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Decision: unknown

 
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 state that: 
Nationally Covered Indications 
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  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. 
Nationally Non-Covered Indications 
 
Effective for services performed on or after July 1, 1999, VNS is not reasonable and necessary for all other 
types of seizure disorders which are medically refractory and for whom surgery is not recommended or for 
whom surgery has failed. 
 
VNS is non-covered for the treatment of TRD when furnished outside of a CMS-approved CED study. 
 
All other indications of VNS for the treatment of depression are nationally non-covered. 
 
You can find this rule at the Medicare National Coverage Determination (NCD) 160.18: Vagus Nerve 
Stimulation (VNS). 
 
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.