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 case involves a male who has been previously diagnosed with sleep apnea, hypertension, insomnia, depression, high cholesterol, reflux, and non-alcoholic state of hepatitis. The submitted documentation indicated the patient has had a trial and failure of continuous positive airway pressure (CPAP) therapy without relief in an attempt to treat the diagnosed sleep apnea. The documentation does detail the patient has undergone a druginduced sleep endoscopy which did not reveal any evidence of complete concentric collapse. The patient has also undergone a prior sleep study revealing an Apnea Hypopnea Index (AHI) of 34.3 with central and mixed apneas. The documentation also detailed in the patient's chart was seen and on physical examination there are no significant abnormalities. The physician detailed the patient was recommended at this visit to utilize Nasonex. 

This device for hypoglossal nerve stimulation was approved by FDA in April 2014. For this device, the evaluation must show that individuals do not have complete concentric collapse at the soft palate level and this is considered a second level treatment and individuals must have failed or cannot tolerate PAP therapy. 

PAP failure is defined as an inability to eliminate OSA despite PAP usage, and PAP intolerance is defined as inability to use PAP greater than 5 nights per week of usage, greater than 4 hours of use per night or unwillingness to use PAP, that is a person returns the PAP system after attempting to use it. 

Based on reliable evidence hypoglossal nerve stimulator therapy device for the treatment of obstructive sleep apnea is not considered experimental investigational. 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 and is not experimental. 

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 scientific evidence in peer-reviewed literature supports a result of improvement in health outcome. Hypoglossal Nerve Stimulation (64568 x 1, 0466T x 1) does have final approval from the appropriate regulatory bodies for this diagnosis. This patient is a good candidate for Hypoglossal Nerve Stimulation (64568 x 1, 0466T x 1) and is the best available treatment for the patient. 

The requested service is likely to be more beneficial than any of the standard treatments/ procedures for this patient. 

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