CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

Urinary Tumor Markers for Cancer Screening, Diagnosis and Surveillance.pdf

Defines coverage stance for urinary tumor marker tests used for diagnosis and monitoring of bladder cancer and for screening for precancerous colonic polyps for BlueCHiP for Medicare and Commercial products. Includes regulatory/FDA-cleared tests, evidence summary, and specific CPT/CPT-like codes considered not covered or not medically necessary.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyUrinary Tumor Markers for Cancer Screening, Diagnosis and Surveillance.pdf

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionVerify benefits and eligibility against the member's subscriber agreement or employer agreement; refer to the Benefit Booklet/Evidence of Coverage/Subscriber Agreement for applicable coverage.

SourceLink

POLICY UPDATE CHANGES

No material changes to policy coverage or clinical guidance.

1BlueCHiP for Medicare: not covered

1Commercial: not medically necessary

7Listed not-covered codes

Coverage Summary

Scope: Defines coverage stance for urinary tumor marker tests used for diagnosis and monitoring of bladder cancer and for screening for precancerous colonic polyps for BlueCHiP for Medicare and Commercial products. BlueCHiP for Medicare: urinary tumor markers are not covered. Commercial products: urinary tumor markers are considered not medically necessary for these indications.

Overview: Urinary tumor markers (including several FDA-cleared urine tests) have been investigated as adjuncts or alternatives to cystoscopy and urine cytology for bladder cancer diagnosis and surveillance and for screening for colorectal adenomatous polyps, but available evidence is insufficient to demonstrate improved health outcomes or clinical utility compared with standard approaches.

Coverage Determination / Medical Necessity

Coverage Determination

Coverage position for urinary tumor marker tests:

ALL of the following

BlueCHiP for Medicare: The use of urinary tumor markers is not covered in the diagnosis of, and monitoring for bladder cancer, and screening for precancerous colonic polyps.
Commercial products: The use of urinary tumor markers is considered not medically necessary in the diagnosis of, and monitoring for bladder cancer, and screening for precancerous colonic polyps.

Not Covered / Not Medically Necessary

Not covered / Not medically necessary: The policy position is that urinary tumor markers are not covered for the diagnosis of, and monitoring for, bladder cancer and for screening for precancerous colonic polyps under BlueCHiP for Medicare. For Commercial products, the use of urinary tumor markers for these indications is considered not medically necessary.

Medicare-specific note: The policy explicitly states BlueCHiP for Medicare does not cover urinary tumor markers for diagnosis and monitoring of bladder cancer and for screening for precancerous colonic polyps; claims for listed CPT and other codes may be denied/not paid as not covered under BlueCHiP for Medicare.

Not Medically Necessary

BlueCHiP for Medicare: Use of urinary tumor markers for the diagnosis of, and monitoring for bladder cancer, and for screening for precancerous colonic polyps is not covered.
Commercial products: Use of urinary tumor markers for the diagnosis of, and monitoring for bladder cancer, and for screening for precancerous colonic polyps is considered not medically necessary.

CPT / Other Codes

Not covered / Not medically necessary CPT and other codesCPT|otherNot Covered

86294	Immunoassay for tumor antigen, qualitative or semi quantitative (e.g., bladder tumor antigen)
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
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 (New code effective 4/1/2018)
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 (New code effective 4/1/2018)
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) using multiple reaction monitoring acquisition, algorithm reported as likelihood of adenomatous polyps

Provider Actions / Billing Implications

Documentation Required

Benefit verification

Verify benefits and eligibility against the member's subscriber agreement or employer agreement because benefits may vary between groups/contracts; refer to Benefit Booklet/Evidence of Coverage/Subscriber Agreement for applicable coverage.

Denial Risk

Claims subject to denial for urinary tumor markers

Claims for the listed urinary tumor marker CPT/CPT-like codes may be denied/not paid as not covered (BlueCHiP for Medicare) or not medically necessary (Commercial products).

86294
86386
88120
88121
0012M
0013M
0002U

Background and Evidence Summary

Urinary tumor markers are biomarker tests performed on voided urine to detect tumor-associated proteins, DNA, RNA, metabolites, or chromosomal abnormalities as adjuncts or alternatives to cystoscopy and urine cytology for bladder cancer diagnosis, surveillance, and for screening colorectal adenomatous polyps.

Regulatory/FDA-cleared tests include commercially available assays such as BTA stat, BTA TRAK, Alere NMP22/BladderChek, uCyt+/ImmunoCyt, and UroVysion, which have indications as adjuncts to cystoscopy, for monitoring, or to aid in diagnosis of bladder cancer.

Evidence summary: Diagnostic accuracy studies and meta-analyses report wide sensitivity (approximately 47% to 85%) and specificity (approximately 53% to 95%) ranges; pooled sensitivity in studies of patients with a history of bladder cancer is about 55% to 75% with pooled specificity about 71% to 83%. Overall, the evidence is insufficient to determine effects on health outcomes or to demonstrate clinical utility compared with standard approaches (cystoscopy and cytology).

For urinary assays intended to screen asymptomatic populations for precancerous colonic polyps, urine metabolite assays are at an early stage of development with insufficient evidence on diagnostic accuracy and no demonstrated impact on health outcomes.

Evidence — diagnostic accuracy

Sensitivity range (diagnostic studies)47%–85%

Specificity range (diagnostic studies)53%–95%

Pooled sensitivity (history of bladder cancer studies)55%–75%

Pooled specificity (history of bladder cancer studies)71%–83%

Urinary tumor markers: Biomarker tests performed on voided urine intended to detect tumor-associated proteins, DNA, RNA, metabolites or chromosomal abnormalities for diagnosis, monitoring, or screening.

Not medically necessary: Services not considered reasonable and necessary for the diagnosis or treatment of illness or injury under the payer's coverage rules.