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
In April, the Committee on Foreign Investment in the United States (CFIUS) issued a Notice of Proposed Rulemaking (NPRM) to “enhance certain CFIUS procedures and sharpen its penalty and enforcement authorities.” If CFIUS...more
Historically, the Centers for Medicare and Medicaid Services (“CMS”) has not aggressively pursued enforcement activity under the Sunshine Act. However, this may change in 2024. Late last year, CMS updated its Open Payments...more
The U.S. Department of Treasury (“Treasury”), which is Chair of the Committee on Foreign Investment in the United States (“CFIUS” or the “Committee”), released a Notice of Proposed Rulemaking on April 11, 2024 (“NPRM”) meant...more
The Occupational Safety and Health Administration (“OSHA”) issued a February 27th news release addressing Henry Brick Co., Inc. (“HBCI”). The news release describes HBCI as a Selma, Alabama, brick manufacturer....more
The long-anticipated final rule addressing substance use disorder (SUD) records at 42 C.F.R. Part 2, commonly referred to as Part 2, is here. The final rule is a joint undertaking by the U.S. Department of Health and Human...more
The Louisiana Department of Environmental Quality (“LDEQ”) and Brookfield District Energy (“Brookfield”) entered into a Settlement Agreement (“Agreement”) addressing alleged violations of an air permit. See SA-AE-230053. ...more
On September 14, 2023, the U.S. Department of the Treasury held the annual Committee on Foreign Investment in the United States (“CFIUS”) Conference in Washington, DC. The interagency Committee is tasked with reviewing...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
The Securities and Exchange Commission (“SEC”) released an annual summary, on November 15, 2022, of actions brought by the Division of Enforcement (“Division”) over fiscal year 2022 (“Enforcement Summary”), providing an...more
The consumer product industry can expect more aggressive enforcement from the Consumer Product Safety Commission (CPSC), including higher civil penalties, increased use of criminal penalties, and the implementation of...more
On September 21, 2016, the Department of Health and Human Services (HHS) published a final rule that greatly expands the information that sponsors of “applicable drug clinical trials” and “applicable device clinical trials”...more
Two recent Federal Energy Regulatory Commission ("FERC") orders will result in the imposition of civil penalties totaling nearly three quarters of a billion dollars on Barclays Bank PLC ("Barclays") and JP Morgan Ventures...more