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
On April 14th, 2025, the U.S. Court of Appeals for the Seventh Circuit reversed the Anti-Kickback Statute (AKS) conviction of Mark Sorensen, the owner and operator of a Medicare-registered durable medical equipment...more
Executive Summary - - Offering equity in MSOs to physicians can be permissible but must be structured to comply with both federal and state laws. Failure to comply with applicable fraud and abuse laws may result in civil...more
In the past few months, federal prosecutors in California have brought multiple indictments under the Eliminating Kickbacks in Recovery Act (EKRA) charging the owners of substance abuse treatment facilities and their...more
On August 7, the US Department of Health and Human Services Office of Inspector General (OIG) issued Advisory Opinion No. 25-09, providing significant guidance for physician-owned medical device companies (PODs)....more
Texas Alleges That Eli Lilly Patient Assistance Programs Violates AKS - The state of Texas and Health Choice Alliance, LLC filed a complaint alleging that pharmaceutical manufacturer Eli Lilly & Company, Inc. violated the...more
Texas AG Ken Paxton has sued pharmaceutical manufacturer Eli Lilly for allegedly bribing and illegally inducing medical providers to prescribe and continue prescribing several Lilly drugs—including GLP-1 medications Mounjaro...more
On August 11, 2025, New Jersey’s Acting Governor, Tahesha Way, signed into law two bills to combat patient brokering and deceptive marketing practices in the Substance Use Disorder (“SUD”) treatment industry. The legislation,...more
It has been a busy summer for telehealth updates. Following is a high-level summary of the latest developments. On June 6, 2025, the Office of Inspector General of the U.S. Department of Health and Human Services (the “OIG”)...more
With the first half of 2025 in the rearview mirror, the government’s continued focus on False Claims Act (FCA) enforcement shows no signs of slowing. In fact, the Department of Justice recently announced the results of a...more
Our Health Care Litigation Team discusses a District of Massachusetts case holding that allows the government to switch liability theories in its False Claims Act lawsuit against Regeneron Pharmaceuticals....more
Regeneron Court Permits Government to Pursue False Certification Theory - On August 4, the district court in the closely watched Regeneron case granted the government’s request to file a second partial summary judgment...more
The federal government has demonstrated that it is more than willing to use the United States criminal code to prosecute home care agencies that pay unlawful financial inducements to generate referrals in violation of the...more
Since its enactment in 2018, the Eliminating Kickbacks in Recovery Act (EKRA) has rapidly gained momentum as a powerful tool against healthcare kickbacks. By 2020, the US Department of Justice (DOJ) had already secured its...more
The Ninth Circuit recently affirmed two decisions that provide additional guidance regarding how arrangements with marketing agents implicate and violate the Eliminating Kickbacks in Recovery Act, 18 U.S.C. § 220(a)(EKRA)....more
On July 7, 2025, the Office of Inspector General (“OIG”) for the Department of Health and Human Services published Advisory Opinion 25-08 (“AO 25-08”), an unfavorable and strongly worded opinion interpreting the “arranging...more
On July 16, 49 attorneys general (AGs) announced that they joined a $202 million settlement with Gilead Sciences, Inc. (Gilead). Previously announced by the Department of Justice in April, the settlement resolved allegations...more
On July 22, 2025, the Fourth Circuit published its opinion in United States v. Donald Booker, No. 23-461, affirming a 200-month prison sentence for the owner of United Youth Care Services, which billed North Carolina’s...more
The United States Department of Health and Human Services, Office of Inspector General (“OIG”) recently released two unfavorable advisory opinions, OIG Advisory Opinion No. 25-04 and -08 (the “Opinions”) to medical device...more
In a matter of first impression, the Ninth Circuit Court of Appeals interpreted the scope of the 2018 Eliminating Kickbacks in Recovery Act (EKRA) in the context of a lab operator who allegedly paid marketers to induce...more
On July 28, the federal district court in the Southern District of Ohio issued a pair of orders in related whistleblower cases under the False Claims Act (FCA): United States ex rel. Murphy v. TriHealth, Inc., et al., No....more
The US Department of Justice (DOJ) and the US Department of Health and Human Services (HHS) recently announced the relaunch of the DOJ-HHS False Claims Act Working Group, intended to “strengthen[] [the agencies’] ongoing...more
The False Claims Act continues to be one of the most commonly used weapons in the government’s enforcement arsenal to address various forms of fraud. In addition to our “Year in Review” publication providing an overview of...more
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
On July 17, the offices of Senators Durbin (D. IL.), Warren (D. MA.), Sanders (I. VT.), and Welch (D. VT.) (collectively, “Senators”) released a report summarizing the results of a nine month investigation into...more
On May 23, 2025, Minnesota Governor Tim Walz signed the Human Services omnibus policy bill into law, which included in part, the addition of a new statutory provision in the state’s criminal code, Chapter 609....more