CMS has approved coverage of Medtronic’s Micra transcatheter pacing system for patients who need a single-chamber pacemaker.
In April 2016, the FDA approved the Micra, which is one-tenth the size of traditional pacemakers and does not require leads or surgical pockets under the skin. The FDA has not approved any other leadless pacemakers.
The CMS decision comes less than two months after the agency finalized its proposal to cover leadless pacemakers. Before approving the Micra, CMS had approved two required studies that enabled Medicare reimbursement.
The two CMS-approved studies are the Micra Post-Approval Study, which the FDA required when it approved the Micra, and the Micra CED Study, which Medtronic developed to address questions that CMS identified.
CMS said earlier this year that leadless pacemakers might provide therapy for fewer than 20 percent of patients who require a pacemaker. They are typically used for patients with atrial fibrillation and bradycardia and patients who need only infrequent pacing.