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Enforcement Actions Risk Management Healthcare

Sheppard Mullin Richter & Hampton LLP

Potential False Claims Act Liability for Providers of Gender-Affirming Care for Minors

On July 9, 2025, the U.S. Department of Justice (“DOJ”) announced it sent more than 20 subpoenas to physicians and clinics involved in providing gender-affirming care to minors, and that the subpoenas related to...more

Greenbaum, Rowe, Smith & Davis LLP

Navigating New Jersey’s Medical Spa Regulatory Landscape: Key Compliance and Risk Management Considerations

The medical spa industry is thriving, but with growth comes complexity, particularly in New Jersey where healthcare and professional licensing rules intersect with business and real-estate regulations. For physicians, nurses,...more

White & Case LLP

DOJ and HHS Relaunch False Claims Act Working Group, Sharpen Healthcare Enforcement Priorities

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On July 2, 2025, the U.S. Department of Justice (DOJ) and the Department of Health and Human Services (HHS) jointly announced the reestablishment of the DOJ-HHS False Claims Act (FCA) Working Group. While the two agencies...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

King & Spalding

CMS Expands Auditing of Medicare Advantage Plans

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On May 21, 2025, CMS announced that it plans to increase its auditing efforts for Medicare Advantage (MA) plans. Effective immediately, CMS will audit all eligible MA contracts for each payment year in all newly initiated...more

Dentons

Ep. 63 – Speaking Fees and Safe Harbors: Lessons from a $202M AKS Settlement

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In April, a pharmaceutical manufacturer agreed to pay a $202 million settlement to resolve allegations of Anti-Kickback Statute (AKS) violations. At the heart of the case were speaker programs, where physicians and...more

Proskauer - Health Care Law Brief

CMS to Immediately Begin Auditing Medicare Advantage Plans in Significant Expansion of Enforcement Efforts

On May 21, 2025, the Centers for Medicare and Medicaid Services (“CMS”) announced a significant expansion of its auditing efforts with respect to Medicare Advantage (“MA”) plans....more

Warner Norcross + Judd

OCR Enforcement Intensifies: Key Takeaways on Risk Analysis and Right of Access

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The Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services has renewed its focus on two critical areas of HIPAA compliance: risk analysis and individual right of access. These enforcement...more

Arnall Golden Gregory LLP

Step by Step: FDA Cracks Down on Unauthorized Medical Device Modifications

The Food and Drug Administration recently issued a Warning Letter concerning unauthorized modifications made to a previously cleared medical device (i.e., 510(k)). ...more

Gardner Law

Why Compliance Audits Are Non-Negotiable

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In today’s heightened enforcement environment, compliance auditing isn’t just a best practice—it’s a necessity. Federal and state laws and industry guidance, including the Office of Inspector General (OIG) Compliance Program...more

Robins Kaplan LLP

Settlement Highlights Issue of Deliberate Indifference Involving Medical Need in Jails

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A recent $2.75 million settlement by Robins Kaplan LLP has drawn attention to a troubling case of deliberate indifference to medical needs at Anoka County Jail (the “Jail”). Deyonta Green, who struggled with addiction issues,...more

Thomas Fox - Compliance Evangelist

Daily Compliance News: March 20, 2025, The Fluid Edition

Welcome to the Daily Compliance News. Each day, Tom Fox, the Voice of Compliance, brings you compliance-related stories to start your day. Sit back, enjoy a cup of morning coffee, and listen to the Daily Compliance News—all...more

Mintz - Health Care Viewpoints

FDA’s Backup LDT Enforcement Method: Specimen Collection Kits

We have written at length about the U.S. Food and Drug Administration’s (FDA’s) actions to promulgate regulations specifying the agency’s authority to regulate laboratory developed tests (LDTs) as medical devices and to phase...more

Dentons

Ep. 51 – Building Effective Compliance Committee Agendas

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Many healthcare organizations understand the importance of having a Compliance Committee but some struggle to use their committee effectively. The key to ensuring the Compliance Committee is effective is building smart...more

Morrison & Foerster LLP

China Issues First Compliance Guidelines to Combat Commercial Bribery Risks - UPDATED February 2025

On January 10, 2025, China’s State Administration for Market Regulation (“SAMR”) put into effect its Compliance Guidelines for Healthcare Companies to Prevent Commercial Bribery Risks (“Compliance Guidelines”)....more

A&O Shearman

Zooming in on AI - #14: Enforcement of the AI Act

A&O Shearman on

The European Union Artificial Intelligence Act (AI Act) entered into force on 1 August 2024. The AI Act establishes a risk-based approach to AI, prohibiting certain practices that are deemed unacceptable, such as social...more

Shook, Hardy & Bacon L.L.P.

Capital Forum Provides Roadmap of Likely State Law Enforcement Priorities in 2025 and Beyond

The National Association of Attorneys General (NAAG) is a nonpartisan national forum for America’s state and territory attorneys general to collaboratively address issues important to their work protecting the rule of law and...more

Jones Day

China Finalizes Its First Anti-Corruption Guidelines for the Health Care and Life Sciences Industry

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On January 14, 2025, China's State Administration for Market Regulation ("SAMR"), the primary regulatory agency in China for overseeing market supervision, issued its Compliance Guidelines for Health Care Companies to Prevent...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

Health Care Compliance Association (HCCA)

Hackers Increasingly Leveraging Threats to Patients to Pressure Health Organizations to Pay Ransom

Cyberhackers—potentially frustrated by their limited ability to extort ransom from health care entities in attacks—have started extorting the patients themselves, threatening them with the release of information or...more

Brooks Pierce

Business Associate Victim of Ransomware Attack Pays $100,000 to HHS OCR

Brooks Pierce on

Is your organization a business associate? You could be subject to enforcement action if you fail to protect health information within your control from ransomware attacks. In October, for the first time, the U.S....more

McDermott Will & Schulte

For the General Counsel’s Desk: Managing Enforcement Risks Involving Cookies, Pixels, and Other Tracking Technologies

Data governance is a mission-critical issue for every company and institution in the United States. GCs face a host of pressing cybersecurity concerns. Triaging them requires time, attention, and a well-rounded strategy...more

Butler Snow LLP

Cybersecurity: What Businesses Need to Know

Butler Snow LLP on

Cybersecurity is a top concern for all industries, particularly for the pharmaceutical and medical device industries. These industries hold some of the most sensitive data and highly valuable technology, making them prime...more

Polsinelli

Ten Individuals Charged in Business Email Compromise Scheme Targeting Medicare, Medicaid and Other Insurers

Polsinelli on

On November 18, 2022, the U.S. Department of Justice (“DOJ”) announced charges against ten defendants across Georgia, South Carolina and Virginia, resulting from a scheme that allegedly targeted Medicare, state Medicaid...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

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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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