This policy became effective 07/01/2019.
The policy was updated to reflect Magellan Healthcare's revised Guidelines. These Guidelines are effective from 07/01/2019, and are available online at: https://www.magellanprovider.com/media/45694/mcg.pdf .
When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.
This Medical Policy Bulletin document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy Bulletin will be reviewed regularly and be updated as scientific and medical literature becomes available. For more information on how Medical Policy Bulletins are developed, go to the About This Site section of this Medical Policy Web site.
TRANSCRANIAL MAGNETIC STIMULATION (TMS) FOR BEHAVIORAL HEALTH CONDITIONS
The Company has delegated the responsibility for utilization management activities for behavioral health services to the contracted behavioral health vendor. TMS for certain behavioral health conditions may be considered medically necessary. Refer to the contracted behavioral health/mental health vendor for complete medically necessary criteria.
TRANSCRANIAL MAGNETIC STIMULATION (TMS) FOR MEDICAL CONDITIONS
TMS for medical conditions including but not limited to, Alzheimer disease, amyotrophic lateral sclerosis, chronic pain, epilepsy, fibromyalgia, migraine headache, Parkinson disease, multiple sclerosis, stroke, is 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 US Food and Drug Administration (FDA) has approved TMS for acute treatment of pain associated with migraine headache with aura, 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 is considered experimental/investigational by the Company and not covered.
Subject to the terms and conditions of the applicable benefit contract, transcranial magnetic stimulation (TMS) for medical conditions is not eligible for payment under the medical benefits of the Company’s products because the service is considered experimental/investigational and, therefore, not covered.
Services that are experimental/investigational are a benefit contract exclusion for all products of the Company. Therefore, they are not eligible for reimbursement consideration.
US FOOD AND DRUG ADMINISTRATION (FDA) STATUS
There are numerous devices approved by the FDA for the acute treatment of pain associated with migraine headache with aura.
The evidence for TMS in individuals who have medical conditions such as neurologic disorders/conditions include numerous small randomized trials. Relevant outcomes are symptoms, functional outcomes, and quality of life. Examples of medical conditions include Alzheimer disease, amyotrophic lateral sclerosis, chronic pain, epilepsy, fibromyalgia, chronic and migraine headache, Parkinson disease, and stroke-induced paralysis or dysphagia.
In 2012, Ahmed et al. randomized 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 three 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/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 six weeks over six different brain areas, followed by biweekly sessions for three 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 six 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 six 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 randomized trials with larger sample size and long-term follow-up.
AMYOTROPHIC LATERAL SCLEROSIS OR MOTOR NEURON DISEASE
In 2013, Fang et al. identified three randomized controlled trials (RCTs) with a total of 50 participants with amyotrophic lateral sclerosis (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.
In 2014, O'Connell NE 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.
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 randomized into two groups; one group received two 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 eight weeks after the end of treatment. With intention to treat 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.
In 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.
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 C 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 et al. 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 three months post treatment. 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 one week to one 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.
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.
A 2015 meta-analysis by Chou YH et al. included 20 sham-controlled RCTs with a total of 470 participants with Parkinson disease. Sample sizes ranged from 8 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 randomized 106 individuals to eight weeks of 1-Hz rTMS, 10-Hz rTMS, or sham stimulation over the supplementary motor area. At nine 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.
Centonze et al. (2007) examined if 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 cortico-spinal 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 two-week period. Clinical improvement was long-lasting (at least seven days after the end of treatment) when individuals underwent five Hz rTMS treatment during a two-week protocol. No effect was obtained after a two-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.
Amatya et al. (2013) reviewed RCTs that reported non-pharmacological 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 non-pharmacologic interventions such as TMS for multiple sclerosis.
A 2013 Cochrane review BY Hao Z 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 Q 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 (five days to 10 years), in the frequency of rTMS applied (1 Hz to 25 Hz for one 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 Y 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 non-invasive brain stimulation, including TMS on post-stroke dysphagia. The authors concluded that non-invasive brain stimulation appears to assist cortical reorganization in post-stroke dysphagia, but emerging factors highlight the need for more data. The authors indicated that, based on this preliminary review, non-invasive brain stimulation facilitated recovery in post-stroke dysphagia but should not yet be considered for clinical use outside of clinical trials.
The available clinical trials for TMS as a treatment for medical conditions including but not limited to, Alzheimer disease, amyotrophic lateral sclerosis, 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.
The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.
In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.
The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.