LCD L33398: Transcranial Magnetic Stimulation

Abstract:

Transcranial magnetic stimulation (TMS) is a noninvasive method of brain stimulation. The technique involves placement of a small coil over the scalp and passing a rapidly alternating current through the coil wire which produces a magnetic field that passes unimpeded through the brain. Depending on stimulation parameters (frequency, intensity, pulse duration, stimulation site), repetitive TMS (rTMS) to specific cortical regions can either increase or decrease the excitability of the affected brain structures. The procedure is usually carried out in an outpatient setting and does not require anesthesia or analgesia.

Transcranial magnetic stimulation has been investigated in the treatment of various disorders, primarily depression. In 2008 the U.S. Food and Drug Administration (FDA) granted 510(k) marketing clearance as a “de novo” device (assessed as low risk, no predicate device) for NeuroStar® TMS to be utilized as a Class II rTMS device for the treatment of major depressive disorder in patients who had not responded to one adequate trial of antidepressant medication.

The FDA first allowed marketing of deep transcranial magnetic stimulation (d-TMS) for the treatment of obsessive-compulsive disorder in August 2018. [FDA.gov (dTMS)] Deep transcranial magnetic stimulation (d-TMS) uses magnetic pulses to target specific areas of the brain that have been implicated in certain conditions.

Indications and Limitations:

Indications:

Repetitive transcranial magnetic stimulation (rTMS) is only considered medically necessary in adults who have a confirmed diagnosis of major depressive disorder (MDD), single or recurrent episode and meet the following criteria:

One or more of the following:

• Resistance to treatment with psychopharmacologic agents as evidenced by a lack of a clinically significant response to one trial of psychopharmacologic agents in the current depressive episode from at least two different agent classes. Each agent in the treatment trial must have been administered at an adequate course of mono- or poly-drug therapy; or

• Inability to tolerate psychopharmacologic agents as evidenced by two trials of psychopharmacologic agents from at least two different agent classes, with distinct side effects; or

• History of response to rTMS in a previous depressive episode; or

• If patient is currently receiving electro-convulsive therapy, rTMS may be considered reasonable and necessary as a less invasive treatment option.

AND

A trial of an evidence-based psychotherapy known to be effective in the treatment of MDD of an adequate frequency and duration without significant improvement in depressive symptoms as documented by standardized rating scales that reliably measure depressive symptoms.

AND

The order for treatment (or retreatment) is written by a physician (MD or DO) who has examined the patient and reviewed the record. The physician will have experience in administering TMS therapy. The treatment shall be given under direct supervision of this physician (physician present in the area but does not necessarily personally provide the treatment).

• Non-physician practitioners (NPPs) providers may order treatment (or retreatment) if it is within the scope of practice of the NPP in the state they are licensed. It is expected that the NPP has examined the patient, reviewed the record and has experience administering TMS therapy.

AND

The rTMS treatment is delivered by a device that is FDA-approved or –cleared for the treatment of MDD in a safe and effective manner. rTMS treatment should generally follow the protocol and parameters specified in the manufacturer’s user manual, with modifications only as supported by the published scientific evidence base.

Limitations:

The benefits of TMS use must be carefully considered against the risk of potential side effects in patients with any of the following:

• Seizure disorder or any history of seizures (except those induced by ECT or isolated febrile seizures in infancy without subsequent treatment or recurrence); or

• Presence of acute or chronic psychotic symptoms or disorders (such as schizophrenia, schizophreniform or schizoaffective disorder) in the current depressive episode; or

• Neurological conditions that include epilepsy, cerebrovascular disease, dementia, increased intracranial pressure, history of repetitive or severe head trauma, or primary or secondary tumors in the central nervous system, or

• Presence of an implanted magnetic-sensitive medical device located less than or equal to 30 cm from the TMS magnetic coil or other implanted metal items including, but not limited to a cochlear implant, implanted cardiac defibrillator (ICD), pacemaker, Vagus nerve stimulator (VNS), or metal aneurysm clips or coils, staples or stents. (Dental amalgam fillings are not affected by the magnetic field and are acceptable for use with TMS).

• Maintenance therapy is not currently supported by evidence from clinical trials and therefore, is considered not reasonable and necessary.

• All other conditions not included in the above list of “Indications.”

Deep TMS (d-TMS) is not considered reasonable and necessary for Obsessive Compulsive Disorder (OCD).

Retreatment

Retreatment may be considered for patients who met the guidelines for initial treatment and subsequently developed relapse of depressive symptoms if the patient responded to prior treatments as evidenced by a greater than 50% improvement in standard rating scale measurements for depressive symptoms.

Blue Cross Blue Shield TEC Assessments. Transcranial Magnetic Stimulation for Depression (October 2009, In Press, April 2011): The Blue Cross and Blue Shield Association performed an extensive literature review to evaluate the efficacy of transcranial magnetic stimulation for depression and published its findings as a TEC Assessment in 2009. The Blue Cross and Blue Shield Association Medical Advisory Panel concluded that “transcranial magnetic stimulation for the treatment of depression does not meet the TEC criteria.” In 2011 an updated report was issued. Literature was reviewed through January 2011 and meta-analyses of sham-controlled studies of TMS were selected for review to determine whether TMS therapy was effective for the treatment of depression.

The authors concluded that although the meta-analyses and recent clinical trials of TMS generally show statistically significant effects on depression outcomes at the end of the TMS treatment period (1–4 weeks), there is a lack of rigorous evaluation beyond the period of treatment. Therefore, the Advisory Panel concluded that “the available evidence does not permit conclusions regarding the effect of TMS on health outcomes or compared with alternatives.” (Blue Cross Blue Shield TEC Assessment, Transcranial Magnetic Stimulation for Depression. In Press, April 2011)

O’Reardon (2007) conducted a study under an Investigational Device Exemption (IDE) from the U.S. Food and Drug Administration (FDA) to determine whether repetitive transcranial magnetic stimulation (rTMS) over the left dorsolateral prefrontal cortex (DLPFC) was effective and safe.

Three hundred and one (301) patients with major depressive disorder (MDD) were enrolled at 23 study sites and randomized to either active or sham rTMS. Treatment and rating personnel were blinded to patient assignments. Eligible patients were antidepressant medication-free, aged 18-70, with a single or recurrent MDD episode and a current MDD episode duration of three (3) years or less. Treatments occurred daily five days a week for six (6) weeks followed by a tapering period of three additional weeks during which time patients were begun on an antidepressant. Subjects achieving less than a 25% reduction on the Hamilton Depression Rating Scale-17 (HAMD-17) at four weeks could crossover to an open-label, acute treatment extension study. The primary outcome was the difference between active and sham TMS using the last visit Montgomery-Asberg Depression Rating Scale (MADRS). Secondary outcomes included changes on the 17- and 24-item Hamilton Depression Rating Scale and response and remission rates using the MADRS and HAMD.