CurrentPremera BluecrossPolicy N/A

Vagus nerve stimulation (VNS)

Defines medical necessity, contraindications, investigational indications, documentation and coding for implanted and non-implanted vagus nerve stimulation devices for seizures, major depressive disorder, and other conditions. Includes guidance on use of VNS in conjunction with other neuromodulation and pharmacologic agents, and lists relevant CPT/HCPCS/HCPCS-like codes and FDA device approvals.

Policy Summary

PayerPremera Bluecross

PolicyVagus nerve stimulation (VNS)

Policy CodePolicy N/A

Change TypeRevised / Added (history entries)

Effective Date

Next Review DateJun 23, 2025

Key ActionObtain prior authorization and submit documentation demonstrating that all policy criteria and required prior treatment failures or legitimate hardship exceptions are met.

POLICY UPDATE CHANGES

08/01/24 Interim Review: updated criteria for VNS for Major Depressive Disorder and added criteria for VNS with TMS; declared transcutaneous auricular VNS investigational for psychiatric disorders.

09/01/24 Policy renumbered to 7.01.593 and added clarifications: exclude bipolar depression and psychosis from MDD criteria; allow cessation of TMS/ECT due to severe side effects to count as trial.

05/01/25 Added HCPCS C1827.

07/01/25 Interim Review (06/23/25): added associated electrode array and pulse generator as approvable with VNS for MDD; added acceptable legitimate hardship factors in lieu of failed TMS/ECT; clarified that desire to avoid TMS/ECT is not a legitimate hardship.

2Main covered indications (seizures, MDD)

MultipleInvestigational indications listed

FDA device approvals timeframe

HistoricCoding updates recorded

ConditionalInvestigational uses noted

Coverage Summary

This policy addresses vagus nerve stimulation (VNS) — both implantable systems (pulse generator and lead/electrode array) and non‑implantable transcutaneous devices — and defines when VNS is considered medically necessary, not medically necessary, or investigational.

Main covered indications for implantable VNS include: medically refractory seizures (pediatric and adult) and Major Depressive Disorder (unipolar, adults ≥18 years) when specific prior‑treatment and documentation criteria are met (see policy criteria).

Non‑implantable (transcutaneous) VNS devices are considered investigational for all indications because published evidence is insufficient to demonstrate improved net health outcomes.

Coverage determinations require meeting the stated clinical criteria and submission of supporting documentation (detailed medication trials, standardized rating scores or symptom documentation for depression, and records showing medically refractory seizures), and appropriate CPT/HCPCS/L coding must be reported for device implantation, components, and programming.

Quick thresholds / facts

Minimum antidepressant trial duration>= 30 continuous days unless stopped due to intolerable adverse effects

Age for Major Depressive Disorder (VNS)>= 18 years

Maximum TMS bridging duration with VNSInitial 3 months; may continue for up to three additional 3-month intervals (up to 12 months total) if VNS has not resulted in improvement to mild or remission

Time to assess VNS responseClinical response typically begins around 3 months; maximum response generally at 6–12 months; improvement unlikely after 12 months if no response by then

Medical-Necessity Criteria

Indications considered medically necessary:

ANY of the following

Medically refractory seizures: Vagus nerve stimulation (NeuroCybernetic Prosthesis, NCP) for refractory seizures is considered medically necessary when seizures are medically refractory, defined as seizures that occur despite therapeutic levels of antiepileptic drugs or seizures that cannot be treated with therapeutic levels of antiepileptic drugs because of intolerable adverse events. This indication is applicable for both pediatric and adult individuals.
Major Depressive Disorder (implantable VNS)
- Vagus nerve stimulation, including surgical implantation, associated electrode array, and pulse generator, and including electronic analysis and reprogramming, may be considered medically necessary for treatment of Major Depressive Disorder (unipolar depression, not bipolar) without psychotic features when the individual is aged 18 years or older and is experiencing a current episode of moderate to severe depression as demonstrated by documentation of symptoms and severity or by one or more standardized depression rating scales and no acute or chronic psychotic symptoms are present.

Contraindications / Not Medically Necessary

Contraindications - Not Medically Necessary

VNS is considered not medically necessary when ANY of the following are present:

Vagotomy history: History of left vagotomy or bilateral vagotomy
Diathermy contraindication: Current or planned therapeutic short-wave diathermy, therapeutic microwave diathermy, therapeutic ultrasound diathermy (does not include diagnostic ultrasound) or surgical diathermy on any body location

Use of VNS with Other Therapies

Use of VNS in conjunction with other therapies

Coverage rules for combining VNS with other neuromodulation or pharmacologic therapies:

TMS bridging initial: VNS in conjunction with TMS may be considered medically necessary for up to 3 months after VNS implantation to bridge while VNS becomes effective if individual has just completed a full or brief intensive course of TMS and is transitioning to or undergoing maintenance TMS and TMS has been partially but inadequately effectiveinitial: 3 months
TMS continuation intervals: TMS in conjunction with VNS may be continued for up to three additional 3-month intervals (up to 12 months total) if at completion of each interval VNS has not resulted in improvement to mild or remission based on a standardized rating scalemay continue up to total 12 months
assess at completion of each 3-month interval

Investigational / Not Covered Indications

Investigational / Not Medically Necessary Indications

VNS (implantable) or non-implantable VNS devices are considered investigational for the following conditions:

Autism
Essential tremor
Fibromyalgia
Headaches (non-cluster/migraine contexts not otherwise covered)
Heart failure (see evidence section; insufficient evidence)

Background & Evidence Summary

Implantable VNS involves surgical placement of a small pulse generator in the chest with a lead to the vagus nerve; it has established use for medically refractory seizures and is also evaluated for treatment‑resistant Major Depressive Disorder and other neurologic and psychiatric conditions.

Non‑implantable transcutaneous VNS devices (for example, gammaCore and transcutaneous auricular VNS) have been studied for headaches, migraine, epilepsy, depression and other disorders, but randomized trials and systematic reviews have produced inconsistent or insufficient evidence of clinically meaningful benefit.

Because of limited and inconsistent evidence, this policy designates all non‑implantable (transcutaneous) VNS devices as investigational for all indications.

Epilepsy evidenceRCTs and observational studies report significant reductions in seizure frequency for partial‑onset seizures; evidence sufficient for improvement in net health outcome

Depression evidenceTwo sham‑controlled RCTs showed no short‑term benefit; larger longer‑term studies, observational series, and meta‑analyses suggest benefit over extended follow‑up but evidence historically limited

Transcutaneous VNS evidenceRCTs for cluster and migraine and other small trials show inconsistent or insufficient evidence to conclude improved net health outcomes; overall investigational for most indications

Coding

Covered/used procedure CPT codesCPTCovered

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 electrodes; cranial nerve.
64568	Open implantation of cranial nerve (vagus nerve) neurostimulator electrode array and pulse generator.
64569	Revision or replacement of cranial nerve (vagus nerve) neurostimulator electrode array, including connection to existing pulse generator.
95970	Electronic analysis of implanted neurostimulator pulse generator/transmitter (various functions described).
95976	Electronic analysis of implanted neurostimulator pulse generator/transmitter with simple cranial nerve neurostimulator programming by physician.
95977	Electronic analysis of implanted neurostimulator generator/transmitter with complex cranial nerve neurostimulator programming by physician.

HCPCS / Implantable device and supply codesHCPCSCovered

C1767	Generator; neurostimulator (implantable), nonrechargeable.
C1778	Lead, neurostimulator (implantable).
C1827	Generator, neurostimulator (implantable), nonrechargeable; with implantable stimulation lead and external paired stimulation controller (use to report: Vivistim).
E0735	Noninvasive vagus nerve stimulator.
K1020	Non-invasive vagus nerve stimulator.
L8680	Implantable neurostimulator electrode; each.
L8681	Patient programmer (external) for use with implantable programmable neurostimulator pulse generator.
L8682	Implantable neurostimulator radiofrequency receiver.
L8683	Radiofrequency transmitter (external) for use with implantable neurostimulator radiofrequency receiver.
L8684	Radiofrequency transmitter (external) for use with implantable sacral root neurostimulator receiver for bowel and bladder management; replacement.

1–10 of 15

1/2

Noninvasive device codes (investigational per policy)mixedExperimental

E0735	Noninvasive vagus nerve stimulator (listed also under HCPCS; policy states non-implantable devices are investigational for all indications).
K1020	Non-invasive vagus nerve stimulator.

HCPCS / CPT / related procedure codes referenced historically or addedmixed

0312T	Historical Vagus nerve blocking therapy code (removed as inappropriate for policy)
0318T	Historical CPT code added 1/1/13
95970	Added (per history)
95976	Added (per history)
95977	Added (per history)
95971	Removed CPT (01/01/2016 deletion noted)
95972	Removed CPT
95973	Removed CPT (deleted 01/01/2016)
95974	Removed CPT
95975	Removed CPT

1–10 of 18

1/2

Provider Actions & Billing Guidance

Prior Authorization

Prior authorization and medical necessity evaluation required

Prior authorization and medical necessity evaluation are required before VNS implantation or related services. Providers must obtain authorization and include documentation demonstrating that medical necessity criteria are met for the requested indication (e.g., medically refractory seizures or treatment‑resistant major depressive disorder). Authorization must specifically reference the indication, proposed procedure(s), and any concurrent neuromodulation plans (see policy for limits on concurrent modalities). Consulting behavioral health or neurology specialists as appropriate is recommended when documenting failure of therapies and consideration of VNS.

Obtain prior authorization before scheduling implantation or billing for device/procedure.
Include clear clinical indication (seizures or Major Depressive Disorder) and summary of treatments tried.
Document any planned concurrent neuromodulation (TMS, ECT) and rationale consistent with policy time limits.

Definitions

Medically refractory seizures: Seizures that occur despite therapeutic levels of antiepileptic drugs OR seizures that cannot be treated with therapeutic levels because of intolerable adverse effects of these drugs; applies to pediatric and adult individuals.

Failure of medication trial: medication was not effective, partially/inadequately effective, lost effect, had to be stopped due to adverse effects, or doses could not be increased due to adverse effects; minimum 30 continuous days unless stopped for intolerable adverse effects; each failed medication must be individually identified with reasons for failure.

VNS: abbreviation for vagus nerve stimulation (implantable pulse generator with lead/electrode array).

FDA PMA/510(k): identifiers for device regulatory status (PMA/510(k) premarket approval and clearance entries listed in the policy and coding/regulatory sections).

Medicare Determinations

Name	Number	Type	Effective
Vagus Nerve Stimulation coverage		NCD
Coverage with Evidence Development for TRD		NCD	2018
Vagus Nerve Stimulation (VNS)	160.18	NCD	2019
Vagus Nerve Stimulation for Treatment Resistant Depression (TRD)	CAG-00313R2	Decision Memo	2019-02
Vagus Nerve Stimulation for Treatment Resistant Depression		Coverage with Evidence Development	2024

Revision History

08/01/24revised

08/01/24 Interim Review: updated criteria for VNS for Major Depressive Disorder and added criteria for VNS with TMS; declared transcutaneous auricular VNS investigational for psychiatric disorders.

09/01/24revised

09/01/24 Policy renumbered to 7.01.593 and added clarifications: exclude bipolar depression and psychosis from MDD criteria; allow cessation of TMS/ECT due to severe side effects to count as trial.

05/01/25added

05/01/25 Added HCPCS C1827.

Policy Summary

PayerPremera Bluecross

PolicyVagus nerve stimulation (VNS)

Policy CodePolicy N/A

Change TypeRevised / Added (history entries)

Effective Date

Next Review DateJun 23, 2025

Key ActionObtain prior authorization and submit documentation demonstrating that all policy criteria and required prior treatment failures or legitimate hardship exceptions are met.

On This Page

Prior treatment failure requirements (ONE of)

Failure of at least 3 antidepressant medications from at least 2 different classes in separate trials.
Failure of at least 2 different antidepressant medications from at least 2 different classes in separate trials, plus failure with the addition of an augmenting agent to at least one of the failed antidepressants.
Depression continued to be moderate or severe after a course of transcranial magnetic stimulation (TMS), or TMS was stopped due to intolerable, incapacitating, or dangerous side effects, or there is a contraindication to TMS or legitimate factors make TMS treatment (typically 5 days/week for 4–6 weeks followed by up to 3 treatments/week depending on type) a hardship for the individual.
Depression continued to be moderate or severe after a course of electroconvulsive therapy (ECT), or ECT was stopped due to intolerable, incapacitating, or dangerous side effects, or there is a contraindication to ECT, or legitimate factors make ECT treatment (typically 3 times/week for 4–5 weeks) a hardship for the individual.

ALL of the following

Standardized scale scores of moderately severe are considered equivalent to severe rating; a diagnosis code alone that includes a numeral for severity or the descriptor moderate or severe is not sufficient to establish severity — documentation of symptoms and/or a standardized rating scale score is required.
Failure of a medication trial means the medication was not effective, was partially but inadequately effective, was effective then lost effectiveness, had to be stopped due to adverse effects, or doses could not be increased to therapeutic levels due to adverse effects. Each failed medication must be individually identified with reasons for failure. Unless stopped for intolerable adverse effects, a minimum of 30 continuous days with no or inadequate improvement is required before a medication trial is considered failed.
Second-generation antipsychotics, lithium, and anticonvulsants used as mood stabilizers are considered augmenting agents, not antidepressants. Antidepressant trials commonly used for insomnia are considered failed trials only if dosed at minimum antidepressant doses (e.g., amitriptyline 150 mg; doxepin 150 mg; mirtazapine 15 mg; trazodone 150 mg) or titration to antidepressant dose was planned but could not be done due to intolerable adverse effects.

ALL of the following

Contraindications: Vagus nerve stimulation is considered not medically necessary when there is a history of left vagotomy or bilateral vagotomy, or when current or planned therapeutic short-wave diathermy, therapeutic microwave diathermy, therapeutic ultrasound diathermy (not diagnostic ultrasound), or surgical diathermy on any body location is present.
Concomitant neuromodulation: Use of VNS in conjunction with TMS may be considered medically necessary for up to three-month intervals (initial 3 months plus up to three additional 3-month intervals) while awaiting VNS effectiveness under specified conditions; continued TMS with VNS is not medically necessary once depression improves to mild or remission by standardized rating scale or 12 months have elapsed since VNS implantation. Use of VNS in conjunction with other neuromodulation modalities (e.g., ECT, DBS, CES) for psychiatric or substance use disorders is not medically necessary. Use of VNS with Spravato (esketamine), other ketamine formulations, or psychedelic drugs is considered investigational.

ANY of the following

Other indications investigational: Vagus nerve stimulation is considered investigational for other conditions including but not limited to: autism, essential tremor, fibromyalgia, headaches, heart failure, obesity, tinnitus, traumatic brain injury, upper-limb impairment due to stroke, psychiatric conditions other than Major Depressive Disorder, and substance use disorders.
Non-implantable devices investigational: Non-implantable (transcutaneous) vagus nerve stimulation devices (e.g., gammaCore; transcutaneous auricular VNS devices) are considered investigational for all indications.

ALL of the following

Documentation requirements for seizures: Medical records must document medically refractory seizures evidenced by persistent seizures despite therapeutic antiepileptic medication levels OR intolerable side effects of drug therapy.
Documentation requirements for depression: Records must include diagnosis, severity of symptoms, brief history, medication trials with outcomes for each medication, and outcome of TMS and ECT or documented contraindications to these treatments.

ALL of the following

Summary of recent criteria changes: History entries: policy last revised Jun 23, 2025; related references updated and cross-references added (e.g., Transcranial Magnetic Stimulation and Spravato/esketamine policies). Clarifications added regarding TMS/ECT hardship definitions, documentation requirements for failed medication trials (minimum 30 days unless intolerable adverse effects), augmentation agents classification, and explicit contraindications including prior vagotomy and therapeutic diathermy. Non-implantable VNS devices and use of VNS with ketamine or psychedelic drugs were specified as investigational. These changes consolidate prior updates into the current medical necessity criteria and documentation sections.

Notes and clarifications for Major Depressive Disorder

Notes and clarifications for Major Depressive Disorder:

ALL of the following

Standardized scale scores of moderately severe are considered equivalent to severe rating.
A diagnosis code that includes a numeral for severity or a diagnosis described as moderate or severe is not sufficient to establish severity; documentation or standardized rating scale score is required.
Failure of a medication trial definition: medication not effective, partially/inadequately effective, lost effectiveness, stopped due to adverse effects, or unable to titrate to therapeutic dose due to adverse effects. Each failed medication must be listed with reasons for failure. Minimum of 30 continuous days at therapeutic dosing is required for a trial to count as failed unless stopped for intolerable adverse effects.
Augmenting agents (second-generation antipsychotics, lithium, anticonvulsants used as mood stabilizers) count as augmenting agents, not antidepressants.
Antidepressant dosing thresholds for insomnia-use medications to count as antidepressant trials: amitriptyline 150 mg; doxepin 150 mg; mirtazapine 15 mg; trazodone 150 mg — lower insomnia doses do not count unless titration to antidepressant dose was planned but prevented by adverse effects.
TMS/ECT: depression must have continued to be moderate or severe after a course of TMS or ECT, or TMS/ECT was stopped due to intolerable or incapacitating or dangerous side effects, or there is a contraindication, or legitimate factors make the standard course a hardship for the individual. Concerns about side effects or preference not to undergo TMS/ECT alone are not considered contraindications.

Limits on continued TMS: Continued TMS with VNS is not medically necessary when depression has improved to mild or remission based on a standardized rating scale, or 12 months have elapsed since VNS implantation12 months

Other neuromodulation: Use of VNS in conjunction with other neuromodulation modalities (including ECT, DBS, CES) for psychiatric or substance use disorders is considered not medically necessary

Spravato/ketamine/psychedelics: Use of VNS in conjunction with Spravato (esketamine), any other formulation of ketamine, or any psychedelic drug is considered investigational

Obesity (refer to separate related policy 7.01.516)

Traumatic brain injury

Upper-limb stroke/Vivistim: Upper-limb impairment due to stroke (e.g., Vivistim) - investigational

Psychiatric other than MDD: Psychiatric conditions other than Major Depressive Disorder

Substance use disorders

Transcutaneous VNS: Any use of non-implantable (transcutaneous) VNS devices (e.g., gammaCore, transcutaneous auricular VNS) for all indications

Cochrane reviewCochrane review(s) for VNS in partial seizures (Panebianco et al.) summarizing evidence for epilepsy

VNS paired with rehab after strokePivotal randomized VNS‑REHAB trial (Dawson 2021) and related studies show mixed results; systematic review pooled data suggest improvement in upper limb motor function but longer‑term data limited

Documentation Required

Documentation for depression

Documentation for depression must demonstrate diagnosis, severity, treatment history, and why VNS is appropriate. Submit complete records that support treatment‑resistant unipolar Major Depressive Disorder and exclusion of bipolar disorder or psychosis.

Diagnosis: confirm unipolar Major Depressive Disorder (age ≥ 18) and absence of bipolar disorder or psychotic features.
Severity: documentation of current episode severity using clinical notes and/or standardized depression rating scales.
Medication trials: list each antidepressant trial (agent, dose, start/stop dates) and for each, the outcome and reason for failure (ineffective, lost effect, intolerable adverse effects, or inadequate dose/duration).
Failed therapy thresholds: unless stopped due to intolerable adverse effects, each medication trial should be at least 30 continuous days at therapeutic doses to be considered a failed trial.
Augmentation: document trials of augmenting agents (e.g., second‑generation antipsychotics, lithium, anticonvulsant mood stabilizers) when used; specify whether augmenting agent trial(s) failed when required by criteria.
TMS/ECT outcomes or contraindications: submit results of a full course of TMS or ECT, documentation that treatment was stopped due to intolerable/incapacitating/dangerous side effects, documented contraindication, or legitimate hardship preventing completion; simple patient preference alone is insufficient as a contraindication.
Documentation of prior failed therapies and any contraindications or intolerances to therapies must be explicitly stated for each treatment tried.

Documentation Required

Documentation for seizures

Documentation for refractory seizures must establish that the member meets the policy definition of medically refractory seizures. Submit medication history and evidence supporting refractoriness or intolerance.

Record of antiseizure medication trials: list each antiepileptic drug tried, therapeutic dose achieved, dates of use, and clinical response.
Medically refractory definition: documentation that seizures persist despite therapeutic levels of antiepileptic drugs, OR that therapeutic levels could not be used because of intolerable adverse effects.
If intolerance is claimed, provide clinical notes describing adverse effects that precluded continuation or dose optimization.
If applicable, include results of relevant diagnostic testing and specialist consultation notes corroborating refractory status.

Billing Rule

Use appropriate CPT/HCPCS/L codes

Use the appropriate CPT/HCPCS/other codes when billing for VNS services and related professional work. Include the key procedural and analysis codes and ensure code selection reflects the services actually provided. Apply any code updates per the policy history and payer guidance.

Key CPT/HCPCS codes include: 61885, 61886, 64553, 64568, 64569, 95970, 95976, 95977 (see coding section/code table for full descriptions).
Report device implantation, revision, or replacement codes consistent with number of electrode arrays and procedure performed.
Report electronic analysis/programming codes for device interrogation and programming as appropriate.
Verify and apply code updates and effective dates according to policy history before claim submission.

Billing Rule

Use of specific HCPCS/CPT codes

Report the specific CPT/HCPCS codes that correspond to the procedure and device services rendered. When codes are added or removed in policy updates, ensure claims reflect the correct codes and effective dates.

Include applicable CPT/HCPCS codes for insertion, replacement, revision, percutaneous vs open implantation, and for electronic analysis/programming as listed in the coding section.
If policy history shows code additions or removals, report the code only if it was valid and in effect on the date of service.
Confirm correct usage of any L‑codes or device‑specific HCPCS where applicable and document device model/serial numbers when required for device tracking.

07/01/25revisedLatest