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.
Federal Enforcers Crack Down on Fraudulent Billing of Genetic Tests
Labs that bill federal health care programs for these tests need to pay especially close attention to ensure compliance.
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University of Miami Settles Lab Testing False Claim Charges for $22 Million
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Health Care Data Breaches Hit a New High in First Half of 2021
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Texas Provider Pays $214K for Violating Federal COVID-19 Workplace Protocols
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