Blue Cross Blue Shield KS serum tumor markers Coverage

Coverage Criteria for Serum Tumor Markers

Covered Indications with Criteria

Covered when the following conditions are met

Monitoring in metastatic disease: Use CA 27.29 to monitor an already elevated titer or antigen in patients with metastatic disease; testing should be used in conjunction with imaging, history, and physical examination during active therapy

Recommend baseline and every 6 weeks during treatment; caution interpreting rises in the first 4–6 weeks of a new therapy

Surveillance after primary tumor removal: Use CA 27.29 in surveillance of patients who had elevated initial marker studies after removal of an initial primary tumor

Recommend every 3 months for post‑treatment follow‑up; present data are insufficient to recommend use of CA 27.29 alone for detection of recurrence

Not Recommended / Insufficient Evidence

Not supported / Not recommended uses

Not recommended for diagnosis/screening/prognosis/staging: Present data are insufficient to recommend CA 15-3 or CA 27.29 for screening, diagnosis, staging, or as routine prognostic markers for breast cancer

Markers lack specificity and sensitivities are low for early disease

Not to be used alone for monitoring response/recurrence: CA 15-3 or CA 27.29 should not be used alone to monitor response to treatment or to declare progression; they should be used alongside imaging and clinical assessment

Isolated increases should rarely be used to declare progression; criteria for interpreting changes in marker levels are not universally validated

General coverage stance

Policy coverage informed by evidence summary and guidelines

Evidence and guideline basis: Controlled studies showing clinical utility of the serum tumor markers addressed are lacking; NCCN advises that rising tumor markers (eg, CEA, CA15-3, CA27.29) may indicate progression but an isolated increase should rarely be used alone to declare progression

CA 19-9 may be prognostic/monitoring in pancreatic cancer but lacks demonstrated impact on management

Use of CA 15-3 or CA 27.29 for screening, diagnosis, staging, or routine prognostic purposes is not supported by the evidence. Present data are insufficient to recommend these markers for early-stage diagnosis or as independent prognostic tests because sensitivities are low and none of the serum tumor markers is specific for breast cancer. (ASCO guidance and policy summary.)

Controlled studies demonstrating that measurement of these serum tumor markers directs management to improve patient outcomes are lacking. Earlier policy language that characterized certain marker uses as experimental/investigational for some gastrointestinal malignancies was revised and removed as described in the revisions history, but the central evidence gap—no controlled trials showing improved health outcomes—remains.

Routine use of serum tumor markers for the diagnosis of primary breast cancer or as independent predictors of prognosis is not supported. The available studies are of limited quality, markers are not specific for breast cancer, and reported sensitivities—particularly for early disease—are low.

Use of serum tumor markers to diagnose disease, to determine prognosis, to select therapy, to assess treatment response, or to monitor for recurrence lacks controlled evidence showing improved outcomes. Guideline statements note that markers may be used adjunctively during monitoring of metastatic disease, but rising values should not be used in isolation to declare progression.

When Testing Is Covered

Monitoring metastatic breast cancer when marker is already elevated; surveillance post-primary tumor removal in patients with previously elevated marker.

Covered when the following conditions are met

Monitoring previously elevated marker in metastatic breast cancer: Use CA 27.29 to follow an already elevated marker in patients with metastatic breast cancer as part of monitoring during active therapy

Recommend baseline and every 6 weeks during treatment; interpret rises cautiously in first 4–6 weeks of a new therapy

Surveillance after primary tumor removal with prior elevation: Use CA 27.29 for surveillance in patients who had elevated markers prior to removal of the primary tumor

Recommend testing every 3 months for post‑treatment follow‑up; increases alone are insufficient to establish recurrence and should prompt correlation with imaging and clinical assessment

Monitoring disease progression or recurrence may be considered in context of clinical picture (eg, bone-dominant metastatic disease) but rising markers should not be used in isolation to declare progression.

Recommended Testing Frequency

inv-26: CA 27.29 — Baseline and every 6 weeks

TestCA 27.29

IndicationDuring active treatment to monitor an already elevated titer or antigen in patients with metastatic disease

FrequencyBaseline and every 6 weeks to assess response

Use noteShould be used alongside imaging, history, and physical exam; interpret rises cautiously in early weeks of new therapy

inv-27: CA 27.29 — Every 3 months (post-treatment surveillance)

TestCA 27.29

Indication

Billing Codes and Clinical Coding Guidance

Covered CPT CodesCPT

No codes listed

CPT/HCPCSCPT

86300

Immunoassay for tumor antigen, quantitative; CA 15-3 (27.29)

ICD-10 DiagnosesICD-10

C50.011	Malignant neoplasm of nipple and areola, right female breast
C50.012	Malignant neoplasm of nipple and areola, left female breast
C50.021	Malignant neoplasm of nipple and areola, right male breast
C50.022	Malignant neoplasm of nipple and areola, left male breast
C50.111	Malignant neoplasm of central portion of right female breast
C50.112	Malignant neoplasm of central portion of left female breast
C50.121	Malignant neoplasm of central portion of right male breast
C50.122	Malignant neoplasm of central portion of left male breast
C50.211	Malignant neoplasm of upper-inner quadrant of right female breast
C50.212	Malignant neoplasm of upper-inner quadrant of left female breast

1–10 of 37

1/4

inv-11: Use of rising markers — Isolated increase should rarely be used to declare progression

GuidanceAn isolated increase in tumor markers should rarely be used to declare progression of disease

ContextRising markers may also be seen with responding disease; interpret in clinical context

Specific scenarioMarkers and patient symptoms may be more helpful in bone-dominant metastatic disease where radiology is limited

Provider Actions, Predetermination, and Verification

Prior Authorization

Predetermination/Preauthorization guidance

No review or update is scheduled on this Medical Policy as it is unlikely that further published literature would change the policy position. There were no claims being received for the service at the time of archiving. If there are questions about coverage of this service, please contact Blue Cross and Blue Shield of Kansas customer service, your professional or institutional relations representative, or submit a predetermination request.

Contact BCBSKS Customer Service to verify member eligibility and benefits.
Submit a predetermination request when coverage is unclear or to confirm benefits prior to providing services.
State and federal mandates and the member's contract language take precedence over this Medical Policy.

Note

Predetermination/prior authorization contact

The codes listed in the policy are informational. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement. Refer to the member's contract benefits in effect at the time of service to determine coverage or noncoverage.

Ordering Requirements and Prior Authorization

Note

Verify benefits and obtain predetermination if unclear

Verify member benefits with Blue Cross and Blue Shield of Kansas Customer Service prior to ordering; if coverage is unclear contact professional relations or submit a predetermination request.

Note

Follow member contract; contact BCBSKS for predetermination if unclear

Follow the member's contract for coverage determination and contact Blue Cross and Blue Shield of Kansas for predetermination when coverage is uncertain before ordering the test.

Services and Uses Not Covered

CA 15-3 or CA 27.29 are not covered when ordered for routine screening, diagnosis, staging, or prognostic purposes, or when used alone to monitor response or to declare disease progression. Serial marker elevations must be interpreted with clinical assessment and imaging; there are no validated, universally accepted criteria for interpreting isolated changes in marker levels.

The use of serum tumor markers as techniques to diagnose, determine prognosis, select therapy, assess response to therapy, or monitor for recurrence is considered unsupported by controlled evidence of clinical benefit and was previously characterized as experimental/investigational for certain gastrointestinal malignancies in earlier policy versions.

Background and Rationale

Serum tumor markers are proteins or other substances shed by tumors into the circulation where they can be detected and quantitated. Examples studied in breast cancer include markers related to the MUC-1 gene—CA 15-3 and CA 27.29—with CA 27.29 generally considered more sensitive. These markers have been evaluated for diagnosis, prognosis, monitoring therapy, and surveillance for recurrence, but they lack specificity, may be elevated in benign conditions (or with impaired clearance), and serial trends are generally more informative than single measurements.

Definitions

inv-21: Serum tumor marker — Molecules or substances shed by a tumor into the circulation where they can be detected and quantitated.

DefinitionMolecules or substances shed by a tumor into the circulation where they can be detected and quantitated.

ExamplesIncludes proteins such as CA 15-3, CA 27.29, HER2 extracellular domain, CEA

Interpretation noteSerial trends are generally more informative than single measurements; noncirculating markers exist (eg, tissue tests)

inv-22: CA 15-3 / CA 27.29 — Monoclonal antibody-based assays detecting epitopes encoded by the MUC-1 gene; CA 27.29 is reportedly more sensitive than CA 15-3.

Test descriptionCA 15-3 and CA 27.29 are monoclonal antibody–based assays detecting epitopes encoded by the MUC-1 gene

Comparative sensitivity

OpenPayer

Serum Tumor Markers for Breast Malignancies

Coverage Criteria for Serum Tumor Markers

When Testing Is Covered

Recommended Testing Frequency

Billing Codes and Clinical Coding Guidance

Provider Actions, Predetermination, and Verification

Ordering Requirements and Prior Authorization

Services and Uses Not Covered

Background and Rationale

Definitions