CMS, FDA launch RAPID coverage pathway for breakthrough devices
The FDA and CMS jointly announced the RAPID Coverage Pathway, a new program designed to accelerate Medicare coverage for FDA-designated breakthrough medical devices. The goal is to reduce the lag between FDA approval and CMS national coverage determinations, which historically has taken years. The program involves concurrent review and more predictable coverage outcomes. For practices that adopt qualifying breakthrough technologies, this could mean faster payer adoption and reduced uncertainty in patient coverage. The agencies will release operational details and a list of initial qualifying devices later this year. Monitor CMS and FDA announcements in Q3 2026 for the initial device list and specific coverage parameters, which will dictate which new technologies your practice can plan to adopt with confidence in reimbursement.