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WASHINGTON  — An array of lawmakers called for a simpler reimbursement pathway for breakthrough devices at a Ways and Means health subcommittee hearing on Wednesday. They echoed a prevalent concern of medical device makers: that when device companies struggle to obtain insurance coverage, it discourages device innovation and limits patient options. 

In 2021, the Center for Medicare and Medicaid Services repealed a Trump-era policy that would have automatically given four years of Medicare coverage to devices granted breakthrough status by the Food and Drug Administration. They rolled this policy back because CMS has a different, and often higher, data standard from the FDA when it comes to approving devices. STAT has found that the FDA’s breakthrough devices program, while meant to benefit patients, has so far shown the biggest gains for device companies


Wednesday’s hearing focused broadly on policies that impact health care innovation. The Center for Medicare and Medicaid Services’ determination to restrict Alzheimer’s drugs was a hot issue, with patient and advocate Tony Gonzales lamenting the decision. But the issue of device reimbursement came up early on in the hearing with testimony from Joshua Makower, the founder of Stanford Byers Center for Biodesign. He described medical technology founders as facing a “valley of death” from when their devices receive approval from the Food and Drug Administration until the time when they secure coverage from health insurers. 

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