Ensuring Patient Access to Critical Breakthrough Products Act

This bill ensures Medicare coverage for new medical devices designated as "breakthrough devices" during a 4-year period after FDA approval. To qualify, devices must meet specific criteria, including FDA priority review, clinical data from Medicare beneficiaries, and a safety review showing benefits outweigh risks. Medicare must finalize coverage decisions within 6 months of manufacturer applications and before the 4-year period ends. The law appropriates $10 million annually (2025-2030) for Medicare to administer this process.