CMS RAPID Coverage Pathway: Breakthrough Device Reimbursement Changes

Medical Device Global Market Access · Aug 18, 2026 · 5m

The U.S. Centers for Medicare & Medicaid Services (CMS) has introduced a major policy change with the new Regulatory Alignment for Predictable and Immediate Device (RAPID) Coverage Pathway. Announced in a procedural notice on August 7, 2026, this pathway aims to significantly reduce the delay between FDA market authorization and a national Medicare coverage decision for eligible FDA Breakthrough-designated devices. This episode breaks down the eligibility criteria for Class II and III devices, the plan for simultaneous FDA and CMS decisions, and the critical public comment deadline of October…