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 early August, the U.S. District Court for the Northern District of Texas ruled that the civil money penalty (CMP) provision in the Food, Drug, and Cosmetic Act (FDCA) for tobacco products, 21 U.S.C. § 333(f)(9), is...more
The U.S. Department of the Treasury ("Treasury") has engaged in a flurry of rulemaking over the last year, most recently issuing a final rule to sharpen and enhance the Committee on Foreign Investment in the United States...more
On June 27, 2024, the United States Supreme Court issued a much-anticipated decision in Securities and Exchange Commission v. Jarkesy, holding that parties subject to an enforcement action brought by the U.S. Securities and...more
In the 2024 Minnesota legislative session, the Legislature granted the Minnesota Pollution Control Agency (MPCA) expanded enforcement powers (Enforcement Legislation or Legislation), including clarified powers to shut down...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
As the lead agency for the Committee on Foreign Investment in the United States (CFIUS or the Committee), the U.S. Department of the Treasury released new proposed rules on April 11, 2024 intended to enhance the enforcement...more
The federal False Claims Act (FCA) is widely regarded as a powerful tool to punish fraud against the federal government. Since 1986, the federal government has recovered more than $75 billion from FCA settlements and...more
El Tribunal Administrativo de Antioquia de Colombia (el Tribunal), el 10 de abril de 2023, expidió sentencia de primera instancia con ponencia de la Magistrada Liliana Navarro Giraldo, por medio de la cual declaró la nulidad...more
The enforcement marks a step-up in scrutiny and enforcement as new amendments to the CCPA are set to come into force Jan. 1, 2023 and as enforcement moves from the CA Attorney General to the new California Privacy Protection...more
The D.C Circuit Court of Appeals sits in a unique position as the primary reviewing court for federal government agency actions. As a result, the D.C. Circuit sits in a high-profile position and several judges have...more
Raritan Baykeeper, Inc., Riverkeeper, Inc., and two individuals (collectively “Baykeeper”) filed a Complaint for Declaratory and Injunctive Relief and Civil Penalties (“Complaint”) in the United States District Court (E.D....more
On June 10, the Federal Trade Commission (FTC) filed an amended complaint for civil money penalties and other relief under Section 5 of the FTC Act prohibiting “unfair or deceptive acts or practices” and Section 521 of the...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
2020 saw continuity in CFTC leadership, programs, and direction from 2019. Overall, the Commission enjoyed an unusually heavy rulemaking calendar and continued the direction of its enforcement program from 2019. On the...more
Report on Medicare Compliance 30, no. 7 (February 22, 2021) - A Michigan woman is the first in the nation to be charged criminally with misappropriating money from the Provider Relief Fund (PRF), the Department of Justice...more
Earlier this month, the U.S. Supreme Court agreed to hear a pair of cases that provide it with the opportunity to severely restrict the Federal Trade Commission’s (“FTC’s”) authority to obtain equitable money relief in...more
The Office of Inspector General for the U.S. Department of Health and Human Services (HHS-OIG) announced the launch of a portal that will post announcements and information issued by OIG that are related to COVID-19. ...more
The proposed rule issued on October 3, 2019 would update 10 CFR Part 810 to include procedures to implement the Department of Energy’s civil penalty authority. The maximum proposed penalty is $102,522 per violation, per day. ...more
Until recently, the annual limit for civil monetary penalties (CMP) that could be levied against covered entities and business associates in violation of the Health Insurance Portability and Accountability Act of 1996, as...more
The HHS Office for Civil Rights (“OCR”) issued a notice in the Federal Register regarding its Enforcement Discretion (84 Fed. Reg. 18151) on April 30, 2019. HHS announced that HHS will now apply a different cumulative annual...more
Executive summary: On 21 January 2019, OFSI issued its first monetary penalty for a breach of financial sanctions, marking a significant development in the UK’s evolving sanctions enforcement landscape. ...more
The amendments would make the CFTC’s whistleblower awards process more uniform with the SEC’s program and would enable the CFTC to bring enforcement actions against employers that retaliate against whistleblowers....more
On July 11, 2016, the Federal Energy Regulatory Commission (FERC or “Commission”) issued an order affirming an Administrative Law Judge’s (ALJ) Initial Decision finding that BP America (“BP”) and certain affiliated entities...more
The recently released revised consultation draft of the Capital Markets Act (CMA) for the proposed Cooperative Capital Markets Regulatory System (Cooperative System) includes changes to the proposed rules around regulatory...more