LCD Reference Article Response To Comments Article

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

A55848

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Article ID
A55848
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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
04/01/2018
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As an important part of Medicare Local Coverage Determination (LCD) development, National Government Services solicits comments from the provider community and from members of the public who may be affected by or interested in our LCDs. The purpose of the advice and comment process is to gain the expertise and experience of those commenting.

We would like to thank those who suggested changes to the LCD for Magnetic Resonance Image Guided High Intensity Focused Ultrasound (MRgFUS) for Essential Tremor. The official notice period for the final LCD begins on February 14, 2018 and the final determination will become effective on April 1, 2018.

 

Response To Comments

Number Comment Response
1

The American Association of Neurological Surgeons (AANS), Congress of Neurological Surgeons (CNS) and the American Association of Stereotactic and Functional Neurosurgery (ASSFN) submitted a joint comment recommending coverage of “unilateral MRgFUS thalamotomy for patients with essential tremor who cannot be controlled with medication therapy or who are not candidates for DBS.” They claim “MRgFUS is the only surgical therapy for medication-refractory essential tremor (ET) with class 1 evidence from a contemporary RCT.”

According to the American Academy of Neurology (AAN),1 prior limited surgical therapy class 1 evidence does exist,2 but the interpretation may hinge on the definition of “contemporary”. That contretemps aside, NGS agrees with coverage in patients who are not candidates for DBS. Please see the revised LCD for details.

1. Zesiewicz TA, Elble R, Louis ED, et al. Practice parameter: therapies for essential tremor: report of the Quality Standards Subcommittee of the American Academy of Neurology. Neurology. 2005;64(12):2008-2020.

2. Schuurman PR, Bosch DA, Bossuyt PM, et al. A comparison of continuous thalamic stimulation and thalamotomy for suppression of severe tremor. N Engl J Med. 2000;342(7):461-468. 

2

Insightec, the manufacturer of the ExAblate system used in MRgFUS, requested coverage for patients with idiopathic, medication refractory ET. They presented the pivotal study results,3 claiming parity with historical DBS outcomes. They also cited a recently published retrospective study which favorably compared MRgFUS with RF thalamotomy and DBS.4 The company notes that “Adjustability of DBS provides balance of efficacy/side effect, but at a cost of hardware complications and lifetime follow up.”

3. Elias WJ, Huss D, Voss T, et al. A pilot study of focused ultrasound thalamotomy for essential tremor. N Engl J Med. 2013;369(7):640-648.

4. Kim M, Jung NY, Park CK, Chang WS, Jung HH, Chang JW. Comparative Evaluation of Magnetic Resonance-Guided Focused Ultrasound Surgery for Essential Tremor. Stereotact Funct Neurosurg. 2017;95(4):279-286.

NGS disagrees with coverage for any patient with refractory ET. Coverage on a par with DBS, the current standard, is contingent on favorable longer-term effectiveness and safety data. However, NGS has revised the policy to cover patients in whom DBS is contraindicated. Please see the revised LCD for details.

3

A neurosurgeon specializing in neuromodulation commented that if surgical thalamotomy is covered by Medicare, ultrasound thalamotomy should be as well, since “comparative studies in animal models have demonstrated that they result in the same MRI and histological lesion, but from different lesioning modalities.” This commenter also cited a recently published meta-analysis5 which concludes: “Magnetic resonance-guided focused ultrasound thalamotomy is cost-effective for tremor compared with DBS and stereotactic radiosurgery and more effective than both.”

5. Ravikumar VK, Parker JJ, Hornbeck TS, et al. Cost-effectiveness of focused ultrasound, radiosurgery, and DBS for essential tremor. Mov Disord. 2017;32(8):1165-1173.

NGS appreciates the comment and meta-analysis citation; they both materially contributed to the change from non-coverage to coverage on a par with surgical thalamotomy in the context of the current standard of care (i.e., as an alternative if DBS is not available or practical). Please see the revised LCD for details.

4

A beneficiary with ET (and director of an ET advocacy group), claimed personal benefit from MRgFUS and requested coverage for “other Medicare beneficiaries who suffer from tremors, who like myself are apprehensive to go through invasive surgery. MRgFUS provides the non-invasive option that so many patients are looking for.”

NGS appreciates the comment and has revised the policy to include coverage parity with surgical thalamotomy in the context of the current standard of care (i.e., as an alternative if DBS is not available or practical). Coverage on par with DBS, the current intervention of choice, is contingent on favorable longer-term effectiveness and safety data. Please see the revised LCD for details.

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Associated Documents

Medicare BPM Ch 15.50.2 SAD Determinations
Medicare BPM Ch 15.50.2
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