HR5343119th CongressWALLET

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.*

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

Roll Call Votes

No roll call votes available for this bill.

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