LCD Reference Article Response To Comments Article

Response to Comments: Magnetic-Resonance-Guided Focused Ultrasound Surgery (MRgFUS) for Essential Tremor

A56254

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
A56254
Original ICD-9 Article ID
Not Applicable
Article Title
Response to Comments: Magnetic-Resonance-Guided Focused Ultrasound Surgery (MRgFUS) for Essential Tremor
Article Type
Response to Comments
Original Effective Date
04/01/2019
Revision Effective Date
N/A
Revision Ending Date
N/A
Retirement Date
N/A
AMA CPT / ADA CDT / AHA NUBC Copyright Statement

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 © 2023, the American Hospital Association, Chicago, Illinois. Reproduced with permission. No portion of the American Hospital Association (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 LCD Magnetic-Resonance-Guided Focused Ultrasound Surgery (MRgFUS) for Essential Tremor DL37738 began on 06/07/2018 and ended on 08/14/2018. Comments were received from the provider community. The notice period begins on 02/14/2019 and ends 03/31/2019. The LCD becomes final on 04/01/2019.

Response To Comments

Number Comment Response
1

Several comments were received from associations representing neurosurgeons and radiologists that recommended Noridian change language for the first reasonable and necessary criterion to a confirmed diagnosis of essential tremor that is refractory to treatment with at least one of the first line medications and/or listing propranolol, primidone, topiramide, gabapentin and benzodiazepines.

We agree it is reasonable to add confirmed diagnosis of essential tremor (ET) but the pivotal study that forms the basis of coverage supports its use only after failure of two different medications indicated for the treatment of ET (circumstances where there is a contraindication to a trial of a second medication can be addressed at appeal).

2

Multiple comments supported changing the second coverage criterion to moderate to severe postural or intentional tremor in the hand to be treated.

We agree and will change to the proposed language.

3

Multiple physician associations recommended another assessment of the essential tremor be used since the CRST is not widely used clinically. Further recommendation was to broaden the statement to read “disability at home or work”.

The simple statement of “disability at home or work” is too nonspecific and subjective. We would consider detailed objective assessments that are nationally accepted such as CRST but none were provided. This could be addressed by appeal or a request for reconsideration.

4

Several comments recommend that criterion 4 be deleted since it is not part of the FDA label, was not a criterion of the clinical trial and MRgFUS is an alternative to DBS based on class I evidence. The procedure to use should be determined by the surgeon and the patient on a case-by-case basis.

There is insufficient peer-reviewed literature at this time to support MRgFUS as being equal to DBS in the treatment of Essential Tremor. There is very limited data on its long-term effectiveness in ET management.

(No comments were submitted regarding #1 and #2 of the limitations section. All comments were directed towards the 8 conditions listed)

 

 

5

Several comments recommend changing the first limiting condition,“neurodegenerative condition” to “advanced neurodegenerative condition” to be determined on a case by case basis by the surgeon and patient.

We agree that it is reasonable to change the wording to “advanced neurodegenerative condition”.

6

Several comments recommended deleting coagulopathy and risk factors for DVT as contraindications as these are addressed by routine preoperative evaluation.

We agree and will eliminate these as limiting criteria.

7

One comment recommends the use of MRgFUS in severe depression be decided on case-by-case basis.

We will address this by changing the language to read “depression sufficiently severe to compromise the patient’s ability to provide informed consent and/or limit likely clinical benefit.”

8

Multiple comments recommend that MRgFUS limitation in Cognitive impairment be removed and that it be decided on a case-by-case basis.

There must be an objective measure of impairment such that it can be determined that the beneficiary has capacity for informed consent. We will change the language to read “Severe cognitive impairment (such as may be defined by a score of <24 on the Mini–Mental Status Examination).”

9

Multiple comments suggest this limitation is reasonable if the patient has existing DBS or a contralateral lesion, but recommend allowing consideration of DBS where the implant has been removed. Also recommend deleting TMS and ECT as contraindications as there is no literature to support exclusion of MRgFUS when these procedures have occurred prior, further stating they were only included in the trial protocol to exclude patients with refractory depression.

We agree and will delete this requirement.

10

Multiple recommendations were received that the skull density ratio (SDR) be lowered from a minimum of 0.45 or deleted entirely, citing that SDR may vary based on the acquisition parameters of the CT Scanner used to obtain it; the threshold value used at the beginning of the trial does not account for refinements in MRgFUS technique subsequent to the trial, excludes some of the Asian population due to thinner SDR’s in this population, and does not account for racial differences in SDR.

We agree with lowering the minimum SDR to 0.40 which will address the exclusion of some Asian patients and some racial differences. The data support a less than 50% response at one year when SDR is < 0.40, so individual cases with SDR < 0.40 with extenuating circumstances who are not candidates for DBS can be addressed at appeal.

N/A

Coding Information

Bill Type Codes

Code Description
N/A

Revenue Codes

Code Description
N/A

CPT/HCPCS Codes

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

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
N/A

Revenue Codes

Code Description
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 Local Coverage Documents
N/A
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
02/07/2019 04/01/2019 - N/A Currently in Effect You are here

Keywords

  • Magnetic-Resonance-Guided Focused Ultrasound Surgery
  • MRgFUS
  • Essential Tremor