News & Analysis as of

Enforcement Actions Penalties Healthcare

Haynes Boone

False Claims Act - 2025 Mid-Year Review

Haynes Boone on

The False Claims Act continues to be one of the most commonly used weapons in the government’s enforcement arsenal to address various forms of fraud. In addition to our “Year in Review” publication providing an overview of...more

Constangy, Brooks, Smith & Prophete, LLP

Fourth Circuit’s Steadfast ruling clarifies independent contractor status

The majority of a three-judge panel of the U.S. Court of Appeals for the Fourth Circuit has upheld a finding that a medical staffing agency misclassified approximately 1,100 nurses as independent contractors and owed them...more

A&O Shearman

European Commission fines Alchem in first cartel case involving a pharmaceutical API

A&O Shearman on

On 4 July 2025, the EC fined Alchem and its subsidiary EUR 489,000 for their role in a long-running cartel concerning the active pharmaceutical ingredient SNBB, used in the production of Buscopan and its generics. This marks...more

Venable LLP

OIG Reminds Us that Flat Fee Business Arrangements Aren’t Immune from AKS Scrutiny

Venable LLP on

On July 1, 2025, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services issued Advisory Opinion No. 25-08, concluding that a medical device manufacturer’s proposed payment to access a...more

Keating Muething & Klekamp PLL

OSHA’s Updated Inspection Program: What Employers Should Know and Expect

On May 20, 2025, the Occupational Safety and Health Administration (OSHA) updated its Site-Specific Targeting (SST) inspection program. The SST inspection program is OSHA’s primary planned inspection initiative for...more

Wiley Rein LLP

FTC Sends Warning Letters to 37 Eyeglass and Contact Lens Prescribers Over Possible Rule Violations

Wiley Rein LLP on

On June 3, 2025, the Federal Trade Commission (FTC) announced its staff had sent warning letters to 37 contact lens prescribers that, according to the FTC, were the subject of consumer complaints concerning possible...more

Dacheng

Regulatory Escalation in Pharma Sector: China Imposes First Executive Sanctions in a Cartel Case

Dacheng on

On May 9, 2025, the Tianjin Municipal Administration for Market Regulation (“Tianjin AMR”) announced administrative penalties against four manufacturers of dexamethasone sodium phosphate (“DSP”) active pharmaceutical...more

Mitchell, Williams, Selig, Gates & Woodyard,...

Air Enforcement: Missouri Department of Natural Resources and St. Louis Medical School Complex Enter into Administrative Order on...

The Missouri Department of Natural Resources (“MDNR”) and The Washington University (“WU”) entered into a May 2nd Administrative Order on Consent (“AOC”) addressing an alleged violation of an Air Permit. See No....more

Kerr Russell

The Corporate Transparency’s Act’s Impact on Medical Practices: Understanding Physicians’ Obligations Amid Recent Judicial and...

Kerr Russell on

Medical practices across the United States are grappling with new compliance obligations under the Corporate Transparency Act (CTA). This article addresses the CTA’s applicability to medical practices, its current legal...more

Health Care Compliance Association (HCCA)

Revised Privacy Rule May Not Emerge for Two Years; Info Blocking Penalty Regulation Published

Report on Patient Privacy Volume 23, no 7 (July 2023) In two public talks this spring, Melanie Fontes Rainer, director of the HHS Office for Civil Rights (OCR), said completing the 2021 proposed regulation extensively...more

DarrowEverett LLP

A HIPAA Privacy Notice A Day Keeps The Doctor Away (And Out Of Trouble)

DarrowEverett LLP on

The start of 2023 has brought with it significant changes to data privacy – new state laws concerning data privacy came into effect January 1 (the California Privacy Rights Act and the Virginia Consumer Data Protection Act),...more

Nelson Mullins Riley & Scarborough LLP

Comparison of Three Federal Fraud and Abuse Laws

In the post-COVID era, health care fraud and abuse issues will be aggressively and swiftly enforced by the government. The legal framework and regulations in the health care space can be intimidating. Below is a comparison of...more

The Volkov Law Group

FCPA Recidivists: Orthofix (Part II of II)

The Volkov Law Group on

In its continuing quest to push the message of aggressive FCPA enforcement, the SEC resolved FCPA charges against Orthofix, a medical device company, for $6 million in penalties and disgorgement. In a related action, the SEC...more

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