Billing and Coding: FDA Approved CLL Companion Diagnostic Test

Medicare covers FISH testing to detect 17p deletion as a companion diagnostic for venetoclax in patients with B-cell CLL who have received at least one prior therapy, limited to testing performed using validated assays—currently only the unmodified Vysis CLL FISH Probe Kit (Abbott Molecular). Claims must be submitted by CLIA-certified laboratories and include specified CPT codes/units based on who performs enumeration and interpretation; the pathologist must read and interpret raw data to bill the professional component. Testing for residual disease monitoring or use of non-validated/modified assays is not covered.

"Cover FISH testing to detect 17p deletion for patients with B-cell chronic lymphocytic leukemia (CLL) who have received at least one prior therapy and who are potential candidates for venetoclax."

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