National Coverage Analysis (NCA) Tracking Sheet

Vagus Nerve Stimulation (VNS) for Treatment Resistant Depression (TRD)



Vagus nerve stimulation (VNS) is a type of brain stimulation therapy that uses a small battery-powered generator (similar to a pacemaker) to send mild pulses of electrical energy to the brain. An external device programs and adjusts the timing and intensity of these pulses from the implanted vagus nerve stimulation device.

Section 160.18 of the Medicare National Coverage Determinations (NCD) Manual states conditions of coverage for vagus nerve stimulation. In 1999, CMS established coverage of vagus nerve stimulation for patients with medically refractory partial onset seizures for whom surgery is not recommended or for whom surgery has failed. In 2007, CMS reconsidered the NCD and determined that, at that time, there was insufficient evidence to conclude that vagus nerve stimulation was reasonable and necessary for treatment resistant depression (TRD), and VNS for TRD was therefore non-covered.

CMS is opening this national coverage analysis (NCA) to reconsider Section C, paragraph 2, in NCD 160.18, Medicare coverage for VNS when used for TRD. CMS is not reconsidering any other section of NCD 160.18. CMS is soliciting public comment relevant to the request. We are particularly interested in comments that include scientific evidence and that address the breadth of the request.

National Coverage Determinations

Benefit Category

Durable Medical Equipment
Incident to a physician's professional Service
Physicians' Services

Requestor Information

Requestor Name Requestor Letter
LivaNova View Letter

Important Dates

Formal Request Accepted and Review Initiated
Expected NCA Completion Date
Public Comment Period
05/30/2018 - 06/29/2018
Proposed Decision Memo Due Date
Proposed Decision Memo Released
Proposed Decision Memo Public Comment Period
11/19/2018 - 12/19/2018
Decision Memo Released
Comments for this NCA
View Public Comments


Lead Analysts
David Dolan, MBA
Lead Medical Officers
Susan Miller, MD

Medicare Benefit Category Determination Date

Actions Taken

May 30, 2018

CMS initiates this national coverage analysis for Section 160.18 of the NCD Manual. The initial 30-day public comment period begins with this posting date, and ends after 30 calendar days. CMS considers all public comments, and is particularly interested in clinical studies and other scientific information relevant to the topic under review.

Instructions on submitting comments can be found at:

To submit a comment, please use the orange "Comment" button at the top of the page. Enter comments directly into the "Submit A Public Comment" webpage. We strongly urge that all public comments be submitted through this website. Please do not submit personal health information in public comments. Comments with personal health information may not be posted to the website.

November 19, 2018

February 15, 2019