Notification



Notification Issue Date:



Medical Policy Bulletin


Title:Endometrial Ablation

Policy #:11.06.05e

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


The Company makes decisions on coverage based on Policy Bulletins, benefit plan documents, and the member’s medical history and condition. 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.

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 Medical Policy Bulletin document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy Bulletin will be reviewed regularly and be updated as scientific and medical literature becomes available. For more information on how Medical Policy Bulletins are developed, go to the About This Site section of this Medical Policy Web site.



Policy

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

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:
  • Ensure contraceptive micro-inserts are in place.
  • 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

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 benefit contract, endometrial ablation is covered under the medical benefits of the Company’s 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 December 20, 2017.

    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.

    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.

    Conceptus Incorporated. Essure Instructions for Use (12/18/02). Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf2/P020014c.pdf. Accessed December 20, 2017.

    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 December 20, 2017.

    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 December 20, 2017.
    National Institute for Health and Clinical Excellence (NICE). Heavy menstrual bleeding. Clinical guideline 44. [NICE Web site]. 2007. Updated August 2016. Available at: www.nice.org.uk/nicemedia/pdf/CG44NICEGuideline.pdf. Accessed December 20, 2017.

    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 December 20, 2017.

    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 December 20, 2017.

    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 December 20, 2017.

    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 December 20, 2017.

    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 December 20, 2017.

    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 December 20, 2017.

    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 December 20, 2017.

    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 December 20, 2017.

    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 December 20, 2017.

    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 December 20, 2017.

    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


Cross References


Policy History

Revisions from 11.06.05e:
02/15/2018This policy has undergone a routine review, and no revisions have been made
Version Effective Date: 01/06/2017
Version Issued Date: 01/06/2017
Version Reissued Date: 02/15/2018

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Independence Blue Cross is an independent licensee of the Blue Cross and Blue Shield Association, serving the health insurance needs of Philadelphia and southeastern Pennsylvania.