Appeal type: Medical necessity
Decision: Upheld

Mental Health
Depression


The patient is a female with a diagnosis of recurrent and severe major depressive disorder without psychotic features. The patient has co-morbid psychiatric disorders that include anxiety disorders (agoraphobia and social phobia), post-traumatic stress disorder (PTSD), borderline personality disorder, and mild alcohol use disorder, as well as documentation of bipolar II disorder and history of attention deficit hyperactivity disorder (ADHD). The patient received transcranial magnetic therapy, thirty deep transcranial magnetic stimulation (dTMS) treatments with an initial Beck Depression Inventory score of 13 with a decrease to 9. There is information provided to document treatment with antidepressants and augmentation with other classes of medications, and combined use of cognitive behavioral therapy and supportive psychotherapy. Failed antidepressant trials due to lack of efficacy or adverse effects include fluoxetine, paroxetine, sertraline, venlafaxine and mirtazapine. Augmentation has occurred with Seroquel, Zyprxa, Risperdal and Latuda, as well as use of Provigil to address daytime sedation with the Seroquel and alprazolam to address associated symptoms of anxiety. The patient has reportedly not been provided treatment with electroconvulsive therapy (ECT), and the documentation does not note whether ECT was offered or received in this case. The clinician and patient are requesting additional dTMS therapy with 14 additional sessions. The health plan has denied authorization for coverage of additional dTMS on the basis of coverage exclusion and that the requested treatment is considered not medically necessary in view of the apparent lack of a robust response to the initial treatments with 30 TMS treatment sessions and/or the health plan's assertion that other treatment with therapy/counseling is more likely to address the patient's multiple mental disorders. Issue under review: Transcranial Magnetic Stimulation (TMS) with 14 additional sessions for the treatment of recurrent and severe major depressive disorder. The health plan's determination of medical necessity is upheld. Yes, the health plan, in its determination of medical necessity, did act reasonably, with sound medical judgment and in the best interest of the patient. There are other clinically appropriate approaches available for treatment of depressive disorder, including combination therapy or another established augmentation therapy, as well as mood stabilizers. Moreover, electroconvulsive therapy may be offered. Thus, alternative, standard therapeutic options known to be effective in the treatment of Major Depressive Disorder and the multiple co-morbid psychiatric conditions are available to this patient to address the recrudescence of depressive symptoms or to continue efforts to achieve a remission of symptoms of the mood disorder. Thus, the health plan has acted reasonably and should not cover the proposed treatment, as requested. The requested Transcranial Magnetic Stimulation treatment is not "medically necessary" for this patient. Repetitive TMS therapy as a primary or adjunctive therapy for treatment of depression has generally been evaluated in patients who have treatment refractory depression, as defined by one or more, antidepressant medication treatment failures with or without augmentation. TMS therapy for depressive disorder has been established by the Food and Drug Administration (FDA) as a safe treatment; and, the data, as reflected in peer reviewed medical literature, supports this assertion. Specifically, when treatments with antidepressant medication with or without augmentation, electroconvulsive therapy, and/or psychotherapy, especially cognitive behavioral therapy, have failed, then TMS may be an appropriate consideration. This assertion is also noted in the American Psychiatric Association Practice Guideline for the assessment and treatment of major depressive disorder, referenced below. The documentation in this case does not meet those guidelines with regard to the use of TMS for maintenance therapy in this case scenario largely due to the lack of a robust response to 30 dTMS treatments and the presence of multiple co-morbid mental disorders. Thus, in this case, the proposed repetitive and deep TMS therapy is not likely to be more beneficial for the patient than other available standard therapy/treatments, and medical necessity is not met. This answer is consistent with practice guidelines concerning major depressive disorder and the scientific literature pertaining to TMS therapy for major depressive disorder.