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
OIG Video Spotlights Physician Kickbacks
From - G2 Compliance Advisor
The U.S. Health and Human Services Office of Inspector General's (OIG's) concern about kickbacks to referral sources is…
Drug Testing Enforcement Cases Lead to Costly Settlements and Convictions
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Labs with International Aspirations Need to Focus on FCPA Compliance Challenges
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Theranos Faces New Challenges and Increasing Federal Scrutiny
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DOJ Continues Focus on Individual Accountability with FCPA Self-Disclosure Pilot
From - G2 Compliance Advisor
If the Foreign Corrupt Practices Act (FCPA) sounds like it shouldn't be of concern to laboratories and the diagnostics industry, think again. Alere, a point-of-care diagnostic test maker, recently disclosed…
Convictions, Sentences and a Costly Settlement in Recent Lab Test Enforcement Cases
From - G2 Compliance Advisor
In just this month, lab anti-kickback and false claims enforcement cases have led to the conviction of two lab professionals, prison sentences for a physician and for…
Physician Jailed for Unnecessary Diagnostic Tests, Office Visits and Prescriptions
From - G2 Compliance Advisor
A Michigan physician has been sentenced to 45 months in prison as part of what the government claims is a…
Second Doctor Indicted in Biodiagnostic Kickback Case
From - Laboratory Industry Report
Another physician has been indicted in the long-running Biodiagnostic Laboratory Services case. Bernard Greenspan, M.D., a family physician in Northern New Jersey, was indicted on…
Federal Fraud and Abuse Recoveries Down from Prior Fiscal Year
From - G2 Compliance Advisor
Despite robust enforcement efforts and large scale investigations and takedowns, the overall recovery received in government coffers last year was…
Kickback Case Settles for Record-breaking $646 Million
From - G2 Compliance Advisor
It has been billed as the largest total amount in U.S. history paid for alleged violations of the Anti-kickback Statute by…
