64568 — Vagus Nerve Stimulation

Vagus Nerve Stimulation (VNS) (NCD 160.18)

CMS: “To meet coverage criteria, the patient’s medical record must contain documentation that fully supports the medical necessity of services. Subsections 6.2.1 to 6.2.13 list the documentation requirements for example services. For detailed documentation requirements, providers who choose to submit a prior authorization request for a WISeR Select Item or Service should refer to the relevant NCDs and/or their MAC jurisdiction’s LCDs and Local Coverage Articles (LCAs), if available, for guidance. They can be found on the Medicare Coverage Database website.”

General documentation requirements for initial implantation10 of vagus nerve stimulation (VNS) for the treatment of medically refractory partial onset seizures are as follows:

• ❑Documentation of medically refractory partial onset seizures with failure of or intolerance to trial(s) of single or combination antiepileptic therapy
• ❑Documentation with rationale that the patient is not a candidate for epilepsy surgery, has failed epilepsy surgery, or refuses epilepsy surgery after shared decision-making General documentation requirements for initial implantation11 of VNS for treatment-resistant depression (TRD) through CMS’ Coverage with Evidence Development (CED)12 are as follows:
• ❑Enrollment in an active CMS-approved trial associated with this NCD/CED
• ❑Documentation of a major depressive disorder (MDD) episode for at least 2 years or at least four episodes of MDD, including the current episode
• ❑Documentation of a minimum criterion of four prior failed treatments of adequate dose and duration, as measured by a tool designed for this purpose
• ❑Documentation of a major depressive episode (MDE) as measured by a guideline- recommended depression scale assessment tool on two visits, within a 45-day span prior to implantation of the VNS device
• ❑Documentation of a stable medication regimen for at least 4 weeks before device implantation
• ❑Documentation that none of the following criteria are present: a) Current or lifetime history of psychotic features in any MDE b) Current or lifetime history of schizophrenia or schizoaffective disorder c) Current or lifetime history of any other psychotic disorder d) Current or lifetime history of rapid cycling bipolar disorder e) Current secondary diagnosis of delirium, dementia, amnesia, or other cognitive disorder f) Current suicidal intent g) Treatment with another investigational device or investigational drugs

1. [9] Prior authorization and pre-payment medical review for Vagus Nerve Stimulation will only be implemented for the indications specified in Appendix B.
2. [10] WISeR will initially focus on initial implantation of VNS. Revisions and replacements are out of scope of WISeR, but this may be subject to change in the future. As per Section D of NCD 160.18, patients implanted with a VNS device for TRD may receive a VNS device replacement if it is required due to the end of battery life or any other device-related malfunction.
3. [11] WISeR will initially focus on initial implantation of VNS. Revisions and replacements are out of scope of WISeR, but this may be subject to change in the future. As per Section D of NCD 160.18, patients implanted with a VNS device for TRD may receive a VNS device replacement if it is required due to the end of battery life or any other device-related malfunction.
4. [12] Centers for Medicare & Medicaid Services. (2024). Vagus nerve stimulation (VNS) for treatment resistant depression (TRD).