Diagnosis: OSA
Issue under review: Hypoglossal nerve stimulation or Inspire upper airway stimulation system

Determination:
The health plan should not cover the Hypoglossal nerve stimulation or Inspire upper airway stimulation system.

The patient is an adult female with a history of OSA. AHI on sleep study was 51.5 with a BMI of 32.4- 33.3. The patient could not tolerate CPAP and underwent a sleep endoscopy, where there was no complete concentric collapse at the velum. There was also a reported failed oral appliance trial. The provider is requesting placement of an Inspire hypoglossal nerve stimulator system to treat the patient's OSA.

There is support in the literature for the efficacy of the Inspire hypoglossal nerve stimulator for the treatment of a subset of patients with OSA who have failed, or cannot tolerate, CPAP therapy. A prospective multi-center study documented a reduction of AHI out to 12 months. In addition, there was a randomized, controlled withdrawal arm of the study which reported AHI reduction out to 18 months. Therefore, based on current scientific literature, scientific evidence would support the efficacy of upper airway stimulation therapy with a hypoglossal nerve stimulator for a subset of patients with OSA who meet FDA criteria for the procedure. In this particular case, the patient would meet FDA criteria for the device in terms of age, AHI and sleep endoscopy findings (there was no complete concentric collapse on sleep endoscopy). The patient has had a previous oral appliance trial, which did not eliminate the symptoms. There was also a reported failed CPAP trial. However, the patient does not have a consistent BMI of 32 or less. There is not conclusive evidence in the scientific literature that the requested service is likely to be more beneficial than any standard treatment or treatments for OSA for patients with a BMI over 32. Therefore, based on the information provided, the previous determination would be upheld at this time.