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LDT Oversight Remains Under CLIA, for Now
Judge rules that the FDA has ‘no authority’ to issue its rule governing laboratory-developed tests
FDA Watch: DOGE Changes at FDA Upend Approval Processes, Observers Say
Pre-submission and Q-Submission meetings apparently have been halted, for now
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PAMA: The New LAB Act Buys Labs One Year of Price Reporting Relief
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Texas Health System Fined $431K for Falsely Billing Genetic Tests
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Genetic Testing: New Medicare Early NGS Cancer Test Coverage Policy Is Less than Meets the Eye
For Myriad Genetics, Foundation Medicine and other manufacturers of next-generation sequencing (NGS)-based test panels for early-stage cancer risk assessment, the recent announcement of CMS’ decision to provide limited Medicare coverage
Enforcement Trends: Increase in OIG Fraud Recoveries Belies Continued Decline in Enforcement Actions
OIG fraud recovery has been a solid growth business for nearly two decades. So, when the agency announced a decline in FY 2018 recovery figures, it was more than a bit surprising. But things got back to normal this year, as far as
Federal Court Dismisses Whistleblowers’ Urine Drug Test False Billing Claim
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OIG Work Plan: Agency to Focus on Vaccine Adverse Event Reporting
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EKRA: More than a Year Out, Major Questions Remain Unresolved
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Sales & Marketing: The Perils of Restructuring Sales Commissions for EKRA
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