Appeal type: Experimental/Investigational
Decision: Upheld Decision of Health Plan

Physician 1: The patient is a 72-year-old female with recurrent refractory depression. She requests coverage for a vagus nerve stimulation (VNS) implanted device as a way to treat her non-responsive depression. The patients provider indicates the patient has failed treatment with ECT, antidepressants, mood stabilizers, antipsychotics agents and inpatient admissions. The Health Plan has denied coverage for VNS therapy on the basis that it is considered investigational for the treatment of patients such as this patient.Although VNS treatment has recently been approved by the Food and Drug Administration for the treatment of refractory depression, the psychiatric community remains cautious concerning the use of this therapy. To date, insufficient well-controlled double blind studies have been performed. Accordingly, there is inadequate data from which to conclude VNS therapy is likely to be more efficacious for this patient than standard pharmacotherapies. As set forth above, I have determined that the requested therapy is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Plans denial should be upheld.Physician 2: The patient is a 72-year-old female with a history of recurrent depression. She and her psychiatrist are requesting coverage for vagus nerve stimulation (VNS) therapy. The psychiatrist indicates the patient has not responded well to oral antidepressants. In addition, although the patient reportedly did obtain some relief from depression after ECT, the response was not sustained. At issue is whether VNS therapy is likely to be more beneficial for the treatment of the patients depression than any available standard therapy.The literature continues to show that VNS remains an investigational modality and double blind studies demonstrating clear benefit over standard therapies have yet to be performed. The submitted articles show no definitive evidence of shortterm efficacy was found for adjunctive VNS in treatment-resistant depression. In addition, the results of an open-trial study concluded that comparative long-term data are needed to determine whether apparent benefits can be attributed to VNS. Thus, as of this time VNS therapy is not widely accepted or proven to be effective within the medical community and cannot be recommended in this case.Therefore, I have determined that the requested therapy is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Plans denial should be upheld.Physician 3: The patient is a 72-year-old female with a long-standing history of major depression, last treated on an inpatient basis in September 2004. She was discharged on a regimen of nortriptyline (NTP), Lamictal and Zyprexa. The patients episodes of depression have been inflected with severe anhedonia. She reports lying in bed for extended periods of time, chronic insomnia and a sense of wanting to scream with anxiety. Past treatment has involved ECT and a variety of antidepressants such as Effexor, Remeron, Elavil, and Abilify. The nature of the ECT is unclear. Since her inpatient discharge, the patient was seen longitudinally on a monthly basis by a new psychiatrist. The psychiatrist noted the patient had chronic depression and was quite anxious, somatically focused, and had poor self-esteem. The patients course of medications largely remained NTP, Buspar, and Zyprexa. Her insomnia was treated with Klonopin and thereafter Lunestra. The patients psychiatrist has now requested authorization for vagus nerve stimulation (VNS) therapy, which has been denied by the Health Plan on the basis it is investigational in nature.One of the issues in this case has to do with the true, operative diagnosis of the patient. For as much insomnia and ruminative anxiety as she has had (not to mention the longevity of her illness) it appears a possible diagnosis may be bipolar disorder, type II. As such, a supplemental course of Lithium may be indicated. The patient has not demonstrated truly refractory illness as there are other therapies available that are likely to be of benefit. Therefore, I have determined that the requested therapy is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Plans denial should be upheld.