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
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,...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
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 eighth episode of When Your Life Sciences Are on the...more
2/25/2025
/ Department of Justice (DOJ) ,
Enforcement Actions ,
Fraud ,
Insider Trading ,
Internal Controls ,
Life Sciences ,
Mergers ,
Risk Management ,
Securities and Exchange Commission (SEC) ,
Securities Fraud ,
Securities Regulation ,
Thought Leadership ,
White Collar Crimes
In 2024, as in years past, healthcare fraud enforcement by the U.S. Department of Justice (DOJ) was substantial. Federal actions under the False Claims Act (FCA) alone resulted in $1.67 billion in settlements and judgments...more
1/28/2025
/ Compliance ,
Cybersecurity ,
Data Privacy ,
Department of Defense (DOD) ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Food and Drug Administration (FDA) ,
Healthcare Fraud ,
Life Sciences ,
Medical Devices ,
NASA ,
Personally Identifiable Information ,
Private Equity ,
Qui Tam ,
Trump Administration ,
Venture Capital ,
Voluntary Disclosure ,
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
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
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 seventh episode of When Your Life Sciences Are on...more
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 sixth episode of When Your Life Sciences Are on the...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
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
Morrison Foerster Investigations + White Collar Defense partner Nate Mendell, former Acting U.S. Attorney for the District of Massachusetts, hosted the fifth episode of When Your Life Sciences Are on the Line, where leading...more
Morrison Foerster Investigations + White Collar Defense partner Nate Mendell, former Acting U.S. Attorney for the District of Massachusetts, hosted the fourth episode of When Your Life Sciences Are on the Line, where leading...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
The use of electric vehicles (EVs) and micromobility devices (EMDs), e.g., electric scooters, electric bikes, and hoverboards, is on the rise and the accompanying potential risks of EVs and EMDs have become a new area of...more
3/22/2024
/ Artificial Intelligence ,
Connected Cars ,
Consumer Product Safety Commission (CPSC) ,
Cybersecurity ,
Department of Justice (DOJ) ,
E-Scooters ,
Electric Vehicles ,
Fires ,
Green Transportation ,
Greenhouse Gas Emissions ,
Incentives ,
Lithium Batteries ,
Public Safety ,
Safety Standards
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
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
On February 14, 2024, Deputy Attorney General Lisa Monaco announced two important developments related to the advent of artificial intelligence (AI) as it relates to the work of the U.S. Department of Justice (DOJ). First,...more
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
Earlier this month, Deputy Attorney General Lisa O. Monaco announced an important extension of DOJ’s voluntary self-disclosure policy aimed specifically at incentivizing companies engaged in mergers and acquisitions “to...more
11/1/2023
/ Aggravating Factors ,
Corporate Misconduct ,
Department of Justice (DOJ) ,
Due Diligence ,
Integration ,
Mergers ,
Risk Mitigation ,
Safe Harbors ,
Self-Disclosure Requirements ,
Voluntary Disclosure ,
White Collar Crimes
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