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Date Printed: December 17, 2017: 04:37 PM

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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: 10/31/17

Revised: 11/15/17

Subject: Magnetic Resonance - Guided High Intensity Focused Ultrasound Ablation

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:

Magnetic resonance-guided focused ultrasound (MGgFUS) (also known as magnetic resonance guided high intensity focused ultrasound ablation) is a noninvasive treatment that combines 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. Ultrasound causes a local increase in temperature in the target tissue, resulting in coagulation necrosis while sparing the surrounding normal structures.

Uterine Fibroids

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. The evidence is insufficient to determine the effects of magnetic resonance-guided focused ultrasound on health outcomes.

Metastatic Bone Disease

Metastatic bone disease is one of the most common causes of cancer pain. Existing treatments include conservative measures (eg, massage, exercise) and pharmacologic agents (eg, analgesics, bisphosphonates, corticosteroids). For patients who fail the above treatments, the standard care is to use external-beam radiotherapy. However, a substantial proportion of patients have residual pain after radiotherapy, and there is a need for alternative treatments for these patients.

Other Tumors

Magnetic resonance-guided focused ultrasound of other tumors, including, but not limited to breast, prostate, and brain tumors are being studied. The evidence is insufficient to determine the effects of magnetic resonance-guided focused ultrasound on health outcomes.

There are several ExAblate medical devices approved by the U.S. Food and Drug Administration (FDA) (e.g., ExAblate 2000 MRgFUS system (InSightec), ExAblate Model 4000 Type 1.0 System (ExAblate Neuro), ExAblate System (Insightec) Model 2000/2100/2100). The U.S. Food and Drug Administration (FDA) approved the ExAblate MRgFUS system (InSightec) for: treatment of uterine fibroids (leiomyomata) and palliation of pain associated with tumors metastatic to bone. The FDA approved the ExAblate Neuro is intended for use in the unilateral thalamotomy treatment of idiopathic essential tremor patients with medication-refractory tremor.

The ExAblate System (Insightec) Model 2000/2100/2100) (2012) medical device is indicated for pain palliation of metastatic bone cancer in patients 18 years of age or older who are suffering from bone pain due to metastatic disease and who arc failures of standard radiation therapy, or not candidates for, or refused radiation therapy. The bone tumor to be treated must be visible on non-contrast MR and device accessible.

POSITION STATEMENT:

Magnetic resonance -guided high intensity focused ultrasound ablation using an FDA approved device 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 -guided high intensity ultrasound ablation for all other indications, including, but not limited to the following is considered experimental or investigational.

The evidence is insufficient to determine the effects of magnetic resonance-guided high intensity focused ultrasound on health outcomes.

BILLING/CODING INFORMATION:

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)

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 (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:

Desmoid tumor: A type of soft tissue tumor that forms in fibrous (connective) tissue, usually in the arms, legs, or abdomen. It may also occur in the head and neck. Desmoid tumors are usually benign (not cancer). They often recur (come back) after treatment and spread to nearby tissue, but they rarely spread to other parts of the body. They may occur in adults or children. Also called aggressive fibromatosis and desmoid-type fibromatosis.

RELATED GUIDELINES:

None applicable.

OTHER:

Other names used to report magnetic resonance-guided high intensity focused ultrasound:

Magnetic resonance guided focused ultrasound (MGgFUS)

Magnetic resonance imaging guided high intensity focused ultrasound (MRI-HIFU)

Magnetic resonance imaging-guided focused ultrasound (MRI-FUS)

MRI guided high intensity focused ultrasound

REFERENCES:

  1. Agency for Healthcare Research and Quality (AHRQ) Management of Uterine Fibroids: An Update of the Evidence, July 2007.
  2. Avedian RS. Is MR-guided High-intensity Focused Ultrasound a Feasible Treatment Modality for Desmoid Tumors? Clinical Orthopaedics and Related Research 2016; 474 (3): 697-704.
  3. Barnard EP, AbdElmagied AM, Vaughan LE, et al. Periprocedural outcomes comparing fibroid embolization and focused ultrasound: a randomized controlled trial and comprehensive cohort analysis. American Journal of Obstetrics and Gynecology 2017; (5): 500.el-500.ell.
  4. Blue Cross Blue Association Medical Policy Magnetic Resonance-Guided Focused Ultrasound 7.01.109, 07/17.
  5. Blue Cross Blue Shield Association TEC Assessment-Magnetic Resonance-Guided Focuses Utrasound Therapy for Symptomic Uterine Fibroids Vol. 20, No 10, 10/05.
  6. Bucknor MD, Rieke V. MRgFUS for desmoid tumors within the thigh: early clinical experiences. Journal of Therapeuic Ultrasound 2017; 5:4.
  7. Carranza-Mamane B. J., Havelock J, Hemmings R, et al. The management of uterine fibroids in women with otherwise unexplained infertility. Journal of Obstetrics and Gynaecology Canada 2015.
  8. Chen R, Keserci B, Bi H et al. The safety and effectiveness of volumetric magnetic resonance-guided high-intensity focused ultrasound treatment of symptomatic uterine fibroids: early clinical experience in China. Journal of Therapeutic Ultrasound 2016; 4:27.
  9. 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.
  10. 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.
  11. 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.
  12. 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.
  13. 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.
  14. 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.
  15. Merckel LG. First clinical experience with a dedicated MRI-guided high-intensity focused ultrasound system for breast cancer ablation. European radiology 2016; 26(11): 4037-4046.
  16. Napoli A, Mastantuono M, Cavallo Marincola B et al. Osteoid osteoma: MR-guided focused ultrasound for entirely noninvasive treatment. Radiology 2013; 267(2):514-21.
  17. National Institutes of Health-Uterine Fibroids, 11/01/06.
  18. 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.
  19. 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.
  20. 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.
  21. 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.
  22. Temple MJ, Waspe AC, Amaral JG et al. Establishing a clinical service for the treatment of osteoid osteoma using magnetic resonance-guided focused ultrasound: overview and guidelines. Journal of Therapeutic Ultrasound 2016; 20;4:16.
  23. U.S. Food and Drug Administration (FDA)-FDA Talk Paper-FDA Approves New Device to Treat Uterine Fibroids, 10/22/04.
  24. U.S. National Institutes of Health – Clinical Trials.gov-Magnetic Resonance (MR) Guided Focused Ultrasound Surgery of Uterine Fibroids, 01/11/06.
  25. 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 10/31/17.

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.

11/15/17

Review; revised position statement. Added code 0398T.

Date Printed: December 17, 2017: 04:37 PM