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Transcranial magnetic stimulation (TMS) is a non-invasive method of delivering electrical stimulation to the brain. TMS involves placement of a small coil over the scalp and passing a rapidly alternating current through the coil wire. The current produces a magnetic field that passes unimpeded through the scalp and bone, resulting in electrical stimulation that affects neuronal function. Repetitive transcranial magnetic stimulation (rTMS) is being evaluated for the treatment of treatment-resistant depression (TRD) and a variety of other psychiatric/neurologic brain disorders.
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; passing a rapidly alternating current through the coil wire, which produces 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 person 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 of depression 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 had shown 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), or deep stimulation with an H1 coil, are also being explored. In contrast to electroconvulsive therapy, TMS does not require anesthesia and does not induce a convulsion.
Repetitive TMS (rTMS) is also being tested as a treatment for a variety of other disorders including alcohol dependence, Alzheimer disease, neuropathic pain, obsessive-compulsive disorder, postpartum depression, Parkinson disease, stroke, post-traumatic stress disorder, panic disorder, epilepsy, dysphagia, Tourette syndrome, schizophrenia, migraine, spinal cord injury, fibromyalgia, and tinnitus. (See Treatment of Tinnitus medical policy on rTMS for tinnitus.) In addition to the potential for altering interhemispheric imbalance, it has been proposed that high-frequency rTMS may facilitate neuroplasticity.
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), was approved in Canada, Israel, and the United States as a therapy for depression. Initially examined by the FDA under a traditional 510(k) process, the NeoPulse, now known as NeuroStar® TMS, was granted a de novo 510(k) classification by FDA in 2008. NeuroStar® TMS is indicated for the treatment of patients with depression who have failed one 6-week course of antidepressant medication. The Brainsway™ H-Coil Deep TMS device (Brainsway Ltd.) received FDA clearance in 2013. This device is indicated for the treatment of depression in patients who have failed to respond to antidepressant medications in their current episode of depression and is a broader indication than that of the NeuroStar® TMS, which specifies the failure of one 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 with the risk-to-benefit profile of predicate electroconvulsive therapy devices. The panel was not asked for a recommendation regarding the regulatory determination of substantial equivalence for this 510(k) submission.
In 2013, the Cerena™ TMS device (eNeura Therapeutics) was granted a de novo 510(k) classification by FDA for the acute treatment of pain associated with migraine headache with aura. Warnings, precautions, and contraindications include the following:
The de novo 510(k) review process allows novel products with moderate or low-risk profiles and without predicates which would ordinarily require premarket approval as a class III device to be down-classified in an expedited manner and brought to market with a special control as a class II device.
Also, see the Vagus Nerve Stimulation medical policy.
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 (1-3) have been met:
1. Confirmed diagnosis of severe major depressive disorder (single or recurrent) documented by standardized rating scales that reliably measure depressive symptoms; AND
2. Any one of the following (a, b, c, or d):
a. Failure of 4 trials of psychopharmacologic agents including 2 different agent classes and 2 augmentation trials; OR
b. Inability to tolerate a therapeutic dose of medications as evidenced by 4 trials of psychopharmacologic agents with distinct side effects; OR
c. History of response to rTMS in a previous depressive episode (at least 3 months since the prior episode); OR
d. Is a candidate for electroconvulsive therapy (ECT) and ECT would not be clinically superior to rTMS (eg, in cases with psychosis, acute suicidal risk, catatonia or life-threatening inanition rTMS should NOT be utilized);
3. 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.
rTMS for major depressive disorder that does not meet the criteria listed above is considered investigational.
Continued treatment with rTMS of the brain as maintenance therapy is considered investigational.
Transcranial magnetic stimulation of the brain is considered investigational as a treatment of all other psychiatric/neurologic disorders, including but not limited to, bipolar disorder, schizophrenia, obsessive-compulsive disorder, or migraine headaches.
POLICY EXCEPTIONSFederal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.
For FEP subscribers, transcranial magnetic stimulation (TMS) of the brain may be considered medically necessary to treat the symptoms of major depressive disorder (MDD) in patients with treatment-resistant depression (TRD) who have failed at least one antidepressant medication and are currently not on any antidepressant therapy.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
Repetitive transcranial magnetic stimulation should be performed using a U.S. Food and Drug Administration (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 transcranial magnetic stimulation (TMS) treatments in week 1, 2 TMS treatments the next week, and 1 TMS treatment in the last week.
Contraindications to rTMS include:
a. Seizure disorder or any history of seizure with increased risk of future seizure; OR
b. Presence of acute or chronic psychotic symptoms or disorders (such as schizophrenia, schizophreniform or schizoaffective disorder) in the current depressive episode; OR
c. 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
d. 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.
The following should be present for the administration of repetitive TMS:
a. 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
b. Adequate resuscitation equipment including, for example, suction and oxygen; AND
c. 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.
Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Nervous/Mental Conditions, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:
A. consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and
B. appropriate with regard to standards of good medical practice; and
C. not solely for the convenience of the Member, his or her Provider; and
D. the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.
For the definition of Medically Necessary, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.
Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.
POLICY HISTORY8/2002: Approved by Medical Policy Advisory Committee (MPAC)
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.
08/14/2013: Added the following FEP exception for FEP subscribers: Transcranial magnetic stimulation (TMS) of the brain may be considered medically necessary to treat the symptoms of major depressive disorder (MDD) in patients with treatment-resistant depression (TRD) who have failed at least one antidepressant medication and are currently not on any antidepressant therapy. Removed deleted CPT codes 0160T and 0161T from the Code Reference section.
05/22/2015: Policy reviewed; no changes.
07/23/2015: Code Reference section updated for ICD-10.
02/11/2016: Policy description updated regarding repetitive transcranial magnetic stimulation and devices. Policy statement updated to add bipolar disorder and obsessive-compulsive disorder as investigational. Investigative definition updated in policy guidelines section.
06/06/2016: Policy number added.
12/30/2016: Policy number changed from L.2.01.424 to A.2.01.50. Policy description updated. Policy section updated with the following changes: 1) Added statement that repetitive transcranial magnetic stimulation (rTMS) of the brain may be considered medically necessary as a treatment of major depressive disorder with certain criteria; 2) added statement that rTMS for major depressive disorder that does not meet the criteria is considered investigational; 3) added statement that continued treatment with rTMS of the brain as maintenance therapy is considered investigational; 4) last policy statement updated to remove treatment of depression as investigational. Policy guidelines updated regarding treatment, contraindications, and administration of rTMS. Code Reference section updated to change the code table from investigational to covered. Added CPT code 90869 and ICD-10 diagnosis codes F32.0 - F32.9, and F33.0 - F33.9.
SOURCE(S)Blue Cross Blue Shield Association Policy # 2.01.50
This may not be a comprehensive list of procedure codes applicable to this policy.
The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.
CPT copyright American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.