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| Medical Policy: | L-28-047 |
| Topic: | Tumor Markers |
| Section: | Laboratory |
| Effective Date: | November 13, 2017 |
| Issue Date: | November 13, 2017 |
| Last Reviewed: | June 2017 |
Tumor markers are substances normally produced in low quantities by cells in the body. Detection of a higher-than-normal serum level by radioimmunoassay or immunohistochemical techniques usually indicates the presence of a certain type of cancer. Currently, the main use of tumor markers is to assess a cancer's response to treatment and to check for recurrence. In some types of cancer, tumor marker levels may reflect the extent or stage of the disease and can be useful in predicting how well the disease will respond to treatment. |
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.
| Policy Position Coverage is subject to the specific terms of the member’s benefit plan. |
Prostate Specific Antigen (PSA)
Prostate-specific antigen (PSA) may be considered medically necessary for ANY ONE of the following:
- Staging; or
- Monitoring response to therapy; or
- Detecting disease recurrence.
Alpha-fetoprotein (AFP) serum
Alpha-fetoprotein (AFP) serum may be considered medically necessary for ANY ONE of the following:
- Serial measurements of alpha fetoprotein (AFP) to diagnose germ cell tumors in members with adenocarcinoma, or carcinoma not otherwise specified, involving mediastinal nodes; or the diagnosis and monitoring of hepatocellular carcinoma; or
- Serial measurements of AFP and HCG together to diagnose and monitor testicular cancer.
Carcinoembryonic Antigen (CEA)
Carcinoembryonic antigen (CEA) may be considered medically necessary for ANY ONE of the following:
- As a preoperative prognostic indicator with known colorectal carcinoma or mucinous appendiceal carcinoma when it will assist in staging and surgical treatment planning; or
- To detect asymptomatic recurrence of colorectal cancer after surgical and/or medical treatment for the diagnosis of colorectal cancer (not as a screening test for colorectal cancer); or
- To monitor response to treatment for metastatic cancer.
CA 125
CA 125 may be considered medically necessary when reported for patients with symptoms suggestive of ovarian cancer or in those with known ovarian cancer. It may also be considered medically necessary for patients with carcinomas of the fallopian tube, endometrium, and endocervix and may be associated with the presence of a malignant mesothelioma, as well as primary peritoneal carcinoma and metastatic adenoma cancer of unknown origin in the peritoneum.
CA 125 is not indicated for diagnosing or screening technique. Therefore, no payment should be made to rule out the covered diagnoses for these markers.
CA 27.29 or CA 15-3
CA 27.29 or CA 15-3 may be considered medically necessary when reported for use in the management of patients with breast cancer. The use of CA 27.29 or CA 15-3 for any other indication will be considered not medically necessary. The efficacy of these tests for any other reason has not been proven to change outcomes.
CA 27.29 or CA 15-3 is not indicated for diagnosing or screening technique. Therefore, no payment should be made to rule out the covered diagnoses for these markers.
CA 19-9
CA 19-9 may be considered medically necessary when reported for monitoring response to treatment in patients with an established diagnosis of pancreatic and biliary ductal carcinoma. This test is not indicated for making the diagnosis of pancreatic or biliary cancer.
CA 19-9 is not indicated for diagnosing or screening technique. Therefore, no payment should be made to rule out the covered diagnoses for these markers.
Serum Calcitonin
Calcitonin (Ct) is a tumor marker essential for the diagnosis and follow-up of medullary thyroid cancer. Calcitonin serum test may be considered medically necessary for the diagnosis and management of medullary thyroid cancer.
Calcitonin (Ct) is considered experimental/investigational for any other indication other than listed above, and therefore, non-covered.
Thyroglobulin Testing
Thyroglobulin (Tg) levels in the blood can be used as a tumor marker for certain kinds of thyroid cancer (particularly papillary or follicular thyroid cancer). Thyroglobulin is not produced by medullary or anaplastic thyroid carcinoma. Thyroglobulin testing may be considered medically necessary for the diagnosis and management of thyroid cancer.
A thyroglobulin antibody (TgAb) test is typically ordered along with the thyroglobulin test to determine the validity of the thyroglobulin testing and may be considered medically necessary.
Thyroglobulin testing and thyroglobulin antibody testing (TgAb) are considered experimental/investigational for any other cancer diagnoses and therefore, non-covered.
Chromogranin A
Chromogranin A (CgA) may be considered medically necessary only in the evaluation of suspected or known neuroendocrine tumors, including carcinoid and neuroblastoma as well as in the assessment of disease progression and treatment efficacy for these conditions. When reported for conditions other than neuroendocrine tumors, CgA is considered experimental/investigational, and therefore, non-covered.
Immunoassay for tumor antigen; other antigen, quantitative, (e.g., CA 50, 72-4, 549) represents immunoassays for tumor antigens other than CgA that are not designated with a specific procedure code. When reported for tumor antigen other than CgA, will be denied as experimental/investigational for cancer diagnoses and will be denied as not medically necessary for any nonmalignant diagnosis. In addition, when performed for asymptomatic patients, tumor markers are considered screening.
Screening for Lung Cancer
Early CDT-Lung for detection of lung cancer is considered experimental/investigational. There is a lack of published peer-reviewed literature assessing the clinical utility of early CDT-lung cancer. Additional studies are needed to determine the role of this test in evaluating patients.
Human Epididymis Protein 4 (HE4) Testing
The HE4 EIA enzyme immunometric assay for the quantitative determination of HE4 in human serum is considered experimental/investigational. There is insufficient evidence to support the clinical efficacy and utility of this testing.
Refer to medical policy L-209 UroVysion FISH for Bladder Cancer for additional information. Refer to medical policy L-210 CellSearch Circulating Tumor Cell Count for Breast Cancer Prognosis for additional information. |
| Place of Service: Outpatient |
Experimental/Investigational (E/I) services are not covered regardless of place of service.
The testing for tumor markers is typically an outpatient procedure which is only eligible for coverage as an inpatient procedure in special circumstances, including, but not limited to, the presence of a co-morbid condition that would require monitoring in a more controlled environment such as the inpatient setting.
| The policy position applies to all commercial lines of business |
| Denial Statements |
Services that do not meet the criteria of this policy will not be considered medically necessary. A network provider cannot bill the member for the denied service unless: (a) the provider has given advance written notice, informing the member that the service may be deemed not medically necessary; (b) the member is provided with an estimate of the cost; and (c) the member agrees in writing to assume financial responsibility in advance of receiving the service. The signed agreement must be maintained in the provider’s records.
Services that do not meet the criteria of this policy will be considered experimental/investigational (E/I). A network provider can bill the member for the experimental/investigational service. The provider must give advance written notice informing the member that the service has been deemed E/I. The member must be provided with an estimate of the cost and the member must agree in writing to assume financial responsibility in advance of receiving the service. The signed agreement must be maintained in the provider’s records.
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Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. They are intended to reflect Highmark's reimbursement and coverage guidelines. Coverage for services may vary for individual members, based on the terms of the benefit contract.
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U.S. Department of Health and Human Services
200 Independence Avenue, SW
Room 509F, HHH Building
Washington, D.C. 20201
1-800-368-1019, 800-537-7697 (TDD)
Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html.
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