Last Review Date: May 12, 2017 Number: MG.MM.SU.06bC2v2 Medical Guideline Disclaimer Property of EmblemHealth. All rights reserved. The treating physician or primary care provider must submit to EmblemHealth the clinical evidence that the patient meets the criteria for the treatment or surgical procedure. Without this documentation and information, EmblemHealth will not be able to properly review the request for prior authorization. The clinical review criteria expressed below reflects how EmblemHealth determines whether certain services or supplies are medically necessary. EmblemHealth established the clinical review criteria based upon a review of currently available clinical information (including clinical outcome studies in the peer-reviewed published medical literature, regulatory status of the technology, evidence-based guidelines of public health and health research agencies, evidence-based guidelines and positions of leading national health professional organizations, views of physicians practicing in relevant clinical areas, and other relevant factors). EmblemHealth expressly reserves the right to revise these conclusions as clinical information changes, and welcomes further relevant information. Each benefit program defines which services are covered. The conclusion that a particular service or supply is medically necessary does not constitute a representation or warranty that this service or supply is covered and/or paid for by EmblemHealth, as some programs exclude coverage for services or supplies that EmblemHealth considers medically necessary. If there is a discrepancy between this guideline and a member's benefits program, the benefits program will govern. In addition, coverage may be mandated by applicable legal requirements of a state, the Federal Government or the Centers for Medicare & Medicaid Services (CMS) for Medicare and Medicaid members. All coding and web site links are accurate at time of publication. EmblemHealth Services Company LLC, ( EmblemHealth ) has adopted the herein policy in providing management, administrative and other services to HIP Health Plan of New York, HIP Insurance Company of New York, Group Health Incorporated and GHI HMO Select, related to health benefit plans offered by these entities. All of the aforementioned entities are affiliated companies under common control of EmblemHealth Inc. Definitions Adhesions Endometriosis Fibroids (aka leiomyomata) Hysterectomy Scarring that binds together the surfaces of tissues A condition in which tissue that lines the uterus is found outside of the uterus, usually on the ovaries, fallopian tubes and other pelvic structures Benign growths that form in the muscle of the uterus Classification: Total removal of entire uterus and cervix Supracervical (aka subtotal or partial) removal of uterus only Radical total hysterectomy that also includes removal of structures around the uterus Oophorectomy Salpingectomy Power morcellators Surgical procedure modalities: Abdominal incisional approach (abdominal hysterectomy) Vaginal approach (vaginal hysterectomy); preferred procedure when only removal of the uterus is necessary Laparoscopic approach (laparoscopic hysterectomy) Removal of one or both ovaries Removal of one or both fallopian tubes Salpingo-oophorectomy is commonly performed, in conjunction with a hysterectomy, for these indications when the criteria in the Guideline section are met: Endometriosis Chronic pelvic inflammatory disease Cancer surgery Medical devices used during different types of laparoscopic surgeries (i.e., myomectomy to treat uterine fibroids or hysterectomy). Morcellation refers to the division of tissue into smaller pieces or fragments in
Page 2 of 10 order to facilitate the removal of tissue through small incision sites. (See Limitations/Exclusions for FDA safety warning and EmblemHealth coverage position) Guideline Members are eligible for hysterectomy when one or more of the following criteria are met: 1. Premalignant or malignant disease of uterus, ovaries or fallopian tubes; either: A. Malignancy Tissue diagnosis demonstrating malignancy Hydatidiform molar disease, if invasive B. Atypical endometrial hyperplasia; both: Tissue diagnosis only in post-menopausal women Tissue diagnosis in premenopausal women who have completed child bearing 2. Premalignant and malignant conditions of the uterine cervix for severe dysplasia and carcinoma in situ (CIN III); all: A. Diagnostic biopsy by cone or colposcopy B. Treatment by conization, or LEEP/loop/LLETZ or laser ablation C. Presence of CIN III, as demonstrated by repeat biopsy > 3 months post treatment 3. Fibroids; 1: A. Presence of submucosal fibroids (not resectable by hysteroscopy) with abnormal bleeding B. Symptomatic fibroids (e.g., bladder pressure with urinary frequency, abnormal bleeding, chronic lower abdominal/ low back pressure/pain/discomfort, etc.) C. Rapid progressive enlargement (doubled from prior year) Note: Less invasive uterus-preserving alternatives may be preferable to hysterectomy (e.g., uterine artery embolization, myomectomy, etc.)
Page 3 of 10 4. Uterine bleeding, persistent, premenopausal; all: A. Interference with work/lifestyle and/or hematocrit <27 and/or Hgb < 9 B. Repetitive periods lasting > 8 days; profuse bleeding with flooding or clots C. Normal TSH D. Conservative management failure; all: Iron therapy 3 months 3 consecutive cycles of progestins/oral contraceptives Hysteroscopy/hysterosonogram with endometrial curettage in prior 18 months Note: A trial of endometrial ablation should be considered prior to hysterectomy for this indication 5. Uterine bleeding, persistent, premenopausal; all: A. Interference with work/lifestyle (related to vaginal bleeding) and/or hematocrit <27 and/or Hgb <9 B. Repetitive periods lasting > 8 days; profuse bleeding with flooding or clots C. Normal TSH reflecting normal thyroid function D. Conservative management failure; all: Iron therapy >3 months for iron deficiency anemia, if present 3 consecutive cycles of progestins/oral contraceptives Hysteroscopy/ hysterosonogram with endometrial curettage in last 18 months Note: A trial of endometrial ablation should be considered prior to hysterectomy for this indication 6. Uterine bleeding, persistent, post-menopausal; both: A. Hysteroscopy/hysterosonogram with endometrial curettage within prior 18 months B. Change in, or discontinuation of, hormone replacement therapy 7. Emergency indications; any: A. Uncontrolled sepsis of pelvic origin B. Obstetrical catastrophes (e.g., uncontrollable postpartum bleeding, uterine rupture, uncontrolled sepsis secondary to septic abortion) C. Severe non-obstetric hemorrhage leading to hemodynamic compromise not otherwise controlled by conservative means
Page 4 of 10 8. Pelvic relaxation associated with cystourethrocele, rectocele, and enterocele or second/third degree uterine prolapse; all: A. Documented presence of 2nd/3d degree prolapse on physical exam and at least 2: Pain, persistent or dyspareunia, not controlled by acceptable doses of non-prescription medication Persistent pelvic pressure symptoms Stress incontinence related to the prolapse Documented presence of ulceration with bleeding/spotting on physical exam 9. Chronic pelvic pain 1: A. Chronic pelvic pain clearly attributable to uterine pathology and present >6 months; B. Adenomyosis inadequately responsive to NSAID use for control of discomfort; C. Disabling dyspareunia due to a surgically remediable condition; e.g., severe chronic cervicitis or uterine prolapse; D. Chronic pelvic inflammatory disease (PID) Acute PID > 2 episodes, and > 1 episode of infection as evidenced by positive culture; or Laparoscopic findings of adhesions with scarring sufficient to cause symptoms and/or hydrosalpinx E. Endometriosis: requires documentation of the diagnosis by laparoscopy (usually treated by hysterectomy with BSO) if persistent pain despite the following: Therapeutic laparoscopy, or Surgical ablation/excision of endometrial tissue. Medical management: - GnRH agonist > 6 months, or - Depot medroxyprogesterone/oral contraceptives > 9 months, or - Danazol > 6 months. 10. Complex constellation of pelvic disease, e.g.; A. Non-malignant disease of the tubes and ovaries without primary uterine involvement (except that uterus is removed due to proximal location to diseased adnexa or appendages such as in chronic advanced tubal infections (refer to PID) or extensive endometriosis unresponsive/inadequately responsive to medical therapy B. Complex pathology (multiple disease) C. In conjunction with vaginal repair with presence of persistent symptoms (e.g., pelvic pain or urinary incontinence), refractory to conservative measures. Note: EmblemHealth covers removal of the uterus in primarily non-gynecologic pelvic surgery where necessary to encompass disease originating elsewhere, as in uterine involvement in colon cancer or in abscess secondary to diverticulitis.
Page 5 of 10 Limitations/Exclusions EmblemHealth does not consider the use of power morcellators (CPT 58558, 58561) to be medically necessary when there is suspected or known uterine cancer or during hysterectomy or myomectomy for fibroid treatment. Requests for prior approval or post-service reimbursement of morcellators will be case-by-case reviewed with the expectation that documentation clearly substantiating the clinical rationale for coverage accompanies the request. Per the FDA Recommended Labeling Statement: Laparoscopic power morcellators are contraindicated in gynecologic surgery in which the tissue to be morcellated is known or suspected to contain malignancy. Laparoscopic power morcellators are contraindicated for removal of uterine tissue containing suspected fibroids in patients who are peri- or post-menopausal, or are candidates for en bloc tissue removal, for example through the vagina or via a mini-laparotomy incision. Applicable Procedure Codes (See also codes not covered when used with power morcellators) 58150 Total abdominal hysterectomy (corpus and cervix), with or without removal of tube(s), with or without removal of ovary(s); 58152 Total abdominal hysterectomy (corpus and cervix), with or without removal of tube(s), with or without removal of ovary(s); with colpo-urethrocystopexy (eg, Marshall-Marchetti-Krantz, Burch 58180 Supracervical abdominal hysterectomy (subtotal hysterectomy), with or without removal of tube(s), with or without removal of ovary(s) 58200 Total abdominal hysterectomy, including partial vaginectomy, with para-aortic and pelvic lymph node sampling, with or without removal of tube(s), with or without removal of ovary(s) 58210 Radical abdominal hysterectomy, with bilateral total pelvic lymphadenectomy and para-aortic lymph node sampling (biopsy), with or without removal of tube(s), with or without removal of ovary(s) 58240 Pelvic exenteration for gynecologic malignancy, with total abdominal hysterectomy or cervicectomy, with or without removal of tube(s), with or without removal of ovary(s), with removal of bladder and ureteral transplantations, and/or abdominoperineal resection of rectum and colon and colostomy, or any combination thereof 58260 Vaginal hysterectomy, for uterus 250 g or less; 58262 Vaginal hysterectomy, for uterus 250 g or less; with removal of tube(s), and/or ovary(s) 58263 Vaginal hysterectomy, for uterus 250 g or less; with removal of tube(s), and/or ovary(s), with repair of enterocele 58267 Vaginal hysterectomy, for uterus 250 g or less; with colpo-urethrocystopexy (Marshall-Marchetti- Krantz type, Pereyra type) with or without endoscopic control 58270 Vaginal hysterectomy, for uterus 250 g or less; with repair of enterocele 58275 Vaginal hysterectomy, with total or partial vaginectomy; 58280 Vaginal hysterectomy, with total or partial vaginectomy; with repair of enterocele 58285 Vaginal hysterectomy, radical (Schauta type operation) 58290 Vaginal hysterectomy, for uterus greater than 250 g;
Page 6 of 10 58291 Vaginal hysterectomy, for uterus greater than 250 g; with removal of tube(s) and/or ovary(s 58292 Vaginal hysterectomy, for uterus greater than 250 g; with removal of tube(s) and/or ovary(s), with repair of enterocele Codes Not Covered When Used with Power Morcellators 58541 58548 Laparoscopy, surgical, supracervical hysterectomy 58550 58554 Laparoscopy, surgical, with vaginal hysterectomy 58558 Hysteroscopy, surgical; with sampling (biopsy) of endometrium and/or polypectomy 58561 Hysteroscopy, surgical; with removal of leiomyomata 58570-58575 Laparoscopy, surgical, with total hysterectomy 58578 Unlisted laparoscopy procedure, uterus 58679 Unlisted laparoscopy procedure C1782 Morcellator Applicable ICD-10 Diagnosis Codes A02.1 Salmonella sepsis A22.7 Anthrax sepsis A26.7 Erysipelothrix sepsis A32.7 Listerial sepsis A40.0 Sepsis due to streptococcus, group A A40.1 Sepsis due to streptococcus, group B A40.3 Sepsis due to Streptococcus pneumoniae A40.8 Other streptococcal sepsis A40.9 Streptococcal sepsis, unspecified A41.01 Sepsis due to Methicillin susceptible Staphylococcus aureus A41.02 Sepsis due to Methicillin resistant Staphylococcus aureus A41.1 Sepsis due to other specified staphylococcus A41.2 Sepsis due to unspecified staphylococcus A41.3 Sepsis due to Hemophilus influenzae A41.4 Sepsis due to anaerobes A41.50 Gram-negative sepsis, unspecified A41.51 Sepsis due to Escherichia coli [E. coli] A41.52 Sepsis due to Pseudomonas A41.53 Sepsis due to Serratia A41.59 Other Gram-negative sepsis A41.81 Sepsis due to Enterococcus A41.89 Other specified sepsis A41.9 Sepsis, unspecified organism A42.7 Actinomycotic sepsis A54.86 Gonococcal sepsis A56.11 Chlamydial female pelvic inflammatory disease
Page 7 of 10 B37.7 Candidal sepsis C53.0 Malignant neoplasm of endocervix C53.1 Malignant neoplasm of exocervix C53.8 Malignant neoplasm of overlapping sites of cervix uteri C53.9 Malignant neoplasm of cervix uteri, unspecified C54.0 Malignant neoplasm of isthmus uteri C54.1 Malignant neoplasm of endometrium C54.2 Malignant neoplasm of myometrium C54.3 Malignant neoplasm of fundus uteri C54.8 Malignant neoplasm of overlapping sites of corpus uteri C54.9 Malignant neoplasm of corpus uteri, unspecified C55 Malignant neoplasm of uterus, part unspecified C56.1 Malignant neoplasm of right ovary C56.2 Malignant neoplasm of left ovary C56.9 Malignant neoplasm of unspecified ovary C57.00 Malignant neoplasm of unspecified fallopian tube C57.01 Malignant neoplasm of right fallopian tube C57.02 Malignant neoplasm of left fallopian tube C57.10 Malignant neoplasm of unspecified broad ligament C57.11 Malignant neoplasm of right broad ligament C57.12 Malignant neoplasm of left broad ligament C57.20 Malignant neoplasm of unspecified round ligament C57.21 Malignant neoplasm of right round ligament C57.22 Malignant neoplasm of left round ligament C57.3 Malignant neoplasm of parametrium C57.4 Malignant neoplasm of uterine adnexa, unspecified C57.7 Malignant neoplasm of other specified female genital organs C57.8 Malignant neoplasm of overlapping sites of female genital organs C57.9 Malignant neoplasm of female genital organ, unspecified C79.60 Secondary malignant neoplasm of unspecified ovary C79.61 Secondary malignant neoplasm of right ovary C79.62 Secondary malignant neoplasm of left ovary C79.82 Secondary malignant neoplasm of genital organs D06.0 Carcinoma in situ of endocervix D06.1 Carcinoma in situ of exocervix D06.7 Carcinoma in situ of other parts of cervix D06.9 Carcinoma in situ of cervix, unspecified D07.0 Carcinoma in situ of endometrium D07.30 Carcinoma in situ of unspecified female genital organs D07.39 Carcinoma in situ of other female genital organs D25.0 Submucous leiomyoma of uterus D25.1 Intramural leiomyoma of uterus D25.2 Subserosal leiomyoma of uterus D25.9 Leiomyoma of uterus, unspecified
Page 8 of 10 D39.0 Neoplasm of uncertain behavior of uterus D39.10 Neoplasm of uncertain behavior of unspecified ovary D39.11 Neoplasm of uncertain behavior of right ovary D39.12 Neoplasm of uncertain behavior of left ovary D39.2 Neoplasm of uncertain behavior of placenta D39.8 Neoplasm of uncertain behavior of other specified female genital organs D39.9 Neoplasm of uncertain behavior of female genital organ, unspecified D49.59 Neoplasm of unspecified behavior of other genitourinary organ (Eff. 10/01/2016) D50.0 Iron deficiency anemia secondary to blood loss (chronic) N70.11 Chronic salpingitis N70.12 Chronic oophoritis N70.13 Chronic salpingitis and oophoritis N70.91 Salpingitis, unspecified N70.92 Oophoritis, unspecified N70.93 Salpingitis and oophoritis, unspecified N73.1 Chronic parametritis and pelvic cellulitis N73.2 Unspecified parametritis and pelvic cellulitis N73.5 Female pelvic peritonitis, unspecified N73.6 Female pelvic peritoneal adhesions (postinfective) N73.8 Other specified female pelvic inflammatory diseases N73.9 Female pelvic inflammatory disease, unspecified N74 Female pelvic inflammatory disorders in diseases classified elsewhere N80.0 Endometriosis of uterus N80.1 Endometriosis of ovary N80.2 Endometriosis of fallopian tube N80.3 Endometriosis of pelvic peritoneum N80.4 Endometriosis of rectovaginal septum and vagina N80.5 Endometriosis of intestine N80.6 Endometriosis in cutaneous scar N80.8 Other endometriosis N80.9 Endometriosis, unspecified N81.0 Urethrocele N81.10 Cystocele, unspecified N81.11 Cystocele, midline N81.12 Cystocele, lateral N81.2 Incomplete uterovaginal prolapse N81.3 Complete uterovaginal prolapse N81.4 Uterovaginal prolapse, unspecified N81.5 Vaginal enterocele N81.6 Rectocele N81.81 Perineocele N81.82 Incompetence or weakening of pubocervical tissue N81.83 Incompetence or weakening of rectovaginal tissue N81.84 Pelvic muscle wasting
Page 9 of 10 N81.85 Cervical stump prolapse N81.89 Other female genital prolapse N81.9 Female genital prolapse, unspecified N84.0 Polyp of corpus uteri N84.8 Polyp of other parts of female genital tract N84.9 Polyp of female genital tract, unspecified N85.02 Endometrial intraepithelial neoplasia [EIN] N85.8 Other specified noninflammatory disorders of uterus N87.0 Mild cervical dysplasia N87.1 Moderate cervical dysplasia N87.9 Dysplasia of cervix uteri, unspecified N89.7 Hematocolpos 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 N94.89 Other specified conditions associated with female genital organs and menstrual cycle N95.0 Postmenopausal bleeding N99.3 Prolapse of vaginal vault after hysterectomy O01.0 Classical hydatidiform mole O01.1 Incomplete and partial hydatidiform mole O01.9 Hydatidiform mole, unspecified O71.00 Rupture of uterus before onset of labor, unspecified trimester O71.02 Rupture of uterus before onset of labor, second trimester O71.03 Rupture of uterus before onset of labor, third trimester O71.1 Rupture of uterus during labor O72.0 Third-stage hemorrhage O72.1 Other immediate postpartum hemorrhage O72.2 Delayed and secondary postpartum hemorrhage O72.3 Postpartum coagulation defects R10.2 Pelvic and perineal pain R65.20 Severe sepsis without septic shock R65.21 Severe sepsis with septic shock References Advancing Minimally Invasive Gynecology Worldwide (AAGL). Morcellation During Uterine Tissue Extraction. May 2014. http://www.aagl.org/wp-content/uploads/2014/05/tissue_extraction_tfr.pdf. Accessed May 15, 2017. American College of Obstetricians and Gynecologists (ACOG). FAQ008. Hysterectomy. 2011. Available at: http://www.acog.org/~/media/for%20patients/faq008.pdf. Accessed May 15, 2017. Centers for Devices and Radiological Health (CDRH). Recommended Labeling Statements Excerpted from: Immediately in Effect Guidance Document: Product Labeling for Laparoscopic Power Morcellators: Guidance for Industry and Food and Drug Administration Staff. November 2014. http://www.fda.gov/downloads/medicaldevices/safety/alertsandnotices/ucm424444.pdf. Accessed May 15, 2017.
Page 10 of 10 Falcone T, Walters MD. Hysterectomy for benign disease. Obstet Gynecol. 2008 Mar;111(3):753-67. Gendy R, Walsh CA, Walsh SR, Karantanis E. Vaginal hysterectomy versus total laparoscopic hysterectomy for benign disease: a meta-analysis of randomized controlled trials. Am J Obstet Gynecol. 2011 May;204(5):388.e1-8. Johnson N, Barlow D, Lethaby A, et al. Methods of hysterectomy: systematic review and meta-analysis of randomised controlled trials. BMJ. 2005 Jun 25;330(7506):1478. Kovac SR. Guidelines to determine the route of hysterectomy. Obstet Gynecol. 1995 Jan;85(1):18-23. Kovac SR. Route of hysterectomy: an evidence-based approach. Clin Obstet Gynecol. 2014 Mar;57(1):58-71. Nieboer TE, Johnson N, Lethaby A, et al. Surgical approach to hysterectomy for benign gynaecological disease. Cochrane Database Syst Rev. 2009 Jul 8;(3):CD003677. Specialty Matched Clinical Peer Review. Walsh CA, Walsh SR, Tang TY, Slack M. Total abdominal hysterectomy versus total laparoscopic hysterectomy for benign disease: a meta-analysis. Eur J Obstet Gynecol Reprod Biol. 2009 May;144(1):3-7.