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
1/28/2025
/ Anti-Kickback Statute ,
Appointments Clause ,
Article II ,
Books & Records ,
CVS ,
Cybersecurity ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Billing ,
False Claims Act (FCA) ,
Genetic Testing ,
Healthcare Fraud ,
Medicare ,
OIG ,
Patient Referrals ,
Qui Tam ,
State and Local Government ,
State Attorneys General ,
Walgreens ,
Whistleblowers
The Department of Justice published its False Claims Act (FCA) statistics for Fiscal Year 2024 this month, revealing a nearly 40% increase in whistleblower filings, increased recoveries year over year, and a near record...more
1/22/2025
/ Anti-Kickback Statute ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Federal Contractors ,
Healthcare Fraud ,
Medicaid ,
Paycheck Protection Program (PPP) ,
Qui Tam ,
Settlement ,
State Attorneys General ,
Whistleblowers
On December 17, 2024, the Department of Health & Human Services, Office of Inspector General (HHS-OIG) issued its second favorable advisory opinion involving an arrangement in which a drug manufacturer sponsors genetic...more
1/22/2025
/ Anti-Kickback Statute ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Genetic Testing ,
Health Care Providers ,
Healthcare Fraud ,
Life Sciences ,
Manufacturers ,
OIG ,
Pharmaceutical Industry
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
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
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 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