CMS and FDA announce RAPID coverage pathway for breakthrough medical devices

CMS and the FDA jointly launched the RAPID Coverage Pathway, a new pilot program designed to accelerate Medicare coverage for FDA-designated breakthrough devices. The pathway aims to synchronize FDA approval and CMS national coverage determination, potentially reducing the typical multi-year coverage lag. For practices that implant or use advanced devices, this signals that coverage for new technologies like certain AI-based diagnostics or novel implants could arrive faster. Monitor the CMS website for the list of initial devices included in the pilot; it may affect procurement and patient counseling decisions later in 2026.