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The rules say that plans must pay for a medical service or item if regular Medicare would pay for it in this case. 
You can find this rule at 42 Code of Federal Regulations (CFR) Section 422.101. 
 
The rules say that effective for services performed on or after July 1, 1999, VNS 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 VNS devices for treatment resistant depression (TRD) through Coverage 
with Evidence 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. 
 
Each study must be approved by CMS and as a fully-described, written part of its protocol, must address 
whether VNS improves health outcomes for TRD patients compared to a control group, by answering all of the 
following research questions below. The details of the prospective longitudinal study must be described in the 
original protocol for the double-blind, randomized, placebo-controlled trial. Response is defined as a = 50% 
improvement in depressive symptoms from baseline, as measured by a guideline recommended depression 
scale assessment tool. Remission is defined as being below the threshold on a guideline recommended 
depression scale assessment tool. The following research questions must be addressed in a separate analysis for 
patients with bipolar and unipolar disease. 
 
Research Questions: 
 
    What is the rate of response (defined as person months of response/total months of study participation)? 
    What is the rate of remission (defined as person months of response/total months of study participation)? 
    What is the time from treatment until response scores are first achieved? 
    What is the time from treatment until remission scores are first achieved? 
    What are the population distributions of the maximum months of response, both consecutive and overall, 
separately? 
    What are the population distributions of the maximum months of remission, both consecutive and overall, separately? 
    What are the patient variables associated with successful treatment of TRD with VNS? 
    What are the observed harms? 
    What are the changes in disability, quality of life, general psychiatric status, and suicidality? 
 
Patient Criteria: 
 
The following criteria must be used to identify patients demonstrating TRD: 
 
    The patient must be in a major depressive disorder (MDD) episode for equals 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 patients 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. 
 
You can find this information in Medicare's National Coverage Determination (NCD): Vagus Nerve 
Stimulation (VNS) (160.18). 
 
If you want to read these Medicare rules, you can go to this website www.medicareappeal.com.