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Enforcement Compliance Healthcare

ArentFox Schiff

Navigating OIG’s Advisory Opinion on Medical Device Billing Arrangements and Anti-Kickback Statute Risks

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On July 1, the US Department of Health and Human Services’ Office of Inspector General (OIG) released Advisory Opinion No. 25-08, issuing an unfavorable determination regarding a proposed arrangement in which a medical device...more

DLA Piper

China Releases First-of-its-kind Compliance Case Handbook for Life Sciences Companies

DLA Piper on

The Shanghai Administration for Market Regulation (AMR) has released a set of illustrative sample cases under the Compliance Guidelines for Pharmaceutical Companies to Prevent Commercial Bribery Risks (《医药企业防范商业贿赂风险合规指引》)...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

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

Sheppard Mullin Richter & Hampton LLP

The One Big Beautiful Bill Act’s Proposed Moratorium on State AI Legislation: What Healthcare Organizations Should Know

Congress is weighing a sweeping proposal that could significantly reshape how artificial intelligence (AI) is regulated across the United States. At the end of May, the United States House of Representatives passed, by a vote...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

Verrill

Healthcare Costs Demystified: Trump's New Executive Order on Healthcare Price Transparency Explained

Verrill on

President Trump’s Executive Order 14224 reinforces and expands a 2019 Executive Order which aimed to improve healthcare price transparency. On February 25, 2025, President Trump signed a new 2025 Executive Order entitled...more

Akin Gump Strauss Hauer & Feld LLP

Making America Healthy Again By Empowering Patients With Clear, Accurate, and Actionable Healthcare Pricing Information (Trump EO...

The EO announces a policy of the United States to put patients first and ensure they have the necessary information to make well-informed healthcare decisions. The order builds upon Executive Order 13877 (Improving Price and...more

McDermott Will & Schulte

This Week in 340B: January 14 – 20, 2025

Find this week’s updates on 340B litigation to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick...more

Gardner Law

Sunshine Act Compliance: How to Take Action to Meet Reporting Requirements and Avoid Costly Penalties

Gardner Law on

The clock is ticking for medical device and pharmaceutical companies to fulfill their obligations under the Physician Payments Sunshine Act (the "Sunshine Act"). With the reporting deadline of March 31 looming and CMS...more

McDermott Will & Schulte

Massachusetts H.5159 Seeks to Reshape Private Equity in Healthcare

On December 30, 2024, both the Massachusetts House of Representatives and the Massachusetts Senate enacted House Bill 5159 (H.5159), and Governor Maura Healey signed it on January 8, 2025. The bill seeks to strengthen...more

Ropes & Gray LLP

Massachusetts Passes Act Implementing Broad Oversight into For-Profit Investment in Health Care

Ropes & Gray LLP on

On January 8, 2025, Massachusetts Governor Maura Healey signed House Bill 5159, An Act Enhancing the Market Review Process (the “Act”) into law, effective April 8, 2025. The Act is a compromise redraft of the separate health...more

McCarter & English Blog: Government Contracts...

Antitrust Corporate Compliance Programs: Late 2024 Changes Mean Companies Should Revisit Their Programs Early in 2025

The US Department of Justice Antitrust Division (DOJ or Division) recently released a revised Evaluation of Corporate Compliance Programs in Criminal Antitrust Investigations (Guidance). The Guidance reflects how the Division...more

Pietragallo Gordon Alfano Bosick & Raspanti,...

Second Circuit Expands Anti-Kickback Statute Liability: “At Least One Purpose” is Enough

In a significant ruling, the Second Circuit Court of Appeals recently expanded the scope of the Anti-Kickback Statute (AKS).The Court joined other circuit courts across the country in adopting, for the first time, the...more

ArentFox Schiff

FCA Enforcement & Compliance Digest — Fall 2024 False Claims Act Newsletter

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Welcome to the Fall 2024 issue of “FCA Enforcement & Compliance Digest,” our quarterly newsletter in which we compile essential updates on False Claims Act (FCA) enforcement trends, litigation, agency guidance, and compliance...more

Health Care Compliance Association (HCCA)

Explore the how and the why

Anytime a compliance violation occurs—or even a breakdown in compliance controls that doesn’t ultimately result in noncompliance—the remediation process takes center stage. And this is where questions of how and why are...more

NAVEX

Healthcare Organizations are Facing Increased Scrutiny – Here's What You Need to Know

NAVEX on

2024 is shaping up to be a very active year for regulatory and enforcement developments in the healthcare industry – developments that concern not just hospitals and nursing facilities, but many non-healthcare companies as...more

NAVEX

Addressing Cybersecurity Expectations in Healthcare

NAVEX on

2024 is shaping up to be a very active year for regulatory and enforcement developments in the healthcare industry – developments that concern not just hospitals and nursing facilities, but many non-healthcare companies as...more

Gardner Law

Highlights from OIG’s New Compliance Program Guidance

Gardner Law on

The U.S. Department of Health and Human Services Office of Inspector General (HHS OIG) released an important new compliance resource in November 2023. The HHS OIG’s new General Compliance Program Guidance (GCPG) is intended...more

NAVEX

Healthcare Compliance Enforcement Trends to Watch in 2024

NAVEX on

2024 is shaping up to be a very active year for regulatory and enforcement developments in the healthcare industry – developments that concern not just hospitals and nursing facilities, but many non-healthcare companies as...more

Foley & Lardner LLP

Health-Care Fraud Scrutiny Heats Up For Companies, Providers

Foley & Lardner LLP on

This year will see a continued proliferation of enforcement against health-care fraud, with old and new theories. Some hot spots for enforcement will involve cases about new technologies; data outliers; entities perceived as...more

Davis Wright Tremaine LLP

Washington's 'Safe Staffing Bill' – What All Healthcare Employers Should Know

Most Washington hospitals will soon be subject to a sweeping 30-page "Safe Staffing Bill" (Bill 5236), aimed at strengthening workplace standards. Starting January 1, 2024, covered hospitals, which is broadly defined to...more

Foley & Lardner LLP

Collusion & Competition: What Antitrust Means for AI in Health Care

Foley & Lardner LLP on

Health care companies are increasingly using artificial intelligence (AI) to create innovations, set prices, and compete with rivals. At the same time, federal and state antitrust enforcers are finding new ways to apply...more

Foley & Lardner LLP

Key Takeaways from the Foley/PYA “Let’s Talk Compliance” 2-Day Virtual Conference

Foley & Lardner LLP on

Session #1: State of the Healthcare Industry Effective Compliance Plans and Enforcement Trends - In their discussion of compliance program effectiveness and enforcement, attorneys Kolarik and Waltz and Ms. Sumner...more

Troutman Pepper Locke

State of the Law: Contours of State False Claims Acts and How to Stay Out of Harm’s Way - Regulatory Oversight Podcast

Troutman Pepper Locke on

In this episode of Regulatory Oversight, Stephen Piepgrass welcomes Regulatory Investigations, Strategy + Enforcement Partner Amy Williams and Health Sciences Partner Asher Funk to discuss the similarities and differences...more

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