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...
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Diagnostic Testing And Reference Labs
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...
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...