Appeal type: Medical Necessity
Decision: Insurer Denial Upheld

Summary Reviewer  
 
The patient is a 12-year-old male who presented for a sleep study on 3/29/21. The patients parent 
has requested authorization and coverage for Inspire Hypoglossal Nerve Stimulator. The Health 
Insurer has denied this request and reported that the requested services are not medically necessary 
for the treatment of this patient. This denial is the subject of this appeal and determination. The 
physician reviewer found that the submitted documentation fails to demonstrate the medical 
necessity of the requested services. The patient has a history of trisomy 21 and severe obstructive 
sleep apnea in the setting of post-adenotonsillectomy. His apnea-hypopnea index (AHI) score was 
17. The patients primary issue is the large tongue base, and he is reportedly non-compliant with 
CPAP secondary to sensory issues related to Down syndrome. According to the U.S. Food and 
Drug Administration (FDA), the Inspire Upper Airway Stimulation device was given a premarket 
approval, dated April 14, 2020, expanding the indications for this device to adolescents aged 18 to 
21. Inspire UAS is indicated for use in patients between the ages of 18 and 21 with moderate to 
severe  OSA  who:  do  not  have  complete  concentric  collapse  at  the  soft  palate  level;  are 
contraindicated for, or not effectively treated by, adenotonsillectomy; have been confirmed to fail, 
or cannot tolerate, positive airway pressure (PAP) therapy despite attempts to improve compliance; 
and  have  followed  standard  of  care  in  considering  all  other  alternative/adjunct  therapies. 
Otherwise, this device is only FDA-approved in adults. A number of recent small case studies, and 
one small trial, have shown that the treatment of OSA with hypoglossal nerve stimulation in Down 
syndrome  patients  does  have  promise  and  is  generally  tolerated.  However,  Amaddeo  and 
colleagues noted that although this treatment has been shown to be effective in adults with OSA 
and no obesity or circumferential velopharynx collapse, information on long-term follow-up is 
lacking for the adolescent Down syndrome population for which this treatment is proposed. 
Likewise, a very recent systematic review by Gounden and Chawla, reviewing the management of 
OSA in Down syndrome post-adenotonsillectomy, found, The most optimal treatment for the 
management of residual obstructive sleep apnea remains uncertain. There are various treatment 
options described in the literature, however, they have not been thoroughly studied, with only eight 
relevant articles found. Studies comparing outcomes following different treatment interventions 
and using consistent parameters are required to gain further understanding of the most optimal 
treatment for residual obstructive sleep apnea in this population. While this patient does meet 
most of the FDA indications for this device, he does not meet the age requirement. This device is 
approved only for those aged 18 and older. In addition, the recent systematic review by Gounden 
and  Chawla  emphasized  that  the  optimal  treatment  for  OSA,  including  hypoglossal  nerve 
stimulation, in this Down syndrome pediatric population is unknown.  Both the lack of FDA 
approval in this age category and the lack of large-scale trials supporting this treatment in this 
population remain relevant in the determination of this case. As such, the requested Inspire 
Hypoglossal Nerve Stimulator is not medically necessary for the treatment of this patient.