Appeal type: Experimental/Investigational
Decision: Overturned

Reviewer #3:

The patient is a male with a past medical history that included anxiety as well as chronic obstructive pulmonary disease (COPD), diabetes, hypertension, sarcoidosis and severe obstructive sleep apnea (OSA).  The submitted documentation indicated that this patient had undergone multiple diagnostic studies, which included a polysomnogram. This study revealed an Apnea-Hypopnea Index (AHI) of 49.  The documentation also indicated that the patient's body mass index was 34.01.
  The patient's initial treatment for his OSA was using the continuous positive airway pressure (CPAP) device. However, the patient was noted to be very claustrophobic and despite multiple trials with different face masks, the patient could not tolerate the use of CPAP during the night.  The documentation noted that the patient had also undergone a drug-induced sleep endoscopy which did not reveal any complete concentric collapse.  The patient's OSA was symptomatic; the patient complained of significant daytime sleepiness.  With this patient's significant OSA noted on testing and inability to tolerate CPAP use, the patient was recommended to undergo implantation of an upper airway stimulation device.

Hypoglossal nerve stimulator therapy for the treatment of obstructive sleep apnea has been in peer reviewed literature for over two decades.  It is FDA approved. Selective upper airway stimulation (UAS) using an implanted hypoglossal nerve stimulator has become a widely available surgical management for obstructive sleep apnea recalcitrant to continuous positive airway pressure (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 apnea-hypopnea index (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.

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.

The patient could not tolerate the use of CPAP, and was poorly compliant with the use of CPAP during the night. Literature supports that sleep apnea, if left untreated has the potential for serious medical sequela.  This patient did not have any clinical contraindication for hypoglossal nerve stimulation therapy. 
Thus, given this patient's clinical circumstances, 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.