Ensuring Patient Access to Critical Breakthrough Products Act
- Last Action
- 9/17/2025
Actions
- 2025-09-17Ordered to be Reported in the Nature of a Substitute (Amended) by the Yeas and Nays: 37 - 3.
- 2025-09-17Committee Consideration and Mark-up Session Held
- 2025-09-15Referred 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.
- 2025-09-15Referred 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.
- 2025-09-15Introduced in House
- 2025-09-15Introduced in House
CRS Summary
As of 2025-09-15 (00)
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.
Cosponsors (20)
- Suzan DelBene (D-WA)
- Rudy Yakym (R-IN)
- Terri Sewell (D-AL)
- Gus Bilirakis (R-FL)
- Lori Trahan (D-MA)
- Claudia Tenney (R-NY)
- Michelle Fischbach (R-MN)
- Bradley Schneider (D-IL)
- J. Correa (D-CA)
- Earl Carter (R-GA)
- Jake Auchincloss (D-MA)
- Carol Miller (R-WV)
- Ted Lieu (D-CA)
- Burgess Owens (R-UT)
- Ami Bera (D-CA)
- Randy Weber (R-TX)
- Darren Soto (D-FL)
- Jennifer Kiggans (R-VA)
- Chris Pappas (D-NH)
- Aaron Bean (R-FL)
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
Sourced from Congress.gov (public domain).
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.