CENTENE Corporation

Clinical Policy: Transcranial Magnetic Stimulation for Treatment Resistant Major Depression

Reference Number: CP.BH.200 Date of Last Revision: 04/25

Coding Implications
Revision Log

See Important Reminder at the end of this policy for important regulatory and legal information.

Description

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.¹

Policy/Criteria

I. It is the policy of Centene Advanced Behavioral Health and health plans affiliated with Centene Corporation® that requests for initial treatment with repetitive transcranial magnetic stimulation (rTMS), deep TMS (dTMS), or Theta Burst Stimulation (iTBS) are considered medically necessary for adults ≥ 18 years of age when meeting all the following criteria: A. The member/enrollee has a confirmed diagnosis of major depressive disorder (MDD), severe (single episode or recurrent), per most recent edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM); B. The member/enrollee does not have a diagnosis of schizophrenia, schizoaffective disorder, or bipolar disorder; C. The member/enrollee has failed a trial of (or has an intolerance to) psychopharmacologic therapy, as evident by a Patient Health Questionnaire-9 (PHQ-9) score of ≥ 15 throughout the current course of treatment (or other equivalent standardized scale score), indicating moderately severe to severe depression, which is documented by one of the following:

1. Failure of two trials of antidepressants from at least two different antidepressant classes administered as an adequate course with a recognized standard therapeutic dose of at least six weeks duration within the last 24 months;
2. Inability to tolerate (i.e., documentation of major adverse interactions with medically necessary medications or intolerable side effects) four trials of antidepressants from at least two different antidepressant classes; D. The member/enrollee has participated in an adequate trial of evidence-based psychotherapy (such as cognitive behavioral therapy and/or interpersonal therapy) during the current episode of illness, without significant improvement. Note: This therapy should overlap with the antidepressant trials; E. The member/enrollee has failed a trial of electroconvulsive therapy (ECT); or its use is contraindicated or there is documentation by a psychiatrist indicating why TMS is clinically preferable; F. The member enrollee is referred for TMS treatment by the provider treating the member/enrollee’s MDD;

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Transcranial Magnetic Stimulation

G. A comprehensive psychiatric evaluation to determine the necessity for TMS has been completed by a qualified licensed provider, such as one of the following:

1. Psychiatrist (MD, DO, or MBBS [Bachelor of Medicine, Bachelor of Surgery]);
2. Psychiatric Nurse Practitioner; H. Direct supervision of treatment is provided by a licensed psychiatrist, trained in TMS therapy, except where state scope of practice acts allows for other provider types to supervise; I. Request is for up to 36 sessions. Note: Recommended schedule is five days a week for six weeks, with an optional six sessions for tapering); J. The treatment is administered using a Food and Drug Administration (FDA)-cleared device and utilized in accordance with the FDA labeled indications such as but not limited to the following:
3. NeuroStar® Advanced TMS Therapy System;
4. Apollo TMS Therapy System;
5. BrainsWay Deep TMS;
6. Horizon TMS Therapy System;
7. MagVita TMS Therapy with MagPro R20;
8. MagVita TMS Therapy System w/Theta Burst Stimulation;
9. Neurosoft TMA (Cloud TMS);
10. Nexstim Brain Therapy;
11. Magstim Horizon 3.0 TMS Therapy System Range; K. The member/enrollee does not have any of the following contraindications:
12. Presence of conductive or ferromagnetic or other magnetic-sensitive metals implanted or embedded in head or neck within 30 cm of TMS coil placement other than dental fillings to include but not limited to the following: a. Cochlear implant; b. Implanted electrodes/stimulators; c. Aneurysm clips or coils; d. Stents; e. Bullet fragments; f. Metallic dyes in tattoos;
13. Vagus nerve stimulator leads in the carotid sheath;
14. Less than three months of substantiated remission from substance use disorder;
15. Concomitant esketamine intranasal, ketamine infusion or other infusion therapies; L. Documentation of rTMS, iTBS or dTMS protocol used; M. Planned use of an evidenced based standardized depression rating scale (including severity), documenting the score prior to treatment, and monitored throughout the course of treatment.

II. It is the policy of Centene Advanced Behavioral Health and health plans affiliated with Centene Corporation that requests for initial treatment with repetitive transcranial magnetic stimulation (rTMS) will be reviewed on a case-by-case basis by a medical director, informed by all the following criteria: A. The treatment is administered using the NeuroStar® TMS Therapy System, as an adjunct for the treatment of major depressive disorder (MDD), in accordance with the specific Food and Drug Administration (FDA)-labeled indication;

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B. The member/enrollee has a confirmed diagnosis of MDD, severe (single episode or recurrent), per most recent edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM); C. The member/enrollee does not have a diagnosis of schizophrenia, schizoaffective disorder, or bipolar disorder; D. The member/enrollee has failed a trial of (or has an intolerance to) psychopharmacologic therapy, as evident by a PHQ-9: Modified for Teens (PHQ-A) score of ≥ 15 throughout the current course of treatment (or other equivalent standardized scale score), indicating moderately severe to severe depression, evidenced by one of the following:

1. Documentation of failure of two trials of antidepressants from at least two different antidepressant classes administered as an adequate course with a recognized standard therapeutic dose of at least six weeks duration within the last 24 months;
2. Inability to tolerate (i.e., documentation of major adverse interactions with medically necessary medications or intolerable side effects) four trials of antidepressants from at least two different antidepressant classes within the last 24 months; E. The member/enrollee has participated in an adequate trial of evidence-based psychotherapy (such as cognitive behavioral therapy and/or interpersonal therapy) during the current episode of illness, without significant improvement. Note: This therapy should overlap with the antidepressant trials; F. The member/enrollee has failed a trial of electroconvulsive therapy (ECT); or its use is contraindicated or there is documentation by a psychiatrist indicating why TMS is clinically preferable; G. The member/enrollee is referred for TMS treatment by the provider treating the member/enrollee’s MDD; H. A comprehensive psychiatric evaluation to determine the necessity for TMS has been completed by a qualified licensed provider, such as one of the following:
3. Psychiatrist (MD, DO, or MBBS [Bachelor of Medicine, Bachelor of Surgery]);
4. Psychiatric Nurse Practitioner; I. Direct supervision of treatment is provided by a licensed psychiatrist, trained in TMS therapy, except where state scope of practice acts allows for other provider types to supervise; J. Request is for up to 36 sessions (Note: recommended schedule is five days a week for six weeks, with an optional six sessions for tapering); K. The member/enrollee does not have any of the following contraindications:
5. Presence of conductive or ferromagnetic or other magnetic-sensitive metals implanted or embedded in head or neck within 30 cm of TMS coil placement other than dental fillings to include but not limited to the following: a. Cochlear implant; b. Implanted electrodes/stimulators; c. Aneurysm clips or coils; d. Stents; e. Bullet fragments; f. Metallic dyes in tattoos;
6. Vagus nerve stimulator leads in the carotid sheath;
7. Less than three months of substantiated remission from substance use disorder;
8. Concomitant esketamine intranasal, ketamine infusion or other infusion therapies;

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L. Documentation of rTMS protocol used; M. Planned use of an adolescent, evidence-based, standardized depression rating scale (including severity), documenting the score prior to treatment, and monitored throughout the course of treatment.

III.It is the policy of Centene Advanced Behavioral Health and health plans affiliated with Centene Corporation that requests for retreatment with rTMS, dTMS or iTBS for adults ≥ 18 years of age will be reviewed on a case-by-case basis by a medical director, informed by all the following: A. The member/enrollee has a confirmed diagnosis of major depressive disorder (MDD), severe (single episode or recurrent), per most recent edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM); B. The member/enrollee does not have a diagnosis of schizophrenia, schizoaffective disorder, or bipolar disorder; C. Current depressive symptoms have worsened to a PHQ-9 severity score ≥ 15 (or equivalent in other standardized depression severity scale); D. Prior treatment response demonstrated at least a 50% improvement in baseline standardized depression rating scores, (with a documented 6-month duration of response); E. The member/enrollee is referred for TMS treatment by the provider treating the member/enrollee’s MDD; F. A comprehensive psychiatric evaluation to determine the necessity for TMS retreatment has been completed by a qualified licensed provider, such as one of the following:

1. Psychiatrist (MD, DO, or MBBS [Bachelor of Medicine, Bachelor of Surgery]);
2. Psychiatric Nurse Practitioner; G. The member/enrollee has participated in an adequate trial of evidence-based psychotherapy (such as cognitive behavioral therapy and/or interpersonal therapy) during the current episode of illness, without significant improvement. H. Direct supervision of treatment is provided by a licensed psychiatrist, trained in TMS therapy, except where state scope of practice acts allows for other provider types to supervise; I. Request is for up to 36 sessions (Note: recommended schedule is five days a week for six weeks, with an optional six sessions for tapering); J. The treatment is administered using a Food and Drug Administration (FDA)-cleared device and utilized in accordance with the FDA labeled indications such as but not limited to the following:
3. NeuroStar® Advanced TMS Therapy System;
4. Apollo TMS Therapy System;
5. BrainsWay Deep TMS;
6. Horizon TMS Therapy System;
7. MagVita TMS Therapy with MagPro R20;
8. MagVita TMS Therapy System w/Theta Burst Stimulation;
9. Neurosoft TMA (Cloud TMS);
10. Nexstim Brain Therapy;
11. Magstim Horizon 3.0 TMS Therapy System Range;

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K. The member/enrollee does not have any of the following contraindications:

1. Presence of conductive or ferromagnetic or other magnetic-sensitive metals implanted or embedded in head or neck within 30 cm of TMS coil placement other than dental fillings to include but not limited to the following: a. Cochlear implant; b. Implanted electrodes/stimulators; c. Aneurysm clips or coils; d. Stents; e. Bullet fragments; f. Metallic dyes in tattoos;
2. Vagus nerve stimulator leads in the carotid sheath;
3. Less than three months of substantiated remission from substance use disorder;
4. Concomitant esketamine intranasal, ketamine infusion or other infusion therapies; L. Documentation of rTMS, iTBS or dTMS protocol used; M. Planned use of an evidence-based standardized depression rating scale (including severity), documenting the score prior to treatment, and monitored throughout the course of treatment. N. If the member/enrollee is not achieving remission, consideration of treatment augmentation or potential alternative treatment such as ECT.

IV.It is the policy of Centene Advanced Behavioral Health and health plans affiliated with Centene Corporation that requests for retreatment with rTMS for adolescents ages 15 through 17 years will be reviewed on a case-by-case basis by a medical director, informed by all the following: A. The requested treatment is with the NeuroStar® TMS Therapy System, as an adjunct for the treatment of MDD, in accordance with the specific Food and Drug Administration (FDA)-labeled indication; B. The member/enrollee has a confirmed diagnosis of major depressive disorder (MDD), severe (single episode or recurrent), per most recent edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM); C. The member/enrollee does not have a diagnosis of schizophrenia, schizoaffective disorder, or bipolar disorder; D. Current depressive symptoms have worsened to a PHQ-A severity score ≥ 15 (or equivalent in other standardized depression severity scale); E. Prior treatment response demonstrated at least a 50% improvement in baseline standardized depression rating scores, (with a documented 6-month duration of response); F. The member/enroll is referred for TMS treatment by the provider treating the member/enrollee’s MDD; G. A comprehensive psychiatric evaluation to determine the necessity for TMS retreatment has been completed by a qualified licensed provider, such as one of the following:

1. Psychiatrist (MD, DO, or MBBS [Bachelor of Medicine, Bachelor of Surgery]);
2. Psychiatric Nurse Practitioner; H. The member/enrollee has participated in an adequate trial of evidence-based psychotherapy (such as cognitive behavioral therapy and/or interpersonal therapy) during the current episode of illness, without significant improvement;

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I. Direct supervision of treatment is provided by a licensed psychiatrist, trained in TMS therapy, except where state scope of practice acts allows for other provider types to supervise; J. Request is for up to 36 sessions. Note: Recommended schedule is five days a week for six weeks, with an optional six sessions for tapering; K. The member/enrollee does not have any of the following contraindications:

1. Presence of conductive or ferromagnetic or other magnetic-sensitive metals implanted or embedded in head or neck within 30 cm of TMS coil placement other than dental fillings to include but not limited to the following: a. Cochlear implant; b. Implanted electrodes/stimulators; c. Aneurysm clips or coils; d. Stents; e. Bullet fragments; f. Metallic dyes in tattoos;
2. Vagus nerve stimulator leads in the carotid sheath;
3. Less than three months of substantiated remission from substance use disorder;
4. Concomitant esketamine intranasal, ketamine infusion or other infusion therapies; L. Documentation of rTMS protocol used; M. Planned use of an evidence-based standardized depression rating scale (including severity), documenting the score prior to treatment, and monitored throughout the course of treatment; N. If the member/enrollee is not achieving remission, consideration of treatment augmentation or potential alternative treatment such as ECT.

V. It is the policy of Centene Advanced Behavioral Health and health plans affiliated with Centene Corporation that maintenance treatment with repetitive transcranial magnetic stimulation (rTMS), Theta Burst Stimulation (iTBS) or deep transcranial magnetic stimulation(dTMS) is considered not medically necessary, as there is insufficient evidence in the published, peer-reviewed literature to support it.

VI.It is the policy of Centene Advanced Behavioral Health and health plans affiliated with Centene Corporation that there is insufficient evidence in the published peer-reviewed literature to support the safety and efficacy of MRI guided theta burst stimulation, including but not limited to, Stanford Accelerated Intelligent Neuromodulation Therapy (SAINT), beyond established TMS/TBS techniques.

Background

Major depressive disorder (MDD), also known as depression, is a debilitating mental health disorder characterized by ≥ 1 depressive episode lasting ≥ 2 weeks and involving depressed mood, loss of interests/pleasure, fatigue, change in weight, sleep disturbances, cognitive impairments, and/or feelings of worthlessness.² According to the National Institute of Mental Health (NIMH), in 2021, an estimated 14.5 million adults (5.7%) aged 18 or older and, an

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estimate of 5.0 million adolescents aged 12 to 17 (20.1%) in the United States has had at least one major depressive episode with severe impairment.³

Psychotherapy and pharmacology are often the standard treatment for MDD. Patients who do not respond to this treatment are candidates for alternative treatments such as repetitive transcranial magnetic stimulation (TMS) and electroconvulsive therapy (ECT). In contrast to electroconvulsive therapy, TMS does not require general anesthesia and does not induce convulsion. The effects of TMS depend on the parameters of waveform, frequency, intensity, and duration of stimulation.⁴

Types of TMS:

Repetitive TMS (rTMS)⁵: rTMS is currently the most widespread form of TMS for clinical applications. In rTMS, magnetic pulses are delivered in a rapid series or “train.” When rTMS is used, multiple single-pulse stimuli are presented at a specific frequency, intensity, and time duration. In the context of MDD treatment, rTMS is often delivered at a frequency ≥ 10 Hertz (Hz) and targets the dorsolateral prefrontal cortex, a region important for high order executive function.

Deep TMS (dTMS): Deep TMS is administered by commercially available rTMS devices that theoretically stimulate brain structures beneath the superficial prefrontal cortex using magnetic coils (H coils); these H coils can induce a magnetic field with a deeper and wider distribution than the standard (figure eight) coils used for surface cortical TMS. The depth of stimulation beneath with H coils is approximately 4 cm. H coils also stimulate surface cortical structures.

Theta burst TMS (iTBS)⁵: iTBS is a form of rTMS wherein short bursts of three to five pulses per second are administered at a higher frequency (50 Hz) but with a specific interburst interval that generates an overall lower stimulation frequency (5 Hz).

Literature Review

Repetitive Transcranial Magnetic Stimulation(rTMS)⁴,⁵ An evidence review of rTMS included a network meta-analysis of 31 randomized trials of pharmacologic and somatic interventions in patients with treatment-resistant depression (sample size not reported), including 11 trials that studied TMS.7 The results indicated that six weeks after baseline, the overall response (improvement of symptoms ≥50 percent) was more than eight times as likely with TMS than placebo pill/sham stimulation (odds ratio 8.6, 95% CI 1.2-112.6).

Deep Transcranial Magnetic Stimulation (dTMS)⁶ In 2019, Filipič, et.al, conducted a randomized trial to the clinical outcome between TMS protocols delivered by H1-coil and the figure 8 coil. Based upon network meta-analyses of randomized trials, the efficacy and acceptability of deep TMS appears to be comparable to that of surface cortical TMS and theta burst TMS. A four-week randomized trial compared add-on deep TMS (20 sessions) with surface cortical TMS in patients with treatment-resistant depression (n = 147) who continued to receive stable, ongoing pharmacotherapy. Although remission in the two groups was comparable, response occurred in more patients who were treated with

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adjunctive deep TMS than surface cortical TMS (67 versus 44 percent). In addition, all-cause discontinuation occurred more than twice as often with deep TMS than surface cortical TMS (10 and 4 percent of patients).

Theta burst Stimulation(iTBS)⁷ In 2021, a systematic review conducted by Voigt et al, focused on theta burst stimulation of TRD. The reviewers included 8 RCTs comparing theta burst stimulation to sham treatment, and 1 comparing theta burst stimulation to conventional rTMS. As measured by the HAM-D, Theta burst stimulation was superior to sham on response (RR 2.4; 95% CI: 1.27 to 4.55; p=.007; I2 = 40%). There was no statistically significant difference between theta burst stimulation and conventional rTMS (RR 1.02; 95% CI: 0.85 to 1.23; p=.80; I2 = 0%). There was There is no difference between theta burst stimulation and rTMS in the incidence of adverse events.⁷

TMS for adolescents⁸. In 2021, Croarkin, et. al, conducted a double blind, randomized, sham controlled trial across 13 sites to examine the safety and efficacy of 10-Hz TMS for adolescents with TRD. The participants included adolescents with TRD (aged 12-21 years). Treatment resistance was defined as an antidepressant treatment record level of 1 to 4 in a current episode of depression. Intention-to-treat patients (n = 103) included those randomly assigned to active NeuroStar TMS monotherapy (n = 48) or sham TMS (n = 55) for 30 daily treatments over 6 weeks. The primary outcome measure was change in the Hamilton Depression Rating Scale (HAM-D-24) score. After 6 weeks of blinded treatment, improvement in the least-squares mean (SE) HAM-D-24 scores were similar between the active (-11.1 (2.03)) and sham groups (-10.6 (2.00); P = 0.8; difference [95% CI], - 0.5 [-4.2 to 3.3]). Response rates were 41.7% in the active group and 36.4% in the sham group (P = 0.6). Remission rates were 29.2% in the active group and 29.0% in the sham group (P = 0.95). There were no new tolerability or safety signals in adolescents. Although TMS treatment produced a clinically meaningful change in depressive symptom severity, this did not differ from sham treatment. The authors concluded that future studies should focus on strategies to reduce the placebo response and examine the optimal dosing of TMS for adolescents with TRD.⁸

On January 25, 2024, Hayes published a medical code brief for 08897-0892T. These codes were added to describe the delivery and management of accelerated, repetitive high-dose functional connectivity magnetic resonance imaging (MRI)-guided theta burst stimulation. Based on a review of full-text clinical practice guidelines and position statements, Hayes determined that there was weak support for the use of intermittent theta burst stimulation (iTBS) and for use of MRI guidance for transcranial magnetic stimulation (TMS) coil positioning for treatment of major depressive disorder (MDD). At the time of the report, there were no published guidelines for accelerated magnetic resonance imaging (MRI)-guided theta burst stimulation (TBS).⁹

On April 24, 2024, Hayes published its annual review of maintenance rTMS for prevention of recurrent depression in adults. The review concluded that there was a very low-quality body of evidence to draw conclusions regarding the effectiveness and safety of rTMS as a maintenance

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treatment. There are currently no clinical practice guidelines or position statements that propose definitive patient selection criteria for maintenance rTMS for treatment of MDD.¹⁰

Food and Drug Administration (FDA)¹¹:

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 trial. In 2013, deep and conventional repetitive TMS (dTMS) was cleared for treatment resistant MDD. In August 2018, Intermittent Theta Burst Stimulation (iTBS) was first approved by the FDA. In 2024, the FDA approved NeuroStar Advanced Therapy as an adjunct to an existing therapy for the treatment of MDD in adolescent patients aged 15-21 years.

Coding Implications

This clinical policy references Current Procedural Terminology (CPT®). CPT® is a registered trademark of the American Medical Association. All CPT codes and descriptions are copyrighted 2024, American Medical Association. All rights reserved. CPT codes and CPT descriptions are from the current manuals and those included herein are not intended to be all-inclusive and are included for informational purposes only. Codes referenced in this clinical policy are for informational purposes only. Inclusion or exclusion of any codes does not guarantee coverage. Providers should reference the most up-to-date sources of professional coding guidance prior to the submission of claims for reimbursement of covered services.

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