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[DOI] [PMC free article] [PubMed] [Google Scholar] 346.Chambers E.S., Hawrylowicz C.M

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At the time of development for rulemaking on the CY 2025 PFS, we did not believe it was necessary to clarify at § 428.202(c)(2) or (c)(4) that the payment amount benchmark period for a subsequently approved drug also must be no earlier than calendar year 2021, since a subsequently approved drug is by definition a Part D rebatable drug first approved or licensed by the FDA after October 1, 2021