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 what is being widely viewed as a welcome breath of fresh air, the Commodity Futures Trading Commission (the Commission or CFTC) Division of Enforcement (the Division) released an advisory on February 25, detailing the...more
The clock is ticking for medical device and pharmaceutical companies to fulfill their obligations under the Physician Payments Sunshine Act (the "Sunshine Act"). With the reporting deadline of March 31 looming and CMS...more
The U.S. Department of Health and Human Services Office of Inspector General (HHS OIG) recently issued Advisory Opinion No. 24-04, which primarily addressed a Refund Program offered by a U.S. pharmaceutical company affiliate....more
Our investment funds team outline the latest developments within the investment funds market in the Cayman Islands including the updated requirements under the Beneficial Ownership Transparency Act, a reminder of obligations...more
This is part four of our examination of the European Union’s new artificial intelligence law, the (“EU AI Act”). In part one, we introduced the scope of the EU AI Act and discussed what types of AI systems are outright...more
Welcome to our fourth issue of The Health Record - our healthcare law insights e-newsletter. In this edition, we address a variety of topics including a recent SCOTUS ruling and the potential impact on CMS, issues of patient...more
The Federal Trade Commission (FTC) issued a new Final Rule (the “Rule”) on Wednesday, August 14, 2024, targeting unfair and deceptive acts or practices specifically related to consumer reviews and testimonials, allowing the...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
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
On March 1, 2024, the Northern District of Alabama Northeastern Division, in National Small Business United v. Yellen, No. 5:22-cv-1448 (N.D. Ala.), ruled the Corporate Transparency Act unconstitutional. However, the holding...more
Although the Corporate Transparency Act (“CTA”) became effective Jan. 1, 2024, in just two short months, its constitutionality was challenged in the U.S. District Court, Northern District of Alabama’s decision issued on March...more
The Corporate Transparency Act (the CTA), which became effective on January 1, 2024, was ruled unconstitutional by the U.S. District Court for the Northern District of Alabama (District Court), in the case styled National...more
On September 1, 2023, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule titled “Minimum Staffing Standards for Long-Term Care (LTC) Facilities and Medicaid Institutional Payment Transparency...more
While the initial swap dealer enforcement actions brought by the Commodity Futures Trading Commission (CFTC) focused on swap data reporting failures, recent enforcement efforts have focused on compliance with business conduct...more
On April 26, the Centers for Medicare and Medicaid Services (CMS) strengthened its enforcement of the hospital price transparency rule by implementing three new enforcement measures. These include...more
The 112th General Assembly adjourned sine die on April 28th, 2022, but many of the successful measures will become effective on July 1st. Public Chapter 1087 – one of the most weighty and intricate bills – made changes to...more
Third-Party Review Services are a Focus- On January 25, the Federal Trade Commission announced that Fashion Nova LLC will be prohibited from suppressing customer reviews of its products and required to pay $4.2 million to...more
The Centers for Medicare & Medicaid Services’ (“CMS”) message this year has been consistent – hospitals need to comply with CMS’ Hospital Transparency Rule. This rule requires hospitals and health systems to disclose a...more
In late October, the Trump Administration, through the Departments of Health and Human Services (“HHS”), the Treasury, and Labor (“Departments”), issued two different rules — one implementing the Coronavirus Aid, Relief, and...more
Report on Supply Chain Compliance 2, no. 20 (Oct. 24, 2019) - The United States Federal Trade Commission (FTC) issued a monetary penalty for “greenwashing” last month, the first such penalty imposed on a company for falsely...more
If you overheard Medicaid providers breathe audible sighs of relief on April Fool’s Day, it may be because on April 1, 2019, the Health Resources & Services Administration of the Department of Health and Human Services...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