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Ensuring Patient Access to Critical Breakthrough Products Act of 2024

H.R. 1691 Rep. Brad Wenstrup (R-OH-2) In committee
Bill text PDF
  1. Introduced Mar 22
  2. Committee Mar 22
  3. Passed House Next
  4. Passed Senate Not yet
  5. To President Not yet
  6. Law Not yet
Where it stands
In committee, Mar 22, 2023Next: House vote
673d ago Dec 24, 2024: Placed on the Union Calendar, Calendar No. 801.
Final votes
No roll callsNo recorded vote on this bill yet
Lobbying
8companies, 9 filings
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Member trades
14trades in the last 90 days
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Companies lobbying on this bill

8 companies
Companies by sector
Medical Devices & Healthcare 7Biotech & Pharma 1
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Summary

Ensuring Patient Access to Critical Breakthrough Products Act of 2023

Full summary3 paragraphs

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).

Library of Congress summary, Mar 22, 2023

Summary versions
  • Introduced in HouseMar 22, 2023

Official record from Congress.gov, the House Clerk and the Senate; lobbying from Lobbying Disclosure Act filings. Updated Oct 28, 2026.