Highmark Commercial Medical Policy - Pennsylvania


 
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Medical Policy: L-28-049
Topic: Tumor Markers
Section: Laboratory
Effective Date: November 20, 2017
Issue Date: August 20, 2018
Last Reviewed: August 2018

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) 
PSA may be considered medically necessary for ANY of the following:

  • Staging; or
  • Monitoring response to therapy; or
  • Detecting disease recurrence.
Procedure Codes
84152, 84153, 84154, 86849



Alpha-fetoprotein (AFP) serum
AFP serum may be considered medically necessary for EITHER of the following:

  • Serial measurements of AFP to diagnose germ cell tumors in individuals with adenocarcinoma, or carcinoma not otherwise specified, involving mediastinal nodes; or the diagnosis and monitoring of hepatocellular carcinoma; or
  • Serial measurements of AFP and human chorionic gonadotropin (HCG) together to diagnose and monitor testicular cancer.
Procedure Codes
82105, 84702, 86849



Carcinoembryonic Antigen (CEA)
CEA may be considered medically necessary for ANY 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.
Procedure Codes
82378, 86849



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 be considered medically necessary for individuals 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 can be made to rule out the covered diagnoses for these markers.

Procedure Codes
86304



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 individuals with breast cancer. CA 27.29 or CA 15-3 is considered not medically necessary for all other indications. The efficacy of these tests for all other indications 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 can be made to rule out the covered diagnoses for these markers.

Procedure Codes
86300



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 can be made to rule out the covered diagnoses for these markers.

Procedure Codes
86301



Serum Calcitonin (Ct)
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. 

Ct is considered experimental/investigational and, therefore, non-covered for any other indication other than listed above. Scientific evidence does not support the use.

Procedure Codes
82308



Thyroglobulin Testing (Tg)
Tg levels in the blood can be used as a tumor marker for certain kinds of thyroid cancer (particularly papillary or follicular thyroid cancer). Tg is not produced by medullary or anaplastic thyroid carcinoma. Tg 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. 

Tg testing and TgAb are considered experimental/investigational and, therefore, non-covered for any other cancer diagnoses. Scientific evidence does not support the use.

Procedure Codes
84432, 86800



Chromogranin A (CgA)
CgA may be considered medically necessary only in the evaluation of suspected or known neuroendocrine tumors, including carcinoid, neuroblastoma and 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 and, therefore, non-covered 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.

Procedure Codes
86316, 86849



Screening for Lung Cancer
Early cancer detection test (CDT)-Lung for detection of lung cancer is considered experimental/investigational and therefore, non-covered. Scientific evidence does not support the use.

Procedure Codes
84999, 86849



Human Epididymis Protein 4 (HE4) Testing
The HE4 enzyme immunometric assay (EIA) for the quantitative determination of HE4 in human serum is considered experimental/investigational and, therefore, non-covered. Scientific evidence does not support the use.

Procedure Codes
86305



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.

Discrimination is Against the Law
The Claims Administrator/Insurer complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. The Claims Administrator/Insurer does not exclude people or treat them differently because of race, color, national origin, age, disability, or sex. The Claims Administrator/ Insurer:
  • Provides free aids and services to people with disabilities to communicate effectively with us, such as:
    • Qualified sign language interpreters
    • Written information in other formats (large print, audio, accessible electronic formats, other formats)
  • Provides free language services to people whose primary language is not English, such as:
    • Qualified interpreters
    • Information written in other languages
If you need these services, contact the Civil Rights Coordinator.

If you believe that the Claims Administrator/Insurer has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with: Civil Rights Coordinator, P.O. Box 22492, Pittsburgh, PA 15222, Phone: 1-866-286-8295, TTY: 711, Fax: 412-544-2475, email: CivilRightsCoordinator@highmarkhealth.org. You can file a grievance in person or by mail, fax, or email. If you need help filing a grievance, the Civil Rights Coordinator is available to help you.

You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at:

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.

Insurance or benefit/claims administration may be provided by Highmark, Highmark Choice Company, Highmark Coverage Advantage, Highmark Health Insurance Company, First Priority Life Insurance Company, First Priority Health, Highmark Benefits Group, Highmark Select Resources, Highmark Senior Solutions Company or Highmark Senior Health Company, all of which are independent licensees of the Blue Cross and Blue Shield Association, an association of independent Blue Cross and Blue Shield plans.

Highmark retains the right to review and update its medical policy guidelines at its sole discretion. These guidelines are the proprietary information of Highmark. Any sale, copying or dissemination of the medical policies is prohibited; however, limited copying of medical policies is permitted for individual use.



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