Clinical UM Guideline


Subject:  Endometrial Ablation
Guideline #:  CG-SURG-15Current Effective Date:  01/14/2014
Status:ReviewedLast Review Date:  11/14/2013

Description

Ablation or destruction of the endometrium is used to treat abnormally heavy uterine bleeding, also known as menorrhagia. Endometrial ablation is typically preceded by hormonal treatment to thin the endometrium. The U.S Food and Drug Administration (FDA) has approved devices for endometrial ablation which include, but may not be limited to: laser therapy, electrical wire loop, rollerball using electric current, and thermal ablation using a liquid-filled balloon, microwave, electrode array, or a cryosurgical device.

Clinical Indications

Medically Necessary:

Endometrial ablation, using an FDA approved device, is considered medically necessary for premenopausal women with dysfunctional uterine bleeding (menorrhagia or menometrorrhagia) who have failed prior hormone therapy, declined hormone therapy or have contraindications to hormone therapy and who have no evidence of polyps or other surgically correctable cause of bleeding on sonogram or hysteroscopy. 

Not Medically Necessary: 

Endometrial ablation is considered not medically necessary for women:

Coding

The following codes for treatments and procedures applicable to this document are included below for informational purposes.  Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy.  Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

CPT 
58353Endometrial ablation, thermal, without hysteroscopic guidance
58356Endometrial cryoablation with ultrasonic guidance, including endometrial curettage, when performed.
58563Hysteroscopy, surgical; with endometrial ablation (e.g., endometrial resection, electrosurgical ablation, thermoablation)
  
ICD-9 Procedure

[For dates of service prior to 10/01/2014]

 

68.23Endometrial ablation
  
ICD-10 Procedure[For dates of services on or after 10/01/2014]
0U5B0ZZDestruction of endometrium, open approach
0U5B3ZZDestruction of endometrium, percutaneous approach
0U5B4ZZDestruction of endometrium, percutaneous endoscopic approach
0U5B7ZZDestruction of endometrium, via natural or artificial opening
0U5B8ZZDestruction of endometrium, via natural or artificial opening endoscopic
0UDB7ZZExtraction of endometrium, via natural or artificial opening
0UDB8ZZExtraction of endometrium, via natural or artificial opening endoscopic
  
ICD-9 Diagnosis

[For dates of service prior to 10/01/2014]

 

 All diagnoses
  
ICD-10 Diagnosis[For dates of services on or after 10/01/2014]
 All diagnoses
Discussion/General Information

Endometrial ablation was originally performed using rollerball ablation. FDA approval of subsequent devices designed explicitly for the purposes of endometrial ablation has been based in part on the results of randomized trials comparing the results of newer devices with rollerball ablation. In general, these studies have suggested equivalent outcomes in terms of reduction in menorrhagia.

Examples of devices approved by the FDA for endometrial ablation are:

There are two groups of techniques typically available for performing endometrial ablation: hysteroscopic procedures and non hysteroscopic procedures. The following have been used for hysteroscopic endometrial ablation: Nd:YAG laser, resecting loop using electric current, and electrosurgical rollerball instruments. The following have been used for non hysteroscopic endometrial ablation: thermal balloon devices, cryosurgical or radiofrequency devices, and microwave endometrial ablation systems.

Guidance on endometrial ablation has been issued from several U.S. organizations including the American College of Obstetricians and Gynecologists (ACOG) and the Practice Committee of the American Society for Reproductive Medicine (ASRM).

ACOG (2007) recommendations which were assessed as being based on good and consistent evidence include:

In 2008, the Practice Committee of the ASRM reviewed their 2006 Practice Committee report and reissued their statement on indications and options for endometrial ablation. Conclusions were:

The Society for Gynecologic Surgeons (SGS) systematic review group (2012) published a clinical practice guideline on treatment of abnormal uterine bleeding. The guideline recommends that, in women with bleeding caused mainly by ovulatory disorders or endometrial hemostatic disorders, any of the following treatments may be chosen: hysterectomy, endometrial ablation, systemic medical therapies or levonorgestrel-releasing intrauterine systems. In choosing between endometrial ablation and hysterectomy, the authors note that if the woman's preference is for amenorrhea, less pain or avoiding additional therapy, hysterectomy is suggested. If her preference is for lower operative and post-operative procedural risk, and a shorter hospital stay, endometrial ablation is recommended. 

Comparison between endometrial ablation and hysterectomy

Matteson and colleagues (2012), in a systematic review of randomized controlled trials (RCTs), compared the efficacy of hysterectomy with less invasive techniques for controlling abnormal uterine bleeding. Nine trials were identified directly comparing hysterectomy with another intervention and reporting health outcomes; seven of these studies compared hysterectomy to endometrial ablation. The seven studies included a total of 1,167 women, and follow-up ranged from 4 to 48 months. Following treatment, amenorrhea rates in the endometrial ablation groups ranged from 13-64% versus an implied 100% rate after hysterectomy. Five trials reported pain beyond the immediate post-operative period. The authors judged the quality of evidence on pain to be low but that results favored hysterectomy over ablation. Three studies reported that pelvic pain was less prevalent in the hysterectomy group than the ablation group; however, only one study compared rates statistically, and this study found a significantly lower rate of pain at 2-3 years' follow-up in the group receiving hysterectomy. All seven trials reported additional treatments obtained by participants after the initial intervention. At one to four years' follow-up, the proportion of women in the ablation group who had an additional surgical procedure for bleeding was 16-42%; of these, 10-29% were treated with hysterectomy. The evidence suggests better outcomes (for example, bleeding control, pelvic pain) and fewer additional surgeries in women who have hysterectomy compared to endometrial ablation. However, endometrial ablation is less invasive and involves retention of the uterus.

In a recent Cochrane review, Lethaby and colleagues (2013) compared the efficacy, safety and acceptability of endometrial destruction techniques to reduce heavy menstrual bleeding (HMB) in premenopausal women. Twenty five randomized trials (4040 women) with sample sizes ranging from 20 to 372 were included in the analysis.  The authors concluded:

Endometrial ablation techniques offer a less invasive surgical alternative to hysterectomy. The rapid development of a number of new methods of endometrial destruction has made systematic comparisons between individual methods and with the "gold standard" first generation techniques difficult. Most of the newer techniques are technically easier to perform than traditional hysteroscopy-based methods but technical difficulties with the new equipment need to be addressed. Overall, the existing evidence suggests that success, satisfaction rates and complication profiles of newer techniques of ablation compare favourably with hysteroscopic techniques.

Safety

Brown and Blank (2012) analyzed adverse events associated with endometrial ablation procedures that were reported in the FDA's Manufacturer and User Facility Device Experience (MAUDE) database. A total of 829 adverse events were reported between 2005 and 2011. Nearly two-thirds of the adverse events (540 of 829, 65%) were genital tract or skin burns and 529 of these events (98%) were associated with hydrothermal endometrial ablation. The next 2 most frequent types of adverse events were thermal bowel injury (93 of 820, 11%) and transmural uterine thermal injury (89 of 820, 11%). Of the 182 thermal injuries, 140 (77%) were associated with radiofrequency endometrial ablation. Additionally, 47 cases of sepsis or bacteremia were reported, and 43 of the 47 cases (91%) were associated with radiofrequency endometrial ablation. Four deaths were reported, two associated with radiofrequency ablation and one each associated with thermal balloon ablation and cryoablation. Sixty-six of the 829 events (8%) occurred when endometrial ablation was performed outside of the labeled instructions for use of the procedure. The total number of endometrial ablations performed during this time period was not reported by the authors; therefore, the proportion of procedures with adverse events could not be determined from these data.

References

Peer Reviewed Publications:

  1. 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.
  2. Brown J, Blank K. Minimally invasive endometrial ablation device complications and use outside of the manufacturers' instructions. Obstet Gynecol. 2012; 120(4):865-870.
  3. Cooley S, Yuddandi V, Walsh T, et al. The medium- and long-term outcome of endometrial ablative techniques. Eur J Obstet Gynecol Reprod Biol. 2005; 121(2):233-235.
  4. 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.
  5. Meyer WR, Walsh BW, Grainger, et al. Thermal balloon and roller ball ablation to treat menorrhagia: a multicenter comparison. Obstet Gynecol. 1998; 92(1):98-103.
  6. 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.

Government Agency, Medical Society, and Other Authoritative Publications:

  1. American College of Obstetricians and Gynecologists. Endometrial Ablation. 2007. Reaffirmed 2012. ACOG Practice Bulletin No. 81. Available at: http://www.guidelines.gov/summary/summary.aspx?ss=15&doc_id=10918&nbr=5698=string=. Accessed on September 27, 2013.
  2. Food and Drug Administration (FDA) Summary of Safety and Effectiveness Data. Her OptionUterine Cryoablation Therapy System. 2000. Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/pma/pma.cfm?num=p000032. Accessed September 27, 2013.
  3. Food and Drug Administration (FDA) Summary of Safety and Effectiveness Data. Hydro ThermAblator® Endometrial Ablation System. 2001. Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/pma/pma.cfm?num=P000040. Accessed September 27, 2013.
  4. Food and Drug Administration (FDA) Summary of Safety and Effectiveness Data. Microsulis Microwave Endometrial Ablation (MEA) System. 2003. Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/pma/pma.cfm?num=P020031. Accessed on September 27, 2013.
  5. Food and Drug Administration (FDA) Summary of Safety and Effectiveness Data. NovaSureImpedance Controlled Endometrial Ablation System. 2001. Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/pma/pma.cfm?num=p010013. Accessed September 27, 2013.
  6. Lethaby A, Hickey M, Garry R. Endometrial destruction techniques for heavy menstrual bleeding. Cochrane Database of Systematic Reviews 2005, Issue 4. Art. No.: CD001501. DOI: 10.1002/14651858.CD001501. pub2.
  7. Lethaby A, Penninx J, Hickey M, et al. Endometrial resection and ablation techniques for heavy menstrual bleeding. Cochrane Database Syst Rev. 2013; 8:CD001501. doi: 10.1002/14651858.CD001501.pub4.
  8. Matteson KA, Abed H, Wheeler TL 2nd, et al. Society of Gynecologic Surgeons Systematic Review Group. A systematic review comparing hysterectomy with less-invasive treatments for abnormal uterine bleeding. J Minim Invasive Gynecol. 2012; 19(1):13-28.
  9. National Institute for Clinical Excellence (NICE). Balloon thermal endometrial ablation. 2003. Available at: http://www.nice.org.uk/page.aspx?o=IP_99. Accessed September 27, 2013.
  10. National Institute for Clinical Excellence (NICE). Free fluid thermal endometrial ablation. 2004. Available at: http://www.nice.org.uk/page.aspx?o=IP_124. Accessed September27, 2013.
  11. National Institute for Clinical Excellence (NICE). Microwave endometrial ablation. 2003. Available at: http://www.nice.org.uk/page.aspx?o=IP_65. Accessed on September 17, 2012.
  12. National Institute for Clinical Excellence (NICE). Photodynamic endometrial ablation. 2004. Available at: http://www.nice.org.uk/page.aspx?o=IP_78. Accessed September 27, 2013.
  13. National Institute for Clinical Excellence (NICE). Impedance-controlled bipolar radiofrequency ablation for menorrhagia. 2004. Available at: http://www.nice.org.uk/guidance/index.jsp?action=byID&r=true&o=11127. Accessed September 27, 2013.
  14. Practice Committee of American Society for Reproductive Medicine. Indications and options for endometrial ablation. Fertil Steril. 2008; 90(5Suppl):S236-240.
  15. Wheeler TL 2nd, Murphy M, Rogers RG, et al. Society of Gynecologic Surgeons Systematic Review Group. Clinical practice guideline for abnormal uterine bleeding: hysterectomy versus alternative therapy. J Minim Invasive Gynecol. 2012; 19(1):81-88.
Index

Endometrial Ablation
Her OptionUterine Cryoablation TherapySystem
Hydro ThermaAblator® System
Intrauterine Ablation
Laser Ablation of the Endometrium
Microwave Endometrial Ablation (MEA) system
Rollerball Ablation of the Endometrium
NovaSure
ThermaChoice® 

The use of specific product names is illustrative 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. 

History

Status

Date

Action

Reviewed11/14/2013Medical Policy & Technology Assessment Committee (MPTAC) review. Discussion and Reference sections updated.
Reviewed11/08/2012MPTAC review. Discussion and Reference sections updated.
Reviewed11/17/2011MPTAC review. Coding, Discussion and Reference sections updated.
Reviewed11/18/2010MPTAC review. Description, Discussion, References, and Index updated.
Reviewed11/19/2009MPTAC review. Removed place of service. References updated.
Reviewed11/20/2008MPTAC review. References updated.
Reviewed11/29/2007MPTAC review. References updated.
Reviewed12/07/2006MPTAC review. References and discussion updated.
Revised12/01/2005MPTAC review. Revision based on Pre-merger Anthem and Pre-merger WellPoint Harmonization.
Pre-Merger Organizations 

Last Review Date

Document Number

Title

Anthem, Inc.

 

 None
Anthem BCBS

 

 None
WellPoint Health Networks, Inc.

06/24/2004

3.09.06Endometrial Ablation
 

06/24/2004

Clinical GuidelineEndometrial Ablation