ModifiedUnitedHealthcarePolicy CS129NM.C

Vagus and External Trigeminal Nerve Stimulation (for New Mexico Only)

This policy governs coverage for implantable vagus nerve stimulators and non‑implantable (transcutaneous/external) vagus and trigeminal nerve stimulation devices for UnitedHealthcare members in New Mexico.

Policy Summary

PayerUnitedHealthcare

PolicyVagus and External Trigeminal Nerve Stimulation (for New Mexico Only)

Policy CodePolicy CS129NM.C

Change TypeMaterial wording added regarding coverage determination and medical records

Effective DateDec 1, 2025

Next Review DateN/A

Key ActionProvide medical records that fully document prior therapy trials and medical necessity when requesting authorization.

SourceLink

POLICY UPDATE CHANGES

Added language clarifying that benefit coverage is determined by federal, state, or contractual requirements and that medical records documentation may be required to assess whether the member meets clinical criteria but does not guarantee coverage.

Updated reference link to reflect the current policy title for Transcranial Magnetic Stimulation for Treating Physical Health Conditions (for New Mexico Only).

Updated definition of 'Shared Decision Making' and updated Supporting Information sections (Description of Services, Clinical Evidence, References).

New MexicoState applicability

≥2AED trial requirement

UnprovenTranscutaneous / eTNS stance

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Multiple RCTs & reviews

Evidence sources cited

History entryDocumented revisions

Coverage Criteria

Implantable Vagus Nerve Stimulator — Medically Necessary

Covered when ALL of the following are met:

Implantable VNS coverage criteria: 1) Medically refractory epileptic seizures with failure of two or more trials of single or combination antiepileptic drug therapy or intolerable side effects of antiepileptic drug therapy; 2) The individual is not a candidate for epilepsy surgery, has failed epilepsy surgery, or refuses epilepsy surgery after a Shared Decision Making discussion; 3) No history of left or bilateral cervical vagotomy (FDA contraindication)see node text

From Coverage Rationale (chunk 3)

Transcutaneous/External Devices — Not Medically Necessary

Not covered / considered unproven:

Non-implantable VNS and external TNS: Transcutaneous (non-implantable) vagus nerve stimulation devices and external/transcutaneous trigeminal nerve stimulation devices are unproven and not medically necessary for preventing or treating all indications.N/A

Includes listed example indications; see device descriptions and rationale (chunks 4, 11)

Condition-specific evidence summaries

Evidence- and guideline-based coverage considerations summarized by condition:

Epilepsy (implantable VNS): VNS may be considered as adjunctive therapy for individuals with drug-resistant seizures after multiple antiseizure medications have failed, particularly when resective epilepsy surgery is not a viable option; engage in shared decision-making with the patient and caregivers.

Supported by Epilepsy Society and NICE guidance (chunks 19,20)

Treatment-Resistant Depression (implantable VNS): Evidence is mixed: large RCTs and registry data report some secondary outcome benefits and improved long-term response/remission versus treatment-as-usual, but primary endpoints have been inconsistent and evidence quality is limited; consider VNS only in appropriate TRD populations after weighing risks and benefits.

Summarized from trials and reviews (chunks 22,23,25)

Cluster Headache (nVNS): nVNS demonstrated efficacy versus sham for episodic cluster headache in randomized trials and meta-analysis but not for chronic cluster headache; evidence supports acute treatment of episodic CH with favorable tolerability.

See ACT1/ACT2 and Silberstein et al. trials and meta-analysis (chunks 32,33,36,37)

Cluster headache (evidence summary)

Evidence supports benefit for episodic cluster headache in trials:

eCH benefit: Randomized trials and pooled analyses showed nVNS superior to sham for episodic cluster headache with higher response and sustained response rates (e.g., Silberstein et al. 2016; De Coo meta-analysis; Goadsby et al. subgroup results). No serious device-related adverse events were reported in these trials.

See ACT1/ACT2, Silberstein et al., Goadsby et al. (chunks 32,33,36,37)

Migraine (evidence summary)

Evidence is mixed for migraine; some trials show benefit in subgroups or with adherence:

Acute migraine treatment: Trials (e.g., Tassorelli et al. 2018) demonstrated nVNS superior to sham for pain freedom at 30 and 60 minutes in episodic migraine; nVNS is generally safe and well tolerated.

Acute trial evidence (chunk 44)

Preventive migraine treatment: PREMIUM and other prevention trials did not meet primary endpoints in ITT analyses; post hoc analyses showed benefit in participants with ≥67% adherence and in those with aura, but limitations include sham activity and suboptimal adherence.>=67% adherence in post hoc analysis

PREMIUM trial and related analyses (chunks 43,41)

External/transcutaneous trigeminal nerve stimulation (eTNS) (evidence summary)

Evidence suggests potential benefit for migraine and some epilepsy/neurological disorders but quality is low to mixed:

Migraine (eTNS): Systematic reviews and randomized trials report reductions in pain and headache days with eTNS versus sham, but the overall evidence quality is low and long-term effects, optimal protocols, and durability are uncertain.

ECRI, Stanak et al. and trial summaries (chunks 51,52)

Epilepsy / DRE (TNS): Small trials and series suggest TNS may reduce seizure frequency in focal drug-resistant epilepsy with reported responder rates, but studies are small, heterogeneous, and at risk of bias; larger comparative studies are needed.

Systematic review and RCTs summarized (chunk 50)

Acute migraine (eTNS/TNS)

Evidence and guidance for external/transcutaneous trigeminal nerve stimulation in acute migraine:

Acute migraine eTNS evidence: A randomized sham-controlled trial (Chou et al. 2019) found that 1-hour external trigeminal nerve stimulation reduced pain intensity at 1 hour versus sham and was well tolerated. NICE considers the evidence for treating an acute migraine attack adequate but recommends use only with special arrangements for governance, consent, audit, or research.

Chou et al. (2019) and NICE guidance (chunks 55,58)

Other indications (ADHD, depression, epilepsy)

Evidence summaries for other studied indications:

ADHD: A blinded sham-controlled trial (McGough et al. 2019) reported improvements in ADHD-RS and CGI favoring active TNS, but the American Academy of Pediatrics does not recommend eTNS for ADHD due to sparse evidence compared with established treatments.

McGough trial and AAP guidance (chunks 54,57)

Major depressive disorder: A small randomized phase II sham-controlled trial (Generoso et al. 2019) reported reductions in HDRS-17 scores after a 10-day TNS protocol with sustained effect at 1 month, but sample size and follow-up were limited.

Generoso et al. (chunk 56)

Drug-resistant epilepsy: Systematic reviews conclude insufficient data to support TNS for drug-resistant epilepsy; available studies are small and heterogeneous, necessitating further research.

Boon et al. and related reviews (chunk 56)

Implantable vagus nerve stimulators are contraindicated in individuals with a history of left or bilateral cervical vagotomy; the FDA identifies prior left or bilateral cervical vagotomy as a contraindication to VNS. Transcutaneous (non‑implantable) vagus nerve stimulation (tVNS) devices and external/transcutaneous trigeminal nerve stimulation (eTNS/TNS) devices are listed in this policy as unproven and not medically necessary for preventing or treating all indications due to insufficient evidence. Examples of nonimplantable devices described in the source include handheld tVNS systems (e.g., gammaCore) and forehead-applied eTNS systems (e.g., Cefaly), but their use across indications (including cluster headache and migraine) is considered unsupported by current evidence and may be subject to denial without adequate documentation or special program arrangements.

Use of VNS (implantable or noninvasive) outside recognized, evidence-supported indications is not covered. In particular, implantable VNS for conditions other than drug‑resistant epilepsy (e.g., Alzheimer disease, anxiety, autism spectrum disorder, chronic pain, heart failure, migraine, bipolar disorder, OCD, sleep disorders, and others) is considered unproven and not medically necessary because existing studies are limited by small sample sizes and weak designs. Similarly, transcutaneous VNS and external trigeminal stimulation are not supported as proven treatments for these off‑label indications.

For many other studied conditions — including Alzheimer disease, heart failure, impaired glucose tolerance, tinnitus, schizophrenia, chronic pain syndromes, and various psychiatric and neurodevelopmental disorders — the evidence base is inadequate to establish safety and effectiveness. The source notes that studies are generally limited, heterogeneous, and underpowered, and therefore insufficient data exist to conclude clinical benefit; additional well‑designed clinical trials are required before coverage can be considered proven for these indications.

Professional guidance is referenced and affects coverage implications. NICE recommends that transcutaneous supraorbital stimulation for acute migraine may be used only with special arrangements for clinical governance, consent, and audit or research, and it finds prevention evidence inadequate. The American Academy of Pediatrics states that eTNS cannot be recommended for ADHD because supporting evidence is sparse compared with established treatments. Epilepsy and headache society statements included in the source emphasize shared decision‑making and careful patient selection when considering neuromodulation.

Implantable VNS is considered proven and medically necessary only for drug‑resistant epilepsy when all coverage criteria are met (including failure of two or more antiepileptic drug trials, not a surgical candidate or declined surgery after shared decision‑making, and no history of left or bilateral cervical vagotomy). For all other conditions, implantable VNS remains unproven and not medically necessary due to insufficient evidence of efficacy and therefore is excluded from coverage as a proven therapy.

Transcutaneous (non‑implantable) vagus nerve stimulation is considered unsupported by sufficient evidence to establish safety and efficacy for routine clinical use. Although some devices (for example, gammaCore) have been investigated for specific uses such as episodic cluster headache, the policy concludes that larger, higher‑quality studies are needed and that routine coverage is not warranted.

Noninvasive vagus nerve stimulation (nVNS) and external/transcutaneous trigeminal nerve stimulation (eTNS/TNS) are considered not proven or insufficient for general migraine treatment. The document summarizes mixed results across trials: some RCTs show benefit in acute episodic migraine or in adherent subgroups for prevention, while larger trials often failed to meet primary endpoints or were limited by sham device activity and adherence issues. Overall, current evidence does not establish routine effectiveness for migraine prevention or broad acute use.

Available data for trigeminal nerve stimulation (TNS/eTNS) in drug‑resistant epilepsy are limited and heterogeneous. Systematic reviews and small trials report seizure reductions in some series, but study sizes, variable protocols, and risk of bias prevent definitive conclusions; therefore, the evidence is insufficient to establish TNS as an effective treatment for drug‑resistant epilepsy at this time.

Additional coverage notes: implantable VNS coverage requires documentation that the member has failed ≥two antiepileptic drug trials or had intolerable side effects, that epilepsy surgery is not appropriate or was declined after shared decision‑making, and confirmation of no prior left or bilateral cervical vagotomy. Prior authorization review should include device model/manufacturer and FDA marketing clearance information when applicable, and benefit determination remains subject to federal, state, or contractual requirements; medical records must fully support medical necessity and be available upon request.

Coding

Applicable CPT/HCPCS/DME Codes (group 1)mixed

61885	Insertion or replacement of cranial neurostimulator pulse generator or receiver; with connection to a single electrode array.
61886	Insertion or replacement of cranial neurostimulator pulse generator or receiver; with connection to 2 or more electrode arrays.
64553	Percutaneous implantation of neurostimulator electrode array; cranial nerve.
64568	Open implantation of cranial nerve (e.g., vagus nerve) neurostimulator electrode array and pulse generator.
64570	Removal of cranial nerve (e.g., vagus nerve) neurostimulator electrode array and pulse generator.
A4541	Monthly supplies for use of device coded at E0733.
E0733	Transcutaneous electrical nerve stimulator for electrical stimulation of the trigeminal nerve.
E0735	Noninvasive vagus nerve stimulator.
E0770	Functional electrical stimulator, transcutaneous stimulation of nerve and/or muscle groups, any type, complete system, not otherwise specified.
E1399	Durable medical equipment, miscellaneous.

1–10 of 11

1/2

Applicable DME/Implantable Device Codes (group 2)mixed

L8680	Implantable neurostimulator electrode, each.
L8682	Implantable neurostimulator radiofrequency receiver.
L8683	Radiofrequency transmitter (external) for use with implantable neurostimulator radiofrequency receiver.
L8685	Implantable neurostimulator pulse generator, single array, rechargeable, includes extension.
L8686	Implantable neurostimulator pulse generator, single array, nonrechargeable, includes extension.
L8687	Implantable neurostimulator pulse generator, dual array, rechargeable, includes extension.
L8688	Implantable neurostimulator pulse generator, dual array, nonrechargeable, includes extension.

Implantable VNS device product codes (FDA reference)mixed

LYJ	FDA product code referenced for implantable VNS devices (documented source)
MUZ	FDA product code referenced for implantable VNS devices (documented source)
QPY	FDA product code referenced for implantable VNS devices (documented source)

Transcutaneous VNS device product codes (FDA reference)mixed

PKR	FDA product code referenced for transcutaneous (non-implantable) VNS devices
QAK	FDA product code referenced for transcutaneous (non-implantable) VNS devices

External/trigeminal stimulation device product codes (FDA reference)mixed

PCC	FDA product code referenced for external/transcutaneous trigeminal nerve stimulation devices
QGL	FDA product code referenced for external/transcutaneous trigeminal nerve stimulation devices

Antiepileptic drug trials — Failure requirement

ThresholdFailure of two or more trials of single or combination antiepileptic drug therapy (or intolerable side effects)

ContextRequired for consideration of implantable vagus nerve stimulation for medically refractory epileptic seizures

Related requirementNot a candidate for epilepsy surgery, has failed epilepsy surgery, or refuses epilepsy surgery after Shared Decision Making

Contraindication noteNo history of left or bilateral cervical vagotomy (FDA contraindication)

Provider Actions / Prior Authorization

Prior Authorization

Prior authorization — nVNS for cluster headache

Prior authorization is recommended for non‑invasive vagus nerve stimulation (nVNS / gammaCore) when requested for cluster headache. Evidence is mixed — benefit is more likely for episodic cluster headache (eCH) than chronic cluster headache (cCH) — and approval decisions should consider subtype, prior therapies, and supporting documentation.

nVNS (gammaCore) more likely to show benefit for episodic CH than chronic CH
Prior authorization requests should include subtype (episodic vs chronic) and prior headache treatment history

Prior Authorization

Prior authorization for neuromodulation devices

Prior authorization is required/recommended for neuromodulation devices (implantable and non‑implantable) to verify indication, prior therapy trials, and that device use aligns with policy criteria and applicable federal/state/contractual coverage requirements.

Verify member benefit coverage and any federal/state/contractual mandates
Confirm indication matches policy-covered uses (e.g., implantable VNS for drug‑resistant epilepsy)

Background

Background: Implantable vagus nerve stimulation (VNS) delivers electrical impulses to the brain via an implanted generator and leads connected to the cervical vagus nerve; mechanisms are incompletely understood but may involve modulation of neurotransmitters, changes in cerebral blood flow, and EEG desynchronization. Transcutaneous VNS and external trigeminal stimulation are noninvasive approaches that apply stimulation via surface electrodes (for example, auricular or cervical tVNS, or supraorbital eTNS devices) and are under active investigation but currently considered unproven for most indications.

Definitions

Shared Decision Making — definition (updated)

DefinitionShared Decision Making is a collaborative process in which a provider/clinician and a patient (including caregivers and family) work together to make healthcare decisions, considering evidence-based information, clinician experience, and patient values/preferences.

PurposeTo compare benefits, harms, and risks of options and discuss what matters most to the patient (AHRQ, About Shared Decision Making, 2023).

DocumentationPolicy revisions note updated the definition; document shared decision-making discussions for VNS in drug‑resistant epilepsy when applicable.

AAN Level C — definition

DefinitionAAN Level C: indicates possibly effective, ineffective, or harmful (or possibly useful/predictive or not useful/predictive) for the given condition in the specified population.

Evidence requirement

Revision History

Policy Summary

PayerUnitedHealthcare

PolicyVagus and External Trigeminal Nerve Stimulation (for New Mexico Only)

Policy CodePolicy CS129NM.C

Change TypeMaterial wording added regarding coverage determination and medical records

Effective DateDec 1, 2025

Next Review DateN/A

Key ActionProvide medical records that fully document prior therapy trials and medical necessity when requesting authorization.

SourceLink

On This Page

Other indications (Alzheimer's, cardiac, pain, etc.): Insufficient and low-quality evidence exists to conclude safety and effectiveness for many other studied indications; further high-quality trials are needed before coverage can be considered established.

Based on limited studies and weak designs (chunk 28)

Transcutaneous (non-implantable) VNS and external TNS: Current evidence is insufficient to support routine use of transcutaneous non-implantable VNS or external/transcutaneous trigeminal nerve stimulation for most indications; larger, higher-quality studies are required.

Explicit conclusions and device descriptions (chunks 29,50,11)

Prior Authorization

Device‑specific prior authorization

Prior authorization requests must identify the specific device, manufacturer, and FDA marketing clearance pathway (PMA, 510(k), PMN) or note absence of clearance. Device model and marketing/clearance documentation should be provided when available.

Include device model/manufacturer and copy or reference to FDA PMA/510(k)/PMN listing
If device has no FDA clearance for the requested indication, note this explicitly

Prior Authorization

Prior authorization and coverage determination

Benefit coverage and any prior authorization determinations are governed by federal, state, and contractual requirements. Medical records may be required to determine if the member meets clinical criteria; submission of records does not guarantee coverage.

Coverage determined by applicable federal/state/contractual rules
Medical records may be requested and reviewed to assess eligibility

Denial Risk

Device considered unproven

Transcutaneous (non‑implantable) VNS devices and external/transcutaneous trigeminal nerve stimulation devices are considered unproven and may be denied for most indications due to insufficient evidence of efficacy. Requests for these devices should include robust supporting evidence to justify off‑label use.

tVNS and external/transcutaneous TNS listed as unproven / not medically necessary for most indications
Cluster headache and migraine evidence for non‑implantable devices is mixed — see policy evidence summaries

Note

Professional guidance implications for coverage

Professional guidance (AHS, NICE, AAP) should inform coverage decisions. AHS supports selected FDA‑cleared neuromodulation uses (eg, nVNS for acute migraine) and notes individualized decisions; NICE recommends shared decision‑making and special arrangements for some transcutaneous procedures; AAP does not recommend eTNS for ADHD.

AHS: FDA‑cleared neuromodulation may be appropriate for individuals preferring non‑drug therapies or after pharmacotherapy failure
NICE: use some transcutaneous procedures only with special arrangements or in research contexts
AAP: eTNS not recommended for ADHD due to sparse evidence

Documentation Required

Epilepsy — shared decision‑making

For implantable VNS in epilepsy, document shared decision‑making discussions when VNS is pursued as treatment for drug‑resistant epilepsy, including discussion of benefits, risks, alternative treatments, and whether resective surgery was considered.

Document discussions with the patient and family/caregivers about benefits, risks, and alternatives
Record reasons if resective surgery is not viable, refused, or previously failed

Documentation Required

Required clinical documentation

Requests must include complete clinical documentation supporting medical necessity: relevant medical history, physical exam findings, diagnosis subtype, prior treatment history (medications, doses, duration), adherence, response or intolerance, and results of pertinent diagnostic tests or procedures.

Diagnosis and subtype (e.g., episodic vs chronic cluster headache; epilepsy seizure type)
Detailed prior treatment history with dates, doses, and outcomes
Relevant test results (eg, EEG, imaging) and physical examination notes

Documentation Required

Required clinical and device documentation

When a device trial or device‑specific data are applicable, include device model, manufacturer, FDA clearance status, trial outcomes (if a wearable or external trial), and documentation of device programming/placement for implantable devices.

Device model and manufacturer
FDA clearance pathway or PMA/510(k)/PMN reference
Trial outcome data for temporary/non‑implant trials or prior device use

Documentation Required

Medical records documentation

Medical records must fully support medical necessity; legible documentation should be maintained in the patient’s chart and made available upon request. Incomplete documentation or failure to provide records may result in denial or closure of the request.

Records should include history, examination, and relevant test results
Failure to provide documentation may lead to denial

Step Therapy

Medication trial prerequisite

Implantable VNS for epilepsy requires documentation of failure of two or more antiepileptic drug (AED) trials (single or combination) or intolerable side effects, consistent with medical necessity criteria.

Document at least two AED trials with names, doses, and durations or documentation of AED intolerance

Step Therapy

Step therapy context — epilepsy

Step therapy context: VNS is typically considered as adjunctive therapy for drug‑resistant epilepsy after failure of multiple antiseizure medications and when resective surgery is not viable, refused, or has failed.

Confirm trials of multiple antiseizure medications and surgical candidacy assessment
Document rationale for choosing VNS over other options

Step Therapy

Step therapy considerations

Step therapy considerations: prior pharmacologic therapies should align with clinical guidance (eg, AHS, NICE). Prior standard therapies (medication and behavioral treatments where applicable) must be documented before device coverage is authorized.

Document pharmacologic trials consistent with guidance and reasons for discontinuation
For headache indications, document prior abortive and preventive therapies tried and responses

Documentation Required

Prior standard therapy documentation

Require documentation of prior standard therapies (both medication and behavioral treatments) where applicable — include duration, adherence, response, and reasons for discontinuation or intolerance.

List prior standard therapies with dates and outcomes
Include behavioral therapy documentation when relevant (eg, migraine prevention strategies)

Requires at least one Class II study or two consistent Class III studies to assign Level C.

InterpretationUsed to denote limited or inconsistent evidence supporting an intervention for a condition.

Transcutaneous (Non-Implantable) VNS — definition

DefinitionTranscutaneous (Non-Implantable) Vagus Nerve Stimulation: externally applied vagus nerve stimulation devices that do not require surgical implantation.

Policy stanceDocument states there is insufficient evidence to support use due to study limitations; larger studies needed to establish safety, efficacy, and long-term outcomes.

Coverage implicationThese devices are considered unproven and not medically necessary for all indications in this policy.

nVNS — definition

DefinitionnVNS (noninvasive vagus nerve stimulation) refers to transcutaneous delivery of vagus nerve stimulation (example device: gammaCore) for acute or preventive treatment of headache disorders.

Evidence summaryRCTs show efficacy versus sham for episodic cluster headache but mixed results for migraine prevention; adherence and sham activity affected some trials.

SafetyMost device-related adverse events reported as mild and transient (application site discomfort most common).

eTNS — definition

DefinitioneTNS (external/transcutaneous trigeminal nerve stimulation) is external stimulation applied to the supraorbital/trigeminal nerve distribution (example device: Cefaly) for acute or preventive migraine treatment.

Evidence qualitySystematic reviews and RCTs report reductions in pain and headache days versus sham, but evidence quality is low and long-term protocols/outcomes are uncertain.

Acute useSham-controlled trials indicate eTNS can reduce pain intensity for acute migraine attacks and is generally well tolerated.

External/transcutaneous trigeminal nerve stimulation (eTNS/TNS) — definition

DefinitionExternal/transcutaneous trigeminal nerve stimulation (eTNS/TNS): noninvasive stimulation applied to the supraorbital/trigeminal nerve distribution via external devices (examples include the Cefaly device).

Indications studiedUsed experimentally or therapeutically for migraine (acute and preventive), and investigated in ADHD, depression, and epilepsy in small trials/series.

Evidence and policyPolicy considers evidence low-to-mixed; eTNS not established as proven for many indications and NICE/AAP provide specific guidance for use in acute migraine or ADHD contexts.

tVNS — definition

DefinitionTranscutaneous (non-implantable) vagus nerve stimulation (tVNS): noninvasive stimulation of the vagus nerve using externally applied devices cleared by the FDA for certain indications.

Regulatory referenceFDA-cleared transcutaneous VNS devices are listed (see product codes PKR and QAK) for device-specific marketing information.

Policy stancePolicy concludes insufficient evidence to support routine use; considered unproven and not medically necessary for all indications.

Implantable VNS — definition

DefinitionImplantable vagus nerve stimulation (VNS): surgically implanted devices that deliver electrical stimulation to the cervical vagus nerve.

Regulatory referenceSeveral implantable VNS devices have FDA PMA or other approvals; FDA product codes referenced (LYJ, MUZ, QPY) for device lookup.

Coverage stanceImplantable VNS is proven and medically necessary for treating medically refractory epilepsy when specified criteria are met; it is unproven for other conditions.

Shared Decision Making (updated definition referenced in policy revisions)

Updated definitionShared Decision Making: a collaborative process in which provider/clinician and patient (including caregivers) jointly make healthcare decisions considering evidence, clinician experience, and patient values and preferences.

Policy revision noteDefinition updated in policy revisions; documentation of shared decision-making discussions recommended for VNS in drug-resistant epilepsy.

Practical useIncludes comparing benefits, harms, and risks of each option and discussing what matters most to the patient (AHRQ reference).