Regulatory Alignment for Predictable and Immediate Device Coverage Pathway (CMS-3487 ...

CMS and FDA propose the RAPID coverage pathway to accelerate Medicare coverage for eligible FDA-designated Breakthrough medical devices, enabling Medicare coverage decisions within 60 to 90 days of FDA market authorisation through aligned evidence requirements and early engagement with manufacturers.

This Wire brief sits within Fusion42's coverage of Medtech, and 4 sources have reported it between 7 Aug 2026 and 12 Aug 2026.