Appeal type: Experimental/Investigational
Decision: Upheld

Physician 1:  The patient is a 37-year-old female with a diagnosis of bipolar disorder with depression that has not been amenable to psychopharmacological treatment and electroconvulsive (ECT) therapy. The patient and her provider are requesting authorization for vagus nerve stimulation (VNS) therapy. The Health Plan has denied this 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. It has not been accepted by the psychiatric community as routine treatment in the management of refractory depression. For these reasons, 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 2:  The patient is a 37-year-old woman who has had extensive treatment for her mood disorder. This included outpatient psychotherapy, many antidepressant trials, electroconvulsive therapy (ECT), a partial hospitalization program, and episodic psychiatric hospitalization. She carries a diagnosis of bipolar disorder but her medical records discuss only depressive symptomatology. At the present time, there is self-injurious behavior (cutting) and suicidality. She had to leave her job and is now on disability.The record describes the patients medication trials for the past 18 months. None of the regimens utilized tricyclic antidepressants and some of the more common augmentation strategies have not been tried. It is quite possible that character pathology is contributing to the patients dysfunction, though it cannot be ruled in or out from the information provided.The patient has some concerning medical comorbidities such as hypertension and morbid obesity. A medical consultant felt she was not a candidate for bariatric surgery secondary to her depression.The patients provider has recommended a trial of vagus nerve stimulation (VNS) therapy. The Health Plan has denied authorization for the therapy on the basis that it has not been shown to be effective for treatment of the patients condition.Despite FDA approval of VNS, the efficacy studies to date have not yielded unequivocal data in support of VNS over placebo. When VNS was approved by the FDA in July 2005, it concluded a process that was marked by two reversals of the decision. Final approval was met with surprise by many psychiatrists and the controversy has continued. The source of the controversy lies with the efficacy data. The FDA requires two randomized, double-blind, placebo-controlled trials that prove a proposed treatment is statistically superior to placebo. In the case of the VNS approval, both of these pivotal studies had serious design and methodology problems that left many scientists wondering what the data actually meant.The National Psychiatric community has not yet embraced VNS as part of the usual standard of care for severe depression. The American Psychiatric Association has stated, While VNS has been studied over the past five years, evidence is not yet sufficient to recommend its use in routine clinical practice.VNS treatment is not indicated for this patient, as the efficacy of the therapy has not been proven. 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 37-year-old woman who has been diagnosed with bipolar disorder, depressed type. She has had multiple adequate trials of medications with minimal response. Electroconvulsive therapy has helped but the patient refused to continue the therapy due to memory loss. She reports experiencing impulses to cut herself. The patients history and response to treatment seems consistent with borderline personality disorder. Her provider has recommended vagus nerve stimulation therapy, which the Health Plan has denied on the basis that it is experimental.Review of the submitted clinical information indicates the patient has a personality disorder, which is not likely to have a long-term response to any medications or physical treatments. Standard of care for patients such as this patient is long-term psychotherapy with a provider familiar with personality disorders. Vagus nerve stimulation remains experimental at this time and is not likely to be effective in this clinical setting. 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.