Medicare Advantage

Medical Policy

Title:

Endometrial Ablation

Policy #:

MA11.065d

Policy

Endometrial ablation, with or without hysteroscopic guidance, is considered medically necessary and, therefore, covered for premenopausal women with abnormal uterine bleeding and a benign endometrium who are unresponsive to, or have a contraindication to, hormone therapy and would otherwise be considered candidates for hysterectomy.

ABSOLUTE CONTRAINDICATIONS

The following are absolute contraindications for endometrial ablation:

The individual is pregnant or desires a pregnancy.
The individual has a history of endometrial cancer or precancerous histology.
The individual has an active infection (genital or urinary tract) at the time of the procedure.
The individual has active pelvic inflammatory disease.
The individual currently has an intrauterine device (IUD) in place.
The individual has any anatomic or pathologic condition (e.g., history of previous classical Caesarean sections or transmural myomectomy) in which weakness of the myometrium could exist.

In addition to the above contraindications for endometrial ablation, the following absolute contraindications apply for microwave ablation:

Presence of contraceptive micro-inserts in uterus (e.g., Essure).
Myometrial thickness is less than 10 mm.
Uterine sounding length is less than 6 cm.

Coverage is limited to procedures performed using devices approved for endometrial ablation by the US Food and Drug Administration (FDA) for individuals who meet the above medical necessity criteria.

Endometrial ablation for all other indications is considered experimental/investigational and, therefore, not covered because the safety and/or effectiveness of this service cannot be established by review of the available published peer-reviewed literature.

REQUIRED DOCUMENTATION

The individual's medical record must reflect the medical necessity for the care provided. These medical records may include, but are not limited to: records from the professional provider's office, hospital, nursing home, home health agencies, therapies, and test reports.

The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the service.

Guidelines

There is no Medicare coverage determination addressing endometrial ablation; therefore, the Company policy is applicable.

Prior to performing endometrial ablation, other medical reasons for menorrhagia should be ruled out or treated. These include, but are not limited to:

Thyroid disease
Coagulopathy
Ingestion of prescribed or over-the-counter substances that could cause excessive bleeding (e.g., anticoagulants, aspirin, warfarin [Coumadin®])
Fibroids/subendometrial myomas
Uterine polyps
Endometrial or cervical malignancy

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable Evidence of Coverage, endometrial ablation is covered under the medical benefits of the Company’s Medicare Advantage products when the medical necessity criteria listed in this medical policy are met. However, when the service is performed on an individual who has any of the contraindications listed in the policy, that service may not be eligible for coverage or reimbursement by the Company.

US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

There are numerous devices approved by the FDA for use in endometrial ablation.

Description

Endometrial ablation is a procedure for the treatment of abnormal uterine bleeding for premenopausal women with a benign lining of the uterus for whom childbearing is complete. It is an alternative to hysterectomy that is used when other treatments, such as hormone therapy, have either failed to reduce menstrual flow or are contraindicated. Endometrial ablation will only work when there is direct contact between the endometrial wall and the procedure's energy source. Therefore, women with an abnormally shaped uterus, fibroids, or polyps are generally not considered candidates for endometrial ablation.

During the procedure, an energy source is used to ablate (destroy) endometrial tissue. Each of the following ablation methods uses a different energy source to deliver treatment:

Laser ablation
Electrosurgical ablation (e.g., resecting loop using electric current, electric rollerball)
Thermal ablation (e.g., liquid-filled balloons, heated saline)
Cryoablation (freezing)
Radiofrequency ablation
Microwave ablation

References

American College of Obstetricians and Gynecologists (ACOG). ACOG Practice Bulletin 136: Management of Abnormal Uterine Bleeding Associated With Ovulatory Dysfunction. Obstet Gynecol. 2013;122(1):176-185. Reaffirmed 2015.

American College of Obstetricians and Gynecologists (ACOG). ACOG Practice Bulletin 81: Endometrial ablation. Obstet Gynecol. 2007;109(5):1233-1248. Reaffirmed 2015. Retired.

American College of Obstetricians and Gynecologists (ACOG). Management of acute abnormal uterine bleeding in nonpregnant reproductive-aged women. Committee Opinion No. 557. Obstet Gynecol. 2013;121(4):891–896. Reaffirmed 2017, 2020, 2024.

American Society for Reproductive Medicine (ASRM). Fact Sheet: endometrial ablation. Revised 2011. Available at: http://www.fertilityanswers.com/wp-content/uploads/2016/04/endometrial-ablation.pdf. Accessed February 23, 2024.

American Society for Reproductive Medicine (ASRM) Practice Committee. Indications and options for endometrial ablation. Fertil Steril. 2008;90(5 Suppl):S236-S240.

Amso NN, Stabinsky SA, McFaul P, et al. ; International Collaborative Uterine Thermal Balloon Working Group. Uterine thermal balloon therapy for the treatment of menorrhagia: the first 300 patients from a multi-centre study. Br J Obstet Gynaecol. 1998;105(5):517-523.

Angioni S, Pontis A, Nappi L, et al. Endometrial ablation: first- vs. second-generation techniques. Minerva Ginecol. 2016;68(2):143-153.

Bain C, Cooper KG, Parkin DE. Microwave endometrial ablation versus endometrial resection: a randomized controlled trial. Obstet Gynecol. 2002;99(6):983-987.

Bhattacharya S, Middleton LJ, Tsourapas A, et al. Hysterectomy, endometrial ablation and Mirena® for heavy menstrual bleeding: a systematic review of clinical effectiveness and cost-effectiveness analysis. Health Technol Assess. 2011;15(19):iii-xvi, 1-252.

Blue Cross Blue Shield Association Technology Evaluation Center (TEC). Intrauterine ablation or resection of the endometrium for menorrhagia. TEC Evaluations 1991; Volume 6, 296.

Bofill Rodriguez M, Dias S, Jordan V, et al. Interventions for heavy menstrual bleeding; overview of Cochrane reviews and network meta-analysis. Cochrane Database Syst Rev. 2022;5(5):CD013180.

Bofill Rodriguez M, Lethaby A, Grigore M, et al. Endometrial resection and ablation techniques for heavy menstrual bleeding. Cochrane Database Syst Rev. 2019;(1):CD001501.

Bongers MY, Bourdrez P, Heintz AP, et al. Bipolar radio frequency endometrial ablation compared with balloon endometrial ablation in dysfunctional uterine bleeding: impact on patients' health-related quality of life. Fertil Steril. 2005;83(3):724-734.

Bongers MY, Bourdrez P, Mol BW, et al. Randomised controlled trial of bipolar radio-frequency endometrial ablation and balloon endometrial ablation. BJOG. 2004;111(10):1095-1102.

Brown J, Blank K. Minimally invasive endometrial ablation device complications and use outside of the manufacturers' instructions. Obstet Gynecol. 2012;120(4):865-870.

Clinical Trials.gov. Medical therapy versus radiofrequency endometrial ablation in the initial treatment of menorrhagia (iTOM). ClinicalTrials.gov Identifier: NCT01165307. First Posted: July 19, 2010. Last Update Posted: January 20, 2017. Available at: https://clinicaltrials.gov/. Accessed February 23, 2024.

Cooper J, Gimpelson R, Laberge P, et al. A randomized, multicenter trial of safety and efficacy of the NovaSure system in the treatment of menorrhagia. J Am Assoc Gynecol Laparosc. 2002;9(4):418-428.

Cooper KG, Bain C, Lawrie L, Parkin, DE. A randomised comparison of microwave endometrial ablation with transcervical resection of the endometrium; follow up at a minimum of five years. BJOG. 2005;112(4):470-475.

Cooper KG, Bain C, Parkin DE. Comparison of microwave endometrial ablation and transcervical resection of the endometrium for treatment of heavy menstrual loss: a randomised trial. Lancet. 1999;354(9193):1859-1863.

Corson SL. A multicenter evaluation of endometrial ablation by Hydro ThermAblator and rollerball for treatment of menorrhagia. J Am Assoc Gynecol Laparosc. 2001;8(3):359-367.

Daniels JP, Middleton LJ, Champaneria R, et al. Second generation endometrial ablation techniques for heavy menstrual bleeding: network meta-analysis. BMJ. 2012;344:e2564.

Dood RL, Gracia CR, Sammel MD, et al. Endometrial cancer after endometrial ablation vs medical management of abnormal uterine bleeding. J Minim Invasive Gynecol. 2014;21(5):744-752.

Duleba AJ, Heppard MC, Soderstrom RM, Townsend DE. A randomized study comparing endometrial cryoablation and rollerball electroablation for treatment of dysfunctional uterine bleeding. J Am Assoc Gynecol Laparosc. 2003;10(1):17-26.

Essure permanent birth control [Prescribing information]. Berlin, Germany: Bayer Pharma, AG. 2002. Available at: https://labeling.bayerhealthcare.com/html/products/pi/essure_ifu.pdf. Accessed February 23, 2024.

Herman MC, Penninx JP, Mol BW, Bonger MY. Ten-year follow-up of a randomised controlled trial comparing bipolar endometrial ablation with balloon ablation for heavy menstrual bleeding. BJOG. 2013;120(8):966-970.

Herman MC, van den Brink MJ, Geomini PM, et al. Levonorgestrel releasing intrauterine system (Mirena) versus endometrial ablation (Novasure) in women with heavy menstrual bleeding: a multicentre randomised controlled trial. BMC Womens Health. 2013;13:32.

Iglesias DA, Madani Sims S, Davis JD. The effectiveness of endometrial ablation with the Hydro ThermAblator (HTA) for abnormal uterine bleeding. Am J Obstet Gynecol. 2010;202(6):622 e1-e6.

Kaunitz AM. Abnormal uterine bleeding in nonpregnant reproductive-age patients: management. [UpToDate Web site]. 01/16/2024. Available at: Abnormal uterine bleeding in nonpregnant reproductive-age patients: Management - UpToDate. [via subscription only]. Accessed February 23, 2024.

Kleijn JH, Engels R, Bourdrez P, et al. Five-year follow up of a randomised controlled trial comparing NovaSure and ThermaChoice endometrial ablation. BJOG. 2008;115(2):193-198.

Laberge P, Garza-Leal J, Fortin C, et al. A randomized controlled multicenter US Food and Drug Administration trial of the safety and efficacy of the Minerva Endometrial Ablation System: one-year follow-up results. J Minim Invasive Gynecol. 2017;24(1):124-132.

Laberge P, Leyland N, Murji A, et al. Endometrial ablation in the management of abnormal uterine bleeding. J Obstet Gynaecol Can. 2015;37(4):362-379.

Laberge P, Sabah R, Fortin C, Gallinat A. Assessment and comparison of intraoperative and postoperative pain associated with NovaSure and ThermaChoice endometrial ablation systems. J Am Assoc Gynecol Laparosc. 2003;10(3):223-232.

Loffer FD, Grainger D. Five-year follow-up of patients participating in a randomized trial of uterine balloon therapy versus rollerball ablation for treatment of menorrhagia. J Am Assoc Gynecol Laparosc. 2002;9(4):429-435.

Marjoribanks J, Lethaby A, Farquhar C. Surgery versus medical therapy for heavy menstrual bleeding. Cochrane Database Syst Rev. 2016;(1):CD003855.

Matteson KA, Abed H, Wheeler TL 2nd, et al. A systematic review comparing hysterectomy with less-invasive treatments for abnormal uterine bleeding. J Minim Invasive Gynecol. 2012;19(1):13-28.

Meyer WR, Walsh BW, Grainger DA, et al. Thermal balloon and rollerball ablation to treat menorrhagia: a multicenter comparison. Obstet Gynecol. 1998;92(1):98-103.

Microsulis Microwave Endometrial Ablation (MEA) System. Instructions for use. [Food and Drug Administration (FDA) Web site]. Waltham, MA: Microsulis Americas. 12/2002. Available at: https://www.accessdata.fda.gov/cdrh_docs/pdf2/p020031c.pdf. Accessed February 23, 2024.

National Institute for Health and Clinical Excellence (NICE). Heavy menstrual bleeding: assessment and management. NICE guideline NG88. [NICE Web site]. 03/14/2018 (updated: 03/2020 and 05/24/2021). Available at: https://www.nice.org.uk/guidance/ng88. Accessed February 23, 2024.

Penninx JP, Herman MC, Kruitwagen RF, et al. Bipolar versus balloon endometrial ablation in the office: a randomized controlled trial. Eur J Obstet Gynecol Reprod Biol. 2016;196:52-56.

Sambrook AM, Bain C, Parkin DE, Cooper KG. A randomised comparison of microwave endometrial ablation with transcervical resection of the endometrium: follow up at a minimum of 10 years. BJOG. 2009;116(8):1033-1037.

Sambrook AM, Elders A, Cooper KG. Microwave endometrial ablation versus thermal balloon endometrial ablation (MEATBall): 5-year follow up of a randomised controlled trial. BJOG. 2014;121(6):747-753.

Sharp HT. Endometrial ablation: non-resectoscopic techniques. [UpToDate Web site]. 01/17/2024. Available at: Endometrial ablation: Non-resectoscopic techniques - UpToDate [via subscription only]. Accessed February 23, 2024.

Sharp HT. Endometrial ablation or resection: resectoscopic techniques. [UpToDate Web site]. 11/08/2022. Available at: Endometrial ablation or resection: Resectoscopic techniques - UpToDate [via subscription only]. Accessed February 23, 2024.

Sharp HT. Overview of endometrial ablation. [UpToDate Web site]. 01/29/2024. Available at: Overview of endometrial ablation - UpToDate [via subscription only]. Accessed February 23, 2024.

Stewart EA. Uterine fibroids (leiomyomas): treatment overview. [UpToDate Web site]. 02/15/2024. Available at: Uterine fibroids (leiomyomas): Treatment overview - UpToDate [via subscription only]. Accessed February 23, 2024.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. Fotona Dualis Nd:YAG/Er: Yag Laser System. 510(k) summary. [FDA Web site]. 12/06/02. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf2/K021548.pdf. February 23, 2024.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. HerOption™ Uterine Cryoblation Therapy™ System. Premarket approval letter. [FDA Web site]. 04/20/01. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf/p000032a.pdf. Accessed February 23, 2024.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. Hydro ThermAblator^® Endometrial Ablation System. Premarket approval letter. [FDA Web site]. 04/20/01. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf/P000040a.pdf. Accessed February 23, 2024.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. MicroCube Minitouch 3.8 Era System (Minitouch System). Premarket approval letter. [FDA Web site]. 07/28/2023. Available at: https://www.accessdata.fda.gov/cdrh_docs/pdf23/P230002A.pdf. Accessed February 23, 2024.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. Microsulis Microwave Endometrial Ablation (MEA) System. Premarket approval letter. [FDA Web site]. 09/23/03. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf2/p020031a.pdf . Accessed February 23, 2024.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. NovaSure™ Impedance Controlled Endometrial Ablation System. Premarket approval letter. [FDA Web site]. 09/28/01. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf/P010013a.pdf. Accessed February 23, 2024.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. ThermaChoice™ Uterine Balloon Therapy™ (UBT) System. Premarket approval letter. [FDA Web site]. 12/12/97. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf/p970021.pdf. Accessed February 23, 2024.

Vilos GA, Fortin CA, Sanders B, et al. Clinical trial of the uterine thermal balloon for treatment of menorrhagia. J Am Assoc Gynecol Laparosc. 1997;4(5):559-565.

Wheeler TL 2nd, Murphy M, Rogers RG, et al. Clinical practice guideline for abnormal uterine bleeding: hysterectomy versus alternative therapy. J Minim Invasive Gynecol. 2012;19(1):81-88.

Zupi E, Centini G, Lazzeri L, et al. Hysteroscopic endometrial resection versus laparoscopic supracervical hysterectomy for abnormal uterine bleeding: long term follow-up of a prospective randomized trial. J Minim Invasive Gynecol. 2015;22(5):841-845.

Coding

CPT Procedure Code Number(s)

58353, 58356, 58563

ICD - 10 Procedure Code Number(s)

N/A

ICD - 10 Diagnosis Code Number(s)

N92.0 Excessive and frequent menstruation with regular cycle

N92.1 Excessive and frequent menstruation with irregular cycle

N92.4 Excessive bleeding in the premenopausal period

N93.8 Other specified abnormal uterine and vaginal bleeding

N93.9 Abnormal uterine and vaginal bleeding, unspecified

HCPCS Level II Code Number(s)

N/A

Revenue Code Number(s)

N/A

MPMiscCodesNarrativesPub

Coding and Billing Requirements

Cross Reference

Policy History

Revisions From MA11.065d:

03/20/2024	The policy has been reviewed and reissued to communicate the Company's continuing position on Endometrial Ablation.
01/01/2024	Effective 01/01/2024 this policy applies to New Jersey Medicare Advantage (MA) lines of business.
06/28/2023	The policy has been reviewed and reissued to communicate the Company's continuing position on Endometrial Ablation.
11/02/2022	The policy has been reviewed and reissued to communicate the Company's continuing position on Endometrial Ablation.
06/02/2021	The policy has been reviewed and reissued to communicate the Company's continuing position on Endometrial Ablation.
04/08/2020	This policy has been reissued in accordance with the Company's annual review process.
05/20/2019	This version of the policy will become effective 05/20/2019. The intent of the policy remains unchanged, but was updated to modify language regarding absolute contraindications for microwave ablation.

Revisions From MA11.065c:

02/15/2018	This policy has undergone a routine review, and no revisions have been made.
02/15/2017	The policy has been reviewed and reissued to communicate the Company’s continuing position on Endometrial Ablation.
01/06/2017	The following policy criteria have been revised: The medical necessity criteria for menorrhagia has been changed to abnormal uterine bleeding. The following ICD-10 CM codes have been added to this policy: N93.8 Other specified abnormal uterine and vaginal bleeding N93.9 Abnormal uterine and vaginal bleeding, unspecified

Revisions From MA11.065b:

04/01/2016

The following policy criteria have been revised:
Endometrial ablation, with or without hysteroscopic guidance, is considered medically necessary and, therefore, covered for premenopausal women with menorrhagia and a benign endometrium who are unresponsive to, or have a contraindication to, hormone therapy and would otherwise be considered candidates for hysterectomy.

The following ICD-10 CM code has been added to this policy: N92.1.

Revisions From MA11.065a:

03/04/2015

The intent of this policy has not changed.

New policy MA11.065:

01/01/2015

This is a new policy.

Version Effective Date:

5/20/2019

Version Issued Date: