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
A win for business. The Supreme Court ends Chevron Deference in a spate of recent decisions limiting administrative authority and assisting regulated parties in challenging agency rulemaking. Loper Bright and Relentless-...more
On June 7, 2024, the New York Legislature passed two bills to protect children online. The Stop Addictive Feeds Exploitation (SAFE) for Kids Act, S7694A, prohibits social media platforms from providing defined "addictive...more
On April 11, 2024, the U.S. Department of the Treasury announced a notice of proposed rulemaking that would expand the enforcement authority of the Committee on Foreign Investment in the United States (“CFIUS” or the...more
The Securities and Exchange Commission (SEC) recently settled charges against J.P. Morgan Securities LLC (JPMS) for impeding hundreds of advisory clients and brokerage customers from reporting potential securities law...more
On November 14, 2023, the SEC’s Division of Enforcement announced its Enforcement Results for Fiscal Year 2023. Below are some key takeaways for fund managers: The Commission brought 760 total enforcement actions in FY...more
Regulatory Developments - FinCEN Proposes Form of Report to Collect Beneficial Ownership Information and Application to Obtain FinCEN Identifiers - On January 17, FinCEN proposed a form of report to collect beneficial...more
The Office for Civil Rights (OCR) of the U.S. Department of Health and Human Services (HHS) released a Request for Information (RFI) to obtain industry feedback and inform potential future rulemaking regarding information...more
Report on Patient Privacy 21, no. 12 (December, 2021) - Amid the letters of congratulations to new HHS Office for Civil Rights (OCR) Director Lisa Pino is a plea from the American Hospital Association (AHA): “victims” of...more
The Federal Trade Commission (FTC) appears poised to begin testing the scope of its rulemaking authority, including new substantive competition rules for the first time in decades. On March 25, 2021, FTC Acting Chairwoman...more
On Friday, November 20, 2020, 60 calendar days prior to the inauguration of President-Elect Biden, the Trump administration released three rulemakings with significant implications for life sciences companies and healthcare...more
On October 9, 2019, the Centers for Medicare and Medicaid Services (“CMS”) proposed sweeping changes to the federal Physician Self-Referral Law, commonly referred to as the Stark Law. While many of the changes reflect CMS’...more
In an effort to modernize and clarify a statute that looms large in the minds of health care providers across the nation, the Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) recently...more
The U.S. Department of Labor issued its bi-annual regulatory agenda update on November 20, 2019. Of the 63 items listed, the Wage & Hour Division (WHD) included seven regulatory priorities. Only one of these is new: a...more
The U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) and the Centers for Medicare & Medicaid Services (CMS) recently released two proposed rules restructuring the Physician Self-Referral...more
On 3 October 2019, the Department of Energy (DOE) published a notice of proposed rulemaking regarding the imposition of civil penalties for violations of the Part 810 regulations (10 CFR Part 810), which control the export of...more
On October 9, 2019, the Centers for Medicare and Medicaid Services (CMS) and Department of Health and Human Services Office of Inspector General (HHS-OIG) issued long-awaited proposed changes “to modernize and clarify the...more
The CFPB is proposing to issue a final rule on annual adjustments to the civil penalties within its jurisdiction. Comments on the proposal must be received by November 13, 2018....more
A recent bill introduced in the US House of Representatives would require the CFPB to issue guidance on federal consumer financial laws, and also provide a framework for civil money penalties. H.R. 5534 would create the Give...more
The Health Resources and Services Administration (HRSA) within the U.S. Department of Health and Human Services (HHS) published a notice of proposed rulemaking impacting the 340B Drug Pricing Program (340B Program) on June...more
Highlights of this edition of the Cozen O’Connor Aviation Regulatory Update include the FAA’s recent rulemakings involving New York area airport slots and safety management systems for U.S. Part 121 air carriers, developments...more
Rengan Rajaratnam settled his insider trading case with the SEC this week, consenting to the entry of a permanent injunction and agreeing to pay disgorgement, prejudgment interest, a civil penalty and to be barred from the...more