CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

Immunoassay Tumor Antigen Tests (CA 15-3/CA 27.29, CA 19-9, other tumor antigens)

Policy governs coverage of immunoassay tumor marker tests (focused on CA 15-3/CA 27.29 and CA 19-9) for management of cancerous conditions for BCBS Rhode Island members; distinguishes Medicare Advantage and Commercial product rules and lists diagnoses that make some tests not covered or not medically necessary.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyImmunoassay Tumor Antigen Tests (CA 15-3/CA 27.29, CA 19-9, other tumor antigens)

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJul 1, 2025

Next Review DateN/A

Key ActionFile claims for immunoassay tumor marker testing with the appropriate diagnosis codes specified in the policy; coverage is determined by the diagnosis submitted and laboratories must not obtain authorization on behalf of ordering physicians.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2primary covered immunoassay CPT codes mentioned

1CPT code listed as not covered / not medically necessary (86316)

9ICD-10-CM diagnosis code ranges specified for exclusion/not covered

Coverage rules for immunoassay tumor antigen tests

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Medicare Advantage Plans - Coverage / Not Covered Logic

For Medicare Advantage members the following applies:

ALL of the following

Covered immunoassay codes (see related policy NCD/LCDs)
- 86300 Immunoassay for tumor antigen, quantitative; CA 15-3 (CA 27.29)
- 86301 Immunoassay for tumor antigen, quantitative; CA 19-9
Immunoassay test for tumor antigen, other antigen (e.g., CA 50, CA 72-4, CA 549) filed with listed ICD-10-CM cancer diagnosis codes is considered not covered
See ICD-10-CM list in coding section

Commercial Products - Coverage / Not Medically Necessary Logic

For Commercial product members the following applies:

ALL of the following

86300 (CA 15-3/CA 27.29) is covered when filed with one of the covered diagnosis codes listed in the policy attachments
86301 (CA 19-9) is covered when filed with one of the covered diagnosis codes listed in the policy attachments
86316 (immunoassay for tumor antigen, other antigen, quantitative — e.g., CA 50, CA 72-4, CA 549) is considered not medically necessary when filed with one of the listed ICD-10-CM cancer diagnosis codes
Benefits may vary between groups and contracts; refer to member's Benefit Booklet or Subscriber Agreement for plan-specific coverage

Laboratory Authorization Restrictions

Authorization process restrictions that must be followed:

ALL of the following

Laboratories are not allowed to obtain clinical authorization or participate in the authorization process on behalf of the ordering physician
Only the ordering physician may be involved in authorization, appeals, or other administrative processes related to prior authorization/medical necessity
Use of a laboratory representative or third party to obtain authorization or support an appeal is a violation and may result in termination from BCBSRI provider network and denial of payment; unauthorized laboratory-provided services will be denied and financial liability rests with the participating laboratory

Relevant CPT and ICD-10 codes

Covered immunoassay CPT codes (Commercial)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 immunoassay CPT codesCPTNot Covered

86316

Immunoassay for tumor antigen, other antigen, quantitative (eg, CA 50, CA 72-4, 549) — not covered or not medically necessary when filed with specified cancer diagnosis codes

ICD-10-CM diagnosis codes referenced for not covered / not medically necessary determinationsICD-10

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 neoplasms 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)

Documentation, authorization, and billing risks

Documentation Required

Order diagnosis must be submitted on claim

Claims for immunoassay tumor marker testing must be filed with the appropriate diagnosis code(s) specified in the policy; coverage or non-coverage is determined based on the diagnosis submitted.

86300
86301
86316

Denial Risk

Laboratory authorization and billing risk

Laboratories are prohibited from obtaining clinical authorization or participating in the authorization process on behalf of the ordering physician; if a laboratory obtains authorization or supports an appeal, BCBSRI may deem this a policy violation and deny payment with financial liability resting with the laboratory.

Clinical context for tumor markers

Serum tumor markers are molecules or substances that can be shed by tumors into the circulation where they can be detected and quantitated; some tumor markers are tissue-detected rather than circulating (e.g., HER2 by immunohistochemistry). These assays — including tests for CA 15-3/CA 27.29, CA 19-9, CEA, PSA, and beta-2 microglobulin — may assist in the management and monitoring of certain cancers but are not specific to malignancy and can be elevated in benign conditions or with nonmalignant physiologic changes.

Because most tumor markers are not unique to cancer, marker concentrations can be influenced by factors such as antigen overexpression by malignant cells, large tumor burden, or impaired clearance (for example, liver dysfunction). Cutoff points for normal versus abnormal levels may be required for single measurements, whereas serial monitoring in established malignancy is often used for trend assessment rather than single-value diagnosis.

This policy focuses specifically on tumor markers used in the management of breast and gastrointestinal malignancies — notably assays related to the MUC-1 gene (e.g., CA 15-3 and CA 27.29) for breast cancer and mucinous glycoprotein markers (e.g., CA 19-9, CA 72-4) and CEA for gastrointestinal cancers — and describes coverage distinctions and billing requirements for those tests.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyImmunoassay Tumor Antigen Tests (CA 15-3/CA 27.29, CA 19-9, other tumor antigens)

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJul 1, 2025

Next Review DateN/A

SourceLink

On This Page

OpenPayer

Immunoassay Tumor Antigen Tests (CA 15-3/CA 27.29, CA 19-9, other tumor antigens)

Coverage rules for immunoassay tumor antigen tests

Relevant CPT and ICD-10 codes

Documentation, authorization, and billing risks

Clinical context for tumor markers

Defined terms used in this policy

Immunoassay Tumor Antigen Tests (CA 15-3/CA 27.29, CA 19-9, other tumor antigens)

Coverage rules for immunoassay tumor antigen tests

Relevant CPT and ICD-10 codes

Documentation, authorization, and billing risks

Clinical context for tumor markers

Defined terms used in this policy

Other policies to read with this policy