Appeal type: Experimental/Investigational
Decision: Overturned

Reviewer #2:

This patient is a male with a diagnosis of severe obstructive sleep apnea based on his sleep study with Apnea-Hypopnea Index (AHI) of 49 and no evidence of central sleep apnea.  The patient's body mass index (BMI) was 34.  The patient had tried multiple masks both full face and nasal in order to tolerate the use of his continuous positive airway pressure (CPAP) machine. However, the patient could not wear and stay on the CPAP for more than two hours at night.  The patient's sleep endoscopy showed no concentric collapse.  All of these factors made this patient a good candidate for the upper airway stimulator.
According to literature, the upper airway stimulator was FDA approved in 2014 and due to its success the inclusion criteria were expanded in 2017 to include patients with an AHI up to 65.  The Otolaryngology-Head and Neck Surgery (OTO-HNS) policy statement supports the upper airway stimulator as a second line treatment after continuous positive airway pressure (CPAP) has failed.  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.

According to Campbell, Pengo, & Steier (2015), "Obstructive sleep apnoea (OSA) is the most common form of sleep-disordered breathing. The standard treatment, continuous positive airway pressure (CPAP), has limited long-term compliance. Alternative treatment options are required and new methods, including hypoglossal nerve stimulation (HNS) and continuous transcutaneous electrical stimulation (CTES), are currently emerging. We report on patients' preference for different treatments of OSA." And the Dedhia, Strollo, & Soose (2015) showed that the "trial demonstrated that hypoglossal nerve stimulation led to significant improvements in objective and subjective measurements of the severity of OSA."                                                    

The continuous positive airway pressure (CPAP) is the gold standard first line treatment for patients with OSA. However, for patients who cannot tolerate CPAP and fit the inclusion criteria, the upper airway stimulator is the second line treatment.  This patient meets the criteria for the upper airway stimulation device to treat his severe OSA.      

This patient is a good candidate for the requested procedure, CPT 64568-RT (incision for implantation of cranial nerve neurostimulator electrode array and pulse generator) and CPT 0466T (insertion of chest wall respiratory sensor electrode or electrode array, including connection to pulse generator). The patient has moderate to severe OSA (AHI range from 15-65 with <25% central apnea), unable to use CPAP, and free of complete concentric collapse at the palate. 

Thus, the requested procedures are likely to be more beneficial than any of the standard treatments/procedures for this patient.

The carrier's denial of CPT 64568-RT (incision for implantation of cranial nerve neurostimulator electrode array and pulse generator) and CPT 0466T (insertion of chest wall respiratory sensor electrode or electrode array, including connection to pulse generator) should be reversed.