CMS recently announced that it will provide reimbursement for leadless cardiac pacemakers.

This will provide heart failure patients with broader access to Medtronic's Micra Transcatheter Pacing System.

Since it's under Medicare's policy of Coverage with Evidence Development, one of the conditions is that additional evidence must be collected. Procedures that are performed in FDA-approved studies and prospective longitudinal studies will be covered by CMS.
Medtronic is seeking coverage for its existing Micra Post-Approval Study and a new study that will track longitudinal data on Medicare patients who receive the Micra TPS. Coverage will become effective once the studies are approved by CMS.



Micra TPS was approved by the FDA in April 2016 for patients who need a single-chamber pacemaker. According to Medtronic, it's the only leadless pacemaker approved for use in the U.S.

It's also the first and only leadless pacemaker approved for use with 1.5T and 3T full-body MR exams. Later this year, remote monitoring capabilities will be available for the Micra devices.

"We are working closely with CMS to ensure patient access to the Micra TPS as quickly as possible under this decision," Dr. John Liddicoat, senior vice president of Medtronic and president of the cardiac rhythm and heart failure division, said in a statement.

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