LCD Reference Article Response To Comments Article

Response to Comments: Transcranial Magnetic Stimulation (TMS)

A59253

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A59253
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Article Title
Response to Comments: Transcranial Magnetic Stimulation (TMS)
Article Type
Response to Comments
Original Effective Date
10/20/2022
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This article summarizes the comments CGS received for Draft Local Coverage Determinations (LCD) Transcranial Magnetic Stimulation (TMS) DL36469. Thank you for the comments.

Response To Comments

Number Comment Response
1

BrainsWay® submitted comments requesting a re-evaluation of Deep TMS evidence for the indication of OCD. They state current CGS’s OCD evidence summary combined all TMS methods for OCD treatments (Deep TMS H7 coil and traditional figure 8 coil TMS studies) to reach a conclusion of mixed results and suggest 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. They state 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.

 

BrainsWay® submitted 10 articles for consideration with the initial LCD reconsideration request and three new sources were cited in the comment letter which have been added to the policy. Additionally, CGS conducted a comprehensive literature search seeking additional studies and over 30 studies and guidelines were reviewed and referenced in the LCD. 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. The existing literature does not provide evidence that was of adequate quality due to small sample sizes, bias, poor design, and very limited follow-up with median around 6 weeks in most studies. It is not felt to meet the minimum criteria for coverage. If additional literature is published that addresses these concerns it can be submitted on reconsideration.

2

The Clinical TMS Society submitted recommendations to change the proposed LCD regarding TMS to include use for OCD in an outpatient office setting and provided detailed criteria for coverage. They state 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 and do not agree with CGSs position it is experimental.

The TMS society submitted a coverage guidance for TMS for OCD to support their guidelines beyond what us already covered in the LCD. There was no new literature that addresses the concerns brought up within the “Analysis of Evidence” section of the LCD. If additional literature is published that addresses these concerns it can be submitted on reconsideration.

3

BrainsWay® and the Clinical TMS Society request changes to MDD indications stating Deep TMS is indicated for patients with moderate-severe MDD based on studies conducted in this population who failed 1 or more medications in current episode. They recommend expanding coverage for:

  1. Changing from severe MDD to moderate to severe MDD.
  2. Reduce the number of failed medication trials from 4 to 1 or more trials.
  3. Deleting the requirement for psychotherapy trial

Supporting references were provided.

 

  1. Changing from severe MDD to moderate to severe MDD: There was no new literature submitted to support this recommendation. While the pivotal study referred to by BrainsWay included moderate to severe depression there was no evidence submitted that Deep TMS is equivalent or superior to current treatments for moderate depression in which there are multiple effective treatment options available.

 

  1. Reduce the number of failed medication trials from 4 to 1 or more trials: Deep TMS is indicated for adults with unipolar major depression who have failed one antidepressant, however most studies patients failed multiple courses of pharmacotherapy and psychotherapy and in many cases also a trial of electroconvulsive therapy. Weissman et al (2021) reports improvement in suicidal ideation (SI) is limited with pharmacotherapy in patients with treatment-resistant depression, however this is based on evidence with significant limitations include study design and small sample size which had too small of a number of subjects with SI to draw conclusions. Individual studies provide support for use of deep TMS with 1 or more failed antidepressant agent, however most participants in these studies had severe treatment resistance depression with 2 or more agents used during depression episode. Only a small percentage of the overall patients had only 1 agent. CGS does not feel there is sufficient evidence at this time to allow prior to a trial of a single agent but that medical management that includes two prior agents from different classes is supported in the current literature and this change has been made.

 

  1. Delete requirement for psychotherapy trial: Psychotherapy is a proven therapy for treatment resistant depression. Evidence regarding repetitive transcranial magnetic stimulation, the appropriate length of its first course, the use of repetitive courses and its long-term durability is still under study. CGS would not drop a requirement for a proven known treatment in favor of one in which the evidence is still evolving.
4

The TMS Society states the CGS proposal limits TMS to 36 treatments and does not cover sessions beyond 36. They request expansion of coverage for:

  1. Induction TMS beyond 36 sessions (initial treatment)
  2. Treatment reintroduction after induction course
  3. Continuation or maintenance treatment after induction

The CGS policy allows 20 sessions over a 4-week period followed by five visits for tapering for those in remission. For those with at least 25% improvement therapy may be continued for an additional 2 weeks (10 visits) with an additional 6 for tapering. Further treatment for those not achieving at least a 50% reduction in symptoms is not covered. Retreatment is allowed if patient has a relapse after achieving 50% improvement using standard rating scale for depressive symptoms or relapse after a remission. The policy does not allow “maintenance therapy” beyond the initial treatment cycle.

 

The literature on the use of TMS treatment for induction beyond 36 weeks, maintenance (also called preservation or continuation) therapy beyond the initial treatment phase in patients who do not respond by at least 25% to the initial to treatment is challenged by small samples sizes, study design flaws with lack of control groups, blinding and risk of bias, and lack of long-term data for safety and effectiveness. There is not a clear benefit of prolongation of TMS past the induction phase to prevent relapse or maintain remission in current literature especially since up to half of patients demonstrate durability, and patient selection, role of antidepressant in maintenance and protocol for this treatment have not been established. There are not recommendations from American Psychiatry Association to support maintenance TMS. At this time there is insufficient published evidence to evaluate the safety and efficacy of this treatment in the context of maintenance therapy to prevent relapse in a patient who had a major depressive episode that remitted with prior treatment. However, retreatment (reintroduction/TMS rescue) for relapse in in appropriately selected previous responders is supported by the current literature. This has been summarized in the LCD.

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Associated Documents

Medicare BPM Ch 15.50.2 SAD Determinations
Medicare BPM Ch 15.50.2
Related Local Coverage Documents
LCDs
L36469 - Transcranial Magnetic Stimulation (TMS)
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