Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Major Depressive Disorder-severe-recurrent
Treatment: Transcranial Magnetic Stimulation
The insurer denied coverage for: Transcranial Magnetic Stimulation
The denial is: Upheld

This adolescent reportedly had depressive symptoms, attention problems, and behavioral issues including depressed mood, difficulty paying attention, tantrums, agitation, irritable and angry mood, and hyperactivity. The patient reportedly had difficulties in academic functioning. The patient had a diagnosis of Major Depressive Disorder-severe-recurrent and was taking Sertraline 150 milligram (mg) per day, Vraylar 4.5 mg per day, and Clonidine .1 mg per day. It was reported that the patient had transcranial magnetic stimulation therapy (TMS) reported improvement in symptoms and functioning. 

The reviewer agrees with the decision to deny coverage for transcranial magnetic stimulation therapy (TMS) for 21 sessions from as there is not sufficient evidence in the medical literature to support the efficacy and long-term safety of transcranial magnetic stimulation therapy (TMS) in patients under 18 years of age. The Food and Drug Administration (FDA) approved Neurostar Transcranial Magnetic Stimulation Therapy for the treatment of depression in October 2008 in patients 18 years old and older and transcranial magnetic stimulation therapy was cleared by the FDA in 10/2008 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. However, there is not sufficient evidence in the medical literature to support the efficacy and long-term safety for patients 18 years old and younger. Also, according to the Journal of Child Adolescent Psychopharmacology 2016 26 (7) 5820589, "Magnetic Resonance Imaging Guided Open Label High Frequency Repetitive Transcranial Magnetic Stimulation for Adolescents with Major Depressive Disorder by Croarkin PE, Marony-Smith MJ it states that transcranial magnetic stimulation therapy is feasible, tolerable, and effective in adolescents with treatment resistant major depressive disorder but larger blinded sham controlled trials are needed for definitive safety and efficacy. It states that further efforts to understand optimal delivery, dosing, and biomarker development for repetitive transcranial magnetic stimulation therapy treatment for adolescent depression is warranted. Transcranial magnetic stimulation therapy (TMS) is only FDA approved for treatment of patients 18 years and older with 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. 

This patient was younger than 18 and there is not sufficient medical literature to support the safety and efficacy in patients treated with transcranial magnetic stimulation therapy (TMS) for that age. 

Based on the above, the insurer's denial must be upheld. The health care plan did act reasonably and with sound medical judgment and in the best interest of the patient. The medical necessity for Transcranial Magnetic Stimulation is not substantiated.