US SB1717

Establishes a 4-year transitional coverage period under Medicare for FDA-designated breakthrough medical devices, beginning when the Secretary designates a device as a breakthrough device

Requires the Secretary to make a determination on breakthrough device designation applications within 6 months of submission, with the process beginning 18 months after enactment

Devices must have received FDA priority review under section 515B of the Federal Food, Drug, and Cosmetic Act to qualify for breakthrough device designation

Mandates that national coverage determinations for breakthrough devices be completed before the transitional coverage period ends if requests are submitted at least 9-12 months before the period concludes

Appropriates $10,000,000 annually for fiscal years 2026 through 2031 to the Centers for Medicare & Medicaid Services Program Management Account to implement these provisions