The Rules They Are A-Changin’: CMS Proposes a Significant Change to the 60-Day Repayment Rule
In February 2024, we published an alert discussing the significant benefits of prompt self-reporting and cooperation during a US Securities and Exchange Commission ("SEC") investigation. This past week, during his keynote...more
The U.S. Food and Drug Administration (FDA) uses warning letters to notify manufacturers that they have violated the FDA’s regulations or federal law. Manufacturers that receive warning letters must respond promptly, and they...more
The U.S. Securities and Exchange Commission (“SEC”), in a couple of recent settled actions, continues to warn companies that the practice of requiring departing employees to sign comprehensive releases in return for...more
In June 2021, Philips notified the ANSM of a field safety action that related to the potential risk of degradation and inhalation of carcinogenic compounds from the sound-absorbing foam used in its ventilation devices for...more
In yet another indication that the Biden administration is continuing to ramp up white collar enforcement, the U.S. Department of Justice (“DOJ”) and Securities and Exchange Commission (“SEC”) announced on April 20, 2022 that...more
Our Virtual Regional Healthcare Compliance Conferences provide updates on the latest news in regulatory requirement, compliance enforcement, and strategies to develop effective compliance programs. Watch, listen, and ask...more
The U.S. Department of Justice (DOJ) routinely encourages the subjects of False Claims Act (FCA) enforcement actions to make voluntary disclosures and fully cooperate with the government on the premise that cooperation leads...more
The U.S. Department of Justice seeks to use the potential for a reduced penalty amount and damages to encourage self-disclosure of misconduct and cooperation during FCA investigations. On May 7, 2019, the U.S. Department...more
The U.S. Department of Justice (DOJ) issued policy guidance on May 6, 2019, about providing credit in False Claims Act (FCA) settlements to corporations for “disclosure, cooperation, and remediation." DOJ has never previously...more
This week, the Department of Justice (DOJ) formalized and expanded its guidance for how defendants can earn cooperation credit in False Claims Act (FCA) cases and thereby reduce settlement amounts. New section 4-4.112 of the...more
Companies facing liability under the False Claims Act (FCA) often desire early resolution with the Department of Justice (DOJ) through settlement. Hand in hand with the decision to settle comes the decision of whether or not...more
The Situation: Using a novel approach, the U.S. Department of the Treasury's Office of Foreign Assets Control ("OFAC") concurrently designated a non-U.S. individual to the Foreign Sanctions Evaders ("FSE") List in connection...more
The Securities & Exchange Commission (“SEC”) announced last week that it charged The Goodyear Tire & Rubber Company (“Goodyear”) with violating the Foreign Corrupt Practices Act (“FCPA”), and that Goodyear agreed to pay more...more