LCD Reference Article Response To Comments Article

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

A56253

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A56253
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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
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The comment period for the LCD Magnetic-Resonance-Guided Focused Ultrasound Surgery (MRgFUS) for Essential Tremor DL37729 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.

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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

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