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Transcranial Magnetic Stimulation as a Treatment of Depression and Other Psychiatric Disorders

Policy Number: MP-170

Latest Review Date: November 2019

Category: Medicine                                                               

Policy Grade:  A

POLICY:

Effective for dates of service on or after September 30, 2019:

Repetitive transcranial magnetic stimulation (rTMS) of the brain may be considered medically necessary as a treatment of major depressive disorder when ALL of the following conditions have been met:

 

  1. Confirmed diagnosis of severe major depressive disorder (single or recurrent) documented by standardized rating scales that reliably measure depressive symptoms;

 

AND

 

  1. Any one of the following (a, b, c, or d):

    1. Failure of 4 trials of psychopharmacologic agents including 2 different agent classes and 2 augmentation trials; OR

    2. Inability to tolerate a therapeutic dose of medications as evidenced by 4 trials of psychopharmacologic agents with distinct side effects; OR

    3. History of response to rTMS in a previous depressive episode (at least 3 months since the prior episode); OR

    4. Is a candidate for electroconvulsive therapy (ECT) and ECT would not be clinically superior to rTMS (e.g., in cases with psychosis, acute suicidal risk, catatonia or life-threatening inanition rTMS should NOT be utilized);

 

AND

 

  1. Failure of a trial of a psychotherapy known to be effective in the treatment of major depressive disorder of an adequate frequency and duration, without significant improvement in depressive symptoms, as documented by standardized rating scales that reliably measure depressive symptoms.

 

rTMS for major depressive disorder that does not meet the criteria listed above is considered not medically necessary and investigational.

 

Continued treatment with rTMS of the brain as maintenance therapy is considered not medically necessary and investigational.

 

Transcranial magnetic stimulation of the brain is considered not medically necessary and investigational as a treatment of all other psychiatric/neurologic disorders, including but not limited to bipolar disorder, schizophrenia, obsessive-compulsive disorder, or migraine headaches.

 

Repetitive transcranial magnetic stimulation should be performed using an FDA-cleared device in appropriately selected patients, prescribed by physicians who are adequately trained and experienced in the specific techniques used. A treatment course should not exceed 5 days a week for 6 weeks (total of 30 sessions), followed by a 3-week taper of 3 TMS treatments in week 1, 2 TMS treatments the next week, and 1 TMS treatment in the last week.

 

Contraindications to rTMS include:

  1. Seizure disorder or any history of seizure with increased risk of future seizure; OR

  2. Presence of acute or chronic psychotic symptoms or disorders (such as schizophrenia, schizophreniform or schizoaffective disorder) in the current depressive episode; OR

  3. Neurologic conditions that include epilepsy, cerebrovascular disease, dementia, increased intracranial pressure, having a history of repetitive or severe head trauma, or with primary or secondary tumors in the central nervous system (CNS); OR

  4. Presence of an implanted magnetic-sensitive medical device located 30 centimeters or less from the TMS magnetic coil 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.

 

Effective for dates of service prior to September 30, 2019:

Repetitive transcranial magnetic stimulation (rTMS) of the brain may be considered medically necessary as a treatment of major depressive disorder when ALL of the following conditions have been met:

 

  1. Confirmed diagnosis of severe major depressive disorder (single or recurrent) documented by standardized rating scales that reliably measure depressive symptoms;

 

AND

 

  1. Any one of the following (a, b, c, or d):

    1. Failure of 4 trials of psychopharmacologic agents including 2 different agent classes and 2 augmentation trials; OR

    2. Inability to tolerate a therapeutic dose of medications as evidenced by 4 trials of psychopharmacologic agents with distinct side effects; OR

    3. History of response to rTMS in a previous depressive episode (at least 3 months since the prior episode); OR

    4. Is a candidate for electroconvulsive therapy (ECT) and ECT would not be clinically superior to rTMS (e.g., in cases with psychosis, acute suicidal risk, catatonia or life-threatening inanition rTMS should NOT be utilized);

 

AND

 

  1. Failure of a trial of a psychotherapy known to be effective in the treatment of major depressive disorder of an adequate frequency and duration, without significant improvement in depressive symptoms, as documented by standardized rating scales that reliably measure depressive symptoms.

 

rTMS for major depressive disorder that does not meet the criteria listed above is considered not medically necessary and investigational.

 

Continued treatment with rTMS of the brain as maintenance therapy is considered not medically necessary and investigational.

 

Transcranial magnetic stimulation of the brain is considered not medically necessary and investigational as a treatment of all other psychiatric/neurologic disorders, including but not limited to bipolar disorder, schizophrenia, obsessive-compulsive disorder, or migraine headaches.

 

Repetitive transcranial magnetic stimulation should be performed using an FDA-cleared device in appropriately selected patients, prescribed by physicians who are adequately trained and experienced in the specific techniques used. A treatment course should not exceed 5 days a week for 6 weeks (total of 30 sessions), followed by a 3-week taper of 3 TMS treatments in week 1, 2 TMS treatments the next week, and 1 TMS treatment in the last week.

 

Contraindications to rTMS include:

  1. Seizure disorder or any history of seizure with increased risk of future seizure; OR

  2. Presence of acute or chronic psychotic symptoms or disorders (such as schizophrenia, schizophreniform or schizoaffective disorder) in the current depressive episode; OR

  3. Neurologic conditions that include epilepsy, cerebrovascular disease, dementia, increased intracranial pressure, having a history of repetitive or severe head trauma, or with primary or secondary tumors in the central nervous system (CNS); OR

  4. Presence of an implanted magnetic-sensitive medical device located 30 centimeters or less from the TMS magnetic coil 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.

 

The following should be present for the administration of rTMS:

  1. An attendant trained in basic cardiac life support and the management of complications such as seizures, as well as the use of the equipment must be present at all times; AND

  2. Adequate resuscitation equipment including, for example, suction and oxygen; AND

  3. The facility must maintain awareness of response times of emergency services (either fire/ambulance or “code team”), which should be available within five minutes. These relationships are reviewed on at least a one year basis and include mock drills.

  4. The prescribing physician should initiate all TMS treatments and be available for emergencies.

 

DESCRIPTION OF PROCEDURE OR SERVICE:

Transcranial magnetic stimulation (TMS) is a non-invasive method of delivering electrical stimulation to the brain. TMS involves placement of a small coil over the scalp; passing a rapidly alternating current through the coil wire. This produces a magnetic field that passes unimpeded through the scalp and bone, resulting in electrical stimulation that affects neuronal function. Repetitive TMS (rTMS) is being evaluated as a treatment of depression and other psychiatric/neurologic 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 5cm 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 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), or deep stimulation with an H1 coil, is also being explored. In contrast to electroconvulsive therapy, transcranial magnetic stimulation does not require anesthesia and does not induce a convulsion.

 

Repetitive TMS (rTMS)

Repetitive TMS (rTMS) is also being tested as a treatment for other disorders including alcohol dependence, Alzheimer’s disease, neuropathic pain, obsessive-compulsive disorder (OCD), post-partum depression, depression associated with Parkinson’s disease, stroke, post-traumatic stress disorder, panic disorder, epilepsy, dysphagia, Tourette’s syndrome, schizophrenia, migraine, spinal cord injury, tinnitus, and fibromyalgia. In addition to the potential for altering interhemispheric imbalance, it has been proposed that high frequency rTMS may facilitate neuroplasticity.

 

 

KEY POINTS:

The most recent literature update was performed through August 26, 2019. This review was informed by 3 TEC Assessments (2009, 2011, and 2013).

 

Summary of Evidence

For individuals who have TRD who receive rTMS, the evidence includes a large number of sham-controlled RCTs and meta-analyses of these trials. Relevant outcomes are symptoms, functional outcomes, and quality of life. The meta-analyses find a clinical benefit associated with rTMS for TRD with improved response rate and rate of remission compared with sham. The most recent meta-analyses concluded that the effect of rTMS on average depression score is smaller than the effect of ECT on TRD and that the mean improvement in depression scores with rTMS does not reach the minimal clinically important difference; however, clinically meaningful improvements were noted in a subgroup of studies using higher frequency pulses. One potential area of benefit for rTMS is in accelerating or enhancing the response to antidepressant medications, and there is some evidence that rTMS, when given in conjunction with the initiation of pharmacologic therapy, improves the response rate compared with pharmacologic therapy alone. The effect of rTMS appears to be less robust when it is given in combination with a stable dose of antidepressant medication. Meta-analyses also find that the efficacy of rTMS decreases with longer follow-up; however, some studies have reported persistent response up to 6-month in some patients. There is limited evidence to compare the effects of these treatments on cognition, although the adverse effects of rTMS appear to be minimal. While the most recent meta-analyses find that the effect of rTMS is smaller than the effect of ECT on TRD, given that rTMS does not require general anesthesia or induction of seizures, some individuals may not wish to use ECT so the balance of incremental benefits and harms associated with rTMS may be a reasonable balance compared with ECT. Based on the short-term benefit observed in randomized controlled trials and the lack of alternative treatments, aside from electroconvulsive therapy in patients with TRD, rTMS may be considered a treatment option in patients with TRD who meet specific criteria. The evidence for theta burst stimulation includes a large randomized trial showing noninferiority with another method of rTMS; no significant differences were noted in the number of adverse events. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.

 

For individuals who have migraine headaches who receive rTMS, the evidence includes a sham-controlled RCT of 201 patients conducted for submission to the FDA for clearance in 2013.The trial results were limited by the 46% dropout rate and the use of a post hoc analysis. No recent studies have been identified with these devices. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have OCD who receive rTMS, the evidence includes a number of small-to-moderate sized sham-controlled RCTs and a meta-analysis of these studies. The meta-analysis of 15 RCTs (total n=483 patients, range 18-65 patients) found a benefit of rTMS on patient-reported OCD symptom severity at time points ranging from 2 to 6 weeks, but there was substantial variability in the stimulation parameters, including the cortical region that was stimulated and the frequency of stimulation. A more recent RCT compared deep rTMS to sham in 99 patients for 6 weeks, with an additional 4 weeks of follow-up as a secondary outcome. Using a modified ITT analysis (n=94), there was a larger mean change from baseline on the primary efficacy outcome; YBOCS score in the active treatment group (-6.0 points) than the sham group (-2.8 points), translating to a moderate effect size of 0.69. At 6 weeks, the response rate was 38.1% in the active treatment group compared to 11.1% in the sham group (P=0.003), as measured by a 30% or greater decrease in the YBOCS. The difference in the primary outcome measure between active and sham groups was not statistically significant in the ITT analysis. There was a benefit for rTMS on clinician-reported measures of improvement, but no significant difference between groups on patient-reported disability and impairment. Additional trials with sufficient sample size and follow-up duration are needed to confirm these results. The evidence is insufficient to determine the effect of the technology on health outcomes.

For individuals who have other psychiatric or neurological conditions other than depression, migraine, or obsessive-compulsive disorder (e.g., amyotrophic lateral sclerosis, chronic pain, epilepsy, fibromyalgia, panic disorder, Parkinson disease, posttraumatic stress disorder, schizophrenia, stroke, and substance abuse and craving) who receive rTMS, the evidence includes numerous small RCTs and meta-analyses of these RCTs. Relevant outcomes are symptoms, functional outcomes, and quality of life. The trials included in the meta-analyses are typically small and of low methodological quality. In addition, stimulation parameters have not been established, and results of the trials are heterogeneous. There are no large, high-quality trials for any of these conditions that have demonstrated efficacy. The durability of any treatment effects would also need to be demonstrated. The evidence is insufficient to determine the effects of the technology on health outcomes.

 

Practice Guidelines and Position Statements

American Psychiatric Association

The American Psychiatric Association (2018) published consensus recommendations on repetitive transcranial magnetic stimulation (rTMS) for the treatment of depression. The guidelines state, "Multiple randomized controlled trials and published literature have supported the safety and efficacy of rTMS antidepressant therapy." The recommendations include information on the following variables: clinical environment, operator requirements, documentation, coils, cortical targets, coil positioning methods, determination of motor threshold, number of treatment sessions for acute treatment, and allowable psychotropic medications during TMS treatment.

 

The American Psychiatric Association’s guidelines on the treatment of patients with obsessive-compulsive disorder (2007, reaffirmed in 2012) state that “findings of the four published trials of repetitive TMS (rTMS) are inconsistent, perhaps because the studies differed in design, stimulation sites, duration, and stimulation parameters. The available results and the technique’s non-invasiveness and good tolerability should encourage future research, but the need for daily treatment may limit the use of TMS in practice.”

 

American Academy of Child and Adolescent Psychiatry

In 2013, the American Academy of Child and Adolescent Psychiatry (AACP) Committee on Quality Issues published practice parameters for the assessment and treatment of children and adolescents with tic disorders. AACP does not recommend repetitive transcranial magnetic stimulation, citing the limited evidence regarding safety, ethics, and long term impact on development.

 

National Institute for Health and Care Excellence

In 2014, NICE provided guidance on the use of rTMS for treating and preventing migraine. The guidance states that evidence on the efficacy of TMS for the treatment of migraine is limited in quantity and for the prevention of migraine is limited in both quality and quantity. Evidence on its safety in the short and medium term is adequate but there is uncertainty about the safety of long-term or frequent use of TMS. Therefore, this procedure should only be used with special arrangement for clinical governance, consent and audit or research.

 

In 2015, the National Institute for Health and Care Excellence (NICE) provided provisional recommendations, revised from earlier guidance, stating that evidence on the short-term efficacy of rTMS for depression is adequate, although the clinical response is variable and some patients may not benefit. rTMS for depression may be used with normal arrangements for clinical governance and audit, “provided that patients are informed about the other treatment options available and they understand the possibility that they may derive little or no benefit from the procedure.” The final recommendation was expected November 2015 but is not yet posted.

 

American Academy of Neurology

2006 Practice Guidelines on the evaluation and treatment of depression, psychosis, and dementia in Parkinson disease from the American Academy of Neurology concluded that there is insufficient evidence to support or refute the efficacy of TMS or ECT in the treatment of depression associated with Parkinson disease (Level U; Data inadequate or conflicting given current knowledge, treatment is unproven).

 

U.S. Preventive Services Task Force Recommendations

Not applicable.

 

KEY WORDS:

Transcranial magnetic stimulation (TMS), depression, NeoPulse®, repetitive transcranial magnetic stimulation (rTMS), NeuroStar TMS®, Therapy System , Brainsway™ H-Coil Deep,

Rapid2 Therapy System, MagVita TMS Therapy, Neurosoft TMS, Cerena™, MagVita TMS Therapy System with Theta Burst Stimulation, SpringTMS™ Total Migraine System,  Deep TMS System, and sTMS Mini System.

 

 

APPROVED BY GOVERNING BODIES:

Devices for transcranial stimulation have been cleared for marketing by the U.S. Food and Drug Administration (FDA) for diagnostic uses (FDA Product Code: GWF). A number of devices subsequently received the FDA clearance for the treatment of major depressive disorder in adults who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode. Indications were expanded to include treating pain associated with certain migraine headaches in 2013, and obsessive-compulsive disorder in 2018.

In 2008, The NeoPulse, now known as NeuroStar® TMS, was granted a de novo 510(k) classification by the FDA. The de novo 510(k) review process allows novel products with moderate or low-risk profiles and without predicates, which would ordinarily require premarket approval as a class III device to be down-classified in an expedited manner and brought to market with a special control as a class II device.

In 2013, the Cerena™ TMS device (eNeura Therapeutics) was granted a de novo 510(k) classification by the FDA for the acute treatment of pain associated with a migraine headache with aura. Warnings, precautions, and contraindications include the following:

  • The device is only intended for 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.

    • for medication overuse headaches.

  • The device has not been demonstrated as safe and/or effective:

    • when treating cluster headache or a chronic migraine headache.

    • when treating during the aura phase.

    • in relieving the associated symptoms of a migraine (photophobia, phonophobia, and nausea).

    • in pregnant women, children under the age of 18, and adults over the age of 65.

In 2014, eNeura Therapeutics received 510(k) marketing clearance for the SpringTMS® for the treatment of migraine headaches. The device differs from the predicate Cerena™ TMS device with the addition of an LCD screen, a use authorization feature, a lithium battery pack, and a smaller size. The stimulation parameters are unchanged. The sTMS Mini (eNeura Therapeutics) received marketing clearance by the FDA in 2016. FDA product code: OKP.

In August 2018, the Deep TMS System (Brainsway) was granted a de novo 510(k) classification by the FDA as an adjunct for the treatment of adult patients with Obsessive-Compulsive Disorder. The new classification applies to this device and substantially equivalent devices of this generic type.

Table 1 lists some devices that are FDA cleared for major depressive disorder (Product Code: OBP), migraine headache pain (Product Code: OKP), and obsessive-compulsive disorder (Product Code: QCI).

Table 1. Repetitive TMS Devices Cleared by FDA for Major Depression, Migraine, or Obsessive-Compulsive Disorder

 

Device

Manufacturer

Indication

FDA Clearance No.

FDA Clearance Date

Neurostar

Neuronetics

Major Depressive Disorder

K083538

12/16/2008

Brainsway Deep TMS System

Brainsway

Major Depressive Disorder

K122288

01/07/2013

Springtms Total Migraine System

Eneura

Migraine headache with aura

K140094

05/21/2014

Rapid Therapy System

Magstim

Major Depressive Disorder

K143531

05/08/2015

Magvita

Tonica Elektronik

Major Depressive Disorder

K150641

07/31/2015

Neurosoft

TeleEMG

Major Depressive Disorder

K160309

12/22/2016

Horizon

Magstim

Major Depressive Disorder

K171051

09/13/2017

Nexstim

Nexstim

Major Depressive Disorder

K171902

11/10/2017

Apollo

Mag & More

Major Depressive Disorder

K180313

05/04/2018

Brainsway Deep TMS System

Brainsway

Obsessive-Compulsive Disorder

K183303

03/08/2019

FDA: Food and Drug Administration; TMS: transcranial magnetic stimulation.

The NeoPulse, now known as NeuroStar® TMS, was granted a de novo 510(k) classification by the FDA in 2008. The de novo 510(k) review process allows novel products with moderate or low-risk profiles and without predicates, which would ordinarily require premarket approval as a class III device to be down-classified in an expedited manner and brought to market with a special control as a class II device.

In 2014, the Cerena™ TMS device (eNeura Therapeutics) was granted a de novo 510(k) classification by the FDA for the acute treatment of pain associated with a migraine headache with aura. Warnings, precautions, and contraindications include the following:

  • The device is only intended for 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.

    • for medication overuse headaches.

  • The device has not been demonstrated as safe and/or effective:

    • when treating cluster headache or a chronic migraine headache.

    • when treating during the aura phase.

    • in relieving the associated symptoms of a migraine (photophobia, phonophobia, and nausea).

    • in pregnant women, children under the age of 18, and adults over the age of 65.

In 2014, eNeura Therapeutics received 510(k) marketing clearance for the SpringTMS® for the treatment of migraine headaches. The device differs from the predicate Cerena™ TMS device with the addition of an LCD screen, a use authorization feature, a lithium battery pack, and a smaller size. The stimulation parameters are unchanged. The sTMS Mini (eNeura Therapeutics) received marketing clearance by the FDA in 2016. FDA product code: OKP.

In August 2018, the Deep TMS System (Brainsway) was granted a de novo 510(k) classification by the FDA as an adjunct for the treatment of adult patients with Obsessive-Compulsive Disorder. The new classification applies to this device and substantially equivalent devices of this generic type.

 

 

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits.  Group specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply.

 

FEP contracts: FEP does not consider investigational if FDA approved and will be reviewed for medical necessity.

 

CURRENT CODING:

 

CPT codes:

 

 

90867

Therapeutic repetitive transcranial magnetic stimulation (TMS) treatment; 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.

Code 90867 is reported once per course of treatment, and codes 90868 and 90869 cannot be reported for the same session.

 

 

REFERENCES:

  1. 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.

  2. American Psychiatric Association. Practice Guidelines for the treatment of patients with major depressive disorder. 2010. psychiatryonline.org/data/Books/prac/PG_Depression3rdEd.pdf.  Accessed September 24, 2019.

  3. American Psychiatric Association. Practice guideline for the treatment of patients with obsessive-compulsive disorder. 2007; psychiatryonline.org/pb/assets/raw/sitewide/practice_guidelines/guidelines/ocd.pdf. Accessed September 24, 2019.

  4. Avery DH, Holtzheimer PE III, et al.  A controlled study of repetitive transcranial magnetic stimulation in medication-resistant major depression.  Biol Psychiatry, January 2006; 59(2): 187-194.

  5. Avery DH, Isenberg KE, et al.  Transcranial magnetic stimulation in the acute treatment of major depressive disorder:  Clinical response in an open-label extension trial.  J Clin Psychiatry 2008; 69: 441-451.

  6. Benninger DH, Iseki K, Kranick S et al. Controlled study of 50-Hz repetitive transcranial magnetic stimulation for the treatment of Parkinson disease. Neurorehabil Neural Repair 2012; 26(9):1096- 105.

  7. Berlim MT, Neufeld NH, Van den Eynde F. Repetitive transcranial magnetic stimulation (rTMS) for obsessive-compulsive disorder (OCD): an exploratory meta-analysis of randomized and sham-controlled trials. J Psychiatr Res 2013; 47(8):999-1006.

  8. Berlim MT, Van den Eynde F, Daskalakis ZJ. Efficacy and acceptability of high frequency repetitive transcranial magnetic stimulation (rTMS) versus electroconvulsive therapy (ECT) for major depression: a systematic review and meta-analysis of randomized trials. Depress Anxiety. Jul 2013; 30(7):614-623.

  9. Berlim MT, Van den Eynde F, Daskalakis ZJ. High-frequency repetitive transcranial magnetic stimulation accelerates and enhances the clinical response to antidepressants in major depression: a meta-analysis of randomized, double-blind, and sham-controlled trials. J Clin Psychiatry. Feb 2013; 74(2):e122-129.

  10. Blue Cross Blue Shield Association.  Transcranial magnetic stimulation for depression.  Technology Evaluation Center (TEC) Assessment, Program, October 2009, Vol. 24, No. 5.

  11. Blue Cross Blue Shield Association.  Transcranial magnetic stimulation as a treatment of depression and other psychiatric disorders.  Medical Policy Reference Manual, December 2009.

  12. Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). Transcranial magnetic stimulation for depression. TEC Assessments 2011; Volume 26, Tab 3.

  13. 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.

  14. Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). Transcranial magnetic stimulation for depression. TEC Assessments. 2013;Volume 28, Tab 9.

  15. Blumberger DM, Christensen BK, Zipursky RB et al. MRI-targeted repetitive transcranial magnetic stimulation of Heschl's gyrus for refractory auditory hallucinations. Brain Stimul 2012; 5(4):577- 85.

  16. Blumberger DM, Vila-Rodriguez F, Thorpe KE, et al. Effectiveness of theta burst versus high-frequency repetitive transcranial magnetic stimulation in patients with depression (THREE-D): a randomized non-inferiority trial. Lancet. Apr 28 2018;391(10131):1683-1692.

  17. Burt T, Lisanby SH, Sackeim HA. Neuropsychiatric applications of transcranial magnetic stimulation: A Meta analysis. Int J Neuropsychopharmacol 2002; 5(1): 73-103.

  18. Carmi L, Tendler A, Bystritsky A et al. Efficacy and Safety of Deep Transcranial Magnetic Stimulation for Obsessive-Compulsive Disorder: A Prospective Multicenter Randomized Double-Blind Placebo-Controlled Trial. Am J Psychiatry, 2019 May 22;appiajp201918101180:appiajp201918101180.

  19. Chen R, Spencer DC, Weston J, et al. Transcranial magnetic stimulation for the treatment of epilepsy. Cochrane Database Syst Rev. Aug 11 2016; (8):CD011025.

  20. Chou YH, Hickey PT, Sundman M, et al. Effects of repetitive transcranial magnetic stimulation on motor symptoms in Parkinson disease: a systematic review and meta-analysis. JAMA Neurol. Apr 2015; 72(4):432-440.

  21. Cohen H, Kaplan Z, Kotler M et al. Repetitive transcranial magnetic stimulation of the right dorsolateral prefrontal cortex in posttraumatic stress disorder: a double-blind, placebo-controlled study. Am J Psychiatry 2004; 161(3):515-24.

  22. Connolly KR, Helmer A, Cristancho MA et al. Effectiveness of transcranial magnetic stimulation in clinical practice post-FDA approval in the United States: results observed with the first 100 consecutive cases of depression at an academic medical center. J Clin Psychiatry 2012; 73(4):e567-73.

  23. Daskalakis ZJ, et al.  Repetitive transcranial magnetic stimulation for major depressive disorder: a review.  Canadian Journal of Psychiatry, September 2008; 53(9):553-554.

  24. Demitrach MA, Thase ME.  Clinical significance of transcranial magnetic stimulation (TMS) in the treatment of pharmaco-resistant depression: synthesis of recent data.  Psychopharmacology Bulletin 2009; 42(2):5-38.

  25. Demirtas-Tatlidede A, Mechanic-Hamilton D, Press DZ, et al.  An open-label, prospective study of repetitive transcranial magnetic stimulation (rTMS) in the long-term treatment of refractory depression: Reproducibility and duration of the

  26. Dinur-Klein L, Dannon P, Hadar A, et al. Smoking cessation induced by deep repetitive transcranial magnetic stimulation of the prefrontal and insular cortices: a prospective, randomized controlled trial. Biol Psychiatry. Nov 1 2014; 76(9):742-749.

  27. Dougall N, Maayan N, Soares-Weiser K, et al. Transcranial magnetic stimulation (TMS) for schizophrenia. Cochrane Database Syst Rev. 2015; 8:CD006081.

  28. 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. Dec 2014;75(12):1394-1401.

  29. Elahi B, Elahi B, Chen R. Effect of transcranial magnetic stimulation on Parkinson motor function-- systematic review of controlled clinical trials. Mov Disord 2009; 24(3):357-63.

  30. Fang J, Zhou M, Yang M, et al. Repetitive transcranial magnetic stimulation for the treatment of amyotrophic lateral sclerosis or motor neuron disease. Cochrane Database Syst Rev. 2013; 5:CD008554.

  31. Farris SG, McLean CP, Van Meter PE et al. Treatment response, symptom remission, and wellness in obsessive-compulsive disorder. J Clin Psychiatry, 2013 Aug 16;74(7). 

  32. Food and Drug Administration. 510(k) Summary: Brainsway deep TMS System (K122288). 2013; www.accessdata.fda.gov/cdrh_docs/pdf12/k122288.pdf. Accessed September 24, 2019.

  33. Food and Drug Administration. De Novo classification request for cerena transcranial magnetic stimulator (TMS) device. 2013; www.accessdata.fda.gov/cdrh_docs/reviews/K130556.pdf. Accessed September 24, 2019.

  34. Fitzgerald PB, Grace N, Hoy KE et al. An open label trial of clustered maintenance rTMS for patients with refractory depression. Brain Stimul, 2013 May; 6(3):292-7.

  35. 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, December 2006; 9(6): 655-666.

  36. Fitzgerald PB, Hoy K, McQueen S, et al. A randomised trial of rTMS targeted with MRI based neuro-navigation in treatment-resistant depression. Neuropsychopharmacology, April 2009; 34(5): 1255-1262.

  37. Fitzgerald PB, Brown TL, et al. Transcranial magnetic stimulation in the treatment of depression: A double-blind, placebo-controlled trial. Arch Gen Psychiatry, October 2003; 60(10): 1002-1008.

  38. Fitzgerald PB, Benitez J, et al. A randomized, controlled trial of sequential bilateral repetitive transcranial magnetic stimulation for treatment-resistant depression. Am J Psychiatry 2006; 163; 88-94.

  39. Gaynes B, Lux L, Lloyd S et al. Nonpharmacologic Interventions for Treatment-Resistant Depression in Adults. Comparative Effectiveness Review No. 33. (Prepared by RTI International-University of North Carolina (RTI-UNC) Evidence based Practice Center under Contract No. 290-02-0016I.) AHRQ Publication No. 11-EHC056- EF. Rockville, MD: Agency for Healthcare Research and Quality. 2011. www.effectivehealthcare.ahrq.gov/ehc/products/76/792/TRD_CER33_20111110.pdf.

  40. Gelenberg AJ, Freeman MP, Markowitz JL, et al. Work group on Major Depressive Disorder. Practice Guidelines. Major Depressive Disorder. Practice guidelines for the treatment of patients with major depressive disorders, 3rd ed. Am J Psychiatry. 2010; 167(10S).

  41. George MS, Lisanby SHm, Avery D, et al. Daily left prefrontal transcranial magnetic stimulation therapy for major depression disorder: s sham-controlled randomized trial. Arch Gen Psychiatry 2010; 67(5):507-16.

  42. George MS, Wassermann EM, Kimbrell TA, et al. Mood improvement following daily left prefrontal repetitive transcranial magnetic stimulation in patients with depression: A placebo-controlled crossover trial. Am J Psychiatry 1997; 154(12):1752-1765.

  43. Graef P, Dadalt ML, Rodrigues DA, et al. Transcranial magnetic stimulation combined with upper-limb training for improving function after stroke: A systematic review and meta-analysis. J Neurol Sci. Oct 15 2016; 369:149-158.

  44. Gross M, Nakamura L, 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, September 2007; 116(3): 165-173.

  45. Grunhaus L, Schreiber S, et al. A randomized controlled comparison of electroconvulsive therapy and repetitive transcranial magnetic stimulation in severe and resistant nonpsychotic major depression. Biol Psychiatry, February 2003; 53(4): 324-331.

  46. Guse B, Falkai P, Wobrock T. Cognitive effects of high-frequency repetitive transcranial magnetic stimulation: a systematic review. Journal of Neural Transmission, January 2010; 117(1):105-122.

  47. Hao Z, Wang D, Zeng Y et al. Repetitive transcranial magnetic stimulation for improving function after stroke. Cochrane Database Syst Rev 2013; 5:CD008862.

  48. Hasey G. Transcranial magnetic stimulation in the treatment of mood disorder: a review and comparison with electroconvulsive therapy. Can J Psychiatr 2001; 46(8): 720-7.

  49. Hausmann A, Kemmler G, Walpoth M, et al. No benefit derived from repetitive transcranial magnetic stimulation in depression: A prospective, single centre, randomized, double blind, sham controlled “add on” trial. J Neurol Neurosurg Psychiatry, February 2004; 75(2): 320-322.

  50. He H, Lu J, Yang L, et al. Repetitive transcranial magnetic stimulation for treating the symptoms of schizophrenia: A PRISMA compliant meta-analysis. Clin Neurophysiol. May 2017;128(5):716-724.

  51. Health Quality Ontario. Repetitive transcranial magnetic stimulation for treatment-resistant depression: a systematic review and meta-analysis of randomized controlled trials. Ont Health Technol Assess Ser. 2016; 16(5):1-66.

  52. Herwig U, Fallgatter AJ, et al. Antidepressant effects of augmentative transcranial magnetic stimulation: Randomised multicentre trial. Br J Psychiatry, November 2007; 191: 441-448.

  53. Holtzheimer PE, Russo J, Avery DH. A meta-analysis of repetitive transcranial magnetic stimulation in the treatment of depression. Psychopharmacol Bull 2001; 35(4): 149-69.

  54. Hoppner J, Schulz M, Irmisch G, et al. Antidepressant efficacy of two different rTMS procedures. High frequency over left versus low frequency over right prefrontal cortex compared with sham stimulation. Eur Arch Psychiatry Clin Neurosci 2003; 253(2): 103-9.

  55. Hsu WY, Cheng CH, Liao KK et al. Effects of repetitive transcranial magnetic stimulation on motor functions in patients with stroke: a meta-analysis. Stroke 2012; 43(7):1849-57.

  56. Isenberg K, Downs D, Pierce K, et al. Low frequency rTMS stimulation of the right frontal cortex is as effective as high frequency rTMS stimulation of the left frontal cortex for antidepressant-free, treatment-resistant depressed patients. Ann Clin Psychiatry, July-September 2005; 17(3): 153-159.

  57. Isserles M, Shalev AY, Roth Y et al. Effectiveness of deep transcranial magnetic stimulation combined with a brief exposure procedure in post-traumatic stress disorder - A pilot study. Brain Stimul, 2013 May;6(3): 377-83.

  58. Janicak PG, Dowd SM, et al. Repetitive transcranial magnetic stimulation versus electroconvulsive therapy for major depression: Preliminary results of a randomized trial. Biol Psychiatry, November 2002; 52(10): 1032-1033.

  59. 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; 3(4): 187-99.

  60. Janicak PG, O’Reardon JP, et al. Transcranial magnetic stimulation in the treatment of major depressive disorder: A comprehensive summary of safety experience from acute exposure, extended exposure, and during reintroduction treatment. J Clin Psychiatry 2008; 69: 222-232.

  61. Jansen JM, Daams JG, Koeter MW, et al. Effects of non-invasive neurostimulation on craving: a meta-analysis. Neurosci Biobehav Rev. Dec 2013; 37(10 Pt 2):2472-2480.

  62. Jorge RE, Moser DJ, et al. Treatment of vascular depression using repetitive transcranial magnetic stimulation. Arch Gen Psychiatry, March 2008; 65(3): 268-276.

  63. Kedzior KK, Reitz SK, Azorina V, et al. Durability of the antidepressant effect of the high-frequency repetitive transcranial magnetic stimulation (rTMS) in the absence of maintenance treatment in major depression: a systematic review and meta-analysis of 16 double-blind, randomized, sham-controlled trials. Depress Anxiety. Mar 2015; 32(3):193-203.

  64. Kennedy SH, Milev R, 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, October 2008; 117(Suppl 1): S44.53.

  65. Khedr EM, Abo-Elfetoh N, Rothwell JC. Treatment of post-stroke dysphagia with repetitive transcranial magnetic stimulation. Acta Neurol Scand 2009; 119(3):155-61.

  66. Kim L, Chun MH, Kim BR et al. Effect of repetitive transcranial magnetic stimulation on patients with brain injury and Dysphagia. Ann Rehabil Med 2011; 35(6):765-71.

  67. Klein E, Kreinin I, Chistyakov A, et al. Therapeutic efficacy of right prefrontal slow repetitive transcranial magnetic stimulation in major depression: A double-blind controlled study. Arch Gen Psychiatry 1999; 56(6):946-948.

  68. Knapp M, et al. Cost-effectiveness of transcranial magnetic stimulation vs. electroconvulsive therapy for severe depression: a multi-centre randomized controlled trial. Journal of Affective Disorders, August 2008; 109(3):273-285.

  69. Koerselman F, Laman DM, et al. A 3-month, follow-up, randomized, placebo-controlled study of repetitive transcranial magnetic stimulation in depression. J Clin Psychiatry, October 2004; 65(10): 1323-1328.

  70. Lam RW, Chan P, et al. Repetitive transcranial magnetic stimulation for treatment-resistant depression: A systematic review and metaanalysis. Can J Psychiatry, September 2008; 53(9): 621-631.

  71. Le Q, Qu Y, Tao Y, et al. Effects of repetitive transcranial magnetic stimulation on hand function recovery and excitability of the motor cortex after stroke: a meta-analysis. Am J Phys Med Rehabil. May 2014; 93(5):422-430.

  72. 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.

  73. 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.

  74. Li Y, Qu Y, Yuan M, et al. Low-frequency repetitive transcranial magnetic stimulation for patients with aphasia after stoke: A meta-analysis. J Rehabil Med. Sep 3 2015; 47(8):675-681.

  75. Lisanby S et al. Daily left prefrontal repetitive transcranial magnetic stimulation (rTMS) in the acute treatment of major depression: clinical predictors of outcome in a multisite, randomized, controlled clinical trial. Neuropsychopharmacology. 2009 Jan; 34(2):522-34.

  76. Loo C, Mitchell P, Sachdev P, et al. Double –blind controlled investigation of transcranial magnetic stimulation for the treatment of resistant major depression. Am J Psychiatry 1999; 156(6):946-948.

  77. Loo CK and Mitchell PB. A review of the efficacy of transcranial magnetic stimulation (TMS) treatment for depression, and current and future strategies to optimize efficacy. J Affect Disorder, November 2005; 88(3): 255-267.

  78. Loo CK, Mitchell PB, et al. Double-blind controlled investigation of bilateral prefrontal transcranial magnetic stimulation for the treatment of resistant major depression. Psychol Med, January 2003; 33(1): 33-40.

  79. Loo CK, et al. A review of the safety of repetitive transcranial magnetic stimulation as a clinical treatment for depression. International Journal of Neuropsychopharmacology, February 2008; 11(1):131-147.

  80. Maestu C, Blanco M, Nevado A, et al. Reduction of pain thresholds in fibromyalgia after very low-intensity magnetic stimulation: A double-blinded, randomized placebo-controlled clinical trial. Pain Res Manag. Nov-Dec 2013; 18(6):e101-106.

  81. Mantovani A, Aly M, Dagan Y, et al. Randomized sham controlled trial of repetitive transcranial magnetic stimulation to the dorsolateral prefrontal cortex for the treatment of panic disorder with comorbid major depression. J Affect Disord. Jan 10 2013;144(1-2):153-159.

  82. Mantovani A, Simpson HB, et al. Randomized sham-controlled trial of repetitive transcranial magnetic stimulation in treatment-resistant obsessive-compulsive disorder. Int J Neuropsychopharmacol, August 2009; 1-11.

  83. 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. 2013 Feb; 13(2):131-45.

  84. Martin JL, Barbanoj MJ, Schlaepfer TE, et al. Transcranial magnetic stimulation for treating depression. Cochrane Database Syst Rev 2002; (2): CD003493.

  85. Martin JL, Barbanoj MJ, Schlaepfer TE, et al. Repetitive transcranial magnetic stimulation for the treatment of depression. Systematic review and meta-analysis. Br J Psychiatry 2003; 182:480-491.

  86. Martin JLR. Transcranial magnetic stimulation for treating depression (Cochrane Review). Cochrane Library, Issue 4, 2002. Oxford.

  87. McClintock SM, Reti IM, Carpenter LL et al. Consensus Recommendations for the Clinical Application of Repetitive Transcranial Magnetic Stimulation (rTMS) in the Treatment of Depression. J Clin Psychiatry, 2017 May 26;79(1).

  88. 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, July 2007; 11(24): 1-54.

  89. Miniussi C, Bonato C, et al. Repetitive transcranial magnetic stimulation (rTMS) at high and low frequency: an efficacious therapy for major drug-resistant depression? Clin Neurophysiol 2005; 116(5): 1052-71.

  90. Mitchell PB and Loo CK. Transcranial magnetic stimulation for depression. Aust N Z J Psychiatry 2006; 40(5): 406-13.

  91. Miyasaki JM, Shannon K, Voon V et al. Practice Parameter: evaluation and treatment of depression, psychosis, and dementia in Parkinson disease (an evidence-based review): report of the Quality Standards Subcommittee of the American Academy of Neurology. Neurology 66(7):996-1002. [Practice Guideline]. 2006; 2006/04/12. www.neurology.org/content/66/7/996.full.pdf+html. Last accessed April, 2014.

  92. 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, March 2008; 38(3): 319-321.

  93. Mosimann UP, Schmitt W, Greenberg BD, et al. Repetitive transcranial magnetic stimulation: A putative add-on treatment for major depression in elderly patients. Psychiatry Res, April 2004; 126(2): 123-33.

  94. Murphy TK, Lewin AB, Storch EA, et al. Practice parameter for the assessment and treatment of children and adolescents with tic disorders. J Am Acad Child Adolesc Psychiatry. Dec 2013;52(12):1341-1359.

  95. Myczkowski ML, Dias AM, Luvisotto T et al. Effects of repetitive transcranial magnetic stimulation on clinical, social, and cognitive performance in postpartum depression. Neuropsychiatr Dis Treat 2012; 8:491-500.

  96. Miyasaki JM, Shannon K, Voon V, et al. Practice Parameter: evaluation and treatment of depression, psychosis, and dementia in Parkinson disease (an evidence-based review): report of the Quality Standards Subcommittee of the American Academy of Neurology. Neurology. Apr 11 2006;66(7):996-1002.

  97. National Institute for Health and Care Excellence (NICE). Repetitive transcranial magnetic stimulation for depression [IPG542]. 2015; www.nice.org.uk/guidance/ipg542. Accessed September 24, 2019.

  98. National Institute for Health and Care Excellence (NICE). Transcranial magnetic stimulation for treating and preventing migraine [IPG477]. 2014; www.nice.org.uk/guidance/ipg477. Accessed September 24, 2019.

  99. National Institute for Health and Clinical Excellence (NICE). Transcranial magnetic stimulation for severe depression. Interventional Procedure Guidance 242. London, UK, 2007.

  100. National Institute for Health and Care Excellence. Interventional Procedure Guideline (IPG) 214 Transcranial magnetic stimulation for severe depression. 2007. publications.nice.org.uk/transcranial-magnetic-stimulation-for-severe-depression-ipg242.

  101. National Institute for Health and Care Excellence. Clinical Practice Guideline (CG) 90 Depression in adults: The treatment and management of depression in adults. 2009. publications.nice.org.uk/depression-in-adults-cg90.

  102. National Institute for Health and Care Excellence. Bipolar disorder: The management of bipolar disorder in adults, children and adolescents, in primary and secondary care. 2006. www.nice.org.uk/nicemedia/live/10990/30194/30194.pdf.

  103. Nonpharmacologic interventions for treatment-resistant depression in adults. Comparative effectiveness review no. 33. Agency for Healthcare Research and Quality. September 2011. Available at www.effectivehealthcare.ahrq.gov/search-for-guides-reviews-and -reports/?pageaction=displayproduct&productID=792.

  104. Nonpharmacologic interventions for treatment-resistant depression: supplementary data and analyses to the comparative effectiveness review of the Agency for Healthcare Research and Quality. England Comparative Effectiveness Public Advisory Council (CEPAC). December 2011. Available at: cepac.icer-review.org/wp-content/uploads/2011/04/final-report-trd_final2.pdf.

  105. O'Connell NE, Wand BM, Marston L, et al. Non-invasive brain stimulation techniques for chronic pain. Cochrane Database Syst Rev. 2014; 4:CD008208.

  106. O'Connell NE, Marston L, Spencer S et al. Non-invasive brain stimulation techniques for chronic pain. Cochrane Database Syst Rev, 2018 Apr 14;4:CD008208. 

  107. 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, December 2007; 62(11): 1208-1216.

  108. Pascual-Leone A, Rubio B, Pallardo F, et al. Rapid-rate transcranial magnetic stimulation of left dorsolateral prefrontal cortex in drug-resistant depression. Lancet 1996; 348(9022):233-237.

  109. Rabey JM, Dobronevsky E, Aichenbaum S et al. Repetitive transcranial magnetic stimulation combined with cognitive training is a safe and effective modality for the treatment of Alzheimer's disease: a randomized, double-blind study. J Neural Transm (Vienna). 2013 May; 120(5):813-9.

  110. Richieri R, Guedj E, Michel P et al. Maintenance transcranial magnetic stimulation reduces depression relapse: a propensity-adjusted analysis. J Affect Disord 2013; 151(1):129-35.

  111. 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, December 2006; 9(6): 667-676.

  112. Rosenberg O, Gersner R, Klein LD et al. Deep transcranial magnetic stimulation add-on for the treatment of auditory hallucinations: a double-blind study. Ann Gen Psychiatry 2012; 11:13.

  113. Rossini D, Lucca A, et al. Transcranial magnetic stimulation in treatment-resistant depressed patients: A double-blind, placebo-controlled trial. Psychiatry Res 2005; 137(1-2): 1-10.

  114. Rossini D, Magri L, Lucca A, et al. Does rTMS hasten the response to escitalopram, sertraline, or venlafaxine in patients with major depressive disorder? A double-blind, randomized, sham-controlled trial. J Clin Psychiatry, December 2005; 66(12): 1569-1575.

  115. Rumi DO, Gattaz WF, Rigonatti SP, Rosa MA, et al. Transcranial magnetic stimulation accelerates the antidepressant effect of amitriptyline in severe depression: A double-blind placebo-controlled study. Biol Psychiatry, January 2005; 57(2): 162-166.

  116. Sachdev PS, Loo CK, Mitchell PB, McFarquhar TF and Malhi GS. Repetitive transcranial magnetic stimulation for the treatment of obsessive compulsive disorder:  Double-blind controlled investigation. Psychol Med, November 2007; 37(11): 1645-1649.

  117. Saltychev M, Laimi K. Effectiveness of repetitive transcranial magnetic stimulation in patients with fibromyalgia: a meta-analysis. Int J Rehabil Res. Mar 2017; 40(1):11-18.

  118. 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, January 2009; 39(1): 65-75.

  119. Seniow J, Bilik M, Lesniak M et al. Transcranial magnetic stimulation combined with physiotherapy in rehabilitation of poststroke hemiparesis: a randomized, double-blind, placebo-controlled study. Neurorehabil Neural Repair 2012; 26(9):1072-9.

  120. Shirota Y, Ohtsu H, Hamada M et al. Supplementary motor area stimulation for Parkinson disease: a randomized controlled study. Neurology 2013; 80(15):1400-1405.

  121. 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.

  122. Slotema CW, Aleman A, Daskalakis ZJ et al. Meta-analysis of repetitive transcranial magnetic stimulation in the treatment of auditory verbal hallucinations: update and effects after one month. Schizophr Res 2012; 142(1-3):40-5.

  123. Slotema CW, et al. Should we expand the toolbox of psychiatric treatment methods to include repetitive transcranial magnetic stimulation (rTMS)? A meta-analysis of the efficacy of rTMS in psychiatric disorders. Journal of Clinical Psychiatry, July 2010; 71(7):873-884.

  124. Storch EA, De Nadai AS, Conceição do Rosário M et al. Defining clinical severity in adults with obsessive-compulsive disorder. Compr Psychiatry, 2015 Nov 12;63:30-5. 

  125. Sun W, Mao W, Meng X et al. Low-frequency repetitive transcranial magnetic stimulation for the treatment of refractory partial epilepsy: a controlled clinical study. Epilepsia 2012; 53(10):1782-1789.

  126. Thase M, Demitrac M. Evaluating clinical significance of treatment outcomes in studies of resistant major depression. Biological’Psychiatry April 2008; vol 63:7s pg 138s.

  127. Tranulis C, Sepehry AA Galinowski A and Stip E. Should we treat auditory hallucinations with repetitive transcranial magnetic stimulation? A metaanalysis.  Can J Psychiatry, September 2008; 53(9): 577-586.

  128. Trevizol AP, Shiozawa P, Cook IA, et al. Transcranial magnetic stimulation for obsessive-compulsive disorder: an updated systematic review and meta-analysis. J ECT. Dec 2016; 32(4):262-266.

  129. Trevizol AP, Barros MD, Silva PO, et al. Transcranial magnetic stimulation for posttraumatic stress disorder: an updated systematic review and meta-analysis. Trends Psychiatry Psychother. Jan-Mar 2016; 38(1):50-55.

  130. 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.

  131. Ullrich H, Kranaster L, Sigges E et al. 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 2012; 66(3):141-8.

  132. U.S. Food and Drug Administration. 510(k) Summary: Brainsway deep TMS System. 2013. www.accessdata.fda.gov/cdrh_docs/pdf12/k122288.pdf.

  133. U.S. Food and Drug Administration. De Novo classification request for cerena transcranial magnetic stimulator (TMS) device. 2013; www.accessdata.fda.gov/cdrh_docs/reviews/K130556.pdf.

  134. Walpoth M, Hoertnagl C, Mangweth-Matzek B, et al. Repetitive transcranial magnetic stimulation in bulimia nervosa: Preliminary results of a single-centre, randomized, double-blind, sham-controlled trial in female outpatients. Psychother Psychosom 2008; 77(1): 57-60.

  135. Watts BV, Landon B, Groft A et al. A sham controlled study of repetitive transcranial magnetic stimulation for posttraumatic stress disorder. Brain Stimul 2012; 5(1):38-43.

  136. Weaver L, Rostain AL, Mace W et al. Transcranial magnetic stimulation (TMS) in the treatment of attention-deficit/hyperactivity disorder in adolescents and young adults: a pilot study. J ECT 2012; 28(2):98-103.

  137. Yang YR, Tseng CY, Chiou SY et al. Combination of rTMS and treadmill training modulates corticomotor inhibition and improves walking in Parkinson disease: a randomized trial. Neurorehabil Neural Repair 2013; 27(1):79-86.

  138. Zhang Y, Liang W, Yang S, et al. Repetitive transcranial magnetic stimulation for hallucination in schizophrenia spectrum disorders: A meta-analysis. Neural Regen Res. Oct 5 2013; 8(28):2666-2676.

  139. Zhang L, Xing G, Fan Y, et al. Short- and long-term effects of repetitive transcranial magnetic stimulation on upper limb motor function after stroke: a systematic review and meta-analysis. Clin Rehabil. Sep 2017;31(9):1137-1153.

 

 

POLICY HISTORY:

Medical Policy Group, June 2004 (4)

Medical Policy Administration Committee, July 2004

Available for comment July 12-August 25, 2004

Medical Policy Group, June 2006 (1)

Medical Policy Group, June 2008 (1)

Medical Policy Group, November 2008 (1)

Medical Policy Group, January 2010 (1)

Medical Policy Group, December 2010: Key Points, References, 2011 Code updates

Medical Policy Group, January 2011: Description, Key Points, References

Medical Policy Group, November 2011 (3): Added new CPT Code 90869 and updated verbiage on 90867 and 90868 effective 1/1/12

Medical Policy Group, January 2012 (1): Update to Key Points and References related to MPP update; no change in policy statement

Medical Policy Panel, January 2013.

Medical Policy Group, January 2013 (3):  2013 Updates: Key Points and References.  Policy statement remains unchanged.

Medical Policy Group, July 2013 (2): 2013 Updates to Key Points and References.

Medical Policy Panel, June 2014.

Medical Policy Group, July 2014 (5):  2014 update to Policy Statement to provide coverage for severe major depressive disorder (single or recurrent) when certain criteria is met; Updates: Description, Key Points, Governing Bodies, and References to support policy statement.

Medical Policy Administration Committee, July 2014.

Available for comment July 17 through September 1, 2014

Medical Policy Panel, December 2014

Medical Policy Group, December 2014 (5): Updates to Key Points and References.  No change to policy statement.

Medical Policy Panel, December 2015

Medical Policy Group, December 2015 (6):  Updates to Description, Key Points, Approved by Governing Bodies, Coding and References; no change in policy statement.

Medical Policy Group, March 2017 (6): Added “prescribed” to physician statement and “d. The

 

 

 

 

 

 

who should be present during rTMS, under policy criteria.

Medical Policy Panel, July 2017

Medical Policy Group, July 2017 (6): Updates to Key Points, Governing Bodies, Practice Guidelines, Key Words and References.

Medical Policy Panel, October 2018

Medical Policy Group, November 2018 (3): Updates to Key Points, Governing Bodies, Practice Guidelines, References, and Key Words: added: MagVita TMS Therapy System with Theta Burst Stimulation and Deep TMS System. Title change to Policy. No changes to policy statement or intent.

Medical Policy Group, September 2019 (3): 2019 Updates to Key Points. Removed criteria from policy guidelines that requires the physician to administer the subsequent/daily rTMS treatment. No other changes to policy statement or intent.

Medical Policy Panel, October 2019

Medical Policy Group, November 2019 (3): 2019 Updates to Key Points, Practice Guidelines and Position Statements, Approved by Governing Bodies, References and added Key Words: sTMS Mini System and SpringTMS™ Total Migraine System. No changes to policy statement or intent.

 

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

 

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

 

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.