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
On September 4, 2024, the New Mexico Environment Department’s Air Quality Bureau (AQB) updated its Civil Penalty Policy, making several key changes to its assessment of civil penalties and administrative compliance costs in...more
While the total number of filings declined in comparison to recent years, CFIUS's latest Annual Report to Congress highlights an uptick in penalties and an increased use of enforcement tools relating to national...more
The Committee on Foreign Investment in the United States (CFIUS) released its statutorily mandated annual report to congress last month. While the report itself highlights several notable developments in 2023 (New Zealand and...more
On June 27, the US Supreme Court issued an opinion in SEC v. Jarkesy that limits the US Securities and Exchange Commission’s (SEC) ability to administratively seek civil penalties against defendants for securities fraud....more
The HIPAA Privacy, Security, and Breach Notification Rules apply to healthcare providers who engage in certain electronic transactions, healthcare clearinghouses, and health plans, including employee group health plans with...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 PCAOB’s Division of Enforcement and Investigations’ 2024 first quarter activity continued the blistering pace of enforcement since Erica Williams became the Board’s Chair. While the Board’s first quarter enforcement...more
On March 1, 2024, a federal judge in the U.S. District Court for the Northern District of Alabama ruled that the Corporate Transparency Act (“CTA”) is unconstitutional. The CTA and its implementing regulations require that...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
EPA recently promulgated a final rule (the Rule) adjusting civil penalties issued by the agency for inflation. This action was performed pursuant to the Federal Civil Penalties Inflation Adjustment Act of 1990, as amended by...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
As the year gets underway, the Securities and Exchange Commission (SEC or Commission) is continuing its ongoing enforcement efforts to target anti-whistleblower practices by pursuing a broader range of entities and...more
The Emergency Medical Treatment and Active Labor Act ("EMTALA") provides that if a patient comes to a hospital or hospital-owned urgent care center, the hospital and relevant on-call physicians must provide an appropriate...more
In a recent speech given at New York University’s School of Law, the Commodity Futures Trading Commission’s (CFTC’s) Director of Enforcement, Ian McGinley, unveiled a new advisory concerning penalties, monitors and admissions...more
In March 2023, the SEC imposed a total monetary settlement of $79.5 million in SEC v. Barksdale et al., of which $56.3 million consisted of disgorgement and prejudgment interest. This was the largest monetary penalty imposed...more
Earlier this month, the U.S. Occupational Safety and Health Administration announced that maximum civil penalties for serious violations would increase from $15,625 to $16,131. The penalties for repeat or willful violations...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
In 2022, Customs and Border Protection (“CBP” or “Customs”) processed $3.35 trillion in imports, issued 2,121 penalties, and collected $19.3 million from penalties and liquidated damages. Section 1592 of the Tariff Act of...more
As we approach year-end, we wanted to remind you about the upcoming implementation of the Corporate Transparency Act ("CTA"), which is set to take effect on January 1, 2024. The CTA will impose significant new reporting...more
New guidance from the Commodity Futures Trading Commission[i] may significantly change the calculus for firms considering whether to settle an enforcement action. Requiring admission of wrongdoing in a greater number of...more
The HIPAA Privacy and Security Rules generally require covered entities (including most healthcare providers) to execute written agreements (“business associate agreements” or “BAAs”) with their business associates before...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
A few months ago I told you about the United States Forest Service's decision to resolve a citizen suit accusing it of violating the Clean Water Act by obtaining a Federal permit and as many as 47 State permits authorizing it...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