Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Major Depressive Disorder.

Treatment: Transcranial Magnetic Stimulation.

The insurer denied coverage for Transcranial Magnetic Stimulation.

The denial is overturned. 

This male patient has Major Depressive Disorder (MDD) and Attention Deficit Hyperactivity Disorder (ADHD). He had depressive symptoms including depressed and irritable mood, low energy and interest, decreased speech, feelings of guilt and remorse, sleeping problems, increased eating, poor concentration, despair, loneliness, and ruminating. He also had a decline in functioning. He tried multiple antidepressant medications including Zoloft, Lexapro, Effexor, Cymbalta, and Wellbutrin, and took antidepressant augmenting medication including Abilify and Seroquel. He also took Depakote. He was taking Vyvanse for ADHD and Klonopin for anxiety. He also tried cognitive behavioral therapy and psychotherapy. Transcranial Magnetic Stimulation (TMS) therapy (codes 90867 and 90868) was recommended.

The Food and Drug Administration (FDA) approved Neurostar TMS therapy for the treatment of depression in October 2008, indicated for the treatment of MDD in 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. The study did not report that one needed to fail more than 1 antidepressant medication trial. In this case it was reported that he had side effects or lack of efficacy 5 total antidepressant medications with reports including minimal improvement, sexual side effects, partial response, sexual side effects, weight gain, worsened anxiety. Of the medications tried, Zoloft and Lexapro are serotonin reuptake inhibitors, Effexor and Cymbalta are norepinephrine serotonin reuptake inhibitors, and  Bupropion is a dopamine norepinephrine reuptake inhibitor. He also had reports of cognitive behavioral therapy and individual psychotherapy. 

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. 

According O'Reardon, patients that had failed to benefit from prior antidepressant drug medications and demonstrated a level of treatment resistance similar to patients treated in studies of electroconvulsive therapy. It also showed clinical efficacy and safety for the treatment of TMS therapy for MDD. 

The 2011 Federally Funded Effective Health Care Program of the Agency for Health Care Research and Quality published comparative effectiveness reviews entitled, "Nonpharmacological Intervention for Treatment Resistant Depression in Adults." It concluded that there was a substituted and well replicated body of evidence for randomized sham controlled clinical trials providing high strength of evidence that TMS therapy procedures were significantly greater in decreasing depression severity and resulting in a greater response rate and remission rate when compared to sham treatment condition and peer reviewed published clinical trials. 

In addition, the American Psychiatric Association (APA) Practice Guidelines for the Treatment of Major Depressive Disorders considers TMS 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 current diagnosis of MDD which is an FDA approved diagnosis for TMS therapy and had depressive symptoms. He was considered a candidate for TMS therapy as he had taken multiple different antidepressant medications with reports of side effects or lack of efficacy. 

The health plan did not act reasonably with sound medical judgment in the best interest of the patient.

The medical necessity for Transcranial Magnetic Stimulation (TMS) treatment (codes 90867 and 90868) for major depressive disorder is substantiated. The insurer's denial is overturned.