Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Obstructive sleep apnea.
Treatment: Outpatient procedure (64582 x 1); upper airway/hypoglossal nerve stimulation device.

The insurer denied coverage for outpatient procedure (64582 x 1); upper airway/hypoglossal nerve stimulation device.  The denial is overturned.

The patient is male presenting with loud snoring and symptomatic sleep-disordered breathing, intolerance of continuous positive airway pressure (CPAP); examination indicates body mass index (BMI) 29.9; sedation endoscopy notes no complete concentric oral pharyngeal collapse; sleep test noted Apnea-hypopnea index (AHI) 24.5 with less than 2% central and mixed apnea events.

The scientific evidence in peer- reviewed literature support a result of improvement in health outcome. The American Academy of Otolaryngology-Head and Neck Surgery position paper considers upper airway stimulation (UAS) via the hypoglossal nerve for the treatment of adult obstructive sleep apnea (OSA) syndrome to be an effective second-line treatment of moderate to severe OSA in patients who are intolerant or unable to achieve benefit with positive pressure therapy (PAP). Not all adult patients are candidates for UAS therapy and appropriate polysomnographic, age, BMI and objective upper airway evaluation measures are required for proper patient selection.

Based on current relevant peer-reviewed literature and the position paper of the American Academy of Otolaryngology, the use of CPT 64568 (Incision for implantation of cranial nerve (e.g., vagus nerve) neurostimulator electrode array and pulse generator), CPT 64999 (Unlisted procedure, nervous system code implantation of sensing lead), and CPT 95970 (Electronic analysis of implanted neurostimulator pulse generator system) is supported in this clinical scenario.

The upper airway/hypoglossal nerve stimulation device has final approval from the appropriate regulatory bodies for this diagnosis. 

Per the Food and Drug Administration (FDA) (2020), Hypoglossal nerve stimulation for treatment of OSA has approval; is not the subject of ongoing phase I, II or III clinical trials; does not require institutional review board approval; published studies in objective authoritative medical peer reviewed literature notes adequate well-controlled clinical trials documenting safety and efficacy as compared with the standard means of treatment or diagnosis of the condition in question. The majority of literature defines the ideal candidate as having BMI less than or equal to 32 (Inspire has not been tested in patients with BMI > 35), AHI between 15 and 65/hour, and without complete concentric collapse at the level of soft palate. Also, patients with a relatively larger tongue tended to have a larger response. 

There is documentation in the medical record of symptomatic OSA, confirmation of obstructive parameters with polysomnogram, favorable patient specific anatomic criteria as listed in the FDA approved indications, intolerance / non acceptance of CPAP, and no contraindications for hypoglossal nerve stimulator implantation. Therefore, this patient meets FDA approved indications and is a good candidate for upper airway/hypoglossal nerve stimulation device.     

The upper airway/hypoglossal nerve stimulation device is the best available treatment for this patient at this time. There is documentation in the available medical record of symptomatic sleep-disordered breathing and failure/intolerance of prior treatment with CPAP.     

The adverse risks are increased over standard treatment/services. Previously attempted standard treatment with CPAP is documented as having failed due to intolerance.     

Hypoglossal nerve similar implantation is likely to be more beneficial than any other standard treatment for this patient.                                                    

The carrier's denial of outpatient procedure (64582 x 1); upper airway/hypoglossal nerve stimulation device should be overturned.