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Healthcare Penalties

Paul Hastings LLP

New Mini-HSR Laws Take Effect This Summer

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Starting Sunday, July 27, 2025, any party to an M&A transaction that triggers a federal Hart-Scott-Rodino (HSR) Act filing must also submit a copy to the Washington attorney general if the filing party (1) maintains a...more

A&O Shearman

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

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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

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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

BakerHostetler

State-Level Merger Scrutiny Grows: Washington, Colorado Lead Expansion of State Premerger Notification Laws

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Earlier this year, Washington state enacted a version of the nascent Uniform Antitrust Pre-Merger Notification Act (the Uniform Act), which is slated to take effect on July 27....more

Cranfill Sumner LLP

Navigating Stark Law and the Anti-Kickback Statute (AKS) in 2025: A Snapshot Guide for Medical Practices

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In today’s healthcare environment, compliance with federal regulations is more than a legal necessity—it’s a cornerstone of ethical and sustainable practice management. Two of the most critical laws that medical practices...more

ArentFox Schiff

Investigations Newsletter: Federal Court Imposes Nearly $1 Billion in FCA Damages and Penalties Against Omnicare and CVS

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Federal Court Imposes Nearly $1 Billion in FCA Damages and Penalties Against Omnicare and CVS - On July 7, Southern District of New York District Judge Colleen McMahon increased a False Claims Act (FCA) judgment from $136...more

Morrison & Foerster LLP

NIS 2: Strengthening Europe’s Cyber Defenses

European cybersecurity risk management and reporting obligations have received a substantial facelift. The Directive (EU) 2022/2555 on measures for a high common level of cybersecurity across the EU (“NIS 2”) became effective...more

Awatif Mohammad Shoqi Advocates & Legal...

Medical Negligence And Its Liabilities Under UAE Law

Medical practitioners form one of the most important professions in the world. The significance of this profession results in a high number of responsibilities on individuals in the medical field. The UAE Government has...more

Troutman Pepper Locke

Virginia's Protection of Reproductive Health Information Law – Part One, Scope, Applicability, and Penalties

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In Part One of this FAQ series, we break down Virginia's Senate Bill 754, Consumer Protection Act; prohibited practices, etc., reproductive or sexual health information (Act), which amends the Virginia Consumer Protection Act...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

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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

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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

Katten Muchin Rosenman LLP

Have You Done Your Part to Comply with Part 2 Changes?

Important changes are coming to 42 CFR Part 2 (Part 2), which deals with the confidentiality of patients’ substance use disorder (SUD) records. On April 16, 2024, the US Department of Health and Human Services (HHS) published...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

King & Spalding

Texas Bills Introduce New Requirements for Healthcare Transactions

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On February 12, 2025, the Texas House of Representatives introduced Texas House Bill 2747 (H.B. 2747), which requires healthcare entities to submit written notice to the Texas attorney general ninety days prior to a material...more

Fox Rothschild LLP

Don’t Get Tripped Up by the San Francisco HCSO and FCO

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If you do business in the city of San Francisco pay attention. Certain employers are covered by the Health Care Security Ordinance (HCSO) and/or the Fair Chance Ordinance (FCO), and are required to submit an annual reporting...more

Arnall Golden Gregory LLP

A Constitutional Perspective on False Claims Act Penalties: District Court Finds That Penalties Conflict With Constitution’s...

In a potential watershed decision issued on February 26, 2025, the United States District Court for the Northern District of Texas ruled, in U.S. ex rel. Taylor v. Healthcare Associates of Texas, that the civil penalties...more

Quarles & Brady LLP

Alabama Bill Rewriting Pharmacy Practice Act Clears Senate Hurdle

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As detailed in our February 24, 2025 update, House Bill 123 continues the operations of the Alabama Board of Pharmacy (“the Board”) until October 1, 2026, with changes to the Board’s structure, operations, and practices....more

Jones Day

Federal Court Rejects False Claims Act's Draconian Penalties

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Following a jury's verdict, a federal court slashed civil penalties under the False Claims Act ("FCA") as violative of the Constitution's 8th Amendment....more

Kerr Russell

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

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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

Bradley Arant Boult Cummings LLP

False Claims Act: 2024 Year in Review

Bradley’s Government Enforcement and Investigations Practice Group is pleased to present the False Claims Act: 2024 Year in Review, our annual review of significant False Claims Act (FCA) cases, developments and trends. ...more

Proskauer - Health Care Law Brief

Spurred on by the Steward Health Care Bankruptcy, Massachusetts Adopts Bill Regulating Private Equity and REITs in Health Care,...

On January 8, 2025, Massachusetts Governor Maura Healey signed into law House Bill 5159 (the “Bill”). The Bill grants the state new regulatory powers to oversee and review health care transactions involving private equity...more

Jones Day

CMS Finalizes The Increasing Organ Transplant Access Model

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The Increasing Organ Transplant Access Model ("IOTA Model") introduces mandatory financial incentives and penalties for selected kidney transplant hospitals....more

Mitratech Holdings, Inc

ACA Reporting Deadlines for 2025: What You Need to Know

Understanding reporting rules for the Affordable Care Act (ACA) is more than a best practice. It’s a legal imperative. If your reports aren’t timely and accurate, you face penalties....more

Stinson LLP

Less Paperwork, More Peace of Mind: New ACA Laws Lighten Employers' Reporting Load

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On December 23, 2024, President Biden signed into law two important pieces of legislation, the Paperwork Burden Reduction Act (Reduction Act) and the Employer Reporting Improvement Act (Reporting Act), that aim to ease the...more

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