Lexology September 23, 2024
On September 20, 2024, the Centers for Medicare & Medicaid Services (CMS) released the long-awaited final rule addressing several important drug pricing matters under the Medicaid Drug Rebate Program (MDRP) (Final Rule). The Final Rule’s provisions also have significant implications for the 340B Drug Pricing Program (340B program). CMS has finalized many aspects of the May 2023 proposed rule and has implemented significant changes to the MDRP’s drug misclassification, program administration, and integrity provisions, in many instances without directly addressing concerns raised in public comments.
Most significantly, CMS has finalized new definitions of “covered outpatient drug,” “internal investigations,” and “market date.” CMS also has finalized several provisions with 340B program implications without addressing the rampant problem of duplicate discounts with...
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