CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

Medical Coverage Policy Urinary Biomarkers for Cancer Screening, Diagnosis and Surveillance

Policy governs coverage for urinary tumor marker tests used for screening, diagnosis, and surveillance of bladder cancer and for urine tests to screen for precancerous colonic polyps, for Commercial and Medicare Advantage products.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyMedical Coverage Policy Urinary Biomarkers for Cancer Screening, Diagnosis and Surveillance

Policy CodePolicy N/A

Change Typeclarified

Effective DateOct 1, 2015

Next Review Date

Key ActionCheck member benefit documents: refer to the member's Benefit Booklet, Evidence of Coverage or Subscriber Agreement for applicable coverage determinations.

SourceLink

POLICY UPDATE CHANGES

Policy statement that use of urinary tumor markers is not covered for screening, diagnosis, and monitoring of bladder cancer and for screening for precancerous colonic polyps.

1Primary policy stance (Not covered indications listed)

5Specific CPT/HCPCS codes enumerated as not covered

Coverage Summary

Policy subject: Urinary tumor/biomarker tests for bladder and colorectal cancer. This policy governs coverage for urine-based tumor marker tests used for screening, diagnosis, and surveillance of bladder cancer and for urine tests to screen for precancerous colonic polyps for Commercial and Medicare Advantage products (effective 2015-10-01; last reviewed 2023-01-04).

Diagnostic accuracy evidence shows pooled sensitivities varying across settings: reported pooled sensitivity ranges include approximately 47%–82% in some analyses and 52%–84% in others, depending on population and test.

Reported pooled specificities across diagnostic studies similarly vary by test and population, with ranges of approximately 53%–95% in some reviews and 71%–91% in surveillance studies.

Medical Necessity / Not Medically Necessary Criteria

Not Medically Necessary / Not Covered

The use of urinary tumor markers is not covered in the following settings:

ALL of the following

Screening for bladder cancer (asymptomatic population-level screening)
Diagnosis of bladder cancer (use of urinary tumor markers for diagnosis)
Monitoring/surveillance for bladder cancer (use of urinary tumor markers to monitor for recurrence)
Screening for precancerous colonic polyps using urinary tests

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Not Medically Necessary / Not Covered

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Commercial Products Specific Statement

Commercial product coverage position:

ALL of the following

Use of urinary tumor markers is considered not medically necessary for screening, diagnosis, and monitoring of bladder cancer
Use of urinary tumor markers is considered not medically necessary for screening for precancerous colonic polyps

Medicare Advantage Coding Exclusions

The following CPT/HCPCS codes are not covered for Medicare Advantage Plans and are not medically necessary for Commercial products:

ANY of the following

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; computer-assisted technology
0012M Oncology (urothelial), mRNA, gene expression profiling by real-time quantitative PCR of five genes using urine, algorithm reported as risk score for urothelial carcinoma
0013M Oncology (urothelial), mRNA, gene expression profiling by real-time quantitative PCR of five genes using urine, algorithm reported as risk score for recurrent urothelial carcinoma

Coding

Not covered / Not medically necessary (Medicare Advantage and Commercial)CPT|HCPCSNot Covered

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; computer-assisted technology
0012M	Oncology (urothelial), mRNA, gene expression profiling by real-time quantitative PCR of five genes using urine, algorithm reported as risk score for urothelial carcinoma
0013M	Oncology (urothelial), mRNA, gene expression profiling by real-time quantitative PCR of five genes using urine, algorithm reported as risk score for recurrent urothelial carcinoma
0002U	Oncology (colorectal), quantitative assessment of three urine metabolites by LC-MS/MS, algorithm reported as likelihood of adenomatous polyps

Relevant CPT (may be used but policy states urinary tumor markers not covered)CPT

86294	Immunoassay for tumor antigen, qualitative or semi-quantitative (eg, bladder tumor antigen)
86386	Nuclear Matrix Protein 22 (NMP22), qualitative

Provider Actions

Documentation Required

Check member benefit documents

Benefits may vary by group/contract; providers must refer to the member's Benefit Booklet, Evidence of Coverage or Subscriber Agreement for applicable coverage determinations.

Denial Risk

Claims for urinary tumor marker tests may be denied

Claims for urinary tumor marker tests for screening, diagnosis, or monitoring of bladder cancer or for screening for precancerous colonic polyps are considered not medically necessary and may be denied.

86294
86386
88120
88121
0012M
0013M
0002U

Background

Urinary tumor markers have been studied as adjuncts to cystoscopy and cytology for detection and surveillance of bladder cancer; multiple diagnostic accuracy studies, meta-analyses, and regulatory-clearance summaries exist. Studies report variable sensitivity and specificity for commercially available and investigational urine tests, and combining markers with cytology may improve test accuracy but still misses a proportion of cancers.

For surveillance and screening populations, evidence includes meta-analyses, decision analyses, retrospective studies, and limited prospective studies. Across these, the evidence is insufficient to demonstrate improved health outcomes (for example, no randomized controlled trials showing benefit of population screening and limited clinical utility data for management decisions).

Evidence for urine metabolite assays to detect adenomatous colonic polyps is limited to a training/validation report and does not support established diagnostic accuracy or demonstrated health outcome benefit.

Definition: Urinary tumor markers/urinary tests are laboratory tests performed on urine to detect tumor-associated antigens, proteins, DNA/RNA, or metabolites intended for screening, diagnosis, or surveillance of bladder or colorectal neoplasia.

Revision History

2015-10-01effective_date

Policy effective date

2023-01-04last_reviewLatest

Policy last updated/reviewed

policy_change_clarifiedLatest

Policy statement that use of urinary tumor markers is not covered for screening, diagnosis, and monitoring of bladder cancer and for screening for precancerous colonic polyps; Commercial products statement that use of urinary tumor markers is not medically necessary for these indications

coding_exclusionsLatest

Specific CPT/HCPCS codes listed as not covered or not medically necessary: 88120, 88121, 0012M, 0013M, 0002U; relevant CPT codes noted (86294, 86386)