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Healthcare Compliance

Sheppard Mullin Richter & Hampton LLP

Inside the Ninth Circuit’s Interpretation of EKRA: Clarity for Kickback Law

On July 11, 2025, in United States v. Schena,[1] the Ninth Circuit adopted an expansive interpretation of the Eliminating Kickbacks in Recovery Act (EKRA), applying the law to any payment that could have the effect of...more

White & Case LLP

New EU Responsibility and Liability Landscape for Smart Medical Devices in a Global Context

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Artificial intelligence (AI) is already indispensable in the healthcare and life sciences sector. Intelligent medical devices promise nothing less than a revolution in the art of healing. With its legislative projects on AI...more

NAVEX

AI in Healthcare: Why Compliance Can’t Afford to Fall Behind

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The healthcare sector is rapidly embracing artificial intelligence (AI), from predictive diagnostics and clinical decision support to patient engagement and operational automation. With this innovation comes an urgent...more

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

Cozen O'Connor

The State AG Report – 07.17.2025

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Here are curated AG and federal regulatory news stories highlighting key areas in which state and federal regulators’ decisions are having an impact across the US: •Democratic AGs Oppose Washing Away Appliance Efficiency...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

Health Care Compliance Association (HCCA)

Federal Judge in Change Class Actions Juggling 90 Cases, Found ‘Misconduct’ by UnitedHealth

In the 18 months since the Change Healthcare breach occurred, class action suits—filed by both patients and providers—continue to multiply, with no resolution yet in sight. In fact, in late June, the Minnesota judge presiding...more

Husch Blackwell LLP

OIG Announces 2025 Work Plan Review: What Clinical Laboratories Need to Know About Medicare Payments for Diagnostic Lab Tests

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In June 2025, the U.S. Department of Health and Human Services Office of Inspector General (OIG) announced a new item in its Work Plan: “Medicare Payments for Clinical Diagnostic Laboratory Tests in 2024.” This annual review,...more

Dentons

Ep. 70 – Use Caution Before Charging Patients Extra Fees

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As healthcare providers face mounting administrative burdens and tighter reimbursement rates, some are exploring the idea of charging patients for “extra” services, such as administrative tasks or added “perks.” But before...more

Gardner Law

LDT Rule Vacated: FDA Backs Down, but Uncertainty Remains

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In December 2024, we published an alert highlighting the FDA’s final rule on Laboratory Developed Tests (LDTs) and the compliance countdown to May 2025. The rule, issued in May 2024, sought to phase out the agency’s...more

Sheppard Mullin Richter & Hampton LLP

Countdown to 2026: What Will the Texas AI Law Mean for Businesses?

Texas is getting into the AI action, with a new law (the Texas Responsible Artificial Intelligence Governance Act) that will place restrictions not only on AI use by government agencies, but businesses as well. In particular,...more

Foley & Lardner LLP

Episode 36: Let’s Talk Compliance: The Risks and Pitfalls of Health Care Supply Chain Compliance

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In this episode, Monica Chmielewski, vice chair of Foley’s Health Care Practice Group and Shannon Sumner, Chief Compliance Officer and Nashville’s Office Managing Principal of PYA explore how supply chain compliance is...more

DLA Piper

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

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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

Polsinelli

HCBS Update: Indiana Implements Home-Grown 70/30 Direct Caregiver Compensation Requirement

Polsinelli on

Executive Summary: On July 10, 2025, Indiana Medicaid issued guidance to providers of attendant care and structured family caregiver services requiring providers to pass through a specific percentage of their Medicaid...more

Woods Rogers

Federal Court Strikes Down HIPAA Reproductive Health Privacy Rule Lifting Compliance Requirements for Regulated Entities

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In a sweeping decision published in June, a federal court in Texas struck down most of the HIPAA Rule to Support Reproductive Health Care Privacy (Reproductive Health Rule) enacted in 2024 under the Biden administration to...more

Foley & Lardner LLP

Colorado Medicaid: RAC Program Overhauled with Enhanced Transparency, Greater Provider Protections, and Increased Oversight

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In June 2025, Colorado passed a new law that makes significant changes to the state’s Medicaid Recovery Audit Contractor (RAC) program. Colorado has one of the most aggressive RAC programs in the country that has been rife...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

Epstein Becker & Green

New OIG Advisory Opinion Approves Manufacturer’s Warranty for Injuries Caused by Medical Device

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On June 30, 2025, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services posted Advisory Opinion 25-05 (AO 25-05) to its website....more

ArentFox Schiff

Investigation Newsletter: DOJ and HHS Emphasize Continued, Robust, and Coordinated Health Care Enforcement with Revival of False...

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The government has announced a renewed and expanded focus on False Claims Act (FCA) enforcement, doubling down on traditional health care priorities like kickbacks and drug pricing while signaling increased scrutiny of...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

Skadden, Arps, Slate, Meagher & Flom LLP

OIG Issues Unfavorable Advisory Opinion: Provision of Free Services to Referral Sources Creates Kickback Risk

Key Points - - The Office of Inspector General of the Department of Health and Human Services (OIG) has issued Advisory Opinion No. 25-04 (AO 25-04), its first advisory opinion of the year addressing a proposed arrangement...more

Robinson+Cole Data Privacy + Security Insider

Mastering Information Governance with the ARMA IGIM 2.1 Framework: Part 2 – Building the Foundation

Last week, we introduced you to the ARMA IGIM Framework. What’s next? Every successful Information Governance (IG) program starts with a strong base....more

Dentons

Ep. 68 – Before You Audit—Why Pre-Audit Planning Matters

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If you’re preparing to launch an audit within your healthcare organization, pause for a moment and consider this: how well you plan before the audit begins can significantly affect the outcome—and your risk exposure. This...more

Foley & Lardner LLP

AI-Powered Text Messaging by Digital Health Companies: Supreme Court Raises the Stakes

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Share on Twitter Share by Email Share Back to top Digital health companies increasingly rely on AI-powered messaging platforms, chatbots, and virtual assistants to engage patients through text and voice. However, a June 2025...more

Jackson Lewis P.C.

When Minor Variations in Prompts Lead to Problematic Outputs

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The Senate recently voting 99-1 to remove a 10-year moratorium on state regulation of AI says something about the impact of AI, but also its challenges. A new MIT study, presented at the ACM Conference on Fairness,...more

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