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...
Diagnostic Testing And Reference Labs
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...
Lab owner agrees to pay $2M to settle AKS claim
The United States Department of Justice (DOJ) continues to crackdown on its fight against illegal kickbacks. The feds are clear in their belief that what it considers bribes within the healthcare industry for medical services or equipment taint the ability to provide...
Feds accuse Dallas-based lab of illegal kickbacks
UnitedHealthcare Services and UnitedHealthcare Insurance Company (plaintiffs) recently filed suit against a Dallas-based lab. In this suit, the plaintiffs claim the lab was making illegal kickback payments to increase the use of their facility. According to court...
What should I know about diagnostic lab accreditation in Texas?
Diagnostic labs are a valuable part of the health care marketplace. These labs can offer a variety of services within hospitals and as stand-alone facilities. Those who are interested in joining this marketplace, or who are relatively new to the health care industry,...
What can labs expect from EKRA in 2021?
Congress enacted the Eliminating Kickbacks in Recovery Act (EKRA) in 2018 to address the potential for bribes, referred to as illegal kickbacks, between diagnostic labs, clinics and other clinical treatment facilities. Lawmakers enacted EKRA as part of the...