Case of the Month: Feds Turn Up the Heat on False Billing of Nuclear Stress Tests

While the feds have made urine drug testing of opioid drug patients their number one target for lab-related False Claims Act (FCA) charges this year, nuclear stress tests (NSTs) ordered by … [Read more...]


You Make the Call: Self-Disclosing Non-Compliant Arrangements with Large Physician Groups

SITUATION Fictional Med (FM), a large physician-owned clinic, is one of your lab's biggest customers. So your heart sinks when during an internal compliance audit, you discover that your lab has been … [Read more...]


Brief Your CEO: 5 Takeaways from OIG’s New Semiannual Report

Like many lab managers, you may provide a year-end compliance briefing to your executive team. If so, you will want to cover the new OIG Semiannual Report to Congress in which the agency explains what … [Read more...]


Tool: Model Sexual Harassment Policy

The sexual harassment policy has been a fixture of the HR manual for decades. And that's the problem. While lack of toleration for sexual harassment is decades-old, the conduct and our understanding … [Read more...]


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

$80K Is the Price for Accepting Free Testing Cups Case: Those turned out to be some pretty expensive cups! A group of addiction centers (aka, AMC) probably did not think twice about accepting free … [Read more...]


5 Common Sexual Harassment Policy Blind Spots & How to Fix Them

Recent weeks have witnessed the morphing of workplace sexual harassment prevention from legal requirement to moral imperative. And while the current fervor is a bit unnerving for employers, to the … [Read more...]


LDTs, FDA-Approved Companion Diagnostics Perform Similarly; Off-Label Use of Companion Diagnostic Kits Common

One of the arguments for U.S. Food and Drug Administration oversight over laboratory-developed tests (LDTs) involves the need for greater assurances regarding the quality and consistency of these … [Read more...]


FDA Warns About Biotin Interference With Lab Tests

In late November the U.S. Food and Drug Administration issued a safety communication warning that the supplement biotin (Vitamin B7) may interfere with laboratory testing results. The warning comes … [Read more...]


PAMA-Geddon: Lab Industry Takes CMS to Court

The nearly three-year struggle between HHS and the lab industry over PAMA has entered a new phase. On December 11, the American Clinical Laboratory Association (ACLA) filed a lawsuit asking the U.S. … [Read more...]


OIG Work Plan Monthly Review: December 2017

None of the six items the OIG added to its Work Plan this month directly address labs or labs services. However, five of the new items, including the two dealing with opioid abuse, might affect labs … [Read more...]