LDT Oversight Remains Under CLIA, for Now
Judge rules that the FDA has ‘no authority’ to issue its rule governing laboratory-developed tests
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Further Details to Note about Updated Clinical Lab Director Qualifications
Put into place late last year, the new rules place more emphasis on formal and continuing education requirements
New CMS TCET Rule Likely Won’t Hasten Medicare Coverage of Breakthrough Devices
Recently proposed rule seems too stringent to reduce the lag between FDA approval and Medicare coverage.
Medicare Outpatient Packaging Policy Will Not Apply to ASCs
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CMS Eliminates 50-50 Payment Rule for ESRD Lab Services
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CMS Proposes New Shared Savings Risk Model
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CMS Releases New CLIA-Waived Tests, Billing Codes
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ACLA Issues White Paper Arguing Against FDA Regulation of LDT
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