Transvenous Phrenic Nerve Stimulation for Central Sleep Apnea: Clinical and Billing Review

Central sleep apnea (CSA) frequently coexists with heart failure and atrial fibrillation and contributes to cardiovascular disease progression and mortality. A transvenous phrenic nerve stimulation (TPNS) system has been approved for the first time by the Food and Drug Administration for the treatment of CSA. This system, remedē System (Zoll Medical, Inc.), is implanted during a minimally invasive outpatient procedure and has shown a favorable safety and efficacy profile. Currently, patient access to this therapy remains limited by the small number of specialized centers in the United States and the absence of a standard coverage process by insurers. Although a period of evaluation by insurers is expected for new therapies in their early stages, the impact on patients is particularly severe given the already limited treatment options for CSA. Implantation and management of this novel therapy require the establishment of a specialized multidisciplinary program as part of a sleep medicine practice and support from health care systems and hospitals. Several centers in the United States have been successful in building sustainable TPNS programs offering this novel therapy to their patients by navigating the current reimbursement environment. In this article, we review the background and efficacy data of TPNS and briefly address relevant aspects of the clinical activities involved in a TPNS program. The article presents the status of coverage and reimbursement for this novel therapy. We also discuss the current approach to obtaining reimbursement from third-party payors during this transitional period of evaluation by Medicare and other insurers.