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Lawmaker presses agency on implementing H.R. 5343 to speed temporary Medicare coverage for breakthrough devices

Congressional hearing · April 16, 2026
AI-Generated Content: All content on this page was generated by AI to highlight key points from the meeting. For complete details and context, we recommend watching the full video. so we can fix them.

Summary

At a congressional hearing, a lawmaker pressed an agency about implementing H.R. 5343 to require temporary Medicare coverage for FDA breakthrough-designated treatments while CMS completes permanent-coverage reviews; the agency said a rulemaking announcement is forthcoming.

A lawmaker in Congress asked an agency official whether the administration will move forward with rulemaking to implement H.R. 5343, the "Insuring Patient Access to Critical Breakthroughs" act, which would require Medicare to provide temporary coverage for treatments or devices that receive FDA breakthrough designation while the Centers for Medicare & Medicaid Services completes its permanent-coverage review.

The lawmaker (identified in the transcript only as S1) said he had introduced H.R. 5343 and described the proposal as building on…

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