In this issue of our newsletter on developments impacting the life sciences industry, we examine topics including how the increased DOJ and FDA focus on cybersecurity issues could lead to new theories of False Claims Act...more
11/3/2023
/ Cybersecurity ,
Department of Justice (DOJ) ,
Enforcement ,
False Claims Act (FCA) ,
Food and Drug Administration (FDA) ,
Hospitals ,
Laboratory Developed Tests ,
Life Sciences ,
Medical Devices ,
OCR ,
Pharmaceutical Industry ,
Popular ,
Prescription Drugs ,
Proposed Rules ,
Regulatory Agenda ,
Regulatory Reform ,
Regulatory Requirements ,
Telehealth ,
Tracking Systems
We are pleased to present the first issue of our newsletter analyzing recent trends and developments impacting the life sciences industry, including DOJ policy updates and key provisions of the Food and Drug Omnibus Reform...more
6/8/2023
/ Clawbacks ,
Compensation ,
Compliance ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Enforcement ,
False Claims Act (FCA) ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Life Sciences ,
New Regulations ,
OIG ,
Self-Disclosure Requirements
Key Points The volume of new False Claims Act (FCA) case filings remained high in 2021, and the Department of Justice (DOJ) collected more than $5.6 billion in settlements and judgments — the second-largest annual total in...more
Despite the challenges posed by the COVID-19 public health emergency in 2020, the Office of Inspector General, U.S. Department of Health and Human Services (HHS-OIG) entered into the highest number of corporate integrity...more
On November 16, 2020, the Office of the Inspector General of the Department of Health and Human Services (HHS-OIG) issued a Special Fraud Alert regarding the inherent fraud and abuse risks associated with...more
11/25/2020
/ Coronavirus/COVID-19 ,
Corporate Integrity Agreement ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Fraud Alerts ,
Health Care Providers ,
Healthcare Fraud ,
Life Sciences ,
OIG ,
Pharmaceutical Industry ,
Speaker Programs
On October 22, 2019, Skadden hosted our Ninth Annual Pharmaceutical and Medical Device Enforcement and Litigation Seminar in New York, which focused on U.S. enforcement issues companies face throughout the industry. The key...more
12/2/2019
/ Anti-Kickback Statute ,
Big Data ,
CDRH ,
Charitable Organizations ,
Co-payments ,
Data Privacy ,
Department of Justice (DOJ) ,
Dietary Supplements ,
Disgorgement ,
Drug Pricing ,
Enforcement Actions ,
False Advertising ,
False Claims Act (FCA) ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Food Manufacturers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Lanham Act ,
Life Sciences ,
Medical Devices ,
NAD ,
Off-Label Promotion ,
OIG ,
OPDP ,
Pharmaceutical Industry ,
Physician Compensation Arrangements ,
Pleading Standards ,
POM Wonderful v Coca Cola ,
REMS ,
RICO ,
Risk Assessment ,
Risk Management ,
SCOTUS ,
Tobacco
On October 30, 2018, Skadden hosted its Eighth Annual Pharmaceutical and Medical Device Enforcement and Litigation Seminar in New York City, which focused on U.S. enforcement issues faced by companies throughout the industry....more
12/13/2018
/ Anti-Bribery ,
Anti-Corruption ,
Anti-Kickback Statute ,
Bribery ,
Compliance ,
Corporate Misconduct ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Digital Health ,
Drug Pricing ,
Enforcement Actions ,
Ethical Standards ,
False Claims Act (FCA) ,
FDA Approval ,
First Amendment ,
Food and Drug Administration (FDA) ,
Foreign Corrupt Practices Act (FCPA) ,
General Data Protection Regulation (GDPR) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Internal Investigations ,
Kickbacks ,
Life Sciences ,
Materiality ,
Medical Devices ,
OIG ,
Pharmaceutical Industry ,
PHRMA ,
Popular ,
Product Labels ,
Rebates ,
Safe Harbors ,
Securities and Exchange Commission (SEC) ,
Sunshine Act ,
Transparency ,
Universal Health Services Inc v United States ex rel Escobar ,
Whistleblowers
The Trump administration and Republican-led Congress spent substantial time and political capital in 2017 on efforts to repeal and replace the Affordable Care Act (ACA) and enact sweeping Medicaid reform. By the end of the...more
1/31/2018
/ Affordable Care Act ,
Block Grants ,
Centers for Medicare & Medicaid Services (CMS) ,
Children's Health Insurance Program (CHIP) ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Deregulation ,
Enforcement Actions ,
Executive Orders ,
False Claims Act (FCA) ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Health Insurance ,
Healthcare Reform ,
Individual Mandate ,
Medicaid ,
Medical Devices ,
Medical Reimbursement Plans ,
Medicare ,
Opioid ,
Orphan Drugs ,
Political Parties ,
Popular ,
Stabilization Issues ,
Trump Administration ,
Universal Health Services Inc v United States ex rel Escobar
Panelists examined major enforcement actions from 2017 and identified key trends. Aggressive Enforcement With a Decrease in High-Dollar Settlements. Panelists noted that the Department of Justice (DOJ) continues its...more
12/5/2017
/ Anti-Kickback Statute ,
Corporate Integrity Agreement ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
First Amendment ,
Food and Drug Administration (FDA) ,
Foreign Corrupt Practices Act (FCPA) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Life Sciences ,
Materiality ,
Medical Devices ,
Off-Label Promotion ,
OIG ,
Patient Assistance Programs ,
Pharmaceutical Industry ,
Popular ,
Securities and Exchange Commission (SEC) ,
Universal Health Services Inc v United States ex rel Escobar
On September 22, 2017, Aegerion Pharmaceuticals resolved a wide-ranging probe by the Department of Justice (DOJ) regarding the company’s U.S. commercial activities relating to Juxtapid, a lipid-lowering agent for the...more
9/28/2017
/ Anti-Kickback Statute ,
Consent Decrees ,
Criminal Conspiracy ,
Criminal Investigations ,
Criminal Penalties ,
Deferred Prosecution Agreements ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Fraudulent Inducement ,
HIPAA Audits ,
HIPAA Breach ,
Medical Devices ,
Misdemeanors ,
Off-Label Promotion ,
Pharmaceutical Industry ,
Prescription Drugs ,
Promotional Items ,
Whistleblowers
2016 was a year of change for the Department of Health and Human Service's Office of Inspector General's (OIG) approach to corporate integrity agreements (CIA). The OIG began to use its new model CIA format and applied its...more
3/14/2017
/ Corporate Integrity Agreement ,
Corporate Misconduct ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Healthcare Fraud ,
Life Sciences ,
Medical Devices ,
New Guidance ,
OIG ,
Permissive Exclusion Authority ,
White Collar Crimes
While President Donald Trump made repeal of the Affordable Care Act (ACA) a centerpiece of his 2016 presidential campaign, he offered few details about how he would replace it or address other health care issues. More...more
2/4/2017
/ Administrative Appointments ,
Affordable Care Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Drug Pricing ,
Fraud Abuse and Waste ,
Health Insurance ,
Health Savings Accounts ,
Healthcare Fraud ,
Healthcare Reform ,
Innovation ,
Legislative Agendas ,
Medicaid ,
Medicare ,
Pharmaceutical Industry ,
Prescription Drugs ,
Repeal ,
Tax Credits ,
Trump Administration
On the eve of a change in administration, the U.S. Food and Drug Administration (FDA or the Agency) released a flurry of documents regarding off-label communications and FDA’s ability to regulate such communications within...more
2/2/2017
/ Administrative Authority ,
Draft Guidance ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Final Rules ,
First Amendment ,
Food and Drug Administration (FDA) ,
Free Speech ,
Life Sciences ,
Medical Devices ,
Off-Label Promotion ,
Pharmaceutical Industry
On December 13, 2016, President Obama signed into law the 21st Century Cures Act (Act), one of the most important pieces of health care and life sciences legislation in several decades. The Act is intended to spur the rapid...more
12/14/2016
/ 21st Century Cures Initiative ,
Barack Obama ,
Cancer ,
Civil Monetary Penalty ,
Clinical Trials ,
Department of Health and Human Services (HHS) ,
Federal Funding ,
Food and Drug Administration (FDA) ,
HCEI ,
Health Information Technologies ,
Healthcare Fraud ,
Hospitals ,
Infectious Diseases ,
Innovation ,
Life Sciences ,
Medical Devices ,
Medical Research ,
Mental Health ,
National Institute of Health (NIH) ,
New Legislation ,
Opioid ,
Patient Privacy Rights ,
Pharmaceutical Industry ,
Prescription Drugs ,
Safe Harbors ,
Software Developers
On December 6, 2016, the Supreme Court of the United States ruled unanimously in State Farm Fire and Casualty Co. v. United States ex rel. Rigsby that violations of the False Claims Act’s (FCA) seal requirement do not require...more
On June 16, 2016, the U.S. Supreme Court in Universal Health Services, Inc. v. United States ex rel. Escobar1 (Escobar) unanimously upheld the implied certification theory of False Claims Act (FCA) liability and strengthened...more
11/7/2016
/ Appeals ,
Conditions of Payment ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
False Implied Certification Theory ,
Fraud ,
Government Knowledge Defense ,
Material Misrepresentation ,
Materiality ,
Motion to Dismiss ,
Pleading Standards ,
Qui Tam ,
Scienter ,
Summary Judgment ,
Universal Health Services Inc v United States ex rel Escobar
The Department of Justice (DOJ) has long had the advantage when investigating False Claims Act (FCA) cases against health care companies. However, recent changes in the courts, including a unanimous U.S. Supreme Court...more
9/28/2016
/ Department of Justice (DOJ) ,
Duty to Disclose ,
Enforcement Actions ,
Exclusions ,
False Claims Act (FCA) ,
Federal Funding ,
Federal Rules of Civil Procedure ,
Health Care Providers ,
Materiality ,
OIG ,
Sealed Records ,
Settlement ,
Universal Health Services Inc v United States ex rel Escobar
On June 16, 2016, the U.S. Supreme Court in Universal Health Services v. United States ex rel. Escobar unanimously upheld the implied certification theory of False Claims Act (FCA) liability. The Court ruled that a party can...more
6/17/2016
/ Conditions of Payment ,
False Claims Act (FCA) ,
False Implied Certification Theory ,
Federal Contractors ,
Fraud ,
Implied Certification ,
Material Misrepresentation ,
Materiality ,
Medicaid ,
Medicare ,
Mental Health ,
SCOTUS ,
Universal Health Services Inc v United States ex rel Escobar ,
Unlicensed Medical Providers
The Office of Inspector General of the Department of Health and Human Services (OIG) has issued updated guidance on the use of its so-called permissive exclusion authority under Section 1128(b)(7) of the Social Security Act...more
4/22/2016
/ Administrative Authority ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Exclusion Orders ,
False Claims Act (FCA) ,
Federal Health Care Programs (FHCP) ,
Fraud and Abuse ,
New Guidance ,
OIG ,
Risk Assessment ,
Willful Misconduct
On April 5, 2016, the Department of Justice’s (DOJ) Fraud Section made two related announcements in its Foreign Corrupt Practices Act (FCPA) Enforcement Plan and Guidance. First, the Fraud Section announced a substantial...more
On March 22, 2016, the U.S. Supreme Court issued a decision in the Fair Labor Standards Act (FLSA) class action Tyson Foods, Inc. v. Bouaphakeo. In an opinion authored by Justice Anthony Kennedy, the majority held that class...more
4/5/2016
/ Admissible Evidence ,
Class Action ,
Department of Justice (DOJ) ,
Fair Labor Standards Act (FLSA) ,
False Claims Act (FCA) ,
Health Care Providers ,
Relators ,
SCOTUS ,
Statistical Sampling ,
Tyson Foods v Bouaphakeo ,
Wage and Hour
In an apparent first, the U.S. Food and Drug Administration (FDA) has conceded that a pharmaceutical company may engage in truthful and nonmisleading speech promoting the off-label use of a prescription drug. This concession...more
Corporate Integrity Agreements (CIAs) are among the most important tools in the U.S. Department of Health and Human Services Office of Inspector General’s (OIG) toolbox for promoting compliance in the health care industry....more
For more than a decade, the Department of Justice (DOJ) has zealously pursued enforcement actions against the health care industry. Given the continued growth in government spending on health care and the billions of dollars...more
1/22/2016
/ Caronia ,
Department of Justice (DOJ) ,
Enforcement Actions ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
First Amendment ,
Healthcare Fraud ,
Inducements ,
Life Sciences ,
Off-Label Promotion ,
Off-Label Use ,
Pharmaceutical Industry ,
Physicians ,
Yates Memorandum
The U.S. export control system has undergone major reform in recent years, and companies have experienced both increased enforcement of export control laws and fines for violations, with more changes on the way. Skadden...more
1/19/2016
/ Acquisitions ,
Bureau of Industry and Security (BIS) ,
Criminal Prosecution ,
Defense Contracts ,
Department of Justice (DOJ) ,
Directorate of Defense Trade Controls (DDTC) ,
Enforcement Actions ,
Export Administration Regulations (EAR) ,
Export Controls ,
Exports ,
ITAR ,
Personal Liability ,
Policy Violations ,
Successor Liability