{"id":15509,"date":"2022-06-29T11:20:11","date_gmt":"2022-06-29T11:20:11","guid":{"rendered":"https:\/\/www.medicalbillersandcoders.com\/blog\/?p=15509"},"modified":"2026-06-01T14:18:11","modified_gmt":"2026-06-01T08:48:11","slug":"medicare-coverage-for-vagus-nerve-stimulation-vns","status":"publish","type":"post","link":"https:\/\/www.medicalbillersandcoders.com\/blog\/medicare-coverage-for-vagus-nerve-stimulation-vns\/","title":{"rendered":"Medicare Coverage for Vagus Nerve Stimulation (VNS)"},"content":{"rendered":"<p><span style=\"font-weight: 400;\">Vagus Nerve Stimulation (VNS) is a pulse generator, similar to a pacemaker, that is surgically implanted under the skin of the left chest and an electrical lead (wire) is connected from the generator to the left vagus nerve. Electrical signals are sent from the battery-powered generator to the vagus nerve via the lead. These signals are in turn sent to the brain. VNS provides indirect modulation of brain activity through the stimulation of the vagus nerve. <\/span><\/p>\r\n<p><span style=\"font-weight: 400;\">The vagus nerve, the tenth cranial nerve, has parasympathetic outflow that regulates the autonomic (involuntary) functions of heart rate and gastric acid secretion and also includes the primary functions of sensation from the pharynx, muscles of the vocal cords, and swallowing. It is a nerve that carries both sensory and motor information to\/from the brain. <em>Medicare coverage<\/em> for many tests, items, and services depends on where you live.\u00a0<\/span><\/p>\r\n<h2 style=\"text-align: left;\">Nationally Covered Indications<\/h2>\r\n<p><span style=\"font-weight: 400;\">VNS treatment is reasonable and necessary for patients with medically refractory partial-onset seizures for whom surgery is not recommended or for whom surgery has failed. <\/span><\/p>\r\n<p><span style=\"font-weight: 400;\">Effective for services performed on or after February 15, 2019, the Centers for Medicare &amp; Medicaid Services (CMS) will cover FDA-approved vagus nerve stimulation (VNS) devices for treatment-resistant depression (TRD) through Coverage with Evidence Development (CED) when offered in a CMS-approved, double-blind, randomized, placebo-controlled trial with a follow-up duration of at least one year with the possibility of extending the study to a prospective longitudinal study when the <a href=\"https:\/\/www.cms.gov\/\">CMS<\/a>-approved, double-blind, randomized placebo-controlled trial has completed enrollment, and there are positive interim findings.\u00a0<\/span><\/p>\r\n<h2 style=\"text-align: left;\">Nationally Non-Covered Indications\u00a0<\/h2>\r\n<p><span style=\"font-weight: 400;\">VNS is not reasonable and necessary for all other types of seizure disorders that are medically refractory and for whom surgery is not recommended or for whom surgery has failed. VNS is non-covered for treatment-resistant depression (TRD) when furnished outside of a CMS-approved Coverage with Evidence Development (CED) study. All other indications of VNS for the treatment of depression are nationally non-covered.\u00a0<\/span><\/p>\r\n<h2 style=\"text-align: left;\">Patient Criteria<\/h2>\r\n<p><span style=\"font-weight: 400;\">The following criteria must be used to identify patients demonstrating treatment-resistant depression (TRD):<\/span><\/p>\r\n<ul>\r\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">The patient must be in a major depressive disorder (MDD) episode for \u2265 two years or have had at least four episodes of MDD, including the current episode. In order to confirm the patient has MDD, accepted diagnostic criteria from the most current edition of the Diagnostic and Statistical Manual for Mental Disorder (DSM) and a structured clinical assessment are to be used.\u00a0<\/span><\/li>\r\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">The patient\u2019s depressive illness meets a minimum criterion of four prior failed treatments of adequate dose and duration as measured by a tool designed for this purpose.\u00a0<\/span><\/li>\r\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">The patient is experiencing a major depressive episode (MDE) as measured by a guideline-recommended depression scale assessment tool on two visits, within a 45-day span prior to implantation of the VNS device.<\/span><\/li>\r\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Patients must maintain a stable medication regimen for at least four weeks before device implantation.\u00a0<\/span><\/li>\r\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">If patients with bipolar disorder are included, the condition must be carefully characterized.<\/span><\/li>\r\n<\/ul>\r\n<p><span style=\"font-weight: 400;\">The applicable CPT code for VNS is CPT\u00ae code 64568: Incision for implantation of cranial nerve (e.g. vagus nerve) neurostimulator electrode array and pulse generator.<\/span><\/p>\r\n<p><span style=\"font-weight: 400;\">The patient&#8217;s medical record must contain documentation that fully supports the medical necessity for services included within the Coverage Indications, Limitations, and\/or Medical Necessity section within the related LCD. This documentation includes but is not limited to, appropriate use criteria, relevant medical history, physical examination, and results of pertinent diagnostic tests or procedures.<\/span><\/p>\r\n<p><span style=\"font-weight: 400;\">We shared information about Medicare coverage for Vagus Nerve Stimulation (VNS) for your reference, for a detailed understanding, you can refer to <\/span><span style=\"font-weight: 400;\">\u201cMedicare National Coverage Determinations Manual Chapter 1, Part 2\u201d<\/span><span style=\"font-weight: 400;\">.\u00a0 <\/span><\/p>\r\n<p><strong>Medical Billers and Coders (MBC)<\/strong> is a leading revenue cycle company providing complete medical billing services, including <a href=\"https:\/\/www.medicalbillersandcoders.com\/speciality\/neurology-medical-billing-services.html\">specialized neurology billing services<\/a> for practices managing complex treatments such as Vagus Nerve Stimulation (VNS). If you need assistance with medical billing and coding for your practice, contact us at <a href=\"mailto:info@medicalbillersandcoders.com\"><strong>info@medicalbillersandcoders.com<\/strong><\/a> or <a href=\"tel:888-357-3226\"><strong>888-357-3226<\/strong><\/a>.<\/p>\r\n<p><span style=\"font-weight: 400;\">CPT \u00a9 Copyright 2022 <a href=\"https:\/\/www.ama-assn.org\/\">American Medical Association<\/a>. All rights reserved. AMA and CPT are registered trademarks of the American Medical Association.<\/span><\/p>\r\n<div class=\"flex max-w-full flex-col flex-grow\">\r\n<div class=\"min-h-8 text-message flex w-full flex-col items-end gap-2 whitespace-normal break-words [.text-message+&amp;]:mt-5\" dir=\"auto\" data-message-author-role=\"assistant\" data-message-id=\"7541dab8-197a-4333-87a9-7336ee0ecb7a\" data-message-model-slug=\"gpt-4o\">\r\n<div class=\"flex w-full flex-col gap-1 empty:hidden first:pt-[3px]\">\r\n<div class=\"markdown prose w-full break-words dark:prose-invert light\">\r\n<h2 style=\"text-align: left;\">FAQs on Vagus Nerve Stimulation (VNS)<\/h2>\r\n<\/div>\r\n<\/div>\r\n<\/div>\r\n<\/div>\r\n\r\n<div class=\"schema-faq wp-block-yoast-faq-block\">\r\n<div id=\"faq-question-1748948250373\" class=\"schema-faq-section\"><strong class=\"schema-faq-question\"><strong>1. What is Vagus Nerve Stimulation (VNS)?<\/strong><\/strong>\r\n<p class=\"schema-faq-answer\">Vagus Nerve Stimulation (VNS) is a procedure in which a pulse generator, similar to a pacemaker, is surgically implanted under the skin of the left chest. This generator sends electrical signals to the vagus nerve, which in turn sends signals to the brain, helping to modulate brain activity.<\/p>\r\n<\/div>\r\n<div id=\"faq-question-1748948401226\" class=\"schema-faq-section\"><strong class=\"schema-faq-question\"><strong>2. What conditions are treated with Vagus Nerve Stimulation?<\/strong><\/strong>\r\n<p class=\"schema-faq-answer\">VNS is primarily used to treat medically refractory partial-onset seizures in patients for whom surgery is not recommended or has failed. It is also covered by Medicare for treatment-resistant depression (TRD) under certain conditions, such as being part of a CMS-approved study.<\/p>\r\n<\/div>\r\n<div id=\"faq-question-1748948418021\" class=\"schema-faq-section\"><strong class=\"schema-faq-question\"><strong>3. Does Medicare cover Vagus Nerve Stimulation (VNS)?<\/strong><\/strong>\r\n<p class=\"schema-faq-answer\">Yes, Medicare covers VNS for patients with medically refractory partial-onset seizures and for treatment-resistant depression (TRD) if the treatment is provided under a CMS-approved clinical trial. VNS is not covered for other types of seizure disorders or depression outside of these approved studies.<\/p>\r\n<\/div>\r\n<div id=\"faq-question-1748948452616\" class=\"schema-faq-section\"><strong class=\"schema-faq-question\"><strong>4. What are the patient criteria for VNS in treating treatment-resistant depression (TRD)?<\/strong><\/strong>\r\n<p class=\"schema-faq-answer\">Patients must meet several criteria, including having been in a major depressive disorder (MDD) episode for at least two years or having experienced at least four episodes of MDD. They must also have failed four prior treatments and maintain a stable medication regimen for at least four weeks before the device is implanted.<\/p>\r\n<\/div>\r\n<div id=\"faq-question-1748948466812\" class=\"schema-faq-section\"><strong class=\"schema-faq-question\"><strong>5. What is the applicable CPT code for Vagus Nerve Stimulation (VNS) procedures?<\/strong><\/strong>\r\n<p class=\"schema-faq-answer\">The applicable CPT code for the VNS procedure is CPT\u00ae code 64568, which refers to the incision for implantation of the cranial nerve (e.g., vagus nerve) neurostimulator electrode array and pulse generator.<\/p>\r\n<\/div>\r\n<div id=\"faq-question-1748948483007\" class=\"schema-faq-section\"><strong class=\"schema-faq-question\"><strong>6. What documentation is required for Medicare to cover VNS?<\/strong><\/strong>\r\n<p class=\"schema-faq-answer\">The patient&#8217;s medical record must include documentation that supports the medical necessity of VNS, including relevant medical history, physical examination, results of diagnostic tests, and evidence that the patient meets the appropriate use criteria.<\/p>\r\n<\/div>\r\n<\/div>\r\n","protected":false},"excerpt":{"rendered":"<p>Vagus Nerve Stimulation (VNS) is a pulse generator, similar to a pacemaker, that is surgically implanted under the skin of the left chest and an electrical lead (wire) is connected from the generator to the left vagus nerve. Electrical signals are sent from the battery-powered generator to the vagus nerve via the lead. These signals [&hellip;]<\/p>\n","protected":false},"author":8,"featured_media":15510,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[2],"tags":[3513,666,50,51,3514,120,3507,20,3255,3512,4405,4404],"class_list":["post-15509","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-medical-billing-services","tag-ama-and-cpt","tag-american-medical-association","tag-centers-for-medicare-medicaid-services","tag-cms","tag-cms-approved-coverage-with-evidence-development","tag-cpt-code","tag-leading-revenue-cycle-company","tag-medical-billing-and-coding","tag-medical-billing-and-coding-for-your-practice","tag-medicare-coverage-for-vagus-nerve-stimulation","tag-medicare-coverage-for-vagus-nerve-stimulation-vns","tag-medicare-national-coverage-determinations-manual-chapter-1"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.9 (Yoast SEO 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Dedicated to educating healthcare professionals on compliance, accuracy, and strategies to improve billing performance.\",\"sameAs\":[\"https:\\\/\\\/www.medicalbillersandcoders.com\\\/\",\"https:\\\/\\\/www.linkedin.com\\\/in\\\/debbie-young-4544a631a\\\/\"]},{\"@type\":\"Question\",\"@id\":\"https:\\\/\\\/www.medicalbillersandcoders.com\\\/blog\\\/medicare-coverage-for-vagus-nerve-stimulation-vns\\\/#faq-question-1748948250373\",\"position\":1,\"url\":\"https:\\\/\\\/www.medicalbillersandcoders.com\\\/blog\\\/medicare-coverage-for-vagus-nerve-stimulation-vns\\\/#faq-question-1748948250373\",\"name\":\"1. What is Vagus Nerve Stimulation (VNS)?\",\"answerCount\":1,\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"Vagus Nerve Stimulation (VNS) is a procedure in which a pulse generator, similar to a pacemaker, is surgically implanted under the skin of the left chest. This generator sends electrical signals to the vagus nerve, which in turn sends signals to the brain, helping to modulate brain activity.\",\"inLanguage\":\"en-US\"},\"inLanguage\":\"en-US\"},{\"@type\":\"Question\",\"@id\":\"https:\\\/\\\/www.medicalbillersandcoders.com\\\/blog\\\/medicare-coverage-for-vagus-nerve-stimulation-vns\\\/#faq-question-1748948401226\",\"position\":2,\"url\":\"https:\\\/\\\/www.medicalbillersandcoders.com\\\/blog\\\/medicare-coverage-for-vagus-nerve-stimulation-vns\\\/#faq-question-1748948401226\",\"name\":\"2. What conditions are treated with Vagus Nerve Stimulation?\",\"answerCount\":1,\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"VNS is primarily used to treat medically refractory partial-onset seizures in patients for whom surgery is not recommended or has failed. It is also covered by Medicare for treatment-resistant depression (TRD) under certain conditions, such as being part of a CMS-approved study.\",\"inLanguage\":\"en-US\"},\"inLanguage\":\"en-US\"},{\"@type\":\"Question\",\"@id\":\"https:\\\/\\\/www.medicalbillersandcoders.com\\\/blog\\\/medicare-coverage-for-vagus-nerve-stimulation-vns\\\/#faq-question-1748948418021\",\"position\":3,\"url\":\"https:\\\/\\\/www.medicalbillersandcoders.com\\\/blog\\\/medicare-coverage-for-vagus-nerve-stimulation-vns\\\/#faq-question-1748948418021\",\"name\":\"3. Does Medicare cover Vagus Nerve Stimulation (VNS)?\",\"answerCount\":1,\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"Yes, Medicare covers VNS for patients with medically refractory partial-onset seizures and for treatment-resistant depression (TRD) if the treatment is provided under a CMS-approved clinical trial. 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