From the Editor’s Desk: Compliance Week’s Insights and Reflections from July to August 2025
AI and the False Claims Act
False Claims Act Insights - Bitter Pills: DOJ Targets Pharmacies for FCA Enforcement
Hospice Insights Podcast - Election Inspection: Be Proactive to Avoid Costly Election Statement Denials
The Trend of Threatening Physicians for Personal Gain
Daily Compliance News: June 17, 2025, The JBS Goes Public Edition
False Claims Act Insights - Will Recent Leadership Changes Lead to FCA Enforcement Policy Changes?
Daily Compliance News: June 16, 2025, The Golden Share Edition
Hospice Insights Podcast - Still Number One: Healthcare Fraud Remains Central in DOJ’s White Collar Enforcement Plan
False Claims Act Insights - How Payment Suspensions Can Impact FCA Litigation
Daily Compliance News: May 16, 2025, The Ethics Nightmare Edition
False Claims Act Insights - Trump DOJ Sharpens Its Focus on Healthcare Fraud
How Life Sciences Companies Can Create a Culture of Compliance When Expanding to the U.S. Market
False Claims Act Insights - DOJ’s Reliance on FCA to Pursue Covid-Related Fraud
UPIC Audits
Criminal Health Care Fraud Enforcement: Projections for 2025 and Beyond – Diagnosing Health Care Video Podcast
AGG Talks: Home Health & Hospice Podcast - Episode 10: Anti-Kickback Compliance for Hospice and Skilled Nursing Providers
False Claims Act Insights - Stranger Than Fiction? An FCA April Fools’ Day Episode
The Presumption of Innocence Podcast: Episode 53 - Diagnosis: Innocent – A Doctor’s Journey to Acquittal
False Claims Act Insights - Reality Checks: How to Approach Healthcare Transactions Without Triggering FCA Liability
The U.S. Court of Appeals for the First Circuit, in United States v. Regeneron, has joined the Sixth and Eighth Circuits in adopting the “but-for” standard to find that a violation of the Anti-Kickback Statute (AKS) triggers...more
Many FDA-regulated companies are exploring ways to support diagnostic testing, especially when early diagnosis can impact treatment options. However, funding diagnostic testing tied to a company’s own product raises important...more
Q: If you had 30 seconds to describe your practice, what would you say? A: I am a partner in AGG’s Litigation & Dispute Resolution practice, focusing on government investigations, white-collar defense, and commercial...more
The Department of Health and Human Services, Office of Inspector General (“OIG”) recently released a favorable advisory opinion, OIG Advisory Opinion No. 24-13 (the “Opinion”) to a pharmaceutical manufacturer (the...more
The Department of Health and Human Services, Office of Inspector General (“OIG”) recently released a favorable advisory opinion, OIG Advisory Opinion No. 24-11 (the “Opinion”), to a pharmaceutical manufacturer (the...more
At the end of December, the Second Circuit joined several other circuit courts in holding that a plaintiff adequately pleads an Anti-Kickback Statute (“AKS”) violation when she states with the requisite particularity that at...more
DOJ Secures Plea in $50 Million Medicare Fraud and Kickback Scheme - On April 26, the US Department of Justice (DOJ) announced that Manishkumar Patel pleaded guilty to charges related to a $50 million health care fraud and...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
The year 2023 was a busy one for regulatory, compliance, and enforcement developments in the healthcare and life sciences industries, and 2024 promises to be even busier. We tapped MoFo’s Life Sciences + Healthcare Compliance...more
On November 6, 2023, the US Department of Health and Human Services (HHS) Office of Inspector General (OIG) published the General Compliance Program Guidance (GCPG) as a revised reference guide for the healthcare compliance...more
We are pleased to bring you our 11th annual Healthcare Fraud & Abuse Review. Our Review provides comprehensive coverage of the most significant civil and criminal enforcement issues facing healthcare providers. Each year, we...more
Clinical laboratories have come under increased scrutiny in the past few years, especially those that deal with COVID-19 testing or drug testing. These federal investigations can be surprising and confusing for lab...more
From new fraud and abuse rules, to telehealth and tax legislation to health care privacy and private equity in the healthcare space, a lot has changed in health law over the past year. Please join us for a two-day virtual...more
William F. Gould In United States v. Merino, No. 19-50291, 2021 WL 754589 (9th Cir. Feb. 26, 2021), the court of appeals reversed the conviction of Marina Merino of conspiracy to commit healthcare fraud in violation of 18...more
Over the past month or so, our Health Care Team has published a number of posts examining important developments and trends in health law and policy during 2019, as well as providing some thoughts on what we expect to see in...more
In December, my colleague Aaron Josephson and I described our observations after attending FDA’s public workshop on Medical Device Servicing and Remanufacturing Activities. In this post, I want to share some additional...more
Enforcement - OIG Issues Advisory Opinion on Provision of Samples by a Device Distributor - On April 30, 2018, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued a...more
A LOOK BACK... A LOOK AHEAD - While the uncertainty associated with legislative efforts to repeal the Patient Protection and Affordable Care Act (PPACA) dominated most of the headlines for the healthcare industry last year,...more