The Centers for Medicare & Medicaid Services (CMS) recently published its final guidance to implement the drug price negotiation provisions of the Inflation Reduction Act. While retaining the active moiety/active ingredient approach to identifying drugs subject to negotiation, CMS now will only include those products with historic or likely Part D utilization in negotiations in 2026. This is intended to avoid subjecting Part B drugs to the process sooner than the statute provides. In this episode of Connected With Latham, partner Chris Schott and associate Danny Machado of the firm’s DC office explain how CMS structures its final guidance and what questions remain for drug manufacturers.
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