Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Respiratory System. 
Treatment: Surgical Services. 
The insurer denied hypoglossal nerve stimulation. The denial is overturned.

The patient is a male with a history of obstructive sleep apnea. A most recent study confirmed obstructive sleep apnea (OSA) with sleep study. This showed an apnea hypopnea index (AHI) of 20. The minimum oxygen desaturation was 83.6%. Other pertinent vitals include a body mass index (BMI) of 28. The examination of the patient showed a Friedman palate position III, a deviated septum to the left, inferior turbinate hypertrophy, and absent tonsils. The patient had failed continuous positive airway pressure (CPAP) (patient complained about claustrophobia with the mask and removed it during sleep) and is not a candidate for an oral appliance. Significant co-morbidity includes atrial fibrillation. The patient suffered from daytime somnolence, gasping for air, and loud snoring. Sleep endoscopy was performed which showed no complete collapse of the upper airway (favorable finding for hypoglossal stimulator implant). The subject under review is the hypoglossal nerve stimulator implant and whether it is likely to be more beneficial for this patient.

The health plan's determination is overturned.

This treatment (Inspire) is considered by the general otolaryngology community to be an accepted surgical treatment in select patients. This is based on clinical evidence. The patient has failed a CPAP trial and is not appropriate candidate for an oral appliance. Therefore, the upper airway stimulation (UAS) is likely to more beneficial that CPAP or other surgical treatment.
The appropriate work up for a hypoglossal stimulator was done with a sleep endoscopy which showed lack of concentric collapse of the upper airway, and significant prolapse of the tongue during sleep. Finally, the patient is at risk for worsening severe medical co-morbidities (atrial fibrillation) if the OSA continues to go untreated.
Current articles by Woodson and Strollo et al. (2015)  have shown significant safety and benefit for patients with OSA. Other authors have even commented that "once it becomes a standard therapy, its advantages might prove sufficient to challenge CPAP as the first-line therapy." (Mwenge et al. 2015). In patients with a lower BMI and a severe apnea hypopnea index (AHI) (such as this patient) the study published by Soose et al. further supports the use of UAS surgery. They found that in those patients with "severe OSA and body mass index less than or equal to (<=) 32 kilograms per square meter (kg/m2), hypoglossal cranial nerve stimulation therapy can provide significant improvement in important sleep related quality-of-life outcome measures and the effect is maintained across a 2-year follow-up period." More recent studies (Huntley et al. 2018) have also commented on patients with higher BMI levels that have undergone UAS. They found that these patients also had a favorable response to hypoglossal surgery. A recent 5 year follow up study by Soose 2020 found that a large majority of hypoglossal stimulation implant patients were clear responders with excellent comfort and adherence as well as showing effective improvement in symptomatic and objective outcome measures.
After review of the chart and the current literature, the proposed treatment of hypoglossal nerve stimulation (Inspire) is appropriate for certain patients. Food and Drug Administration (FDA) approval of the device for obstructive sleep apnea, and the current research shows strong evidence that upper airway stimulation is an effective treatment in certain patients who meet a certain inclusion criteria. A hypoglossal stimulator is the most viable option for this patient for treatment for OSA.