LCD Reference Article Response To Comments Article

Response to Comments: Transcranial Magnetic Stimulation

A59328

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Article ID
A59328
Original ICD-9 Article ID
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Article Title
Response to Comments: Transcranial Magnetic Stimulation
Article Type
Response to Comments
Original Effective Date
04/01/2023
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As an important part of Medicare Local Coverage Determination (LCD) development, National Government Services solicits comments from the provider community and from members of the public who may be affected by or interested in our LCDs. The purpose of the advice and comment process is to gain the expertise and experience of those commenting.

We would like to thank those who suggested changes to the Transcranial Magnetic Stimulation Local Coverage Determination. The official notice period for the final LCD begins on February 9, 2023, and the final determination will become effective on April 1, 2023.

Response To Comments

Number Comment Response
1

The following comments were received from members of the Minnesota Psychiatric Society (MPS) in support of approving coverage of TMS for OCD:

  • OCD is a condition which tends to start in adolescence and it tends to be a chronic and lifelong condition which typically causes continuous symptomatology rather than episodic. It can cause significant and enduring distress and disability.
  • Medication options that currently exist are less than ideal, often have to be prescribed at relatively high doses (often at higher doses than needed for depressive disorders or other anxiety disorders). Often times combination therapy with up to several medications at a time is required.
  • Response to medications is often suboptimal and the medication options carry a significant side effect burden.
  • Neurosurgery can be helpful for individuals with refractory disease, but it is invasive and carries a higher risk than TMS.
  • TMS has minimal to no side effects
  • The FDA has now approved two coils for TMS for OCD, H7 and Cool D-B80.
  • Patients with OCD may also suffer from major depressive disorder and both conditions can be responsive to treatment with the H-7 coil
  • Psychiatrists in MPS find that TMS provides an invaluable tool that is effective and well tolerated.

NGS appreciates your statements collated from the group’s membership on Obsessive Compulsive Disorder (OCD) and Transcranial Magnetic Stimulation (TMS). However, there is no literature submitted in support of your comments.

See Internet Only Manual 100-08, Medicare Program Integrity Manual, Chapter 13 – Local Coverage Determinations, Section 13.2.3. Acceptance by individual health care providers, or even a limited group of health care providers, does not indicate general acceptance of the item or service by the medical community.

2

Two comments were received from BrainsWay employee Scott Blackman. The first was a request received to re-evaluate the evidence for Deep TMS (dTMS) for OCD only and to avoid looking at information that was not on topic, while also adding in four additional studies that were not included in the review but were submitted in an evidence update for the reconsideration of 8/1/2022. The second request were comments received to evaluate the LCD’s evidence analysis and to request a re-evaluation of the Deep TMS evidence for OCD. The request contained many suggested articles for review by BrainsWay without full copies of the literature.

The request to avoid looking at other sources of information is reasonable, and the changes needed were made to the Final by removing any articles not about dTMS and OCD. The evidence was reviewed, changes were made and reflected in the final version.

Concerning the second request, while we appreciate the many articles of literature given with extensive summaries for all, unfortunately, many of the articles had significant conflicts of interest, including funding by BrainsWay. The remaining literature that did not have significant COI, was not well validated, had very small samples and did not provide strong evidence for dTMS for OCD but did encourage for further studies to be done. Thank you in advance.

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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
L33398 - Transcranial Magnetic Stimulation
Related National Coverage Documents
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