Appeal type: Experimental/Investigational
Decision: Overturned Decision of Health Plan

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for implantable hypoglossal nerve stimulator (Inspire UAS System) for treatment of the enrollees obstructive sleep apnea (OSA). Findings:  2/3 of the physician reviewers found that there is sufficient support for the requested services in this clinical setting.  Implantation with a hypoglossal nerve stimulator is U.S. Food and Drug Administration approved and recognized by the American Academy of Otolaryngology Head and Neck Surgery and also by the International Sleep Surgery Society.  Obstructive sleep apnea (OSA) is an increasingly prevalent clinical problem with significant effects on both personal and public health. CPAP has demonstrated excellent efficacy and low morbidity with long term adherence rates approaching 50%. Although traditional upper airway surgical procedures target the anatomic component of obstruction, upper airway stimulation tackles the twin goals of improving anatomic and neuromuscular pathology. After decades of trials demonstrating proof of concept of hypoglossal nerve stimulation in animal and human subjects, the three and four year results of a large multicenter, prospective trial were published in January 2016 and February 2017. The STAR trial demonstrated that hypoglossal nerve stimulation led to significant improvements in objective and subjective measurements of the severity of OSA. This trial has demonstrated the hypoglossal nerve stimulator to be safe and effective in a small subset of patients with OSA who have failed CPAP. With a BMI of 30, AHI of 45 and nonconcentric airway collapse, this patient meets the criteria. He has failed CPAP which is the gold standard treatment for OSA and is at risk for untoward cardiac sequelae of untreated OSA. Therefore, implantable hypoglossal nerve stimulator (Inspire UAS System) is likely to be more effective than other modalities for treatment of this patients medical condition.  Final Result: 2/3 of the reviewers determined that the requested services are likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Therefore, the Health Plans denial should be overturned. Credentials/Qualifications: Physician reviewer number one is board certified in otolaryngology and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.Physician reviewer number two is board certified in otolaryngology and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.Physician reviewer number three is board certified in otolaryngology and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.