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Medical Policy: 04.01.09
Original Effective Date: August 2007
Reviewed: August 2011
Revised:
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:
Uterine fibroids (leiomyomata) are one of the most common conditions affecting women in the reproductive years; symptoms include menorrhagia, pelvic pressure, or pain. Hysterectomy and various myomectomy procedures are considered the gold standard treatment. However, there has been longstanding research interest in developing minimally invasive alternatives including endometrial ablation, various laparoscopic ablative procedures using differing energy sources (i.e., laser, radiofrequency ablation or cryotherapy), and uterine artery embolization.
Recently, there has been interest in using high-intensity focused ultrasound treatment that is guided by magnetic resonance imaging (MRI) as a totally noninvasive approach to the ablation of uterine fibroids. 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 can be focused into a maximum tissue volume of 4.3 cubic centimeters, causing a rapid rise in temperature sufficient to cause tissue ablation at the focal point. Initial protocols allowed treatment of only up to 33% volume of each fibroid, although this has subsequently been expanded to permit treatment of up to 50% volume of each fibroid. In addition to providing guidance, the associated MRI imaging 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. The ultrasound equipment is all specially designed to be compatible with MRI magnets.
MRI-guided high-intensity focused ultrasound ablation as a treatment of benign prostatic hypertrophy (BPH) and of tumors of the breast, prostate, and brain is also being studied, as well as use in the palliative treatment of painful bone metastases. However, the only FDA approved device for MRI-guided ultrasound ablation is for the treatment of uterine fibroids.
Research has also been conducted involving the use of B-mode ultrasound and computerized tomography as the image guidance mechanisms to target tissues for ablation.
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Prior Approval:
Not applicable
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Policy:
Image guided high-intensity ultrasound ablation of uterine fibroids is considered investigational.
Image guided high-intensity ultrasound ablation is considered investigational for the treatment of benign and malignant tumors including, but not limited to, tumors of the breast, brain, and prostate; benign prostatic hypertrophy; and palliative treatment of bone metastases.
To date, there are no randomized controlled trials and only one non-randomized study comparing MRI-guided high intensity ultrasound to a different treatment. Other than lack of randomization, this study was limited in that data on the comparison group was not published until 5 years after data on the treatment group, the clinical significance of the primary outcome was unclear, and there were no follow-up data beyond 1 year. There is insufficient evidence on the long-term treatment effects, recurrence rates, and impact on future fertility and pregnancy.
MRI-guided high intensity ultrasound is being investigated for use in several applications that are not currently approved by the FDA. There are some preliminary reports of safety and efficacy in small numbers of patients. Due to a lack of regulatory approval and insufficient evidence of the impact on health outcomes, MRI-guided high intensity ultrasound is considered investigational for treatment of other benign and malignant tumors.
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Procedure Codes and Billing Guidelines:
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To report provider services, use appropriate CPT* codes, Modifiers, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or ICD-9-CM diagnostic codes.
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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
- There are no specific codes for other applications of MRI-guided or ultrasound guided focused ultrasound ablation
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Selected References:
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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.
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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.
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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.
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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.
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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.
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The Technology Evaluation Center. Magnetic resonance-guided focused ultrasound therapy for symptomatic uterine fibroids. Vol. 20 No. 10. 2005, October.
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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.
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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.
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ECRI; TARGET [database online]. Plymouth Meeting (PA): MRI-guided focused ultrasound ablation of uterine fibroids. TARGET Report 874; March 2007
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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.
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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.
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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.
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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.
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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.
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MRI-Guided Focused Ultrasound Feasibility Study for Brain Tumors. (NCT00147056). Last updated January 13, 2009. Available online at clinicaltrials.gov. Last accessed August 2011.
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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.
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Policy History:
Date Reason Action
August 2011 Annual review Policy renewed
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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
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and therefore are subject to change without notice.
*Current Procedural Terminology © 2010 American Medical Association. All Rights Reserved.
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