ModifiedUnitedHealthcarePolicy CS129NM.C

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

This policy governs coverage and medical necessity determinations for implantable vagus nerve stimulators and non‑implant/transcutaneous vagus and external 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 TypeDocumentation and definition updates

Effective DateDec 1, 2025

Next Review Date

Key ActionSubmit prior authorization with medical records demonstrating required trials, device identity and FDA clearance, baseline/run-in documentation, and shared decision-making when applicable.

SourceLink

POLICY UPDATE CHANGES

Updated Medical Records Documentation section to clarify that benefit coverage is determined by federal, state, or contractual requirements and that medical records may be required to assess clinical criteria but do not guarantee coverage.

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

Updated definitions (including 'Shared Decision Making') and supporting information (Description of Services, Clinical Evidence, References).

New Mexicoapplies only to

coveredimplantable VNS

not coveredtranscutaneous/external VNS & TNS

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.

3documentation examples

493TRD trial subjects

Coverage and Medical Necessity Criteria

Implantable Vagus Nerve Stimulator — Medical Necessity

Covered when ALL of the following are met

Implantable VNS for epilepsy coverage: 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; AND the individual is not a candidate for epilepsy surgery, has failed epilepsy surgery, or refuses epilepsy surgery after Shared Decision Making discussion; AND no history of left or bilateral cervical vagotomy (FDA-identified contraindication).

Transcutaneous VNS and External TNS — Not Medically Necessary

Not medically necessary / unproven for all indications

Non-implantable VNS and external TNS: Transcutaneous (non-implantable) vagus nerve stimulation devices and external/transcutaneous trigeminal nerve stimulation devices are considered unproven and not medically necessary for preventing or treating all indications due to insufficient evidence of efficacy.

Examples of conditions include ADHD, depression, epilepsy, headache, migraine, and others listed in the policy.

Covered with criteria — Epilepsy and TRD

Covered when criteria and clinical context align with guideline and evidence recommendations

VNS for drug-resistant epilepsy: Patient has drug-resistant epilepsy (seizures not adequately controlled after trials of multiple antiseizure medications) AND resective epilepsy surgery is not a viable option or patient declines surgery AND shared decision-making discussing benefits and risks has occurredN/A

Based on NICE recommendation and Epilepsy Society statement

Implantable VNS for treatment-resistant depression (TRD): Patient meets criteria for treatment-resistant depression (multiple failed treatments) AND clinician documents consideration of evidence limitations AND special arrangements for clinical governance, consent, and audit or research are in placeN/A

Reflects NICE and AHRQ guidance and registry/RCT evidence noting limited quality and need for further research

Mixed/insufficient evidence — nVNS for cluster headache

Coverage for noninvasive/transcutaneous VNS and cluster headache use is mixed and depends on evidence strength

nVNS for episodic cluster headache (eCH): Randomized sham-controlled trials and systematic reviews report superiority of nVNS versus sham for episodic cluster headache endpoints (e.g., pain relief within 15 minutes; sustained response), supporting potential benefit for eCH.N/A

ACT1/ACT2 and Silberstein et al. show benefit in eCH

nVNS for chronic cluster headache (cCH): Randomized trials and meta-analyses do not consistently show benefit for chronic cluster headache; evidence insufficient for routine coverage of cCH.N/A

Several trials and meta-analyses found no significant cCH benefit

Investigational/Unproven indications

Not covered or considered investigational when evidence is lacking

Other conditions: Use of VNS (implantable or noninvasive) for other indications such as Alzheimer's disease, anxiety, autism spectrum disorder, obsessive-compulsive disorder, chronic pain, heart failure, asthma, fibromyalgia, sleep disorders, stroke motor recovery, autoimmune and musculoskeletal disorders, and other psychiatric disorders is considered investigational/unproven due to limited and low-quality evidence.N/A

Further trials required before routine coverage

Coverage consideration groups

Coverage considerations informed by available evidence and guideline statements

Episodic cluster headache (eCH): nVNS demonstrated significantly higher response rates versus sham in episodic cluster headache in randomized trial data; consider coverage for acute treatment of eCH when diagnosis and prior standard therapy trials are documented.

Supported by Silberstein et al. and NICE recommendations

Episodic migraine — acute treatment: Randomized trials (e.g., Tassorelli et al.) showed nVNS superior to sham for pain freedom at 30 and 60 minutes in episodic migraine; consider coverage for acute use with documentation of migraine diagnosis and prior acute therapy history.

Tassorelli et al. demonstrated acute efficacy at 30 and 60 minutes

Migraine prevention — select subgroups: Preventive nVNS trials (PREMIUM, etc.) did not meet primary endpoints in ITT populations but post hoc and adherent-subgroup analyses showed benefit; consider preventive coverage only for selected patients meeting documented adherence and subgroup criteria.Adherence >=67% per month; documented prior preventive treatment failures

Evidence-informed coverage considerations

Evidence summary and inferred coverage considerations from cited randomized trials and guideline statements

Indication-level evidence: Randomized sham-controlled trials show eTNS may provide acute migraine pain reduction and TNS shows efficacy signals in ADHD and short-term depression trials; however, effect sizes, long-term durability, and overall evidence quality vary and guideline bodies (AAP, NICE) caution or limit recommendations. Coverage decisions should reflect this mixed evidence base and favor indications and patient subgroups supported by higher-quality data.

See individual trial results and guideline statements in supporting references.

Use of transcutaneous (non‑implantable) vagus nerve stimulation (tVNS/nVNS) and external/transcutaneous trigeminal nerve stimulation (TNS/eTNS) devices is listed in this policy as unproven and not medically necessary for preventing or treating all indications because current studies are limited by small sample sizes, heterogeneous methods, and other design weaknesses. Examples of devices and noninvasive approaches are described in the policy and include handheld cervical/auricular stimulators (e.g., gammaCore) and supraorbital stimulators (e.g., Cefaly), but the insufficiency of high‑quality evidence precludes routine coverage for these non‑implantable therapies.

When considering requests for noninvasive VNS or TNS, prior authorization reviewers should expect documentation of the specific device used, the indication being treated, prior conventional therapies tried, and clinical rationale; however, meeting these documentation elements does not establish medical necessity where evidence is lacking.

Multiple other indications have been investigated with transcutaneous VNS or TNS but currently lack sufficient, consistent evidence to support coverage. These include, but are not limited to, atrial fibrillation, heart failure, epilepsy outside defined trials, depression, tinnitus, impaired glucose tolerance, sleep disorders, chronic pain, and various psychiatric and neurodevelopmental conditions. The policy notes that limited study numbers, small sample sizes, and weak study designs prevent concluding that these therapies are safe and effective for these conditions.

For such indications, the policy considers use investigational/unproven and states that further larger and higher‑quality clinical trials are required before routine coverage can be recommended.

External or transcutaneous trigeminal nerve stimulation (TNS/eTNS) is also considered unsupported by sufficient evidence for general use. The document summarizes systematic reviews and randomized studies with mixed results and emphasizes the need for larger, more rigorous trials to establish safety and efficacy across non‑headache indications.

Specific small randomized or phase II studies have reported preliminary signals in disorders such as depression and drug‑resistant epilepsy, but limitations in follow‑up duration, sample size, and study heterogeneity mean these findings do not yet justify routine coverage outside of research or special governance arrangements.

Professional guidance is referenced in the policy to frame coverage considerations. The National Institute for Health and Care Excellence (NICE) recommends adoption of certain noninvasive devices for cluster headache with special arrangements for clinical governance, consent, and audit or research, and requires continuation criteria (e.g., symptom reduction in an initial evaluation period).

The American Headache Society and other specialty statements are cited to support selective use of noninvasive stimulation (for example, as an option after failure or intolerance of pharmacotherapy), while other professional bodies provide cautionary stances where evidence is sparse.

Medical record documentation is required to support any request for VNS or TNS therapies. Records should include relevant medical history, physical examination findings, results of pertinent diagnostic tests or procedures, and documentation of prior therapies and shared decision‑making as applicable. Providing requested documentation does not guarantee coverage; benefit determination remains subject to federal, state, or contractual requirements.

Implantable vagus nerve stimulation is considered proven and medically necessary for medically refractory epilepsy when all coverage criteria are met (failure of two or more antiepileptic drug regimens, not a candidate for or refusal of resective epilepsy surgery after shared decision‑making, and no history of left or bilateral cervical vagotomy). For non‑epilepsy indications, the policy explicitly states that implantable VNS is unproven and not medically necessary due to insufficient evidence.

When implantable VNS is pursued for covered epilepsy indications, prior authorization should identify the specific implantable device and may reference FDA product codes or marketing authorizations as part of required device documentation.

The policy does not support routine coverage of transcutaneous (non‑implantable) vagus nerve stimulation for any indication. It states there is insufficient evidence to establish safety, efficacy, or long‑term outcomes, and that larger, well‑designed trials are needed before these therapies can be considered proven.

Examples and descriptions of transcutaneous devices (such as handheld cervical/auricular stimulators) are provided for context, but their availability or FDA clearance status does not by itself confer coverage where evidence is insufficient.

Use of transcutaneous VNS (nVNS) or eTNS beyond the specific headache indications studied—particularly for routine prevention or treatment across heterogeneous patient populations—is not broadly supported. Some randomized trials show benefit for acute migraine or select subgroups in preventive trials, but primary ITT endpoints were often not met and benefits were generally observed only in adherent participants or prespecified subgroups.

Therefore, preventive or off‑label use beyond studied migraine and episodic cluster headache indications should be considered experimental outside of research or defined continuation criteria; adherence documentation (e.g., ≥ 67% adherence per month in post hoc analyses) and baseline diary data were important factors in trials that demonstrated benefit.

Evidence is insufficient to support trigeminal nerve stimulation (TNS/eTNS) as an established therapy for drug‑resistant epilepsy; systematic reviews and guideline summaries note promising signals but call for larger comparative trials before routine adoption.

The American Academy of Pediatrics reviewed available TNS evidence in the context of ADHD and concluded that eTNS cannot be recommended as a treatment for ADHD because supporting evidence is sparse and does not approach the robust strength of evidence for established medication and behavioral therapies.

The provided policy extract does not list any additional explicit statements framed under the label 'not medically necessary' beyond the general categorizations already described for non‑implantable VNS and external TNS. Reviewers should rely on the policy's coverage criteria, exclusions, and documentation requirements when assessing medical necessity.

Procedure, Supply, and Product 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	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.

HCPCS / supply 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.

Implantable device HCPCS-like codesHCPCS

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 Vagus Nerve Stimulator product codesmixed

LYJ	FDA product code reference for implantable VNS devices (per document)
MUZ	FDA product code reference for implantable VNS devices (per document)
QPY	FDA product code reference for implantable VNS devices (per document)

Transcutaneous VNS product codesmixed

PKR	FDA product code reference for transcutaneous (non-implantable) VNS devices (per document)
QAK	FDA product code reference for transcutaneous (non-implantable) VNS devices (per document)

External/Transcutaneous Trigeminal Nerve Stimulation product codesmixed

PCC	FDA product code reference for External/Transcutaneous Trigeminal Nerve Stimulation devices (per document)
QGL	FDA product code reference for External/Transcutaneous Trigeminal Nerve Stimulation devices (per document)

References (no explicit billing codes in this extract)mixed

No codes listed

inv-25: Adherence threshold

Adherence threshold>= 67% adherence per month (post hoc analysis in PREMIUM showed benefit in adherent participants)

ContextApplied in PREMIUM preventive migraine trial as a post hoc adherence cutoff to identify treatment effect

Documentation expectedPrior authorization and medical record review may request adherence monitoring data to support preventive nVNS benefit

inv-26: Modified ITT adherence

Modified ITT criteria>= 66% adherence and >= 70 days of the double-blind period to be included in the prespecified modified intention-to-treat population

Prior Authorization, Documentation, and Submission Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for implantable and non‑implantable VNS devices and related procedures. Submit documentation demonstrating the indication (epilepsy or treatment‑resistant depression for implantable VNS) and that clinical criteria are met prior to authorization.

A prior authorization request is required for implantation, replacement, removal, and for billing of device pulse generators and electrodes (see applicable CPT/HCPCS/L-codes in policy).
Implantable VNS for epilepsy: medical necessity requires drug‑resistant epilepsy with failure of ≥2 appropriate antiepileptic drug trials (single or combination) or intolerable side effects, not a candidate for epilepsy surgery (or refused/failed surgery after shared decision‑making), and no history of left or bilateral cervical vagotomy.
Implantable VNS for treatment‑resistant depression (TRD): prior authorization required; use only for individuals meeting TRD criteria per policy and with documentation consistent with guidance (see clinical evidence and NICE recommendations).
Transcutaneous (non‑implantable) VNS and other non‑implant neuromodulation devices require prior authorization when billed — however, coverage is limited by the policy’s determination of insufficient evidence for many indications (see Insufficient Evidence item).

Description and Context

Background: Implantable Vagus Nerve Stimulation (VNS) involves a surgically implanted generator and lead(s) that deliver electrical impulses to the cervical vagus nerve to modulate neural activity; it is an FDA‑approved therapy for epilepsy and has also been used for treatment‑resistant depression. Proposed mechanisms include alteration of neurotransmitter release and modulation of central autonomic pathways.

Noninvasive approaches—transcutaneous VNS (auricular or cervical stimulation) and external trigeminal nerve stimulation (supraorbital/transcutaneous stimulation)—use surface electrodes or handheld stimulators to target vagal or trigeminal branches and are being investigated for acute and preventive treatment of headache disorders and a variety of neuropsychiatric and other conditions.

Key Terms and Definitions

inv-49: Shared Decision Making

DefinitionA collaborative process in which a provider/clinician and a patient (including caregivers and family) work together to make healthcare decisions that consider evidence-based options, the provider's experience, and the patient's values, goals, preferences, and circumstances (AHRQ, 2023).

Elements to documentDiscussion of benefits, harms, risks, alternatives, and what matters most to the patient; informed consent when offering procedures such as VNS

Policy expectationShared decision-making documentation is recommended prior to offering VNS for drug-resistant epilepsy and for treatment‑resistant depression and may be requested during prior authorization review

inv-50: AAN Level C definition

AAN Level C meaningIndicates possibly effective or possibly not effective/harmful; requires at least one Class II study or two consistent Class III studies.

Policy Summary

PayerUnitedHealthcare

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

Policy CodePolicy CS129NM.C

Change TypeDocumentation and definition updates

Effective DateDec 1, 2025

Next Review Date

Key ActionSubmit prior authorization with medical records demonstrating required trials, device identity and FDA clearance, baseline/run-in documentation, and shared decision-making when applicable.

SourceLink

On This Page

PREMIUM post hoc analyses indicate benefit in adherent patients

Chronic cluster headache and chronic migraine: Evidence for benefit is limited or inconsistent for chronic cluster headache and chronic migraine; routine coverage is not supported without further high-quality evidence or within research settings.

cCH and chronic migraine trials show limited or inconsistent benefit

External/Transcutaneous Trigeminal Nerve Stimulation (eTNS): eTNS has low-to-moderate quality evidence for reducing migraine pain and days in some trials but heterogeneity and limited high-quality data warrant cautious coverage decisions; consider acute migraine coverage when prior therapies failed and use follows evidence-based protocols.

Cefaly and related trials show benefit but evidence quality is variable

Trial contextUsed in Najib et al. (2022) migraine prevention study where 113 participants met these requirements after a 4-week run-in

Implication for coveragePrior authorization may request evidence of run-in diary and adherence >=66% over the treatment period to consider modified-ITT–like effect observations

inv-27: N/A (placeholder)

N/ANo threshold specified

NoteThis placeholder item has no applicable numeric threshold in the policy extract

DocumentationOperational updates clarified required medical record elements but did not add thresholds here

Documentation Required

Prior Authorization — Baseline and Adherence Documentation

Baseline and adherence documentation must accompany prior authorization and continuation requests. A baseline headache/migraine diary or seizure diary and documentation of adherence to prescribed device use are required to establish benefit and monitor response.

For migraine or headache indications involving noninvasive devices: include a 4‑week run‑in baseline diary prior to device initiation and objective adherence data during treatment (daily diaries and device usage logs).
For VNS trials in epilepsy: provide seizure frequency baseline documentation and any device adherence records or programming logs available.
For continuation/renewal requests, provide objective evidence of adherence (percentage use) and clinical response (e.g., reduction in monthly migraine days, seizure frequency, or validated rating scales).

Prior Authorization

Device‑Specific Prior Authorization

Device‑specific prior authorization must identify the exact device, model, and associated supply codes. Include manufacturer, model, and FDA clearance/approval information when available.

When requesting authorization for an implantable neurostimulator, list CPT codes (e.g., 61885, 61886, 64568, 64570, 64553) and L‑codes (e.g., L8679, L8680–L8688) as applicable.
For external/transcutaneous devices, include HCPCS E‑codes (e.g., E0735 for noninvasive VNS, E0733 supplies A4541) and any miscellaneous DME codes (E1399) when used.
Specify whether the implantable pulse generator is rechargeable vs nonrechargeable and single vs dual array (L8685–L8688) to support correct billing and authorization.

Note

Coverage and Documentation Note

Coverage and documentation note: Listing of a code in the policy is for reference only and does not guarantee coverage or payment. Benefit coverage is determined by federal, state, and contractual requirements and applicable law.

Include all relevant clinical records when submitting a prior authorization; absence of supporting documentation may result in denial.
Coding alone does not establish medical necessity — clinical justification tied to policy criteria is required.

Denial Risk

Medical Records Required — Denial Risk for Missing Documentation

Lack of sufficient medical record documentation may lead to denial. Providers must ensure records are legible, maintained in the patient chart, and available upon request to support the requested service.

Medical records should include relevant medical history, physical examination, diagnostic testing results, prior treatment history, and notes documenting shared decision‑making when applicable.
Denials may be issued if documentation does not demonstrate that the member meets the policy’s clinical criteria.

Denial Risk

Insufficient Evidence — Noninvasive (Transcutaneous) VNS

Transcutaneous (non‑implantable) VNS (nVNS) is considered insufficiently evidenced for many indications. Prior authorization may be denied when clinical evidence is lacking for the requested indication.

nVNS has mixed evidence in migraine prevention trials; some post hoc analyses suggest benefit in adherent patients or subgroups (e.g., aura), but overall evidence is limited — coverage may be restricted to specific documented circumstances or denied as experimental.
NICE and AHS note limited efficacy evidence and recommend use with special arrangements (research, audit, or governance) for certain indications.
When requesting authorization for nVNS, include trial data, adherence logs, and objective outcome measures to support medical necessity.

Documentation Required

Device Regulatory and Clearance Documentation

Device regulatory documentation should be provided. Include FDA approval, clearance (PMA/510(k)/PMN) or manufacturer documentation identifying device product codes when available.

For implantable VNS devices, reference PMA product codes (e.g., LYJ, MUZ, QPY) or PMA numbers when available.
For transcutaneous or trigeminal stimulation devices, reference PMN/510(k) product codes (e.g., PKR, QAK, PCC, QGL) or clearance documentation.
Lack of device regulatory documentation may delay review or lead to denial if safety/clearance status cannot be verified.

Documentation Required

Required Medical Records Elements

Required medical record elements for authorization requests. Provide concise but complete elements to establish medical necessity and prior therapy attempts.

Diagnosis and problem list with duration and severity of symptoms (e.g., seizure frequency, migraine days per month).
Prior medication trials: names, doses, dates of use, reason for discontinuation (inefficacy or intolerable side effects). For epilepsy, documentation of failure of ≥2 antiepileptic drug trials is required.
Surgical candidacy documentation (e.g., evaluation indicating not a candidate for resective epilepsy surgery, refusal, or failed surgery) and evidence of shared decision‑making discussions.
Baseline diaries (seizure or headache/migraine diary), prior therapeutic interventions and responses, and objective device adherence/log data.
Relevant imaging, EEG, or other diagnostic test results when applicable, and operative notes if prior procedures were performed.

Step Therapy

Medication Trial Requirement and Step Therapy Context

Medication trial and step therapy context. Prior authorization requests must show prior conventional therapy trials per indication before neuromodulation is considered.

For epilepsy: document trials of ≥2 appropriate antiseizure medications (single or combination) at therapeutic doses and durations, or documented intolerable side effects.
For migraine and other headache disorders: document trials of guideline‑recommended pharmacologic therapies and adherence/intolerance evidence before considering nonpharmacologic neuromodulation options, per AHS guidance.
Step therapy policies may apply; include documentation of failed or contraindicated standard therapies to avoid step‑therapy denials.

Note

Shared Decision‑Making and Special Arrangements

Shared decision‑making and special arrangements. For indications with limited evidence (e.g., TRD, migraine/cluster headache with nVNS), document informed consent and any participation in clinical governance, audit, or research per guidance.

Document discussions of risks, benefits, alternatives, and expected outcomes in the medical record.
When NICE or other guidance recommends use only with special arrangements, include documentation of such arrangements (consent, audit plan, or research participation) where applicable.

Evidence implication

Used to categorize interventions where evidence is limited or inconclusive and further high-quality trials are needed

ApplicationSupports cautious interpretation of nVNS/eTNS trial results when AAN assigns Level C

inv-51: nVNS (noninvasive vagus nerve stimulation)

DefinitionExternally applied cervical or auricular stimulation targeting the vagus nerve (examples include gammaCore) studied for acute and preventive management of cluster and migraine headaches.

Evidence summaryRandomized trials show acute efficacy for episodic migraine (Tassorelli 2018) and benefit for episodic cluster headache in some RCTs (Silberstein et al. 2016); preventive trials had mixed ITT results with benefit in adherent subgroups (PREMIUM).

Coverage stance in policyNoninvasive (transcutaneous) VNS is generally considered unproven/not medically necessary for many indications, with selective consideration for acute eCH and episodic migraine based on trial evidence and adherence criteria

inv-52: eTNS / TNS (external or transcutaneous trigeminal nerve stimulation)

DefinitionExternal stimulation of the trigeminal nerve (example device: Cefaly) applied for acute relief and prevention of migraine; investigated for epilepsy, ADHD, depression, and other conditions.

Evidence summarySystematic reviews and RCTs report reductions in migraine pain and days versus sham, but evidence quality is low-to-moderate and optimal protocols/frequency are uncertain

Policy implicationeTNS/TNS considered investigational/unproven for many indications; may be considered cautiously for acute migraine relief when prior therapies have failed and documentation follows evidence-based protocols

inv-53: External/transcutaneous trigeminal nerve stimulation (eTNS/TNS)

DescriptionNoninvasive electrical stimulation applied to the supraorbital/trigeminal nerve distribution to modulate neural activity; device example: Cefaly.

Trial findingsTrials show acute pain reduction and some preventive benefit in migraine, but heterogeneity and limited sample sizes reduce confidence in routine use

Regulatory and guideline notesEvidence assessments (ECRI, systematic reviews) deem benefits uncertain; NICE recommends supraorbital TENS with special arrangements and AAP cautions use in ADHD

inv-54: Transcutaneous (non-implantable) vagus nerve stimulation (tVNS/nVNS)

DefinitionNoninvasive (transcutaneous) vagus nerve stimulation targets auricular or cervical vagal branches using externally applied devices for acute and preventive neuromodulation in headache, depression, and other disorders.

Device examples and regulatory noteFDA-cleared devices exist (see product codes PKR, QAK) and are listed in FDA PMN/PMN databases referenced by the policy.

Evidence summaryShows abortive efficacy for episodic migraine and mixed preventive results (benefit in adherent subgroups); overall considered unproven/not medically necessary for many indications in this policy

inv-55: Implantable vagus nerve stimulation (VNS)

DefinitionSurgically implanted neurostimulation device that delivers electrical stimulation to the cervical vagus nerve; approved for epilepsy and treatment‑resistant depression among other indications.

Coverage criteriaImplantable VNS is covered for medically refractory epilepsy when criteria are met (failure of >=2 AED regimens, not a candidate for resective surgery or declines surgery, and no history of left or bilateral cervical vagotomy).

Regulatory noteFDA-approved implantable VNS devices are referenced with product codes LYJ, MUZ, QPY in the policy; prior authorization should reference device and clearance info

inv-56: Shared Decision Making (updated definition)

Updated definitionShared Decision Making is a collaborative process where clinician and patient (including caregivers) jointly make healthcare decisions considering evidence-based options, clinician experience, and the patient's values, goals, preferences, and circumstances (AHRQ, 2023).

Policy applicationThe policy explicitly recommends documentation of shared decision‑making before offering VNS for drug‑resistant epilepsy and TRD, including discussion of evidence limitations and risks.

Documentation expectationsRecords should reflect the discussion of alternatives (including surgery), benefits/harms, and the patient's informed choice; such documentation may be requested during prior authorization review.