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119-hr-5343Committee
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Ensuring Patient Access to Critical Breakthrough Products Act

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Summary

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This bill amends Medicare law to establish a pathway for prompt coverage of FDA-designated breakthrough medical devices. Devices that receive FDA priority review and meet specified clinical criteria would be automatically covered by Medicare for a four-year transitional period following their FDA clearance or approval, unless the Secretary determines they present undue risk. The bill requires the Secretary to make breakthrough device designations within six months of application and to complete national coverage determinations before the transitional period ends, and appropriates $10 million annually through fiscal year 2030 to implement these provisions.

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Bill details

Congress
119
Bill type
hr
Introduced
September 15, 2025
Sponsor
Blake MooreRUT
Cosponsors
51
Last action
September 17, 2025— Ordered to be Reported in the Nature of a Substitute (Amended) by the Yeas and Nays: 37 - 3.

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