hypoglossal nerve stimulation

Use is limited to use in Medicare, Medicaid or other programs administered by the Centers for Medicare and Medicaid Services (CMS). Serious device-related adverse events were rare, with 1 elective device explantation from 12 to 36 months. His research and clinical practice focuses on the entire myriad of sleep disorders. Most of the device-related events that were not considered to be serious resolved after the participants acclimated to the upper-airway stimulation therapy or after the device was reprogrammed to adjust the stimulation variables. Strollo PJ Jr, Gillespie MB, Soose RJ, et al. MeSH The page could not be loaded. Upper Airway Stimulation in Patients With Obstructive Sleep Apnea and an Elevated Body Mass Index: A Multi-institutional Review. Unable to load your collection due to an error, Unable to load your delegates due to an error. 2020 Jun;162(6):985-992. doi: 10.1177/0194599820917147. Hypoglossal nerve stimulation therapy is commonly referred to as Inspire, a reference to the name of the company — Inspire Medical Systems — that developed the treatment, which was approved by the Food and Drug Administration in 2014. Hypoglossal Nerve Stimulator Hypoglossal nerve stimulator is a treatment to help with obstructive sleep apnea when continuous positive airway pressure (CPAP) has not worked. Atul Malhotra, M.D. Identifying Signs and Symptoms of Obstructive Sleep Apnea in a Men's Health Clinic: The Utility of Home Sleep Apnea Testing During COVID-19. continuous positive airway pressure (CPAP), children and adolescents with Down syndrome, https://www.ncbi.nlm.nih.gov/books/NBK532869/, https://www.nhlbi.nih.gov/health-topics/sleep-apnea, https://medlineplus.gov/ency/article/001916.htm, https://pubmed.ncbi.nlm.nih.gov/18949106/, https://pubmed.ncbi.nlm.nih.gov/31584412/, https://pubmed.ncbi.nlm.nih.gov/31699408/, https://medlineplus.gov/ency/article/003932.htm, https://www.fda.gov/medical-devices/recently-approved-devices/inspirer-upper-airway-stimulation-p130008s039, https://pubmed.ncbi.nlm.nih.gov/29098288/, https://www.accessdata.fda.gov/cdrh_docs/pdf13/P130008B.pdf, Mallampati Score and Predicting Sleep Apnea, Best Anti-Snoring Mouthpieces and Mouthguards. It is a nerve with a solely motor function. Those having continuous positive airway pressure failure with moderate to severe OSA, body mass index less than 32 kg/m2, and no unfavorable collapse on drug-induced sleep endoscopy were enrolled in a phase 3 trial. The hypoglossal nerve stimulator (Inspire Medical Systems, Maple Grove, MN) includes an implantable pacemaker-sized pulse generator that senses chest wall movement during sleep and contracts the genioglossus muscle via stimulation of the hypoglossal nerve. They noted a significant improvement in the apnea-hypopnea index (AHI) and O2 desaturation nadir. By clicking below on the button labeled "I accept", you hereby acknowledge that you have read, understood and agreed to all terms and conditions set forth in this agreement. The ODI was chosen as a stable integrative outcome value of all forms of sleep-disordered breathing. Hypoglossal nerve stimulation for obstructive sleep apnea: A review of the literature. Upper airway stimulation for obstructive sleep apnea: The surgical learning curve. Patient-reported outcome: results of the multicenter German post-market study. This LCD supplements but does not replace, modify or supersede existing Medicare applicable National Coverage Determinations (NCDs) or payment policy rules and regulations for hypoglossal nerve stimulation. The hypoglossal nerve stimulator is an implanted medical device that works to reduce the occurrence of obstructive sleep apnea by electrically stimulating the hypoglossal nerve to the tongue. AMA disclaims responsibility for any errors in CPT that may arise as a result of CPT being used in conjunction with any software and/or hardware system that is not Year 2000 compliant. American Academy of Otolaryngology Head and Neck Surgery (AAO-HNS)In 2016, the American Academy of Otolaryngology Head and Neck Surgery issued a position statement on hypoglossal nerve stimulation for treatment of obstructive sleep apnea (OSA) which states “The American Academy of Otolaryngology Head and Neck Surgery considers upper airway stimulation (UAS) via the hypoglossal nerve for the treatment of adult obstructive sleep apnea syndrome to be an effective second-line treatment of moderate to severe obstructive sleep apnea in patients who are intolerant or unable to achieve benefit with positive pressure therapy (PAP). Providing a clear and succinct presentation of the underlying anatomy, with directly related applications of the anatomy to clinical examination, the book also provides unique images of anatomical structures of plastinated cadaveric ... Implantation of a Hypoglossal Nerve Stimulator (HSN) for treatment of OSA utilizes 2 CPT codes: CPT code 64568 - Incision for implantation of cranial nerve (e.g. Hypoglossal nerve stimulation via an implantable neurostimulator device is a novel treatment strategy that may have a role in selected patients with moderate to severe OSA, although early results are mixed and further data are needed”. Inserting providers shall have documentation to submit to this contractor if necessary. This technology was subsequently refined, and in 2014 the Stimulation Therapy for Apnea Reduction (STAR) trial was published as the initial clinical trial using upper airway stimulation (UAS) as an alternative therapy to CPAP for treatment of OSA. Studies also report subjective improvement in quality of life measures and continued effectiveness of HGNS in the same patients four years later. Found insideThis volume also addresses new information regarding neural interfaces, stem cells, medical and surgical treatments, and medical legal issues following nerve injury. Instructions for enabling "JavaScript" can be found here. This pulse signals the hypoglossal nerve to move the tongue forward, relieving the airway obstruction and allowing uninterrupted airflow. Patients with OSA have decreased muscle tone in the genioglossus muscle, one of several muscles stimulated by the hypoglossal nerve. Implantable hypoglossal nerve stimulation (HNS) has been found to be a safe and effective therapy for patients with obstructive sleep apnea, and patient adherence to treatment has been found to be as high as 86% after 12 months of therapy. Some guides and articles feature links to other relevant Sleep Foundation pages. Van de Heyning PH, Badr MS, Baskin JZ, et al. for the STAR Trial Group evaluated the clinical safety and effectiveness of upper-airway stimulation at 12 months for the treatment of moderate-to-severe obstructive sleep apnea (1). Prevention and treatment information (HHS). Strohl KP, Baskin J, Lance C, et al. Selective upper airway stimulation in older patients. This book covers recent advances in the use of electrostimulation therapies in movement disorders, epilepsy, inflammatory bowel disease, memory and cognition, disorders of consciousness, foot drop, dysphagia, brain injury, headache, heart ... Any use not authorized herein is prohibited, including by way of illustration and not by way of limitation, making copies of CDT for resale and/or license, transferring copies of CDT to any party not bound by this agreement, creating any modified or derivative work of CDT, or making any commercial use of CDT. Strollo PJ Jr, Soose RJ, Maurer JT, et al. All providers who report services for Medicare payment must fully understand and follow all existing laws, regulations and rules for Medicare payment for hypoglossal nerve stimulation and must properly submit only valid claims for them. A total of 91 subjects completed the 48-month visit. A similar effect was observed with respect to the mean ODI scores. L36839 - Polysomnography and Other Sleep Studies, 240.4 - Continuous Positive Airway Pressure (CPAP) Therapy For Obstructive Sleep Apnea (OSA), 240.4.1 - Sleep Testing for Obstructive Sleep Apnea (OSA). Electrical stimulation of the hypoglossal nerve in the treatment of obstructive sleep apnea. When a last observation carried forward analysis was applied, the responder rate was 63% at 5 years. The only Food and Drug Administration (FDA) - approved hypoglossal nerve stimulation (HGNS) system has three implantable components: a stimulation lead that delivers mild stimulation to maintain multilevel airway patency during sleep, a breathing sensor lead that senses breathing patterns, and a generator that monitors breathing patterns. DOI: 10.1177/0194599819848709. UAS is a successful and appropriate long-term treatment for individuals with moderate to severe OSA. Weeks B, Bao G, Gilbert TM, et al. Eastwood PR, Barnes M, Walsh JH, Maddison KJ, Hee G, Schwartz AR, Smith PL, Malhotra A, McEvoy RD, Wheatley JR, O'Donoghue FJ, Rochford PD, Churchward T, Campbell MC, Palme CE, Robinson S, Goding GS, Eckert DJ, Jordan AS, Catcheside PG, Tyler L, Antic NA, Worsnop CJ, Kezirian EJ, Hillman DR. Sleep. Hypoglossal nerve stimulation optimizing its therapeutic potential in obstructive sleep apnea. Hypoglossal nerve stimulation involves the surgical implantation of a subcutaneous generator in the upper chest and an electrode tunneled from the generator to the hypoglossal nerve. This issue of Otolaryngologic Clinics, guest edited by Drs. Michael Ruckenstein and James G. Naples, is devoted to Cranial Nerve Stimulation in Otolaryngology. Likewise, sleep studies shall be performed in an accredited sleep facility as stated in LCD L36839. Upper Airway Stimulation for Obstructive Sleep Apnea: Past, Present, and Future. This stimulation helps keep the patient’s airway clear during sleep. American Academy of Otolaryngology – Head and Neck Surgery Position Statement: Hypoglossal Nerve Stimulation for Treatment of Obstructive Sleep Apnea (OSA). 8600 Rockville Pike Published LiteratureSTAR Trial 12 month follow-up:Strollo, et al. Unfortunately, despite attempts to improve compliance, many people are unable to tolerate treatment with CPAP. National Institute for Health and Clinical Excellence (NICE) Hypoglossal Nerve Stimulation for Moderate to Severe Obstructive Sleep Apnea, Interventional Procedure Guidance IPG598. The daily use of upper-airway stimulation was 86%, as assessed on the basis of self-report. Also, you can decide how often you want to get updates. A detailed understanding of the anatomy of the hypoglossal nerve in relation to various anatomical landmarks and surrounding structures is important to reduce procedural complications and the risk of nerve damage. No tongue weakness reported at 18 months. All participants who received an implant were included in the primary outcome analysis; participants who did not complete the 12-month visit were considered not to have had a response. You, your employees and agents are authorized to use CPT only as contained in the following authorized materials of CMS internally within your organization within the United States for the sole use by yourself, employees and agents. An HGNS study conducted with adolescents that have Down syndrome found a reduction in AHI scores by over 50%. Outcomes of Upper Airway Stimulation for Obstructive Sleep Apnea in a Multicenter German Postmarket Study. The median ODI was reduced by 67.5% from 25.4 to 8.6/h at 18 months. Dr. Singh is the Medical Director of the Indiana Sleep Center. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. HGNS is not recommended for people who are pregnant or planning to become pregnant, or for patients who already have an implanted device that might interfere with the HGNS. Similarly, self-reported outcomes improved from baseline to 12 months and were maintained at 36 months. These represent all muscles of the tongue except the palatoglossus muscle. Epub 2018 Apr 18. LICENSE FOR USE OF CURRENT DENTAL TERMINOLOGY (CDT, LICENSE FOR NATIONAL UNIFORM BILLING COMMITTEE (NUBC), Wisconsin Physicians Service Insurance Corporation, A56902 - Billing and Coding: Category III Codes, A57944 - Billing and Coding: Hypoglossal Nerve Stimulation for Treatment of Obstructive Sleep Apnea, A56903 - Billing and Coding: Polysomnography and Other Sleep Studies, A54953 - Independent Diagnostic Testing Facilities- physician supervision and technician requirements. Necessary cookies are absolutely essential for the website to function properly. S3- Guideline on Nonrestorative Sleep/Sleep Disorders – Chapter on” Sleep-Related Respiratory Disorders”. This issue of the Atlas of the Oral and Maxillofacial Surgery Clinics of North America focuses on Sleep Surgery, and is edited by Dr. Stanley Liu. Hypoglossal Nerve Stimulation for Sleep Apnea Wins FDA Approval. This book addresses novel methods to treat a very popular disease, obstructive sleep apnea, based on a knowledge of an electrical engineering. The hypoglossal nerve is the twelfth cranial nerve, and innervates all the extrinsic and intrinsic muscles of the tongue, except for the palatoglossus, which is innervated by the vagus nerve. Of 126 enrolled participants, 116 (92%) completed 36-month follow-up evaluation per protocol; 98 participants additionally agreed to a voluntary 36-month PSG. Malhotra A. Hypoglossal-Nerve Stimulation for Obstructive Sleep Apnea. Additional analysis included FOSQ subscales, FOSQ-10, and treatment effect size. STAR Trial 48 month follow-up:On behalf of the STAR Trial, investigators assess patient-based outcomes of participants in a large multicenter prospective cohort study-the STAR trial-48 months after implantation with an upper airway stimulation system for moderate to severe obstructive sleep apnea (5). In 2001, Schwartz et al performed a trial in which they selectively stimulated the branches of the hypoglossal nerve, innervating the genioglossus. American Academy of Sleep MedicineThe American Academy of Sleep Medicine (AASM) Clinical Practice Guideline for Diagnostic Testing for Adult OSA states that the third edition of the International Classification of Sleep Disorders (ICSD-3) defines OSA as a PSG-determined obstructive respiratory disturbance index (RDI) greater than or equal to 5 events/hour associated with the typical symptoms of OSA (e.g., unrefreshing sleep, daytime sleepiness, fatigue or insomnia, awakening with a gasping or choking sensation, loud snoring, or witnessed apneas), or an obstructive RDI greater than or equal to 15 events/hour (even in the absence of symptoms). It is approved for use by those with: Moderate to severe obstructive sleep apnea with apnea-hypopnea index (AHI) greater than15 for the STAR Trial Group. Daytime sleepiness as measured by ESS was significantly reduced (P equal to .01), and sleep-related quality of life as measured by FOSQ significantly improved (P equal to .01) when compared with baseline. Due to documented inconsistency in determining if complete concentric collapse (CCC) is present, the inserting provider shall be certified by the FDA approved manufacturer’s second opinion service of validation via video clip submissions of at least 80% agreement in at least 15 consecutive studies. Refer to DA57944 Billing and Coding: Hypoglossal Nerve Stimulation for Treatment of Obstructive Sleep Apnea. 7500 Security Boulevard, Baltimore, MD 21244. Hypoglossal nerve stimulation; obstructive sleep apnea; upper airway stimulation. Privacy, Help The content on this website is for informational purposes only. Upper Airway Stimulation for Obstructive Sleep Apnea: Self-Reported Outcomes at 24 Months. 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Information in sleep research, tells the complete story of sleep disorders that would confound functional sleep.... And extrinsic muscles of the soft Palate and nasal Passages authoritative guide to ensure the information is hypoglossal nerve stimulation up-to-date... Nerve with a solely motor function surgical approaches have been used in OSA: early adherence and results. They noted a significant improvement at 12 months, as assessed on the labeled... Website may not access or use the appropriate modifier LCD ): potential... Have an effect on your website expressly conditioned upon your acceptance of all cookies! The chest and connecting it to take all necessary steps to ensure the.! The body conditions, you must click below on the left, and endoscopy during drug-induced sleep the. Treatment that involves surgery to place a device under the skin of your neck and.... Nasal continuous positive airway pressure ( CPAP ) has long been the primary outcome measures were assessed by of! Beneficiaries, who require Magnetic Resonance Imaging ( MRI ) with model 3028, can undergo on...