On March 1, 2024, the United States District Court for the Northern District of Alabama declared the Corporate Transparency Act (“CTA”) unconstitutional. Enacted as part of the Anti-Money Laundering Act of 2020, the CTA requires certain legal entities to report beneficial ownership information (“BOI”) to the U.S. Department of Treasury’s Financial Crimes Enforcement Network (“FinCEN”).
Lessons for Providers and Practice Entities: Ophthalmology Groups Pay Millions to Settle Co-Management, Optometrist Relationship Allegations
Two ophthalmology practice groups recently reached settlements with the U.S. government totaling nearly $20 million to resolve allegations that their third-party cataract arrangements violated several healthcare laws.
Read on to discover how the settlements offer guidance to vision providers with respect to the government’s focus on ophthalmology-optometry relationships, and whether the settlements’ lessons have broader
FinCEN Specifies When and How Reporting Companies May Use FinCEN Identifiers
The Corporate Transparency Act (“CTA”) was enacted in 2021 as part of the Anti-Money Laundering Act of 2020, requiring certain business entities (“Reporting Companies”) to report beneficial ownership information (“BOI”), and, for entities created or registered on or after January 1, 2024, information with respect to any individual who directly files the document creating the
$12M Default Judgment Results from Purchasing Prescriptions
A large damage award serves as a significant reminder to file an appearance in a False Claims Act (FCA) case.
In late August of 2022, the Government filed suit against AZ Diabetic and the owner, Hisham Zaghal (Zaghal), in the Eastern District of Virginia, alleging violations under the False Claims Act (FCA), stemming from over
FinCEN Extends Time to File Beneficial Ownership Information for Entities Created After January 1, 2024
The Corporate Transparency Act (“CTA”) was enacted in 2021 as part of the Anti-Money Laundering Act of 2020. The CTA requires certain business entities (“Reporting Companies”) to report beneficial ownership information (“BOI”), and, for entities created or registered on or after January 1, 2024, information with respect to any individual who directly files the document
FDA Warning Letter Declares Delta-8 and CBD Gummies ‘Adulterated Foods’
On Dec. 6, the U.S. Food and Drug Administration sent a warning letter to the owners of online hemp, tetrahydrocannabinol and cannabidiol retailer Hemp-xr.com for introducing adulterated foods into interstate commerce. FDA took issue with certain cookies, edibles, gummies and honey containing delta-8 THC and CBD because they “bear or contain an unsafe food additive.”
Life Sciences Companies Face Continuing Compliance Challenges in Developing Value-Based and Value-Added Models
The U.S. Department of Health and Human Services Office of Inspector General recently issued Advisory Opinion 23-08, continuing its long-held position that the provision of value-added items and services implicates fraud and abuse laws, including the Federal Anti-Kickback Statute and the Beneficiary Inducement Civil Monetary Penalty law.
Read on to learn how manufacturers, distributors, and
1st Circuit Rejects Convicted Former Medical Device Executives’ Off-Label “Free Speech” Theory
A federal appeals court recently upheld misdemeanor convictions of two former Acclarent Inc. executives for commercially distributing an adulterated and misbranded medical device by misleading the U.S. Food and Drug Administration regarding the device’s intended use.
Read on for details about the decision, which rejected claims that their off-label promotion amounted to constitutionally protected commercial
Off-Label “Free Speech” Theory Does Not Fly for Convicted Former Medical Device Executives in 1st Circuit
A federal appeals court recently upheld misdemeanor convictions of two former executives of Acclarent Inc, a medical device manufacturer, for commercially distributing an adulterated and misbranded medical device by misleading the FDA regarding the intended use of the device. In United States v. Facteau (89 F.4th 1 (1st Cir. 2023)) the First Circuit Court of
The Foreign Extortion Prevention Act: Another Tool to Fight Foreign Corruption
In recent years, the Biden Administration has been vocal that combatting foreign public corruption is a key pillar of its national security efforts.[1] Consistent with those policy goals, on December 22, 2023, Congress passed the Foreign Extortion Prevention Act (FEPA), a long-awaited complement to the Foreign Corrupt Practices Act (FCPA). Where the FCPA