Appeal type: Medical necessity
Decision: Overturned

Diagnosis:  Major Depressive Disorder-Severe-recurrent without psychotic features
Treatment:  Transcranial magnetic stimulation (TMS)

The insurer denied coverage for Transcranial magnetic stimulation (TMS).  The denial is reversed. 

This patient is a female, who reportedly had depressive symptoms including depressed mood, low energy, feelings of guilt, concentration problems, sleeping problems, low appetite, and limited ability in ADL's and functioning.  She had a reported diagnosis of Major Depressive Disorder-Severe-recurrent without psychotic features.  She reportedly had several trials of antidepressant medications in several different classes, as well as augmenting medications with no prolonged efficacy.  She reportedly took Prozac up to 40 mg per day for several months with only partial response, Cymbalta up to 90 mg for several months with a partial response only, Effexor up to 225 mg per day for a year with no response, Wellbutrin 300 mg per day with no response, Viibryd up to 40 mg for 11 months with no response, and also had augmenting medication of Cytomel 1 mg for 6 months, Lithium 600 mg, and 20 mg of Abilify. The request was for transcranial magnetic stimulation therapy.

This reviewer disagrees with the decision to deny coverage for the request for transcranial magnetic stimulation therapy (TMS).  The FDA approved Neurostar Transcranial Magnetic Stimulation Therapy for the treatment of depression in October 2008.  Transcranial magnetic stimulation therapy was cleared by the FDA in October of 2008 and indicated for the treatment of major depressive disorder 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. Neurostar TMS Therapy System was the largest multisite (23 centers) randomized sham controlled trial ever conducted with transcranial magnetic stimulation therapy. This was the principal study for the FDA's approval of transcranial magnetic stimulation therapy for major depressive disorders in October 2008.  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 recurrent, which is an FDA approved diagnosis for transcranial magnetic stimulation therapy (TMS) treatment, and she tried and failed several antidepressant medications in different classes including Prozac, which is a serotonin reuptake inhibitor, and it was an adequate dosage of 40 mg and adequate duration, 2 serotonin norepinephrine reuptake inhibitors, including Effexor at an adequate dosage of 225 mg and adequate duration and Cymbalta at an adequate dosage of 90 mg and duration, Wellbutrin, which is a dopamine norepinephrine reuptake inhibitor and is FDA approved for major depressive disorder, and she took it at an adequate dosage of 300 mg per day, Viibryd, which is a unique mechanism antidepressant at an adequate dose of 40 mg, as well as adequate dosages and durations of augmenting agents.

The standard recommendation for transcranial magnetic stimulation therapy (TMS) 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.  She was considered a candidate for transcranial magnetic stimulation therapy (TMS) treatment, and it was considered medically necessary treatment then.

Based on the above, the medical necessity for Transcranial magnetic stimulation (TMS) is substantiated.  The insurer's denial is reversed.