Clinical UM Guideline
|Guideline #:||CG-SURG-15||Current Effective Date:||01/05/2016|
|Status:||Reviewed||Last Review Date:||11/05/2015|
This document addresses endometrial ablation. 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.
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:
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.
|58353||Endometrial ablation, thermal, without hysteroscopic guidance|
|58356||Endometrial cryoablation with ultrasonic guidance, including endometrial curettage, when performed|
|58563||Hysteroscopy, surgical; with endometrial ablation (e.g., endometrial resection, electrosurgical ablation, thermoablation)|
|0U5B0ZZ||Destruction of endometrium, open approach|
|0U5B3ZZ||Destruction of endometrium, percutaneous approach|
|0U5B4ZZ||Destruction of endometrium, percutaneous endoscopic approach|
|0U5B7ZZ||Destruction of endometrium, via natural or artificial opening|
|0U5B8ZZ||Destruction of endometrium, via natural or artificial opening endoscopic|
|0UDB7ZZ||Extraction of endometrium, via natural or artificial opening|
|0UDB8ZZ||Extraction of endometrium, via natural or artificial opening endoscopic|
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).
In 2012, ACOG reaffirmed their 2007 endometrial ablation recommendations which were based on good and consistent evidence and included the following:
A 2013 ACOG committee opinion for the management of acute abnormal uterine bleeding in nonpregnant reproductive-aged women stated:
Endometrial ablation, although readily available in most centers, should be considered only if other treatments have been ineffective or are contraindicated, and it should be performed only when a woman does not have plans for future childbearing and when the possibility of endometrial or uterine cancer has been reliably ruled out as the cause of the acute abnormal uterine bleeding.
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.
The 2007 National Institute for Health and Clinical Excellence (NICE) guidance on heavy menstrual bleeding includes the following recommendations for endometrial ablation:
Comparison of Treatments
Different methods of endometrial ablation have been compared in published randomized controlled trials (RCTs) and systematic reviews of RCTs. In 2012, Matteson and colleagues performed a systematic review of RCTs that compared the efficacy of hysterectomy with less invasive techniques for controlling abnormal uterine bleeding. A total of 9 trials were identified directly comparing hysterectomy with another intervention and reporting health outcomes; seven of these studies compared hysterectomy to endometrial ablation. The 7 studies included a total of 1167 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 1 study compared rates statistically, and this study found a significantly lower rate of pain at 2 to 3 years' follow-up in the group receiving hysterectomy. All seven trials reported additional treatments obtained by participants after the initial intervention. At 1 to 4 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.
A Cochrane review by 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.
Sambrook and colleagues (2014) reported 5-year outcomes of a prospective, double-blind randomized controlled trial in the United Kingdom comparing microwave endometrial ablation and thermal balloon endometrial ablation (Thermachoice). The study consisted of women with heavy menstrual bleeding who were premenstrual and had completed their families. A total of 217 of 314 women originally randomized (69.1%) responded to a written questionnaire at 5 years. The analysis was intention-to-treat, with non-responders classified as treatment failures. Menstrual outcomes did not differ significantly between groups at 5 years. The rate of amenorrhea was 51% in the microwave ablation group and 45% in the thermal ablation group. The proportion of women with light menstrual bleeding was 27% in the microwave ablation group and 33% in the thermal ablation group. There was no statistically significant difference in the number of women undergoing hysterectomy. Ten women (8.8%) in the microwave ablation group and 7 women (6.8%) in the thermal ablation group subsequently had a hysterectomy. The authors concluded that the long-term results achieved in both groups were comparable.
A small double blind, randomized controlled trial by Athanotos and colleagues (2015) compared the safety and efficacy of two second-generation endometrial ablation devices: the MEA and the Novasure impedance control system. A total of 66 women with dysfunctional uterine bleeding, unresponsive to prior therapy, were allocated at a 1:1 ratio to either bipolar radio-frequency ablation or MEA. The women were assessed at 3 and 12 months post ablative procedure, and the primary outcome measure was the rate of amenorrhea at 12 months post treatment. The authors reported that the rate of amenorrhea at 12-months post-ablation was significantly higher in women treated by Novasure (25/33; 75.8%) as compared to those treated by MEA (8/33; 24.2%).
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. A total of 66 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.
In 2014, Dood and colleagues investigated whether endometrial ablation carried an increased risk of endometrial cancer or delay in diagnosis as compared to medically managed abnormal uterine bleeding. Data were collected from a population-based cohort that included a total of 234,721 women with abnormal bleeding, 4776 of whom underwent endometrial ablation. The remaining 229,945 underwent medical management. During a median follow-up time of 4.07 years, 3 women with a history of endometrial ablation and 601 women who were treated medically developed endometrial cancer. There was not a statistically significant difference in endometrial cancer rates between groups (age-adjusted HR=0.61; 95% CI, 0.20 to 1.89; p=0.17). Additionally, the median time to endometrial cancer diagnosis, 237 days after ablation and 299 days with medical management, did not differ significantly between groups. The authors conclude their study finds that the comparative effectiveness of medical management and endometrial ablation for abnormal uterine bleeding is similar in regards to endometrial cancer outcomes.
Peer Reviewed Publications:
Government Agency, Medical Society, and Other Authoritative Publications:
Her Option Uterine Cryoablation Therapy System
Hydro ThermaAblator System
Laser Ablation of the Endometrium
Microwave Endometrial Ablation (MEA) system
Rollerball Ablation of the Endometrium
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.
|Reviewed||11/05/2015||Medical Policy & Technology Assessment Committee (MPTAC) review. Discussion and Reference sections updated. Removed ICD-9 codes from Coding section.|
|Reviewed||11/13/2014||MPTAC review. Discussion and Reference sections updated.|
|Reviewed||11/14/2013||MPTAC review. Discussion and Reference sections updated.|
|Reviewed||11/08/2012||MPTAC review. Discussion and Reference sections updated.|
|Reviewed||11/17/2011||MPTAC review. Coding, Discussion and Reference sections updated.|
|Reviewed||11/18/2010||MPTAC review. Description, Discussion, References, and Index updated.|
|Reviewed||11/19/2009||MPTAC review. Removed place of service. References updated.|
|Reviewed||11/20/2008||MPTAC review. References updated.|
|Reviewed||11/29/2007||MPTAC review. References updated.|
|Reviewed||12/07/2006||MPTAC review. References and discussion updated.|
|Revised||12/01/2005||MPTAC review. Revision based on Pre-merger Anthem and Pre-merger WellPoint Harmonization.|
|Pre-Merger Organizations||Last Review Date||Document Number||Title|
|WellPoint Health Networks, Inc.||06/24/2004||3.09.06||Endometrial Ablation|
|06/24/2004||Clinical Guideline||Endometrial Ablation|