The US Department of Health and Human Services’ Office of the Inspector General (OIG) recently released a report calling on federal agencies to review diagnostic and testing laboratories that bill for COVID-19 tests. The agency encourages those who review these labs...
Diagnostic Testing And Reference Labs
What do I need to know before starting a diagnostic lab in NY?
Medical professionals who are interested in starting a diagnostic lab can benefit from the following tips: Check the market. This is pretty foundational to any business. Check to make sure this market makes sense for your lab. If not, look elsewhere. Spread the word....
EKRA in 2022: What do we know about the law and its impact on labs?
Lawmakers passed the Eliminating Kickbacks in Recovery Act (EKRA) in 2018. At the time, Congress touted it as a way to hold bad actors accountable for illegal kickbacks in drug treatment centers. Even then legal leaders voiced concern that the language within the law...
DOJ uses EKRA to pursue COVID fraud
The Department of Justice (DOJ) just made an already ambiguous law even more difficult to navigate. Lawmakers originally touted the Eliminating Kickbacks in Recovery Act (EKRA) as a weapon to help combat the growing opioid crisis. In reality, we have seen the...
What did we learn about EKRA in 2021?
Lawmakers enacted the Eliminating Kickbacks in Recovery Act (EKRA) in 2018 to help address the use of illegal kickbacks to physicians who would refer patients to certain treatment centers. Unfortunately, because drafters wrote the law so broadly it likely extended...
Case provides guidance on labs, commissions and EKRA
The Eliminating Kickbacks in Recovery Act (EKRA) generally prohibits the use of kickbacks and other forms of remuneration for referrals. The law applies to various medical practices, including labs. One of the biggest critiques to the law is the lack of transparency....
Labs, COVID-19 testing and EKRA: Three things to know
The feds are coming down hard on anyone that is taking advantage of the COVID-19 pandemic for their own personal gain. They have various tools to help build cases against those that it believes misappropriates funds or otherwise abuses the system, but is EKRA one of...
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...