Ensuring Patient Access to Critical Breakthrough Products Act of 2025
The Ensuring Patient Access to Critical Breakthrough Products Act of 2025 would speed Medicare coverage for certain innovative medical devices called “breakthrough devices.” It creates a four-year transitional coverage period during which Medicare Part A and Part B beneficiaries could receive coverage for a designated breakthrough device even if the device is not yet fully aligned with FDA labeling, or if the Secretary, after reviewing clinical data, determines there is an undue risk that outweighs potential benefits. The bill also establishes a process to designate devices as breakthrough based on priority review status with the FDA (a new section 1899C), requires timely Medicare coverage decisions (NCDs) during the transition, and provides funding to CMS to implement these changes. Finally, it requires annual reporting to Congress on designation activity and coverage decisions, and it authorizes a dedicated funding amount for several fiscal years. In plain terms, if a device is deemed a breakthrough device by the Secretary, Medicare would cover it for a four-year period during which coverage could occur even if the labeling or full evidence is still evolving, with protections to withhold coverage if there is clear undue risk. The act also creates a formal designation pathway tied to FDA priority review and speeds up CMS’s coverage determinations during the transition, with new reporting and a dedicated funding stream for implementation.
Key Points
- 1Transitional coverage period for breakthrough devices: Establishes a four-year window starting when a device is designated as a breakthrough device, during which Medicare can cover the device even if it is not furnished strictly in accordance with FDA labeling or if the Secretary determines, based on clinical data, that there is an undue risk that outweighs benefits (subject to safety safeguards for Part A and Part B beneficiaries).
- 2Breakthrough device designation process (new Sec. 1899C): Beginning 18 months after enactment, manufacturers can apply for designation if the device is cleared/classified/approved under FDA pathways (510(k), 513(f)(2), or 515) on or after enactment. Designation requires that the device meet criteria (priority review under FDA section 515B). The Secretary must make a designation decision within six months, and if the device does not meet criteria, the Secretary must provide an explanation to the manufacturer.
- 3Ongoing reporting to Congress: The Secretary must annually report the number of applications received for designation, the number of devices designated as breakthrough devices, and the number of designation applications that did not meet the criteria.
- 4National Coverage Determination (NCD) during transition: Requires final Medicare coverage decisions for breakthrough devices to be issued before the end of the transitional period if applicable timing criteria are met, ensuring timely formal coverage decisions while the transitional coverage is in effect.
- 5Funding for implementation: Creates a dedicated appropriation of $10 million per fiscal year (FY2026–FY2031) for the CMS Program Management Account, available until expended, to carry out the amendments in the bill.
- 6Scope of devices and labeling: The designation relies on FDA priority review status and applies to devices cleared/classified/approved under FDA pathways after enactment, creating a link between FDA review speed and Medicare coverage dynamics.