LCD Reference Article Response To Comments Article

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

A59702

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Article ID
A59702
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Article Title
Response to Comments: Magnetic Resonance Image Guided High Intensity Focused Ultrasound (MRgFUS) for Essential Tremor
Article Type
Response to Comments
Original Effective Date
04/18/2024
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The comment period for the Magnetic Resonance Image Guided High Intensity Focused Ultrasound (MRgFUS) for Essential Tremor DL37761 Local Coverage Determination (LCD) began on 01/04/24 and ended on 02/17/24. The notice period for L37761 begins on 4/18/24 and will become effective on 6/2/24.

The comments below were received from the provider community.

Response To Comments

Number Comment Response
1

Thank you for taking steps to revise LCD 37761, changing the MRgFUS exclusion criteria point from an SDR of <0.45 to an SDR of <0.40.

I support the decision to exclude patients with an SDR of <0.40 as this exclusion guideline is in line with the FDA’s guidance noted in this link: 1 (fda.gov) [accessdata.fda.gov] and is in line with the recommended clinical study exclusion criteria outlined in the FDAs MRgFUS Summary of Safety and Effectiveness Data P150038S014B.

This change will also align Palmetto’s SDR exclusion with other MACs.

Thank for updating the LCD. We have several patients who were previously rejected because they had an SDR of <0.45. These patients will now qualify to have their essential tremor treated with MRgFUS.

Thank you for your comments and support of the policy.

2

I am a neurosurgeon offering MRI guided Focused Ultrasound Thalamotomy for Essential Tremor. I am writing to encourage Palmetto GBA to revise their current criteria for covering this procedure. Specifically, I am asking that the skull density ratio threshold be lowered from 0.45 to 0.40 – as is the case with other MACs across the country. In addition to consistency for patients regardless of region, there is also substantial data supporting the safety and efficacy of using an SDR of 0.40 to guide inclusion criteria for this procedure.

Thank you for your comments and support of the policy.

3

Thank you for the opportunity to submit formal comments on the draft LCD within the subject line. Our company and Palmetto GBA contracted providers applaud Palmetto’s actions to modify the SDR calculation, leading to uniform language in line with all local Medicare Administrative Contractors. We support this change and ask Palmetto to finalize this language.

Thank you for your comments and support of the policy.

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Associated Documents

Medicare BPM Ch 15.50.2 SAD Determinations
Medicare BPM Ch 15.50.2
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Updated On Effective Dates Status
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Keywords

  • MRgFUS