Coverage Policies

Effective Date:

a)    This policy will apply to all services performed on or after the above revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

1.    Transcranial magnetic stimulation (TMS) is a non-invasive method of induction of a focal current in the brain and transient modulation of the function of the targeted cerebral cortex used to treat depression and other mental problems.

2.    TMS requires pre-authorization, and is only covered for major disabling depression not responsive to other forms of treatment.

I.     Repetitive Transcranial magnetic stimulation (rTMS) requires pre-authorization and is considered medically necessary when all of the following are met:  

A.   Age ≥ 18 years with a diagnosis of major depressive disorder without psychosis;

B.   Oversight of treatment is provided by a licensed psychiatrist;

C.   Failure to respond to a combination of multiple trials of medication and evidence based psychotherapy treatment during the current episode of illness, with the Physician’s Health Questionaire-9 (PHQ-9) score of > 15 throughout the current course of treatment (or other standardized scale indicating moderately severe to severe depression);

D.   The major depressive disorder diagnosis is not part of a presentation with multiple psychiatric comorbidities that could masquerade as major depression symptoms;

E.   Failure of or intolerance to psychopharmacologic agents, choose one:

1.    Failure of psychopharmacologic agents, both of the following:

a.    Lack of clinically significant response in the current depressive episode to four trials of agents from at least two different agent classes;

b.    At least two of the treatment trials were administered as an adequate course of mono- or poly-drug therapy with antidepressants, involving standard therapeutic doses of at least 6 weeks duration;

2.    The patient is unable to take anti-depressants due to one of the following:

a.    Drug interactions with medically necessary medications;

b.    Inability to tolerate psychopharmacologic agents, as evidenced by trials of four such agents with distinct side effects in the current episode;

F.    Failure of an evidence based psychotherapy such as a formal trial of cognitive behavioral therapy and/or interpersonal therapy;

G.   Failure of an adequate trial of electroconvulsive therapy (ECT) unless its use is contraindicated or physician documentation states why TMS is clinically preferable;

H.   The initial request can be reviewed for up to 20 TMS sessions.

II.    Additional sessions of TMS also require prior authorization are considered medically necessary when all of the following criteria are met:

A.   when there has been a positive treatment response, evidenced by a ≥25% reduction of depression symptom severity, as measured by the Physician’s Health Questionaire-9 (PHQ-9) score (or other  standardized depression scale), Up to 10 additional sessions may be authorized.

B.   For patients who demonstrated >50% reduction in baseline severity scores who are approaching PHQ-9 scores of 9 or for those who have a history of good response to TMS followed by relapse into depression over a 6 months period, authorization of up to 6 taper TMS sessions over a period 3 weeks will be considered. 

Clinical documentation of the above treatment failures covering the previous 18 months of treatment must be submitted along with the prior authorization request for TMS. 

Limitations:

1.    Use of TMS is not indicated in patients with:

1. Seizure disorder, or
2. A vagus nerve stimulator, or
3. An implanted medical device or metal in close proximity to the brain. Transcranial magnetic stimulation is considered experimental and investigational and is not covered for indications listed below (Note: This is not an all-inclusive list):

·         Depressive disorder that does not meet above criteria

·         Patients with psychotic symptoms

·         Alzheimer`s disease

·         Amyotrophic lateral sclerosis

·         Anxiety disorders

·         Auditory verbal hallucinations

·         Autism

·         Blepharospasm

·         Bulimia nervosa

·         Chronic pain

·         Dystonia

·         Fibromyalgia

·         Levodopa-induced dyskinesia

·         Migraine

·         Neuropathic pain

·         Obsessive-compulsive disorder

·         Panic disorder

·         Parkinson disease

·         Post-stroke dysphagia

·         Schizophrenia

·         Smell and taste dysfunction (e.g., phantosmia and phantageusia)

·         Spasticity

·         Stroke treatment (e.g., motor impairment, post-stroke aphasia, and post-stroke hemiplegia)

·         Tourette syndrome

·         Tinnitus

·         Traumatic brain injury.

2.    Navigated transcranial magnetic stimulation is considered experimental and investigational for motor function mapping and/or treatment planning of neurological diseases/disorders (e.g., epilepsy, and resection of brain tumors) because its value and effectiveness has not been established.

1.    Cranial electrical stimulation (also known as cerebral electrotherapy, craniofacial electrostimulation, electric cerebral stimulation, electrosleep, electrotherapeutic sleep, transcerebral electrotherapy, transcranial electrotherapy, as well as the Liss Body Stimulator that is used to treat alcoholism) is considered experimental and investigational because its value and effectiveness has not been established. It is not covered for any indication, including the following (not an all-inclusive list):

·         Alcoholism

·         Alzheimer`s disease

·         Autism

·         Chemical dependency

·         Chronic pain

·         Dementia

·         Depression

·         Headaches

·         Fibromyalgia

·         Mood and sleep disturbances

·         Neuropathic pain

·         Parkinson disease

·         Stroke treatment (e.g., motor impairment, post-stroke aphasia, and post-stroke hemiplegia)

·         Traumatic brain injury

·         Visual rehabilitation

Codes Used In This BI:

0310T             Motor function mapping using non-invasive TMS (Code term 01/01/2018 and replaced by 64999)

90867             Therapeutic repetitive TMS treatment; initial

90868             Subsequent delivery and management

90869             Subsequent motor threshold re-determination

64999            Unlisted procedure, nervous system

1.    Use of TMS is not indicated in patients with:

1. Seizure disorder, or
2. A vagus nerve stimulator, or
3. An implanted medical device or metal in close proximity to the brain. Transcranial magnetic stimulation is considered experimental and investigational and is not covered for indications listed below. Note: This is not an all-inclusive list.

·         Alzheimer`s disease

·         Amyotrophic lateral sclerosis

·         Anxiety disorders

·         Auditory verbal hallucinations

·         Autism

·         Blepharospasm

·         Bulimia nervosa

·         Chronic pain

·         Depressive disorder that does not meet above criteria

·         Dystonia

·         Fibromyalgia

·         Levodopa-induced dyskinesia

·         Migraine

·         Mood disorders

·         Neuropathic pain

·         Obsessive-compulsive disorder

·         Panic disorder

·         Parkinson disease

·         Patients with psychotic symptoms

·         Post-stroke dysphagia

·         Schizophrenia

·         Smell and taste dysfunction (e.g., phantosmia and phantageusia)

·         Spasticity

·         Stroke treatment (e.g., motor impairment, post-stroke aphasia, and post-stroke hemiplegia)

·         Tourette syndrome

·         Tinnitus

·         Traumatic brain injury

2.    Navigated transcranial magnetic stimulation is considered experimental and investigational for motor function mapping and/or treatment planning of neurological diseases/disorders (e.g., epilepsy, and resection of brain tumors) because its value and effectiveness has not been established.

3.    Cranial electrical stimulation (also known as cerebral electrotherapy, craniofacial electrostimulation, electric cerebral stimulation, electrosleep, electrotherapeutic sleep, transcerebral electrotherapy, transcranial electrotherapy, as well as the Liss Body Stimulator that is used to treat alcoholism) is considered experimental and investigational because its value and effectiveness has not been established. It is not covered for any indication, including the following. Note: This is not an all-inclusive list.

·         Alcoholism

·         Alzheimer`s disease

·         Autism

·         Chemical dependency

·         Chronic pain

·         Dementia

·         Depression

·         Headaches

·         Fibromyalgia

·         Mood and sleep disturbances

·         Neuropathic pain

·         Parkinson disease

·         Stroke treatment (e.g., motor impairment, post-stroke aphasia, and post-stroke hemiplegia)

·         Traumatic brain injury

·         Visual rehabilitation

Transcranial magnetic stimulation has been investigated in the treatment of various psychiatric disorders, especially depression. This procedure is usually carried out in an outpatient setting. In contrast to electroconvulsive therapy, TMS does not require anesthesia or analgesia. Furthermore, it does not affect memory and usually does not cause seizures. Martin et al (2003) conducted a systematic review of randomized controlled trials that compared rTMS with sham in patients with depression. The authors concluded that current trials are of low quality and provide insufficient evidence to support the use of rTMS in the treatment of depression. This is in accordance with the observations of Fitzgerald and colleagues (2002) who noted that TMS has a considerable role in neuropsychiatric research. It appears to have considerable potential as a therapeutic tool in depression, and perhaps a role in several other disorders, although widespread application requires larger trials and establishment of sustained response, as well as Gershon et al (2003) who stated that TMS shows promise as a novel anti-depressant treatment. Systematic and large-scale studies are needed to identify patient populations most likely to benefit and treatment parameters most likely to produce success.

An Agency for Healthcare Research and Quality`s review (Gaynes et al, 2011) reported that there is insufficient evidence to evaluate whether non-pharmacological treatments are effective for TRD. The review summarized evidence of the effectiveness of 4 non-pharmacological treatments: (i) ECT, (ii) rTMS, (iii) VNS, and (iv) Cognitive behavioral therapy (CBT) or inter-personal psychotherapy. With respect to maintaining remission (or preventing relapse), there were no direct comparisons (evidence) involving ECT, rTMS, VNS, or CBT. With regard to indirect evidence, there were 3 fair trials compared rTMS with a sham procedure and found no significant differences, however, too few patients were followed during the relapse prevention phases in 2 of the 3 studies (20-week and 6-month follow-up) and patients in the 3rd study (3-month follow-up) received a co-intervention providing insufficient evidence for a conclusion. There were no eligible studies for ECT, VNS or psychotherapy. The review concluded that that comparative clinical research on non-pharmacologic interventions in a TRD population is early in its infancy, and many clinical questions about efficacy and effectiveness remain unanswered. Interpretation of the data is substantially hindered by varying definitions of TRD and the paucity of relevant studies. The greatest volume of evidence is for ECT and rTMS. However, even for the few comparisons of treatments that are supported by some evidence, the strength of evidence is low for benefits, reflecting low confidence that the evidence reflects the true effect and indicating that further research is likely to change our confidence in these findings. This finding of low strength is most notable in 2 cases: ECT and rTMS did not produce different clinical outcomes in TRD, and ECT produced better outcomes than pharmacotherapy. No trials directly compared the likelihood of maintaining remission for non-pharmacologic interventions. The few trials addressing adverse events, subpopulations, subtypes, and health-related outcomes provided low or insufficient evidence of differences between non-pharmacologic interventions. The most urgent next steps for research are to apply a consistent definition of TRD, to conduct more head-to-head clinical trials comparing non-pharmacologic interventions with themselves and with pharmacologic treatments, and to delineate carefully the number of treatment failures following a treatment attempt of adequate dose and duration in the current episode. There is also a lack of scientific evidence in the use of TMS as a diagnostic tool for psychiatric disorders, and treatment for chronic pain. Pridmore et al (2005) stated that in studies of TMS for the treatment of chronic pain, there is some evidence that temporary relief can be achieved in a proportion of sufferers. Work to this point is encouraging, but systematic assessment of stimulation parameters is necessary if TMS is to attain a role in the treatment of chronic pain. Furthermore, Canavero and Bonicalzi (2005) noted that TMS has no role in the management of patients with central pain, a major chronic pain syndrome.

In 2014, Dunner et al reported 1 year follow-up with maintenance therapy from a large multicenter observational study (42 sites) of rTMS for patients with TRD (Dunner, 2014). A total of 257 patients agreed to participate in the follow-up study out of 307 who were initially treated with rTMS. Of these, 205 completed the 12-month follow-up, and 120 patients had met the Inventory of Depressive Symptoms-Self Report (IDS-SR) response or remission criteria at the end of treatment. Ninety-three of the 257 patients (36.2%) who enrolled in the follow-up study received additional rTMS (mean of 16.2 sessions). Seventy-five of the 120 patients (62.5%) who met response or remission criteria at the end of the initial treatment phase (including a 2 month taper phase) continued to meet response criteria through follow-up.

The literature on repetitive TMS (rTMS) for treatment-resistant depression (TRD) includes numerous double-blind, randomized sham-controlled short-term trials. Results of these trials show mean improvements of uncertain clinical significance across groups as a whole. The percentage of subjects who show a clinically significant response is reported at approximately 2 to 3 times that of sham controls, with approximately 15% to 25% of patients meeting the definition of clinical response. Based on the short-term benefit observed in randomized controlled trials, clinical input, and the lack of alternative treatments aside from electroconvulsive therapy (ECT) in patients with treatment resistant depression, rTMS meets primary coverage criteria in patients with TRD who meet specific criteria.

1. Gaynes BN, Lux L, Lloyd S, et al. Nonpharmacological interventions for treatment-resistant depression in adults. Comparative effectiveness review No. 33. (Prepared by RTI International-University of North Carolina (RTI-UNC) Evidence based Practice Center under Contract No. 290-02-0016I). AHRQ Publication No. 11-EHC056-EF. Rockville, MD: Agency for Healthcare Research and Quality. September 2011. Available at: http://www.effectivehealthcare.ahrq.gov/ehc/products/76/787/Treatment-Resistant-Depression_executivesummary.pdf
2. Henkin RI, Potolicchio SJ Jr, Levy LM. Improvement in smell and taste dysfunction after repetitive transcranial magnetic stimulation. Am J Otolaryngol. 2011; 32(1):38-46.
3. Meng Z, Liu S, Zheng Y, Phillips JS. Repetitive transcranial magnetic stimulation for tinnitus. Cochrane Database Syst Rev. 2011; (10):CD007946.
4. Guo 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. 2011; (9):CD008554.
5. Freitas C, Mondragón-Llorca H, Pascual-Leone A. Noninvasive brain stimulation in Alzheimer`s disease: Systematic review and perspectives for the future. Exp Gerontol. 2011; 46(8):611-627.
6. Avenanti A, Coccia M, Ladavas E, et al. Low-frequency rTMS promotes use-dependent motor plasticity in chronic stroke: A randomized trial. Neurology. 2012; 78(4):256-264.
7. Corti M, Patten C, Triggs W. Repetitive transcranial magnetic stimulation of motor cortex after stroke: A focused review. Am J Phys Med Rehabil. 2012; 91(3):254-270.
8. Steeves T, McKinlay BD, Gorman D, et al. Canadian guidelines for the evidence-based treatment of tic disorders: Behavioural therapy, deep brain stimulation, and transcranial magnetic stimulation. Can J Psychiatry. 2012; 57(3):144-151.
9. Kupfer DJ, Frank E, Phillips ML. Major depressive disorder: New clinical, neurobiological, and treatment perspectives. Lancet. 2012; 379(9820):1045-1055.
10. Leung A, Donohue M, Xu R, et al. rTMS for suppressing neuropathic pain: A meta-analysis. J Pain. 2009; 10(12):1205-1216.
11. Schneider SA, Pleger B, Draganski B, et al. Modulatory effects of 5Hz rTMS over the primary somatosensory cortex in focal dystonia -- an fMRI-TMS study. Mov Disord. 2010; 25(1):76-83.
12. Allan CL, Herrmann LL, Ebmeier KP. Transcranial magnetic stimulation in the management of mood disorders. Neuropsychobiology 2011; 64(3):163-169.
13. Szaflarski JP, Vannest J, Wu SW, et al. Excitatory repetitive transcranial magnetic stimulation induces improvements in chronic post-stroke aphasia. Med Sci Monit. 2011; 17(3):CR132-CR139.
14. Short EB, Borckardt JJ, Anderson BS, et al. Ten sessions of adjunctive left prefrontal rTMS significantly reduces fibromyalgia pain: A randomized, controlled pilot study. Pain. 2011; 152(11):2477-2484.
15. Peng Z, Chen XQ, Gong SS. Effectiveness of repetitive transcranial magnetic stimulation for chronic tinnitus: A systematic review. Otolaryngol Head Neck Surg. 2012; 147(5):817-825.
16. Plewnia C, Vonthein R, Wasserka B, et al. Treatment of chronic tinnitus with theta burst stimulation: A randomized controlled trial. Neurology. 2012; 78(21):1628-1634.
17. Triggs WJ, Hajioff D. Transcranial magnetic stimulation for tinnitus: No better than sham treatment? Neurology. 2012; 78(21):1624-1625.

Addendum:

1.    Effective 05/01/2017: Added verbiage for diagnosis of severe major depressive disorder (single or recurrent) to be documented by standardized rating scales.

2.    Effective 01/01/2018: Request for TMS requires failure of at least three different drug regimens from two different drug classes. Also, prior authorization request will require submission of clinical documentation of drug treatment failures covering the previous 18 months of treatment.

3.    Effective 3/1/2021: TMS requires failure or intolerance to adequate pharmacotherapy, psychotherapy and documentation by ordering physician for reasons for ECT to not be clinically appropriate for the member.

Updated to show 0310T termed 01/01/2018 and replaced by code 64999.

EOC Statement:

 See investigational section.