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Clinical Laboratories Medicare False Claims Act (FCA)

Husch Blackwell LLP

OIG Announces 2025 Work Plan Review: What Clinical Laboratories Need to Know About Medicare Payments for Diagnostic Lab Tests

Husch Blackwell LLP on

In June 2025, the U.S. Department of Health and Human Services Office of Inspector General (OIG) announced a new item in its Work Plan: “Medicare Payments for Clinical Diagnostic Laboratory Tests in 2024.” This annual review,...more

Husch Blackwell LLP

Navigating Compliance Risks in Laboratory Operations—Key Lessons from a Recent FCA Case

Husch Blackwell LLP on

A recent False Claims Act (FCA) litigation—Jensen ex rel. United States of America v. Genesis Laboratory—highlights critical compliance risks for laboratories. This case reinforces the need for laboratories to ensure...more

ArentFox Schiff

Investigations Newsletter: Clinical Laboratory and CEO To Pay Over $13 Million to Settle False Claims Act Allegations

ArentFox Schiff on

Clinical Laboratory and CEO To Pay Over $13 Million to Settle False Claims Act Allegations - A New Jersey-based laboratory, RDx Bioscience Inc. (RDX), and its owner and CEO, Eric Leykin, agreed to pay $10,315,023 to the US...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

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

Womble Bond Dickinson

What to Expect as OIG and CMS Audits Focus on COVID-19 Testing?

Womble Bond Dickinson on

The COVID-19 pandemic has caused an enormous need for testing and has spawned the creation of new labs and specimen collection agencies to (try to) meet that need. In 2020 alone, Medicare spent $1.5 billion on COVID-19 tests....more

The Volkov Law Group

False Claims Investigations and Criminal Prosecutions: Recent Examples of Criminal Charges – a Lab Owner, A Physician and a Nurse...

The Volkov Law Group on

A False Claims Act case can easily turn into a criminal prosecution.  The Federal Bureau of Investigation often initiates criminal investigations as part of its commitment to reducing health care fraud....more

Oberheiden P.C.

EKRA Rules, Regulations & Compliance: 5 Tips that Health Care Providers Need to Know

Oberheiden P.C. on

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

Bricker Graydon LLP

Clinical trials and Medicare billing: Avoiding false claims liability

Bricker Graydon LLP on

Participating in clinical trials can leave health care providers vulnerable to false claims liability if Medicare rules are not closely followed. This publication reviews settlements involving clinical trials, provides an...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

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

Epstein Becker & Green

D.C. District Court Clarifies Standard for Laboratory Determination of Medical Necessity

This past June, a federal district court in the District of Columbia made headlines when it declined to dismiss an action brought by a qui tam plaintiff (“Relator”) against defendant Boston Heart Diagnostics (“Boston Heart”),...more

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