
202207-151336
2022
Beacon Health Options
Self-Funded
Mental Health
Mental Health: Outpatient
Medical necessity
Upheld
Case Summary
Diagnosis: Major depressive disorder
Treatment: Transcranial magnetic stimulation (TMS)
The insurer denied coverage for TMS.
The denial is upheld.
This patient reportedly had depressive symptoms and major depressive disorder and had tried multiple past medications for depression with lack of efficacy including Prozac, Zoloft, Lexapro, Viibryd, Cymbalta, and Wellbutrin, and tried augmenters Rexulti, Abilify, Lithium, Lamictal, and Latuda. She reportedly had difficult functioning in school and interpersonally. The request was for transcranial magnetic stimulation (TMS) therapy.
The insurer denied coverage for TMS therapy for her, stating that she was under the age of 18 and that TMS therapy is FDA (food and drug administration) approved for major depressive disorder 18 years of age or older.
The reviewer agrees with the decision to deny coverage for TMS therapy as there is not sufficient evidence in the medical literature to support its efficacy and long-term safety in patients under 18 years of age. The FDA approved Neurostar TMS Therapy for the treatment of depression in October 2008 in patients 18 years old and older and TMS therapy was cleared by the FDA in October 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. According to Biology Psychiatry, NY (New York) May 2018, "Open Trial of Repetitive Transcranial Magnetic Stimulation in Youth with Treatment-Resistant Major Depression" by MacMaster FP, Croarkin PE, and Wilkes TC it states that a single center open trial suggest TMS is safe and effective in youth with treatment resistant major depression, but larger randomized controlled trials are needed. 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 TMS 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 TMS therapy treatment for adolescent depression is warranted. As a result, the recommendation is to uphold the previous decision and deny coverage for TMS therapy.
The health plan acted reasonably, with sound medical judgment, and in the best interest of the patient.
The insurer's denial of coverage for the for TMS is upheld. Medical necessity is not substantiated.