Ensuring Patient Access to Critical Breakthrough Products Act

Bill Number

H.R. 5343

Origin Chamber

House

Congress

119th Congress, Session 1

Policy Area

Health

Status

Introduced

Latest Action

2025-09-17: Ordered to be Reported in the Nature of a Substitute (Amended) by the Yeas and Nays: 37 - 3.

Last Updated

2026-07-01T08:08:38Z

AI-Generated Summary

Purpose

The Ensuring Patient Access to Critical Breakthrough Products Act (H.R. 5343) aims to speed up Medicare coverage for innovative medical devices that receive priority review from the Food and Drug Administration (FDA). It ensures these "breakthrough devices" are covered during an initial four-year period, helping Medicare patients access cutting-edge treatments more quickly while maintaining safety checks.

Key Provisions

• Definition of Breakthrough Devices: A breakthrough device is a medical device (as defined by the FDA) that:
• Receives priority review from the FDA under section 515B of the Federal Food, Drug, and Cosmetic Act (a process for devices addressing life-threatening conditions with no approved alternatives).
• Is cleared, classified, or approved by the FDA on or after the bill's enactment.
• Meets additional criteria, including clinical data from trials involving Medicare patients, potential for coverage under Medicare without this law, and no undue risk of harm outweighing benefits (as determined by the Secretary of Health and Human Services).
• Transitional Coverage Period: Medicare must cover breakthrough devices for four years starting from their designation, unless the device is used outside FDA-approved labeling or poses excessive risks based on clinical data review.
• Designation Process:
• Manufacturers can apply to the Secretary for designation starting 18 months after enactment.
• The Secretary must decide within six months, providing explanations for denials.
• Annual reports to Congress on applications, designations, and denials.
• National Coverage Determinations: If a request for a Medicare-wide coverage decision (a formal review to determine if an item is medically necessary) is submitted at least nine (or 12) months before the transitional period ends, the Secretary must finalize it before the period expires.
• Oversight and Funding: Allows review of unusual billing patterns for these devices to prevent abuse. Provides $10 million annually from 2025 to 2030 to the Centers for Medicare & Medicaid Services (CMS) for implementation.

Significant Changes to Existing Law

• Amends Section 1862(a)(1) of the Social Security Act to add an exception to Medicare's general rule against covering experimental or investigational items, specifically mandating coverage for breakthrough devices during the transitional period.
• Adds new definitions to Section 1861 (e.g., "breakthrough device" and "transitional coverage period").
• Introduces a new Section 1899D for the designation process, linking it to FDA priority review and requiring involvement of Medicare patient data in approvals.
• Modifies Section 1862(l)(2) to prioritize and expedite national coverage decisions for these devices, ensuring decisions align with the four-year window.

These changes build on existing FDA breakthrough device programs but integrate them directly into Medicare rules, which previously lacked automatic or expedited coverage pathways for such innovations.

Potential Impacts

• On Government Agencies: CMS gains new administrative duties, including processing applications, making designations, and conducting billing reviews, supported by dedicated funding. This could increase workload but streamline coverage decisions, reducing delays in Medicare policy.
• On Citizens: Medicare beneficiaries (primarily seniors and people with disabilities) may gain faster access to advanced devices for serious conditions, potentially improving health outcomes and quality of life. However, coverage is limited to FDA-approved uses, with safeguards against unsafe applications.
• On International Relations: No direct impacts; the bill focuses on domestic U.S. healthcare policy and FDA/Medicare processes.

Main Stakeholders Affected

• Medicare Beneficiaries: Primary beneficiaries who could access innovative devices sooner for treating illnesses or injuries.
• Device Manufacturers: Gain a faster path to Medicare reimbursement, encouraging investment in priority-reviewed technologies.
• Healthcare Providers and Suppliers: Can furnish covered devices without immediate coverage denials, but must adhere to FDA labeling and face billing audits for outliers.
• CMS and HHS Secretary: Responsible for designations, reviews, and reports, influencing how quickly innovations reach patients.
• FDA: Indirectly affected, as its priority review designations trigger Medicare processes.

Notable Legal, Constitutional, or Political Implications

• Legal: Strengthens integration between FDA approvals and Medicare coverage, potentially reducing legal challenges over "experimental" device denials under existing Social Security Act rules. Includes due process via explanations for denials and clinical data reviews to ensure evidence-based decisions.
• Constitutional: Aligns with Congress's authority to regulate interstate commerce and spending (via Medicare), without raising clear separation-of-powers issues, as it delegates implementation to the executive branch (HHS/CMS) with reporting requirements to Congress.
• Political: Promotes bipartisan support for medical innovation (introduced by a diverse group of representatives), but could spark debates on healthcare costs, as expedited coverage might increase Medicare spending without offsetting savings. Annual congressional reports provide oversight to monitor effectiveness and prevent overuse.

This summary was generated by AI and may contain inaccuracies. Refer to the official source document for the authoritative text.

Sponsor

Rep. Moore, Blake D. [R-UT-1]

Cosponsors (56)

Rep. DelBene, Suzan K. [D-WA-1], Rep. Yakym, Rudy [R-IN-2], Rep. Sewell, Terri A. [D-AL-7], Rep. Bilirakis, Gus M. [R-FL-12], Rep. Trahan, Lori [D-MA-3], Rep. Tenney, Claudia [R-NY-24], Rep. Fischbach, Michelle [R-MN-7], Rep. Schneider, Bradley Scott [D-IL-10], Rep. Correa, J. Luis [D-CA-46], Rep. Carter, Earl L. "Buddy" [R-GA-1], Rep. Auchincloss, Jake [D-MA-4], Rep. Miller, Carol D. [R-WV-1], Rep. Lieu, Ted [D-CA-36], Rep. Owens, Burgess [R-UT-4], Rep. Bera, Ami [D-CA-6], Rep. Weber, Randy K. Sr. [R-TX-14], Rep. Soto, Darren [D-FL-9], Rep. Kiggans, Jennifer A. [R-VA-2], Rep. Pappas, Chris [D-NH-1], Rep. Bean, Aaron [R-FL-4], Rep. Panetta, Jimmy [D-CA-19], Rep. Bentz, Cliff [R-OR-2], Rep. Ross, Deborah K. [D-NC-2], Rep. Lawler, Michael [R-NY-17], Rep. Strickland, Marilyn [D-WA-10], Rep. Carey, Mike [R-OH-15], Rep. Gottheimer, Josh [D-NJ-5], Rep. Malliotakis, Nicole [R-NY-11], Rep. Pettersen, Brittany [D-CO-7], Rep. Fitzpatrick, Brian K. [R-PA-1], Rep. Lofgren, Zoe [D-CA-18], Rep. Joyce, John [R-PA-13], Rep. Cohen, Steve [D-TN-9], Rep. Maloy, Celeste [R-UT-2], Rep. Houlahan, Chrissy [D-PA-6], Rep. Meuser, Daniel [R-PA-9], Rep. Craig, Angie [D-MN-2], Rep. Valadao, David G. [R-CA-22], Rep. Whitesides, George [D-CA-27], Rep. Obernolte, Jay [R-CA-23], Rep. Boyle, Brendan F. [D-PA-2], Rep. Ciscomani, Juan [R-AZ-6], Rep. Crow, Jason [D-CO-6], Rep. Kennedy, Mike [R-UT-3], Rep. Goodlander, Maggie [D-NH-2], Rep. Murphy, Gregory F. [R-NC-3], Rep. Mullin, Kevin [D-CA-15], Rep. Kustoff, David [R-TN-8], Rep. Davids, Sharice [D-KS-3], Rep. Rutherford, John H. [R-FL-5] and 6 more

Recent Actions

• 2025-09-17: Ordered to be Reported in the Nature of a Substitute (Amended) by the Yeas and Nays: 37 - 3.
• 2025-09-17: Committee Consideration and Mark-up Session Held
• 2025-09-15: Referred 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.
• 2025-09-15: Referred 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.
• 2025-09-15: Introduced in House
• 2025-09-15: Introduced in House

Bill Versions

• Ensuring Patient Access to Critical Breakthrough Products Act — issued 2025-09-15 — PDF (7 pages)