CMS administers the CLIA program. This is about their ability to operate as a lab, not just about Medicare reimbursement. See here for a clear breakdown of re

CMS administers the CLIA program. This is about their ability to operate as a lab, not just about Medicare reimbursement. See here for a clear breakdown of responsibility among government agencies: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/IVDRegulatoryAssistance/ucm124105.htm http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidanc...