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).
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.)
Cancer antigen 125 (CA 125) measurement for other conditions, including, but not limited to, the following is considered investigational:
To screen asymptomatic individuals for ovarian cancer
To differentiate diagnosis of individuals with symptoms of ovarian cancer
To differentiate diagnosis of pelvic masses
To determine the prognosis of individuals with ovarian cancer
Used without other diagnostic and/or treatment methods
Measurement of all other tumor markers for ovarian cancer is considered investigational.
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
Any specific products referenced in this policy are just examples and are intended for illustrative purposes only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available. These examples are contained in the parenthetical e.g. statement.
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.
There is a lack of high quality studies that support CA 125 measurement when used for screening for ovarian cancer, or the diagnosis of unknown pelvic or ovarian mass.
American College of Obstetricians and Gynecologists. (2017, September). Committee opinion #716: the role of the obstetrician-gynecologist in the early detection of epithelial ovarian cancer in women at average risk. Retrieved June 20, 2018 from http://www.acog.org.
Buys, S., Partridge, E., Black, A., Johnson, C., Camerato, L., Isaacs, C. et al. (2011). Effect of screening on ovarian cancer mortality. The prostate, lung, colorectal and ovarian (PLCO) cancer screening randomized controlled trial. Journal of American Medical Association, 305 (22), 2295-2303. (Level 1 evidence)
Centers for Medicare & Medicaid Services. CMS.gov. NCD for tumor antigen by immunoassay - CA 125 (190.28). Retrieved February 12, 2016 from https://www.cms.gov.
Giuliani, M., Gui, B., Valentini, A., Giovanni, S., Miccò, M., Rodolfino, E. (2017, June) Early detection of recurrence or progression disease in patients with ovarian cancer after primary debulking surgery: a diagnostic challenge still unresolved. Correlation between CT findings and CA 125 levels. Minerva Ginecologic. June . doi: 10.23736/S0026-4784.17.04062-X. Abstract retrieved July 7, 2017 from PubMed database.
National Comprehensive Cancer Network. (2018, March). NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines ®). Ovarian cancer including fallopian tube cancer and primary peritoneal cancer. version 2.2018 Retrieved June 20, 2018 from http://www.nccn.org.
National Institute for Health and Clinical Excellence. (2011, April). Ovarian cancer: the recognition and initial management of ovarian cancer. Retrieved May 30, 2012 from http://www.nice.org.uk.
Nguyen, A., Miller, E., Wichman, C., Berim, I., & Agrawal, D. (2015). Diagnostic value of tumor antigens in malignant pleural effusion: a meta-analysis. Translational Research: The Journal of Laboratory and Clinical Medicine, 166 (5), 432-439. Abstract retrieved February 12, 2016 from PubMed database.
Society of Gynecologic Oncologists. (2017, March). An update on post-treatment surveillance and diagnosis of recurrence in women with gynecologic malignancies: Society of Gynecologic Oncology (SGO) recommendations. Retrieved June 20, 2018 from https://www.sgo.org.
Sölètormos, G., Duffy, M., Hassan, S., Verheijen, R., Tholander, B., Bast, R., et al. (2016). Clinical use of cancer biomarkers in epithelial ovarian cancer. International Journal of Gynecological Cancer, 26 (1), 43-51. (Level 1 evidence)
U. S. Food and Drug Administration. (2009, April). Center for Devices and Radiological Health. P510(k) Premarket Notification Database. K080561. Retrieved June 1, 2012 from http://www.accessdata.fda.gov.
ORIGINAL EFFECTIVE DATE: 9/1998
MOST RECENT REVIEW DATE: 8/9/2018
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.
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