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
Regeneron Court Permits Government to Pursue False Certification Theory -
On August 4, the district court in the closely watched Regeneron case granted the government’s request to file a second partial summary judgment...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
Massachusetts District Court Judge Applies Heightened Causation Standard in FCA Case -
On January 6, a District Court of Massachusetts judge granted summary judgment for defendants on allegations of violating the...more
1/27/2025
/ Anti-Kickback Statute ,
Causation ,
Compliance ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Health Care Providers ,
Healthcare Fraud ,
Kickbacks ,
Medicare ,
Medicare Advantage ,
Opioid ,
Paycheck Protection Program (PPP) ,
Qui Tam ,
SCOTUS ,
Settlement ,
Skilled Nursing Facility ,
Whistleblowers
Federal Government Urges Court of Appeals to Uphold Constitutionality of FCA Qui Tam Provisions -
In a brief filed earlier this week, the US federal government has urged the Eleventh Circuit Court of Appeals to uphold the...more
1/13/2025
/ Anti-Kickback Statute ,
Appeals ,
Appointments Clause ,
Article III ,
Constitutional Challenges ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Fraud ,
Health Care Providers ,
Healthcare Fraud ,
Medicare ,
Misrepresentation ,
National Institute of Health (NIH) ,
Pharmaceutical Industry ,
Qui Tam ,
SCOTUS ,
Settlement ,
Stark Law ,
Unconstitutional Condition ,
Whistleblowers
Second Circuit Partially Affirms Novartis’ Motion to Dismiss AKS Claims -
Last week, the Second Circuit Court of Appeals affirmed the district court’s ruling that dismissed allegations from a whistleblower who claimed that...more
1/6/2025
/ Anti-Kickback Statute ,
Appeals ,
Department of Justice (DOJ) ,
Digital Assets ,
False Claims Act (FCA) ,
False Statements ,
Foreign Agents Registration Act (FARA) ,
Fraud ,
Kickbacks ,
Medicaid ,
Medicare ,
Misleading Statements ,
Motion to Dismiss ,
New Regulations ,
Non-Fungible Tokens (NFTs) ,
Popular
Welcome to the Fall 2024 issue of “FCA Enforcement & Compliance Digest,” our quarterly newsletter in which we compile essential updates on False Claims Act (FCA) enforcement trends, litigation, agency guidance, and compliance...more
12/10/2024
/ Advisory Opinions ,
Anti-Kickback Statute ,
Artificial Intelligence ,
Compliance ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Enforcement ,
False Claims Act (FCA) ,
Federal Health Care Programs (FHCP) ,
Florida ,
Fraud ,
Health Technology ,
Healthcare ,
Manufacturers ,
Medicare Part D ,
OIG ,
Qui Tam ,
Risk Assessment ,
Settlement ,
Whistleblowers ,
White Collar Crimes
Seventh Circuit Considers When Legal Marketing Transforms Into Illegal Kickbacks -
On December 4, the US Court of Appeals for the Seventh Circuit heard oral arguments regarding whether the January 2023 jury conviction of...more
12/9/2024
/ Anti-Kickback Statute ,
Appeals ,
Bribery ,
Department of Justice (DOJ) ,
Fraud ,
Healthcare Fraud ,
Kickbacks ,
Marketing ,
Medicare Fraud ,
Sentencing ,
TRICARE
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
Teva Pharmaceuticals Agrees to Pay $450 Million to Resolve FCA Claims -
On October 10, the US Department of Justice (DOJ) announced that Teva Pharmaceuticals USA Inc. and Teva Neuroscience Inc. will pay $450 million to...more
10/18/2024
/ Anti-Kickback Statute ,
Appeals ,
Causation ,
Charitable Donations ,
DEA ,
Department of Justice (DOJ) ,
Enforcement ,
False Claims Act (FCA) ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Medical Devices ,
Medicare ,
Opioid ,
Prescription Drugs ,
Settlement
US Supreme Court Declines to Consider AKS ‘Willfulness’ Question -
On October 7, the US Supreme Court denied a petition in which a whistleblower asked the Court to decide whether a “willful” act under the federal...more
10/14/2024
/ Anti-Kickback Statute ,
Bribery ,
Criminal Conspiracy ,
Denial of Certiorari ,
False Claims Act (FCA) ,
Healthcare Fraud ,
Home Health Care ,
Kickbacks ,
Medicaid ,
Money Laundering ,
Popular ,
Scienter ,
SCOTUS ,
Telehealth ,
Whistleblowers
Florida Federal Judge Strikes Down FCA’s Qui Tam Provision as Unconstitutional -
On September 30, US District Judge Kathryn Kimball Mizelle of the Middle District of Florida held in a historic decision that the federal...more
10/7/2024
/ Anti-Kickback Statute ,
Appointments Clause ,
Criminal Convictions ,
Department of Health and Human Services (HHS) ,
False Claims Act (FCA) ,
False Statements ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Federal Health Care Programs (FHCP) ,
Healthcare Fraud ,
Kickbacks ,
Medicaid ,
Medicare ,
Misrepresentation ,
OIG ,
Qui Tam ,
Sentencing ,
Settlement ,
Unconstitutional Condition
Walgreens Settles for $106.8 Million Over FCA Violations -
On September 13, the US Department of Justice (DOJ) announced that Walgreens Boots Alliance Inc. and Walgreen Co. (collectively, Walgreens) agreed to pay $106.8...more
9/23/2024
/ Anti-Kickback Statute ,
CVS ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Federal Health Care Programs (FHCP) ,
Kickbacks ,
Medicare Advantage ,
Money Laundering ,
Prescription Drugs ,
Settlement ,
Stark Law ,
Walgreens
Federal Court Permits Investors to Resume Kickback Suit Against Teva -
After a two-year long stay, on August 30, Judge Karen S. Marston of the US District Court for the Eastern District of Pennsylvania ruled that investors...more
9/9/2024
/ Anti-Kickback Statute ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Healthcare Fraud ,
Investors ,
Kickbacks ,
Medicaid ,
Medicare ,
Permits ,
Reimbursements ,
Settlement
Former Congressman George Santos Pleads Guilty to Wire Fraud and Aggravated Identity Theft -
On August 19, former US Representative George Santos pleaded guilty to wire fraud and aggravated identity theft. As part of the...more
8/26/2024
/ Anti-Kickback Statute ,
Bribery ,
Cash Transactions ,
Corruption ,
Economic Sanctions ,
Embezzlement ,
Evasion ,
False Claims Act (FCA) ,
False Documentation ,
False Statements ,
FBI ,
Federal Election Commission (FEC) ,
Fraud ,
Identity Theft ,
International Emergency Economic Powers Act (IEEPA) ,
Investors ,
Kickbacks ,
Plea Agreements ,
Unemployment Benefits ,
Venezuela ,
Whistleblowers ,
Wire Fraud
Precision Lens Pays $12 Million to Resolve FCA and AKS Violations -
Late last week, Precision Lens and the estate of its former principal agreed to pay $12 million to resolve allegations regarding violations of the False...more
8/5/2024
/ Anti-Kickback Statute ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Federal Trade Commission (FTC) ,
Fraud ,
Healthcare ,
Insurance Fraud ,
Kickbacks ,
Medicare ,
Reimbursements ,
Settlement ,
Stark Law ,
Telemarketing ,
Whistleblowers