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April 2024
January 2024

CMS Transmittals

National Coverage Determination
Procedure Code: 8XXXX
Tumor Antigen by Immunoassay CA 125
CMS Policy Number: 190.28
Back to NCD List

Description: Immunoassay determinations of the serum levels of certain proteins or carbohydrates serve as tumor markers. When elevated, serum concentration of these markers may reflect tumor size and grade.

This policy specifically addresses tumor antigen CA 125.

CA 125 is a high molecular weight serum tumor marker elevated in 80% of patients who present with epithelial ovarian carcinoma. It is also elevated in carcinomas of the fallopian tube, endometrium, and endocervix. An elevated level may also be associated with the presence of a malignant mesothelioma or primary peritoneal carcinoma.

A CA 125 level may be obtained as part of the initial pre-operative work-up for women presenting with a suspicious pelvic mass to be used as a baseline for purposes of post- operative monitoring. Initial declines in CA 125 after initial surgery and/or chemotherapy for ovarian carcinoma are also measured by obtaining three serum levels during the first month post treatment to determine the patient’s CA 125 half-life, which has significant prognostic implications.

The CA 125 levels are again obtained at the completion of chemotherapy as an index of residual disease. Surveillance CA 125 measurements are generally obtained every 3 months for 2 years, every 6 months for the next 3 years, and yearly thereafter. CA 125 levels are also an important indicator of a patient’s response to therapy in the presence of advanced or recurrent disease. In this setting, CA 125 levels may be obtained prior to each treatment cycle.

These services are not covered for the evaluation of patients with signs or symptoms suggestive of malignancy. The service may be ordered at times necessary to assess either the presence of recurrent disease or the patient’s response to treatment with subsequent treatment cycles.

The CA 125 is specifically not covered for aiding in the differential diagnosis of patients with a pelvic mass as the sensitivity and specificity of the test is not sufficient. In general, a single “tumor marker” will suffice in following a patient with one of these malignancies.

Documentation Requirements: Indicated if service request for CA125 is requested more frequently than stipulated.

To review all requirements of this policy, please see: CMS NCD listing by Chapter

Covered ICD-10 Codes.

C45.1Mesothelioma of peritoneum
C48.1Malignant neoplasm of specified parts of peritoneum
C48.2Malignant neoplasm of peritoneum, unspecified
C48.8Malig neoplasm of ovrlp sites of retroperiton and peritoneum
C51.8Malignant neoplasm of overlapping sites of vulva
C53.0Malignant neoplasm of endocervix
C54.1Malignant neoplasm of endometrium
C54.2Malignant neoplasm of myometrium
C54.3Malignant neoplasm of fundus uteri
C54.9Malignant neoplasm of corpus uteri, unspecified
.... and many more.

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