SUPERSEDED LCD Reference Article Billing and Coding Article

Billing and Coding: MolDX: Targeted and Comprehensive Genomic Profile Next-Generation Sequencing Testing in Cancer

A55624

Expand All | Collapse All
Draft Article
Draft Articles are works in progress and not necessarily a reflection of the current billing and coding practices. Revisions to codes are carefully and thoroughly reviewed and are not intended to change the original intent of the LCD.
Superseded
To see the currently-in-effect version of this document, go to the section.

Document Note

Note History

Contractor Information

Article Information

General Information

Source Article ID
N/A
Article ID
A55624
Original ICD-9 Article ID
Not Applicable
Article Title
Billing and Coding: MolDX: Targeted and Comprehensive Genomic Profile Next-Generation Sequencing Testing in Cancer
Article Type
Billing and Coding
Original Effective Date
10/09/2017
Revision Effective Date
03/16/2022
Revision Ending Date
03/20/2024
Retirement Date
N/A

CPT codes, descriptions, and other data only are copyright 2023 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.

Current Dental Terminology © 2023 American Dental Association. All rights reserved.

Copyright © 2024, the American Hospital Association, Chicago, Illinois. Reproduced with permission. No portion of the AHA copyrighted materials contained within this publication may be copied without the express written consent of the AHA. AHA copyrighted materials including the UB‐04 codes and descriptions may not be removed, copied, or utilized within any software, product, service, solution, or derivative work without the written consent of the AHA. If an entity wishes to utilize any AHA materials, please contact the AHA at 312‐893‐6816.

Making copies or utilizing the content of the UB‐04 Manual, including the codes and/or descriptions, for internal purposes, resale and/or to be used in any product or publication; creating any modified or derivative work of the UB‐04 Manual and/or codes and descriptions; and/or making any commercial use of UB‐04 Manual or any portion thereof, including the codes and/or descriptions, is only authorized with an express license from the American Hospital Association. The American Hospital Association (the "AHA") has not reviewed, and is not responsible for, the completeness or accuracy of any information contained in this material, nor was the AHA or any of its affiliates, involved in the preparation of this material, or the analysis of information provided in the material. The views and/or positions presented in the material do not necessarily represent the views of the AHA. CMS and its products and services are not endorsed by the AHA or any of its affiliates.

CMS National Coverage Policy

N/A

Article Guidance

Article Text

Next Generation Sequencing (NGS)

NGS allows identification of somatic and/or germline alterations in multiple genes simultaneously. This guideline focuses on Targeted and Comprehensive Genomic Profile testing for somatic variant detection using tumor tissue only-based panels for cancer.

Definitions:

Targeted Tumor Panels

Targeted Next-Generation Sequencing (NGS) panels are hereby defined as tests that identify somatic alterations known to occur in certain regions (i.e., 'hotspots') within specific genes of interest for cancer management (i.e., diagnosis, selection of molecularly targeted therapies, prognosis in a context where prognostic classification is essential for treatment selection). Generally, these NGS panels can detect single nucleotide variants (SNVs) and small insertions or deletions (INDELs) within these regions. These alterations typically represent response or lack of response to corresponding targeted cancer therapies. The hotspot test should include relevant regions in the genes required for companion diagnostic testing and/or known to be necessary for proper patient management.

Comprehensive Genomic Profile (CGP) Testing

CGP refers to NGS-based molecular assays that provide additional insight beyond individual gene hotspots; these assays seek to describe the genomic makeup of a tumor and can help identify underlying mechanisms of disease to guide clinical decision making. These tests include not only mutations in individual relevant genes, but also patterns of mutations across related genes in established cancer pathways and often include an assessment of overall mutational burden. These tests typically involve sequencing of entire exonic regions of genes of interest (within a comprehensive gene panel or whole exome sequencing) and may also include selected intronic regions. CGP can detect multiple types of molecular alterations (i.e., SNVs, small and large INDELs, copy number alterations (CNAs), structural variants (SVs), and splice-site variants) in a single assay. Patterns of mutations seen across multiple genes may be used to infer clinically relevant etiologies, such as DNA mismatch repair deficiency and microsatellite instability, and total mutational load/burden (TMB) may be determined. CGP testing may also include RNA sequencing to detect structural variations, such as translocations or large deletions, and to detect functional splicing mutations. CGP is not defined as a targeted panel by MolDX.

CPT® coding Instructions

Targeted Panels

To bill for targeted NGS gene panel services for somatic variant detection, review CPT® codes 81445 and 81450. The units of service (UOS) for an NGS gene panel is one (UOS=1). Providers must also provide the approved DEX Z-Code identifier for the test.

Effective July 1, 2017, laboratories with 2 to 4 genes on their targeted NGS panel should use CPT® 81479 and one (1) UOS along with their test identifier (DEX Z-CodeTM) to represent this service on their claims.

CGP

As CGP testing is not defined as a targeted panel by MolDX, and it is a test not currently satisfactorily described by any existing CPT® code. Therefore, to report a CGP service, test providers should use CPT® code 81479 at this time, in addition to the approved DEX Z-CodeTM for the test. Coverage of CGP is limited to one test per surgical specimen and precludes the use of any other molecular testing on that specimen.

For NGS-based tests that do not fit under the above definitions of “targeted” or “Comprehensive” panels, billing with the “Not Otherwise Classified” (NOC) code 81479 along with the approved DEX Z-CodeTM identifier is appropriate.

Tier 1 and/or Tier 2 individual biomarker CPT codes should not be used for a single gene or any combination of genes when testing is performed as part of a NGS or other multiplexing technology panel.

Refer to Billing and Coding: MolDX: Next-Generation Sequencing for Solid Tumors A57901 for CPT/HCPCS codes and ICD-10 codes relevant for solid tumors.

Refer to Billing and Coding: MolDX: Next-Generation Sequencing Lab-Developed Tests for Myeloid Malignancies and Suspected Myeloid Malignancies A57891 for CPT/HCPCS codes and ICD-10 codes relevant for myeloid malignancies.

Response To Comments

Number Comment Response
1
N/A

Coding Information

Bill Type Codes

Code Description

Please accept the License to see the codes.

N/A

Revenue Codes

Code Description

Please accept the License to see the codes.

N/A

CPT/HCPCS Codes

Please accept the License to see the codes.

N/A

CPT/HCPCS Modifiers

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

N/A

ICD-10-CM Codes that Support Medical Necessity

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

N/A

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

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

N/A

ICD-10-PCS Codes

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

N/A

Additional ICD-10 Information

N/A

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.

Code Description

Please accept the License to see the codes.

N/A

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.

N/A


Code Description

Please accept the License to see the codes.

N/A

Other Coding Information

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

N/A

Coding Table Information

Excluded CPT/HCPCS Codes - Table Format
Code Descriptor Generic Name Descriptor Brand Name Exclusion Effective Date Exclusion End Date Reason for Exclusion
N/A N/A
N/A
Non-Excluded CPT/HCPCS Ended Codes - Table Format
Code Descriptor Generic Name Descriptor Brand Name Exclusion Effective Date Exclusion End Date Reason for Exclusion
N/A

Revision History Information

Revision History Date Revision History Number Revision History Explanation
03/16/2022 R9

Updated to indicate this article is an LCD Reference Article.

03/16/2022 R8

Under Article Text added verbiage and hyperlinks for “Refer to Billing and Coding: MolDX: Next-Generation Sequencing for Solid Tumors for CPT/HCPCS codes and ICD-10 codes relevant for solid tumors. Refer to Billing and Coding: MolDX: Next-Generation Sequencing Lab-Developed Test for CPT/HCPCS codes and ICD-10 codes relevant for myeloid malignancies”. Under CPT/HCPCS Codes Group 1: Paragraph deleted the verbiage. Under CPT/HCPCS Codes Group 1: Codes deleted all CPT/HCPCS codes listed. Under CPT/HCPCS Group 2: Paragraph deleted the verbiage. Under CPT/HCPCS Codes Group 2: Codes deleted all CPT/HCPCS codes listed. Under ICD-10 Codes that Support Medical Necessity Group 1: Paragraph deleted the verbiage. Under ICD-10 Codes that Support Medical Necessity Group 1: Codes deleted all ICD-10 codes listed. Under ICD-10 Codes that Support Medical Necessity Group 2: Paragraph deleted the verbiage. Under ICD-10 Codes that Support Medical Necessity Group 2: Codes deleted all ICD-10 codes listed.

01/01/2022 R7

Under CPT/HCPCS Codes Group 2: Codes the description was revised for 0244U. This revision is due to the 2022 Annual CPT/HCPCS Code Update and is effective on January 1, 2022.

Under ICD-10 Codes that Support Medical Necessity Group 1: Codes added D46.4, D47.9, D72.829, and D75.9. Under ICD-10 Codes that Support Medical Necessity Group 2: Codes added: C00.2, C00.5, C00.6, C00.9, C02.3, C02.9, C03.9, C04.9, C05.9, C06.80, C06.9, C08.9, C09.9, C10.9, C11.9, C13.9, C14.0, C15.9, C16.5, C16.6, C16.9, C17.9, C18.9, C21.0, C22.8, C24.9, C25.9, C26.0, C31.9, C32.9, C34.00, C34.10, C34.30, C34.80, C34.90, C34.91, C34.92, C38.3, C39.0, C39.9, C40.00, C40.10, C40.20, C40.30, C40.80, C40.90, C40.91, C40.92, C41.9, C43.10, C43.20, C43.30, C43.60, C43.70, C43.9, C4A.10, C4A.20, C4A.30, C4A.60, C4A.70, C4A.9, C44.00, C44.101, C44.1021, C44.1022, C44.1091, C44.1092, C44.111, C44.121, C44.191, C44.201, C44.202, C44.209, C44.211, C44.221, C44.291, C44.300, C44.301, C44.309, C44.310, C44.320, C44.390, C44.40, C44.500, C44.501, C44.509, C44.601, C44.602, C44.609, C44.611, C44.621, C44.691, C44.701, C44.702, C44.709, C44.711, C44.721, C44.791, C44.80, C44.90, C44.91, C44.92, C44.99, C45.9, C47.10, C47.20, C47.6, C47.9, C48.2, C49.10, C49.20, C49.6, C49.9, C49.A0, C50.019, C50.029, C50.119, C50.129, C50.219, C50.229, C50.319, C50.329, C50.419, C50.429, C50.519, C50.529, C50.619, C50.629, C50.819, C50.829, C50.911, C50.912, C50.919, C50.921, C50.922, C50.929, C51.9, C53.9, C54.9, C55, C56.9, C57.00, C57.10, C57.20, C57.4, C57.9, C60.9, C62.00, C62.10, C62.90, C62.91, C62.92, C63.00, C63.10, C63.9, C64.9, C65.9, C66.9, C67.9, C68.9, C69.00, C69.10, C69.20, C69.30, C69.40, C69.50, C69.60, C69.80, C69.90, C69.91, C69.92, C70.9, C71.9, C72.20, C72.30, C72.40, C72.50, C72.9, C74.00, C74.10, C74.90, C74.91, C74.92, C75.8, C75.9 C7A.00, C7A.019, C7A.029, C7A.094, C7A.095, C7A.096, C76.40, C76.50, C80.0, and C80.1. The deletion of these codes with Revision 11 was done in error and is retroactive effective for dates of service on or after 06/24/2021.

11/08/2021 R6

11/08/2021: Under ICD-10 Codes that Support Medical Necessity Group 1: Codes deleted D46.9

10/01/2021:  Under CPT/HCPCS Codes Group 2: Codes added 0250U. This revision is due to the Q3 2021 CPT/HCPCS Code Update and is effective for dates of service on or after 7/1/2021.

Under ICD-10 Codes that Support Medical Necessity Group 1: Codes added D75.838. Under ICD-10 Codes that Support Medical Necessity Group 2: Codes added C56.3. This revision is due to the Annual ICD-10 Update and will become effective on 10/1/2021.

06/24/2021 R5

Under CPT/HCPCS Codes Group 2: Codes added 0244U. This revision is due to the Q2 2021 CPT/HCPCS Code Update and is effective for dates of service on or after 4/1/2021.

Under Article Text subsection Targeted Panels revised second paragraph to read “Effective July 1, 2017, laboratories with 2 to 4 genes on their targeted NGS panel should use CPT 81479 and one (1) UOS along with their test identifier (DEX Z-CodeTM) to represent this service on their claims” and moved second sentence to end of article text.

Under ICD-10 Codes that Support Medical Necessity Group 1: Codes deleted D46.4, D47.9, D72.829, and D75.9.

Under ICD-10 Codes that Support Medical Necessity Group 2: Codes deleted C00.2, C00.5, C00.6, C00.9, C02.3, C02.9, C03.9, C04.9, C05.9, C06.80, C06.9, C08.9, C09.9, C10.9, C11.9, C13.9, C14.0, C15.9, C16.5, C16.6, C16.9, C17.9, C18.9, C21.0, C22.8, C24.9, C25.9, C26.0, C31.9, C32.9, C34.00, C34.10, C34.30, C34.80, C34.90, C34.91, C34.92, C38.3, C39.0, C39.9, C40.00, C40.10, C40.20, C40.30, C40.80, C40.90, C40.91, C40.92, C41.9, C43.10, C43.20, C43.30, C43.60, C43.70, C43.9, C4A.10, C4A.20, C4A.30, C4A.60, C4A.70, C4A.9, C44.00, C44.101, C44.1021, C44.1022, C44.1091, C44.1092, C44.111, C44.121, C44.191, C44.201, C44.202, C44.209, C44.211, C44.221, C44.291, C44.300, C44.301, C44.309, C44.310, C44.320, C44.390, C44.40, C44.500, C44.501, C44.509, C44.601, C44.602, C44.609, C44.611, C44.621, C44.691, C44.701, C44.702, C44.709, C44.711, C44.721, C44.791, C44.80, C44.90, C44.91, C44.92, C44.99, C45.9, C47.10, C47.20, C47.6, C47.9, C48.2, C49.10, C49.20, C49.6, C49.9, C49.A0, C50.019, C50.029, C50.119, C50.129, C50.219, C50.229, C50.319, C50.329, C50.419, C50.429, C50.519, C50.529, C50.619, C50.629, C50.819, C50.829, C50.911, C50.912, C50.919, C50.921, C50.922, C50.929, C51.9, C53.9, C54.9, C55, C56.9, C57.00, C57.10, C57.20, C57.4, C57.9, C60.9, C62.00, C62.10, C62.90, C62.91, C62.92, C63.00, C63.10, C63.9, C64.9, C65.9, C66.9, C67.9, C68.9, C69.00, C69.10, C69.20, C69.30, C69.40, C69.50, C69.60, C69.80, C69.90, C69.91, C69.92, C70.9, C71.9, C72.20, C72.30, C72.40, C72.50, C72.9, C74.00, C74.10, C74.90, C74.91, C74.92, C75.8, C75.9 C7A.00, C7A.019, C7A.029, C7A.094, C7A.095, C7A.096, C76.40, C76.50, C80.0, and C80.1

12/01/2019 R4

As required by CR 10901, article is converted to a formal billing and coding type article. Under Article Title changed the title from “MolDX: Targeted and Comprehensive Genomic Profile Next-Generation Sequencing Testing in Cancer” to “Billing and Coding: MolDX: Targeted and Comprehensive Genomic Profile Next-Generation Sequencing Testing in Cancer”. Formatting, punctuation and typographical errors were corrected throughout the article.  There is no change in coverage.

05/27/2019 R3

HCPCS coding was divided into two paragraphs to provide greater clarity in billing.

05/27/2019 R2

Title is revised from MolDX: Next Generation Sequencing Coding and Billing Guidelines, to MolDX: Targeted and Comprehensive Genomic Profile Next-Generation Sequencing Testing in Cancer.  

Deleted CPT code 81455. Added ICD-10 codes.

01/01/2018 R1

Article is revised to expand and/or clarify the Next Generation Sequencing (NGS), Targeted (aka Hot Spot) Tumor Panels and Comprehensive Genomic Profile (CGP) Testing sections consistent with the MolDX Contractor.

N/A

Associated Documents

Medicare BPM Ch 15.50.2 SAD Determinations
Medicare BPM Ch 15.50.2
Related National Coverage Documents
N/A
SAD Process URL 1
N/A
SAD Process URL 2
N/A
Statutory Requirements URLs
N/A
Rules and Regulations URLs
N/A
CMS Manual Explanations URLs
N/A
Other URLs
N/A
Public Versions
Updated On Effective Dates Status
03/15/2024 03/21/2024 - N/A Currently in Effect View
11/22/2023 03/16/2022 - 03/20/2024 Superseded You are here
03/22/2022 03/16/2022 - N/A Superseded View
Some older versions have been archived. Please visit the MCD Archive Site to retrieve them.

Keywords

N/A