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The Centers for Medicare & Medicaid Services aims to cover leadless pacemakers, but only in the context of use in FDA-approved studies, according to a draft of the agency's for the devices.

The document details the coverage within FDA-approved studies for leadless pacemakers through the Coverage with Evidence Development (CED) program. Those studies must address peri-procedural and post-procedural complications of leadless pacemakers, long-term outcomes associated with their use, and potential differences between patient subgroups.

"The study protocol must explicitly discuss beneficiary subpopulations affected by the item or service under investigation, particularly traditionally underrepresented groups in clinical studies, how the inclusion and exclusion criteria effect enrollment of these populations, and a plan for the retention and reporting of said populations in the trial," the document noted. "If the inclusion and exclusion criteria are expected to have a negative effect on the recruitment or retention of underrepresented populations, the protocol must discuss why these criteria are necessary."

Another of the 13 criteria proposed included registration on ClinicalTrials.gov prior to enrollment. Moreover, use will not be covered in studies designed to test toxicity or disease pathophysiology in healthy individuals.

The duration of the public comment period was not specified but is usually 30 days.

While the national coverage determination process started in May, shortly after the FDA approval of Medtronic's Micra as the first leadless pacemaker, CMS initiated the determination itself without its request by any manufacturers.

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