Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Obstructive sleep apnea.
Treatment: Outpatient procedure (64582 x 1); upper airway/hypoglossal nerve stimulation device.

The insurer denied coverage for outpatient procedure (64582 x 1); upper airway/hypoglossal nerve stimulation device.  The denial is overturned.

This is male with a diagnosis of severe obstructive sleep apnea (OSA). He underwent a sleep study and had an apnea-hypopnea index (AHI) of 27.8. There was no evidence of central sleep apnea. His body mass index (BMI) was documented as 30. The patient has continuous positive airway pressure (CPAP) machine but is not tolerant to it. He has tried multiple masks but cannot wear it for more than two hours at night.

The most recent home sleep test showed AHI of 28, with a central-mixed apnea component of 2%. He is not able to tolerate CPAP. His BMI is 29.9. During drug-induced sleep endoscopy (DISE) was absence of complete concentric velopharyngeal collapse.

The scientific evidence in peer-reviewed literature supports a result of improvement in health outcome. Several studies have shown improvement in AHI after such procedures and reported symptoms from OSA.

"Results: The registry has enrolled 1,017 patients from October 2016 through February 2019. Thus far, 640 patients have completed their 6-month follow-up and 382 have completed the 12-month follow-up. After 12 months, median AHI was reduced from 32.8 (interquartile range [IQR], 23.6-45.0) to 9.5 (IQR, 4.0-18.5); mean, 35.8  15.4 to 14.2  15.0, P < .0001. Epworth Sleepiness Scale was similarly improved from 11.0 (IQR, 7-16) to 7.0 (IQR, 4-11); mean, 11.4  5.6 to 7.2  4.8, P < .0001. Therapy usage was 5.6  2.1 hours per night after 12 months. In a multivariate model, only female sex and lower baseline body mass index remained as significant predictors of therapy response.

Across a multi-institutional study, upper airway stimulation (UAS) therapy continues to show significant improvement in subjective and objective OSA outcomes. This analysis shows that the therapy effect is durable, and adherence is high." (Thaler et al., 2020)

Kent et al., (2019), stated "Hypoglossal nerve stimulation demonstrated clinically significant improvements in OSA severity, daytime sleepiness, and sleep-related quality of life in this pooled cohort of patient-level results. Age, BMI, and preoperative AHI appeared to be associated with treatment outcomes, and these variables may explain some of the difference between 2- to 6-month and 12-month outcomes."      

The outpatient procedure (64582 x 1); upper airway/hypoglossal nerve stimulation device has final approval from the appropriate regulatory bodies for this diagnosis. Upper airway/hypoglossal nerve stimulations have received approval by the Food and Drug Administration (FDA); it is acknowledged by the sleep society.     

The patient is a good candidate for the upper airway/hypoglossal nerve stimulation device. He has moderate sleep apnea, without central sleep apnea component, he has tried and failed CPAP, so, at this time this is the best available choice. The adverse risks are the typical risk(s) associated with any surgical procedure.      

The patient has moderate OSA, without central sleep apnea component, BMI less than 30, has described intolerance to CPAP, claustrophobia, feelings of suffocating, and no comfortable positions, as explained in his own letter of appeal. This therapy has proven its efficacy in selected group of patients such his case. Thus, the requested procedure is likely to be more beneficial than any standard therapies. 

The carrier's denial of outpatient procedure (64582 x 1); upper airway/hypoglossal nerve stimulation device should be overturned.