DraftBlue Cross Blue Shield - OklahomaPolicy CPCPLAB038

Urinary Tumor Markers for Bladder Cancer

This policy defines reimbursement and coding guidance for urinary biomarkers and tumor marker tests used to detect or monitor bladder cancer for Blue Cross and Blue Shield of Oklahoma members and providers.

Policy Summary

PayerBlue Cross Blue Shield - Oklahoma

PolicyUrinary Tumor Markers for Bladder Cancer

Policy CodePolicy CPCPLAB038

Change TypeAdded billing codesliterature/references updated

Effective DateApril 15, 2025

Next Review DateN/A

Key ActionReview current payer code list and prior authorization requirements before submitting claims.

SourceLink

POLICY UPDATE CHANGES

Added code 0549U.

Added codes 0420U and 0465U.

Document updated with literature review; reimbursement information unchanged in 04/29/2024 update

Document updated with literature review and reimbursement information revised for clarity on 11/01/2023

New policy created 11/01/2022

1.0policy version

2025-04-15plan effective

Adjunct onlycoverage stance

Hematuria/screeningexplicit denials

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Coverage Criteria for Urinary Tumor Markers

Reimbursable Indications (Adjunctive use)

Covered when used as an adjunct in specific situations:

Adjunct diagnostic uses: Urinary biomarkers (BTA, NMP22, UroVysion FISH) may be reimbursable as an adjunct in: (1) diagnostic exclusion of bladder cancer for individuals with atypical or equivocal cytology; or (2) monitoring of high-risk, non–muscle-invasive bladder cancer.

Supported by chunk 3

ImmunoCyt/uCyt adjunct use

Covered when used as adjunct to cystoscopy/cytology:

ImmunoCyt adjunct use: Fluorescence immunocytology (ImmunoCyt/uCyt) may be reimbursable as an adjunct to cystoscopy or cytology for monitoring individuals with bladder cancer.

Supported by chunk 3

Adjunct to exclude bladder cancer when cytology is atypical or equivocal

Applies to urinary biomarkers: BTA, NMP22, UroVysion FISH

Adjunct to exclude when cytology atypical/equivocal: Test is used as an adjunct to exclude bladder cancer when cytology findings are atypical or equivocal.

Applies to BTA, NMP22, UroVysion FISH; supported by chunk 3

Adjunct in monitoring high-risk, non–muscle-invasive bladder cancer

Applies to urinary biomarkers: BTA, NMP22, UroVysion FISH

Adjunct monitoring high-risk NMIBC: Used as an adjunct in the monitoring of individuals with high‑risk, non‑muscle‑invasive bladder cancer.

Applies to BTA, NMP22, UroVysion FISH; supported by chunk 3

Adjunct to cystoscopy or cytology for monitoring bladder cancer

Applies to ImmunoCyt/uCyt fluorescence immunocytology

Adjunct to cystoscopy/cytology for monitoring: Fluorescence immunocytology (ImmunoCyt/uCyt) may be reimbursable as an adjunct to cystoscopy or cytology for monitoring individuals with bladder cancer.

Supported by chunk 3

Not Reimbursable Indications

Not reimbursable for the following indications:

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

Explicit denial language in chunk 3

Any urinary tumor markers for bladder cancer not specifically mentioned in this policy are considered not reimbursable. This includes newer or other urine-based tumor marker assays beyond the tests named (BTA, NMP22, UroVysion FISH, ImmunoCyt/uCyt).

This policy fragment does not contain additional, explicit coverage criteria, medical necessity rules, or exclusion lists beyond the reimbursable and non-reimbursable statements. The document does, however, include literature and vendor references and a policy update history; providers should consult the complete policy and referenced materials for supporting evidence and details.

The use of listed urinary biomarkers (bladder tumor antigen/BTA, NMP22, UroVysion FISH) or fluorescence immunocytology (ImmunoCyt/uCyt) is not reimbursable when performed for: evaluation of hematuria, screening asymptomatic individuals for bladder cancer, diagnosis in symptomatic individuals, or any other indications not described as adjunctive or otherwise reimbursable in this policy.

Not specified in this portion of the document.

Covered Indications (fragment)

References and other biomarker tests are discussed but no explicit covered indications are stated in this fragment:

Tests referenced without explicit coverage: Several urine‑based biomarker tests (e.g., Bladder CARE, BLADDER EPICHECK, URO17, Bladder Tumor Antigen DetectR, and others) are referenced in the literature and vendor materials; this fragment does not itself establish separate reimbursable indications for those tests.

Supported by reference list in chunks 18–21

Procedure and Billing Codes

Procedure/Service Codes referencedmixed

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

1–10 of 16

1/2

Policy-added CPT/PLA CodesCPT

0420U	code added (description not provided in this fragment)
0465U	code added (description not provided in this fragment)
0549U	code added (description not provided in this fragment)

Coding

Primary CPT/PLA codes referenced86294, 86316, 86386, 88120, 88121, 88346, 88350, 0012M, 0013M, 0363U, 0365U, 0366U, 0367U, 0420U, 0465U, 0549U

Policy-added CPT/PLA codes (recent updates)0420U, 0465U, 0549U

Coding systemMixed CPT, PLA and HCPCS-style codes as listed

Provider Actions, Billing and Prior Authorization Notes

Documentation Required

Plan applicability and documentation

The Plan has implemented certain lab management reimbursement criteria. Not all requirements apply to each product. Providers are urged to review Plan documents for eligible coverage for services rendered.

Prior Authorization

Prior authorization and product applicability

Providers must verify prior authorization and product-specific requirements with the member's plan before ordering or billing lab tests. Not all codes or indications are covered for every product; check plan documents and PA systems for applicability.

Verify prior authorization requirements with the member's plan
Review plan documents (Certificates, benefit booklets, SPDs) for product-specific applicability

Background and Test Overview

Urinary biomarkers — including the bladder tumor antigen (BTA) test, nuclear matrix protein (NMP22) test, UroVysion fluorescence in situ hybridization (FISH), and fluorescence immunocytology (ImmunoCyt/uCyt) — are urine-based assays used as adjuncts in the diagnosis and surveillance of urothelial (bladder) cancer. Per the policy, these tests may be reimbursable as adjuncts when used to exclude bladder cancer after atypical or equivocal cytology or for monitoring high-risk, non–muscle-invasive bladder cancer, and ImmunoCyt/uCyt may be reimbursable as an adjunct to cystoscopy or cytology for monitoring.

Definitions and Test Names

UroVysion FISH — definition

TermUroVysion FISH (fluorescence in situ hybridization)

UseUrinary biomarker assay referenced for adjunctive diagnostic use when cytology is atypical or equivocal and for monitoring high-risk non–muscle-invasive bladder cancer

Policy statusMay be reimbursable as an adjunct per policy; not reimbursable for hematuria evaluation, screening asymptomatic individuals, or primary diagnosis in symptomatic individuals

NMP22 — definition

TermNMP22 (nuclear matrix protein test)

UseUrinary biomarker assay referenced for adjunctive diagnostic use when cytology is atypical or equivocal and for monitoring high‑risk non–muscle-invasive bladder cancer

Frequency and Ordering Limits

Frequency limits — overview

Frequency rule presentNo specific frequency limits defined in this policy fragment

Recommendation to providersReview plan documents for product-specific requirements as not all lab management criteria apply to every product

Claims implicationAbsence of frequency limits in this document means claims will be adjudicated per plan/product rules or other payer guidance

Frequency limits — literature/reference notes

Documented frequency dataNo test‑specific limit or period is provided in the reference or literature fragments cited

ImplicationEmerging biomarkers referenced in literature lack explicit policy frequency limits; coverage determination requires plan rules or policy naming

Ordering and Authorization Requirements

Note

Check plan coverage and provide supporting documentation when ordering

Review plan documents for eligible coverage and any ordering restrictions, and ensure submitted documentation supports the medical necessity and adjunctive indication for the test ordered.

Confirm whether the member's specific product/benefit applies to the lab management criteria in this policy.
Be prepared to supply clinical notes showing cytology atypia/equivocal results or rationale for monitoring high‑risk disease.

Note

Confirm who may order tests if unsure — policy does not specify

The policy fragment does not specify clinician‑type restrictions for who may order these tests (e.g., PCP vs specialist); if ordering privileges are in question, confirm with the member's plan or provider contract.

When unclear, verify ordering provider rules in the member's plan documents or with payer provider relations.
Follow any payer-specific ordering or PA rules discovered in plan documents.

Not Covered Indications

Urinary biomarkers (BTA, NMP22, UroVysion FISH) and fluorescence immunocytology (ImmunoCyt/uCyt) are not covered when used for the following purposes: evaluation of hematuria, screening of asymptomatic individuals for bladder cancer, diagnosing symptomatic individuals, or for any other indications not listed as reimbursable in this policy. Additionally, any urinary tumor markers not named in the policy are also not covered.

This portion of the document does not list additional specific tests or indications that are not covered; the fragment primarily provides references and policy update history rather than expanded exclusion lists.