CurrentUnitedHealthcarePolicy CS129PA.S

Vagus and External Trigeminal Nerve Stimulation (for Pennsylvania Only)

Policy applies to Pennsylvania members and addresses coverage criteria for implantable vagus nerve stimulators, transcutaneous (non-implantable) vagus nerve stimulation, and external/transcutaneous trigeminal nerve stimulation. Defines medically necessary indications (epilepsy) and lists conditions/devices considered unproven and not medically necessary.

Policy Summary

PayerUnitedHealthcare

PolicyVagus and External Trigeminal Nerve Stimulation (for Pennsylvania Only)

Policy CodePolicy CS129PA.S

Change TypeRevised / Added / Clarified (multiple entries)

Effective DateMar 1, 2026

Next Review Date

Key ActionEnsure the patient's medical record contains legible documentation supporting medical necessity (history, exam, diagnostic tests) and make it available upon request.

SourceLink

POLICY UPDATE CHANGES

Updated reference link to reflect the current policy title for Transcranial Magnetic Stimulation for Treating Physical Health Conditions (for Pennsylvania Only). Listed in 04/01/2026 summary of changes.

Revised list of unproven and not medically necessary devices to replace a specific example with the broader term 'transcutaneous (non-implantable) vagus nerve stimulation devices'. Listed in 03/01/2026 Summary of Changes under Coverage Rationale for Noninvasive Trigeminal and Vagus Nerve Stimulators.

Added language clarifying that benefit coverage is determined by federal, state, or contractual requirements and applicable laws which may require coverage for a specific service. Included under Medical Records Documentation Used for Reviews.

Added language specifying examples of documentation supporting medical necessity and that documentation must be made available upon request. Multiple entries in the revision history emphasize documentation requirements.

Updated definition of 'Shared Decision Making' and updated Description of Services, Clinical Evidence, and References sections. Listed across multiple summary of changes; previous policy version CS129PA.R archived.

1Covered Indication (implantable VNS for epilepsy)

2Required antiepileptic drug trials

multipleIndications discussed

limitedStrong evidence for most non-headache indications

2Recent revision dates listed

Coverage Summary

Policy Number: CS129PA.S. Effective Date: March 1, 2026. This policy applies only to Pennsylvania members and defines coverage for implantable and non-implantable vagus nerve stimulation (VNS) and external/transcutaneous trigeminal nerve stimulation (TNS).

Implantable VNS (surgically implanted pulse generator and leads) is covered as medically necessary for medically refractory epilepsy when all criteria are met (failure of ≥2 antiepileptic drug trials or intolerable side effects; not a candidate for or has failed/refuses epilepsy surgery after Shared Decision Making; no history of left or bilateral cervical vagotomy).

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

Covered IndicationImplantable VNS for medically refractory epilepsy

Required antiepileptic drug trials2 failed trials

Geographic scopePennsylvania only

Policy numberCS129PA.S

Effective date2026-03-01

Medical Necessity Criteria

Medically Necessary (Implantable Vagus Nerve Stimulators) for Epilepsy

Covered when ALL of the following are met:

ALL of the following

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
The individual is not a candidate for epilepsy surgery, has failed epilepsy surgery, or refuses epilepsy surgery after Shared Decision Making discussion
Shared Decision Making defined in policy definitions
No history of left or bilateral cervical vagotomy (FDA contraindication)
FDA identifies left or bilateral cervical vagotomy as a contraindication

Not Medically Necessary / Unproven (Implantable VNS)

Implantable vagus nerve stimulators are unproven and not medically necessary for treating all other conditions due to insufficient evidence of efficacy; this includes but is not limited to:

ANY of the following

Alzheimer's disease
Anxiety disorder
Autism spectrum disorder
Autoimmune disorders
Back and neck pain

Not Medically Necessary / Unproven (Non-implantable Devices)

The following non-implantable devices are unproven and not medically necessary due to insufficient evidence of efficacy:

ANY of the following

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 ADHD, depression, epilepsy, headache)

Evidence-based coverage considerations (narrative findings)

Implantable VNS: Systematic reviews, registry analyses, and guideline statements support implantable VNS as an effective and generally well-tolerated adjunctive therapy for drug-resistant epilepsy, with responder rates that increase over time (registry and meta-analyses reporting ~40–63% responders and low seizure-freedom rates of ~2–8%). Cochrane and AAN reviews note moderate-to-low certainty in some trials but a preponderance of evidence and guideline recommendations endorse VNS as an option when resective surgery is not viable.

Noninvasive VNS and TNS for headache: Randomized trials and systematic reviews show mixed and indication-specific results. Noninvasive VNS (e.g., gammaCore) demonstrated benefit for acute episodic cluster headache and some positive signals for episodic migraine (acute and preventive) in certain trials, but many studies had inconsistent ITT findings, sham devices with residual activity, adherence issues, and small sample sizes. PREVA/ACT and ACT2/ACT1 analyses indicate nVNS is superior to sham in episodic but not chronic cluster headache cohorts; PREMIUM and PREMIUM II showed no ITT superiority for migraine prevention but suggested benefit in adherent or subgroup (aura) analyses.

External/transcutaneous TNS (eTNS/ETNS): Systematic reviews and trials report low-to-moderate quality evidence of reductions in migraine pain and attack frequency versus sham in some studies, but heterogeneity, limited trial numbers, and uncertain durability of effects limit definitive conclusions.

Evidence quality and guidance synthesis: Overall evidence for non-implantable modalities is limited by small, heterogeneous studies, methodological limitations, and inconsistent intention-to-treat results; adherence and subgroup effects appear to influence outcomes. ECRI, NICE, and specialty society guidance (NICE, AHS) acknowledge potential benefit for select neuromodulation uses but recommend adoption with governance/consent/audit or continued use only when short-term response is demonstrated (e.g., gammaCore continuation criteria at 3 months) and emphasize need for further high-quality trials. For indications beyond epilepsy and selected headache subtypes, current evidence is insufficient to support routine use.

Coding (CPT / HCPCS / DME / Product Codes)

CPT / HCPCS Procedures and Supplies (reference list)mixed

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

1–10 of 18

1/2

FDA device product codes (informational)mixed

LYJ	Implantable Vagus Nerve Stimulator product code (PMA reference)
MUZ	Implantable Vagus Nerve Stimulator product code (PMA reference)
QPY	Implantable Vagus Nerve Stimulator product code (PMA reference)
PKR	Transcutaneous (Non-Implantable) Vagus Nerve Stimulation product code (PMN reference)
QAK	Transcutaneous (Non-Implantable) Vagus Nerve Stimulation product code (PMN reference)
PCC	External or Transcutaneous Trigeminal Nerve Stimulation product code (PMN reference)
QGL	External or Transcutaneous Trigeminal Nerve Stimulation product code (PMN reference)

Provider Actions & Documentation Requirements

Documentation Required

Medical record documentation required

Patient medical records must document relevant medical history, physical examination findings, and results of pertinent diagnostic tests or procedures that support medical necessity for the requested service. Records should be legible, maintained in the patient's medical record, and made available upon request.

Relevant medical history
Physical examination findings
Pertinent diagnostic test results
Legible documentation
Available upon request

Documentation Required

Shared Decision Making requirement

When the coverage criterion requires that the patient is not a candidate for epilepsy surgery or refuses surgery, documentation that a Shared Decision Making discussion occurred is required if the patient declines surgery. Shared Decision Making is a collaborative process documenting discussion of evidence, benefits, risks, alternatives, and the patient's values and preferences.

Definitions

Shared Decision Making: A collaborative process in which provider and patient (and caregivers as appropriate) jointly make healthcare decisions, weighing evidence, clinician experience, and patient values/preferences, including discussion of benefits, harms, and alternatives (AHRQ reference).

nVNS: Noninvasive vagus nerve stimulation referring to transcutaneous cervical or auricular stimulation delivered by handheld or surface electrode devices (example: gammaCore).

eTNS / ETNS / TNS: External or transcutaneous trigeminal nerve stimulation, typically applied via supraorbital or forehead electrodes (example: Cefaly device) to modulate trigeminal nerve input.

gammaCore: A branded noninvasive vagus nerve stimulator referenced in clinical trials and evidence assessments; used as an example of an nVNS device in the evidence base.

Note: The definition of Shared Decision Making was updated in recent policy revisions; providers should document Shared Decision Making discussions when applicable (e.g., when a patient refuses epilepsy surgery).

Revision History

04/01/2026clarified

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

03/01/2026revisedLatest

Revised list of unproven and not medically necessary devices by replacing a specific example with the broader term 'transcutaneous (non-implantable) vagus nerve stimulation devices' under Coverage Rationale for Noninvasive Trigeminal and Vagus Nerve Stimulators.

03/01/2026added

Policy Summary

PayerUnitedHealthcare

PolicyVagus and External Trigeminal Nerve Stimulation (for Pennsylvania Only)

Policy CodePolicy CS129PA.S

Change TypeRevised / Added / Clarified (multiple entries)

Effective DateMar 1, 2026

Next Review Date

Key ActionEnsure the patient's medical record contains legible documentation supporting medical necessity (history, exam, diagnostic tests) and make it available upon request.

SourceLink

On This Page

Chronic pain syndrome

Musculoskeletal disorders

Obsessive-compulsive disorder

Upper limb impairment related to stroke

Evidence highlights

Panebianco Cochrane summaryVNS as adjunctive for partial seizures appears effective and well tolerated but evidence limited (moderate to low certainty)

Registry responder ratesResponder rates ~40-63% over months to years; seizure freedom low (≈2-8%)

Major RCT outcomes — epilepsyRandomized trials support VNS efficacy vs low stimulation; evidence limited by few participants and reporting

PREMIUM (Diener 2019) — migraine preventionnVNS not superior to sham in ITT; adherent subgroup showed benefit

Tassorelli 2018 (PRESTO) — acute migrainenVNS superior to sham for pain freedom at 30 and 60 minutes

PREVA / ACT2 (cluster headache)nVNS showed benefit in episodic cluster headache; mixed/inconsistent for chronic cluster headache

Systematic reviews / meta-analysesMultiple reviews conclude mixed findings with limited quantity/quality of evidence

Efficacy statement for non-implantable devicesTranscutaneous VNS and external TNS investigated for many conditions but evidence insufficient for routine use

NICE / guidance notesNICE: use of cervical tVNS and supraorbital eTNS only with special arrangements; gammaCore continued only if symptoms reduce in first 3 months

Adherence and sham challengesSome trials affected by active sham devices or suboptimal adherence influencing results

eTNS (Cefaly) evidenceLow-to-moderate quality evidence suggests reduction in migraine pain/frequency vs sham but overall evidence limited

Overall conclusionMixed/limited evidence: implantable VNS proven for epilepsy; non-implantable devices show promising but inconsistent results across indications

Document that Shared Decision Making discussion occurred
Describe alternatives, benefits, harms, and patient preferences
Record that patient refused surgery (if applicable) following the discussion

Documentation Required

Use special arrangements / research governance per NICE

The use of transcutaneous cervical VNS or supraorbital external TNS for migraine or cluster headache should be undertaken only with special arrangements for clinical governance, informed consent, and audit or research oversight in accordance with NICE guidance.

Ensure clinical governance arrangements are in place
Obtain informed consent documenting risks and uncertainties
Arrange audit or research data collection as applicable

Documentation Required

Trial continuation criteria (gammaCore for cluster headache)

For gammaCore use in cluster headache, continue therapy only for individuals whose symptoms show reduction within the first 3 months of treatment.

Assess symptom reduction during first 3 months
Document response to determine continuation

Prior Authorization

FDA clearance informational use

Confirm device marketing clearance or approval via FDA databases (CDRH 510(k), PMA/PMN) when evaluating devices, but note that FDA approval/clearance is informational only and is not by itself a basis for coverage determinations.

Search CDRH 510(k), PMA, or PMN databases for device-specific clearance/approval
Treat FDA clearance as informational; not sole coverage determinant

Documentation Required

Medical records documentation requirement

Medical records must fully support medical necessity and may be requested for review. Acceptable documentation includes relevant medical history, physical examination findings, and results of pertinent diagnostic tests or procedures. Records should be legible, maintained in the patient's chart, and made available upon request to verify that clinical criteria are met.

Relevant medical history (e.g., prior treatments, medication trials)
Physical examination findings
Diagnostic test results (e.g., EEG, imaging, headache diaries)
Evidence of treatment trials and responses
Legible records available upon request

Added language under Medical Records Documentation Used for Reviews clarifying that benefit coverage is determined by federal, state, or contractual requirements and applicable laws which may require coverage for a specific service; also added documentation expectations (relevant medical history, physical exam, diagnostic tests) and requirement that documentation be made available upon request.

03/01/2026added

Added language specifying examples of documentation supporting medical necessity and that documentation must be made available upon request; multiple entries in the revision history emphasize documentation requirements and record availability.

03/01/2026revised

Updated definition of 'Shared Decision Making' and updated Description of Services, Clinical Evidence, and References sections; previous policy version CS129PA.R archived.