Lifetime Citizen Portal Access — AI Briefings, Alerts & Unlimited Follows
Lawmaker presses agency on implementing H.R. 5343 to speed temporary Medicare coverage for breakthrough devices
Loading...
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 prior policy efforts. "This bill requires CMS to provide temporary medical coverage for treatments or devices that receive breakthrough designation from the FDA," S1 said, arguing that if a treatment meets the FDA's standard for breakthrough designation there is no reason Medicare "shouldn't be able to provide temporary medical coverage while CMS completes its review for permanent coverage." S1 told the hearing the measure has bipartisan support and said he looked forward to working with the agency.
An agency official (identified in the transcript only as S2) replied that a rulemaking announcement would be made "soon" and that the agency is "happy to work with you on it." The official cautioned that temporary payments would be intended to be revocable and noted that with many medical devices "we find problems with them later," framing temporary coverage as a provisional measure that can be rescinded if safety or effectiveness concerns emerge.
The exchange also included personal context from S1, who said his 10-year-old child is "neurodivergent on the autism spectrum" and told agency staff he appreciated the administration's focus on autism while urging further work on the underlying research. S1 said he was "underwhelmed" by a recent research summary and encouraged the agency team to keep investigating causes and solutions.
The agency's pledge of an upcoming announcement is the most recent procedural update in the exchange; no formal vote or motion was recorded in the transcript. The lawmaker closed by reiterating bipartisan support for the initiative and thanking the agency official for the discussion.
