H.R. 5343: Ensuring Patient Access to Critical Breakthrough Products Act
This bill, titled the Ensuring Patient Access to Critical Breakthrough Products Act
, aims to modify the Medicare program to enhance the coverage of breakthrough devices. Here’s a summary of its main provisions:
1. Definition of Breakthrough Devices
The bill establishes a formal definition for breakthrough device
, which refers to devices designated by the Secretary of Health and Human Services that meet specific criteria. These devices are typically those that have received priority review by the FDA and are intended for patients who would benefit from new technology for treatment or diagnosis.
2. Transitional Coverage Period
The bill introduces a transitional coverage period
of four years for breakthrough devices upon their designation by the Secretary. During this period, Medicare will provide coverage for these devices under certain conditions.
3. Ensured Coverage During Transitional Period
To ensure that breakthrough devices receive prompt coverage, the bill amends the Social Security Act to allow coverage unless the device has been determined to:
- Not meet FDA-approved labeling requirements.
- Present an undue risk of harm outweighing clinical benefits.
4. Designation Process for Breakthrough Devices
Manufacturers can request designation for their devices. The Secretary has up to six months to determine whether the device meets specified criteria, which include:
- Having priority review as outlined in existing FDA regulations.
- Clinical data supporting its effectiveness for Medicare beneficiaries.
- Being eligible for coverage under Medicare.
- Not presenting undue risks compared to potential benefits.
5. Reports and Reviews
The Secretary of Health and Human Services is required to submit annual reports to Congress detailing the number of applications for breakthrough designations and the outcomes of those applications.
6. National Coverage Determinations
The bill mandates that decisions regarding national coverage for breakthrough devices be made within the transitional coverage period if requests are submitted in a timely manner.
7. Funding Provisions
The legislation includes provisions for funding, allocating $10 million annually from 2025 to 2030 for the Centers for Medicare & Medicaid Services (CMS) to implement the provisions of this act.
8. Review of Billing Patterns
The Secretary is empowered to review the medical necessity and billing patterns of health care providers with regards to the provision of breakthrough devices to ensure that services provided are reasonable and necessary.
Relevant Companies
- MDGL - The company manufactures and may develop breakthrough medical devices aligned with the act's criteria, thus potentially increasing their market reach and Medicare reimbursement opportunities.
- DHR - As a global leader in medical technology, any breakthrough devices they launch could be expedited through Medicare under this bill, potentially boosting sales.
This is an AI-generated summary of the bill text. There may be mistakes.
Sponsors
36 bill sponsors
-
TrackBlake D. Moore
Sponsor
-
TrackJake Auchincloss
Co-Sponsor
-
TrackAaron Bean
Co-Sponsor
-
TrackCliff Bentz
Co-Sponsor
-
TrackAmi Bera
Co-Sponsor
-
TrackGus M. Bilirakis
Co-Sponsor
-
TrackMike Carey
Co-Sponsor
-
TrackEarl L. "Buddy" Carter
Co-Sponsor
-
TrackSteve Cohen
Co-Sponsor
-
TrackJ. Luis Correa
Co-Sponsor
-
TrackSuzan K. DelBene
Co-Sponsor
-
TrackMichelle Fischbach
Co-Sponsor
-
TrackBrian K. Fitzpatrick
Co-Sponsor
-
TrackJosh Gottheimer
Co-Sponsor
-
TrackChrissy Houlahan
Co-Sponsor
-
TrackJohn Joyce
Co-Sponsor
-
TrackJennifer Kiggans
Co-Sponsor
-
TrackMichael Lawler
Co-Sponsor
-
TrackTed Lieu
Co-Sponsor
-
TrackZoe Lofgren
Co-Sponsor
-
TrackNicole Malliotakis
Co-Sponsor
-
TrackCeleste Maloy
Co-Sponsor
-
TrackCarol D. Miller
Co-Sponsor
-
TrackBurgess Owens
Co-Sponsor
-
TrackJimmy Panetta
Co-Sponsor
-
TrackChris Pappas
Co-Sponsor
-
TrackBrittany Pettersen
Co-Sponsor
-
TrackDeborah K. Ross
Co-Sponsor
-
TrackBradley Scott Schneider
Co-Sponsor
-
TrackTerri A. Sewell
Co-Sponsor
-
TrackDarren Soto
Co-Sponsor
-
TrackMarilyn Strickland
Co-Sponsor
-
TrackClaudia Tenney
Co-Sponsor
-
TrackLori Trahan
Co-Sponsor
-
TrackRandy K. Weber, Sr.
Co-Sponsor
-
TrackRudy Yakym III
Co-Sponsor
Actions
4 actions
| Date | Action |
|---|---|
| Sep. 17, 2025 | Committee Consideration and Mark-up Session Held |
| Sep. 17, 2025 | Ordered to be Reported in the Nature of a Substitute (Amended) by the Yeas and Nays: 37 - 3. |
| Sep. 15, 2025 | Introduced in House |
| Sep. 15, 2025 | 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. |
Corporate Lobbying
4 companies lobbying
