Uterine fibroids are one of the most common conditions affecting women in the reproductive years; symptoms include menorrhagia, pelvic pressure or pain. This policy addresses MRI Guided Intensity Focused Ultrasound Ablation of the Uterine Fibroids. The ultrasound beam penetrates through the soft tissues and can be focused to target sites, using MRI for guidance and monitoring. The ultrasound causes a local increase in temperature in the target tissue, resulting in coagulation necrosis while sparing the surrounding normal structures.

Please see the following related document for additional information:
CG-SURG-28  Transcatheter Uterine Artery Embolization

Investigational/Not Medically Necessary:

MRI guided high intensity focused ultrasound ablation of uterine fibroids is considered investigational/not medically necessary.

Rationale

One study reported the results of a case series of 55 women with symptomatic uterine fibroids who either underwent high intensity focused ultrasound treatment or who underwent a planned hysterectomy within one month after the ultrasound treatment. In this latter group, hysterectomy specimens provided pathologic correlation of treatment. Typically only one fibroid was targeted for treatment and no attempt was made to target the fibroid that was the most likely to cause symptoms. Additionally, fibroids that would require the ultrasound beam to pass through bowel or bladder were excluded from treatment (Stewart 2003). While the procedure was well tolerated, there is no long term efficacy data (Bachmann 2006). Furthermore, a relatively small number of patients have been studied relative to the prevalence of uterine fibroids. The literature does not adequately address the potential for regrowth of treated fibroids over time. A one to two year follow-up is necessary to determine the durability of the treatment effect. Longer follow-up intervals with larger, well-controlled comparison studies with comparability between treatment groups need to be studied.

High intensity focused ultrasound is being studied for oncologic, cardiac and neurological applications as an alternative to radiofrequency ablation.

Background/Overview

The cause of fibroid tumors of the uterus is unknown. However, it is suggested that fibroids may enlarge with estrogen therapy (such as oral contraceptives) or with pregnancy. Fibroid growth seems to depend on regular estrogen stimulation, and rarely affects women younger than 20 or postmenopausal women. As long as a woman with fibroids is menstruating, the fibroids will probably continue to grow, although growth is usually quite slow.

Hysterectomy and various myomectomy procedures are considered the gold standard treatment. However, there has been a 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) or uterine artery embolization. Most recently there has been interest in using MRI guided high intensity focused ultrasound treatment as a totally noninvasive approach to ablation of uterine fibroids. This technology uses an ultrasound beam that penetrates through the soft tissues and can be focused to target sites, using MRI for guidance and monitoring. The ultrasound causes a local increase in temperature in the target tissue, resulting in coagulation necrosis while sparing the surrounding normal structures.

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. The 2004 FDA approval letter states that patients must have a uterine gestational size of less than 24 weeks and that patients must have completed childbearing (FDA 2004).

Definitions

Fibroids: benign fibrous tissue collected in the uterine wall

Menorrhagia: excessive uterine bleeding occurring at the expected intervals of the menstrual periods

MRI (magnetic resonance imaging): the use of a nuclear magnetic resonance spectrometer to produce electronic images of specific atoms and molecular structures in solids, especially human cells, tissues, and organs

Myomectomy: a surgical procedure to remove only fibroids, is frequently the chosen treatment for premenopausal women who want to bear more children, because it usually can preserve fertility

Uterine: of, relating to, or in the region of the uterus

Coding

The following codes for treatments and procedures applicable to this policy are included below for informational purposes.  Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy.  Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

When services are Investigational/Not Medically Necessary:

CPT

ICD-9 Diagnosis

References

Peer Reviewed Publications:

1. Bachmann G. Expanding treatment options for women with symptomatic uterine leiomyomas: timely medical breakthroughs. Fertil Steril. 2006; 85(1):46-47.
2. Gelet A, Chapelon JY, Bouvier R et al. Local control of prostate cancer by transrectal high intensity focused ultrasound therapy: Preliminary results. J Urol 1999; 161:156-162. 
3. Hindley J, Gedroyc WM, Regan L et al. MRI guidance of focused ultrasound therapy of uterine fibroids: early results. AJR Am J Roentgenol 2004; 183(6):1713-1719.
4. Hynynen K, Pomeroy O, Smith DN et al. MRI imaging-guided focused ultrasound surgery of fibroadenomas in the breast: A feasibility study: Radiology 2001; 219:176-185. 
5. Kohrmann KU, Michel MS, Gaa J et al. High intensity focused ultrasound as noninvasive therapy for multilocal renal cell carcinoma. Case study and review of the literature. J Urol 2002; 167:2397-2403. 
6. Ren XL, Zhou XD, Zhang J, et al. Extracorporeal ablation of uterine fibroids with high-intensity focused ultrasound: imaging and histopathologic evaluation.  J Ultrasound Med. 2007; 26(2):201-212.
7. Stewart EA, Rabinovici J, Tempany CM, et al. Clinical outcomes of focused ultrasound surgery for the treatment of uterine fibroids Fertil Steril. 2006; 85(1):22-29.
8. Stewart EA, Gedroyc WMW, Tempany CM, et al. Focused ultrasound treatment of uterine fibroid tumors. Safety and feasibility of a noninvasive thermoablative technique. Am J Obstet Gynecol 2003; 189:48-54. 
9. Zippel DB, Papa MZ. The use of MR imaging guided focused ultrasound in breast cancer patients; a preliminary phase one study and review. Breast Cancer 2005; 12(1):32-38.

Government Agency, Medical Society, and Other Authoritative Publications:

1. Blue Cross Blue Shield Association. Magnetic Resonance-Guided Focused Ultrasound Therapy for Symptomatic Uterine Fibroids. TEC Assessment, 2005; 18(10).
2. FDA Talk Paper. FDA approves new device to treat uterine fibroids. 2004. Available at:  http://www.fda.gov/bbs/topics/ANSWERS/2004/ANS01319.html. Accessed on March 1, 2007.

1. U.S. National Library of Medicine. Uterine fibroids. Available at: http://www.nlm.nih.gov/medlineplus/ency/article/000914.htm. Accessed on March 1, 2007.

Estrogen Therapy
ExAblate® 2000 System
Fibroids
Myomectomy

The use of specific product names is illustrative only.  It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

Policy History

Federal and State law, as well as contract language, including definitions and specific contract provisions/exclusions, take precedence over Medical Policy and must be considered first in determining eligibility for coverage. The member's contract benefits in effect on the date that services are rendered must be used. Medical Policy, which addresses medical efficacy, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving, and we reserve the right to review and update Medical Policy periodically.

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