Premera Bluecross VNS Coverage Prior Auth

Refractory Seizures (Implanted VNS)

Covered when ALL of the following are met

Refractory seizure criteria: Medically refractory seizures defined as seizures that occur despite therapeutic antiepileptic drug levels OR seizures that cannot be treated with therapeutic levels because of intolerable adverse effects of these drugs.

Applicable for pediatric and adult individuals.

Major Depressive Disorder (Implanted VNS)

Covered when ALL of the following are met

Age: Individual is aged 18 years old and older.

Diagnosis and severity: Current episode of moderate to severe unipolar major depressive disorder without psychotic features, documented by symptoms or standardized rating scales.

No acute or chronic psychotic symptoms present.

Prior medication trials: Either failure of ≥3 antidepressant medications from ≥2 different classes in separate trials OR failure of ≥2 antidepressant medications from ≥2 classes plus failure with the addition of an augmenting agent to at least one of the failed antidepressants.

Trials of antidepressants commonly used for insomnia count only if antidepressant dose reached (amitriptyline 150 mg; doxepin 150 mg; mirtazapine 15 mg; trazodone 150 mg).

Prior neuromodulation: Depression remained moderate to severe after a course of transcranial magnetic stimulation (TMS), or TMS was stopped for intolerable/incapacitating/dangerous side effects or contraindicated or impractical; AND/OR depression remained moderate to severe after a course of electroconvulsive therapy (ECT), or ECT was stopped for intolerable/incapacitating/dangerous side effects or contraindicated or impractical.

Concerns or desire to avoid TMS or ECT are not considered contraindications; legitimate hardship that makes usual schedules impractical may be acceptable.

VNS with TMS (Concurrent use)

Covered when ALL of the following are met

Time-limited combined therapy: Use of VNS in conjunction with TMS may be considered medically necessary for up to 3 months after VNS implantation while waiting for VNS effect if the individual has just completed an intensive course of TMS and is transitioning to maintenance TMS, or is undergoing maintenance TMS and TMS was partially but inadequately effective.

May be extended for up to three additional 3‑month intervals if VNS has not resulted in improvement to mild or remission at end of each interval; continued concurrent TMS beyond these limits is not medically necessary, and total combined use should be reassessed if depression improves to mild or remission or 12 months have elapsed since implantation.

Not routine concurrent: Use of TMS with VNS is not medically necessary except in the specified transition/maintenance circumstances described above.

Any other concurrent use of VNS with other neuromodulation modalities (ECT, DBS, CES) is considered not medically necessary.

Coverage summaries by indication

Coverage stance summarized from evidence sections

Insufficient evidence for many indications: For several indications (e.g., implanted VNS for non-seizure neurologic conditions; transcutaneous/nVNS for cluster or migraine prevention; many other neurologic, psychiatric, or metabolic disorders), the evidence is insufficient to determine improvement in net health outcome because of small trials, methodological limitations, or lack of durable outcomes.

Supported by case series, small RCTs, and short treatment periods in cited studies.

Implanted VNS for refractory partial-onset seizures: Medicare and guideline statements recognize implanted VNS as safe and effective for medically refractory partial-onset seizures when resective surgery is not recommended or has failed.

CMS national coverage referenced.

Implanted VNS for treatment-resistant depression: Evidence shows delayed onset of effect (typically beginning ~3 months, with maximum response by 6–12 months); more recent larger observational studies report clinically meaningful response/remission in patients who have failed multiple prior treatments, but randomized trials had earlier methodological limitations. CMS expanded Medicare coverage for FDA-approved devices for TRD only through Coverage with Evidence Development in approved RCTs.

Device-labeled Indications

Indications and cleared uses (device-labeled):

FDA-cleared indications: Includes: adjunctive long-term treatment of chronic or recurrent depression for patients ≥18 years with a major depressive episode not responding to ≥4 adequate antidepressant treatments; adjunctive therapy for partial-onset seizures in patients ≥4 years refractory to antiepileptic medications; acute and preventive treatment of cluster and migraine headache in adults for specified gammaCore devices; vagus nerve stimulation paired with rehabilitation to improve upper-extremity motor deficits in chronic ischemic stroke patients (Vivistim).

Extracted from device regulatory listings (PMA/510(k) summaries).

Emerging/Investigational Uses

Other clinical areas discussed in cited literature:

Investigational or emerging uses: Stroke motor recovery, fibromyalgia, tinnitus, autism and other neurodevelopmental disorders, schizophrenia, impaired glucose tolerance, and other neuropsychiatric or neurologic indications have been examined in trials or pilot studies but are not FDA-cleared indications (except where specifically cleared, e.g., Vivistim); evidence is limited and often consists of small trials, case series, or preliminary studies.

Based on systematic reviews, randomized trials, and case series referenced in the evidence section.

MDD and Concomitant Modality Criteria (history notes)

Policy updates and criteria for Major Depressive Disorder (MDD) and use with other modalities noted in history

VNS for Major Depressive Disorder - historical additions: Policy updated (08/01/24 onward) with criteria when VNS may be considered medically necessary for MDD, including limited use in conjunction with TMS; added that VNS is investigational for other psychiatric disorders and substance use disorders; added exclusions 'not bipolar depression' and 'No acute or chronic psychosis'; added documentation expectations for failed medication, TMS, and ECT trials and acceptance of legitimate hardship/contraindication reasons for incomplete TMS/ECT schedules.

Subsequent interim reviews (2025–2026) clarified maintenance TMS transition language, documentation requirements, and coding updates.

Vagus nerve stimulation (VNS) is considered investigational (not covered) for a variety of other clinical conditions where evidence is insufficient to support a net health benefit. Examples include, but are not limited to: autism, essential tremor, fibromyalgia, headaches (non‑cluster), heart failure, obesity, tinnitus, traumatic brain injury, upper‑limb impairment due to stroke (excluding the FDA‑cleared Vivistim indication), psychiatric conditions other than Major Depressive Disorder, and substance use disorders. The evidence for these indications is predominantly limited to case series, small randomized trials with methodological limitations, or short follow‑up, and therefore does not demonstrate durable, clinically meaningful benefit.

Non‑implantable (transcutaneous or noninvasive) vagus nerve stimulation devices (e.g., gammaCore and transcutaneous auricular VNS) are investigational for all indications. Randomized trials for cluster headache and migraine have shown mixed or inconsistent results, and trials for other neurologic or psychiatric conditions are small or methodologically limited; overall, the body of evidence is insufficient to establish improvement in net health outcomes.

Under the Centers for Medicare & Medicaid Services (CMS) national coverage determination, VNS is covered for medically refractory partial‑onset seizures but is not covered for other seizure types. CMS explicitly limits coverage to partial‑onset seizure disorders when surgery is not recommended or has failed.

This policy segment does not list discrete administrative exclusions beyond the investigational and not‑medically‑necessary statements elsewhere; historically, certain indications (for example, essential tremor) have been noted as investigational in prior history entries. Where an FDA‑cleared device indication exists (e.g., Vivistim for post‑stroke upper‑limb rehabilitation), that regulatory status is described separately and does not imply general coverage outside the policy criteria.

Policy history updates specify that VNS is considered investigational for the treatment of any other psychiatric disorders other than Major Depressive Disorder and for substance use disorders; the history also clarifies that transcutaneous auricular VNS is considered investigational. These stipulations were added during the 08/01/24 interim review and are reflected in the exclusions and investigational statements of the policy.

Clarifying edits added to the Major Depressive Disorder criteria include the specification that the indication is not for bipolar depression and that individuals must have no acute or chronic psychosis. These additions were recorded in policy history to further define appropriate candidate selection for implanted VNS in MDD.

Use of VNS together with Spravato (esketamine), any other formulation of ketamine, or any psychedelic drug is classified as investigational. This policy statement was added in the 08/01/24 update to address concomitant use of VNS with these agents.

Continuation of TMS concurrently with VNS is considered not medically necessary when depression has improved to mild or remission on a standardized rating scale, or when 12 months have elapsed since VNS implantation. The policy allows limited, time‑boxed concurrent use of TMS with VNS (see criteria for transition/maintenance circumstances) but identifies continued concurrent TMS beyond improvement or the 12‑month post‑implantation period as not medically necessary.

Both implanted and transcutaneous VNS have been evaluated for numerous neurologic, psychiatric, and metabolic disorders (for example, essential tremor, fibromyalgia, tinnitus, autism, noncluster headache, and others), but the current evidence is generally limited to small RCTs, feasibility studies, or case series. Because of these methodological limitations and inconsistent findings, use of implanted VNS or transcutaneous VNS for these other indications is considered investigational or has insufficient evidence to support routine coverage.

This segment of the policy synthesizes numerous trials and guideline documents but does not itself present a discrete list of 'not medically necessary' administrative rules beyond the clinical statements cited. The evidence review references randomized trials, systematic reviews, and guideline assessments that inform the policy’s investigational and not medically necessary determinations.

VNS used in combination with any other neuromodulation modality (other than the limited, specified TMS transition/maintenance circumstance) for psychiatric disorders or for substance use disorders is considered not medically necessary. The policy also reiterates that combining VNS with Spravato or other ketamine formulations or psychedelics is investigational.

The policy reiterates that VNS in conjunction with Spravato (esketamine), other ketamine formulations, or psychedelic drugs is investigational. This provision was added in the 08/01/24 interim review and is maintained in the policy history and coverage statements.

Billing and Coding

Covered CPT Codes (procedures and analysis)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 2 or more electrode arrays.
64553	Percutaneous implantation of neurostimulator electrodes; cranial nerve.
64568	Open implantation of cranial nerve (e.g., 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.
95970	Electronic analysis of implanted neurostimulator pulse generator/transmitter without programming.
95976	Electronic analysis of implanted neurostimulator pulse generator/transmitter with simple cranial nerve neurostimulator programming.
95977	Electronic analysis of implanted neurostimulator pulse generator/transmitter with complex cranial nerve neurostimulator programming.

HCPCS and supply codesHCPCS

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.
L8685	Implantable neurostimulator pulse generator, single array, rechargeable, includes extension.
L8686	Implantable neurostimulator pulse generator, single array, non-rechargeable, includes extension.
L8687	Implantable neurostimulator pulse generator, dual array, rechargeable, includes extension.

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Codes for non‑implantable devicesHCPCSNot Covered

E0735	Noninvasive vagus nerve stimulator.
K1020	Non-invasive vagus nerve stimulator.

Regulatory identifiers and product codesmixed

P970003 / S50 / S207 / S050	PMA/510(k) identifiers referenced for VNS Therapy and supplement clearances (device PMA/510k numbers listed in table).
DEN150048 / K171306 / K173442 / K172270 / K180538 / K182369 / K191830 / K203456 / K211856	PMA/510(k) and de novo identifiers associated with gammaCore device clearances cited in table.
QPY	Product code listed for Vivistim System.
LYJ, MUZ, PKR, QAK	Product codes listed for various VNS devices.

Regulatory identifiers and product codesmixed

P970003 / S50	PMA/510(k) identifiers associated with VNS Therapy (epilepsy/depression) noted in regulatory listing.
P970003 / S207	PMA/510(k) supplement identifier for expanded depression indication.
DEN150048 / K171306 / K173442	gammaCore 510(k)/de novo identifiers.
K172270 / K180538 / K182369 / K191830 / K203456 / K211856	gammaCore-2 / gammaCore-Sapphire 510(k) identifiers.
MUZ	Product code listed for SYMMETRY (VNS therapy system).
PKR, QAK	Product codes listed for gammaCore devices.
QPY	Product code listed for Vivistim System.

Historical coding actionsmixed

0312T-0318T	Previously added then removed vagus nerve blocking therapy codes referenced in historical notes.
95970, 95976, 95977	CPT codes added in 2024 update (historical note).
95971, 95972, 95973, 95974, 95975	CPT codes removed in historical updates (deleted/removed as of various dates).
61888, 64570	CPT codes removed historically.
C1767, C1778, K1020, E0735, C1827, C1607	HCPCS/HCPC codes added or removed in historical notes (added C1767/C1778; added K1020; added E0735; added C1827; C1607 later removed).

Antidepressant trial minimum dosing for insomnia agents — Minimum doses required to count as failed trials

AmitriptylineMinimum antidepressant dose to count as a failed trial: 150 mg

DoxepinMinimum antidepressant dose to count as a failed trial: 150 mg

MirtazapineMinimum antidepressant dose to count as a failed trial: 15 mg

TrazodoneMinimum antidepressant dose to count as a failed trial: 150 mg

Prior Authorization, Documentation, and Administrative Actions

Prior Authorization

Prior Authorization Required

Prior authorization is expected for implanted VNS procedures and associated device codes. Verification of member benefits and medical necessity evaluation is required prior to scheduling services. This policy is intended as a guide; always confirm specific benefit coverage with the member's benefit booklet or customer service.

Prior authorization expected for implanted VNS procedures and associated device and procedural codes (see Coding section for CPT/HCPCS codes).
Verify member benefits and plan-specific coverage; this policy does not substitute for the member benefit booklet or a member service inquiry.
Medical necessity determinations should follow the clinical criteria in this policy (e.g., refractory seizures or detailed TRD sequencing requirements).

Note

Reference Device Indications for Prior Authorization

FDA-cleared and approved device indications for both implantable and non‑implantable VNS devices are summarized in the Regulatory Status section and should be referenced when requesting prior authorization. Device-specific regulatory details (manufacturer, approval/clearance date, PMA/510(k) numbers, product codes, and labeled indications) must be considered during authorization and documentation.

Refer to Table 2 (Regulatory Status) for FDA-approved/cleared devices (e.g., LivaNova VNS Therapy systems, gammaCore noninvasive devices, Vivistim) and their labeled indications and age limits.
For TRD, prior authorization reviewers should confirm that the implanted device type and indication align with the FDA-labeled use being sought.
Include device model, manufacturer, and relevant PMA/510(k) or product code in the prior authorization request when available.

Denial Risk

Non‑implantable VNS Devices Investigational

Non‑implantable (transcutaneous or auricular) VNS devices are considered investigational for all indications in this policy and are not covered. Requests for coverage of non‑implantable devices should be denied as investigational unless and until policy or evidence changes.

Examples: gammaCore and other transcutaneous auricular VNS devices — investigational for indications outside their specific FDA-cleared uses (policy classifies non‑implantable VNS devices as investigational for all indications).
If a non‑implantable device has an FDA-cleared indication relevant to the member, reference the Regulatory Status section; otherwise treat as investigational per this policy.

Documentation Required

Therapeutic Sequencing and Prior Treatment Expectations

Clinical prior treatment expectations and therapeutic sequencing for VNS — document prior therapies and failures for treatment-resistant depression and seizures per policy criteria. For Major Depressive Disorder, the record must show multiple failed antidepressant trials and prior course(s) of TMS and/or ECT where applicable; allow for exceptions when TMS or ECT are contraindicated or constitute a legitimate hardship.

Major Depressive Disorder: failure of ≥3 antidepressant medications from ≥2 different classes OR failure of ≥2 antidepressants from ≥2 classes plus failure of augmentation to one failed antidepressant; documentation must state the medication trials and outcomes (reasons for failure may be stated per-medication or collectively).
Require documentation of TMS and ECT trials: depression must have continued to be moderate or severe after a course of TMS or ECT, or TMS/ECT stopped due to intolerable/incapacitating/dangerous side effects, contraindication, or legitimate hardship that makes standard schedules impractical.
Therapeutic sequencing: VNS is generally considered after multiple prior treatment failures (often ≥4 adequate treatments including medications and ECT/TMS in clinical studies); VNS effect may require 3–12 months to manifest, with maximum response typically by 6–12 months — continued benefit beyond 12 months is unlikely if no response is seen.
Clinical prior treatment expectations: for seizures, document medically refractory partial‑onset seizures with persistent seizures despite therapeutic antiepileptic drug levels or inability to tolerate therapeutic levels.

Step Therapy

Step Therapy / Sequencing Notes

No formal step‑therapy rules are specified in this document; however, the clinical indications reference refractory or treatment‑resistant conditions that imply sequenced prior treatments. There are no insurer-imposed step therapy protocols listed in this policy segment.

Providers should still document the sequence and adequacy of prior therapies in the medical record to support medical necessity determinations.
If plan-level step therapy programs exist separate from this policy, verify and follow those benefit plan requirements.

Denial Risk

Benefit Limitations and Denial Risk

Benefit limitations and denial risks: coverage is subject to the member's benefit plan. Services failing to meet the policy's medical necessity criteria, contraindications, investigational classifications, or lacking adequate documentation are at risk for denial.

VNS is not medically necessary for individuals with a history of left or bilateral vagotomy, or with current/planned therapeutic diathermy.
Coverage for indications listed as investigational (e.g., autism, fibromyalgia, obesity, tinnitus, upper‑limb impairment outside approved uses, substance use disorders, etc.) should be denied.
If documentation does not demonstrate required prior therapies, adequate trial details, or device/indication alignment, prior authorization may be denied or returned for more information.

OpenPayer

Vagus Nerve Stimulation (VNS)

Coverage and Medical Necessity Criteria

Billing and Coding

Prior Authorization, Documentation, and Administrative Actions

Clinical and Device Background

Key Definitions