title: Clinical Genomic Profiling of a Diverse Array of Oncology Specimens at a Large Academic Cancer Center: Identification of Targetable Variants and Experience with Reimbursement.
abstract: Large cancer panels are being increasingly used in the practice of precision medicine to generate genomic profiles of tumors with the goal of identifying targetable variants and guiding eligibility for clinical trials. To facilitate identification of mutations in a broad range of solid and hematological malignancies, a 467-gene oncology panel (Columbia Combined Cancer Panel) was developed in collaboration with pathologists and oncologists and is currently available and in use for clinical diagnostics. Herein, we share our experience with this testing in an academic medical center. Of 255 submitted specimens, which encompassed a diverse range of tumor types, we were able to successfully sequence 92%. The Columbia Combined Cancer Panel assay led to the detection of a targetable variant in 48.7% of cases. However, although we show good clinical performance and diagnostic yield, third-party reimbursement has been poor. Reimbursement from government and third-party payers using the 81455 Current Procedural Terminology code was at 19.4% of billed costs, and 55% of cases were rejected on first submission. Likely contributing factors to this low level of reimbursement are the delays in valuation of the 81455 Current Procedural Terminology code and in establishing national or local coverage determinations. In the absence of additional demonstrations of clinical utility and improved patient outcomes, we expect the reimbursement environment will continue to limit the availability of this testing more broadly.
authors.affiliation: Department of Pathology and Cell Biology, Columbia University Medical Center, New York, New York.
authors.forename: Anthony N
authors.initials: AN
authors.lastname: Sireci
authors.affiliation: Department of Pathology and Cell Biology, Columbia University Medical Center, New York, New York.
authors.forename: Vimla S
authors.initials: VS
authors.lastname: Aggarwal
authors.affiliation: Department of Pathology and Cell Biology, Columbia University Medical Center, New York, New York.
authors.forename: Andrew T
authors.initials: AT
authors.lastname: Turk
authors.affiliation: Department of Pathology and Cell Biology, Columbia University Medical Center, New York, New York.
authors.forename: Tatyana
authors.initials: T
authors.lastname: Gindin
authors.affiliation: Department of Pathology and Cell Biology, Columbia University Medical Center, New York, New York.
authors.forename: Mahesh M
authors.initials: MM
authors.lastname: Mansukhani
authors.affiliation: Department of Pathology and Cell Biology, Columbia University Medical Center, New York, New York. Electronic address: sjh2155@cumc.columbia.edu.
authors.forename: Susan J
authors.initials: SJ
authors.lastname: Hsiao
mesh_terms: D000046:Academic Medical Centers; D014408:Biomarkers, Tumor; D002173:Cancer Care Facilities; D004252:DNA Mutational Analysis / Q000379:methods / Q000592:standards; D020869:Gene Expression Profiling / Q000379:methods* / Q000592:standards; D005820:Genetic Testing / Q000379:methods* / Q000592:standards; D014644:Genetic Variation; D023281:Genomics / Q000379:methods* / Q000592:standards; D006801:Humans; D007349:Insurance, Health, Reimbursement; D009154:Mutation; D009369:Neoplasms / Q000175:diagnosis* / Q000235:genetics*; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D013997:Time Factors
chemical_list: D014408:Biomarkers, Tumor