HHS Policy Changes, Supreme Court Rulings, and the DOJ-HHS False Claims Act Working Group
New DOJ Memo Warns Employers: Rethink DEI Programs Now - #WorkforceWednesday® - Employment Law This Week®
Compliance into the Weeds: Two Cyber Security Cases for the Compliance Professional
False Claims Act Insights - Beyond Adversarialism: How to Steer FCA Investigations
Work This Way: A Labor & Employment Law Podcast | Compliance Clarity for Federal Contractors with Joan Moore and Mim Munzel of Arbor Consulting Group
Great Women in Compliance: LATAM Compliance Update with Alejandra Montenegro Almonte
AI and the False Claims Act
False Claims Act Insights - The Mathematics of Nuclear FCA Verdicts
Episode 379 -- Update on False Claims Act and Customs Evasion Liability
Everything Compliance: Episode 157, The Q2 2025 Great Women in Compliance Edition
Great Women in Compliance: The Compliance Influencer with Bettina Palazzo
Blowing the Whistle: What Employers Should Know About DEI & the False Claims Act
When DEI Meets the FCA: What Employers Need to Know About the DOJ’s Civil Rights Fraud Initiative
False Claims Act Insights - Bitter Pills: DOJ Targets Pharmacies for FCA Enforcement
False Claims Act Insights - Will Recent Leadership Changes Lead to FCA Enforcement Policy Changes?
Enforcement Priorities of the Second Trump Administration: The False Claims Act
Episode 372 -- DOJ Applies False Claims Act to Tariff and Trade Violations
False Claims Act Insights - How Payment Suspensions Can Impact FCA Litigation
False Claims Act Insights - Trump DOJ Sharpens Its Focus on Healthcare Fraud
False Claims Act Insights - DOJ’s Reliance on FCA to Pursue Covid-Related Fraud
The Centers for Medicare & Medicaid Services (CMS) recently published its Proposed 2026 Physician Fee Schedule Rule (Proposed Rule), with extensive implications for drug pricing, Average Sales Price (ASP) calculations, and...more
On this Ropes & Gray podcast, health care partner Michael Lampert and counsel Sam Perrone, and litigation & enforcement partner Andrew O’Connor, rejoin to discuss patient assistance programs, recent enforcement actions, and...more
Last month, the United States Department of Justice (“DOJ”) issued its “Civil Division Enforcement Priorities” memorandum, memorializing a shift from its predecessor administration’s policy on gender‑affirming healthcare...more
The US Food and Drug Administration (FDA) is confronted with significant challenges in its inspection processes due to recent layoffs. Among other effects, the latest reduction in force of full-time FDA employees is raising...more
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
Pharmaceutical company sponsorship of diagnostic testing remains an area with a gaping divide between the views of regulators and industry, with regulators focused on potential fraud and abuse concerns while industry...more
On 18 February 2025, the First Circuit Court of Appeals issued its decision in United States v. Regeneron Pharmaceuticals, Inc., determining that “but-for” causation is the proper standard for False Claims Act (FCA) actions...more
Bass, Berry & Sims is pleased to announce the release of the 13th annual Healthcare Fraud & Abuse Review examining important healthcare fraud developments in 2024. Compiled by the firm's Healthcare Fraud & Abuse Task Force,...more
“Manufacturers are responsible for meeting all four parts of the definition of bona fide service fee before a fee can qualify as a bona fide service fee.” ...more
In a closely watched appeal, the U.S. Court of Appeals for the First Circuit ruled on February 18 that to satisfy the causation requirement in False Claims Act (FCA) actions based on alleged Anti-Kickback Statute (AKS)...more
In United States v. Regeneron Pharmaceuticals, Inc., the First Circuit joined the emerging majority view that False Claims Act (FCA) claims based on violations of the Anti-Kickback Statute (AKS) require a showing of “but-for”...more
The U.S. Food and Drug Administration (“FDA”), in partnership with the Department of Justice (“DOJ”), pursued significant and, in some cases, precedent-setting enforcement actions in 2024. The government continued to...more
On January 8, the governor of Massachusetts signed House Bill 5159 into law (Law). At a high level, the new Law expands Massachusetts’ existing health care transaction notice process and implements new reporting and oversight...more
Looking for compliance education and networking in your area? HCCA’s Regional Healthcare Compliance Conferences offer practitioners convenient, local compliance education on a wide variety of current and emerging topics...more
Join Gardner Law for a half-day CLE event in person at the Capital Factory in Austin, TX or attend virtually. Prepare for the regulatory rodeo with confidence by learning how to navigate regulatory, compliance, and privacy...more
Get ready to be inspired with game-changing insights and industry connections! For over two and a half decades, healthcare compliance professionals have gathered at HCCA’s Compliance Institute (CI) to share ideas, learn...more
In this issue of our newsletter on developments impacting the life sciences industry, we examine topics including how the increased DOJ and FDA focus on cybersecurity issues could lead to new theories of False Claims Act...more
FDA law firm Gardner Law and EU-based Fieldfisher discuss regulatory, compliance, and privacy matters relevant to high-tech healthcare products. - - Harnessing AI and Connected Devices in Medical Innovation in an...more
Hear directly from the enforcement community - Want to gain insight into properly monitoring, detecting, investigating, and managing violations? Join us at HCCA’s Annual Healthcare Enforcement Compliance Conference to...more
The only conference that presents strategies and solutions for every link of the controlled substances supply chain. Attend and learn how to best conform business practices to meet industry and regulatory demands, bolster...more
Our Virtual Regional Healthcare Compliance Conferences provide updates on the latest news in regulatory requirement, compliance enforcement, and strategies to develop effective compliance programs. Watch, listen, and ask...more
The Supreme Court held that the FCA’s extended limitations period is available to relators in qui tam cases even when the government declines to intervene. Lower courts continued to divide over the first-to-file bar,...more