Subject: CMS National Coverage Analysis (NCA) for Vagus Nerve Stimulation (VNS) for
Treatment-Resistant Depression (TRD) (CAG-00313R2)
Dear Ms. Jensen:
The American Association of Neurological Surgeons (AANS), Congress of Neurological Surgeons (CNS),
and the American Society for Stereotactic and Functional Neurosurgery (ASSFN), appreciate the
opportunity to comment on the above referenced draft coverage decision memo regarding Medicare
coverage for vagus nerve stimulation (VNS) for treatment-resistant depression (TRD).
Despite decades of research, patients with TRD continue to have very limited options. In fact, in four
decades, there has not been a single new and unique class of medication to address this significantly at risk population that has reached the market. The only new available therapy that has received Medicare
coverage is repetitive transcranial magnetic stimulation (rTMS), the results of which are described below.
While VNS for TRD had been FDA approved since 2005, CMS’ 2007 National Coverage Determination
(NCD) has left Medicare patients without this significant treatment option for their TRD — despite the
continuing body of evidence of its efficacy and cost-benefit for society.
…
Read full letter here
