Wed, 08/04/2021 - 09:53
The Clinical TMS Society recommends the following coverage for Transcranial Magnetic Stimulation for Major Depressive Disorder
COVERAGE INDICATIONS, LIMITATIONS, AND/OR MEDICAL NECESSITY
Introduction: Transcranial Magnetic Stimulation (TMS) is a non-invasive treatment that uses pulsed magnetic fields to induce an electric current in a localized region of the cerebral cortex. An electromagnetic coil placed on the scalp induces focal, patterned current in the brain that temporarily modulates cerebral cortical functioning. Stimulation parameters may be adjusted to alter the excitability of the targeted structures in specific cortical regions. TMS parameters include cranial location, stimulation frequency, pattern, duration, intensity and the state of the brain under the coil.
History/Regulatory: In October 2008, conventional repetitive TMS (TMS) was FDA cleared for the treatment of adults with major depressive disorder (MDD) who had one failed medication trial1. TMS has since been established as a treatment with an excellent safety profile. TMS is minimally invasive and does not require anesthesia, has no cognitive side effects, and is carried out in outpatient clinics. TMS can be administered with different coils and different protocols. In 2013 deep2 and conventional3 repetitive TMS (dTMS) were cleared for treatment resistant MDD, defined as having failed to respond to antidepressant medication, without a specific number of medication trials. In 2018 theta burst stimulation (iTBS) was cleared for MDD4.
Major Depressive Disorder: TMS is used for Major Depressive Disorder5–8. Other non-invasive treatment options for MDD include psychotherapy and pharmacotherapy. Psychotherapy for MDD is indicated in mild major depressive disorder and can be useful as an augmentation to treatment of moderate to severe major depressive disorder. Pharmacotherapy options include selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), heterocyclic agents, other FDA-approved antidepressants from other classes, monoamine oxidase inhibitors (MAOIs) and augmentation of these agents with drugs from different classes (antipsychotics/mood stabilizers/stimulants/lithium/ketamine). Electroconvulsive Therapy (ECT) is indicated for severe MDD, bipolar disorder, schizophrenia, catatonia, and acute suicidal ideation. ECT is a burdensome treatment for patients, requires general anesthesia for a seizure multiple times a week, and carries risks of both the anesthesia as well as the ECT itself, primarily cognitive impairment. This prevents patients from functioning independently through their treatment course. The only invasive treatment approved for MDD is vagal nerve stimulation.
INDICATIONS FOR COVERAGE
TMS for MDD should be considered medically necessary and should be covered when prescribed by a licensed psychiatrist trained in the use of TMS, when the patient meets the below criteria:
Initial Treatment Criteria: Adults 18 years and older meeting the following criteria:
1. (Required): A diagnosis of Moderate or Severe Major Depressive Disorder (MDD), single episode or recurrent as per DSM-5 criteria as documented by a clinical evaluation. The severity and current symptoms may be quantified using a standardized patient or clinician rating scale.
AND
2. One or more of the following:
- Failure of one (1) trial of a psychopharmacologic agent for depression of adequate dose and duration in the current depressive episode, or failure to respond to electroconvulsive therapy.
- Inability to tolerate a therapeutic dose of medications as evidenced by two (2) trials of psychopharmacologic agents for depression, with documented side effects (trials do not need to have been during the current depressive episode), or inability to tolerate electroconvulsive therapy, or patient declining a recommendation for ECT.
- History of response to repetitive TMS as demonstrated by 50% improvement in symptoms.
- A current or prior medical condition, or history indicating the use of additional antidepressant medication would be contraindicated. The order for treatment (or retreatment) must be written by a psychiatrist (MD or DO) who has examined the patient, reviewed the record, and is prescribing an evidence-based TMS protocol on an FDA-cleared device the physician is trained to operate. A physician shall oversee the treatment, but does not have to personally administer the sessions nor be in the area. A prescribing or covering physician must be immediately reachable and interruptible in case of questions or problems during treatment.
CONTRAINDICATION
The only absolute contraindication to TMS is the presence of ferromagnetic metal in the head, such as a plate, screws, or an implanted magnetically sensitive medical device located less than or equal to 10 cm from the TMS coil9.
UTILIZATION GUIDELINES
The treatment must be provided by a device cleared by the FDA for the purpose of TMS for depression, using an evidence-based protocol. It is expected that the services will be performed as indicated by current medical literature and standards of practice.
TMS for adolescents with MDD may be appropriate and should be considered on a case-by-case basis, if there is a high level of treatment resistance10, and the patient meets all criteria for TMS other than age. These cases should be reviewed individually for medical necessity and considered for compassionate use.
TMS is reasonable and necessary for at least 36 visits. The initial authorization therefore includes 36 treatments to reflect usual practice. For patients who demonstrate a late response to TMS, subsequent treatment extensions in ten treatment increments are allowed based on clinical need. TMS response should be monitored by periodic outcome testing with appropriate standardized patient or clinician depression symptom measures.
If patients cannot come in five days a week, treatments may be administered at a lower frequency over a longer period of time[11]. Electroconvulsive Therapy (ECT) is not a pre-requisite for TMS authorization or coverage.
CODING
CPT/HCPCS Codes Group 1 Paragraph:
|
Group 1 Codes: CODE |
DESCRIPTION |
|
90867 x 1 |
THERAPEUTIC REPETITIVE TRANSCRANIAL MAGNETIC STIMULATION (TMS) TREATMENT; INITIAL, INCLUDING CORTICAL MAPPING, MOTOR THRESHOLD DETERMINATION, DELIVERY AND MANAGEMENT |
|
90868 (all other days) |
THERAPEUTIC REPETITIVE TRANSCRANIAL MAGNETIC STIMULATION (TMS) TREATMENT; SUBSEQUENT DELIVERY AND MANAGEMENT, PER SESSION |
|
90869 (once weekly, and more frequently when clinically indicated such as a change of medication or if clinically indicated) |
THERAPEUTIC REPETITIVE TRANSCRANIAL MAGNETIC STIMULATION (TMS) TREATMENT; SUBSEQUENT MOTOR THRESHOLD RE-DETERMINATION WITH DELIVERY AND MANAGEMENT |
REFERENCES
[1] O’Reardon JP, Solvason HB, Janicak PG, Sampson S, Isenberg KE, Nahas Z, et al. Efficacy and safety of transcranial magnetic stimulation in the acute treatment of major depression: a multisite randomized controlled trial. Biol Psychiatry 2007;62:1208–16. doi:10.1016/j.biopsych.2007.01.018.
[2] Levkovitz Y, Isserles M, Padberg F, Lisanby SH, Bystritsky A, Xia G, et al. Efficacy and safety of deep transcranial magnetic stimulation for major depression: a prospective multicenter randomized controlled trial. World Psychiatry 2015;14:64–73. doi:10.1002/wps.20199.
[3] George MS, Lisanby SH, Avery D, McDonald WM, Durkalski V, Pavlicova M, et al. Daily left prefrontal transcranial magnetic stimulation therapy for major depressive disorder: a sham-controlled randomized trial. Arch Gen Psychiatry 2010;67:507–16. doi:10.1001/archgenpsychiatry.2010.46.
[4] Blumberger DM, Vila-Rodriguez F, Thorpe KE, Feffer K, Noda Y, Giacobbe P, et al. Effectiveness of theta burst versus high-frequency repetitive transcranial magnetic stimulation in patients with depression (THREE-D): a randomised non-inferiority trial. Lancet 2018;391:1683–92. doi:10.1016/S0140-6736(18)30295-2.
[5] Perera T, George MS, Grammer G, Janicak PG, Pascual-Leone A, Wirecki TS. The clinical TMS society consensus review and treatment recommendations for TMS therapy for major depressive disorder. Brain Stimulat 2016;9:336–46. doi:10.1016/j.brs.2016.03.010.
[6] McClintock SM, Reti IM, Carpenter LL, McDonald WM, Dubin M, Taylor SF, et al. Consensus recommendations for the clinical application of repetitive transcranial magnetic stimulation (rtms) in the treatment of depression. J Clin Psychiatry 2018;79. doi:10.4088/JCP.16cs10905.
[7] Milev RV, Giacobbe P, Kennedy SH, Blumberger DM, Daskalakis ZJ, Downar J, et al. Canadian Network for Mood and Anxiety Treatments (CANMAT) 2016 Clinical Guidelines for the Management of Adults with Major Depressive Disorder: Section 4. Neurostimulation Treatments. Can J Psychiatry 2016;61:561–75. doi:10.1177/0706743716660033.
[8] Lefaucheur J-P, Aleman A, Baeken C, Benninger DH, Brunelin J, Di Lazzaro V, et al. Evidence-based guidelines on the therapeutic use of repetitive transcranial magnetic stimulation (rTMS): An update (2014-2018). Clin Neurophysiol 2020;131:474–528. doi:10.1016/j.clinph.2019.11.002.
[9] Rossi S, Antal A, Bestmann S, Bikson M, Brewer C, Brockmöller J, et al. Safety and recommendations for TMS use in healthy subjects and patient populations, with updates on training, ethical and regulatory issues: Expert Guidelines. Clin Neurophysiol 2020. doi:10.1016/j.clinph.2020.10.003.
[10] Croarkin PE, Elmaadawi AZ, Aaronson ST, Schrodt GR, Holbert RC, Verdoliva S, et al. Left prefrontal transcranial magnetic stimulation for treatment-resistant depression in adolescents: a double-blind, randomized, sham-controlled trial. Neuropsychopharmacology n.d.;46:462–9. doi:10.1038/s41386-020-00829-y.
[11] Tendler A, Gersner R, Roth Y, Zangen A. Alternate day dTMS combined with SSRIs for chronic treatment resistant depression: A prospective multicenter study. J Affect Disord 2018;240:130–6. doi:10.1016/j.jad.2018.07.058.
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