Bills · HR 5343
REPORTED· 119TH CONGRESS
House BillHR 5343MedicareDrug safety, medical device, and laboratory regulation
Ensuring Patient Access to Critical Breakthrough Products Act
INTRO SEP 15· LAST ACTION SEP 17
READING
6MIN
COSPONSORS
45BIPARTISAN
READER REACTIONS0 TOTAL
NO VOTES YET · BE THE FIRST
- Reported, not passed
LEGISLATIVE PROGRESS
STEP 3 / 8Introduced
In Committee
Reported
Passed House
Passed Senate
Conference
To President
Became Law
WHAT THE BILL DOES
AI-writtenThis bill matters because it addresses a common frustration: the significant delay between a new medical device receiving FDA approval and Medicare deciding to cover it. These delays can mean that seniors and people with disabilities, who rely on Medicare, are unable to access potentially life-changing or life-saving technologies, or they might have to pay out-of-pocket.
If this bill becomes law, patients on Medicare could get much faster access to new, innovative medical devices that have been identified as breakthroughs. This could lead to improved health outcomes and a better quality of life for many. For the medical device industry, it creates a more predictable pathway for market entry and reimbursement, which could encourage further innovation. If it doesn't pass, the current, slower process for Medicare coverage decisions for new devices would continue, potentially delaying patient access to advanced treatments.
KEY PROVISIONS
5AI-extractedPROVISION 01
Requires Medicare to cover designated 'breakthrough devices' for a four-year 'transitional coverage period'.
This ensures immediate, albeit temporary, access to promising new medical technologies for Medicare patients.
PROVISION 02
Establishes criteria and a process for CMS to designate devices as 'breakthrough devices' within six months of application.
This formalizes how new devices qualify for expedited Medicare coverage, providing clear guidelines for manufacturers.
PROVISION 03
Mandates that CMS finalize a national coverage determination for breakthrough devices before the end of their four-year transitional coverage period.
This ensures that a permanent decision on Medicare coverage is made promptly, preventing uncertainty after the transitional period.
PROVISION 04
Appropriates $10 million annually for fiscal years 2025 through 2030 to CMS to carry out the provisions of this bill.
This provides dedicated funding to support the new administrative workload associated with breakthrough device designations and coverage.
PROVISION 05
Allows the Secretary to review billing patterns for breakthrough devices if a provider has unusual or 'aberrant' billing.
This provision helps prevent potential fraud or misuse of the new coverage pathway.
SPONSORSHIP
1 + 45
R· Utah
YRS IN OFFICE
5
BILLS LED
43
COSPONSOR BREAKDOWNBIPARTISAN · 98%
DEM 23 REP 22 IND 0
ACTION TIMELINE
4 EVENTSSEP 17
Committee Consideration and Mark-up Session Held
SEP 17
Ordered to be Reported in the Nature of a Substitute (Amended) by the Yeas and Nays: 37 - 3.
SEP 15
Introduced in House
SEP 15
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.
BILL INFO
TypeHouse Bill
NumberHR 5343
Congress119th
StatusReported
IntroducedSep 15, 2025
Last actionSep 17, 2025
READER REACTIONS
OVERALL SENTIMENT
No reactions yet. Be the first to weigh in.
Discussion
Loading comments...
REPORTED· 119TH CONGRESS · ENERGY AND COMMERCE COMMITTEE · INTRODUCED SEP 15, 2025
House BillHR 5343MedicareDrug safety, medical device, and laboratory regulation
Ensuring Patient Access to Critical Breakthrough Products Act
INTRODUCED SEP 15, 2025· LAST ACTION SEP 17, 2025
PASSAGE CHANCES
—%
READING
6 min
COSPONSORS
45
COMPLEXITY
Moderate
