Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Severe obstructive sleep apnea

Treatment: Hypoglossal nerve stimulator therapy

The insurer is denied coverage for hypoglossal nerve stimulator therapy. The denial is reversed. 

This case involves a then male patient who had been recommended to receive an upper airway stimulator for the treatment of his severe obstructive sleep apnea (OSA).  The patient was seen for a follow-up. The patient had been utilizing continuous positive airway pressure (CPAP) for severe OSA and no longer felt he could continue to do so.  The patient had trialed multiple mask interfaces but, the patient found all of them very uncomfortable and disruptive to his sleep.   The patient recently underwent a drug-induced sleep endoscopy and was found to have an ideal anatomy for the hypoglossal nerve stimulation placement (i.e. Inspire).  The physician stated that the patient met the criteria: the patient had severe OSA, the patient had intolerance to use of a CPAP machine, the patient had a primarily anterior posterior collapse in the basal pharynx, and the patient's body mass index (BMI) was 28.7. 

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. 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, BMI and objective upper airway evaluation measures are required for proper patient selection

This was then a male patient who had severe obstructive sleep apnea (AHI-47.2; BMI-28.7). During this patient's sleep study, oxygen desaturations were as low as 82%.  The patient's drug-induced sedation endoscopy did not reveal complete concentric collapse of the palate, nasopharynx, or velopharynx. The patient had trialed multiple CPAP masks, but still could not tolerate using CPAP. This patient met the criteria for proper patient selection for hypoglossal nerve stimulator therapy. The patient did not have any contraindication for hypoglossal nerve stimulation therapy. 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 procedure for this condition. Thus, hypoglossal nerve stimulation therapy is considered medically necessary to treat this patient's medical condition.

The health plan did not act reasonably with sound medical judgment, and in the best interest of the patient.

Based on the above, the medical necessity for the Treatment for Sleep Procedure Codes 64568 (incision for implantation of cranial nerve neurostimulator electrode array and pulse generator) and 0466T (insertion of chest wall respiratory sensor electrode or electrode array, including connection to pulse generator) is substantiated.  The insurer's denial should be reversed.