Appeal type: Experimental/Investigational
Decision: Overturned

Reviewer#3

Diagnosis: Obstructive sleep apnea (OSA)

Treatment: Procedure hypoglossal nerve stimulation

The insurer denied coverage for procedure hypoglossal nerve stimulation. The denial is reversed.

The patient was a male with sleep-disordered breathing, intolerant of continuous positive airway pressure (CPAP), not well rested after sleep. Examination indicates body mass index (BMI) of 31.1, rapid in folding of lateral pharyngeal walls, macroglossia, mild arytenoid erythema, Mallampati class III.  Sleep test noted to show apnea-hypopnea index (AHI) 24.5.  The sedation endoscopy report indicates primary AP collapse, no obstruction oropharynx, no obstruction hypopharynx.  Review is for hypoglossal nerve stimulator implantation. The peer-reviewed literature does support a result of improvement in health outcomes.

Mwenge GB, Rombaux P, Dury M, Lengele B, Rodenstein D. (2013) stated, "The present study represents the longest study of any hypoglossal neurostimulation reported to date.  We conclude that THN is safe and effective to treat OSA in patients not compliant with CPAP."Shah, Janki, et al. (2018) concluding: While both traditional surgery and HNS are effective treatments for patients with moderate to severe OSA with CPAP intolerance, our study demonstrates that HNS is "curative" in normalizing the AHI to <5 in the majority of patients.  For select patients, HNS therapy provides excellent objective improvement in outcome measures.

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

Hypoglossal nerve stimulation for treatment of obstructive sleep apnea has approval of the US Food and Drug Administration (FDA); 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 35 kg/m2 (Inspire has not been tested in patients with BMI > 35), AHI between 15 and 65/hr, 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 available medical record of symptomatic obstructive sleep apnea, confirmation of obstructive parameters as listed in the FDA approved indications with polysomnogram, favorable patient specific anatomic criteria as listed in the FDA approved indications, intolerance / non acceptance of CPAP, and no contraindications as listed above for hypoglossal nerve stimulator implantation. Therefore, the hypoglossal nerve stimulation is the best available treatment for this patient at this time.     
  
The requested service is likely to be more beneficial than any of the standard treatments/procedures for this patient.                                                    

The carrier's denial of coverage for the procedure hypoglossal nerve stimulation to treat the patient's obstructive sleep apnea should be reversed.