Ensuring Patient Access to Critical Breakthrough Products Act
Sponsored By: Representative Moore (UT)
In Committee
Summary
This bill would create a structured, four-year pathway that gives Medicare special, time-limited coverage for FDA-designated breakthrough medical devices. Coverage during that transition is tied to following FDA-approved labeling or to a Secretary review that the device's benefits outweigh its risks.
Show full summary
- Medicare beneficiaries: Seniors and other people on Parts A and B would have a defined four-year window of transitional coverage for devices the FDA designates as breakthrough. Coverage depends on using the device as labeled or on a Secretary risk-benefit finding.
- Device manufacturers: Manufacturers can seek a breakthrough designation starting 18 months after enactment and would get a decision within six months of application. A designation triggers the four-year transitional coverage period and faster coverage review timelines.
- CMS and providers: CMS must report annually on applications and designations and may review providers with unusual billing for these devices to protect program integrity. The Secretary must issue final national coverage decisions within set deadlines so decisions finish during the transition when requests meet timing rules.
*This bill would increase federal spending by $10 million per year from fiscal 2025 through 2030, about $60 million total, to fund CMS implementation and oversight.*
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Bill Overview
Analyzed Economic Effects
4 provisions identified: 3 benefits, 0 costs, 1 mixed.
Faster Medicare decisions on new devices
If enacted, Medicare would need to finish a national coverage decision for a breakthrough device before its 4-year transition ends. This would apply when a request is filed at least 9 months before the end of the transition. In some cases, the filing would need to be 12 months ahead. This aims to give patients and providers clearer answers before temporary coverage runs out.
Temporary Medicare coverage for breakthrough devices
This bill would create a new path for some FDA-designated "breakthrough" devices to get Medicare coverage. Starting 18 months after enactment, makers could apply for a breakthrough label, and the Secretary would decide within 6 months. If designated, a 4-year transition period would start on the designation date. During that period, Medicare would cover the device only when used as the FDA label says for the priority-reviewed use. The Secretary could deny coverage if clinical data show the device’s risks outweigh its benefits.
Checks on unusual Medicare device billing
If enacted, the Secretary could review providers who bill unusually for a breakthrough device. Reviews would check if using the device was medically necessary and reasonable. This tool would target outliers and protect Medicare from improper payments.
Funds to run Medicare device program
This bill would give CMS $10 million each year from 2025 through 2030. The money would stay available until spent. CMS would use it to carry out the bill’s Medicare device coverage changes.
Sponsors & CoSponsors
Sponsor
Moore (UT)
UT • R
Cosponsors
DelBene
WA • D
Sponsored 9/15/2025
Yakym
IN • R
Sponsored 9/15/2025
Sewell
AL • D
Sponsored 9/15/2025
Bilirakis
FL • R
Sponsored 9/15/2025
Trahan
MA • D
Sponsored 9/15/2025
Tenney
NY • R
Sponsored 9/16/2025
Fischbach
MN • R
Sponsored 9/16/2025
Schneider
IL • D
Sponsored 9/17/2025
Correa
CA • D
Sponsored 9/19/2025
Carter (GA)
GA • R
Sponsored 10/31/2025
Auchincloss
MA • D
Sponsored 10/31/2025
Miller (WV)
WV • R
Sponsored 11/7/2025
Lieu
CA • D
Sponsored 11/7/2025
Owens
UT • R
Sponsored 11/18/2025
Bera
CA • D
Sponsored 11/18/2025
Weber (TX)
TX • R
Sponsored 12/2/2025
Soto
FL • D
Sponsored 12/2/2025
Kiggans (VA)
VA • R
Sponsored 12/9/2025
Pappas
NH • D
Sponsored 12/9/2025
Bean (FL)
FL • R
Sponsored 12/17/2025
Panetta
CA • D
Sponsored 1/6/2026
Bentz
OR • R
Sponsored 1/14/2026
Ross
NC • D
Sponsored 1/14/2026
Lawler
NY • R
Sponsored 2/3/2026
Strickland
WA • D
Sponsored 2/3/2026
Carey
OH • R
Sponsored 2/3/2026
Gottheimer
NJ • D
Sponsored 2/3/2026
Malliotakis
NY • R
Sponsored 2/3/2026
Pettersen
CO • D
Sponsored 2/3/2026
Fitzpatrick
PA • R
Sponsored 2/10/2026
Lofgren
CA • D
Sponsored 2/10/2026
Joyce (PA)
PA • R
Sponsored 2/11/2026
Cohen
TN • D
Sponsored 2/11/2026
Maloy
UT • R
Sponsored 2/11/2026
Houlahan
PA • D
Sponsored 2/11/2026
Meuser
PA • R
Sponsored 3/16/2026
Craig
MN • D
Sponsored 3/16/2026
Valadao
CA • R
Sponsored 4/2/2026
Whitesides
CA • D
Sponsored 4/2/2026
Roll Call Votes
No roll call votes available for this bill.
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