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Superiority Standard? Groups Bristle At CMS’ Transcatheter Valve Trial Proposal

Some worry that a provision in CMS’ proposed national coverage decision for transcatheter aortic valve replacement devices, which restricts coverage for off-label indications to trials designed to show superiority, signals the agency’s intent to play a more active role in dictating trial designs.

CMS’ proposal to limit coverage for unapproved transcatheter aortic valve replacement indications to clinical trials intended to prove superiority rather than non-inferiority to alternatives was widely panned by stakeholders in recent comments to the agency.

Some in the device industry worry the provision signals CMS’ intent to play a more active role in

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