Clinical Policy Title: Leiomyosarcoma and Laparoscopic Power Morcellation

Clinical Policy Title: Leiomyosarcoma and Laparoscopic Power Morcellation Clinical Policy Number: 12.03.01 Effective Date: January 1, 2015 Initial Review Date: August 20, 2014 Most Recent Review Date: August 19, 2015 Next Review Date: August 2016 Policy contains: Power morcellation. Leiomyosarcoma. Hysterectomy. Uterine fibroids. ABOUT THIS POLICY: AmeriHealth Caritas Pennsylvania has developed clinical policies to assist with making coverage determinations. AmeriHealth Caritas Pennsylvania clinical policies are based on guidelines from established industry sources, such as the Centers for Medicare & Medicaid Services (CMS), state regulatory agencies, the American Medical Association (AMA), medical specialty professional societies, and peerreviewed professional literature. These clinical policies along with other sources, such as plan benefits and state and federal laws and regulatory requirements, including any state- or plan-specific definition of medically necessary, and the specific facts of the particular situation are considered by AmeriHealth Caritas Pennsylvania when making coverage determinations. In the event of conflict between this clinical policy and plan benefits and/or state or federal laws and/or regulatory requirements, the plan benefits and/or state and federal laws and/or regulatory requirements shall control. AmeriHealth Caritas Pennsylvania clinical policies are for informational purposes only and not intended as medical advice or to direct treatment. Physicians and other health care providers are solely responsible for the treatment decisions for their patients. AmeriHealth Caritas Pennsylvania clinical policies are reflective of evidence-based medicine at the time of review. As medical science evolves, AmeriHealth Caritas Pennsylvania will update its clinical policies as necessary. AmeriHealth Caritas Pennsylvania clinical policies are not guarantees of payment. Coverage policy AmeriHealth Caritas Pennsylvania considers the use of laparoscopic power morcellation to be investigational and, therefore, not medically necessary. Limitations: None. NOTE: The following CPT code is not included in the Pennsylvania Medicaid fee schedule: C1782 - Morcellator Alternative covered services Surgical hysterectomy and myomectomy. Laparoscopic hysterectomy and myomectomy without morcellation. Laparotomy using a smaller incision (minilaparotomy). Deliberate blocking of the uterine artery (catheter-based uterine artery embolization). 1

High-intensity focused ultrasound. Drug therapy. Background Uterine sarcomas are a rare form of uterine cancer, accounting for 3 percent to 5 percent of all uterine cancers diagnosed in the US. They arise in the myometrium or connective tissue of the uterus. Uterine sarcomas are highly aggressive, with five-year overall survival rates ranging between 17 percent and 55 percent. Leomyosarcomas are a rare form of soft tissue cancer that is often dormant, but often fatal after diagnosis. They can be found in multiple sites, often in the uterus and gastrointestinal system. Laparoscopic power morcellation is a minimally invasive technique used to treat uterine fibroids, compared to removing the uterus or removing uterine fibroids. Morcellation devices generally cut tissue into smaller fragments to facilitate removal of tissue through small incisions. Recent clinical information suggests laparoscopic power morcellation poses a risk of spreading unsuspected cancerous tissue such as uterine sarcomas to travel beyond the uterus. On April 17, 2014, the U.S. Food and Drug Administration (FDA) withdrew approval of laparoscopic power morcellators because of this risk of spreading cancer. Although many women develop uterine fibroids in their lifetime, most cause no symptoms. Some cases result in heavy or prolonged menstrual bleeding, pelvic pressure or pain, or frequent urination. It is estimated that one in 350 women undergoing hysterectomy or myomectomy for the treatment of fibroids is found to have an unsuspected uterine sarcoma, a type of uterine cancer that includes leiomyosarcoma. Since no reliable method exists to predict whether a woman s uterine fibroid may have sarcoma, and with the risk of spreading possible cancerous tissue within the abdomen and pelvis, laparoscopic power morcellation is discouraged by the FDA. On July 30, 2014, a morcellation device manufacturer instituted a recall on all its morcellation devices, citing uncertainty in the risk-benefit assessment associated with the use of power morcellators. Methods Searches: AmeriHealth Caritas Pennsylvania searched PubMed and the databases of: UK National Health Services Centre for Reviews and Dissemination. Agency for Healthcare Research and Quality s National Guideline Clearinghouse and other evidencebased practice centers. The Centers for Medicare & Medicaid Services (CMS). We conducted searches on August 11, 2015. Search terms were: Leiomyosarcoma, morcellation and uterine fibroids. Systematic reviews, which pool results from multiple studies to achieve larger sample sizes and greater precision of effect estimation than in smaller primary studies. Systematic reviews use predetermined transparent methods to minimize bias, effectively treating the review as a scientific endeavor, and are thus rated highest in evidence-grading hierarchies. Guidelines based on systematic reviews. 2

Economic analyses, such as cost-effectiveness, and benefit or utility studies (but not simple cost studies), reporting both costs and outcomes sometimes referred to as efficiency studies which also rank near the top of evidence hierarchies. Findings Although many women develop uterine fibroids in their lifetime, most cause no symptoms. Some cases result in heavy or prolonged menstrual bleeding, pelvic pressure or pain, or frequent urination. It is estimated that 1 in 350 women undergoing hysterectomy or myomectomy for the treatment of fibroids is found to have an unsuspected uterine sarcoma, a type of uterine cancer that includes leiomyosarcoma. Recent clinical information suggests laparoscopic power morcellation poses a risk of spreading unsuspected cancerous tissue such as uterine sarcomas to travel beyond the uterus. On April 17, 2014, the U.S. Food and Drug Administration (FDA) withdrew approval of laparoscopic power morcellators because of this risk of spreading cancer. On July 30, 2014, a morcellation device manufacturer instituted a recall on all its morcellation devices, citing uncertainty in the risk-benefit assessment associated with the use of power morcellators. Subsequent analyses showed that power morcellation used on women with uterine fibroids who had undetected tumors was associated with an increased risk of the tumor spreading throughout the abdomen, and increased risk of subsequent death. Because uterine sarcomas are often difficult to detect pre-operatively, reviews concluded that uterine morcellation is contraindicated in women with fibroids and suspected cancer; abdominal hysterectomy should be performed instead. More research is needed in understanding the risk and deciding when morcellation is indicated. Summary of clinical evidence: Citation Felix (2013) Shibley (2014) Content, Methods, Recommendations Key points: Etiology of Uterine Sarcomas Significant risk factors for uterine sarcoma included obesity and history of diabetes. Older age at menarche was inversely associated with uterine sarcoma risk. BMI was significantly, but less strongly related to uterine sarcomas compared with EECs or MMMTs. Key points: Safety Techniques Regarding Morcellation Inflation of a morcellation bag creates an artificial pneumoperitoneum, possibly creating a safe environment for the morcellation procedures. Glossary Medically necessary A service or benefit is medically necessary if it is compensable under the Medicaid program and if it meets any one of the following standards: The service or benefit will, or is reasonably expected to, prevent the onset of an illness, condition or disability. 3

The service or benefit will, or is reasonably expected to, reduce or ameliorate the physical, mental or developmental effects of an illness, condition, injury or disability. The service or benefit will assist the member in achieving or maintaining maximum functional capacity in performing daily activities, taking into account both the functional capacity of the member and those functional capacities that are appropriate for members of the same age. Uterine fibroids Noncancerous growths that develop from the muscular tissue of the uterus. References Professional society guidelines/others: Ethicon, Inc. Medical device market withdrawal: morcellation devices including generators and disposables. July 30, 2014. United States Food and Drug Administration. Laparoscopic Uterine Power Morcellation in Hysterectomy and Myomectomy: FDA Safety Communication. April 17, 2014. Peer-reviewed references: Bognani G, Cliby WA, Aletti, GD. Impact of morcellation on survival outcomes of patients with unexpected uterine leiomyosarcoma: a systematic review and meta-analysis. Gynecol Oncol. 2015;137(1):167-72. 1 Felix AS, Cook LS, Gaudet MM, et al. The etiology of uterine sarcomas: a pooled analysis of the epidemiology of endometrial cancer consortium. Br J Cancer. 2013: 108:727 734. Graebe K, Garcia-Soto A, Aziz M, et al. Incidental power morcellation of malignancy: a retrospective cohort study. Gynecol Oncol. 2015;136(2):274-7. Hayes, Inc. Hayes Medical Technology Report. Unsuspected Uterine Cancer in Women Undergoing Hysterectomy with Power Morcellation. Lansdale, PA: Hayes, Inc.; July, 2014. Shibley T, Nezhat CH, Taylor B. Safety techniques regarding morcellation. International Medical News Group. June 2014: p.14. Singh SS, Scott S, Bougie O, et al. Technical update on tissue morcellation during gynaecologic surgery: its uses, complications, and risks of unsuspected malignancy. J Obstet Gynaecol Can. 2015;37(1):68-81. Wright JD, Tergas AI, Burke WM, et al. Uterine Pathology in Women Undergoing Minimally Invasive Hysterectomy Using Morcellation. JAMA. Published online July 22, 2014. doi:10.1001/jama.2014.9005. Clinical trials: 4

Searched clinicaltrials.gov on August 11, 2015, using the terms Leiomyosarcoma, morcellation and uterine fibroids. Intracorporeal Versus Extracorporeal Morcellation: Clinical Efficacy and Safety Outcomes (IEME). NCT02086435. A Modified Technique for Laparoscopic Subtotal Hysterectomy NCT 02328274 CMS National Coverage Determinations (NCDs): There is no national coverage determination related to this policy. Local Coverage Determinations (LCDs): There are no local coverage determinations related to this policy. Commonly submitted codes: Below are the most commonly submitted codes for the service(s)/item(s) subject to this policy. This is not an exhaustive list of codes. Providers are expected to consult the appropriate coding manuals and bill accordingly. CPT Code Description Comment 58541 Laparoscopy, surgical, supracervical hysterectomy, for uterus 250 g for less 58542 58543 58544 Laparoscopy, surgical, supracervical hysterectomy, for uterus 250 g for less; with removal of tube(s) and/or ovary(s) Laparoscopy, surgical, supracervical hysterectomy, for uterus greater than 250 grams Laparoscopy, surgical, supracervical hysterectomy, for uterus greater than 250 grams;; with removal of tube(s) and/or ovary(s 58545 Laparoscopy, surgical, myomectomy, excision; 1 to 4 intramural myomas 58546 Laparoscopy, surgical, myomectomy, excision; 5 or more intramural myomas ICD-9 Code Description Comment 179 Malignant neoplasm, sarcoma, uterus 171.9 Leiomyosarcoma, uterus 218.9 Uterine Fibroid ICD-10 Code Description Comment C49.9 Malignant neoplasm of connective and soft tissue, unspecified C55 Malignant neoplasm of uterus, part unspecified D25.0 Submucous leiomyoma of uterus D25.1 Intramural leiomyoma of uterus D25.2 Subserosal leiomyoma of uterus D25.9 Leiomyoma of uterus, unspecified 5

HCPCS Level II C1782 Morcellator Description Comment 6