LCD L34869: Repetitive Transcranial Magnetic Stimulation (rTMS) in Adults

Transcranial Magnetic Stimulation (TMS) is a non-invasive treatment that uses pulsed magnetic fields to induce an electric current in a localized region of the cerebral cortex. An electromagnetic coil placed on the scalp induces focal current in the brain that temporarily modulates cerebral cortical function. Capacitor discharge provides electrical current in alternating on/off pulses. Stimulation parameters may be adjusted to alter the excitability of the targeted structures in specific cortical regions. Repetitive TMS (rTMS) has been investigated as treatment for pharmacoresistant depression.

TMS parameters include cranial location, stimulation frequency, duration, and intensity. TMS is delivered in outpatient settings without anesthesia or analgesia. Typically for the treatment of depression, the coil is located over the left prefrontal cortex. The rTMS is performed daily (weekdays) for 6 weeks. There is no need for anesthesia or analgesia and there are no restrictions about activities before or after treatment (e.g., driving, working, operating heavy machinery).

When used as an antidepressant therapy, TMS produces a clinical benefit without the systemic side effects attendant with standard oral medications. TMS does not have adverse effects on cognition. Unlike electroconvulsive therapy (ECT), rTMS does not induce amnesia or seizures.

Indications for Coverage

TMS may be covered if prescribed and administered by a licensed physician who is knowledgeable in the use of rTMS. Outpatient rTMS may be indicated for patients with Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) defined Major Depressive Disorder (MDD) who have failed to benefit from initial treatment of their depression.

Initial Treatment

Left prefrontal rTMS of the brain is considered medically necessary for use in an adult who meets #1 and #2 of the following criteria:

1. Has a confirmed diagnosis of severe MDD single or recurrent episode; and

2. One or more of the following:

• Resistance to treatment with psychopharmacologic agents as evidenced by a lack of a clinically significant response to 2 trials of psychopharmacologic agents in the current depressive episode from at least 2 different agent classes. At least 1 of the treatment trials must have been administered at an adequate course of mono- or poly-drug therapy; or

• Inability to tolerate psychopharmacologic agents as evidenced by 2 trials of psychopharmacologic agents from at least 2 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

3. 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

4. The order for treatment (or retreatment) is written by a psychiatrist (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).

TMS for Obsessive Compulsive Disorder (OCD) may be covered if prescribed and administered by a licensed physician who is knowledgeable in the use of rTMS. Outpatient rTMS may be indicated for patients with DSM-5 defined OCD who have failed to benefit from initial treatment of their OCD.

Initial Treatment:

rTMS of the brain is considered medically necessary for use in an adult who meets #1 and #2 of the following criteria:

1. Has a confirmed diagnosis of OCD as per DSM-5 criteria; and

2. One or more of the following:

• Resistance to treatment with psychopharmacologic agents as evidenced by a lack of a clinically significant response to a trial of 2 distinct psychopharmacologic agents, administered for a minimum of 8 weeks; or

• Inability to tolerate psychopharmacologic agents as evidenced by trials of psychopharmacologic agents from 2 distinct psychopharmacologic agents; or

• History of response to TMS for OCD in the past that was clinically meaningful; or

• If patient is currently receiving antipsychotics, opioids, benzodiazepines, glutamatergic agents or other agents which could be considered investigational or risky treatments, TMS may be considered reasonable and necessary as a safer treatment option.

AND

3. A trial of an evidence-based psychotherapy known to be effective in the treatment of OCD for a minimum of 8 weeks duration without significant improvement in OCD symptoms as documented by standardized rating scales that reliably measure OCD symptoms.

AND

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

The Brainsway Deep TMS System is 1 TMS System for OCD, however any TMS system that has received FDA clearance for treatment of OCD may be utilized.

Coverage 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.

Retreatment

Retreatment for MDD 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, (e.g., Geriatric Depression Scale (GDS), Patient Health Questionnaire Depression Scale (PHQ-9), Beck Depression Inventory (BDI), Hamilton Rating Scale for Depression (HAM-D), Montgomery-Asberg Depression Rating Scale (MADRS), Quick Inventory of Depressive Symptomatology (QIDS) or Inventory of Depressive Symptomatology-Systems Review (IDS-SR).

Retreatment for OCD may be considered for patients who met the guidelines for initial treatment and experienced at least a 30% reduction in the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) score, as long as the improvement persisted for at least 1 month after the prior treatments ended.

All other uses of TMS are experimental and are not covered.

Two articles regarding meta-analyses of studies pertaining to the use of rTMS for maintenance therapy in treatment resistant MDD in the absence of relapse or recurrence of symptoms were presented in support of a request for Medicare coverage for the use of rTMS in patients who have responded to a previous course(s) of rTMS as ongoing maintenance therapy without recurrence of symptoms of depression.

Review of the first meta-analysis “Durability of antidepressant response to repetitive transcranial magnetic stimulation: Systemic review and meta-analysis” 1 reveals a number of weaknesses that would bring into question the results of a comparison of the data that this article includes. Those weaknesses include:

• Maintenance rTMS was defined as any rTMS session delivered after the induction cycle. There is no differentiation of maintenance in the asymptomatic patient versus a patient in relapse of major depression.

• The few randomized controlled clinical trials (RCT) included in the meta-analysis had either very small numbers of enrolled subjects or had serious design flaws.