CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

Urinary Tumor Marker Tests for Bladder and Colorectal Polyp Screening/Monitoring

This policy addresses coverage and coding for urinary tumor marker tests used for screening, diagnosis, or monitoring of bladder cancer and for screening for precancerous colonic polyps for Blue Cross Blue Shield - Rhode Island members.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyUrinary Tumor Marker Tests for Bladder and Colorectal Polyp Screening/Monitoring

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionOrdering physicians must verify member benefits and submit authorization/documentation themselves; laboratories may not obtain authorizations on the provider's behalf.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

NCCN/AUA/SUO/USPSTFguideline sources cited

3guideline sources count

50%-75%NMIBC recurrence

90%-100%urine cytology specificity

50%-60%urine cytology sensitivity

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.

Coverage Criteria

Coverage stance by product type

Medicare Advantage - coverage stance: Use of urinary tumor markers is not covered for screening, diagnosis, or monitoring of bladder cancer or screening for precancerous colonic polyps in Medicare Advantage Plans.

Refer to the Coding section for details.

Commercial products - coverage stance: Use of urinary tumor markers is considered not medically necessary for screening, diagnosis, or monitoring of bladder cancer or screening for precancerous colonic polyps for Commercial products.

Some genetic testing services may be subject to contract exclusions per the Biomarker Testing Mandate policy; refer to the Coding section and the member's Benefit Booklet for plan-specific coverage.

Some genetic testing services may be excluded from coverage for self‑funded groups that have opted out of the state biomarker testing mandate (R.I.G.L. §27‑19‑81). For these employer groups, coverage determinations (including services covered with prior authorization, services considered not medically necessary, and services that are contract exclusions) are specified in the Coding sections of the Genetic Testing Services and Proprietary Laboratory Analyses policies and in the member's Benefit Booklet.

Member benefits, the subscriber agreement or member certificate, and employer participation agreements take precedence over this medical policy. Verify member‑specific benefits and eligibility with the provider call center; those documents will supersede the provisions of this policy when determining coverage.

For Medicare Advantage Plans, the use of urinary tumor markers is not covered for screening, diagnosis, or monitoring of bladder cancer, or for screening for precancerous colonic polyps. For Commercial products, the use of urinary tumor markers is considered not medically necessary for the same indications. Refer to the Coding section for specific test and CPT/HCPCS code details.

Coding and Billing

Not covered / Not medically necessary (selected immunoassays)CPTNot Covered

86294	Immunoassay for tumor antigen, qualitative or semi quantitative (e.g., bladder tumor antigen)
86386	Nuclear Matrix Protein 22 (NMP22), qualitative

Proprietary/PLA test codes referencedmixed

0012M	Oncology (urothelial), mRNA, gene expression profiling by real-time quantitative PCR of five genes (MDK, HOXA13, CDC2 [CDK1], IGFBP5, and XCR2), utilizing urine, algorithm reported as a risk score for having urothelial carcinoma (CxBladder Detect)
0013M	Oncology (urothelial), mRNA, gene expression profiling by real-time quantitative PCR of five genes (MDK, HOXA13, CDC2 [CDK1], IGFBP5, and CXCR2), utilizing urine, algorithm reported as a risk score for having recurrent urothelial carcinoma (CxBladder Monitor)
0002U	Oncology (colorectal), quantitative assessment of three urine metabolites (ascorbic acid, succinic acid and carnitine) by liquid chromatography with tandem mass spectrometry (LC-MS/MS), algorithm reported as likelihood of adenomatous polyps (PolypDX)
0363U	Oncology (urothelial), mRNA gene expression profiling by real-time quantitative PCR of 5 genes (MDK, HOXA13, CDC2 [CDK1], IGFBP5, and CXCR2), utilizing urine, algorithm incorporates age, sex, smoking history, and macrohematuria frequency, reported as a risk score for having urothelial carcinoma (Cxbladder Triage)
0420U	Oncology (urothelial), mRNA expression profiling by real-time quantitative PCR of MDK, HOXA13, CDC2, IGFBP5, and CXCR2 in combination with droplet digital PCR (ddPCR) analysis of single-nucleotide polymorphisms in TERT and FGFR3, urine, algorithm reported as a risk score for urothelial carcinoma (Cxbladder Detect+)

Provider Actions and Authorization

Prior Authorization

Prior Authorization Not Applicable

Prior authorization: Not applicable. The ordering physician is responsible for any authorization, documentation, and appeals related to medical necessity. Laboratories may not obtain authorizations on behalf of the ordering physician.

Prior authorization not applicable — ordering physician responsible
Authorization and documentation must be handled by the ordering physician

Documentation Required

Verify Benefits and Medical Necessity

Verify member-specific benefits and medical necessity requirements before providing services. Providers should contact the BCBSRI provider call center for eligibility and benefit verification and retain documentation supporting medical necessity.

Benefit and medical necessity dependent on member benefits and eligibility — contact provider call center for verification
Providers should document medical necessity and retain supporting records

Background

Bladder cancer commonly presents with hematuria and is typically diagnosed by cystoscopy with biopsy. Approximately 70% of bladder cancers are non–muscle‑invasive at diagnosis and carry a high recurrence risk (about 50%–75% recurrence), which necessitates periodic surveillance with cystoscopy and urine cytology. Urine cytology has high specificity but limited sensitivity, particularly for low‑grade tumors, and this performance gap has driven evaluation of urinary tumor markers as adjunctive tests for detection and surveillance.

Definitions and Test Descriptions

Non–muscle-invasive bladder cancer

DefinitionNon–muscle-invasive bladder cancer (NMIBC) — bladder cancer confined to the epithelium or subepithelial connective tissue at diagnosis; typically managed with transurethral resection with or without intravesical therapy and requires periodic surveillance due to high recurrence.

Prevalence at diagnosisApproximately 70% of bladder cancers are non–muscle-invasive at initial diagnosis.

Recurrence riskObserved recurrence rate is 50%–75% with 10%–15% progressing to muscle invasion over 5 years.

SurveillanceFollow-up protocols commonly include flexible cystoscopy and urine cytology every 3 months for 1–3 years, then every 6 months for 2–3 years, then annually if no recurrence.

Clinical contextUrine cytology is specific (90%–100%) but has limited sensitivity (50%–60%), especially for low-grade tumors, motivating investigation of adjunct urinary tumor markers.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyUrinary Tumor Marker Tests for Bladder and Colorectal Polyp Screening/Monitoring

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionOrdering physicians must verify member benefits and submit authorization/documentation themselves; laboratories may not obtain authorizations on the provider's behalf.

SourceLink

On This Page

Denial Risk

Denial Risk for Unauthorized Lab Services

Unauthorized laboratory services will be denied. If a laboratory provides a service that has not been authorized, the service will be denied and the financial liability will fall on the participating laboratory; the service may not be billed to the member.

Unauthorized laboratory services will be denied and may not be billed to the member

Billing Rule

Laboratory Participation Prohibited

Laboratories are prohibited from participating in or obtaining prior authorizations on behalf of the ordering physician. Use of a laboratory or a laboratory-affiliated representative to obtain authorization or support appeals is a violation and may result in severe action up to termination from the BCBSRI provider network.

Prohibition on lab participation in authorization or appeals
If a lab or third party supports the authorization process, BCBSRI may take action up to termination from the provider network

FDA-cleared urinary tumor marker tests

FDA-cleared assays (examples)BTA stat and BTA TRAK (bladder tumor-associated antigen)

NMP22 assaysAlere NMP22 (quantitative NuMA/mitotic apparatus protein in stabilized voided urine) and BladderChek (adjunct to cystoscopy)

UroVysion FISHUroVysion — aid in initial diagnosis and monitoring of previously diagnosed bladder cancer (Abbott Molecular)

Bladder EpiCheckBladder EpiCheck — monitoring for tumor recurrence in conjunction with cystoscopy in patients with previously diagnosed NMIBC (Nucleix)

NoteThese FDA-cleared tests include both immunoassays and molecular/cytogenetic assays cleared for adjunctive use with cystoscopy and/or monitoring.

FGFR3 mutation analysis

DefinitionFGFR3 — fibroblast growth factor receptor 3; mutation analysis of FGFR3 performed on voided urine has been studied for surveillance of patients with low-grade NMIBC.

Clinical use (study)Referenced study: Zuiverloon et al., Clin Cancer Res. 2010;16(11):3011-8 — FGFR3 mutation analysis on voided urine for surveillance.

RoleUsed as a urinary molecular marker evaluated for detection/surveillance of low-grade non–muscle-invasive bladder cancer in published research.

NMP22 (nuclear matrix protein 22) urine test

Test nameNMP22 (Nuclear Matrix Protein 22) urine test — detects NuMA/mitotic apparatus protein in voided urine; used as an adjunct to cystoscopy for detection of recurrent bladder cancer.

Clinical evidenceMultiple references discuss NMP22 performance and utility in surveillance (eg, Grocela & McDougal, Urol Clin North Am. 2000; Shariat et al., Cancer. 2011).

Performance contextUrine cytology is highly specific but has limited sensitivity; NMP22 has been evaluated as an adjunctive urinary marker given cytology limitations.

Xpert Bladder Cancer Monitor

AssayXpert Bladder Cancer Monitor — a urinary molecular assay evaluated for follow-up surveillance of patients with non–muscle-invasive bladder cancer.

EvidenceDiagnostic value and follow-up utility updated in literature (eg, D'Elia et al., Ther Adv Urol. 2021;13:1756287221997183).

Intended useUsed in surveillance settings as an adjunct to standard follow-up to detect recurrence in patients with NMIBC.