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.
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New HCPCS Codes for COVID-19 Specimen Collection
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VITAL Act Would Eliminate FDA Regulation of New Tests During Health Emergencies
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FDA Takes Unprecedented Measures to Promote Rapid Development of Coronavirus Diagnostic Tests
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Billing & Coding: CMS Sets Rules for Medicare Coronavirus Testing Reimbursement with Private Payors Expected to Follow Suit
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Lab industry leaders meet with White House on COVID-19 testing
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Two commercial labs testing now for COVID-19
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