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Lawmakers weigh faster Medicare coverage for FDA‑designated breakthrough medical devices
Summary
A House Energy and Commerce subcommittee hearing examined proposals to accelerate Medicare access to FDA‑designated breakthrough medical devices and to reform CMS national coverage processes.
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…
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