NCD190.28

 

TUMOR ANTIGEN BY IMMUNOASSAY - CA 125

 

Effective Date of this Version

1/3/2006

 

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

• Immunoassay determinations of the serum levels of certain proteins or carbohydrates serve as tumor markers.

o When elevated, serum concentration of these markers may reflect tumor size and grade.

• This policy specifically addresses tumor antigen CA 125.

 

Indications and Limitations of Coverage

 

Indications

• CA 125 is a high molecular weight serum tumor marker elevated in 80% of patients who present with epithelial ovarian carcinoma.

o It is also elevated in carcinomas of the fallopian tube, endometrium, and endocervix.

o 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.

o 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.

o Surveillance CA125 measurements are generally obtained every 3 months for 2 years, every 6 months for the next 3 years and yearly thereafter.

o CA 125 levels are also an important indicator of a patient's response to therapy in the presence of advanced or recurrent disease.

o 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.

o 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.

o 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).

 

Cross Reference

• Also see the Medicare Claims Processing Manual, Chapter 120, Clinical Laboratory Services Based on Negotiated Rulemaking.

 

Coverage Transmittal Link

• http://www.cms.gov/transmittals/downloads/R47NCD.pdf

 

Other

Covered Code Lists (including narrative)

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National Coverage Analyses (NCAs)

• This NCD has been or is currently being reviewed under the National Coverage Determination process. The following are existing associations with NCAs, from the National Coverage Analyses database.

• First reconsideration for Tumor Antigen by Immunoassay CA 125 (Addition of Primary Peritoneal Adenocarcinoma as a Covered Indication) (CAG-00290R)

 

Coding Analyses for Labs (CALs)

• This NCD has been or is currently being reviewed under the National Coverage Determination process.

• The following are existing associations with CALs, from the Coding Analyses for Labs database.

• Original consideration for Tumor Antigen by Immunoassay CA 125 (Modification of Code List to Include ICD-9-CM Codes for Suspicious Ovarian Mass) (CAG-00284N)

• Original consideration for Tumor Antigen by Immunoassay CA 19-9 (Modification of Code List to Include ICD-9-CM Code 156.2, Malignant neoplasm of Ampulla of Vater) (CAG-00275N)

• Original consideration for Tumor Antigen Immunoassay CA 125 (Revision to Include Additional Personal History of Malignancy Codes) (CAG-00245N)

 

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