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 a male diagnosed with severe obstructive sleep apnea (OSA) based on sleep study with Apnea-hypopnea index (AHI) 27.8 and no evidence of central sleep apnea. He has a normal body mass index (BMI) of 30. The patient has tried multiple masks both full face and nasal in order to use his continuous positive airway pressure (CPAP) machine but is not tolerant to it and cannot wear it for more than two hours at night.  

A sleep endoscopy was performed showing no concentric collapse. All of these factors make him a good candidate for the upper airway stimulator.

A final adverse determination noted the role of the requested service remains uncertain. It is not proven that it improves health outcomes over usual standard care, and the health plan does not cover experimental or investigational tests or treatments.

The scientific evidence in peer-reviewed literature supports a result of improvement in health outcome. The upper airway stimulator was Food and Drug Administration (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 (2020) support the upper airway stimulator as a second line treatment after CPAP has failed.  

According to the American Academy of Otolaryngology-Head and Neck Surgery (2016), upper airway stimulation (UAS) via the hypoglossal nerve for the treatment of adult OSA syndrome is an effective second-line treatment of moderate to severe OSA 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. 

CPAP is the gold standard first line, but 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.      

The upper airway/hypoglossal nerve stimulation device has final approval from the appropriate regulatory bodies for this diagnosis 

This patient is a good candidate for the procedure. Inspire therapy is indicated for patients who are 22 years of age or older, have moderate to severe OSA (AHI range from 15-65 with <25% central apneas), unable to use CPAP and free of complete concentric collapse at the palate. This patient meets all criteria.   

"Hypoglossal nerve stimulation (HGNS) therapy was approved in 2014 for the treatment of OSA in patients who are intolerant to CPAP therapy, which is reported in up to 4060% of patients. This therapy works via direct neurostimulation of the hypoglossal nerve in synchrony with respiration, to open the airway via tongue stiffening and protrusion. Studies have demonstrated significant reductions in both respiratory parameters such as disordered breathing indices, as well as subjective sleep complaints, such as daytime sleepiness, with the use of this therapy. This has increased the repertoire of treatment options for sleep providers to recommend to those patients that are intolerant to CPAP therapy." (Olson & Junna, 2021)   

There are no adverse risks increased over standard treatment/service. There are increased risks which are standard for any surgery. The requested procedure is likely to be more beneficial than any other standard service.

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