Populations	Interventions	Comparators	Outcomes
Individuals: With migraine	Interventions of interest are: Repetitive transcranial magnetic stimulation	Comparators of interest are: Pharmacotherapy	Relevant outcomes include: Symptoms Functional outcomes Quality of life
Individuals: With psychiatric or neurologic disorders other than depression, migraine, or obsessive-compulsive disorder	Interventions of interest are: Repetitive transcranial magnetic stimulation	Comparators of interest are: Pharmacotherapy Therapy as appropriate including either physical and occupational therapy or psychological and behavioral therapy	Relevant outcomes include: Symptoms Functional outcomes Quality of life

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. TMS was initially used to investigate nerve conduction; eg, 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. The stimulation site for the treatment of depression is usually 5 cm anterior to the motor stimulation site.

In contrast to electroconvulsive therapy, TMS does not require general anesthesia and does not generally induce a convulsion. 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 (eg, 5-10 Hz) TMS of the left dorsolateral prefrontal cortex had antidepressant effects. Low-frequency (1-2 Hz) stimulation of the right dorsolateral prefrontal cortex has also been investigated. The rationale for low-frequency TMS is inhibition of right frontal cortical activity to correct the interhemispheric imbalance. A combination approach (bilateral stimulation), or deep stimulation with an H1 coil, is also being explored, as is thetaburst stimulation.

Repetitive TMS is also being tested as a treatment for a variety of other disorders. i In addition to the potential for altering interhemispheric imbalance, it has been proposed that high-frequency repetitive TMS may facilitate neuroplasticity.

Regulatory Status

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

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

In 2013, the Cerena™ TMS device (eNeura Therapeutics) was granted a de novo510(k) classification by the FDA for the acute treatment of pain associated with a migraine headache with aura. Warnings, precautions, and contraindications include the following:

• The device is only intended for patients experiencing the onset of pain associated with a migraine headache with aura.
• The device should not be used:
  • on headaches due to underlying pathology or trauma.
  • for medication overuse headaches.
• The device has not been demonstrated as safe and/or effective:
  • when treating cluster headache or a chronic migraine headache.
  • when treating during the aura phase.
  • in relieving the associated symptoms of a migraine (photophobia, phonophobia, and nausea).
  • in pregnant women, children under the age of 18, and adults over the age of 65.

In August 2018, the Deep TMS System (Brainsway) was granted a de novo510(k) classification by the FDA as an adjunct for the treatment of adult patients with Obsessive-Compulsive Disorder. The new classification applies to this device and substantially equivalent devices of this generic type.

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

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

Device	Manufacturer	Indication	FDA Clearance No.	FDA Clearance Date
Neurostar	Neuronetics	Major Depressive Disorder	K083538	12/16/2008
Brainsway Deep TMS System	Brainsway	Major Depressive Disorder	K122288	01/07/2013
Springtms Total Migraine System	Eneura	Migraine headache with aura	K140094	05/21/2014
Rapid Therapy System	Magstim	Major Depressive Disorder	K143531	05/08/2015
Magvita	Tonica Elektronik	Major Depressive Disorder	K150641	07/31/2015
Neurosoft	TeleEMG	Major Depressive Disorder	K160309	12/22/2016
Horizon	Magstim	Major Depressive Disorder	K171051	09/13/2017
Nexstim	Nexstim	Major Depressive Disorder	K171902	11/10/2017
Apollo	Mag & More	Major Depressive Disorder	K180313	05/04/2018
Brainsway Deep TMS System	Brainsway	Obsessive-Compulsive Disorder	K183303	03/08/2019

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

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

In 2014, the Cerena™ TMS device (eNeura Therapeutics) was granted a de novo510(k) classification by the FDA for the acute treatment of pain associated with a migraine headache with aura. Warnings, precautions, and contraindications include the following:

• The device is only intended for patients experiencing the onset of pain associated with a migraine headache with aura.
• The device should not be used:
  • on headaches due to underlying pathology or trauma.
  • for medication overuse headaches.
• The device has not been demonstrated as safe and/or effective:
  • when treating cluster headache or a chronic migraine headache.
  • when treating during the aura phase.
  • in relieving the associated symptoms of a migraine (photophobia, phonophobia, and nausea).
  • in pregnant women, children under the age of 18, and adults over the age of 65.

In August 2018, the Deep TMS System (Brainsway) was granted a de novo510(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.

Related Policies

• Vagus Nerve Stimulation (VNS) (Policy #014 in the Surgery Section)
• Treatment of Tinnitus (Policy #017 in the Treatment Section)

Repetitive transcranial magnetic stimulation (rTMS) of the brain is considered investigational as a treatment for neurologic disorders and all other non-psychiatric and non-behavioral health-related disorders, including but not limited to migraine headaches, amyotrophic lateral sclerosis, chronic pain, epilepsy, fibromyalgia, Parkinson disease, and stroke.

FIDE SNP: For members enrolled in a Fully Integrated Dual Eligible Special Needs Plan (FIDE-SNP): (1) to the extent the service is covered under the Medicare portion of the member’s benefit package, the above Medicare Coverage statement applies; and (2) to the extent the service is not covered under the Medicare portion of the member’s benefit package, the above Medicaid Coverage statement applies.

[RATIONALE: This policy was created in 2009 and has been updated regularly with searches of the MEDLINE database. The most recent literature update was performed through August 26, 2019.

This review was informed by 3 TEC Assessments (2009, 2011, 2013).^1,2,3,

Evidence reviews assess the clinical evidence to determine whether the use of technology improves the net health outcome. Broadly defined, health outcomes are the length of life, quality of life (QOL), and ability to function¾including benefits and harms. Every clinical condition has specific outcomes that are important to patients and managing the course of that condition. Validated outcome measures are necessary to ascertain whether a condition improves or worsens; and whether the magnitude of that change is clinically significant. The net health outcome is a balance of benefits and harms.

To assess whether the evidence is sufficient to draw conclusions about the net health outcome of technology, two domains are examined: the relevance, and quality and credibility. To be relevant, studies must represent one or more intended clinical use of the technology in the intended population and compare an effective and appropriate alternative at a comparable intensity. For some conditions, the alternative will be supportive care or surveillance. The quality and credibility of the evidence depend on study design and conduct, minimizing bias and confounding that can generate incorrect findings. The randomized controlled trial (RCT) is preferred to assess efficacy; however, in some circumstances, nonrandomized studies may be adequate. RCTs are rarely large enough or long enough to capture less common adverse events and long-term effects. Other types of studies can be used for these purposes and to assess generalizability to broader clinical populations and settings of clinical practice.

Migraine Headache

Clinical Context and Therapy Purpose

The purpose of rTMS is to provide a treatment option that is an alternative to or an improvement on existing therapies in patients with migraine headache pain.

The question addressed in this policy is: Does the use of rTMS of the brain for patients with migraine headaches improve the net health outcome?

The following PICOs were used to select literature to inform this review.

Patients

The relevant population of interest are individuals with migraine headaches.

Interventions

The therapy being considered is rTMS.

Comparators

The following therapies are currently being used to treat migraine headache pain: pharmacotherapy (e.g., triptans, ibuprofen, combination analgesics)

Outcomes

The general outcomes of interest are reductions in symptoms and improvements in QOL and functional outcomes.

Study Selection Criteria

Methodologically credible studies were selected using the following principles:

• To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs;
• In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.
• To assess long-term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.
• Studies with duplicative or overlapping populations were excluded.

Section Summary: Migraine Headache

There is little evidence on the use of TMS devices to treat a migraine headache. The results of the pivotal trial were limited by the 46% dropout rate and post hoc analysis. According to the Food and Drug Administration(FDA) labeling, the device has not been demonstrated as safe or effective when treating cluster headache, chronic migraine headache, or migraine headache during the aura phase. The device has not been demonstrated to be as effective in relieving the associated symptoms of migraine (photophobia, phonophobia, nausea). No recent studies have been identified with these devices.

Neurologic Disorders Other Than Migraine

Clinical Context and Therapy Purpose

The purpose of rTMS is to provide a treatment option that is an alternative to or an improvement on existing therapies in patients with neurologic disorders other than migraine.

The question addressed in this policy is: Does the use of rTMSof the brain for various psychiatric or neurologic conditions improve the net health outcome?

The following PICOs were used to select literature to inform this review.

Patients

The relevant population of interest are individuals with neurologic disorders other than migraine .

Interventions

The therapy being considered is rTMS.

Comparators

The following therapies are currently being used to treat neurologic disorders other than migraine: pharmacotherapy and therapy as appropriate including either physical and occupational therapy

Outcomes

The general outcomes of interest are reductions in symptoms and improvements in QOL and functional outcomes.

Follow-up over months is of interest to monitor outcomes.

Study Selection Criteria

Methodologically credible studies were selected using the following principles:

• To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs;
• In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.
• To assess long-term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.
• Studies with duplicative or overlapping populations were excluded.

A Cochrane review by Fang et al (2013) identified 3 RCTs with a total of 50 participants with amyotrophic lateral sclerosis that compared rTMS with sham TMS. All trials were considered of poor methodologic quality. Heterogeneity prevented pooling of results, and the high rate of attrition further increased the risk of bias. Reviewers concluded that evidence was insufficient to draw conclusions about the efficacy and safety of rTMS in the treatment of amyotrophic lateral sclerosis.

Chronic Pain

A Cochrane review by O’Connell et al (2018) evaluating noninvasive brain stimulation techniques was first published in 2010 and was updated in 2014 and 2018. The reviewers identified42 RCTs (range 4 to 70 participants) on TMS for chronic pain. Meta-analysis of rTMS studies vs sham for pain intensity at short-term follow-up (0 to < 1 week postintervention), (27 studies, involving 655 participants), demonstrated a small effect with heterogeneity (SMD -0.22, 95%CI -0.29 to -0.16, low-quality evidence). This equates to a 7% (95% CI 5% to 9%) reduction in pain, or a 0.40 (95% CI 0.53 to 0.32) point reduction on a 0 to 10 pain intensity scale, which did not meet the minimum clinically important difference threshold of 15% or greater. There is very low-quality evidence that single doses of high-frequency rTMS of the motor cortex and tDCS may have short-term effects on chronic pain and QOL but multiple sources of bias exist that may have influenced the observed effects. We did not find evidence that low-frequency rTMS, rTMS applied to the dorsolateral prefrontal cortex and cranial electrotherapy stimulation are effective for reducing pain intensity in chronic pain.

Epilepsy

A Cochrane review by Chen et al (2016) included 7 RCTs on low-frequency rTMS for epilepsy, 5 of which were completed studies with published data. The total number of participants was 230. All studies had active or placebo controls and four were double-blinded. However, a meta-analysis could not be conducted due to heterogeneity in designs, interventions, and outcomes of the trials. Therefore, a qualitative synthesis was performed. For the outcome of seizure rate, two studies showed a significant reduction and five studies did not. Of the four studies evaluating the mean number of epileptic discharges, three studies showed a statistically significant reduction in discharges. Adverse events were uncommon and mild, involving headaches, dizziness, and tinnitus. There were no significant changes in medication use.

A number of RCTs have been conducted on the effect of rTMS on epilepsy. All but 1 were conducted between 2002 and 2008, with the most recent study conducted in 2012. Some trials reported a significant reduction in epileptic discharges, but most did not find a reduction in seizures. The lack of recent primary studies may suggest a loss of interest and support for this intervention following the initial negative results.

Fibromyalgia

Saltychev and Laimi (2017) published a meta-analysis of rTMS for the treatment of patients with fibromyalgia. The meta-analysis included seven sham-controlled double-blinded controlled trials with a low risk of bias. Trial sample sizes ranged from 18 to 54 patients. Five 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% 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% 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.

Parkinson Disease

A meta-analysis by Chou et al (2015) included 20 sham-controlled randomized trials (total n=470 patients) evaluating Parkinson disease. Sample sizes ranged from 8 to 102 patients. The total effect size of low- and high-frequency rTMS on Unified Parkinson’s Disease Rating Scale part III score was 0.46, which is considered a small-to-medium effect size, and the mean change in the Unified Parkinson’s Disease Rating Scale part 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 (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 trial included in the systematic review was an exploratory, multicenter, double-blind trial reported by Shirota et al (2013) who randomized 106 patients to 8 weeks of 1-Hz rTMS, 10-Hz rTMS, or sham stimulation over the supplementary motor area. At nine9 weeks, all groups showed a similar amount of improvement.

Stroke

A number of RCTs and systematic reviews have evaluated rTMS for recovery from stroke. For example, a Cochrane review by Hao et al (2013) included 19 RCTs (total n=588 participants) evaluating the effect of low- and high-frequency TMS for improving function after stroke. The 2 largest trials (n=183 patients) showed that rTMS was not associated with a significant improvement in Barthel Index scores. Four trials (n=73) found no significant effect on motor function. Subgroup analyses for different stimulation frequencies or durations of illness also did not show a significant benefit of rTMS compared with sham rTMS or no treatment. Reviewers concluded that current evidence did not support the routine use of rTMS for the treatment of stroke.

Hand Function

A meta-analysis by Le et al (2014) assessed the effect of rTMS on the recovery of hand function and excitability of the motor cortex after stroke. Eight RCTs (total n=273 participants) were selected. The quality of the trials 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 (1-25 Hz for 1 second to 25 min/d), and the stimulation sites (primary motor cortex or premotor cortex of the unaffected hemisphere). Meta-analysis found a positive effect on finger motor ability (4 studies; n=79 patients; SMD=0.58) and hand function (3 studies; n=74 patients; SMD=-0.82), but no significant change in motor evoked potentials (n=43) or motor threshold (n=62).

Aphasia

A meta-analysis by Li et al (2015) included 4 RCTs on low-frequency rTMS over the right parstriangularis for patients (total n=137) with aphasia after stroke. All studies used double-blinding, but therapists were not blinded. Every trial used a different outcome measure, and sample sizes were small (range, 12-40 patients). 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 patients would be needed to determine with greater certainty the effect of this treatment on aphasia after stroke.

Upper-Limb Motor Function

Zhang et al (2017) published a systematic review and meta-analysis evaluating the effects of rTMS on upper-limb motor function after stroke. A search through October 2016 yielded 34 RCTs with a total of 904 participants (range, 6-108 participants). Pooled estimates found improvement with rTMS for both short-term (SMD=0.43; p<0.001) and long-term (SMD=0.49; p<0.001) manual dexterity. Of the 28 studies reporting on adverse events, 25 studies noted none. Mild adverse events, such as headache and increased anxiety were reported in three studies. The review was limited by variation in TMS protocols across studies.

Graef et al (2016) reported a systematic review of rTMS combined with upper-limb training for improving function after stroke. Included were 11 sham-controlled randomized trials with 199 patients that evaluated upper-limb motor and functional status and spasticity; 8 RCTs with sufficient data were included in the meta-analysis. These studies were considered to have a low-to-moderate risk of bias. In the overall analysis, there was no benefit of rTMS on upper-limb function or spasticity (SMD=0.03; 95% CI, -0.25 to 0.32).

Section Summary: Neurologic Disorders Other Than Migraine

For individuals who have neurological disorders other than migraine (eg, amyotrophic lateral sclerosis, chronic pain, epilepsy, fibromyalgia, Parkinson disease, stroke, substance use disorder, and craving) who receive rTMS, the evidence includes numerous small RCTs and meta-analyses of these randomized trials. The relevant outcomes are symptoms, functional outcomes, and QOL. 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.

Summary of Evidence

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

For individuals who have other non-psychiatric and non-behavioral health-related disorders (eg, amyotrophic lateral sclerosis, chronic pain, epilepsy, fibromyalgia, Parkinson disease, stroke, who receive rTMS, the evidence includes numerous small RCTs and meta-analyses of these randomized trials. The 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 the effects of the technology on health outcomes.

SUPPLEMENTAL INFORMATION

Clinical Input From Physician Specialty Societies and Academic Medical Centers

While the various physician specialty societies and academic medical centers may collaborate with and make recommendations during this process, through the provision of appropriate reviewers, input received does not represent an endorsement or position statement by the physician specialty societies or academic medical centers, unless otherwise noted.

In response to requests, input was received from 1 physician specialty society and 3 academic medical centers while this policy was under review in 2014. Reviewers considered repetitive transcranial magnetic stimulation to be medically necessary for treatment-resistant depression. Input agreed with the proposed criteria for treatment of treatment-resistant depression with repetitive transcranial magnetic stimulation, as included in the policy statement.

Practice Guidelines and Position Statements

National Institute for Health and Care Excellence

The Institute (2014) provided guidance on the use of rTMS for treating and preventing migraine.^49, The guidance stated that evidence on the efficacy of TMS for the treatment of migraine was limited in quantity and for the prevention of migraine was limited in both quality and quantity. Evidence on its safety in the short- and medium-term was adequate, but there was uncertainty about the safety of long-term or frequent use of TMS.

American Academy of Neurology

The American Academy of Neurology (2006) issued practice guidelines on the evaluation and treatment of depression, psychosis, and dementia in Parkinson disease. The guidelines found the evidence insufficient to support or refute the efficacy of TMS or electroconvulsive therapy in the treatment of depression associated with Parkinson disease (level U; data inadequate or conflicting given current knowledge, treatment is unproven).

U.S. Preventive Services Task Force Recommendations

Not applicable.

Ongoing and Unpublished Clinical Trials

Some currently ongoing and unpublished trials that might influence this review are listed in Table 9.

Table 9. Summary of Key Trial

NCT No.	Trial Name	Planned Enrollment	Completion Date
NCT02910024	Theta-Burst-Stimulation in Early Rehabilitation of Stroke (TheSiReS)	150	Feb 2021

NCT: national clinical trial.]
________________________________________________________________________________________

Horizon BCBSNJ Medical Policy Development Process:

This Horizon BCBSNJ Medical Policy (the “Medical Policy”) has been developed by Horizon BCBSNJ’s Medical Policy Committee (the “Committee”) consistent with generally accepted standards of medical practice, and reflects Horizon BCBSNJ’s view of the subject health care services, supplies or procedures, and in what circumstances they are deemed to be medically necessary or experimental/ investigational in nature. This Medical Policy also considers whether and to what degree the subject health care services, supplies or procedures are clinically appropriate, in terms of type, frequency, extent, site and duration and if they are considered effective for the illnesses, injuries or diseases discussed. Where relevant, this Medical Policy considers whether the subject health care services, supplies or procedures are being requested primarily for the convenience of the covered person or the health care provider. It may also consider whether the services, supplies or procedures are more costly than an alternative service or sequence of services, supplies or procedures that are at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of the relevant illness, injury or disease. In reaching its conclusion regarding what it considers to be the generally accepted standards of medical practice, the Committee reviews and considers the following: all credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, physician and health care provider specialty society recommendations, the views of physicians and health care providers practicing in relevant clinical areas (including, but not limited to, the prevailing opinion within the appropriate specialty) and any other relevant factor as determined by applicable State and Federal laws and regulations.

___________________________________________________________________________________________________________________________

Index:
Transcranial Magnetic Stimulation as a Treatment of Disorders Other Than Psychiatric/Behavioral Health-Related Conditions
Repetitive Transcranial Magnetic Stimulation
Depression, Transcranial Magnetic Stimulation
Magnetic Stimulation, Transcranial
NeoPulse, Transcranial Magnetic Stimulation
NeuroStar, Transcranial Magnetic Stimulation
Transcranial Magnetic Stimulation, Depression
Cerena Transcranial Magnetic Stimulation Device
Brainsway H-Coil Deep Transcranial Magnetic Stimulation Device
rTMS

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

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

3. U.S. Food and Drug Administration. De novo classification request for Brainsway Deep Transcranial Magnetic Stimulation System. 2018; https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN170078.pdf. Accessed September 23, 2019.

4. 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. May 31 2013;5(5):CD008554. PMID 23728676.

5. O'Connell NE, Wand BM, Marston L, et al. Non-invasive brain stimulation techniques for chronic pain. Cochrane Database Syst Rev. Apr 11 2014;4(4):CD008208. PMID 24729198.

6. 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. PMID 29652088.

7. Chen R, Spencer DC, Weston J, et al. Transcranial magnetic stimulation for the treatment of epilepsy. Cochrane Database Syst Rev. Aug 11 2016(8):CD011025. PMID 27513825.

8. Sun W, Mao W, Meng X, et al. Low-frequency repetitive transcranial magnetic stimulation for the treatment of refractory partial epilepsy: a controlled clinical study. Epilepsia. Oct 2012;53(10):1782-1789. PMID 22950513.

9. 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. PMID 27977465.

10. 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. PMID 25686212.

11. Shirota Y, Ohtsu H, Hamada M, et al. Supplementary motor area stimulation for Parkinson disease: a randomized controlled study. Neurology. Apr 9 2013;80(15):1400-1405. PMID 23516319 Disorders.

12. Hao Z, Wang D, Zeng Y, et al. Repetitive transcranial magnetic stimulation for improving function after stroke. Cochrane Database Syst Rev. May 31 2013;5(5):CD008862. PMID 23728683.

13. 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. PMID 24429509.

14. 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. PMID 26181486.

15. Zhang L, Xing G, Fan Y, et al. Short- and long-term effects of repetitive transcranial magnetic stimulation on upper limb motor function after stroke: a systematic review and meta-analysis. Clin Rehabil. Sep 2017;31(9):1137-1153. PMID 28786336.

16. 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. PMID 27653882.

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

18. Miyasaki JM, Shannon K, Voon V, et al. Practice Parameter: evaluation and treatment of depression, psychosis, and dementia in Parkinson disease (an evidence-based review): report of the Quality Standards Subcommittee of the American Academy of Neurology. Neurology. Apr 11 2006;66(7):996-1002. PMID 16606910.

Codes:
(The list of codes is not intended to be all-inclusive and is included below for informational purposes only. Inclusion or exclusion of a procedure, diagnosis, drug or device code(s) does not constitute or imply authorization, certification, approval, offer of coverage or guarantee of payment.)

CPT*

90867
90868
90869