February 2016 Version of MOLDX M00130 Guidelines, V2, NGS and T1 T2 Coding

As of summer 2017, MolDX guideline M00130 V2 appears to be taken down from the MolDX website, although some MoLDX documents still guide the reader to look up needed instructions within M00130.

M00130 V2 was still available in June 2017 via GOOGLE CACHE.  As below.

https://webcache.googleusercontent.com/search?q=cache:ASsLgFP_fBYJ:https://www.palmettogba.com/palmetto/providers.nsf/vMasterDID/A6LLL81487%3FOpenDocument+&cd=1&hl=en&ct=clnk&gl=us

Next Generation Sequencing (NGS) and Tier 1 and Tier 2 Coding and Billing Guidelines (M00130, V2)

When the AMA developed and published the descriptions for the Tier 1 (T1) and Tier 2 (T2) codes in the Molecular Pathology Procedure Section, the technology for NGS was not fully developed. At that time labs typically used polymerase chain reaction (PCR) and non-NGS sequence analysis to interrogate a single gene or gene component. Therefore, the T1 and T2 codes describe services for a single or occasionally two genes test and subdivide the descriptions by full gene sequence, common variants, duplication/deletion variants, and known familial variants.

NGS platforms have the ability to target and detect multiple specific genes of interest, including common variants, duplication/deletion variants, and known familial variants in one run to create a single report. Therefore, MolDX considers an NGS panel a single test with multiple potential indications. The AMA describes NGS gene panels in the Genomic Sequencing Procedure and Other Molecular Multianalyte Assay (GSP) Section.

To correctly report NGS panels for MolDX claim processing, please review the following guidelines:

• Compare the CPT code descriptions in the GSP Section and select the panel that describes your test. Appropriate GSP codes include the following: 81410, 81412, 81415, 81417, 81420, 81425, 81430, 81432, 81433, 81434, 81435, 81437, 81440, 81442, 81445, 81450, 81455, 81460, 81465, and 81470.
• Do NOT report NGS tests with T1 (codes 81161-81355) and T2 (codes 81400-81408) even if a single gene or multiple genes are selected for testing. MolDX will deny NGS panels reported with T1 and T2 codes as an unbundled service from the primary NGS panel.
• Report codes 81445, 81450 and 81455 for tumor-based targeted (i.e. “hotspot”) panels that test only for SNVs and small indels (10bp)
• Report circulating tumor DNA (ctDNA) and matched tumor-normal testing with 81479
• Report comprehensive NGS panels that perform tumor tissue testing (e.g.SNVs, indels, CNVs and translocations/rearrangements) with 81479.
• Tests reported with CPT code 81479 should be submitted for a teachnical assessment (TA) through DEX after a Z-Code Identifier has been assigned. 

Please suspend claims submission until MolDX has determined coverage and reimbursement for your test. 

Somatic and germline NGS test panel claim submission examples: 

1. One somatic NGS “hotspot” panel split into two tests based on indication and INCORRECTLY submitted with T1/T2 codes and two different Z-Code Identifiers

NGS Test	Investigated Genes	CPT Code	Claim Submission	ID
NGS Colon Cancer Panel 1	BRAF, KRAS, and NRAS	81210, 81275, 81311	Incorrect	Z1234
NGS Lung Cancer Panel 2	EGFR, KRAS, and BRAF	81235, 81275, 81210	Incorrect	Z4567

2. One somatic NGS “hotspot” panel split into two tests based on indication and INCORRECTLY submitted with CPT code 81479 and two different Z-Code Identifiers.

NGS Test	Investigated Genes	CPT Code	Claim Submission	ID
NGS Colon Cancer Panel 1	BRAF, KRAS, and NRAS	81479	Incorrect	Z1234
NGS Lung Cancer Panel 2	EGFR, KRAS, and BRAF	81479	Incorrect	Z4567

3. One somatic NGS “hotspot” panel for two different solid tumor indications and CORRECTLY submitted with CPT code 81445 and one Z-Code Identifier.

NGS Test	Patient Indication	CPT Code	Claim Submission	ID
NGS: targeted genomic sequence analysis panel, solid organ	Colon cancer	81445	Correct	Z4444
NGS: targeted genomic sequence analysis panel, solid organ	Lung cancer	81445	Correct	Z4444

4. One germline test for two patients with different hereditary cancer indications and CORRECTLY submitted with CPT code 81432 and one Z-Code Identifier.

NGS Test	Patient Indication	CPT Code	Claim Submission	ID
NGS: Hereditary breast cancer-related disorders (breast, ovarian, endometrial…)	Breast cancer	81432	Correct	Z5555
NGS: Hereditary breast cancer-related disorders	Endometrial cancer	81432	Correct	Z5555

   *Do not submit code 81432 in addition to T1/T2 testing on the same patient.

February 16, 2016