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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 state that 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. The Food and Drug Administration (FDA) 
approved VNS for treatment of refractory epilepsy in 1997 and for resistant depression in 2005. 
Indications and Limitations of Coverage 
 
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. 
 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.