STAT+: Lawmakers press CMS to release new breakthrough device coverage rule

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In 2021, the Center for Medicare and Medicaid Services repealed a Trump-era policy that would have automatically given four years of Medicare coverage to devices granted breakthrough status by the Food and Drug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. 

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