Transcranial magnetic stimulation (TMS) is a noninvasive method of delivering electrical stimulation to the brain. The technique involves the placement of a small coil over the scalp and passing a rapidly alternating current through the coil wire. The electrical current produces a magnetic field that passes unimpeded through the scalp and bone and stimulates neuronal function. Repetitive TMS is being evaluated for the treatment of treatment-resistant depression (TRD) and other psychiatric and neurologic disorders. A variety of TMS modalities have been developed, which differ on parameters including stimulation intensity, frequency, pattern, and site of the brain stimulation. In conventional TMS, high frequency stimulation is delivered over the left dorsolateral prefrontal cortex (DLPFC) or low frequency stimulation over the right DLPFC. In bilateral TMS, both procedures are performed in the same session. Deep TMS employs an H-coil helmet designed to encompass a broader surface area and stimulate deeper brain structures than conventional TMS. Theta burst stimulation is administered at lower intensities and shorter intervals than conventional TMS.

Accelerated TMS is now emerging and being proposed to deliver more than one daily TMS session, reducing treatment duration, improving response time and with the goal of achieving similar (or superior) levels of efficacy as conventional TMS. Recently, the FDA cleared an accelerated TMS protocol for depression (i.e., (SNT) Stanford Neuromodulation Therapy also known as (SAINT) Stanford accelerated intelligent neuromodulation therapy) consisting of 1800 pulses of intermittent theta burst stimulation done every hour, ten times a day, for 5 days. The innovative technology will be available late 2023.

TMS devices 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).

POLICY

Transcranial magnetic stimulation (TMS) 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.
Any device utilized for this procedure must have FDA approval specific to the indication, otherwise it will be considered investigational.
Transcranial magnetic stimulation (TMS) using nonstandard variations (i.e., accelerated TMS) is considered investigational.

MEDICAL APPROPRIATENESS

Transcranial magnetic stimulation (TMS) is considered medically appropriate if ALL 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
- Treatment consists of a maximum of 30 sessions (5 days a week for 6 weeks) plus 6 tapering sessions (over 3 weeks)
- Documentation of ANY ONE of the following:
- - Failure of two (2) trials of psychopharmacologic agents for depression, including two (2) different agent classes and at least one of the treatment trials must have been administered as an adequate course of mono- or poly- drug therapy
  - Inability to tolerate a therapeutic dose of medications as evidenced by two (2) trials of psychopharmacologic agents with documented side effects
  - History of response to TMS in a previous depressive episode
  - Individual is a candidate for electroconvulsive therapy (ECT), and ECT would not be clinically superior to TMS
- Absence of ALL the following:
- - Pregnancy
  - 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)

IMPORTANT REMINDERS

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 or government program (e.g., TennCare), the express terms of the health plan or government program will govern.

ADDITIONAL INFORMATION

For conditions other than treatment-resistant major depression, the evidence is insufficient to determine if treatment with TMS leads to improved outcomes.

Treatments beyond 36 sessions (e.g., 30 treatment sessions followed by 6 tapering sessions) may be reviewed for medical necessity. There is a lack of evidence of the effectiveness of additional sessions beyond 36 to treat "late responders", to solidify response, or to attain remission. There is a lack of evidence that persons who fail to respond or become refractory to one brand of repetitive transcranial magnetic stimulation (rTMS) device will respond to another brand of rTMS or deep TMS (dTMS) device.

SOURCES

American Psychological Association. (2019). Clinical practice guideline for the treatment of depression across three age cohorts. Retrieved August 3, 2021 from https://www.apa.org.

BlueCross BlueShield Association. Evidence Positioning System (11:2024). Transcranial magnetic stimulation as a treatment of depression and other psychiatric/neurologic disorders (2.01.50). Retrieved April 14, 2025 from https://www.bcsaoca.com/eps/. (52 articles and/or guidelines reviewed)

Carmi, L., Tendler, A., Bystritshy, A., Hollander, E., Blumberger, D.M., Daskalakis, J., et al. (2019). Efficacy and safety of deep transcranial magnetic stimulation for obsessive-compulsive disorder: A prospective multicenter randomized double-blind placebo-controlled trial. The American Journal of Psychiatry, 176 (11), 931-938. (Level 1 evidence)

Chen, H., Hu, X., Gao, J., Han, H., Wang, X., & Xue, C. (2022). Early effects of repetitive transcranial magnetic stimulation combined with sertraline in adolescents with first-episode major depressive disorder. Frontiers in Psychiatry, 13, 853961. (Level 1 evidence)

CMS.gov: Centers for Medicare & Medicaid Services. Palmetto, GBA. (2025, January). Local Coverage Determination (LCD): Repetitive transcranial magnetic stimulation (rTMS) in adults (LCD: ID L34869). Retrieved April 14, 2025 from https://www.cms.gov.

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)

Liang, K., Li, H., Bu, X., Li, X., Cao, L., Liu, J., et al. (2021). Efficacy and tolerability of repetitive transcranial magnetic stimulation for the treatment of obsessive-compulsive disorder in adults: a systematic review and network meta-analysis. Translational Psychiatry, 11 (1), 332. (Level 1 evidence)

Milev, R.V., Giacobbe, P., Kennedy, S.H., Blumberger, D.M., Daskalakis, Z.J., Downar, J., et al. (2016). Canadian network for mood and anxiety treatments (CANMAT) 2016 clinical guidelines for the management of adults with major depressive disorder: section 4. neurostimulation treatments. Canadian Journal of Psychiatry, 61 (9), 561-575. (Level 1 evidence)

Mostofavi, S-A., Khaleghi, A., & Mohammadi, M.R. (2020). Noninvasive brain stimulation in alcohol craving: A systematic review and meta-analysis. Progress in Neuro-psychopharmacology and Biological Psychiatry, doi: 10.1016/j.pnpbp.2020.109938. Abstract retrieved May 1, 2020 from PubMed database.

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.

National Institute for Health and Clinical Excellence (NICE). (2015, December). Repetitive transcranial magnetic stimulation for depression. Retrieved May 1, 2020 from http://www.nice.org.uk.

National Institute for Health and Clinical Excellence (NICE). (2020, August). Transcranial magnetic stimulation for obsessive-compulsive disorder. Retrieved August 3, 2021 from http://www.nice.org.uk.

National Institute for Health and Clinical Excellence (NICE). (2020, September). Transcranial magnetic stimulation for auditory hallucinations. Retrieved August 3, 2021 from http://www.nice.org.uk.

Perera, T., George, M.S., Grammar, G., Janicak, P.G., Pascual-Leone, A., & Wierck, T.S. (2016). The clinical TMS society consensus review and treatment recommendations for TMS therapy for major depressive disorder. Brain Stimulation, 9 (3), 336-346. (Level 1 evidence)

Rapinesi, C., Kotzalidis, G.D., Ferracuti, S., Sani, G., Girardi, P., & Del Casale, A. (2019). Brain stimulation in obsessive-compulsive disorder (OCD): A systematic review. Current Neuropharmacology, 17 (8), 787-807. (Level 1 evidence)

Rhen, S., Eslick, G.D., & Brakoulias, V. (2018). A meta-analysis of the effectiveness of different cortical targets used in repetitive transcranial magnetic stimulation (rTMS) for the treatment of obsessive-compulsive disorder (OCD). The Psychiatric Quarterly, 89 (3), 645-665. Abstract retrieved September 1, 2022 from PubMed database.

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)

Sigrist, C., Vöckel, J., MacMaster, F. P., Farzan, F., Croarkin, P. E., et al. (2022). Transcranial magnetic stimulation in the treatment of adolescent depression: a systematic review and meta-analysis of aggregated and individual-patient data from uncontrolled studies. European Child & Adolescent Psychiatry, 31 (10), 1501–1525. (Level 1 evidence)

Sun, C. H., Mai, J. X., Shi, Z. M., Zheng, W., Jiang, W. L., et al. (2023). Adjunctive repetitive transcranial magnetic stimulation for adolescents with first-episode major depressive disorder: a meta-analysis. Frontiers in Psychiatry, 14, 1200738. (Level 1 evidence)

U.S. Food and Drug Administration. (2019, March). Centers for Devices and Radiological Health. 510(k) Premarket Notification Database. K083538. Retrieved September 1, 2022 from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K083538.

U.S. Food and Drug Administration. (2019, March). Centers for Devices and Radiological Health. 510(k) Premarket Notification Database. K183303. Retrieved September 1, 2022 from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K183303.

U.S. Food and Drug Administration. (2022, September). Centers for Devices and Radiological Health. 510(k) Premarket Notification Database. K220177. Retrieved November 29, 2023 from https://www.accessdata.fda.gov/cdrh_docs/pdf22/K220177.pdf.

U.S. Food and Drug Administration. (2024, March). Centers for Devices and Radiological Health. 510(k) Premarket Notification Database. K231926. Retrieved April 14, 2025 from https://www.accessdata.fda.gov.

U.S. Food and Drug Administration. (2025, March). Centers for Devices and Radiological Health. 510(k) Premarket Notification Database. K243869. Retrieved April 14, 2025 from https://www.accessdata.fda.gov.

Winifred S. Hayes, Inc. Medical Technology Directory. (2023, April; last updated April 2024) Maintenance repetitive transcranial magnetic stimulation for prevention of recurrent depression in adults. Retrieved April 14, 2025 from www.Hayesinc.com/subscribers. (46 articles and/or guidelines reviewed)

Winifred S. Hayes, Inc. Medical Technology Directory. (2023, March; last updated April 2025). Repetitive transcranial magnetic stimulation for treatment of bipolar disorder. Retrieved April 14, 2025 from www.Hayesinc.com/subscribers. (46 articles and/or guidelines reviewed)

ORIGINAL EFFECTIVE DATE: 12/21/2016

MOST RECENT REVIEW DATE: 6/12/2025

ID_BT

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.

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