Vagus Nerve Stimulation For Treatment Resistant Depression
Medicare coverage summary governing coverage, limitations, and medical necessity for FDA-approved VNS devices for treatment resistant depression under Coverage with Evidence Development (CED) when provided in CMS-approved clinical trials; non-covered when furnished outside CMS-approved CED studies.
Annual review performed April 21, 2026; summary of changes = Annual Review.
Coverage Summary
Overview: This coverage summary addresses Vagus Nerve Stimulation (VNS) for Treatment Resistant Depression (TRD). Effective 2019-02-15, CMS policy implements a Coverage with Evidence Development (CED) approach: CMS will cover FDA-approved VNS devices for TRD only when furnished as part of a CMS-approved CED study. Coverage stance: mixed — VNS for TRD is covered under specified CED trial conditions and is non-covered when furnished outside CMS-approved CED studies.