88271
HCPCS/CPT
Prior Authorization
No Prior Auth Required
Code is covered without prior authorization (high confidence)
Medicare Pricing
Work RVU
0.00
Facility
N/A
Non-Facility
N/A
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.
- Use CPT codes 88271-88291 when in situ hybridization (ISH) is performed as an ancillary analysis to cytogenetic studies for oncologic or inherited disorders.
- Use CPT codes 88365-88377 when a pathologist performs ISH techniques as an adjunct to a surgical pathology or cytopathology case, distinguishing qualitative versus quantitative methods (computer-assisted versus manual).
20 Active Policies
L37772 — MDS FISH
J05
A57576 — Billing and Coding: MDS FISH
J05
AMBETTER-CG-Multi-Inher-DO.-Intel-Dis.-DD-2025.1 — Concert Genetic Testing: Multisystem Inherited Disorders, Intellectual Disability, and Developmental Delay
AETNA-CPB-0349 — Alzheimer's Disease Tests
A56008 — Billing and Coding: FDA Approved CLL Companion Diagnostic Test
Related Codes
Have a follow-up question?
Ask Verity about documentation requirements, denial risks, or coverage in your state.