Appeal type: Medical necessity
Decision: Overturned

Diagnosis: depression
treatment: transcranial magnetic stimulation (TMS) 
The insurer denied transcranial magnetic stimulation (TMS). The health plan's determination is overturned.

The patient is an adult female with a history of a mood disorder best characterized as bipolar I disorder with the most recent episode, major depressive disorder, severe and recurrent without psychotic features. The patient has a documented history of multiple medication treatments, including Prozac, Zoloft, Celexa, Lexapro, Wellbutrin, Effexor extended release (XR), and Cymbalta, prescribed over the past several years without sustained benefit or remission. She has received augmentation with Seroquel, Vraylar, Abilify, Lithium, Tegretol, and supplemental treatment with clonazepam, gabapentin, and zolpidem targeting anxiety, as well as Ritalin and Vyvanse addressing attention deficit hyperactivity disorder (ADHD). Due to adverse effects, or lack of efficacy, or sustained benefit, the patient has continued to experience severe symptoms of depression and functional impairments, scoring as much as 26 on the PHQ-9 (personal health questionnaire) in the severe range of depression. Additionally, the patient has had treatment with evidence-based psychotherapy (cognitive behavioral therapy (CBT)) combined with medication without sustained benefit or a remission of symptoms, along with an emotional support animal and other supports from family and her significant other.
The patient has no significant general medical issues that interfere with the treatment for depression and does not have a diagnosis of substance use disorder, eating disorder, or sleep disorder.
The patient's clinician has recommended transcranial magnetic stimulation (TMS). The recommendation is in the context of an episode of major depression that is treatment-resistant/refractory. The patient has severe depression with loss of interest, hypersomnia, low energy and appetite, concentration difficulties, and associated symptoms of anxiety and sleep disturbance. She has trauma history with childhood sexual abuse. The patient is functionally impaired and took a leave from college following a suicide attempt. She has been hospitalized for mania, depression, and suicidality, as well as having a history of self-harm with cutting and banging her head. The patient has borderline personality traits or disorder.

The requested health service/treatment of Transcranial Magnetic Stimulation (TMS) is medically necessary for this patient.
TMS therapy as a primary or adjunctive therapy for the 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 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 course of treatment with TMS therapy is reasonable in cases of treatment resistant depression as defined in the scientific literature.
In this case, at least four or more alternative therapeutic trials with augmentation together with other therapeutic measures have been provided, and the proposed treatment with TMS therapy is considered clinically appropriate and medically necessary. Additionally, the use of repetitive 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 warranted in this case scenario and is consistent with prevailing standards of medical practice. Moreover, the scientific literature does support the use of TMS therapy in patients with both unipolar and bipolar depression consistent with the prevailing standards of medical practice for the condition diagnosed in this case, including treatment-resistant depression.