S. 1717 — Ensuring Patient Access to Critical Breakthrough Products Act of 2025

This section amends Medicare coverage exclusions under section 1862(a)(1) of the Social Security Act to provide a four-year transitional coverage period for breakthrough devices (i.e., devices designated by the Secretary receiving priority review under FDA section 515B), during which Medicare covers such devices unless furnished outside FDA-approved labeling or determined by the Secretary to present undue risk based on clinical data. It establishes a process, beginning 18 months after enactment, for manufacturers to apply for breakthrough device designation for certain FDA-cleared, classified, or approved devices, with determinations required within six months and annual reports to Congress on applications and designations. The section further requires the Secretary to issue national coverage determinations for breakthrough devices before the end of the transitional period if requests are submitted at least nine months (or 12 months for certain requests) prior to expiration and appropriates $10 million annually for FY2026 through FY2031 to CMS for implementation. (As background, Medicare generally excludes coverage for items and services not reasonable and necessary for diagnosis or treatment; thus, this creates a presumptive coverage pathway for prioritized innovative devices to expedite beneficiary access pending full review.)