Medicare Coverage for Vagus Nerve Stimulation (VNS)
                     
Medicare Coverage for Vagus Nerve Stimulation (VNS)
Vagus Nerve Stimulation (VNS) is a pulse generator, similar to a pacemaker, that is surgically implanted under 
the skin of the left chest and an electrical lead (wire) is connected from the generator to the left vagus nerve. 
Electrical signals are sent from the battery-powered generator to the vagus nerve via the lead. These signals 
are in turn sent to the brain. VNS provides indirect modulation of brain activity through the stimulation of the 
vagus nerve. The vagus nerve, the tenth cranial nerve, has parasympathetic outflow that regulates the 
autonomic (involuntary) functions of heart rate and gastric acid secretion and also includes the primary 
functions of sensation from the pharynx, muscles of the vocal cords, and swallowing. It is a nerve that carries 
both sensory and motor information to/from the brain. Medicare coverage for many tests, items, and 
services depends on where you live. 
Nationally Covered Indications 
VNS treatment is reasonable and necessary for patients with medically refractory partial-onset seizures for 
whom surgery is not recommended or for whom surgery has failed. Effective for services performed on or 
after February 15, 2019, the Centers for Medicare & Medicaid Services (CMS) will cover FDA-approved vagus 
nerve stimulation (VNS) devices for treatment-resistant depression (TRD) through Coverage with Evidence
www.medicalbillersandcoders.com Follow us:
Medicare Coverage for Vagus Nerve Stimulation (VNS)
Development (CED) when offered in a CMS-approved, double-blind, randomized, placebo-controlled trial 
with a follow-up duration of at least one year with the possibility of extending the study to a prospective 
longitudinal study when the CMS-approved, double-blind, randomized placebo-controlled trial has 
completed enrollment, and there are positive interim findings. 
Nationally Non-Covered Indications 
VNS is not reasonable and necessary for all other types of seizure disorders that are medically refractory and 
for whom surgery is not recommended or for whom surgery has failed. VNS is non-covered for treatment-
resistant depression (TRD) when furnished outside of a CMS-approved Coverage with Evidence Development 
(CED) study. All other indications of VNS for the treatment of depression are nationally non-covered. 
Patient Criteria
The following criteria must be used to identify patients demonstrating treatment-resistant depression (TRD):
www.medicalbillersandcoders.com Follow us:
Medicare Coverage for Vagus Nerve Stimulation (VNS)
• The patient must be in a major depressive disorder (MDD) episode for ≥ two years or have had at least 
four episodes of MDD, including the current episode. In order to confirm the patient has MDD, accepted 
diagnostic criteria from the most current edition of the Diagnostic and Statistical Manual for Mental 
Disorder (DSM) and a structured clinical assessment are to be used. 
• The patient’s depressive illness meets a minimum criterion of four prior failed treatments of adequate 
dose and duration as measured by a tool designed for this purpose. 
• The patient is experiencing 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.
• Patients must maintain a stable medication regimen for at least four weeks before device implantation. 
• If patients with bipolar disorder are included, the condition must be carefully characterized.
The applicable CPT code for VNS is CPT® code 64568: Incision for implantation of cranial nerve (e.g. vagus 
nerve) neurostimulator electrode array and pulse generator.
www.medicalbillersandcoders.com Follow us:
Medicare Coverage for Vagus Nerve Stimulation (VNS)
The patient’s medical record must contain documentation that fully supports the medical necessity for 
services included within the Coverage Indications, Limitations, and/or Medical Necessity section within the 
related LCD. This documentation includes but is not limited to, appropriate use criteria, relevant medical 
history, physical examination, and results of pertinent diagnostic tests or procedures.
We shared information about Medicare coverage for Vagus Nerve Stimulation (VNS) for your reference, for a 
detailed understanding, you can refer to “Medicare National Coverage Determinations Manual Chapter 1, 
Part 2”.  MedicalBillersandCoders (MBC) is a leading revenue cycle company providing complete medical 
billing services. If you need any assistance in medical billing and coding for your practice, you can contact us 
at [email protected] / 888-357-3226.
CPT © Copyright 2022 American Medical Association. All rights reserved. AMA and CPT are registered 
trademarks of the American Medical Association.
www.medicalbillersandcoders.com Follow us: