Medical Policy: 02.01.46
Original Effective Date: January 2012
Reviewed: October 2015
Revised: October 2015
Benefit determinations are based on the applicable contract language in effect at the time the
services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary
based on contract, and individual member benefits must be verified. Wellmark determines medical
necessity only if the benefit exists and no contract exclusions are applicable. This medical
policy may not apply to FEP. Benefits are determined by the Federal Employee Program.
This Medical Policy document describes the status of medical technology at the time the document
was developed. Since that time, new technology may have emerged or new medical literature may
have been published. This Medical Policy will be reviewed regularly and be updated as scientific
and medical literature becomes available.
Transcranial magnetic stimulation
Transcranial magnetic stimulation (TMS) is a noninvasive method of delivering electrical stimulation to the brain. A magnetic field is delivered through the skull, where it induces electric currents that affect neuronal function. Repetitive TMS (rTMS) is being evaluated as a treatment of depression and other psychiatric/neurologic brain disorders.
Repetitive transcranial magnetic stimulation (rTMS) was introduced as a method of noninvasive stimulation of the brain. The technique involves placement of a small coil over the scalp; passing a rapidly alternating current through the coil wire, which produces a magnetic field that passes unimpeded through the scalp and bone, resulting in electrical stimulation of the cortex. TMS was initially used to investigate nerve conduction; for example, TMS over the motor cortex will produce a contralateral muscular-evoked potential. The motor threshold, which is the minimum intensity of stimulation required to induce a motor response, is empirically determined for each individual by localizing the site on the scalp for optimal stimulation of a hand muscle, then gradually increasing the intensity of stimulation. The stimulation site for treatment is usually 5 cm anterior to the motor stimulation site. Interest in the use of TMS as a treatment for depression was augmented by the development of a device that could deliver rapid, repetitive stimulation. Imaging studies had shown a decrease in activity of the left dorsolateral prefrontal cortex (DLPFC) in depressed patients, and early studies suggested that high frequency (e.g., 5-10 Hz) TMS of the left DLPFC had antidepressant effects. Low frequency (1-2 Hz) stimulation of the right DLPFC has also been investigated. The rationale for low frequency TMS is inhibition of right frontal cortical activity to correct the interhemispheric imbalance. A combination approach (bilateral stimulation) is also being explored. In contrast to electroconvulsive therapy, rTMS does not require anesthesia and does not induce a convulsion.
TMS is also being studied as a treatment for a variety of other disorders including alcohol dependence, Alzheimer's disease, neuropathic pain, obsessive-compulsive disorder, post-partum depression, depression associated with Parkinson's disease, schizophrenia, migraine, spinal cord injury, tinnitus, and fibromyalgia.
The National Institute for Health and Care Excellence (NICE)
Current evidence suggests that there are no major safety concerns associated with transcranial magnetic stimulation (TMS) for severe depression. There is uncertainty about the procedure’ s clinical efficacy, which may depend on higher intensity, greater frequency, bilateral application and/or longer treatment durations than have appeared in the evidence to date. TMS should therefore be performed only in research studies designed to investigate these factors.
Based on Hayes meta-analysis (2014): Questions still remain about the standard treatment plan, the longevity, duration, the need for maintenance, and the actual effect of transcranial magnetic stimulation. Transcranial magnetic stimulation over sham transcranial magnetic stimulation, may not last beyond 2 or 3 weeks after the end of treatment. Low quality evidence suggested that transcranial magnetic stimulation may be at least as effective as electroconvulsive therapy under certain circumstances, but under other circumstances, electroconvulsive may be superior; this evidence is of low quality because of unexplained inconsistency in study results. Low quality evidence suggested that if transcranial magnetic stimulation has any effect on quality of life or function, it is very small. The review found insufficient evidence on the use of transcranial magnetic stimulation as maintenance therapy after acute response.
Transcranial Magnetic Stimulation (TMS) and Repetitive Transcranial Magnetic Stimulation (rTMS)
Devices for transcranial stimulation/repetitive transcranial stimulation have received clearance by the U.S. Food and Drug Administration (FDA) for diagnostic uses which include:
- NeoPulse (Neuronetics, Atlanta, GA), received approval in Canada, Israel, and the United States as a therapy for depression. Initially examined by the FDA under a 510(k) application, the NeoPulse, now known as NeuroStar® TMS, received clearance for marketing as a "De Novo" device in 2008. NeuroStar® TMS is indicated for the treatment of patients with depression who have failed one 6-week course of antidepressant medication.
- The Brainsway H-Coil Deep TMS device received FDAclearance in 2013. This device is indicated for the treatment of depression in patients who have failed to respond to antidepressant medications in their current episode of depression and is a broader indication than that of the NeuroStar® TMS, which specifies the failure of one course of antidepressant medication.
- In 2013 the Cerena™ TMS device (Eneura Therapeutics) received De Novo marketing clearance for the acute treatment of pain associated with migraine headache with aura. Warnings, precautions, and contraindications include the following: The device is only intended for use by patients experiencing the onset of pain associated with a migraine headache with aura. The device should not be used on headaches due to underlying pathology or trauma. The device should not be used for medication overuse headaches..Safety and effectiveness have not been established in pregnant women, children under the age of 18, and adults over the age of 65.
- A number of devices for CES have received marketing clearance through the FDA 510(k) process. The Alpha-Stim® CES device (Electromedical Products International) received marketing clearance in 1992 for the treatment of anxiety, insomnia, and depression.
Cranial Electrical Stimulation
Cranial electrical stimulation (CES) is a noninvasive method of delivering electrical stimulation, frequently in the home setting. Via a small, battery-operated device that delivers low level electrical stimulation (i.e., microcurrent) to the brain through electrodes that attach to the ear lobes via clips. Treatment time generally ranges from 20-60 minutes daily, or as directed by the patient’s physician. Its proposed indications include, but may not be limited to, anxiety, depression, insomnia, fibromyalgia, Alzheimer’s Disease, and pain-related disorders.
Cranial electrical stimulation (also known as electrosleep, electrotherapeutic sleep, cerebral electrotherapy, transcranial electrotherapy, transcerebral electrotherapy, craniofacial electrostimulation, and electric cerebral stimulation) is being studied for the treatment of insomnia, anxiety and depression. Low levels of electrical current are applied via electrodes clipped onto the ear lobes or attached behind the ears. CES is thought to have a direct effect on the brain's limbic system, hypothalamus, and/or reticular activation system. It has also been suggested that CES may activate the parasympathetic autonomic nervous system by stimulating the vagus nerve.
Navigated Transcranial Magnetic Stimulation (nTMS)
A navigated TMS (nTMS) system received Naclearance from the FDA in 2009. The Nexstim eXimia Navigated Brain Stimulation System is marketed for use in pre-surgical planning of patients undergoing brain surgery. This system provides non-invasive functional mapping of the motor cortex using transcranial magnetic stimulation with standard MRI guidance. The studies to date on nTMS are limited by small sample size, limiting the validity of the study conclusions.
Transcranial Magnetic Stimulation
Transcranial magnetic stimulation and repeat transcranial magnetic stimulation of the brain is considered investigational as a treatment of depression, migraines and other disorders such as but not limited to:
- Alzheimer's disease
- Neuropathic pain
- Obsessive compulsive disorder
- Post partum depression
- Parkinson's disease or other degenerative neurological conditions (eg, multiple sclerosis, ALS)
- Spasticity associated with spinal cord injury
- Substance use disorders (alcohol and illicit drugs)
Based on peer reviewed literature on the use of rTMS in the treatment of depression, many of the individualized studies randomized less than 20 patients, and were insufficient in showing sustained changes in health outcomes, particularly remission of depression. Also, the studies did not show that rTMS is as effective as current treatment alternatives. Therefore, TMS is considered investigational for the treatment of depression. Further studies are necessary that show a decrease in overall treatments through the addition of TMS therapy. Guidelines are necessary to define treatment course and maintenance appropriateness. Information is lacking in overall standard of treatment and the lasting effects of participation in TMS.
Based on peer reviewed literature, the evidence is insufficient to determine whether TMS/rTMS leads to improved outcomes. The available clinical trials are small and report mixed results for a variety of conditions other than depression. There are no high quality trials for any of these other conditions. Therefore, TMS is considered investigational for depression and the treatment of all other disorders.
Cranial Electrical Stimulation
Cranial electrical stimulation (CES) is investigational for all uses, such as but not limited to:
- Substance abuse treatment
Review of available literature reveals a lack of controlled clinical trials that prove the value and effectiveness of the procedure. As such, CES devices used in the home and clinical setting are investigational.
Navigated Transcranial Magnetic Stimulation (nTMS)
Navigated transcranial magnetic stimulation (nTMS) is considered investigational in preoperative treatment planning and diagnostic testing of motor function. There is limited evidence at this time to permit conclusions regarding the impact of this diagnostic testing on net health outcomes. Additional well-designed clinical studies with larger patient populations are required.
Procedure Codes and Billing Guidelines:
- To report provider services, use appropriate CPT* codes, Modifiers, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or diagnosis codes.
- 90867 Therapeutic repetitive transcranial magnetic stimulation (TMS) treatment; initial, including cortical mapping, motor threshold determination, delivery and management
- 90868 Therapeutic repetitive transcranial magnetic stimulation (TMS) treatment; subsequent delivery and management, per session
- 90869 Therapeutic repetitive transcranial magnetic stimulation (TMS) treatment; subsequent motor threshold re-determination with delivery and management
- 0310T Motor function mapping using non-invasive navigated transcranial magnetic stimulation (nTMS) for therapeutic treatment planning, upper and lower extremity
- E1399 Durable Medical Equipment, misc
- Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). Transcranial magnetic stimulation for depression. TEC Assessments 2011; Volume 26, Tab 3.
- Schutter DJ. Antidepressant efficacy of high-frequency transcranial magnetic stimulation over the left dorsolateral prefrontal cortex in double-blind sham-controlled designs: a meta-analysis. Psychol Med 2009; 39(1):65-75.
- Lam RW, Chan P, Wilkins-Ho M et al. Repetitive transcranial magnetic stimulation for treatment-resistant depression: a systematic review and metaanalysis. Can J Psychiatry 2008; 53(9):621-31.
- O'Reardon JP, Solvason HB, Janicak PG et al. Efficacy and safety of transcranial magnetic stimulation in the acute treatment of major depression: a multisite randomized controlled trial. Biol Psychiatry 2007; 62(11):1208-16.
- George MS, Lisanby SH, Avery D et al. Daily left prefrontal transcranial magnetic stimulation therapy for major depressive disorder: a sham-controlled randomized trial. Arch Gen Psychiatry 2010; 67(5):507-16.
- Rossini D, Lucca A, Zanardi R et al. Transcranial magnetic stimulation in treatment-resistant depressed patients: a double-blind, placebo-controlled trial. Psychiatry Res 2005; 137(1-2): 1-10.
- Lisanby SH, Husain MM, Rosenquist PB et al. Daily left prefrontal repetitive transcranial magnetic stimulation in the acute treatment of major depression: clinical predictors of outcome in a multisite, randomized controlled clinical trial. Neuropsychopharmacology. 2009 Jan; 3492): 522-34. Epub 2008 Aug 13.
- Triggs WJ, Ricciuti N, Ward HE et al. Right and left dorsolateral pre-frontal rTMS treatment of refractory depression: a randomized, sham-controlled trial. Psychiatry Res. 2010 Aug 15; 178(3):467-74. Epub 2010 Jun 18.
- Janicak PG, Nahas Z, Lisanby SH et al. Durability of clinical benefit with transcranial magnetic stimulation (TMS) in the treatment of pharmacoresistent major depression: assessment of relapse during a 6-month, multisite, open-label study. Brain Stimul. 2010 Oct; 3(4):187-99. Epub 2010 Aug 11.
- Dell'osso B, Camuri G, Castellano F et al. Meta-review of Meta-analytic studies with repetitive transcranial magnetic stimulation (rTMS) for the treatment of major depression. Clin Pract Epidemiol Ment Health. 2011; 7:167-77. Epub 2011 Oct 26.
- ECRI Institute. Repetitive transcranial magnetic stimulation versus electroconvulsive therapy for treatment resistant depression. Plymouth Meeting (PA): ECRI Institute; 2011 Dec 20.
- Agency for Healthcare Research and Quality (AHRQ). Nonpharmacologic interventions for treatment-resistant depression in adults. 2011 Sep 23.
- Herbsman T, Avery D, Ramsey D et al. More lateral and anterior prefrontal coil location is associated with better repetitive transcranial magnetic stimulation antidepressant response. Biol Psychiatry. 2009 Sep 1; 66(5): 509-15. Epub 2009 Jul 9.
- ECRI Institute. Repetitive Transcranial Magnetic Stimulation Using the NeuroStar System for Treating Major Depressive Disorder. Plymouth Meeting (PA): ECRI Health Technology Assessment Information ServiceExternal Site. 2012 April. [Emerging Technology Evidence Report].
- Picht T, Schulz J, Hamma M, Schmidt S, Suess O, Vajkoczy P. Assessment of the influence of navigated transcranial magnetic stimulation on surgical planning for tumors in or near the motor cortex. Neurosurgery. 2012 May;70(5):1248-56.
- Pollak TA, Nicholson TR, Edwards MJ, David AS. A systematic review of transcranial magnetic stimulation in the treatment of functional (conversion) neurological symptoms. J Neurol Neurosurg Psychiatry. 2013 Jan 8. [Epub ahead of print]
- Berlim MT Van den Eynde F, Jeff Daskalakis Z. Clinically meaningful efficacy and acceptability of low-frequency repetitive transcranial magnetic stimulation for treating primary major depression: A meta-analysis of randomized, double-blind and sham-controlled trials.
- Hsu WY, Cheng CH, Liao KK, Lee IH, Lin YY. Effects of repetitive transcranial magnetic stimulation on motor functions in patients with stroke: a meta-analysis. Stroke 2012 Jul;43(7):1849-57.
- Carpenter LL, Janicak PG, Aaronson ST, Boyadjis T, et al. Transcranial magnetic stimulation (TMS) for major depression: a multisite, naturalistic, observational study of acute treatment outcomes in clinical practice. Depress Anxiety. 2012 Jul.29(7):587-96.
- Marlow NM, Bonilha HS, Short EB. Efficacy of transcranial direct current stimulation and repetitive transcranial magnetic stimulation for treating fibromyalgia syndrome: A systematic review. Pain PRact. 2012 May 28. [Epub ahead of print]
- California Technology Assessment Forum. June 17, 2009. Repetitive Transcranial Magentic Stimulation for Treatment Resistant Depression.
- Canadian Agency for Drugs and Technologies in Health. January 15, 2013. Repetative Transcranial Magentic Stimulation for Specific Patient Populations: Clinical and Cost Effectiveness and Safety
- UpToDateExternal Site. Unipolar Depression in Adults: Treatment with Transcranial Magentic Simulation (TMS). Paul E. Holtzheimer M.D. Topic last updated September 9, 2013.
- American Psychiatric AssociationExternal Site. Practice Guideline for the Treatment of Patients with Major Depressive Disorder, Third Edition 2010.
Kavirajan HC, Lueck K, Chuang K. Alternating current cranial electrotherapy stimulation (CES) for depression. Cochrane Database Syst Rev. Jul 8 2014;7:CD010521. PMID 25000907.
Barclay TH, Barclay RD. A clinical trial of cranial electrotherapy stimulation for anxiety and comorbid depression. J Affect Disord. Aug 2014;164:171-177. PMID 24856571.
Loo CK, Mitchell PB, Croker VM, Malhi GS, Wen W, Gandevia SC, Sachdev PS. Double-blind controlled investigation of bilateral prefrontal transcranial magnetic stimulation for the treatment of resistant major depression. Psychological Medicine. 2003 Jan;33(1):33-40.
Li H, Wang J, Li C, et al. Repetitive transcranial magnetic stimulation (rTMS) for panic disorder in adults. Cochrane Database Syst Rev. 2014;9:CD009083. PMID 25230088
Lefaucheur JP, Andre-Obadia N, Antal A, et al. Evidence-based guidelines on the therapeutic use of repetitive transcranial magnetic stimulation (rTMS). Clin Neurophysiol. Jun 5 2014. PMID 25034472
O'Connell NE, Wand BM, Marston L, et al. Non-invasive brain stimulation techniques for chronic pain. Cochrane Database Syst Rev. 2014;4:CD008208. PMID 24729198
Dunner DL, Aaronson ST, Sackeim HA, et al. A multisite, naturalistic, observational study of transcranial magnetic stimulation for patients with pharmacoresistant major depressive disorder: durability of benefit over a 1- year follow-up period. J Clin Psychiatry. Sep 16 2014. PMID 25271871
Speer AM, et al. Antidepressant efficacy of high and low frequency rTMS at 110% of motor threshold versus sham stimulation over left prefrontal cortex. Brain Stimul 2014 Jan-Feb;7(1):36-41.
The National Institute for Health and Care Excellence (NICE) Transcranial magnetic stimulation for treating and preventing migraine. 2014 Jan.
Washington State Health Care Authority. Non-pharmacologic treatments for treatment-resistant depression. Final Evidence Report 2014 Feb 21.
October 2015 - Annual Review, Policy Revised
November 2014 - Annual Review, Policy Revised
July 2014 - Interim Review, Policy Renewed
January 2014 - Annual Review, Policy Revised
January 2013 - Annual Review, Policy Revised
January 2012 - Literature Review, New Policy
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*Current Procedural Terminology © 2012 American Medical Association. All Rights Reserved.