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...
Diagnostic Testing And Reference Labs
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...
EKRA prosecutions in 2020: 3 lessons for lab managers
The fact that the United States Department of Justice (DOJ) prosecuted 3 EKRA cases in 2020 shows that the feds are serious about this law. As such, lab owners are wise to take steps to better ensure compliance. One important step: learning from past mistakes. This...
Key reason EKRA poses unique risk for labs
Congress enacted the Eliminating Kickbacks in Recovery Act (EKRA) in 2018 as part of an overall push to address the opioid crisis. Lawmakers intended this law to provide authorities with the ability to hold medical professionals accountable who received kickbacks in...
OIG calls on diagnostic labs to implement compliance plans
The Office of the Inspector General (OIG) of the Department of Health and Human Services (HHS) along with other federal agencies who enforce the regulations that apply to diagnostic labs have called on these healthcare facilities to implement compliance plans. What...