Download (CA-125) Testing File name: Cancer Antigen 125 (CA

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:
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•
•
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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.
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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:
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•
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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
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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
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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
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