USA's Breakthrough Device Dilemma: Closing the Medicare Reimbursement Gap

Medical Device Global Market Access · Mar 9, 2026 · 3m

This episode delves into the critical reimbursement gap facing innovative medical devices in the United States. We explore why FDA Breakthrough Device designation doesn't guarantee Medicare payment, the financial "valley of death" this creates for MedTech startups, and how the proposed "Ensuring Patient Access to Critical Breakthrough Products Act" aims to provide a vital four-year bridge of temporary coverage. - What is the FDA's Breakthrough Devices Program? - Why does FDA approval not automatically lead to Medicare reimbursement? - What is the "reimbursement valley of death" for MedTech…