88377
HCPCS/CPT
Prior Authorization
Prior Auth Required
Conditional coverage; review criteria to confirm PA need (medium confidence)
Medicare Pricing
Work RVU
1.37
Facility
$384.11
Non-Facility
$384.11
Documentation Required
- Medical necessity for the test must be documented (e.g., diagnosis of CLL, documentation of ≥1 prior therapy, and documentation that the patient is a potential candidate for venetoclax).
- The performing laboratory must be CLIA‑certified and CLIA certification must be available for claims review.
- To bill the professional component, documentation must show that a pathologist read and interpreted the raw data; technician/scientist‑only interpretation cannot be billed as the professional component.
- Claims must include the appropriate CPT codes and specified units of service per the billing guidance and indicate whether enumeration was performed and by whom.
Key Coverage Criteria
- 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 received at least one prior therapy and who are potential candidates for venetoclax, when medically necessary.
- 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.
- Cover detection of 17p deletion only when performed using validated assays; the FDA-approved Vysis CLL FISH Probe Kit (Abbott Molecular) is the validated companion diagnostic for venetoclax.
- Allow billing and Medicare reimbursement for the unmodified Vysis CLL FISH Probe Kit by Abbott Molecular when the above clinical criteria are met.
- Genetic testing CPT codes are covered when testing is reasonable and necessary per Local Coverage Determination L39365 and the AMA CPT Codebook and Medicare NCCI Policy Manual instructions are followed.
- If a CPT code specifies a medical condition (e.g., CPT 81432 - hereditary breast cancer-related disorders), bill that code only when the beneficiary's documented disease matches the code's described medical condition and all genes billed under that code relate to that condition.
7 Active Policies
A59492 — Billing and Coding: Genetic Testing for Oncology
J09
A59491 — Billing and Coding: Genetic Testing for Oncology
J12
A56050 — Billing and Coding: FDA Approved CLL Companion Diagnostic Test
AMBETTER-CG-Onc-Cytogenetics-2025.1 — Concert Genetic Oncology: Cytogenetic Testing
Related Codes
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