I. Disclaimer

This document is intended to be used as a reference for non-VA providers and is not intended to replace clinical judgment when determining care pathways. These guidelines do not guarantee benefits or constitute medical advice. 

II. Clinical Determinations and Indications

1. Indications for Implantable Vagus Nerve Stimulation  

1. Medically Refractory Seizures
2. Vagus nerve stimulation with an implantable vagus nerve stimulator may be considered medically necessary/covered for the treatment of medically refractory seizures when ALL the following criteria are met:  
   • Confirmed diagnosis of seizures with electroencephalogram (EEG) 
   • Documented failure or intolerance of treatment for seizures as defined by ONE of the following: 
   • Persistent seizures despite drug therapy from more than one trial of a single or combination of antiepileptic medication 
   • Presence of debilitating side effects from drug therapy 
3. Upper Extremity Weakness Post-Stroke 
4. Vagus nerve stimulation with an implantable vagus nerve stimulator may be considered medically necessary/covered for the treatment of upper extremity weakness due to a stroke when ALL the following criteria are met: 
   • Confirmed moderate-to-severe upper extremity weakness that is due to an ischemic stroke 
   • Upper extremity weakness severity as defined by Fugl-Meyer Assessment score of greater than or equal to 20 and less than or equal to 50  
   • Persistent upper extremity weakness for at least six months following an ischemic stroke 
5. Rheumatoid Arthritis 
6. Vagus nerve stimulation with an implantable vagus nerve stimulator may be considered medically necessary/covered for the treatment of rheumatoid arthritis due to a stroke when ALL the following criteria are met: 
   • A trial of maximal standard medical management for at least 12 weeks and on a continuous non-changing dose and route of administration for at least four weeks with documented failure, inadequate response, or intolerance to treatment with one or more biological or targeted synthetic Disease-Modifying Anti-Rheumatic Drugs (DMARDs) (e.g., tumor necrosis factor (TNF) inhibitor or Janus kinase (JAK) inhibitor) 
7. Treatment Resistant Depression 
8. Vagus nerve stimulation with an implantable vagus nerve stimulator may be considered medically necessary/covered for the treatment of treatment resistant depression when ALL the following criteria are met: 
   • Diagnosis of unipolar, major depressive disorder (MDD) or bipolar disorder, as per DSM-5 by a qualified mental health provider 
   • Failure to achieve a full therapeutic remission from four total adequate antidepressant trials in the Veteran’s lifetime 
     • At least two antidepressant trials from different classes, one of which includes a trial of an augmentation strategy in the current episode of depression 
   • Failure to achieve remission with or has been evaluated by the treating or referring provider and is not a candidate for at least two other complex interventions commonly used for treatment resistant depression such as transcranial magnetic stimulation (TMS), esketamine/ketamine, or electroconvulsive therapy (ECT) 
   • Score of 15 or greater on the Patient Health Questionnaire-9 (PHQ-9) (moderate or severe depression) within the past 30 days or an equivalent severity measure from an appropriate test when the patient can participate in the assessment, such as Montgomery-Åsberg Depression Rating Scale (MADRS) or the Hamilton Rating Scale for Depression (HAM-D) 

2. Limitations/Exclusions
3. Implantable vagus nerve stimulation is considered not medically necessary and is not covered for the following conditions or indications: 
   • Anxiety disorders 
   • Headaches 
   • Post-traumatic stress disorder 

Implantable vagus nerve stimulation is considered not medically necessary and not covered when any of the following contraindications are present: 

• Vocal cord paralysis 
• History of a bilateral, unilateral, or contralateral vagotomy to the intended implantation site 

Implantable vagus nerve stimulation is considered not medically necessary and not covered for the treatment of upper extremity weakness post-stroke when any of the following contraindications are present:  

• Veterans with severe spasticity (Ashworth score greater than or equal to three) 

Implantable vagus nerve stimulation is considered not medically necessary and not covered for the treatment of rheumatoid arthritis when any of the following contraindications are present: 

• Veterans who have had a splenectomy 

For all other conditions or indications not listed in section II.a. of this document, implantable vagus nerve stimulation is considered not medically necessary and not covered due to insufficient evidence of efficacy and safety. 

3. Description of Treatment
4. Vagus nerve stimulation is a therapy involving the surgical implantation of a small device under the skin on the left upper chest area. The device is connected by a wire to the vagus nerve in the neck and is controlled by an external programmer. This procedure may occur in an outpatient surgery center or operating room by a licensed and trained surgeon.  

Once implanted, the device works by intermittently delivering programmed electrical pulses to the vagus nerve which serves to communicate between the brain and other internal organs. The pulses allow for electrical signals to be sent from the neck to the brain to produce anti-inflammatory effects, reduced depression, and reduced frequency and severity of refractory seizures.  

The devices operate in two models: open-loop and closed-loop. In open-loop systems, stimulation is delivered at preset intervals regardless of physiological changes. In contrast, closed-loop systems monitor physiological signals, such as heart rate, and adjust stimulation in real time. The latter is a more recent advancement. Although the device operates automatically, individuals can manually trigger extra stimulation by swiping a magnet over the implant site. This can reduce the likelihood of a seizure if an individual senses the onset of a seizure. 

III. Background and Supporting Information

The following information is for reference purposes only in accordance with the medical benefits package outlined in 38 C.F.R. § 17.38 (b). Each subsection supports VA’s determinations for medical necessity and alignment with generally accepted standards of medical practice. 

1. Background Information
   Medically Refractory Seizures 
2. Epilepsy is one of the most common neurological disorders, affecting approximately three million people in the United States. It is diagnosed under any of the following conditions as defined by the International League Against Epilepsy: i) at least two unprovoked seizures occurring more than 24 hours apart, ii) one unprovoked seizure and a probability of further seizures similar to the general recurrence risk (at least 60%) after two unprovoked seizures, occurring over the next 10 years, or iii) diagnosis of an epilepsy syndrome. Seizures, which are brief disruptions in normal brain activity, are typically classified into two main types: generalized and focal. 

The first line of treatment for seizure activity is antiepileptic drug therapy. It has proven to be effective in two-thirds of cases of people with epilepsy. Surgical intervention is also used for people with focal seizures, particularly in cases that involve the temporal lobe of the brain. Despite advancements in antiepileptic medications and surgical interventions, more than 200,000 people experience refractory seizures unresponsive to first line treatments. In those cases, nonpharmacologic therapies such as vagus nerve stimulation are employed as part of the treatment approach. The U.S. Food & Drug Administration (FDA) has approved an implantable vagus nerve stimulation device for the treatment of partial onset seizures. 

Upper Extremity Weakness Post-Stroke 
Upper extremity weakness due to stroke is a common post-stroke impairment and may present as hemiparesis or hemiplegia and affects motor control, coordination, sensation, and muscle tone. This affects up to 80% of stroke patients in the acute phase and persists chronically in approximately 40% of patients. The severity and pattern of weakness are directly impacted by the location and extent of the cerebral damage, particularly to the corticospinal tract. Recovery is variable and dependent on early intervention, intensity of rehabilitation, and neuroplastic potential.  

The first line of treatment for upper extremity weakness post-stroke is a comprehensive rehabilitation program including repetitive and task-specific training. Interventions may include functional electrical stimulation (FES), constraint-induced movement therapy (CIMT), mirror therapy, and mental imagery to enhance sensorimotor recovery. In patients with chronic upper limb impairment, vagus nerve stimulation may be used. Implantable vagus nerve stimulation has been approved by the FDA for stroke survivors with moderate-to-severe upper extremity weakness at least six months post-stroke. 

Rheumatoid Arthritis 
Rheumatoid arthritis is a chronic autoimmune disorder that affects the joints and causes inflammation, pain, swelling, and ultimately joint damage. This disorder occurs when the immune system attacks the synovium— the lining of the membranes that surround joints. The immune system responds by triggering inflammation which can damage cartilage and bone, resulting in joint deformity and lack of function. It commonly affects smaller joints and progresses to larger joints and may also cause systemic symptoms such as fatigue, fever, and weight loss. 

The first line of treatment for rheumatoid arthritis are disease-modifying antirheumatic drugs (DMARDs). Disease-modifying antirheumatic drugs work by suppressing the immune system to reduce inflammation and prevent joint damage. They are usually recommended as monotherapy for patients with moderate-to-high disease activity. Nonsteroidal anti-inflammatory drugs (NSAIDs) and corticosteroids may also be used to assist with symptom relief; however, they do not prevent disease progression. In patients who are either non-responsive or cannot tolerate the first line of treatment, the FDA has approved the use of an implantable vagus nerve stimulation to reduce the symptoms of rheumatoid arthritis without the systemic side effects usually associated with immunosuppressant medications.  

Treatment Resistant Depression 
Treatment Resistant Depression (TRD) is defined as a form of major depressive disorder (MDD) that does not adequately respond to at least two trials of standard antidepressant treatments from different pharmacologic classes. Treatment resistant depression affects approximately 30% of patients diagnosed with MDD and is associated with longer lasting and more severe depressive episodes, increased risk of suicide, and significant impairments in daily functioning.  

The first-line treatment approach for TRD involves optimizing pharmacotherapy and may include switching antidepressants, combining agents, or augmenting the dosage of medications. Psychotherapeutic interventions are often recommended in conjunction with pharmacologic therapies. For patients with chronic, severe TRD who have not responded to multiple treatment modalities, implantable vagus nerve stimulation may be considered.  

2. Research, Clinical Trials, and Evidence Summaries
   Vagus nerve stimulation was approved in July 1997 by the FDA as an adjunctive treatment for refractory seizures in adults and adolescents. Numerous studies support the use of implantable vagus nerve stimulation as an effective treatment for the reduction in seizure frequency. 

Elliot et al. (2010) conducted a retrospective study of 436 patients with treatment resistant epilepsy who underwent vagus nerve stimulation implantation between November 1997 and April 2008. Of the 400 patients that were included in the study and available for adequate follow-up, there was a mean seizure reduction of 55.8%. The authors noted a decrease in seizure frequency, from four occurrences preoperatively to one and a half seizures per week postoperatively. Greater than 50% seizure control was observed in 63.75% of patients. The study indicates that vagus nerve stimulation is an effective and safe treatment for people experiencing refractory seizures. 

Iimura et al. (2023) retrospectively studied 136 patients with drug-resistant epilepsy, who had vagus nerve stimulators implanted between 2010 and 2022. A total of 125 patients who met the inclusion criteria were monitored at intervals of 6-, 12-, and 24-months post-implantation. Among patients diagnosed with generalized seizures, 46% achieved a greater than 50% reduction in seizure frequency one-year post-implantation. The rate of this outcome increased to 49% two years following the implantation of a vagus nerve stimulator. These findings support the efficacy of vagus nerve stimulation in reducing seizure burden, particularly in generalized epilepsy. 

Batson et al. (2023) conducted a systematic review and meta-analysis which evaluated the efficacy and safety of vagus nerve stimulation as an adjunct treatment to antiseizure medications in adults with drug resistant epilepsy. They incorporated data from four randomized controlled trials and six comparative observational studies. Pooled analysis showed that vagus nerve stimulation significantly increased the likelihood of achieving greater than or equal to 50% and greater than or equal to 75% seizure reduction, compared to low-stimulation vagus nerve stimulation, best medical practice, or antiseizure medication alone.  Their findings support the use of vagus nerve stimulation as a safe and effective adjunctive treatment for seizure reduction in adults with drug resistant epilepsy, and for those who are unsuitable for or unwilling to undergo resective surgery. 

Dawson et al. (2021) conducted a pivotal, randomized, triple-blinded, sham-controlled trial that evaluated the safety and efficacy of vagus nerve stimulation paired with rehabilitation for improving upper limb function in patients with moderate-to-severe arm weakness at least nine months post-ischemic stroke. Conducted across 19 stroke rehabilitation centers in the U.S. and U.K., 108 participants were implanted with a vagus nerve stimulation device and randomized to receive either active vagus nerve stimulation or sham stimulation during a six week in-clinic therapy program followed by home exercises. The primary outcome, improvement in Fugl-Meyer Assessment-Upper Extremity (FMA-UE) scores, showed a statistically significant greater mean increase in the vagus nerve stimulation group (5.0 points) compared to the control group (2.4 points), with a between-group difference of 2.6 points (p=0.0014). At 90 days post-therapy, 47% of vagus nerve stimulation participants achieved a clinically meaningful response versus 24% in the control group (p=0.0098). The intervention was well tolerated, with only one serious adverse event unrelated to active vagus nerve stimulation. The authors concluded that vagus nerve stimulation paired with rehabilitation is a safe and effective treatment option for improving arm function in patients with chronic post-stroke impairment and recommended its consideration as a novel therapeutic approach in this population. 

Peterson et al. (2024) conducted a randomized, double-blinded, sham-controlled, multi-center pivotal trial (RESET-RA) to evaluate the clinical safety and feasibility of a novel implantable neuroimmune modulation device for the treatment of moderate-to-severe rheumatoid arthritis in patients with inadequate response or intolerance to at least one biologic or targeted synthetic DMARD. In stage one of the study, 60 patients were implanted with the device, which delivers daily vagus nerve stimulation to activate the inflammatory reflex. The implantation procedures were completed without intraoperative complications, infections, or surgical revisions. No unanticipated adverse device effects were reported. Two serious adverse events (vocal cord paresis and prolonged hoarseness) were related to the implantation procedure and are known complications of vagus nerve stimulation surgery. The device and stimulation were otherwise well tolerated, with no stimulation-related serious adverse events and no study discontinuations due to adverse events. The authors concluded that the device and surgical procedure were safe and well tolerated, supporting the feasibility of neuroimmune modulation as a novel, potentially safer and more cost-effective treatment approach for rheumatoid arthritis. They recommend continued investigation of this therapy, with efficacy outcomes to be reported upon completion of the full study. 

Aaronson et al. (2017) conducted a 5-year, prospective, open-label, nonrandomized, observational registry study evaluating the long-term effectiveness of adjunctive vagus nerve stimulation in patients with treatment-resistant depression (TRD). The study included 795 patients across 61 U.S. sites, comparing outcomes between those receiving vagus nerve stimulation plus treatment as usual (TAU) and those receiving TAU alone. Patients in the vagus nerve stimulation group demonstrated significantly higher cumulative response (67.6% vs. 40.9%) and remission rates (43.3% vs. 25.7%) compared to the TAU group. Additionally, vagus nerve stimulation was associated with faster time to response, longer duration of remission, and reduced suicidality and all-cause mortality. Subgroup analyses confirmed benefits across patients with prior electroconvulsive therapy (ECT) exposure, comorbid anxiety, and bipolar depression. The authors concluded that adjunctive vagus nerve stimulation provides superior clinical outcomes and reduced mortality in a severely ill TRD population and recommended its consideration as a viable treatment option when multiple prior therapies, including ECT, have failed. ***

3. U.S. Food & Drug Administration Information
   VA generally only approves use of medical devices that have received at least Food & Drug Administration (FDA) clearance for 510(k) Premarket Notification. The following device has received Premarket Approval from the FDA and is indicated for use in partial onset seizures which are refractory to antiepileptic medications, the reduction of upper extremity motor deficits and improve motor function in chronic ischemic stroke patients with moderate-to-severe arm impairment, and treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response, loss of response, or intolerance to one or more biological or targeted synthetic disease-modifying antirheumatic drugs. 

To search for devices that have received FDA 510(k) clearance or Premarket Approval (PMA), please visit the FDA Devices database.

Information	Description
Product Name	Vagus Nerve Stimulation (VNS) Therapy System
PMA Applicant	LivaNova USA , Inc
Address	100 Cyberonics Blvd  Houston, TX 77058
Approval Date	03/04/1998
Pre-Market Notification	P970003

Information	Description
Product Name	MicroTransponder Vivistim Paired VNS System
PMA Applicant	MicroTransponder Inc.
Address	2802 Flintrock Trace Suite 226  Austin, TX 78738
Approval Date	08/27/2021
Pre-Market Approval	P210007

Information	Description
Product Name	SetPoint System
BLA Applicant	SetPoint Medical
Address	25101 Rye Canyon Loop  Valencia, CA 91355
BLA Number
Approval Date	07/30/2025
Product Details	P240039

4. Medicare Coverage Determinations
5. Available Medicare national and local coverage determinations are listed below as a resource. VA and Medicare are governed by separate laws and regulations; thus, VA coverage determinations may be different.

NCD Number	Name	Effective Date
160.18	Vagus Nerve Stimulation	02/15/2019

LCD Number	Contractor	Original/Revision Effective Date
None	N/A	N/A

• NCD: National Coverage Determination
• LCD: Local Coverage Determination

5. TRICARE Policy Manual
6. Available TRICARE coverage determinations are listed below as a resource. VA and TRICARE are governed by separate laws and regulations; thus, VA coverage determinations may be different. 

TRICARE Policy Manual 6010.60-M, Chapter 04, Section 20.1 

• Implantation of an U.S. Food and Drug Administration (FDA) approved vagus nerve stimulator and battery replacement may be covered for the following indication: 
  • As adjunctive therapy in reducing the frequency of seizures in adults and adolescents over 12 years of age, which are refractory to antiepileptic medication 

6. Health Care Procedural Coding Information
7. The following CPT^®/HCPCS codes listed in this section are provided for informational purposes only. Inclusion or exclusion of a code does not constitute or imply VA coverage or provider reimbursement. The list of codes may not be all-inclusive since the American Medical Association (AMA) and Centers for Medicare & Medicaid Services (CMS) code updates may occur more frequently than CDI updates. Please refer to section II.a. in this document to review indications and clinical criteria for medical necessity. 

The following CPT codes are considered medically necessary/covered if the indications and clinical criteria outlined in section II.a. are met. Additional codes may also apply.

CPT Code	Description
61885	Insertion or replacement of cranial neurostimulator pulse generator or receiver, direct or inductive coupling; with connection to a single electrode array
61886	Insertion or replacement of cranial neurostimulator pulse generator or receiver, direct or inductive coupling; with connection to two or more electrode arrays
61888	Revision or removal of cranial neurostimulator pulse generator or receiver
64568	Open implantation of cranial nerve (e.g., vagus nerve) neurostimulator electrode array and pulse generator
64569	Revision or replacement of cranial nerve (e.g., vagus nerve) neurostimulator electrode array, including connection to existing pulse generator
64570	Removal of cranial nerve (e.g., vagus nerve) neurostimulator electrode array and pulse generator

CPT copyright 2026 American Medical Association. All rights reserved. 

IV. Definitions

Term	Definition
Epilepsy	A neurological disorder that causes recurring, unprovoked seizures
Focal seizure	Brief disruptions in normal brain activity that are localized to one side of the brain and present as twitching and altered sensory perceptions
Generalized seizure	Brief disruptions in normal brain activity that involve both sides of the brain and present as rapid blinking, loss of consciousness, and muscle spasms
Neurostimulator	A small device implanted into the body that produces repeating, low-level pulses of electrical current
Refractory seizure	Seizures that occur despite treatment with therapeutic levels of antiepileptic drugs or seizures that cannot be treated with therapeutic levels of antiepileptic drugs because of intolerable adverse side effects
Resective surgery	A common epilepsy surgery involving the removal of the part of the brain where seizures occur
Vagus nerve	Also known as cranial nerve X, the vagus nerve is part of the parasympathetic nervous system which carries messages to and from the brain and other parts of the body. The vagus nerve has many paths, including one that goes from the neck up to the brain. It controls motor, sensory and other functions of the spleen, gastrointestinal tract, heart, and larynx

V. References

Aaronson, S. T., Sears, P., Ruvuna, F., Bunker, M., Conway, C. R., Dougherty, D. D., Reimherr, F. W., Schwartz, T. L., & Zajecka, J. M. (2017). A 5-Year Observational Study of Patients With Treatment-Resistant Depression Treated With Vagus Nerve Stimulation or Treatment as Usual: Comparison of Response, Remission, and Suicidality. The American journal of psychiatry, 174(7), 640–648.  

Batson, S., Shankar, R., Conry, J., Boggs, J., Radtke, R., Mitchell, S., Barion, F., Murphy, J., & Danielson, V. (2022). Efficacy and safety of VNS therapy or continued medication management for treatment of adults with drug-resistant epilepsy: systematic review and meta-analysis. Journal of neurology, 269(6), 2874–2891.  

Brauer, P. R., Lamarre, E. D., Gau, V. L., Lorenz, R. R., Wu, S. S., & Bryson, P. C. (2023). Laryngology Outcomes Following Implantable Vagus Nerve Stimulation. JAMA otolaryngology– head & neck surgery, 149(1), 49–53.  

Dawson, J., Engineer, N. D., Cramer, S. C., Wolf, S. L., Ali, R., O’Dell, M. W., Pierce, D., Prudente, C. N., Redgrave, J., Feng, W., Liu, C. Y., Francisco, G. E., Brown, B. L., Dixit, A., Alexander, J., DeMark, L., Krishna, V., Kautz, S. A., Majid, A., Tarver, B., … Kimberley, T. J. (2023). Vagus Nerve Stimulation Paired With Rehabilitation for Upper Limb Motor Impairment and Function After Chronic Ischemic Stroke: Subgroup Analysis of the Randomized, Blinded, Pivotal, VNS-REHAB Device Trial. Neurorehabilitation and neural repair, 37(6), 367–373.  

Defense Health Agency (2015, April 1). Nervous System. TRICARE Policy Manual 6010.60-M. Chapter 04, Section 20.1. Retrieved May 09, 2025. 

Elliott, R. E., Morsi, A., Kalhorn, S. P., Marcus, J., Sellin, J., Kang, M., Silverberg, A., Rivera, E., Geller, E., Carlson, C., Devinsky, O., & Doyle, W. K. (2011). Vagus nerve stimulation in 436 consecutive patients with treatment-resistant epilepsy: long-term outcomes and predictors of response. Epilepsy & behavior: E&B, 20(1), 57–63.  

Iimura, Y., Suzuki, H., Mitsuhashi, T., Ueda, T., Nishioka, K., Horikoshi, K., Nomura, K., Sugano, H., & Kondo, A. (2023). Effect of vagus nerve stimulation against generalized seizure and status epilepticus recurrence. Frontiers in neurology, 14, 1258854.  

Liu, C. Y., Russin, J., Adelson, D. P., Jenkins, A., Hilmi, O., Brown, B., Lega, B., Whitworth, T., Bhattacharyya, D., Schwartz, T. H., Krishna, V., Williams, Z., Uff, C., Willie, J., Hoffman, C., Vandergrift, W. A., Achrol, A. S., Ali, R., Konrad, P., Edmonds, J., … Engineer, N. D. (2022). Vagus nerve stimulation paired with rehabilitation for stroke: Implantation experience from the VNS-REHAB trial. Journal of clinical neuroscience : official journal of the Neurosurgical Society of Australasia, 105, 122–128.  

MCG Health. (2025, January 25). Vagus Nerve Stimulation, Implantable. Ambulatory Care. 27th Edition. 

Medicare Coverage Database (n.d.). Retrieved May 09, 2025. 

Peterson, D., Van Poppel, M., Boling, W., Santos, P., Schwalb, J., Eisenberg, H., Mehta, A., Spader, H., Botros, J., Vrionis, F. D., Ko, A., Adelson, P. D., Lega, B., Konrad, P., Calle, G., Vale, F. L., Bucholz, R., & Richardson, R. M. (2024). Clinical safety and feasibility of a novel implantable neuroimmune modulation device for the treatment of rheumatoid arthritis: initial results from the randomized, double-blind, sham-controlled RESET-RA study. Bioelectronic medicine, 10(1), 8.  

Roy, J. M., Musmar, B., Ritz, C., Sizdahkhani, S., Karadimas, S., Papadopoulos, E., Patel, S., Wu, C., Jabbour, P., Rosenwasser, R. H., Tjoumakaris, S. I., & Gooch, M. R. (2025). Vagus nerve stimulation paired with rehabilitation for post-stroke recovery: A single center experience of patient satisfaction and outcomes. Clinical neurology and neurosurgery, 257, 109043.  

U.S. Food & Drug Administration Premarket Approval (PMA) Database. (n.d.). Retrieved May 09, 2025. 

VI. CDI History/Revision Information

Date	Summary of Updates
08/01/2026	New CDI created describing medically necessary and not medically necessary indications

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