CMS Issues Guidance and Solicits Comment on the 2026 Inflation Reduction Act Part D Negotiation Process

On April 5, 2023, Goodwin’s Matt Wetzel and Heath Ingram published a client alert addressing the initial guidance memorandum issued by the Centers for Medicare & Medicaid Services (CMS) on the Medicare Drug Price Negotiation Program created by the Inflation Reduction Act of 2022. Public comments are due to CMS by April 14, 2023.

The alert provides an overview of:

  • The process that CMS lays out in its guidance to identify and select the Medicare Part D drugs and biologics for which it will negotiate a maximum fair price (MFP) for the 2026 Initial Price Year
  • The data and evidence that manufacturers will be required to submit that will inform CMS’s initial price proposals
  • The structure of the negotiation process, as well as implementation and enforcement of the MFP along with other important considerations and requests for public comment

Matt Wetzel and Heath Ingram have also previously reported that the IRA established a Medicare Inflation Rebate Program that requires drug manufacturers to pay inflation rebates to the federal government if the prices of their rebate-eligible Medicare Part B or Part D drugs increase faster than the rate of inflation. Click here for their prior alerts on the Part B and Part D inflation rebates.