Repetitive transcranial magnetic stimulation (rTMS) of the brain may be considered medically necessary as a treatment of major depressive disorder when ALL of the following conditions have been met:

• Confirmed diagnosis of severe major depressive disorder (single or recurrent) documented by standardized rating scales that reliably measure depressive symptoms; and
• ANY ONE of the following:
  • Failure of 4 trials of psychopharmacologic agents including 2 different agent classes and 2 augmentation trials; or
  • Inability to tolerate a therapeutic dose of medications as evidenced by 4 trials of psychopharmacologic agents with distinct side effects; or
  • History of response to rTMS in a previous depressive episode (at least 3 months since the prior episode); or
  • Is a candidate for electroconvulsive therapy (ECT) and ECT would not be clinically superior to rTMS (e.g., in cases with psychosis, acute suicidal risk, catatonia or life-threatening inanition rTMS should NOT be utilized);

AND

• Failure of a trial of a psychotherapy known to be effective in the treatment of major depressive disorder of an adequate frequency and duration, without significant improvement in depressive symptoms, as documented by standardized rating scales that reliably measure depressive symptoms; and
• None of the following conditions are present:
  • Seizure disorder or any history of seizure with increased risk of future seizure; or
  • Presence of acute or chronic psychotic symptoms or disorders (such as schizophrenia, schizophreniform or schizoaffective disorder) in the current depressive episode; or
  • Neurologic conditions that include epilepsy, cerebrovascular disease, dementia, increased intracranial pressure, having a history of repetitive or severe head trauma, or with primary or secondary tumors in the central nervous system (CNS); or
  • Presence of an implanted magnetic-sensitive medical device located 30 centimeters or less from the TMS magnetic coil or other implanted metal items, including but not limited to a cochlear implant, implanted cardioverter defibrillator (ICD), pacemaker, vagus nerve stimulator, or metal aneurysm clips or coils, staples, or stents.

rTMS should be performed using an FDA-cleared device in appropriately selected patients, by physicians who are adequately trained and experienced in the specific techniques used. A treatment course should not exceed 5 days a week for 6 weeks (total of 30 sessions), followed by a 3-week taper of 3 TMS treatments in week 1, 2 TMS treatments the next week, and 1 TMS treatment in the last week.

All of the following should be present for the administration of rTMS and documented in the medical record and available upon request:

• An attendant trained in basic cardiac life support and the management of complications such as seizures, as well as the use of the equipment must be present at all times; and
• Adequate resuscitation equipment including, for example, suction and oxygen; and
• The facility must maintain awareness of response times of emergency services (either fire/ambulance or “code team”), which should be available within five minutes. These relationships are reviewed on at least a one year basis and include mock drills.

rTMS for major depressive disorder that does not meet the criteria listed above is considered experimental/investigational and therefore, not covered. A participating, preferred, or network provider can bill the member for the non-covered service.

Continued treatment with rTMS of the brain as maintenance therapy is considered experimental/investigational and therefore, not covered. A participating, preferred, or network provider can bill the member for the non-covered service.

Transcranial magnetic stimulation of the brain is considered experimental/investigational and therefore not covered for any other indication. There is insufficient evidence in medical literature to support the effectiveness of this procedure.  A participating, preferred, or network provider can bill the member for the denied service.

Place of Service: Outpatient

TMS is typically an outpatient procedure which is only eligible for coverage as an inpatient procedure in special circumstances including, but not limited to the presence of a co-morbid condition that would require monitoring in a more controlled environment such as the inpatient setting.

Description

Transcranial magnetic stimulation (TMS) is a method of  noninvasive stimulation of the brain through a small coil placed over the scalp. A rapidly alternating current is then 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. This “motor threshold” (MT), which is the minimum intensity of stimulation required to induce a motor response, is empirically determined for each individual by gradually increasing the intensity of stimulation. TMS has been investigated as a treatment for major depressive disorders that are resistant to treatment. It is also being tested as a treatment for other disorders including, but not limited to, schizophrenia, obsessive-compulsive disorder, and bulimia.

This medical policy may not apply to FEP. Medical policy is not an authorization, certification, explanation of benefits, or a contract. Benefits are determined by the Federal Employee Program.