Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Severe major depressive disorder

Treatment: Transcranial magnetic stimulation (TMS)

The insurer denied coverage for transcranial magnetic stimulation (TMS)

The denial is overturned

This young adult male reportedly had severe major depressive disorder and had reports of depressed mood, suicidal ideation including almost daily wishes that he was dead, decreased activities of daily living (ADL's), erratic sleep and appetite, decreased energy including feeling exhausted always, feeling miserable, and disabled functioning. He has a diagnosis of major depressive disorder- severe. He reportedly tried Wellbutrin 300 milligrams(mg) and had marked side effects including hypertension, Prozac 40 mg for, and also an augmentation medication including Rexulti 2 mg. He also reportedly took 3 different attention-deficit/hyperactivity disorder (ADHD) medications including Concerta, Adderall, and Vyvanse. The request was for transcranial magnetic stimulation therapy (TMS) for the treatment of severe depression. 
    
The Food and Drug Administration (FDA) approved Neurostar TMS Therapy for the treatment of depression for those who did not have satisfactory improvement from 1 past antidepressant medication at or above minimal effective dose and duration in the current episode. Neurostar TMS Therapy System was the largest multisite (23 centers) randomized sham controlled trial ever conducted with TMS therapy. This was the principal study for the FDA's approval of TMS therapy for major depressive disorders.  

In addition, the American Psychiatric Association (APA) Practice Guidelines for the Treatment of Major Depressive Disorders considers transcranial magnetic stimulation therapy as an appropriate acute phase option for patients who do not respond adequately to pharmacotherapy or psychotherapy and were considered treatment resistant.  

In this case this patient had a documented diagnosis of major depressive disorder-severe which is an FDA approved diagnosis for TMS therapy treatment and he reportedly tried 2 antidepressant medications in different classes including Fluoxetine (Prozac) at 40 milligrams (mg) for with minimal response and this is a serotonin reuptake inhibitor, and it was considered an adequate dosage and duration. He also reportedly took Wellbutrin (Bupropion) 300 mg, and this is another antidepressant and is a different class as it is a norepinephrine dopamine reuptake inhibitor. This was considered an adequate dosage and duration. He also reportedly took an augmenting medication, Rexulti 2 mg and did not have reported efficacy and this was considered an adequate dosage and duration.  He also reportedly took 3 psychostimulants including Concerta, Adderall, and Vyvanse without efficacy. As a result, he met criteria for TMS therapy.  

The standard recommendation for TMS therapy treatment is for patients who failed or who did not have satisfactory improvement from 1 past antidepressant medication at or above minimal effective dose and duration in the current episode and this patient met the criteria. He was considered a candidate for TMS therapy treatment, and it was considered medically necessary treatment and also is an FDA approved treatment for his diagnosis of major depressive disorder. 

The health care plan did not act reasonably, with sound clinical judgment, or in the best interests of the patient.

The insurer's denial of coverage for the transcranial magnetic stimulation (TMS) is overturned. Medical Necessity is substantiated.