PATIENT SAFETY

Lab CEO Pleads Guilty to Distributing Medically Unnecessary Opioids

Case: The CEO of Tri-County Wellness Group and owner of labs and pain clinics in Michigan and Ohio, pleaded guilty to criminal charges for his role in $300 million health care fraud scheme involving … [Read more...]

PATIENT SAFETY

Diagnostics & Demographics: Is Your Lab Prepared to Accommodate an Aging Population?

Talk of an aging population isn't idle chatter. According to the U.S. Census Bureau, 2030 will mark a significant turning point in the nation's history. By then, all baby boomers will be older than … [Read more...]

EXPOSED THERANOS FRAUD

Investigative Journalist Wins Kellison Award

John Carreyrou, the Pulitzer prize-winning journalist who exposed Theranos as a fraud, was presented with the Kellison & Company Distinguished Service Award at Lab Institute today. Pictured … [Read more...]

CONSUMER FRAUD

Labs In Court: A roundup of recent cases and enforcement actions involving the diagnostics industry

Aetna Settles with States of Victims of HIV Meds Envelope Privacy Snafu Case: Aetna is still paying for a disastrous miscalculation that may have revealed the HIV status of 12,000 beneficiaries … [Read more...]

PATIENT SAFETY

Labs In Court: A roundup of recent cases and enforcement actions involving the diagnostics industry

Free Testing Supplies to Physicians Costs Massachusetts Lab $1.374 Million Case: A federal court ordered Calloway Laboratories, Inc. to pay $1,374,058 to settle claims of falsely billing … [Read more...]

COMPLIANCE PLANS

OIG Monthly Work Plan Review: September 2018

Neither of the two new OIG Work Plan items directly impacts labs but both address areas of national concern and have potential long-term implications on at least some labs. 1. Follow-Up Review of … [Read more...]

ANTI-KICKBACK

Labs In Court: A roundup of recent cases and enforcement actions involving the diagnostics industry

Kickback Settlement Costs Pennsylvania Hospital $13.1 Million Case: The most expensive kickback settlement of 2018 to date features Post Acute Medical, LLC (PAM) in the starring role. The case … [Read more...]

PUBLIC HEALTH

New Zika Blood Testing Guidance Effective Immediately

On July 6, the FDA issued revised guidance for testing of donated blood for Zika virus. Summary After initially recommending universal nucleic acid testing of individual blood donation units, the … [Read more...]

GENETIC TESTING

Compliance Perspectives: Genetic Test Labs Face Growing Risk of Medical Malpractice Liability

Compliance managers of lab involved in the $3 billion consumer-based genetic testing business need to safeguard their flank against a growing legal risk: the threat of liability for malpractice. As … [Read more...]

PATIENT SAFETY

Labs In Court: A roundup of recent cases and enforcement actions involving the diagnostics industry

Ex-CEO of HDL Settles Bankruptcy Claims for $10 Million Case: Health Diagnostic Laboratory co-founder and former CEO Tonya Mallory has agreed to pay $10 million to settle claims brought by the … [Read more...]


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