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CurrentRegence BlueCross BlueShieldPolicy 74

Vagus Nerve Stimulation

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This policy governs coverage and medical necessity for implantable and non-implantable vagus nerve stimulation, including initial treatment, revisions, and device or generator replacement. It applies to providers seeking coverage for VNS services, with clinical documentation required for review.

Policy Summary

PayerRegence BlueCross BlueShield

PolicyVagus Nerve Stimulation

Policy CodePolicy N/A

Change TypeNo material change

Effective DateAugust 1, 2026

Last ReviewJun 1, 2026

Next Review DateApril 1, 2027

Key ActionSubmit the patient's history and physical or chart notes, current symptoms, and antiepileptic medications and treatment response for review.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2+Antiepileptic drugs required for medically necessary implantable VNS

25%Approximate seizure-frequency reduction after three months of VNS

All indicationsNon-implantable and transcutaneous VNS investigational

3Required documentation categories for medical necessity review

Medical Necessity and Coverage Criteria

Initial implantable VNS for medically refractory seizures

Implantable VNS may be considered medically necessary when the following criterion is met:

Medically refractory seizures: The patient has medically refractory seizures and has tried and been unresponsive to or intolerant of at least two antiepileptic drugs.At least 2 antiepileptic drugs

Revision of existing stimulator

Revision of an existing stimulator may be considered medically necessary when:

Existing stimulator revision: The existing stimulator has been placed and requires revision.Existing stimulator already placed

Policy Summary

PayerRegence BlueCross BlueShield

PolicyVagus Nerve Stimulation

Policy CodePolicy N/A

Change TypeNo material change

Effective DateAugust 1, 2026

Last ReviewJun 1, 2026

Next Review DateApril 1, 2027

Key ActionSubmit the patient's history and physical or chart notes, current symptoms, and antiepileptic medications and treatment response for review.

SourceLink

On This Page

Replacement of stimulator or generator

Replacement of all or part of an existing stimulator and/or generator is medically necessary only when all of the following conditions are met:

Replacement eligibility

The existing stimulator and/or generator is malfunctioning.
The existing stimulator and/or generator cannot be repaired.
The existing stimulator and/or generator is no longer under warranty.

Not medically necessary replacement

Replacement is not medically necessary when Criterion III is not met, including when:

Replacement criterion not met

The existing stimulator and/or generator is not malfunctioning.
The existing stimulator and/or generator can be repaired.
The existing stimulator and/or generator remains under warranty.

Investigational implantable VNS

Implantable VNS is considered investigational when either of the following applies:

Criterion I for medically refractory seizures is not met.
The implantable VNS is used for another indication, including but not limited to essential tremor.

Investigational transcutaneous or non-implantable VNS

Transcutaneous and non-implantable VNS devices are considered investigational when:

Non-implantable VNS: The requested device is transcutaneous or otherwise non-implantable.All indications

Initial implanted VNS for medically refractory seizures

Implanted VNS may be considered medically necessary for medically refractory seizures when:

Medically refractory seizures: The patient has medically refractory seizures and has had an inadequate response to or is intolerant of at least two antiepileptic drugs.At least 2 antiepileptic drugs

Revision of existing stimulator

Revision may be considered medically necessary when:

Existing stimulator revision: An existing vagus nerve stimulator has been placed and revision is needed to allow proper functioning of the device.Existing stimulator in place

Replacement of all or part of a stimulator

Replacement of all or part of a stimulator may be considered medically necessary when all of the following conditions are met:

Device replacement

The stimulator can no longer perform its basic function because of damage or wear.
The stimulator is out of its warranty period.
The stimulator cannot be repaired adequately to meet the patient's medical needs.
The applicable device replacement criteria are met.

Investigational implanted VNS indications

Implanted VNS is considered investigational when:

Implanted VNS for other indications: The indication is other than medically refractory seizures, or the patient is not among the selected patients with refractory seizures for whom implanted VNS may be considered.No qualifying refractory-seizure indication

Investigational transcutaneous or non-implantable VNS

Transcutaneous and non-implantable VNS are considered investigational for every indication when:

Non-implantable VNS: The requested device is transcutaneous or otherwise non-implantable VNS, regardless of the condition being treated, including cluster headache.Transcutaneous or non-implantable device

Vagus nerve blocking therapy is outside the scope of this policy.

Implantable vagus nerve stimulators placed at the gastroesophageal junction and contacting the vagus nerve trunks are not addressed in this evidence review.

Replacement is not medically necessary when the stimulator remains within its warranty period or can be repaired or adapted adequately to meet the patient's medical needs.

Transcutaneous and non-implantable vagus nerve stimulators are considered investigational for all indications, including cluster headache.

Replacement of all or part of an existing stimulator or generator is not medically necessary when the device is not malfunctioning or when the applicable replacement criterion is not met.

Replacement of a stimulator is not medically necessary when the device is under warranty or can be repaired or adapted adequately to meet the patient's medical needs.

Coding and Reference Metrics

FDA Product Codesmixed

LYJ	FDA product code for implantable VNS devices
PKR	FDA product code for noninvasive VNS devices

CPT CodesCPT

0908T	Open implantation of integrated neurostimulation system, vagus nerve, including analysis and programming, when performed.
0909T	Replacement of integrated neurostimulation system, vagus nerve, including analysis and programming, when performed.
0910T	Removal of integrated neurostimulation system, vagus nerve.
0911T	Electronic analysis of implanted integrated neurostimulation system, vagus nerve; without programming by physician or other qualified health care professional.
0912T	Electronic analysis of implanted integrated neurostimulation system, vagus nerve; with simple programming by physician or other qualified health care professional.
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 two or more electrode arrays.
61888	Revision or removal of cranial neurostimulator pulse generator or receiver.
64553	Percutaneous implantation of neurostimulator electrode array; cranial nerve.
64568	Open implantation of cranial nerve (eg, vagus nerve) neurostimulator electrode.

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Vagus and cranial nerve neurostimulator procedure and analysis 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 two or more electrode arrays
61888	Revision or removal of cranial neurostimulator pulse generator or receiver
64553	Percutaneous implantation of neurostimulator electrode array; cranial nerve
64568	Open implantation of cranial nerve (eg, vagus nerve) neurostimulator electrode array and pulse generator
64569	Revision or replacement of cranial nerve (e.g., vagus nerve) neurostimulator electrode array, including connection to existing pulse generator
64570	Removal of cranial nerve (e.g., vagus nerve) neurostimulator electrode array and pulse generator
95970	Electronic analysis of implanted neurostimulator pulse generator/transmitter (eg, contact group[s], interleaving, amplitude, pulse width, frequency [Hz], on/off cycling, burst, magnet mode, dose lockout, patient selectable parameters, responsive neurostimulation, detection algorithms, closed loop parameters, and passive parameters) by physician or other qualified health care professional; with brain, cranial nerve, spinal cord, peripheral nerve, or sacral nerve
95971	Electronic analysis of implanted neurostimulator pulse generator/transmitter, without programming

Cranial nerve neurostimulator implantation, management, and analysis codesCPT

61888	Implanted neurostimulator pulse generator/transmitter
64553	Percutaneous implantation of neurostimulator electrode array; cranial nerve
64568	Open implantation of cranial nerve (eg, vagus nerve) neurostimulator electrode array and pulse generator
64569	Revision or replacement of cranial nerve (e.g., vagus nerve) neurostimulator electrode array, including connection to existing pulse generator
64570	Removal of cranial nerve (e.g., vagus nerve) neurostimulator electrode array and pulse generator
95970	Electronic analysis of implanted neurostimulator pulse generator/transmitter by physician or other qualified health care professional; with brain, cranial nerve, spinal cord, peripheral nerve, or sacral nerve
95971	Electronic analysis of implanted neurostimulator pulse generator/transmitter, without programming; with simple spinal cord, or peripheral nerve (eg, sacral nerve) neurostimulator
95976	Neurostimulator pulse generator/transmitter programming code listed in the policy

Vagus nerve neurostimulator implantation, revision/replacement, and removalCPT

64568	Open implantation of cranial nerve (eg, vagus nerve) neurostimulator electrode array and pulse generator
64569	Revision or replacement of cranial nerve (e.g., vagus nerve) neurostimulator electrode array, including connection to existing pulse generator
64570	Removal of cranial nerve (e.g., vagus nerve) neurostimulator electrode array and pulse generator

Neurostimulator electronic analysis and programmingCPT

95970	Electronic analysis of implanted neurostimulator pulse generator/transmitter; with brain, cranial nerve, spinal cord, peripheral nerve, or sacral nerve neurostimulator pulse generator/transmitter, without programming
95971	Electronic analysis of implanted neurostimulator pulse generator/transmitter; with simple spinal cord, or peripheral nerve (eg, sacral nerve) neurostimulator pulse generator/transmitter programming by physician or other qualified health care professional
95976	Electronic analysis of implanted neurostimulator pulse generator/transmitter

Vagus nerve stimulation and implanted neurostimulator management codesCPT

64569	Revision or replacement of cranial nerve (e.g., vagus nerve) neurostimulator electrode array, including connection to existing pulse generator
64570	Removal of cranial nerve (e.g., vagus nerve) neurostimulator electrode array and pulse generator
95970	Electronic analysis of implanted neurostimulator pulse generator/transmitter (eg, contact group[s], interleaving, amplitude, pulse width, frequency [Hz], on/off cycling, burst, magnet mode, dose lockout, patient selectable parameters, responsive neurostimulation, detection algorithms, closed loop parameters, and passive parameters) by physician or other qualified health care professional; with brain, cranial nerve, spinal cord, peripheral nerve, or sacral nerve, neurostimulator pulse generator/transmitter, without programming
95971	Electronic analysis of implanted neurostimulator pulse generator/transmitter; with simple spinal cord, or peripheral nerve (eg, sacral nerve) neurostimulator pulse generator/transmitter programming by physician or other qualified health care professional
95976	Electronic analysis of implanted neurostimulator pulse generator/transmitter; with simple spinal cord, or peripheral nerve (eg, sacral nerve) neurostimulator pulse generator/transmitter programming by physician or other qualified health care professional

Procedure CodesCPT

64569	Revision or replacement of cranial nerve (e.g., vagus nerve) neurostimulator electrode array, including connection to existing pulse generator
64570	Removal of cranial nerve (e.g., vagus nerve) neurostimulator electrode array and pulse generator
95970	Electronic analysis of implanted neurostimulator pulse generator/transmitter by physician or other qualified health care professional; with brain, cranial nerve, spinal cord, peripheral nerve, or sacral nerve neurostimulator pulse generator/transmitter, without programming
95971	Electronic analysis of implanted neurostimulator pulse generator/transmitter by physician or other qualified health care professional; with simple spinal cord, or peripheral nerve (e.g., sacral nerve) neurostimulator pulse generator/transmitter programming
95976	Electronic analysis of implanted neurostimulator pulse generator/transmitter; with simple spinal cord, or peripheral nerve (eg, sacral nerve) neurostimulator pulse generator/transmitter programming by physician or other qualified health care professional

Procedure codesCPT

64570	Removal of cranial nerve (e.g., vagus nerve) neurostimulator electrode array and pulse generator; electrode array, including connection to existing pulse generator
95970	Electronic analysis of implanted neurostimulator pulse generator/transmitter (eg, contact group[s], interleaving, amplitude, pulse width, frequency [Hz], on/off cycling, burst, magnet mode, dose lockout, patient selectable parameters, responsive neurostimulation, detection algorithms, closed loop parameters, and passive parameters) by physician or other qualified health care professional; with brain, cranial nerve, spinal cord, peripheral nerve, or sacral nerve, neurostimulator pulse generator/transmitter, without programming
95971	With simple spinal cord, or peripheral nerve (eg, sacral nerve) neurostimulator pulse generator/transmitter programming by physician or other qualified health care professional
95976	Electronic analysis of implanted neurostimulator pulse generator/transmitter (eg, contact group[s], interleaving, amplitude, pulse width, frequency [Hz], on/off cycling, burst, magnet mode, dose lockout, patient selectable parameters, responsive neurostimulation, detection algorithms, closed loop parameters, and passive parameters) by physician or other qualified health care professional

CPT CodesCPT

64570	Removal of cranial nerve (e.g., vagus nerve) neurostimulator electrode array and pulse generator
95970	Electronic analysis of implanted neurostimulator pulse generator/transmitter (eg, contact group[s], interleaving, amplitude, pulse width, frequency [Hz], on/off cycling, burst, magnet mode, dose lockout, patient selectable parameters, responsive neurostimulation, detection algorithms, closed loop parameters, and passive parameters) by physician or other qualified health care professional; with brain, cranial nerve, spinal cord, peripheral nerve, or sacral nerve, neurostimulator pulse generator/transmitter, without programming
95971	Electronic analysis of implanted neurostimulator pulse generator/transmitter (eg, contact group[s], interleaving, amplitude, pulse width, frequency [Hz], on/off cycling, burst, magnet mode, dose lockout, patient selectable parameters, responsive neurostimulation, detection algorithms, closed loop parameters, and passive parameters) by physician or other qualified health care professional; with brain, cranial nerve, spinal cord, peripheral nerve, or sacral nerve, neurostimulator pulse generator/transmitter, without programming
95976	Electronic analysis of implanted neurostimulator pulse generator/transmitter by physician or other qualified health care professional; with simple spinal cord or peripheral nerve (eg, sacral nerve) neurostimulator pulse generator/transmitter programming; the document also identifies simple cranial nerve neurostimulator pulse generator/transmitter programming

Vagus nerve and neurostimulator procedure codesCPT

64570	Removal of cranial nerve (e.g., vagus nerve) neurostimulator electrode array and pulse generator
95970	Electronic analysis of implanted neurostimulator pulse generator/transmitter (eg, contact group[s], interleaving, amplitude, pulse width, frequency [Hz], on/off cycling, burst, magnet mode, dose lockout, patient selectable parameters, responsive neurostimulation, detection algorithms, closed loop parameters, and passive parameters) by physician or other qualified health care professional; with brain, cranial nerve, spinal cord, peripheral nerve, or sacral nerve neurostimulator pulse generator/transmitter, without programming
95971	Electronic analysis of implanted neurostimulator pulse generator/transmitter by physician or other qualified health care professional; with simple spinal cord or peripheral nerve (eg, sacral nerve) neurostimulator pulse generator/transmitter programming
95976	Electronic analysis of implanted neurostimulator pulse generator/transmitter (eg, contact group[s], interleaving, amplitude, pulse width, frequency [Hz], on/off cycling, burst, magnet mode, dose lockout, patient selectable parameters, responsive neurostimulation, detection algorithms, closed loop parameters, and passive parameters) by physician or other qualified health care professional; with simple cranial nerve neurostimulator pulse generator/transmitter

Vagus nerve stimulation procedure and neurostimulator analysis/programming codesCPT

64570	and pulse generator
95970	Electronic analysis of implanted neurostimulator pulse generator/transmitter (eg, contact group[s], interleaving, amplitude, pulse width, frequency [Hz], on/off cycling, burst, magnet mode, dose lockout, patient selectable parameters, responsive neurostimulation, detection algorithms, closed loop parameters, and passive parameters) by physician or other qualified health care professional
95971	Electronic analysis of implanted neurostimulator pulse generator/transmitter; with brain, cranial nerve, spinal cord, peripheral nerve, or sacral nerve neurostimulator pulse generator/transmitter, without programming
95976	Electronic analysis of implanted neurostimulator pulse generator/transmitter; with simple cranial nerve neurostimulator pulse generator/transmitter programming by physician or other qualified health care professional

Prior antiepileptic drug trials

Minimum prior trialsAt least two antiepileptic drugs must have been tried.

Required responseThe patient must have been unresponsive to the tried antiepileptic drugs.

Alternative to unresponsivenessIntolerance of the tried antiepileptic drugs also satisfies the stated requirement.

Observed seizure-frequency reduction

Observed outcomeRandomized controlled trials reported an approximate 25% reduction in partial-onset seizure frequency.

Time pointThe reduction was reported following three months of VNS.

PopulationThe finding concerns patients with drug-resistant partial-onset seizures.

FDA depression indication

Minimum ageThe indication applies to patients 18 years of age or older.

ConditionThe patient must be experiencing a major depressive episode.

Prior treatmentThe patient must not have had an adequate response to four or more adequate antidepressant treatments.

Documentation and Review Requirements

Documentation Required

Submit Clinical Records for Review

Submit clinical documentation supporting the applicable coverage criteria for review. Missing documentation may affect the review and coverage decision.

Clinical documentation supporting the criteria is required.
Submit the requested records for review to determine whether policy criteria are met.

Documentation Required

Required Clinical Documentation

The following information must be submitted for review: history and physical or chart notes, current symptomology, and antiepileptic medications given with the patient's response.

History and Physical/Chart Notes
Current Symptomology
Antiepileptic medications given and response

Denial Risk

Replacement Criteria Not Met

Replacement of all or part of an existing stimulator and/or generator is considered not medically necessary when Criterion III is not met.

Replacement coverage is denied when the applicable replacement criterion is unsatisfied.

Denial Risk

Implantable VNS Indication Not Covered

Implantable VNS is considered investigational when Criterion I is not met and for all other indications, including but not limited to essential tremors.

Coverage is limited to selected patients who meet the medically refractory seizure criterion.

Denial Risk

Non-Implantable VNS Is Investigational

Transcutaneous and other non-implantable vagus nerve stimulation devices are considered investigational for all indications.

This includes non-implantable vagus nerve stimulators (nVNS), including devices used for cluster headache or any other condition.
Non-implantable VNS is investigational regardless of the indication.

Denial Risk

Insufficient Clinical Documentation

If required supporting records are not submitted, this could affect the review and decision outcome.

Ensure the history and physical or chart notes, current symptomology, and antiepileptic medication history and response are included.

Denial Risk

Replacement Is Repairable or Under Warranty

Replacement of a stimulator is considered not medically necessary when the device is within its warranty period or can be repaired or adapted adequately to meet the patient's medical needs.

Confirm that the device is not under warranty.
Confirm that repair or adaptation cannot adequately meet the patient's medical needs.

Denial Risk

Investigational Indication or Device Type

VNS is considered investigational for indications other than selected patients with medically refractory seizures, and transcutaneous or non-implantable devices are investigational for all indications.

Non-selected indications, including but not limited to essential tremors and cluster headache, are investigational.
Transcutaneous and non-implantable vagus nerve stimulators are investigational for every indication.

Clinical Background

Vagus nerve stimulation uses an implanted pulse generator located in the infraclavicular region. The generator delivers mild electrical impulses through two electrodes connected to and wrapped around the vagus nerve in the neck. Stimulation may be programmed in advance or activated on demand by placing a magnet over the generator site. The therapeutic mechanism is not fully understood; stimulation of vagal afferent pathways projects through the brainstem to multiple areas of the brain and may broadly affect neuronal excitability.

Key Terms and Clinical Definitions

Implantable vagus nerve stimulation

System typeAn implanted vagus nerve stimulation system.

Pulse generatorAn infraclavicular pulse generator sends weak electrical impulses.

Target nerveThe impulses are delivered to the left vagus nerve within the carotid sheath in the neck.

Transcutaneous or non-implantable vagus nerve stimulation

Delivery methodVagus nerve stimulation is delivered without an implanted device.

ExamplesThe category includes transcutaneous stimulation systems.

Surgical requirementNo surgical implantation is required.

Medically refractory seizures

DefinitionSeizures are medically refractory when the patient has tried and been unresponsive to or intolerant of antiepileptic drugs.

Minimum treatment historyAt least two antiepileptic drugs must have been tried.

Qualifying outcomesEither unresponsiveness or intolerance meets the treatment-history description.

Transcutaneous or noninvasive VNS (nVNS)

DeliveryVNS is delivered externally through the skin.

Device distinctionThe system uses neither an implanted generator nor an implanted lead.

TerminologyThis approach is also called transcutaneous or noninvasive VNS, abbreviated nVNS.

Episodic and chronic cluster headache

Episodic cluster headacheEpisodic cluster headache (eCH) is one of the prespecified cluster-headache cohorts evaluated in the cited studies.

Chronic cluster headacheChronic cluster headache (cCH) is the other prespecified cohort evaluated in the cited studies.

Study classificationThe cited studies evaluated episodic and chronic cluster-headache subgroups separately.

Response rate

Response rateThe proportion of subjects who achieved pain relief.

Pain-relief thresholdPain relief was defined as pain intensity of 0 or 1.

Assessment windowThe measure applied at 15 minutes after treatment initiation for the first cluster-headache attack, without rescue medication through 60 minutes.