Five years ago Congress enacted the Eliminating Kickbacks in Recovery Act of 2018 (“EKRA”). Aimed at combating kickbacks in the addiction treatment industry, EKRA prohibits remunerations in return for patient referrals to...more
OIG has a long history of scrutinizing laboratory arrangements because of the agency’s view that these arrangements are particularly susceptible to fraud and abuse. Much of OIG’s past guidance focused on laboratory...more
EKRA stands for the Eliminating Kickbacks in Recovery Act, and it has become a prominent enforcement tool against fraud in the healthcare and medical testing industries. Although the law was developed in 2018 to help combat...more
In many ways, the COVID-19 pandemic increased the business opportunities available to clinical labs, including molecular and respiratory labs. As the nation—and the world—struggled to develop adequate testing infrastructure,...more
Most health care providers have at least a basic understanding of the Anti-Kickback Statute. This federal law prohibits providers from offering, paying, soliciting, or accepting any form of “remuneration” for patient...more
What appears to be the United States’ first conviction under the Eliminating Kickbacks in Recovery Act (“EKRA”) occurred last month when the United States District Court for the Eastern District of Kentucky accepted the...more
Following the launch of several platforms in recent years, it seems that private equity’s interest in the fertility space is trending up again. Investment in this sector brings some unique issues that potential investors...more
The Department of Justice announced on June 27, 2019 that David Brock Lovelace, the owner of DBL Management LLC, was found guilty by a federal jury in the U.S. District Court for the Middle District of Florida of conspiracy...more
Effective October 24, 2018, Congress enacted the Eliminating Kickbacks in Recovery Act of 2018 (EKRA) as part of the “Substance Use–Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities...more
The Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (the “SUPPORT for Patients and Communities Act”) – which is intended to combat the spread and pernicious...more
Notwithstanding its name, the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act of 2018 or the SUPPORT Act appears to regulate behavior that has nothing to do with...more
When you look outside the FCPA arena and examine DOJ criminal prosecutions in healthcare, antitrust, tax, fraud, and other white-collar areas, there is no shortage of cases against individual violators. I am perplexed, to say...more
On March 25, 2015, the U.S. HHS Office of Inspector General (OIG) released an unfavorable Advisory Opinion in which it found that it could potentially impose administrative sanctions and exercise its permissive exclusion...more
In an important advisory opinion, the U.S. Department of Health and Human Services Office of Inspector General (OIG) gave a thumbs-down to a proposed clinical laboratory “pull-through” arrangement even though the patients in...more
On March 25, 2015, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) posted Advisory Opinion No. 15-04. In the opinion, the OIG addresses a laboratory’s proposal to enter into agreements...more
Yesterday the Office of Inspector General for the Department of Health and Human Services (the “OIG”) issued Advisory Opinion 15-04 (“Advisory Opinion”) in which it found that an exclusive arrangement between a laboratory...more
The Department of Health and Human Services Office of Inspector General (OIG) released an advisory opinion (No. 15-04) today that states a proposed arrangement to provide free laboratory tests for certain patients of...more