Tumor Antigen by Immunoassay - CA 125

CMS National Coverage Determination | ncd_id=130 | manual_section=190.28 | coverage_level_code=2 | national_coverage_type=True | under_review=True | lab_ncd=True

Indications 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 CA125 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 CA125 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. Limitations 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. (This NCD last reviewed November 2005) Note: Scroll down for links to the quarterly Covered Code Lists (including narrative).

Item/Service 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. Cross Reference: Also see the Medicare Claims Processing Manual , Chapter 120, Clinical Laboratory Services Based on Negotiated Rulemaking. Other Text: Covered Code Lists (including narrative) January 2026 (PDF) ( ICD-10 ) October 2025 (PDF) ( ICD-10 ) January 2025 (PDF) ( ICD-10 ) October 2024 (PDF) ( ICD-10 ) July 2024 (PDF) ( ICD-10 ) April 2024 (PDF) ( ICD-10 ) January 2024 (PDF) ( ICD-10 ) October 2023 (PDF) ( ICD-10 ) July 2023 (PDF) ( ICD-10 ) April 2023 (PDF) ( ICD-10 ) January 2023 (PDF) ( ICD-10 ) October 2022 (PDF) ( ICD-10 ) July 2022 (PDF) ( ICD-10 ) April 2022 (PDF) ( ICD-10 ) January 2022 (PDF) ( ICD-10 ) October 2021 (PDF) ( ICD-10 ) July 2021 (PDF) ( ICD-10 ) April 2021 (PDF) ( ICD-10 ) January 2021 (PDF) ( ICD-10 ) October 2020 (PDF) ( ICD-10 ) July 2020 (PDF) ( ICD-10 ) April 2020 (PDF) ( ICD-10 ) January 2020 (PDF) ( ICD-10 ) October 2019 (PDF) ( ICD-10 ) July 2019 (PDF) ( ICD-10 ) April 2019 (PDF) ( ICD-10 ) January 2019 (PDF) ( ICD-10 ) October 2018 (PDF) ( ICD-10 ) July 2018 (PDF) ( ICD-10 ) April 2018 (PDF) ( ICD-10 ) January 2018 ( ICD-10 ) October 2017 ( ICD-10 ) July 2017 ( ICD-10 ) April 2017 ( ICD-10 ) January 2017 ( ICD-10 ) October 2016 ( ICD-10 ) January 2016 ( ICD-10 ) October 2015 ( ICD-10 , ICD-9 ) October 2014 ( ICD-10 , ICD-9 ) Changes to Lab NCD Edit Software January 2026 October 2025 January 2025 October 2024 July 2024 January 2024 October 2023 April 2023 January 2023 October 2022 April 2022 January 2022 October 2021 July 2021 October 2020 April 2020 January 2020 October 2019 July 2019 January 2019 October 2018 April 2018 January 2018 July 2017 April 2017 January 2017 January 2016 October 2014 Revision History: 02/2006 - Changes to the Covered Indications for Tumor Antigen by Immunoassay CA 125 to Add Primary Peritoneal Carcinoma. Effective Date: 01/01/2006. Implementation Date: 01/03/2006. ( TN 47 ) (CR 4257) 07/2004 - Published NCD in the NCD Manual without change to narrative contained in PM AB-02-110. Coding guidance now published in Medicare Lab NCD Manual. Effective and Implementation dates NA. ( TN 17 ) (CR 2130) 07/2002 - Implemented NCD. Effective date 11/25/02. Implementation date 1/01/03. ( TN AB-02-110 ) (CR 2130) Benefit Categories: 18 - Diagnostic Laboratory Tests Transmittal: transmittal_number=47 | transmittal_issue_date=2006-02-24 | change_request_number=4257