Recently, in United States ex rel. Kyer v. Thomas Health Systems, the judge overseeinga whistleblower’s False Claims Act (FCA) suit against Thomas Health Systems Inc. stalled further decisions until both parties could file supplemental briefs addressing the U.S. Supreme Court’s decision in Loper Bright Enterprises v. Raimondo. The judge’s order requires the parties to articulate
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“Call Us Before We Call You”: DOJ’s New Corporate Whistleblower Awards Pilot Program
On Sept. 17, 2024, Deputy Assistant Attorney General Nicole Argentieri stressed the intense focus placed by the U.S. Department of Justice (DOJ) on incentivizing companies to maintain healthy corporate compliance programs – and highlighted key aspects of the Department’s newest enforcement tool. Speaking at the NYU School of Law’s Program on Corporate Compliance and Enforcement,
Key Takeaways From McGuireWoods’ Webinar on Enforcement Against PE Funds in Healthcare
On July 9, 2024, McGuireWoods partners Brett Barnett, Mindy Sauter, Mike Elliott, and Michael Podberesky conducted a solution-oriented discussion of key enforcement and compliance developments that impact private equity (“PE”) funds in healthcare. They also highlighted relevant cases regarding the government’s increased interest in compliance diligence in the PE space.
Federal District Court Finds Private-Insurer Relator Can Proceed with False Claims Action
Last month, the U.S. District Court for the District of New Jersey held that a private company, Allstate Insurance Company, could proceed with its whistleblower action against a clinical laboratory, Phoenix Toxicology and Lab Services, LLC, which allegedly submitted false claims to the federal government for medically unnecessary urine drug tests (“UDT”). See generally United
CMS Again Settles Record Stark Self-Disclosures in 2023
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
At the American Bar Association’s 39th National Institute on White Collar Crime on March 7, U.S. Deputy Attorney General Lisa Monaco provided updates on criminal enforcement efforts and announced new Department of Justice initiatives, including a new whistleblower program.
Read on for key insights into the DOJ’s recent efforts and developments in its enforcement strategy.
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
OIG’s New Compliance Guidance: 10 Action Items and Six Themes for Providers
On Nov. 6, 2023, the U.S. Department of Health and Human Services Office of Inspector General (OIG) issued its General Compliance Program Guidance for healthcare providers and other industry stakeholders. The guidance follows OIG’s previous announcement about a modernization initiative and signifies a major update to OIG’s prior approach to providing guidance on effective compliance
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