CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

Tumor marker immunoassay testing (CA 15-3, CA 27.29, CA 19-9, other tumor antigens)

Defines coverage positions for specific serum tumor antigen immunoassay tests for Medicare Advantage and commercial products, specifying which CPT codes are covered or not covered when filed with listed ICD-10-CM diagnosis codes and references related policies for Medicare determinations and genetic testing exclusions.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyTumor marker immunoassay testing (CA 15-3, CA 27.29, CA 19-9, other tumor antigens)

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJan 1, 2024

Next Review Date

Key ActionReport covered CPTs 86300 and 86301 only when filed with one of the covered diagnosis codes listed in the policy; 86316 will be denied/not covered when filed with specified ICD-10-CM codes listed in the policy.

SourceLink

POLICY UPDATE CHANGES

No material changes to clinical coverage or criteria.

3Explicit CPT codes addressed

7ICD-10-CM diagnosis code ranges listed

2Related policies referenced

Coverage Summary

This policy addresses coverage of serum and noncirculating tumor antigen immunoassays used in the management of cancer, with primary focus on breast markers (CA 15-3/CA 27.29 and HER2) and gastrointestinal markers (CEA, CA 19-9, CA 72-4). It specifies payer product distinctions: Medicare Advantage references National and Local Coverage Determinations (see Related Policies) for CA 15-3/CA 27.29 and CA 19-9, and Commercial products may cover CA 15-3/CA 27-29 and CA 19-9 when filed with covered diagnosis codes per the policy attachments. Coverage for other tumor antigen immunoassays (eg, CA 50, CA 72-4, CA 549) is restricted and may be considered not covered or not medically necessary when filed with specified diagnosis codes listed in the policy attachments.

Coverage / Medical Necessity Criteria

Medicare Advantage - Covered vs Not Covered

Coverage depends on test and diagnosis code:

ALL of the following

Covered immunoassay tests (when filed with one of the related diagnosis codes per Related Policies)
- 86300 Immunoassay for tumor antigen, quantitative; CA 15-3 (CA 27-29)
- 86301 Immunoassay for tumor antigen, quantitative; CA 19-9
86316 Immunoassay for tumor antigen, other antigen, quantitative (eg, CA 50, 72-4, 549) is considered not covered when filed with one of the diagnosis codes listed in the Coding section of this policy.
See Coding section for the specific ICD-10-CM codes that render 86316 not covered.

Commercial Products - Covered vs Not Medically Necessary

Coverage depends on test and diagnosis code filed:

ALL of the following

86300 is covered when filed with one of the covered diagnosis codes listed in the Coding section of this policy (attachments).
86301 is covered when filed with one of the covered diagnosis codes listed in the Coding section of this policy (attachments).
86316 Immunoassay for tumor antigen, other antigen, quantitative (eg, CA 50, CA 72-4, CA 549) is considered not medically necessary when filed with one of the ICD-10-CM codes listed in this policy.
See Coding section for the specific ICD-10-CM codes.
Some genetic services and expanded biomarker coverage may be excluded for self-funded groups per contract; refer to Genetic Testing Services or Biomarker Testing Mandate policies and the member's Benefit Booklet for member-specific coverage.

Coding

Covered CPTs (Medicare Advantage where allowed / Commercial when filed with covered diagnosis codes)CPTCovered

86300	Immunoassay for tumor antigen, quantitative; CA 15-3 (CA 27.29)
86301	Immunoassay for tumor antigen, quantitative; CA 19-9

Not Covered / Not Medically Necessary CPTCPTNot Covered

86316

Immunoassay for tumor antigen, other antigen, quantitative (eg, CA 50, 72-4, 549)

ICD-10-CM diagnosis codes that render 86316 not covered / not medically necessary (listed in policy)ICD-10Not Covered

C16.0-C16.9	Malignant neoplasm of stomach (range)
C18.0-C18.9	Malignant neoplasm of colon (range)
C19	Malignant neoplasm of rectosigmoid junction
C20	Malignant neoplasm of rectum
C21.0-C21.8	Malignant neoplasm of anus and anal canal (range)
C25.0-C25.9	Malignant neoplasm of pancreas (range)
C50.01-C50.929	Malignant neoplasm of breast (range including laterality/subsites)

Operational note: See policy attachments for complete lists of covered diagnosis codes; coding in the attachments determines whether CPTs such as 86300 and 86301 are allowable. Coding requirements and Medicare-specific determinations may differ between Medicare Advantage and Commercial products—refer to the Related Policies (Medicare Advantage Plans National and Local Coverage Determinations) and the policy attachments for product-specific coding guidance.

Provider Actions / Billing Guidance

Documentation Required

Use appropriate diagnosis codes

Report CPT codes 86300 and 86301 only when filed with one of the covered diagnosis codes listed in the policy; CPT 86316 is considered not covered/denied when filed with the specified ICD-10-CM diagnosis codes listed in the Coding section.

86300
86301
86316

Documentation Required

Check member-specific benefits and contracts

Confirm the member's Benefit Booklet / Subscriber Agreement for applicable coverage and note that self-funded groups may have contract exclusions for expanded biomarker or genetic testing; refer to the Genetic Testing Services and Biomarker Testing Mandate related policies for details.

Genetic Testing Services
Biomarker Testing Mandate

Prior Authorization

Prior authorization not applicable

Prior authorization is listed as not applicable for tumor marker testing in this policy, but member-specific benefit or plan documents may still impose requirements—verify with the payer.

Background

Background: Serum tumor markers are molecules shed by tumors into the circulation and can be detected and quantitated; noncirculating markers are detected in tissue (eg, HER2 by immunohistochemistry). This policy focuses on markers most relevant to breast cancer (MUC-1–related markers CA 15-3 and CA 27.29, and HER2) and gastrointestinal malignancies (eg, CEA, CA 19-9, CA 72-4). Interpretation is limited because many markers can be present in benign conditions and marker levels can be affected by hepatic clearance, so cutoff points and clinical context are important.

Definition — Tumor marker: Substances produced by tumor cells or by other cells of the body in response to cancer or certain benign conditions; may be serum markers or noncirculating (tissue-based) markers.

Name	Number/Type
Tumor Antigen by Immunoassay CA 15-3/CA 27.29	NCD referenced in Related Policies (type: NCD)
Tumor Antigen by Immunoassay CA 19-9	NCD referenced in Related Policies (type: NCD)