The federal government recently accused a group of over three dozen healthcare professionals from throughout the country of working together to defraud the government. The prosecution claims the accused conspired to falsely charge the government for medically...
Diagnostic Testing And Reference Labs
Texas diagnostic lab owners face 10 years for healthcare fraud
The Department of Justice (DOJ) recently announced that it will move forward with criminal charges against two Texas business owners. The diagnostic laboratory owners claim to own multiple locations throughout the state. The feds argue that the business owners made up...
Two important lessons from EKRA cases in 2022
Lawmakers initially enacted the Eliminating Kickbacks Recovery Act (EKRA) four years ago as part of the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (SUPPORT Act). Although touted by Congress as a law...
When is ordering a lab test a violation of federal law?
Ordering a test for a patient seems like an innocuous and potentially necessary step towards quality medical care, but the government does not always see it this way. The federal government is cracking down on physician practices and hospitals who overutilize testing....
EKRA, sales agents, and diagnostic labs: 2 cases, 2 different holdings
The Eliminating Kickbacks in Recover Act (EKRA) is known for many things, but clarity is not one of them. It provides a tool for the government to fight the opioid epidemic in our country, which is a noble cause. Unfortunately, lawmakers left portions of the law too...
DOJ goes after lab execs and employees for FCA violations: 3 things to know
The feds have continued their crackdown on misuse of federal funds. A recent case provides an example of how the United States Department of Justice (DOJ) handles a situation with a focus specifically on diagnostic laboratories. The government claims the lab in this...
What happens if the feds accuse my lab of an EKRA violation?
The law is constantly evolving. One of the most recent examples is lawmakers’ attempts to address the opioid crisis. In an effort to curtail the abuse of this highly addictive medication, Congress passed the Eliminating Kickbacks in Recovery Act of 2018 (EKRA),...
The feds say my COVID-19 testing lab violated EKRA, now what?
The federal government chose to ease enforcement of certain regulations during the COVID-19 pandemic, but the Eliminating Kickbacks in Recovery Act (EKRA) was not one of them. This provision within the Substance Use-Disorder Prevention that Promotes Opioid Recovery...
Can labs legally pay marketers?
The law is constantly evolving. Arguably, this is a good thing. In many cases this evolution helps to better ensure the laws remain relevant. However, in some cases the changes may cause more problems than they fix. That is the issue diagnostic labs are currently...
Labs and pharmacies take note, FDA announces regulation change
There are various regulations that help better ensure patient safety when compounding medications. Although mostly beneficial, these regulations can prove challenging for pharmacies as well as diagnostic testing and reference labs. The government will conduct audits...