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.