CMS releases initial guidance on negotiating certain Medicare drug prices

The Centers for Medicare & Medicaid Services this week released for comment initial guidance implementing a program for Medicare to negotiate prices with drug makers for certain high-cost, single-source drug and biological products beginning in 2026 under the Inflation Reduction Act. The guidance details requirements and procedures for implementing negotiations in 2023 and 2024 for prices effective in 2026. CMS in January released a memo and timeline outlining how it will approach the program. According to the memo, the agency plans to actively engage hospitals and other stakeholders in the policymaking process.