Medical Policy: 02.01.46
Original Effective Date: January 2012
Reviewed: August 2020
Revised: August 2020
This policy contains information which is clinical in nature. The policy is not medical advice. The information in this policy is used by Wellmark to make determinations whether medical treatment is covered under the terms of a Wellmark member's health benefit plan. Physicians and other health care providers are responsible for medical advice and treatment. If you have specific health care needs, you should consult an appropriate health care professional. If you would like to request an accessible version of this document, please contact customer service at 800-524-9242.
Benefit determinations are based on the applicable contract language in effect at the time the
services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary
based on contract, and individual member benefits must be verified. Wellmark determines medical
necessity only if the benefit exists and no contract exclusions are applicable. This medical
policy may not apply to FEP. Benefits are determined by the Federal Employee Program.
This Medical Policy document describes the status of medical technology at the time the document
was developed. Since that time, new technology may have emerged or new medical literature may
have been published. This Medical Policy will be reviewed regularly and be updated as scientific
and medical literature becomes available.
Transcranial magnetic stimulation
Transcranial magnetic stimulation (TMS) is a noninvasive method of delivering electrical stimulation to the brain. A magnetic field is delivered through the skull, where it induces electric currents that affect neuronal function. Repetitive TMS (rTMS) is being evaluated as a treatment of depression and other psychiatric/neurologic brain disorders. Imaging studies had showed 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. In contrast to electroconvulsive therapy, transcranial magnetic stimulation can be performed in an office setting as it does not require anesthesia and does not induce a convulsion.
There is a neurostimulation/transcranial magnetic stimulation being marketed that would be completed in the home setting. There is little information about safety and efficacy of the at home neurostimulation devices.
TMS is also being studied as a treatment for a variety of other disorders including alcohol dependence, Alzheimer's disease, neuropathic pain, obsessive-compulsive disorder, post-partum depression, depression associated with Parkinson's disease, schizophrenia, migraine, spinal cord injury, tinnitus, autism, eating disorders, and fibromyalgia. Currently FDA approval for conditions outside of major depression only include obsessive compulsive disorder (OCD). In the management of OCD studies on efficacy are extremely limited.
Other forms of rTMS include:
- Accelerated which proposes an accelerated treatment schedule, using multiple sessions per day for fewer weeks duration.
- Bilateral combines high frequency stimulation of the left dorsolateral prefrontal cortex with low frequency stimulation of the right dorsolateral prefrontal cortex (either simultaneously or sequentially) during each session.
- High dose delivers more pulses than usual over the same treatment time frame (eg, 6000 pulses per session instead of 3000).
- Theta burst, also called intermittent theta-burst stimulation (iTBS) or express TMS, delivers magnetic pulses that are administered at such a rapid speed of delivery that the session may be completed in only six minutes rather than 30 to 40 minutes.
Monitoring Treatment Efficacy
There are a number of evaluation tools used in the management of depression. Below is one example of a frequently used evaluation tool.
The Patient Health Questionnaire (PHQ) is an instrument for making criteria-based diagnoses of depression and other mental disorders.
The PHQ-9 is the depression module, which scores each of the 9 DSM-IV criteria as “0” (not at all) to “3” (nearly every day).The total score can range from 0 to 27, with higher scores indicating greater severity of depression. The clinician is asked to review the score of each item on the measure during the clinical interview and indicate the raw score for each item in the section provided for “Clinician Use.” The raw scores on the 9 items should be summed to obtain a total raw score and should be interpreted using the Interpretation Table for the PHQ-9 below:
Interpretation Table for the PHQ-9
|Levels of depressive symptoms severity||PHQ-9 Score
|Moderately severe depression
Tracking changes in the PHQ-9 score would be used to guide treatment by defining treatment efficacy and remission.
Additional research is needed to determine the durability of remission produced by TMS.
Defining Major Depression
A major depressive episode as defined in the DSM-5 implies a prominent and relatively persistent (e.g., nearly every day for at least two weeks) depressed or dysphoric mood that represents a change from previous functioning, and includes at least five of the following nine symptoms, one of which is either of the first two symptoms
- Depressed mood
- Markedly diminished interest or pleasure in usual activities
- Significant change in weight and/or appetite
- Insomnia or hypersomnia
- Psychomotor agitation or retardation
- Fatigue or loss of energy
- Feelings of worthlessness or excessive or inappropriate guilt
- Slowed thinking or impaired concentration
- Recurrent thoughts of death or suicidal ideation or a suicide attempt
Reponse is clinically defined as an improvement in symptoms from the initial onset of depression. The term remission has typically been applied to being symptom free or having minimal symptoms, representing an end to the immediate episode. The DSM-5 defines remission as a period of two or more months with no symptoms or only 1-2 mild symptoms. Partial remission involves significant improvement but mild symptoms of MDD are still present or there are no longer any significant symptoms of a Major Depressive Episode, but the period of remission has been less than two months. Recovery is the absence of symptoms for at least four months following the onset of remission with periods of improvement. Relapse has been defined as the re-emergence or early return of the depressive episode of full or significant depressive symptoms after remission.
Practice Guidelines and Position Statements
National Institute for Health and Care Excellence (NICE)
Repetitive Transcranial Magnetic Stimulation for Depression Guideline states:
- The evidence on [rTMS] for depression shows no major safety concerns. The evidence on its efficacy in the short-term is adequate, although the clinical response is variable. [RTMS] for depression may be used with normal arrangements for clinical governance and audit.
- During the consent process, clinicians should, in particular, inform patients about the other treatment options available, and make sure that patients understand the possibility the procedure may not give them benefit.
- NICE encourages publication of further evidence on patient selection, details of the precise type and regime of stimulation used, the use of maintenance treatment and long-term outcomes.
Repetitive Transcranial Magnetic Stimulation (rTMS), and Deep transcranial magnetic stimulation (dTMS)
Devices for transcranial stimulation/repetitive transcranial stimulation have received clearance by the U.S. Food and Drug Administration (FDA) include:
- The NeuroStar® TMS Therapy System is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode.
- The US Food and Drug Administration (FDA) granted marketing approval in 2018 for the Brainsway deep transcranial magnetic stimulation (dTMS) system (Brainsway Ltd) as a adjuncttreatment of adults suffering from obsessive-compulsive disorder (OCD).
A number of devices for CES have received marketing clearance through the FDA 510(k) process. The Alpha-Stim® CES device (Electromedical Products International) received marketing clearance in 1992 for the treatment of anxiety, insomnia, and depression.
Intermittent Theta Burst Stimulation Transcranial Magnetic Stimulation (iTBS)
Devices for theta-burst repetitive TMS have received clearance by the U.S. Food and Drug Administration (FDA) include:
- Magstim® has received FDA clearance to include intermittent Theta Burst Stimulation (iTBS) as a treatment for major depressive disorder with its Horizon® TMS Therapy systems.
Devices for the Treatment of Alzheimer’s
In 2019 an advisory panel appointed by the FDA recommended that Neuronix not be allowed to market its neuroAD Therapy System in the U.S.
Prior approval is required.
For information regarding nTMS see policy 02.01.58
Prolonged treatment sessions of initial or repeat courses of therapy generally at a lower dose, is considered maintenance therapy. Repeating therapy within the same episode: meaning no remission has occurred or sessions prior to documented relapse is considered maintainance therapy. Treatment response is usually defined as at least a 50% drop from the baseline depression scores. The definition for remission is generally accepted as a PHQ-9 score of <9, if PHQ-9 is the evaluation model of choice.
There is insufficient evidence that prove value of therapy in these scenarios at this time.
Currently the use of TMS as maintenance therapy is considered investigational.
Guidelines are necessary to define treatment course and maintenance appropriateness. Maintenance regimens have not been established and reported outcomes are conflicting. Information is lacking in overall standard of treatment and the lasting effects of participation in TMS. Repetitive transcranial magnetic stimulation had a small short-term effect for improving depression in comparison with sham, but follow-up studies did not show that the small effect will continue for longer periods. There is a lack of evidence supporting the long-term, maintenance effects of TMS.
There is no evidence that continued treatment when an individual does not respond to initial treatment is necessary or beneficial.
Additional Courses of Treatment
Currently there is medically necessary indications for an initial round of sessions, followed by a repeat round of sessions: after remission has occurred, when initial therapy has been successful the repeated request of treatment brings into question treatment durability, and overall value on net health outcomes. There is little medical evidence that additional repeated sessions are of value. Therefore: Rounds of sessions after the initial repeat sessions are considered investigational.
Transcranial Magnetic Stimulation (TMS) in the Pediatric Population
Currently updated guidelines that include management of major depressive disorder with the use of TMS only recommends the therapy in adults. The available studies do not establish that TMS is as good as available alternatives in the pediatric population. The additional concerns of using stimulation in the developing brain need to be addressed in well-designed studies that can show safety and long-term efficacy of therapy.
Transcranial magnetic stimulation therapy in the pediatric population (those under 18 years of age) is considered investigational.
Transcranial Magnectic Stimulation (TMS) for Conditions Outside of Major Depression
Transcranial Magnetic Stimulation is considered investigational for all conditions outside of major depressive disorder including, but not limited to:
- Bipolar disorder
- Obsessive-compulsive disorder
- Chronic pain
- Post-traumatic stress disorder (PTSD)
- Eating disorders
- Alzheimer’s (Alone or as a part of neuroAD)
- Amyotrophic lateral sclerosis
- Communication and swallowing Disorders
- Neurodevelopmental Disorders
- Traumatic Brain Injury
Other Types of Transcranial Magnetic Stimulation (TMS)
All other forms of repetitive TMS (rTMS) are considered investigational including, but not limited to:
- accelerated rTMS (e.g. MagVenture)
- high-dose rTMS
- theta-burst repetitive TMS (iTBS) (e.g. Magstim)
Procedure Codes and Billing Guidelines:
To report provider services, use appropriate CPT* codes, Modifiers, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or diagnosis codes.
- 90867 Therapeutic repetitive transcranial magnetic stimulation (TMS) treatment; initial, including cortical mapping, motor threshold determination, delivery and management
- 90868 Therapeutic repetitive transcranial magnetic stimulation (TMS) treatment; subsequent delivery and management, per session
- 90869 Therapeutic repetitive transcranial magnetic stimulation (TMS) treatment; subsequent motor threshold re-determination with delivery and management
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