CurrentHumanaPolicy LAB2023055

Laboratory Urinary Tumor Markers for Bladder Cancer

This Humana Medicare Advantage payment policy explains when urinary tumor marker tests for bladder cancer are reimbursable or not reimbursable for Humana Medicare Advantage members and lists applicable procedure codes and referenced diagnostic tests and manufacturers.

Policy Summary

PayerHumana

PolicyLaboratory Urinary Tumor Markers for Bladder Cancer

Policy CodePolicy LAB2023055

Change TypeNo material changes

Effective DateJul 1, 2023

Next Review Date

Key ActionReimburse NMP22 or BTA only for individuals with a bladder neoplasm or a personal history of bladder neoplasm; other listed urinary biomarker panels and immunocytology tests are not reimbursable.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

NMP22/BTAReimbursable conditionally

MultipleProprietary panels excluded

ImmunoCytImmunocytology exclusion

Medicare AdvantageApplicable product

Coverage and Medical Necessity Criteria

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Coverage criteria

Covered when ALL of the following criteria are met:

ALL of the following

ALL of the following
- ALL of the following
  - NMP22 (CPT 86386) or BTA (CPT 86294, CPT 86316) is performed in an individual with a bladder neoplasm or a personal history of bladder neoplasm.
Not reimbursable — examples
- NMP22 or BTA when performed in situations other than a bladder neoplasm or a personal history of bladder neoplasm (IS NOT REIMBURSABLE).
- Fluorescence immunocytology tests (e.g., ImmunoCyt/uCyt+, CPT 88346, CPT 88350) when used for screening for malignant neoplasm of the bladder or for individuals with symptoms including dysuria, hematuria, low back pain, pyuria, or other abnormal findings (ARE NOT REIMBURSABLE).
- Urinary protein biomarker panels to detect, monitor, or predict recurrence of bladder cancer (e.g., Oncuria Detect/Monitor/Predict; CPT 0365U, 0366U, 0367U) ARE NOT REIMBURSABLE.
- All other urinary biomarker panels designed to diagnose or prognose bladder cancer (CPT 0012M, 0013M, 0363U, 0420U, 0452U, 0465U, 0549U, 0613U) ARE NOT REIMBURSABLE.

Claims remain subject to other plan requirements, medical necessity determinations, and applicable Original Medicare national or local coverage determinations (NCDs/LCDs).

Coverage stance not specified in provided excerpts

The following excerpts contain references and literature citations but do not state additional explicit coverage criteria, medical necessity rules, or payment determinations within the provided text:

No explicit coverage criteria, medical necessity rules, or payment determinations are provided in these excerpts; they list guidelines, technology evaluations, and peer-reviewed literature (e.g., NCCN, USPSTF, NICE, and multiple studies) referenced by the policy.

Procedure and Billing Codes

Conventional urinary tumor marker and immunocytology codesCPT

86386	Nuclear matrix protein 22 (NMP22), qualitative
86294	Immunoassay for tumor antigen, qualitative or semiquantitative (e.g., bladder tumor antigen)
86316	Immunoassay for tumor antigen; other antigen, quantitative
88346	Immunofluorescence, per specimen; initial single antibody stain procedure
88350	Immunofluorescence, per specimen; each additional single antibody stain procedure

Proprietary urinary biomarker panels and molecular testsCPTNot Covered

0012M	Cxbladder Detect (mRNA gene expression profiling, proprietary)
0013M	Cxbladder Monitor (mRNA gene expression profiling, proprietary)
0363U	Cxbladder Triage (mRNA gene expression profiling, proprietary)
0365U	Oncuria Detect (10 protein biomarkers, proprietary)
0366U	Oncuria Monitor (10 protein biomarkers, proprietary)
0367U	Oncuria Predict (10 protein biomarkers, proprietary)
0420U	Cxbladder Triage Plus (mRNA + ddPCR SNPs, proprietary)
0452U	EarlyTect BCD (methylated PENK DNA)
0465U	UriFind Urothelial Carcinoma Assay (ONECUT2, VIM DNA methylation)
0549U	Bladder CARE (methylated TRNA-Cys, SIM2, NKX1-1)

1–10 of 11

1/2

No CPT/HCPCS/ICD-10 codes in provided textmixed

No codes listed

inv-06: Reimbursable indication

Reimbursable indicationNMP22 (CPT 86386) or BTA (CPT 86294, CPT 86316) is reimbursable only when performed in individuals with a bladder neoplasm or a personal history of bladder neoplasm.

Not reimbursable otherwiseAn NMP22 test or a BTA test is not reimbursable for situations other than having a bladder neoplasm or a personal history of bladder neoplasm.

Product scopePolicy applies to Humana Medicare Advantage members; claims remain subject to other plan requirements and applicable Original Medicare NCDs/LCDs.

inv-07: Miscellaneous coding note (empty label in inventory)

Related CPT codesCPT 86294, 86316, 86386 are listed as applicable procedures for Medicare Advantage plans in this policy.

Immunofluorescence codingCPT 88346 and 88350 are identified for immunofluorescence (ImmunoCyt/uCyt+).

Code descriptions sourceCode descriptions and examples (e.g., 'bladder tumor antigen') are provided in the applicable procedures section.

Billing, Authorization, and Documentation Guidance

Prior Authorization

Prior authorization / coverage notice — which urinary tumor marker codes are reimbursable

For Humana Medicare Advantage members: NMP22 (CPT 86386) or BTA (CPT 86294, CPT 86316) is reimbursable only when performed in individuals with a bladder neoplasm or a personal history of bladder neoplasm. Fluorescence immunocytology tests (e.g., ImmunoCyt/uCyt+, CPT 88346, 88350) and listed proprietary urinary biomarker panels and molecular tests (e.g., CPT 0012M, 0013M, 0363U, 0365U, 0366U, 0367U, 0420U, 0452U, 0465U, 0549U, 0613U) are not reimbursable. Claims remain subject to other plan requirements, medical necessity, and applicable Original Medicare NCDs/LCDs.

Reimbursable: CPT 86386 (NMP22), CPT 86294 and CPT 86316 (BTA) only for individuals with a bladder neoplasm or a personal history of bladder neoplasm.
Not reimbursable: CPT 88346, CPT 88350 (ImmunoCyt/uCyt+); urinary protein biomarker panels (e.g., CPT 0365U, 0366U, 0367U); and other listed panels/molecular tests (CPT 0012M, 0013M, 0363U, 0420U, 0452U, 0465U, 0549U, 0613U).
Claims remain subject to medical necessity, plan requirements, and applicable Original Medicare NCDs/LCDs.

Note

No provider action required in excerpts

No prior authorization, denial risk, specific documentation, billing rule, or step therapy instructions are specified in the provided policy excerpts.

Test Definitions and Named Assays

inv-10: NMP22 / BTA

NMP22 definitionNMP22 = nuclear matrix protein 22, a urine-based assay (CPT 86386) used to detect NMP22 associated with bladder neoplasm.

BTA definitionBTA = bladder tumor antigen, an immunoassay for tumor antigen (CPT 86294; related quantitative code CPT 86316) performed on urine to detect bladder tumor antigen.

Applicable CPT codesRelevant CPT codes listed in the policy: 86386 (NMP22), 86294 and 86316 (BTA/immunoassay for tumor antigen).

inv-11: Urinary protein biomarker panel

Examples of multi-analyte protein panelsOncuria® Detect (CPT 0365U), Oncuria® Monitor (CPT 0366U), Oncuria® Predict (CPT 0367U) analyze 10 protein biomarkers in urine.

Other proprietary panelsCxbladder Detect/Monitor/Triage (CPT 0012M, 0013M, 0363U) and Cxbladder Triage Plus (CPT 0420U) are mRNA-based multi-analyte assays referenced.

Coverage stanceUrinary protein biomarker panels designed to detect, monitor, or predict bladder cancer (including Oncuria variants and other listed proprietary panels) are not reimbursable under this policy.

inv-12: ImmunoCyt/uCyt+

Test descriptionImmunoCyt/uCyt+ is a fluorescence immunocytology test (CPT 88346, CPT 88350) performed on urine specimens.

Non-reimbursable usesImmunoCyt/uCyt+ is not reimbursable as part of screening for malignant neoplasm of the bladder or for individuals with symptoms such as dysuria, hematuria, low back pain, or pyuria.

Coding noteCodes associated: CPT 88346 (initial single antibody stain) and CPT 88350 (each additional single antibody stain).

inv-13: BLADDER EPICHECK

Test identityBLADDER EPICHECK is referenced as a commercial mRNA-based urine test in the literature citations (Nucleix link).

Reference sourcePolicy cites Nucleix: BLADDER EPICHECK (https://www.nucleix.com/bladder-epicheck/) among literature and technology references.

inv-14: Bladder CARE

Test identityBladder CARE is listed as a commercial urinary biomarker test/technology and referenced via Pangea (Pangea lab pages cited).

Reference sourcePolicy cites Pangea pages describing features of Bladder CARE and announcements about licensing Bladder CARE technology.

inv-15: URO17

Biomarker identityURO17 is noted in the policy's literature citations as a urinary biomarker evaluated for detecting bladder cancer (NICE URO17 advice cited).

Reference sourcePolicy cites NICE. URO17 for detecting bladder cancer (Updated Feb 4, 2021) among other literature references.