Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Sleep Apnea
Treatment: Inspire Upper Airway Stimulation System 
The insurer denied the Inspire Upper Airway Stimulation System. The health plan's determination is upheld.

The patient is a male who was diagnosed with obstructive sleep apnea. He began treatment with continuous positive airway pressure (CPAP). He reports using the device for three years and he tried 6 different masks, and despite this had a minimal ability to tolerate the device. The patient's Epworth Sleepiness scale score was 14 and his body mass index was 31.46. The patient had symptoms including daytime sleepiness, nocturnal awakenings, loud snoring, witnessed apneas, and a need for daytime naps. Exam of the oral cavity was within normal limits. A sleep study revealed an apnea hypopnea index of 25.5. A drug induced sleep endoscopy (DICE) demonstrated close to concentric collapse at the level of the Velopharynx, an elongated soft palate and epiglottic prolapse. Candidacy was deemed to be borderline for the Inspire hypoglossal nerve stimulator system but in a second opinion, he was deemed to be a good candidate for the device based upon a review of his DICE video.

The proposed Inspire Upper Airway Stimulation System is not likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.
Clinically, this is a patient with moderate obstructive sleep apnea that did not tolerate CPAP well. Drug induced sleep endoscopy was borderline for treatment with the Inspire device by the provider due to close to concentric collapse. There are alternatives to the Inspire system that may include mandibulomaxillary/mandibular osteotomies, positional therapy, an oral appliance, and uvulopalatopharyngoplasty.

According to Chang et al (2020) because of the controversies and unanswered questions about obstructive sleep apnea (OSA) treatments, further studies are needed to define what treatments are best for specific OSA patients. The Stimulation Therapy for Apnea Reduction (STAR) trial, described as "pivotal" was was funded by Inspire Medical Systems, the manufacturer of the technology under review, with the possibility of bias and a review of the literature by Wray and Thaler concluded that the results of the STAR trials may be limited in their generalizability to the broader obstructive sleep apnea population. In a literature review by Certal et al, the studies reviewed were based upon highly specific populations which may not have been representative of the population with moderate to severe obstructive sleep apnea with the heterogenicity of comparing different devices. The authors concluded that based upon a limited number of case reports, which do not necessarily represent real world practice, and that more long-term data was required and further studies comparing hypoglossal nerve stimulation with conventional therapies are needed to definitively evaluate outcomes.
Therefore, the proposed Inspire Upper Airway Stimulation System is not likely to be more beneficial than any standard treatment or treatments for the treatment of the insured obstructive sleep apnea.