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 August 14, 2024, the Committee on Foreign Investment in the United States (“CFIUS” or “Committee”) announced a $60 million penalty, “the largest penalty CFIUS has ever issued,” following its finding of material violations...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
On November 28, 2023, the United States Department of Labor’s (“DOL”) Wage and Hour Division (“WHD”) issued a Field Assistance Bulletin (“FAB”) explaining changes to its process to assess civil money penalties for child labor...more
The U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) is tasked with providing objective oversight to protect the integrity and promote the efficiency of Medicare, Medicaid, and more than...more
USDC Report Published, Crypto Firms Announce USDC Integrations - Circle, the U.S. fintech company that manages the stablecoin USDC, recently released the “State of the USDC Economy” report, highlighting the “efforts to...more
On January 8, the Office of the Comptroller of the Currency (OCC) announced adjustments to the maximum amount of each civil money penalty (CMP) within its jurisdiction. The 2015 Adjustment Act requires federal agencies with...more
In October 2023, the Division of Enforcement of the Commodity Futures Trading Commission (“CFTC” or the “Commission”) issued an Enforcement Advisory clarifying the Commission’s approach to negotiated resolutions of...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 Office of Inspector General (OIG) recently unveiled a quicker process to answer the healthcare industry’s most pressing questions on the Anti-Kickback Statute (AKS), allowing healthcare stakeholders to attain more timely...more
On March 23, the Office of Inspector General (OIG) for the U.S. Department of Health and Human Services (HHS) announced a new, expanded frequently asked questions (FAQs) process. Although OIG has long maintained FAQs on...more
On January 6, 2023, the U.S. Environmental Protection Agency (EPA) announced its Final Rule, listed at 88 FR 986, updating the maximum civil monetary penalties that may be assessed for violations of environmental statutes....more
The guidelines provide useful insights into the mechanism of settlement agreements in criminal cases, and supersede previous guidelines published on June 26, 2019. Article 22 of Law No. 2016-1691 of December 9, 2016...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 U.S. Department of Energy issued a final rule regarding procedures for imposing civil penalties for violations of DOE’s 10 CFR Part 810 regulations governing civil nuclear technology export controls. The language of...more
On October 20, 2022, the US Department of the Treasury, as Chair of the Committee on Foreign Investment in the United States (CFIUS), released the first-ever CFIUS Enforcement and Penalty Guidelines (Guidelines). The...more
On September 27, 2022, 15 broker-dealers and one investment adviser agreed to pay more than $1.8 billion in total civil penalties to the US Securities and Exchange Commission (SEC), and, for those same companies or affiliates...more
After the publication of our Legal Alert on the Supreme Court decision lifting the stay on the Omnibus COVID-19 Health Care Staff Vaccination Interim Final Rule (the “Rule”) published by the Centers for Medicare & Medicaid...more
On September 24, 2021, the Department of Labor published its most recent rule regarding tip regulations under the Fair Labor Standards Act (“FLSA”). This final rule will go into effect on November 23, 2021....more
On May 24, 2021, OIG provided additional guidance in the form of an FAQ as to whether an offer or provision of cash, cash-equivalent, or in-kind incentives or rewards to Federal health care program beneficiaries who receive...more
Federally Qualified Health Centers (FQHCs) deliver care to some of the nation's most vulnerable individuals and families, including federal Medicare and Medicaid health care program beneficiaries. As safety net providers,...more
On November 20, 2020, the Centers for Medicare and Medicaid Services (“CMS”) and the Office of Inspector General (“OIG”) promulgated much-anticipated and significant final rules intended to “modernize” and “clarify”...more
On September 10, 2020, the Commodity Futures Trading Commission’s (CFTC, or the Commission) Division of Enforcement (Division) director issued a memorandum to Division staff setting forth a framework for evaluating the...more
As part of a broader Trump administration announcement made on August 25, 2020, the Centers for Medicare & Medicaid Services (CMS) issued sweeping oversight changes in the form of an Interim Final Rule with Comment Period...more
In a significant move toward more transparency, the Treasury Department’s Financial Crimes Enforcement Network (“FinCEN”) released new guidance (the “Guidance”) on August 18, 2020, setting forth its enforcement approach and...more
On August 17, 2020, the Centers for Medicare and Medicaid Services (CMS) issued a Guidance Memorandum (Guidance) setting forth revised state survey agency priorities as well as providing information regarding the resumption...more