Ensuring Patient Access to Critical Breakthrough Products Act
Official title: To amend title XVIII of the Social Security Act to ensure prompt coverage of breakthrough devices under the Medicare program.
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Ordered to be Reported in the Nature of a Substitute (Amended) by the Yeas and Nays: 37 - 3.
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.
- Introduced in House Formatted Text PDF Formatted XML
- WILLIAMS AND JENSEN, PLLC
- MEDTRONIC, INC.
- AVENUE SOLUTIONS
- AVENUE SOLUTIONS
- JOHNSON & JOHNSON SERVICES, INC.
- HEARTFLOW, INC.
Bodies those filers lobbied
- HOUSE OF REPRESENTATIVES
- SENATE
- Centers For Medicare and Medicaid Services (CMS)
- Health & Human Services, Dept of (HHS)
- Food & Drug Administration (FDA)
- Commerce, Dept of (DOC)
- U.S. Trade Representative (USTR)
- White House Office
Cite this page
U.S. Congress. (2026). H.R. 5343: Ensuring Patient Access to Critical Breakthrough Products Act. 119th Congress. Open America. https://openamerica.io/bill/119-HR-5343/
"H.R. 5343: Ensuring Patient Access to Critical Breakthrough Products Act." 119th Congress, 2026, Open America, https://openamerica.io/bill/119-HR-5343/.
H.R. 5343, 119th Cong. (2026), https://openamerica.io/bill/119-HR-5343/.
[H.R. 5343: Ensuring Patient Access to Critical Breakthrough Products Act](https://openamerica.io/bill/119-HR-5343/)