Bills · S 1717
IN COMMITTEE· 119TH CONGRESS
Senate BillS 1717Health
Ensuring Patient Access to Critical Breakthrough Products Act of 2025
INTRO MAY 12· LAST ACTION MAY 12
READING
4MIN
COSPONSORS
5BIPARTISAN
READER REACTIONS0 TOTAL
NO VOTES YET · BE THE FIRST
- Introduced only
LEGISLATIVE PROGRESS
STEP 2 / 8Introduced
In Committee
Reported
Passed Senate
Passed House
Conference
To President
Became Law
WHAT THE BILL DOES
AI-writtenCurrently, even after a new medical device is approved by the FDA as safe and effective, there can be a significant delay before Medicare decides whether it will pay for it. This gap means that patients, often those with serious conditions, might not be able to access the latest treatments, and manufacturers face uncertainty, which can stifle innovation.
This bill addresses that delay by creating a pathway for immediate, albeit temporary, Medicare coverage for breakthrough devices. If it becomes law, patients could gain earlier access to potentially life-changing or life-saving technologies. If it doesn't pass, the existing delays in Medicare coverage for new devices would likely continue, potentially limiting patient access and slowing the adoption of medical innovation.
KEY PROVISIONS
4AI-extractedPROVISION 01
Establishes a 4-year "transitional coverage period" during which Medicare will automatically cover breakthrough devices once they are designated as such.
This ensures immediate access for Medicare beneficiaries to innovative medical technologies, removing the delay often experienced between FDA approval and Medicare coverage.
PROVISION 02
Requires the Secretary of Health and Human Services to make a final national coverage decision for breakthrough devices before the end of their 4-year transitional coverage period.
This provision ensures that a permanent coverage decision is made in a timely manner, providing certainty for patients and manufacturers regarding long-term access.
PROVISION 03
Defines "breakthrough device" and sets up a process for manufacturers to apply for this designation, linking it to devices receiving priority review from the FDA.
This creates clear criteria and a mechanism for identifying which innovative devices are eligible for the expedited Medicare coverage.
PROVISION 04
Appropriates $10,000,000 annually for fiscal years 2026 through 2031 to the Centers for Medicare & Medicaid Services (CMS) to implement these new processes.
This funding supports CMS in developing and managing the systems required to handle the accelerated coverage and designation of breakthrough devices.
SPONSORSHIP
1 + 5
R· Indiana
YRS IN OFFICE
15
BILLS LED
65
COSPONSOR BREAKDOWNBIPARTISAN · 80%
DEM 3 REP 2 IND 0
ACTION TIMELINE
2 EVENTSMAY 12
Introduced in Senate
MAY 12
Read twice and referred to the Committee on Finance.
BILL INFO
TypeSenate Bill
NumberS 1717
Congress119th
StatusIn Committee
IntroducedMay 12, 2025
Last actionMay 12, 2025
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IN COMMITTEE· 119TH CONGRESS · FINANCE COMMITTEE · INTRODUCED MAY 12, 2025
Senate BillS 1717Health
Ensuring Patient Access to Critical Breakthrough Products Act of 2025
INTRODUCED MAY 12, 2025· LAST ACTION MAY 12, 2025
PASSAGE CHANCES
—%
READING
4 min
COSPONSORS
5
COMPLEXITY
Moderate
