Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Obstructive Sleep Apnea
Treatment: Hypoglossal Nerve Stimulator (0466T), Pre-service
The insurer denied the Hypoglossal Nerve Stimulator (0466T), Pre-service
The denial is overturned.

The patient is a male with obstructive sleep apnea. His BMI (body mass index) is 34. There is documentation of prior use of a dental appliance, and new documentation shows failed CPAP (continuous positive airway pressure) therapy. His AHI (apnea hypopnea index) was 19.6. He had nadir oxygen saturation of 83% with 12% of the polysomnogram time below 90% saturation. The patient had septoplasty endoscopic sinus surgery and sleep endoscopy. This study did not demonstrate concentric collapse of the airway. For the hypoglossal nerve stimulator implantation, the implant code 0466T was denied.

Yes, the Hypoglossal Nerve Stimulator is medically necessary.
Medical necessity was established for the device and procedure with the documentation of a trial and failure of conservative therapy with CPAP.  This is a generally accepted requirement for the use of hypoglossal nerve stimulator.

As noted, the plan's rationale for denial is not supported by the medical literature.

The procedure and device are FDA (United States Food and Drug Administration)-approved as referenced below and recognized in the treating community as efficacious and safe for properly selected patients.  This patient with significant desaturations and favorable anatomy would be a good candidate for this intervention, having failed conservative therapy.  By virtue of review of the literature, the procedure and device are not unproven.  This is particularly evident with the withdrawal study by Woodson, referenced below, which showed the efficacy of the therapy and the reversal of efficacy by discontinuing the stimulation.

Medical necessity is generally defined as required to diagnose or treat an illness, injury, disease or its symptoms; in accordance with generally accepted standards of medical practice; clinically appropriate in terms of type, frequency, extent, site and duration; not primarily for the convenience of the patient, Physician or other health care provider; and rendered in the least intensive setting that is appropriate for the delivery of the services and supplies.

For this patient, the proposed procedure would be required to treat the sleep apnea, if not controlled by more conservative measures.  It meets the standard of care and is not for the convenience of the patient.

The principal specialty in Otolaryngology (the American Academy of Otolaryngology- Head and Neck Surgery) has examined the scientific support for hypoglossal nerve stimulator in sleep apnea and concludes the following:

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 (upper airway stimulation) therapy and appropriate polysomnographic, age, BMI (body mass index) and objective upper airway evaluation measures are required for proper patient selection.

The procedure itself (and the implant) are FDA (United State Food and Drug Administration)-approved for patients with sleep apnea. This patient meets all criteria, including conservative management based on their sleep study results, and drug induced sleep endoscopy.

This patient has had proper evaluation and has failed conservative therapy. Therefore, the requested health service is medically necessary.