MitraClip Medicare Gains: National Coverage Follows Bonus Payment Decision
This article was originally published in The Gray Sheet
CMS finalized a national coverage determination for transcatheter mitral valve repair, conditioned on a registry and on minimum facility and experience requirements for hospitals. The policy follows close behind a new-technology add-on payment granted to Abbott’s MitraClip device.
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Abbott plans to require additional training for physicians implanting the mitral valve repair device and to add a new warning to the device’s labeling after nine instances in which users could not properly deploy the system.
CMS agreed to grant new tech add-on payments to St. Jude’s CardioMEMS implantable heart failure monitoring system and Abbott’s MitraClip mitral valve repair system, but it took some convincing. The agency also granted an add-on for NeuroPace’s RNS responsive neurostimulator system to treat seizures.
A new draft national Medicare coverage policy offers to pay for transcatheter mitral valve repair procedures with devices like Abbott’s MitraClip only if they are conducted by a qualified heart team and are part of a national registry.