Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Respiratory Problems. Treatment: Surgical Services. The insurer denied hypoglossal nerve stimulator. The denial is upheld.

This is a female who complained about loud snoring, gasping in sleep, frequent naps, nocturnal choking in sleep and nocturnal witnessed apneas. The patient's Epworth sleepiness scale score was 13/24. Her sleep study demonstrated an apnea hypopnea index of 46.2. Continuous positive airway pressure (CPAP) was recommended from which she had a feeling of suffocation after a month trial. Exam revealed 1+/4 tonsillar hypertrophy and a mild to moderate palatal/uvular redundancy. A drug induced sleep endoscopy revealed complete anteroposterior collapse at the level of the palate, lateral pharyngeal closure in the hypopharynx and oropharynx with partial mild to moderate collapse at the level of the base of tongue. Implantation of a hypoglossal nerve stimulation system was recommended and is the service under review.

No, implantation of a hypoglossal nerve stimulator is not likely to be more beneficial than any standard treatment or treatments for the insured's obstructive sleep apnea. Alternative therapies can include CPAP desensitization, an oral appliance, modified Uvulopalatopharyngoplasty / tonsillectomy, staged hypopharyngeal surgery and surgery of the base of tongue and hyoid, mandibular/maxillary osteotomies, and positional therapy.
Based on the evidence-based literature, implantation of a hypoglossal nerve stimulation system is not medically appropriate as there is insufficient evidence in the peer-reviewed literature to support the safety, efficacy, and long-term outcome in the treatment of obstructive sleep apnea. The STAR trial considered "pivotal", (Strollo et al.) was funded by Inspire Medical Systems, the manufacturer of the technology under review. The study reviewed outcomes of a cohort of 126 only as late as 18 months post procedure where the baseline apnea hypopnea index (AHI) dropped with the use of the device from a median 32 +/- 11.8 to a median 14.1 +/- 14.4. The median is still consistent with mild obstructive sleep apnea with no long-term patient outcome data. A study by Soose et al. (2015), funded by Inspire Medical systems, provided statistics based upon subjective self-reported data, including the Epworth Sleepiness Scale score, functional outcomes of sleep questionnaire and self/bed partner reports of snoring intensity. In a literature review by Certal et al. (2015), according to the authors, the studies reviewed were based upon highly specific populations which may not be representative of the population with moderate to severe obstructive sleep apnea with the heterogenicity of comparing different devices. Based upon a limited number of case reports, which do not necessarily represent real world practice, the authors concluded that more long-term data is required and further studies comparing hypoglossal nerve stimulation with conventional therapies are needed to definitively evaluate outcomes. Based upon the evidence based literature, the implantation of a hypoglossal nerve simulation system for the treatment of obstructive sleep apnea is not likely to be more beneficial than any standard treatment or treatments for the insured's obstructive sleep apnea.