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Corporate Medical Policy Cancer Antigen 125 (CA-125) Testing File name: Cancer Antigen 125 (CA-125A) Testing Origination: 02/2011 Last Review: N/A Next Review: 02/2012 Effective Date: 07/01/2011 Description Ovarian cancer is a malignancy of the ovaries that tends to elude early diagnosis. Most women with this malignancy seek medical attention late in the disease course, at which point the five year survival is only 15% to 20%. However, if diagnosed early, the five-year survival rate can be as high as 90%. Therefore, researchers have tried to develop various means of screening the general population for ovarian cancer to improve long-term survival. CA-125 is a high molecular-weight protein antigen that is commonly elevated in patients with known ovarian cancer. CA-125 may also be elevated in other gynecologic malignancies, such as endometrial cancer, although the association is not as consistent as that with ovarian cancer. CA125 has been widely used as a technique to monitor patients with known ovarian cancer or other gynecologic malignancies that are associated with elevated levels of CA-125 in individual patients. Frequently, a rising CA-125 will be the initial sign of recurrent disease. Policy Medically Necessary: CA-125 testing may be medically necessary under the following circumstances: • • • • Patients with symptoms suggestive of ovarian cancer Patients with known ovarian cancer. Individual patients with other malignancies, such as endometrial cancer, in whom baseline levels of CA-125 have been shown to be elevated. As a screening test for ovarian cancer when there is a history of hereditary cancer syndrome (a pattern of clusters of ovarian cancer within two or more generations) Investigational and Not Medically Necessary: Measurement of CA-125 is considered experimental/investigational in asymptomatic patients as a screening technique for ovarian cancer. 1 When service or procedure is covered Women known to be at high risk for ovarian cancer are often screened regularly using a combination of the CA-125 test, transvaginal ultrasound and a rectal/pelvic examination. It should never be used as an isolated test. These include: • • • • • As a preoperative diagnostic aid in women with ovarian masses that are suspected to be malignant, such that arrangements can be made for intraoperative availability of a gynecological oncologist if the CA 125 is increased; or As a screening test for ovarian cancer when there is a history of hereditary cancer syndrome (a pattern of clusters of ovarian cancer within two or more generations); or Diagnosis of ovarian cancer in women with new symptoms (bloating, pelvic or abdominal pain, difficulty eating or feeling full quickly, or urinary frequency and urgency) that have persisted for three or more weeks, where the clinician has performed a pelvic and rectal examination and suspects ovarian cancer; or In members with adenocarcinoma of unknown primary, to rule out ovarian cancer; or In members with known ovarian cancer, as an aid in the monitoring of disease, response to treatment, detection of recurrent disease, or assessing value of performing second-look surgery. Benefit Application Benefits are subject to all terms, limitations and conditions of the subscriber contract. For New England Health Plan (NEHP) members an approved referral authorization is required. Federal Employee Program (FEP) members may have different benefits that apply. For further information please contact FEP customer service. When service or procedure may not be covered CA-125 as a Screening Tool for Ovarian Cancer Currently, there is no definitive evidence that ovarian cancer screening of the general public using serum CA-125 measurements decreases mortality of the screened group. To date, the published reports utilizing CA-125 with or without other modalities do not demonstrate a high enough sensitivity to justify its use in low-risk, asymptomatic women. Billing and Coding/Physician Documentation Information See Attachment I 2 Eligible Providers Allopathic Physicians (M.D.) Osteopathic Physicians (D.O.) Policy Implementation/Update information New Policy 02/2011 Scientific Background and Reference Resources Buys, Saundra S., MD, et al., “Ovarian cancer screening in the Prostate, Lung, Colorectal and Ovarian (PLCO) cancer screening trial: Findings from the initial screen of a randomized trial.” American Journal of Obstetrics and Gynecology,” Volume 193, pp. 1630-9, 2005). · Centers for Medicare & Medicaid Services (CMS), Medicare Coverage Database, “NCD for Tumor Antigen by Immunoassay-CA-125,” Manual Section Number 190.28, Original effective date 11/25/02, current effective date 1/1/06, < http://www.cms.hhs.gov/pf/printpage.asp?ref=http://www.cms.hhs.gov/mcd/viewncd.asp?nc d_id=190.28&ncd_version=2&basket=ncd%3A190%2E28%3A2%3ATumor+Antigen+by+Im munoassay+%2D+CA+125 >, (accessed 3/4/09). · Goonewardene, Tyronne, MRCP, et al., “Management of asymptomatic patients on follow up for ovarian cancer with rising CA-125 concentrations,” The Lancet Oncology,” Volume 8, Issue 9, September 2007, pp. 813-821. · Graham, Lisa, “ACOG Releases Guidelines on Management of Adnexal Masses,” American Family Physician,” Volume 77, Number 9, May 1, 2008, pp. 1320-1323. · HAYES Medical Technology Directory, “CA-125 for Ovarian Cancer Screening in AverageRisk Women," Lansdale, PA: HAYES, Inc., February 22, 2005. · Hayes Update Search, “Ca 125 for Ovarian Cancer Screening in Average-Risk Women, Lansdale, PA: Hayes, Inc. February 21, 2008. · Kurman, Robert J., MD, et al., “Early detection and treatment of ovarian cancer: shifting from early stage to minimal volume of disease based on a new model of carcinogenesis,” American Journal of Obstetrics and Gynecology (Reviews), April 2008, pp. 351-356. · Mironov, Svetlana, MD, et al., “Ovarian Cancer,” Radiologic Clinics of North America, Volume 45, Number 1, January 2007. · Nossov, Vladimir, MD, et al., “The early detection of ovarian cancer: from traditional methods to proteomics. Can we really do better than serum CA-125?” American Journal of Obstetrics and Gynecology, Volume 199, Issue 3, September 2008, pp, 215-223. · Pavelka, James C., MD, et al., “Hereditary Ovarian Cancer-Assessing Risk and Prevention Strategies,” Obstet Gynecol Clin N Am, Volume 34, 2007, pp. 651–665. · Sevinc, Alper, et al., “Benign causes of increased serum CA-125 concentration,” The Lancet Oncology, Volume 8, Issue 12, December 2007, pp. 1054-1055. · U.S. Preventive Services Task Force, “Screening for Ovarian Cancer: Recommendation Statement,” American Family Physician, Volume 71, Number 4, February 15, 2005. · van Nagell, Jr., J. R., MD, and P. D. DePriest, MD, “Management of adnexal masses in postmenopausal women,” American Journal of Obstetrics and Gynecology, Volume 193, 2005, pp.30–5. Approved by BCBSVT Medical Director Date Approved Antonietta Sculimbrene, MD Chair, Medical Policy Committee 3 Attachment I CPT 86304 ICD-9 158.0 158.8 158.9 180.0 182.0 182.1 182.8 183.0-183.9 184.8 198.6 198.82 199.0 236.0-236.3 338.3 789.30-789.39 795.82 795.89 V10.43-V10.44 V16.41 V71.1 V76.46 Description Immunoassay for tumor antigen, quantitative; CA 125 Malignant neoplasm of retroperitoneum Malignant neoplasm of specified parts of perito Malignant neoplasm of peritoneum, unspecified Malignant neoplasm of endocervix Malignant neoplasm of corpus uteri, except isthmus Malignant neoplasm of isthmus Malignant neoplasm of other specified sites of body of uterus Malignant neoplasm of other specified sites of female genital organs Secondary malignant neoplasm of ovary Secondary malignant neoplasm of genital organs Disseminated malignant neoplasm Disseminated malignant neoplasm Elevated cancer antigen CA 125 Other abnormal tumor markers Family history of malignant neoplasm, ovary Observation for suspected malignant neoplasm Special screening for malignant neoplasms, ovaries 4