Analysis: Secretary's Advisory Committee on Genetics, Health, and Society Report falls short.

摘要: On April 30, 2008, the Secretary's Advisory Committee on Genetics, Health, and Society released its Report, "US System of oversight genetic testing: a response to charge Secretary HHS." Positive features this Report include recommendations for increased funding development characterization reference materials methods; enhanced support growth improvement public sequence databases; encouragement implementation electronic medical records; promotion efforts clinical utility-oriented study groups such as Evaluation Genomic Applications in Practice Prevention Working Group; enforcement prohibitions against testing by laboratories that lack Clinical Laboratory Improvement Amendments certification. The reaffirmed set forth publication, "Coverage reimbursement tests services," would expand Medicare coverage increase payment rates appropriately performed tests. However, used an overly broad definition is neither scientifically sound nor practically workable. This led Committee's inability distinguish from other complex laboratory assays. has fallen short unnecessarily advocating Food Drug Administration review all developed proposing creation mandatory registry