LCD Reference Article Response To Comments Article

Response to Comments: Repetitive Transcranial magnetic Stimulation (rTMS) in Adults with Treatment Resistant Major Depression Disorder

A54791

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Source Article ID
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Article ID
A54791
Original ICD-9 Article ID
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Article Title
Response to Comments: Repetitive Transcranial magnetic Stimulation (rTMS) in Adults with Treatment Resistant Major Depression Disorder
Article Type
Response to Comments
Original Effective Date
02/08/2016
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The formal draft period for Repetitive Transcranial magnetic Stimulation (rTMS) in Adults with Treatment Resistant Major Depression Disorder DL36469 was from 12/21/2015 through 12/07/2015. Comment received are below with the final being effective 02/08/2016.

Response To Comments

Number Comment Response
1 Requestor asks that dementia not be an exclusionary criteria and submitted literature to show studies done. After review of the literature for this CGS found this was still in the investigational stage and will not expand coverage at this time.
2 Requestors ask that comparable valuation be taken into account of the work, skill, and high level of care needed to perform. Our pricing takes all of this into account. CGS appreciates the comments we recievd on this and will review our pricing model at the annual review of this procedure.
3 Several requestors commented on the indication section, listed TMS as occurring daily M-F for 6 weeks (30 treatments). However, in the utiliaton section, you are only approving 20 sessions UNLESS there is a 25% improvement after visit 20, in which case the additional 10 sessions are covered. Propose that all patients be allotted 30 treatments followed by 6 taper treatments. Retreatment would be limited to those patients who have shown 50% improvement with all 36 of those treatments in a prior TMS therapy course. Rationale: Most patients BEGIN to improve by weeks 3-5. It is not uncommon for most of the improvement to occur in treatments 20-30. Routinely are granted authorization for extension of treatment after 20 or even 30 treatments, even if there is no improvement or only a 25% improvement. For some very treatment-resistant, and espcially older patients (those covered by medicare) it is common to see a very delayed response to TMS therapy. Therefore, all 36 treatments may be necessary to achieve a 50% reduction in symptoms. It would be very sad indeed to stop treatment after 20 sessions for lack of a 25% improvement. It would be estimated that 30-40% of patients would respond by 25-50% during treatments 20-30. The literature reviewed and the SME’s utilized to establish this LCD all agree with our current guidelines. If there are peer reviewed, adequate sized studies to validate the opinion expressed regarding patients requiring 25-30 treatments before they get results, we will be happy to consider the suggested changes.
4 Request by several requestors to modify direct supervision by psychiatrist to general supervision.
  • It is reasonable to stipulate that the MT rechecks (CPT code 90869) be done under DIRECT supervision. Code 90868, however, should have general supervision (MD immediately available by phone or pager, but not necessarily physically present in the office). If the concern is seizure management, then you can stipulate that the TMS technician be certified in Basic Cardiac Life Support (BLS) and also certified by the manufacturer and the prescribing psychiatrist as being trained in the management of seizures.
CGS established this level of supervision based on SME input and has elected not to change the level of supervision at this time.
5 Comment on policy shows Vagal Nerve Stimulator (VNS) as a Coverage Limitation. Proposal: Clarify this section since you have mixed up absolute, vs. relative contraindications, vs. CAUTIONARY conditions. The VNS should either a relative contraindication or a CAUTION. You could always refer to the device manuals provided by each manufacturer, which lists these various medical conditions and categorizes them as I have outlined. If this is just a reference section advising caution with these listed conditions to the practitioners, then it seems ok as it is currently listed. If it is actually a list of contraindications it should state that, and VNS should not be an absolute contraindication. Thank you for your comment. Our LCD reflects the manufacturers recommendation and published literature recommendations.
6 Requestor feels psychotherapy should not be a requirement before authorizing rTMS since severely depressed patients can not participate in psychotherapy. Our LCD follows the current literature and SME input. Thanks for your comment. At this time there will be no change to the LCD.
7 Requestor would like to see policy updated to show that other physicians be allowed to adminster TMS since they also treat patients with majot depression disorder. Our LCD follows the most recent published literature, SME input, and CGS willnot be changing the LCD at this time.
8 Requestor feels one previous failed psychophamological trial is more apprpriate than four. Also many patients do not have access to evidence based therapy due to limited access of therapists and insurance limitations would like to see this removed. The current literature and SME recommendations have been followed in establishing this LCD. At this time, CGS is maintaining the four medication requirement. As the literature matures, CGS will be happy to receive additional input.
9 Requestor feels rating scale should not be used or relied on as sole outcome measure for treatment and that if a therapist chose supportive pyschotherapy instead of cognitive behavior therapy is unfair to the patient and TMS should not be denied. CGS will look at the documentation as a whole but one of the rating scales listed in the documentation requirements should be used to show objective improvement of patient.
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Associated Documents

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Medicare BPM Ch 15.50.2
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