Transcranial magnetic stimulation (TMS) is a noninvasive method of delivering electrical stimulation to the brain at various frequencies or stimulus intensities. When the device delivers a rapid repetitive stimulation, it is referred to as repetitive transcranial magnetic stimulation (rTMS). Conventional rTMS is a repetition of individual pulses at a pre-set interval (train of pulses), whereas theta-burst rTMS is a repetition of short bursts of pulses at a pre-set interval (train of bursts). Stimulation can either be delivered unilaterally, over the left or right dorsolateral prefrontal cortex, or bilaterally over both cortices. Bilateral stimulation may be done sequentially or simultaneously.
Repetitive transcranial magnetic stimulation has been evaluated for treatment-resistant major depression and is proposed to relieve symptoms by stimulating nerve cells in the brain believed to be associated with mood regulation. A treatment course is usually 36 treatment sessions, beginning with one session daily five times per week for six weeks and tapering to three sessions the next week, two sessions the next week, and then one session the following week. The treatment course may be repeated after a 3 month cessation period if needed. Clinical trials show that about 1/3 of individuals treated will experience a return of symptoms.
TMS devices (repetitive and single-pulse) are also being evaluated for other psychiatric/neurologic disorders (e.g., alcohol dependence, Alzheimer disease, post-traumatic stress disorder, panic disorder, obsessive-compulsive disorder, epilepsy, migraine).
Repetitive transcranial magnetic stimulation (rTMS) is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Transcranial magnetic stimulation (TMS) for any other indication, including but not limited to migraine headaches and maintenance therapy, is considered investigational.
Repetitive transcranial magnetic stimulation (rTMS) is considered medically appropriate if ALL of the following have been met:
Age 18 years or older
Confirmed diagnosis of severe Major Depressive Disorder (initial or recurrent episode) documented by a standardized-rating scale that reliably measures depressive symptoms (e.g., Hamilton Rating Scale for Depression, Beck Depression Inventory-II, or Clinically Useful Depression Outcome Scale).
Failure of a trial of psychotherapy
Documentation of ANY ONE of the following:
Failure of four (4) trials of psychopharmacologic agents for depression, including two (2) different agent classes and two (2) augmentation trials (e.g., pharmacologic strategy using combinations of drugs)
Inability to tolerate a therapeutic dose of medications as evidenced by four (4) trials of psychopharmacologic agents with documented side effects
History of response to repetitive TMS in a previous depressive episode (at least three (3) months since the prior episode)
Individual is a candidate for electroconvulsive therapy (ECT), and ECT would not be clinically superior to repetitive TMS
Absence of ALL of the following:
Ongoing substance abuse
Presence of acute or chronic psychotic symptoms/disorders (such as schizophrenia, schizophreniform or schizoaffective disorder) in the current depressive episode
Neurologic conditions including but not limited to: epilepsy, history of seizure disorder with increased risk of future seizures, cerebrovascular disease, dementia, increased intracranial pressure, history of repetitive or severe head trauma, primary or secondary tumors in the central nervous system (CNS)
Presence of implanted magnetic-sensitive medical device located 30 centimeters or less from the TMS magnetic coil (examples include, but are not limited to, cochlear implants, implanted electrodes/stimulators, aneurysm clips or coils, stents, bullet fragments)
Any specific products referenced in this policy are just examples and are intended for illustrative purposes only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available. These examples are contained in the parenthetical e.g. statement.
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.
For conditions other than treatment-resistant major depression, the evidence is insufficient to determine if treatment with repetitive TMS leads to improved outcomes. Currently, FDA approved devices are indicated for adult use only (e.g. NeuroStar®, Brainsway™ H-Coil Deep TMS, Rapid Therapy System, Mag Vita TMS Therapy® system, Mag Vita TMS Therapy System with Theta Burst Stimulation, Neurosoft TMS).
BlueCross BlueShield Association. Evidence Positioning System (10:2018). Transcranial magnetic stimulation as a treatment of depression and other psychiatric/neurologic disorders (2.01.50). Retrieved July 1, 2019 from https://www.evidencepositioningsystem.com/. (45 articles and/or guidelines reviewed)
CMS.gov: Centers for Medicare & Medicaid Services. Palmetto, GBA. (2018, March). Local Coverage Determination (LCD): Repetitive transcranial magnetic stimulation (rTMS) in adults with treatment resistant major depressive disorder (L34869). Retrieved July 26, 2018 from https://www.cms.gov.
Croarkin, P. Nakonezny, P., Wall, C. Murphy, L. Sampson, S. Frye, M., et al. (2015). Transcranial magnetic stimulation potentiates glutamatergic neurotransmission in depressed adolescents. Psychiatry Research: Neuroimaging, 247, 25-33. (Level 3 evidence)
Donaldson, A., Gordon, M., Melvin, G., Barton, D., and Fitzgerald, P. (2013). Addressing the needs of adolescents with treatment resistant depressive disorders: a systematic review of rTMS. Brain Stimulation, 7, 7-12. (Level 4 evidence)
Janicak, P. and Dokucu, M. (2015). Transcranial magnetic stimulation for the treatment of major depression. Neuropsychiatric Disease and Treatment, 11, 1549-1560. (Level 2 evidence)
Kelly, M., Oliveira-Maia, A., Bernstein, M., Stern, A., Press, D., Pascual-Leone, A., et al. (2017). Initial response to transcranial magnetic stimulation treatment for depression predicts subsequent response. Journal of Neuropsychiatry and Clinical Neuroscience, 29, 179-182. (Level 4 evidence)
Krishnan, C., Santos, L., Peterson, M., and Ehingeraa, M., (2015) Safety of noninvasive brain stimulation in children and adolescents. Brain Stimulation, 8 (1), 76-87. (Level 4 evidence)
Lan, L., Zhang, X., Li, X., Rong, X., & Peng, Y. (2017). The efficacy of transcranial magnetic stimulation on migraine: a meta-analysis of randomized controlled trials. The Journal of Headache and Pain, 18, 86. (Level 2 evidence)
National Institute for Health and Clinical Excellence (NICE). (2014, January). Repetitive transcranial magnetic stimulation for depression. Retrieved July 12, 2017 from http://www.nice.org.uk.
National Institute for Health and Clinical Excellence (NICE). (2014, January). Transcranial magnetic stimulation for treating and preventing migraine. Retrieved March 20, 2015 from http://www.nice.org.uk.
Pedapati, E., Gilbert, D., Horn, P., Huddleson, D., Laue, C., Shahana, N., et al. (2015). Effects of 30 Hz theta burst transcranial magnetic stimulation on the primary motor cortex in children and adolescents. Frontiers in Human Neuroscience, Vol. 9, Article 91. (Level 4 evidence)
Rapinesi, C., Bersani, F., Kotzalidis, G., Imperatori, C., Casale, A., DiPietro, S., et al. (2015). Maintenance deep transcranial magnetic stimulation sessions are associated with reduced depressive relapses in patients with unipolar or bipolar depression. Frontiers in Neuroscience, Vol 6, Article 16. (Level 4 evidence)
Sahu, A.K., Sinha, V.K., & Goyal, N. (2019). Effect of adjunctive intermittent theta-burst repetitive transcranial magnetic stimulation as a prophylactic treatment in migraine patients: a double-blind sham-controlled study. Indian Journal of Psychiatry, 61 (2), 139-145. (Level 2 evidence)
U. S. Food and Drug Administration. (2008, December). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K083538 (NeuroStar®). Retrieved September 12, 2014 from http://www.accessdata.fda.gov.
Winifred S. Hayes, Inc. Medical Technology Directory. (2014, March). Transcranial magnetic stimulation for treatment-resistant depression. Retrieved May 16, 2016 from www.Hayesinc.com/subscribers. (120 articles and/or guidelines reviewed)
Winifred S. Hayes, Inc. Medical Technology Directory. (2016, December; last updated November 2018). Comparative effectiveness review of high-frequency left repetitive transcranial magnetic stimulation versus other neurostimulation approaches to treatment-resistant depression. Retrieved July 2, 2019 from www.Hayesinc.com/subscribers. (66 articles and/or guidelines reviewed)
Winifred S. Hayes, Inc. Medical Technology Directory. (2016, November; last update search November 2018). High-frequency left repetitive transcranial magnetic stimulation for treatment-resistant major depressive disorder. Retrieved July 3, 2019 from www.Hayesinc.com/subscribers. (78 articles and/or guidelines reviewed)
Winifred S. Hayes, Inc. Medical Technology Directory. (2016, September; last update search September 2018). Low-frequency right repetitive transcranial magnetic stimulation for treatment-resistant major depressive disorder. Retrieved July 26, 2018 from www.Hayesinc.com/subscribers. (30 articles and/or guidelines reviewed)
Winifred S. Hayes, Inc. Medical Technology Directory. (2019, March). Transcranial magnetic stimulation for the treatment of obsessive-compulsive disorder. Retrieved July 3, 2019 from www.Hayesinc.com/subscribers. (56 articles and/or guidelines reviewed)
ORIGINAL EFFECTIVE DATE: 12/21/2016
MOST RECENT REVIEW DATE: 10/31/2019
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.