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136 STAT. 1865 PUBLIC LAW 117–169—AUG. 16, 2022 PART 2—PRESCRIPTION DRUG INFLATION REBATES SEC. 11101. MEDICARE PART B REBATE BY MANUFACTURERS. (a) IN GENERAL.—Section 1847A of the Social Security Act (42 U.S.C. 1395w–3a) is amended by redesignating subsection (i) as subsection (j) and by inserting after subsection (h) the following subsection: ‘‘(i) REBATE BY MANUFACTURERS FOR SINGLE SOURCE DRUGS AND BIOLOGICALS WITH PRICES INCREASING FASTER THAN INFLA- TION.— ‘‘(1) REQUIREMENTS.— ‘‘(A) SECRETARIAL PROVISION OF INFORMATION.—Not later than 6 months after the end of each calendar quarter beginning on or after January 1, 2023, the Secretary shall, for each part B rebatable drug, report to each manufacturer of such part B rebatable drug the following for such cal- endar quarter: ‘‘(i) Information on the total number of units of the billing and payment code described in subpara- graph (A)(i) of paragraph (3) with respect to such drug and calendar quarter. ‘‘(ii) Information on the amount (if any) of the excess average sales price increase described in subparagraph (A)(ii) of such paragraph for such drug and calendar quarter. ‘‘(iii) The rebate amount specified under such para- graph for such part B rebatable drug and calendar quarter. ‘‘(B) MANUFACTURER REQUIREMENT.—For each calendar quarter beginning on or after January 1, 2023, the manu- facturer of a part B rebatable drug shall, for such drug, not later than 30 days after the date of receipt from the Secretary of the information described in subparagraph (A) for such calendar quarter, provide to the Secretary a rebate that is equal to the amount specified in paragraph (3) for such drug for such calendar quarter. ‘‘(C) TRANSITION RULE FOR REPORTING.—The Secretary may, for each part B rebatable drug, delay the timeframe for reporting the information described in subparagraph (A) for calendar quarters beginning in 2023 and 2024 until not later than September 30, 2025. ‘‘(2) PART B REBATABLE DRUG DEFINED.— ‘‘(A) IN GENERAL.—In this subsection, the term ‘part B rebatable drug’ means a single source drug or biological (as defined in subparagraph (D) of subsection (c)(6)), including a biosimilar biological product (as defined in subparagraph (H) of such subsection) but excluding a quali- fying biosimilar biological product (as defined in subsection (b)(8)(B)(iii)), for which payment is made under this part, except such term shall not include such a drug or biological— ‘‘(i) if, as determined by the Secretary, the average total allowed charges for such drug or biological under this part for a year per individual that uses such Determination. Reports. Deadlines. Effective dates. Time periods. VerDate Sep 11 2014 13:57 Oct 25, 2022 Jkt 029139 PO 00169 Frm 00049 Fmt 6580 Sfmt 6581 E:\PUBLAW\PUBL169.117 PUBL169 jmbennett on LAP3P8D0R2PROD with Publaw