BlueCross BlueShield of Tennessee Medical Policy Manual

Endometrial Ablation for Treatment of Menorrhagia

DESCRIPTION

Menorrhagia is defined as profuse menstrual bleeding lasting greater than eight days or with greater than eighty mL per cycle. Ablation or destruction of the endometrium is used to treat menorrhagia in women who fail to respond to first line therapy such as hormone therapy and/or dilatation and curettage (D&C). Ablation procedures, with general or epidural anesthesia, can be performed on an outpatient basis.

Multiple energy sources have been proposed to accomplish the ablation.

The following techniques require hysteroscopic guidance: Nd: YAG laser, resecting loop, rollerball using electric current or thermal ablation.

The following techniques do not require hysteroscopic guidance: Liquid-filled balloon, cryosurgical or radiofrequency devices.

POLICY

MEDICAL APPROPRIATENESS

(NOTE: For the description of the indications and contraindications of combined hormonal contraceptives, published in Appendix B and Appendix C of the CDC document U.S. Medical Eligibility Criteria for Contraceptive Use 2010, use the link to the Glossary (hormone therapy).

IMPORTANT REMINDERS

ADDITIONAL INFORMATION

Well-designed randomized controlled trials regarding the use of endometrial ablation with or without hysteroscopic guidance for the treatment of other conditions/diseases are lacking.

The following are brief descriptions of examples of second-generation endometrial ablation procedures:

Balloon Endometrial Ablation: (e.g., ThermaChoice) involves the use of a balloon at the tip of a catheter tube that is filled with fluid and inflated until it conforms to the walls of the uterus. A probe in the balloon heats the fluid to destroy the endometrial lining. After eight minutes the fluid is drained out and the balloon is removed. Hysteroscopic guidance is not required for this procedure.

Electric Wand Ablation: (e.g., NovaSure System) involves inserting a slender wand up through the cervix. A triangular mesh-like device is the passed through the wand and expands to fit the uterus. Electrical energy is passed through it for about 90 seconds and the mesh and wand are then withdrawn. Hysteroscopic guidance is not required for this procedure.

Freezing (Cryoablation): (e.g., Her Option uterine cryoablation therapy system) involves placing a liquid nitrogen probe into the uterus to destroy tissue by freezing. Ultrasound is used to guide the procedure.

Hot Saline: (e.g., the Hydro-Therm-Ablator [HTA] system). This method involves the use of hot saline to destroy the uterine lining. This device is a closed loop system designed to ablate the endometrial lining of the uterus by recirculating heated saline within the uterus. This is not a "blind" procedure but uses hysteroscopy so that the surgeon can view the uterus.

Laser Ablation: Endometrial laser ablation (ELA) uses a distention media delivered into the uterus. After the uterus has been distended, a laser is used to destroy the lining of the uterus. This is not a blind procedure, but uses hysteroscopy so that the surgeon can view the uterus.

Contraception Methods: The Center for Disease Control and Prevention (CDC), with the collaboration of the American College of Obstetricians and Gynecologists (ACOG) and several contraception experts, has published an American version of the World Health Organization (WHO) Medical Eligibility Criteria for Contraceptive Use, 4th edition. The American version; U.S. Medical Eligibility Criteria for Contraceptive Use, 2010 was published in May of 2010 in the CDC Morbidity and Mortality Weekly Report. (See link to glossary (hormone therapy) in the Medical Appropriateness criteria)

The guidelines include a classification system using one of four categories to define the indications, contraindications, safety and efficacy for each contraceptive method with regard to specific medical conditions and characteristics. The recommendations refer to contraceptive methods being used for contraceptive purposes; the recommendations do not consider the use of contraceptive methods for treatment of medical conditions. Health-care providers can use these categories when assessing the safety of contraceptive methods use for women and men with specific medical conditions or characteristics.

The categories for classifying all forms of contraception methods are as follows:

1 = A condition for which there is no restriction for the use of the contraceptive method.

2 = A condition for which the advantages of using the method generally outweigh the theoretical or proven risks.

3 = A condition for which the theoretical or proven risks usually outweigh the advantages of using the method.

4 = A condition that represents an unacceptable health risk if the contraceptive method is used.

SOURCES

ACOG Practice Bulletin. Clinical management guidelines for obstetrician-gynecologists. Number 81. Endometrial ablation. Obstetrics and Gynecology, 109 (5), 1233-1248.

American College of Obstetricians and Gynecologists (ACOG) Committee on Practice Bulletins. (2007, May).

BlueCross BlueShield Association. Medical Policy Reference Manual. (7:2012). Endometrial ablation (4.01.04). Retrieved June 18, 2013 from BlueWeb. (14 articles and/or guidelines reviewed)

BlueCross BlueShield of Tennessee network physicians. July 2008.

Center for Disease Control and Prevention. Morbidity and Mortality Weekly Report. (2010, May). U S. Medical Eligibility Criteria for Contraceptive Use, 2010: adapted from the World Health Organization Medical Eligibility Criteria for Contraceptive Use, 4th edition. Retrieved July 20, 2010 from http://www.cdc.gov/mmwr/pdf/rr/rr59e0528.pdf.

ECRI Institute. Health Technology Information Service. Emerging Technology (TARGET) Evidence Report. (2008, June). Magnetic resonance imaging-guided focused ultrasound ablation of uterine fibroids. Retrieved July 21, 2007 from ECRI Institute. (22 articles and/or guidelines reviewed)

ECRI Institute. Health Technology Information Service. Emerging Technology (TARGET) Evidence Review. (2011, December). Treating uterine fibroids using MR-guided ultrasound. Retrieved June 28, 2013 from https://www.ecri.org/Documents/Reprints/Treating_Uterine_Fibroids_Using_MR-Guided_Ultrasound(Managed_Care)_December2011.pdf.

Iglesias, D., Madani Sims, S., & Davis, J. (2010). The effectiveness of endometrial ablation with Hydro ThermAblator (HTA) for abnormal uterine bleeding. American Journal of Obstetrics and Gynecology, 202 (6), 622 - e 1-6. (Level 4 Evidence)

Longinotti, M., Jacobson, G., Hung, Y., & Learman, L. (2008). Probability of hysterectomy after endometrial ablation. Obstetrics and Gynecology, 112 (6), 1214 - 1220. (Level 4 Evidence)

National Institute for Health and Clinical Excellence. National Collaborating Centre for Women’s and Children’s Health. (2007, January). Heavy menstrual bleeding. Retrieved July 20, 2010 from http://www.nice.org.uk/nicemedia/live/11002/30401/30401.pdf.

U. S. Food and Drug Administration. (2001, April). Center for Devices and Radiological Health. New Device Approvals: HerOption™ Uterine Cryoablation Therapy™ System - P000032. Retrieved July 20, 2010 from http://www.accessdata.fda.gov/cdrh_docs/pdf/p000032a.pdf.

U. S. Food and Drug Administration. (2001, April). Center for Devices and Radiological Health. New Device Approvals: Hydro ThermAblator® Endometrial Ablation System - P000040. Retrieved July 20, 2010 from http://www.accessdata.fda.gov/cdrh_docs/pdf/p000040a.pdf.

U. S. Food and Drug Administration. (2001, September). Center for Devices and Radiological Health. New Device Approvals: Microsulis Microwave Endometrial Ablation (MEA) System - P020031. Retrieved July 20, 2010 from http://www.accessdata.fda.gov/cdrh_docs/pdf2/P020031a.pdf.

U. S. Food and Drug Administration. (2003, September). Center for Devices and Radiological Health. New Device Approvals: NovaSure™ Impedance Controlled Endometrial Ablation System - P010013. Retrieved July 20, 2010 from http://www.accessdata.fda.gov/cdrh_docs/pdf/P010013a.pdf.

ORIGINAL EFFECTIVE DATE:  3/1985

MOST RECENT REVIEW DATE:  8/8/2013

ID_BT

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