Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Obstructive Sleep Apnea

Treatment: Hypoglossal Nerve Stimulation or Inspire Upper Airway Stimulation System (procedure code 64565 and 0466T)
The insurer denied the Hypoglossal Nerve Stimulation or Inspire Upper Airway Stimulation System (procedure code 64565 and 0466T)

The denial was overturned.

This patient is a female currently diagnosed with obstructive sleep apnea, arrhythmia, left breast cancer, hypothyroidism, pain in joints, papillary carcinoma of the thyroid, and bilateral trigeminal neuralgia.  The patient had a polysomnogram which indicated an apnea hypopnea index of 32.7.  The patient's body mass index was 25.13.  The case history also stated because of the trigeminal neuralgia she could not use her continuous positive airway pressure (CPAP) mask.  The provider's letter noted that the polysomnogram eliminated the possibility of central sleep apnea or complex sleep apnea.  The patient had failed and was intolerant to continuous positive airway pressure (CPAP).  The patient took it off at night and had tried different masks and machines without improvement.  The patient had reported loud snoring, waking up frequently gasping for air, and that she was very tired during the day. After the sleep endoscopy, it was noted that the patient did not have complete concentric collapse of the upper airway.  Given the combination of indicators including severe obstructive sleep apnea without central sleep apnea syndrome, failure of CPAP treatment, and a lack of complete concentric collapse, the patient was an excellent candidate for stimulation of the upper airway via Inspire therapy.

Continuous positive airway pressure (CPAP) is a first line of treatment for obstructive sleep apnea; however, long-term use for many patients is suboptimal.  The hypoglossal nerve stimulator was US Food and Drug Administration (FDA)-approved in 2014 for the treatment of moderate and severe obstructive sleep apnea.  A five-year study indicated that the treatment was effective and improved sleepiness, quality of life and respiratory outcomes.

In their updated (2017) position statement, The American Academy of Otolaryngology-Head and Neck Surgery stated it 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).  Candidates for this therapy are selected based on appropriate polysomnographic testing, age, body mass index and objective upper airway evaluation.  The current US Food and Drug Administration (FDA) eligibility criteria for upper airway stimulator implantation includes age of at least 22 years, an apnea-hypopnea index (AHI) of 15-65, a lack of central apnea and a favorable pattern of the palatal collapse during drug-induced sleep endoscopy. 

The hypoglossal nerve stimulator (i.e. the Inspire system) has final approval from the FDA for this diagnosis (severe OSA), this patient meets all inclusion criteria to be a candidate for this device, which are:  BMI<32, age >22, moderate to severe OSA, intolerance to CPAP therapy, <25% central apneas, no concentric collapse of the velopharynx on drug induced sleep endoscopy. 
 
Hypoglossal Nerve Stimulation or Inspire Upper Airway Stimulation System (procedure code 64565 and 0466T) is the best available treatment for this patient at this time. Other surgical procedures for the treatment of OSA have poorer outcomes with higher morbidity. 
 
The carrier's denial of Hypoglossal Nerve Stimulation or Inspire Upper Airway Stimulation System (procedure code 64565 and 0466T) should be overturned.