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National Coverage Determination (NCD) for Alpha-fetoprotein (190.25)

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Benefit Category
Diagnostic Laboratory Tests

Note: This may not be an exhaustive list of all applicable Medicare benefit categories for this item or service.

Item/Service Description

AFP is a polysaccharide found in some carcinomas. It is effective as a biochemical marker for monitoring the response of certain malignancies to therapy.

Indications and Limitations of Coverage

AFP is useful for the diagnosis of hepatocellular arcinoma in high-risk patients (such as alcoholic cirrhosis, cirrhosis of viral etiology, hemochromatosis, and alpha 1-antitrypsin deficiency) and in separating patients with benign hepatocellular neoplasms or metastases from those with hepatocellular carcinoma and, as a non-specific tumor associated antigen, serves in marking germ cell neoplasms of the testis, ovary, retro peritoneum, and mediastinum.

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Cross Reference
Also see the Medicare Claims Processing Manual, Chapter 120, Clinical Laboratory Services Based on Negotiated Rulemaking.
Transmittal Number


Revision History

07/2002 - Implemented NCD. Effective date 11/25/02.  Implementation date 1/01/03. (TN AB-02-110) (CR 2130)

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)