DESCRIPTION
Tumor marker antigens can be detected in higher-than-normal amounts in the blood, urine, or body tissues of some individuals with certain types of cancer. A tumor marker may be produced by a tumor itself or by the body's response to the presence of cancer. A variety of substances, including enzymes, hormones, antigens, and proteins may be called tumor markers.
The use of tumor markers to diagnose cancer is limited at this time. Researchers are seeking markers that are specific to a particular type of cancer and detect the presence of cancer before symptoms appear.
Cancer antigen 125 (CA-125) is a high-molecular-weight protein antigen that is commonly elevated in individuals with known ovarian cancer. A rising CA-125 may be the initial sign of recurrent disease. Levels of CA-125 may also be elevated in nonmalignant conditions (e.g., pregnancy, endometriosis, pelvic inflammatory disease, benign ovarian masses) without any identifiable cause.
POLICY
Cancer antigen 125 (CA-125) measurement for detection of ovarian cancer is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Measurement of all other tumor markers for ovarian cancer is considered investigational.
MEDICAL APPROPRIATENESS
Cancer antigen 125 (CA-125) measurement is considered medically appropriate for ALL of the following:
Used as a key decision-making tool to avoid the risks of second-look surgery for an individual with suspected recurrent ovarian cancer
Used for monitoring response to treatment of ovarian cancer when used for the purpose of guiding an individual's management
ABSENCE of ALL of the following:
Used to screen asymptomatic women for ovarian cancer
Used to differentiate diagnosis of individuals with symptoms of ovarian disease
Used to differentiate diagnosis of pelvic masses
Used to determine the prognosis in individuals with ovarian cancer
Used without other diagnostic and/or treatment methods
IMPORTANT REMINDER
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.
ADDITIONAL INFORMATION
There is no published evidence that any screening test, including CA-125, ultrasound, or pelvic examination, reduces mortality from ovarian cancer.
According to the National Cancer Institute, potential screening tests for ovarian cancer include transvaginal ultrasound and the serum cancer antigen (CA) 125 assay. Several biomarkers with potential application to ovarian cancer screening are under development but have not been validated or evaluated for efficacy in early detection and mortality reduction.
SOURCES
Agency for Healthcare Research & Quality. (2004). Screening for ovarian cancer: Brief evidence update. Retrieved July 25, 2006 from http://www.ahrq.gov/clinic/3rduspstf/ovariancan/ovcanup.pdf.
American Cancer Society. (2006, May). Detailed guide: Ovarian cancer. Can ovarian cancer be found early? Retrieved July 25, 2006 from http://www.cancer.org/docroot/CRI/content/CRI_2_4_3X_Can_ovarian_cancer_be_found_early_33.asp?sitearea=CRI&viewmode=print&.
BlueCross BlueShield Association. Medical Policy Reference Manual. (1:2005). CA-125 (2.04.27). Retrieved July 30, 2009 from BlueWeb.
Clarke-Pearson, D. (2009). Screening for ovarian cancer. New England Journal of Medicine, 361 (2), 170-177. (Level of Evidence 5)
Complete Guide to Medicare Coverage Issues [Computer software]. (2009, July). Tumor Antigen by Immunoassay CA 125 (NCD 190.28, p. 2-141, 2-143). The Complete Guide to Medicare Coverage Issues.
Costa, F.P., Junior, E.B., Zelmanowicz, A., Svedman, C., Devenz, G., Alves, S. et al. (2009). Prostasin, A potential tumor marker in ovarian cancer- a pilot study. Clinics (Sao Paulo), 64 (7), 641-644. (Level of Evidence: 4)
Dann, R.B., Kelly, J.L., & Zorn, K.K. (2007). Strategies for ovarian cancer prevention. Obstetric and Gynecology Clinics of North America, 34 (4), 667-686. (Level of Evidence 5)
Hayes. Medical Technology Directory. (2009, March). CA 125 for ovarian cancer screening in average-risk women. Retrieved July 30, 2009 from Hayesinc.com/subscribers. (61 articles and/or guidelines reviewed)
National Cancer Institute. (2009, July). Ovarian cancer: Screening. Retrieved August 10, 2009 from http://www.cancer.gov/cancertopics/pdq/screening/ovarian/healthprofessional/allpages.
National Guideline Clearinghouse. (2004, May). Screening for ovarian cancer: Recommendation statement. Retrieved July 25, 2006 from http://www.guidelines.gov/summary/summary.aspx?doc_id=4857&nbr=003498&string=CA-125.
National Guideline Clearinghouse. (2005). Ovarian cancer screening. Retrieved July 25, 2006 from http://www.guidelines.gov/summary/summary.aspx?doc_id=8319&nbr=004651&string=CA-125.
U. S. Food and Drug Administration. (2006, July). Center for Devices and Radiological Health. Product Classification Database. Retrieved July 28, 2006 from http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?ID=2459.
U.S. Preventive Task Force. (2004). Screening for ovarian cancer: recommendation statement. Annals of Family Practice, 2 (3), 260- 262.
Urban, N., McIntosh, M. W., Anderson, M., & Karlan, B. Y. (2003). Ovarian cancer screening. Hematology/ Oncology Clinic of North America, 17 (4), 980-1005.
ORIGINAL EFFECTIVE DATE: 9/1998
MOST RECENT REVIEW DATE: 11/12/2009
ID_BT
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
This document has been classified as public information.