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Uterine fibroids (leiomyomata) are 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. 

Recently, there has been interest in using high intensity focused ultrasound (HIFU) treatment that is guided by magnetic resonance imaging (MRgFUS) 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 cm3, causing a rapid rise in temperature sufficient to cause tissue ablation at the focal point.  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.

In October 2004, the U.S. Food and Drug Administration (FDA) approved via the Premarket Application (PMA) process, the ExAblate® 2000 System for “ablation of uterine fibroid tissue in pre- or peri-menopausal 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. (1) In the initial safety and efficacy studies, the FDA limited MRI-guided focused ultrasound to 33% of fibroid volume with a maximum treatment time of 120 minutes. Guidelines were modified on April 30, 2004, to allow up to 50% treatment volume, 180-minute maximum treatment time, and a second treatment, if within a 14-day period. The ExAblate® 2000 treatment is contraindicated for use in women who have MRI-related issues, such as metallic implants, or sensitivity to MRI contrast agents; obstructions in the treatment beam path, such as a scar, skin fold, or irregularity, bowel, pubic bone, intrauterine device, surgical slips, or any hard implants; and fibroids that are close to sensitive organs such as the bowel or bladder, or are outside the image area. In December 2009, the ExAblate® 2100 System received premarket approval. It includes several modifications to the previous system including enhanced sonication and a detachable cradle. Approval remains limited to treatment of symptomatic uterine fibroids and is indicated in women with a uterine size of less than 24 weeks and those who have completed child bearing.

MRI-guided high-intensity focused ultrasound ablation of other tumors, including breast, prostate, brain tumors and for the treatment of tumors metastatic to bone for the palliation of pain is also being studied.  However, the FDA-approved device for MRI-guided ultrasound ablation is only for uterine fibroids.

MRI-guided high-intensity ultrasound ablation of other tumors, including but not limited to breast, brain, prostate cancer, and palliative treatment of bone metastases is considered investigational.

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

6/6/2005: Code Reference section completed

12/13/2006: Policy reviewed, ablation of tumors other than uterine fibroids as investigational added

1/8/2009: Policy reviewed, no changes

4/27/2010:  Policy Title changed - "High-Intensity" and "Ablation of" were removed and "Focused (MRgFUS) for the Treatment" was added.  Policy Description section was revised to add information about the ExAblate® 2000 system.  Policy statement revise to add "palliative treatment of bone metastases" is considered investigational for treatment other than uterine fibroids.

04/20/2011: Policy description updated; policy statement unchanged. Added FEP verbiage to the Policy Exceptions section.

03/27/2012:  Policy reviewed; no changes.

http://www.fda.gov/

All codes billed for this procedure are considered investigational and not eligible for coverage.

Non-Covered Codes

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