Diagnosis: OSA (obstructive sleep apnea)

Treatment hypoglossal nerve stimulation

The insurer denied coverage for hypoglossal nerve stimulation.

The denial is overturned.

This was an adult male with a history of obstructive sleep apnea (OSA). The chart documented that he could not tolerate continuous positive airway pressures (CPAP) or bilevel positive airway pressure (BIPAP), he had a body mass index (BMI) of 29.8 and the sleep induced endoscopy, which revealed:

"The vellum was clearly seen to collapse in an anterior posterior direction without significant mobility of the lateral walls. This view was documented using a recording device. Additionally, there was no evidence of tongue base hypertrophy or other contributing factors. Next, the endoscope was advanced further to evaluate the patient's bilateral tongue base, piriformis sinuses, molecular, vocal cords and other structures of the super robotic region. There were no lesions, masses or ulceration seen."

There is only one sleep study which was performed which showed an apnea hypopnea index (AHI) of 71.2.

There is extensive literature showing the efficacy of hypoglossal nerve stimulation and the treatment of obstructive sleep apnea (1-7). The use of hypoglossal nerve stimulation has been approved by international and national professional societies (8-12). The Food and Drug Administration (FDA) has twice approved the use of hypoglossal nerve stimulation for the effective treatment of obstructive sleep apnea (13,14).

The patient fulfilled two of the three of the FDA requirements for the uses of hypoglossal stimulation which included (1) AHI of greater than 15 and less than 65; his was out of range at 71.2; (2) who have been confirmed to fail or cannot tolerate positive airway pressure (CPAP), this has been documented; and (3) who do not have a complete concentric collapse at the soft palate level, which was documented by the endoscopy.

As noted in the two FDA approvals and the peer-reviewed literature documented that in two different studies, all of patients with AHIs greater than 65 were cured of their obstructive sleep apnea as was noted with postoperative AHIs of less than or equal to five.

Use of hypoglossal nerve stimulation for the treatment of obstructive sleep apnea is medically necessary for this patient. The scientific evidence in peer-reviewed literature does support a result of improvement in health outcome. Although the patient's AHI was greater than what had been approved by the FDA, at least two different peer-reviewed reports found that all their patients who had AHI's greater than 65 were cured with the criteria that postoperatively their AHI were all less than 5.

The health care plan did not act reasonably, with sound medical judgment or in the best interest of the patient as the cases in the peer-reviewed literature have shown that the use of hypoglossal nerve stimulation in patients with AHIs greater than 65 is efficacious.

The insurer's denial of coverage for a hypoglossal nerve/ upper airway stimulator device to treat obstructive sleep apnea (OSA) is overturned. Medical necessity is substantiated.