Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Obstructive sleep apnea (OSA)

Treatment: Procedure hypoglossal nerve stimulation

The insurer denied coverage for procedure hypoglossal nerve stimulation. The denial is reversed.

The patient was a male diagnosed with moderate obstructive sleep apnea based on sleep study with apnea-hypopnea index (AHI) 24.5 and a no evidence of central sleep apnea.  He has a normal body mass index (BMI) of 31.12.  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 2 hours at night.  A sleep endoscopy was performed showing no concentric collapse.

The OTO-HNS policy statement support the upper airway stimulator as a second line treatment after CPAP has failed. Therefore, the scientific evidence in peer-reviewed literature does support a result of improvement in health outcome. The STAR trial (Woodson, B. T. et al., 2016) showed long term follow up (48 months) with significant improvement in Epworth Sleepiness Scale and Quality of Life outcomes. More than 9 out of 10 of the respondents were interested in trying emerging technologies to treat OSA, most preferring continuous transcutaneous electrical stimulation (CTES). (Campbell, T., Pengo, M. F., & Steier, J., 2015).

This review reveals that hypoglossal nerve stimulation therapy may be considered in selected patients with OSA who fail medical treatment. (Certal VF, et al., 2015).The trial demonstrated that hypoglossal nerve stimulation led to significant improvements in objective and subjective measurements of the severity of OSA. (Dedhia RC. et al., 2015).      

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 OTO-HNS policy statement support the upper airway stimulator as a second line treatment after CPAP has failed.     

Inspire therapy is indicated for patients with the following characteristics of 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. Therefore, this patient is a good candidate for hypoglossal nerve stimulation.     

The OTO-HNS policy statement support the upper airway stimulator as a second line treatment after 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.  This patient has severe OSA, a normal BMI and has failed multiple attempts at CPAP therapy.  He therefore meets the criteria for upper airway stimulation device implantation.  In conclusion, the hypoglossal nerve stimulation is the best available treatment for this patient at this time.     
  
This patient has severe OSA, a normal BMI and has failed multiple attempts at CPAP therapy.  He therefore meets the criteria for upper airway stimulation device implantation.                                                    

The carrier's denial of coverage for the procedure hypoglossal nerve stimulation to treat the patient's obstructive sleep apnea should be reversed.