CurrentAmbetter NevadaPolicy CP.MP.12

Vagus Nerve Stimulation (VNS)

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Medical policy governing coverage and medical necessity criteria for implantable vagus nerve stimulation for epilepsy and statements on investigational/unproven indications; affects Ambetter Nevada members and providers requesting VNS-related services.

Policy Summary

PayerAmbetter Nevada

PolicyVagus Nerve Stimulation (VNS)

Policy CodePolicy CP.MP.12

Change TypeNo material change

Effective Date

Next Review Date

Key ActionObtain prior authorization with documentation of diagnosis, ≥1 year failure of two anti-seizure drugs, and supporting CPT/HCPCS codes for implantation, revision, or removal.

SourceLink

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CurrentAmbetter NevadaPolicy CP.MP.12

Vagus Nerve Stimulation (VNS)

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Policy Summary

PayerAmbetter Nevada

PolicyVagus Nerve Stimulation (VNS)

Policy CodePolicy CP.MP.12

Change TypeNo material change

Effective Date

Next Review Date

Key ActionObtain prior authorization with documentation of diagnosis, ≥1 year failure of two anti-seizure drugs, and supporting CPT/HCPCS codes for implantation, revision, or removal.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Medically refractory seizuresPrimary covered indication

>20%Typical seizure reduction

Not supportedNon-implantable stance

64553,64568-70Key CPT codes

K1020Non-supporting HCPCS

Coverage and Medical Necessity Criteria

Initial VNS Implantation (Medically Necessary)

Covered when ALL of the following are met:

Primary coverage criteria: A. Diagnosis of focal onset (formerly partial onset) seizures or generalized onset seizures; B. Intractable epilepsy (both): 1) Failure of at least one year of adherent therapy of at least two anti-seizure drugs; 2) Continued seizures which have a major impact on activities of daily living; C. Not a suitable candidate for, is opposed to, or has failed epilepsy surgery; D. Request is for an FDA approved device.

From policy Section I

Implanted VNS — Covered with criteria (coding listed)

Covered implantable procedures and device/HCPCS codes that support coverage for VNS implantation, revision, and removal:

Implanted VNS coding and coverage: CPT codes 64553, 64568-64570 and supporting HCPCS codes (C1767, C1778, C1816, C1883, L8680-L8683, L8685-L8689) are included as covered/supported by the policy for VNS implantation, revision, and removal.

Specific medical necessity clinical criteria (indications, prior therapy failures, etc.) are detailed in the Initial VNS Implantation criteria (Section I).

Provider actions: Prior authorization is required supporting the covered indication and use of the listed CPT/HCPCS codes for implantation, revision, removal, and associated device items.

See coding tables and prior authorization requirements referenced in policy.

Noninvasive VNS — Not supported

Noninvasive vagus nerve stimulation is not supported by this policy:

Noninvasive VNS: HCPCS K1020 (noninvasive vagus nerve stimulator) is listed in 'HCPCS Codes that Do Not Support Coverage Criteria' and therefore is not supported by the coverage criteria in this policy.

Policy history documents addition of K1020 and replacement of 'experimental/investigational' language with descriptive wording in Section II.

The policy states that VNS is considered medically necessary only for members with medically refractory focal onset or generalized onset seizures who meet all listed criteria. Use of VNS for conditions other than medically refractory epilepsy is not supported. The policy explicitly lists multiple non-epilepsy conditions for which safety and efficacy have not been proven, including but not limited to: refractory major depression or bipolar disorder, headaches, cognitive impairment associated with Alzheimer’s disease, addiction, anxiety disorders, autism, eating disorders, cancer, Crohn’s disease, essential tremor, fibromyalgia, heart failure, impaired glucose tolerance/pre-diabetes, inflammation, overweight/obesity, obsessive-compulsive disorder, panic disorder, post-traumatic stress disorder, Prader-Willi syndrome, Sjogren’s syndrome, rheumatoid arthritis, schizophrenia, sleep disorders, stroke, tinnitus, Tourette’s syndrome, and traumatic brain injury.

The policy identifies HCPCS K1020 (Noninvasive vagus nerve stimulator) in the table of HCPCS codes that do not support coverage criteria. As such, billing or requests for treatment using HCPCS K1020 do not meet the policy’s coverage criteria and may be denied.

Non-implantable and transcutaneous VNS modalities are not supported by the evidence according to this policy. The document names transcutaneous VNS (including auricular and cervical noninvasive tVNS) among those not supported and specifically identifies the AspireSR Model 106 device as lacking sufficient high-quality evidence. The policy therefore considers these non-implantable VNS approaches investigational or not proven for clinical use.

Section II and related sections of the policy are referenced to indicate investigational or not supported VNS uses. The policy language in Section III states that current research does not support use of certain VNS therapies over alternatives due to lack of large, high-quality studies; the revision history notes addition of investigational indications and replacement of ‘experimental/investigational’ wording with descriptive language in policy statements. Requests for VNS modalities or indications listed in these sections are therefore considered investigational and are not supported by the coverage criteria.

CPT and HCPCS Codes

Covered CPT Codes (cranial neurostimulator)CPTCovered

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 two or more electrode arrays.
61888	Revision or removal of cranial neurostimulator pulse generator or receiver

Covered CPT Codes (cranial nerve implantation/removal)CPTCovered

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 (eg, vagus nerve) neurostimulator electrode array, including connection to existing pulse generator.
64570	Removal of cranial nerve (eg, vagus nerve) neurostimulator electrode array and pulse generator.

HCPCS/Device CodesHCPCSCovered

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 pulse generator, single array, rechargeable, includes extension.
L8686	Implantable neurostimulator pulse generator, single array, nonrechargeable, includes extension.

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Covered CPT CodesCPTCovered

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 (eg, vagus nerve) neurostimulator electrode array, including connection to existing pulse generator.
64570	Removal of cranial nerve (eg, vagus nerve) neurostimulator electrode array and pulse generator.

HCPCS 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 pulse generator, single array, rechargeable, includes extension.
L8686	Implantable neurostimulator pulse generator, single array, nonrechargeable, includes extension.

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HCPCS Codes that Do Not Support Coverage CriteriaHCPCSNot Covered

K1020

Noninvasive vagus nerve stimulator.

Anti-seizure drug trial duration — medication trial requirement

Required medication trial duration>= 1 year of adherent therapy of at least two anti-seizure drugs

Minimum number of drugs triedAt least two anti-seizure (antiepileptic) drugs

Adherence requirementTherapy must be documented as adherent for the full >=1 year period

Purpose of requirementDemonstrates intractable epilepsy prior to VNS consideration

Prior Auth, Documentation, and Billing Actions

Prior Authorization

Obtain prior authorization for listed CPT/HCPCS

Prior authorization is required for the listed CPT and HCPCS codes to support the covered indication and use for implantation, revision, removal, and associated device items.

CPT codes (examples listed in policy): 61885, 61886, 61888, 64553, 64568, 64569, 64570
HCPCS/device codes (examples listed in policy): C1767, C1778, C1816, C1883, L8680-L8683, L8685-L8689

Prior Authorization

Verify prior authorization for implantable VNS procedures

Verify prior authorization with the Health Plan for implantable VNS procedures and supporting device codes before scheduling implantation, revision, or removal.

Covered procedural CPT codes include 64553, 64568, 64569, 64570 for implantation, revision/replacement, and removal.
Supporting HCPCS/device codes include C1767, C1778, C1816, C1883 and L8680–L8689.

Background and Rationale

Vagus nerve stimulation delivers intermittent electrical stimulation to the vagus nerve using an implanted system. The implanted device is a pacemaker-like pulse generator placed subcutaneously in the left chest with an attached lead array that connects to the left cervical vagus nerve. Implantation is usually performed as outpatient surgery by a trained surgeon, and therapy is intended to provide chronic intermittent stimulation to modulate neuronal activity for seizure control.

Definitions

Vagus nerve stimulator — device definition

Device descriptionPacemaker-like implantable device placed subcutaneously in the left chest with leads to the cervical vagus nerve

FunctionDelivers chronic intermittent electrical stimulation to the left vagus nerve

Surgical approachImplanted via small incision in the left chest and a second incision at the base of the neck; outpatient procedure typically by neurosurgeon

Medically refractory epilepsy — definition

Definition of medically refractory epilepsyFailure of at least one year of adherent therapy of at least two anti-seizure drugs with continued seizures that have a major impact on activities of daily living

Clinical implicationMeets 'intractable epilepsy' criterion for VNS consideration when documented

Policy Revision History

as writtencoding update

HCPCS K1020 (noninvasive vagus nerve stimulator) added to 'HCPCS Codes that Do Not Support Coverage Criteria' and age criteria deleted; policy language revised to describe noninvasive devices as not supporting coverage.

as writteninvestigational indications addedLatest

Additional investigational indications for VNS were added to Section II and references were reviewed and updated; ICD-10 codes were removed.

Policy Summary

PayerAmbetter Nevada

PolicyVagus Nerve Stimulation (VNS)

Policy CodePolicy CP.MP.12

Change TypeNo material change

Effective Date

Next Review Date

Key ActionObtain prior authorization with documentation of diagnosis, ≥1 year failure of two anti-seizure drugs, and supporting CPT/HCPCS codes for implantation, revision, or removal.

SourceLink

On This Page

Step Therapy

Document anti‑seizure medication trials (>=1 year, ≥2 drugs)

Document failure of at least two anti-seizure drugs with at least one year of adherent therapy prior to consideration of VNS for medically refractory epilepsy.

Policy requires: failure of at least one year of adherent therapy of at least two anti-seizure drugs (part of intractable epilepsy definition).

Step Therapy

No additional step‑therapy sequence specified

The policy and its revision history do not establish a separate step therapy sequence beyond the documented medication trial requirement; no additional step therapy requirements are specified in the cited sections.

Policy history notes additions and wording changes but does not define additional step therapy steps in these chunks.

Documentation Required

Include required CPT/HCPCS codes and supporting clinical documentation

Submit the appropriate CPT and HCPCS codes shown in the policy and include clinical documentation that supports the diagnosis, prior medication trials, functional impact, and surgical candidacy.

Include CPT codes for procedures (e.g., 61885, 61886, 61888, 64553, 64568–64570) and HCPCS/device codes (e.g., C1767, C1778, L8680–L8689) as applicable.
Document diagnosis (focal or generalized onset seizures), intractable epilepsy criteria (medication trial history and impact on activities of daily living), candidacy or contraindication for epilepsy surgery, and device FDA status.

Billing Rule

Ensure claims and documentation align with member coverage

Submit claims and documentation consistent with the policy and the member's coverage documents; coverage decisions are subject to the terms, exclusions, and limitations of the member's plan.

This policy is a guide to medical necessity and does not guarantee payment; follow applicable coverage documents, NCDs/LCDs, and plan procedures when submitting claims.

Denial Risk

Denial risk for non‑covered indications

Requests for VNS for indications other than medically refractory focal or generalized seizures (or other non‑FDA–approved uses) may be denied because safety and efficacy are not proven for those conditions.

Policy II lists numerous conditions not supported for VNS (e.g., refractory depression, headaches, Alzheimer’s cognitive impairment, autism, PTSD, etc.).

Denial Risk

Noninvasive VNS (HCPCS K1020) not supported

Do not expect coverage for noninvasive VNS (HCPCS K1020); use of HCPCS K1020 is listed as not supporting coverage criteria and may result in denial.

HCPCS K1020 is explicitly listed in 'HCPCS Codes that Do Not Support Coverage Criteria' as Noninvasive vagus nerve stimulator.

Additional requirement linkageNot a suitable candidate for, is opposed to, or has failed epilepsy surgery (per policy criteria)

Implanted VNS — procedural definition and coding

Procedural CPT referencesCPT 64553, 64568, 64569, 64570 (implantation, revision/replacement, removal of cranial nerve neurostimulator)

Procedure descriptionSurgically implanted cranial nerve (vagus) neurostimulator electrode array and pulse generator procedures

Supportive device HCPCSImplantable device HCPCS listed in policy (e.g., C1767, C1778, L8680-L8689) for covered implanted VNS items

Noninvasive VNS — definition and coverage stance

Noninvasive VNS (definition)External transcutaneous or gammaCore-type devices represented by HCPCS K1020

Coverage stanceHCPCS K1020 is listed in 'HCPCS Codes that Do Not Support Coverage Criteria' and is not supported by this policy

Clinical noteTranscutaneous (non-implantable) VNS modalities are considered investigational/unproven in policy sections