LCD Reference Article Response To Comments Article

Response to Comments: Magnetic Resonance Guided Focused Ultrasound Surgery (MRgFUS) for Essential Tremor and Tremor Dominant Parkinson's Disease

A59419

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Source Article ID
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Article ID
A59419
Original ICD-9 Article ID
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Article Title
Response to Comments: Magnetic Resonance Guided Focused Ultrasound Surgery (MRgFUS) for Essential Tremor and Tremor Dominant Parkinson's Disease
Article Type
Response to Comments
Original Effective Date
07/30/2023
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The comment period for the Magnetic Resonance Guided Focused Ultrasound Surgery (MRgFUS) for Essential Tremor and Tremor Dominant Parkinson's DL37729 Local Coverage Determination (LCD) began on 02/09/2023 and ended on 03/25/2023. The notice period for L37729 begins on 06/15/2023 and will become effective on 07/30/2023.

Response To Comments

Number Comment Response
1

Requests that Noridian amend the following item under “Coverage Guidance”; Item #2 under “MRgFUS unilateral thalamotomy is considered medically reasonable and necessary in patients with all four of the following criteria”:

  1. moderate to severe postural or intention tremor of the dominant hand or another nationally accepted clinical measure of tremor severity

Requests that Noridian consider removing the verbiage “dominant hand” based on the most recent FDA PMA approval attached. The language from the FDA PMA labeling states the following:

“In the unilateral thalamotomy treatment of idiopathic essential tremor patients with medication refractory tremor. Patients must be at least age 22. The designated area in the brain responsible for the movement disorder symptoms (ventralis intermedius) must be identified and accessible for targeted thermal ablation by the Exablate device”

Noridian would like to thank the commenter for her comments. We do however respectfully decline the recommendations. As regards to the first recommendation, the second part of the referenced portion of the LCD specifically states tremor of the dominant hand or “another nationally accepted clinical measure of tremor severity. This would include any measure including the involvement of the non dominant hand as recognized in any nationally accepted measure of tremor severity.

2

Requests that Noridian consider removal of “bilateral” from the limitations based on the most recent FDA PMA approval attached. Bilateral sides in the sense that MRgFUS would NEVER be performed on the same date of service. The FDA approval was based on a staged procedure by at least 9 months.

Under the most recent Food and Drug Administration (FDA) PMA approval letter P150038/S014 and P1500387/S022 (attached), available via the following link: Premarket Approval (PMA) (fda.gov), The FDA has approved ExAblate using the following approval/labeling language: In the unilateral thalamotomy treatment of idiopathic Essential tremor patients with medication-refractory tremor and in the staged (by at least 9 months from the first thalamotomy), unilateral thalamotomy of idiopathic Essential tremor patients with medication-refractory tremor of their contralateral side that was not previously treated in the index unilateral thalamotomy. Patients must be at least age 22. The designated area in the brain responsible for the movement disorder symptoms (ventralis intermedius) must be identified and accessible for targeted thermal ablation by the Exablate device”.

MRgFUs is used to treat a focal lesion or abnormality causing the tremor. This statement refers to the use of MRgFUS bilaterally at the time of each procedure to treat the tremor and would not preclude the use of MRgFUS on a contralateral site at a later date as specified in the FDA Premarket approval letter received by INSIGHTEC, Inc.

3

Two commenters expressed support of the addition of the indication of Tremor Dominant Parkinson’s Disease to the covered indications for MRgFUS.

Noridian thanks you for your comments and the support of the additional indication for MRgFUS and for your participation in the Medicare Program.

4

A comment was received requesting to, eliminate the following language under the criteria section: “Not a candidate for DBS (e.g., advanced age, anticoagulant therapy, surgical comorbidities, or has failed Deep Brain Stimulation (DBS), but has no retained cranial implants)”

Noridian appreciates the comment, but at this time will not be changing the language as requested under the criteria section.

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Associated Documents

Medicare BPM Ch 15.50.2 SAD Determinations
Medicare BPM Ch 15.50.2
Related National Coverage Documents
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SAD Process URL 2
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