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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; a rapidly alternating current is passed through the coil wire, producing 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 showed 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) is also being explored. TMS is also being tested as a treatment for other disorders including schizophrenia, migraine, spinal cord injury, tinnitus and fibromyalgia. In contrast to electroconvulsive therapy, TMS does not require anesthesia and does not induce a convulsion.

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.

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.

Also, see the Vagus Nerve Stimulation medical policy.  

Investigative service is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized by certifying boards and/or approving or licensing agencies or published peer review criteria as standard, effective medical practice for the treatment of the condition being treated and as such therefore is not considered medically necessary.

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

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.

Non-Covered Codes

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