ModifiedUnitedHealthcarePolicy CS129OH.C

Vagus and External Trigeminal Nerve Stimulation (for Ohio Only)

This UnitedHealthcare medical policy governs coverage and medical necessity determinations for implantable and noninvasive vagus nerve stimulation (VNS) and external/transcutaneous trigeminal nerve stimulation (TNS) for members in Ohio.

Policy Summary

PayerUnitedHealthcare

PolicyVagus and External Trigeminal Nerve Stimulation (for Ohio Only)

Policy CodePolicy CS129OH.C

Change TypeOperational and clarifying editsexamples removed

Effective Date04/01/2025

Next Review Date

Key ActionSubmit prior authorization with device FDA clearance details and supporting clinical evidence; InterQual will be used for medical necessity review per Ohio requirements.

SourceLink

POLICY UPDATE CHANGES

Replaced specific example device wording (e.g., gammaCore) with a broader reference to transcutaneous (non-implantable) vagus nerve stimulation devices.

Added language clarifying listed devices are unproven and not medically necessary for initial requests due to insufficient evidence of efficacy.

Removed list of examples of external or transcutaneous (non-implantable) trigeminal nerve stimulation devices.

Revised description for CPT code 64568.

Ohio-onlystate applicability

Several indicationsunproven/not medically necessary

episodic benefitcluster headache evidence

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CPT/HCPCS/Lcodes listed

Coverage Criteria and Policy Positions

inv-04: Cluster headache

Treatment-resistant depression

paragraphs':['Evidence summaries (e.g., Aaronson 2017 registry, systematic reviews) show some long-term benefit signals for adjunctive implanted VNS in very severe, treatment-resistant populations, but randomized controlled trial data are limited and biased by study design limitations. Therefore, implantable VNS may be considered only when all above documentation and prior authorization criteria are satisfied and when InterQual (if applicable) supports medical necessity.'],'title':'inv-03: Treatment-resistant depression','type':'criteria_group','variant':''},{

Denial Risk

inv-32: Denial risk for unproven indications

Providers should be aware that requests for devices or indications designated as unproven are at substantial risk of denial when submitted without supporting evidence that meets the policy’s documentation and prior authorization requirements.

Denial is likely for initial requests for implantable VNS or noninvasive devices when used for conditions listed as unproven/not medically necessary.
Provide full documentation per prior authorization guidance to reduce risk of denial; absence of regulatory clearance for an intended indication increases denial likelihood.

Procedure, Device, and Billing Codes

Procedure 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	generator.
64570	Removal of cranial nerve (e.g., vagus nerve) neurostimulator electrode array and pulse generator

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

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

Applicable CPT CodesCPT

64568

Revised description of services (CPT code referenced in Summary of Changes).

Documentation Required

Include applicable CPT/HCPCS/L-codes on claims

Claims and prior authorization requests should include the applicable CPT, HCPCS, or L-codes referenced in this policy; the listing of codes is for reference and does not guarantee coverage or payment.

Prior Authorization, Documentation, and Denial Risk

Prior Authorization

Ohio prior authorization and InterQual use

Prior authorization/medical necessity review is required for members in Ohio; implantable and noninvasive VNS/TNS requests will be evaluated using InterQual criteria where referenced.

Prior Authorization

PA guidance for noninvasive devices in migraine/cluster headache

Prior authorization is likely required for noninvasive vagus nerve stimulation used for migraine or cluster headache; requests should document the indication subtype (episodic vs chronic), trial data, and adherence.

Specify episodic vs chronic cluster or migraine subtype
Provide treatment trial details and adherence information

Prior Authorization

Document device clearance and evidence (PCC, QGL)

Background, Definitions, and Evidence Context

Vagus nerve stimulation (VNS) involves surgical placement of a pulse generator and leads to stimulate the cervical vagus nerve and modulate brain activity. Noninvasive approaches (transcutaneous or external) deliver stimulation through the skin to vagal or trigeminal branches without implantation.

Implantable VNS: definition

DefinitionVagus nerve stimulation involving surgical placement of a generator and leads to the cervical vagus nerve.

Typical useImplantable VNS is used to deliver electrical impulses to the cervical vagus nerve to modulate brain activity for indications such as epilepsy; mechanism includes implanted pulse generator and stimulating leads.

Device typeImplanted pulse generator with leads surgically placed around the vagus nerve in the carotid sheath.

Transcutaneous/non-implantable VNS (nVNS/t-VNS): definition

Definition

Policy Changes and Revision Notes

2025-04-01policy_revisionLatest

Revised coverage rationale to clarify that transcutaneous (non-implantable) vagus nerve stimulation devices and external/transcutaneous trigeminal nerve stimulation devices are unproven and not medically necessary for initial requests due to insufficient evidence; removed named example devices and deleted lists of external/transcutaneous trigeminal device examples.

Policy Summary

PayerUnitedHealthcare

PolicyVagus and External Trigeminal Nerve Stimulation (for Ohio Only)

Policy CodePolicy CS129OH.C

Change TypeOperational and clarifying editsexamples removed

Effective Date04/01/2025

Next Review Date

Key ActionSubmit prior authorization with device FDA clearance details and supporting clinical evidence; InterQual will be used for medical necessity review per Ohio requirements.

SourceLink

On This Page

Include device FDA clearance details and product codes (e.g., PCC, QGL) and supporting clinical evidence with prior authorization submissions when device efficacy is uncertain.

Prior Authorization

Prior authorization and CPT 64568 description

Prior authorization requirements follow UnitedHealthcare standard benefit plan processes and state/contractual rules; note that the description for CPT code 64568 was revised in this policy update.

Follow applicable state/contractual prior authorization procedures
Be aware CPT 64568 description was updated in this revision

Step Therapy

Prior medication trial expectation

When requesting device therapy, document prior medication trials; clinical guidance indicates neuromodulation may be considered for patients who prefer nondrug therapy or who have failed/intolerant to pharmacotherapy.

List prior pharmacologic therapies tried and reasons for discontinuation or intolerance

Note

Step therapy — informational

No explicit step therapy rules are provided in this policy; consider standard therapeutic options before pursuing modalities considered investigational or of insufficient evidence.

Note

Use of InterQual criteria

UnitedHealthcare uses InterQual for primary medical/surgical criteria and may use other UnitedHealthcare policies or guidelines when InterQual does not have applicable criteria.

Documentation Required

Governance and documentation expectations (NICE)

If devices are used under special arrangements, documentation of clinical governance, informed consent, and audit or research arrangements is expected consistent with NICE recommendations.

Provide evidence of clinical governance or audit arrangements when applicable
Include documentation of informed consent if used under research or special arrangements

Documentation Required

Device model and clearance documentation

When submitting records, document the device model and FDA clearance status (product codes PCC, QGL) for external/transcutaneous trigeminal and vagus nerve stimulation devices.

Documentation Required

Reference legal and contractual requirements

Refer to and document compliance with applicable federal, state (Ohio Administrative Code), or contractual benefit plan requirements when requesting coverage; those requirements govern in the event of conflict.

Denial Risk

Denial triggers — insufficient evidence for intended use

Requests for transcutaneous vagus nerve stimulation or external/transcutaneous trigeminal nerve stimulation may be denied when proposed for indications where the evidence is insufficient to establish safety and efficacy (including many headache subtypes and other investigated conditions).

Denial Risk

Evidence insufficiency triggers coverage risk

Coverage may be denied or considered not supported when relying on eTNS owing to insufficient or low‑quality evidence for efficacy and unclear long-term outcomes.

Denial Risk

Denial risk for initial requests for listed noninvasive devices

Initial requests for listed noninvasive trigeminal and vagus nerve stimulation devices may be denied as unproven and not medically necessary due to insufficient evidence of efficacy.

Billing Rule

Coding documentation — include referenced codes

Claims should list the applicable CPT, HCPCS, or L-codes referenced in this policy; inclusion is for reference and does not guarantee coverage or payment.

Noninvasive handheld or surface devices that deliver stimulation to the vagus nerve without implantation (transcutaneous or nVNS/t‑VNS).

Policy languagePolicy references these as transcutaneous (non‑implantable) vagus nerve stimulation devices and indicates they are unproven and not medically necessary for initial requests due to insufficient evidence of efficacy.

Example device (historical)gammaCore was previously cited as an example of a noninvasive handheld device, but example device names were removed and wording was generalized in the 04/01/2025 revision.

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

DefinitionNoninvasive stimulation applied to branches of the trigeminal nerve via stimulating electrodes on the skin of the forehead (external/transcutaneous TNS/eTNS).

Clinical contextseTNS devices (e.g., Cefaly, Monarch historically) are investigated for headache prevention, ADHD, epilepsy, and depression; current evidence is insufficient to establish safety and efficacy for most indications.

Delivery methodExternal electrodes placed on the supraorbital/infraorbital regions to stimulate trigeminal nerve branches transcutaneously.

nVNS / transcutaneous vagus nerve stimulation: definition

DefinitionNon‑implantable devices that stimulate the cervical or auricular branches of the vagus nerve through the skin for acute or preventive treatment (nVNS/transcutaneous VNS).

Evidence/policy stanceUnitedHealthcare policy states transcutaneous (non‑implantable) vagus nerve stimulation devices are considered unproven and not medically necessary for initial requests due to insufficient evidence; larger studies are needed to establish safety, efficacy, and long‑term outcomes.

Clinical investigationnVNS has been investigated for pain, epilepsy, tinnitus, depression, and headaches; historically gammaCore was an example but policy now uses generalized device language.

eTNS / external trigeminal nerve stimulation: definition

DefinitionNon‑implantable external stimulation of trigeminal nerve branches delivered transcutaneously for indications such as migraine prevention and other neurologic or psychiatric conditions.

Evidence/policy stancePolicy notes insufficient evidence to support eTNS for many indications and lists external/transcutaneous trigeminal nerve stimulation as unproven; larger, higher‑quality trials are needed.

DeliveryApplied via external/transcutaneous device to the supraorbital (forehead) area to stimulate trigeminal branches.

External/Transcutaneous Trigeminal Nerve Stimulation (eTNS/TNS): definition

DefinitionA noninvasive neuromodulation approach applying electrical stimulation to the trigeminal (supraorbital) nerve via an external/transcutaneous device to treat headaches, epilepsy, and other neuropsychiatric conditions.

Evidence summarySystematic reviews and RCTs exist but overall quality is low; ECRI and other reviews find potential symptom improvement but note uncertainty about durability and optimal protocols.

Typical indication areasInvestigated for migraine (prevention and acute treatment), focal drug‑resistant epilepsy, depression, and ADHD, but evidence is limited.

Noninvasive/transcutaneous vagus nerve stimulation devices (generalized policy language)

DefinitionExternal, non‑implantable devices that deliver electrical stimulation to the vagus nerve through the skin (transcutaneous/noninvasive VNS devices).

Policy status (most actionable)UnitedHealthcare lists noninvasive/transcutaneous vagus nerve stimulation devices as unproven and not medically necessary for initial requests due to insufficient evidence of efficacy (policy revision effective 04/01/2025).

Regulatory/context noteDevice example names were removed from the policy and device categories were generalized; FDA clearances may exist but do not imply coverage.