Tumor Antigen by Immunoassay - CA 15-3/CA 27.29

CMS National Coverage Determination | ncd_id=134 | manual_section=190.29 | coverage_level_code=2 | national_coverage_type=True | under_review=False | lab_ncd=True

Indications Multiple tumor markers are available for monitoring the response of certain malignancies to therapy and assessing whether residual tumor exists post-surgical therapy. CA 15-3 is often medically necessary to aid in the management of patients with breast cancer. Serial testing must be used in conjunction with other clinical methods for monitoring breast cancer. For monitoring, if medically necessary, use consistently either CA 15-3 or CA 27.29, not both. CA 27.29 is equivalent to CA 15-3 in its usage in management of patients with breast cancer. 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. 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 the following tumor antigens: CA 15-3 and CA 27.29 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: 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=17 | transmittal_issue_date=2004-07-02 | change_request_number=2130