Appeal type: Experimental/Investigational
Decision: Upheld

Physician 1:  This patient is a 50-year-old female with a long-standing history of mood disorder, apparently resistant to multiple trials of various medications. The patient has been treated with lithium, Lamictal, Depakote, Zyprexa, Abilify, Celexa, Lexapro, and Wellbutrin in the past and is currently prescribed Eskalith, Cymbalta, Antabuse, Revia and Campral. Her providers notes also indicate problems with compliance and a significant history of alcohol abuse. The patient has undergone treatment with electroconvulsive therapy (ECT) with some benefit, but does not want to continue with this modality due to memory loss affecting her ability to work. She was hospitalized in April 2005 for attempted suicide. The clinical records submitted consist of hospital records and letters from her psychiatrist summarizing her condition and treatment history and progress notes from her psychologist. The patients psychiatrist has recommended vagus nerve stimulation (VNS) therapy, which was denied by the Health Plan as an experimental/investigational treatment.Although significant problems with memory do appear to preclude additional ECT, there is no evidence to support the use of an experimental treatment such as VNS therapy for the patient at this time. Issues of alcohol abuse/dependence and borderline personality traits are likely to have contributed to the poor treatment compliance noted by her provider. There is no clinical basis for the supposition that VNS therapy would be more beneficial than the optimized application of standard therapies. Accordingly, I have determined 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 50-year-old female with bipolar disorder, alcohol dependence and borderline personality disorder who has been treated with mood stabilizers and antidepressants such as lithium, Depakote, and Zyprexa. She is currently treated with Eskalith, Cymbalta, and Revia. The patient has previous treatment experience with ECT, but did not want to return to this due to memory impairment and the limited help it provided. Her providers notes show that both Cymbalta and lithium have been helpful in the past. Although the patient did experience a tremor with lithium, other details of this medication trial are not documented in the record. The patients provider has requested authorization for VNS therapy to treat her depressive symptoms. The Health Plan denied the request citing the investigational nature of the therapy.There is no evidence that the patient has exhausted conventional treatments for her bipolar depression. Ironically, there is some evidence of a response to the medications she has been prescribed. The patient has also suffered a tragic loss, has been diagnosed with borderline personality disorder and still drinks to the point of intoxication. In this context, it is simply not reasonable to expect complete euthymia with medicinal treatment alone, or even with the additional of ECT. The patients illness is multi-faceted and regular psychotherapy along with medication is often the approach in such situations and may offer some benefit. It should also be recognized there are genuine limitations with each and every treatment and the measure of a successful treatment must take into account all aspects of the patients condition. 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 50-year-old female said to be refractory to all treatments for her bipolar depression over the past several years. The record also indicates a history of alcohol dependence, emotional instability and questionable compliance with treatment recommendations.  ECT has been performed with some response, but the patient declines additional ECT based on memory loss and concern over job performance. She has received varied pharmacologic treatments including Lamictal, Depakote, Zyprexa, Abilify, Celexa, Lexapro, and Wellbutrin, however there is limited detail of her responses to the various medications. She is now taking Eskalith, Cymbalta, Antabuse, Revia and Campral. The patient has requested authorization and coverage for vagus nerve stimulation (VNS) therapy. The Health Plan denied this request on the basis that the therapy is experimental/investigational.Upon review of the submitted clinical evidence it is not readily apparent that the patients bipolar depression is truly treatment resistant. There are other psychological factors that may be contributing to her lack of sustained progress in treatment, particularly her use of alcohol. Even if the patients depression is truly refractory to treatment, VNS is not likely to be of clinical benefit. Based upon the evidence available to date, VNS therapy remains unproven as there are too few well-controlled, blinded studies establishing the benefits, durability, and safety of this treatment modality. Vagus nerve stimulation therapy for the amelioration of treatment resistant depression 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.