Medical Device Legal News with Sam Bernstein: Episode 10
Compliance Perspectives: Changes to the Physician Self-Referral and Anti-Kickback Rules
Investment Management Roundtable Discussion – Regulatory and Enforcement Update
FCPA Compliance and Ethics Report-Episode 131, The FCPA Professor Takes a Look Back at 2014
Conducting due diligence for physician and provider compensation arrangements during a healthcare transaction is critical for the acquirer. Appropriate due diligence is necessary, regardless of whether the transaction is a...more
A long-awaited Third Circuit decision held that securitization trusts holding student loans are “covered persons” subject to the CFPB’s enforcement and investigative powers because they “engage” in offering or providing...more
The United States manages more than three dozen separate economic and trade sanctions programs. Those programs target specified foreign governments along with thousands of named individuals, groups and entities in accordance...more
After a year-over-year reduction in drug, device, and biologic Warning Letters from 2012 through 2019, Warning Letters spiked to pre-2014 levels in 2020 during the pandemic. This was due in large part to a significant number...more
The United States, the European Union, and Germany have recently adopted or proposed new rules requiring enhanced due diligence in supply chains, targeting human rights and environmental issues. This alert examines key...more
On December 15, 2022, the Financial Crimes Enforcement Network (“FinCEN”) issued a Notice of Proposed Rulemaking (the “NPRM”) that would implement provisions of the Corporate Transparency Act (the “CTA”) regarding access to...more
In a recent decision, the FCC’s Media Bureau entered into a consent decree with the licensee of a low-power TV station that violated the sponsorship identification rules. The station paid a civil penalty of $60,000 and agreed...more
On April 29, 2021, the US Department of the Treasury’s Office of Foreign Assets Control (OFAC) announced two settlements of potential civil liability with two companies over their apparent violations of its regulations. The...more
In order to provide an overview for busy in-house counsel and compliance professionals, we summarize below some of the most important international anti-corruption developments from the past month, with links to primary...more
- A tone-at-the-top business culture with CEO leadership is a critical component of effective anti-corruption and anti-bribery policy implementation. - CEO leadership helps set an example for lower management and company...more
Das Justizministerium arbeitet mit Hochdruck an einem Entwurf für ein Unternehmensstrafrecht. Der Entwurf verfolgt das Ziel, die Sanktionierung von Unternehmen und sonstigen Verbänden auf eine eigene gesetzliche Grundlage zu...more
Firms will need to ensure their systems and controls to prevent financial crime and money laundering are working effectively: this is just part of the message contained in the FCA’s Business Plan for 2019/20. The Business...more
• In an unusual move, the government has decided to pursue a False Claims Act (FCA) suit against a private equity firm based on an alleged commission scheme at its pharmacy portfolio company to promote sales of products...more
On February 27, 2017, FinCEN announced a $7 million civil monetary penalty against Merchants for willful violations of the BSA. Additionally, the Office of the Comptroller of the Currency (OCC), Merchants’ federal functional...more
New York-based hedge fund Och-Ziff Capital Management Group (the “Hedge Fund”) agreed to pay approximately $412 million to resolve charges brought by the U.S. Securities and Exchange Commission (“SEC”) and Department of...more
The SEC recently affirmed its ALJ’s ruling barring Alan Stanford’s former CCO from the industry and ordering monetary penalties of $260,000 together with $591,992 in disgorgement. The Commission held the CCO approved false...more
On November 7, 2014, the Antitrust Division of the U.S. Department of Justice (“DOJ”) reached a $5 million settlement with Flakeboard America Limited (“Flakeboard”), its foreign parents, and SierraPine to settle allegations...more
DOJ fines particleboard manufacturers $4.95 million for gun-jumping violations - On Friday, November 7, 2014, two companies agreed to pay $4.95 million to settle U.S. Department of Justice (DOJ) allegations that the...more
On November 7, 2014, the United States Department of Justice, Antitrust Division (DOJ) announced a $5 million agreement to settle charges that Flakeboard and SierraPine had engaged in unlawful pre-merger coordination. The...more
On November 7, 2014, the Antitrust Division of the Department of Justice ("DOJ") announced that it had imposed a civil penalty of $3.8M and disgorgement of $1.15M in profits on Flakeboard America Limited (and its parent...more
The OCC entered into a consent order with a small, New Jersey-based bank with approximately $118 million in total assets for violations of the Bank Secrecy Act (the “BSA”). The OCC assessed a civil money penalty (“CMP”)...more