CurrentCentenePolicy CP MP.12

Clinical Policy: Vagus Nerve Stimulation

Defines medical necessity criteria for implantable vagus nerve stimulation (VNS) for medically refractory epilepsy (focal or generalized seizures) and lists conditions/uses considered not proven or not supported; includes coding guidance for CPT and HCPCS codes that support or do not support coverage.

Policy Summary

PayerCentene

PolicyClinical Policy: Vagus Nerve Stimulation

Policy CodePolicy CP MP.12

Change TypeAnnual review; coding and minor criteria corrections

Effective DateJul 1, 2025

Next Review Date

Key ActionRequests must document diagnosis, failure of at least one year of adherent therapy with at least two anti-seizure drugs, impact on activities of daily living, surgical candidacy status, and that the device is FDA-approved.

POLICY UPDATE CHANGES

Annual review. References reviewed and updated. Reviewed by external.

Corrected criteria text to read 'essential tremor'.

Added HCPCS code K1020 to table of HCPCS codes that do not support coverage criteria (noninvasive VNS).

1Covered Indication (Epilepsy)

>20Investigational/Not Supported Indications

~20CPT/HCPCS codes referenced

Coverage Summary

Scope: Defines medical necessity criteria for implantable vagus nerve stimulation (VNS) for members with medically refractory epilepsy (focal or generalized onset seizures), lists conditions and uses considered not proven or not supported, and provides coding guidance for CPT and HCPCS codes that support or do not support coverage. Policy Number: CP MP.12. Effective Date: 2025-07-01 (Date of Last Revision/Approval: 07/25).

Overview (Medical Necessity Summary): Implantable VNS is considered medically necessary when ALL of the following are met: diagnosis of focal onset (formerly partial onset) seizures or generalized onset seizures; intractable epilepsy defined as continued seizures that have a major impact on activities of daily living despite at least one year of adherent therapy with at least two anti-seizure drugs; the patient is not a suitable candidate for, is opposed to, or has failed epilepsy surgery; and the request is for an FDA-approved device.

Not proven / Not supported indications: Safety and efficacy of VNS have not been proven for many other conditions (examples include headaches, treatment‑resistant major depression or bipolar disorder, Alzheimer’s cognitive impairment, anxiety disorders, addiction, autism, cancer, eating disorders, Crohn’s disease, essential tremor, heart failure, fibromyalgia, impaired glucose tolerance/pre‑diabetes, overweight/obesity, inflammation, OCD, panic disorder, PTSD, Prader‑Willi syndrome, rheumatoid arthritis, Sjogren’s syndrome, schizophrenia, stroke, sleep disorders, tinnitus, traumatic brain injury, Tourette’s syndrome).

Coding guidance: CPT and HCPCS codes that support coverage (examples listed in policy) should be used for implant, revision, removal, and device supplies; the HCPCS code K1020 (Noninvasive vagus nerve stimulator) is listed as not supporting coverage criteria and should not be used to justify coverage for implantable VNS.

Coding

CPT Codes that Support Coverage CriteriaCPTCovered

61885	Insertion or replacement of cranial neurostimulator generator or receiver, direct or inductive coupling; with connection to a single electrode array/pulse
61886	Insertion or replacement of cranial neurostimulator generator or receiver; direct or inductive coupling; with connection to two or more electrode arrays/pulse
61888	Revision or removal of cranial neurostimulator pulse generator or receiver
64553
64568	Open implantation of cranial nerve (eg, vagus nerve) neurostimulator electrode array and pulse generator
64569	Revision or replacement of cranial nerve (eg, vagus nerve) neurostimulator electrode array including connection to existing generator/pulse
64570	Removal of cranial nerve (eg, vagus nerve) neurostimulator electrode array and pulse generator

HCPCS / Supply Codes that Support Coverage CriteriaHCPCSCovered

C1767	Generator, neurostimulator (implantable) nonrechargeable
C1778	Lead, neurostimulator (implantable)
C1816	Receiver and/or transmitter, neurostimulator (implantable)
C1883	Adaptor/extension pacing lead or neurostimulator lead (implantable)
L8680	Implantable neurostimulator electrode, each
L8681	Patient programmer (external) for use with implantable programmable neurostimulator pulse generator, replacement only
L8682	Implantable neurostimulator radiofrequency receiver
L8683	Radiofrequency transmitter (external) for use with implantable neurostimulator radiofrequency receiver
L8685	Implantable neurostimulator generator, single array, rechargeable, includes extension/pulse
L8686	Implantable neurostimulator pulse generator, single array, nonrechargeable, includes extension

1–10 of 13

1/2

HCPCS Codes that Do Not Support Coverage CriteriaHCPCSNot Covered

K1020

Noninvasive vagus nerve stimulator

Provider Actions

Prior Authorization

Prior authorization required for implantable VNS

Requests for implantable VNS require prior authorization. Documentation should include the diagnosis, evidence of failure of at least one year of adherent therapy with at least two anti-seizure drugs, description of the major impact on activities of daily living, the member's surgical candidacy status (not a candidate for, opposed to, or failed epilepsy surgery), and confirmation that the requested device is FDA-approved.

Documentation Required

Document medication adherence and duration

Document that the patient has had at least one year of adherent therapy with at least two antiseizure medications prior to requesting implantable VNS.

Billing Rule

Use CPT/HCPCS codes that support coverage

Report the CPT and HCPCS codes for implantable VNS procedures, revisions, removals, and device supplies that support coverage. Do not use HCPCS K1020 (noninvasive vagus nerve stimulator) to justify coverage for implantable VNS because K1020 is listed as not supporting the coverage criteria.

61885
61886
61888
64568
64569
64570
C1767
C1778
C1816
C1883
L8680
L8681
L8682
L8683
L8685
L8686
L8687
L8688
L8689
K1020

Background & Evidence

Background: Implantable VNS delivers chronic intermittent electrical pulses to the cervical portion of the vagus nerve via a generator implanted under the skin in the left chest connected to a lead placed at the base of the neck; the device functions like a pacemaker and is typically implanted by a neurosurgeon as an outpatient procedure.

Mechanism and primary uses: Chronic intermittent stimulation of the left vagus nerve is designed to treat medically refractory epilepsy and has evidence of reducing seizure frequency in focal and some generalized epilepsies; VNS is also FDA‑approved as an adjunctive therapy for treatment‑resistant major depression, though randomized controlled trials have not consistently demonstrated benefit.

Noninvasive VNS (tVNS): Transcutaneous VNS devices (auricular or cervical; e.g., gammaCore, Phoenix) are noninvasive alternatives under investigation for indications including epilepsy, migraine/cluster headache, depression, and PTSD. Current evidence is limited and of variable quality — the policy states that tVNS and active auricular transcutaneous electrical nerve stimulation are not supported over other alternatives due to lack of high‑quality studies and that further larger, controlled trials are needed.

Evidence	Summary
Seizure frequency reduction (EOS study)	High stimulation showed average 28% reduction vs 15% low; overall mean decline about 25-30% vs baseline
AspireSR Model 106	Insufficient evidence to establish safety and efficacy of AspireSR Model 106 in reducing seizures until further high-quality trials
Depression RCTs	Two RCTs found no benefit; one RCT response rates 15% active vs 10% sham

Name	Number	Effective Date	Type
Vagus nerve stimulation	160.18	2019-02-15	NCD

Revision History

07/25revisedLatest

Annual review. References reviewed and updated. Reviewed by external.

09/24revised

Corrected criteria text to read 'essential tremor'.

Earlier (added previously)added (material)