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
China’s Supreme People’s Court is stepping up enforcement against medical insurance fraud, with severe penalties and a focus on protecting public healthcare funds. Recent cases show fraud schemes ranging from hospital-level...more
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
On July 11, 2025, in United States v. Schena, the U.S. Court of Appeals for the Ninth Circuit issued the first appellate decision interpreting the Eliminating Kickbacks in Recovery Act (“EKRA”). The decision marks a...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
Often there is a lot of attention paid to the Centers for Medicare & Medicaid Services (“CMS”) Inpatient Prospective Payment System (“IPPS”), Outpatient Prospective Payment System (“OPPS”), and Medicare Physician Fee Schedule...more
In a qui tam action filed under the False Claims Act, the relator, Barbara Senters, appealed the district court’s dismissal of her fourth amended complaint (FAC), which alleged that Quest Diagnostics submitted false claims...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
The U.S. Department of Health and Human Services Office of Inspector General (OIG) has recently issued two audit reports revealing substantial improper Medicaid fee-for-service (FFS) payments for Applied Behavior Analysis...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
As Holland & Knight previously reported, since its enactment in 2018, the Eliminating Kickbacks Recovery Act (EKRA) has been a source of anxiety and confusion for the clinical laboratory and behavioral health industries in...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
The US Department of Justice’s settlement with Illumina, Inc. is a first-of-its-kind involving alleged cybersecurity deficiencies causing violations of the False Claims Act (FCA) based on FDA quality standards. The...more
On July 17, 2025, the U.S. Court of Appeals for the Fourth Circuit held that a federal district court was “within bounds to order a do-over” in the case of Ron Elfenbein, a Maryland doctor who was found guilty of...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
In June 2025, the Department of Justice (DOJ) announced its 2025 National Health Care Fraud Takedown, marking the largest coordinated healthcare fraud enforcement action in DOJ history. The sweep included charges against a...more
On July 31, the U.S. Department of Justice (DOJ) announced a settlement in United States ex rel. Lenore v. Illumina, Inc, the first case in which underlying cybersecurity issues formed the basis of a settlement under 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
An article in the August issue of Healthcare Risk Management, “DOJ Targeting Healthcare for False Claims Act Enforcement,” discussed recent enforcement activity by the U.S. Department of Justice (DOJ) under the False Claims...more
Much has been written about the healthcare policy changes implemented by the 2025 Trump administration. President Trump has issued numerous Executive Orders that establish new policies and rescind actions taken by previous...more