Transcranial Magnetic Stimulation as a Treatment of Depression and Other Psychiatric/Neurologic Disorders

POLICY NUMBER

A.2.01.50

DESCRIPTION

Transcranial magnetic stimulation (TMS) is a noninvasive method of delivering electrical stimulation to the brain. The technique involves the placement of a small coil over the scalp and passing a rapidly alternating current through the coil wire. The electrical current produces a magnetic field that passes unimpeded through the scalp and bone and stimulates neuronal function. Repetitive TMS is being evaluated for the treatment of treatment-resistant depression (TRD) and other psychiatric or neurologic disorders. A variety of TMS modalities have been developed, which differ on parameters including stimulation intensity, frequency, pattern, and site of the brain stimulation. In conventional TMS, high frequency stimulation is delivered over the left dorsolateral prefrontal cortex (DLPFC) or low frequency stimulation over the right DLPFC. In bilateral TMS, both procedures are performed in the same session. Deep TMS employs an H-coil helmet designed to encompass a broader surface area and stimulate deeper brain structures than conventional TMS. Theta burst stimulation is administered at lower intensities and shorter intervals than conventional TMS.

Transcranial Magnetic Stimulation

Transcranial magnetic stimulation (TMS), introduced in 1985 as a new method of noninvasive stimulation of the brain, 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. Transcranial magnetic stimulation was initially used to investigate nerve conduction (eg, 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. Interest in the use of TMS 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 in depressed patients, and early studies suggested that high-frequency (e.g., 5 to 10 Hz) TMS of the left dorsolateral prefrontal cortex had antidepressant effects. In contrast to electroconvulsive therapy (ECT), TMS does not require general anesthesia and does not generally induce a convulsion. Repetitive TMS is also being tested as a treatment for a variety of other psychiatric and neurologic disorders.

Conventional TMS delivers repeated electromagnetic pulses to induce prolonged modulation of neural activity, typically applied over the dorsolateral prefrontal cortex. High-frequency rTMS (usually ≥10 Hz) induces an increase in neural activity whereas low-frequency TMS (usually ≤1 Hz) has the opposite effect. If both procedures are performed in the same session, the intervention is described as bilateral rTMS.

A variety of TMS modalities have been developed, which differ on parameters including stimulation intensity, frequency, pattern, and site of the brain stimulation. Deep TMS employs an H-coil helmet design to encompass a broader surface area and stimulate deeper brain structures than conventional TMS. Theta burst stimulation is administered at lower intensities and shorter intervals than conventional rTMS.

Devices for transcranial stimulation have been cleared for marketing by the U.S. Food and Drug Administration (FDA) for diagnostic uses. A number of devices subsequently received FDA clearance for the treatment of major depressive disorders in adults who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode. Some of these devices use deep TMS or theta burst protocols. For example, the Brainsway Deep TMS system was FDA cleared for treatment-resistant depression in 2013 based on substantial equivalence to the Neurostar TMS Therapy System, and the Horizon (Magstim) and MagVita (Tonica Elektronik) have FDA clearance for their theta burst protocols.

Indications were expanded to include treating pain associated with certain migraine headaches in 2013, and obsessive-compulsive disorder in 2018.

In 2014, eNeura Therapeutics received 510(k) marketing clearance for the SpringTMS® for the treatment of migraine headaches. The device differs from the predicate Cerena™ TMS device with the addition of an LCD screen, a use authorization feature, a lithium battery pack, and a smaller size. The stimulation parameters are unchanged. The sTMS Mini (eNeura Therapeutics) received marketing clearance by the FDA in 2016. FDA product code: OKP.

In August 2018, the Deep TMS System (Brainsway) was granted a de novo 510(k) classification by the FDA as an adjunct for the treatment of adult patients with obsessive-compulsive disorder. The new classification applies to this device and substantially equivalent devices of this generic type.

The NeoPulse, now known as NeuroStar® TMS, was granted a de novo 510(k) classification by the FDA in 2008.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.

In 2014, the Cerena™ TMS device (eNeura Therapeutics) was granted a de novo 510(k) classification by the FDA for the acute treatment of pain associated with migraine headache with aura. Warnings, precautions, and contraindications include the following:

• The device is only intended for patients experiencing the onset of pain associated with a migraine headache with aura.

• The device should not be used:

  • on headaches due to underlying pathology or trauma.

  • for medication overuse headaches.

• The device has not been demonstrated as safe and/or effective:

  • when treating cluster headache or chronic migraine headache.

  • when treating during the aura phase.

  • in relieving the associated symptoms of a migraine (photophobia, phonophobia, and nausea).

  • in pregnant women, children under the age of 18, and adults over the age of 65.

The FDA has cleared multiple rTMS systems for adjunctive treatment of major depressive disorder in adolescents aged 15 to 21, including the NeuroStar Advanced Therapy System (K231926), the Magstim Horizon (K243869), and the MagVenture (K251125) stimulators.

The table below lists some devices that are FDA cleared for major depressive disorder (Product Code: OBP), migraine headache pain (Product Code: OKP), and obsessive-compulsive disorder (Product Code: QCI).

Repetitive TMS Devices Cleared by the U.S. FDA for Major Depression, Migraine, or Obsessive-Compulsive Disorder

Also, see the Vagus Nerve Stimulation medical policy.

POLICY

Transcranial magnetic stimulation (TMS) of the brain using an FDA-cleared device and modality, which can include but is not limited to, conventional TMS, deep TMS, and theta burst stimulation (see Policy Guidelines) may be considered medically necessary as a treatment of major depressive disorder when all of the following conditions (1 to 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):

   1. Individual has tried and had an inadequate response to 2 antidepressant agents from 2 different antidepressant classes (i.e., selective serotonin reuptake inhibitors, serotonin and norepinephrine reuptake inhibitors, tricyclic antidepressants, bupropion, or mirtazapine). An adequate trial of an antidepressant is defined by BOTH of the following:

      1. The trial length was at least 6 weeks at generally accepted doses or of sufficient duration as determined by the treating physician at the generally accepted doses; AND

      2. Individual was ≥80% adherent to the agent during the trial.

   2. Inability to tolerate a therapeutic dose of medications due to distinct side effects; OR

   3. History of response to TMS in a previous depressive episode (at least 3 months since the prior episode); OR

   4. Is a candidate for electroconvulsive therapy; further, electroconvulsive therapy would not be clinically superior to TMS (eg, in cases with psychosis, acute suicidal risk, catatonia or life-threatening inanition TMS should NOT be used);

AND

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.

TMS for major depressive disorder that does not meet the criteria listed above is considered investigational.

Continued treatment with TMS 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 and neurologic disorders, including but not limited to, bipolar disorder, schizophrenia, obsessive-compulsive disorder, or migraine headaches.

POLICY EXCEPTIONS

Federal 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.

POLICY GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

Transcranial magnetic stimulation should be performed using a U.S. Food and Drug Administration (FDA) cleared device in appropriately selected individuals over age 15 years, by health care professionals who are adequately trained and experienced in the specific techniques used.

A variety of TMS modalities have been developed, which differ on parameters including stimulation intensity, frequency, pattern, and site of the brain stimulation.

In conventional TMS, high frequency stimulation is delivered over the left dorsolateral prefrontal cortex (DLPFC) or low frequency stimulation over the right DLPFC. In bilateral TMS, both procedures are performed in the same session.

Theta burst stimulation is administered at lower intensities and at shorter intervals than conventional TMS.

Deep TMS employs an H-coil helmet designed to encompass a broader surface area and stimulate deeper brain structures than conventional TMS.

A treatment course of conventional TMS usually does not exceed 5 days a week for 6 weeks (total of 30 sessions), however, the treatment plan can be individualized depending on the type of device used, safety, and side effect considerations and response to treatment.

Theta burst stimulation may be administered using an accelerated protocol. One example of an accelerated theta burst protocol is the Stanford Accelerated Intelligent Neuromodulation Therapy (SAINT) protocol, consisting of 10 daily sessions over 5 consecutive days.

Contraindications to repetitive TMS include:

1. Seizure disorder or any history of seizure with increased risk of future seizure; OR

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

3. 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; OR

4. 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, pacemaker, vagus nerve stimulator, or metal aneurysm clips or coils, staples, or stents.

The following should be present for the administration of repetitive TMS:

1. 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

2. Adequate resuscitation equipment including, for example, suction and oxygen; AND

3. 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 Mental Health Disorders, 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 medical necessity, “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 HISTORY

8/2002: 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.

08/07/2017: Policy description updated regarding devices. Last investigational policy statement updated to add "Repetitive."

10/24/2018: Policy description updated regarding devices. Policy statements unchanged.

11/13/2019: Policy description updated regarding devices. Policy statements unchanged.

11/18/2020: Policy reviewed; no changes.

04/19/2022: Policy description updated regarding devices. Policy statements updated to remove "repetitive." Medically necessary statement regarding treatment of major depressive disorder updated to specify "using an FDA-cleared device and modality, which can include but is not limited to, conventional TMS, deep TMS, and theta burst stimulation." Policy Guidelines updated to add information regarding different modalities, including theta burst stimulation.

03/08/2023: Policy description updated regarding devices. Medically necessary policy statement criteria updated. Policy Guidelines updated regarding treatment of conventional TMS.

11/09/2023: Policy description updated regarding devices. Policy statements unchanged.

12/13/2024: Policy description updated regarding devices. Policy statements unchanged.

12/02/2025: Policy description updated regarding devices. Policy guidelines updated regarding patient's age from "selected individuals over age 18 years" to "selected individuals over age 15 years." Policy statements unchanged.

SOURCE(S)

Blue Cross Blue Shield Association Policy # 2.01.50

CODE REFERENCE

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.

Covered Codes

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