Texas Alleges That Eli Lilly Patient Assistance Programs Violates AKS -
The state of Texas and Health Choice Alliance, LLC filed a complaint alleging that pharmaceutical manufacturer Eli Lilly & Company, Inc. violated the...more
Johnson & Johnson Challenges the Constitutionality of FCA $1.6 Billion Verdict -
Following a record $1.6 billion jury verdict for off-label promotion of HIV drugs Prezista and Intelence, Johnson & Johnson (J&J) subsidiary...more
7/28/2025
/ Anti-Kickback Statute ,
Appeals ,
CARES Act ,
Constitutional Challenges ,
Coronavirus/COVID-19 ,
Department of Justice (DOJ) ,
Economic Injury Disaster Loans ,
False Claims Act (FCA) ,
First Amendment ,
Jury Verdicts ,
Paycheck Protection Program (PPP) ,
Penalties ,
Pharmaceutical Industry ,
Prescription Drugs ,
Scienter ,
Tax Fraud ,
Whistleblowers
DOJ Plans to Use the FCA to Attack DEI Initiatives -
On May 19, the US Department of Justice (DOJ) announced a novel use of the False Claims Act (FCA) to enforce Trump Administration policies against antisemitism, gender...more
5/27/2025
/ Anti-Kickback Statute ,
Department of Justice (DOJ) ,
Diversity and Inclusion Standards (D&I) ,
Educational Institutions ,
Enforcement Actions ,
False Claims Act (FCA) ,
Federal Contractors ,
Healthcare Fraud ,
Medicare Fraud ,
Trump Administration ,
Universities
DOJ Announces Updated White-Collar Enforcement Priorities and Revised Policies -
Earlier this week, the Criminal Division of the US Department of Justice (DOJ) introduced a new white-collar enforcement plan, which sets...more
5/19/2025
/ Anti-Kickback Statute ,
Department of Justice (DOJ) ,
Enforcement Priorities ,
False Claims Act (FCA) ,
Fraud ,
Healthcare Fraud ,
Investment Fraud ,
Securities Fraud ,
Settlement ,
Whistleblowers ,
White Collar Crimes
Gilead to Pay $202 Million to Settle DOJ Claims Over Speaker Program Kickbacks -
Gilead Sciences, Inc. has agreed to pay $202 million to resolve allegations brought by the US Department of Justice (DOJ) that it violated...more
Walgreens to Pay $300 Million to Settle DOJ Claims Over Invalid Opioid Prescriptions -
Walgreens Boots Alliance has agreed to pay more than $300 million to resolve allegations brought by the US Department of Justice (DOJ)...more
4/28/2025
/ Anti-Kickback Statute ,
Causation ,
Controlled Substances ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Fraud ,
Healthcare Fraud ,
Opioid ,
Pharmaceutical Industry ,
Pharmacies ,
Settlement ,
Whistleblowers
Seventh Circuit Reverses AKS Conviction Involving Allegations of Illegal Marketing and Advertising -
On April 14, the US Court of Appeals for the Seventh Circuit reversed the criminal conviction of Mark Sorensen after a...more
4/21/2025
/ Anti-Kickback Statute ,
Appeals ,
Criminal Prosecution ,
Department of Justice (DOJ) ,
Department of Veterans Affairs ,
False Claims Act (FCA) ,
Federal Rules of Civil Procedure ,
Healthcare Fraud ,
Medical Devices ,
Medicare ,
Money Laundering ,
Pharmacies ,
Physicians ,
Wire Fraud
Long Island Businessman Arrested in $22 Million Medicare Fraud Scheme -
A Long Island, New York, businessman was arrested on conspiracy, kickback, and money laundering charges stemming from an alleged scheme to defraud...more
Jury Clears SuperValu of Liability in Whistleblower FCA Prescription Pricing Case -
A federal jury in Illinois recently found SuperValu not liable in a whistleblower lawsuit that accused the company of overcharging the...more
3/10/2025
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Health Care Providers ,
Healthcare Fraud ,
Kickbacks ,
Medicare ,
Medicare Fraud ,
Prescription Drugs ,
SCOTUS ,
Settlement ,
Whistleblowers
First Circuit Joins Sixth and Eighth Circuits in Adopting Heightened, But-For Causation Standard for AKS-Based FCA Claims -
On February 18, the US Court of Appeals for the First Circuit became the latest court to agree...more
2/24/2025
/ Anti-Kickback Statute ,
But For Causation ,
Causation ,
Compliance ,
Cybersecurity ,
DCIS ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Healthcare Fraud ,
Medicare ,
Overpayment ,
Paycheck Protection Program (PPP) ,
Pharmaceutical Industry ,
SBA ,
Settlement ,
TRICARE
Pfizer Settles Its Subsidiary’s Kickback Allegations for Nearly $60 Million -
Pfizer Inc. agreed to pay over $59,746,277 to resolve allegations that its wholly owned subsidiary, Biohaven Pharmaceutical Holding Company...more
2/3/2025
/ Acquisitions ,
Anti-Kickback Statute ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Healthcare Fraud ,
Medicare Part D ,
Mergers ,
Pharmaceutical Industry ,
Purdue Pharma ,
Sentencing ,
Settlement ,
Whistleblowers
Connecticut State Court Finds Defunct Pharmacy Liable for $39.2 Million in Damages and Penalties -
A Connecticut Superior Court judge found Assured Rx, LLC, a Florida-based pharmacy, liable for violating the Connecticut...more
11/4/2024
/ Anti-Kickback Statute ,
Damages ,
Department of Justice (DOJ) ,
Depositions ,
False Claims Act (FCA) ,
Fraud ,
Guilty Pleas ,
Healthcare Fraud ,
IRS ,
Liability ,
Medicare ,
Penalties ,
Pharmacies ,
Settlement
On March 12, the Second Circuit affirmed in part and reversed in part a district court dismissal of False Claims Act (FCA) claims predicated on alleged Anti-Kickback Statute (AKS) violations. Adam Hart brought the claims...more
Ultragenyx to Pay $6 Million To Settle False Claims Act Case -
Ultragenyx Pharmaceutical Inc. recently agreed to pay $6 million to settle a qui tam action filed under the False Claims Act (FCA).
Ultragenyx manufactures a...more
1/8/2024
/ Anti-Kickback Statute ,
Billing Errors ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Food and Drug Administration (FDA) ,
Fraud ,
Health Care Providers ,
Medicare ,
Popular ,
Qui Tam ,
Settlement
Ophthalmology Distributer and Owner Oppose Government Request for $490 Million Award After Jury Verdict -
A federal jury in Milwaukee recently returned a verdict against the Cameron-Ehlen Group, Inc., d/b/a Precision Lens,...more
CEO of Defunct Medical Testing Lab to Pay $1.1 Million to Settle FCA and AKS Case -
Jae Lee, the former CEO of defunct Northwest Physicians Laboratory (NWPL), agreed to pay $1.1 million to resolve allegations that he...more
10/22/2021
/ Anti-Kickback Statute ,
CARES Act ,
Contractors ,
Coronavirus/COVID-19 ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
False Statements ,
Fraud ,
Healthcare Fraud ,
Kickbacks ,
Medicare ,
Paycheck Protection Program (PPP) ,
SBA ,
Settlement ,
TRICARE ,
Unemployment Benefits ,
Wire Fraud
Pharmaceutical Company Agrees to Pay $12.6 Million to Settle FCA Allegations Involving Kickbacks -
On Tuesday, the Department of Justice announced a $12.6 million settlement with Incyte Corporation, a Delaware...more
5/10/2021
/ Anti-Kickback Statute ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Frivolous Lawsuits ,
Healthcare Fraud ,
Kickbacks ,
Medicaid ,
Medicare ,
Money Laundering ,
Settlement ,
Telemarketing ,
TRICARE
Despite Decrease in 2020 False Claims Act Recoveries, Investigations and Litigation Expected to Rise Under the Biden Administration -
As previously detailed by Arent Fox, total False Claims Act (FCA) recoveries for the...more
2/1/2021
/ Anti-Kickback Statute ,
Biden Administration ,
CARES Act ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Healthcare Fraud ,
Investigations ,
Kickbacks ,
Medicare ,
Paycheck Protection Program (PPP) ,
Recovery Plans ,
Settlement Agreements ,
TRICARE
HHS Announces Formation of FCA Working Group -
On December 4, 2020, the US Department of Health and Human Services (HHS) announced that it is creating a False Claims Act Working Group to enhance the partnership between...more
12/14/2020
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Civil Monetary Penalty ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Fraud ,
Healthcare Fraud ,
Integrity Policies ,
Medicare ,
OIG ,
Proposed Rules ,
SCOTUS ,
Settlement Agreements ,
Stark Law ,
Value-Based Care ,
Working Groups
HHS Announces Final Rules Amending Stark Law Regulations and Anti-Kickback Statute -
On November 20, 2020, the Centers for Medicare and Medicaid Services and the Department of Health and Human Services (HHS) published...more
12/7/2020
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Criminal Conspiracy ,
DEA ,
Department of Health and Human Services (HHS) ,
False Claims Act (FCA) ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Final Rules ,
Fraud ,
Health Care Providers ,
Inflated Projections ,
Medicaid ,
Medicare ,
Opioid ,
Physician Medicare Reimbursements ,
Purdue Pharma ,
Securities Fraud ,
Stark Law ,
Value-Based Care
House Committee Chairs Direct White House and Federal Agencies to Preserve Documents during Transition Period to the Biden Administration -
On November 10, 2020, Committee Chairs from the House of Representatives sent...more
Department of Justice Announces $8.3 Billion Settlement with Opioid Manufacturer Purdue Pharma and Members of the Sackler Family -
On October 21, the Department of Justice (DOJ) announced that it reached a global resolution...more
10/26/2020
/ Anti-Kickback Statute ,
Bankruptcy Court ,
DEA ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Fraud ,
Health Care Providers ,
Opioid ,
Pharmaceutical Industry ,
Purdue Pharma ,
Securities Act of 1933 ,
Securities and Exchange Commission (SEC) ,
Settlement Agreements ,
Substance Abuse
Biotechnology Company Settles False Claims Act Charges for $11.5 million -
The Acting U.S. Attorney for the Southern District of New York announced a settlement with Bio-Reference Laboratories, Inc. (“BRL”), a New...more
9/28/2020
/ Anti-Fraud Provisions ,
Anti-Kickback Statute ,
Biotechnology ,
Broker-Dealer ,
False Claims Act (FCA) ,
Fraud ,
Kickbacks ,
Medicare ,
New Jersey ,
Securities and Exchange Commission (SEC) ,
Settlement Agreements ,
TRICARE ,
Whistleblowers
Acute Care Hospital Agrees to Pay $50 Million to Settle Alleged Stark Law and Anti-Kickback Statute Violations -
On September 9, 2020, the Department of Justice (“DOJ”) announced that Wheeling Hospital Inc. (“Wheeling...more
9/14/2020
/ Anti-Kickback Statute ,
California ,
Campaign Contributions ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Fair Market Value ,
False Claims Act (FCA) ,
Fraud ,
Medicaid ,
Medicare ,
Qui Tam ,
Risk Assessment ,
Settlement Agreements ,
Stark Law ,
TRICARE ,
Wire Fraud
Drug Testing Lab Pays Nearly $12 Million to Settle False Claims Act Allegations -
On July 20, 2020, the Department of Justice (DOJ) announced a civil settlement with Sterling Healthcare Opco, LLC d/b/a Cordant Health...more
7/27/2020
/ Anti-Fraud Provisions ,
Anti-Kickback Statute ,
Corporate Integrity Agreement ,
Department of Justice (DOJ) ,
Drug Testing ,
False Claims Act (FCA) ,
Fraud ,
Inspector General ,
Kickbacks ,
Medicare ,
Securities and Exchange Commission (SEC) ,
TRICARE