Transcranial Magnetic Stimulation (TMS) in the Treatment of Adults with Major Depressive Disorder

Jurisdiction: JL MAC Part B. States: Delaware, District of Columbia, Maryland, New Jersey, Pennsylvania. Type: Active LCD

Compliance with the provisions in this policy may be monitored and addressed through post payment data analysis and subsequent medical review audits. History/Background and/or General Information Transcranial Magnetic Stimulation (TMS) is FDA approved for the treatment of depression and obsessive-compulsive disorders. 1-3 It is a non-invasive procedure that uses pulsed magnetic fields to induce an electric current in a localized region of the cerebral cortex. 4-7 An electromagnetic coil is placed on the scalp inducing a focal current into the brain that temporarily modulates cerebral cortical function. A capacitor discharge provides electrical current in an alternating on/off pulse. Based on stimulation parameters this may be adjusted to alter the excitability of the targeted structures in specific cortical regions. 8 The electromagnetic current parameters include cranial location, frequency, strength, width, and volume dependent on the motor threshold that is individualized for each patient. 1,2 TMS is delivered daily in an outpatient setting without anesthesia or analgesia for up to six weeks and there are no restrictions related to activities before or after treatment (e.g., driving, working, operating heavy machinery). 9 Definitions Major Depressive Disorder: The diagnosis that is based on the definition in the current Diagnostic and Statistical Manual of Mental Disorders (DSM). It is based on symptoms, characteristics, and requirements that are needed in order to be diagnosed with depression. Major Depressive Disorder – Severe: A subcategory of major depressive disorder as differentiated within the DSM manual from mild, moderate, and severe. For example: “The number of symptoms is substantially in excess of that required to make the diagnosis, the intensity of the symptoms is seriously distressing and unmanageable, and the symptoms markedly interfere with social and occupational functioning.” 10 Failure of a trial of a pharmacological agent: The failure of one or more psychopharmacological medications that are administered at both an adequate dose and adequate duration that are consistent with the FDA label and with a duration that would elicit a favorable response. 9,11-13 Intolerance of a psychopharmacologic agent: Intolerable side effect(s) that are not expected to diminish or resolve with continued administration of the medication. 5,14,15 Motor Threshold (MT) Intensity: The minimum stimulator setting that induces an observable motor response when applied to the patient. 1 Frequency: The number of pulses delivered per second, measured in Hertz (Hz). 1 Magnetic Field Strength: The measurement of voltage induced to the identified area. 1 Pulse Width: The duration of time from the peak of a pulse to the peak of the next pulse. 1 Stimulation Volume: The region of cortical tissue that is stimulated based on the Motor Threshold identified for the individual patient. 1 Covered Indications TMS of the brain for severe MDD, single or recurrent episode, is considered medically reasonable and necessary for up to six weeks 3,5,6,16-19 when the following criteria are met: The patient has a confirmed diagnosis of severe MDD as defined by the current DSM. AND The patient has demonstrated a failure of one or more trials of a pharmacological medication and/or demonstrates an intolerance to psychopharmacologic medications as defined in the definition section above. AND The order for TMS procedure is written by a psychiatrist (MD or DO), who has examined the patient face to face and reviewed the record. 20 Limitations The following is considered an ABSOLUTE CONTRAINDICATION: The presence of a medically implanted magnetic-sensitive device or other implanted metal items including, but not limited to, a cochlear implant, implanted cardiac defibrillator (ICD), pacemaker, vagus nerve stimulator (VNS), metal aneurysm clips/coils, staples, or stents, that are located less than or equal to 30 cm from the TMS magnetic coil. 1,6,15 The following are considered RELATIVE CONTRAINDICATIONS: The presence of a seizure disorder or any history of seizures (except those induced by Electroconvulsive therapy [ECT] or isolated febrile seizures in infancy without subsequent treatment or recurrence). The presence of acute or chronic psychotic symptoms or disorders in the current depressive episode. The presence of any neurological conditions including epilepsy, cerebrovascular disease, dementia, increased intracranial pressure, history of repetitive or severe head trauma, or primary or secondary tumors in the central nervous system. The following is considered not medically reasonable and necessary: All other uses of TMS, including the use of TMS for OCD. 7,12,20-23 Provider Qualifications Services will be considered medically reasonable and necessary when all aspects of care are within the scope of practice of the provider’s professional licensure, when performed according to the supervision requirements per state scope of practice laws, and when all procedures are performed by appropriately trained providers in the appropriate setting. Notice: Services performed for any given diagnosis must meet all the indications and limitations stated in this LCD, the general requirements for medical necessity as stated in CMS payment policy manuals, any and all existing CMS national coverage determinations, and all Medicare payment rules.