MRI-guided focused ultrasound (MRgFUS) is a noninvasive treatment that combines two technologies: focused ultrasound (US) and MRI. 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. The integrated system is proposed as a noninvasive therapy for pain palliation of bone metastases and uterine fibroids. MRgFUS is being investigated for the treatment of other benign and malignant tumors.
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.
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.
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
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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, the express terms of the health plan will govern.
There is evidence from a sham-controlled, randomized trial that MRI-guided focused ultrasound (MRgFUS) improves the health outcome for adults with painful bone metastases who failed or are unsuitable for radiotherapy treatment. There is insufficient evidence from randomized controlled trials or other controlled studies that MRgFUS improves the health outcome for individuals with any other clinical condition.
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.
BlueCross BlueShield Association. Evidence Positioning System. (7:2018). Magnetic resonance imaging-guided focused ultrasound (7.01.109). Retrieved February 4, 2019 from http://www.evidencepositioningsystem.com (31 articles and/or guidelines reviewed)
ECRI Institute. Health Technology Assessment Information Service. Product Brief. (2017, June). ExAblate Neuro (InSightec, Inc.) for treating essential tremor. Retrieved February 4, 2019 from ECRI Institute. (11 articles and/or guidelines reviewed)
ECRI Institute. Health Technology Information Service. Emerging Technology Evidence Report. (2014, August). Magnetic resonance-guided focused ultrasound for palliating pain from bone metastases. Retrieved October 8, 2014 from ECRI Institute. (91 articles and/or guidelines reviewed)
Elias, W., Lipsman, N., Ondo, W., Ghanouni, P., Kim, Y., Lee, W., et al. (2016, August). 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.
Geiger, D., Napoli, A., Conchiglia, A., Gregori, L. M., Arrigoni, F., Bazzocchi, A., et al. (2014). MR-guided focused ultrasound (MRgFUS) ablation for the treatment of nonspinal osteoid osteoma: a prospective multicenter evaluation. Journal of Bone and Joint Surgery, 96 (9), 743-751. Abstract retrieved May 5, 2016 from PubMed database.
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)
Joo, B., Park, M. S., Lee, S. H., Choi, J. J., Lim, S. T., Rha, S. Y., et al. (2015). Pain palliation in patients with bone metastases using magnetic resonance-guided focused ultrasound with conformal bone system: a preliminary report. Yonsei Medical Journal, 56 (2), 503-509. Abstract retrieved April 22, 2015 from PubMed database.
Kim, H. S., Baik, J., Pham, L. D., & Jacobs, M. A. (2011). MR-guided high intensity focused ultrasound treatment for symptomatic uterine leiomyomata: Long-term outcomes. Academic Radiology, 18 (8), 970-976. (Level 3 evidence)
Menikou, G., Yiallouras, C., Yiannakou, M., & Damianou, C. (2016). MRI-guided focused ultrasound robotic system for the treatment of bone cancer. International Journal of Medical Robotics, Epub ahead of print. Abstract retrieved March 1, 2017 from PubMed database.
Mohammed, N., Patra, D., and Nanda, A. (2018, February) 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.
Napoli, A., Anzidei, M. De Nunzio, C., Cartocci, G., Panebianco, V., De Dominicis, C., et al. (2013). Real-time magnetic resonance-guided high-intensity focused ultrasound focal therapy for localised prostate cancer: Preliminary experience. European Urology, 63 (2), 395-398. (Level 4 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. Health Technology Brief. (2016, July, last update search 2018, July). Magnetic resonance–guided focused ultrasound therapy (ExAblate 2000; InSightec Ltd.) for ablation of uterine fibroids. Retrieved February 4, 2019 from www.hayesinc.com. (33 articles/guidelines reviewed)
Winifred S. Hayes, Inc. Health Technology Brief. (2016, March; last update search 2018, March). Magnetic resonance–guided focused ultrasound therapy (ExAblate; InSightec Ltd.) for palliation of painful bone metastases. Retrieved February 4, 2019 from www.hayesinc.com. (28 articles/guidelines reviewed)
ORIGINAL EFFECTIVE DATE: 3/1/2005
MOST RECENT REVIEW DATE: 3/28/2019
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.
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