HIGHMARK COMMERCIAL MEDICAL POLICY - PENNSYLVANIA

 
 
Medical Policy:
L-28-057
Topic:
Tumor Markers
Section:
Laboratory
Effective Date:
July 5, 2021
Issued Date:
July 5, 2021
Last Revision Date:
June 2021
Annual Review:
August 2020
 
 

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.

Policy Position

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.

 AFP for any other condition not stated above is considered not medically necessary. 

82105

84702 

86849 

 

 

 

 


CA 19-9

CA 19-9 may be considered medically necessary when reported for monitoring response to treatment in individuals 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.

CA 19-9 for any other condition not stated above is considered not medically necessary.

86301

 

 

 

 

 

 


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.

CA 27.29 and CA 15-3 for any other condition not stated above is considered not medically necessary.

86300

 

 

 

 

 

 


CA 125

CA 125 may be considered medically necessary when reported for individuals 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.

CA 125 for any other condition not stated above is considered not medically necessary.

86304

 

 

 

 

 

 


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 its use for any other indication.

82308

 

 

 

 

 

 


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.

CEA for any other condition not stated above is considered not medically necessary. 

82378

86849

 

 

 

 

 


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. 

Scientific evidence does not support its use for any other indication except what is stated above.

 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 individuals, tumor markers are considered screening.

 

86316

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 its use for any indication. 

86305

 

 

 

 

 

 


Lung Cancer Screening

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

84999

86849

 

 

 

 

 


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 its use for any other indication except what is stated above. 

84432

86800

 

 

 

 

 


Covered Diagnosis Codes for Procedure Code 86304

C45.1   

C48.0   

C48.1   

C48.2   

C48.8   

C51.8   

C53.0   

C54.1   

C54.2   

C54.3   

C54.9   

C56.1   

C56.2   

C56.9   

C57.00 

C57.01 

C57.02 

C57.4   

C57.7   

C57.8   

C78.6   

C79.60 

C79.61 

C79.62 

C79.82 

D07.30 

D07.39 

D39.0  

D39.10 

D39.11 

D39.12 

D39.2  

D39.8  

D39.9  

Z85.42

Z85.43

 

 

 

 

 

 

 

Covered Diagnosis Codes for Procedure Code 86300

C50.011

C50.012

C50.019

C50.021

C50.022

C50.029

C50.111

C50.112

C50.119

C50.121

C50.122

C50.129

C50.211

C50.212

C50.219

C50.221

C50.222

C50.229

C50.311

C50.312

C50.319

C50.321

C50.322

C50.329

C50.411

C50.412

C50.419

C50.421

C50.422

C50.429

C50.511

C50.512

C50.519

C50.521

C50.522

C50.529

C50.611

C50.612

C50.619

C50.621

C50.622

C50.629

C50.811

C50.812

C50.819

C50.821

C50.822

C50.829

C50.911

C50.912

C50.919

C50.921

C50.922

C50.929

D05.00

D05.01

D05.02

D05.10

D05.11

D05.12

D05.80

D05.81

D05.82

D05.90

D05.91

D05.92

Z85.3

 

 

 

 

Covered Diagnosis Codes for Procedure Code 86301

C22.1

C24.0

C24.1

C24.8

C24.9

C25.0

C25.1

C25.2

C25.3

C25.4

C25.7

C25.8

C25.9

 

 

Covered Diagnosis Codes for Procedure Code 86316

C7A.1

C7A.8

C7B.8

C7B.01

C7B.02

C7B.03

C7B.04

C7B.09

D3A.8

D3A.00

E34.0

 

 

 


Covered Diagnosis Codes for Procedure Codes 82308, 84432, and 86800

C73

Z85.850

 

 

 

 

 

 

Covered Diagnosis Codes for Procedure Code 82378

C18.0

C18.1

C18.2

C18.3

C18.4

C18.5

C18.6

C18.7

C18.8

C18.9

C19

C20

D01.0

D01.1

D01.2

D01.3

D01.40

D01.49

D01.5

R97.0

Z85.030

Z85.038

Z85.040

 

 

 

 

 


Covered Diagnosis Codes for Procedure Codes 82105 and 84702

C22.0

C22.1

C22.2

C22.3

C22.4

C22.7

C22.8

C22.9

C62.00

C62.01

C62.02

C62.10

C62.11

C62.12

C62.90

C62.91

C62.92

C77.1

D07.60

D07.61

D07.69

Z80.0

Z85.47

 

 

 

 

 

Non-covered Diagnosis Codes for Procedure Code 84999

V76.0

 

 

 

 

 

 


Place of Service: Inpatient/Outpatient

Experimental/Investigational (E/I) services are not covered regardless of place of service.

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. 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



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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 or other circumstances may warrant individual consideration, based on review of applicable medical records, as well as other regulatory, contractual and/or legal requirements.

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, and subject to the applicable laws of your state.


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.

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. 




Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. They are intended to reflect 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.