News & Analysis as of

Department of Justice (DOJ) Clinical Laboratories

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

Epstein Becker & Green

The 2023 DOJ Health Care Fraud Enforcement (f/k/a “Takedown”): Big Dollars or Clever Packaging?

Epstein Becker & Green on

On June 28, 2023, the U.S. Department of Justice (“DOJ”) and the U.S. Department of Health and Human Services, Office of Inspector General (“HHS-OIG”), along with other federal and state law enforcement partners, announced a...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

Bass, Berry & Sims PLC on

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

Epstein Becker & Green on

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

Benesch on

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

Robinson & Cole LLP

Clinical ColLABorative - Legal Insights in Laboratory Compliance

Robinson & Cole LLP on

What To Do When The Government Knocks On Your Lab’s Door - The volume of federal enforcement actions involving laboratories has increased dramatically over the last few years. Not a month seems to pass without a press...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

Bass, Berry & Sims PLC

False Claims Act Settlements to Know from Q1 2022

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The first quarter of 2022 brought news of several noteworthy False Claims Act (FCA) settlements, including several settlements by physicians regarding arrangements deemed to be unlawful kickbacks and the first settlement...more

Rivkin Radler LLP

DOJ Intervenes in Kickback Lawsuit Against Lab and Hospital Execs

Rivkin Radler LLP on

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

Oberheiden P.C.

Key Elements of an OIG Compliance Program That Respiratory and Clinical Labs Need to Know

Oberheiden P.C. on

Clinical laboratories such as respiratory and clinical labs that bill Medicare, Department of Health and Human Services (“DHHS”) programs, and other federal programs are subject to oversight by the Office of Inspector General...more

Nossaman LLP

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

Nossaman LLP on

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

Snell & Wilmer

EKRA Guidance for Clinical Laboratories in the Wake of COVID-19 Testing Surge

Snell & Wilmer on

The U.S. Department of Justice (“DOJ”), the Federal Trade Commission (“FTC”) and various other federal, state and local government agencies have focused enforcement efforts on the COVID-19 pandemic and are aggressively...more

K&L Gates LLP

COVID-19: Labs Beware! – EKRA Expands DOJ’s Enforcement Arsenal in the COVID-19 Fraud Battle

K&L Gates LLP on

I. INTRODUCTION - As discussed in recent alerts, federal and state authorities have focused their enforcement efforts on combatting fraud related to the COVID-19 pandemic....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

King & Spalding

DOJ Reports More Than $3 Billion Recovered from False Claims Act Cases in Fiscal Year 2019

King & Spalding on

On January 9, 2020, DOJ announced it recovered more than $3 billion in settlements and judgments from civil cases involving fraud and false claims against the government in the fiscal year ending September 30, 2019. DOJ...more

Akerman LLP - Health Law Rx

Owner of Medical Marketing Company Found Guilty in $2 Million Medicare Fraud Scheme…Again!

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

Epstein Becker & Green

Healthcare Fraud Prevention Partnership Issues a Review of Clinical Laboratory Services

The Healthcare Fraud Prevention Partnership (“HFPP”) recently published its second white paper, entitled “Examining Clinical Laboratory Services,” which provides a comprehensive overview of practices that raise fraud and...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

The Volkov Law Group on

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

Manatt, Phelps & Phillips, LLP

Health Update - September 2015

Latest Healthcare False Claims Act Roundup and Top 3 Best Practices to Reduce Exposure - As the legal landscape in healthcare becomes increasingly complex, healthcare companies that receive federal program funds face...more

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