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EKRA and COVID-19: What do labs need to know?

The United States Department of Justice (DOJ) and the Office of the Inspector General (OIG) have stated they will aggressively pursue health care fraud claims related to COVID-19. These agencies further clarify that they will continue to focus on prosecution for violations of the Eliminating Kickbacks in Recovery Act (EKRA). The announcement comes at an uncertain time, when diagnostic labs are working to help patients who are waiting for testing while living amidst a global pandemic.

What has changed?

Both Medicare and Medicaid have adjusted some of their regulations to help better ensure patients can receive prompt care during the current coronavirus pandemic. These changes include more flexibility to Stark law and Anti-Kickback Statute (AKS) violations if the alleged violation was an act completed in good faith in response to COVID-19 and remove of the requirement to have an order from a treating physician filed before the government would approval a claim for certain related lab diagnostic testing.

Although these changes are helpful for labs that are trying to navigate the pandemic, the government’s current reminder that it will prosecution violations is disheartening. Navigating these laws is difficult even in the best of times, but now, amidst a pandemic, it is even more trying to know if your business’ practices are in violation or within the bounds of the law.

What should labs learn from this announcement?

If nothing else, the announcement serves as a reminder to move forward carefully. It may be wise to proactively reach out to legal counsel if you have concerns that your lab is not in full compliance with EKRA. It is also wise for labs that are accused of a violation and under investigation to seek legal counsel. If the allegations are substantiated, the penalties are harsh. Violations of EKRA can come with up to 10 years’ imprisonment and $200,000 in fines per occurrence.