Clinical Policy: Deep Transcranial Magnetic Stimulation for the Treatment of Obsessive Compulsive Disorder Form

# Clinical Policy: Deep Transcranial Magnetic Stimulation for the Treatment of Obsessive Compulsive Disorder
Reference Number: CP.BH.201  
Date of Last Revision: 03/24  

[Coding Implications](Coding Implications)  
[Revision Log](Revision Log)  

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

## Description  
Obsessive Compulsive Disorder (OCD) is a mental health disorder which includes obsessional thoughts and/or compulsions that are time consuming (more than one hour a day), and often and contributes to substantial functional impairment.^1  

Deep Transcranial Magnetic Stimulation (dTMS) is a non-invasive tool using an H-7 coil that stimulates deep regions of the brain, such as the anterior cingulate cortex (ACC) and the medial prefrontal cortex (mPFC). This contributes to a wider and deeper distribution than the coil used for repetitive TMS (rTMS).^2  

  

  

III. It is the policy of Centene Advanced Behavioral Health and health plans affiliated with Centene Corporation that maintenance treatment with dTMS is considered not medically necessary, as there is not sufficient peer reviewed literature to support maintenance for dTMS at this time.  

  

## Background  
According to the American Psychological Association (APA) 2-3% of individuals in the United States are impacted by obsessive compulsive disorder (OCD). Pharmacological treatment, such as selective serotonin reuptake inhibitors, combined with psychotherapy such as cognitive behavioral therapy (CBT) and exposure response prevention (ERP), are considered first line treatment for OCD.^1  

Deep Transcranial Magnetic Stimulation(dTMS) is the first noninvasive device the FDA cleared to treat OCD. It does not require anesthesia or cause adverse or significant side effects which can easily be incorporated into a patient’s daily routine. Treatment sessions typically occur in a six-week acute phase that includes five sessions a week. Prior to each treatment, patients undergo individually tailored provocations to activate the abnormal OCD circuitry. Patients are presented with a script, images, or activity tailor-made to trigger their specific obsessions and compulsions.^3  

In 2018, the FDA reviewed data from a randomized, multi-center study of 100 patients, of which 49 patients received treatment with the Brainsway TMS device and 51 received treatment with a non-working (sham) device. The study evaluated the reduction in patients’ Yale-Brown Obsessive-Compulsive Scale (YBOCS) score. The results indicated that 38% of patients responded to the Brainsway device (i.e., greater than 30 percent reduction in YBOCS score), whereas 11 percent of patients responded when using the sham device.^4  

In 2019, Carmi et al. conducted a prospective multicenter randomized double-blind placebo-controlled trial which examined the therapeutic effect of dTMS. The research was conducted at 11 centers in which 99 OCD patients were randomly assigned to dTMS treatment with either high-frequency (20 Hz) or sham dTMS. The sessions were conducted daily following individualized symptom provocative inhibitors for 6 weeks. The clinical responses were determined using YBOCS and the primary efficacy endpoint was the change in score from baseline to posttreatment assessment. The results indicated a reduction in YBOCS score among those who received active dTMS treatment. This was significantly greater than those who received sham treatment, with response rates of 38.1% and 11.1%, respectively. At the one-month follow-up,  

Page 3 of 10  

the response rates were 45.2% in the active treatment group and 17.8% in the sham treatment group. The study suggests that high frequency dTMS over the medial prefrontal cortex and anterior cingulate cortex significantly improved OCD symptoms and may be considered as a potential intervention for members/enrollees who do not respond adequately to pharmacological and psychological interventions.^5  

In 2021, Roth et al. conducted a review of the efficacy of dTMS for OCD in real world practices. This post marketing study entailed twenty-two clinical sites with H7-coils providing data on details of treatment and outcome (YBOCS) measures from a total of 219 patients. One-hundred-sixty-seven patients who had at least one post-baseline YBOCS measure were included in the main analyses. Overall first and sustained response rates were 72.6% and 52.4%, respectively. The response rate was 57.9% in patients who had YBOCS scores after 29 dTMS sessions. First response was achieved in average after 18.5 sessions (SD = 9.4) or 31.6 days (SD = 25.2). Onset of sustained one-month response was achieved in average after 20 sessions (SD = 9.8) or 32.1 days (SD = 20.5). Average YBOCS scores demonstrated continuous reduction with increasing numbers of dTMS sessions. The conclusion proposed that majority of OCD patients benefited from dTMS, and the onset of improvement usually occurs within 20 sessions. Extending the treatment course beyond 29 sessions results in continued reduction of OCD symptoms, raising the prospect of value for extended treatment protocols in non-responders.^6  

Additional recent meta-analyses conclude that TMS of several brain targets represents a safe and effective treatment option for OCD, however, further research is needed to help clinicians individualize TMS protocols and targets for each member/enrollee.^7,^8  

### Clinical TMS Society^2  
Prior to each treatment, patients will go through individually tailored provocations (intentionally trigger symptoms) to activate the abnormal OCD circuitry. The treatment does not require anesthesia or analgesia, therefore there are no activity restrictions before or after treatment. TMS for OCD is typically performed 5 days per week for 6 weeks for a total of 29 sessions.  

### International OCD Foundation^9  
TMS should be used as an add on treatment for those who have already tried first line treatment modalities such as ERP and/or medication.  

### Anxiety and Depression Association of America (ADAA)^10  
Practice guidelines for treating OCD are recommend as the following: first-line treatments cognitive-behavioral therapy (CBT) consisting of exposure and response prevention (EX/RP), pharmacotherapy with serotonin reuptake inhibitors (SRIs), or their combination. Suggestions for other strategies to manage treatment refractory conditions when first line treatments fail include: increasing the intensity of EX/RP and/or level of care (i.e., intensive outpatient care, residential EX/RP program); somatic therapies (transcranial magnetic stimulation); or neurosurgical interventions (deep brain stimulation or ablative procedures). The ADAA list criteria for treatment refractory OCD in adults as: three adequate SRI trials and at least two of the following medications for at least 1 month: antipsychotic, clonazepam, lithium, buspirone and adequate CBT with at least 20 sessions of EX/RP.  

Page 4 of 10  

## Yale Brown Obsessive Compulsive Scale (Y-BOCS)^11  
The Y-BOCS was developed by Goodman, W.K., Price, L.H. Rassmussen, S.A., et al. in 1989. It is a standardized rating scale designed to rate the severity and type of symptoms in patients with obsessive compulsive disorder (OCD), measuring 10-items pertaining to obsessions and components on a five-point Likert scale. Scores range from 0 (no symptoms) to 4 (extreme symptoms) with the total score calculated by subtotalling the items which can range from 0 to 40.  

## 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 2023, 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.  

| CPT® Codes | Description |
|------------|-------------|
| 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 |
| 97014 | Application of a modality to 1 or more areas; electrical stimulation (unattended) |
| 97032 | Application of a modality to 1 or more areas; electrical stimulation (manual), each 15 minutes |

## Reviews, Revisions, and Approvals  

| Reviews, Revisions, and Approvals | Revision Date | Approval Date |
|----------------------------------|--------------|--------------|
| New Policy | 8/20 | 11/20 |
| Additional language to Section I. Policy/Criteria, D. includes “score 16-23 for moderate symptoms and up to 31 for severe symptoms, minimum score being 24. A score indicating moderately severe to severe OCD throughout the current course of treatment (or other standardized scale indicating moderately severe to severe OCD); a. The Y-BOCS provides five rating dimensions for obsessions and compulsions: time spent or occupied; interference with functioning or relationships; degree of distress; resistance; and control (i.e., success in resistance). The 10 Y-BOCS items are each scored on a four-point scale from 0 = "no symptoms" to 4 = "extreme symptoms." The sum of the first five items is a severity index for obsessions, and the sum of the last five an index for compulsions. A translation of total score into an approximate index of overall severity is: Subclinical <8, Mild 8-15, Moderate 16-23, Severe 24-31 Extreme 32-40: | 2/21 | 2/21 |

Page 5 of 10  

| Reviews, Revisions, and Approvals | Revision Date | Approval Date |
|----------------------------------|--------------|--------------|
| a., a reduction in Y-BOCS score of 25% or 35% with a final Y-BOCS is considered the criteria for response to treatment. There is also a Children’s YBOCS however, these procedures are currently only approved for adults. |  |  |
| Changed all medical necessity statements to require medical director review. Moved YBOC scale information in section I to the background. Minor edits made for clarity of review process. | 3/21 | 4/21 |
| Annual review of policy. Confirmed current CPT codes for TMS and ICD-10 codes for OCD, and updated policy with grammar and format revisions. | 2/22 | 2/22 |
| Added CMS Local Coverage Determination (LCD L33398, Transcranial Magnetic Stimulation, effective 10/1/20, (published indications and limitations for Deep TMS (d-TMS) to the background section and reference section. | 3/22 | 4/22 |
| Ad-hoc review. Changed “review date” in the header to “date of last revision: and “date” in the revision log header to “revision date.” Edited policy statements I-IV to note that they apply to Centene Advanced Behavioral Health as well as plans affiliated with Centene Corporation. Replaced all instances of “dashes (–)” in page numbers with the word “to.” | 12/22 | 12/22 |
| Annual Review. Policy restructured and reformatted with no impact to meaning. Added the following statement to the description section: “obsessive compulsive disorder (OCD) treatment with TMS delivers magnetic stimulation to the frontal brain structures and networks, targeting previously unreachable areas of the brain.” In policy statement I. changed the initial request of sessions from “20” to “30” sessions. In criteria point I.A.: added the statement “per DSM-5-TR Criteria”. Added criteria point I.B, “Administered using and Food and Drug Administration (FDA) cleared device and utilized in accordance with the FDA labeled indications such as but not limited to the following” and added a list of FDA approved devices. In criteria point I.F.4.: Added the following statement “such as but not limited to the following”. Removed the following statement from criteria point I.F.11.: “previously categorized as “Axis I” psychiatric disorders”. Added the following contraindication to I.F.12.: “No active suicidal ideation with intent”. In policy statement II. replaced “request for an additional 10 sessions” with “request for taper of six final sessions”. Added to criteria point IIA. “Criteria for initial dTMS treatment guidelines continues to be met.” In criteria point IIB. replaced “25% reduction of OCD symptom severity” with “30% reduction of OCD symptom severity”. In criteria point IIC. replaced “25% reduction in baseline severity scores” with “30% reduction in baseline severity scores”. Added to criteria point IV.A.: “Criteria for initial dTMS treatment guidelines continues to be met.” In criteria point IV.C. changed the responses percentage baseline drop from “50% drop from the baseline OCD scores” to “30% drop from the baseline OCD scores”. Deleted criteria point IV. D.1-9, as this information is captured in IV.A. Replaced all instances of “member” with “member/enrollee”. Added semicolons throughout the | 02/23 | 03/23 |

Page 6 of 10  

| Reviews, Revisions, and Approvals | Revision Date | Approval Date |
|----------------------------------|--------------|--------------|
| criteria section. Coding reviewed. Background section updated. References reviewed, updated, and reformatted. Policy reviewed by internal specialist. Policy reviewed by external specialist. |  |  |
| Annual Review. Updated description with no clinical significance. Minor rewording throughout the policy for clarity with no clinical significance. Separated former criteria point IA into two sub points (A and B).Criteria point I. D. reworded for clarity “Direct supervision of treatment is provided by a licensed psychiatrist except where state scope of practice acts allows for other provider types to supervise.” Removed I.H.3. “Vagus nerve stimulator leads in the carotid sheath” as this is captured in I.H.2. In criteria point I.H.4. Replaced “substance abuse at time of treatment” with “less than three months of substantiated remission from a substance use disorder.” Removed “Neurological disease or head injury” and “pregnancy” from the contraindication list. Added new CPT/HCPCS codes: “97014: Application of a modality to 1 or more areas; electrical stimulation (unattended); 97032: Application of a modality to 1 or more areas; electrical stimulation (manual), each 15 minutes. Background section updated. References reviewed and updated. | 03/24 | 03/24 |

  
2. Clinical Transcranial Magnetic Stimulation Society. Coverage guidance for TMS for OCD. https://www.clinicaltmsociety.org/. Published February 2, 2021. Accessed February 28, 2024.  
3. Brainsway. Introducing BrainsWay Deep TMS for OCD. https://www.brainsway.com/treatments/obsessive-compulsive-disorder/. Accessed February 28, 2024.  
4. U.S Food and Drug Administration. https://www.fda.gov/. Accessed February 28, 2024.  
5. Carmi L, Tendler A, Bystritsky A, et al. Efficacy and Safety of Deep Transcranial Magnetic Stimulation of the Orbitofrontal Cortex for Obsessive-Compulsive Disorder: A Prospective Multicenter Randomized Double-Blind Placebo-Controlled Trial. Am J Psychiatry. 2019;176(11):931-938. doi: 10.1176/appi.ajp.2018.1011180  
6. Roth Y, Tendler A, Arikian MK, et al. Real-world efficacy of deep TMS for obsessive-compulsive disorder: post-marketing data collected from twenty-two clinical sites. J Psychiatr Res. 2021; 137:667-672. doi: 10.1016/j.jpsychires.2020.11.009  
7. Harmelech T, Roth T, Tendler A. Transcranial Magnetic Stimulation in Obsessive-Compulsive Disorder. Psychiatr Clin North Am. 2023;46(1):133-166. doi: 10.1016/j.psc.2022.10.003  
8. Grassi G, Moradi C, Cecchelli C. Will Transcranial Magnetic Stimulation Improve the Treatment of Obsessive-Compulsive Disorder? A Systematic Review and Meta-Analysis of Current Targets and Clinical Evidence. Life (Basel). 2023;13(7):1494. Published 2023 Jul 1. doi:10.3390/life13071494  

Page 7 of 10  

9. The International OCD Foundation. Transcranial Magnetic Stimulation (TMS) for OCD. https://iocdf.org/about-ocd/treatment/tms/. Accessed February 28, 2024.  
10. Anxiety and Depression Association of America. Clinical Practice Review for OCD. https://adaa.org/resources-professionals/practice-guidelines-ocd. Published June 15, 2015. Accessed February 28, 2024.  
11. Goodman WK, Price LH, Rasmussen SA, et al. The Yale-Brown Obsessive-Compulsive Scale. I. Development, use, and reliability. Arch Gen Psychiatry. 1989;46(11):1006-1011. doi:10.1001/archpsyc.1989.018110048007  
12. U.S Food and Drug Administration. FDA News Release. FDA permits marketing of transcranial magnetic stimulation for treatment of obsessive-compulsive disorder. https://www.fda.gov/news-events/press-announcements/fda-permits-marketing-transcranial-magnetic-stimulation-treatment-obsessive-compulsive-disorder. Published August 17, 2018. Accessed February 28, 2024.  
13. U.S Food and Drug Administration. Indication for use. MagVenture TMS Atlas Neuro Navigation System. https://www.accessdata.fda.gov/cdrh_docs/pdf22/K221544.pdf. Published March 17, 2023. Accessed February 28, 2024.  
14. Sejvar,M. Magstim. FDA clears Magstim transcranial magnetic stimulation for obsessive compulsive disorder. https://www.magstim.com/us-en/fda-clears-magstim-transcranial-magnetic-stimulation-for-obsessive-compulsive-disorder/. Published January 18, 2023. Accessed February 28, 2024.  
15. U.S Food and Drug Administration. Indication for use. Horizon 3.0 TMS Therapy system. Published January 13, 2023. Accessed February 28, 2024. https://www.accessdata.fda.gov/cdrh_docs/pdf22/K222171.pdf.  
16. Health Technology Assessment. Transcranial Magnetic Stimulation for the Treatment of Obsessive-Compulsive Disorder. Hayes. www.hayesinc.com.Published March 5, 2019 (Annual review February 15, 2022). Accessed February 28, 2024.  

## Important Reminder  
This clinical policy has been developed by appropriately experienced and licensed health care professionals based on a review and consideration of currently available generally accepted standards of medical practice; peer-reviewed medical literature; government agency/program approval status; evidence-based guidelines and positions of leading national health professional organizations; views of physicians practicing in relevant clinical areas affected by this clinical policy; and other available clinical information. The Health Plan makes no representations and accepts no liability with respect to the content of any external information used or relied upon in developing this clinical policy. This clinical policy is consistent with standards of medical practice current at the time that this clinical policy was approved. “Health Plan” means a health plan that has adopted this clinical policy and that is operated or administered, in whole or in part, by Centene Management Company, LLC, or any of such health plan’s affiliates, as applicable.  

The purpose of this clinical policy is to provide a guide to medical necessity, which is a component of the guidelines used to assist in making coverage decisions and administering benefits. It does not constitute a contract or guarantee regarding payment or results. Coverage decisions and the administration of benefits are subject to all terms, conditions, exclusions, and limitations of the coverage documents (e.g., evidence of coverage, certificate of coverage, policy,  

Page 8 of 10  

contract of insurance, etc.), as well as to state and federal requirements and applicable Health Plan-level administrative policies and procedures.  

This clinical policy is effective as of the date determined by the Health Plan. The date of posting may not be the effective date of this clinical policy. This clinical policy may be subject to applicable legal and regulatory requirements relating to provider notification. If there is a discrepancy between the effective date of this clinical policy and any applicable legal or regulatory requirement, the requirements of law and regulation shall govern. The Health Plan retains the right to change, amend or withdraw this clinical policy, and additional clinical policies may be developed and adopted as needed, at any time.  

This clinical policy does not constitute medical advice, medical treatment, or medical care. It is not intended to dictate to providers how to practice medicine. Providers are expected to exercise professional medical judgment in providing the most appropriate care and are solely responsible for the medical advice and treatment of members/enrollees. This clinical policy is not intended to recommend treatment for members/enrollees. Member/enrollee should consult with their treating physician in connection with diagnosis and treatment decisions.  

Providers referred to in this clinical policy are independent contractors who exercise independent judgment and over whom the Health Plan has no control or right of control. Providers are not agents or employees of the Health Plan.  

This clinical policy is the property of the Health Plan. Unauthorized copying, use, and distribution of this clinical policy or any information contained herein are strictly prohibited. Providers, members/enrollees, and their representatives are bound to the terms and conditions expressed herein through the terms of their contracts. Where no such contract exists, providers, members/enrollees and their representatives agree to be bound by such terms and conditions by providing services to members/enrollees and/or submitting claims for payment for such services.  

**Note:** For Medicaid members/enrollees, when state Medicaid coverage provisions conflict with the coverage provisions in this clinical policy, state Medicaid coverage provisions take precedence. Please refer to the state Medicaid manual for any coverage provisions pertaining to this clinical policy.  

**Note:** For Medicare members/enrollees, to ensure consistency with the Medicare National Coverage Determinations (NCD) and Local Coverage Determinations (LCD), all applicable NCDs, LCDs, and Medicare Coverage Articles should be reviewed prior to applying the criteria set forth in this clinical policy. Refer to the CMS website at http://www.cms.gov for additional information.  

  

Page 10 of 10