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October 12, 2015

Bladder Tumor Marker FISH Coding and Coding Guidelines (CM00037)

MolDX will only cover bladder tumor marker FISH testing services when performed using validated assays. To date, UroVysion Bladder Cancer Kit is the only FDA approved assay that is designed to detect aneuploidy for chromosomes 3, 7, 17 and loss of the 9p21 locus via FISH. The assay is performed on urine specimens from persons with hematuria suspected of having bladder cancer as an aid for initial diagnosis of bladder carcinoma and subsequent monitoring for tumor recurrence in patient previously diagnosed with bladder cancer. UroVysion Bladder Kit services may only be billed by a CLIA certified lab.

To bill UroVysion Bladder Kit services, submit the following claim information:

  • CPT code 88120 or 88121 as appropriate
  • Enter the appropriate 'Z identifier' in the comment/narrative field for the following claim field/types:
  • Loop 2300 NTE01 for Part A or Loop 2400 or SV101-7 for the 5010A1 837P for Part B
  • Submit the appropriate 'Z identifier' on an attachment to the claim form for paper claim( Form locator 80 for APrt A or Box 19 for Part B)
  • Laboratories reporting only the technical component for a UroVysion service should append the appropriate CPT code 88120 or 88121 with the TC HCPCS modifier.

All other services that meet the CPT code 88120 or 88121 definition performed by any provider type MUST bill the following claim information.

  • CPT code 88120 or 88121 as appropriate
  • Enter the identifier if available in the comment/narrative field for the following claim field/types:
  • Loop 2300 NTE 01 for Part A or Loop 2400 or SV101-7  for the 5010A1 837P for Part B
  • Submit identifier if available on an attachment to the claim form for paper claim (Form locator 80 for Part A or Box 19 for Part B)

To register a test for an identifier, follow the registration process outlined in the MolDX Test Registration article located on the MolDX site. Once an identifier has been assigned, submit a technical assessment request as documented on the MolDX site Technical Assessment (TA) Process.

Note: Physicians may NOT submit claims for a CPT code 88120 and 88121 professional component when the interpretive information is provided by a lab technician or scientist. Per Chapter 10 in the NCCI Policy Manual for Medicare Services, Version 16.3, the physician work component requires a physician to read, quantitate and interpret the tissues/cells stained with the probes(s). Physicians who knowingly report and interpretation based on the documented results of another professional may be subject to additional corrective action including RAC or fraud referrals.

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