ModifiedUnitedHealthcarePolicy CS129NJ.Q

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

Medical policy governing coverage and medical necessity criteria for implantable vagus nerve stimulators and noninvasive vagus and external trigeminal nerve stimulation devices for members in New Jersey.

Policy Summary

PayerUnitedHealthcare

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

Policy CodePolicy CS129NJ.Q

Change TypeDocumentation clarifications and content updates

Effective DateJan 1, 2026

Next Review Date

Key ActionProvide complete, legible medical record documentation (history, exam, diagnostic results, baseline diaries and prior therapy trials) when requesting prior authorization to demonstrate medical necessity.

SourceLink

POLICY UPDATE CHANGES

Updated medical records documentation language clarifying that documentation may be required to assess clinical criteria and does not guarantee coverage.

Updated Related Policies link/title for Transcranial Magnetic Stimulation for Treating Physical Health Conditions (for New Jersey Only).

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

NJPolicy application state

NJApplicable state

5CPT codes listed

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

HCPCS/DME codes listed

mixedEvidence stance

Coverage Criteria and Indications

Coverage Criteria (Summary)

Covered when ALL of the following are met:

ALL of the following

Implantable vagus nerve stimulation (VNS) is being requested for treatment of drug-resistant epilepsy (DRE), defined as persistent seizures after adequate trials of two or more antiseizure medications (single-agent or combination) at therapeutic doses;
The individual is not a candidate for resective epilepsy surgery, has failed epilepsy surgery, or has undergone a documented Shared Decision Making discussion and refuses epilepsy surgery;
There is no history of left or bilateral cervical vagotomy (an FDA-identified contraindication to VNS);
Device implantation and programming will be performed by qualified providers and documentation of prior antiseizure medication trials, seizure frequency, and prior surgical evaluations is available in the medical record.

Applicable Procedure, HCPCS and Device 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 / DME / 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.

1–10 of 13

1/2

Implantable VNS device product codesmixed

LYJ	FDA product code referenced for implantable VNS devices
MUZ	FDA product code referenced for implantable VNS devices
QPY	FDA product code referenced for implantable VNS devices

Transcutaneous VNS device product codesmixed

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 codesmixed

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

Coding referenced in policy (none in this excerpt)mixed

N/A	No explicit CPT/HCPCS/ICD-10 codes present in this document excerpt.

inv-25: Medication trials — Failure of two or more trials of single or combination antiepileptic drug therapy

Medication trials requiredFailure of two or more trials of single or combination antiepileptic drug therapy

Alternative to surgeryNot a candidate for epilepsy surgery, has failed epilepsy surgery, or refuses surgery after Shared Decision Making discussion

Contraindication checkNo history of left or bilateral cervical vagotomy (FDA‑identified contraindication)

inv-26: adherence threshold used in post hoc analysis (operational detail)

Adherence threshold (post hoc)>= 67% adherence per month (used in post hoc analysis showing greater therapeutic effect)

Prior Authorization, Documentation, and Clinical Workflow

Prior Authorization

Prior authorization and coding reference

Prior authorization may be required for services billed with the procedure and HCPCS/DME codes listed in this policy. Benefit coverage is determined by federal, state, or contractual requirements and applicable laws; prior authorization does not guarantee payment.

Codes listed in the policy may trigger prior authorization review
In some cases, medical record documentation must be submitted to support the request

Prior Authorization

Prior authorization and required documentation for less‑established indications

Prior authorization and medical review will be performed when devices or indications lack robust evidence of efficacy (for example, transcutaneous VNS or eTNS used for unapproved indications). Use for indications with insufficient evidence may result in denial.

Claims for transcutaneous (non‑implantable) VNS for indications without strong evidence are at risk for denial
eTNS for ADHD is not recommended per AAP guidance and may be non‑covered

Background and Rationale

Background: Vagus nerve stimulation (VNS) delivers electrical impulses to the brain via the vagus nerve and is used clinically in both implantable and noninvasive forms. Implantable VNS devices have FDA clearance and established use for drug‑resistant epilepsy, whereas noninvasive/transcutaneous VNS (tVNS/nVNS) and external trigeminal nerve stimulation (eTNS/TNS) are investigational or have limited approvals for specific headache indications; the policy’s coverage positions reflect differences in the strength and quality of evidence across indications.

Definitions and Device Terminology

inv-50: Shared Decision Making — definition

DefinitionShared Decision Making is a collaborative process where a provider/clinician and a patient (including caregivers and family) work together to make healthcare decisions considering evidence, clinician experience, and the patient's values, goals, preferences, and circumstances (AHRQ).

ScopeIncludes comparing benefits, harms, and risks of each option and discussing what matters most to the patient

DocumentationDocumentation of Shared Decision Making with the patient/family is recommended prior to proceeding with VNS

inv-51: Transcutaneous (Non-Implantable) Vagus Nerve Stimulation (nVNS) — definition and evidence note

DefinitionTranscutaneous (non-implantable) vagus nerve stimulation (nVNS) is a non‑implantable method of stimulating the vagus nerve through the skin (e.g., cervical applications like gammaCore) used for acute or preventive treatment in headache disorders and investigational for other indications.

Policy Revision History and Changes

Revision note: coding lists and device product codes referenced in this policy were reviewed and updated as part of the 03/01/2026 policy revision; providers should reference the policy coding section and device‑specific FDA clearance information when preparing prior‑authorization documentation.

Policy Summary

PayerUnitedHealthcare

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

Policy CodePolicy CS129NJ.Q

Change TypeDocumentation clarifications and content updates

Effective DateJan 1, 2026

Next Review Date

SourceLink

On This Page

Adherence contextPost hoc subgroup analysis restricted to participants meeting the monthly adherence threshold demonstrated significant benefit versus sham

Documentation implicationDocument adherence to prescribed stimulation regimen when assessing effectiveness

inv-27: time-to-assess continued benefit — 3 months

Time-to-assess continued benefitReassess clinical response at approximately 3 months; continue only if symptoms reduce in the first 3 months (NICE recommendation)

Objective follow-up3-month reassessment consistent with trial follow-up intervals used to determine ongoing therapy

Evidence basisNICE guidance and trial protocols recommend short-term response assessment to guide continuation

inv-28: None specified in excerpt (placeholder)

No additional thresholds specifiedNone specified in this excerpt

Policy noteRefer to full policy for any other operational thresholds not present in this excerpt

DocumentationMedical records required to substantiate any applied thresholds or continuation decisions

Documentation Required

Clinical baseline and follow‑up required

Document baseline clinical status and follow‑up plans in the medical record. Reviewers expect evidence of prior conservative therapy trials, explicit baseline measures, and planned timing and metrics for follow‑up assessments.

For migraine: include a baseline headache/migraine diary (run‑in) and specify adherence monitoring and planned assessment intervals
For epilepsy: document failure of antiseizure medication trials and rationale for VNS candidacy (see therapy sequencing)
Include a treatment plan that defines how response will be measured and the timing of reassessment

Documentation Required

Medical record requirements

Medical records must contain documentation that fully supports medical necessity. This includes relevant medical history, physical examination findings, diagnostic test results, prior therapies (including dates, doses, and responses), and documentation of shared decision‑making where applicable.

Maintain legible documentation in the patient record and make it available upon request
Document prior therapies with dates, durations, response, and adverse effects
For epilepsy, document that the member is not a candidate for resective surgery, has failed surgery, or refused surgery after shared decision‑making discussion

Documentation Required

Device clearance documentation

Device marketing clearance or approval information may be requested. Provide FDA clearance/PMA/510(k)/PMN identification for the specific device when applicable.

For implantable devices: cite PMA product codes (e.g., LYJ, MUZ, QPY) or PMA reference
For transcutaneous/non‑implantable devices: cite PMN/510(k) numbers or product codes (e.g., PKR, QAK, PCC, QGL)

Denial Risk

Documentation insufficiency and denial risk

Insufficient or missing documentation that supports medical necessity may result in denial of the requested service. coverage determinations require adequate clinical evidence in the record.

Failure to provide prior therapy details, baseline assessments (e.g., headache diary), or device clearance information may lead to claim denial
Use of transcutaneous VNS or eTNS for indications lacking sufficient evidence is particularly vulnerable to denial

Note

Governance and research requirements (NICE)

NICE recommends that certain transcutaneous neurostimulation procedures be used only with special arrangements for clinical governance, consent, audit, or research. For prevention indications where evidence is inadequate, use in the context of research is advised.

Transcutaneous supraorbital stimulation for migraine prevention: only in research or with special governance arrangements
Transcutaneous therapies with limited evidence should follow documented governance, consent, and audit processes

Documentation Required

Response‑based continuation and reassessment

Continued therapy should be contingent on documented treatment response. Lack of improvement within recommended evaluation periods may warrant discontinuation and may affect continued coverage.

For therapies like gammaCore in cluster headache, continue only if symptoms reduce within the first 3 months
Document objective measures of response and plan for discontinuation if ineffective

Step Therapy

Therapy sequencing and step‑therapy context for epilepsy

Sequence neuromodulation appropriately relative to pharmacotherapy and other established treatments. For implantable VNS in epilepsy, document failure of two or more trials of single or combination antiepileptic drug therapy (or intolerable side effects) prior to implant consideration. VNS is typically considered after multiple antiseizure medication trials and when surgery is not an option or is declined after shared decision‑making.

Implantable VNS: document ≥2 adequate antiseizure medication trials (or intolerance) before VNS
Document that the member is not a candidate for, has failed, or declined resective surgery after shared decision‑making

Documentation Required

Positioning relative to pharmacotherapy and shared decision‑making

Position neuromodulation relative to pharmacotherapy per guideline recommendations: neuromodulation may be appropriate for individuals who prefer nondrug options or who have contraindications, intolerance, or inadequate response to pharmacologic therapy. Discuss and document shared decision‑making about risks, benefits, and alternatives.

Document the counseling discussion and patient preference when choosing neuromodulation over pharmacotherapy
Include rationale if neuromodulation is selected due to contraindication or intolerance to drugs

Note

Preferred established therapies for ADHD

For pediatric ADHD, established guidelines do not recommend eTNS as a substitute for standard therapies. Prefer and document evidence‑based medication and behavioral treatments when applicable.

eTNS is not recommended for ADHD per the American Academy of Pediatrics
Document use of established medication and behavioral treatments and rationale if considering neuromodulation

Denial Risk

Documentation‑related denials

Failure to provide requested medical records or required supporting documentation may result in denial of the service request. Ensure timely submission of all requested documentation to avoid adverse coverage decisions.

Submit complete, legible records including prior therapy details, baseline assessments (e.g., run‑in headache diary), device clearance information, and shared decision‑making notes when applicable
Requests lacking documentation are at higher risk for denial

Evidence noteCurrent evidence is insufficient for many indications due to study limitations; some trials show benefit in specific subgroups (e.g., episodic cluster headache, acute episodic migraine) while prevention trials had mixed ITT results with benefit in adherent subgroups

SafetyDevice-related adverse events in trials were generally mild and transient (most commonly application site discomfort)

inv-52: Episodic vs Chronic Cluster Headache — eCH vs cCH distinction

DistinctionEpisodic cluster headache (eCH) and chronic cluster headache (cCH) are separate subtypes; randomized trials (ACT1, ACT2) showed nVNS was superior to sham in episodic but not in chronic cluster headache

Clinical implicationnVNS may be considered for acute treatment of episodic CH based on RCT evidence; effectiveness not demonstrated for chronic CH

Evidence limitationsLong-term outcomes and broader applicability require further study

inv-53: nVNS — noninvasive vagus nerve stimulation (gammaCore) definition

DefinitionnVNS refers to noninvasive vagus nerve stimulation devices (e.g., gammaCore) applied to the cervical vagus for acute or preventive migraine and cluster headache treatment, typically delivered as 120‑second stimulations per protocol.

Trial usageStudies used bilateral 120‑second stimulations multiple times per day for prevention protocols and targeted applications for acute attacks in abortive trials

LimitationsSham devices in some trials provided inadvertent vagal stimulation and adherence issues affected outcomes in prevention trials

inv-54: eTNS / TNS — external or transcutaneous trigeminal nerve stimulation definition

DefinitioneTNS/TNS is external or transcutaneous trigeminal nerve stimulation (e.g., Cefaly) applied to the supraorbital/trigeminal sensory area for acute or preventive treatment of migraine and investigational uses in other disorders.

Evidence summaryRandomized sham‑controlled trials and systematic reviews report pain reduction for acute migraine and modest preventive effects, but overall evidence quality is low and longer-term effects are uncertain

SafetyNo serious adverse events reported in key trials; most adverse events were minor

inv-55: eTNS / external trigeminal nerve stimulation — Cefaly device and use cases

Device exampleCefaly device is an external trigeminal nerve stimulation (eTNS) system used for acute and preventive migraine treatment in trials (e.g., Chou 2019, systematic reviews)

Use casesShown to provide significant headache pain relief in acute migraine trials and modest reductions in migraine days in preventive studies; evidence quality is low

Research implicationFurther high‑quality comparative studies with larger samples and standardized outcomes are needed to define long‑term benefits

inv-56: tVNS / transcutaneous vagus nerve stimulation — product code references and definition

DefinitiontVNS (transcutaneous vagus nerve stimulation) denotes nonimplantable transcutaneous stimulation of the vagus nerve using FDA‑cleared devices (product codes PKR and QAK).

Regulatory noteFDA product codes PKR and QAK referenced for marketed transcutaneous VNS devices; consult FDA 510(k)/PMN databases for device‑specific clearance details

Indications reviewedDevices have been evaluated across indications including migraine, cluster headache, depression, and cardiac conditions, but evidence strength varies by indication

inv-57: Implantable VNS — surgically implanted systems (product codes LYJ, MUZ, QPY)

DefinitionImplantable VNS refers to surgically implanted vagus nerve stimulation systems approved by the FDA for indications such as epilepsy and treatment‑resistant depression (product codes LYJ, MUZ, QPY).

Regulatory referenceFDA product codes LYJ, MUZ, and QPY referenced for implantable VNS devices; see FDA PMA/510(k) databases for device‑specific approvals

Clinical positioningImplantable VNS is supported by evidence and considered medically necessary for drug‑resistant epilepsy meeting specified criteria

inv-58: Shared Decision Making — updated definition in this revision

Updated definitionShared Decision Making (updated): a collaborative process in which provider and patient (and caregivers as appropriate) jointly make healthcare decisions considering evidence, clinician experience, and patient values, goals, and preferences; policy revision clarifies and updates this definition.

Policy implicationDocument Shared Decision Making discussions (benefits, risks, alternatives) before proceeding with VNS to support medical necessity determinations

ReferenceDefinition aligned with AHRQ description and noted as updated in the policy revision history