CMS Grants Outpatient Pass-through Payment to the remedē® System for the Treatment of Central Sleep Apnea
Pass-through Payment to Provide Additional Medicare Reimbursement for the remedē System
Respicardia, Inc. announced today that the Centers for Medicare and Medicaid Services (CMS) has approved an outpatient Transitional Pass-through Payment for the remedē® System, an implantable device that uses phrenic nerve stimulation to treat central sleep apnea. This announcement follows the CMS New Technology Add-on Payment (NTAP), granted to the remedē System in August, for procedures performed in an inpatient setting.
Transitional Pass-through Payment is a Medicare program designed to supplement the payment for innovative medical technologies that substantially improve the diagnosis or treatment of a disease in outpatient settings. The Pass-through Payment program will provide hospitals with additional reimbursement and will become effective on January 1, 2019.
“We are very pleased that CMS will extend supplemental reimbursement of the remedē System into the outpatient setting. The majority of remedē System procedures are performed in the outpatient setting, so we expect that this payment will provide substantial support to implanting centers,” said Peter Sommerness, President and CEO of Respicardia. “Equally important, we are pleased that CMS again recognized the remedē System as a substantial clinical improvement in the options available for the treatment of central sleep apnea. We are grateful to CMS for its pivotal role in supporting the accessibility of new technologies through improved reimbursement.”
About Central Sleep Apnea (CSA) and the remedē® System
Central Sleep Apnea (CSA) is a serious breathing disorder that disrupts the normal breathing pattern during sleep and negatively affects quality of life and overall cardiovascular health. CSA results from the brain’s inability to send appropriate signals to the respiratory muscles to stimulate breathing.
The remedē System is a breakthrough, implantable system that treats the harmful effects of CSA by restoring a more normal breathing pattern during sleep. The remedē System pivotal clinical trial, published in The Lancet, demonstrated that transvenous neurostimulation with the remedē System can significantly reduce the severity of CSA, improve sleep, and improve both quality of life and patient satisfaction. Recently published data in the American Journal of Cardiology demonstrates continued, long term efficacy of the therapy.1,2
The remedē System received U.S. Food and Drug Administration (FDA) approval in October 2017 and is commencing market release in a limited number of centers in the United States and Europe.
Respicardia is a leader in innovative technologies that address the unmet needs in respiratory and cardiovascular disease with safe and effective therapies. Founded in 2006 and headquartered near Minneapolis, Minn., Respicardia is dedicated to improving patient outcomes, quality of life and overall cardiovascular health via novel transvenous neurostimulation therapies. Learn more at www.respicardia.com.
1 Costanzo M, et al. Transvenous neurostimulation for central sleep apnoea: a randomised controlled trial. The Lancet. 2016; 388: 974–82
2 Costanzo M, et al. Sustained Twelve Month Benefit of Phrenic Nerve Stimulation for Central Sleep Apnea. Am J Cardiol. 2018. pii: S0002-9149(18)30258-3. doi: 10.1016/j.amjcard.2018.02.022.
SOURCE Respicardia, Inc.
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