Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Obstructive sleep apnea.
Treatment: Procedure code 65468 (incision for implantation of cranial nerve (ex: vagus nerve) (neurostimulator electrode array and pulse generator) and code 0466T (insertion of chest wall respiratory sensor electrode or electrode array, including connection to pulse generator).
The insurer denied coverage for procedure codes 65468 and 0466T.
The denial is overturned. 

This is a female patient with severe obstructive sleep apnea (OSA). She underwent a polysomnogram which revealed an apnea hypopnea index (AHI) of 34. The provider performed a drug-induced sleep endoscopy which revealed the patient did not have complete concentric collapse of the upper airway. The patient had a failure of continuous positive airway pressure (CPAP). The provider opined the patient was an excellent candidate for stimulation of the upper airway via Inspire therapy. He further noted that the patient had a body mass index (BMI) of 32.29 and according to the Food and Drug Administration (FDA); a BMI of 32 or under is not an FDA label requirement for criteria for the procedure.   

Hypoglossal nerve stimulator therapy for the treatment of OSA 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 OSA recalcitrant to 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 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.

This patient presents with severe OSA with an AHI of 34 and BMI of 32.29. She is unable to tolerate CPAP. She has also undergone a sleep endoscopy and the physician has confirmed she does not have complete concentric collapse of the upper airway. The patient meets the standard of care criteria for the implantation of a hypoglossal nerve stimulator. The proposed procedure has been denied because it has been deemed investigational. 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). The hypoglossal nerve stimulator has been approved by the FDA. In addition, The National Institute for Health and Care Excellence (NICE) did an extensive literature search looking at the efficacy of hypoglossal nerve stimulation implantation for OSA. Due to the predominance of medical literature supporting the effectiveness of hypoglossal nerve stimulation for the treatment of OSA, the decision should be overturned.

The scientific evidence in peer-reviewed literature supports a result of improvement in health outcomes for this device.

Procedure code 65468 and code 0466T has final approval from the FDA for this diagnosis. This patient is a good candidate for procedure code 65468 and code 0466T. Procedure code 65468 and code 0466T is the best available treatment for this patient at this time. Procedure code 65468 and code 0466T is likely to be more beneficial than any of the standard treatments/procedures for this patient.

The insurer's denial of coverage for procedure code 65468 (incision for implantation of cranial nerve (ex: vagus nerve) (neurostimulator electrode array and pulse generator) and code 0466T (insertion of chest wall respiratory sensor electrode or electrode array, including connection to pulse generator) is overturned.