|MP 2.01.50||Transcranial Magnetic Stimulation as a Treatment of Depression and Other Psychiatric/Neurologic Disorders|
|Original Policy Date
|Last Review Status/Date
Reviewed with literature search/1:2012
|Return to Medical Policy Index|
Our medical policies are designed for informational purposes only and are not an authorization, or an explanation of benefits, or a contract. Receipt of benefits is subject to satisfaction of all terms and conditions of the coverage. Medical technology is constantly changing, and we reserve the right to review and update our policies periodically.
Transcranial magnetic stimulation (TMS) is a non-invasive 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.
Transcranial magnetic stimulation (TMS) was first introduced in 1985 as a new method of noninvasive stimulation of the brain. 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 scalp and bone, resulting in electrical stimulation of the cortex. Transcranial magnetic stimulation was initially used to investigate nerve conduction; for example, transcranial magnetic stimulation 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 transcranial magnetic stimulation as a treatment for depression was augmented by the development of a device that could deliver rapid, repetitive stimulation. Imaging studies had showed 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. TMS is also being tested as a treatment for other disorders including schizophrenia, migraine, spinal cord injury, tinnitus, and fibromyalgia. In contrast to electroconvulsive therapy, transcranial magnetic stimulation does not require anesthesia and does not induce a convulsion.
TMS is also being tested as a treatment for a variety of other disorders including alcohol dependence, Alzheimer’s disease, neuropathic pain, obsessive-compulsive disorder (OCD), post-partum depression, depression associated with Parkinson’s disease, Tourette’s syndrome, schizophrenia, migraine, spinal cord injury, fibromyalgia, and tinnitus. (See policy No. 8.01.39 regarding TMS for tinnitus.)
Devices for transcranial stimulation have received clearance by the U.S. Food and Drug Administration (FDA) for diagnostic uses. One device, NeoPulse (Neuronetics, Atlanta, GA), received approval in Canada, Israel and the U.S. as a therapy for depression. Initially examined by the U.S. Food and Drug Administration (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.
Note: An FDA advisory panel met in January 2007 to determine if the risk-to-benefit profile for the NeoPulse was comparable to the risk-to-benefit profile of predicate electroconvulsive therapy (ECT) devices. The panel was not asked for a recommendation regarding the regulatory determination of substantial equivalence for this 510(k) submission. Materials presented at the Neurological Devices Panel meeting are posted at www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4273b1_00-index.htm. A summary of the meeting is available at http://www.fda.gov/cdrh/panel/summary/neuro-012607.html.
Transcranial magnetic stimulation of the brain is considered investigational as a treatment of depression and other psychiatric/neurologic disorders such as schizophrenia or migraine headaches.
Effective January 1, 2011, there are CPT category I codes for this procedure:
90867: Therapeutic repetitive transcranial magnetic stimulation treatment; planning
90868: Therapeutic repetitive transcranial magnetic stimulation treatment; delivery and management, per session
BlueCard/National Account Issues
State or federal mandates (e.g., FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.
This policy was created in 2001 and updated periodically with searches of the MEDLINE database. At the time this policy was created, the U.S. Food and Drug Administration (FDA) had not cleared transcranial magnetic stimulation (TMS) as a therapeutic device for any neuropsychiatric disorder, including depression. In October 2008, the NeuroStar® TMS received U.S. Food and Drug Administration (FDA) marketing clearance as a de novo device for therapy of patients with treatment-resistant depression (TRD) who have failed one 6-week course of antidepressant medication.
The Blue Cross and Blue Shield Technology Evaluation Center (TEC) published an assessment of repetitive TMS (rTMS) for depression in 2009. (1) The TEC Assessment concluded that the available evidence did not permit conclusions regarding the effect of TMS on health outcomes. Limitations of the evidence included:
- 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).
TEC published an updated Assessment of TMS for depression in 2011. (2) Included were 6 recent meta-analyses, the largest of which evaluated 30 double-blind sham-controlled trials with a total of 1,383 patients. Recent clinical trials were also reviewed. The 2011 TEC Assessment reached the following conclusions:
- The meta-analyses and recent clinical trials of TMS generally show statistically significant effects on depression outcomes at the end of the TMS treatment period. However, the clinical significance and durability of the effect are not well-characterized.
- The largest randomized clinical trial showed a greater effect in patients with only one prior treatment failure, with possibly minimal or no effect in patients with greater than one prior treatment failure. Based on current evidence, it cannot be determined whether TMS after one treatment failure would be as effective as the current standard of a second course of antidepressant therapy.
- Also identified as gaps in current knowledge are whether TMS is effective as an adjunctive treatment and whether retreatment is effective.
Following is a summary of the key literature to date, focusing on randomized controlled trials (RCTs). Studies published prior to 2008 are included if the study design was a randomized sham-controlled double-blind trial that enrolled at least 40 subjects; refer to the 2008 meta-analysis by Schutter for a summary of study characteristics and stimulation parameters used in these trials. (3) The evidence review is divided by key differences in treatment protocols, specifically high-frequency left dorsolateral prefrontal cortex stimulation (DLPFC), low-frequency (1–2 Hz) stimulation of the right dorsolateral prefrontal cortex, or combined high-frequency and low-frequency stimulation.
Note that over the last decade, there has been a trend to increase the intensity, trains of pulses, total pulses per session, and number of sessions. (4) Unless otherwise indicated in the trials described below, stimulation was set at 100% to 120% of motor threshold, clinical response was defined as an improvement of 50% or more on the Hamilton Depression Rating Scale (HAM-D), and remission was considered to be a score of 7 or less on the HAM-D.
High Frequency rTMS of the Left Dorsolateral Prefrontal Cortex for Treatment-Resistant Depression
Lam and colleagues conducted a meta-analysis of 24 randomized controlled trials (RCTs) comparing active versus sham repetitive TMS (rTMS) in patients with TRD, although there were varying definitions of TRD. (5) This analysis calculated a number needed to treat of 6, with a clinical response in 25% of active rTMS and 9% of sham rTMS patients. Remission was reported for 17% of active rTMS and 6% of sham rTMS patients.
The largest study (23 study sites) included in the meta-analysis was a double-blind multicenter trial with 325 TRD patients randomly assigned to daily sessions of high-frequency active or sham rTMS (Monday to Friday for 6 weeks) of the left dorsolateral prefrontal cortex (DLPFC). (6) Treatment-resistant depression was defined as failure of at least 1 adequate course of antidepressant treatment. Patients had failed an average of 1.6 treatments in the current episode, with approximately half of the study population failing to benefit from at least 2 treatments. Loss to follow-up was similar in the 2 groups, with 301 (92.6%) patients completing at least 1 post-baseline assessment and an additional 8% of patients from both groups dropping out before the 4-week assessment. Intent-to-treat (ITT) analysis showed a trend favoring the active rTMS group in the primary outcome measure (2 points on the Montgomery-Asberg Depression Rating Scale (MADRS); p=0.057) and a modest (2-point) but significant improvement over sham treatment on the HAM-D. The authors reported that after 6 weeks of treatment, subjects in the active rTMS group were more likely to have achieved remission than the sham controls (14% vs. 5%, respectively), although this finding is limited by loss to follow-up.
In 2010, George et al. reported a randomized sham-controlled trial that involved 199 patients treated with left-prefrontal rTMS. (7) This was a multi-centered study involving patients with a moderate level of treatment resistance. The response rate using an ITT analysis was 14% for rTMS and 5% for sham (p=0.02). In this study, the site for stimulation was determined through pre-treatment magnetic resonance imaging (MRI). Results from Phase 2 (open treatment of non-responders) and Phase 3 (maintenance and follow-up) will be reported in the future.
Another randomized sham-controlled double-blind trial was conducted in 68 patients who had failed at least 2 courses of antidepressants. (8) Three patients in each group did not complete the 15 treatment sessions or were excluded due to a change in medication during treatment, resulting in 91% follow-up. Independent raters found a clinical response in 31% (11 of 35) of the active rTMS patients and 6% (2 of 33) of the sham group. The average change in HAM-D was 7.8 for the active group and 3.7 for the control group. The Beck Depression Inventory (BDI) decreased by 11.3 points in the active rTMS group and 4.8 points in controls. Remission was observed in 7 patients (20%) in the active rTMS group and 1 patient (3%) in the control group. Regarding effectiveness of blinding; 15% of subjects in each group guessed that they were receiving active TMS after the first session. After the 15th session, 58% of the rTMS group and 43% of the sham group guessed that they had received active TMS; responders were more likely than non-responders (85% vs. 42%, respectively) to think that they had received the active treatment. The 11 responders were treated with antidepressant medication and followed up for 6 months. Of these, 1 was lost to follow-up, 5 (45%) relapsed, and 5 (45%) did not relapse.
Rossini and colleagues randomly assigned 54 patients who had failed at least 2 adequate courses of antidepressants to sham control or active rTMS at 80% or 100% of motor threshold (MT) for 10 sessions over a 2-week period. (9) Double-blind evaluation found an intensity-dependent response with 6% (1 of 16) of the sham, 28% (5 of 18) of the 80% MT, and 61% (11 of 18) of the 100% MT groups showing improvement of 50% or more over a 5-week evaluation. All of the patients reported that they were unaware of the differences between sham and active stimulation.
In a 2008 report, Mogg et al. randomly assigned 59 patients with major depression who had failed at least 1 course of pharmacotherapy for the index depressive episode. (10) In this study population, 78% of the patients had failed 2 treatment courses and 53% had failed 3. The sham coil, which was provided by Magstim, was visually identical to the real coil and made the same clicking sound but did not deliver a magnetic field to scalp or cortex. Blinded assessments were measured 2 days after the fifth and final (tenth) sessions (97% follow-up), with additional assessments at 6 weeks (90% follow-up) and 4 months (83% follow-up). The mean group difference was estimated to be 0.3 points in HAM-D scores for the overall analysis. Interpretation of this finding is limited, since 7 sham patients (23%) were given a course of real rTMS after the 6-week assessment and analyzed as part of the sham group in the ITT analysis. The study was powered to detect a difference of 3.5 points in the HAM-D between the active and sham groups, and the 2.9-point group difference observed at the end of treatment was not significant. A higher percentage of patients in the active rTMS group achieved remission criteria of 8 points or less on the HAM-D (25% vs.10% control, respectively), and there was a trend for more patients to achieve clinical response in the active rTMS group (32% vs.10%, respectively, p=0.06). All of the 12 patients who met the criterion for clinical response (9 active and 3 sham) thought that they had received real rTMS, with more patients in the active group (70%) than the sham group (38%) guessing that they had received the real treatment. Interpretation of this finding is also limited, since the reason the subjects guessed that they had active treatment was not reported, and the subjects were not asked to guess before they began to show a clinical response.
A small double-blind randomized trial from 2009 suggests that specific targeting of Brodmann areas 9 and 46 may enhance the anti-depressant response compared with the standard targeting procedure, i.e., measuring 5 cm anterior from the motor cortex. (11) Fifty-one patients who had failed at least two 6-week courses of antidepressant medication (average 5.7 failed courses) were randomly assigned to a standard localization procedure or to structural magnetic resonance imaging (MRI)-aided localization for 3 weeks (with 1-week extension if >25% reduction on the MADRS). Six patients in the targeted group and 10 in the standard group withdrew due to lack of response. A single patient in the targeted group and 5 in the standard group withdrew for other reasons, resulting in 17 patients in the targeted group and 12 in the standard group continuing for the full 4 weeks of treatment. To adjust for the imbalance in discontinuation rates, a mixed model statistical analysis was used. There was a significant difference between the groups in the overall mixed model analysis, and planned comparisons showed significant improvement in MADRS scores for the targeted group at 4 weeks. Response criteria were met by 42% of the targeted group and 18% of the standard group. Remission criteria were met by 30% of the targeted group and 11% of the standard group. Although encouraging, additional trials with a larger number of subjects are needed to evaluate this procedure.
Several studies have compared the outcomes of rTMS with those from electroconvulsive therapy. In one study, 40 patients with nonpsychotic major depression were treated over the course of 1 month (20 total sessions) and evaluated with the HAM-D, in which a response was defined as a 50% decrease with a final score of less than or equal to 10. (12) There was no difference in response rate between the 2 groups; 12 of 20 responded in the electroconvulsive therapy group compared to 11 of 20 in the magnetic stimulation group. A United Kingdom National Institute for Health Research health technology assessment compared efficacy and cost effectiveness of rTMS and electroconvulsive therapy. (13) Forty-six patients who had been referred for electroconvulsive therapy were randomly assigned to either electroconvulsive therapy (average of 6.3 sessions) or a 15-day course (5 treatments per week) of rTMS of the left DLPFC. Electroconvulsive therapy resulted in a 14-point improvement in the HAM-D and a 59% remission rate. Repetitive TMS was less effective than electroconvulsive therapy (5-point improvement in HAM-D and a 17% remission rate). Another study reported no significant difference between electroconvulsive therapy and rTMS in 42 patients with TRD; however, response rates for both groups were low. (14) The number of remissions (score of 7 or less on the HAM-D) totaled 3 (20%) for electroconvulsive therapy and 2 (10%) for rTMS.
Janicak and colleagues reported on assessment of relapse during a multisite, open-label study. (15) In this study, patients who met criteria for partial response during either a sham–controlled or open-label phase of a prior study were tapered from rTMS and simultaneously started on maintenance antidepressant monotherapy. They were then followed for 24 weeks. Ten of 99 patients relapsed. Thirty-eight patients had symptom worsening, and 32 of these (84%) had symptomatic benefit with adjunctive rTMS. Additional data are needed related to durability of effect and to maintenance phases.
Low Frequency rTMS of the Right Dorsolateral Prefrontal Cortex or Bilateral Stimulation for Treatment-Resistant Depression
Fitzgerald et al. randomly assigned 60 patients who had failed a minimum of at least two 6-week courses of antidepressant medications into 1 of 3 groups; high frequency left rTMS, low frequency right rTMS, or sham stimulation over 10 sessions. (16) All patients who entered the study completed the double-blind randomized phase, which showed no difference between the 2 active treatments (left: 13.5% reduction; right: 15% reduction) and greater improvements in the MADRS scores compared to the sham group (0.76% reduction). Only 1 patient achieved 50% improvement during the initial 2 weeks. Then, only the subjects who showed at least 20% improvement at the end of the 10 sessions (15 active and 2 sham) continued treatment. Patients who did not respond by at least 20% were switched to a different active treatment. From week 2 to week 4, there was greater improvement in the low frequency right rTMS group compared with the high frequency left rTMS group (39% vs. 14% improvement in MADRS, respectively). Seven patients (18% of 40) showed a clinical response of greater than 50% by the end of the 4 weeks.
In a subsequent study, Fitzgerald and colleagues randomly assigned 50 patients with TRD to sequential bilateral active or sham rTMS. (17) After 2 weeks of treatment, 3 subjects had dropped out of the sham treatment group, and there was a slight but non-significant improvement favoring the active group for the MADRS (26.2 vs. 30.9, respectively) and the BDI (18.3 vs. 21.6, respectively). At this time point, 60% of subjects receiving active rTMS and 50% of subjects receiving sham treatment guessed that they were in the active group. The clinical response was reported by subjects as the major reason for their guess, with 11 of 13 responders (9 active and 2 sham) guessing that they were in the active group. As in the earlier study, only the subjects who showed at least 20% improvement at the end of each week continued treatment. Treatment on week 3 was continued for 15 subjects in the active group and 7 subjects in the sham group. By week 6, 11 subjects in the active rTMS remained in the study, with no control subjects remaining. Final ratings for the 11 subjects who continued to respond through week 6 were 8.9 on the MADRS and 9.2 on the BDI.
Another multicenter double-blind trial randomly assigned 130 patients with TRD to 5 sessions per week of either 1- or 2-Hz rTMS over the right dorsolateral prefrontal cortex. (18) Sixty-eight patients (52%) completed 4 weeks of treatment; there was an approximate 30% improvement in depression scales, with no differences between the 1- or 2-Hz groups. Due to the potential for placebo effects for this type of intervention, the absence of a sham control group limits interpretation.
A small randomized, sham-controlled trial was published in 2010 that involved either right or left rTMS in 48 patients with TRD. (19) Overall reductions in the HAM-D-24 from baseline to 3 months were not significantly different between rTMS and sham treatment groups. In this small study, right cranial stimulation was significantly more effective than left cranial stimulation (sham or rTMS).
rTMS as an Adjunctive Treatment for Moderate to Severe Depression
Schutter conducted a meta-analysis of 30 double-blind randomized sham-controlled trials (1,164 patients) of high-frequency rTMS over the left dorsolateral prefrontal cortex in patients with major depression. (3) The pooled weighted mean effect size for treatment was calculated with Hedges g, a standardized mean difference that adjusts for sampling variance, to be 0.39 (95% confidence interval [CI]: 0.25–0.54), which is considered moderate. For 27% of the population, rTMS was used as a primary/adjunctive treatment; 3 trials were included that used rTMS as a primary/adjunctive treatment for depression and enrolled more than 40 subjects. (20-22) Repetitive TMS has also been examined in patients with clinical evidence of cerebrovascular disease and late-life depression. (23) Additional research on whether adjunctive rTMS can improve response to pharmacologic treatment as a first-line therapy is needed.
The largest area of TMS research outside of depressive disorders appears to be treatment of auditory hallucinations in schizophrenia resistant to pharmacotherapy. In 2011, TEC published an Assessment of TMS as an adjunct treatment for schizophrenia. (24) Five meta-analyses were reviewed, along with randomized controlled trials (RCTs) in which measurements were carried out beyond the treatment period. A meta-analysis of the effect of TMS on positive symptoms of schizophrenia (hallucinations, delusions, and disorganized speech and behavior) did not find a significant effect of TMS. Four meta-analyses that looked specifically at auditory hallucinations showed a significant effect of TMS. It was noted that outcomes were evaluated at the end of treatment, and the durability of the effect is unknown. The Assessment concluded that the available evidence is insufficient to demonstrate that TMS is effective in the treatment of schizophrenia.
Other Psychiatric/Neurologic Disorders
Two small (n=18 and 30) randomized sham-controlled trials found no evidence of efficacy for treatment of obsessive compulsive disorder (OCD), although another small sham-controlled trial (n=21) reported promising results with bilateral stimulation of the supplementary motor area. (25-27)
In 2011, Short et al. evaluated the efficacy of adjunctive rTMS as a treatment for fibromyalgia pain in a small randomized controlled pilot study. (28) Twenty patients with fibromyalgia, defined by the American College of Rheumatology criteria, were randomized to 10 sessions of left prefrontal rTMS or sham TMS along with their standard medications. At 2 weeks after treatment, there was a significant change from baseline in average visual analog scale (VAS) for pain in the rTMS group (from 5.60 to 4.41) but not in the sham-treated group (from 5.34 to 5.37). There was also a significant improvement in depression symptoms in the active group compared to baseline (from 21.8 to 14.10) but not in the sham group (from 17.6 to 16.4). There were no statistically significant differences between the groups in this small trial. Additional study with a larger number of subjects is needed.
Ahmed et al. randomized 45 patients with probable Alzheimer’s disease to 5 sessions of bi-lateral high-frequency rTMS, bi-lateral low-frequency rTMS, or sham TMS over the dorsolateral prefrontal cortex. (29) Thirty-two patients had mild to moderate dementia and 13 had severe dementia. There were no significant differences between groups at baseline. Measures of cortical excitability immediately after the last treatment session showed that treatment with high-frequency rTMS reduced the duration of transcallosal inhibition. At 3 months after treatment, the high-frequency rTMS group improved significantly more than the other 2 groups in standard rating scales, and subgroup analysis showed that this was due primarily to improvements in patients with mild/moderate dementia. Patients in the subgroup of mild to moderate dementia who were treated with high-frequency rTMS improved from 18.4 to 22.6 on the Mini Mental State Examination (MMSE), from 20.1 to 24.7 on the Instrumental Daily Living Activity (IADL) scale and from 5.9 to 2.6 on the Geriatric Depression Scale (GDS).
In 2008, Walpoth et al. reported no evidence of efficacy of rTMS in a small trial (n=14) of patients with bulimia nervosa. (30)
Evidence on rTMS for depression and other psychiatric/neurologic disorders is insufficient to permit conclusions regarding the effect of this technology on health outcomes. The literature on rTMS for treatment-resistant depression is the most developed and includes a number of double-blind randomized sham-controlled short-term trials. Results of these trials show mean improvements of uncertain clinical significance across groups as a whole. The percentage of subjects who show a clinically significant response is reported at approximately 2 to 3 times that of sham controls, with approximately 15% to 25% of patients meeting the definition of clinical response. (26)
The treatment protocols are time intensive, and the patients who are most likely to benefit from treatment are not currently known. Importantly, a number of open issues need to be addressed before this procedure is widely implemented. The available studies do not establish that rTMS is as good as available alternatives, as the vast majority of the trials do not compare rTMS to alternative active treatments. Alternative treatments include a variety of different medication regimens and psychological talk therapy, both of which have demonstrated efficacy. In addition, further research is needed to determine which of the locations and treatment parameters examined to date are most effective to guide the number of sessions needed to elicit a clinically significant response, to determine whether the response is durable with or without anti-depressant medications, and to provide some information about whether maintenance treatments are needed, and which types of maintenance treatment are most effective..
A search for transcranial magnetic stimulation on online site clinicaltrials.gov indicates that these issues are being actively investigated. Given the number of important questions that remain for this novel treatment approach, the current state of knowledge is not sufficient to expand utilization outside of the research setting. Therefore, rTMS is considered investigational for the treatment of depression and other psychiatric/neurologic disorders.
Practice Guidelines and Position Statements
The Canadian Network for Mood and Anxiety Treatments (CANMAT) updated their clinical guidelines on neurostimulation therapies for the management of major depressive disorder in adults. (31) The evidence reviewed supported electroconvulsive therapy (ECT) as a first-line treatment under specific circumstances; when used in patients who have failed to respond to one or more adequate antidepressant medication trials, ECT response rates have been estimated to be 50–60%. The guidelines considered rTMS to be a safe and well-tolerated treatment, with no evidence of cognitive impairment. Based on the 2008 meta-analysis by Lam et al., (5) response (25%) and remission (17%) rates were found to be greater than sham but lower than for other interventions for TRD, leading to a recommendation for rTMS as a second-line treatment. The guidelines indicated that there is a major gap in the evidence base regarding maintenance rTMS, as only one open-label case series was identified.
The Movement Disorder Society published an evidence-based review of treatments for the non-motor symptoms of Parkinson’s disease in 2011. (32) The review found insufficient evidence to make adequate conclusions on the efficacy rTMS for the treatment of depression in Parkinson’s disease.
Medicare National Coverage
No national coverage determination was identified.
- Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). Transcranial magnetic stimulation for depression. TEC Assessments 2009; Volume 24, Tab 5.
- 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.
- Gross M, Nakamura L, Pascual-Leone A et al. Has repetitive transcranial magnetic stimulation (rTMS) treatment for depression improved? A systematic review and meta-analysis comparing the recent vs. the earlier rTMS studies. Acta Psychiatr Scand 2007; 116(3):165-73.
- 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.
- Avery DH, Holtzheimer PE, 3rd, Fawaz W et al. A controlled study of repetitive transcranial magnetic stimulation in medication-resistant major depression. Biol Psychiatry 2006; 59(2):187-94.
- 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.
- Mogg A, Pluck G, Eranti SV et al. A randomized controlled trial with 4-month follow-up of adjunctive repetitive transcranial magnetic stimulation of the left prefrontal cortex for depression. Psychol Med 2008; 38(3):323-33.
- Fitzgerald PB, Hoy K, McQueen S et al. A randomized trial of rTMS targeted with MRI based neuro-navigation in treatment-resistant depression. Neuropsychopharmacology 2009; 34(5):1255-62.
- Grunhaus L, Schreiber S, Dolberg OT et al. A randomized controlled comparison of electroconvulsive therapy and repetitive transcranial magnetic stimulation in severe and resistant nonpsychotic major depression. Biol Psychiatry 2003; 53(4):324-31.
- McLoughlin DM, Mogg A, Eranti S et al. The clinical effectiveness and cost of repetitive transcranial magnetic stimulation versus electroconvulsive therapy in severe depression: a multicentre pragmatic randomised controlled trial and economic analysis. Health Technol Assess 2007; 11(24):1-54.
- Rosa MA, Gattaz WF, Pascual-Leone A et al. Comparison of repetitive transcranial magnetic stimulation and electroconvulsive therapy in unipolar non-psychotic refractory depression: a randomized, single-blind study. Int J Neuropsychopharmacol 2006; 9(6):667-76.
- Janicak PG, Nahas Z, Lisanby SH et al. Durability of clinical benefit with transcranial magnetic stimulation (TMS) in the treatment of pharmacoresistant major depression: assessment of relapse during a 6-month, multisite, open-label study. Brain Stimul 2010; 3(4):187-99.
- Fitzgerald PB, Brown TL, Marston NA et al. Transcranial magnetic stimulation in the treatment of depression: a double-blind, placebo-controlled trial. Arch Gen Psychiatry 2003; 60(10):1002-8.
- Fitzgerald PB, Benitez J, de Castella A et al. A randomized, controlled trial of sequential bilateral repetitive transcranial magnetic stimulation for treatment-resistant depression. Am J Psychiatry 2006; 163(1):88-94.
- Fitzgerald PB, Huntsman S, Gunewardene R et al. A randomized trial of low-frequency right-prefrontal-cortex transcranial magnetic stimulation as augmentation in treatment-resistant major depression. Int J Neuropsychopharmacol 2006; 9(6):655-66.
- 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; 178(3):467-74.
- Koerselman F, Laman DM, van Duijn H et al. A 3-month, follow-up, randomized, placebo-controlled study of repetitive transcranial magnetic stimulation in depression. J Clin Psychiatry 2004; 65(10):1323-8.
- Rumi DO, Gattaz WF, Rigonatti SP et al. Transcranial magnetic stimulation accelerates the antidepressant effect of amitriptyline in severe depression: a double-blind placebo-controlled study. Biol Psychiatry 2005; 57(2):162-6.
- Herwig U, Fallgatter AJ, Hoppner J et al. Antidepressant effects of augmentative transcranial magnetic stimulation: randomised multicentre trial. Br J Psychiatry 2007; 191:441-8.
- Jorge RE, Moser DJ, Acion L et al. Treatment of vascular depression using repetitive transcranial magnetic stimulation. Arch Gen Psychiatry 2008; 65(3):268-76.
- Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). Transcranial magnetic stimulation for the treatment of schizophrenia. TEC Assessments 2011; Volume 26, Tab 6.
- Sachdev PS, Loo CK, Mitchell PB et al. Repetitive transcranial magnetic stimulation for the treatment of obsessive compulsive disorder: a double-blind controlled investigation. Psychol Med 2007; 37(11):1645-9.
- Mantovani A, Simpson HB, Fallon BA et al. Randomized sham-controlled trial of repetitive transcranial magnetic stimulation in treatment-resistant obsessive-compulsive disorder. Int J Neuropsychopharmacol 2010; 13(2):217-27.
- Mansur CG, Myczkowki ML, de Barros Cabral S et al. Placebo effect after prefrontal magnetic stimulation in the treatment of resistant obsessive-compulsive disorder: a randomized controlled trial. Int J Neuropsychopharmacol 2011; 14(10):1389-97.
- Short EB, Borckardt JJ, Anderson BS et al. Ten sessions of adjunctive left prefrontal rTMS significantly reduces fibromyalgia pain: A randomized, controlled pilot study. Pain 2011; 152(11):2477-84.
- Ahmed MA, Darwish ES, Khedr EM et al. Effects of low versus high frequencies of repetitive transcranial magnetic stimulation on cognitive function and cortical excitability in Alzheimer's dementia. J Neurol 2011.
- Walpoth M, Hoertnagl C, Mangweth-Matzek B et al. Repetitive transcranial magnetic stimulation in bulimia nervosa: preliminary results of a single-centre, randomised, double-blind, sham-controlled trial in female outpatients. Psychother Psychosom 2008; 77(1):57-60.
- Kennedy SH, Milev R, Giacobbe P et al. Canadian Network for Mood and Anxiety Treatments (CANMAT) Clinical guidelines for the management of major depressive disorder in adults. IV. Neurostimulation therapies. J Affect Disord 2009; 117 Suppl 1:S44-53.
- Seppi K, Weintraub D, Coelho M et al. The Movement Disorder Society Evidence-Based Medicine Review Update: Treatments for the non-motor symptoms of Parkinson's disease. Mov Disord 2011; 26 Suppl 3:S42-80.
|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|
|ICD-9 Diagnosis||Investigational for all relevant diagnoses|
|HCPCS||0310T||Motor function mapping using non-invasive navigated transcranial magnetic stimulation (nTMS) for therapeutic treatment planning, upper and lower extremity (new code effective 1/1/2013)|
|ICD-10-CM (effective 10/1/13)||Investigational for all relevant diagnoses|
|F20.0 - F20.9||Schizophrenia code range|
|F33.0 - F33.9||Major depressive disorder, recurrent, code range|
|G43.001 - G43.919||Migraine code range|
|ICD-10-PCS (effective 10/1/13)||ICD-10-PCS codes are only used for inpatient services. There is no specific ICD-10-PCS code for this procedure.|
|Type of Service||Medicine|
|Place of Service||Outpatient|
Depression, Transcranial Magnetic Stimulation
Magnetic Stimulation, Transcranial
NeoPulse, Transcranial Magnetic Stimulation
NeuroStar, Transcranial Magnetic Stimulation
Transcranial Magnetic Stimulation, Depression
Repetitive Transcranial Magnetic Stimulation, Depression
|11/20/01||Add to Medicine section||New policy|
|11/20/01||Replace policy||Policy reissued due to a correction to the word electrical in the policy statement. The statement reads: Transcranial electrical stimulation etc., but it should read: Transcranial magnetic stimulation etc. No other changes were made|
|04/29/03||Replace policy||Policy reviewed with literature search; policy statement unchanged|
|04/16/04||Replace policy||Policy reviewed with literature search; policy statement unchanged|
|3/15/05||Replace policy||Policy reviewed with literature search; policy statement unchanged; reference numbers 10–12 added|
|12/14/05||Replace policy||Policy reviewed with literature search; policy statement unchanged; reference numbers 13–15 added. New CPT category III codes for July 2006 added to policy guidelines and code table.|
|12/12/06||Replace policy||Policy reviewed with literature search; reference numbers 15–20 added; title and policy statement modified to include neurologic conditions|
|12/13/07||Replace policy||Policy updated with literature search; references 20-23 added; no change in policy statement.
|12/11/08||Replace policy||Policy updated with literature search; rationale revised; reference numbers 24-35 added; no change in policy statement|
|12/10/09||Replace policy||Policy updated with literature search through October 2009; references 29, 36-38 added; no change in policy statement|
|01/13/11||Replace policy||Policy updated with literature search through October 2010; references 39-41 added; no change in policy statement|
|1/12/12||Replace policy||Policy updated with literature search through November 2011; references added and reordered; 14 older references removed; no change in policy statement|
|1/20/13||replace policy- coding update only||new HCPCS code added|