Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Major Depressive Disorder
Treatment: Transcranial Magnetic Stimulation

The insurer denied Transcranial Magnetic Stimulation. 
The denial is overturned.

The patient is a female with a history of major depressive disorder, recurrent and moderately severe without psychotic features. The patient has a documented history of multiple medication treatments for depression including treatment with more than two disparate classes of medication and at least four or more six-week or longer trials with antidepressant medications (selective serotonin reuptake inhibitor [SSRIs] and Wellbutrin), as well as combination treatment with an SSRI and Wellbutrin. Additionally, the patient has received augmentation with lamotrigine, risperidone, stimulants and other treatments treatment targeting sleep disturbance and anxiety including guanfacine, clonidine, modafinil and prazosin. She has been treated with an evidence-based psychotherapy with weekly therapy sessions for over one year. She has not received electroconvulsive therapy (ECT) or vagus nerve stimulation (VNS) therapy. She underwent treatment with transcranial magnetic stimulation (TMS) for the treatment resistant depression with a robust clinical response resulting in a decrease in the Patient Health Questionnaire (PHQ)-9 scale score from 16 to 2 with a remission. However, she subsequently had a recrudescence of symptoms of depression with a PHQ-9 scale score of 16 in the moderately severe range. The patient is also diagnosed with a co-morbid generalized anxiety disorder with a generalized anxiety disorder (GAD-7) scale score of 16 reflecting severe symptoms of anxiety. The subject under review is the medical necessity for transcranial magnetic stimulation. 

The requested transcranial magnetic stimulation (TMS) is medically necessary for this patient.
TMS therapy as a primary or adjunctive therapy for treatment of depression has generally been evaluated in patients who have treatment refractory/resistant 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, or with electroconvulsive therapy, and/or psychotherapy, especially cognitive behavioral therapy, have failed to produce a response or remission, then TMS is an appropriate consideration. This assertion is noted in the American Psychiatric Association Practice Guideline for the assessment and treatment of major depressive disorder, referenced below. Moreover, the scientific literature indicates that a second course of treatment is reasonable in cases that have shown a robust response to TMS as in this case.
In this case, at least four or more alternative therapeutic trials with augmentation together with other therapeutic measures have been provided, and TMS provided a robust clinical response in 2021. Thus, in this case, the proposed TMS therapy is considered clinically appropriate and medically necessary. Additionally, the proposed TMS therapy is reasonable, and in the best interest of the patient. The decision to proceed with TMS therapy reflects sound medical judgment based upon the current scientific literature and American Psychiatric Association practice guidelines concerning the assessment and treatment of major depressive disorder. The patient in this case has demonstrated that her depressive disorder is treatment refractory or resistant, and the proposed treatment of recurrent major depressive disorder using TMS therapy with a clinically appropriate number of sessions is reasonable and warranted in this case scenario and is consistent with prevailing standards of medical practice.