Special Report: The 2024 Lab Enforcement Landscape
Lab leaders should be wary of telemedicine arrangements, certain marketing firms, and unnecessary PGx and CGx testing
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Articles and Reports
Getting Started with the FDA’s New LDT Rule
Experts explain what the phase-in process will look like—and how labs can get ahead of the game.
LDTs Around the World
Curious about how laboratory-developed tests are regulated in other countries? We compare in-house test guidance across six regions
Florida Lab Pays $100K to Settle Claims of Violating Bioterrorism Law
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OIG Work Plan Monthly Review: July 2018
From - G2 Compliance Advisor
None of the six new items that OIG added to its Work Plan last month directly impact labs…
Insurer Accuses Florida Lab, California Hospital of Toxicology Test Billing Fraud
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Case of the Month: Jury Socks HDL Blood Test Fraud Principles with $114.1 Million Verdict
From - G2 Compliance Advisor
Roughly three years ago at this time, mega-scandals were in the news featuring diagnostic giants like Millennium, Health Diagnostic Laboratory (HDL), Biodiagnostic Laboratory Service and…
OIG Semiannual Report: Opioid Crackdown Is Making Labs a Prime Enforcement Target Once Again
From - G2 Compliance Advisor
Once the favorite whipping boy of federal enforcers, labs have been demanding less and less of the OIG's attention in recent years. But the newly published…
OIG Work Plan Monthly Review: April 2018
From - G2 Compliance Advisor
Four of the six new items that the OIG added to its workplan have an impact–albeit indirect–on labs…
OIG Work Plan Monthly Review: March 2018
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Enforcement Trends: Why Fending Off Whistleblowers Might Have Just Gotten Easier
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Labs In Court: A roundup of recent cases and enforcement actions involving the diagnostics industry
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OIG Work Plan Monthly Review: February 2018
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