Implantable Hypoglossal Nerve Stimulation
DESCRIPTION
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.
POLICY
Implantable hypoglossal nerve stimulator is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Implantable hypoglossal nerve stimulator for the treatment of other conditions/diseases is considered investigational.
MEDICAL APPROPRIATENESS
Implantable hypoglossal nerve stimulator is 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 on 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 on drug-induced sleep endoscopy
IMPORTANT REMINDERS
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.
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the medical policy and a health plan or government program (e.g., TennCare), the express terms of the health plan or government program will govern.
ADDITIONAL INFORMATION
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.
SOURCES
American Academy of Otolaryngology - Head and Neck Surgery. (2021). Position statement: hypoglossal nerve stimulation for treatment of obstructive sleep apnea (OSA). Retrieved January 21, 2022 from http://www.entnet.org/content/position-statement-hypoglossal-nerve-stimulation-treatment-obstructive-sleep-apnea-osa.
American Academy of Sleep Medicine. (2021). Referral of adults with obstructive sleep apnea for surgical consultation: an American Academy of Sleep Medicine clinical practice guideline. Retrieved February 24, 2023 from http://www.aasmnet.org/Resources/clinicalguidelines/OSA_Adults.pdf.
BlueCross BlueShield Association. Evidence Positioning System. (7:2022). Surgical treatment of snoring and obstructive sleep apnea (7.01.101). Retrieved February 24, 2023 from https://www.evidencepositioningsystem.com. (50 articles and/or guidelines reviewed)
Caloway, C.L., Dierks, G.R., Keamy, D., Guzman, V.D., Soose, R., Raol, N., et al. (2020). Update on hypoglossal nerve stimulation in children with down syndrome and obstructive sleep apnea. The Laryngoscope, 130 (4), E263-E267. Abstract retrieved February 25, 2021 from PubMed database.
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.
CMS.gov: Centers for Medicare & Medicaid Services. Palmetto GBA. (2020, June). Hypoglossal Nerve Stimulation for Obstructive Sleep Apnea. (LCD ID: L38276). Retrieved February 24, 2021 from https://www.cms.gov.
Costantino, A., Rinaldi, V., Moffa, A., Luccarelli, V., Bressi, F., Cassano, M., et al. (2020). Hypoglossal nerve stimulation long-term clinical outcomes: a systematic review and meta-analysis. Sleep & Breathing = Schlaf & Atmung, 24 (2), 399-411. Abstract retrieved February 27, 2023 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 Otolaryngology 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.
Huntley, C., Boon, M., Tschopp, S., Tschopp, K., Jenks, C., Thaler, E., et al. (2021). Comparison of traditional upper airway surgery and upper airway stimulation for obstructive sleep apnea. The Annals of Otology, Rhinology, and Laryngology, 130 (4), 370–376. Abstract retrieved February 27, 2023 from PubMed database.
Kompelli, A., Ni, J., Nguyen, S., Lentsch, E., Neskey, D., Meyer, T. (2018). The outcomes of hypoglossal nerve stimulation in the management of OSA: A systematic review and meta-analysis. The World Journal of Otorhinolaryngology Head Neck Surgery, 5 (1), 41-48. (Level 1 evidence)
Liu, P., Kong, W., Fang, C., Zhu, K., Dai, X., & Meng, X. (2022). Hypoglossal nerve stimulation in adolescents with down syndrome and obstructive sleep apnea: A systematic review and meta-analysis. Frontiers in Neurology, 13, 1037926. (Level 1 evidence)
National Institute for Health and Clinical Evidence (NICE). (2017, November). Hypoglossal nerve stimulation for moderate to severe obstructive sleep apnoea. Retrieved February 25, 2021 from http://www.nice.org.uk.
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, 128 (2), 509-515. (Level 3 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)
Winifred S. Hayes, Inc. Medical Technology Directory. (2018, October; last update search December 2022). Hypoglossal nerve stimulation for the treatment of obstructive sleep apnea. Retrieved February 24, 2023 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)
Yu, P., Stenerson, M., Ishman, S., Shott, S., Raol, N., Soose, R., et al. (2022). Evaluation of upper airway stimulation for adolescents with down syndrome and obstructive sleep apnea. JAMA Otolaryngology - Head & Neck Surgery, 148 (6), 522-528. Abstract retrieved February 27, 2023 from PubMed database.
ORIGINAL EFFECTIVE DATE: 12/1/2017
MOST RECENT REVIEW DATE: 4/13/2023
ID_BT
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