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
FISH Testing Case Yields $3.8 Million Settlement
From - G2 Compliance Advisor
A Florida-based urologist is the latest 21st Century Oncology defendant to fork over seven figures to settle charges of false billing for…
Fraud and Abuse Enforcement Efforts Face Declining ROI
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Yates Is Gone But Her Memo Remains
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FISH Test Crackdown against 21st Century Oncology Nets Nearly $25 Million… and Counting
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Brief Your CEO about Individual Liability
From - G2 Compliance Advisor
False Claims Act (FCA) and Anti-Kickback (AKS) prosecutions against labs are just two ways the US Justice Department cracks down on…
DOJ Touts 2016 as Bumper Year for False Claim Act Recoveries
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Enforcement Firsts: Presence Health Fined $475,000 for Taking Too Long to Report HIPAA Breach
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First HIPAA Breach Notification Settlement Totals $475,000
From - G2 Compliance Advisor
Patient health information breaches—whether from hacking, glitches or just plain old carelessness…
OIG Targets Sleep Study Tests
From - G2 Compliance Advisor
If your lab performs sleep studies on Medicare patients, beware. It is now a high-priority target for federal fraud and…
Civil Monetary Penalties Rules Updated
From - G2 Compliance Advisor
One aspect of the Affordable Care Act (ACA) that is not likely to be repealed is the enhancement of penalties for Medicare and Medicaid fraud and abuse. That includes…
