Bill · S. 1717· Senate(119-S-1717)
Ensuring Patient Access to Critical Breakthrough Products Act of 2025
- Introduced
- 5/12/2025
- Last activity
- 5/12/2025 — Read twice and referred to the Committee on Finance.
- Sponsored by
- Todd Young
- Cosponsors
- - 2 - 3
- Introduced
- In Committee
What this bill would do
This bill, known as the "Ensuring Patient Access to Critical Breakthrough Products Act of 2025," seeks to amend the Social Security Act regarding Medicare coverage. It aims to ensure prompt coverage for "breakthrough devices" through a transitional coverage period. This period is defined as a 4-year window starting from the device's designation by the Secretary. The bill establishes a process for the Secretary to designate these devices based on priority review status. It also mandates specific timelines for making final decisions on national coverage determinations. Finally, it provides dedicated funding for the Centers for Medicare & Medicaid Services to manage these changes.
Yes· 3 of 5
Does this make health care easier to get in general?+6
The bill ensures prompt coverage for breakthrough medical devices through a transitional period to improve patient access to new technology.
Would people over 65 be better off under this?+5
The bill expands Medicare benefits which specifically serves the senior population through improved access to breakthrough devices.
Would retired people be better off under this?+5
The bill improves Medicare coverage and access to new medical technologies for retirees.
The opposite
Does this reduce what the federal government spends?-1
The bill appropriates $10,000,000 annually for CMS program management through 2031.
Who it would affect, and how
Potential Positive Impacts for People
-
Prompt Coverage for Breakthrough Devices: The bill amends the Social Security Act to include coverage for breakthrough devices during a "transitional coverage period" (Section 2(a)(1)(A)). This could provide individuals entitled to benefits under part A or enrolled under part B with earlier access to new medical technology.
-
Defined Designation Process: The Secretary is required to make a determination on a device application within 6 months of submission (Section 2(a)(3)(c)(1)). This creates a predictable timeline for manufacturers seeking breakthrough status.
-
Accountability Through Reporting: The Secretary must submit an annual report to Congress detailing the number of applications received, the number of devices designated, and the number of applications that did not meet the criteria (Section 2(a)(3)(d)). This ensures congressional oversight of the designation process.
-
Timely Coverage Decisions: The bill requires the Secretary to ensure a final decision on a national coverage determination request is made before the end of the transitional coverage period, provided the request was submitted within specific timeframes (Section 2(b)).
Potential Negative Impacts for People
- Risk of Harm: The bill notes that coverage may be impacted if the Secretary determines, based on clinical data, that a device "presents an undue risk of harm that outweighs the potential clinical benefits" (Section 2(a)(1)(A)). This acknowledges that new devices could potentially result in harm to individuals entitled to benefits.
Groups and Interests Ranking
Every group the model scored this bill for, from -10 to +10. Hover a score for the reason it gave.
- Demographic And Interest Groups
- Good For Retirees+5Good For Seniors+5Good For Low Income Households+2
- Healthcare
- Improves Healthcare Access+6Increases Medicare Funding+5
- Economy And Finance
- Reduces Government Spending-1
- 6/10/2026
- 2 Cosponsors added.
- 11/10/2025
- 2 Cosponsors added.
- 5/12/2025
- Read twice and referred to the Committee on Finance.
- 1 Cosponsor added.
- Introduced in Senate
John BarrassoRepublican · Wyoming
Roger MarshallRepublican · Kansas
Alex PadillaDemocrat · California
Adam SchiffDemocrat · California
Jeanne ShaheenDemocrat · New Hampshire