The Centers for Medicare & Medicaid Services (CMS) recently released data on its 2023 settlements of voluntary self-disclosures related to past violations or potential violations of the physician self-referral law (the Stark Law). In 2023, CMS settled an agency record 176 self-disclosures, with settlement amounts totaling over $12,000,000 in the aggregate. Both totals exceeded its
OIG Plans New Guidance for Medicare Advantage and Nursing Homes
On Feb. 21, the Office of Inspector General of the U.S. Department of Health and Human Services announced the first four subsectors for which it will publish industry segment-specific compliance program guidance. Guidance published in 2024 will focus on Medicare Advantage and nursing facilities. Subsequent guidance will focus on hospitals and clinical laboratories.
Deputy Attorney General Monaco Announces New DOJ Whistleblower Program
On March 7, 2024, U.S. Deputy Attorney General Lisa Monaco gave remarks at the American Bar Association’s 39th National Institute on White Collar Crime in San Francisco, California. Monaco provided updates on the U.S. Department of Justice’s (DOJ or the Department) corporate criminal enforcement efforts and announced a handful of new Department initiatives, including a
Federal District Court Declares Corporate Transparency Act (CTA) Unconstitutional
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