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
Enforcement Trends: 5 Insights from the OIG Semi-Annual Report
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New OIG Rules Make It Easier to Sock Labs with Civil Monetary Penalties
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Brief Your CEO: The New Anti-Kickback Safe Harbors & Their Impact on Your Lab
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OIG Highlights Hotline to Encourage Fraud Reporting
From - G2 Compliance Advisor
Reporting compliance concerns is a key component of effective compliance plans. A recent U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) podcast highlights…
Brief Your CEO: Use New OIG Work Plan to Keep Your Lab Compliant in 2017
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Labs Among Top 10 Management Challenges Facing HHS
From - G2 Compliance Advisor
The U.S. Department of Health and Human Services (HHS) Office of Inspector General recently spotlighted 10 top management challenges it says…
Labs In Court: A roundup of recent cases and enforcement actions involving the diagnostics industry
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Labs In Court: A roundup of recent cases and enforcement actions involving the diagnostics industry
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Drug Testing Case Settles for $7.4 Million
From - G2 Compliance Advisor
A Florida clinic has settled a False Claims Act case relating to drug testing for $7.4 million. Quantitative drug tests that…
Theranos Announces Appeal of CMS Sanctions
From - G2 Compliance Advisor
Theranos has announced that it is appealing the Centers for Medicare & Medicaid's threatened sanctions. The announcement also indicated that…