Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Sleep Apnea
Treatment: Implantation of a hypoglossal nerve stimulation 
The insurer denied the implantation of a hypoglossal nerve stimulation .
The determination is upheld.

The patient was diagnosed with obstructive sleep apnea on a polysomnogram. The patient had undergone bariatric surgery and his body mass index was 31.84. His apnea hypopnea index was 49 with an oxygen nadir of 81%. His complaints include loud snoring, daytime sleepiness, nocturnal gasping and apneic episodes; he reports taking daytime naps. His exam was within normal limits. A drug induced sleep exam revealed anteroposterior at the level of the palate, lateral pharyngeal collapse at the levels of the oropharyngeal and hypopharyngeal, and moderate anteroposterior collapse at the level of the base of tongue. Implantation of a hypoglossal nerve stimulator system was recommended and is the service under review for medical necessity.

The requested service, implantation of a hypoglossal nerve stimulation device performed during ambulatory surgery is not medically necessary.
Clinically this is a patient with obstructive sleep apnea which demonstrated an apnea hypopnea index of 49 with an oxygen nadir of 81%. It is not well documented that he failed a trial of positive airway pressure, in accordance with the American Academy of Otolaryngology Head and neck Surgery that states "The American Academy of Otolaryngology-Head and Neck Surgery considers upper airway stimulation (UAS) via the hypoglossal nerve for the treatment of adult obstructive sleep apnea syndrome to be a safe and effective second-line treatment of moderate to severe obstructive sleep apnea in patients who are intolerant or unable to achieve benefit with positive pressure therapy. " There is no continuous positive airway pressure (CPAP) compliance data provided  having been downloaded from the CPAP. The only information provided is anecdotal. 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 heterogeneity of comparing different devices. 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. 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 the data was only based over 6 month period. The authors concluded that further study comparing hypoglossal nerve stimulation to other therapies is required. 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 apnea hypopnea index (AHIs)s in the cohort ranging from 14.2 to 96.2.
Based upon the clinical information provided and the evidence based literature, implantation of a hypoglossal nerve stimulator system is not medically necessary.