Medicare issues leadless pacer coverage proposal

The Centers for Medicare and Medicaid Services said this week it is changing its coverage to now cover leadless pacemakers, but only for FDA approved studies.

The change comes with a newly released draft of CMS’ national coverage determination for the devices, which outlines 3 protocols the studies must address to receive coverage.

Currently, Medtronic‘s (NYSE:MDT) Micra transcatheter pacing system is the only leadless device to have won FDA coverage, after gaining approval from the agency in April.

Studies must ask what the peri-procedural and post procedural complications of headless pacemakers are, seek to examine the long term outcomes of the devices and explore the effects of patient characteristics, including age, gender and comorbidities, on the use and health effects of the devices.

The release also held 13 distinct criteria for trials of the devices, including registration on ClinicalTrials.gov and compliance with all applicable federal regulations.

CMS said that while it believes the devices could be beneficial, there’s currently not sufficient evidence to determine long-term health outcomes or to identify who gains the most benefit from them.

“CMS believes that the available evidence is not sufficient to determine long term health outcomes or to identify the characteristics of the patient, practitioner or facility that predict which beneficiaries are more likely to experience overall benefit or harm from leadless pacemakers. Significant questions remain regarding the potential for deterioration in left ventricular function and other long term outcomes, as well as device longevity,” the agency wrote in its determination release.

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