Lawmakers weigh faster Medicare coverage for FDA‑designated breakthrough medical devices

A House Energy and Commerce subcommittee hearing examined proposals to accelerate Medicare access to FDA‑designated breakthrough medical devices and to reform national coverage and reconsideration procedures at the Centers for Medicare & Medicaid Services (CMS).

Why it mattered: Witnesses described a persistent delay — often called the “valley of death” — between FDA authorization and Medicare coverage that can keep seniors from accessing new, potentially life‑saving technologies. Todd Brinton, corporate vice president and chief scientific officer at Edwards Lifesciences, said delays in coverage “stifle innovation” and described the company’s experience using CMS’s pilot transitional pathway. He told the subcommittee the pilot for Edwards’ Evoque transcatheter tricuspid valve replacement required about 13 months from authorization to coverage and that a broader, adequately funded transitional program could reduce such waits.

What proponents proposed: Industry witnesses urged Congress to create or expand statutory transitional coverage for FDA‑authorized breakthrough devices, including features such as a two‑year look‑back period for recently authorized technologies, consistent rules for Medicare Advantage plans, and dedicated funding to help CMS implement the pathway. Supporters argued a predictable process would encourage investment in U.S. device innovation and prevent the erosion of American competitiveness internationally.

Safety and evidence concerns: Diana Zuckerman, Ph.D., president of the National Center for Health Research, and David Lipschutz of the Center for Medicare Advocacy cautioned that many devices designated as “breakthrough” receive market authorization via less stringent premarket pathways (for example, 510(k)) and that clinical trial evidence often does not include older, Medicare‑age patients. Zuckerman testified that only a minority of the devices labeled breakthrough had publicly reported clinical trials that included older adults; she urged retaining CMS’s ability to make “reasonable and necessary” determinations based on evidence specific to Medicare beneficiaries.

Points of disagreement and suggested reforms: Committee members and witnesses debated whether a statutory transitional pathway would improperly limit CMS’s discretion or whether it would provide necessary predictability. Recommendations offered during the hearing included shortening duplicative public comment periods during NCD reconsiderations, ensuring that CMS has resources to meet timelines, and requiring post‑authorization data collection (coverage with evidence development) to protect patients while enabling access.

Next steps: The hearing produced no votes. Members asked for written follow‑up and signaled intentions to refine legislative text to balance access, beneficiary safety, and CMS authorities.