LCD Reference Article Billing and Coding Article

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

A55197

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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.

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Source Article ID
N/A
Article ID
A55197
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
02/16/2017
Revision Effective Date
06/01/2023
Revision Ending Date
N/A
Retirement Date
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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 panel is one (UOS=1). Providers must provide the approved DEX Z-CodeTM 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” of “Comprehensive” panels, billing with the “Not Otherwise Classified” (NOC) code 81479 along with the approved DEX Z-CodeTM identifier is appropriate.

Refer to Billing and Coding: MolDX: Next-Generation Sequencing for Solid Tumors A57858 1 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 A57878 for CPT/HCPCS codes and ICD-10 codes relevant for myeloid malignancies.

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.

Response To Comments

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Coding 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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Revision History Information

Revision History Date Revision History Number Revision History Explanation
06/01/2023 R14

Posted 06/01/2023: Review completed 05/08/2023 with no change in coverage. No changes were made to the article.

03/31/2022 R13

Posted 03/31/2022-Under Article Text added verbiage and hyperlinks for “Refer to Billing and Coding: MolDX: Next-Generation Sequencing for Solid Tumors A57831 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 R12

Posted 02/24/2022-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 7 was done in error and is retroactive effective for dates of service on or after 06/24/2021. C84.7A was added in error and has been removed from ICD-10 Codes that Support Medical Necessity Group 2. Updated the Related Local Coverage Document(s).

01/01/2022 R11

12/30/2021-CPT/HCPCs code update: desc change 0244U.

11/08/2021 R10

10/28/2021-Removed unspecified dx code D46.9 from ICD-10 Codes that Support Medical Necessity Group 1: Codes.

10/01/2021 R9

09/30/2021-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 07/01/2021.

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 & C84.7A. This revision is due to the Annual ICD-10 Update and will become effective on 10/01/2021.

07/29/2021 R8

07/29/2021-CPT 0224U was added in error to CPT/HCPCS Codes Group 2. It has been removed and replaced with CPT 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.

06/24/2021 R7

06/24/2021-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 D47.9, D72.829, 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. Review completed 05/13/2021.

11/01/2019 R6

Content moved to the new template.

04/25/2019 R5

05/30/2019- Added “Definitions” after the first paragraph. Moved 81445 to CPT/HCPCS Group 2 & added 81479. All the CPT codes had been listed in Group 1.

04/25/2019 R4

04/25/2019 – Article review completed 03/29/2019. The title of this article was changed to MolDX: Targeted and Comprehensive Genomic Profile Next Generation Sequencing Testing in Cancer. Revisions were to:

  1. Clarify the definitions of “targeted” and “CGP” to be more compatible with both accepted terminology and the language used in the CPT codes.
  2. Remove unnecessary restrictions from sample types (i.e., “fluid” samples).
  3. Clarify appropriate CPT coding-and removed CPT 81455.
  4. Set up the rationale why CGP is best classified with a NOC code.
  5. Added covered diagnostic codes.
08/01/2018 R3

08/01/2018 -Removed “genomic target” and added “somatic alteration” in the 3rd sentence, of the 2nd paragraph for clarity.  Annual review completed 07/02/2018.

12/16/2017 R2

11/01/2017- Revised article to incorporate A55196 - MolDX: Next Generation Sequencing (NGS) and Tier 1 and Tier 2 Coding and Billing Guidelines information.

 

08/01/2017 R1

08/01/2017- Annual review completed 07/06/2017; Updated billing instructions, added Labs may either use the SV101-7 or SV202-7 (preferred) or the NTE field to submit this required information & added Part A and Part B billing instructions.

 

 

 

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