Billing and Coding: FDA Approved CLL Companion Diagnostic Test

Coverage is limited to the unmodified Vysis CLL FISH Probe Kit (Abbott) as the FDA‑approved companion diagnostic to detect 17p deletion in patients with B‑cell CLL who have received at least one prior therapy and are potential candidates for venetoclax, when medically necessary. The test must be performed and billed by a CLIA‑certified laboratory, with appropriate documentation of medical necessity and provider interpretation; specific CPT codes and units of service apply depending on whether enumeration and interpretation are performed by a pathologist/physician or a cytotechnologist. Monitoring of residual disease and modified or alternative assays are not covered under this guideline.

"The Vysis CLL FISH Probe Kit (unmodified, Abbott) is covered as the FDA‑approved companion diagnostic to detect 17p deletion in patients with B‑cell chronic lymphocytic leukemia (CLL) who have rece..."