Liability Traps to Avoid:
Commission-Based Lab 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...]


Enforcement E¢onomi¢$: ROI on US Fraud & Abuse Program Continues to Decline

While still profitable, the business of enforcing health care fraud laws has been providing the federal government a steadily declining return on investment (ROI) in recent years. This long-term trend … [Read more...]


Feds Net Another Million-Dollar Settlement in 21st Century Oncology FISH Testing Case

AFlorida-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...]


Arizona Fraud Suit Opens New Front in the Legal War against Theranos

The Arizona Attorney General's Office (AGO) recently issued a request for proposal signaling a new legal battle for Theranos: state consumer fraud lawsuits. The AGO indicated in its request that it … [Read more...]


New Laws: Civil Monetary Penalties Get More Expensive—and Easier to Dish Out

One aspect of the Affordable Care Act (ACA) that is not likely to be repealed is the enhancement of penalties for Medicare and Medicaid fraud and abuse.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 the new Regulation on civil … [Read more...]


False Claims Act Cases Continue to Be a Cash Cow for the Feds

Easy liability; High penalties; Private individuals willing to do the heavy lifting by bringing qui tam whistleblower lawsuits. It is not hard to understand why few federal government ventures … [Read more...]


CMS Bars Theranos’ California Lab from Medicare Program

Elizabeth Holmes dropped out of college to start up Theranos. Now Theranos and Holmes have been dropped from the Medicare program. Theranos has confirmed that the Centers for Medicare & Medicaid … [Read more...]


Dallas Dermatopathology Lab Accused of Fraudulent Billing of Tricare

By Ron Shinkman, Editor, Laboratory Industry Report A prominent dermatopathology laboratory in Dallas has been implicated in a CBS News investigation regarding potential fraudulent billing of the … [Read more...]


Theranos Now Under Criminal Investigation

The plot continues to thicken for Theranos. As the California-based startup tries to strain toward greater transparency, it is now apparently the subject of a criminal investigation. Both the Wall … [Read more...]


FDA Recalls Focus Diagnostics Test Kit

The U.S. Food and Drug Administration has issued a rare recall of a laboratory test kit, claiming a fault in its manufacturing process could endanger patients. The test in question is manufactured … [Read more...]