DESCRIPTION
MRI-guided focused ultrasound (MRgFUS) is a noninvasive treatment proposed for pain palliation of bone metastases, uterine fibroids, essential tremor, and other benign and malignant tumors. This technology may also be referred to as magnetic resonance-guided high-intensity ultrasound ablation (e.g., ExAblate®). The US beam penetrates through the soft tissues and, using MRI for guidance and monitoring, the beam can be focused on targeted sites. The US causes a local increase in temperature in the target tissue resulting in coagulation necrosis while sparing the surrounding normal structures. In addition to providing guidance, the associated MRI can provide online thermometric imaging that provides a temperature “map” that can further confirm the therapeutic effect of the ablation treatment and allow for real-time adjustment of the treatment parameters.
Metastatic bone disease is one of the most common causes of cancer pain. Existing treatments include conservative measures (e.g., massage, exercise) and pharmacologic agents (e.g., analgesics, bisphosphonates, and corticosteroids). External beam radiotherapy is standard of care for individuals who fail these treatments; however, a substantial proportion of individuals experience residual pain after radiotherapy. MRgFUS is used to destroy nerves in the bone surface surrounding the tumor in individuals who either fail or are not candidates for radiotherapy.
Essential Tremors (ET) are the most common movement disorder, with an estimated prevalence of 5% worldwide. It most often affects the hands and arms, may affect head and voice, and rarely includes the face, legs, and trunk. Some evidence suggest that ET is localized in the brainstem and cerebellum. Initial therapy is with drugs (b-blockers or anticonvulsants) if individuals with ET experience intermittent or persistent disability due to the tremors. For medicine-refractory individuals, surgery (deep brain stimulation or thalamotomy) may be offered, though high rates of adverse events have been observed.
POLICY
MRI-guided focused ultrasound (MRgFUS) is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
MRI-guided focused ultrasound (MRgFUS) for the treatment of all other conditions/diseases is considered investigational.
MEDICAL APPROPRIATENESS
MRI-guided focused ultrasound (MRgFUS) is considered medically appropriate if ANY ONE of the following are met:
Diagnosis of metastatic bone cancer if ALL the following are met:
Treatment is for palliation of cancer pain
Individual is eighteen years or older
Individual has failed or is not a candidate for radiotherapy
Treatment of medication-refractory essential tremors
IMPORTANT REMINDERS
Any specific products referenced in this policy are just examples and are intended for illustrative purposes only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available. These examples are contained in the parenthetical e.g. statement.
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan or government program (e.g., TennCare), the express terms of the health plan or government program will govern.
ADDITIONAL INFORMATION
There is insufficient evidence from randomized controlled trials or other controlled studies that MRgFUS improves the health outcome for individuals with any clinical condition other than palliative treatment for bone metastasis and treatment for medication refractory essential tremor.
SOURCES
Altinel, Y., Alkhalfan, F., Qiao, N., & Velimirovic, M. (2019). Outcomes in lesion surgery versus deep brain stimulation in patients with tremor: A systematic review and meta-analysis. World Neurosurgery, 123, 443-452. (Level 1 evidence)
American Academy of Neurology. (2005; updated 2011; reaffirmed 2022). Update: treatment of essential tremor. Retrieved October 3, 2023 from https://www.aan.com/Guidelines/.
American Society for Radiation Oncology. (2017). Palliative radiotherapy for bone metastases: Update of an ASTRO evidence-based guideline. Practical Radiation Oncology, 4-12. Retrieved March 1, 2017 from www.practicalradonc.org.
American Society for Stereotactic and Functional Neurosurgery. (2019). Position statement on magnetic resonance-guided focused ultrasound for the management of essential tremor. Neurosurgery, 1-4. Retrieved September 21, 2020 from http://www.assfn.org.
BlueCross BlueShield Association. Evidence Positioning System. (8:2023). Magnetic resonance imaging-guided focused ultrasound (7.01.109). Retrieved October 3, 2023 from http://www.evidencepositioningsystem.com. (41 articles and/or guidelines reviewed)
Boutet, A., Ranjan, M., Zhong, J., Germann, J., Xu, D., Schwartz, M.L., et al. (2018). Focused ultrasound thalamotomy location determines clinical benefits in patients with essential tremor. Brain: A Journal of Neurology, 141, 3405-3414. (Level 4 evidence)
Chang, J.W., Park, C.K., Lipsman, N., Schwartz, M.L., Ghanouni, P., Henderson, J.M., et al. (2018). A Prospective trial of magnetic resonance–guided focused ultrasound thalamotomy for essential tremor: results at the 2-year follow-up. Annals of Neurology, 83 (1), 107-114. (Level 4 evidence)
CMS.gov: Centers for Medicare & Medicaid Services. Palmetto GBA. (2020, August). Magnetic resonance image guided high intensity focused ultrasound (MRgFUS) for essential tremor. (LCD ID L37761). Retrieved June 30, 2022 from https://www.cms.gov.
Elias, W., Lipsman, N., Ondo, W., Ghanouni, P., Kim, Y., Lee, W., et al. (2016). A randomized trial of focused ultrasound thalamotomy for essential tremor. New England Journal of Medicine, 375 (8), 730-739. Abstract retrieved July 24, 2018 from PubMed database.
Ferreira, J.J., Mestre, T.A., Lyons, K.E., Benito-Leon, J., Tan, E.K., Abbruzzese, G., et al. (2019). MDS evidence-based review of treatments for essential tremor. Movement Disorders, 34 (7), 950-958. Abstract retrieved January 14, 2020 from PubMed database.
Fisherman, P.S., Elias, W.J., Ghanouni, P., Gwinn, R., Lipsman, N., Schwartz, M., & et al. (2018). Neurological adverse event profile of magnetic resonance imaging–guided focused ultrasound thalamotomy for essential tremor. Movement Disorders, DOI: 10.1002/mds.27401. (Level 2 evidence)
Halpern, C.H., Santini, V., Lipsman, N., Lozano, A.M., Schwartz, M.L., Shah, B.B., et al. (2019). Three-year follow-up of prospective trial of focused ultrasound thalamotomy for essential tremor. Neurology, 93 (24), DOI 10.1212/WNL.0000000000008561. (Level 4 evidence)
Han, X., Huang, R., Meng, T., Yin, H., & Song, D. (2021). The roles of magnetic resonance-guided focused ultrasound in pain relief in patients with bone metastases: A systemic review and meta-analysis. Frontiers in Oncology, doi: 10.3389/fonc.2021.617295. (Level 1 evidence)
Hurwitz, M., Ghanouni, P., Kanaev, S., Iozeffi, D., Gianfelice, D., et al. (2014). Magnetic resonance-guided focused ultrasound for patients with painful bone metastases: phase III trial results. Journal of the National Cancer Institute, 106 (5). (Level 2 evidence)
Menikou, G., Yiallouras, C., Yiannakou, M., & Damianou, C. (2017). MRI-guided focused ultrasound robotic system for the treatment of bone cancer. International Journal of Medical Robotics, 13 (1). Abstract retrieved January 14, 2020 from PubMed database.
Mohammed, N., Patra, D., & Nanda, A. (2018). A meta-analysis of outcomes and complications of magnetic resonance-guided focused ultrasound in the treatment of essential tremor. Neurosurgical Focus, 44 (2), E4. Retrieved July 24, 2018 from PubMed database.
Park, Y-S., Jung, N.Y., Na, W.C., & Chang, J.W. (2019). Four-year follow-up results of magnetic resonance-guided focused ultrasound thalamotomy for essential tremor. Movement Disorder, DOI: 10.1002/mds.27637. (Level 2 evidence)
Schreglmann, S.R., Krauss, J.K., Chang, J.W., Bhatia, K.P., Kägi, G. (2018). Functional lesional neurosurgery for tremor: a systematic review and meta-analysis. Journal of Neurology, Neurosurgery, & Psychiatry, 89, 717-726. (Level 1 evidence)
U. S. Food and Drug Administration. (2004, October). Center for Devices and Radiological Health. Medical Devices. ExAblate® 2000System - P040003. Retrieved April 5, 2013 from http://www.accessdata.fda.gov.
Winifred S. Hayes, Inc. Medical Technology Directory. (2019, August; last update search September 2022). Magnetic resonance-guided focused ultrasound therapy for treatment of uterine fibroids. Retrieved October 3, 2023 from www.hayesinc.com/subscribers. (30 articles and/or guidelines reviewed)
ORIGINAL EFFECTIVE DATE: 3/1/2005
MOST RECENT REVIEW DATE: 11/9/2023
ID_BA
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
This document has been classified as public information.