Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Obstructive Sleep Apnea
Treatment: Medical Procedure 64568 x 1(upper airway stimulation device), Pre-service
The insurer denied the Medical Procedure 64568 x 1(upper airway stimulation device), Pre-service
The denial is overturned.

The patient is a male with sleep apnea. He has AHI (apnea hypopnea index) of 19.6 and desaturations to 83%. The patient has tried dental appliance unsuccessfully, and documentation shows failure of CPAP (continuous positive airway pressure) therapy.  The patient had septoplasty with turbinectomy (and endoscopic sinus surgery). He had drug induced sleep endoscopy without circumferential collapse.

Yes, the Medical Procedure 64568 x 1 (upper airway stimulation device) is medically necessary.
Medical necessity for inspire hypoglossal stimulator was established with documented CPAP (continuous positive airway pressure) trial and failure. This conservative management is a base criterion to proceed with the more invasive stimulator implant.

The plan's determination is rejected, as this procedure is a standard of care, FDA (United States Food and Drug Administration)-approved and widely implemented successfully for patients who fail conservative therapy.

The plan rejected the procedure based on unproven status.  As noted, the decision should be overturned as it is documented that the patient has failed prior conservative therapy.

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 severe desaturations and favorable anatomy is a good candidate for this intervention. Records have shown failure of both dental appliance and CPAP (continuous positive airway pressure) therapy.  By virtue of review of the literature, this procedure is 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 is required to treat the sleep apnea, 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.

This patient has had proper evaluation and meets clinical criteria for this intervention.