Lexology July 15, 2024
Since our last edition of the Mintz IRA Update, the Medicare Drug Price Negotiation Program (the “Negotiation Program” or “Program”) and related maximum fair price (MFP) negotiation process for each of the 10 high-expenditure Medicare Part D drugs selected for negotiation (the “Selected Drugs”) has gone into full swing. After the Centers for Medicare and Medicaid Services (CMS) sent initial offers to the manufacturers participating in the first cycle of the Negotiation Program, the Biden administration confirmed that it had received counteroffers from each of the Selected Drugs’ manufacturers. The Biden administration later confirmed in April that it had sent subsequent counteroffers to manufacturers for the Selected Drugs. Pursuant to the Draft Guidance for Initial Price Applicability Year 2027 and...
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