Lexology August 8, 2023
1. Introduction
On June 30, 2023, the Centers for Medicare and Medicaid Services (CMS) released its much-anticipated final guidance (“Final Guidance”) for the Medicare Drug Price Negotiation Program (“Negotiation Program”) through the Inflation Reduction Act (IRA).[1] The Negotiation Program is an unprecedented program intended to lower the cost of healthcare for millions of Americans by requiring that manufacturers of the top ten highest cost prescription drugs covered by Medicare engage in a negotiation process to determine a “maximum fair price” (MFP). The Final Guidance, which follows an initial guidance released on March 15, 2023 (“Initial Guidance”),[2] provides few substantive changes to the Initial Guidance but does fill in some details in response to public comments regarding the Negotiation Program.[3] While...
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