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Leadless Pacers Would Only Be Covered In Clinical Trials Under Medicare Proposal

 
• By Reed Miller

The proposed national coverage policy, which was generated from an internal request by the US Medicare agency, would provide Medicare coverage of leadless pacemakers only if they are part of an FDA-approved trial that evaluates peri-procedural complications, post-procedural complications, long-term outcomes, and the influence of patient characteristics on outcomes.

The US Centers for Medicare and Medicaid Services is proposing to confine Medicare coverage of leadless cardiac pacemakers – like Medtronic PLC's Micra – to clinical trials through a national coverage-with-evidence-development (CED) policy.

In a Nov. 14 proposal, the agency lays out the criteria for the FDA-approved studies of leadless pacemakers that Medicare would cover if the proposal is finalized. CMS...

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