Avoid Liability for Commission-Based Marketing Arrangements

Contracts between labs and sales and marketing firms raise red flags under both the Anti-Kickback Statute (AKS) and Stark Law, especially when payment is by commission or based on the volume or value … [Read more...]


CMS Exercises Enforcement Discretion for PAMA Reporting

As we previously reported, the Centers for Medicare & Medicaid Services (CMS) has indicated that laboratories had sought relief from the March 31 deadline for reporting applicable information … [Read more...]


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...]


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...]


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...]


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...]


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...]


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...]


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...]


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...]