Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Respiratory Problems. 
Treatment: Surgical Services (implantation of a hypoglossal nerve stimulator). 

The insurer denied surgical services (implantation of a hypoglossal nerve stimulator). 
The denial is upheld.

The patient is a female with a history of poor quality sleep and daytime sleepiness. A polysomnogram revealed an apneas hypopnea index of 32.8. Her body mass index was 29.87 after unknown bariatric surgery. She complained that her positive pressure mask dislodges in sleep and that she removes it inadvertently in her sleep. It is not documented that she tried different masks. A drug induced sleep endoscopy demonstrated zero collapse at the level of the velopharynx, Grade 2 collapse (greater than 75% obstruction) at the level of the oropharynx, and grade 1 anteroposterior collapse (50-75% collapse) at the levels of the base of tongue and epiglottis. Implantation of a hypoglossal nerve stimulator system was recommended and is the service under review.

The health plan's determination is upheld.

The proposed health service, implantation of hypoglossal nerve stimulation system, is not likely to be more beneficial than any standard treatment for the patient's diagnosis, obstructive sleep apnea. At this time hypoglossal nerve stimulation remains in clinical trials (National Clinical Trial [NCT] 037682 and NCTO2263859) unproven by definition. A Hayes report (2017) concluded that the overall quality of the evidence evaluating hypoglossal nerve stimulation for treating obstructive sleep apnea (OSA) was very low. It was concluded that stimulation of the hypoglossal nerve may provide a treatment option for patients with moderate-to-severe OSA for whom continuous positive airway pressure (CPAP) has failed to provide relief, but the procedure may carry risks for complications and post implantation surgical procedures. In addition, evidence is still unclear as to whether improvements translate to better sleep quality and improved quality of life. The authors called for additional good-quality comparative studies with larger sample sizes to define the patient population that is most likely to respond to this therapy option. For example, studies by Woodson et al. 2018 was limited by a lack of a control group and the study group was limited to males that were obese, positive airway pressure intolerant, and of European descent and therefore cannot be generalized. Two prior Woodson studies were paid for by the manufacturer with marked increase in chance of bias in results. The Stimulation Therapy for Apnea Reduction (STAR) trial, considered "pivotal" was funded by Inspire Medical Systems. This is a prospective single-group cohort study of the Inspire upper-airway stimulation system developed by Inspire Medical Systems with results published in 2014. Study participants met eligibility criteria with moderate-to-severe OSA if they had difficulty adhering to CPAP treatment. This is an uncontrolled cohort study. The lack of control group limits the validity of the results of this study, and the cohort of 83% men. In addition, in the STAR trial study by Soose et al. (2015), provided statistics based upon subjective self-reported data that was subjective not objective, including functional outcomes of sleep questionnaire and self/bed partner reports of snoring intensity. There is no absence of alternative therapies for the treatment of obstructive sleep apnea. Therefore, implantation of hypoglossal nerve stimulator system is not likely to be more beneficial than any standard treatment or treatments.