RAPID Pathway Aims to Fast-Track Medicare Coverage for Breakthrough Devices
CMS and FDA unveiled the RAPID coverage pathway to align FDA market authorization with Medicare national coverage decisions for eligible Breakthrough Devices (Class II and III). The program enables early, coordinated engagement with manufacturers, uses the FDA's market authorization to trigger a proposed NCD the same day, includes a 30‑day public comment period, and aims for coverage as soon as two months after FDA approval. The Transitional Coverage for Emerging Technologies (TCET) pathway will be paused to focus on RAPID, and a procedural notice will be published in the Federal Register for public input.