LDT Appeal: Looking at the Legal Nuances Behind Potential FDA Actions Following Court Decision
Marginal LDT scenarios could be where the FDA focuses on next, a lawyer notes
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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
Enforcement Trends: OIG Calls Out CMS for Not Preventing Medicare Genetic Testing Overpayments
Inadequate CMS oversight resulted in $888.2 million in improper payments for the highest reimbursing molecular pathology genetic tests, report says.
U.S. Supreme Court Recognizes FCA Liability for Implied False Certification
From - National Intelligence Report
While the long awaited release of the PAMA rule has received a lot of attention, a significant False Claims Act (FCA) decision by the U.S. Supreme Court was also…
CMS Reports Medicare Fraud Prevention System Saves $1.5 Billion
From - National Intelligence Report
While Big Data can mean new opportunities for increasing efficiencies and revenues for the laboratory industry, the Centers for Medicare & Medicaid Services (CMS) claims Big Data has yielded big savings for…
OIG Mid-Year Work Plan Update Adds PAMA-Focused Lab Item
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Focus Diagnostics Simplexa Test Kit Faces Recall
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Government Scrutiny of Theranos Increases
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DOJ Report Reveals Fraud and Abuse Recoveries Declined in Fiscal Year 2015
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