Appeal type: Experimental/Investigational
Decision: Upheld

Physician 1:  The patient is a 37-year-old female with an extensive history of mental illness. She has been diagnosed as having major depression with psychotic features and/or schizoaffective disorder, and has tried numerous psychotropic medications which include Geodon, Wellbutrin, Effexor, Seroquel, Risperdal, Lorazepam, Lamictal, Cymbalta, Celexa, Depakote and Xanax along with electroconvulsive therapy (ECT). According to the patient and her provider, she has had adequate trials of the various treatments.  The patient currently has depressed mood, crying spells, anxiety, disturbed sleep, disturbed concentration and feelings of hopelessness/helplessness with suicidal ideation. Her current regimen of medications is not helpful.  The patient, as well as her provider, feels that they have exhausted all available treatment alternatives. Her request for authorization of VNS therapy was denied by the Health Plan based upon their determination that the therapy remains unproven for the treatment depression.Studies such as those cited above have shown VNS therapy to result in substantial improvement in patients with chronic treatment resistant depression and it is considered a valid adjunct treatment for patients with treatment-resistant depression. This patient has had more than acceptable trials of standard treatment, all of which have failed. It is not likely that continued attempts at standard treatment will be effective. Given the lack of available treatment options, pursuit of VNS therapy is acceptable in this case. As such, 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 37-year-old female with a diagnosis of major depression. She is now seeking vagus nerve stimulation (VNS) therapy for treatment and management of her illness. She reports her condition has been refractory to various treatment approaches until this point in time. The patients request for authorization of VNS therapy was denied by the Health Plan on the basis that it is an experimental treatment and therefore a non-covered benefit. The patient is appealing the Health Plans denial.To date, VNS therapy remains a highly debated 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. Current Senate investigations cast doubt over the process utilized for FDA approval of VNS therapy in July 2005. Medicare has delayed a national coverage decision regarding VNS therapy citing the ongoing Senate investigation and the controversial manner in which approval was obtained. VNS therapy has not been accepted by the psychiatric community as a standard treatment in the management of refractory depression. The therapy is considered experimental and unproven at this time. 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 3:  The patient is a 37-year-old female who has struggled with psychiatric illness since late adolescence.  For several years she had many admissions, been treated with antipsychotics and antidepressants, and had chronic suicidal ideation. She ultimately overdosed (while hospitalized) and underwent ECT. Her mood improved but the improvement could not be maintained.In 1990 the patient was started on Clozaril while hospitalized on the east coast. This greatly improved her symptoms; her psychosis remitted, her functioning improved and she was eventually able to obtain a two-year degree in x-ray technology. For the past eight years the patient has held a job, but has been depressed and has had chronic suicidal ideation without intention or plan despite trials of various antidepressants, mood stabilization, and the use of augmentation strategies.The patients current treatment consists of psychotherapy and medication which includes Clozaril, Adderall, Lithium and Sertraline. Additional ECT was strongly considered in 2004, but the patient was reluctant to begin this treatment. She is presently requesting authorization and coverage for VNS therapy. The Health Plan has denied the patients request based upon the experimental/investigational nature of the treatment.The vagus nerve stimulation (VNS) treatment system for treatment-resistant depression was finally approved by the FDA in July 2005.  The source of the controversy does not lie with safety concern (VNS has been used safely by many patients with refractory epilepsy) but, rather, with the efficacy data.The FDA requires two randomized, double-blinded, placebo-controlled trials that prove a proposed treatment to be statistically superior to placebo. Very briefly, the first study had significant design problems and failed to demonstrate the superiority of VNS over the sham (placebo) treatment. This was true for the primary outcome measure and two of the three secondary measures. Only the self-report questionnaire showed statistical superiority in the VNS group. The Second study was a one-year observational study (an open trial) that could be submitted to the FDA only after data from a parallel Cyberonics (VNS manufacturer) study was co-opted as a control group. Their data was positive but there is debate about what the data actually means. All further studies have been open label or care reports. The psychiatric community at large has not yet embraced VNS as part of the national standard of care for severe depression. The American Psychiatric Association (APA) has gone on record in stating, While VNS has been studied over the part five years, evidence is not yet sufficient to recommend its use in routine clinical care. VNS is not, at this time, included in the APA treatment guidelines for major depression.More specifically, ECT had improved the patients mood in the early years of her illness, but there was not sustained improvement. Another course of ECT may be worthwhile, especially if a maintenance schedule is considered as part of the treatment. If trycyclic antidepressants and/monoamine oxidase inhibitors (MAOIs) have not been tried in adequate doses, then that would also offer a possible alternative to vagus nerve stimulation therapy.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.