Coordination of federal regulation and payment for new diagnostic tests: a proposed new approach.
Schoonmaker
Michele
M
Vysis, Inc, Downes Grove, IL, USA
Bagley
Grant P
GP
Scanlan
M Kay
MK
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