Vagus Nerve Stimulation denials in California external review

What the reviewers wrote

Where the denial was overturned

Nature of Statutory Criteria/Case Summary: A patient has requested authorization and coverage for implantation of a cranial nerve neurostimulator electrode array and pulse generator. Findings: The physician reviewer found that treatment-resistant depression is well-documented in the records provided. The patient has tried and failed trials on numerous anti-depressant medications, an antipsychotic used as augmentation for the treatment of acute depressive symptoms, cognitive behavioral therapy targeting his depressive symptoms, repetitive transcranial magnetic stimulation (rTMS), ketamine, and an intensive outpatient therapeutic program. The patient has also required inpatient hospitalization. Vagus nerve stimulation (VNS) is U.S.

Nature of Statutory Criteria/Case Summary: A patient has requested authorization and coverage for a vagus nerve stimulation (VNS) therapy system. The medical literature supports the use of VNS for patients with treatment-resistant depression. One study conducted a five-year observational study comparing patients receiving VNS plus treatment as usual (TAU) to TAU alone. The VNS group demonstrated a significantly higher cumulative response rate (68%) compared to the TAU group (41%). Another review also highlights the efficacy of VNS in patients with highly treatment-resistant depression, noting that VNS offers durable antidepressant effects in select patients. In this case, the patient’s clinical profile is consistent with patients described in the supporting literature. The patient has had a chronic, treatment-resistant course of illness for over two decades.

Where the denial was upheld

Physician 1: The patient is a 31-year-old female who is requesting authorization for vagus nerve stimulation (VNS) treatment for major depression. The patient has not shown sustained improvement with conventional anti-depressants and electroconvulsive (ECT) therapy. The Health Plan has denied the patient’s request indicating VNS therapy is investigational and therefore not a covered benefit.To date, VNS remains a highly controversial treatment for refractory depression. There are no valid, controlled, double-blind, research centered and clinically based reproducible studies showing that VNS is any better than sham treatment. VNS is not a part of established principles of health care practice as of this date for the management of refractory depression. VNS remains an experimental, controversial and unproven procedure at this time.

Physician 1: The patient is a 39-year-old man with long history of depressive disorder resistant to multiple antidepressant medications and some medication combinations. He has had multiple psychiatric hospitalizations for treatment of depression and associated suicidal ideation. ECT treatments have not been of consistent benefit, both bilateral and unilateral series with monthly maintenance. A review of documents seems to indicate that mono-amine oxidase inhibitors (MAOI) are the only class of antidepressant medications that have not been utilized. The patient has requested authorization for vagus nerve stimulation (VNS) therapy to treat his depression.

These outcomes describe eligible cases completed through California DMHC’s Independent Medical Review program. They do not estimate the chance that an internal appeal, an external review in another jurisdiction, or your individual case will succeed. Use the record to identify evidence patterns involving Vagus Nerve Stimulation, then check the rights and deadlines that apply to your plan.