Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Sleep Apnea 
Treatment: Hypoglossal Nerve Stimulation (64568 x 1, 0466T x 1) 

The insurer is denied coverage for Hypoglossal Nerve Stimulation (64568 x 1, 0466T x 1). The denial is overturned. 

This is a male patient with a medical history of sleep apnea, hypertension, high cholesterol, chronic insomnia, depression, gastroesophageal reflux disease, esophagitis and nonalcoholic steatohepatitis. The patient underwent a sleep study and had an apnea hypopnea index (AHI) of 34.3 with central and mixed apneas less than 25%. He had tried continuous positive airway pressure (CPAP) without relief. The patient removed his mask during sleep and tried various masks without relief. The provider did not feel that oral appliance therapy was appropriate. The drug induced sleep endoscopy revealed no evidence of complete concentric collapse. The request was made for a hypoglossal nerve stimulator. 

Hypoglossal nerve stimulator therapy for the treatment of obstructive sleep apnea has been in peer reviewed literature for over two decades. It is FDA approved. Selective upper airway stimulation (UAS) using an implanted hypoglossal nerve stimulator has become a widely available surgical management for obstructive sleep apnea recalcitrant to continuous positive airway pressure (CPAP) treatment or for those patients for whom CPAP is not an option. Clinical trials have shown that in carefully selected adult patients there are dramatic clinical improvements. One study showed a 68% decrease in the apnea-hypopnea index (AHI) and 70% decrease in oxygen desaturation index. Another study showed that UAS lead to significantly improved sleepiness, quality of life, and respiratory outcomes at 5 years. 

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 an 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 (PAP). Not all adult patients are candidates for UAS therapy and appropriate polysomnographic, age, body mass index (BMI) and objective upper airway evaluation measures are required for proper patient selection. 

"The following criteria are standard of care indications for hypoglossal nerve stimulator
therapy: 1) 22 years of age or older 2) Have moderate to severe OSA (AHI range from 15-65 with <25% central apneas) 3) Unable to use CPAP 4) Free of complete concentric collapse at the palate as seen on drug-induced sedation endoscopy" 

It is FDA approved. The following press release was in May 2014. "Inspire Medical Systems, Inc. announced May 1 that the U.S. Food and Drug Administration (FDA) has approved Inspire Upper Airway Stimulation (UAS) therapy for use in a subset of
patients with moderate to severe obstructive sleep apnea (OSA) who are unable to use continuous positive airway pressure (CPAP) therapy. Inspire therapy is a fully implanted
neurostimulation device that senses breathing patterns and delivers mild stimulation to key airway muscles, which keeps the airway open during sleep. The company, which is based in Minneapolis, Minn., indicated that Inspire therapy will be commercially available to patients in the U.S. in the second half of 2014." 

In the systematic review and meta-analysis of 200 patients, there was a statistically significant decrease in the Epworth sleepiness scale (scores range from 0 to 24 with higher scores indicating more daytime sleepiness). At 3-, 6-, and 12 month follow-up the mean differences from baseline were -4.17 (CI -6.45 to -1.90, 34 patients), -3.82 (95% CI-5.37 to -2.27, 60 patients) and -4.42 (95% CI -5.39 to -3.44, 170 patients) respectively (p<0.001 for all time points).

The carrier's denial of coverage for Hypoglossal Nerve Stimulation (64568 x 1, 0466T x 1) should be overturned.