title: Diagnostic testing managed by hematopathology specialty and other laboratories: costs and patient diagnostic outcomes.
abstract: BACKGROUND
  Successful management of patients with hematologic malignancies depends upon accurate and timely diagnosis, which frequently requires integration and interpretation of multiple tests. Our retrospective analysis compared diagnostic uncertainty, resource utilization, and costs for patients with diagnostic bone marrow (BM) tests managed by commercial laboratories.
  
  
  METHODS
  Patients with BM biopsies and suspected hematologic cancer/condition were identified from claims (2005-2011) within a large US health plan (coverage ≥6 pre- and ≥3-months post-biopsy). Cohorts defined by laboratories performing BM morphologic assessment/directing testing sequence: Genoptix (GX, specialty hematology-testing laboratory), large commercial laboratories (LL), other laboratories (OL). One-year post-biopsy changes in diagnosis or treatments, tests performed, and diagnostic/treatment medical costs (measured as per-patient-per-month [PPPM]) were examined.
  
  
  RESULTS
  The study population included 1,387 GX, 4,162 LL, and 19,115 OL patients with suspected hematologic malignancy/disease and BM morphology assessment. GX had lower diagnostic uncertainty measured between 2 time periods by diagnostic stability (no conditions the same; 6.16% GX, 8.04% LL, 9.73% OL; p < 0.001) and changes (≥1 condition different; 7.88% GX, 11.19% LL, and 14.08% OL; p < 0.001), fewer repeat BM biopsies, and fewer chemotherapy changes (30-days and 60-days post-initiation). One-year PPPM costs adjusted for patient characteristics differences were $8,202 GX, $7,711 LL, and $10,302 OL (p < 0.05); adjusted PPPM costs (excluding testing period) were $6,019 GX, $6,649 LL, and $7,801 OL (p < 0.05).
  
  
  CONCLUSIONS
  Our data suggests that a hematopathology specialty laboratory may result in earlier final diagnosis, fewer subsequent diagnosis changes, reduced need for follow-on testing requiring repeat biopsy procedures, and may result in lower downstream healthcare costs. Further evaluations using medical chart abstractions or registries will be valuable.
authors.affiliation: Optum, Eden Prairie, MN, USA ; Health Economics and Outcomes Research, Optum, 12125 Technology Drive, Eden Prairie, MN 53344, USA.
authors.forename: Nicole M
authors.initials: NM
authors.lastname: Engel-Nitz
authors.affiliation: Novartis Molecular Diagnostics, Cambridge, MA, USA ; Present address Metamark Genetics, Cambridge, MA, USA.
authors.forename: Benjamin
authors.initials: B
authors.lastname: Eckert
authors.affiliation: Optum, Eden Prairie, MN, USA.
authors.forename: Rui
authors.initials: R
authors.lastname: Song
authors.affiliation: Optum, Eden Prairie, MN, USA.
authors.forename: Priyanka
authors.initials: P
authors.lastname: Koka
authors.affiliation: Optum, Eden Prairie, MN, USA.
authors.forename: Erin M
authors.initials: EM
authors.lastname: Hulbert
authors.affiliation: Optum, Eden Prairie, MN, USA.
authors.forename: Jeffrey
authors.initials: J
authors.lastname: McPheeters
authors.affiliation: Optum, Eden Prairie, MN, USA ; Present address Heme Onc Associates, Carlsbad, CA, USA ; AHT BioPharma Advisory Services, Carlsbad, CA, USA.
authors.forename: April
authors.initials: A
authors.lastname: Teitelbaum
keywords: Diagnostic costs; Diagnostic laboratory tests; Hematopathology; Leukemia; Lymphoma