Appeal type: Experimental/Investigational
Decision: Overturned

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

The patient is a female with a history of severe obstructive sleep apnea (associated with loud snoring, bed partner complaints, daytime fatigue). A prior study confirmed obstructive sleep apnea (OSA). This showed an apnea hypopnea index (AHI) of 70. A more recent study noted an AHI 46.2 The minimum oxygen desaturation was 80%. Other pertinent vitals include a body mass index (BMI) of 29.3.
Previous surgical history was negative for prior head and neck surgery. The patient had failed continuous positive airway pressure (CPAP) for several months and is not a candidate for an oral appliance. During CPAP, the patient was repeatedly pulling off the mask. The patient complains of constant daytime fatigue and falling asleep during the day. Examination of the patient noted tonsils 1+ in size, Class I occlusion, mild to moderate redundancy of the soft palate and uvula, and Mallampati III.
Sleep endoscopy was performed, which showed no complete collapse of the upper airway (favorable finding for hypoglossal stimulator implant) and mostly anterior to posterior collapse. Findings on endoscopy also noted boggy nasal mucosa and edema, clear drainage bilaterally, and inferior turbinate hypertrophy bilaterally.
The request for the Inspire Upper Airway Stimulation by the patient's health plan as it was denied based on the assessment that the technology was considered not the standard of care.

This proposed treatment (Inspire/hypoglossal stimulation) 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 an appropriate candidate for an oral appliance. 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 developing severe medical co-morbidities if the OSA continues to go untreated. Although the patient does have 1+ tonsils and redundancy of the soft palate, uvulopalatopharyngoplasty as shown to have a limited sustained affect and is not an appropriate treatment for the OSA. Hypoglossal stimulation remains the most appropriate treatment for patients who have failed CPAP (Sheen and Abdulateef 2021).
There is sufficient evidence to support upper airway surgery (UAS) in certain instances. Articles by Woodson et al. (2015), Strollo et al. (2015), and Whelan and Soose (2020) 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 AHI (such as this patient), the study published by Soose et al. further supports the use of Upper Airway Stimulation 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."