New Guidance & Ongoing Litigation: Summer 2023 Updates on the Inflation Reduction Act’s Medicare Drug Pricing Negotiation Program

On June 30, 2023, the Centers for Medicare & Medicaid Services (CMS) released its updated final program guidance covering the Inflation Reduction Act’s Medicare Drug Price Negotiation Program for the first round of negotiations, which will occur during 2023 and 2024 and result in prices that will be effective beginning in 2026. In its guidance, CMS addresses a few core areas, including:

  1. Clarifications of how CMS will identify selected drugs
  2. Revisions to and clarifications of the process applicable for participating drug companies of selected drugs
  3. Inclusion of additional opportunities for drug companies and members of the public to engage with CMS during the negotiation process on the selected drugs

In recognition of the revised guidance release, Matt Wetzel and Heath Ingram, from Goodwin’s Life Sciences Regulatory & Compliance team, will host a webinar on July 26, 2023 to break down the latest information from CMS on its plans to implement the IRA’s provisions. They will spend time answering questions about the program, including what companies should anticipate for next steps. Matt and Heath will also review the four recent lawsuits that have been filed to challenge the constitutionality of the IRA’s Medicare drug pricing provisions.

Click here to register for the webinar.