Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Obstructive Sleep Apnea
Treatment: Inspire Upper Airway Stimulation System [Hypoglossal Nerve Stimulation]
The health plan denied the Inspire Upper Airway Stimulation System [Hypoglossal Nerve Stimulation].
The determination is overturned.


This is a patient with ahistory of obstructive sleep apnea. A most recent study confirmed obstructive sleep apnea (OSA). This showed an apnea hypopnea index (AHI) of 68.5. The minimum oxygen desaturation was 87%. Other pertinent information includes a body mass index (BMI) of 32.3 The examination of the patient showed a normal palate (post uvulopalatopharyngoplasty (UPPP)), absent tonsils, and deviated septum to the right. The patient had failed continuous positive airway pressure (CPAP), previous sleep surgery, and an oral appliance. The patient suffered from loud snoring, daytime fatigue, and a dry mouth. A sleep endoscopy was performed, which showed a thick base of tongue, deviated nasal septum to the right, anterior and posterior collapse, no complete collapse of the upper airway was seen (favorable finding for hypoglossal stimulator implant). At issue is whether the request Inspire Upper Airway Stimulation [Hypoglossal Nerve Stimulation] is likely to be more beneficial than any standard treatment(s).

The patient has tried a CPAP machine without relief and was removing the mask during sleep. In addition, the patient has tried various types of mask without relief. Associated symptoms of the OSA include skin irritation and dry mouth. Previous treatment has included a dental appliance, septoplasty, turbinectomy, tonsillectomy, and UPPP. The hypoglossal stimulation is more beneficial in light of these failed therapies.
Although, the patient has a BMI of greater than 32 kilograms per square meter [kg/m2] (patients over BMI 32 kg/m2 were previously excluded from hypoglossal stimulation trials as success rates became inconsistent), there is a greater likelihood that the patient would benefit from the hypoglossal stimulation versus CPAP. This is based on clinical evidence, physical exam, and history of prior CPAP use. and failed sleep surgery. Therefore, hypoglossal stimulation is more likely to be beneficial.
The patient has failed CPAP trials, in addition to a an oral appliance. The appropriate work up for the Inspire device was done with a sleep endoscopy which showed lack of concentric collapse of the upper airway, and significant prolapse of the tongue/palate during sleep. The patient is at risk for developing severe medical comorbidities if the OSA continues to go untreated.
There is sufficient evidence to support the proposed hypoglossal stimulator surgery. Support for implantation of the device is provided by Woodson et al (2015) and Strollo et al. Both of these studies have shown significant safety and benefit for patients with OSA. Later studies have also supported its continued efficacy (Woodson et al 2018, Heiser et al 2017.) Other authors have even commented that "once it becomes a standard therapy, its advantages might prove sufficient to challenge CPAP as the first-line therapy." (Mwenge et al 2015).
Concerning the elevated BMI of this patient, Sarber et al 2019 found a success rate for patients outside the Food and Drug Administration guidelines for hypoglossal stimulation (67%) was similar to the 1-year STAR trial results (66%). A recent 2 year follow up study by Steffen et al 2019 confirmed previously published studies finding about 76% of patients at 2 years and 68% of patients at 3 years met the criterion of therapy success defined as an AHI below 15.
Hypoglossal stimulation has Food and Drug Administration (FDA) approval. In addition, there is support for the device by leading medical societies. In review of the research in the current literature, there is sufficient evidence to support approval for hypoglossal stimulation for this patient who has failed multiple medical therapies.