Medicare Advantage

Medical Policy

Notification

Transcranial Magnetic Stimulation (TMS)

Notification Issue Date:

This version of the policy will be issued on 12/02/2024 with a retroactively effective date of 07/01/2024.

The following policy criteria have been revised:

FROM: The individual has demonstrated medication treatment resistance during the current depressive episode as evidenced by lack of a clinically significant response to at least one or more failed trials of psychopharmacologic agents.

TO: The individual has demonstrated a failure of one or more medical trials at adequate dose and duration that are consistent with the FDA label and with a duration that would elicit a favorable response trials of a pharmacological medication.

FROM: The individual has demonstrated a failure of one or more medical trials...
TO: The individual has demonstrated a failure of one or more medication trials...

FROM: The individual has demonstrated a failure of one or more medical trials...
TO: The individual has demonstrated a failure of one or more medication trials...

FROM:

All of the following conditions are absent:

a. Seizure disorder or any history of seizures (except those induced by ECT or isolated febrile seizures in infancy without subsequent treatment or recurrence, or any condition or treatment that may lower the seizure threshold)
b. Presence of acute or chronic psychotic symptoms or disorders (e.g., schizophrenia, schizophreniform disorder, or schizoaffective disorder), in the current depressive episode.
c. 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.
d. Presence of an implanted magnetic-sensitive medical device located less than or equal to 30 cm from the TMS magnetic coil or other implanted metal items (e.g., cochlear implant, implanted cardiac defibrillator [ICD], pacemaker, vagus nerve stimulator [VNS], or metal aneurysm clips or coils, staples or stents) is an absolute contraindication.

TO:

The following absolute contraindication is absent:

Presence of an implanted magnetic-sensitive medical device located less than or equal to 30 cm from the TMS magnetic coil or other implanted metal items (e.g., cochlear implant, implanted cardiac defibrillator [ICD], pacemaker, vagus nerve stimulator [VNS], or metal aneurysm clips or coils, staples or stents) is an absolute contraindication.

Documentation shows that risks and benefits were considered regarding the following relative contraindications:

Seizure disorder or any history of seizures (except those induced by ECT or isolated febrile seizures in infancy without subsequent treatment or recurrence, or any condition or treatment that may lower the seizure threshold)
Presence of acute or chronic psychotic symptoms or disorders (e.g., schizophrenia, schizophreniform disorder, or schizoaffective disorder), in the current depressive episode.
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.

The following policy criteria have been removed:

Pregnancy must be absent
Concomitant esketamine intranasal, ketamine infusion or other infusion therapies for major depressive disorder must be absent

The following service has been added to this policy as medically necessary:

Stanford Neuromodulation Therapy or Stanford Accelerated Intelligent Neuromodulation Therapy (SNT/SAINT)

The following CPT Codes have been added to this policy as medically necessary:

0889T, 0890T, 0891T, 0892T

Title:

Transcranial Magnetic Stimulation (TMS)

Policy #:

MA07.035h

Policy

This policy uses coverage criteria primarily based on applicable Medicare statutes, regulations, NCDs, LCDs, CMS manuals and other applicable Medicare coverage documents. In the absence of fully established coverage criteria from these Medicare coverage documents for a specific medical service or item, the criterion/indication/service indicated by an asterisk below (*) is based on internal coverage criteria developed by the Company in consideration of peer-reviewed medical literature, clinical practice guidelines, regulatory status, and/or expert opinion.

MEDICALLY NECESSARY

TRANSCRANIAL MAGNETIC STIMULATION (TMS) FOR MAJOR DEPRESSIVE DISORDER

Transcranial magnetic stimulation (TMS) administered by an approved US Food and Drug Administration (FDA) device and modality, which can include but is not limited to, conventional TMS, deep TMS, and theta-burst stimulation for individuals 15 years of age or older is considered medically necessary and, therefore, covered for treatment of severe major depressive disorder without psychotic features when ALL of the following criteria are met:

Confirmed diagnosis of major depressive disorder, severe (single or recurrent episode) documented by the current Diagnostic and Statistical Manual of Mental Disorders.
The order for TMS procedure is written by a psychiatrist (MD or DO), who has examined the individual face to face and reviewed the record.
Either of the following has been demonstrated:

The individual has demonstrated a failure of one or more medication trials at adequate dose and duration that are consistent with the FDA label and with a duration that would elicit a favorable response to trials of a pharmacological medication.

The individual has demonstrated an intolerance to psychopharmacologic medications that is not expected to diminish or resolve with continued administration of the medication.

The following absolute contraindication is absent:

Presence of an implanted magnetic-sensitive medical device located less than or equal to 30 cm from the TMS magnetic coil or other implanted metal items (e.g., cochlear implant, implanted cardiac defibrillator [ICD], pacemaker, vagus nerve stimulator [VNS], ferrous, or metal aneurysm clips or coils, staples or stents) is an absolute contraindication.

Documentation shows that risks and benefits were considered regarding the following relative contraindications:

Seizure disorder or any history of seizures (except those induced by ECT or isolated febrile seizures in infancy without subsequent treatment or recurrence, or any condition or treatment that may lower the seizure threshold)

Presence of acute or chronic psychotic symptoms or disorders (e.g., schizophrenia, schizophreniform disorder, or schizoaffective disorder), in the current depressive episode.

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.

When the above medically necessary criteria are met, TMS as treatment of a severe major depressive disorder episode is considered medically necessary and, therefore, covered for up to 30, once-daily treatment sessions over a 6-week period followed by a 3-week tapering period of three TMS treatments in week 1, two TMS treatments the next week, and one TMS treatment in the last week. More than one TMS session per day is not medically necessary.*

When the above medically necessary criteria are met, accelerated theta-burst stimulation (e.g., Stanford Accelerated Intelligent Neuromodulation Therapy [SAINT] protocol ) as initial treatment of severe major depressive disorder is considered medically necessary, and therefore will be covered for at total of 5 treatment days plus target development based on imaging as follows*:

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 (1 session, 0889T)
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 (1 session, 0890T)
Accelerated, repetitive high-dose functional connectivity MRI-guided theta-burst stimulation, including neuronavigation, delivery and management, subsequent treatment day (3 sessions, 0891T)
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 (1 session, 0892T)

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 is inclusive of 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.*

PROFESSIONAL PROVIDER REQUIREMENTS
Services may be covered when all procedures are performed by appropriately trained professional providers in the appropriate setting and all aspects of care are within the scope of practice of the professional provider's professional licensure.

NOT MEDICALLY NECESSARY

The continued treatment of an individual when the maximum therapeutic goals of a treatment plan have been achieved and no additional functional improvement is apparent or expected to occur, is considered not medically necessary, and, therefore, not covered because the provision of services cease to be of therapeutic value.

EXPERIMENTAL/INVESTIGATIONAL

TMS for all other conditions, including but not limited to, bipolar disorder, obsessive-compulsive disorder (OCD), schizophrenia, attention-deficit hyperactivity disorder (ADHD), Alzheimer disease, amyotrophic lateral sclerosis (ALS), chronic pain, epilepsy, fibromyalgia, migraine headache, Parkinson disease, multiple sclerosis, stroke, are considered experimental/investigational and, therefore, not covered because the safety and/or effectiveness of this service cannot be established by review of the available published peer-reviewed literature.

Although the FDA has approved TMS for acute treatment of pain associated with migraine headache with aura and OCD, the Company has determined that the safety and/or effectiveness of this procedure cannot be established by review of the available published peer-reviewed literature. Therefore, TMS for acute treatment of pain associated with migraine headache with aura and OCD is considered experimental/investigational by the Company and not covered.

REQUIRED DOCUMENTATION

The medical record documentation must support that the attending professional provider has met with the individual face to face for the initial assessment and for subsequent delivery and management when there is a change in the individual's mental status and/or other significant change in clinical status.

The medical record documentation must include evidence of clinical judgment of the treating professional provider in evaluation of the absolute and relative contraindications in the pre-procedure record for the present episode of care.

The individual's medical record must reflect the medical necessity for the care provided. These medical records may include, but are not limited to: records from the professional provider's office, hospital, nursing home, home health agencies, therapies, and test reports.

The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the service.

US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

Although the FDA has approved TMS for acute treatment of pain associated with migraine headache with aura and OCD, the Company has determined that the safety and/or effectiveness of this procedure cannot be established by review of the available published peer-reviewed literature. Therefore, TMS for acute treatment of pain associated with migraine headache with aura and OCD is considered experimental/investigational by the Company and not covered.

Guidelines

MEDICATION TRIALS

Classes of medications after failure of medication trials at adequate dose and duration that are consistent with the US Food and Drug Administration (FDA) label include:

Selective serotonin reuptake inhibitors [SSRIs] (Celexa, Lexapro, Luvox, Paxil/Paxil CR/ Pexeva, Prozac/Prozac Weekly, Trintellix, Viibryd, Zoloft)
Serotonin-norepinephrine reuptake inhibitors [SNRIs] (Cymbalta, Effexor/Effexor XR, Fetzima, Pristiq/Khedezla)
Tricyclic antidepressants [TCAs] (Anafranil, Asendin, Elavil, Ludiomil, Norpramin, Pamelor, Surmontil, Tofranil, Vivactil)
Monoamine oxidase inhibitors [MAOIs] (Emsam-skin patch, Marplan, Nardil, Parnate)
Other Antidepressants (Auvelity, Ketalar, Remeron, Serzone, Spravato-nasal spray)
Wellbutrin/Wellbutrin SR/Wellbutrin XL, Zulresso-medicine given as an intravenous infusion
Augmentation agents (Abilify, Cytomel, Lithobid/Eskalith, Seroquel/Seroquel XR, Rexulti, Risperdal, Synthroid, Zyprexa)

STANDARDIZED RATING SCALES TO MEASURE DEPRESSIVE SYMPTOMS

The Personal Health Questionnaire Depression Scale (PHQ-9)
The Beck Depression Inventory (BDI)
The Montgomery–Åsberg Depression Rating Scale (MADRS)
Geriatric Depression Scale (GDS)
The Quick Inventory of Depressive Symptomatology (QIDS)
The Hamilton Rating Scale for Depression (HAM-D)
The Inventory for Depressive Symptomatology Systems Review (IDS-SR).

EDUCATION AND TRAINING

Physicians performing transcranial magnetic stimulation (TMS) meet the following qualifications:

Completion of a psychiatric residency program accredited by the Accreditation Council for Graduate Medical Education (ACGME) or the American Osteopathic Association (AOA) or the Royal College of Physicians and Surgeons of Canada (RCPSC). Board certification in psychiatry by the American Board of Psychiatry and Neurology is preferred.
Completion of a university-based course in TMS, or the course approved by the device manufacturer. The training must be specific to the device in use at the authorization request.

Psychiatric-mental health nurse practitioners (PMHNP-BC) performing TMS meet the following qualifications, when within the scope of their license and training:

Current ANCC certification as a psychiatric-mental health nurse practitioner (PMHNP-BC)
Licensure for full authority or autonomous practice
Completion of a university-based course in TMS, or the course approved by the device manufacturer. The training must be specific to the device in use at the authorization request

TMS SETTING REQUIREMENTS

The following should be present for the administration of TMS:

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
Adequate resuscitation equipment including suction and oxygen
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.

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable Evidence of Coverage, TMS is covered under the medical benefits of the Company's Medicare Advantage products when the medical necessity criteria listed in this medical policy are met.

However, services that are identified in this policy as not medically necessary or experimental/investigational are not eligible for coverage or reimbursement by the Company.

FDA STATUS

Brainsway Deep TMS System was approved by the FDA on March 8, 2019, as an adjunct for the treatment of adult individuals with obsessive-compulsive disorder.

SpringTMS Total Migraine System was approved by the FDA on May 21, 2014, for the treatment of pain associated with migraine headache with aura.

NeuroStar Advanced Therapy was approved by the FDA on March 22, 2024, as an adjunct for the treatment of Major Depressive Disorder (MDD) in adolescent individuals (age 15-21 years).

Description

Transcranial magnetic stimulation (TMS) is a noninvasive method of delivering electrical stimulation to the brain. Due to the repeated nature of the treatment, TMS is sometimes referred to as repetitive TMS (rTMS). 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. TMS is used and/or studied for treatment-resistant depression (TRD) and other psychiatric and neurologic disorders. A variety of TMS modalities have been developed that 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 uses 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.

DEPRESSION

There are a large number of sham-controlled randomized trials (RCTs) and meta-analyses of these RCTs evaluating the use of TMS for depression. Meta-analyses found improved response rates and rates of remission for conventional rTMS and theta burst stimulation compared with sham TMS. Additionally, a head-to-head trial showed noninferiority of theta-burst stimulation to conventional rTMS, with no difference in the incidence of adverse events. 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, while the effect of rTMS is less robust when it is given in combination with a stable dose of antidepressant medication. There is limited evidence to compare the effects of these treatments on cognition, although the adverse events of rTMS appear to be minimal. While the most recent meta-analyses have found that the effect of rTMS is smaller than the effect of electroconvulsive therapy (ECT) on TRD, given that rTMS does not require general anesthesia or induce seizures and some individuals may not elect ECT, the balance of incremental benefits and harms associated with rTMS may be reasonable compared with ECT.

BIPOLAR DISORDER

In 2020, Tee et al. conducted a systematic review and meta-analysis of sham-controlled RCTs of rTMS for the treatment of bipolar disorder. Eight trials of rTMS in bipolar depression showed small but statistically significant improvements in depression scores compared to sham control (standardized mean difference [SMD], 0.302; P<0.05). However, most studies had a high risk of bias, which could have exaggerated the treatment effects. The effect of rTMS was inconclusive in bipolar mania due to the high heterogeneity and limited number of controlled trials.

OBSESSIVE-COMPULSIVE DISORDER (OCD)

The evidence on rTMS for obsessive-compulsive disorder (OCD) includes a number of small-to-moderate sized, sham-controlled, double-blind RCTs and meta-analyses of these RCTs. A meta-analysis of 15 RCTs (N=483 individuals, range 18-65 individuals) conducted in 2016 found a benefit of rTMS on individual-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 second meta-analysis conducted in 2021 included 22 RCTs. Three of five TMS protocols assessed were significantly more efficacious than sham TMS, and all treatment strategies were similar to sham TMS regarding tolerability. Deep TMS was not more effective than sham TMS, but there was direct evidence from only one RCT for this comparison. The overall quality of the evidence was rated very low for efficacy and low for tolerability, and the reviewers concluded that high-quality RCTs with low selection and performance bias are needed to further verify the efficacy of specific rTMS strategies for OCD treatment. In a network meta-analysis that included both direct and indirect evidence, the authors did not find that deep TMS was more effective than sham rTMS. The RCT that was the basis of FDA clearance of deep TMS for treatment of OCD 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 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 percent in the active treatment group compared to 11.1 percent in the sham group (P=0.003), as measured by a 30 percent 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 rTMS on clinician-reported measures of improvement, but no significant difference between groups on individual-reported disability and impairment. Additional trials with sufficient sample size and follow-up duration are needed to confirm these results.

A 2021 meta-analysis of 26 RCTs on rTMS in the treatment of OCD found moderate improvement in Yale-Brown Obsessive Compulsive Scale (Y-BOCS) scores vs. sham (effect size 0.64. There were small to medium reductions in comorbid anxiety (0.3) and depression (0.24). The best results were seen targeting the Dorsolateral prefrontal Cortex for decreasing both anxiety and depressive symptoms. The limitations included small sample sizes and limited reporting on comorbidities.

SCHIZOPHRENIA

In 2017, He et al. published a meta-analysis of the effects of 1-Hz (low frequency) and 10-Hz (high frequency) rTMS for auditory hallucinations and negative symptoms of schizophrenia, respectively. For 1-Hz rTMS, 13 studies were included. Compared with sham, the rTMS group showed greater improvement in auditory hallucinations (SMD, -0.29; 95% CI, -0.57 to -0.01). However, significant heterogeneity across the studies was found (P=0.06). In the seven studies using 10-Hz rTMS, the overall effect size for improvement in negative symptoms was -0.41 (95% CI, -1.16 to -0.35); again, there was significant heterogeneity across studies (P<0.001). The review was further limited by the small number of articles included and by the lack of original data for some studies.

A Cochrane review by Dougall et al. (2015) selected 41 studies (N=1473 participants). Based on very low-quality evidence, there was a significant benefit of low- and high-frequency temporoparietal TMS compared with sham for the global state (seven RCTs) and positive symptoms (five RCTs). For prefrontal rTMS compared with sham, the evidence on global and cognitive state was of very low quality and equivocal. Reviewers concluded that the evidence was insufficient to support or refute the use of TMS to treat symptoms of schizophrenia and, although some evidence suggested that temporoparietal TMS might improve certain symptoms (e.g., auditory hallucinations, positive symptoms of schizophrenia), the results were not sufficiently robust to provide certainty.

ATTENTION DEFICIT HYPERACTIVITY DISORDER

A systematic review published by Masuda et al. (2019) examined literature on rTMS for children and adolescents with neurodevelopmental disorders. The search identified 264 articles; 14 articles met eligibility criteria. In individuals included with attention deficit hyperactivity disorder (ADHD), low-frequency rTMS applied to the DLPFC and high-frequency rTMS applied to the right dorsolateral prefrontal cortex may target inattention, hyperactivity, and impulsivity. This systematic review suggests that rTMS may be a promising intervention for children and adolescents with neurodevelopmental disorders. However, the results warrant further large RCTs of rTMS in children with neurodevelopmental disorders.

In a randomized, sham-controlled crossover study, researchers tested the safety and efficacy of TMS in the treatment of young adults and adolescents aged between 14 and 21 (n=9) with ADHD (Weaver et al., 2012). During the study, individuals were randomly assigned in the first treatment phase to receive active TMS or sham and were crossed over to the other treatment modality in the second phase. Results showed significant improvement in Clinical Global Impression-Improvement Scale (CGI-I) in those randomly assigned to active TMS first as well as to those randomized first to sham TMS. Although both groups improved during the first phase of treatment, only those assigned to active TMS improved during the second phase, suggesting that placebo-type effects were washed out with completion of the first phase. No serious adverse effects, including seizures and EEG changes, resulted from the treatment (the study excluded individuals with increased risk of seizure). Researchers in this study concluded that this exploratory study shows encouraging results of the potential efficacy of TMS for ADHD. Although the sham-controlled crossover study design was well conceived, the number of study subjects was far too small to allow for any conclusions regarding efficacy of TMS for ADHD treatment.

ALZHEIMER DISEASE

In 2012, Ahmed et al. reported a RCT on 45 individuals with probable Alzheimer disease to five sessions of bilateral high-frequency rTMS, bilateral low-frequency rTMS, or sham TMS over the DLPFC. Thirty-two individuals had mild to moderate dementia and 13 had severe dementia. There were no significant differences between groups at baseline. Measures of cortical excitability immediately after the last treatment session showed that treatment with high-frequency rTMS reduced the duration of transcallosal inhibition. At 3 months after treatment, the high-frequency rTMS group improved significantly more than the other two groups in standard rating scales, and subgroup analysis showed that this was due primarily to improvements in individuals with mild to moderate dementia. Individuals in the subgroup of mild to moderate dementia who were treated with high-frequency rTMS improved from 18.4 to 22.6 on the Mini-Mental State Examination, from 20.1 to 24.7 on the Instrumental Daily Living Activity scale, and from 5.9 to 2.6 on the Geriatric Depression Scale.

In 2012, Rabey et al. reported an industry-sponsored randomized double-blind trial of rTMS with cognitive training (NeuroAD system) in 15 individuals with probable mild to moderate Alzheimer disease. Individuals received five sessions per week for 6 weeks over six different brain areas, followed by biweekly sessions for 3 months. Specific cognitive tasks were designed for the six targeted brain regions. These included syntax and grammar for Broca area, comprehension and categorization for Wernicke area, action naming, object naming and spatial memory tasks for the right and left DLPFC, and spatial attention tasks for the right and left somatosensory association cortex. After 6 weeks of treatment, there was an improvement in the average Alzheimer Disease Assessment Scale, cognitive subsection (ADAS-cog) score of 3.76 points in the rTMS group compared with 0.47 in the placebo group. After 4.5 months of treatment, the ADAS-cog score in the rTMS group had improved by 3.52 points compared with a worsening of 0.38 in the placebo group. The Clinical Global Impression of Change improved significantly by an average of 3.57 after 6 weeks and 3.67 after 4.5 months compared with 4.25 and 4.29, respectively, in the placebo group.

The limited data from these studies do not allow definitive conclusion regarding the possible benefits of TMS. The studies present with methodological limitations, including small study populations and short-term follow-up. The findings of these studies need to be validated by RCTs with larger sample size and long-term follow-up.

AMYOTROPHIC LATERAL SCLEROSIS (ALS) OR MOTOR NEURON DISEASE

In 2013, Fang et al. identified three RCTs with a total of 50 participants with ALS that compared rTMS with sham TMS. All of the trials were considered to be of poor methodological quality. Heterogeneity prevented pooling of results, and the high rate of attrition further increased the risk of bias. The authors concluded that evidence is currently insufficient to draw conclusions about the efficacy and safety of rTMS in the treatment of ALS.

CHRONIC PAIN

In 2014, O'Connell et al. reviewed noninvasive brain stimulation techniques identified 30 RCTs (528 participants) on TMS for chronic pain. The authors concluded there was low to very low quality evidence that low-frequency rTMS or rTMS to the DLPFC is ineffective. Studies on high-frequency rTMS to the motor cortex were heterogeneous, of low quality, and did not demonstrate a significant effect. Due to the low quality of the identified studies, additional RCTs are needed to determine if TMS is effective for chronic pain.

EPILEPSY

In 2012, Sun et al. reported a double-blind RCT of low-frequency rTMS to the epileptogenic zone for refractory partial epilepsy. Sixty individuals were randomly assigned into two groups: one group received 2 weeks of rTMS at 90 percent of resting motor threshold, and the other group received rTMS at 20 percent of resting motor threshold. Outcomes were measured for 8 weeks after the end of treatment. With ITT analysis, high-intensity rTMS resulted in a significant decrease in seizures when compared with baseline (from 8.9 per week at baseline to 1.8 per week at follow-up) and when compared with low-intensity rTMS (from 8.6 at baseline to 8.4 per week at follow-up). High-intensity rTMS also decreased interictal discharges (from 75.1 to 33.6 per hour) and improved ratings on the Symptom Checklist-90.

In a 2016 Cochrane review, Chen et al. assessed the evidence for the use of TMS in individuals with drug-resistant epilepsy compared with other available treatments in reducing seizure frequency and improving quality of life. Seven RCTs that were double-blinded, single-blinded or unblinded, and placebo, no treatment, or active controlled were included in the analysis. The total number of participants in the seven trials was 230. Two of the seven studies analyzed showed a statistically significant reduction in seizure rate from baseline (72% and 78.9% reduction of seizures per week from the baseline rate, respectively). The other five studies showed no statistically significant difference in seizure frequency following rTMS treatment compared with controls. The authors concluded the quality of evidence for the primary outcomes of this review to be low. According to the authors, there is evidence that rTMS is safe and not associated with any adverse events, but given the variability in technique and outcome reporting that prevented meta-analysis, the evidence for efficacy of rTMS for seizure reduction is still lacking despite reasonable evidence that it is effective at reducing epileptiform discharges.

FIBROMYALGIA

A 2012 systematic review by Marlow et al. included four studies on transcranial direct current stimulation and five studies on rTMS for treatment of fibromyalgia pain. Three of the five trials were considered to be high quality. Four of the five were double-blind RCTs; the fifth included study was a case series of four individuals who were blinded to treatment. Quantitative meta-analysis was not conducted due to variability in brain site, stimulation frequency/intensity, total number of sessions, and follow-up intervals, but four of the five studies on rTMS reported significant decreases in pain. Greater durability of pain reduction was observed with stimulation of the primary motor cortex compared with the DLPFC.

A 2013 report by Maestu et al. evaluated the effect of very low-intensity rTMS in a randomized sham-controlled double-blinded trial of 54 individuals with fibromyalgia. Six weeks of rTMS (once per week) with 33 magnetic coils around the head resulted in a significant improvement in pain thresholds (28 percent) across the eight sessions and in the ability to perform daily activities (11 percent), perceived chronic pain (39 percent), and sleep quality (75 percent) beginning at week six. Fatigue, anxiety, depression, and severity of headaches were unaffected by treatment. Additional studies are needed to determine effective treatment parameters in a larger number of subjects and to evaluate durability of the effect.

In 2017, Saltychev and Laimy published a meta-analysis of rTMS for the treatment of individuals with fibromyalgia. The meta-analysis included seven sham-controlled double-blinded controlled trials with low risk of bias. The sample sizes of the trials ranged from 18 to 54. Five of the studies provided high-frequency stimulation to the left primary motor cortex, and the others were to the right or left DLPFC. The number of sessions ranged from 10 to 24, and follow-up ranged from immediately after treatment to 3 months posttreatment. In the pooled analysis, pain severity decreased after the last simulation by 1.2 points (95 percent CI, -1.7 to -0.8 points) on a 10-point numeric rating scale, while pain severity measured at 1 week to 1 month after the last simulation decreased by 0.7 points (95 percent CI, -1.0 to -0.3 points). Both were statistically significant but not considered clinically significant, based on a minimal clinically important difference of 1.5 points. These results do not support the use of rTMS for the treatment of pain in fibromyalgia. A limitation of the meta-analysis was the relatively small size of the studies and differences in stimulation parameters.

MIGRAINE

The FDA approved the Cerena® single-pulse TMS (sTMS) device (eNeura Therapeutics LLC, Sunnyvale, CA) on December 13, 2013, for the acute treatment of pain associated with migraine headache with aura. On May 21, 2014, the Spring TMS® (eNeura Therapeutics, LLC, Sunnyvale, CA), sTMS device received 510(k) clearance as substantially equivalent to the Cerena sTMS device for use in the acute treatment of pain associated with migraine headache with aura. These portable, hand-held devices emit a single pulse of magnetic stimulation as opposed to the rapid, repetitive pulses. They are designed for individual use where treatments are self-administered and can be delivered in a variety of settings, including the home or office. According to the FDA labeling, these devices have not been demonstrated as safe or effective when treating cluster headache, chronic migraine headache, or when treating migraine headache during the aura phase. In addition, the devices have not been demonstrated as effective in relieving the associated symptoms of migraine (photophobia, phonophobia, nausea). The study results are limited by small sample size, high dropout rate, and limited follow-up intervals, leading to uncertainty about the safety of long-term or frequent use of TMS. Additional RCTs are needed to determine optimal treatment parameters, including the range of doses and timing of treatment, to confirm the effectiveness and durability of TMS for the treatment of pain associated with migraine headache with aura.

PARKINSON DISEASE

A 2015 meta-analysis by Chou et al. included 20 sham-controlled RCTs with a total of 470 participants with Parkinson disease. Sample sizes ranged from eight to 102 individuals. The total effect size of rTMS on Unified Parkinson’s Disease Rating Scale (UPDRS) part III score was 0.46, which is considered a small to medium effect size, and the mean change in the UPDRS-III score (-6.42) was considered a clinically important difference. The greatest effect on motor symptoms was from high-frequency rTMS over the primary motor cortex (standardized mean difference [SMD]=0.77; P<0.001) and low-frequency rTMS over other frontal regions (SMD=0.50, P=0.008). High-frequency rTMS at other frontal regions and low-frequency rTMS over the primary motor cortex did not have a statistically significant benefit. The largest study included in the systematic review was an exploratory, multicenter, double-blind trial that randomly assigned 106 individuals to 8 weeks of 1-Hz rTMS, 10-Hz rTMS, or sham stimulation over the supplementary motor area. At 9 weeks, all groups showed a similar amount of improvement. It cannot be determined from these results whether the negative results of the largest trial were due to a lack of effect of rTMS on motor symptoms in general or to the location of stimulation. Additional study with a larger number of subjects and longer follow-up is needed to determine if high-frequency rTMS over the primary motor cortex improves motor symptoms in individuals with Parkinson disease.

MULTIPLE SCLEROSIS

In 2007, Centonze et al. examined whether rTMS can modify spasticity. These researchers used high-frequency (5 Hz) and low-frequency (1 Hz) rTMS protocols in 19 remitting participants with relapsing-remitting multiple sclerosis and lower-limb spasticity. A single session of 1 Hz rTMS over the leg primary motor cortex increased Hoffman reflex/muscle response (H/M) amplitude ratio of the soleus H reflex, a reliable neurophysiologic measure of stretch reflex. Five hertz rTMS decreased H/M amplitude ratio of the soleus H reflex and increased corticospinal excitability. Single sessions did not induce any effect on spasticity. A significant improvement of lower-limb spasticity was observed when rTMS applications were repeated during a 2-week period. Clinical improvement was long-lasting (at least 7 days after the end of treatment) when individuals underwent five Hz rTMS treatment during a 2-week protocol. No effect was obtained after a 2-week sham stimulation. The authors concluded that rTMS may improve spasticity in multiple sclerosis. The findings of this study need to be validated by prospective RCTs with larger participant numbers.

In 2013, Amatya et al. reviewed RCTs that reported nonpharmacological interventions for treatment of spasticity in adults with multiple sclerosis and compared them with some form of control intervention (such as sham/placebo interventions or lower level or different types of intervention, minimal intervention, waiting list controls, or no treatment; interventions given in different settings). The authors concluded that there is low-level evidence for TMS for beneficial effects on spasticity outcomes in individuals with multiple sclerosis. More robust trials are needed to build evidence about nonpharmacologic interventions such as TMS for multiple sclerosis.

STROKE

A 2013 Cochrane review by Hao et al. included 19 RCTs, with a total of 588 participants, on the effect of TMS for improving function after stroke. The two largest trials (N=183) showed that rTMS was not associated with a significant improvement in the Barthel Index (scale used to measure performance in activities of daily living). Four trials (N=73) found no significant effect for motor function. Subgroup analysis for different stimulation frequencies or duration of illness also did not show a significant benefit of rTMS when compared with sham rTMS or no treatment. The review concluded that current evidence does not support the routine use of rTMS for the treatment of stroke.

A 2014 meta-analysis by Le et al. assessed the effect of rTMS on recovery of hand function and excitability of the motor cortex after stroke. Eight RCTs with a total of 273 participants were included in the review. The quality of the studies was rated moderate to high, although the size of the studies was small. There was variability in the time since stroke (5 days to 10 years), in the frequency of rTMS applied (1 Hz to 25 Hz for 1 second to 25 min/d), and the stimulation sites (primary motor cortex or premotor cortex of the unaffected hemisphere). Meta-analysis reported a positive effect on finger motor ability (four studies; N=79; standardized mean difference, 0.58) and hand function (three studies; N=74; standardized mean difference, -0.82), but no significant change in motor evoked potential (n=43) or motor threshold (n=62).

A 2015 meta-analysis by Li et al. included four RCTs on rTMS over the right pars triangularis for individuals (N=137) with aphasia after stroke. All studies used double-blinding, but therapists were not blinded. Every study used a different outcome measure, and sample sizes were small (range, 12-40 participants). Meta-analysis showed a medium effect size for naming (P=0.004), a trend for a benefit on repetition (P=0.08), and no significant benefit for comprehension (P=0.18). Additional study in a larger number of individuals is needed to determine with greater certainty the effect of this treatment on aphasia after stroke.

A 2016 systematic review and meta-analysis by Pisegna et al. of RCTs evaluated the effects of noninvasive brain stimulation, including TMS on poststroke dysphagia. The authors concluded that noninvasive brain stimulation appears to assist cortical reorganization in poststroke dysphagia, but emerging factors highlight the need for more data. The authors indicated that, based on this preliminary review, noninvasive brain stimulation facilitated recovery in poststroke dysphagia but should not yet be considered for clinical use outside of clinical trials.

ACCELERATED INTERMITTENT THETA BURST STIMULATION (SNT/SAINT)

Accelerated intermittent theta-burst stimulation (iTBS), also known as Stanford Neuromodulation Therapy or Stanford Accelerated Intelligent Neuromodulation Therapy (SNT/SAINT) is a high-dose, patterned, functional connectivity MRI (fMRI)–guided rTMS protocol aimed at optimizing the treatment of treatment-resistant depression using neuroscience-informed stimulation parameters. The protocol advises 10 daily sessions over 5 consecutive days.

The best available evidence includes three single-arm trials and one double-blind RCT by Cole et al. (2022). Thirty-two individuals were randomly assigned, but only 30 were assigned in a 1:1 ratio to receive active or sham SNT. Participant inclusion criteria included a moderate to severe depressive episode (scores ≥20 on the 17-item Hamilton Depression Rating Scale [HAM-D] and the Montgomery-Åsberg Depression Rating Scale [MADRS]); 22 and 80 years old, and moderate to severe levels of treatment resistance as measured by the Maudsley Staging Method. The fMRI was used to position the TMS coil over the individualized stimulation target at each session. Ten sessions of active or sham iTBS were delivered daily, for a total of 18,000 pulses per day, for 5 consecutive days. The primary endpoint evaluated MADRS score 4 weeks after treatment (week 5), normalized to baseline (week 0). Using an ITT analysis, the mean percent reduction in ITT MADRS scores 0, 1, 2, 3, and 4 weeks after treatment were 62.0%, 70.9%, 62.4%, 57.8%, and 52.5% of baseline in the active treatment group and 14.3%, 20.6%, 10.4%, 10.9%, and 11.1% in the sham treatment group.

ADOLESCENT

A 2022 blinded, randomized clinical study examined the efficacy of 10-Hz add-on rTMS for first-onset adolescent depression which examined 100 participants ages 12-18 years of age. One group received sertraline plus 10 TMS sessions; the other group received sertraline only. The primary outcome was remission of depression was observed in 31.25% of the active group vs. 6.12% of the controls (p=0.001). The early improvement (2 weeks): 95.83% vs 73.47% (P=.002) with a responder rate at 4 weeks: 62.50% vs. 28.57% (p=0.001). The depression severity scores (HAMD,-17, CDRS-R) were significantly lower in TMS group (p<0.05). Cognitive function, as measured by IVA-CPT and THINC-it, improved significantly in the TMS group (P<0.05). Limitations included the control group did not receive sham TMS, long term efficacy was not evaluated, and placebo effects may have influenced results due to study design factors such as limited sites and lower baseline severity.

SUMMARY

The evidence for TMS as a treatment for behavioral health disorders other than depression (e.g., bipolar disorder, OCD, schizophrenia) includes numerous small or moderate-sized 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 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. In addition, the available clinical trials for TMS as a treatment for conditions including but not limited to, ADHD, Alzheimer disease, ALS, chronic pain, epilepsy, fibromyalgia, migraine headache, Parkinson disease, multiple sclerosis, stroke, are small and report mixed results. Larger and more well-controlled clinical trials that address the durability of the potential benefits are needed to explore the therapeutic potential of TMS.

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Coding

CPT Procedure Code Number(s)

MEDICALLY NECESSARY

90867, 90868, 90869, 0889T, 0890T, 0891T, 0892T

EXPERIMENTAL/INVESTIGATIONAL

0997T, 0998T

ICD - 10 Procedure Code Number(s)

N/A

ICD - 10 Diagnosis Code Number(s)

F32.2 Major depressive disorder, single episode, severe without psychotic features

F33.2 Major depressive disorder, recurrent severe without psychotic features

HCPCS Level II Code Number(s)

N/A

Revenue Code Number(s)

N/A

MPMiscCodesNarrativesPub

Coding and Billing Requirements

Cross Reference

Policy History

Revisions From MA07.035h:

10/19/2026

This version of the policy will become effective 10/19/2026. Revised policy number MA07.035h.

The policy was updated to clarify standard TMS treatment duration and tapering schedule and multiple daily TMS sessions are only covered under the SAINT protocol.

Updated SAINT/iTBS criteria to define covered treatment days and target development requirements.

Clarified target development services are included in the initial SAINT treatment.

Revisions From MA07.035g:

01/01/2026

This version of the policy will become effective 01/01/2026. This policy is updated to include specific behavioral health criteria for transcranial magnetic stimulation (TMS).

The following CPT codes have been added to this policy:

0997T, 0998T

Revisions From MA07.035f:

12/25/2025

Revised policy number MA07.035f. The References were updated accordingly. The policy was updated to be consistent with current template wording and format.

The coverage criteria was updated to reflect the treatment of MDD in the adolescent population, 15 years of age and older.

This policy is updated to include specific examples of drug classes used to treat prior to transcranial magnetic stimulation (TMS).

NeuroStar Advanced Therapy was approved by the FDA on March 22, 2024, as an adjunct for the treatment of Major Depressive Disorder (MDD) in adolescent individuals (age 15-21 years).

In the desciption section, updated literature summary was added to OCD and Adolescents MDD.

Revisions From MA07.035e:

07/01/2024

This version of the policy will be issued on 12/02/2024 with a retroactively effective date of 07/01/2024.

The following policy criteria have been revised:

FROM: The individual has demonstrated medication treatment resistance during the current depressive episode as evidenced by lack of a clinically significant response to at least one or more failed trials of psychopharmacologic agents.

TO: The individual has demonstrated a failure of one or more medical trials at adequate dose and duration that are consistent with the FDA label and with a duration that would elicit a favorable response trials of a pharmacological medication.

FROM: The individual has demonstrated a failure of one or more medical trials...
TO: The individual has demonstrated a failure of one or more medication trials...

FROM: The individual has demonstrated a failure of one or more medical trials...
TO: The individual has demonstrated a failure of one or more medication trials...

FROM:

All of the following conditions are absent:

a. Seizure disorder or any history of seizures (except those induced by ECT or isolated febrile seizures in infancy without subsequent treatment or recurrence, or any condition or treatment that may lower the seizure threshold)
b. Presence of acute or chronic psychotic symptoms or disorders (e.g., schizophrenia, schizophreniform disorder, or schizoaffective disorder), in the current depressive episode.
c. 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.
d. Presence of an implanted magnetic-sensitive medical device located less than or equal to 30 cm from the TMS magnetic coil or other implanted metal items (e.g., cochlear implant, implanted cardiac defibrillator [ICD], pacemaker, vagus nerve stimulator [VNS], or metal aneurysm clips or coils, staples or stents) is an absolute contraindication.

TO:

The following absolute contraindication is absent:

Presence of an implanted magnetic-sensitive medical device located less than or equal to 30 cm from the TMS magnetic coil or other implanted metal items (e.g., cochlear implant, implanted cardiac defibrillator [ICD], pacemaker, vagus nerve stimulator [VNS], or metal aneurysm clips or coils, staples or stents) is an absolute contraindication.

Documentation shows that risks and benefits were considered regarding the following relative contraindications:

Seizure disorder or any history of seizures (except those induced by ECT or isolated febrile seizures in infancy without subsequent treatment or recurrence, or any condition or treatment that may lower the seizure threshold)
Presence of acute or chronic psychotic symptoms or disorders (e.g., schizophrenia, schizophreniform disorder, or schizoaffective disorder), in the current depressive episode.
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.

The following policy criteria have been removed:

Pregnancy must be absent

Concomitant esketamine intranasal, ketamine infusion or other infusion therapies for major depressive disorder must be absent

The following service has been added to this policy as medically necessary:

Stanford Neuromodulation Therapy or Stanford Accelerated Intelligent Neuromodulation Therapy (SNT/SAINT)

The following CPT Codes have been added to this policy as medically necessary:

0889T, 0890T, 0891T, 0892T

Revisions From MA07.035d:

04/17/2024	This policy has been reissued in accordance with the Company's annual review process.
01/01/2024	Effective 01/01/2024 this policy applies to New Jersey Medicare Advantage (MA) lines of business.
11/01/2023	This policy has been reissued in accordance with the Company's annual review process.
01/01/2023	This version of the policy is an update to the policy published in Notification and will become effective 01/01/2023. This policy is updated to include specific behavioral health criteria for transcranial magnetic stimulation (TMS) in accordance with updated Novitas Solutions, Inc. Local Coverage determination (LCD). LCD L34998: Transcranial Magnetic Stimulation (TMS) in the Treatment of Adults with Major Depressive Disorder. (12/11/2022) The following ICD-10 CM codes have been added to this policy: F32.2 Major depressive disorder, single episode, severe without psychotic features F33.2 Major depressive disorder, recurrent severe without psychotic features

Revisions From MA07.035c:

06/02/2021	This policy has been reissued in accordance with the Company's annual review process.
09/23/2020	This policy has been reissued in accordance with the Company's annual review process.
12/04/2019	The policy has been reviewed and reissued to communicate the Company’s continuing position on transcranial magnetic stimulation (TMS).
09/10/2018	This version of the policy will become effective 09/10/2018. Policy title was updated to remove for medically conditions. The intent of this policy remains unchanged. This policy statement was updated to add medically necessary language for transcranial magnetic stimulation (TMS) for behavioral health conditions. Policy statement indicates to refer to the contracted behavioral health/mental health vendor for medically necessary criteria for TMS.

Revisions From MA07.035b:

12/01/2017

This version of the policy will become effective 12/01/2017.

The intent of this policy remains unchanged, but this policy was updated to address transcranial magnetic stimulation (TMS) for medical conditions and to refer to the contracted behavioral health/mental health vendor for behavioral health/mental health conditions eligible for coverage for TMS.

The following ICD-10 CM codes and revenue code have been removed from this policy:

F32.2 Major depressive disorder, single episode, severe without psychotic features
F33.2 Major depressive disorder, recurrent severe without psychotic features
0900 Behavioral Health Treatments/Services

Revisions From MA07.035a:

07/06/2016	The policy has been reviewed and reissued to communicate the Company’s continuing position on repetitive transcranial magnetic stimulation (rTMS).
05/06/2015	The intent of this policy remains unchanged, but the policy has been updated to further clarify the experimental/investigational status of bulimia nervosa. The following revenue code has been added to this policy: 0900 Behavioral Health Treatments/Services

Revisions From MA07.035:

01/01/2015

This is a new policy.

Version Effective Date:

10/19/2026

Version Issued Date:

10/19/2026

Version Reissued Date: