Wednesday, February 24, 2016

MolDX NGS/CGP Article V2 2016/02/16

Next Generation Sequencing Coding and Billing Guidelines 

(M00127, V2)


http://www.palmettogba.com/palmetto/MolDX.nsf/DocsCat/MolDx%20Website~MolDx~Browse%20By%20Topic~Covered%20Tests~A59HL70436?open&navmenu=Browse^By^Topic||||

Next Generation Sequencing (NGS)
NGS testing platforms allow identification of somatic and/or germline alterations in multiple genes at the same time. This guideline focuses on two main types of somatic, tumor tissue-based, testing panels.  Germline panels will be addressed in another article as needed.
Targeted (aka Hot Spot) Tumor Panels
Targeted NGS panels identify somatic alterations known to occur in certain areas (i.e., 'hotspots') in specific genes of interest. Generally, these NGS panels can detect single nucleotide variants (SNVs or point mutations) and small (typically ≤10 bp) insertions or deletions. These alterations typically represent genomic targets with corresponding targeted cancer therapies. Identification of a genomic target guides use of the corresponding targeted therapy.
To bill for targeted NGS services, review CPT codes 81445, 81450 and 81455. Base the selected code on the number of genes in your laboratory’s NGS panel and the test indication for solid organ and hematolymphoid neoplasms. The UOS for the NGS panel is one.
Note: Individual gene tests performed in the NGS panel should NOT be registered and reported with multiple CPT Tier 1 and/or Tier II codes. 
Comprehensive Genomic Profile (CGP) TestingCGP refers to NGS-based testing that has been optimized to identify all types of molecular alterations (i.e., SNVs, small and large insertions and deletions, CNVs, and rearrangements/translocations/fusions) in cancer-related genes in a single test using complex proprietary bioinformatics. 
Because CGP includes SNVs, small (≤ 10 bp) and large (> 10 bp) insertions and deletions, CNVs, AND rearrangements (i.e., translocations/fusions), CPT codes 81445, 81450, and 81455 do NOT describe a CGP service. Therefore, to report a CGP service, test providers should use CPT code 81479 - Unlisted molecular pathology procedure.

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