Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Mental Health/Depression/MDD (Major Depressive Disorder)
Treatment: Outpatient/Transcranial Magnetic Stimulation (TMS)
The health plan denied the requested Transcranial Magnetic Stimulation (TMS) as experimental/investigational. 
The health plan's determination is overturned.

The patient is an adult female with a history of a mood disorder best characterized as bipolar disorder with most recent episode, major depressive disorder, severe and recurrent without psychotic features. The patient has a documented history of multiple medication treatments including treatment with Prozac, Celexa, Zoloft, Cymbalta, Effexor, and Wellbutrin XL. She has received augmentation with Abilify, Vraylar, Lithium, Ritalin and Tegretol, as well as past treatment with Gabapentin and Ativan. Current treatment includes Trintellix together with Lamictal, Rexulti, Zyprexa and prn use of risperidone. Due to adverse effects or lack of efficacy or sustained benefit, the patient has continued to experience severe symptoms of depression and functional impairments. Additionally, the patient has had treatment with an evidence-based psychotherapy (CBT) combined with medication without sustained benefit or a remission of symptoms.
The patient has history of psychiatric hospitalizations and manic episodes  associated with a suicide attempt, and additional manic episodes. There is comorbid generalized and social anxiety disorders. The patient has no significant general medical issues that interfere with the treatment for depression. She has hypertension, dyslipidemia, and gastroesophageal reflux disease (GERD) with associated treatments.
Mental status examination reveals depressed mood, sad affect with anxiety, and anhedonia. She has loss of interest and low energy with fatigue and other neuro-vegetative disturbances related to depression. She was noted to be motivated for treatment. 
The patient's clinician has recommended transcranial magnetic stimulation (TMS). The recommendation is in the context of the episode of major depression that is treatment-resistant/refractory.

In this case scenario, the health plan's determination regarding the proposed health service or treatment is overturned, in whole.

Yes, the proposed health service or treatment is likely to be more beneficial than any other standard treatment or treatments for the insured's life threatening or disabling condition or disease.
Rationale: 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 unipolar or bipolar depression 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 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, and in the peer reviewed scientific literature pertaining to the use of TMS in bipolar treatment resistant depression.

Thus, in this case, the proposed TMS therapy is considered clinically appropriate and more likely to be beneficial that any additional standard treatments. Additionally, the proposed TMS therapy is reasonable, and in the best interest of the patient.