The following tumor markers are eligible for payment when medically necessary and should be processed as follows:

• Prostate specific antigen (PSA); total - 84153
• Prostate specific antigen (PSA); free - 84154
• Prostate specific antigen (PSA); complexed (direct method) - 84152
• Immunoassay for prostate specific antigen (PSA); asymptomatic patient - G0103
  Note: Only covered by certain groups or programs as indicated in the benefit schedule.
• Alpha-fetoprotein (AFP); serum - 82105
• Carcinoembryonic antigen (CEA) - 82378
• Immunoassay for tumor antigens:

CA 125 (86304)
CA 125 is payable when reported for patients with symptoms suggestive of ovarian cancer or in those with known ovarian cancer (183.0, 198.6, 233.3, V10.43).  It is also payable for patients with carcinomas of the fallopian tube, endometrium, endocervix and may be associated with the presence of a malignant mesothelioma (180.0, 182.0, 183.2, 183.8, 184.8, 198.82, 236.0-236.3, V10.42, V10.43), as well as primary peritoneal carcinoma and metastatic adeno cancer of unknown origin in the peritoneum (158.0-158.9, 197.6). 

CA 27.29 or CA 15-3 (86300)
CA 27.29 or CA 15-3 are payable when reported for use in the management of patients with breast cancer (174.0-174.9, 175.0-175.9, 198.2, 198.81, V10.3).

CA 19-9 (86301)
CA 19-9 is payable when reported for monitoring response to treatment in patients with an established diagnosis of pancreatic and biliary ductal carcinoma (155.1, 156.1, 156.8, 156.9, 157.0-157.9, 197.8, 230.9, 235.3, 235.5, V10.09). This test is not indicated for making the diagnosis of pancreatic or biliary cancer.

BTA  or NMP-22 (86294)
Bladder Tumor Antigen (BTA) or nuclear matrix protein 22 (NMP-22) are payable when reported as an adjunct to cystoscopy in the diagnosis of bladder cancer and to monitor for eradication of the cancer, or recurrences after eradication (188.0-188.9, 198.1, 233.7, 239.4, V10.51).

There is insufficient scientific evidence to determine the efficacy of CA 125, CA 27.29, CA 15-3, CA 19-9, BTA and NMP-22 in the clinical management of malignancies other than those listed above. Therefore, when reported for cancer diagnoses other than those listed above, these tumor markers are considered experimental/investigational and not covered. A participating, preferred, or network provider can bill the member for the test. In addition, when performed for patients with non-malignant diagnoses, tumor marker testing is considered not medically necessary and not covered. A participating, preferred, or network provider cannot bill the member for the denied test in this case. When performed for asymptomatic patients, tumor marker testing is considered screening and only covered by certain groups or programs as indicated in benefits.

CA 125, CA 27.29, CA 15-3,  and CA 19-9 are not indicated for diagnosing. Therefore, no payment should be made to "rule out" the covered diagnoses for these markers.

NOTE:

Code 86316 (Immunoassay for tumor antigen; other antigen, quantitative) represents immunoassays for tumor antigens not designated with a specific procedure code. When reported, code 86316 will be denied as experimental/investigational for cancer diagnoses and will be denied as noncovered for any nonmalignant diagnosis. In addition, when performed for asymptomatic patients, tumor markers reported under code 86316 are considered screening and only covered by certain groups or programs as indicated in benefits.

The use of fluorescence in situ hybridization (FISH) (88365) is payable when reported as an adjunct to cystoscopy in the diagnosis (in persons with hematuria suspected of having bladder cancer) and monitoring of bladder cancer (188.0-188.9, 198.1, 233.7, 239.4, V10.51).

Description

Radioimmunoassay and immunohistochemical determination of the serum levels of certain proteins or carbohydrates have been developed as "markers" for various cancers. Normal cells express these chemicals in low quantities. Tumor size and grade are believed to be reflected by significant elevations in serum concentration of these markers. The uses of tumor marker testing include screening, diagnosis and monitoring response to treatment.

Fluorescence In Situ Hybridization (FISH) is a molecular cytogenetic test used to investigate chromosomal abnormalities associated with cancer and genetic disorders.  The major difference between the FISH test and the immunoassay tests is that they detect different substances and use different detection methods.   FISH testing is different from BTA and NMP-22 tests because the results are not affected by the presence of hematuria at the time of the test.  Unlike most of the immunoassay tests, its specificity remains high among patients with inflammatory conditions and those treated with Calmette-Guerin (BCG).  FISH DNA probe technology is a technique to visualize nucleic acid sequences within cells by creating short sequences of fluorescently labeled, single-stranded DNA called probes, that match target sequences.  The probes bind to complementary strands of DNA, allowing for identification of the locations of the chromosomes targeted.

NOTE:

This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

Frequency parameters specified in this bulletin do not apply to FEP.

Under the Federal Employee’s Program, all services that utilize FDA-approved drugs, devices, or biological products are eligible when intended for the treatment of a serious or life-threatening condition and when medically necessary and appropriate for the patient’s condition. Lab tests using an FDA approved "kit" for a condition other than the covered conditions listed on this policy, are considered eligible when determined medically necessary based on the patient’s condition.

PRN References

03/1994, Tumor markers, codes and reimbursement for
06/1997, Tumor marker CA 27.29, code for
08/2000, Use of tumor markers CA 19-9 and BTA approved
04/2002, Coverage guidelines for tumor markers clarified
06/2003, Use of tumor marker CA 15-3 approved
06/2006, Coverage expanded for bladder cancer tumor markers

National Blue Cross Blue Shield Association Medical Policy 2.04.07, Urinary Tumor Markers for Bladder Cancer, 3:2005