Appeal type: Experimental/Investigational
Decision: Upheld

Physician 1: The patient is a 46-year-old female with a several-year history of depression apparently refractory to multiple types of antidepressants, antipsychotics, lithium, mood stabilizers and electro-convulsive therapy (ECT). She has had two hospitalizations and her psychiatrist is now recommending vagus nerve stimulation (VNS) therapy.  The Health Plan has denied authorization and coverage citing the investigational nature of the therapy.  The FDA has approved the use of VNS therapy for certain patients.  It is no longer considered experimental or investigational for treatment of chronic or refractory depression.  This patient meets all the criteria for use of this therapy/device and it is reasonable and medically appropriate for her treatment. Therefore, I have determined that the requested therapy is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Plans denial should be overturned.Physician 2: The patient is a 46-year-old woman with a reportedly refractory major depressive disorder (MDD) with bipolar features who has been in treatment for approximately 11 years. She has been unresponsive to multiple and varied antidepressants, mood stabilizers and antipsychotic agents.  Additionally, she did not benefit from electro-convulsive therapy (ECT).  The patient is marginally functioning and she and her psychiatrist have requested authorization for vagus nerve stimulation (VNS) therapy. The Health Plan denied the request based on a determination that the therapy is experimental/investigational for the treatment of the patients depression.It is well recognized by many clinical psychiatrists that the FDAs July 2004 approval of VNS for the treatment of refractory MDD was hasty and premature. This patients treatment appears to be largely medication management, and biologic attempts to remediate her symptoms have not produced a notable change. We have no data or detail as to her capacity to respond to a more traditional or psychotherapeutic effort, although we are told briefly that behavioral approaches have also failed.  VNS, despite the FDAs approval, must still be considered investigational with insufficient study as to the long-term efficacy. 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 46-year-old female with recurrent refractory depression with bipolar features. Her provider indicates she has failed treatment with ECT, antidepressants, mood stabilizers, antipsychotics agents and inpatient admissions. The patient requests coverage for vagus nerve stimulation (VNS) therapy as a way to mitigate her long-standing symptoms. The Health Plan has denied coverage for VNS therapy on the basis that it is considered investigational for the treatment of this patients depression.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. There is no definitive evidence of shortterm efficacy found for adjunctive VNS therapy 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 or to other factors. 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.Based upon the information 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.