ModifiedColorado Rocky Mountain Health PlansPolicy CS129OH.D

Vagus and External Trigeminal Nerve Stimulation (for Ohio Only)

Clinical coverage policy for implantable and noninvasive vagus nerve stimulation (VNS) and external trigeminal nerve stimulation (TNS) services as applied to members in Ohio.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyVagus and External Trigeminal Nerve Stimulation (for Ohio Only)

Policy CodePolicy CS129OH.D

Change TypeClarified jurisdictional/ documentation expectationsupdated references

Effective DateJan 1, 2026

Next Review Date

Key ActionApply InterQual clinical criteria and obtain prior authorization when required; ensure medical records document prior therapies, device details, and early symptomatic response for continued use.

SourceLink

POLICY UPDATE CHANGES

Added language clarifying that benefit coverage is determined by federal, state (OAC), or contractual requirements and that medical records may be required to assess whether a member meets clinical criteria for coverage.

Updated Description of Services, Clinical Evidence, and References sections to reflect the most current information.

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

InterQualInterQual referenced

MultipleUnproven indications

eCH benefitPositive subgroup findings

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tVNS limitedEvidence gaps

OhioGeographic scope

Coverage Criteria & Policy Stance

Summary of coverage stance, evidence limitations, administrative updates, and documentation expectations for implantable and noninvasive trigeminal and vagus nerve stimulation devices.

For implantable vagus nerve stimulators: Refer to InterQual® CP: Procedures (Vagus Nerve Stimulation and Pediatric VNS) for medical necessity clinical coverage criteria.

Implantable vagus nerve stimulators are considered unproven and not medically necessary for all other conditions not covered by InterQual criteria due to insufficient evidence of efficacy. Examples include Alzheimer’s disease, anxiety disorder, autism spectrum disorder, autoimmune disorders, back and neck pain, bipolar disorder, bulimia, cerebral palsy, chronic pain syndrome, cluster headaches, depression, fibromyalgia, heart failure, migraines, morbid obesity, and musculoskeletal disorders.

For non-invasive trigeminal and vagus nerve stimulators: Refer to InterQual® CP: Durable Medical Equipment, Trigeminal and Vagus Nerve Stimulator Devices, Noninvasive for medical necessity clinical coverage criteria. InterQual criteria are authoritative for coverage determinations when applicable.

The following non-implantable devices are unproven and not medically necessary for initial requests due to insufficient evidence of efficacy: transcutaneous (non-implantable) vagus nerve stimulation devices for preventing or treating all indications; external or transcutaneous trigeminal nerve stimulation devices for preventing or treating all conditions including but not limited to ADHD, depression, epilepsy, and headache.

Transcutaneous (non-implantable) vagus nerve stimulation: Current evidence is insufficient to support use for many indications (including cluster headache and migraine) because of study limitations (small sample sizes, short durations, heterogeneous stimulation parameters, potential active sham effects). Some subgroup or device-specific studies suggest benefit (e.g., episodic cluster headache, selected migraine subgroups, or adherence-dependent effects), but overall evidence is inadequate to establish general effectiveness and long-term safety.

External/transcutaneous trigeminal nerve stimulation (eTNS): Evidence is limited and of low to very low quality for migraine prevention and acute treatment, epilepsy, ADHD, and other indications. The American Academy of Pediatrics does not recommend eTNS for ADHD due to sparse evidence. eTNS and TNS remain investigational for many uses.

Other conditions (investigational/not established): Transcutaneous VNS and TNS have been studied for atrial fibrillation, epilepsy, depression, frequent premature ventricular contractions, heart failure, impaired glucose tolerance, pain, schizophrenia, tinnitus, sleep quality, and others. Studies are limited by small samples and methodological weaknesses; therefore these indications are not proven.

Administrative updates and documentation requirements: Benefit coverage is determined by federal, state (Ohio Administrative Code where applicable), and contractual requirements; these govern if conflicts exist. Medical records documentation may be required to assess whether a member meets clinical criteria but does not guarantee coverage. Patient records must fully support medical necessity and may include relevant history, physical exam, diagnostic test results, and other pertinent information. Documentation must be legible, maintained in the patient record, and made available upon request.

Cross-references and related policies: For vagus nerve blocking for obesity, refer to the Bariatric Surgery policy (Ohio only). See related policies for Deep Brain and Cortical Stimulation, Implanted Electrical Stimulator for the Spinal Cord, and Transcranial Magnetic Stimulation for Treating Physical Health Conditions (Ohio only).

Policy history note: Updates on 01/01/2026 added medical records documentation language and supporting information; 04/01/2026 updated related policy links.

Billing & Procedure Codes

Applicable CPT CodesCPT

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 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.

Applicable HCPCS / L CodesHCPCS

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.
L8679	Implantable neurostimulator, pulse generator, any type.
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.

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Implantable VNS product codesmixed

LYJ, MUZ, QPY

Product codes cited for implantable vagus nerve stimulators

Transcutaneous VNS product codesmixed

PKR, QAK

Product codes cited for transcutaneous (non-implantable) VNS devices

External TNS product codesmixed

PCC, QGL

Product codes cited for external/transcutaneous trigeminal nerve stimulation devices

Coding references and systems usedmixed

CPT	Current Procedural Terminology (procedure codes listed in policy).
HCPCS	Healthcare Common Procedure Coding System (E-codes listed in policy).
L-codes	Durable medical equipment L-codes for implantable neurostimulator components.
FDA product codes	Product codes (e.g., LYJ, MUZ, QPY, PKR, QAK, PCC, QGL) used to locate device marketing/clearance records in FDA databases.

Coding thresholds — extract status

Coding thresholds in this extractNone reported in this policy excerpt; no numeric coding thresholds or quantity limits provided.

Action for codersRefer to the 'Applicable CPT Codes' and 'HCPCS/L Codes' sections for code lists; confirm device-specific product codes via FDA references before billing.

Where to find full coding detailsSee the Coding module lists (Applicable CPT and HCPCS/L Codes) in the complete policy for full code sets and product codes.

Prior Auth, Documentation & Operational Steps

Prior Authorization

InterQual-based prior authorization

Clinical coverage determinations for implantable and noninvasive trigeminal/vagus nerve stimulator devices must be evaluated using InterQual clinical criteria and may require prior authorization for the listed CPT/HCPCS/L codes.

Refer to InterQual CP: Procedures: Vagus Nerve Stimulation (VNS) and VNS (Pediatric) for implantable devices.
Refer to InterQual CP: Durable Medical Equipment, Trigeminal and Vagus Nerve Stimulator Devices, Noninvasive for nonimplantable devices.

Prior Authorization

Trial period and documented response required

Continuation of noninvasive device therapy should be contingent on documented symptom reduction within the initial treatment window; review at approximately 2–4 weeks for some cluster headache studies and at 3 months per NICE guidance for continued use.

Document early symptomatic response (example windows: 2–4 weeks in some CH studies; continue only if symptoms reduce within first 3 months).

Clinical Background & Evidence Summary

Vagus nerve stimulation (VNS) delivers electrical impulses to modulate brain activity via the vagus nerve. Implantable VNS consists of a surgically implanted pulse generator and leads targeting the cervical vagus nerve and has established use in epilepsy and investigational use in treatment‑resistant depression. Noninvasive approaches (transcutaneous VNS and external trigeminal nerve stimulation) apply surface electrodes to auricular, cervical, or trigeminal branches and are under study for headache, epilepsy, mood disorders, ADHD, and other conditions; evidence for noninvasive modalities is generally limited and indication‑specific.

inv-03: Evidence-based subgroup findings

Evidence-based subgroup findings and clinical background relevant to coverage decisions (duplicate context placement).

Episodic cluster headache (eCH): Randomized, sham‑controlled trials and a meta‑analysis show nVNS superior to sham for eCH in acute treatment and some prophylactic trials suggest adjunctive benefit; studies are limited but consistently favor benefit for eCH.

ACT1/ACT2 and PREVA findings summarized in policy evidence.

Chronic cluster headache (cCH): Trials and analyses did not show consistent benefit of nVNS for cCH; evidence insufficient to conclude efficacy.

Definitions & Terminology

Implantable VNS — definition & context

DefinitionSurgically implanted generator and leads that deliver electrical impulses to the cervical vagus nerve to modulate brain activity.

Primary historical useHistorically used as a treatment for epilepsy by delivering impulses via leads placed around the vagus nerve in the carotid sheath.

Mechanism notesMechanism unclear; proposed pathways include increased neurotransmitter release (norepinephrine, serotonin), increased cerebral blood flow to thalamus/cortex, and EEG alpha desynchronization.

Device model typesIncludes traditional open-loop VNS (on/off cycles with magnet for on-demand stimulation) and closed-loop/responsive VNS that triggers stimulation by physiologic signals (e.g., ictal heart rate increases).

Transcutaneous VNS (tVNS) — noninvasive auricular/cervical

Definition

Modalities & Level of Care

inv-48: VNS / tVNS / eTNS

Grouped modalities: implantable VNS and noninvasive modalities (nVNS, tVNS, eTNS) with modality-specific evidence considerations.

Implantable VNS modality: Implantable VNS involves a surgically implanted generator and leads that deliver electrical stimulation to the cervical vagus nerve; InterQual criteria apply for medical necessity in indications such as epilepsy and selected cases of treatment‑resistant depression.

Device approvals and product codes should be confirmed; prior authorization may be required.

Noninvasive VNS / TNS modalities: Noninvasive modalities (nVNS, transcutaneous VNS, and external TNS) are handheld or surface‑electrode devices cleared for specific acute headache indications (eg, gammaCore) but have limited evidence for other uses; initial requests are considered unproven for many indications and require documentation of trial response when used clinically.

Follow InterQual durable equipment criteria for authorization; document device model, stimulation parameters, headache subtype, and response metrics.

inv-49: Noninvasive VNS (nVNS, gammaCore, t-VNS)

Policy Updates & Change Log

2026-04-01reference_updateLatest

Updated related policy reference link to the current policy title for Transcranial Magnetic Stimulation for Treating Physical Health Conditions; archived previous policy version CS129OH.C.

2026-01-01administrative_update

Added operational language clarifying that benefit coverage is determined by federal, state (OAC), or contractual requirements, that medical records may be requested to assess clinical criteria and do not guarantee coverage, and specified required medical record documentation elements and availability upon request.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyVagus and External Trigeminal Nerve Stimulation (for Ohio Only)

Policy CodePolicy CS129OH.D

Change TypeClarified jurisdictional/ documentation expectationsupdated references

Effective DateJan 1, 2026

Next Review Date

SourceLink

On This Page

Prior Authorization

Confirm FDA clearance

Prior authorization reviews should confirm the specific device has the cited FDA marketing authorization by referencing the device's PMA/PMN/510(k) records or product code.

Search the FDA CDRH 510(k) or PMA databases by product or manufacturer name or use the product codes listed in the policy (e.g., LYJ, MUZ, QPY; PKR, QAK; PCC, QGL).

Documentation Required

Check Jurisdictional & Medical Necessity Criteria

Before applying this policy, verify federal, state (OAC), or contractual benefit requirements because those terms govern coverage and UnitedHealthcare may require InterQual or other approved criteria for medical necessity determinations.

If InterQual lacks applicable criteria, UnitedHealthcare may apply its Medical Policies, Coverage Determination Guidelines, or Utilization Review Guidelines approved by Ohio Medicaid.

Step Therapy

Step therapy context for VNS in TRD

Vagus nerve stimulation (including implantable VNS) is considered adjunctive for treatment‑resistant depression and generally reserved for patients after multiple prior treatment failures; document prior treatment history when requesting authorization.

Use of VNS in TRD should follow guideline and evidence context noting VNS as an option after several failed therapies.

Step Therapy

Prior pharmacotherapy documented

Prior authorization and utilization review require documentation of prior pharmacologic therapies tried and the reason they failed or were not tolerated.

Record prior medication names, doses, durations, and documented inadequate response or intolerance.

Step Therapy

Consider pharmacotherapy trial before neuromodulation

Consider a trial of appropriate pharmacotherapy before neuromodulation unless the patient has contraindications, cannot tolerate medications, or declines drug therapy; document clinical rationale.

Document patient preference, contraindications, or intolerance if pharmacologic therapy was not attempted.

Note

Use of InterQual / Utilization Criteria

UnitedHealthcare uses InterQual as the primary source for medical/surgical utilization criteria; if InterQual criteria are not applicable, other UnitedHealthcare guidelines may be used for utilization review.

Providers should follow applicable utilization review processes and reference InterQual when submitting requests.

Documentation Required

Required documentation

Patient medical records submitted for review must fully support medical necessity and include relevant medical history, physical examination, and results of pertinent diagnostic tests or procedures; records must be legible and available upon request.

Include prior treatment history, examination findings, and diagnostic test results that justify the requested device/service.

Documentation Required

Documentation of response and device details

Document early symptomatic response and device-specific details when continuing therapy: record response metrics within the initial trial window and device model, stimulation parameters, and headache subtype when applicable.

Document device model and stimulation settings, headache subtype (episodic vs chronic), and objective response measures (e.g., attack frequency reduction).
Record timing of observed response (e.g., within 2–12 weeks for cluster headache; review at 3 months per NICE).

Billing Rule

Device marketing clearance reference

When seeking device-specific regulatory information during authorization, reference FDA 510(k) or PMN/PMA marketing clearance records and associated product codes for the manufacturer and device.

Search the FDA CDRH 510(k) or PMA databases by product or manufacturer name and include the clearance reference in the submission.

Documentation Required

Medical Records Documentation Requirements

The patient's medical record must contain documentation that fully supports medical necessity for requested services, including relevant history, physical examination, and diagnostic test results; documentation must be legible and made available upon request.

Medical records may be requested to assess whether the member meets clinical criteria for coverage; provision of records does not guarantee coverage.

Denial Risk

Denial triggers for implantable VNS for listed indications

Requests for implantable vagus nerve stimulators for the policy's enumerated conditions (for example Alzheimer's disease, anxiety disorder, bipolar disorder, depression, migraines, and others) are listed as unproven and not medically necessary and may be denied.

The policy lists specific conditions considered unproven and not medically necessary for implantable VNS; authorization requests for these indications risk denial.

Denial Risk

Denial triggers for noninvasive devices

Initial requests for transcutaneous (non‑implantable) vagus nerve stimulation or external/transcutaneous trigeminal nerve stimulation devices for prevention or treatment of listed conditions are identified as unproven and not medically necessary and may be denied.

The policy explicitly lists transcutaneous VNS and external TNS as unproven for initial requests across indications including ADHD, depression, epilepsy, and headache.

Denial Risk

Insufficient evidence denial risk

Use of transcutaneous (non‑implantable) vagus nerve stimulation is not supported by sufficient evidence; claims may be denied when evidence is judged insufficient for the requested indication.

Larger, higher‑quality studies are needed to establish safety and efficacy for many noninvasive VNS indications.

Denial Risk

Insufficient evidence for non-headache indications

Use of VNS or TNS for many non–headache indications (e.g., atrial fibrillation, epilepsy beyond limited studies, depression, heart failure, tinnitus, impaired glucose tolerance, pain, schizophrenia) may be denied due to insufficient data and weak study designs.

The policy notes multiple investigated conditions with limited or inconclusive evidence; authorization requests for these indications carry denial risk.

Documentation Required

Documentation & Jurisdictional Requirements

Coverage and authorization decisions must reference and comply with federal, state (Ohio Administrative Code), or contractual benefit requirements; missing required documentation or failure to reference jurisdictional requirements may result in denial.

Before using this policy, check applicable federal, state (OAC), or contractual requirements; documentation may be requested to assess whether clinical criteria are met.

Subgroup analyses failed to demonstrate efficacy in cCH cohorts.

Migraine (episodic and chronic): Evidence is heterogeneous: some trials show benefit in subgroups (eg, aura, adherent subjects) and acute trials show abortive efficacy, but overall evidence is inconclusive for broad migraine populations due to sham activity, adherence issues, and underpowered studies.

PREMIUM, PRESTO, Tassorelli, Najib and systematic reviews provide mixed findings.

This policy excerpt includes administrative updates and clarified documentation expectations. Notable operational changes state that benefit coverage is determined by federal, state (Ohio Administrative Code), or contractual requirements; medical records may be requested to assess whether a member meets clinical criteria; and the policy's Description of Services, Clinical Evidence, and References sections have been updated with current supporting information.

Noninvasive delivery of electrical impulses via surface electrodes targeting auricular (ear) or cervical (neck) branches of the vagus nerve.

Example devicegammaCore (ElectroCore, LLC) — a handheld, noninvasive prescription device used for acute treatment of pain associated with episodic cluster headache.

Clinical explorationtVNS is being explored for treatment‑resistant depression, epilepsy, chronic pain, migraine, tinnitus, insomnia, inflammatory disorders, and cognitive/social functioning improvements.

Regulatory noteFDA product codes for transcutaneous VNS devices are cited in the policy (see product codes PKR, QAK for more information).

External Trigeminal Nerve Stimulation (TNS) — description

DefinitionNoninvasive stimulation delivered to trigeminal nerve branches, commonly via stimulating electrodes applied to the forehead (supraorbital/infraorbital regions).

Development examplesDevices under development or in clinical use include the Monarch eTNS system (development for ADHD, epilepsy, depression) and Cefaly (for headache by supraorbital/infraorbital stimulation).

Evidence summarySystematic reviews find low‑quality evidence that eTNS can reduce migraine pain and improve quality of life compared with sham, but optimal protocols and long‑term effects remain uncertain.

Episodic vs chronic cluster headache — definitions & evidence relevance

Episodic vs Chronic — clinical distinctionEpisodic cluster headache (eCH) and chronic cluster headache (cCH) are separate subtypes analyzed in trials; eCH typically refers to cluster periods with remission intervals, while cCH is continuous without remission.

Relevance to evidenceRandomized, sham‑controlled trials and meta‑analysis show nVNS (gammaCore) is superior to sham for acute treatment in episodic cluster headache but not in chronic cluster headache.

Implication for coveragePositive trial signals for eCH support considering an initial trial period with documented response; lack of consistent benefit in cCH means evidence is insufficient for routine use in chronic cases.

eTNS / TNS — device examples (Cefaly, Monarch)

Examples of eTNS/TNS devicesCefaly — supraorbital/infraorbital stimulation device evaluated for migraine prevention and acute treatment.

Other device examplesMonarch eTNS system (development) — being evaluated for ADHD, epilepsy, and depression.

Evidence noteSystematic reviews report low‑quality but positive signals for pain reduction and reduced migraine days versus sham; larger, higher‑quality trials are needed to confirm benefits and protocols.

nVNS — noninvasive vagus nerve stimulation (gammaCore) & indications

DefinitionNoninvasive vagus nerve stimulation (nVNS) delivers transcutaneous stimulation to vagus nerve branches without surgical implantation.

Representative productgammaCore (ElectroCore, LLC) — handheld nVNS device cleared for acute treatment of episodic cluster headache and evaluated for migraine indications.

Cleared indications & guidanceGuidance (e.g., AHS, NICE) and FDA clearances note gammaCore for certain headache indications; some authorities recommend continuing treatment only if symptoms reduce within an initial trial (e.g., 3 months).

nVNS / e‑TNS — grouping and device-class note

Grouping of noninvasive approachesNoninvasive neuromodulation includes nVNS (transcutaneous auricular/cervical), auricular tVNS, and external trigeminal nerve stimulation (eTNS); these are distinct device classes with overlapping but separate mechanisms.

Regulatory & evidence distinctionsDevices have different FDA product codes and clearances; evidence quality and indication support vary by modality and by specific device (device‑specific evidence should guide use).

Clinical implicationPolicy treats nVNS and e‑TNS as separate noninvasive modalities — some positive RCT signals exist for episodic cluster headache and select migraine subgroups, but overall evidence is limited for many other indications.

Noninvasive vagus nerve stimulation (nVNS) — evidence and operational expectations.

nVNS (gammaCore) clinical notes: nVNS (eg, gammaCore) is FDA‑cleared for acute treatment of episodic cluster headache and for certain migraine indications; RCTs show efficacy for acute eCH and mixed/pre‑specified subgroup benefits for migraine. Continued use should be based on documented early symptomatic response (commonly within weeks to 3 months).Documented response within initial trial (eg, 2–12 weeks) for continuation

Document adherence, attack frequency, device model, and response in medical record; sham device activity and adherence caveats noted in trials.

inv-50: VNS (implantable and transcutaneous)

Vagus nerve stimulation (implantable and transcutaneous) — clinical context and TRD considerations.

Implantable VNS for epilepsy: Implantable VNS is an established treatment for epilepsy; medical necessity criteria and surgical procedure coverage decisions should follow InterQual CP: Vagus Nerve Stimulation.

Device codes and FDA approvals should be confirmed during authorization.

VNS for treatment‑resistant depression (TRD): Implantable VNS has long‑term registry and randomized trial data with mixed results; it is considered an adjunctive option for severe TRD after multiple prior treatment failures and where registry/long‑term evidence supports benefit. Noninvasive modalities have limited evidence in TRD.Document prior adequate trials of pharmacotherapy and other standard therapies per InterQual/guidelines

Document reasons for considering neuromodulation, prior therapies, and response history.

inv-51: TNS / eTNS

Transcutaneous/external trigeminal nerve stimulation (TNS/eTNS) — pediatric ADHD, migraine evidence, and limitations.

eTNS for migraine: Systematic reviews and RCTs indicate eTNS may reduce migraine frequency and improve pain compared with sham in some trials, but the quality of evidence is low and maintenance of benefit and optimal protocols remain uncertain.

NICE and ECRI assessments highlight low‑quality evidence and the need for larger comparative studies.

TNS for ADHD (pediatric): A randomized sham‑controlled trial in children 8–12 years showed some efficacy for nightly TNS treatment, but the American Academy of Pediatrics does not recommend eTNS for ADHD because the evidence is sparse and insufficient compared with established treatments.

Further research needed before routine coverage; consider as investigational in pediatric ADHD.