Tumor Markers

Policy ID: L-28-061

Section: Laboratory

Effective Date: September 01, 2019

Revised Date: May 26, 2022

Revision Effective Date: July 04, 2022

Last Reviewed: May 24, 2022

Applies To: Commercial and Medicaid Expansion

Description

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.

Criteria

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 AFP measurements are indicated for members at high-risk group (overgrowth syndromes) germ tumors such as hepatoblastoma.

AFP not meeting the criteria as indicated in this policy is considered not medically necessary.

Procedure Codes

82105

84702

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 not meeting the criteria as indicated in this policy is considered not medically necessary.

Procedure Codes

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 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 not meeting the criteria as indicated in this policy is considered not medically necessary.

Procedure Codes

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 may be considered medically necessary when reported for women who are BRCA variant positive to screen for ovarian cancer (when combined with transvaginal ultrasound?) [per NCCN guidelines]

CA 125 is not indicated for diagnosing or screening technique except as specified above. Therefore, no payment can be made to rule out the covered diagnoses for these markers.

CA 125 not meeting the criteria as indicated in this policy is considered not medically necessary.

Procedure Codes

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 not meeting the criteria as indicated in this policy is considered not medically necessary.

Procedure Codes

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 not meeting the criteria as indicated in this policy is considered not medically necessary.

Procedure Codes

82378

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.

CgA not meeting the criteria as indicated in this policy is considered not medically necessary.

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.

Immunoassay for tumor antigen; other antigen, quantitative, (e.g., CA 50, 72-4, 549) represents immunoassays for tumor antigens other than CgA not meeting the criteria as indicated in this policy is considered not medically necessary.

Procedure Codes

86316

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, because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.

Procedure Codes

86305

Lung Cancer Screening

Early cancer detection test (CDT)-Lung for detection of lung cancer is considered experimental/investigational and therefore, non-covered, because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.

Procedure Codes

84999

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.

Procedure Codes

84432

86800

Diagnosis Codes

Covered Diagnosis Codes for Procedure Code 86304

C45.1

C45.0

C45.2

C45.7

C45.9

C48.0

C48.1

C48.2

C48.8

C51.8

C53.0

C54.1

C54.2

C54.3

C54.9

C56.1

C56.2

C56.3

C57.01

C57.02

C57.4

C57.7

C57.8

C78.6

C79.61

C79.62

C79.63

C79.82

D07.30

D07.39

D39.0

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

C50.021

C50.022

C50.111

C50.112

C50.121

C50.122

C50.211

C50.212

C50.221

C50.222

C50.311

C50.312

C50.321

C50.322

C50.411

C50.412

C50.421

C50.422

C50.511

C50.512

C50.521

C50.522

C50.611

C50.612

C50.621

C50.622

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

C76.0

Z85.850

Professional Statements and Societal Positions Guidelines

Not Applicable

ND Committee Review

Internal Medical Policy Committee 5-19-2020 Removed PSA and codes due to ND Mandate

Internal Medical Policy Committee 9-21-2020 ND adding indication for CA-125 for individuals with BRCA mutation to screen for ovarian cancer

Internal Medical Policy Committee 5-20-2021 Coding update-Removed Z80.41, Added C56.1; C56.2; C56.9

Internal Medical Policy Committee 7-22-2021 Coding update-Added 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, and C78.6 covered under procedure code 86304; Removed procedure code 86849 throughout policy

Internal Medical Policy Committee 9-21-2021 Updating wording and Added diagnosis codes C56.3; C76.0; C79.63 and Z12.71

Internal Medical Policy Committee 5-24-2022 Revision with Coding updates

Covered Diagnosis Codes for Procedure Code 86304
- Removed Diagnosis codes: C56.9; C57.00; C79.60 and D39.10
- Added Diagnosis codes: C45.0; C45.2; C45.7 and C45.9
Covered Diagnosis Codes for Procedure Code 86300
- Removed Diagnosis codes: C50.019; C50.029; C50.119; C50.129; C50.219; C50.229; C50.319; C50.329; C50.419; C50.429; C50.519; C50.529; C50.619; C50.629; C50.819;C50.829; C50.919; C50.929; D05.10; D05.80 and D05.90
Covered Diagnosis Codes for Procedure Codes 82105 and 84702
- Removed:00; C62.10; C62.90; and Z80.0
- Added: 440; Q87.3 and Q87.89

Links

References (PDF)

Disclaimer

Current medical policy is to be used in determining a Member's contract benefits on the date that services are rendered. Contract language, including definitions and specific inclusions/exclusions, as well as state and federal law, must be considered in determining eligibility for coverage. Members must consult their applicable benefit plans or contact a Member Services representative for specific coverage information. Likewise, medical policy, which addresses the issue(s) in any specific case, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving, and the Company reserves the right to review and update medical policy periodically.

Policy ID: L-28-060

Section: Laboratory

Effective Date: September 01, 2019

Revised Date: September 23, 2021

Revision Effective Date: October 01, 2021

Last Reviewed: September 21, 2021

Archived Date: July 03, 2022

Applies To: Commercial and Medicaid Expansion

Description

Criteria

Alpha-fetoprotein (AFP) serum

AFP serum may be considered medically necessary for EITHERof 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 not meeting the criteria as indicated in this policy is considered not medically necessary.

Procedure Codes

82105

84702

CA 19-9

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 not meeting the criteria as indicated in this policy is considered not medically necessary.

Procedure Codes

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 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 not meeting the criteria as indicated in this policy is considered not medically necessary.

Procedure Codes

86300

CA 125

CA 125 may be considered medically necessary when reported for women who are BRCA variant positive to screen for ovarian cancer (when combined with transvaginal ultrasound?) [per NCCN guidelines]

CA 125 is not indicated for diagnosing or screening technique except as specified above. Therefore, no payment can be made to rule out the covered diagnoses for these markers.

CA 125 not meeting the criteria as indicated in this policy is considered not medically necessary.

Procedure Codes

86304

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.

Procedure Codes

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 not meeting the criteria as indicated in this policy is considered not medically necessary.

Procedure Codes

82378

Chromogranin A (CgA)

CgA not meeting the criteria as indicated in this policy is considered not medically necessary.

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.

Procedure Codes

86316

Human Epididymis Protein 4 (HE4) Testing

Procedure Codes

86305

Lung Cancer Screening

Procedure Codes

84999

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.

Procedure Codes

84432

86800

Diagnosis Codes

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

C56.3

C56.9

C57.00

C57.01

C57.02

C57.4

C57.7

C57.8

C78.6

C79.60

C79.61

C79.62

C79.63

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 86301

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

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

C76.0

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

Z12.71

Z80.0

Z85.47

Non-covered Diagnosis Codes for Procedure Code 84999

V76.0

Professional Statements and Societal Positions Guidelines

Not Applicable

ND Committee Review

Internal Medical Policy Committee 5-19-2020 Removed PSA and codes due to ND Mandate

Internal Medical Policy Committee 9-21-2020 ND adding indication for CA-125 for individuals with BRCA mutation to screen for ovarian cancer

Internal Medical Policy Committee 5-20-2021 Coding update-Removed Z80.41, Added C56.1; C56.2; C56.9

Internal Medical Policy Committee 9-21-2021 Updating wording and Added diagnosis codes C56.3; C76.0; C79.63 and Z12.71

Links

References (PDF)

Disclaimer

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Tumor Markers

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