Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Obstructive sleep apnea.
Treatment: The implant of an upper airway stimulator device to treat obstructive sleep apnea (procedure codes 64568 and 0466T).
The insurer denied coverage for the implant of an upper airway stimulator device to treat obstructive sleep apnea (procedure codes 64568 and 0466T).
The denial is upheld. 

This is a male patient who has a history of obstructive sleep apnea (OSA) with an apnea-hypopnea index (AHI) of 18 found on a home sleep study. His body mass index (BMI) is 38. A drug-induced sleep endoscopy (DISE) showed strong anterior-posterior (AP) collapse with some lateral collapse. There is no history of a dental appliance trial, and he finds it difficult to keep his continuous positive airway pressure (CPAP) mask on all night. 

There are numerous peer-review papers of the benefits of upper airway stimulation (UAS) with appropriate indications for treatment of UAS. "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 a safe and 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" (American Academy of Otolaryngology-Head and Neck Surgery (AAOHNS) 2019).      

The implant of an upper airway stimulator device to treat OSA (procedure codes 64568 and 0466T) has final approval from the appropriate regulatory bodies for this diagnosis.     

This patient is not a good candidate for the implant of an upper airway stimulator device to treat OSA (procedure codes 64568 and 0466T).

The patient has not had a trial of a dental appliance. In addition, the DISE study showed some circumferential collapse, and the patient's BMI is 38 which is high.

The only current Food and Drug Administration (FDA)-approved hypoglossal nerve stimulation (HNS) device "for the treatment of moderate-to-severe OSA is produced by Inspire Medical Systems, which recently published its 36-month outcomes data from its Stimulation Therapy for Apnea Reduction (STAR) trial. Hypoglossal nerve stimulation (HNS) therapy is currently indicated for moderate-to-severe OSA patients who are CPAP-intolerant, have a body mass index <32, apnea-hypopnea index <50, and without a concentric pattern of upper airway collapse on sleep endoscopy" (Wray et al 2016).     

The implant of an upper airway stimulator device to treat OSA (procedure codes 64568 and 0466T) is not the best available treatment for this patient at this time.

A properly fit dental appliance may improve the OSA, and/or fitting a different CPAP mask, may allow it to be retained while sleeping. Also, a BMI of greater than 32 makes this patient a poor candidate.

According to Kent et al., The degree of change in outcomes at 2 to 6 and at 12 months appeared to be associated with age, BMI, and preoperative OSA burden. Patients with greater preoperative disease burden tended to experience greater improvements, while younger and heavier patients experienced less improvement in disease.

The carrier's denial of the implant of an upper airway stimulator device to treat obstructive sleep apnea (procedure codes 64568 and 0466T) should be upheld. The requested service is not likely to be more beneficial than any standard treatment/procedures.