H.R. 5343 · 119th Congress

Ensuring Patient Access to Critical Breakthrough Products Act

Introduced on Sep 15, 2025 by Blake D. Moore (R-UT-1). 65 cosponsors, 32 of them from another party. Latest action (Sep 17, 2025): Ordered to be Reported in the Nature of a Substitute (Amended) by the Yeas and Nays: 37 - 3.

Stage
Introduced
Introduced
Sep 15, 2025
Cosponsors
65
32 from the other party
Policy area
Health
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Progress

The furthest stage the measure reached. Simple and concurrent resolutions do not go to the President.

  1. Introduced
  2. 2Reported by committee
  3. 3Passed one chamber
  4. 4Passed both chambers
  5. 5Sent to the President
  6. 6Became law

Official title

To amend title XVIII of the Social Security Act to ensure prompt coverage of breakthrough devices under the Medicare program.

Subjects

  • Congressional oversight
  • Drug safety, medical device, and laboratory regulation
  • Health care costs and insurance
  • Health care coverage and access
  • Health programs administration and funding
  • Health technology, devices, supplies
  • Medicare

Summary

By the Congressional Research Service (Introduced in House, Sep 15, 2025). Public domain.

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.

Sponsor and cosponsors

Cosponsors by party as of the day they signed on. Original cosponsors signed on the day of introduction.

Blake D. MooreR-UT-1Sponsor

Democrats · 32

Republicans · 33

Roll calls

Recorded votes on the measure. Most measures move by voice vote or unanimous consent, which record no individual positions.

No recorded roll call on this measure: it moved by voice vote or unanimous consent, or has not reached the floor.

History

Every action as published, oldest first. Roll calls link to how each member voted.

  1. Sep 15, 2025Introduced in House
  2. Sep 15, 2025Introduced in House
  3. Sep 15, 2025 · HouseReferred 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.
  4. Sep 15, 2025 · HouseReferred 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.
  5. Sep 17, 2025 · HouseCommittee Consideration and Mark-up Session Held
  6. Sep 17, 2025 · HouseOrdered to be Reported in the Nature of a Substitute (Amended) by the Yeas and Nays: 37 - 3.

Committees

Committees and subcommittees the measure was referred to.

Agencies in its committees' jurisdiction

Analisa's mapping of committee jurisdiction to federal agencies; the bill may touch others, or none of these.

Who lobbied on it

Organizations whose lobbying reports (LD-2) name this measure. Spending is what they reported for those quarters on all issues, not on this measure alone.

  1. MEDICAL DEVICE MANUFACTURERS ASSOCIATION11 reports
    $1.2M reported (all issues)
  2. Advanced Medical Technology Association (AdvaMed)8 reports
    $440K reported (all issues)
  3. EDWARDS LIFESCIENCES8 reports
    $1.3M reported (all issues)Federal contractor: EDWARDS LIFESCIENCES LLC$28.2M in contracts, FY2026AI match · 100%
  4. JOHNSON & JOHNSON SERVICES, INC.7 reports
    $8.9M reported (all issues)
  5. NOVOCURE INC.7 reports
    $560K reported (all issues)
  6. SIEMENS MEDICAL SOLUTIONS USA INC.5 reports
    $2.3M reported (all issues)Federal contractor: SIEMENS MEDICAL SOLUTIONS USA, INC.AI match · 100%
  7. ADVANCED MEDICAL TECHNOLOGY ASSN4 reports
    $3.9M reported (all issues)
  8. BOSTON SCIENTIFIC CORPORATION4 reports
    $2.4M reported (all issues)Federal contractor: BOSTON SCIENTIFIC CORP$20M in contracts, FY2026AI match · 100%
  9. COOK GROUP INC4 reports
    $560K reported (all issues)
  10. F. Hoffmann-La Roche Ltd4 reports
    $430K reported (all issues)
  11. Life Sciences Pennsylvania4 reports
  12. MEDTRONIC INC.4 reports
    $5.2M reported (all issues)Federal contractor: MEDTRONIC USA INC$10M in contracts, FY2026AI match · 99%
  13. Philips Holding USA, Inc.4 reports
    $2.4M reported (all issues)
  14. ROCHE DIAGNOSTICS CORPORATION4 reports
    $160K reported (all issues)Federal contractor: ROCHE DIAGNOSTICS CORPORATION$89.1M in contracts, FY2026AI match · 100%
  15. Alzheimer's Association2 reports
    $2.3M reported (all issues)
  16. CURE SMA2 reports
    $150K reported (all issues)
  17. Insightec, Inc.2 reports
    $60K reported (all issues)
  18. National Health Council2 reports
    $42K reported (all issues)
  19. Thermo Fisher Scientific Inc.2 reports
    $990K reported (all issues)Federal contractor: THERMO FISHER SCIENTIFIC (ASHEVILLE) LLC$2.2M in contracts, FY2026AI match · 100%
  20. American Medical Association1 report
    $4.6M reported (all issues)Federal contractor: AMERICAN MEDICAL ASSOCIATION$371K in contracts, FY2026AI match · 99%
  21. Epilepsy Foundation1 report
    $60K reported (all issues)
  22. HEARTFLOW, INC.1 report
    $100K reported (all issues)
  23. THE NEW ENGLAND COUNCIL1 report
    $10K reported (all issues)
  24. UNITED SPINAL ASSOCIATION1 report

Reports filed in 2025, 2026.

Sources and method

Every figure on this page traces to these records.

  • Bill status: bills and resolutions, sponsors, actions, subjects and CRS summaries (U.S. Government Publishing Office (GovInfo), from Congress.gov (Library of Congress))GovInfo Bill Status bulk data (Congress.gov; summaries by the Congressional Research Service) · data current to Oct 6, 2026 · loaded Oct 6, 2026 · license: Public domain (U.S. Government work, 17 U.S.C. § 105)
  • Members of Congress, their terms, committees and identifiers (The @unitedstates project (from the Biographical Directory of the U.S. Congress, the House and the Senate))unitedstates/congress-legislators: legislators, committees and current committee membership · data current to Oct 3, 2026 · loaded Oct 3, 2026 · license: CC0 1.0 (public domain dedication)
  • House roll-call votes (Office of the Clerk, U.S. House of Representatives)Office of the Clerk, U.S. House of Representatives, roll-call vote records · data current to Oct 3, 2026 · loaded Oct 3, 2026 · license: Public domain (U.S. Government work, 17 U.S.C. § 105)
  • Senate roll-call votes and DW-NOMINATE scores (Voteview (UCLA Department of Political Science))Lewis, Jeffrey B., Keith Poole, Howard Rosenthal, Adam Boche, Aaron Rudkin, and Luke Sonnet (2026). Voteview: Congressional Roll-Call Votes Database. https://voteview.com/ · data current to Oct 3, 2026 · loaded Oct 3, 2026 · license: Free to use with the required citation
  • Lobbying disclosures (LD-1 registrations, LD-2 quarterly reports, LD-203 contribution reports) (Clerk of the U.S. House of Representatives)Clerk of the House, Lobbying Disclosure Act filings (organizations only; lobbyists' names are not loaded) · data current to Oct 6, 2026 · loaded Oct 6, 2026 · license: Public domain (U.S. Government work, 17 U.S.C. § 105)
  • Positions are shown only where a roll call recorded them; voice votes and unanimous consent record none.
  • Money and votes are shown side by side; neither explains the other.