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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CLIA: CMS Issues Guidance on How Labs Should Perform Coronavirus Testing
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By the Numbers: Improper Medicare Payments Hit 10-Year Low
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PAMA: The New LAB Act Buys Labs One Year of Price Reporting Relief
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Genetic Testing: CMS Proposes Expanding NGS Testing Eligibility
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CLIA: CMS Revises State Operations Manual for Labs
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Hospital Labs: CMS Pushes Forward with Controversial Price Transparency Rules
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The Year in Labs Regulation: The 6 Biggest Stories of 2019
"May you live...
Medicare Reimbursement: CMS Eases Coverage Restrictions on NGS Testing of Early-Stage Cancer Patients
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