Notification



Notification Issue Date:



Medicare Advantage Policy

Title:Endometrial Ablation
Policy #:MA11.065d

This policy is applicable to the Company’s Medicare Advantage products only. Policies that are applicable to the Company’s commercial products are accessible via a separate commercial policy database.


The Company makes decisions on coverage based on the Centers for Medicare and Medicaid Services (CMS) regulations and guidance, benefit plan documents and contracts, and the member’s medical history and condition. If CMS does not have a position addressing a service, the Company makes decisions based on Company Policy Bulletins. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable. Although the Medicare Advantage Policy Bulletin is consistent with Medicare’s regulations and guidance, the Company’s payment methodology may differ from Medicare.

When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.


This Policy Bulletin document describes the status of CMS coverage, medical terminology, and/or benefit plan documents and contracts at the time the document was developed. This Policy Bulletin will be reviewed regularly and be updated as Medicare changes their regulations and guidance, scientific and medical literature becomes available, and/or the benefit plan documents and/or contracts are changed.



Policy

Coverage is subject to the terms, conditions, and limitations of the member's Evidence of Coverage.

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.
Policy 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):176-85. Reaffirmed 2015.

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

American College of Obstetricians and Gynecologists (ACOG). ACOG Practice Bulletin 81: Endometrial ablation. Obstet Gynecol. 2007;109(5): 1233-48. Reaffirmed 2015.

American College of Obstetricians and Gynecologists. Management of acute abnormal uterine bleeding in nonpregnant reproductive-aged women. Committee Opinion No. 557. Obstet Gynecol. 2013;121:891–6. Reaffirmed 2017.

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 April 01, 2019.

American Society for Reproductive Medicine. The Practice Committee. Indications and options for endometrial ablation. Fertil Steril. 2008; 90(5 Suppl):S236-40.

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

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

Bayer HealthCare Pharmaceuticals, Inc. Essure clinical resource: Physician training manual. (12/2016). Available at: https://www.hcp.essure-us.com/assets/pdf/Essure_Clinical_Resource_Guide.pdf. Accessed April 01, 2019.

Bayer HealthCare Pharmaceuticals, Inc. Essure permanent birth control: Instructions for use. (2002). Available at: https://labeling.bayerhealthcare.com/html/products/pi/essure_ifu.pdf. Accessed April 01, 2019.

Bhattacharya S, Middleton LJ, Tsourapas A, et al. Hysterectomy, endometrial ablation and Mirena(R) 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.

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):865-70.

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 HydroThermAblator 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):744-52.

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.

Herman MC, Penninx JP, Mol BW, et al. Ten-year follow-up of a randomised controlled trial comparing bipolar endometrial ablation with balloon ablation for heavy menstrual bleeding. BJOG. 2013;120(8):966-70.

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(1):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 e1-6.

Kaunitz AM. Management of abnormal uterine bleeding. 06/07/2017. Up to Date. [UpToDate Web site]. http://www.uptodate.com/home/index.html. [via subscription only]. Accessed April 01, 2019.

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, 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 PY, 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.

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(4):684-685.

Lethaby A, Hickey M, Garry R, et al. Endometrial resection / ablation techniques for heavy menstrual bleeding. Cochrane Database Syst Rev. 2009; (4):CD001501.

Lethaby A, Penninx J, Hickey M, et al. Endometrial resection and ablation techniques for heavy menstrual bleeding. Cochrane Database Syst Rev. 2013;8:CD001501.

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;8: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.

Medical Therapy Versus Radiofrequency Endometrial Ablation in the Initial Treatment of Menorrhagia (iTOM) (NCT01165307). Last updated January 20, 2017. Sponsored the Mayo Clinic and Hologic. Available at: www.clinicaltrials.gov. Accessed December 20, 2017.

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. Waltham, MA: Microsulis Americas; 2002. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf2/P020031c.pdf. Accessed April 01, 2019.

Microsulis Americas, Inc. Instructions for use: Microsulis microwave endometrial ablation (MEA) system. [Food and Drug Administration (FDA) Web site]. Available at: https://www.accessdata.fda.gov/cdrh_docs/pdf2/p020031c.pdf Accessed March 29, 2019.

National Institute for Health and Clinical Excellence (NICE). Heavy menstrual bleeding: assessment and management. Clinical guideline NG88. [NICE Web site]. Original: 03/2018. Updated: November 2018. Available at: https://www.nice.org.uk/guidance/ng88. Accessed April 01, 2019.

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;196:52-6.

Sambrook A, Elders A, Cooper K. Microwave endometrial ablation versus thermal balloon endometrial ablation (MEATBall): 5-year follow up of a randomised controlled trial. BJOG. 2014;121(6):747-53.

Sambrook AM, Bain C, Parkin DE, et al. 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.

Sharp HT. An overview of endometrial ablation. 10/12/2017. Up to Date. [UpToDate Web site]. http://www.uptodate.com/home/index.html. [via subscription only]. Accessed April 01, 2019.

Sharp HT. Endometrial ablation: Non-resectoscopic techniques. 06/01/2017. Up to Date. [UpToDate Web site]. http://www.uptodate.com/home/index.html. [via subscription only]. Accessed April 01, 2019.

Sharp HT. Endometrial ablation or resection: Resectoscopic techniques. 09/05/2017. Up to Date. [UpToDate Web site]. http://www.uptodate.com/home/index.html. [via subscription only]. Accessed April 01, 2019.

Stewart EA. Overview of treatment of uterine leiomyomas (fibroids). 11/30/2017. Up to Date. [UpToDate Web site]. http://www.uptodate.com/home/index.html. [via subscription only]. Accessed April 01, 2019.

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. Accessed April 01, 2019.

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 April 01, 2019.

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 April 01, 2019.

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 April 01, 2019.

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 April 01, 2019.

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 April 01, 2019.

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):841-5.



Coding

Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.

CPT Procedure Code Number(s)

58353, 58356, 58563


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD - 10 Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


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

Coding and Billing Requirements






Policy History

Revisions from MA11.065d
05/20/2019This 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
02/15/2018This policy has undergone a routine review, and no revisions have been made.
02/15/2017The policy has been reviewed and reissued to communicate the Company’s continuing position on Endometrial Ablation.
01/06/2017The 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
04/01/2016The 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
03/04/2015The intent of this policy has not changed.


Revisions from MA11.065
01/01/2015This is a new policy.




Version Effective Date: 05/20/2019
Version Issued Date: 05/20/2019
Version Reissued Date: N/A