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

Physician 1: The clinical documentation concerns a 53-year-old male who has a history of depression that he states has occurred over the last 21 years.   He has had multiple pharmacological trials but reports that he still has symptoms and has been unable to pursue his profession as a veterinarian.  His primary symptom appears to be his memory loss. The patient gives an example in his letter of not being able to recognize his old patients.  His treating psychiatrist recommended neuropsychiatric testing but the submitted documentation does not contain the results of a MMSE or formal neuropsychological testing. The patient also reported a tremor and some possible weakness in his extremity. Although some of his symptoms may be a side effect of the stimulating SSRIs, a formal neurological examination is also absent from the submitted documentation.The patient and his provider state a concern that electroconvulsive therapy (ECT) will exacerbate the patients memory loss. The etiology of the memory loss is not addressed in the submitted records. The suggestion by the patients provider is to initiate the implantation of a vagus nerve stimulation (VNS) device because the patient has refractive depression and multiple pharmacological trials have failed. The Health Plan has denied coverage for the requested therapy on the basis it is considered experimental/investigational.The documentation provided does not offer information concerning the etiology of the memory loss with this patient. Memory loss may be part of a refractive depression, especially with psychosis. Anxiety can also cause some memory loss. The clinical history presented by the attending psychiatrist does not offer an explanation for the memory loss being part of a refractive depression.The literature reviewed includes the manufacturer supported open research study, the FDA release of the marketing phase and peer-reviewed literature.  The open study research that the FDA utilized has not been found in the peer-reviewed literature to demonstrate clinical efficacy at this point in time. The FDA is still monitoring the prospective study to determine the efficacy of treatment, the appropriate dose of electrical activity for VNS and the safety of such.  Even though the FDA did release the marketing of the product, it did not determine the clinical efficacy of such. Review of all the relevant literature including the peer-reviewed articles, the Kaiser Study, the Medical Letter article and the APA recent updates on depression, reveals a consensus that the clinical efficacy of VNS for refractive depression remains undocumented.In conclusion, the use of VNS implantation for this patient cannot be recommended at this time. 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 2: The patient is a 53-year-old male with an apparent long history of depression, worse for the past five years. He has not been responsive to multiple medications and combinations thereof. He is refusing ECT, fearful that his already poor memory will worsen. He is a veterinarian who has not worked in two years due to his depression. The patient has requested authorization and coverage for vagus nerve stimulation (VNS) therapy. The Health Plan has denied this request on the basis that there is insufficient evidence of its efficacy at this time.The Health Plans denial should be upheld. Review of the submitted clinical information does not indicate the patient has been tried on an MAOI. Additionally, there is no evidence that neuropsychiatric testing has been performed and little information about his brain injury has been documented. Given this, standard treatments such as MAOIs or perhaps ECT are more appropriate at this time. Accordingly, 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. Therefore, the Health Plans denial should be upheld.Physician 3:The patient is a 53-year-old veterinarian with reported medication resistant depression, which is said to be refractory to a wide variety of antidepressants offered over a 20-year period. Based on the information provided, he currently receives Adderall, Cymbalta, desipramine, and Lamictal. He reports varied soft cognitive signs, which he feels eliminates electroconvulsive therapy (ECT) as a possible treatment. He seeks vagus nerve stimulation (VNS) therapy. The Health Plan has determined VNS therapy remains unproven at this time.Based upon the submitted clinical materials, the patient has never received treatment with MAOIs; nor has he undergone ECT performed unilaterally. In addition, there is no evidence he has tried the recently introduced selegiline patch (an MAOI). Putting these issues aside, VNS therapy is still considered by most clinicians to be experimental in the absence of long-term, well-blinded efficacy studies. Until large series, multi-centered studies are reported, VNS therapy remains an unproven therapy.For the reasons stated 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. Therefore, the Health Plans denial should be upheld.