Response to Comments: Transcranial Magnetic Stimulation (TMS) (DL34641)

The purpose of our comments is to request a re-evaluation of Deep TMS evidence for the indication of OCD. The current WPS Draft LCD reviewed limited references/studies to Deep TMS for OCD (only the pilot and multicenter RCTs (Carmi 2018 and 2019). WPS’ OCD evidence summary combined/comingled all TMS for OCD treatments (Deep TMS H7 coil and traditional figure 8 coil TMS studies) to reach a conclusion of mixed results. Studies had mixed protocols & parameters: Type of sham used, Brain regions stimulated, Low or high frequency (LF/HF), Small patient numbers, Mixed effectiveness results and blinding bias. Systematic reviews and meta-analyses combined all TMS studies (4 without Deep TMS) to summarize outcomes of all protocols and devices used. Deep TMS OCD evidence should be reviewed separately and not combined with previous Figure 8 coil TMS studies or meta-analyses which did not use the FDA-cleared OCD protocol. Figure 8 coil TMS have not published effectiveness studies using the FDA cleared TMS for OCD protocol. Therefore, your analysis of “evidence based” H7 coil Deep TMS studies with the FDA cleared OCD treatment protocol (stimulating the mPFC and ACC) should not be confused with or include studies of the traditional Figure 8 coil evidence which used other less proven treatment protocols.

Based upon the strength of Deep TMS evidence supporting OCD effectiveness outcomes with the FDA cleared protocol, the evidence supports coverage for this chronic and underserved patient population where there are limited treatments available, and a significant unmet need exists. The rationale for coverage is supported by 14 studies including both pilot and large pivotal multicenter clinical trials demonstrating patients who have failed to respond to first-line medication or psychotherapy treatments did respond (38.1 – 45.2% in 6 weeks of treatment and 1 month post treatment); real-world evidence with follow-up over two years demonstrating a 57.9% response; long-term-effectiveness with 87% of patients sustaining their response for > 1 year and an average of 2 years durability; improvement in functional disability both in productive work days and reduced lost days per week; and that Deep TMS treatment is the best treatment strategy and most cost-effective strategy in the treatment continuum after SRI non-response.

Should WPS decide to cover Deep TMS for OCD, we would request your OCD coverage criteria be similar to that published by Palmetto GBA and in line with that of the Clinical TMS Society’s OCD Coverage Policy guidance provided (Attachment 3). Thank you for your review of this new evidence and analysis of Deep TMS for less restrictive MDD coverage criteria and for OCD coverage.

Brainsway, on a letter dated March 12, 2021, proposed to WPS a reconsideration to cover Treatment resistant obsessive-compulsive disorder (OCD) with TMS. Submitted were 10 articles by the company for consideration.

These 10 items were considered by WPS and the reconvened TMS multijurisdictional workgroup. These studies were reviewed and the consensus was that the literature did not suggest safety and long term data obtained by the literature and presented by the company. There was a trend toward benefit in the meta-analysis and in the randomized control trial; however, many questions remained about long term response, duration of treatment, and how often treatment should be given. Due to the lack of supportive data being presented, the workgroup expanded its own search for TMS for OCD in an effort to give a more complete analysis of the reconsideration. Brainsway did not present additional full text peer-reviewed articles for consideration.
Literature search items were:

• PubMed – “Obsessive-Compulsive Disorder & Transcranial Magnetic Stimulation”, =>141
• MedLine Complete – “Obsessive-Compulsive Disorder” & “Transcranial Magnetic Stimulation” Limited to 2015 – 2021 => 139 -> 55 after duplicates removed.
• ECRI – “Transcranial Magnetic Stimulation OCD”
• UpToDate – Transcranial Magnetic Stimulation & OCD

As far as literature the company presented, the median follow-up or endpoint was 6 weeks. Comments received from the manufacturer were reviewed but additional information did not provide evidence that was of adequate quality due to small group sizes, bias, poor design, and very limited follow-up. It was not felt to meet the minimum criteria for coverage. Comments made that we considered additional information that was not consistent with current practice standards may be true, but we were looking for documentation in additional references that might support the companies’ arguments for coverage.

As members of the Clinical TMS Society, we are reaching out to request a reassessment of criteria used to determine when transcranial magnetic stimulation (TMS) is appropriate for WPS members. Our intent with this letter is to advocate for changes in the proposed LCD(1) based on clinical standards and science regarding TMS therapy, a vital, evidence-based treatment that alleviates the morbidity and mortality associated with MDD and OCD.

We find WPS TMS LCD proposed coverage falls short of promoting evidence-based practices and unnecessarily limits its members’ access to TMS therapy. TMS is an essential treatment that is medically necessary for WPS Medicare members with MDD and OCD who have not responded or remitted to one or more pharmacological agents. Unfortunately, as written this clinical policy effectively excludes potentially many of WPS members with OCD who would benefit from TMS therapy. This is especially critical given that the ongoing COVID-19 pandemic rates of depression, anxiety and OCD are rapidly increasing; and evidence-based, cost-effective treatments are needed. In this letter, we detail some needed changes in the current LCD proposal so that revisions will be consistent with the clinical evidence, community standards, guidelines of non-profit professional societies, and government organizations.

Recommended Indications and Changes to Proposed LCD regarding TMS

An initial regimen (i.e. the induction course) of TMS administered in an outpatient office setting using a U.S. (FDA) -cleared device is considered medically necessary when an individual with OCD meets all the following criteria:

• Diagnosis of OCD, as defined by the most recent edition of Diagnostic and Statistical Manual of Mental Disorders.
  
  
• One or more of the following:
  • Resistance to treatment with psychopharmacologic agents as evidenced by a lack of a clinically significant response to a trial of 2 distinct psychopharmacologic agents, administered for a minimum of 8 weeks; or
  • Inability to tolerate psychopharmacologic agents FDA approved for OCD, as evidenced by trials from 2 distinct classes; or
  • History of response to TMS for OCD in the past that was clinically meaningful;
    or
  • If patient is currently receiving antipsychotics, opioids, benzodiazepines, glutamatergic agents or other agents which could be considered investigational or risky treatments; TMS therapy may be considered reasonable and necessary as a safer treatment option; or
  • Resistance to treatment with psychopharmacologic agents as evidenced by a lack of a clinically significant response to a trial of 1 agent, administered for a minimum of 8 weeks and a trial of an evidence-based psychotherapy known to be effective in the treatment of OCD for a minimum of 8 weeks without significant improvement in symptoms. Therapy may include 10-12 sessions delivered weekly or biweekly as well as more intensive forms such as group therapy and programs with multiple therapy sessions per day (e.g., IOP, PHP or inpatient/residential programs).
    
    
• Validated OCD monitoring scales are administered at the beginning and end of the initial and each subsequent course of TMS.
  
  
• Induction course is typically 30-36 treatments. However, some patients may require longer induction courses (e.g., with more severe symptoms and/or treatment resistance) to respond or remit to TMS therapy. Patients should be considered for an extended induction course if they have at least a 20% reduction in their YBOCS by treatment 30.
  
  
• Repeat TMS administered in an outpatient office setting for a recurrence or an acute relapse of OCD and is considered medically necessary when ALL the following criteria are met:
  • All the above criteria for initial TMS therapy were met prior to the initial course;
  • Experienced at least a 30% reduction in the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) score;
  • Individual had evidence of clinical worsening validated by a rating scale (i.e., 20% or greater increase in OCD symptoms after responding or remitting to the initial course of TMS therapy).

In summary, deep transcranial magnetic stimulation (dTMS) has been shown to be a safe and effective treatment for OCD in patients who are not responsive to medication, CBT/ERP or their combination. WPS’s position regarding TMS as experimental is not consistent with the evidence, FDA-clearance for OCD, the recommendations of the CTMSS, experience from community practice, nor evidence in the literature from real world effectiveness trials.

We urge you to reconsider this position since it prevents WPS members from receiving an effective treatment for their OCD when they fail to respond to one or more medication and psychotherapy trials. In this light, the CTMSS recommends WPS update its LCD proposal for patients with a primary diagnosis of OCD. Specifically, we ask for you to focus your review on FDA cleared treatment parameters and devices.

WPS’s LCD proposal provides no coverage for patients with OCD who have failed first line treatments. WPS’s policy is not consistent with the scientific literature, non-profit professional society guidelines or the community standard

The TMS society submitted a coverage guidance for TMS for OCD with no other full text documentation to support their guidelines.

From the Clinical TMS Society Website:

Mission Statement

A professional association dedicated to optimizing clinical practice, awareness, and accessibility of Transcranial Magnetic Stimulation therapy.

Legal Entity

Clinical TMS Society is organized as a 501 (c)(6) “Trade Association”, not a charitable or scientific organization. It is registered in the states of Connecticut and California.

Due to no peer reviewed data being presented and this being a trade organization and not a scientific organization, we did not consider this letter or the proposed guidelines in our decision process.