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MRI-Guided High-Intensity Focused Ultrasound (MRgFUS) Ablation

» Summary» Procedure Codes
» Description» Selected References
» Prior Approval» Policy History
» Policy

Medical Policy: 04.01.09 
Original Effective Date: August 2007 
Reviewed: February 2015 
Revised: February 2015 

Benefit Application
Benefit determinations are based on the applicable contract language in effect at the time the services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary based on contract, and individual member benefits must be verified. Wellmark determines medical necessity only if the benefit exists and no contract exclusions are applicable. This medical policy may not apply to FEP. Benefits are determined by the Federal Employee Program.

This Medical Policy document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy will be reviewed regularly and be updated as scientific and medical literature becomes available.


An integrated system providing magnetic resonance imaging (MRI)-guided focused ultrasound (MRgFUS) treatment is proposed as a noninvasive therapy for uterine fibroids and for pain palliation of bone metastases. MRgFUS is also being investigated for the treatment of other benign and malignant tumors.

Magnetic resonance-guided focused ultrasound (MRgFUS) is a non-invasive treatment that combined 2 technologies, focused ultrasound and magnetic resonance imaging (MRI). The ultrasound beam penetrates through the soft tissues and using MRI for guidance and monitoring, the beam can be focused on targeted sites. The ultrasound causes a local increase in temperature in the target tissue, resulting in coagulation necrosis while sparing the surrounding normal structures. The ultrasound waves from each sonication are focused at a focal point which has a maximum focal volume of 20 nm in diameter and 15 nm in height/length. This causes a rapid rise in temperature (i.e., to approximately 57°C to 95°C), which is sufficient to achieve tissue ablation at the focal point. In addition to providing guidance, the associated MRI can provide on-line 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.


Treatment of Uterine Fibroids
To date, the primary clinical application of MRgFUS has been for treatment of uterine fibroids (leiomyomata) which is one of the most common conditions affecting women in the reproductive years; symptoms include menorrhagia, pelvic pressure, or pain. There are several approaches that are currently available to treat symptomatic uterine fibroids: hysterectomy; abdominal myomectomy; laparoscopic and hysteroscopic myomectomy; hormone therapy; uterine artery embolization; and watchful waiting. Hysterectomy and various myomectomy procedures are considered the gold standard treatment.


Treatment of Other Tumors
MRI-guided high-intensity focused ultrasound (MRgFUS) ablation is also being studied as a treatment of other tumors including breast, prostate, liver, pancreas and brain, as well as palliative treatment of painful bone metastases.


Palliative Treatment of Bone Metastases

Interest in minimally invasive local treatment options that target pain from bone metastases has increased because patient longevity and advances in cancer management have led to more people living with bone metastases. Magnetic resonance guided focused ultrasound (MRgFUS) is being used for palliating pain from bone metastases.

Bones are a common place for metastatic cancer cells to colonize and establish secondary tumor sites. Higher grade tumors and late diagnosis are also associated with the presence of bone metastasis. Metastases can develop in any bone, but certain cancers such as solid tumors (breast, prostate, lung, thyroid, and kidney cancers) are more likely than others to spread to bone, and bone metastases occur in late stages of most solid tumor cancers.

Bone metastases are common cause of significant morbidity or mortality, metastatic lesions can predispose the bone to fractures. When metastases form in bone, the cancer cells release substances that can activate nearby bone cells, called osteoclasts and osteoblasts. Osteoclasts dissolve and weaken surrounding bone, which can lead to formation of osteolytic lesions. Osteoblasts stimulate bone formation, causing sclerotic, osteoblastic lesions. Both types of bone metastases can cause pain, but osteolytic lesions usually lead to fracture more often than osteoblastic lesions.

Clinical condition, life expectancy, and impact on quality of life (QOL) guide pain palliation treatment decisions. First line treatment is pain medication with nonsteroidal anti-inflammatory drugs progressing to opioids. Increasing opioid doses can result in nausea, sedation, constipation, somnolence, and dependence, which negatively affects a patient’s QOL. External beam radiation therapy (EBRT) is the standard second line treatment for pain from bone metastases; however, radiation is effective in only 60% to 65% of patients, and pain relief may not occur in those patients for two to four weeks after treatment. EBRT is also limited by is cumulative radiation effects to healthy organs, bone and surrounding tissue. Patients who have previously had EBRT may be unable to tolerate additional EBRT. Furthermore, for patients who experience some relief from EBRT, the relief is only temporary for about 30% because of disease progression. Retreatment of patients who can be re-irradiated is effective only one about 30% of patients. Its effectiveness may be diminished by having to deliver a smaller dose because of concerns about cumulative radiation dose to normal tissues. Other systemic palliative therapies (e.g., chemotherapy, hormonal therapy, radioisotopes, bisphosphonates) are available; however, many patients experience inadequate pain control or unwanted side effects with these options. Thus, new options are needed, particularly for patients who are ineligible for EBRT. 

More recent options involve methods to ablate the pain-transmitting cells at the boundary of bone tumors, which is believed to inhibit the patient’s ability to feel pain. One such option is magnetic resonance imaging (MRI) – guided focused ultrasound (MRgFUS). Unlike diagnostic ultrasound, which exposes tissue to biologically insignificant acoustic energy levels, MRgFUS energy acts on bone primarily through thermal effects. MRgFUS energy can rapidly heat tissue to the point at which irreversible thermal ablation and coagulative necrosis occurs. The outer covering of the bone is the target for MRgFUS energy as the bone tumor itself may be more or less absorptive depending on whether it is osterolytic or osteoblastic (or mixed). Bone is particularly conducive to MRgFUS ablation because of its higher ultrasound energy absorption, lower thermal conductance, and less susceptibility to penetration of ultrasound waves than soft tissue. As a result, the absorption pattern by bones allows wider surface areas of the bone to be treated with each energy pulse.

MRgFUS to palliate bone metastases typically requires locoregional anesethesia or a combination of local anesthesia and deep sedation. Clinicians typically perform MRgFUS in the outpatient setting. Treatment typically requires about 1.5 hours per lesion but may vary depending on tumor size and location. Immediately after the procedure, a technologist performs contract enhanced MRI scan to verify ablation and assess potential damage to tissues adjacent to the target bone sites.

The reported benefits of MRgFUS for palliation of bone metastases are as follows:

  • A noninvasive procedure
  • Single session treatment usually performed on an outpatient basis
  • Return to activity possible the next day; procedure discomfort dissipates in two to three days
  • No ionizing radiation exposure
  • No toxic effects on bone marrow
  • Rapid (24 to 72 hours) pain relief lasting up to 3 months
  • Both osteroblastic and osterolytic tumors can be treated
  • Low reported occurrences of complications and side effects
  • Retreatment for symptom recurrence or new tumors possible
  • Provider option for patients who cannot receive further EBRT for bone metastases
  • Can be combined with EBRT for primary tumor without increasing radiation side effects
  • May reduce or obviate need for opioids and non-narcotic analgesics, thus eliminating side effects from these medications

In addition to pain palliation, MRgFUS has a potential role in achieving local tumor control, allowing remineralization of trabecular bone or reduction in lesion size. For some patients tumor debulking may play a clinically significance role in symptom relief.

The Hurwitz et al. 2014 RTC provided comparative data on pain severity, analgesic use, QOL (quality of life), and pain response at various time points up to three month follow up. This multi-center phase III trial demonstrated that MRgFUS is a safe and effective, non-invasive treatment for alleviating pain resulting from bone metastases in patients that have failed standard treatments.


There is evidence from a sham-controlled, randomized trial that magnetic resonance imaging (MRI) guided focused ultrasound (MRgFUS0 improves the net 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 health outcome for patients with other clinical conditions. Therefore, MRgFUS may be considered medically necessary for pain palliation in selected patients with metastatic bone cancer and investigational in all other situations. 

Practice Guidelines and Position Statements


National Comprehensive Cancer Network (NCCN)
Adult Cancer Pain Version 2.2014
Non-Pharmacologic Interventions for Cancer Pain Management: Interventional Strategies:
Ablation therapy (e.g. RF ablation, US ablation) for bone lesions can also be helpful in reducing pain.


American College of Radiology (ACR)
ACR Appropriateness Criteria (2012): Radiologic Management of Uterine Leiomyomas

MR-guided high intensity ultrasound is another uterine sparing option to treat focal leiomyomas. It is noninvasive, though each treatment may take several hours to be completed. To date, there is little long term information on the efficacy of this technology. 


American College of Obstetricians and Gynecologists (ACOG)
ACOG Practice Bulletin (2008): Alternatives to Hysterectomy in the Management of Leiomyomas
Surgical Alternatives to Hysterectomy

  • Abdominal myomectomy
  • Laparoscopic myomectomy
  • Hysteroscopic myomectomy
  • Uterine artery embolization
  • Magentic resonance imaging-guided focused ultrasound surgery (considered, but not specifically recommended)

Regulatory Status
In October 2004, the U.S. Food and Drug Administration (FDA) approved via the premarket application (PMA) process, the ExAblate® 2000 System (Insightec, Inc., Haifa, Israel) for “ablation of uterine fibroid tissue in pre- or perimenopausal women with symptomatic uterine fibroids who desire a uterine sparing procedure.” Treatment is indicated for women with a uterine gestational size of less than 24 weeks who have completed childbearing.

In October 2012, the FDA approved the ExAblate® System, Model 2000/2100/2100 VI via the PMA process. The intended use of the device is for pain palliation in adult patients with metastatic bone cancer who failed or are not candidates for radiation therapy. The device was evaluated through an expedited review process. The FDA required a post-approval study with 70 patients to evaluate the effectiveness of the system under actual clinical conditions. The results of this trial have not been published in a peer reviewed journal.


Prior Approval: 


Not applicable



See also medical policy 02.01.53 High Intensity Focused Ultrasound (HIFU)


MRI-guided high intensity ultrasound ablation may be considered medically necessary for pain palliation in adult patients with metastatic bone cancer who failed or are not candidates for radiotherapy.


MRI-guided high-intensity focused ultrasound (MRgFUS) ablation is considered investigational in all other situations including but is not limited to:

  • Treatment of uterine fibroids
  • Treatment of other tumors
    • Brain cancer
    • Prostate cancer
    • Breast cancer
    • Liver cancer
    • Pancreas cancer

There is evidence from a sham-controlled, randomized trial that magnetic resonance imaging (MRI) guided focused ultrasound (MRgFUS0 improves the net 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 health outcome for patients with other clinical conditions. Therefore, MRgFUS may be considered medically necessary for pain palliation in selected patients with metastatic bone cancer and investigational in all other situations.


Procedure Codes and Billing Guidelines: 

  • To report provider services, use appropriate CPT* codes, Modifiers, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or diagnosis codes.
  • 0071T Focused ultrasound ablation of uterine leiomyomata, including MR guidance; total leiomyomata volume less than 200 cc of tissue
  • 0072T Focused ultrasound ablation of uterine leiomyomata, including MR guidance; total leiomyomata volume greater or equal to 200 cc of tissue
  • C9734 Focused ultrasound ablation/therapeutic intervention, other than uterine leiomyomata, with magnetic resonance (MR) guidance


Selected References: 

  • Hynynen K, Pomeroy O, et al. MR imaging-guided focused ultrasound surgery of fibroadenomas in the breast: a feasibility study. Radiology 2001; 219(1):176-84.
  • Jaaskelainen J. Non-invasive transcranial high intensity focused ultrasound (HIFUS) under MRI thermometry and guidance in the treatment of brain lesions. Acta Neurochir Suppl 2003; 88:57-60. Abstract viewed on line.
  • Gianfelice D, Khiat A, et al. Feasibility of magnetic resonance imaging-guided focused ultrasound surgery as an adjunct to tamoxifen therapy in high-risk surgical patients with breast carcinoma. J Vasc Interv Radiol 2003; 14(10):1275-82.
  • Diederich CJ, Nau WH, et al. Catheter-based ultrasound applications for selective thermal ablation: progress towards MRI-guided applications in prostate. Int J Hyperthermia 2004; 20(7):739-56.
  • Jolesz FA, Hynynen K, et al. MR imaging-controlled focused ultrasound ablation: a noninvasive image-guided surgery. Magn Reson Imaging Clin N Am 2005 Aug;13(3):545-60.
  • The Technology Evaluation Center.  Magnetic resonance-guided focused ultrasound therapy for symptomatic uterine fibroids. Vol. 20 No. 10. 2005, October.
  • Smart OC, Hindley JT, et al. Gonadotrophin-releasing hormone and magnetic-resonance-guided ultrasound surgery for uterine leiomyomata. Obstet Gynecol 2006; 108(1):49-54.
  • Stewart EA, Rabinovici J, et al. Clinical outcomes of focused ultrasound surgery for the treatment of uterine fibroids. Fertil Steril 2006; 85(1):22-9.
  • ECRI; TARGET [database online]. Plymouth Meeting (PA): MRI-guided focused ultrasound ablation of uterine fibroids.  TARGET Report 874; March 2007
  • Liberman B, Gianfelice D, Inbar Y et al. Pain palliation in patients with bone metastases using MR-guided focused ultrasound surgery: a multicenter study. Ann Surg Oncol. 2009 Jan; 16(1): 140-6. Epub 2008 Nov 11.
  • Gianfelice D, Gupta C, Kucharczyk W et al. Palliative treatment of painful bone metastases using MR imaging-guided focused ultrasound. Radiology 2008; 249(1):355-63.
  • Viswanathan M, Hartmann K, McKoy N et al. Management of uterine fibroids: an update of the evidence. Evidence Report/Technology Assessment No. 154 (Prepared by RTI international-University of North Carolina Evidence-based Practice Center under Contract No. 290-02-0016. AHRQ Publication No. 07-E011. Rockville, MD: Agency for Healthcare Research and Quality. July 2007.
  • Funaki K, Fukunishi H, Sawada K. Clinical outcomes of magnetic resonance-guided focused ultrasound surgery for uterine myomas: 24-month follow-up. Ultrasound Obstet Gynecol. 2009 Nov; 34(5):584-9.
  • Okada A, Morita Y, Fukunishi H et al. Non-invasive magnetic resonance-guided focused ultrasound treatment of uterine fibroids in a large, Japanese population: impact of learning curve on patient outcome. Ultrasound Obstet Gynecol 2009;34(5):579-83.
  • MRI-Guided Focused Ultrasound Feasibility Study for Brain Tumors. (NCT00147056). Last updated January 13, 2009. Available online at Last accessed August 2011.
  • McDannold N, Clement GT, Black P et al. Transcranial magnetic imaging-guided focused ultrasound surgery of brain tumors: initial findings in 3 patients. Neurosurgery 2010; 66(2):323-32.
  • ECRI. Health Technology Assessment Info Service. MRI-guided Focused Ultrasound for Alating Uterine Fibroids. [Hotline Service]. Plymouth Meeting (PA): ECRI Institute;  2012 April 2.
  • National Institute for Clinical Excellence (NICE). Magnetic resonance image-guided transcutaneous focused ultrasound for uterine fibroids. Interventional procedure guidance 413. 2011 November. Accessed May 23, 2012.
  • ECRI. Hotline Response. MRI Guided Focused Ultrasound for Ablating Uterine Fibroids. July 2013. Also available at http//
  • ECRI. Health Technology Forecast. Magnetic Resonance Guided Focused Ultrasound for Treatment and Palliation of Selected Cancers. January 2014.
  • ECRI. Can Ultrasound Energy Save Brain Tumor Patients for Radiosurgery. November 2007.
  • PubMed. MR-Guided High Intensity Focused Ultrasound Ablation of Breast Cancer with Dedicated Breast Platform. April 2013.
  • American College of Obstetricians and Gynecologists (ACOG), practice bulletin no. 16, Alternatives to Hysterectomy in the Mangement of Leiomyomas
  • American College of Radiology (ACR), Appropriateness Criteria, Radiologic Management of Uterine Leiomyomas. National Institute of Health and Clinical Excellence, Magentic Resonance Image-Guided Transcutaneous Focused Ultrasound for Uterine Fibroids. November 2011.
  • UpToDate. Overview of Treatment of Uterine Leiomyomas (Fibroids), Elizabeth A. Stewart, M.D.,  Topic last updated July 19, 2013.
  • UpToDateRadiation Therapy for the Management of Painful Bone Metastases. Lisa A. Kachnic, M.D., Steven J. DiBiase, M.D., Topic last updated December 24, 2013.
  • UpToDate. Management of Bone Metastases in Advanced Prostate Cancer. A Oliver Sartor, M.D., Steven J. DiBiase, M.D. Topic last updated February 5, 2014.
  • MedScape. Managing Uterine Fibroids: Alternatives to Hysterectomy. July 20, 2012.
  • Mark. D. Hurwitz, et al. Magnetic Resonance Guided Focused Ultrasound for Patients with Painful Bone Metastases: Phase III Trial Results, Journal of National Cancer Institute Advance Access, Published April 23, 2014.
  • ECRI. Emerging Technology Evidence Report. Magnetic Resonance – Guided Focused Ultrasound for Palliating Pain from Bone Metastases, August 2014. Also available at
  • National Comprehensive Cancer Network (NCCN), Adult Cancer Pain Version 2.2014. Also available at


Policy History: 



Date                                        Reason                               Action

August 2011                           Annual review                     Policy renewed

May 2012                               Annual review                     Policy renewed

April 2013                              Annual review                     Policy renewed

March 2014                            Annual review                     Policy revised

February 2015                        Annual review                     Policy revised


Wellmark medical policies address the complex issue of technology assessment of new and emerging treatments, devices, drugs, etc.   They are developed to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. Wellmark medical policies contain only a partial, general description of plan or program benefits and do not constitute a contract. Wellmark does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Wellmark or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. Our medical policies may be updated and therefore are subject to change without notice.

*Current Procedural Terminology © 2012 American Medical Association. All Rights Reserved.

Contact Information
New information or technology that would be relevant for Wellmark to consider when this policy is next reviewed may be submitted to:
  Wellmark Blue Cross and Blue Shield
  Medical Policy Analyst
  P.O. Box 9232
  Des Moines, IA 50306-9232
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