HR5343Referred to Committee

Ensuring Patient Access to Critical Breakthrough Products Act

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Introduced
In Committee
3
Passed One Chamber
4
Passed Both
5
Signed into Law
119th
Congress
2025-09-15
Introduced
65
Cosponsors
HR
ⓘ
Type

Sponsor

Blake D. Moore
Blake D. Moore
Republican · UT · Representative
Votes with party: 97.9% (652 recorded votes)

Full profile: /officials/M001213

Source: Congress.gov · FEC

Cosponsors (65)

Members who have signed on to support this bill since introduction. Source: Congress.gov.

Latest Action

The most recent step in the bill's legislative path. Committee Activity below shows referrals and reports; the full action-by-action history including floor proceedings lives at Congress.gov →

Ordered to be Reported in the Nature of a Substitute (Amended) by the Yeas and Nays: 37 - 3.

2025-09-17

Source: Congress.gov

Committee Activity

Currently in

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Plain-English Summary

Ensuring Patient Access to Critical Breakthrough Products Act 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.

Plain-English rewrite of the Congressional Research Service summary published on Congress.gov. Cached and reviewed.

Subjects

Health
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