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July 11, 2018

CGS-MolDX: FDA Approved CLL Companion Diagnostic Test Coding and Billing Guidelines (CM00104)

Effective April 11, 2016, the FDA approved venetoclax (VENCLEXTA®/AbbVie), a new drug treatment for patients with B-cell chronic lymphocytic leukemia (CLL) with 17p deletion and at least one prior therapy, and a new indication for Vysis CLL FISH Probe Kit, a laboratory test to detect 17p deletion, as a companion diagnostic for venetoclax.

Venetoclax is an inhibitor that binds directly to the BCL-2 protein whose overexpression has been associated with resistance to chemotherapeutics. The 17p deletion is more frequently observed in treated patients than in patients who have received no treatment. Therefore, venetoclax has been approved for patients with previous treatment for CLL with the 17p deletion as detected by the Vysis CLL FISH Probe Kit. Vysis CLL FISH Probe Kit is not intended for monitoring of residual disease.

Palmetto GBA will only cover 17p deletion detection by FISH testing services when performed using validated assays. To date, Vysis CLL FISH Probe Kit is the only FDA validated and approved assay for the detection of the 17p deletion as the companion diagnostic for Venetoclax. Vysis CLL FISH Probe Kit services may only be billed by a CLIA certified lab. Vysis Fish Probe Kit by Abbott Molecular meets the reasonable and necessary criteria for Medicare reimbursement.

To report a Vysis FISH Probe kit service, please submit the following claim information:

  • When medically necessary and enumeration is performed, reviewed, and interpreted by a physician or pathologist:
  • Select the CPT code 88374 or 88377 for your service as appropriate and enter 2 units of service (UOS)
  • When medically necessary and enumeration is performed and reviewed by a cytotechnologist:
  • Select the CPT code 88271 and 88275 for your service as appropriate and enter 4 units and 1 unit of service respectively (UOS)
  • Select the CPT code 88291 with 1 unit of service for physician interpretation

The following diagnoses are appropriate for the test:

C91.10 Chronic lymphocytic leukemia of B-cell type not having achieved remission
C91.12 Chronic lymphocytic leukemia of B-cell type in relapse

Additional Information: To bill the PC component, the pathologist must read and interpret the raw data. Per Chapter 10, Version 16.3 in the NCCI Policy Manual for Medicare Services, physicians may not report the professional component provided by the technician or scientist.

Note: This MolDX coding and billing guideline ONLY applies to the UNMODIFIED, Vysis CLL FISH Probe Kit by Abbott for patients with CLL who have received at least one prior therapy and who are potential candidates for venetoclax.

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