Join Troutman Pepper White Collar and Government Investigation Partners Callan Stein, Miranda Hooker, and Allison DeLaurentis for a podcast discussion on the DOJ’s updated guidelines regarding corporate criminal enforcement....more
9/27/2022
/ Compliance Monitoring ,
Corporate Crimes ,
Corporate Culture ,
Criminal Prosecution ,
Department of Justice (DOJ) ,
Enforcement ,
Individual Accountability ,
Internal Controls ,
New Guidance ,
Policies and Procedures ,
Risk Mitigation ,
Self-Disclosure Requirements ,
White Collar Crimes
There are many concerns that can keep private equity (PE) firms’ management teams up at night. Economic headwinds, geopolitical instability, and supply chain problems can change the fortunes of a PE firm and its portfolio...more
In the wake of the global pandemic, which forced manufacturers, trade organizations, and all other players in the health care industry to rethink how to provide medical education and communication on new product offerings to...more
On March 18, the Advanced Medical Technology Association (AdvaMed) announced revisions to its Code of Ethics on Interactions with Health Care Professionals (AdvaMed Code or Code), last revised January 1, 2020. The new version...more
The Department of Justice (DOJ) has once again raised the bar for corporations seeking cooperation credit in government investigations. Last Thursday, DOJ issued a department memorandum and announced three significant...more
In a highly watched case relating to the ability of pharmaceutical manufacturers to support patient copay assistance, the Southern District of New York recently denied Pfizer’s request for a declaratory judgment that two...more
On September 23, the U.S. Senate advanced legislation that puts all businesses at risk of defending antitrust lawsuits across different jurisdictions at the same time. Senate Bill 1787 (S. 1787) — the Antitrust Enforcement...more
The year is 2012, and the biotech you founded has just received FDA approval for a wildly promising product with significant differentiation from other products in its class. You only have 35 employees, but begin to build a...more
Pharmaceutical Research and Manufacturers of America (PhRMA) recently announced revisions to its voluntary “Code on Interactions with Health Care Professionals” (HCPs), which will take effect January 1, 2022. These revisions...more
Public companies should prepare for a more strenuous auditing process, and the increased likelihood that the information that they share with their auditors could be compelled by the Securities and Exchange Commission (SEC)...more
On Jan. 13, 2021, District of Columbia Mayor Muriel Bowser signed the False Claims Amendment Act, which expanded liability under the Washington, D.C., False Claims Act, or FCA, to encompass tax-related claims.
Originally...more
In early March, New York State Attorney General Letitia James and New York City Corporation Counsel John E. Johnson announced a $105 million settlement against a hedge fund manager for tax evasion. The New York authorities...more
Why It Matters -
As evidenced in the recently published 2020 Year in Review Report (Report), the Department of Justice’s Fraud Section (Fraud Section) demonstrated its resilience despite the COVID-19 pandemic, as well as its...more
On January 13, District of Columbia Mayor Muriel Bowser signed the False Claims Amendment Act of 2020 (the Amendment), which expanded liability under the D.C. False Claims Act (D.C. FCA) to encompass tax-related claims. The...more
I. Introduction -
While 2020 was a year like no other in many ways, the challenges posed by the global COVID-19 pandemic do not appear to have stalled the Department of Justice’s (DOJ) health care fraud enforcement...more
2/3/2021
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Fraud and Abuse ,
Health Care Providers ,
Healthcare Fraud ,
Medicare ,
OIG ,
Telemedicine
The Department of Justice (DOJ) entered into its first civil settlement for loan fraud involving the Paycheck Protection Program (PPP). On January 12, the U.S. Attorney’s Office for the Eastern District of California...more
Telemedicine providers – whether they are established or new to the space – should examine the type of conduct DOJ has recently focused on and adapt their compliance systems accordingly. Providers should also consider the...more
Why It Matters -
In order to safeguard their information, health care and life science organizations should remain vigilant in monitoring DHCoE developments and initiatives, including any policy/regulation clarifications...more
10/7/2020
/ Artificial Intelligence ,
Centers for Medicare & Medicaid Services (CMS) ,
Cybersecurity ,
Department of Health and Human Services (HHS) ,
Digital Health ,
Electronic Health Record Incentives ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Life Sciences ,
Machine Learning ,
OCR ,
Security Risk Assessments
A judge in the District of Massachusetts recently questioned whether Congress intended to criminalize off-label promotion through misbranding and adulteration statutes. In an order denying a Rule 29 motion brought by two...more
9/17/2020
/ Criminalization ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
First Amendment ,
Free Speech ,
Medical Devices ,
Misbranding ,
Off-Label Promotion ,
Off-Label Use ,
Pharmaceutical Industry ,
Strict Liability ,
White Collar Crimes
Recently, the Department of Justice (DOJ) updated its “Evaluation of Corporate Compliance Programs” guidance — the third iteration of DOJ’s guidance on this topic. The update is intended to offer transparency as to how DOJ...more
Last week, in the In re Plavix decision, the Third Circuit addressed the question of whether relators can be added or substituted in an amended complaint and, in the process, weighed in on whether the first-to-file bar is...more
Companies often consider trade secrets to be their crown jewels. But in the digital age, where copying and sending files is as easy as one click, protecting trade secrets has become even more challenging. Losing control over...more
8/17/2020
/ Civil Liability ,
Confidential Information ,
Criminal Convictions ,
Criminal Prosecution ,
Defend Trade Secrets Act (DTSA) ,
Department of Justice (DOJ) ,
Economic Espionage Act ,
Guilty Pleas ,
Indictments ,
Non-Disclosure Agreement ,
Proprietary Information ,
Theft ,
Trade Secrets ,
Uber
As scientists around the globe team up to discover and develop treatments and vaccine candidates for COVID-19, we are also seeing unprecedented speed and coordination in the effort to quell a different kind of virus — the...more
8/4/2020
/ CARES Act ,
Coronavirus/COVID-19 ,
Criminal Investigations ,
Criminal Prosecution ,
Department of Justice (DOJ) ,
Enforcement Actions ,
Federal Trade Commission (FTC) ,
Healthcare Fraud ,
Memorandum of Understanding ,
Securities Fraud ,
SIGPR ,
White Collar Crimes
As the world’s health care facilities grapple with the devastating and unexpected operational struggles brought by COVID-19, nursing homes and long-term care facilities face the added challenge of protecting their residents...more
The initiation of a government investigation is often a stressful and anxiety-producing event for a health care company. The Department of Justice (DOJ) is known for its aggressive investigation and prosecution of health care...more
9/9/2019
/ Civil Liability ,
Compliance Management Systems ,
Cooperative Compliance Regime ,
Criminal Prosecution ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Fraud and Abuse ,
Government Investigations ,
Health Care Providers ,
Healthcare Fraud ,
Internal Controls ,
Third-Party ,
Whistleblowers