Breast Cancer Tumor Markers
DESCRIPTION
Tumor markers are substances that are elevated in blood, urine, or body tissues of some individuals with certain types of cancer. The marker may be expressed by the tumor itself, or by the body in response to the presence of the tumor. It can also be expressed in certain benign conditions. Measurement of tumor markers is commonly used to monitor and detect disease recurrence and / or progression of disease. Radioimmunoassay and immunohistochemical determination of the serum levels of certain carbo-proteins has been developed as markers for various cancers. However, normal cells in low amounts express these chemicals.
POLICY
The use of CA 27.29 and CA 15.3 tumor markers as adjuncts in the follow-up and management of metastatic breast cancer when elevated levels of these markers would change the treatment option is considered medically necessary.
The use of CA 27.29 and CA 15.3 tumor markers as a screening tool when symptoms are not present is considered investigational.
Breast cancer tumor marker screening for diagnosis, monitoring, or prognosis determination is considered investigational for the following:
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CA 125 and TPA tumor marker screening of asymptomatic individuals for breast cancer and for monitoring response to treatment of breast cancer is considered not medically necessary.
CA 125 and TPA tumor marker screening, as an adjunct in the follow-up and management of individuals with metastatic breast cancer who have elevated levels, is considered not medically necessary.
ADDITIONAL INFORMATION
No controlled studies were found in the published literature that validate the application of CA 27.29 and CA 15.3 tumor markers as a screening tool when symptoms are not present, or breast cancer tumor marker screening for diagnosis, monitoring or prognosis determination for those listed within the policy statement as investigational.
SOURCES
American Cancer Society. (2007, November). Tumor markers. Retrieved January 5, 2010 from http://www.cancer.org/docroot/PED/content/PED_2_3X_Tumor_Markers.asp?sitearea=PED&viewmode=print&.
American Society of Clinical Oncologists. (2007). Breast cancer tumor markers. Retrieved January 5, 2010 from http://www.asco.org/ASCO/Downloads/Cancer%20Policy%20and%20Clinical%20Affairs/Clinical%20Affairs%20(derivative%20products)/Breast%20TM%20Recs%20by%20tumor%20type%20%202.pdf.
BlueCross BlueShield Association. Medical Policy Reference Manual. (3:2007). Serum tumor markers for breast and gastrointestinal malignancies (2.03.02). Retrieved January 4, 2010 from BlueWeb. (26 articles and/or guidelines reviewed)
Cen, P., Duvic, M., Cohen, P. R., & Kurzrock, R. (2008). Increased cancer antigen 27.29 (CA27.29) level in patients with mycosis fungoides. Journal of the American Academy of Dermatology, 58 (3), 382-386. (Level 4 Evidence - Independent study)
Complete Guide to Medicare Coverage Issues [Computer software]. (2009, July). Tumor antigen by immunoassay CA 125 (NCD 190.28, p. 2-138). The Ingenix Complete Guide to Medicare Coverage Issues.
Complete Guide to Medicare Coverage Issues [Computer software]. (2009, July). Tumor antigen by immunoassay CA 15-3/CA 27.29 (NCD 190.29, p. 2-140). The Ingenix Complete Guide to Medicare Coverage Issues.
Complete Guide to Medicare Coverage Issues [Computer software]. (2009, July). Tumor antigen by immunoassay CA 19-9 (NCD 190.30, p. 2-142). The Ingenix Complete Guide to Medicare Coverage Issues.
Duffy, M.J. (2006). Serum tumor markers in breast cancer: are they of clinical value? Clinical Chemistry, 52 (3), 345-351.
Henry, N. L., & Hayes, D. F. (2006). Uses and abuses of tumor markers in the diagnosis, monitoring, and treatment of primary and metastatic breast cancer. The Oncologist, 11 (6), 541-542.
Khatcheressian, J. L., Wolff, A. C., Smith. T. J., Grunfeld, E., Muss, H. B., Vogel, V. G., et al. (2006). American Society of Clinical Oncology 2006 update of the breast cancer follow-up and management guidelines in the adjuvant setting. Journal of Clinical Oncology, 24 (31), 5091-5097.
National Guideline Clearinghouse. (2007, October). American Society of Clinical Oncology 2007 update recommendations for the use of tumor markers in breast cancer. Retrieved April 17, 2008 from http://www.guidelines.gov.
U. S. Food and Drug Administration. (2007, July). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K071675. Retrieved January 5, 2010 from http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=25126.
ORIGINAL EFFECTIVE DATE: 9/1998
MOST RECENT REVIEW DATE: 3/11/2010
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.