CurrentOptumPolicy BH803MCSVNS0426

Vagus Nerve Stimulation For Treatment Resistant Depression

Medicare coverage summary governing coverage, limitations, and medical necessity for FDA-approved VNS devices for treatment resistant depression under Coverage with Evidence Development (CED) when provided in CMS-approved clinical trials; non-covered when furnished outside CMS-approved CED studies.

Policy Summary

PayerOptum

PolicyVagus Nerve Stimulation For Treatment Resistant Depression

Policy CodePolicy BH803MCSVNS0426

Change TypeAnnual Review

Effective DateFeb 15, 2019

Next Review Date

Key ActionProviders must enroll patients in a CMS-approved, double-blind, randomized, placebo-controlled trial with CMS-approved protocol to obtain coverage for VNS for TRD; services outside approved CED studies are non-covered.

POLICY UPDATE CHANGES

Annual review performed April 21, 2026; summary of changes = Annual Review.

1Covered Indications under CED

All otherNational Non-covered Indications

2019-02-15CED Effective Date

Coverage Summary

Overview: This coverage summary addresses Vagus Nerve Stimulation (VNS) for Treatment Resistant Depression (TRD). Effective 2019-02-15, CMS policy implements a Coverage with Evidence Development (CED) approach: CMS will cover FDA-approved VNS devices for TRD only when furnished as part of a CMS-approved CED study. Coverage stance: mixed — VNS for TRD is covered under specified CED trial conditions and is non-covered when furnished outside CMS-approved CED studies.

Medical Necessity / Coverage Criteria

Coverage under CMS Coverage with Evidence Development (CED)

CMS will cover FDA-approved VNS devices for TRD through CED when ALL of the following are met:

ALL of the following

Service is furnished on or after February 15, 2019
VNS device is FDA-approved
Treatment is for Treatment Resistant Depression (TRD)
Provided as part of a CMS-approved, double-blind, randomized, placebo-controlled trial
Trial must have follow-up duration of at least one year
Trial protocol must be approved by CMS and fully describe whether VNS improves health outcomes for TRD compared to control by answering CMS research questions
The details of the prospective longitudinal study must be described in the original protocol; possibility to extend to a prospective longitudinal study when trial completes enrollment and has positive interim findings must be described.
Response defined as ≥ 50% improvement in depressive symptoms from baseline measured by a guideline recommended depression scale assessment tool≥ 50% improvement
Remission defined as being below the threshold on a guideline recommended depression scale assessment toolBelow scale threshold

Device Replacement

Covered when ALL of the following are met:

ALL of the following

Patient was previously implanted with a VNS device for TRD
Replacement is required due to end of battery life or other device-related malfunction

Non-Coverage / Exclusions

Services are non-covered when ANY of the following apply:

ANY of the following

VNS for TRD furnished outside of a CMS-approved CED study
Effective for services performed on or after February 15, 2019
Any other indications of VNS for the treatment of depression (nationally non-covered)

Provider Actions & Requirements

Prior Authorization

Participation in CMS-approved CED trial required for coverage

Providers must enroll patients in a CMS-approved Coverage with Evidence Development (CED) study to obtain Medicare coverage for VNS for treatment resistant depression. The study must be a CMS-approved, double-blind, randomized, placebo-controlled trial with at least one year of follow-up and a protocol approved by CMS. Services furnished outside an approved CED study are non-covered. Coverage effective date reference: services on or after February 15, 2019.

Enrollment in a CMS-approved CED trial is required for coverage
Trial design: double-blind, randomized, placebo-controlled with ≥1 year follow-up
Coverage effective date: on or after February 15, 2019

Documentation Required

Trial protocol and outcomes measurement documentation

The trial protocol must be fully described and approved by CMS and must address whether VNS improves health outcomes for TRD compared to control by answering CMS research questions. Protocols must use guideline-recommended depression scale assessment tools to measure outcomes. Response is defined as a ≥ 50% improvement in depressive symptoms from baseline on a guideline-recommended depression scale; remission is defined as being below the threshold on a guideline-recommended depression scale.

Define response threshold: ≥ 50% improvement in depressive symptoms from baseline (guideline-recommended scale)
Define remission: below the threshold on a guideline-recommended depression scale

Billing Rule

Replacement device billing allowed for device end-of-life or malfunction

Patients previously implanted with VNS for TRD may receive and bill for a replacement device when replacement is required due to battery end-of-life or other device-related malfunction. Prior authorization requirements may vary by payer and could apply.

Replacement allowed for battery end-of-life
Replacement allowed for device-related malfunction

Coding & Medicare Determinations

Applicable National Coverage Determinationmixed

NCD 160.18

NCD 160.18 - Vagus Nerve Stimulation: National Coverage Determination for Vagus Nerve Stimulation (VNS) (applies to all states).

Medicare determination: NCD 160.18 (Vagus Nerve Stimulation) is the applicable National Coverage Determination. It became effective on 2019-02-15 and, per CMS, coverage for VNS for TRD is provided under Coverage with Evidence Development (CED) for FDA-approved devices when delivered within CMS-approved trials.

Background & Evidence

Background: VNS consists of a surgically implanted pulse generator in the left chest connected to the left vagus nerve; electrical signals from the device are transmitted to the brain. The device was FDA-approved for refractory epilepsy in 1997 and for resistant depression in 2005. CMS will cover FDA-approved VNS devices for TRD only through CED — i.e., when offered in a CMS-approved, double-blind, randomized, placebo-controlled trial with at least one year of follow-up; VNS for TRD furnished outside an approved CED study is non-covered. Patients already implanted for TRD may receive device replacement if required due to battery end-of-life or device-related malfunction.

Source	Details
CMS Decision Memo / CED	Decision Memo for Vagus Nerve Stimulation (VNS) for Treatment Resistant Depression (TRD) and Coverage with Evidence Development; references CMS materials and lists CED study locations (NCT03887715)

Definitions

Response≥ 50% improvement in depressive symptoms from baseline measured by a guideline-recommended depression scale assessment tool.

RemissionBeing below the threshold on a guideline-recommended depression scale assessment tool.

Coverage with Evidence Development (CED)CMS mechanism to cover items/services only when provided in the context of CMS-approved clinical studies that collect evidence about clinical outcomes.