News & Analysis as of

Clinical Laboratories Department of Justice (DOJ) Anti-Kickback Statute

Health Care Compliance Association (HCCA)

[Event] Healthcare Basic Compliance Academy - July 21st - 24th, Nashville, TN

Grounded in the OIG’s General Compliance Program Guidance and DOJ’s Evaluation of Corporate Compliance Programs, our immersive, three-and-a-half-day, classroom-style Healthcare Basic Compliance Academy equips compliance...more

Lowenstein Sandler LLP

In Trump’s Second Term, Healthcare Enforcement May Remain Business as Usual

Compared with other issues, healthcare enforcement during President-elect Donald Trump’s upcoming second term has received little attention. When he takes office again on January 20, should industry actors like pharmaceutical...more

Bass, Berry & Sims PLC

Settlement Roundup: Heart-Valve Replacements, Federal Research Grants, and Clinical Laboratory Marketing

The Department of Justice (DOJ) recently announced settlements involving alleged noncompliance with Medicare billing requirements for heart-valve replacement surgeries, false statements in federal funding research grants, and...more

Health Care Compliance Association (HCCA)

[Event] 2023 Healthcare Enforcement Compliance Conference - November 5th - 7th, Washington, DC

Hear directly from the enforcement community - Want to gain insight into properly monitoring, detecting, investigating, and managing violations? Join us at HCCA’s Annual Healthcare Enforcement Compliance Conference to...more

Oberheiden P.C.

Ten Things You Should Know if Your Clinical Laboratory is Under Investigation

Oberheiden P.C. on

Similar to other types of healthcare entities, clinical laboratories have been facing enhanced scrutiny from federal authorities over the past couple of years. While this is due in part to fraud concerns related to COVID-19...more

Bass, Berry & Sims PLC

[Virtual Conference] Nashville Healthcare Fraud Conference - December 15th - 16th, 8:00 am - 1:00 pm CST

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Please join us for the 8th Annual Nashville Healthcare Fraud Conference hosted by Bass, Berry & Sims and the Tennessee Hospital Association. Eligible for more than seven hours of CLE credit (including ethics), this...more

Epstein Becker & Green

Four Years After EKRA: Reminders for Clinical Laboratories

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It has been four years since Congress enacted the Eliminating Kickbacks in Recovery Act (“EKRA”), codified at 18 U.S.C. § 220. EKRA initially targeted patient brokering and kickback schemes within the addiction treatment and...more

Benesch

Modern Vascular is the Latest Defendant in a Growing Trend of Qui Tam Relator Cases against Office-based Lab Companies

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Earlier this month a federal judge unsealed a federal qui tam relator complaint originally filed in January 2020 by Dr. Jay Radhakrishnan and Dr. William Julien against Arizona-based Modern Vascular and certain of its...more

Holland & Knight LLP

The State of EKRA: Summer 2022

Holland & Knight LLP on

Enacted in 2018, the Eliminating Kickbacks Recovery Act (EKRA) remains a source of anxiety and confusion in the clinical laboratory industry. In the four years since EKRA's enactment, U.S. Department of Justice (DOJ)...more

Rivkin Radler LLP

DOJ Intervenes in Kickback Lawsuit Against Lab and Hospital Execs

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The U.S. Department of Justice (DOJ) recently intervened in an action filed in Texas against two laboratory CEOs, one hospital CEO, and numerous other executives, employees, and recruiters, seeking civil penalties and treble...more

Oberheiden P.C.

6 Frequently Asked Questions with Lab Defense Attorney Nick Oberheiden

Oberheiden P.C. on

Clinical laboratories have come under increased scrutiny in the past few years, especially those that deal with COVID-19 testing or drug testing. These federal investigations can be surprising and confusing for lab...more

Goodwin

DOJ False Claims Act Recoveries Exceed $5.6 Billion in 2021

Goodwin on

The U.S. Department of Justice (“DOJ”) recently announced that over $5.6 billion in False Claims Act (“FCA”) settlements and judgments had been reached during the 2021 fiscal year, with over $5 billion of those settlements...more

Maynard Nexsen

Federal Enforcement Actions Against Clinical Laboratories

Maynard Nexsen on

As in the previous fiscal year, we expect the federal government to direct much of its fraud and abuse law enforcement activities at the health care industry. The federal government has many civil, criminal, and...more

Nossaman LLP

DOJ Broadly Applies New Kickback Law Beyond Its Original Opioid-Related Purpose

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On October 24, 2018, Congress passed the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (the “SUPPORT Act”), two sections of which constitute the Eliminating...more

Dorsey & Whitney LLP

First EKRA Enforcement Announced

Dorsey & Whitney LLP on

The first publicly disclosed prosecution under the Eliminating Kickbacks in Recovery Act (“EKRA”) occurred last month, a little over a year after EKRA became law. As we described in a previous blog post, EKRA criminalizes...more

Bradley Arant Boult Cummings LLP

Designing Clinical Studies To Avoid Regulatory Scrutiny

Practical advice following the Primex Clinical Laboratories settlement - Earlier this year, the Department of Justice (DOJ) announced a $3.5 million settlement against Primex Clinical Laboratories, a California laboratory...more

The Volkov Law Group

Criminal Prosecutions of Individuals Outside the FCPA

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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

Baker Donelson

Pricing Issues Affecting Laboratories

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Craig Holden co-presented "New Compliance Red Flags Workshop," a workshop hosted by G2 Intelligence. Over the past five years, the Departments of Justice and Health and Human Services have recovered $19.2 billion from...more

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