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Section 1860D-14B(a)(3) of the Act allows CMS to delay the timeframe for reporting the information and rebate amount described in 428.401 for the applicable periods beginning October 1, 2022, and October 1, 2023, until not later than December 31, 2025

CMS intends to apply this unit exclusion at the month level and would exclude all units of a generic drug that ceases to meet the definition of a Part D rebatable drug beginning with the first day of the first month when a therapeutically equivalent drug approved under a 505(j) ANDA is marketed based on the marketing start date in the NDC Directory or when the reference listed drug, or an authorized generic of the reference listed drug is marketed based on the marketing start date in the NDC Directory