Subject: CMS Proposed Decision Memo 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 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), released on November 19, 2018.
As we mentioned in our comments submitted on June 29, 2018, when CMS announced their intention to
review their non-coverage decision for VNS for TRD, we support coverage for this procedure. Despite
decades of research, patients with TRD continue to have very limited options. We are pleased to see
that CMS will be permitting some Medicare patients to have access to this important treatment option for
their TRD. However, we question the decision to restrict Medicare coverage to patients enrolled in a
clinical trial. We feel the current literature submitted as part of the initial request for review is robust and
shows clear evidence of efficacy and cost-benefit for VNS for TRD. Medicare patients who meet the
established criteria for this treatment should, therefore, have unfettered access to this life-changing and
life-saving therapy. As part of the FDA approval process in 2005 and since that time, a strong body of
evidence has been developed for VNS for TRD. With suicide continuing to be among the top ten causes
of death in the United States, we urge CMS to make this potentially life-saving procedure available to
appropriately selected patients without undue burden on the patient or the treating surgeon.
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Read full letter here
