Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Obstructive Sleep Apnea
Treatment: Implantable Hypoglossal Nerve Stimulator
The health plan denied the requested Implantable Hypoglossal Nerve Stimulator. 
The health plan's determination is upheld.

This is a male with a history of obstructive sleep apnea. He complained of frequent daytime napping, restless sleep, gasping in sleep with apneic events and daytime tiredness. The patient's body mass index was 24. His past surgical history includes a uvulopalatopharyngoplasty. Endoscopic exam revealed mild retrognathia, mild to moderate redundancy of the soft palate and uvula, moderate nasal airway narrowing, and lateral wall collapse/narrowing in a Mallampati 2 oropharynx. His polysomnogram revealed an apnea hypopnea index of 26.8 with 14% central/mixed apneas, and a body mass index of 24. He was continuous positive airway pressure (CPAP) intolerant with a feeling of suffocation while wearing the mask, that he inadvertently removed in sleep. Positional therapy failed. He has not tried an oral appliance.
A drug induced sleep endoscopy demonstrated complete anteroposterior collapse at the level of the palate and base of tongue. Implantation of a hypoglossal nerve stimulator system was recommended and is the service under review.

The health plan's determination of medically necessary is upheld.

No, implantation of a hypoglossal nerve stimulator system is not medically necessary.

Based on the evidence-based literature, the implanted neurostimulator pulse generator system is not medically necessary, as there is insufficient evidence in the peer-reviewed literature to support the safety, efficacy, and long-term outcomes in the treatment of obstructive sleep apnea. The STAR trial (Strollo) 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. For example, in a 2018 review of the literature by Kompelli et al, the authors concluded across 16 studies that the hypoglossal nerve stimulation was safe and effective, but this was only over a 6-month period. They concluded that further study comparing hypoglossal nerve stimulation to other therapies is required. The authors concluded that based upon a limited number of case reports, which do not necessarily represent real world practice, and that more long-term data is required and further studies comparing hypoglossal nerve stimulation with conventional therapies are needed to definitively evaluate outcomes. A 2016 study by Kent et al was a case review and limited by its small cohort of 21. A 2016 study by Thaler et al was limited by its small sample size of 11, and its heterogeneity, with patients who had undergone different previous surgical procedures for treatment of obstructive sleep apnea and with AHI's in the cohort ranging from 14.2 to 96.2. Based upon the evidence-based literature, implantation of a hypoglossal nerve stimulator system for the treatment of obstructive sleep apnea is not medically necessary.