DESCRIPTION
Endometrial ablation is a potential alternative to hysterectomy for treatment of abnormal uterine bleeding. When considering treatment, two techniques present themselves: the hysteroscopic technique (e.g., Nd-YAG laser, electrosurgical rollerball) and the non-hysteroscopic techniques (e.g., cryosurgical, radiofrequency ablation).
Menorrhagia is defined as menstrual periods with abnormally heavy or prolonged bleeding. Metrorrhagia is defined as uterine bleeding at irregular intervals, particularly between the expected menstrual periods. Menometrorrhagia is prolonged or excessive uterine bleeding occurring irregularly and more frequently than normal; thus, a combination of metrorrhagia and menorrhagia. Ablation or destruction of the endometrium is used to treat these conditions in women who fail standard therapy (e.g., hormone therapy and/or dilatation and curettage). It is considered a less invasive alternative than hysterectomy; however, as with hysterectomy, the procedure is not recommended for women who wish to preserve fertility.
Techniques for endometrial ablation are generally divided into two categories: those that do and do not require hysteroscopic procedures. Other terminology for these categories of techniques includes first-generation versus second-generation procedures and resectoscopic versus non-resectoscopic.
The techniques that require hysteroscopic guidance are: Nd-YAG laser; electrosurgical ablation using an electrical rollerball or electrical wire loop; hydrothermal ablation; and microwave ablation.
The techniques that do not require hysteroscopic guidance are: thermal fluid-filled balloon; cryosurgical; instillation of heated saline; and radiofrequency ablation.
POLICY
Endometrial ablation with or without hysteroscopic guidance is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Endometrial ablation with or without hysteroscopic guidance for the treatment of other conditions/diseases is considered investigational.
Any device utilized for this procedure must have FDA approval specific to the indication, otherwise it will be considered investigational.
MEDICAL APPROPRIATENESS
Endometrial ablation with or without hysteroscopic guidance is considered medically appropriate if ALL of the following are met:
Premenopausal menorrhagia, metrorrhagia or menometrorrhagia
Endometrial cavity evaluated to ensure the length and configuration are suitable for device (lack of extreme retroversion or anteflexion) by ANY ONE of the following:
Hysteroscopy
Transvaginal ultrasound
Sonohysterography
Hormonal therapy cannot be used due to ANY ONE of the following:
Documentation indicates it is contraindicated (for example, allergy, history of blood clots, liver disease, kidney disease)1
It was tried for a minimum three months and did not adequately stop the bleeding
Documentation indicates it was not tolerated (for example, migraine with visual disturbance, itching, jaundice, shortness of breath)
No contraindications; including ABSENCE of ALL the following:
Evidence of uterine cancer, endometrial hyperplasia, or endometrial atrophy on endometrial sampling
Uterine prolapse greater than 1st degree
Intention of continued childbearing
Intrauterine device (IUD) currently in place or removed less than one week prior to surgery
Uterine polyps and/or submucosal fibroids greater than 3cm in diameter
Adnexal pathology
History of previous uterine surgery (e.g., classical cesarean section or transmural myomectomy) in which weakness of the myometrium could exist
Active pelvic inflammatory disease
Bleeding disorder (e.g., hemophilia)
Untreated symptomatic urinary tract or uterine infection
Pregnancy or recent pregnancy (i.e. within six months)
IMPORTANT REMINDERS
Any specific products referenced in this policy are just examples and are intended for illustrative purposes 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. These examples are contained in the parenthetical e.g. statement.
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan or government program (e.g., TennCare), the express terms of the health plan or government program will govern.
ADDITIONAL INFORMATION
Brief descriptions & examples of 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.
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, Genesys 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.
Microwave Ablation: (e.g., Microwave Endometrial Ablation (MEA) System) this system delivers fixed-frequency microwave energy, may be performed in a physician’s office, and requires use of the hysteroscope.
1 Smoking is not considered a contraindication to hormone therapy.
SOURCES
fibroids evidence summary. Retrieved January 27, 2021 from http://www.ahrq.gov.
American College of Obstetricians and Gynecologists (ACOG). (2013). Endometrial ablation. Frequently asked questions. Retrieved December 19, 2016 from https://www.acog.org.
American College of Obstetricians and Gynecologists (ACOG). (2013, April; reaffirmed 2024). Committee opinion #557: management of acute abnormal uterine bleeding in nonpregnant reproductive –aged women. Retrieved March 4, 2024 from https://www.acog.org.
American College of Obstetricians and Gynecologists (ACOG). (May, 2007; reaffirmed 2018). Practice bulletin #81: endometrial ablation. Retrieved December 11, 2018 from https://www.acog.org.
Angioni, S., Pontis, A., Nappi, L., Sedda, F., Sorrentino, F., Litta, P., et al. (2016). Endometrial ablation: first – vs. second-generation techniques. Minerva Ginecologica, 68 (2), 143-153. Abstract retrieved December 20, 2016 from PubMed database.
Beelen, P., van der Velde, M., Herman, M.C., Geomini, P.M., van den Brink, M., Duijnhoven, R.G., et al. (2021). Treatment of women with heavy menstrual bleeding: Results of a prospective cohort study alongside a randomised controlled trial. European Journal of Obstetrics, Gynecology, and Reproductive Biology, 257, 1-5. Abstract retrieved January 27, 2021 from PubMed database.
Biggs, W. S., & Marks, S. T. (2016). Diagnosis and Management of Adnexal Masses. American Family Physician, 93(8), 676–681. (Level 5 evidence)
Daniels, J., Middleton, L., Champaneria, R., Khan, K., Cooper, K., Mol, B., et al. (2012). Second generation endometrial ablation techniques for heavy menstrual bleeding: network meta-analysis. BMJ, 344, e2564. Abstract retrieved December 20, 2016 from PubMed database.
Johns, D.A., Garza-Leal, J.G., Diamond, M.P., & Harris, M. (2020). Post-ablation cavity evaluation: A prospective multicenter observational clinical study to evaluate hysteroscopic access to the uterine cavity 4 years after water vapor endometrial ablation for the treatment of heavy menstrual bleeding. Journal of Minimally Invasive Gynecology, 27 (6), 1273-1280. (Level 4 evidence)
Laberge, P., Leyland, N., Murji, A., Fortin, C., Martyn, P., Vilos, G., et al. (2015). Endometrial ablation in the management of abnormal uterine bleeding. Journal of Obstetrics and Gynaecology Canada, 37 (4), 362-379. Abstract retrieved December 20, 2016 from PubMed database.
National Institute for Health and Clinical Excellence. (2018, March; last updated May 2021). Heavy menstrual bleeding: assessment and management. Retrieved November 8, 2021 from www.nice.org.uk/guidance.
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.
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.
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.
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 .
ORIGINAL EFFECTIVE DATE: 3/1985
MOST RECENT REVIEW DATE: 4/11/2024
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