ENFORCEMENT

CMS, OIG Reps Address Attendees at ACLA Annual Meeting

At the American Clinical Laboratory Association annual meeting in Washington, D.C. March 23, representatives of the Centers for Medicare & Medicaid Services (CMS) and the Office of Inspector … [Read more...]

ENFORCEMENT

Dealing with the FDA: 12 Best Practices for Responding to a Form 483

Laboratory diagnostic tests and affiliation with drug and device manufacturers have made labs a popular target for U.S. Food and Drug Administration (FDA) quality system inspection. Going through an … [Read more...]

ENFORCEMENT

FISH Testing Case Yields $3.8 Million Settlement

A Florida-based urologist is the latest 21st Century Oncology defendant to fork over seven figures to settle charges of false billing for fluorescence in situ hybridization (FISH) tests. The Original … [Read more...]

ENFORCEMENT

Fraud and Abuse Enforcement Efforts Face Declining ROI

The federal government's return on investment (ROI) in the fight against health care fraud continues a recent decline according to the latest numbers reported for the Health Care Fraud and Abuse … [Read more...]

BRIEF YOUR CEO

Yates Is Gone But Her Memo Remains

Pursuing False Claims Act (FCA) and Anti-Kickback Statute (AKS) prosecutions is just one of the things the US Department of Justice does to crack down on corporate wrongdoing. But while the enterprise … [Read more...]

ENFORCEMENT TRENDS

FISH Test Crackdown against 21st Century Oncology Nets Nearly $25 Million… and Counting

$24.86 million. That's how much a whistleblower has made for the government and herself—so far—in a case against 21st Century Oncology for alleged fraudulent billing of fluorescence in situ … [Read more...]

ENFORCEMENT

Brief Your CEO about Individual Liability

False Claims Act (FCA) and Anti-Kickback (AKS) prosecutions against labs are just two ways the US Justice Department cracks down on corporate wrongdoing. But while the threat of FCA and AKS corporate … [Read more...]

NEWS

DOJ Touts 2016 as Bumper Year for False Claim Act Recoveries

The False Claims Act (FCA) remains the federal government's most potent fraud enforcement tool. After sagging a tad in recent years, FCA recoveries bounced back in fiscal year 2016. As usual, the … [Read more...]

NEWS

Enforcement Firsts: Presence Health Fined $475,000 for Taking Too Long to Report HIPAA Breach

Patient health information breaches—whether from hacking, glitches or just plain old carelessness—remain an all too common occurrence in labs and other health care institutions. A new HIPAA rule took … [Read more...]

HIPAA

First HIPAA Breach Notification Settlement Totals $475,000

Patient health information breaches—whether from hacking, glitches or just plain old carelessness—remain an all too common occurrence in labs and other health care institutions. Four years ago, a new … [Read more...]


(-0000g2)