, subject to subparagraph (C), paragraph (5)(B), and paragraph (6), the estimated amount equal to the product of— ‘‘(i) subject to subparagraph (B) of this paragraph, the total number of units of such dosage form and strength for each rebatable covered part D drug dis- pensed under this part during the applicable period; and ‘‘(ii) the amount (if any) by which— ‘‘(I) the annual manufacturer price (as deter- mined in paragraph (2)) paid for such dosage form and strength with respect to such part D rebatable drug for the period; exceeds ‘‘(II) the inflation-adjusted payment amount determined under paragraph (3) for such dosage Determinations. Time period. Effective date. Deadline. Reports. 42 USC 1395w–114b. VerDate Sep 11 2014 13:57 Oct 25, 2022 Jkt 029139 PO 00169 Frm 00055 Fmt 6580 Sfmt 6581 E:\PUBLAW\PUBL169.117 PUBL169 jmbennett on LAP3P8D0R2PROD with Publaw