Local Coverage Article Billing and Coding

Billing and Coding: MolDX: FDA Approved CLL Companion Diagnostic Test

A56013

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Contractor Information

Article Information

General Information

Article ID
A56013
Article Title
Billing and Coding: MolDX: FDA Approved CLL Companion Diagnostic Test
Article Type
Billing and Coding
Original Effective Date
06/15/2018
Revision Effective Date
12/17/2021
Revision Ending Date
N/A
Retirement Date
N/A
AMA CPT / ADA CDT / AHA NUBC Copyright Statement

CPT codes, descriptions and other data only are copyright 2022 American Medical Association. All Rights Reserved. Applicable FARS/HHSARS apply.

Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein.

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CMS National Coverage Policy

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Article Guidance

Article Text

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.

Noridian 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:

  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 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.

 

Coding Information

CPT/HCPCS Codes

Group 1

(5 Codes)
Group 1 Paragraph

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Group 1 Codes
CodeDescription
88271 MOLECULAR CYTOGENETICS; DNA PROBE, EACH (EG, FISH)
88275 MOLECULAR CYTOGENETICS; INTERPHASE IN SITU HYBRIDIZATION, ANALYZE 100-300 CELLS
88291 CYTOGENETICS AND MOLECULAR CYTOGENETICS, INTERPRETATION AND REPORT
88374 MORPHOMETRIC ANALYSIS, IN SITU HYBRIDIZATION (QUANTITATIVE OR SEMI-QUANTITATIVE), USING COMPUTER-ASSISTED TECHNOLOGY, PER SPECIMEN; EACH MULTIPLEX PROBE STAIN PROCEDURE
88377 MORPHOMETRIC ANALYSIS, IN SITU HYBRIDIZATION (QUANTITATIVE OR SEMI-QUANTITATIVE), MANUAL, PER SPECIMEN; EACH MULTIPLEX PROBE STAIN PROCEDURE

CPT/HCPCS Modifiers

Group 1

Group 1 Paragraph

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Group 1 Codes

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ICD-10-CM Codes that Support Medical Necessity

Group 1

(2 Codes)
Group 1 Paragraph

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Group 1 Codes
CodeDescription
C91.10 Chronic lymphocytic leukemia of B-cell type not having achieved remission
C91.12 Chronic lymphocytic leukemia of B-cell type in relapse

ICD-10-CM Codes that DO NOT Support Medical Necessity

Group 1

Group 1 Paragraph

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Group 1 Codes

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ICD-10-PCS Codes

Group 1

Group 1 Paragraph

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Group 1 Codes

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Additional ICD-10 Information

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Bill Type Codes

Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service. Absence of a Bill Type does not guarantee that the article does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the article should be assumed to apply equally to all claims.

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Revenue Codes

Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory. Unless specified in the article, services reported under other Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the article should be assumed to apply equally to all Revenue Codes.

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Other Coding Information

Group 1

Group 1 Paragraph

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Group 1 Codes

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Revision History Information

Revision History DateRevision History NumberRevision History Explanation
12/17/2021 R2

Noridian has modified certain language in this article to mirror the language used presently by the MolDX team at Palmetto GBA as part of an annual review. Revision history dates and language may not exactly match the MolDX PGBA revision history. However, these revision do not change coverage or guidance.

12/01/2019: 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.

12/01/2019 R1

As required by CR 10901, article is converted to a formal billing and coding type article. There is no change in coverage.

Added CPT codes 88271, 88275, 88291, 88374, 88377 to the CPT/HCPCS section

Associated Documents

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Public Versions
Updated On Effective Dates Status
02/17/2022 12/17/2021 - N/A Currently in Effect You are here
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