Bladder/Urothelial Tumor Markers (Jurisdiction F)

September 20th, 2017 - Chris Woolstenhulme, CPC, CMRS

CMS recently released a new LCD for Jurisdiction F, Bladder/Urothelial Tumor Markers (L36680).

Documentation Requirements

The medical record must clearly identify the number and frequency of bladder marker testing. Medical record documentation must be legible, must be maintained in the patient’s medical record (hard copy or electronic copy), and must meet the criteria contained in this LCD and be made available to the A/B MAC upon request.

Utilization Guidelines

Only one bladder cancer test per single date of service (e.g., FISH then reflex cytology) are considered reasonable and necessary.

• For high risk patients with persistent hematuria and a negative FISH assay following a comprehensive diagnostic (no tumor identified) workup, ONE repeat FISH testing in conjunction with cystoscopy is considered reasonable and necessary within 1 year of the original attempted diagnosis.

Follow-up after initial/most recent occurrence and treatment

• Maximum of four (4) bladder tumor marker studies per year for years 1-2

• Maximum of three (3) bladder tumor marker studies per year for year 3

• Maximum of two (2) bladder tumor marker studies for year 4 and

• Maximum of one (1) bladder tumor marker studies follow-up annually for up to 15 years.

Diagnostic and Surveillance Tests

• BTA TRAK® - a quantitative determination of human complement factor H-related protein

• Nuclear matrix protein 22 (NMP-22) – detects nuclear mitotic apparatus protein believed to be released during apoptosis; a quantitative assay, which is either positive of negative

• NMP-22 BladderChek® – a CLIA-waved assay, point of care test with an immunochromographic qualitative format taking 20 minutes to perform

• The UroVysion® Bladder Cancer Kit is fluorescence in situ hybridization (FISH) DNA probe technology. It is designed to detect aneuploidy for chromosomes 3, 7, 17 and loss of the 9p21 locus. This assay involves visualization of nucleic acid sequences within cells by creating short sequences of fluorescently labeled, single-strand DNA probes that match target sequences. The probes bind to complementary strands of DNA to identify the targeted chromosome(s) location. It is used to detect chromosomal abnormalities in voided urine to assist not only in bladder cancer surveillance but also in the initial identification of bladder cancer.

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