LCD Reference Article Response To Comments Article

Response to Comments: Magnetic Resonance Image Guided High Intensity Focused Ultrasound (MRgFUS) for Tremor

A60159

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Source Article ID
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Article ID
A60159
Original ICD-9 Article ID
Not Applicable
Article Title
Response to Comments: Magnetic Resonance Image Guided High Intensity Focused Ultrasound (MRgFUS) for Tremor
Article Type
Response to Comments
Original Effective Date
08/17/2025
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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 Magnetic Resonance Image Guided High Intensity Focused Ultrasound (MRgFUS) for Tremor LCD. The official notice period for the final LCD begins on July 3, 2025, and the final determination will become effective on August 17, 2025.

Response To Comments

Number Comment Response
1

NGS received a comment from a neurosurgeon from New York. He recommended our Medicare beneficiaries have access to multiple surgical options for treatment of their movement disorders. He recommended coverage for magnetic resonance guided focused ultrasound pallidotomy especially for those patients with comorbidities contradicting deep brain stimulation surgery. This decision should be based in part on the clinical evidence published in the February 23rd, 2023, New England Journal of Medicine as well as a recent publication in the June 24, 2024, issue of Neurologic Journal Safety and Efficacy of Unilateral Focused Ultrasound Pallidotomy on Motor Complications in Parkinson's Disease: a systemic review and meta-analysis, (first author is Abdullah Abba).

NGS will be adding coverage for treatment of Parkinson's disease patients with MR guided focused ultrasound (MRgFUS) pallidotomy after reviewing the 2024 article from Neurologic Science. Meta analysis was done to evaluate the safety and efficacy of unilateral focused ultrasound pallidotomy on motor complications in Parkinson's disease patients. They identified studies relevant to unilateral focused ultrasound pallidotomy and Parkinson's disease. It included observational studies, clinical trials and case series reporting the impact of the intervention on motor complications in Parkinson's disease patients. Five studies were included in the meta-analysis involving 112 Parkinson's disease patients undergoing the procedure. There was a significant improvement from baseline. The effect of the procedure on motor complications is effective with a significant decrease in the UPDRS and the UDYSRS, reflecting improvement. The incidence of adverse effects was not statistically significant.

2

NGS received a comment from a neurosurgeon from Rhode Island. He was in support of Medicare coverage for unilateral focused ultrasound pallidotomy for idiopathic, intractable Parkinson's disease. He felt there are high quality studies and at least one meta-analysis that supports the safety and reasonable efficiency of focused ultrasound pallidotomy. Focused ultrasound pallidotomy offers at least a palliative, low-cost option to improve the management, even if it is not as effective as gold standard deep brain stimulation (DBS).

NGS thanks this physician for his years of experience and review of the literature. We appreciate your written comments.

3

NGS received comments from Dee Kolanek from Insightec, the makers of Exablate 4000. The note commends NGS for making three of the requested changes from the reconsideration request. They continue to ask us to reconsider our position on the use of this procedure for focused ultrasound pallidotomy. The recent publication in the June 24, 2024, issue of Neurologic Science titled Safety and Efficacy of Unilateral Focused Ultrasound Pallidotomy on Motor Complications in Parkinson's Disease: a systemic review and meta-analysis, (first author is Abdullah Abba) is now available for review. Also included is summary of safety and effectiveness data for the Exablate model 4000.

Please see comment #1 for the NGS response to the information in the article from June of 2024 found in the journal Neurologic Science. We cannot use the safety and effectiveness data to form our determination.

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