Currentblue cross blue shield - louisianaPolicy AHS - G2125

Urinary Tumor Markers for Bladder Cancer

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This policy governs coverage criteria for urinary tumor marker tests used to detect or monitor bladder cancer for members of Blue Cross Blue Shield - Louisiana. It specifies when certain urinary biomarker tests meet coverage criteria and which tests do not meet coverage criteria.

Policy Summary

Payerblue cross blue shield - louisiana

PolicyUrinary Tumor Markers for Bladder Cancer

Policy CodePolicy AHS - G2125

Change TypeLiterature reviewno changes to coverage criteria

Effective DateAug 1, 2026

Last ReviewAug 1, 2026

Next Review DateAug 1, 2026

Key ActionVerify member benefits and prior authorization requirements at time of request.

SourceLink

OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.

Currentblue cross blue shield - louisianaPolicy AHS - G2125

Urinary Tumor Markers for Bladder Cancer

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Policy Summary

Payerblue cross blue shield - louisiana

PolicyUrinary Tumor Markers for Bladder Cancer

Policy CodePolicy AHS - G2125

Change TypeLiterature reviewno changes to coverage criteria

Effective DateAug 1, 2026

Last ReviewAug 1, 2026

Next Review DateAug 1, 2026

Key ActionVerify member benefits and prior authorization requirements at time of request.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2 situationsAdjunct coverage

hematuria/screeningExcluded uses

UroVysion, ImmunoCytFDA-listed tests

do not replace cystoscopyGuideline consensus

08/01/2026Last review

Coverage Criteria for Urinary Tumor Markers

Inv-01: Covered Indications (Adjunct to cystoscopy)

Covered when ANY of the following are met as an adjunct to cystoscopy:

Adjunct coverage indications: Urinary biomarker testing (BTA, NMP22, or FISH UroVysion) meets coverage criteria when used as an adjunct to cystoscopy for either: a) diagnostic exclusion of bladder cancer in individuals with atypical or equivocal urinary cytology; OR b) monitoring of high-risk, non–muscle invasive bladder cancer.

From policy 'III. Indications and/or Limitations of Coverage'

Inv-02: Covered Indication — ImmunoCyt/uCyt

Covered when ALL of the following are met as an adjunct:

ImmunoCyt/uCyt adjunct monitoring: Fluorescence immunocytology (ImmunoCyt/uCyt) meets coverage criteria when used as an adjunct to cystoscopy or urinary cytology for monitoring individuals with bladder cancer.

From policy 'III. Indications and/or Limitations of Coverage'

Inv-03: Guideline-based coverage positions

Guidelines generally agree on the following conditional positions:

Adjunctive use: Urinary tumor markers may be considered as adjuncts to cystoscopy for surveillance of high-risk non–muscle-invasive bladder cancer or to improve detection during cystoscopic evaluation, but should not replace cystoscopy.

Supported by NCCN, AUA/SUO, EAU, ICUD-SIU

Use in equivocal situations: Markers (eg, UroVysion FISH, ImmunoCyt) may be used to adjudicate equivocal cytology or assess response to intravesical BCG therapy.

Referenced in AUA/SUO and guideline updates

Not for routine initial evaluation of microhematuria: Urine markers and urine cytology are not recommended for routine initial evaluation to decide whether to perform cystoscopy in patients with asymptomatic microhematuria due to insufficient evidence of added value.

AUA microhematuria guideline statements

Inv-04: Coverage criteria status

Policy coverage criteria unchanged after literature review

Coverage criteria are defined in the policy. Literature review and recent advisory review did not necessitate modifications to coverage criteria.

Review/Revision History: literature review did not necessitate changes to coverage criteria.

Use of urinary tumor biomarkers (including BTA, NMP22, and UroVysion FISH) and ImmunoCyt/uCyt is covered only when used as an adjunct to cystoscopy in specific situations described in the policy. Specifically, these tests meet coverage criteria when used to: 1) help exclude bladder cancer in individuals with atypical or equivocal urinary cytology, or 2) monitor individuals with high-risk, non–muscle invasive bladder cancer. Outside these adjunctive indications, the listed urinary biomarkers and ImmunoCyt/uCyt do not meet coverage criteria.

Any urinary tumor marker for bladder cancer that is not explicitly named in this policy is considered not to meet coverage criteria. The policy lists BTA, NMP22, UroVysion FISH, and ImmunoCyt/uCyt as covered adjuncts in defined situations; other markers not mentioned above do not meet coverage.

Urinary biomarkers are intended as adjuncts and should not replace cystoscopy for diagnosis or routine surveillance. Clinical guidelines cited in the policy (AUA/SUO, EAU and others) consistently state that biomarkers may be used to adjudicate equivocal cytology or assess response to intravesical therapy, but a biomarker alone is not a substitute for cystoscopic evaluation. For patients with a history of low‑risk disease and a normal cystoscopy, routine use of urinary biomarkers or cytology during surveillance is not recommended.

Policy history documents that at initial implementation an exclusion was specified for use of urinary tumor markers in patients who have an atypical or equivocal cytology. The current policy, however, clarifies that such markers (BTA, NMP22, UroVysion) may meet coverage criteria as an adjunct to cystoscopy specifically to aid diagnostic exclusion in individuals with atypical or equivocal urinary cytology.

Testing with urinary tumor markers (including BTA, NMP22, UroVysion, and ImmunoCyt/uCyt) does not meet coverage criteria when ordered for evaluation of hematuria, for screening asymptomatic individuals for bladder cancer, to diagnose bladder cancer in symptomatic individuals, or for any indication not explicitly listed as meeting coverage.

Routine screening of asymptomatic adults for bladder cancer with urine tumor markers is unsupported by current evidence and is therefore not recommended. The USPSTF and the National Cancer Institute conclude that evidence is inadequate to support screening of asymptomatic individuals with urine markers, and the policy states that such screening does not meet coverage criteria.

The most recent literature review and policy update (effective 08/01/2026) did not necessitate changes to the coverage criteria. There are no explicit new statements in the reviewed sections designating additional tests as 'not medically necessary' beyond the existing coverage exclusions; the policy coverage stance remains unchanged after review.

Procedure and Proprietary Test Codes

Applicable CPT/HCPCS Procedure Codesmixed

No codes listed

Applicable CPT CodesCPT

86294	Immunoassay for tumor antigen, qualitative or semiquantitative (eg, bladder tumor antigen).
86316	Immunoassay for tumor antigen, other antigen, quantitative (eg, CA 50, 72-4, 549), each.
86386	Nuclear Matrix Protein 22 (NMP22), qualitative.
88120	Cytopathology, in situ hybridization (eg, FISH), urinary tract specimen with morphometric analysis, 3-5 molecular probes, each specimen; manual.
88121	Cytopathology, in situ hybridization (eg, FISH), urinary tract specimen with morphometric analysis, 3-5 molecular probes, each specimen; using computer-assisted technology.
88346	Immunofluorescence, per specimen; initial single antibody stain procedure.
88350	Immunofluorescence, per specimen; each additional single antibody stain procedure.

Applicable HCPCS / Proprietary Test CodesHCPCS

0365U

Oncology (bladder), analysis of 10 protein biomarkers by immunoassays, urine, diagnostic algorithm (Oncuria® Detect).

Codes referenced/modified in revision historymixed

0012M	PLA/CPT code removed from this policy
0013M	PLA/CPT code removed from this policy
0363U	PLA/CPT code removed from this policy
0365U	PLA code mentioned in prior revisions (see history)
0366U	PLA code mentioned in prior revisions (see history)
0367U	PLA code mentioned in prior revisions (see history)
0420U	PLA/CPT code removed from this policy
0452U	PLA/CPT code removed from this policy
0465U	PLA/CPT code removed from this policy
0549U	PLA/CPT code removed from this policy

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Provider Actions, Documentation, and Billing Guidance

Prior Authorization

Verify member benefits / prior authorization

Verify member benefits and prior authorization requirements at the time of the request; coverage determination depends on the member's individual benefit plan and any Medicare/Medicaid specifications in the policy.

Prior Authorization

Document procedure code and proprietary assay when requesting coverage

When requesting coverage, document the specific CPT/HCPCS or proprietary test code being billed (examples include CPT codes 86294, 86386, 88120–88121, 88346–88350 and HCPCS 0365U for Oncuria® Detect).

Include the test name and code (e.g., Oncuria® Detect — 0365U) on authorization requests.

Background and Clinical Context

Bladder cancer most commonly arises from the urothelium and often presents with hematuria. Cystoscopy (white light) is the diagnostic gold standard and is required for definitive diagnosis and histologic confirmation. Urinary tumor markers have been developed to provide noninvasive, adjunctive information; however, their sensitivity and specificity vary. Current guidance and the policy position limit coverage of these assays to adjunctive use with cystoscopy for specific clinical scenarios (for example, adjudication of equivocal cytology and surveillance of high‑risk non–muscle invasive disease).

Definitions and Test Descriptions

BTA — bladder tumor antigen description

Test targetDetects complement factor H-related protein (hCFHrp) elevated in bladder cancer cells

Available formatsQualitative (BTA stat) and quantitative (BTA TRAK) assays

Manufacturer cut-offManufacturer-recommended cut-off ~14 U/mL (quantitative) as reported by manufacturers

FDA status and indicationFDA-cleared tests (BTA stat, BTA TRAK) indicated as an aid in management of bladder cancer in conjunction with cystoscopy

NMP22 — nuclear matrix protein 22 description

Test targetDetects nuclear matrix protein 22 (NMP22), a protein released from cancer cells during apoptosis

Policy Summary

Payerblue cross blue shield - louisiana

PolicyUrinary Tumor Markers for Bladder Cancer

Policy CodePolicy AHS - G2125

Change TypeLiterature reviewno changes to coverage criteria

Effective DateAug 1, 2026

Last ReviewAug 1, 2026

Next Review DateAug 1, 2026

Key ActionVerify member benefits and prior authorization requirements at time of request.

SourceLink

On This Page

Screening asymptomatic adults for bladder cancer using urine markers is unsupported due to inadequate evidence and no demonstrated mortality benefit.

NCI and guideline statements

Billing Rule

Codes migrated to G2054 — follow current GTM policy

Several PLA/CPT codes were removed from this policy and are now managed under GTM policy G2054; follow the authorization requirements and coding guidance in the policy that currently manages those codes.

Codes removed from this policy and moved to G2054 include 0012M, 0013M, 0363U, 0420U, 0452U, 0465U, 0549U and 0613U.

Documentation Required

State clinical indication and adjunctive use with cystoscopy

Ensure that any request for urinary tumor marker testing cites the specific clinical indication and that the test is being used as an adjunct to cystoscopy when claiming coverage.

Indicate whether the test is for diagnostic exclusion in atypical/equivocal cytology or for monitoring high‑risk NMIBC.

Step Therapy

No step therapy; urine markers do not replace cystoscopy

No step therapy requirements are specified in this policy; do not use urine tumor markers as a replacement for cystoscopy — markers are considered adjuncts to cystoscopic evaluation.

Markers may be used adjunctively for surveillance or to adjudicate equivocal cytology but should not replace cystoscopy.

Documentation Required

Document exact test name and rationale for medical necessity

When ordering tests, include the exact test name (proprietary or LDT) and rationale in the clinical documentation to support medical necessity under the policy.

Specify whether the assay is FDA‑approved (e.g., UroVysion, ImmunoCyt) or a laboratory‑developed test requiring CLIA validation.

Prior Authorization

Confirm benefit applicability for each member

Benefit application is dependent on the individual's coverage at the time of request; verify plan specifics and Medicare/Medicaid applicability per the policy's state and federal regulations section.

Medicare/Medicaid specifications are outlined in the 'Applicable State and Federal Regulations' section and govern when in conflict.

Documentation Required

Document use with cystoscopy/cytology and specify the test

Document that urine marker testing was performed in conjunction with cystoscopy and/or cytology and name the specific test used (many assays are LDTs and several FDA‑approved tests are indicated as adjuncts).

Record contemporaneous cystoscopy/cytology findings and the specific marker assay (brand/name) in the chart.

Documentation Required

Reference coding revisions and GTM policy for migrated codes

Note coding revisions in the record and follow current coding guidance; if a code has been migrated to GTM policy G2054, reference that policy for authorization and billing instructions.

Policy revision history lists removed/migrated codes and instructs providers to use the managing policy for those codes.

Denial Risk

Do not submit requests for hematuria evaluation or asymptomatic screening

Requests for urinary tumor marker testing will be denied when used for evaluation of hematuria, screening asymptomatic individuals, or diagnosing symptomatic individuals — these indications do not meet coverage criteria.

Tests specifically excluded for these indications include BTA, NMP22, UroVysion, and ImmunoCyt when used for hematuria evaluation or screening.

Denial Risk

Government coverage (LCD/NCD) may govern and cause denial

If an applicable government policy (LCD or NCD) conflicts with this policy for the member, the government policy will govern and may result in denial if that policy disallows coverage.

Check Medicare and state Medicaid coverage determinations at the CMS coverage database or applicable state Medicaid site.

Denial Risk

Coding-based denial risk for tests moved to G2054

Tests that were removed from this policy or mapped to another policy (G2054) may be denied if billed under this policy; ensure billing uses the policy that currently manages the code.

Do not bill migrated PLA/CPT codes under this policy; follow GTM policy G2054 for those codes.

Available formatsQuantitative (enzyme immunoassay) and qualitative (BladderChek) versions

FDA-approved cut-offFDA-approved cut-off ~10 U/mL for quantitative assays

FDA status and indicationFDA-approved NMP22 tests (Matritech NMP22 Test Kit, NMP22 BladderChek) indicated for use as an aid in management of bladder cancer in conjunction with standard diagnostic procedures/cystoscopy

UroVysion (FISH) — description

MethodologyFluorescence in situ hybridization (FISH) assay using DNA probes

Targets detectedAneuploidy of chromosomes 3, 7, and 17 or loss of the 9p21 locus

FDA status and indicationUroVysion Bladder Cancer Kit is FDA-approved to detect these chromosomal alterations in urine specimens and indicated to aid evaluation of patients suspected of bladder cancer

ImmunoCyt (uCyt+) — description

MethodologyFluorescence immunocytology (direct immunofluorescence)

Targets detectedSpecific glycoproteins expressed on malignant urothelial cells

FDA status and indicationImmunoCyt (uCyt+) is FDA-approved for use as an adjunct to cytology and cystoscopy to increase sensitivity for detecting tumor cells and is indicated for surveillance use

Examples include FDA-approved tests (BTA stat, BTA TRAK, NMP22, UroVysion, ImmunoCyt)

FDA-approved BTA testsBTA stat (qualitative) and BTA TRAK (quantitative) — FDA-cleared as aids in management in conjunction with cystoscopy

FDA-approved NMP22 testsMatritech NMP22 Test Kit (quantitative) and NMP22 BladderChek (qualitative) — FDA-approved as aids in management/surveillance

Other FDA-approved assaysUroVysion (FISH) and ImmunoCyt (uCyt+) — FDA-approved urinary tumor marker tests

Laboratory-developed tests (LDTs) — in-house assays under CLIA

DefinitionLaboratory-developed tests (LDTs) are in-house assays that laboratories develop and validate under CLIA '88; they are not FDA-cleared or approved

Regulatory oversightRegulated by CMS as high-complexity tests under CLIA '88 rather than by FDA

Clinical use noteFDA clearance/approval is not required for clinical use of LDTs per the policy text

Urinary tumor markers — definition and types (protein, genetic, epigenetic, proteomic)

DefinitionUrinary tumor markers are urine-based assays (protein, genetic, epigenetic, or proteomic) intended to detect or monitor bladder cancer

Types/examplesProtein markers (eg, BTA, NMP22), genetic/epigenetic markers (eg, URO17), and proteomic multi-marker panels (eg, Oncuria)

Intended roleTypically used as adjuncts to cystoscopy or cytology for detection or surveillance rather than as standalone screening tests