HR. 5343Reported
Ensuring Patient Access to Critical Breakthrough Products Act
Establishes temporary Medicare coverage for qualifying FDA breakthrough medical devices while setting an application process and timeline for permanent coverage decisions
Plain-English overview
What this bill does
Establishes temporary Medicare coverage for qualifying FDA breakthrough medical devices while setting an application process and timeline for permanent coverage decisions
Key points
- Require CMS application decisions
- Direct permanent coverage determinations
- Allow temporary device coverage
- Fund CMS implementation
Current status
Where it stands
Status
Reported
Latest action
2025-09-17 — Ordered to be Reported in the Nature of a Substitute (Amended) by the Yeas and Nays: 37 - 3.
Related context
Topics and policy areas
undefinedCongressional oversightDrug safety, medical device, and laboratory regulationHealthHealth care costs and insuranceHealth care coverage and accessHealth programs administration and fundingHealth technology, devices, supplies