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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, a vagus nerve stimulation (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  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. 
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. 
Patients must not have: 
 Current or lifetime history of psychotic features in any MDE; 
 Current or lifetime history of schizophrenia or schizoaffective disorder; 
 Current or lifetime history of any other psychotic disorder; 
 Current or lifetime history of rapid cycling bipolar disorder; 
 Current secondary diagnosis of delirium, dementia, amnesia, or other cognitive disorder; 
 Current suicidal intent; or, 
 Treatment with another investigational device or investigational drugs. 
Individuals who receive placebo VNS will be offered active VNS at the end of the trial. 
In addition, CMS will review studies to determine if they meet the 13 criteria listed below. If CMS determines 
that they meet these criteria, the study will be posted on CMS CED website 
(https://www.cms.gov/Medicare/Coverage/Coverage-with-Evidence-Development/index.html). 
a. The principal purpose of the study is to test whether the item or service meaningfully improves health 
outcomes of affected beneficiaries who are represented by the enrolled subjects. 
b. The rationale for the study is well supported by available scientific and medical evidence. 
c. The study results are not anticipated to unjustifiably duplicate existing knowledge. 
d. The study design is methodologically appropriate, and the anticipated number of enrolled subjects is 
sufficient to answer the research question(s) being asked in the National Coverage Determination. 
e. The study is sponsored by an organization or individual capable of completing it successfully. 
f. The research study is in compliance with all applicable Federal regulations concerning the protection of 
human subjects found in the Code of Federal Regulations (CFR) at 45 CFR Part 46. If a study is 
regulated by the Food and Drug Administration (FDA), it is also in compliance with 21 CFR Parts 50 
and 56. In addition, to further enhance the protection of human subjects in studies conducted under 
CED, the study must provide and obtain meaningful informed consent from patients regarding the risks 
associated with the study items and/or services, and the use and eventual disposition of the collected 
data. 
g. All aspects of the study are conducted according to appropriate standards of scientific integrity. 
h. The study has a written protocol that clearly demonstrates adherence to the standards listed here as 
Medicare requirements. i. The study is not designed to exclusively test toxicity or disease pathophysiology in healthy individuals. 
Such studies may meet this requirement only if the disease or condition being studied is life threatening 
as defined in 21 CFR 312.81(a) and the patient has no other viable treatment options. 
j. The clinical research studies and registries are registered on the www.ClinicalTrials.gov website by the 
principal sponsor/investigator prior to the enrollment of the first study subject. Registries are also 
registered in the Agency for Healthcare Quality (AHRQ) Registry of Patient Registries (RoPR). 
k. The research study protocol specifies the method and timing of public release of all prespecified 
outcomes to be measured including release of outcomes if outcomes are negative or study is terminated 
early. The results must be made public within 12 months of the studys primary completion date, which 
is the date the final subject had final data collection for the primary endpoint, even if the trial does not 
achieve its primary aim. The results must include number started/completed, summary results for 
primary and secondary outcome measures, statistical analyses, and adverse events. Final results must be 
reported in a publicly accessibly manner; either in a peer-reviewed scientific journal (in print or on-
line), in an on-line publicly accessible registry dedicated to the dissemination of clinical trial 
information such as ClinicalTrials.gov, or in journals willing to publish in abbreviated format (e.g., for 
studies with negative or incomplete results). 
l. The study protocol must explicitly discuss beneficiary subpopulations affected by the item or service 
under investigation, particularly traditionally underrepresented groups in clinical studies, how the 
inclusion and exclusion criteria effect enrollment of these populations, and a plan for the retention and 
reporting of said populations in the trial. If the inclusion and exclusion criteria are expected to have a 
negative effect on the recruitment or retention of underrepresented populations, the protocol must 
discuss why these criteria are necessary. 
m. The study protocol explicitly discusses how the results are or are not expected to be generalizable to 
affected beneficiary subpopulations. Separate discussions in the protocol may be necessary for 
populations eligible for Medicare due to age, disability or Medicaid eligibility. 
You can find this in the Medicare 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. 
 
The Plan contract says that the Plan covers items and services in accordance with Medicare rules.