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HR 5343 - 119

Ensuring Patient Access to Critical Breakthrough Products Act

Ordered to be Reported in the Nature of a Substitute (Amended) by the Yeas and Nays: 37 - 3.

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Healthcare
2 evidence matches
Impact 99% Confidence 90%

Health

Ensuring Patient Access to Critical Breakthrough Products Act Ordered to be Reported in the Nature of a Substitute (Amended) by the Yeas and Nays: 37 - 3. Health

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Issue areas in linked filings
Health Issues: 3
Clients in linked filings
INSIGHTEC, INC.: 2CURE SMA: 1
2026 · 1st Quarter (Jan 1 - Mar 31) · 1st Quarter - Report

CURE SMA

Registrant: CURE SMA
Health Issues Matched H.R. 5343

Research into spinal muscular atrophy, timely access to care, treatments, medical devices, and home and community-based services, Give Kids a Chance Act (H.R.1261/ S.932- FDA Pediatric Priority Review Voucher Program), DOD Congressionally Directed Medical Research Program & Peer-Reviewed Medical Research Program, Labor-Health and Human Services, and Education Appropriations bill, Family Caregiver Awareness, Resources, and Education (CARE) Partnerships Act, Pediatric Palliative Care Homes, National Institute on Disability, Independent Living, and Rehabilitation Research funding, Seat Elevation in Group 2 Non-Complex Power Wheelchairs, Coverage of Standing Systems in Group 3 Power Wheelchair, Competitive Bidding for Tracheostomy, Ostomy and Urological Supplies; FDA Rare Disease Patient Listening Session, Coverage of Respiratory Assist Devices (RADs) and Home Mechanical Ventilators (HMVs), Accelerating Kids Access to Care Act (H.R. 1509/S. 752, National Institutes of Health funding; Medicaid home and community-based services, Public Law 119-21 Medicaid Community Engagement Requirements - disability and medically frail definition; Ensuring Patient Access to Critical Breakthrough Products Act (H.R. 5343), Veterans STAND Act (H.R. 6835), Veterans SPORTS Act (S. 3138) Consolidated Appropriations Act of 2026 (P.L. 119-75)

Open LDA filing source

Summary

00 Introduced in House Jul 29, 2026

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.

Sponsors

Crow, Jason
Cosponsor

Crow, Jason

Democratic · CO-6 · C001121

Joined Apr 9, 2026
Website
N/A
Office
1323 Longworth House Office Building

Amendments

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