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
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
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
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
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
On April 20, 2015, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services (HHS) published its “Practical Guidance for Health Care Governing Boards on Compliance Oversight” (the Guidance).1...more
On May 21, 2014, the U.S. Department of Health and Human Services Office of Inspector General (OIG) issued a special advisory bulletin addressing independent charity patient assistance programs (PAPs) for federal health care...more
While predicting enforcement trends over the next five years is not without uncertainty, the best marker for future activity may be to look to the past. We believe that industry members and counsel can expect the Department...more
6/26/2013
/ Affordable Care Act ,
Criminal Prosecution ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
FBI ,
Food and Drug Administration (FDA) ,
Healthcare ,
Medical Devices ,
OIG ,
Pharmaceutical Industry
On April 17, 2013, the Office of the Inspector General (OIG) of the United States Department of Health and Human Services released an updated Provider Self-Disclosure Protocol (SDP). As self-described, OIG updated the SDP to...more