Morrison Foerster partners Kate Driscoll and Nate Mendell, both former federal prosecutors and members of the firm’s Investigations + White Collar Defense Group, hosted the ninth episode of When Your Life Sciences Are on the...more
This year, at the Federal Bar Association’s (FBA) annual Qui Tam Conference, United States Department of Justice (DOJ) leadership confirmed that DOJ will remain committed to aggressive enforcement of the False Claims Act...more
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
Artificial Intelligence (AI), specifically generative AI technologies, hold significant promise for improving the healthcare industry by streamlining clinical operations, freeing service providers from mundane tasks, and...more
3/4/2024
/ Algorithms ,
Anti-Kickback Statute ,
Artificial Intelligence ,
Automated Decision Systems (ADS) ,
Deferred Prosecution Agreements ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Health Information Technologies ,
Healthcare ,
Innovative Technology ,
Life Sciences ,
Machine Learning ,
Popular ,
Prior Authorization
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)
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