Ensuring Patient Access to Critical Breakthrough Products Act of 2025

This bill, titled the "Ensuring Patient Access to Critical Breakthrough Products Act of 2025," aims to guarantee prompt Medicare coverage for innovative medical technologies. It establishes a 4-year transitional coverage period for devices designated as "breakthrough," during which Medicare will cover these products unless they are used off-label or pose an undue risk to beneficiaries. To qualify, a device must have received priority review from the Food and Drug Administration , and manufacturers can apply for this designation from the Secretary of Health and Human Services. The Secretary is required to make a determination within six months of application and must finalize a national coverage determination for these devices before their transitional coverage period expires. The legislation appropriates $10,000,000 annually to the Centers for Medicare & Medicaid Services Program Management Account for fiscal years 2026 through 2031 to implement these new provisions.