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Medical Policy

Mental Health Section - Transcranial Magnetic Stimulation as a Treatment of Depression and Other Disorders

Topic:Transcranial Magnetic Stimulation as a Treatment of Depression and Other Disorders Date of Origin: 04/02/2002
Section: Mental Health Policy No: 17
Effective Date: 01/01/2012  

IMPORTANT REMINDER

Regence Medical Policies are developed to provide guidance for members and providers regarding coverage in accordance with contract terms. Benefit determinations are based in all cases on the applicable contract language. To the extent there may be any conflict between the Medical Policy and contract language, the contract language takes precedence.

PLEASE NOTE: Contracts exclude from coverage, among other things, services or procedures that are considered investigational or cosmetic. Providers may bill members for services or procedures that are considered investigational or cosmetic. Providers are encouraged to inform members before rendering such services that the members are likely to be financially responsible for the cost of these services.

DESCRIPTION

Transcranial magnetic stimulation (TMS) is a noninvasive method of brain stimulation. The technique involves placement of a small coil over the scalp; a rapidly alternating current is passed through the coil wire, producing a magnetic field that passes unimpeded through the brain. In contrast to electroconvulsive therapy, transcranial magnetic stimulation does not require anesthesia and does not induce convulsions.

The Food and Drug Administration (FDA) granted 510(k) approval for the NeuroStar® TMS Therapy system (Neuronetics, Inc) for the treatment of major depressive disorder in adults who have failed one antidepressant medication.

POLICY/CRITERIA

Transcranial magnetic stimulation of the brain is considered investigational as a treatment for all indications, including but not limited to:

  1. Alcohol dependence
  2. Alzheimer’s disease
  3. Attention deficit hyperactivity disorder (ADHD)
  4. Autism
  5. Bipolar mania
  6. Bulimia nervosa (BN)
  7. Depression
  8. Fibromyalgia
  9. Migraine
  10. Obsessive compulsive disorder (OCD)
  11. Pain
  12. Parkinson’s disease
  13. Posttraumatic stress disorder (PTSD)
  14. Schizophrenia
  15. Spasticity
  16. Stroke rehabilitation
  17. Tinnitus

POSITION STATEMENT [1]

TMS or repetitive TMS (rTMS) has not been established as an effective treatment for any condition.

  • Randomized controlled trials comparing active TMS to sham devices are unreliable and do not allow conclusions about true treatment effects.

Effectiveness:

Depression

BlueCross BlueShield Association (BCBSA) Technology Evaluation Center Assessment (TEC)

The 2009 BCBSA TEC assessment evaluated rTMS for depression. [2] The Assessment concluded that the available evidence does not permit conclusions regarding the effect of TMS on health outcomes due to the following limitations:

  • Equivocal efficacy in the largest sham-controlled trial of TMS,
  • Uncertain clinical significance of the short-term anti-depressant effects found in meta-analyses,
  • A lack of information beyond the acute period of treatment, and
  • Lack of comparison with standard therapy (a second course of antidepressant therapy) in the population for whom TMS is indicated (patients who have failed one 6-week course of antidepressant medication).

Cochrane Review

In a meta-analysis of 16 published trials, a Cochrane review concluded that there was no strong evidence of benefit from TMS when used in the treatment of depression, finding no difference between TMS and sham TMS based on results of the Beck Depression Inventory or Hamilton Depression Rating Scale. [3]

Meta-analyses

Additional meta-analyses of randomized controlled trials exhibited consistent results. [4-7] Each analysis identified a number of limitations of the included studies such as small patient populations, short study time-lines, confounding co-therapies, and inconsistency with rTMS treatment parameters. The meta-analyses concluded that rTMS indicated some effect when compared to the sham groups, but the clinical significance of this effect and its impact on health outcomes was not demonstrated. The above analyses concluded that additional, larger long-term studies were needed to better define optimal treatment parameters including frequency, positioning, and equipment for rTMS.

Other Randomized Clinical Trials

The majority of additional randomized controlled trials, that were not included in the Cochrane Review or meta-analyses, also had significant limitations which did not allow reliable conclusions to be made about the effectiveness of TMS as a treatment for depression. Limitations of individual studies and the body of the literature as a whole include one or more of the following:

  • Standardized optimal treatment parameters for rTMS have not been established. Studies varied with respect to frequency, location, intensity, and duration. No study mentioned repeat treatments using rTMS after their intervention phase or in the follow-up assessments. [8-14]
  • There were significant (greater than 10%) or unclear loss to follow-up  and/or poorly defined intention-to-treat (ITT) analyses. [8-17]
  • Use of co-therapies such as antidepressants, sham devices in which potential for some therapeutic effect was possible, and mental health counseling were allowed but not quantified in the results, potentially confounding the findings. [8-13,15,18,19]
  • Follow-up of all study subjects was over a short period of time, less than 6 months, so durability of the results are unknown. [8-18,20,21]
  • Study populations were small, less than 100 patients total, making results unreliable and difficult to apply to patients requiring treatment in the general population. [8-13,15,16,18,20-28]
  • Statistical power calculations were inadequate or unclear, and/or the study failed to enroll a sufficient number of participants in order to have adequate statistical power to reliably detect differences between the treatment groups. [17,29]
  • Randomization methods were not clearly stated or weak methods of randomization were used (e.g. one provider randomly assigned patients to groups using their own personal judgment). [9-11,15,17,18,20,21]
  • Strict inclusion/exclusion criteria were used which were not representative of patients requiring treatment in the general population, for example,  a mild to moderate level of depression or illness, no comorbidities (or only a few that were well controlled), and treatment resistance to standard therapies to name a few. [8-11,13,15,18,21]
  • Studies used previously published unreliable data for new and/or further analyses. [30,31]

rTMS Compared to Electroconvulsive Therapy (ECT)

From the published studies, no conclusion is possible to indicate that rTMS is better than or as effective as electroconvulsive therapy:

  • A United Kingdom National Institute for Health Research health technology assessment compared efficacy and cost-effectiveness of rTMS and ECT. [32] Forty-six patients who had been referred for ECT were randomized to either ECT (average of 6.3 sessions) or a fifteen day course (five treatments per week) of rTMS of the left dorsolateral prefrontal cortex (DLPFC). ECT resulted in a fourteen point improvement in the Hamilton Depression Rating Scale (HDRS) and a 59% remission rate. rTMS was less effective than ECT (five point improvement in HDRS and a 17% remission rate).
  • Rosa et al. reported no significant difference between ECT and rTMS in forty-two patients with treatment-resistant depression; however, response rates for both groups were low. [33]  The number of remissions (score of seven or less on the HDRS) totaled three (20%) for ECT and two (10%) for rTMS.
  • The 2001 Cochrane Review found electroconvulsive therapy was more effective than TMS. [3]

Summary

The evidence is not sufficient to determine whether TMS or rTMS are effective treatments of depression. Small study populations, short follow-up periods (3 weeks, 6 months) and significant drop-out rates undermine the validity of reported study results.

Other Psychiatric Disorders

Randomized Controlled Trials

A number of randomized controlled studies explored the efficacy of TMS for a variety of mental health  disorders other than depression, including, but not limited to, schizophrenia, bipolar mania, obsessive-compulsive disorder (OCD),  bulimia, alcohol dependence, posttraumatic stress disorder, autism, Alzheimer’s disease, and ADHD. Many of these studies are preliminary (feasibility) studies and/or have serious methodological limitations that render outcomes unreliable. Some limitations of these studies include:

  • Poorly defined or unmet endpoints [34-39]
  • Significant or unclear loss to follow-up and poorly defined intention-to-treat (ITT) analyses [36,40]
  • Lack of long-term follow up [34-41]
  • Small patient populations [34-53]
  • Lack of standardized optimal treatment parameters [34-41]
  • Use of co-therapies [34-41]
  • Strict inclusion/exclusion criteria which were not representative of patients requiring treatment in the general population [34-41]

Cochrane Reviews

  • The 2003 Cochrane review of TMS for the treatment of OCD concluded that there was no strong evidence of benefit from rTMS when used in the treatment of this disorder, finding no difference between rTMS and sham rTMS based on results of the Yale-Brown Obsessive Compulsive Scale (which is used to measure the severity of OCD) or the Hamilton Depression Rating Scale. A meta-analysis was not possible due to the lack of information and poor data available from the three published trials on OCD. [39]

  • The 2010 Cochrane review of non-invasive stimulation techniques for chronic pain, including rTMS, concluded the following:

    “There is evidence that low-frequency rTMS is not clinically effective in the treatment of chronic pain. Subgroup analysis suggests that single doses of high-frequency rTMS of the motor cortex have small short-term effects on chronic pain although the limited evidence from multiple-dose studies of high-frequency rTMS to the motor cortex is conflicting. As such it is not currently clear whether rTMS represents a useful clinical tool and more evidence is needed.” [54]

Other Medical Indications

Randomized controlled studies have been published exploring the efficacy of rTMS for a variety of central nervous system-related disorders such as migraine headaches, central pain related to spinal cord injury, fibromyalgia, recovery post stroke, tinnitus, Parkinson’s disease, dysphagia, blepharospasm, amyotrophic lateral sclerosis (ALS), and chronic pain. [55-93] In addition, symptom management in breast cancer has been examined as well. [94] All of these studies had one or more significant methodological limitations, including but not limited to small patient populations, short follow-up times, continued use of concurrent therapies, and/or significant loss to follow-up.  Generally, the authors agreed that  larger, long-term randomized controlled trials are needed, along with better defined optimal treatment parameters for administering rTMS.

All of the randomized controlled trials indicated that rTMS was relatively safe for use. [4-18,20,21,32,34-41,55-64,66,95-106] No serious adverse safety issues were reported, but some side effects did occur which varied depending on the rTMS parameters that were used in the study.  Some of the reported side effects included:

  • Seizures (rare)
  • Pain at stimulation site, face, and skin
  • Headaches
  • Muscle twitching
  • Eye pain
  • Toothache
  • Stress which lead to thoughts of self harm or mania
  • Nausea
  • Facial numbness
  • Neurocardiogenic syncope

REFERENCES

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CROSS REFERENCES

None

Codes Number Description

CPT

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

HCPCS

None

 

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