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Transcranial magnetic stimulation (TMS) is a non-invasive method of delivering electrical stimulation to the brain. TMS involves placement of a small coil over the scalp and passing a rapidly alternating current through the coil wire. The current produces a magnetic field that passes unimpeded through the scalp and bone, resulting in electrical stimulation that affects neuronal function. Repetitive TMS (rTMS) is being evaluated for the treatment of treatment-resistant depression (TRD) and a variety of other psychiatric/neurologic brain disorders.
Transcranial magnetic stimulation (TMS) was first introduced in 1985 as a new method of noninvasive stimulation of the brain. The technique 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; for example, 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 individual 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 treatment is usually 5 cm anterior to the motor stimulation site.
Interest in the use of transcranial magnetic stimulation 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 activity of the left dorsolateral prefrontal cortex (DLPFC) in depressed patients, and early studies suggested that high frequency (e.g., 5 -10 Hz) TMS of the left DLPFC had antidepressant effects. Low-frequency (1 - 2 Hz) stimulation of the right DLPFC 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, are also being explored. In contrast to electroconvulsive therapy, TMS does not require anesthesia and does not induce a convulsion.
Repetitive TMS (rTMS) is also being tested as a treatment for a variety of other disorders including alcohol dependence, Alzheimer disease, neuropathic pain, obsessive-compulsive disorder, postpartum depression, Parkinson disease, stroke, post-traumatic stress disorder, panic disorder, epilepsy, dysphagia, Tourette syndrome, schizophrenia, migraine, spinal cord injury, fibromyalgia, and tinnitus. (See Treatment of Tinnitus medical policy on rTMS for tinnitus.) In addition to the potential for altering interhemispheric imbalance, it has been proposed that high-frequency rTMS may facilitate neuroplasticity.
Devices for transcranial stimulation have received clearance by the U.S. Food and Drug Administration (FDA) for diagnostic uses. One device, NeoPulse® (Neuronetics, Atlanta, GA), received approval in Canada, Israel, and the United States as a therapy for depression. Initially examined by the FDA under a 510(k) application, the NeoPulse, now known as NeuroStar® TMS, received clearance for marketing as a “De Novo” device in 2008. NeuroStar® TMS is indicated for the treatment of patients with depression who have failed one 6-week course of antidepressant medication. The Brainsway™ H-Coil Deep TMS device (Brainsway Ltd.) received FDA clearance in 2013. This device is indicated for the treatment of depression in patients who have failed to respond to antidepressant medications in their current episode of depression and is a broader indication than that of the NeuroStar® TMS, which specifies the failure of 1 course of antidepressant medication.
Note: An FDA advisory panel met in January 2007 to determine if the risk-to-benefit profile for the NeoPulse was comparable to the risk-to-benefit profile of predicate electroconvulsive therapy (ECT) devices. The panel was not asked for a recommendation regarding the regulatory determination of substantial equivalence for this 510(k) submission.
In 2013, the Cerena™ TMS device (eNeura Therapeutics) was granted a de novo 510(k) classification by FDA for the acute treatment of pain associated with migraine headache with aura. Warnings, precautions, and contraindications include the following:
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.
Also, see the Vagus Nerve Stimulation medical policy.
Transcranial magnetic stimulation of the brain is considered investigational as a treatment of depression and other psychiatric/neurologic disorders such as, but not limited to, bipolar disorder, schizophrenia, obsessive-compulsive disorder, or migraine headaches.
POLICY EXCEPTIONSFederal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.
For FEP subscribers, transcranial magnetic stimulation (TMS) of the brain may be considered medically necessary to treat the symptoms of major depressive disorder (MDD) in patients with treatment-resistant depression (TRD) who have failed at least one antidepressant medication and are currently not on any antidepressant therapy.
Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
POLICY HISTORY8/2002: Approved by Medical Policy Advisory Committee (MPAC)
11/5/2003: Code Reference section updated
3/10/2006: Policy reviewed, no changes
3/15/2006: Coding updated. CPT4 2006 revisions added to policy
12/12/2006: Additional indications listed in policy section, still investigational
12/13/2006: Code reference section updated. Added CPT codes 0160T and 0161T to the non-covered codes.
1/15/2008: Policy reviewed, no changes
3/27/2008: Reviewed and approved by MPAC
1/6/2009: Policy reviewed, no changes
04/22/2010: Policy description updated regarding new treatment approaches and FDA status of devices. Policy statement unchanged. FEP verbiage added to the Policy Exceptions section.
03/07/2011: Added new CPT codes 90867 and 90868 to the Code Reference section.
04/12/2012: Policy reviewed; no changes.
04/04/2013: Policy reviewed; no changes.
08/14/2013: Added the following FEP exception for FEP subscribers: Transcranial magnetic stimulation (TMS) of the brain may be considered medically necessary to treat the symptoms of major depressive disorder (MDD) in patients with treatment-resistant depression (TRD) who have failed at least one antidepressant medication and are currently not on any antidepressant therapy. Removed deleted CPT codes 0160T and 0161T from the Code Reference section.
05/22/2015: Policy reviewed; no changes.
07/23/2015: Code Reference section updated for ICD-10.
02/11/2016: Policy description updated regarding repetitive transcranial magnetic stimulation and devices. Policy statement updated to add bipolar disorder and obsessive-compulsive disorder as investigational. Investigative definition updated in policy guidelines section.
SOURCE(S)Blue Cross Blue Shield Association Policy # 2.01.50
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.