Ensuring Patient Access to Critical Breakthrough Products Act of 2024
Official title: To amend title XVIII of the Social Security Act to ensure prompt coverage of breakthrough devices under the Medicare program, and for other purposes.
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Placed on the Union Calendar, Calendar No. 801.
Ensuring Patient Access to Critical Breakthrough Products Act of 2023
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. The Centers for Medicare & Medicaid Services (CMS) must assign payment codes for such devices within three months of FDA approval. The CMS must also establish a process to allow for continued coverage after the transitional period has expired, taking into account any additional evidence or data the CMS deems necessary.
The CMS must also provide for temporary and, where appropriate, permanent Medicare coverage of breakthrough devices for which there is no existing benefit category (i.e., classification).
- Introduced in House Formatted Text PDF Formatted XML
- Reported in House Formatted Text PDF Formatted XML
- LMH STRATEGIC SOLUTIONS
- HEALTHCARE INSTITUTE OF NEW JERSEY
- HEALTHCARE INSTITUTE OF NEW JERSEY
- LMH STRATEGIC SOLUTIONS
- ALZHEIMER'S ASSOCIATION
- LMH STRATEGIC SOLUTIONS
Bodies those filers lobbied
- HOUSE OF REPRESENTATIVES
- SENATE
- Health & Human Services, Dept of (HHS)
- Centers For Medicare and Medicaid Services (CMS)
- Food & Drug Administration (FDA)
- Centers For Disease Control & Prevention (CDC)
- White House Office
- Veterans Affairs, Dept of (VA)
Cite this page
U.S. Congress. (2026). H.R. 1691: Ensuring Patient Access to Critical Breakthrough Products Act of 2024. 118th Congress. Open America. https://openamerica.io/bill/118-HR-1691/
"H.R. 1691: Ensuring Patient Access to Critical Breakthrough Products Act of 2024." 118th Congress, 2026, Open America, https://openamerica.io/bill/118-HR-1691/.
H.R. 1691, 118th Cong. (2026), https://openamerica.io/bill/118-HR-1691/.
[H.R. 1691: Ensuring Patient Access to Critical Breakthrough Products Act of 2024](https://openamerica.io/bill/118-HR-1691/)