title: Coordination of federal regulation and payment for new diagnostic tests: a proposed new approach.
authors.affiliation: Vysis, Inc, Downes Grove, IL, USA
authors.forename: Michele
authors.initials: M
authors.lastname: Schoonmaker
authors.forename: Grant P
authors.initials: GP
authors.lastname: Bagley
authors.forename: M Kay
authors.initials: MK
authors.lastname: Scanlan
mesh_terms: D014487:Centers for Medicare and Medicaid Services, U.S.; D018795:Device Approval; D003955:Diagnostic Tests, Routine / Q000191:economics*; D006801:Humans; D008962:Models, Theoretical; D011358:Product Surveillance, Postmarketing; D012051:Reimbursement Mechanisms / Q000331:legislation & jurisprudence*; D014481:United States; D014486:United States Food and Drug Administration