Ensuring Patient Access to Critical Breakthrough Products Act of 2025

This bill would help Medicare cover certain new medical devices faster. If the device gets a special “breakthrough” label from the government, Medicare would give it temporary coverage for four years starting when it’s designated. During this time, Medicare could still refuse coverage if the device is used outside its FDA-approved instructions or if it’s found to pose more risk than benefit for patients. The goal is to get promising devices to people sooner while keeping safety checks in place .

Makers of these devices could apply for the “breakthrough” label once the program starts 18 months after the law takes effect. The government would have six months to decide on each application, and it must base the label on whether the device received FDA priority review. The agency would also issue yearly reports on how many devices applied and were approved. Medicare would have to finish any national coverage decision on a breakthrough device before the end of the four-year window if the request was filed at least 9 months (or 12 months in certain cases) before that window ends. The bill also sets aside $10 million per year for 2026–2031 to run this program .

• Who is affected: People with Medicare who may need new medical devices; companies making those devices; Medicare itself as the payer .
• What changes: A defined, four-year “transitional” coverage period for breakthrough devices, faster decisions on device status, and deadlines for national coverage decisions, with safety guardrails on use and risk .
• When: The breakthrough designation process starts 18 months after the law takes effect; funding runs 2026–2031; the four-year coverage window starts when a device is designated as a breakthrough .