Latest Review Date: October 2024

Category: Medical                                                           

POLICY:

Effective for dates of service April 15, 2023, and after:

Transcranial magnetic stimulation (TMS) of the brain using an FDA-cleared device and modality* may be considered medically necessary as a treatment of major depressive disorder when all 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

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

a. The individual has tried and had an inadequate response to 2 antidepressant agents from 2 different antidepressant classes (i.e., selective serotonin reuptake inhibitors, serotonin and norepinephrine reuptake inhibitors, tricyclic antidepressants, bupropion, or mirtazapine). An adequate trial of an antidepressant is defined by both of the following:

1. The trial length was at least 6 weeks at generally accepted doses or of sufficient duration as determined by the treating physician at the generally accepted doses; and
2. Individual was ≥80% adherent to the agent during the trial.

b. Inability to tolerate a therapeutic dose of medications due to distinct side effects; or

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

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

3. 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** (e.g., Becks Depression Inventory, Zung Self-Rating Depression Scale, PHQ-9, Hamilton Depression Rating Scale, or Montgomery-Asberg Depression Rating Scale (MADRS) that reliably measure depressive symptoms; and

4. Treatment consists of a maximum of 30 sessions (5 days a week for 6 weeks) plus 6 tapering sessions (6 sessions over three weeks).

TMS for major depressive disorder that does not meet the criteria listed above is considered investigational.

Continued treatment with TMS of the brain as maintenance therapy is considered investigational.

Accelerated treatment with TMS of the brain is considered investigational.

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

POLICY GUIDELINES:

Transcranial magnetic stimulation (TMS) should be performed using a U.S. Food and Drug Administration cleared device appropriately selected patients over the age 18 years old, by health care professionals who are adequately trained and experienced in the specific techniques used.

*A variety of TMS modalities have been developed, which differ on parameters including stimulation intensity, frequency, pattern, and site of the brain stimulation.

**The TMS provider must review and maintain the following clinical documentation in the patient record:

• Provider who administered the psychotherapy
• Type, frequency and duration of psychotherapy
• Failed psychotherapy documentation as noted by standardized rating scales
• Failed medication trials in the medical record

In conventional TMS, high frequency stimulation is delivered over the left dorsolateral prefrontal cortex (DLPFC) or low frequency stimulation over the right DLPFC.

In bilateral TMS, both procedures are performed in the same session.

Theta burst stimulation is administered at lower intensities and at shorter intervals than conventional TMS.

Deep TMS employs an H-coil helmet designed to encompass a broader surface area and stimulate deeper brain structures than conventional TMS.

A treatment course of conventional TMS usually does not exceed 5 days a week for 6 weeks (total of 30 sessions), however the treatment plan can be individualized depending on the type of device used, safety and side effect considerations and response to treatment.

Contraindications to repetitive TMS 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 repetitive TMS:

a. 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

b. Adequate resuscitation equipment including, e.g., suction and oxygen; and

c. The facility must maintain awareness of response times of emergency services (either fire/ambulance or “code team”), which should be available within 5 minutes. These relationships are reviewed on at least a 1-year basis and include mock drills.

Effective for dates of service September 30, 2019 through April 14, 2023:

Transcranial magnetic stimulation (TMS) of the brain using an FDA-cleared device and modality* 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

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

a. The individual has tried and had an inadequate response to 2 antidepressant agents from 2 different antidepressant classes (i.e., selective serotonin reuptake inhibitors, serotonin and norepinephrine reuptake inhibitors, tricyclic antidepressants, bupropion, or mirtazapine). An adequate trial of an antidepressant is defined by BOTH of the following:

1. The trial length was at least 6 weeks at generally accepted doses or of sufficient duration as determined by the treating physician at the generally accepted doses; and

2. Individual was ≥80% adherent to the agent during the trial.

b. Inability to tolerate a therapeutic dose of medications due to distinct side effects; or

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

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

3. 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 (e.g., Becks Depression Inventory, Zung Self-Rating Depression Scale, PHQ-9, Hamilton Depression Rating Scale, or Montgomery-Asberg Depression Rating Scale (MADRS) that reliably measure depressive symptoms.

TMS for major depressive disorder that does not meet the criteria listed above is considered investigational.

Continued treatment with TMS of the brain as maintenance therapy is considered investigational.

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

POLICY GUIDELINES:

Transcranial magnetic stimulation (TMS) should be performed using a U.S. Food and Drug Administration cleared device appropriately selected patients over the age 18 years old, by health care professionals who are adequately trained and experienced in the specific techniques used.

* A variety of TMS modalities have been developed, which differ on parameters including stimulation intensity, frequency, pattern, and site of the brain stimulation.

In conventional TMS, high frequency stimulation is delivered over the left dorsolateral prefrontal cortex (DLPFC) or low frequency stimulation over the right DLPFC.

In bilateral TMS, both procedures are performed in the same session.

Theta burst stimulation is administered at lower intensities and at shorter intervals than conventional TMS.

Deep TMS employs an H-coil helmet designed to encompass a broader surface area and stimulate deeper brain structures than conventional TMS.

A treatment course of conventional TMS usually does not exceed 5 days a week for 6 weeks (total of 30 sessions), however the treatment plan can be individualized depending on the type of device used, safety and side effect considerations and response to treatment.

Theta burst stimulation may be administered using an accelerated protocol. One example of an accelerated theta burst protocol is the Stanford Accelerated Intelligent Neuromodulation Therapy (SAINT) protocol, consisting of 10 daily sessions over 5 consecutive days.

Contraindications to repetitive TMS 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 repetitive TMS:

a. 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

b. Adequate resuscitation equipment including, e.g., suction and oxygen; and

c. The facility must maintain awareness of response times of emergency services (either fire/ambulance or “code team”), which should be available within 5 minutes. These relationships are reviewed on at least a 1-year basis and include mock drills.

DESCRIPTION OF PROCEDURE OR SERVICE:

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

Transcranial Magnetic Stimulation

Transcranial magnetic stimulation (TMS), introduced in 1985 as a new method of noninvasive stimulation of the brain, involves placement of a small coil over the scalp, passing a rapidly alternating current through the coil wire, which produces a magnetic field that passes unimpeded through the scalp and bone, resulting in electrical stimulation of the cortex. Transcranial magnetic stimulation was initially used to investigate nerve conduction (e.g., TMS over the motor cortex will produce a contralateral muscular-evoked potential). The motor threshold, which is the minimum intensity of stimulation required to induce a motor response, is empirically determined for each person by localizing the site on the scalp for optimal stimulation of a hand muscle, then gradually increasing the intensity of stimulation. Interest in the use of TMS as a treatment for depression was augmented by the development of a device that could deliver rapid, repetitive stimulation. Imaging studies had shown a decrease in the activity of the left dorsolateral prefrontal cortex in depressed patients, and early studies suggested that high frequency (e.g., 5 to 10 Hz) TMS of the left dorsolateral prefrontal cortex had antidepressant effects. In contrast to electroconvulsive therapy (ECT), TMS does not require general anesthesia and does not generally induce a convulsion. Repetitive TMS (rTMS) is also being tested as a treatment for a variety of other psychiatric and neurologic disorders.

Conventional rTMS delivers repeated electromagnetic pulses to induce prolonged modulation of neural activity, typically applied over the dorsolateral prefrontal cortex. High-frequency rTMS (usually ≥10 Hz) induces an increase in neural activity whereas low-frequency rTMS (usually ≤1 Hz) has the opposite effect. If both procedures are performed in the same session, the intervention is described as bilateral rTMS.

A variety of TMS modalities have been developed, which differ on parameters including stimulation intensity, frequency, pattern, and site of the brain stimulation. Deep TMS employs an H-coil helmet design to encompass a broader surface area and stimulate deeper brain structures than conventional TMS. Theta burst stimulation is administered at lower intensities and shorter intervals than conventional rTMS.

KEY POINTS:

This evidence review has been updated regularly with searches of the PubMed database. The most recent literature update was performed through August 12, 2024.

Summary of Evidence

For individuals who have treatment-related depression (TRD) who receive transcranial magnetic stimulation (TMS), the evidence includes a large number of 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. Meta-analyses concluded that the effect of rTMS on average depression score is smaller than the effect of electroconvulsive (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 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 no inferiority 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 an improvement in the net health outcome.

For individuals who have migraine headaches who receive TMS, the evidence includes a systematic review (n=8 trials) and a sham-controlled RCT of 201 patients conducted for submission to the FDA for clearance in 2013. Relevant outcomes are symptoms, functional outcomes, and quality of life. The systematic review found that rTMS reduced migraine pain intensity and frequency compared to sham; it was unclear whether patients were receiving background pharmacotherapy. 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 that the technology results in an improvement in the net health outcome.

For individuals who have obsessive-compulsive disorder who receive TMS, the evidence includes a number of small-to-moderate sized, sham-controlled, double-blind RCTs and meta-analyses of these studies. Relevant outcomes are symptoms, functional outcomes, and quality of life. A meta-analysis of 15 RCTs (N=483 patients, range 18-to 65 patients) conducted in 2016 found a benefit of TMS 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 meta-analysis conducted in 2021 included 26 RCTs. The primary analysis found a significant effect of rTMS compared to sham on OCD symptoms, but the effect seemed to last only until 4 weeks after the last treatment. The RCT that was the basis of FDA clearance of deep TMS for treatment of OCD compared deep TMS to sham in 99 patients for 6 weeks, with an additional 4 weeks of follow-up as a secondary outcome. Using a modified intention-to-treat (ITT) analysis (n=94), there was a larger mean decrease from baseline (improvement) on the Yale-Brown Obsessive Compulsive Scale (YBOCS) score (the primary efficacy outcome) 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=.003), as measured by a 30% or greater increase 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 TMS 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 that the technology results in an improvement in the net health outcome.

For individuals who have psychiatric or neurological disorders other than depression, migraine, or OCD (e.g., bipolar disorder, generalized anxiety disorder, substance use disorder and craving, amyotrophic lateral sclerosis, chronic pain, epilepsy, fibromyalgia, Parkinson disease, stroke recovery) who receive TMS, the evidence includes numerous small RCTs and meta-analyses of these randomized trials. Relevant outcomes are symptoms, functional outcomes, and quality of life. The trials included in the meta-analyses are typically small and of low methodologic quality. In addition, stimulation parameters have not been established, and trial results are heterogeneous. There are no large, high-quality trials for any of these conditions demonstrating efficacy or the durability of any treatment effects. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have TRD who receive theta burst stimulation of the brain with accelerated therapy, the evidence includes only two studies. Both studies were done with insufficient sample sizes to establish effectiveness and neither study was done for an adequate length of time to demonstrate durability. The first study demonstrated that the participants knew that they were receiving the SNT/SAINT treatment and was done without a comparison group receiving a sham version of the treatment. The second study included a comparison group that received a sham version of the treatment, but only 29 patients finished the study, which was not a sufficient sample size to establish effectiveness. Finally, only a small percentage of all potential subjects were screened, suggesting the possibility of selection bias. Additional trials with sufficient sample size and follow-up duration are needed to determine that the technology results in an improvement in the net health outcome.

Practice Guidelines and Position Statements

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.

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.”

Veteran's Affairs/Department of Defense

The 2022 Veteran's Affairs/Department of Defense guideline for management of major depressive disorder recommends offering rTMS to patients who have experienced partial response or no response to an adequate trial of 2 or more pharmacologic treatments(strength of recommendation: weak). Recommended options for the second treatment attempt after the initial therapy tried include switching to another antidepressant or adding augmentation therapy with a second-generation antipsychotic. The recommendation for rTMS was graded as weak due to limitations of the available literature including small study effects, high rates of discontinuation, lack of allocation concealment, and the practical limitations of the need for daily treatment and lack of widespread access to facilities that offer this therapy. The guideline also concluded that there is limited evidence to recommend for or against theta-burst stimulation for treatment of depression.

The 2023 VA/DoD guideline for management of bipolar disorder states "for individuals with bipolar disorder who have demonstrated partial or no response to pharmacologic treatment for depressive symptoms, we suggest offering repetitive transcranial magnetic stimulation [rTMS] as an adjunctive treatment.", However, the recommendation was rated as "weak" and the confidence in the evidence was very low. For the management of PTSD, the 2023 guideline found insufficient evidence for or against rTMS.

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.

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.

In 2020, the NICE stated that rTMS has not demonstrated any major safety concerns for management of obsessive-compulsive disorder or auditory hallucinations, but evidence for both uses is lacking; therefore, NICE recommends that rTMS be used in patients with these conditions only in the context of research.

International Neuromodulation Society/North American Neuromodulation Society

In 2020, an expert consensus panel from the International Neuromodulation Society-North American Neuromodulation Society performed a literature review and published recommendations for transcranial magnetic stimulation in the treatment of pain and headache. For neuropathic pain, the panel recommended transcranial magnetic stimulation to the primary motor cortex (high level evidence) or the left dorsolateral prefrontal cortex (F3 location) (at least moderate level evidence). The panel recommended that transcranial magnetic stimulation to the F3 location be only selectively offered for postoperative pain, due to at least moderate certainty that the net benefit is small. For primary headache, the panel only based 2 recommendations on moderate certainty evidence: single transcranial magnetic stimulation for acute migraine and high-frequency rTMS to the primary motor cortex for migraine prevention. For posttraumatic brain injury, high level evidence supported a recommendation for high-frequency transcranial magnetic stimulation to the primary motor cortex or the F3 location.

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, Horizon TMS Therapy System (Theta Burst Protocol), ALTMS Magnetic Stimulation Therapy System, Savi Dual™ Migraine Therapy

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 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. Some of these devices use deep TMS or theta burst protocols. For example, the Brainsway Deep TMS system was FDA cleared for treatment-resistant depression in 2013 based on substantial equivalence to the Neurostar TMS Therapy System, and the Horizon (Magstim) and MagVita (Tonica Elektronik) have FDA clearance for their theta burst protocols.

Indications were expanded to include treating pain associated with certain migraine headaches in 2013, and obsessive-compulsive disorder in 2018.

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. 

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.

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.

Table 1 lists some devices that are FDA cleared for major depressive disorder, migraine headache pain, and obsessive-compulsive disorder.

Table 1. Transcranial Magnetic Stimulation Devices Cleared by the U.S. Food and Drug Administration for Major Depression, Migraine, or Obsessive-Compulsive Disorder

Device	Manufacturer	Indication	FDA Clearance No.	FDA Clearance Date
Savi Dual™ Migraine Therapy	ENeura	Migraine (acute and prophylactic treatment in individuals ≥12 years of age)	K230358	05/16/2023
Horizon 3.0 TMS Therapy System	Magstim	Major depressive disorder and obsessive-compulsive disorder	K222171	01/13/2023
ALTMS Magnetic Stimulation Therapy System	REMED Co., Ltd	Major Depressive disorder	K220625	04/06/2022
Neurostar	Neuronetics	Major Depressive Disorder	K083538	102/16/208
		Obsessive-Compulsive Disorder	K212289	05/06/2022
Brainsway Deep TMS system	Brainsway	Major Depressive Disorder	K122288	01/07/2013
		Obsessive-Compulsive Disorder	K183303	03/08/2019
Springtms Total Migraine System	Enerua	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
Mag Vita TMS Therapy System w/Theta Burst Stimulation	Tonica Elektronik	Major Depressive Disorder	K173620	08/14/2018
Neurosoft	TeleEMG	Major Depressive Disorder	K160309	12/22/2016
Horizon	Magstim	Major Depressive Disorder	K171051	09/13/2017
Horizon TMS Therapy System (Theta Burst Protocol)	Magstim	Major Depressive Disorder	K182853	03/15/2019
Nexstim	Nexstim	Major Depressive Disorder	K171902	11/10/2017
Apollo	Mag & More	Major Depressive Disorder	K180313	05/04/2018

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: Special benefit consideration may apply.  Refer to member’s benefit plan.

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.
0889T	Personalized target development for accelerated, repetitive high-dose functional connectivity MRI–guided theta-burst stimulation derived from a structural and resting-state functional MRI, including data preparation and transmission, generation of the target, motor threshold–starting location, neuronavigation files and target report, review and interpretation. (Effective 7/1/24)
0890T	Accelerated, repetitive high-dose functional connectivity MRI–guided theta-burst stimulation, including target assessment, initial motor threshold determination, neuronavigation, delivery and management, initial treatment day.  (Effective 7/1/24)
0891T	Accelerated, repetitive high-dose functional connectivity MRI–guided theta-burst stimulation, including neuronavigation, delivery and management, subsequent treatment day. (Effective 7/1/24)
0892T	Accelerated, repetitive high-dose functional connectivity MRI–guided theta-burst stimulation, including neuronavigation, delivery and management, subsequent motor threshold redetermination with delivery and management, per treatment day. (Effective 7/1/24)

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

REFERENCES:

1. Alphs L, Fu D-J, Williamson D, et al. Validation and mapping of the Suicidal Ideation and Behavior Assessment Tool (SIBAT). (abstract W88) Neuropsychopharmacology. 2018; 43: S427S428.
2. Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). Transcranial magnetic stimulation for depression. TEC Assessments 2011; Volume 26, Tab 3.
3. Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). Transcranial magnetic stimulation for depression. TEC Assessments. 2013;Volume 28, Tab 9.
4. 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.
5. Brown R, Cherian K, Jones K, et al. Repetitive transcranial magnetic stimulation for post-traumatic stress disorder in adults. Cochrane Database Syst Rev. Aug 02 2024; 8(8): CD015040.
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8. Center for Drug Evaluation and Research Application Number: 211243Orig1s000 Summary Review www.accessdata.fda.gov/drugsatfda_docs/nda/2019/211243Orig1s000SumR.pdf.
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11. 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.
12. Cole EJ, Stimpson KH, Bentzley BS, et al. Stanford Accelerated Intelligent Neuromodulation Therapy for treatment-resistant depression. American Journal of Psychiatry. 2020; 177(8): 716-726.
13. Cole EJ, Phillips AL, Bentzley BS, et al. Stanford Accelerated Intelligent Neuromodulation Therapy (SNT): a double-blind randomized controlled trial. American Journal of Psychiatry. 2022 ; 179(2) : 132-141.
14. 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.
15. Cui H, Jiang L, Wei Y, et al. Efficacy and safety of repetitive transcranial magnetic stimulation for generalised anxiety disorder: A metaanalysis. Gen Psychiatr. 2019; 32(5): e100051.
16. 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.
17. Dougall N, Maayan N, Soares-Weiser K, et al. Transcranial magnetic stimulation (TMS) for schizophrenia. Cochrane Database Syst Rev. 2015; 8:CD006081.
18. 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.
19. 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.
20. 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).
21. FDA Briefing Document Psychopharmacologic Drugs Advisory Committee (PDAC) and Drug Safety and Risk Management (DSaRM) Advisory Committee Meeting February 12, 2019. www.natap.org/2019/newsUpdates/PDAC_DSaRM-2122019-FDABackgrounder.pdf
22. Food and Drug Administration. 510(k) Summary: Brainsway deep TMS System (K122288). 2013; www.accessdata.fda.gov/cdrh_docs/pdf12/K122288.pdf.
23. 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.
24. Goodman WK, Price LH, Rasmussen SA, et al. The Yale-Brown Obsessive Compulsive Scale. I. Development, use, and reliability. Arch Gen Psychiatry. Nov 1989; 46(11): 1006-11.
25. 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.
26. Guan HY, Zhao JM, Wang KQ, et al. High-frequency neuronavigated rTMS effect on clinical symptoms and cognitive dysfunction: a pilot double-blind, randomized controlled study in Veterans with schizophrenia. Transl Psychiatry. Feb 25 2020; 10(1): 79.
27. Hao Z, Wang D, Zeng Y et al. Repetitive transcranial magnetic stimulation for improving function after stroke. Cochrane Database Syst Rev 2013; 5:CD008862.
28. 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.
29. 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.
30. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
31. 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.
32. 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.
33. Jiang X, Yan W, Wan R, et al. Effects of repetitive transcranial magnetic stimulation on neuropathic pain: A systematic review and meta-analysis. Neurosci Biobehav Rev. Jan 2022; 132: 130-141.
34. 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.
35. Konstantinou G, Hui J, Ortiz A, et al. Repetitive transcranial magnetic stimulation (rTMS) in bipolar disorder: A systematic review. Bipolar Disord. Feb 2022; 24(1): 10-26.
36. Kumar N, Vishnubhatla S, Wadhawan AN, et al. A randomized, double blind, sham-controlled trial of repetitive transcranial magnetic stimulation (rTMS) in the treatment of negative symptoms in schizophrenia. Brain Stimul. May 2020; 13(3): 840-849.
37. 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.
38. 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.
39. Leung A, Shirvalkar P, Chen R, et al. Transcranial Magnetic Stimulation for Pain, Headache, and Comorbid Depression: INS-NANS Expert Consensus Panel Review and Recommendation. Neuromodulation. Apr 2020; 23(3): 267-290.
40. Li H, Wang J, Li C, et al. Repetitive transcranial magnetic stimulation (rTMS) for panic disorder in adults. Cochrane Database Syst Rev. 2014; 9:CD009083.
41. Li R, He Y, Qin W, et al. Effects of Repetitive Transcranial Magnetic Stimulation on Motor Symptoms in Parkinson's Disease: A Meta-Analysis. Neurorehabil Neural Repair. Jul 2022; 36(7): 395-404.
42. 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.
43. Liang K, Li H, Bu X, et al. Efficacy and tolerability of repetitive transcranial magnetic stimulation for the treatment of obsessive-compulsive disorder in adults: a systematic review and network meta-analysis. Transl Psychiatry. May 28 2021; 11(1): 332.
44. 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.
45. 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.
46. 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.
47. 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. Jan/Feb 2018; 79(1).
48. Mishra A, Maiti R, Mishra BR, et al. Effect of Repetitive Transcranial Magnetic Stimulation on Seizure Frequency and Epileptiform Discharges in Drug-Resistant Epilepsy: A Meta-Analysis. J Clin Neurol. Jan 2020; 16(1): 9-18.
49. 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.
50. National Institute for Health and Care Excellence (NICE). Transcranial magnetic stimulation for obsessive-compulsive disorder [IPG676]. 2020; www.nice.org.uk/guidance/ipg676.
51. National Institute for Health and Care Excellence (NICE). Transcranial magnetic stimulation for auditory hallucinations [IPG680]. 2020; www.nice.org.uk/guidance/ipg680/chapter/1-Recommendations.
52. National Institute for Health and Care Excellence (NICE). Repetitive transcranial magnetic stimulation for depression[IPG542]. 2015; www.nice.org.uk/guidance/ipg542.
53. National Institute for Health and Care Excellence (NICE). Transcranial magnetic stimulation for treating and preventing migraine [IPG477]. 2014; www.nice.org.uk/guidance/ipg477.
54. 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.
55. O'Connell NE, Wand BM, Marston L, et al. Non-invasive brain stimulation techniques for chronic pain. Cochrane Database Syst Rev. 2014; 4:CD008208.
56. Papakostas GI, Trivedi MH, Shelton RC, et al. Comparative effectiveness research trial for antidepressant incomplete and non-responders with treatment resistant depression (ASCERTAIN-TRD) a randomized clinical trial. Mol Psychiatry. Aug 2024; 29(8): 2287-2295.
57. Perera MPN, Mallawaarachchi S, Miljevic A, et al. Repetitive Transcranial Magnetic Stimulation for Obsessive-Compulsive Disorder: A Meta-analysis of Randomized, Sham-Controlled Trials. Biol Psychiatry Cogn Neurosci Neuroimaging. Oct 2021; 6(10): 947-960.
58. Qiao J, Ye QP, Wu ZM, et al. The Effect and Optimal Parameters of Repetitive Transcranial Magnetic Stimulation on Post-stroke Dysphagia: A Meta-Analysis of Randomized Controlled Trials. Front Neurosci. 2022; 16: 845737.
59. 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.
60. 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.
61. Saltychev M, Juhola J. Effectiveness of high-frequency repetitive transcranial magnetic stimulation (rTMS) in migraine - a systematic review and meta-analysis. Am J Phys Med Rehabil. Jan 14 2022.
62. 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.
63. Sehatzadeh Sh, Tu HA, Palimaka S, et al. Repetitive Transcranial Magnetic Stimulation for Treatment-Resistant Depression: ASystematic Review and Meta-Analysis of Randomized Controlled Trials. Ont Health Technol Assess Ser. 2016; 16(5): 1-66.
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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.

Medical Policy Panel, October 2020

Medical Policy Group, November 2020 (3): 2020 Updates to Key Points and References. No changes to policy statement or intent.

Medical Policy Panel, October 2021

Medical Policy Group, October 2021 (3): 2021 Updates to Description, Key Points, Practice Guidelines and Position Statements, Approved By Governing Bodies, References and Key Words: added: Horizon TMS Therapy System (Theta Burst Protocol). Policy clarification made to include all FDA Approved modalities of Transcranial Magnetic Stimulation with descriptions of each therapy and therapy guidelines. Policy statement updated to remove “not medically necessary,” no change in intent.

Medical Policy group, May 2022 (3): Clarification added to define acceptable standardized rating scales for depression in the policy. No changes to policy intent.

Medical Policy Panel, October 2022

Medical Policy Group, November 2022 (3): 2022 Updates to Description, Policy Guidelines, Key Points, Practice Guidelines and Position Statements, Approved By Governing Bodies, and References. Added to Key Words: ALTMS Magnetic Stimulation Therapy System. Minor changes in policy statement that does not change policy intent: Changed “Failure of 4 trials of psychopharmacologic agents including 2 different agent classes and 2 augmentation trials” to “Patient has tried and had an inadequate response to 2 antidepressant agents from 2 different antidepressant classes.”

Medical Policy Group, February 2023 (3): 2023 Updates to Description, Policy Guidelines, Key Points, Benefit Applications, and References. Policy statements added to emphasize the use of conventional therapy and considered the use of accelerated therapy (e.g., SNT/SAINT protocol) investigational.

Medical Policy Administration Committee, March 2023.

Available for comment March 1, 2023 through April 14, 2023.

Medical Policy Panel, October 2023

Medical Policy Group, November 2023 (6): Updates to Policy title: Transcranial Magnetic Stimulation as a Treatment of Depression and Other Psychiatric/Neurologic Disorders, Description, Key Points, Approved by Governing Bodies, Benefit Application and References.

Medical Policy Group, May 2024 (3): Quarterly Coding Update: CPT codes 0889T, 0890T, 0891T, and 0892T are investigational effective 7/1/24  were added to Current Coding Section. No change to the policy statement.     

Medical Policy Panel, October 2024

Medical Policy Group, October 2024 (9): Updates to Key Points, Key Words, Approved by Governing Bodies, and References. No changes to policy statement or intent.

Medical Policy Group, December 2024 (9): Added policy clarification to Policy Guidelines.

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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.