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
Labs in Court: Alleged Stark Law Violations Lead to $10m Settlement with DOJ
Other recent legal actions include a self-disclosure settlement and punishment for alleged improper diagnostic test add-ons
Leaders of Republican Doctors Caucus See No Action on SGR During Lame Duck
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CMS Releases New CLIA-Waived Tests, Billing Codes
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Enforcement Trends — Labs Continue to Be a Focus
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EBOLA Continues to Warrant Attention From Labs
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ACLA Issues White Paper Arguing Against FDA Regulation of LDT
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NIR Current
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