Implantable Hypoglossal Nerve Stimulation
Hypoglossal nerve stimulation is proposed as a treatment for obstructive sleep apnea in individuals who are unable to use CPAP. Stimulation of the hypoglossal nerve contracts the genioglossus muscle causing tongue protrusion and stiffening of the anterior pharyngeal wall, potentially decreasing apneic events. Implantable hypoglossal nerve stimulation systems, such as the Inspire® II Upper Airway Stimulation System, include respiratory sensing leads that permit intermittent stimulation during inspiration. Stimulation parameters are titrated during an in-laboratory polysomnography and can be adjusted during home use. The device is turned on only during sleep periods.
Implantable hypoglossal nerve stimulators are considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below)
hypoglossal nerve stimulators for the treatment of all other conditions/diseases
are considered investigational.
hypoglossal nerve stimulators are considered medically
appropriate if ANY ONE
of the following are met:
Adults with obstructive sleep apnea (OSA) when ALL the following criteria are met:
Age greater than 22 years
Apnea hypopnea index (AHI) greater than or equal to 15 with less than 25% central apnea
Inability to tolerate CPAP or failure of CPAP (residual AHI > 15 or failure to use CPAP > 4 hr per night for > 5 nights per week)
BMI less than or equal to 35 kg/m2
Non-concentric retropalatal obstruction was confirmed by drug-induced sleep endoscopy
Adolescents or young adults with Down syndrome and obstructive sleep apnea (OSA) when ALL the following criteria are met:
Age 10 to 21 years
Apnea hypopnea index (AHI) greater than 10 and less than 50 with less than 25% central apneas after prior adenotonsillectomy
Have tracheotomy or ineffectively treated with CPAP due to noncompliance, discomfort, undesirable side effects, persistent symptoms despite compliance, or refusal to use device
BMI less than or equal to 95th percentile for age
Non-concentric retropalatal obstruction was confirmed by drug-induced sleep endoscopy.
Any specific products referenced in this policy are just examples and are intended for illustrative purposes only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available. These examples are contained in the parenthetical e.g. statement.
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Hypoglossal nerve stimulation has shown increased success rates for about two-thirds of a subset of individuals who met selection criteria that included AHI, body mass index, and favorable pattern of palatal collapse. These results were maintained out to five years in the pivotal single-arm study. Clinical input supplements and informs the interpretation of the published evidence. Clinical input indicates that HNS leads to a meaningful improvement in health outcomes in appropriately selected adult individuals with a favorable pattern of non-concentric palatal collapse.
American Academy of Otolaryngology - Head and Neck Surgery. (2016). Position statement: hypoglossal nerve stimulation for treatment of obstructive sleep apnea (OSA). Retrieved July 10, 2017 from http://www.entnet.org/content/position-statement-hypoglossal-nerve-stimulation-treatment-obstructive-sleep-apnea-osa.
American Academy of Sleep Medicine. (2009). Clinical guideline for the evaluation, management and long-term care of obstructive sleep apnea in adults. Retrieved July 10, 2017 from http://www.aasmnet.org/Resources/clinicalguidelines/OSA_Adults.pdf.
BlueCross BlueShield Association. Evidence Positioning System. (1:2019). Surgical treatment of snoring and obstructive sleep apnea (7.01.101). Retrieved April 1, 2019 from https://www.evidencepositioningsystem.com. (28 articles and/or guidelines reviewed)
Certal, V., Zaghi, S., Riaz, M., Vieira, A., Pinheiro, C., Kushida, C., et al. (2015). Hypoglossal nerve stimulation in the treatment of obstructive sleep apnea: a systematic review and meta-analysis. Laryngoscope, 125 (5), 1254-1264. Abstract retrieved July 10, 2017 from PubMed database.
Dierks, G.R., Wentland, C., Keamy, D., Kinane, T.B., Skoto, B., Guzman, V.D., et al. (2017). Hypoglossal nerve stimulation in adolescents with down syndrome and obstructive sleep apnea. JAMA Otolaryngol Head Neck Surgery, 144 (1), 37-42. (Level 4 evidence)
Gillespie, M., Soose, R., Woodson, B., Strohl, K., Maurer, J., de Vries, N., et al. (2017). Upper airway stimulation for obstructive sleep apnea: patient-reported outcomes after 48 months of follow-up. Otolaryngology - Head Neck Surgery, 156 (4), 7658-771. Abstract retrieved July 14, 2017 from PubMed database.
Kompelli, A.R., Ni, J.S., Nguyen, S.A., Lentsch, E.J., Neskey, D.M., Meyer, T.A. (2018). The outcomes of hypoglossal nerve stimulation in the management of OSA: A systematic review and meta-analysis. The World Journal of Otorhinolaryngol Head Neck Surgery, 5 (1), 41-48. (Level 1 evidence)
Soose, R., Woodson, B., Gillespie, M., Maurer, J., de Vries, N., Steward, D. (2016). Upper airway stimulation for obstructive sleep apnea: self-reported outcomes at 24 months. Journal of Clinical Sleep Medicine, 12 (1), 43-48. (Level 3 evidence)
Steffen, A., Sommer, J., Hofauer, B., Maurer, J., Hasselbacher, K., & Heiser, C. (2017). Outcome after one year of upper airway stimulation for obstructive sleep apnea in a multicenter German post-market study. The Laryngoscope, Doi: 10.1002/lary.26688. [Epub ahead of print]. (Level 4 evidence)
Strollo, P., Gillespie, M., Soose, R., Maurer, J., de Vries, N., Cornelius, J., et al. (2015). Upper airway stimulation for obstructive sleep apnea: durability of the treatment effect at 18 months. Sleep, 38 (10), 1593-1598C. (Level 3 evidence)
Strollo, P., Soose, R., Maurer, J., de Vries, N., Cornelius, J., Froymovich, O., et al. (2014). Upper-airway stimulation for obstructive sleep apnea. The New England Journal of Medicine, 370, 139-149. (Level 3 evidence)
Winifred S. Hayes, Inc. Medical Technology Directory. (2018, October). Hypoglossal nerve stimulation for the treatment of obstructive sleep apnea. Retrieved April 3, 2019 from www.hayesinc.com/subscribers (63 articles and/or guidelines reviewed)
Woodson, B., Soose, R., Gillespie, M., Strohl, K., Maurer, J., de Vries, N., et al. (2016). Three-year outcomes of cranial nerve stimulation for obstructive sleep apnea: the STAR trial. Otolaryngology – Head and Neck Surgery, 154 (1), 181-188. (Level 3 evidence)
ORIGINAL EFFECTIVE DATE: 12/1/2017
MOST RECENT REVIEW DATE: 8/30/2019
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
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