Ensuring Patient Access to Critical Breakthrough Products Act of 2025
Sponsored By: Senator Young, Todd [R-IN]
Introduced
Summary
This bill would speed Medicare access to FDA-priority medical devices by creating a formal "breakthrough device" designation and a four-year transitional coverage window. It ties temporary coverage to FDA labeling and safety reviews so Medicare only covers devices that meet labeling rules and do not pose undue risk during that window.
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Bill Overview
Analyzed Economic Effects
2 provisions identified: 1 benefits, 0 costs, 1 mixed.
New Medicare rules for breakthrough devices
If enacted, the bill would create a new "breakthrough device" designation and give such devices a 4-year transitional coverage period. Definitions take effect on enactment and manufacturers could apply starting 18 months after enactment. The Secretary must decide designation applications within 6 months. Medicare would not cover a breakthrough device during the 4-year period if it is used outside FDA-approved labeling. Medicare could also deny coverage if the Secretary finds clinical data show undue risk that outweighs benefits. If an NCD request is filed at least 9 months before the transitional period ends, the Secretary must issue a final decision before that period ends. In some cases the cutoff is 12 months. The Secretary would report to Congress yearly on applications, designations, and denials.
Medicare agency funding for implementation
If enacted, the bill would give CMS $10 million per year for each fiscal year 2026 through 2031 to carry out these changes. The money would be in addition to other funds and would remain available until spent. CMS would use the funds to implement the breakthrough device designation and coverage rules.
Sponsors & CoSponsors
Sponsor
Young, Todd [R-IN]
IN • R
Cosponsors
Sen. Padilla, Alex [D-CA]
CA • D
Sponsored 5/12/2025
Roll Call Votes
No roll call votes available for this bill.
View on Congress.gov