Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Obstructive Sleep Apnea
Treatment: hypoglossal nerve stimulation (inspire upper airway stimulation system)
The insurer denied coverage for hypoglossal nerve stimulation (inspire upper airway stimulation system).
The denial is overturned.

This is male patient diagnosed with obstructive sleep apnea (OSA). His case summary reveals an apnea hypopnea index (AHI) of 30.3 and a body mass index (BMI) of 30.88.  His polysomnogram eliminated the possibility of central sleep apnea or complex sleep apnea. The patient had failed and was intolerant to continuous positive airway pressure (CPAP) use. He found it uncomfortable and took it off at night. He had tried different masks and machines without improvement. The patient was unable to utilize an oral appliance due to prior facial injury and pain. He reported feeling tired upon awaking, and falling asleep all the time and was concerned about driving. He also reported loud snoring and waking up frequently gasping for air. There were limited alternative treatments available.  

The combination of indications, including severe OSA syndrome without central apnea syndrome, failure of CPAP, and a lack of complete concentric collapse, made this patient an excellent candidate for stimulation of the upper airway via inspire therapy.

CPAP is the first line of treatment for OSA; however, long-term use for many patients is suboptimal. The hypoglossal nerve stimulator is US Food and Drug Administration (FDA)-approved for the treatment of moderate and severe OSA. A five-year study indicated that the treatment was effective and improved sleepiness, quality of life, and respiratory outcomes. In their position statement, the American Academy of Otolaryngology-Head and Neck Surgery stated that it considers upper airway stimulation via the hypoglossal nerve for the treatment of adult OSA syndrome to be an effective second-line treatment of moderate to severe OSA in patients who are intolerant or unable to achieve benefit with positive pressure therapy.  Candidates for this therapy are selected based on appropriate polysomnographic testing, age, BMI, and objective upper airway evaluation. US FDA eligibility criteria for upper airway stimulator implantation includes an AHI of 15-65, a lack of central apnea, and a favorable pattern of the palatal collapse during drug-induced sleep endoscopy. Patients with OSA, who have an elevated BMI and are unable to tolerate CPAP, can be successfully treated with upper airway stimulation therapy.

Hypoglossal nerve stimulator therapy for the treatment of OSA is FDA approved and is not experimental. Selective upper airway stimulation using an implanted hypoglossal nerve stimulator has become a widely available surgical management for OSA recalcitrant to CPAP treatment or for those patients for whom CPAP is not an option. Due to the predominance of medical literature supporting the effectiveness of hypoglossal nerve stimulation for the treatment of OSA, the requested service is likely to be more beneficial than any of the standard treatments/procedures for this patient.

The carrier's denial of hypoglossal nerve stimulation (inspire upper airway stimulation system) for OSA should be overturned.