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119th Congress Health

H.R. 5343: Ensuring Patient Access to Critical Breakthrough Products Act

In CommitteeSep 17, 2025

  1. Introduced (completed)Sep 15, 2025
  2. Passed House (not reached)
  3. Passed Senate (not reached)
  4. To the President (not reached)
  5. Became law (not reached)

Summary

Introduced in House, Sep 15, 2025

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.

Read the full summary

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

Written by the Congressional Research Service, Library of Congress.

Roll calls

0 votes on this bill

No roll call votes have been held on this bill.

Amendments

0 offered

No amendments were offered to this bill.

Cosponsors

65

Bipartisan support.

Who scored on this bill

30 points earned
  1. 1Blake Moore R-UT SponsorDrew cross-party cosponsors, introduced, marked up, reached a cosponsor milestone5 events+30
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Introductions and cosponsorships count toward weekly caps and show no points.

Other bills by Blake Moore

History

  1. Sep 15, 2025Introduced in the House by Blake Moore.
Show the full action history (4 actions)
  1. Sep 17, 2025Committee Consideration and Mark-up Session Held
  2. Sep 17, 2025Ordered to be Reported in the Nature of a Substitute (Amended) by the Yeas and Nays: 37 - 3.
  3. Sep 15, 2025Introduced in House
  4. Sep 15, 2025Referred to the Committee on Ways and Means, and in addition to the Committee on Energy and Commerce, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.