This week, the Centers for Medicare & Medicaid Services (CMS) issued a proposed Decision Memorandum regarding coverage for leadless pacemakers. If approved, it will provide conditional coverage for leadless pacemakers only if they are used in an approved clinical study as determined by the Coverage with Evidence Development (CED) program.
CED is a function of CMS that establishes national Medicare coverage for services or procedures by requiring clinical trials or additional data collection in order for the service to be covered. When a Medicare National Coverage Determination (NCD) requires CED, it’s because the available evidence about a particular item or service is insufficient to support coverage outside the context of a well-designed clinical research study. CED trials must answer specific questions about potential complications and long-term outcomes of the service. A CED cycle is complete when CMS removes the requirement for study participation as a condition of coverage.
To provide some context, leadless pacemakers are designed for patients who require what is known as single-chamber ventricular pacing. While the terminology might be unfamiliar to some, individuals with this need make up approximately 15% of patients in the U.S. who require a pacemaker. Coverage restrictions resulting from the CED requirement could have a significant impact on the utilization of leadless pacemakers in the United States. A final decision on the proposal is expected in February 2017.
At present, the only leadless pacemaker that is approved for marketing in the U.S. is the Micra Transcatheter Pacing System (TPS), manufactured by Medtronic Inc. Another leadless pacemaker, the Nanostim (St. Jude Medical), is approved for marketing in Europe, but St. Jude Medical recently voluntarily halted implantation due to reports of battery issues. St. Jude Medical has also paused enrollment in the U.S. pivotal trial.
The Hayes Prognosis team has been monitoring the development of leadless pacemakers, and will continue to monitor the evolving evidence about the safety and efficacy of both the Micra TPS and the Nanostim leadless pacemakers, as well as other emerging leadless pacemakers. Trust Hayes to keep you informed about the proposed use, regulatory status, and the estimated commercial availability of health technologies. We never accept compensation from manufacturers. As a result, our fiercely unbiased look at the evidence assists payers with their coverage policy determinations as well as providers interested in the latest devices and procedures.