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
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
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
DOJ Launches Corporate Whistleblower Awards Pilot Program -
On August 1, the US Department of Justice (DOJ) announced the details of its new Corporate Whistleblower Awards Pilot Program. According to the DOJ, the...more
8/12/2024
/ Bribery ,
Controlled Substances Act ,
DEA ,
Department of Justice (DOJ) ,
Durable Medical Equipment ,
False Claims Act (FCA) ,
FinCEN ,
Foreign Corrupt Practices Act (FCPA) ,
Health Insurance ,
Healthcare Fraud ,
Internal Reporting ,
Kickbacks ,
Opioid ,
Pilot Programs ,
Securities and Exchange Commission (SEC) ,
Whistleblower Awards ,
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
Federal Court Dismisses $680 Million FCA Suit -
On July 23, a Maryland federal judge, Ellen L. Hollander, dismissed a $680 million False Claims Act (FCA) suit that was previously revived by the US Supreme Court. The suit...more
On June 7, Adam Hart, a former employee of McKesson Corporation, filed a petition for certiorari to the US Supreme Court asking the Court to define the “willfulness” element of the Anti-Kickback Statute (AKS). United States...more
Florida Lab Owner Agrees to Pay Over $27 Million to Resolve Three Whistleblower Lawsuits -
Daniel Hurt, the prior owner and operator of Fountain Health Services LLC, Verify Health, Landmark Diagnostics LLC, First Choice...more
6/3/2024
/ Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Healthcare Fraud ,
Insurance Fraud ,
Kickbacks ,
Medicaid ,
Medicare ,
OIG ,
Qui Tam ,
Reimbursements ,
Settlement ,
Stark Law ,
Whistleblowers
DOJ Secures Plea in $50 Million Medicare Fraud and Kickback Scheme -
On April 26, the US Department of Justice (DOJ) announced that Manishkumar Patel pleaded guilty to charges related to a $50 million health care fraud and...more
5/6/2024
/ Anti-Kickback Statute ,
Coronavirus/COVID-19 ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Food and Drug Administration (FDA) ,
Guilty Pleas ,
Healthcare Fraud ,
HRSA ,
Kickbacks ,
Medicare Fraud ,
Money Laundering ,
Paycheck Protection Program (PPP) ,
Retaliation ,
Telemarketing ,
Whistleblowers ,
Wire Fraud
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
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
1/15/2024
/ CEOs ,
Clinical Laboratories ,
Department of Health and Human Services (HHS) ,
False Claims Act (FCA) ,
FBI ,
Health Care Providers ,
Healthcare Fraud ,
Kickbacks ,
Medicaid ,
Medicare ,
Reimbursements ,
Settlement ,
Whistleblowers
Engineering Company Agrees to Pay $4.4 Million to Settle FCA -
On Friday, September 15, 2023, the US Department of Justice (DOJ) announced a settlement agreement with Navmar Applied Sciences Corporation, a...more
9/25/2023
/ Centers for Medicare & Medicaid Services (CMS) ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Federal Acquisition Regulations (FAR) ,
Federal Health Care Programs (FHCP) ,
Healthcare Fraud ,
Identity Theft ,
Kickbacks ,
Settlement ,
U.S. Navy ,
Whistleblowers
New FCA Filings Point to Future Path Forward For Companies -
The US Supreme Court recently ruled in United States ex rel. Proctor v. Safeway Inc. and United States ex rel. Schutte, et al. v. SuperValu Inc. et al. that...more
Supreme Court Justices Signal Skepticism of Qui Tam Constitutionality -
On Friday, June 16, the US Supreme Court ruled that the US Department of Justice (DOJ) has the authority to dismiss qui tam suits brought under the...more
On June 16, 2023, in United States, ex rel. Polansky v. Executive Health Resources, Inc., the US Supreme Court addressed the government’s authority to dismiss a qui tam False Claims Act (FCA) suit over a relator’s objection...more
6/22/2023
/ Article II ,
Constitutional Challenges ,
Corporate Misconduct ,
Dismissals ,
False Claims Act (FCA) ,
Federal Rules of Civil Procedure ,
Fraud ,
Healthcare ,
Inpatient Billing ,
Investigations ,
Qui Tam ,
Relators ,
SCOTUS ,
United States ex rel Polansky v Executive Health Resources Inc ,
Whistleblowers
The US Supreme Court brushed aside novel assertions from two pharmacy retailers on June 1 and ruled unanimously that False Claims Act liability hinges on whether defendants subjectively believed their claims were “false.” In...more
6/8/2023
/ Appeals ,
Drug Pricing ,
Fair Credit Reporting Act (FCRA) ,
False Claims Act (FCA) ,
Healthcare ,
Medicaid ,
Medicare ,
Pharmacies ,
Prescription Drugs ,
Reimbursements ,
Safeco Insurance Co of America v Burr ,
SCOTUS ,
US ex rel Thomas Proctor v Safeway Inc ,
US ex rel Tracy Schutte et al v SuperValu Inc et al ,
Whistleblowers
Recent Interview With FCA Plaintiff Bar Attorneys Offers Key Insight into Trends in Anti-Kickback Litigation -
During a recent interview commemorating the 50th anniversary of the enactment of the Anti-Kickback Statute, two...more
Headlines that Matter for Companies and Executives in Regulated Industries-
Government Wins $43 Million Verdict in False Claims Act Case -
On February 28, 2023, a federal jury in Minnesota handed down a $43 million...more
DOJ Issues Corporate Self-Disclosure Policy -
The US Department of Justice (DOJ) released a Voluntary Self-Disclosure Policy that sets a consistent standard for corporate self-disclosures for all US Attorney’s Offices. The...more
2/27/2023
/ Appeals ,
Corporate Misconduct ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Fraud ,
Health and Welfare Plans ,
Medicaid ,
Medicare ,
NBA ,
Proposed Amendments ,
Restitution ,
SCOTUS ,
Self-Disclosure Requirements ,
Whistleblowers
Top Reasons for 2022’s Downward Trend in False Claims Act Recoveries -
Following the US Department of Justice’s (DOJ) release of statistics regarding FCA settlements and judgments for the 2022 fiscal year, Law360 spoke...more
2/20/2023
/ CARES Act ,
Coronavirus/COVID-19 ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Fees ,
Fraud and Abuse ,
Healthcare ,
Kickbacks ,
Medicare Advantage ,
Opioid ,
Private Equity ,
Proposed Amendments ,
Qui Tam ,
Settlement ,
Stark Law ,
Telehealth ,
Whistleblowers
Headlines that Matter for Companies and Executives in Regulated Industries-
Amici Seek Dismissal of Qui Tam Suit From High Court -
Various medical, business and legal organizations are asking the US Supreme Court to...more
10/28/2022
/ Amicus Briefs ,
Anti-Money Laundering ,
Coronavirus/COVID-19 ,
Criminal Prosecution ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Fraud ,
Healthcare Fraud ,
Indictments ,
Motion to Dismiss ,
Paycheck Protection Program (PPP) ,
Qui Tam ,
Whistleblowers ,
Wire Fraud
SCOTUS Denies Cert In Cases Addressing FCA Pleadings Requirements -
On Monday, October 17, 2022, the US Supreme Court rejected three petitions asking the Court to resolve a circuit split regarding the Rule 9(b)...more
10/21/2022
/ CIGNA ,
Denial of Certiorari ,
False Claims Act (FCA) ,
Federal Health Care Programs (FHCP) ,
Health Care Providers ,
Kickbacks ,
Medicare ,
Medicare Advantage ,
SCOTUS ,
Solicitor General ,
TRICARE ,
Whistleblowers
DC Circuit Adopts Pro Tanto Approach to False Claims Act Settlement Offsets -
In an opinion issued on August 30, 2022, the US Court of Appeals for the DC Circuit held in United States v. Honeywell International, Inc., ---...more
Supreme Court To Decide on DOJ Authority in FCA Suits -
On Tuesday, the US Supreme court agreed to hear a case examining whether the federal government has lost its authority to dismiss a whistleblowers False Claims Act...more
DOJ Denies Alleged Circuit Split on Particularity Requirement in FCA Cases -
In a much-anticipated filing by the Department of Justice (DOJ), following the US Supreme Court’s request for briefing by the US Office of the...more