Benefit Application
Plans may wish to review their contract language on Transcranial Magnetic Stimulation to ensure that the contract language is consistent with the Plan’s medical policy. 

Description
Transcranial magnetic stimulation (TMS) is a method of noninvasive stimulation of the brain through a small coil placed over the scalp to produce an electromagnetic field that will stimulate the cortex of the brain and temporarily modulate cerebral cortical functioning. 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. fMRI guided TMS theta burst stimulation targets individualized brain areas with a compressed treatment duration.  TMS is used in the treatment of major depressive disorders and obsessive-compulsive disorders (OCD) that are resistant to treatment.

Policy Guidelines for Major Depressive Disorder
Repetitive transcranial magnetic stimulation (rTMS) of the brain using an FDA-cleared device may be considered MEDICALLY NECESSARY as a treatment of major depressive disorder when ALL of the following conditions have been met:

• The individual is age 15 or older
• The individual has a confirmed diagnosis of severe major depressive disorder (single or recurrent) documented by standardized rating scales that reliably measure depressive symptoms, such as Hamilton Depression Rating Scale, Beck Depression or Montgomery-Asberg Depression Rating Scale  
• Treatment is indicated by ONE or more of the following:

• The individual has tried and had an inadequate response to two (2) antidepressant agents from two (2) different antidepressant classes for at least 8 weeks (i.e., selective serotonin reuptake inhibitors, serotonin and norepinephrine reuptake inhibitors, tricyclic antidepressants, bupropion, or mirtazapine). To qualify as an adequate antidepressant trial, the individual’s dose during the failed trials should have been at or above the minimal effective therapeutic dose for that antidepressant.
• The individual is unable to tolerate a therapeutic dose of medications as evidenced by two (2) trials of psychopharmacologic agents with distinct side effects.
• The individual has a history of positive response to rTMS, as documented by standardized rating scales that reliably measure depressive symptoms, in a previous depressive episode (at least three (3) months since the prior episode)

• TMS treatment is administered in appropriately selected individuals by a board-certified psychiatrist (MD/DO) or by a psychiatric-mental health nurse practitioner (PMHNP) trained in TMS therapy, if it is within the scope of practice of the PMHNP in the state in which they are licensed.  A trained technician, working under the supervision of a board-certified psychiatrist or PMHNP trained in TMS therapy, may administer the treatment, but the board-certified psychiatrist or PMHNP trained in TMS therapy must be present in the building and immediately available.
• TMS treatment is administered by the appropriate FDA cleared device for the treatment of MDD according to one of the following specified stimulation parameters and protocols:

• Standard treatment course: 36 sessions as single-session per day treatment, each lasting approximately 20-40 minutes, over approximately a  9-week period that can be performed daily as 36 sessions or after 30 sessions, the last 6 sessions may proceed with a three-week taper of three (3) TMS treatments in week one (1), two (2) TMS treatments the next week, and one (1) TMS treatment in the last week (for a total of 36 standard sessions.)
• Extension of standard treatment course: daily TMS may be extended beyond 36 sessions if there is a documented 50% reduction in depressive symptoms by depression rating scales by session 36. An extension request can be made for a total of 10 additional sessions of conventional daily TMS.

OR

• Accelerated TMS treatment course: There are two approved accelerated TMS theta burst stimulation protocols, SAINT and SWIFT that may be administered in individuals age 18 and older.
  • SAINT: Stanford Accelerated Intelligent Neuromodulation Therapy (SAINT) protocol, consisting of 10 daily sessions over 5 consecutive days.

• An initial MRI scan to generate fMRI-guided target is required prior to treatment.
• Treatment must be performed using an FDA-cleared integrated system consisting of a stimulator and coil, neuronavigation system and target generation software.
• A course of 50 treatment sessions using theta burst stimulation delivered per FDA-cleared treatment parameters over 5 consecutive days (10 treatment sessions per day) using neuronavigated stimulation of the personalized target.
• SWIFT Deep TMS Accelerated Protocol:
  • Device specific treatment consists of 5 theta burst treatments per day for 6 days over a 14-day period (the acute phase), followed by two sessions per day once weekly for four weeks, for a total of 38 sessions.
• The individual has NONE of the following conditions:

• Poorly controlled seizure disorder or history of a recent seizure
• Presence of acute or chronic psychotic symptoms or disorders (such as schizophrenia, schizophreniform or schizoaffective disorder) in the current depressive episode
• Presence of metallic hardware or implanted magnetic‑sensitive medical device within 30 centimeters for deep TMS or 10 centimeters for figure‑8 coils (examples include: cochlear implants, implantable cardioverter‑defibrillators (ICDs), pacemakers, vagus nerve stimulators, or metal aneurysm clips or coils, staples, or stents).

NOTE: A facility providing TMS is required to have ALL of the following:

• The TMS environment has features that allow all of the following: rapid access to the patient, immediate termination of pulsing, rapid removal of the coil from the patient and the ability to place the patient in a safe position for seizure management;
• A physician available who is adequately trained and experienced in the specific TMS techniques being administered.
• The facility must have a physician or nurse on site who is trained in seizure management;
• An attendant trained in basic cardiac life support, seizure management, and the operation of emergency equipment must be present in the treatment room with the patient at all times;
• The facility must have an emergency plan in place to ensure access to Basic Life Support measures including having the ability to monitor vital signs, and awareness of response times of emergency services (either fire/ambulance or “code team”), which should be available within five (5) minutes.

rTMS for major depressive disorder that does not meet the criteria listed above is considered experimental/investigational and therefore, non-covered because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.

Continued treatment with rTMS of the brain as maintenance therapy is considered experimental/investigational and therefore, non-covered because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.

Policy Guidelines for Obsessive-Compulsive Disorder
Repetitive transcranial magnetic stimulation (rTMS) of the brain using a FDA-cleared device may be considered MEDICALLY NECESSARY as a treatment of obsessive-compulsive disorder when ALL of the following conditions have been met:

• The individual is age 18 or older
• The individual has a confirmed diagnosis of obsessive-compulsive disorder (OCD) documented by standardized rating scales that reliably measure symptoms such as Yale-Brown Obsessive-Compulsive Scale (YBOCS)
• Treatment is indicated by ONE or more of the following

• The individual has tried and had an inadequate response to two (2) different medications with each trial length at least 8 weeks. To qualify as an adequate medication trial, the individual’s dose during the failed trials should have been at or above the minimal effective therapeutic dose for that medication.

• The individual is unable to tolerate psychopharmacologic agents as evidenced by trials with two (2) psychopharmacologic agents with distinct side effects.
• The individual has a history of positive response to rTMS for OCD (as documented by standardized rating scales that reliably measure symptoms of OCD), and at least six (6) months have elapsed since the prior treatment episode ended.

• The individual has had a course of exposure response prevention (ERP) therapy without clinically meaningful improvement (>25% Y-BOCS score reduction) by 12 weeks  

• TMS treatment is administered in appropriately selected individuals by a board-certified psychiatrist (MD/DO) or by a PMHNP trained in TMS therapy, if it is within the scope of practice of the PMHNP in the state in which they are licensed.  A trained technician, working under the supervision of a board-certified psychiatrist or PMHNP trained in TMS therapy, may administer the treatment, but the board-certified psychiatrist or PMHNP trained in TMS therapy must be present in the area and immediately available.
• The individual has NONE of the following conditions

• Poorly controlled seizure disorder or history of a recent seizure
• Presence of acute or chronic psychotic symptoms or disorders (such as schizophrenia, schizophreniform or schizoaffective disorder) in the current depressive episode
• Presence of metallic hardware or implanted magnetic‑sensitive medical device within 30 centimeters for deep TMS or 10 centimeters for figure‑8 coils (examples include: cochlear implants, implantable cardioverter‑defibrillators (ICDs), pacemakers, vagus nerve stimulators, or metal aneurysm clips or coils, staples, or stents).

Prescribed treatment is 29 visits over a six (6) week period.

An extension of TMS for OCD may be requested when the member demonstrates at least a 30% reduction in OCD symptoms, as measured by the Y-BOCS, by Session 29. If this criterion is met, coverage may be extended for up to 11 additional sessions, for a maximum total of 40 sessions.

NOTE: A facility providing TMS is required to have ALL of the following

• The TMS environment has features that allow all of the following: rapid access to the patient, immediate termination of pulsing, rapid removal of the coil from the patient and the ability to place the patient in a safe position for seizure management;
• A physician available who is adequately trained and experienced in the specific TMS techniques being administered.
• The facility must have a physician or nurse on site who is trained in seizure management;
• An attendant trained in basic cardiac life support, seizure management, and the operation of emergency equipment must be present in the treatment room with the patient at all times;
• The facility must have an emergency plan in place to ensure access to Basic Life Support measures including having the ability to monitor vital signs, and awareness of response times of emergency services (either fire/ambulance or “code team”), which should be available within five (5) minutes.

rTMS for obsessive-compulsive disorder that does not meet the criteria listed above is considered experimental/investigational and therefore NOT MEDICALLY NECESSARY because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.

Retreatment may be considered for patients who met the guidelines for initial treatment and experienced at least a 30% reduction in the YBOCS score, as long as the improvement persisted for at least one month after the prior treatments ended.

Retreatment with rTMS for OCD not meeting the criteria as indicated in this policy is considered experimental/investigational and therefore, NOT MEDICALLY NECESSARY because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.

Repetitive TMS of the brain is considered experimental/investigational and therefore NOT MEDICALLY NECESSARY as a treatment of all other psychiatric and neurologic disorders, including but not limited to Alzheimer’s disease, bipolar disorder, schizophrenia, or migraine headaches because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.

References

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Coding Section

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each Policy. They may not be all-inclusive.

This medical policy was developed through consideration of peer-reviewed medical literature generally recognized by the relevant medical community, U.S. FDA approval status, nationally accepted standards of medical practice and accepted standards of medical practice in this community, and other nonaffiliated technology evaluation centers, reference to federal regulations, other plan medical policies and accredited national guidelines.

"Current Procedural Terminology © American Medical Association. All Rights Reserved" 

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