Proposed LCD - Magnetic-Resonance-Guided Focused Ultrasound Surgery (MRgFUS) for Essential Tremor and Tremor Dominant Parkinson's Disease (DL37729)

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.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.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 NEUROL2018;83:107-114.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.Krishna V, Sammartino, F, Cosgrove R, et al.Tremor Outcomes Improve with Experience in Focused Ultrasound Thalamotomy. In press.Moosa S, Martnez-Fernndez R, Elias WJ, Del Alamo M, Eisenberg HM, Fishman PS. The role of high-intensity focused ultrasound as a symptomatic treatment for Parkinsons disease.Mov Disord. 2019;34(9):1243-1251. doi:10.1002/mds.27779Ahmed N, Gandhi D, Melhem ER, Frenkel V. MRI guided focused ultrasound-mediated delivery of therapeutic cells to the brain: A review of the state-of-the-art methodology and future applications.Front Neurol. 2021;12:669449. doi:10.3389/fneur.2021.669449Lin F, Wu D, Yu J, et al. Comparison of efficacy of deep brain stimulation and focused ultrasound in parkinsonian tremor: a systematic review and network meta-analysis.J Neurol Neurosurg Psychiatry. 2021;92(4):434-443. doi:10.1136/jnnp-2020-323656Schreglmann SR, Krauss JK, Chang JW, Bhatia KP, Kgi G. Functional lesional neurosurgery for tremor: a systematic review and meta-analysis.J Neurol Neurosurg Psychiatry. 2018;89(7):717-726. doi:10.1136/jnnp-2017-316302Xu Y, He Q, Wang M, et al. Safety and efficacy of magnetic resonance imaging-guided focused ultrasound neurosurgery for Parkinsons disease: a systematic review.Neurosurg Rev. 2021;44(1):115-127. doi:10.1007/s10143-019-01216-yLennon JC, Hassan I. Magnetic resonance-guided focused ultrasound for Parkinsons disease since ExAblate, 2016-2019: a systematic review.Neurol Sci. 2021;42(2):553-563. doi:10.1007/s10072-020-05020-1Ge Y, Wang Z, Gu F, et al. Clinical application of magnetic resonance-guided focused ultrasound in Parkinsons disease: a meta-analysis of randomized clinical trials.Neurol Sci. 2021;42(9):3595-3604. doi:10.1007/s10072-021-05443-4Magara A, Bhler R, Moser D, Kowalski M, Pourtehrani P, Jeanmonod D. First experience with MR-guided focused ultrasound in the treatment of Parkinsons disease.J Ther Ultrasound. 2014;2(1):11. doi:10.1186/2050-5736-2-11Schlesinger I, Eran A, Sinai A, et al. MRI Guided Focused Ultrasound Thalamotomy for Moderate-to-Severe Tremor in Parkinsons Disease. Parkinsons Disease.; 2015.Zaaroor M, Sinai A, Goldsher D, Eran A, Nassar M, Schlesinger I. Magnetic resonanceguided focused ultrasound thalamotomy for tremor: a report of 30 Parkinsons disease and essential tremor cases.J Neurosurg. 2018;128(1):202-210. doi:10.3171/2016.10.jns16758Fasano A, Llinas M, Munhoz RP, Hlasny E, Kucharczyk W, Lozano AM. MRI-guided focused ultrasound thalamotomy in non-ET tremor syndromes.Neurology. 2017;89(8):771-775. doi:10.1212/WNL.0000000000004268Bond AE, Shah BB, Huss DS, et al. Safety and efficacy of focused ultrasound thalamotomy for patients with medication-refractory, tremor-dominant Parkinson disease: A randomized clinical trial.JAMA Neurol. 2017;74(12):1412-1418. doi:10.1001/jamaneurol.2017.3098Martnez-Fernndez R, Rodrguez-Rojas R, Del lamo M, et al. Focused ultrasound subthalamotomy in patients with asymmetric Parkinsons disease: a pilot study.Lancet Neurol. 2018;17(1):54-63. doi:10.1016/S1474-4422(17)30403-9Ito H, Fukutake S, Yamamoto K, Yamaguchi T, Taira T, Kamei T. Magnetic resonance imaging-guided focused ultrasound thalamotomy for Parkinsons disease.Intern Med. 2018;57(7):1027-1031. doi:10.2169/internalmedicine.9586-17Iacopino DG, Gagliardo C, Giugno A. Preliminary experience with a transcranial magnetic resonance- guided focused ultrasound surgery system integrated with a 1.5- T MRI unit in a series of patients with essential tremor and Parkinsons disease.Neurosurg Focus. 2018;44.Fasano A, De Vloo P, Llinas M, et al. Magnetic resonance imaging-guided focused ultrasound thalamotomy in Parkinson tremor: Reoperation after benefit decay.Mov Disord. 2018;33(5):848-849. doi:10.1002/mds.27348Jung NY, Park CK, Kim M. The efficacy and limits of magnetic resonance guided focused ultrasound pallidotomy for Parkinsons disease: a phase I clinical trial.J Neurosurg. 2018:1-9.Sperling SA, Shah BB, Barrett MJ, et al. Focused ultrasound thalamotomy in Parkinson disease: Nonmotor outcomes and quality of life: Nonmotor outcomes and quality of life.Neurology. 2018;91(14):e1275-e1284. doi:10.1212/WNL.0000000000006279Ito H, Fukutake S, Yamamoto K, et al. Magnetic resonance imaging-guided focused ultrasound thalamotomy for Parkinsons disease with cardiac pacemaker: A case report.Mov Disord Clin Pract. 2018;5(3):339-340. doi:10.1002/mdc3.12578Gallay MN, Moser D, Rossi F, et al. MRgFUS pallidothalamic tractotomy for chronic therapy-resistant Parkinsons disease in 51 consecutive patients: Single center experience.Front Surg. 2019;6:76. doi:10.3389/fsurg.2019.00076Martnez-Fernndez R, Mez-Mir JU, Rodrguez-Rojas R, et al. Randomized trial of focused ultrasound subthalamotomy for Parkinsons disease.N Engl J Med. 2020;383(26):2501-2513. doi:10.1056/NEJMoa2016311Yamamoto K, Ito H, Fukutake S, et al. Focused ultrasound thalamotomy for tremor-dominant Parkinsons disease: A prospective 1-year follow-up study.Neurol Med Chir (Tokyo). 2021;61(7):414-421. doi:10.2176/nmc.oa.2020-0370Food and Drug Administration. Exablate Model 4000 Types 1.0 and 1.1 System Summary of Safety and Effectiveness Data. December 16, 2018. Accessed 11/07/2022. https://www.accessdata.fda.gov/cdrh_docs/pdf15/P150038S006B.pdfNational Government Services, Inc. Magnetic Resonance Image Guided High Intensity Focused Ultrasound (MRgFUS) for Tremor.LCDL37421. Revised effective date 4/01/2018. Accessed 11/07/2022.Pouratian N, Baltuch G, Elias WJ, Gross R. American Society for stereotactic and Functional Neurosurgery position statement on magnetic resonance-guided focused ultrasound for the management of essential tremor.Neurosurgery. 2020;87(2):E126-E129. doi:10.1093/neuros/nyz510Wisconsin Physicians Service Insurance Corp. Category III Codes. LCD L35490. Revised effective date 6/12/2022. Accessed 11/07/2022.Palmetto GBA. Magnetic Resonance Image Guided High Intensity Focused Ultrasound (MRgFUS) for Essential Tremor.LCDL37761.Revised effective date 8/13/2020. Accessed 11/07/2022.CGS Administrators, LLC. Magnetic Resonance Guided Focused Ultrasound Surgery System (MRgFUS) for the treatment of neurologic conditions.LCDL37790. Revised effective date 6/12/2022. Accessed 11/07/2022.Parkinsons Disease. Medical Policy Bulletin 0307. Revised effective date 9/16/2022. Accessed 11/07/2022.MRI Guided High Intensity Focused Ultrasound Ablation for Non-Oncologic Indications. Medical Policy MED.00057. Revised effective date 9/16/2022. Accessed 11/07/2022.Blue Cross Blue ShieldLA. Magnetic Resonance-Guided Focused Ultrasound. Policy 00180. Revised effective date 1/10/2022. Accessed 11/07/2022.Blue Cross Blue ShieldNC. MRI-Guided Focused Ultrasound (MRgFUS). Medical Policy. Revised effective date 5/2022. Accessed 11/07/2022.Magnetic ResonanceGuided Focused Ultrasound. Medical Policy 7.01.109. Revised effective date 8/22/2022. Accessed 11/07/2022.Magnetic Resonance (MR) Guided Focused Ultrasound (MRgFUS) and High Intensity Focused Ultrasound (HIFU) Ablation. Surgery Policy 139. Revised effective date 12/01/2021. Accessed 11/07/2022.Tufts Health Plan. Medical Necessity Guidelines: Noncovered Investigational Services. Revised effective date 10/01/2022. Accessed 11/07/2022.Wellmark. MRI-Guided High-Intensity Focused Ultrasound (MRgFUS) Ablation. Medical Policy 04.01.09. Revised effective date 1/2022. Accessed 11/07/2022.Deuschl G, Antonini A, Costa J, et al. European Academy of Neurology/Movement Disorder Society-European section guideline on the treatment of Parkinsons disease: I. invasive therapies.Mov Disord. 2022;37(7):1360-1374. doi:10.1002/mds.29066ECRI. ExAblate Neuro (InSightec, Inc.) for Treating Tremor-dominant Parkinson Disease. Plymouth Meeting (PA):2020 Jul 23. (Clinical Evidence Assessment).Chou KL, Tarsey D. Device-assisted and lesioning procedures for Parkinson disease. UpToDate. Updated 10/13/2022. Accessed 11/07/2022. https://www.uptodate.com/contents/device-assisted-and-lesioning-procedures-for-parkinson-disease?search=deep%20brain%20stimulation%20parkinsons&source=search_result&selectedTitle=1~150&usage_type=default&display_rank=1#H3670506581Ghanouni P, Pauly KB, Elias WJ, et al. Transcranial MRI-Guided Focused Ultrasound: A Review of the Technologic and Neurologic Applications.AJR Am J Roentgenol. 2015;205:150.Na YC, Chang WS, Jung HH, et al. Unilateral magnetic resonance-guided focused ultrasound pallidotomy for Parkinson disease.Neurology. 2015;85:549.