Doctors argue leadless pacemakers deserve broader Medicare coverage


Physicians want wider Medicare coverage for leadless pacemakers, arguing the current reimbursement proposal puts the device out of reach for too many patients.

Last month, the CMS proposed limited Medicare coverage for leadless pacemakers that are used in federally approved clinical studies.

The agency collected public comments on the decision through Dec. 14 and received around 50 comments, mostly from cardiologists. They called for the CMS to cover Food and Drug Administration-approved leadless pacemaker devices for all Medicare beneficiaries who meet FDA-approved indications.

Medtronic’s Micra Transcatheter Pacing System is the only leadless device now on the market with FDA approval. It was approved for patients suffering from abnormal heart rhythms and is not intended for patients who have implanted devices that would interfere with the pacemaker, who are severely obese, or who have an intolerance to materials in the device or the blood thinner heparin. It is also contraindicated for patients with veins that may be too small for the device.

In its proposed coverage decision issued in November, the CMS said additional studies were needed to support further reimbursement for the device, concluding there’s not enough evidence to determine long-term health outcomes or to identify who would be most likely to “experience overall benefit or harm.” […]

Experts agreed with the CMS that more research is needed. Evidence shows that while the leadless pacemaker eliminates some of the key drawbacks of existing pacemakers, they also increase the likelihood of some complications and may introduce new ones, according to Dr. Jay Ronquillo, director of biomedical informatics at the National Center for Health Research, a no-for-profit think tank focused on health research.

“At this point, there is no reason for patients to feel cheated if Medicare doesn’t cover the cost of leadless pacemakers, because leadless pacemakers may be no better, and possibly worse, than pacemakers with leads,” Ronquillo said.

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