The History and Impact of Molecular Coding Changes on Coverage and Reimbursement of Molecular Diagnostic Tests  Susan J. Hsiao, Mahesh M. Mansukhani,

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The History and Impact of Molecular Coding Changes on Coverage and Reimbursement of Molecular Diagnostic Tests  Susan J. Hsiao, Mahesh M. Mansukhani, Melissa C. Carter, Anthony N. Sireci  The Journal of Molecular Diagnostics  Volume 20, Issue 2, Pages 177-183 (March 2018) DOI: 10.1016/j.jmoldx.2017.10.006 Copyright © 2018 American Society for Investigative Pathology and the Association for Molecular Pathology Terms and Conditions

Figure 1 Time line of major events in molecular diagnostics coding and valuation. PAMA, Protecting Access to Medicare Act of 2014. The Journal of Molecular Diagnostics 2018 20, 177-183DOI: (10.1016/j.jmoldx.2017.10.006) Copyright © 2018 American Society for Investigative Pathology and the Association for Molecular Pathology Terms and Conditions

Figure 2 Reimbursement for T-cell receptor β rearrangement test using stacking codes and tier 1 code. Reimbursement (red bars) is expressed as a percentage of charges. Case volumes (blue bars) are annualized volumes of cases. Payers are categorized into managed government (green), government (orange), and commercial (gold). The Journal of Molecular Diagnostics 2018 20, 177-183DOI: (10.1016/j.jmoldx.2017.10.006) Copyright © 2018 American Society for Investigative Pathology and the Association for Molecular Pathology Terms and Conditions

Figure 3 Trends in reimbursement for T-cell receptor β rearrangement test using tier 1 code. Percentage of charges reimbursed is displayed quarterly (gray bars) and shows 2.4% quarter-over-quarter decrease from 2013 quarter (Q) 1 to 2015 Q3 and a 4.3% quarter-over-quarter decrease from 2015 Q4 to 2016 Q3 (linear trend lines shown in red). Percentage rejected payments are shown in blue. The Journal of Molecular Diagnostics 2018 20, 177-183DOI: (10.1016/j.jmoldx.2017.10.006) Copyright © 2018 American Society for Investigative Pathology and the Association for Molecular Pathology Terms and Conditions

Figure 4 Reimbursement for Columbia Combined Cancer Panel (467-gene cancer panel) test using tier 1 and 2 codes and using the Genomic Sequencing Procedure (GSP) code. Reimbursement (red bars) is expressed as a percentage of charges. Case volumes (blue bars) are annualized volumes of cases. Payers are categorized into managed government (green), government (orange), and commercial (gold). The Journal of Molecular Diagnostics 2018 20, 177-183DOI: (10.1016/j.jmoldx.2017.10.006) Copyright © 2018 American Society for Investigative Pathology and the Association for Molecular Pathology Terms and Conditions

Figure 5 Trends in reimbursement for Columbia Combined Cancer Panel test using the Genomic Sequencing Procedure code. Percentage of charges reimbursed is displayed quarterly (gray bars) and shows 7.3% quarter-over-quarter decrease from 2015 quarter (Q) 1 to 2016 Q3 (linear trend line shown in red). Percentage rejected payments are shown in blue. The Journal of Molecular Diagnostics 2018 20, 177-183DOI: (10.1016/j.jmoldx.2017.10.006) Copyright © 2018 American Society for Investigative Pathology and the Association for Molecular Pathology Terms and Conditions

Figure 6 Complete denials of reimbursement for T-cell receptor (TCR) β rearrangement and Columbia Combined Cancer Panel (CCCP) testing. Annual percentage of cases with zero payments for TCR β rearrangement (blue) and CCCP test (red). Changes from stacking to tier 1 codes or from stacking to Genomic Sequencing Procedure (GSP) codes are indicated by arrows. The Journal of Molecular Diagnostics 2018 20, 177-183DOI: (10.1016/j.jmoldx.2017.10.006) Copyright © 2018 American Society for Investigative Pathology and the Association for Molecular Pathology Terms and Conditions