(Medicare National Coverage Determinations Manual)

Limitations   This test is not appropriate for patients on digitoxin or treated with digoxin FAB (fragment antigen binding) antibody.  190.25 - Alpha-fetoprotein  (Rev. 17, Issued: 07- 02-04) (Effective/Implementation: Not Applicable) PM AB -02-110  Alpha -fetoprotein (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   The AFP is useful for the diagnosis of hepatocellular carcinoma in high- risk patients (such a s 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, retroperitoneum, and mediastinum.   190.26 - Carcinoembryonic Antigen  (Rev. 17, Issued: 07- 02-04) (Effective/Implementation: Not Applicable) PM AB -02-110  Carcinoembryonic antigen (CEA) is a protein polysaccharide found in some carcinomas.  It is effective as a biochemical marker for monitoring the response of certain malignancies to therapy.   Indications   The CEA may be medically necessary for follow -up of patients with colorectal carcinoma.  It would however only be medically necessary at treatment decision- making points.  In some clinical situations (e.g., adenocarcinoma of the lung, small cell carcinoma of the lung, and some gastrointestinal carcinomas) w hen a more specific marker is not expressed by the tumor, CEA may be a medically necessary alternative marker for monitoring.  Preoperative CEA may also be helpful in determining the post -operative adequacy of surgical resection and subsequent medical management.  In general, a single tumor marker will suffice in following patients with colorectal carcinoma or other malignancies that express such tumor markers.   In following patients who have had treatment for colorectal carcinoma, ASCO guideline suggests t hat if resection of liver metastasis would be indicated, it is recommended that post-operative CEA testing be performed every two to three months in patients with initial stage II or stage III disease for at least two years after diagnosis.   For patients w ith metastatic solid tumors, which express CEA, CEA may be measured at the start of the treatment and with subsequent treatment cycles to assess the tumors response to therapy.   Limitations   Serum CEA determinations are generally not indicated more freque ntly than once per chemotherapy treatment cycle for patients with metastatic solid tumors which express CEA or every two months post -surgical treatment for patients who have had colorectal carcinoma.  However, it may be proper to order the test more freque ntly in certain situation, for example, when there has been a significant change from prior CEA level or a significant change in patient status which could reflect disease progression or recurrence.   Testing with a diagnosis of an in situ carcinoma is not reasonably done more frequently than once, unless the result is abnormal, in which case the test may be repeated once.   190.27 - Human Chorionic Gonadotropin  (Rev. 17, Issued: 07- 02-04) (Effective/Implementation: Not Applicable) PM AB -02-110  Human Chorionic Gonadotropin (hCG) is useful for monitoring and diagnosis of germ cell neoplasms of the ovary, testis, mediastinum, retroperitoneum, and central nervous system.  In addition, hCG is useful for monitoring pregnant patients with vaginal bleeding, hypertension and/or suspected fetal loss.  It is not reasonable and necessary to perform hCG testing more than once per month for diagnostic purposes.  It may be performed as needed for monitoring of patient progress and treatment.  Qualitative hCG assays are not appropriate for medically managing patients with known or suspected germ cell neoplasms.  190.28 - Tumor Antigen by Immunoassay - CA 125 (Rev. 47, Issued: 02- 24-06, Effective: 01 -01-06, Implementation: 01- 03-06)  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.  Indications   The CA 125 is a high molecular weight serum tumor marker elevated in 80 percent 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 pr esence 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 patients CA 125 half -life, whic h 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 patients 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.   Limitat ions  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 patients response to treatment wi th 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 suff ice in following a patient with one of these malignancies.   (This NCD last reviewed November 2005)   190.29 - Tumor Antigen by Immunoassay CA 15 -3/CA 27.29  (Rev. 17, Issued: 07- 02-04) (Effective/Implementation: Not Applicable) PM AB -02-110  Immunoassay dete rminations 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  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 necessary, use consistently either CA 15- 3 or CA 27.29, not both.  CA 27.29 is equivalent t o 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 time necessary to assess either  the presence of recurrent disease or the patients response to treatment with subsequent treatment cycles.   190.30 - Tumor Antigen by Immunoassay CA 19 -9 (Rev. 17, Issued: 07- 02-04) (Effective/Implementation: Not Applicable) PM AB -02-110  Immunoassay dete rminations 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 antigen:  CA 19- 9.  Indications   Multiple tumor markers are available for monitoring the response of certain malignancies to therapy and assessing whether residual tumor exists post -surgical therapy.   Levels are useful in following the course of patients with established diagnosis of pancreatic and biliary ductal carcinoma.  The test is not indicated for diagnosing these two diseases.   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 patients response to treatment with subsequent treatment cycles.   190.31 - Prostate Specific Antigen  (Rev. 17, Issued: 07- 02-04) (Effective/Implementation: Not Applicable) PM AB -02-110  Prostate Specific Antigen (PSA), a tumor marker for adenocarcinoma of the prostate, can predict residual tumor in the post -operative phase of prostate cancer.  Three to six months after radical prostatectomy, PSA is reported to provide a sensitive indicator of persistent disease.  Six months following introduction of antiandrogen therapy, PSA is reported as capable of distinguishing patients with favorable response form those in whom limited response is anticipated.   The PSA when used in conjunction with ot her prostate cancer tests, such as digital rectal examination, may assist in the decision making process for diagnosing prostate cancer, PSA also, serves as a marker in following the progress of most prostate tumors once a diagnosis has been established.  This test is also an aid in the management of prostate cancer patients and in detecting metastatic or persistent disease in patients following treatment.   Indications   The PSA is of proven value in differentiating benign from malignant disease in men with lower urinary tract signs and symptoms (e.g., hematuria, slow urine stream, hesitancy, urgency, frequency, nocturia and incontinence) as well as with patients with palpably abnormal prostate glands on physician exam, and in patients with other laboratory or imaging studies that suggest the possibility of a malignant prostate disorder.  PSA is also a marker used to follow the progress of prostate cancer once a diagnosis has been established, such as in detecting metastatic or persistent disease in patients w ho may require additional treatment.  PSA testing may also be useful in the differential diagnosis of men presenting with as yet undiagnosed disseminated metastatic disease.   Limitations   Generally, for patients with lower urinary tract signs or symptoms, the test is performed only once per year unless there is a change in the patients medical condition.   Testing with a diagnosis of in situ carcinoma is not reasonably done more frequently than once, unless the result is abnormal, in which case the test may be repeated once.   190.32 - Gamma Glutamyl Transferase  (Rev. 17, Issued: 07- 02-04) (Effective/Implementation: Not Applicable) PM AB -02-110  Gamma glutamyltransferase (GGT) is an intracellular enzyme that appears in blood following leakage from cells.  Renal tubules, liver, and pancreas contain high amounts, although the measurement of GGT serum is almost always used for assessment of hepatobiliary function.  Unlike other enzymes, which are found in heart, skeletal muscle, and intestinal mucosa as well as l iver, the appearance of an elevated level of GGT is serum is almost always the result of liver disease or injury.  It is specifically useful to differentiate elevated alkaline phosphatase level when the source of the alkaline phosphatase increase (bone, li ver, or placenta) is unclear.  The combination of high alkaline phosphatase and a normal GGT does not, however, rule out liver disease completely.   As well as being a very specific marker of hepatobiliary function, GGT is also a very sensitive marker for h epatocellular damage.  Abnormal concentrations typically appear before elevations of other liver enzymes or bilirubin are evident.  Obstruction of the biliary tract, viral infection (e.g., hepatitis, mononucleosis), metastatic cancer, exposure to hepatotoxins (e.g., organic cimetidine, barbiturates, phenytoin, and carbamazepine) all can cause a moderate to marked increase in GGT serum concentration.  In addition, some drugs can cause or exacerbate liver dysfunction (e.g., atorvastatin, troglitazone, and others as noted in FDA Contraindications and Warning.)   The GGT is useful for diagnosis of liver disease or injury, exclusion of hepatobiliary involvement related to other disease, and patient management during the resolution of existing disease or following injury.  Indications   1. To provide information about known or suspected hepatobiliary disease, for example:   a. Following chronic alcohol or drug ingestion  b. Following exposure to hepatotoxins   c. When using medication known to have a potential for causing liver toxicity (e.g., following the drug manufacturers recommendations)