The Value of Precision Medicine is Clear!

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There are now many studies that support the thesis that patients who receive a treatment matched to a tumor molecular profile have a longer progression free survival (PFS).  Von Hoff et al JCO 2010;28 4877-4883, Tsimberridou et al., Clin Cancer Res 2014;20 4827-4836, Schwaederle et al (Abstract 11097) presented at ASCO summarized the analysis of… Read more »

Ph.D Laboratory Directors May Not be Allowed to Sign out Cases

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In an adjacent proposed local coverage decision (LCD) Palmetto (Medicare contractor) suggests the following guidelines for oncological molecular profiling and sign outs.  Some of the analytical requirements are timely but it continue to amaze me how prescriptive these coverage policies are getting.  (Analytical Performance Specifications for Comprehensive Genomic Profiling (M00118, V1)) It includes the following… Read more »

Genomic Sequencing Procedures Under Assault

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Only Four of the new Genomic Sequencing Procedure (GSPs) were priced in the latest gapfilling proposal by CMS and only in limited jurisdictions. 81435          Hereditary colon cancer syndromes (eg, Lynch syndrome, familial adenomatosis polyposis); genomic sequence analysis panel, must include analysis of at least 7 genes, including APC, CHEK2, MLH1, MSH2, MSH6, MUTYH, and PMS2… Read more »

NGS Reimbursement in 2015

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The Centers for Medicare and Medicaid Services (CMS) recently published its final payment determination for the new and reconsidered laboratory codes for Calendar Year 2015. Highlights include a decision to use gapfilling to set the pricing for the Genomic Sequencing Procedures (GSPs) codes, CPT 81410 through 81471. Professional societies and industry members had recommended both crosswalking or… Read more »