Medicare Plans to Cover Leadless Pacers—Sometimes

CMS recently proposed reimbursement coverage for leadless pacemakers through its Coverage with Evidence Development process. That means only implants that are part of FDA-approved studies will be eligible for coverage.

The Micra Transcatheter Pacing System was the first--and currently only--leadless pacemaker to gain FDA approval.

In a recent proposed decision memo, CMS detailed its plan to offer reimbursement coverage for FDA-approved studies of leadless pacemakers. The proposal, part of CMS's National Coverage Determination (NCD) process, would allow Coverage with Evidence Development (CED) for the new leadless pacemaker technology. 

According to CMS, the proposal, which will be subject to a public comment period before a final decision is issued, would cover leadless pacemakers that are evaluated in FDA-approved studies that seek to answer these questions:

CMS added that it will evaluate any submitted FDA-approved studies to ensure they meet 13 criteria to be classified as CED, several of which are related to proper trial design, purpose, sponsorship, and registration on the www.ClinicalTrials.gov website. 

Explaining the reasoning behind its proposed decision, CMS wrote, "Remaining gaps in knowledge include real world safety and effectiveness, long term reliability and safety, battery longevity, device retrieval, device-device interactions, and best practices at device end of life."

CMS called current evidence on leadless pacemakers "insufficient to confidently determine whether pacemakers improve health outcomes in real world practice outside the controlled study environment" and added that medical society guidelines and recommendations have not been published on leadless pacemakers. 

FDA approved Medtronic's Micra TPS leadless pacemaker in April 2016. The device is the smallest pacemaker in the world and the only FDA-approved leadless pacemaker today. Physicians in the United States are being trained to use Micra and the NCD was expected by the end of Medtronic's 2017 fiscal year (April 2017), according to management commentary on the company's August earnings call. 

"We are in the process of reviewing this draft NCD, and we will work with and provide comment to CMS during the 30-day comment period," Medtronic spokesperson Christopher Garland told Qmed in an e-mail.

CMS opened a National Coverage Analysis (NCA) in May 2016. Without an NCD, Medicare reimbursement coverage is left up to the local Medicare Administrative Contractors (MACs) around the country.

Dozens of comments on that initial NCA were submitted by individuals and companies. CMS summarized these comments as backing reimbursement coverage for the technology, noting that many came from electrophysiologists who had experience implanting leadless pacemakers, as well as leadless pacemaker manufacturers, medical societies, and research groups. 

So far, the only comment posted on the CED proposed decision memo asks for clarification on what steps must be taken for leadless pacemaker trials that have already been approved for coverage by a local MAC.

Leadless pacemakers are a burgeoning area of medical devices. St. Jude Medical's Nanostim leadless pacemaker has had CE Mark since 2013 and until recently, was implanting U.S. patients under a Continued Access Protocol as part of its FDA trial. In late October, St. Jude Medical announced a voluntary halt on Nanostim implants, as a battery problem resulting in loss of pacing and telemetry had been observed in seven out of approximately 1400 global implants (0.5% rate). 

Boston Scientific is also developing a leadless pacemaker. Called Empower, that device is being designed to work on its own or in coordination with the company's subcutaneous ICD (S-ICD).

[Image courtesy of MEDTRONIC]