Moldx has an elaborate article regarding billing and coding of tumor panels - A54795, which is now up to "revision 16." Find it here:
https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleid=54795&ver=42&bc=0
What's New?
It may take a master's degree in "MolDxology" to decipher some of this, but here's their handy guide to what you have to know about this revision.
Under Article Title revised to MolDX: Targeted and Comprehensive Genomic Profile Testing in Cancer.
Under Article Text subsection heading Next Generation Sequencing (NGS) 2nd sentence revised “tumor tissue only-based panels” to read “tumor-based panels for cancer that may be performed by NGS”. Added verbiage and hyperlink for “Refer to MolDX: Defining panel services in MolDX A59678 for further guidance on the distinction between single analyte tests and panel tests”. Under subsection heading Targeted Tumor Panels revised 1st sentence “Targeted Next-Generation Sequencing (NGS) panels” to read “Targeted tumor panels”. Revised 2nd sentence to read “Generally, these panels are limited to specific variant types at defined sites, such as single nucleotide variants (SNVs), small insertions or deletions (INDELs), single site copy number variants, or gene fusions”. Revised last sentence to delete “regions in the genes” and replaced with “targets”. Under subsection heading Comprehensive Genomic Profile (CGP) Testing revised 1st sentence “CGP” to read “CGP testing”. Revised 4th sentence “CGP” to read “CGP tests” and replaced “copy number alterations (CNAs)” with “copy number variants (CNVs)”. Revised 5th sentence to add “and chromosome abnormalities such as loss of heterozygosity (LOH)”. Revised 6th sentence “CGP” to read “CGP testing”. Added new sentences “CGP tests are expected to yield information of clinical relevance beyond a targeted panel, for example, to identify relevant clinical trials for patient management or identify possible therapeutic interventions for off-label use. It is expected that a CGP will identify all clinically relevant information attainable for the type of service performed”. Revised subsection heading “Targeted Panels” to read “Targeted Tumor Panels”. Revised 1st sentence to read “To bill for DNA-based panels that measure SNVs, INDELs, CNVs or rearrangements, review CPT codes 81445 and 81450” and deleted 2nd and 3rd sentences. Added new sentences “If a DNA-based targeted panel meeting the coverage requirements is used, and MSI is also performed, 81457 can be billed. If a DNA-based targeted test meeting coverage requirements is performed that includes MSI and CNVs, 81458 can be billed” and 2 new paragraphs. Revised last paragraph “DEX Z-Code™” to read “DEX Z-Code®”. Under subsection heading CGP deleted first paragraph and added new paragraph. Revised 2nd paragraph 1st sentence to add “81459 or” and replaced “DEX Z-Code™” with “DEX Z-Code®”. Revised 2nd sentence to replace “other” with “further”. Revised 3rd paragraph sentence “DEX Z-Code™” to read “DEX Z-Code®”. Formatting, punctuation, and typographical errors were corrected throughout the article.
Got that? Quiz Tuesday.
Notably, one standout is that (while they never accepted 81455) they will accept 81459 instead of 81479 in some circumstances. Note, though, that under separate current gapfill processes, 81459 is to be paid at $2990, basically the same as 81455.
To help, I've put in the cloud a PDF of a redline from R15 to R16:
https://drive.google.com/file/d/1lvuE9t2awnT81E1H0KOkufUYJjQgPsjl/view?usp=sharing
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AI CORNER
Refer only to the original text of A54795 for MolDx rules and terminology.
However, for fun, I asked Chat GPT4 to compare the older and newer documents ("March" vs "April.")
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Attached, you will find an OLD version called MARCH 2024, and a NEW version called APRIL 2024. Please explain the details and differences, focusing on what your readers need to know to transition from operations under the MARCH version and move to new rules and operations under the APRIL version. We're counting on you to make sense of this!
ChatGPT
Overview:
The two versions of the article "MolDX: Targeted and Comprehensive Genomic Profile Testing in Cancer" describe billing and coding guidelines for Next-Generation Sequencing (NGS) testing in cancer. The key changes in the APRIL 2024 version provide updated definitions and coding instructions.
Below, I'll highlight the details and differences between the MARCH 2024 version and the APRIL 2024 version, focusing on what readers need to know when transitioning to the new version.
1. Definition Changes:
Targeted Tumor Panels:
MARCH 2024 Version:
Panels identify somatic alterations in specific genes, focusing on 'hotspots' for cancer management.
Generally, these panels detect SNVs and small INDELs.
APRIL 2024 Version:
The definition has been refined to specify that the panels are limited to specific variant types at defined sites.
Includes specific mention of CNVs and gene fusions in addition to SNVs and small INDELs.
Comprehensive Genomic Profile (CGP) Testing
1. Definitions
MARCH 2024 Version:
CGP refers to NGS-based assays that describe the genomic makeup of a tumor.
Tests include mutations in individual genes, patterns across related genes, and overall mutational burden.
APRIL 2024 Version:
The definition has been expanded to include LOH and MSI as part of the CGP description.
The new definition emphasizes the clinical relevance beyond a targeted panel, like identifying clinical trials or therapeutic interventions for off-label use.
2. Coding Instructions Changes:
Targeted Tumor Panels:
MARCH 2024 Version:
DNA-based targeted panels for somatic variant detection: CPT codes 81445 and 81450.
Laboratories with 2 to 4 genes: CPT 81479.
APRIL 2024 Version:
DNA-based targeted panels: CPT codes 81445, 81450, 81457, 81458.
RNA-based targeted testing: CPT codes 81449, 81451.
Combined DNA and RNA testing: use CPT 81479.
Comprehensive Genomic Profile (CGP) Testing:
MARCH 2024 Version:
CGP testing should be reported with CPT 81479.
APRIL 2024 Version:
CGP testing should be reported with CPT codes 81459 or 81479.
Specific details are provided on when to use each code.
3. Key Points to Note for Transition:
Updated Definitions: The APRIL 2024 version provides clearer and more detailed definitions for Targeted Tumor Panels and CGP testing, which are important for ensuring accurate coding.
New Coding Instructions: The new version introduces specific coding for targeted panels, differentiating between DNA-based, RNA-based, and combined testing. This differentiation is crucial for proper billing.
CGP Testing: The APRIL 2024 version introduces CPT code 81459 for CGP testing alongside the previously used 81479. This offers a more precise code for some CGP tests.
Compliance: It's important to use the approved DEX Z-Code® identifier for all tests to ensure compliance with the guidelines.
Conclusion:
Transitioning from the MARCH 2024 version to the APRIL 2024 version of the article requires attention to the new definitions and coding instructions. The updated definitions provide better clarity, and the new coding guidelines are essential for accurate billing and reimbursement.
User:
Can you infer anything about the goals and intentions of the authors?
ChatGPT
From the differences between the MARCH 2024 and APRIL 2024 versions of the MolDX billing and coding guidelines for NGS testing in cancer, it's clear that the authors aim to:
Clarify Definitions:
The revised definitions of "Targeted Tumor Panels" and "Comprehensive Genomic Profile Testing" provide more detailed and precise explanations of the types of tests involved. This helps ensure that providers understand the distinctions between the different types of genomic testing.
By refining these definitions, the authors aim to prevent misinterpretation and ensure that tests are appropriately categorized.
Improve Coding Accuracy:
The introduction of specific CPT codes, especially for CGP testing, indicates the authors’ intent to improve coding accuracy.
By differentiating between DNA-based, RNA-based, and combined testing, the authors are facilitating correct billing, which is crucial for accurate reimbursement.
Enhance Compliance:
The emphasis on the use of the DEX Z-Code® identifier reflects the authors' intent to maintain compliance with MolDX requirements. This ensures that laboratories using NGS testing for cancer are following appropriate guidelines and that claims are correctly processed.
Reflect Clinical Practice:
The revised definitions and coding instructions align with current clinical practices in cancer genomic profiling.
By including broader insights, such as patterns of mutations and molecular alterations, the authors acknowledge the evolving nature of genomic testing in cancer and aim to match the guidelines with these advances.
Facilitate Appropriate Use:
The authors intend to guide providers towards the appropriate use of NGS testing. The APRIL 2024 version clarifies when certain tests are warranted and how they should be reported, helping to prevent unnecessary or redundant testing.
In summary, the goals and intentions of the authors seem to center on clarifying the guidelines, enhancing coding accuracy, ensuring compliance, aligning with clinical practices, and facilitating appropriate use of genomic testing in cancer. These changes demonstrate a commitment to precision and clarity in the evolving field of cancer diagnostics and treatment.
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