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Date Printed: October 20, 2017: 11:47 AM

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This medical policy (medical coverage guideline) is Copyright 2017, Blue Cross and Blue Shield of Florida (BCBSF). All Rights Reserved. You may not copy or use this document or disclose its contents without the express written permission of BCBSF. The medical codes referenced in this document may be proprietary and owned by others. BCBSF makes no claim of ownership of such codes. Our use of such codes in this document is for explanation and guidance and should not be construed as a license for their use by you. Before utilizing the codes, please be sure that to the extent required, you have secured any appropriate licenses for such use. Current Procedural Terminology (CPT) is copyright 2017 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use. CPT® is a trademark of the American Medical Association. 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.

02-56000-27

Original Effective Date: 12/15/04

Reviewed: 09/24/15

Revised: 10/15/15

Subject: Magnetic Resonance Imaging (MRI) - Guided High Intensity Ultrasound Ablation of Uterine Fibroids and Other Tumors

THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION OF BENEFITS, OR A GUARANTEE OF PAYMENT, NOR DOES IT SUBSTITUTE FOR OR CONSTITUTE MEDICAL ADVICE. ALL MEDICAL DECISIONS ARE SOLELY THE RESPONSIBILITY OF THE PATIENT AND PHYSICIAN. BENEFITS ARE DETERMINED BY THE GROUP CONTRACT, MEMBER BENEFIT BOOKLET, AND/OR INDIVIDUAL SUBSCRIBER CERTIFICATE IN EFFECT AT THE TIME SERVICES WERE RENDERED. THIS MEDICAL COVERAGE GUIDELINE APPLIES TO ALL LINES OF BUSINESS UNLESS OTHERWISE NOTED IN THE PROGRAM EXCEPTIONS SECTION.

           
Position Statement Billing/Coding Reimbursement Program Exceptions Definitions Related Guidelines
           
Other References Update    
           

DESCRIPTION:

Uterine fibroids 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. 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. 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 U.S. Food and Drug Administration (FDA) approved via the Premarket Application (PMA) process, the ExAblate® 2000 System for alation of uterine fibroid tissue in pre- or peri-menopausal women with symptomatic uterine fibroids who desire a uterine sparing procedure.

Also, MRI-guided high-intensity focused ultrasound ablation of other tumors, including breast, prostate, and brain tumors are being studied. The FDA approved device for MRI-guided ultrasound ablation is only for uterine fibroids. Limited data are available for the application of MRI-guided high-intensity focused ultrasound ablation in the breast and prostate. There is no data available for the application of MRI-guided high-intensity focused ultrasound ablation in the brain.

POSITION STATEMENT:

Magnetic resonance imaging (MRI)-guided high-intensity ultrasound ablation meets the definition of medical necessity for pain palliation in adult patients with metastatic bone cancer who failed or are not candidates for radiotherapy.

Magnetic resonance imaging (MRI)-guided high intensity ultrasound ablation of uterine fibroids is considered experimental or investigational, as there is insufficient clinical evidence to support the use of MRI-guided ultrasound ablation of uterine fibroids.

Magnetic resonance imaging (MRI)-guided high intensity ultrasound ablation is considered experimental or investigational, as there is insufficient clinical evidence to support the use of MRI-guided high intensity ultrasound ablation of other tumors, and specifically for the following tumors:

Published data are limited and longer, larger comparative studies are needed to compare MRI-guided high intensity focused ultrasound ablation of all tumors with existing alternatives.

BILLING/CODING INFORMATION:

The following codes may be used to describe MRI-guided high intensity ultrasound ablation of uterine fibroids.

CPT Coding

0071T

Focused ultrasound ablation of uterine leiomyomata, including MR guidance; total lieomyomata volume less than 200cc of tissue (investigational)

0072T

Focused ultrasound ablation of uterine leiomyomata, including MR guidance; total leiomyomata volume greater or equal to 200cc or tissue (investigational)

REIMBURSEMENT INFORMATION:

Refer to section entitled POSITION STATEMENT.

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Advantage products:

No National Coverage Determination (NCD) and/or Local Coverage Determination (LCD) were found at the time of the last guideline reviewed date.

DEFINITIONS:

No guideline specific definitions apply.

RELATED GUIDELINES:

None applicable.

OTHER:

None applicable.

REFERENCES:

  1. Agency for Healthcare Research and Quality (AHRQ) Management of Uterine Fibroids: An Update of the Evidence, July 2007.
  2. Blue Cross Blue Shield Association Medical Policy-MRI-Guided High Intensity Ultrasound Ablation of Uterine Fibroids and Other Tumors (7.01.109), 02/15.
  3. Blue Cross Blue Shield Association TEC Assessment-Magnetic Resonance-Guided Focuses Utrasound Therapy for Symptomic Uterine Fibroids Vol. 20, No 10, 10/05.
  4. Hesley GK, Gorny KR, Henrichsen TL et al. A clinical review of focused ultrasound ablation with magnetic resonance guidance: an option for treatment uterine fibroids. Ultrasound Quarterly 2008; 24(2): 131-139.
  5. Hindley J, Gedroyc WM, Regan L et al. MRI Guidance of Focused Ultrasound Therapy of Uterine Fibroids: Early Results. American Journal of Radiology American Journal of Roentgenology 2004; 183(6): 1713-1719.
  6. Huber PE, Jenne JW, Rastert R et al. A New Noninvasive Approach in Breast Cancer Therapy Using Magnetic Resonance Imaging – Guided Focused Ultrasound Surgery. Cancer Research 2001; 61(23): 8441-8447.
  7. Hurwitz MD, Ghanouni P, Kanaev SV et al. Magnetic resonance-guided focused ultrasound for patients with painful bone metastases: phase III trial results. Journal of the National Cancer Institute 2014; 106(5): pii: dju082.
  8. Hynynen K, Pomeroy O, Smith DN et al. MR Imaging-Guided Focused Ultrasound Surgery of Fibroadenomas in the Breast: A Feasibility Study. Radiology 2001; 219(1): 176-185.
  9. 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. Journal of Urology 2002; 167(6): 2397-403.
  10. National Institutes of Health-Uterine Fibroids, 11/01/06.
  11. Smart OC, Hindley JT, Regan L et al. Gonadotrophin-Releasing Hormone and Magnetic-Resonance-Guided Ultrasound Surgery for Uterine Leiomyomata. Obstetric Gynecology 2006; 108:49-54.
  12. Stewart EA, Gedroyc WM, Tempany CM et al. Focused ultrasound treatment of uterine fibroid tumors: safety and feasibility of a noninvasive thermoablative technique. American Journal of Obstetrics and Gynecology 2003; 189(1): 48-54.
  13. Stewart EA, Rabinovici J, Tempany CM et al. Clinical Outcomes of Focused Ultrasound Surgery for the Treatment of Uterine Fibroids. Fertility Sterility 2006; 85:22-29.
  14. Tempany C M, Stewart, E A, McDonald, N, et al. MR Imaging – Guided Focused Ultrasound Surgery of Uterine Leiomyomas: A Feasibility Study, Radiology Vol. 226 No. 3: 897-905, 03/03.
  15. U.S. Food and Drug Administration (FDA)-FDA Talk Paper-FDA Approves New Device to Treat Uterine Fibroids, 10/22/04.
  16. U.S. National Institutes of Health – Clinical Trials.gov-Magnetic Resonance (MR) Guided Focused Ultrasound Surgery of Uterine Fibroids, 01/11/06.
  17. 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.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Medical Policy & Coverage Committee on 12/03/09.

GUIDELINE UPDATE INFORMATION:

12/15/04

New Medical Coverage Guideline.

01/01/06

Scheduled review. No change in investigational status. Updated references.

01/01/07

Added investigational statement for other tumors. Updated references.

06/15/07

Reformatted guideline.

08/15/07

Annual review, investigational status maintained,references updated.

01/01/09

Scheduled review. No change in position statement. Updated references.

12/15/09

Annual review; no change in position statement. Updated references.

05/15/14

Revision; Program Exceptions section updated.

10/15/15

Review and revision; added position statement for pain palliation in adult members with metastatic bone cancer who failed or are not candidates for radiotherapy. Updated references.

Date Printed: October 20, 2017: 11:47 AM