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.
Recent $3.9 Million Settlement and Task Force Announcement Focus Attention on Health Care Information Security
From - National Intelligence Report
A $3.9 million settlement arising from a potential HIPAA breach and an announcement regarding a U.S. Department of Health and Human Services Task Force emphasize the…
FDA Report Asserts Case Studies Support Need for More Oversight of LDTs
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HHS’ Top Ten Management Problems Include Labs
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Latest Major False Claims Act Settlement Involves 457 Hospitals in 43 States
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Millennium Settles False Claims Allegations for $256 Million
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Expect More Concerted HIPAA Enforcement Due to OIG Reports
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DOJ Memo Emphasizes Focus on Individual Liability for Corporate Misconduct
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FTC Issues Guidance on Unfair Competition Enforcement
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