Medical Policy: 04.01.09 
Original Effective Date: August 2007 
Reviewed: January 2016 
Revised: January 2016 


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.


Description:

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, essential tremor and chronic neuropathic pain.


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 65°C to 85°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 geno typical 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.  Further studies are needed to determine the long-term efficacy of MRgFUS and to evaluate the efficacy and safety of this procedure relative to other treatments for uterine fibroids.

 

Treatment of Essential Tremors and Chronic Neuropathic Pain

Essential tremor (ET) is one of the most common movement disorders. The cause of the disease and it pathomechanism are still unknown. The main symptoms include tremor of the hands, arms and head. The clinical course is frequently benign, however disability due to ET is common. Pharmacotherapy is usually the first line treatment and patients who do not respond to medications may be considered for surgical treatment (radiofrequency identification (RFID), stereotactic radiosurgery, gamma knife thalamotomy or deep brain stimulation). An alternative treatment being investigated for the treatment of essential tremor is the use of magnetic resonance guided focused ultrasound (MRgFUS) to produce thermal ablation of the thalamic ventral intermediate nucleus (i.e. MRI-guided focused ultrasound thalamotomy). Preliminary uncontrolled studies have shown improvement compared with baseline scores for contralateral hand tremor, disability and quality of life. Adverse effects included transient sensory and cerebellar symptoms; and persistent paresthesia. However, large, randomized, controlled trials will be required to assess the long term efficacy and safety of MRgFUS for this indication.   

 

Chronic neuropathic pain is frequently the result of damage to or dysfunction of the nerve fibers which send incorrect signals to pain centers. Pain significantly lowers patients’ quality of life and complicates normal functioning. An alternative treatment being investigated for the treatment of chronic neuropathic pain is the use of magnetic resonance guided focused ultrasound (MRgFUS) to produce thermal ablation of areas within the thalamus. However, large, randomized controlled trials will be required to assess the long term efficacy and safety of MRgFUS for this indication.

 

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


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
  • May reduce or obviate need for opioids and non-narcotic analgesics, thus eliminating side effects from these medications

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.

  

Summary

There is evidence from a sham-controlled, randomized trial that magnetic resonance imaging (MRI) guided focused ultrasound (MRgFUS) 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 adult 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 2.2015

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. Its use currently is restricted to patients with fewer than six leiomyomas or leimyoma volume less than 900 cm3.  To date, there is little long term information on the efficacy of this technology. 

 

American College of Obstetricians and Gynecologists (ACOG)

 

ACOG Practice Bulletin No. 96: Alternatives to Hysterectomy in the Management of Leiomyomas (Reaffirmed in 2012)

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.


Prior Approval:

 

Not applicable


Policy:

 

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

 

MRI-guided high intensity ultrasound (MRgFUS) 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 for all other indications including but is not limited to the following:

  • Treatment of uterine fibroids
  • Treatment of essential tremor
  • Treatment of chronic neuropathic pain
  • Brain cancer
  • Prostate cancer
  • Breast cancer
  • Liver cancer
  • Pancreas cancer
  • Treatment of pain palliation for patients with metastatic bone cancer except as indicated above

There is evidence from a sham-controlled, randomized trial that magnetic resonance imaging (MRI) guided focused ultrasound (MRgFUS) 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 adult 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
  • 0398T Magnetic resonance image guided high intensity focused ultrasound (MRgFUS), stereotactic ablation lesion, intracranial for movement disorder including stereotactic navigation and frame placement when performed
  • 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 clinicaltrials.gov. 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 External Site(NICE). Magnetic resonance image-guided transcutaneous focused ultrasound for uterine fibroids. Interventional procedure guidance 413. 2011 November. Accessed May 23, 2012.
  • ECRI External SiteHotline Response. MRI Guided Focused Ultrasound for Ablating Uterine Fibroids. July 2013.
  • ECRI External SiteHealth Technology Forecast. Magnetic Resonance Guided Focused Ultrasound for Treatment and Palliation of Selected Cancers. January 2014.
  • ECRI External SiteCan 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. 96, Alternatives to Hysterectomy in the Mangement of Leiomyomas. Reaffirmed 2012
  • American College of Radiology External Site(ACR), Appropriateness Criteria, Radiologic Management of Uterine Leiomyomas. National Institute of Health and Clinical Excellence External SiteMagentic Resonance Image-Guided Transcutaneous Focused Ultrasound for Uterine Fibroids. November 2011.
  • UpToDate External SiteOverview of Treatment of Uterine Leiomyomas (Fibroids), Elizabeth A. Stewart, M.D.,  Topic last updated November 24, 2015.
  • UpToDate External SiteRadiation 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 External SiteManagement of Bone Metastases in Advanced Prostate Cancer. A Oliver Sartor, M.D., Steven J. DiBiase, M.D. Topic last updated October 21, 2015.
  • MedScape External SiteManaging 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. jnci.oxfordjournals.org
  • ECRI External SiteEmerging Technology Evidence Report. Magnetic Resonance – Guided Focused Ultrasound for Palliating Pain from Bone Metastases, August 2014.
  • National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology External SiteAdult Cancer Pain Version 2.2015.
  • UpToDate External SiteSurgical Treatment of Essential Tremor, Daniel Tarsy M.D., Topic last updated March 11, 2015.
  • UpToDate External SiteNonsurgical Therapies for Localized Hepatocellular
  • UpToDate External SiteCarcinoma: Radiofrequency Ablation, Percutaneous Ethanol Injection, Thermal Ablation and Cryoablation. Steven A. Curley, M.D., FACS, Keith E. Stuart M.D., Jonathan M. Schwartz M.D., Robert L. Carithers Jr, M.D., Topic last updated October 16, 2015.
  • UpToDate External SiteImage Guided Ablation of Skeletal Metastases, Anil Nicholas Kurup, M.D., Matthew R. Callstrom, M.D., PhD. Topic last updated November 2, 2015.
  • Lutz S, Berk L, Change E, et. al. Guideline Palliative Radiotherapy for Bone Metastases: An ASTRO Evidence Based Guideline. Int. J. Radiation Oncology Biol. Phys. Vol 79. No. 4. pp. 965-976, 2011
  • Elias WJ, Huss D, Voss T, et. al. A Pilot Study of Focused Ultrasound Thalamotomy for Essential Tremor. N Engl J Med 2013 Aug 15;369(7):640-8
  • Jeanmonod D, Werner B, Morel A, et. al. Transcranial Magnetic Resonance Imaging-Guided Focused Ultrasound: Noninvasive Central Lateral Thalamotomy for Chronic Neuropathic Pain. Neurosurg Focus 2012 Jan:32(1):E1
  • Moser D, Zadicario E, Schiff G, Jeanmonod D. Measurement of Targeting Accuracy in Focused Ultrasound Functional Neurosurgery. Neurosurg Focus 2012 Jan;32(1):E2
  • Martin E, Jean, Jeanmonod D, et. al. High Intensity Focused Ultrasound for Noninvasive Functional Neurosurgery. Ann Neurol 2009 Dec;6696):858-61
  • Dobrakowski PP, Machowska-Majchrzak, et. al. MR-Guided Focused Ultrasound: A New Generation Treatment of Parkinson’s Disease, Essential Tremor and Neuropathic Pain. Interv Neuroradiol 2014 May-June;20(3):275-82
  • Schlesinger D, Benedict S, et. al. MR-Guided Focused Ultrasound Surgery, Present and Future, Med. Phys. 40(8), August 2013  
  • Lipsman N, Schwartz M, et. al. MR-Guided Focused Ultrasound Thalamotomy for Essential Tremor: A Proof of Concept Study. The Lancet Neurology Volume 12, No.5 p 462-468 May 2013

Policy History:

  • January 2016 - Annual Review, Policy Revised
  • February 2015 - Annual Review, Policy Revised
  • March 2014 - Annual Review, Policy Revised
  • April 2013 - Annual Review, Policy Renewed
  • May 2012 - Annual Review, Policy Renewed
  • August 2011 - Annual Review, Policy Renewed

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.