Designed for busy in-house counsel and compliance professionals, this newsletter seeks to bring you up to speed on key federal and state False Claims Act (FCA) developments, with links to primary resources. Each quarter, we...more
10/31/2024
/ Cybersecurity ,
Defense Contracts ,
Denial of Certiorari ,
Department of Justice (DOJ) ,
E-Rates ,
False Claims Act (FCA) ,
FCC ,
Federal Contractors ,
Fraud ,
Healthcare Fraud ,
Overpayment ,
Qui Tam ,
Reimbursements ,
Retaliation ,
SCOTUS
Last year, Justice Clarence Thomas’s dissent in United States ex rel. Polansky v. Executive Health Resources, Inc., 599 U.S. 419 (2023) (“Polansky”), resurrected an old debate about whether the False Claims Act (FCA) qui tam...more
The ECCP is intended to assist federal prosecutors in determining whether a corporation’s compliance program was effective at the time of the alleged offense(s) and, if not, what type of enforcement, monetary penalty, and...more
Designed for busy in-house counsel and compliance professionals, this newsletter seeks to bring you up to speed on key federal and state False Claims Act (FCA) developments, with links to primary resources. Each quarter, we...more
7/25/2024
/ Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Fraud ,
Health Care Providers ,
Healthcare Fraud ,
Lenders ,
Lockheed Martin ,
National Institute of Health (NIH) ,
OIG ,
Self-Disclosure Requirements
On April 9, 2024, the United States Department of Justice (DOJ) released a report on the COVID-19 Fraud Enforcement Task Force (“Task Force”), by far DOJ’s most comprehensive review of the Task Force since its creation in...more
4/25/2024
/ Coronavirus/COVID-19 ,
Department of Justice (DOJ) ,
Economic Injury Disaster Loans ,
Enforcement ,
False Claims Act (FCA) ,
FBI ,
Fraud ,
Health Care Providers ,
Healthcare ,
Healthcare Fraud ,
Medicare ,
Paycheck Protection Program (PPP) ,
Qui Tam
Designed for busy in-house counsel and compliance professionals, this newsletter seeks to bring you up to speed on key federal and state False Claims Act (FCA) developments, with links to primary resources. Each quarter, we...more
4/12/2024
/ Anti-Kickback Statute ,
Department of Defense (DOD) ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Federal Contractors ,
Federal Employees ,
Healthcare ,
Healthcare Fraud ,
Medicare ,
Nursing Homes ,
Popular
On February 22, 2024, the U.S. Department of Justice (DOJ) announced its False Claims Act (FCA) statistics for fiscal year (FY) 2023. Using DOJ’s FY 2023 Data Table and our analysis from previous years, MoFo’s FCA team...more
2/27/2024
/ Anti-Kickback Statute ,
Coronavirus/COVID-19 ,
Department of Defense (DOD) ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Federal Contractors ,
Healthcare Fraud ,
Medicare Advantage ,
SBA ,
Whistleblowers ,
White Collar Crimes
The year 2023 was a busy one for regulatory, compliance, and enforcement developments in the healthcare and life sciences industries, and 2024 promises to be even busier. We tapped MoFo’s Life Sciences + Healthcare Compliance...more
1/10/2024
/ Anti-Kickback Statute ,
Antitrust Violations ,
Artificial Intelligence ,
CDRH ,
Cyber Attacks ,
Cybersecurity ,
Data Security ,
Department of Justice (DOJ) ,
Enforcement ,
Enforcement Actions ,
False Claims Act (FCA) ,
Food and Drug Administration (FDA) ,
Foreign Corrupt Practices Act (FCPA) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare Fraud ,
Life Sciences ,
Medical Devices ,
OPDP ,
Popular ,
Ransomware ,
Securities and Exchange Commission (SEC)
Designed for busy in-house counsel and compliance professionals, this newsletter seeks to bring you up to speed on key federal and state False Claims Act (FCA) developments, with links to primary resources. Each quarter, we...more
1/4/2024
/ Anti-Kickback Statute ,
Compliance ,
Cybersecurity ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Federal Acquisition Regulations (FAR) ,
Federal Contractors ,
Health Care Providers ,
Healthcare Fraud ,
Internal Investigations ,
Patient Referrals ,
Pharmaceutical Industry ,
Popular
Designed for busy in-house counsel and compliance professionals, this newsletter seeks to bring you up to speed on key federal and state False Claims Act (FCA) developments, with links to primary resources. Each quarter, we...more
10/11/2023
/ Anti-Kickback Statute ,
Causation ,
Cybersecurity ,
Denial of Certiorari ,
Department of Justice (DOJ) ,
DFARS ,
Failure To Disclose ,
Failure to Monitor ,
False Billing ,
False Claims Act (FCA) ,
Foreign Subsidies ,
General Services Administration (GSA) ,
Healthcare Fraud ,
Kickbacks ,
Medicare ,
NIST ,
Pharmaceutical Industry ,
Popular ,
Remuneration ,
Risk Management ,
SCOTUS ,
State Grants ,
TRICARE ,
Whistleblowers
Designed for busy in-house counsel and compliance professionals, this newsletter seeks to bring you up to speed on key federal and state False Claims Act (FCA) developments, with links to primary resources. Each quarter, we...more
7/31/2023
/ Centers for Medicare & Medicaid Services (CMS) ,
Defense Contracts ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
False Billing ,
False Claims Act (FCA) ,
Federal Contractors ,
Federal Rules of Civil Procedure ,
Medicare ,
National Institute of Health (NIH) ,
Qui Tam ,
SCOTUS ,
United States ex rel Polansky v Executive Health Resources Inc ,
US ex rel Tracy Schutte et al v SuperValu Inc et al
On June 16, 2023, the Supreme Court issued a decision in United States ex rel. Polansky v. Executive Health Resources, Inc., giving the United States government broad power to dismiss qui tam FCA lawsuits even when it has...more
On June 1, 2023, the Supreme Court issued a decision in United States ex rel. Schutte v. SuperValu, Inc., clarifying when a defendant “knowingly” submits a false claim for payment under the False Claims Act (FCA). The Court...more
6/6/2023
/ Drug Pricing ,
False Claims Act (FCA) ,
Healthcare ,
Medicaid ,
Medicare ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Scienter ,
SCOTUS ,
US ex rel Tracy Schutte et al v SuperValu Inc et al
On March 28, 2023, the U.S. Court of Appeals for the Sixth Circuit issued a decision in U.S. ex rel. Martin v. Hathaway limiting the scope of liability under the Anti-Kickback Statute (AKS) and the False Claims Act (FCA) in...more
Designed for busy in-house counsel and compliance professionals, this newsletter seeks to bring you up to speed on key federal and state False Claims Act (FCA) developments, with links to primary resources. Each quarter, we...more
4/11/2023
/ Amicus Briefs ,
Anti-Kickback Statute ,
Bribery ,
Cost-Sharing ,
Cybersecurity ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare Fraud ,
Popular ,
Qui Tam
On March 3, 2023, the Criminal Division of the U.S. Department of Justice ("DOJ") revised its Evaluation of Corporate Compliance Programs or ECCP (the “March 2023 ECCP”) for the first time since June 2020....more
On February 7, 2023, the U.S. Department of Justice (DOJ) announced its fiscal year (FY) 2022 False Claims Act (FCA) statistics. Utilizing DOJ’s FY 2022 Data Table and comparing back to our FY 2021 coverage, MoFo’s FCA team...more
2/15/2023
/ Coronavirus/COVID-19 ,
Cybersecurity ,
Department of Defense (DOD) ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Federal Contractors ,
Health Care Providers ,
Kickbacks ,
Medical Devices ,
Paycheck Protection Program (PPP) ,
Pharmaceutical Industry ,
Purdue Pharma ,
Qui Tam ,
Subcontractors ,
Whistleblowers
The U.S. Supreme Court recently declined to review a Second Circuit decision that blocked Pfizer from implementing a cost sharing assistance program. Pfizer had sought to cover out-of-pocket expenses for financially eligible...more
On Friday, January 13, the Supreme Court agreed to consider whether the False Claims Act (“FCA”) covers compliance lapses tied to regulatory interpretations that are incorrect but “objectively reasonable.” The Supreme Court...more
1/18/2023
/ Billing ,
Certiorari ,
False Claims Act (FCA) ,
Fraud ,
Medicare ,
Misrepresentation ,
Oral Argument ,
Reckless Disregard ,
Scienter ,
SCOTUS ,
Statutory Interpretation
Designed for busy in-house counsel and compliance professionals, this newsletter seeks to bring you up to speed on key federal and state False Claims Act (FCA) developments, with links to primary resources. Each quarter, we...more
1/6/2023
/ Corporate Counsel ,
Cybersecurity ,
Department of Defense (DOD) ,
Department of Justice (DOJ) ,
False Billing ,
False Claims Act (FCA) ,
Federal Contractors ,
Financial Institutions ,
GAO ,
Medicaid ,
NIST ,
Pharmaceutical Industry ,
Popular ,
Retaliation ,
SCOTUS ,
Whistleblowers
Two weeks ago, President Biden signed two laws extending the statute of limitations for civil and criminal fraud actions involving the Paycheck Protection Program (PPP) and Economic Injury Disaster Loans (EIDL) to ten years....more
On the eve of the pandemic’s two-year anniversary, the U.S. Department of Justice (DOJ) released updated statistics on its efforts to combat COVID-19 related fraud and announced the appointment of a director of COVID-19 Fraud...more
3/16/2022
/ CARES Act ,
Coronavirus/COVID-19 ,
Department of Justice (DOJ) ,
Economic Injury Disaster Loans ,
Enforcement ,
False Claims Act (FCA) ,
FinTech ,
Fraud ,
Healthcare ,
Investigations ,
Paycheck Protection Program (PPP) ,
Popular ,
Price Gouging ,
SBA ,
Securities and Exchange Commission (SEC) ,
Whistleblowers
In the first year of the Biden administration, leadership at the U.S. Department of Justice (DOJ), U.S. Securities and Exchange Commission (SEC), and other U.S. government agencies announced expansive efforts to investigate...more
3/16/2022
/ Bribery ,
California ,
Coronavirus/COVID-19 ,
Corporate Crimes ,
Department of Defense (DOD) ,
Department of Justice (DOJ) ,
Employee Misconduct ,
Enforcement ,
Federal Contractors ,
GAO ,
Paycheck Protection Program (PPP) ,
Procurement Collusion Strike Force ,
Securities and Exchange Commission (SEC) ,
White Collar Crimes
On February 1, 2022, the U.S. Department of Justice (DOJ) announced that it collected more than $5.6 billion in False Claims Act (FCA) settlements and judgments in fiscal year 2021. This is the largest annual total since...more
In this episode of MoForecast, James Koukios, co-chair of the Securities Litigation, Enforcement, and White Collar Defense and the FCPA + Global Anti-Corruption Practice Groups, speaks with fellow MoFo partners Brandon L. Van...more