LCD Reference Article Billing and Coding Article

Billing and Coding: FDA Approved CLL Companion Diagnostic Test

A56008

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Draft Article
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Source Article ID
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Article ID
A56008
Original ICD-9 Article ID
Not Applicable
Article Title
Billing and Coding: FDA Approved CLL Companion Diagnostic Test
Article Type
Billing and Coding
Original Effective Date
06/07/2018
Revision Effective Date
11/21/2024
Revision Ending Date
N/A
Retirement Date
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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.

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.

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

  1. 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)
  2. 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

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 billing and coding 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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Coding Information

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ICD-10-CM Codes that Support Medical Necessity

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Group 1 Codes
Code Description
C91.10 Chronic lymphocytic leukemia of B-cell type not having achieved remission
C91.12 Chronic lymphocytic leukemia of B-cell type in relapse
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Coding Table Information

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Revision History Information

Revision History Date Revision History Number Revision History Explanation
11/21/2024 R3

Under Article Text deleted the first and last sentence in the third paragraph.

06/23/2022 R2

Under Article Title removed the word “MolDX”. Under Article Text deleted “MolDX” from the last sentence.

10/24/2019 R1

This article is being revised in order to adhere to CMS requirements per Chapter 13, Section 13.5.1 of the Program Integrity Manual. Under Article Title changed title from “MolDX: FDA Approved CLL Companion Diagnostic Test Coding and Billing Guidelines” to “Billing and Coding: MolDX: FDA Approved CLL Companion Diagnostic Test”. Under Article Text changed verbiage in last paragraph from “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” to “Note: This MolDX billing and coding 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”. Under CPT/HCPCS Codes Group 1: Codes added CPT® codes 88271, 88275, 88291, 88374, and 88377.

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Associated Documents

Medicare BPM Ch 15.50.2 SAD Determinations
Medicare BPM Ch 15.50.2
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Public Versions
Updated On Effective Dates Status
11/13/2024 11/21/2024 - N/A Currently in Effect You are here
06/13/2022 06/23/2022 - 11/20/2024 Superseded View
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Keywords

  • CLL