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

CMS National Coverage PolicyLanguage 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 Indications, Limitations, and/or Medical NecessityThis LCD addresses use of Magnetic-Resonance-Guided Focused Ultrasound Surgery (MRgFUS) for the treatment of idiopathic essential tremor (ET) patients including Tremor Dominant Parkinson's disease (TDPD) patients with medication-refractory tremor.MRgFUS unilateral thalamotomy is considered medically reasonable and necessary in patients with all four of the following criteria:medication refractory ET (defined as refractory to at least two trials of medical therapy, including at least one first-line agent)moderate to severe postural or intention tremor of the dominant handor another nationally accepted clinical measure of tremor severitydisabling 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)nota 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):Treatment of head or voice tremorBilateral thalamotomyAn advanced neurodegenerative conditionUnstable cardiac diseaseDepression sufficiently severe to compromise beneficiarys ability to provide informed consent and limit likely clinical benefit of the treatmentSevere cognitive impairment (such as may be defined by a score of <24 on the MiniMental State Examination)A skull density ratio (SDR) (the ratio of cortical to cancellous bone) <0.40MRI contraindicatedGeneral InformationAssociated InformationN/ASources of InformationN/ABibliographyTarsy D, Shih L. Surgical treatment of essentialtremor. http://www.uptodate.com/contents/surgical-treatment-of-essential-tremor. Accessed 3/7/2018.Louis ED. Treatment of medically refractory essential tremor.N Engl J Med.2016;375;8:792-793.FDA approval ExAblate Neuro. https://www.accessdata.fda.gov/cdrh_docs/pdf15/P150038a.pdf. Accessed 3/5/2018.Jeanmonod D, Werner B, Morel A, et al. Transcranial magnetic resonance imagingguided focused ultrasound: noninvasive central lateral thalamotomy for chronic neuropathic pain.Neurosurg Focus.2012;32(1):1-11.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.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.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.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.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.Jung HH, Chang WS, Rachmilevitch I, Tlusty T, Zadicario E, Chang JW. Different magnetic resonance imaging patterns after transcranial magnetic resonanceguided 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.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.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.Alterman RL. A trial of focused ultrasound thalamotomy for essential tremor.N Engl J Med.2016;375;22:2201-2203.Novitas LCD Services That Are Not Reasonable and Necessary (L35094).Noridian LCD Non Covered Services (L36219).First Coast Service Options LCD Noncovered Services (DL33777).Palmetto GBA LCD Non-Covered Category III CPT Codes (DL34555).BCBSMA Policy Number 243. Magnetic Resonance-Guided Focused Ultrasound. https://www.bluecrossma.org/medical-policies/sites/g/files/csphws2091/files/acquiadam-assets/243%20MRI-Guided%20Focused%20Ultrasound%20-%20MRgFUS%20prn.pdf. Accessed 2/1/2022.Aetna Policy Number 0153. Thalamotomy. http://www.aetna.com/cpb/medical/data/100_199/0153.html. Accessed 3/5/2018.UnitedHealthcare Guideline Number MPG043.05. Category III CPT Codes. UnitedHealthCareOnline.Category III CodesAnthem Policy Number MED.00057. MRI Guided High Intensity Focused Ultrasound Ablation for Non-Oncologic Indications. https://www.empireblue.com/dam/medpolicies/ebcbs/active/policies/mp_pw_a050053.html. Accessed 2/1/2022.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.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.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.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.