Transcranial magnetic stimulation (TMS) is a noninvasive method of delivering electrical stimulation to the brain. When the device delivers a rapid repetitive stimulation it is referred to as repetitive transcranial magnetic stimulation (rTMS). Repetitive transcranial magnetic stimulation is being evaluated for the treatment of treatment-resistant depression and a variety of other psychiatric/neurologic disorders. The goal for rTMS is to stimulate nerve cells in the brain believed to be associated with mood regulation (i.e. left prefrontal cortex) and relieve the symptoms of depression. Currently, all of the FDA approved devices are indicated for adults use only.
During rTMS the individual remains awake, while reclining a crescent shaped magnet is placed over the patient’s prefrontal cortex, transmitting magnetic pulses through the skull (e.g. NeuroStar®, Brainsway™ H-Coil Deep, MagVita TMS Therapy® system). The therapy is administered in an inpatient, outpatient or office setting. A treatment course is usually 1 daily session, 5 times per week for up to 6 weeks, followed by a 3-week taper of 3 rTMS session in week one, 2 rTMS sessions the next week, and one rTMS session in the last week (total of 36 sessions). 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 and that those who benefited most from the initial treatments will likely benefit from subsequent treatments.
Multiple devices are now appearing on the commercial market that use various forms of TMS; such as single pulse TMS or sTMS (i.e. Cerena™ TMS; Spring TMS), dual pulse, high frequency, etc., as proposed treatment for a variety of disorders including alcohol dependence, Alzheimer disease, neuropathic pain, obsessive-compulsive disorder, postpartum depression, Parkinson disease, stroke, posttraumatic stress disorder, panic disorder, epilepsy, dysphagia, Tourette syndrome, schizophrenia, migraine headaches, spinal cord injury, fibromyalgia, obesity and tinnitus. There are no high-quality studies for any of these conditions and the evidence is insufficient to determine their effect on health outcomes.Note: Similar sounding devices (i.e. Alpha Stim®, Fisher Wallace Stimulator®, BrainStimulator® tDCS) are also marketed to treat chronic pain, headache, insomnia, obesity, Parkinson’s disease, Rheumatoid Arthritis, depression, and/or anxiety; however, they are addressed in other medical policies.
Repetitive transcranial magnetic stimulation (rTMS) of the brain for the treatment of Major Depressive Disorder may be considered medically necessary if the medically appropriateness criteria are met. (See Medical Appropriateness below.)
Continued treatment with rTMS as maintenance therapy is considered investigational.
All other types of transcranial magnetic stimulation (TMS) of the brain (e.g. single pulse, dual pulse, high frequency) are considered investigational as a treatment of all other disorders, including but not limited to bipolar disorder, schizophrenia, obsessive-compulsive disorder, or migraine headaches.
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 (e.g. Hamilton Rating Scale for Depression, Beck Depression Inventory-II, or Clinically Useful Depression Outcome Scale) that reliably measures depressive symptoms.
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 TMS or rTMS 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 TMS or rTMS
Failure of a trial of a psychotherapy
Absence of ALL of the following:
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)
Implanted magnetic-sensitive medical device or other implanted metal items, including but not limited to a cochlear implant, implanted cardioverter defibrillator (ICD), pacemaker, vagus nerve stimulator, or metal aneurysm clips or coils, staples, or stents
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.
Based on the short-term benefit observed in randomized controlled trials, clinical input, and the lack of alternative treatments aside from electroconvulsive therapy (ECT) for patients with treatment resistant depression, repetitive transcranial magnetic stimulation (rTMS) may be considered medically necessary in patients who meet specific criteria. For other psychiatric/neurologic conditions, the evidence is insufficient to determine whether rTMS leads to improved outcomes.
American Academy of Child and Adolescent Psychiatry (AACAP) Committee on Quality Issues (2013, December) Practice Parameter for the Assessment and Treatment of Children and Adolescents with Tic Disorders. Journal of the American Academy of Child and Adolescent Psychiatry. Vol. 52, No. 12, 1341-1359.
Bhola, R., Kinsella, E., Giffin, N., Lipscombe, S., Ahmed, F., Weatherall, M., Goadsby, P. (2015) Single-pulse transcranial magnetic stimulation (sTMS) for the acute treatment of migraine: evaluation of outcome data for the UK post market pilot program. The Journal of Headache and Pain. DOI 10.1186/s10194-015-0535-3. (Level 3 evidence)
BlueCross BlueShield Association. Medical Policy Reference Manual. (7:2017). Transcranial magnetic stimulation as a treatment of depression and other psychiatric/neurologic disorders (2.01.50). Retrieved July 26, 2018 from BlueWeb. (45 articles and/or guidelines reviewed)
California Technology Assessment Forum/Institute for Clinical and Economic Review (2014, June) Controversies in Migraine Management. Retrieved May 16, 2016 from: http://www.ctaf.org (123 articles and/or guidelines reviewed)
Carpenter, L. L., Janicak, P. G., Aaronson, S. T., Boyadjis, T., Brock, D. G.,& Cook, I. A. (2012). Transcranial magnetic stimulation (TMS) for major depression: A multisite, naturalistic, observational study of acute treatment outcomes in clinical practice. Depression and Anxiety, 29 (7), 587-596. (Level 1 evidence - Industry sponsored)
Croarkin, P. Nakonezny, P., Wall, C. Murphy, L. Sampson, S. Frye, M., et. al., (2015, August) 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, October). Addressing the needs of adolescents with treatment resistant depressive disorders: a systematic review of rTMS. Brain Stimulation, 2014 (7) 7-12. (Level 4 evidence)
Dunner, D., Aaronson, S., Sackeim, H., Janiak, P., Carpenter, L., Boyadjis, T., et. al. (2014, September) A multisite, naturalistic, observational study of transcranial magnetic stimulation for patients with pharmacoresistent major depressive disorder: durability of benefit over a 1-year follow-up period.Journal of Clinical Psychiatry, doi:10.4088/JCP.13m08977. (Level 3 evidence)
ECRI Institute. Health Technology Information Service. Emerging Technology Evidence Report. (2012, April). Repetitive transcranial magnetic stimulation using the NeuroStar system for treating major depressive disorder. Retrieved September 12, 2014 from ECRI Institute. (63 articles and/or guidelines reviewed)
Galletly, C., Clarke, P., Carnell, B., and Gill, S. (2015, November) A clinical repetitive transcranial magnetic stimulation service in Australia: 6 years on. Australia/New Zeeland Journal of Psychiatry, 49(11):1040-7. Abstract retrieved July 14, 2017 from PubMed database.
Gaynes, B., Lloyd, S., Lux, L., Gartlehner, G., Hansen, R., Brode, S., et. al., (2014, May) Repetitive transcranial magnetic stimulation for treatment-resistant depression: a systematic review and meta-analysis. Journal of Clinical Psychiatry; 75(5) 477-89. Abstract retrieved August 2, 2016 from PubMed database.
George, M., Lisanby, S., Avery, D., McDonald, W., Durkalski, V., Pavlicova, M., et. al. (2010, May) Daily left prefrontal transcranial magnetic stimulation therapy for major depressive disorder: a sham-controlled randomized trial. Archives of General Psychiatry Journal. 67(5):507-16. Abstract retrieved August 2, 2016 from PubMed database.
Janicak, P. and Dokucu, M. (2015, June) Transcranial magnetic stimulation for the treatment of major depression. Neuropsychiatric Disease and Treatment,11: 1549-1560. (Level 2 evidence)
Janicak, P. G., Dunner, D. L., Aaronson, S. T., Carpenter, L. L., Boyadjis, T. A., Brock, D. G., et al. (2013). Transcranial magnetic stimulation (TMS) for major depression: A multisite, naturalistic, observational study of quality of life outcome measures in clinical practice. International Journal of Neuropsychiatric Medicine, 18 (6), 322-332. (Level 1 evidence - Industry sponsored)
Jin, Y., & Phillips, B. (2014). A pilot study of the use of EEG-based synchronized transcranial magnetic stimulation (sTMS) for treatment of major depression. BMC Psychiatry, 14 (1), 13. (Level 3 evidence - Industry sponsored)
Kelly, M., Oliveira-Maia, A., Bernstein, M., Stern, A., Press, D., Pascual-Leone, A., et. al. (2017, Spring) 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)
Micallef-Trigona, B. (2014, July) Comparing the effects of repetitive transcranial magnetic stimulation and electroconvulsive therapy in the treatment of depression: a systematic review and meta-analysis. Depression Research and Treatment. Vol. 2014, Article ID 135049. (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.
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.
Pedapati, E., Gilbert, D., Horn, P., Huddleson, D., Laue, C., Shahana, N., et. al. (2015, February) 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, February) 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)
Technology Evaluation Center. (2011, December). Transcranial magnetic stimulation for the treatment of schizophrenia (Vol. 26, No. 6). Retrieved September 12, 2014 from BlueWeb. (20 articles and/or guidelines reviewed)
Technology Evaluation Center. (2014, January). Transcranial magnetic stimulation for depression (Vol. 28, No. 9). Retrieved September 12, 2014 from BlueWeb. (33 articles and/or guidelines reviewed)
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.
U. S. Food and Drug Administration. (2013, December). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K130556. (Cerena®) Retrieved August 2, 2016, 2016 from: http://www.accessdata.fda.gov.
U. S. Food and Drug Administration. (2013, January). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K122288 (Brainsway®). Retrieved January 24, 2014 from http://www.accessdata.fda.gov.
U. S. Food and Drug Administration. (2015, July). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K150641 (MagVita™). Retrieved May 16, 2016 from: http://www.accessdata.fda.gov.
Ullrich, H., Kranaster, L, et al (2012) Ultra-high-frequency left prefrontal transcranial magnetic stimulation as augmentation in severely ill patients with depression: a naturalistic sham-controlled, double-blind, randomized trial. Neuropsychobiology, 66 (3) 141-8. (Level 2 evidence)
Wall, C., Croarkin, P., Maroney-Smith, M., Haugen, L., Baruth, J., Frye, M., et. al., (2016) Magnetic resonance imaging-guided, open-label, high-frequency repetitive transcranial magnetic stimulation for adolescents with major depressive disorder. Journal of Child and Adolescent Psychopharmacology Vol. X, No. x, p1-8. (Level 4 evidence)
Winifred S. Hayes, Inc. Medical Technology Directory. (2010, June; updated February 2018). Transcranial magnetic stimulation for major depression. Retrieved July 26, 2018 from www.Hayesinc.com/subscribers. (50 articles and/or guidelines reviewed)
Winifred S. Hayes, Inc. Medical Technology Directory. (2014, March; updated February 2016). Transcranial magnetic stimulation (TMS) to enhance pharmacotherapy for depression. Retrieved May 16, 2016 from www.Hayesinc.com/subscribers. (87 articles and/or guidelines reviewed)
Winifred S. Hayes, Inc. Medical Technology Directory. (2016, December) Comparative effectiveness review of high-frequency left repetitive transcranial magnetic stimulation versus other neurostimulation approaches to treatment-resistant depression. Retrieved July 26, 2018 from www.Hayesinc.com. (66 articles and/or guidelines reviewed)
Winifred S. Hayes, Inc. Medical Technology Directory. (2016, November; last update search October 2017) High-frequency left repetitive transcranial magnetic stimulation for treatment-resistant major depressive disorder. Retrieved July 26, 2018 from www.Hayesinc.com. (78 articles and/or guidelines reviewed)
Winifred S. Hayes, Inc. Medical Technology Directory. (2016, September; last update search September 2017) Low-frequency right repetitive transcranial magnetic stimulation for treatment-resistant major depressive disorder. Retrieved July 26, 2018 from www.Hayesinc.com. (30 articles and/or guidelines reviewed)
ORIGINAL EFFECTIVE DATE: 12/21/2016
MOST RECENT REVIEW DATE: 9/13/2018
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.
This document has been classified as public information.