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

Expand All | Collapse All
Draft Article
Draft Articles are works in progress and not necessarily a reflection of the current billing and coding practices. Revisions to codes are carefully and thoroughly reviewed and are not intended to change the original intent of the LCD.

Document Note

Note History

Contractor Information

Article Information

General Information

Source Article ID
N/A
Article ID
A59419
Original ICD-9 Article ID
Not Applicable
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
Revision Effective Date
N/A
Revision Ending Date
N/A
Retirement Date
N/A

CPT codes, descriptions, and other data only are copyright 2023 American Medical Association. All Rights Reserved. Applicable FARS/HHSARS apply.

Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein.

Current Dental Terminology © 2023 American Dental Association. All rights reserved.

Copyright © 2024, the American Hospital Association, Chicago, Illinois. Reproduced with permission. No portion of the AHA copyrighted materials contained within this publication may be copied without the express written consent of the AHA. AHA copyrighted materials including the UB‐04 codes and descriptions may not be removed, copied, or utilized within any software, product, service, solution, or derivative work without the written consent of the AHA. If an entity wishes to utilize any AHA materials, please contact the AHA at 312‐893‐6816.

Making copies or utilizing the content of the UB‐04 Manual, including the codes and/or descriptions, for internal purposes, resale and/or to be used in any product or publication; creating any modified or derivative work of the UB‐04 Manual and/or codes and descriptions; and/or making any commercial use of UB‐04 Manual or any portion thereof, including the codes and/or descriptions, is only authorized with an express license from the American Hospital Association. The American Hospital Association (the "AHA") has not reviewed, and is not responsible for, the completeness or accuracy of any information contained in this material, nor was the AHA or any of its affiliates, involved in the preparation of this material, or the analysis of information provided in the material. The views and/or positions presented in the material do not necessarily represent the views of the AHA. CMS and its products and services are not endorsed by the AHA or any of its affiliates.

CMS National Coverage Policy

N/A

Article Guidance

Article Text

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.

N/A

Coding Information

Bill Type Codes

Code Description

Please accept the License to see the codes.

N/A

Revenue Codes

Code Description

Please accept the License to see the codes.

N/A

CPT/HCPCS Codes

Please accept the License to see the codes.

N/A

CPT/HCPCS Modifiers

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

N/A

ICD-10-CM Codes that Support Medical Necessity

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

N/A

ICD-10-CM Codes that DO NOT Support Medical Necessity

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

N/A

ICD-10-PCS Codes

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

N/A

Additional ICD-10 Information

Bill Type Codes

Code Description

Please accept the License to see the codes.

N/A

Revenue Codes

Code Description

Please accept the License to see the codes.

N/A

Other Coding Information

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

N/A

Coding Table Information

Excluded CPT/HCPCS Codes - Table Format
Code Descriptor Generic Name Descriptor Brand Name Exclusion Effective Date Exclusion End Date Reason for Exclusion
N/A N/A
N/A
Non-Excluded CPT/HCPCS Ended Codes - Table Format
Code Descriptor Generic Name Descriptor Brand Name Exclusion Effective Date Exclusion End Date Reason for Exclusion
N/A

Revision History Information

Revision History Date Revision History Number Revision History Explanation
N/A

Associated Documents

Medicare BPM Ch 15.50.2 SAD Determinations
Medicare BPM Ch 15.50.2
Related National Coverage Documents
N/A
SAD Process URL 1
N/A
SAD Process URL 2
N/A
Statutory Requirements URLs
N/A
Rules and Regulations URLs
N/A
CMS Manual Explanations URLs
N/A
Other URLs
N/A
Public Versions
Updated On Effective Dates Status
06/09/2023 07/30/2023 - N/A Currently in Effect You are here

Keywords

N/A