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Ensuring Patient Access to Critical Breakthrough Products Act

H.R. 5343 Rep. Blake Moore (R-UT-1) In committee
Bill text PDF
  1. Introduced Sep 15
  2. Committee Sep 15
  3. Passed House Next
  4. Passed Senate Not yet
  5. To President Not yet
  6. Law Not yet
Where it stands
In committee, Sep 15, 2025Next: House vote
405d ago Sep 17, 2025: Ordered to be Reported in the Nature of a Substitute (Amended) by the Yeas and Nays: 37 - 3.
Final votes
No roll callsNo recorded vote on this bill yet
Lobbying
7companies, 43 filings
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21trades in the last 90 days
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Companies lobbying on this bill

7 companies
Companies by sector
Medical Devices & Healthcare 5Biotech & Pharma 1Industrials 1
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Summary

Ensuring Patient Access to Critical Breakthrough Products Act

Full summary4 paragraphs

This bill provides for Medicare coverage of medical devices that are approved under the Food and Drug Administration (FDA) Breakthrough Devices Program. (Under the program, manufacturers work with the FDA to expedite the review and approval of certain medical devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human diseases or conditions.)

The bill allows designated medical breakthrough devices to be temporarily covered under Medicare during a four-year transitional period. Manufacturers must apply to the Centers for Medicare & Medicaid Services (CMS) to receive this designation. Qualifying devices must (1) have received priority review from the FDA, (2) received premarket approval (if applicable) based on clinical data that includes data from Medicare beneficiaries, (3) already generally qualify for Medicare coverage, and (4) not present an undue risk of harm that outweighs potential clinical benefits for Medicare beneficiaries.

The CMS must approve or deny applications within six months of receipt and must provide an explanation in the case of a denial. In addition, the CMS must make permanent coverage decisions before the end of the transitional period upon a timely request to do so, as specified.

The bill provides funds through FY2030 for the CMS to implement the bill.

Library of Congress summary, Sep 15, 2025

Summary versions
  • Introduced in HouseSep 15, 2025

Official record from Congress.gov, the House Clerk and the Senate; lobbying from Lobbying Disclosure Act filings. Updated Oct 27, 2026.