SUPERSEDED Local Coverage Determination (LCD)

Magnetic-Resonance-Guided Focused Ultrasound Surgery (MRgFUS) for Essential Tremor

L37729

Expand All | Collapse All
Proposed LCD
Proposed LCDs are works in progress that are available on the Medicare Coverage Database site for public review. Proposed LCDs are not necessarily a reflection of the current policies or practices of the contractor.
Superseded
To see the currently-in-effect version of this document, go to the section.

Document Note

Note History

Contractor Information

LCD Information

Document Information

Source LCD ID
N/A
LCD ID
L37729
Original ICD-9 LCD ID
Not Applicable
LCD Title
Magnetic-Resonance-Guided Focused Ultrasound Surgery (MRgFUS) for Essential Tremor
Proposed LCD in Comment Period
N/A
Source Proposed LCD
DL37729
Original Effective Date
For services performed on or after 04/01/2019
Revision Effective Date
For services performed on or after 11/01/2019
Revision Ending Date
N/A
Retirement Date
N/A
Notice Period Start Date
02/14/2019
Notice Period End Date
03/31/2019
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 © 2024, 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.

Issue

Issue Description
Issue - Explanation of Change Between Proposed LCD and Final LCD

CMS National Coverage Policy

Language quoted from Centers for Medicare and Medicaid Services (CMS), National Coverage Determinations (NCDs) and coverage provisions in interpretive manuals is italicized throughout the policy. NCDs and coverage provisions in interpretive manuals are not subject to the LCD Review Process (42 CFR 405.860[b] and 42 CFR 426 [Subpart D]). In addition, an administrative law judge may not review an NCD. See Section 1869(f)(1)(A)(i) of the Social Security Act. 

Unless otherwise specified, italicized text represents quotation from one or more of the following CMS sources: 

Title XVIII of the Social Security Act (SSA): 

Section 1862(a)(1)(A) excludes expenses incurred for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member. 

Section 1862(a)(1)(D) refers to limitations on items or devices that are investigational or experimental. 

Section 1833(e) prohibits Medicare payment for any claim which lacks the necessary information to process the claim.

Coverage Guidance

Coverage Indications, Limitations, and/or Medical Necessity

This LCD addresses use of Magnetic-Resonance-Guided Focused Ultrasound Surgery (MRgFUS) for the treatment of idiopathic essential tremor (ET) patients with medication-refractory tremor.

MRgFUS unilateral thalamotomy is considered medically reasonable and necessary in patients with all four of the following criteria:

  1. medication refractory ET (defined as refractory to at least two trials of medical therapy, including at least one first-line agent)

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

  3. disabling ET (defined by a score of ≥2 on any of the eight items in the disability subsection of the CRST or another nationally accepted clinical measure of tremor severity)

  4. 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)  

Limitations (not covered):

  1. Treatment of head or voice tremor
  2. Bilateral thalamotomy
  3. An advanced neurodegenerative condition
  4. Unstable cardiac disease
  5. Depression sufficiently severe to compromise beneficiary’s ability to provide informed consent and limit likely clinical benefit of the treatment
  6. Severe cognitive impairment (such as may be defined by a score of <24 on the Mini–Mental State Examination)
  7. A skull density ratio (SDR) (the ratio of cortical to cancellous bone) <0.40
  8. MRI contraindicated

 

 

 

 

Summary of Evidence

Essential tremor (ET) is the most common movement disorder as well as one of the most treated surgically. The prevalence of ET has been estimated at approximately 3% or 10 million people in the United States. While ET does not shorten life expectancy, the associated disabling symptoms, such as hand tremor, can greatly impact quality of life (functional ADLs, work activities, mood, and socialization).

Although there are no curative therapies, symptoms of ET are well managed medically in up to 70% of patients, with surgery reserved for medication-refractory severe impairments. Current surgical options include thalamotomy with radiofrequency (RF) ablation and deep-brain stimulation (DBS); both effectively suppress tremor but require intracranial surgery. Stereotactic radiosurgery (SRS), while non-operative, suffers from delay in tremor reduction (making intraoperative validation impossible), a greater than 10% cumulative risk of adverse events, and theoretical concerns about radiation side effects.(6, 22) DBS is currently the intervention of choice, “because of its proven efficacy, reversibility, adjustability, and durability” (22), with thalamotomy “a reasonable alternative….if DBS is not available or practical”.(1) This attribute of DBS in creating an adjustable “functional lesion” causes fewer adverse events than thalamotomy (24, 25), and resulted in a general shift away from ablation methods. (23)

Neuromodulation with ultrasound energy also required craniotomy until recently; advances in ultrasound transducer design and high-resolution magnetic resonance imaging now allow precise transcranial delivery of high-intensity focused ultrasound. The ultrasound causes a local increase in temperature in the target tissue, resulting in coagulation necrosis while sparing the surrounding normal structures. In addition to providing location guidance, MRI provides real-time clinical monitoring of treatment intensity via thermal imagery. On 1/1/16, a CPT Category III tracking code specific to MRgFUS treatment of movement disorder became effective. FDA PMA approval for the Magnetic-Resonance-Guided Focused Ultrasound Surgery System (MRgFUS) (ExAblate Model 4000, InSightec, Inc.) “for the unilateral thalamotomy treatment of idiopathic essential tremor patients with medication-refractory tremor” came on 7/11/16.(3)

Among the peer-reviewed clinical studies of MRgFUS for the treatment of medication-refractory ET, all but one were small, uncontrolled, pilot studies with short follow-up.(4-11) FDA approval for MRgFUS treatment of ET was based on its pivotal study, a prospective, double-blind, randomized, sham-controlled trial (RCT) of MRgFUS to create a unilateral thalamic ablation for the treatment of ET.(12) Seventy-six patients with moderate-to-severe essential tremor refractory to at least two trials of medical therapy were randomized in a 3:1 ratio to either MRgFUS or a sham procedure. The primary endpoint, the CRST at 3 months, was significantly improved in the MRgFUS group (p<0.001). Secondary outcome measures, including disability and quality of life, were also significantly improved. However, both hand and total tremor scores steadily deteriorated over the year, 23% and 38% respectively. In fact, this drop in efficacy and the limited follow-up period were cited as major concerns in the accompanying editorial which advocates for much longer follow-up (2-5 years or more) to demonstrate sustained benefit.(2) Another concern was persistent adverse neurologic effects in the MRgFUS group at 12 months, including gait disturbance (9%) or numbness (14%).

The editorial concludes that “A head-to-head comparison with DBS would facilitate the direct comparison of the two approaches.” Some contend that a direct comparative trial between MRgFUS and DBS will be unlikely “due to the significant differences in invasiveness of the two procedures.” Interestingly, a letter to the editor agrees a direct comparative study isn’t warranted, but apparently for the opposite ethical reason, noting “that the high rate of adverse events that is consistently reported with thalamotomy of any kind suggests that equipoise does not exist”.(13) While it is true that MRgFUS is less invasive than DBS in terms of not requiring cranial penetration with hardware, it is more invasive than DBS in the creation of a fixed thalamic brain lesion, which can result in permanent neurologic deficit.

More recently, follow-up on this same cohort of seventy-six patients with refractory moderate-to-severe essential tremor has been reported on sixty-seven of the patients continued with monitoring for two years.  The improvement in tremor was durable at 1 year (53%; 8.9 ± 4.8; 70 patients) and at 2 years (56%; 8.8 ± 5.0; 67 patients).  Disability score improved throughout this period, none of the adverse effects worsened, two resolved and there were no new delayed complications.(27)

A recently published meta-analysis is meant to provide “an approximation of an RCT” head-to-head comparison between MRgFUS, DBS, and SRS; the authors claim an actual RCT is unlikely.(22) Pre- and postoperative tremor-related disability scores were collected from 32 studies involving 83 MRgFUS, 615 DBS, and 260 SRS cases. MRgFUS thalamotomy resulted in significantly higher utility scores (defined as quality of life and derived from percent change in functional disability) compared with DBS (P < 0.001) or SRS (P < 0.001). The authors conclude that “preliminary experience with MRgFUS supports its broad adoption for medically refractory ET.”

A retrospective analysis of 59 patients who underwent unilateral treatment for drug-resistant ET with RF thalamotomy (n=17), DBS (n=19), and MRgFUS (n=23) showed no statistical differences in tremor severity improvement at 1 month or 1 year follow-up.(23) However, MRgFUS had a significantly lower complication rate (p < 0.01) at 1 year (4.4%) compared with RF (11.8%) and DBS (21.1%). The authors conclude that “MRgFUS is a promising therapy with the potential to replace DBS for patients who cannot tolerate DBS, the standard surgical treatment for ET,” but that “the long-term effects of MRgFUS should be systematically evaluated in a future prospective, randomized study in order to demonstrate whether MRgFUS provides superior management of ET symptoms.”

Analysis of Evidence (Rationale for Determination)

In summary, MRgFUS is a promising new treatment approach that has attributes, positive and negative, distinct from both traditional thalamotomy and DBS. However, long-term effectiveness and safety remain uncertain (1, 23) and warrant a direct comparison with DBS, the current surgical standard. Widespread non-coverage by both Medicare (14-17) and commercial payers (18-21) supports this interpretation.

However, given the support for traditional thalamotomy, generally, as an alternative “if DBS is not available or practical”, and the support for MRgFUS thalamotomy, specifically, as an alternative in patients “who are not a candidate for DBS” by the American Association of Neurological Surgeons (AANS), Congress of Neurological Surgeons (CNS) and the American Association of Stereotactic and Functional Neurosurgery (ASSFN), Noridian considers MRgFUS reasonable and necessary in that context. Patient selection criteria will largely mirror those used in the pivotal study (see Coverage and Limitations section for details).

Proposed Process Information

Synopsis of Changes
Changes Fields Changed
N/A
Associated Information
Sources of Information
Bibliography
Open Meetings
Meeting Date Meeting States Meeting Information
N/A
Contractor Advisory Committee (CAC) Meetings
Meeting Date Meeting States Meeting Information
N/A
MAC Meeting Information URLs
N/A
Proposed LCD Posting Date
Comment Period Start Date
Comment Period End Date
Reason for Proposed LCD
Requestor Information
This request was MAC initiated.
Requestor Name Requestor Letter
View Letter
N/A
Contact for Comments on Proposed LCD

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

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

Additional ICD-10 Information

General Information

Associated Information

N/A

Sources of Information

N/A

Bibliography
  1. Tarsy D, Shih L. Surgical treatment of essential tremor. http://www.uptodate.com/contents/surgical-treatment-of-essential-tremor. Accessed 3/7/2018.

  2. Louis ED. Treatment of medically refractory essential tremor. N Engl J Med. 2016;375;8:792-793.

  3. FDA approval ExAblate Neuro. https://www.accessdata.fda.gov/cdrh_docs/pdf15/P150038a.pdf. Accessed 3/5/2018.

  4. Jeanmonod D, Werner B, Morel A, et al. Transcranial magnetic resonance imaging–guided focused ultrasound: noninvasive central lateral thalamotomy for chronic neuropathic pain. Neurosurg Focus. 2012;32(1):1-11.

  5. Lipsman N, Schwartz ML, Huang Y, et al. MR-guided focused ultrasound thalamotomy for essential tremor: a proof-of-concept study. Lancet Neurol. 2013;12(5):462-468.

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

  7. Wintermark M, Druzgal J, Huss DS, et al. Imaging findings in MR imaging-guided focused ultrasound treatment for patients with essential tremor. Am J Neuroradiol. 2014;35(5):891-896.

  8. Chang WS, Jung HH, Kweon EJ, Zadicario E, Rachmilevitch I, Chang JW. Unilateral magnetic resonance guided focused ultrasound thalamotomy for essential tremor: practices and clinicoradiological outcomes. J Neurol Neurosurg Psychiatry. 2015;86(3):257-264.

  9. Huss DS, Dallapiazza RF, Shah BB, Harrison MB, Diamond J, Elias WJ. Functional assessment and quality of life in essential tremor with bilateral or unilateral DBS and focused ultrasound thalamotomy. Mov Disord. 2015;30(14):1937-1943.

  10. Jung HH, Chang WS, Rachmilevitch I, Tlusty T, Zadicario E, Chang JW. Different magnetic resonance imaging patterns after transcranial magnetic resonance–guided focused ultrasound of the ventral intermediate nucleus of the thalamus and anterior limb of the internal capsule in patients with essential tremor or obsessive-compulsive disorder. J Neurosurg. 2015;122:162-168.

  11. Gallay MN, Moser D, Rossi F, et al. Incisionless transcranial MR-guided focused ultrasound in essential tremor: cerebellothalamic tractotomy. J Ther Ultrasound. 2016;4:5. DOI 10.1186/s40349-016-0049-8.

  12. Elias WJ, Lipsman N, Ondo WG, et al. A randomized trial of focused ultrasound thalamotomy for essential tremor. N Engl J Med. 2016;375;8:730-739.

  13. Alterman RL. A trial of focused ultrasound thalamotomy for essential tremor. N Engl J Med. 2016;375;22:2201-2203.

  14. Novitas LCD Services That Are Not Reasonable and Necessary (L35094).

  15. Noridian LCD Non Covered Services (L36219).

  16. First Coast Service Options LCD Noncovered Services (DL33777).

  17. Palmetto GBA LCD Non-Covered Category III CPT Codes (DL34555).

  18. BCBSMA Policy Number 243. Magnetic Resonance-Guided Focused Ultrasound. https://www.bluecrossma.com/common/en_US/medical_policies/243%20MRI-Guided%20Focused%20Ultrasound%20-%20MRgFUS%20prn.pdf. Accessed 3/5/2018.

  19. Aetna Policy Number 0153. Thalamotomy. http://www.aetna.com/cpb/medical/data/100_199/0153.html. Accessed 3/5/2018.

  20. UnitedHealthcare Guideline Number MPG043.05. Category III CPT Codes. UnitedHealthCareOnline.Category III Codes

  21. Anthem Policy Number MED.00057. MRI Guided High Intensity Focused Ultrasound Ablation for Non-Oncologic Indications. https://www.anthem.com/medicalpolicies/policies/mp_pw_a050053.htm. Accessed 3/5/2018.

  22. 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.

  23. 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.

  24. 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.

  25. Zesiewicz TA, Elble RJ, Louis ED, et al. Evidence-based guideline update: treatment of essential tremor: report of the Quality Standards subcommittee of the American Academy of Neurology. Neurology. 2011;77(19):1752-1755.

  26. 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.

  27. Chang JW, Chang KP, Lipsman N, et al. A prospective trial of magnetic resonance-guided focused ultrasound thalamotomy for essential tremor: results of the 2-year follow-up. ANN NEUROL 2018;83:107-114.
  28. P.S. Fishman, W.J. Elias,  P. Ghanouni, R. Gwinn, N. Lipsman, M. Schwartz, J. W. Chang, T. Taira, V. Krishna, A. Rezai, K. Yamada, K. Igase, R. Cosgrove, H. Kashima, M.G.Kaplitt, T.S. Tierney, and H.M. Eisenberg, "Neurological adverse event profile of magnetic resonance imaging-guided focused ultrasound thalamotomy for essential tremor," Moy Disord, vol. 33, no. 5, pp. 843-847-, May 2018.
  29. Krishna V, Sammartino, F, Cosgrove R, et al. Tremor Outcomes Improve with Experience in Focused Ultrasound Thalamotomy. In press.

Revision History Information

Revision History Date Revision History Number Revision History Explanation Reasons for Change
11/01/2019 R2

The LCD is revised to remove CPT/HCPCS codes in the Keyword Section of the LCD.

At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.

  • Other (The LCD is revised to remove CPT/HCPCS codes in the Keyword Section of the LCD.)
11/01/2019 R1

11/1/19: At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage.

As requested by CR 10901, all billing and coding information has been moved to the companion article, this article is linked to the LCD.

  • Provider Education/Guidance
  • Revisions Due To Code Removal
N/A

Associated Documents

Attachments
N/A
Related National Coverage Documents
N/A
Public Versions
Updated On Effective Dates Status
06/09/2023 07/30/2023 - N/A Currently in Effect View
02/24/2023 11/01/2019 - 07/29/2023 Superseded View
12/22/2022 11/01/2019 - N/A Superseded View
01/28/2020 11/01/2019 - N/A Superseded You are here
10/22/2019 11/01/2019 - N/A Superseded View
Some older versions have been archived. Please visit the MCD Archive Site to retrieve them.

Keywords

N/A

Read the LCD Disclaimer