Medical policy: Vagus Nerve and Implantable Peripheral Nerve Stimulators

Policy number: MP 1.034

Effective date: 2/1/2026

Policy

Vagus nerve stimulator

Vagus nerve stimulation may be considered medically necessary as a treatment of medically refractory seizures.

Vagus nerve stimulation is considered investigational as a treatment of other conditions, including but not limited to depression, heart failure, upper-limb impairment due to stroke, essential tremors, headaches, fibromyalgia, tinnitus, and traumatic brain injury as there is insufficient evidence to support a general conclusion concerning the health outcomes or benefits associated with this procedure.

Transcutaneous (nonimplantable) vagus nerve stimulation devices are considered investigational for all indications as there is insufficient evidence to support a general conclusion concerning the health outcomes or benefits associated with this procedure.

Implantable peripheral nerve stimulator

Peripheral nerve stimulation as a treatment for chronic pain is considered investigational as there is insufficient evidence to support a general conclusion concerning the health outcomes or benefits associated with this procedure.

Restorative neuromodulation therapy (ReActiv8) is considered investigational as there is insufficient evidence to support a general conclusion concerning the health outcomes or benefits associated with this procedure.

Policy guidelines

Medically refractory seizures are defined as seizures that occur despite therapeutic levels of antiepileptic drugs or seizures that cannot be treated with therapeutic levels of antiepileptic drugs because of intolerable adverse events of these drugs.

Spinal cord and dorsal root ganglion stimulation are covered in policy MP 1.069 and are not reviewed herein.

The Nau Medical, Inc. and Neuspera Medical Inc. device indications state “trial devices are solely for trial stimulation (no longer than 30 days) to determine efficacy before recommendation for a permanent (long term) device.”

Cross-references:

• MP 1.069 Spinal Cord Stimulation
• MP 1.141 Peripheral Subcutaneous Field Stimulation (PSFS)
• MP 2.092 Cranial Electrotherapy Stimulation (CES) and Auricular Electrostimulation
• MP 6.050 Percutaneous Electrical Nerve Stimulation (PENS) and Percutaneous Neuromodulation Therapy (PNT)

Product variations

This policy is only applicable to certain programs and products administered by Capital Blue Cross and subject to benefit variations. Please see additional information below.

FEP PPO - Refer to FEP Medical Policy Manual.

Description/Background

Vagus nerve stimulation

Vagus nerve stimulation (VNS) was initially investigated as a treatment alternative in patients with medically refractory partial-onset seizures for whom surgery is not recommended or for whom surgery has failed. Over time, the use of VNS has expanded to include generalized seizures, and it has been investigated for a range of other conditions.

While the mechanisms for the therapeutic effects of VNS are not fully understood, the basic premise of VNS in the treatment of various conditions is that vagal visceral afferents have a diffuse central nervous system projection, and activation of these pathways has a widespread effect on neuronal excitability. An electrical stimulus is applied to axons of the vagus nerve, which have their cell bodies in the nodose and junctional ganglia and synapse on the nucleus of the solitary tract in the brainstem. From the solitary tract nucleus, vagal afferent pathways project to multiple areas of the brain. VNS may also stimulate vagal efferent pathways that innervate the heart, vocal cords, and other laryngeal and pharyngeal muscles, and provide parasympathetic innervation to the gastrointestinal tract.

Other types of implantable vagus nerve stimulators that are placed in contact with the trunks of the vagus nerve at the gastroesophageal junction are not addressed in this evidence review.

Regulatory status

Table 1 includes updates on the U.S. Food and Drug Administration (FDA) approval and clearance for VNS devices pertinent to this evidence review.

Table 1. FDA-approved or -cleared vagus nerve stimulators

FDA: Food and Drug Administration; PMA: premarket approval; VNS: vagus nerve stimulation

Peripheral nerve stimulation

Peripheral nerve stimulation (PNS) has been used to treat chronic pain. It is a system consisting of leads, electrodes, and a pulse transmitter that delivers electrical impulses to peripheral nerves. Leads are placed using ultrasound guidance and can be placed for temporary or permanent use in an outpatient procedure.

Peripheral nerve stimulation for neuropathic chronic pain

Chronic, noncancer pain is responsible for a high burden of illness and can be defined as persistent pain that lasts for more than 3 months. Chronic pain of peripheral origin may be caused by damage to peripheral nerves impacting the upper and lower extremities.

Regulatory status for PNS devices for neuropathic chronic pain

A number of PNS devices have been cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process. These are listed in Table 2.

Two PNS devices by Stimwave Technologies Inc., the StimQ Peripheral Nerve Stimulator (PNS) System and the Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, SWAG Kit, SWAG Accessory Kit, Charger Kit, were recalled in September 2020 for the product containing a nonfunctional component not referenced in product labeling.

Table 2. FDA-cleared peripheral nerve stimulation devices (FDA product code: GZF)

Restorative neuromodulation for chronic lower back pain attributed to multifidus dysfunction

Restorative neuromodulation therapy (ReActiv8) uses an implanted device to deliver electrical stimulation to the nerves controlling the multifidus muscles of the lumbar spine. It is proposed that restorative neuromodulation reduces pain by triggering contractions of the multifidus muscles to restore neuromuscular control and help stabilize the spine. It is intended for individuals with intractable chronic low back pain associated with multifidus dysfunction for whom available low back pain treatments do not provide sufficient or durable symptomatic relief.

Regulatory status for restorative neuromodulation devices

In 2020, the ReActiv8 (Mainstay Medical) was FDA approved through the premarket approval (PMA) process (PMA P190021) for individuals with intractable chronic low back pain associated with multifidus dysfunction for whom available low back pain treatments do not provide sufficient or durable symptomatic relief. FDA product code: QLK.

Rationale

Summary of evidence

Vagus nerve stimulation

For individuals who have seizures refractory to medical treatment who receive VNS, the evidence includes randomized controlled trials (RCTs) and multiple observational studies. Relevant outcomes are symptoms, change in disease status, and functional outcomes. The RCTs have reported significant reductions in seizure frequency for patients with partial-onset seizures. The uncontrolled studies have consistently reported large reductions in a broader range of seizure types in both adults and children. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have treatment-resistant depression who receive VNS, the evidence includes 2 RCTs evaluating the efficacy of implanted VNS for treatment-resistant depression compared to sham, 1 RCT comparing therapeutic to low-dose implanted VNS, nonrandomized comparative studies, and case series. Relevant outcomes are symptoms, change in disease status, and functional outcomes. The sham-controlled RCTs only reported short-term results and found no significant improvement in the primary outcome. The low-dose VNS controlled trial reported no statistically significant differences between the dose groups for change in depression symptom score from baseline. Other available studies are limited by small sample sizes, potential selection and confounding biases, and lack of a control group in the case series. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have chronic heart failure who receive VNS, the evidence includes a systematic review including 4 RCTs and case series. Relevant outcomes are symptoms, change in disease status, and functional outcomes. Meta-analyses of the RCTs evaluating chronic heart failure found significant improvements in the New York Heart Association functional class, quality of life, 6-minute walk test, and N-terminal-pro brain natriuretic peptide levels in patients treated with VNS compared to control. An analysis of the ANTHEM-HF uncontrolled trial evaluated longer-term outcomes of VNS use in chronic heart failure. They found that left ventricular ejection fraction improved by 18.7%, 19.3%, and 34.4% at 12, 24, and 36 months, respectively, in high-intensity VNS. Individuals with low-intensity VNS only showed improvement in left ventricular ejection fraction at 24 months (12.3%). The ANTHEM-HF trial found improvements in New York Heart Association functional class, quality of life, and 6-minute walk test distances in patients with preserved ejection fraction and implanted VNS. Although this data is promising, a lack of a no-VNS comparator group precludes drawing conclusions based on findings from the uncontrolled studies. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have upper-limb impairment due to stroke who receive VNS, the evidence includes 3 pilot RCTs. Relevant outcomes are symptoms, change in disease status, and functional outcomes. Two RCTs comparing VNS plus rehabilitation to rehabilitation alone failed to show significant improvements for the VNS group on response and function outcomes, but the other RCT, which had a larger patient population, found a significant difference in response and function outcomes. The other RCT compared VNS to sham and found that although VNS significantly improved response rate, there were no serious adverse events related to surgery. Longer-term follow-up studies are needed to evaluate long-term efficacy and safety. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have other neurologic conditions (e.g., essential tremors, headache, fibromyalgia, tinnitus, autism) who receive VNS, the evidence includes case series. Relevant outcomes are symptoms, change in disease status, and functional outcomes. Case series are insufficient to draw conclusions regarding efficacy. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Transcutaneous vagus nerve stimulation

For individuals with cluster headaches who receive transcutaneous VNS (tVNS; also referred to as noninvasive VNS [nVNS]) to prevent cluster headaches, the evidence includes 1 RCT. Relevant outcomes are symptoms, change in disease status, quality of life, and functional outcomes. One RCT reported significant reductions in cluster headache frequency but did not include a sham treatment group. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals with cluster headaches who receive nVNS to treat acute cluster headache, the evidence includes RCTs. Relevant outcomes are symptoms, change in disease status, quality of life, and functional outcomes. The ACT1 and ACT2 RCTs compared nVNS to sham for treatment of acute cluster headaches in patients including both chronic and episodic cluster headache. In ACT1, there was no statistically significant difference in the overall population in the proportion of patients with pain score of 0 or 1 at 15 minutes in the first attack and no difference in the proportion of patients who were pain-free at 15 minutes in 50% or more of the attacks. In the episodic cluster headache subgroup (n=85), both outcomes were statistically significant favoring nVNS although the interaction p-value was not reported. In ACT2, the proportion of attacks with pain intensity score of 0 or 1 at 30 minutes was higher for nVNS in the overall population (43% vs. 28%, p=.05) while the proportion of attacks that were pain-free at 15 minutes was similar in the 2 treatment groups in the overall population (14% vs. 12%). However, a statistically significant higher proportion of attacks in the episodic subgroup (n=79) were pain-free at 15 minutes in the nVNS group compared to sham (48% vs. 6%, p<.01). These results suggest that people with episodic and chronic cluster headaches may respond differently to acute treatment with nVNS. Studies designed to focus on episodic cluster headache are needed. Quality of life and functional outcomes have not been reported. Treatment periods ranged from only 2 weeks to 1 month with extended open-label follow-up of up to 3 months. There were few adverse events of nVNS and they are mild and transient. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals with migraine headaches who receive nVNS to treat acute migraine headaches, the evidence includes 1 RCT. Relevant outcomes are symptoms, change in disease status, quality of life, and functional outcomes. One RCT has evaluated nVNS for acute treatment of migraine with nVNS in 248 patients with episodic migraine with/without aura. There was not a statistically significant difference in the primary outcome of the proportion of patients who were pain-free without using rescue medication at 120 minutes (30% vs. 20%; p=.07). However, the nVNS group had a higher proportion of patients with decrease in pain from moderate/severe to mild or no pain at 120 minutes (41% vs. 28%; p=.03) and a higher proportion of patients who were pain-free at 120 minutes for 50% or more of their attacks (32% vs. 18%; p=.02). There were few adverse events of nVNS and they are mild and transient. Quality of life and functional outcomes were not reported, and the double-blind treatment period was 4 weeks with an additional 4 weeks of open-label treatment. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals with chronic migraine headaches who receive nVNS to prevent migraine headaches, the evidence includes 3 RCTs. Relevant outcomes are symptoms, change in disease status, quality of life, and functional outcomes. The EVENT RCT was a feasibility study of prevention of migraine that was not powered to detect differences in efficacy outcomes. It does not demonstrate the efficacy of nVNS for prevention of migraine. The PREMIUM RCT was a phase 3, multicenter, sham-controlled RCT including 341 randomized participants with a 12-week double-blind treatment period. The results of PREMIUM demonstrated that nVNS was not statistically significantly superior to sham with respect to the outcomes of reduction of at least 50% in migraine days from baseline to the last 4 weeks, reduction in number of migraine days from baseline to the last 4 weeks, or acute medication days. The PREMIUM II trial was a randomized controlled trial including 231 randomized participants with a 12-week double-blind treatment period. The trial was terminated early due to the COVID-19 pandemic and results were based on a modified intention-to-treat population that included 113 total participants. Results demonstrated that treatment with nVNS was not statistically significantly superior to sham with respect to the primary outcome of reduction in the number of migraine days per month during weeks 9 through 12, nor other outcomes such as mean change in the number of headache days or acute medication days. However, the percentage of patients with at least a 50% reduction in the number of migraine days was significantly greater in the nVNS group than in the sham group. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have other neurologic, psychiatric, or metabolic disorders (e.g., epilepsy, depression, schizophrenia, noncluster headache, impaired glucose tolerance, fibromyalgia, stroke) who receive tVNS, the evidence includes RCTs, systematic reviews of these RCTs, and case series for some of the conditions. Relevant outcomes are symptoms, change in disease status, and functional outcomes. The RCTs are all small and have various methodologic problems. None showed definitive efficacy of tVNS in improving patient outcomes. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Peripheral nerve stimulators for neuropathic pain

For individuals who have peripheral, neuropathic, chronic pain who receive peripheral nerve stimulation (PNS), the evidence includes several randomized controlled trials (RCTs). Relevant outcomes are symptoms, medication use, and quality of life. Statistically significant differences in response rates were reported in the RCTs ranging from 38% to 88% in the treatment groups and 0% to 24% in the control groups. Overall limitations of the current evidence include small sample sizes, heterogeneous patient populations, high attrition rates, and lack of long-term follow-up data. Additional evidence from RCTs with larger sample sizes and longer durations of comparative data are necessary to assess the efficacy and durability of PNS. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Restorative neuromodulation therapy

For individuals who have chronic pain conditions including low back pain who receive restorative neuromodulation therapy (ReActiv8), the evidence includes 1 sham-controlled randomized controlled trial (RCT) (n=204), 1 open-label RCT (n=203), 1 prospective single-arm trial (n=53), and case series (n=44). Relevant outcomes are symptoms, functional outcomes, quality of life, and medication use. In the sham-controlled RCT, there was no difference between groups on the primary endpoint of treatment response at 120 days, defined as the composite of 30% or greater reduction in visual analog scale and no increase in pain medications (57.1% intervention vs. 46.6% sham; p=.1377). Prespecified secondary analyses of primary outcome data favored the intervention group, but clinical significance is unclear. An uncontrolled follow-up phase of the RCT reported continued improvement in pain scores through 3 years but results are at high risk of bias due to lack of a control group and high attrition. The open-label RCT showed statistically significant improvements in the treatment arm compared to the control arm in the primary and secondary outcomes. However, limitations included lack of blinding, imbalance in baseline depression between treatment and control arms, and greater clinical contact than standard management protocols in the treatment arm. Nonrandomized studies are limited by lack of blinding, no sham control, high attrition, and small sample sizes. Additional evidence from longer-term sham-controlled RCTs is needed. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Definitions

Epilepsy is a group of neurologic disorders characterized by recurrent episodes of convulsive seizures, sensory disturbances, abnormal behavior, loss of consciousness, or all of these. Common to all types of epilepsy is an uncontrolled electrical discharge from the nerve cells of the cerebral cortex.

Partial-onset seizures refers to seizures that have a discrete focal onset. There are three subtypes of partial-onset seizures:

• Simple partial seizures: these do not involve alteration of consciousness but may have observable motor components or may solely be a subjective sensory or emotional phenomenon.
• Complex partial seizures: these are partial-onset seizures that involve an alteration of consciousness.
• Complex partial seizures, secondary generalized: these are partial-onset seizures that progress to involve both sides of the brain and result in a complete loss of consciousness.

Vagus nerve refers to either one of the longest pair of cranial nerves mainly responsible for parasympathetic control over the heart and many other internal organs, including thoracic and abdominal viscera.

Disclaimer

Capital Blue Cross’ medical policies are used to determine coverage for specific medical technologies, procedures, equipment, and services. These medical policies do not constitute medical advice and are subject to change as required by law or applicable clinical evidence from independent treatment guidelines. Treating providers are solely responsible for medical advice and treatment of members. These policies are not a guarantee of coverage or payment. Payment of claims is subject to a determination regarding the member’s benefit program and eligibility on the date of service, and a determination that the services are medically necessary and appropriate. Final processing of a claim is based upon the terms of contract that applies to the member’s benefit program, including benefit limitations and exclusions. If a provider or a member has a question concerning this medical policy, please contact Capital Blue Cross’ Provider Services or Member Services.

Coding information

Note: This list of codes may not be all-inclusive, and codes are subject to change at any time. The identification of a code in this section does not denote coverage as coverage is determined by the terms of member benefit information. In addition, not all covered services are eligible for separate reimbursement.

Investigational; therefore, not covered: Non-implantable vagus nerve stimulator and implantable VNS for conditions other than medically refractory seizures

Investigational; therefore, not covered: Implantable peripheral nerve stimulator

Covered when medically necessary: Vagus nerve stimulator to treat medically refractory seizures

ICD-10-CM diagnosis codes

Covered when medically necessary when billed with an allowed surgery:

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Peripheral nerve stimulation

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