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118th Congress Health

H.R. 1691: Ensuring Patient Access to Critical Breakthrough Products Act of 2024

ReportedDec 24, 2024

  1. Introduced (completed)Mar 22, 2023
  2. Passed House (not reached)
  3. Passed Senate (not reached)
  4. To the President (not reached)
  5. Became law (not reached)

Summary

Introduced in House, Mar 22, 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).

Written by the Congressional Research Service, Library of Congress.

Roll calls

0 votes on this bill

No roll call votes have been held on this bill.

Amendments

0 offered

No amendments were offered to this bill.

Cosponsors

89

Bipartisan support.

Who scored on this bill

74 points earned
  1. 1Brad Wenstrup R-OH SponsorDrew cross-party cosponsors, introduced, reached a cosponsor milestone, marked up, reported, discharged7 events+74
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Introductions and cosponsorships count toward weekly caps and show no points.

Other bills by Brad Wenstrup

History

  1. Mar 22, 2023Introduced in the House by Brad Wenstrup.
Show the full action history (10 actions)
  1. Dec 24, 2024Reported (Amended) by the Committee on Ways and Means. H. Rept. 118-952, Part I.
  2. Dec 24, 2024Committee on Energy and Commerce discharged.
  3. Dec 24, 2024Placed on the Union Calendar, Calendar No. 801.
  4. Jun 27, 2024Committee Consideration and Mark-up Session Held
  5. Jun 27, 2024Ordered to be Reported in the Nature of a Substitute (Amended) by the Yeas and Nays: 36 - 5.
  6. Nov 15, 2023Subcommittee Consideration and Mark-up Session Held
  7. Nov 15, 2023Forwarded by Subcommittee to Full Committee by the Yeas and Nays: 21 - 6.
  8. Mar 31, 2023Referred to the Subcommittee on Health.
  9. Mar 22, 2023Introduced in House
  10. Mar 22, 2023Referred 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.