Coverage limited to specified adjunct uses

Urinary biomarker tests (BTA, NMP22, UroVysion, ImmunoCyt, and other urinary tumor markers listed in this policy) are covered ONLY as adjunctive tests in the specific situations listed in the policy; requests for use outside those adjunct indications do not meet coverage criteria and may be denied.

• Covered adjunct uses: (a) adjunct in diagnostic exclusion for individuals with atypical or equivocal cytology; (b) adjunct in monitoring high‑risk, non‑muscle invasive bladder cancer; (c) ImmunoCyt/uCyt as an adjunct to cystoscopy or cytology for monitoring.

Billing/authorization reference — codes are reference only

Procedure and HCPCS/CPT codes in this policy are provided for reference only; listing of a procedure code does not guarantee payment—verify payer billing rules and plan contract for authorization and payment requirements.

• Refer to the member's Evidence of Coverage/plan contract and payer billing rules for authorization/payment decisions.

Procedure codes may require verification / prior authorization

Procedure codes for urinary tumor marker tests (including CPT and PLA/HCPCS codes listed in the policy) may require verification of coverage and prior authorization per the member's plan or payer rules; coverage/payment is subject to policy rules and updates.

• Examples of codes listed in the policy include 86294, 86386, 88346, 88350 and PLA/0363U–0549U series; providers should verify PA requirements for the specific code/test prior to ordering.

Adjunct to cystoscopy — do not replace cystoscopy

Cystoscopy with cytology remains the diagnostic gold standard for bladder cancer; urinary biomarkers are intended to be used adjunctively and not as replacements for cystoscopic diagnosis.

• Use biomarkers in conjunction with cystoscopy and cytology per guideline recommendations.

Adjunctive use before replacement — follow guideline expectations

Clinical guidelines recommend urinary tumor markers should not replace cystoscopy; when used, markers are adjunctive and should not be the sole method prior to omitting or replacing cystoscopic evaluation.

• NCCN and AUA/SUO guidance state markers may be considered during surveillance but should not replace cystoscopy.

Adjunctive use only — avoid requests that imply replacement

Tests are covered only as adjuncts and not as standalone replacements; do not submit requests that imply use of urinary tumor markers as primary diagnostic replacement for cystoscopy.

• Orders implying a replacement of cystoscopy or standalone diagnostic use outside covered adjunct indications may be denied.

Clinical indication documentation required

Document the clinical indication in the medical record showing that testing is being used as an adjunct (e.g., atypical/equivocal cytology or monitoring high‑risk NMIBC); absence of supporting documentation for an adjunct indication risks denial.

• State the specific adjunct rationale (atypical/equivocal cytology; high‑risk NMIBC surveillance) in the order/medical record.

LDT validation documentation required (CLIA high‑complexity)

Laboratory‑developed tests (LDTs) must be validated and performed in‑house under CLIA; provide documentation of CLIA high‑complexity validation and internal performance characteristics when ordering/claiming LDTs.

• Include evidence of CLIA regulation and internal validation when the test is an LDT; note that LDTs are not FDA‑cleared/approved.

Document intended FDA‑indicated use for specific assays

When ordering FDA‑approved assays (for example, UroVysion or ImmunoCyt), document the intended FDA‑indicated use in the clinical record (e.g., ImmunoCyt is indicated as an aid in surveillance in conjunction with cytology and cystoscopy).

• Record the assay name and that the intended use aligns with the FDA‑approved indication (diagnosis vs surveillance) in the chart.

Denied indications — hematuria, screening, diagnostic use outside listed indications

Requests for urinary biomarker testing for hematuria evaluation, population screening of asymptomatic individuals, diagnosis in symptomatic individuals, or any indication not explicitly listed in the policy do NOT meet coverage criteria and are at high risk for denial.

• Explicitly excluded: evaluation of hematuria, screening asymptomatic individuals, diagnosing symptomatic patients, and any other non‑listed indications.

Defer to applicable government coverage (LCD/NCD); conflicts may lead to denial

If there is any conflict between this policy and an applicable government (Medicare/Medicaid) coverage determination (LCD/NCD or state Medicaid policy), the government policy controls; noncompliance with such government rules may result in denial.

• Verify applicable LCDs/NCDs or state Medicaid rules for the member before ordering/testing.

Code listing is not a guarantee of payment

Procedure and CPT/HCPCS codes listed in this policy are provided as a reference and are not a guarantee of payment; the list may not be all‑inclusive and is subject to updates.

• Providers must confirm code applicability and payer reimbursement policy; listing a code in this document does not ensure coverage.