ModifiedBlue Cross Blue Shield - IllinoisPolicy CPCPLAB038

Urinary Tumor Markers for Bladder Cancer

Reimbursement and coding guidance for urinary tumor marker tests for bladder cancer and their use as adjuncts to cytology or cystoscopy, describing reimbursable and non-reimbursable indications and applicable procedure codes for Blue Cross Blue Shield - Illinois products and providers.

Policy Summary

PayerBlue Cross Blue Shield - Illinois

PolicyUrinary Tumor Markers for Bladder Cancer

Policy CodePolicy CPCPLAB038

Change TypeNew policy

Effective DateJan 1, 2026

Next Review DateN/A

Key ActionSubmit accurate documentation for services performed and provide additional documentation upon request to support claims and medical policy review.

SourceLink

POLICY UPDATE CHANGES

New policy.

3situations reimbursable

1reimbursable tests listed

7procedure codes listed

4not reimbursable examples

2026-01-01effective date token

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Coverage Criteria for Urinary Tumor Markers

Reimbursement criteria

Reimbursement guidance for urinary biomarkers and fluorescence immunocytology:

Covered when used as an adjunct in the diagnostic exclusion of bladder cancer for individuals who have an atypical or equivocal cytology: urinary biomarkers (BTA, NMP22, UroVysion FISH).

Covered when used as an adjunct in the monitoring of high-risk, non-muscle invasive bladder cancer: urinary biomarkers (BTA, NMP22, UroVysion FISH).

Covered when used as an adjunct to cystoscopy or cytology in the monitoring of individuals with bladder cancer: fluorescence immunocytology (ImmunoCyt/uCyt).

Not reimbursable for the evaluation of hematuria, for screening asymptomatic individuals for bladder cancer, for diagnosing bladder cancer in symptomatic individuals, or for any other indications not listed as reimbursable: urinary biomarkers (BTA, NMP22, UroVysion FISH) and fluorescence immunocytology (ImmunoCyt/uCyt).

Any other urinary tumor markers for bladder cancer not mentioned above are not reimbursable.

Coverage information missing in provided segment

No coverage criteria available in this excerpt.

Coverage stance and specific criteria not present in these chunks; see other parts of the policy for detailed coverage rules.

Procedure and Laboratory Coding

Procedure and laboratory codes mentionedCPT

86294
86316
86386
88120
88121
88346
88350
0012M
0013M
0363U

1–10 of 17

1/2

References to tests and biomarkers in literature (no CPT/HCPCS codes listed in this segment)mixed

No codes listed

inv-05: Evidence citations

Selected primary studiesPiao et al. 2019: urinary cell-free microRNA biomarker discriminates bladder cancer from benign hematuria (Int J Cancer).

mRNA-based urine test accuracy studyPichler et al. 2018: increased accuracy of novel mRNA-based urine test for bladder cancer surveillance (BJU Int).

Systematic reviews and meta-analysesSathianathen et al. 2018; Tan et al. 2018: systematic reviews and meta-analyses of urinary biomarkers for hematuria and bladder cancer detection.

Consensus/guideline resourcesSchmitz-Dräger et al. 2015 (WHO/ICUD consensus) and EAU/urothelial cancer guideline references (Witjes et al. 2022) provide guideline context on molecular markers.

USPSTF screening statementUSPSTF 2021: Bladder Cancer in Adults — screening guidance referenced.

Provider Documentation and Actions

Documentation Required

Documentation and claims review — submit accurate documentation and provide additional records on request

Providers must submit accurate documentation of services performed, use valid HIPAA-approved code combinations, and code claims according to industry-standard coding guidelines. Claims are subject to code edit protocols and medical policy review, and upon request providers are urged to submit additional documentation to support the claim.

Submit claims using valid HIPAA-approved code sets and appropriate code combinations.
Code claims per industry standards (UB, AMA CPT, HCPCS, ICD-10, NDCs, DRG, CMS CCI edits).
Be prepared to provide additional documentation upon request; claims are subject to claim review and code edit protocols.

Note

Policy creation note — new policy effective 01/01/2026; no authorization/billing/step therapy rules in this segment

This policy was created with an effective date of 01/01/2026. No prior authorization, billing edits, or step therapy requirements are specified in the provided policy segment.

Policy Update History: 09/05/2025 entry indicating Summary of Changes = 01/01/2026: New policy.
No prior authorization, billing rule, or step therapy provisions appear in the cited segment.

Definitions and Related Items

inv-08: Plan documents

Definition of plan documentsPlan documents include Certificates of Health Care Benefits, benefit booklets, Summary Plan Descriptions, and other coverage documents; these govern in case of conflict with policy.

Applicability noteNot all lab management reimbursement criteria apply to every product; providers should review plan documents for eligible coverage.

Provider contract precedenceIf a conflict arises between policy and a provider contract, the provider contract will govern.

inv-09: References (51-63)

Scope of cited literatureReferences 51–63 include primary studies, diagnostic accuracy studies, and early cost-effectiveness analyses related to urinary biomarkers (e.g., Piao 2019; Pichler 2018; Sutton 2018).

Guidance and consensus statementsIncludes WHO/ICUD consensus on molecular markers for bladder cancer screening, diagnosis, and surveillance (Schmitz-Dräger et al. 2015).

Test-specific reports and evaluationsCommercial/diagnostic test sources cited (Protean Biodiagnostics URO17; Quest Bladder Tumor Antigen DetectR™).

Recent guideline resourcesWitjes et al. 2022 (EAU/muscle-invasive and metastatic bladder cancer guideline) and USPSTF 2021 screening statement are included.

inv-10: Policy Update History

Policy creation entryNew policy created. Summary of changes notes: 01/01/2026 — New policy.

Policy Update date recorded09/05/2025 listed as Effective Date entry in Policy Update History referencing the 01/01/2026 summary of changes.

Policy identifierPolicy number CPCPLAB038 (policy context indicates new policy creation).