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119th Congress · House bill · Last action Sep 17, 2025
Bills›Health›H.R. 5343Congress.gov ↗
H.R. 5343IntroducedHealth

Ensuring Patient Access to Critical Breakthrough Products Act

Sponsor: Rep. Moore, Blake D. (R-UT)68 cosponsorsIntroduced Sep 15, 2025
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In plain English

H.R. 5343 requires Medicare to cover FDA-approved breakthrough medical devices for up to four years while manufacturers seek permanent coverage. Device makers must apply to Medicare and meet requirements including FDA priority review, premarket approval based on clinical data from Medicare patients, and acceptable safety profiles. Medicare must approve or deny applications within six months and issue a written decision, then make a permanent coverage determination before the transitional period ends. The bill authorizes funding through fiscal year 2030 for Medicare to carry out these requirements. Sponsor: Rep. Blake Moore (R-UT); passed committee 37-3 on September 17, 2025.

Generated by ThePolitibase from the bill text and CRS summary. Read the official text →
Note: the official CRS summary for this bill was written on 2025-09-15, but the bill text was revised on 2025-09-15T04:00:00Z. Provisions may have been added since the summary was written — the section list above reflects the current text.

Where it is in the process

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Introduced
Sep 15
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House committee
Sep 17
3
House floor
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4
Senate
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5
Signed
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What happens next: Awaiting committee assignment or hearings in the House.

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Sponsor

Cosponsors (68)

SR
RR
TR
GR
LR
CR
MR
+61
33 Democrats, 35 Republicans (of 68 shown).

Activity timeline

Sep 17
Sep 17, 2025
Ordered to be Reported in the Nature of a Substitute (Amended) by the Yeas and Nays: 37 - 3.
Sep 17
Sep 17, 2025
Committee Consideration and Mark-up Session Held
Sep 15
Sep 15, 2025
Referred 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.
Sep 15
Sep 15, 2025
Referred 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.
Sep 15
Sep 15, 2025
Introduced in House
Sep 15
Sep 15, 2025
Introduced in House
Read the bill text
Official text via Congress.gov. Opens in a new tab.
Read full text →

Full action log

All 6 recorded actions since introduction · Source: Congress.gov
Sep 17
HOUSEOrdered to be Reported in the Nature of a Substitute (Amended) by the Yeas and Nays: 37 - 3.
Sep 17
HOUSECommittee Consideration and Mark-up Session Held
Sep 15
HOUSEReferred 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.
Sep 15
HOUSEReferred 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.
Sep 15
Introduced in House
Sep 15
Introduced in House

All 68 cosponsors

33 Democrats · 35 Republicans
Democrats (33)
Republicans (35)

In the news

H.R.5343: Prescription Transparency Act of 2018 - OpenSecrets
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