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Date Printed: December 16, 2017: 09:12 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.

02-56000-30

Original Effective Date: 11/15/14

Reviewed: 10/31/17

Revised: 11/15/17

Subject: Laparoscopic and Percutaneous Techniques for the Treatment of Uterine Fibroids

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 Updates    
           

DESCRIPTION:

A variety of minimally invasive treatments, alternatives to surgery, have been proposed for treatment of uterine fibroids (also called leiomyomas, fibromyomas, fibromas, myofibromas, and myomas). Among these approaches are laparoscopic and percutaneous techniques to induce myolysis, which includes Nd:YAG lasers, bipolar electrodes, supercooled cryoprobes, and ultrasonographically guided radiofrequency ablation.

The Acessa System received premarket approval from the U.S. Food and Drug Administration (FDA) in November 2012. The Acessa System is indicated for “use in percutaneous, laparoscopic coagulation and ablation of soft tissue, including treatment of symptomatic uterine fibroids under laparoscopic ultrasound guidance.”

POSITION STATEMENT:

Minimally invasive laparoscopic and percutaneous techniques, including but not limited to (e.g., Nd: YAG lasers, bipolar electrodes, supercooled cryoprobes, radiofrequency ablation) for the treatment of uterine fibroids are considered experimental or investigational. There is insufficient evidence in the published peer-reviewed medical literature about the impact of minimally invasive laparoscopic and percutaneous techniques for the treatment of uterine fibroids on health outcomes.

BILLING/CODING INFORMATION:

CPT Coding:

0336T

Laparoscopy, surgical, ablation of uterine fibroid(s), including intraoperative ultrasound guidance and monitoring, radiofrequency (Investigational)

0404T

Transcervical uterine fibroid(s) ablation with ultrasound guidance, radiofrequency (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 review. The following Local Coverage Determination (LCD) was reviewed: Non-covered Services (L33777) located at fcso.com

DEFINITIONS:

No guideline specific definitions apply.

RELATED GUIDELINES:

Transcatheter Uterine Artery Embolization and Occlusion of Uterine Arteries for the Treatment of Uterine Fibroids, 02-56000-26
Magnetic Guided High Intensity Ultrasound , 02-56000-27

OTHER:

Other names used to report laparoscopic and percutaneous techniques for the treatment of uterine fibroids:

Note: 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.

Crymomyolysis
Laparoscopic ultrasound-guided radiofrequency ablation
Laparoscopic ultrasound-guided radiofrequency volumetric thermal ablation (RFVTA)
Laparoscopic uterine artery occlusion
Laparoscopic myolysis
Myolysis
Percutaneous myolyisis
Radiofrequency ablation of uterine fibroids

In November 2014, the U.S. Food and Drug Administration (FDA) published a safety communication on laparoscopic power morcellators in hysterectomy and myomectomy. FDA recommends that manufacturers of laparoscopic power morcellators include in their product labeling specific safety statements in the form of a boxed warning and contraindications.

REFERENCES:

  1. American College of Obstetricians and Gynecologists (ACOG). Alternatives to hysterectomy in the management of leiomyomas. Washington (DC): American College of Obstetricians and Gynecologists (ACOG); 2008 Aug. 14 p. (ACOG practice bulletin; no. 96).
  2. Blue Cross Blue Shield Laparoscopic and Percutaneous Techniques for the Myolysis of Uterine Fibroids Medical Policy 4.01.19, 08/17.
  3. Berman JM, Guido RS, Garza Leal JG et al. Three-year outcome of the Halt trial: a prospective analysis of radiofrequency volumetric thermal ablation of myomas. Journal of Minimally Invasive Gynecology 2014; 21(5): 767-74.
  4. Brucker SY, Hahn M, Kraemer D, et al. Laparoscopic radiofrequency volumetric thermal ablation of fibroids versus laparoscopic myomectomy. International Journal of Gynecology and Obstetrics 2014; 125(3): 261-265.
  5. Chudnoff SG, Berman JM, Levine DJ et al. Outpatient procedure for the treatment and relief of symptomatic uterine myomas. Obstetrics and Gynecology 2013; 121(5): 1075-82.
  6. Galen DI. Electromagnetic image guidance in gynecology: prospective study of a new laparoscopic imaging and targeting technique for the treatment of symptomatic uterine fibroids. Biomedical Engineering Online 2015; 40:90.
  7. Galen DI, Pemueller RR, Leal JG et al. Laparoscopic radiofrequency fibroid ablation: Phase II and Phase III Results. Journal of the Society of Laparoendoscopic Surgeons 2014; 18(2): 182-190.
  8. Guido RS, Macer JA, Abbott K et al. Radiofrequency volumetric thermal ablation of fibroids: a prospective, clinical analysis of two years' outcome from the Halt trial. Health and Quality Life Outcomes 2013; 11:139
  9. Hahn M, Brucker S, Kraemer D et al. Radiofrequency volumetric thermal ablation of fibroids and laparoscopic myomectomy: long-term follow-up from a randomized trial. Geburtshilfe Frauenheilkd 2015; 75(5):442-449.
  10. Kramer B, Hahn M, Taran FA, et al. Interim analysis of a randomized controlled trial comparing laparoscopic radiofrequency volumetric thermal ablation of uterine fibroids with laparoscopic myomectomy. International Journal of Gynecology and Obstetrics 2016;133(2):206-211.
  11. Thompson MJ, Carr BR. Intramural myomas: to treat or not to treat. International Journal of Women's Health 2016; 8: 145-149.
  12. Vilos GA, Allaire C, Laberge PY et al. The management of uterine leiomyomas. Journal of Obstetrics and Gynaecology Canada 2015; 37(2): 157-178.
  13. Yin G, Chen M, Yang S et al. Treatment of uterine myomas by radiofrequency thermal ablation: a 10-year retrospective cohort study. Reproductive Sciences 2015; 22 (5): 609-614.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Medical Policy & Coverage Committee on 10/31/17.

GUIDELINE UPDATE INFORMATION:

11/15/14

New Medical Coverage Guideline.

11/01/15

Revision: ICD-9 Codes deleted.

12/15/15

Review; added “including but not limited to (e.g., Nd: YAG lasers, bipolar electrodes, supercooled cryoprobes, radiofrequency ablation)” to position statement. Added FDA safety communication statement on laparoscopic power morcellators used for myomectomy and hysterectomy. Updated references.

01/01/16

Annual HCPCS code update. Added 0404T.

12/15/16

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

11/15/17

Review; no change to position statement, Updated program exception and references.

Date Printed: December 16, 2017: 09:12 PM