CMS administers the CLIA program.  This is about their ability to operate as a lab, not just about Medicare reimbursement.<p>See here for a clear breakdown of responsibility among government agencies: <a href="http:&#x2F;&#x2F;www.fda.gov&#x2F;MedicalDevices&#x2F;DeviceRegulationandGuidance&#x2F;IVDRegulatoryAssistance&#x2F;ucm124105.htm" rel="nofollow">http:&#x2F;&#x2F;www.fda.gov&#x2F;MedicalDevices&#x2F;DeviceRegulationandGuidanc...</a>