HR 5343 119th Congress
Ensuring Patient Access to Critical Breakthrough Products Act
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Introduction Congress.gov
Introduced
Introduced in the House.
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Referred 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.
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Referred 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.
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Introduced in House
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Introduced in House
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Introduced in House
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Ordered to be Reported in the Nature of a Substitute (Amended) by the Yeas and Nays: 37 - 3.
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Committee Consideration and Mark-up Session Held
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| Date and time | Record | Official detail | Source |
|---|---|---|---|
| IntroductionIntroduced | Introduced in the House. | Congress.gov | |
| Official actionReferred 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. | No additional detail supplied.IntroReferral · House floor actions · Code H11100 | Congress.gov | |
| Official actionReferred 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. | No additional detail supplied.IntroReferral · House floor actions · Code H11100 | Congress.gov | |
| Official actionIntroduced in House | No additional detail supplied.IntroReferral · Library of Congress · Code Intro-H | Congress.gov | |
| Official actionIntroduced in House | No additional detail supplied.IntroReferral · Library of Congress · Code 1000 | Congress.gov | |
| Text versionIntroduced in House | A dated text-version record is available. | Congress.gov | |
| Official actionOrdered to be Reported in the Nature of a Substitute (Amended) by the Yeas and Nays: 37 - 3. | No additional detail supplied.Committee · House committee actions · Code H19000 | Congress.gov | |
| Official actionCommittee Consideration and Mark-up Session Held | No additional detail supplied.Committee · House committee actions · Code H15001 | Congress.gov |
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Congressional Research Service
CRS summary
Ensuring Patient Access to Critical Breakthrough Products ActThis 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.
Official documents
Text versions
- Introduced in HouseSep 15, 2025