Sunflower Health Plan Endomatrial Ablation (PDF) Form

This policy describes the medical necessity guidelines for an endometrial ablation. Endometrial ablation is a minimally invasive surgical procedure used to treat premenopausal abnormal uterine bleeding.2,12,21 Although this procedure preserves the uterus, endometrial ablation is indicated for those who have no desire for future fertility.11 The two major classifications of endometrial ablation procedures are first generation resectoscopic techniques and second generation non- resectoscopic methods. Quality of life resulting from reduced bleeding and amenorrhea may improve following endometrial ablation procedures. Note: For criteria applicable to Medicare plans, please see MC.CP.MP.106 Endometrial Ablation. Policy/Criteria I. It is the policy of non-Medicare health plans affiliated with Centene Corporation® that endometrial ablation using an FDA approved device is medically necessary when all the following criteria are met: A. One of the following indications: 1. Menorrhagia unresponsive to at least three months of hormonal or medical therapy (unless contraindicated to such therapy);25 2. Abnormal uterine bleeding, including residual menstrual bleeding after at least six months of androgen therapy in a member/enrollee with a female reproductive system undergoing treatment for gender affirmation;23 B. Cervical cytology or human papillomavirus (HPV) testing and gynecological exam excludes significant cervical disease;25 C. Endometrial sampling prior to the procedure has excluded malignancy or hyperplasia;25 D. No structural anomalies, such as fibroids or polyps that require transmural surgery or represent a contraindication to an ablation procedure; E. If anatomic or pathologic conditions exist that may result in a weakened myometrium, only a resectoscopic endometrial ablation is appropriate;81 F. Thyroid disorders have been treated or ruled out; G. Does not have any of the following contraindications: 1. Premenopausal with future desire for fertility; 2. Untreated disorders of hemostasis;81 3. Pregnancy at time of procedure; 4. Intrauterine device at time of procedure; 5. Active pelvic infection; II. It is the policy of non-Medicare health plans affiliated with Centene Corporation that there is insufficient scientific evidence to support effectiveness for the following: A. Photodynamic endometrial ablation procedures; Page 1 of 8 CLINICAL POLICY Endometrial Ablation B. Endometrial ablation for the treatment of all other conditions than those specified above. Background Menstrual disorders are among the most prevalent gynecological health problems in the United States, and abnormal menstrual bleeding affects up to 30% of people at some time during their reproductive years.4 Traditionally, medication therapy has been the initial treatment of choice, followed by hysterectomy, when medication does not provide the desired outcome. The levonorgestrel-releasing intrauterine device (e.g., Mirena or Liletta; referred to as LNG 52 mg IUD) is an option in patients who do not desire pregnancy. Both the LNG 52 mg IUD and endometrial ablation are effective in reducing menstrual blood loss. The decision to use the LNG 52 mg IUD or endometrial ablation depends on a patient’s preferences regarding treatment factors, such as plans for fertility and contraception, convenience, and risks of anesthesia.21,24,29 Endometrial ablation can offer an alternative to the more invasive hysterectomy treatment option.9 Endometrial ablation can also be used to treat residual menstrual bleeding in transgender men.23 Generally, masculinizing hormones cause cessation of menses within two to six months of initiation. The addition of a progestational agent or endometrial ablation may be considered for those wishing to completely cease menses.17 Endometrial ablation encompasses several techniques of targeted destruction of the endothelial surface of the uterine cavity through a vast array of energy sources. While hysterectomies provide permanent relief from abnormal uterine bleeding, they are associated with longer recovery times, higher rates of postoperative complications, substantial convalescent time and morbidity.8,9 Although endometrial ablation has a high success rate, there are specific cases of endometrial ablation failures in which the patient will return for repeat care, often for a hysterectomy.9 The effectiveness of endometrial ablation was demonstrated in a report of 26 patients who underwent ablation. After one year, 25 of the 26 patients reported reduced bleeding with no further medical or surgical interventions; one patient required a hysterectomy due to persistent uterine bleeding related to a leiomyoma.30 Among patients who return for hysterectomy after failure of endometrial ablation, adenomyosis, leiomyomata and endometriosis are the most common contributing diagnoses.20,31 Pregnancy following endometrial ablation can occur, and premenopausal patients should be counseled that an appropriate contraception method should be used. Endometrial ablation is predominately indicated for patients who have no desire for future fertility.20 Post-operative complications from endometrial ablation include: (1) pregnancy after endometrial ablation; (2) pain-related to obstructed menses (hematometra, post ablation tubal sterilization syndrome); (3) failure to control menses; (4) risk from preexisting conditions (endometrial neoplasia, cesarean section; and (5) infection.13,21 Uterine perforation has been reported in 0.3 percent of non- resectoscopic endometrial ablation procedures and 1.3 percent of resectoscopic ablations or resections.21 Table 1: FDA-Approved Techniques Approved For Endometrial Ablation Page 2 of 8 CLINICAL POLICY Endometrial Ablation Procedure1,2,3 System1,2,13 Device Size1 (mm) Treatment Time1, 13(min) Amenorrhea Rate2 Resectoscopic Ablation Laser Vaporization Electrosurgical Rollerball Transcervical resection of endometrium Radiofrequency Vaporization Non-Resectoscopic Ablation Cryotherapy Heated Free Fluid Vapor ablation Radiofrequency Electricity Combined thermal and bipolar radiofrequency ablation device 37% 25 to 60% 26 to 40% N/A Cerene Hydro ThermAblator Mara NovaSure 4.5 7.8 7.2 10 to 8 approx. 14* 2.0 1.5 53% 71% 41% Minerva 2.0 * Three minutes to heat the fluid to 90°C, 10 minutes to maintain that temperature to ablate the endometrium, and approximately one minute for the fluid to cool down allowing the device to be removed. Coding Implications This clinical policy references Current Procedural Terminology (CPT®). CPT® is a registered trademark of the American Medical Association. All CPT codes and descriptions are copyrighted 2020 American Medical Association. All rights reserved. CPT codes and CPT descriptions are from the current manuals and those included herein are not intended to be all-inclusive and are included for informational purposes only. Inclusion or exclusion of any codes does not guarantee coverage. Providers should reference the most up-to-date sources of professional coding guidance prior to the submission of claims for reimbursement of covered services. CPT® Codes 58353 58356 58563 Endometrial ablation, thermal, without hysteroscopic guidance Endometrial cryoablation with ultrasonic guidance, including endometrial curettage, when performed Hysteroscopy, surgical; with endometrial ablation (eg, endometrial resection, electrosurgical ablation, thermoablation) ICD-10-CM Diagnosis Codes that Support Coverage Criteria ICD-10-CM Code N92.0 N92.1 N92.4 N92.5 N92.6 N93.8 N93.9 Excessive and frequent menstruation with regular cycle Excessive and frequent menstruation with irregular cycle Excessive bleeding in the premenopausal period Other specified irregular menstruation Irregular menstruation, unspecified Other specified abnormal uterine and vaginal bleeding Abnormal uterine and vaginal bleeding, unspecified Page 3 of 8 CLINICAL POLICY Endometrial Ablation Reviews, Revisions, and Approvals Policy developed, reviewed by specialist Added “previous transmyometrial uterine surgery” in I.D. References reviewed and updated. Added additional FDA approved devices (i.e., Mara, Minerva) to table 1. References reviewed and updated. Specialist review. Added “abnormal uterine bleeding” as an indication and combined this with the residual menstrual bleeding after androgen therapy in a female to male transgender person indication. Removed reference to criteria in CP.MP.95 Gender Affirming Procedures. Added the following codes as medically necessary: N92.5, N92.6, N93.8, N93.9. References reviewed and updated. Annual review completed. References reviewed and updated and reformatted for AMA style. Changed “members” to “members/enrollees.” Removed “experimental and investigation” from II, changing to “insufficient evidence.” Changed “review date” in the header to “date of last revision” and “date” in the revision log header to “revision date.” Specialty review completed. Added ThermaChoice to Table 1 per UpToDate reference “3”. Annual review completed. Added “or HPV testing” to I.B. References reviewed and updated. Background updated with no impact to criteria. Changed criteria I.D. from “no structural anomalies, such as fibroids or polyps that require surgery or represent a contraindication to an ablation procedure, or previous transmyometrial uterine surgery (including classical cesarean)” to “no structural anomalies, such as fibroids or polyps that require transmural surgery or represent a contraindication to an ablation procedure.” Added contraindication criteria I.F.6. “Previous classical cesarean or other transmural surgery.” In I.A.2, reworded portion pertaining to abnormal bleeding in transgender members from “female to male transgender person” to “member/enrollee with a female reproductive system undergoing treatment for gender affirmation.” Annual review completed. Added requirement in I.F. that thyroid disorders have been treated or ruled out. Removed contraindication “previous classic cesarean or other transmural surgery” from I.G. Background and Table 1 updated. Minor rewording with no clinical significance. References reviewed and updated. Internal specialist reviewed. Added note to policy to refer to MC.CP.MP.106 for Medicare criteria. Added “non-Medicare” to health plans in Policy/Criteria I. and II. Revision Date 12/15 06/18 Approval Date 01/16 07/18 06/19 07/19 10/19 11/19 07/20 07/21 07/20 07/21 03/22 03/22 04/22 04/22 09/22 03/23 03/23 08/23