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
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
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
Just months after the US Department of Justice (DOJ) designated healthcare fraud as one of its key criminal enforcement priorities, two recent announcements underscore the federal government’s continued focus on combating...more
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
On Wednesday, July 2, 2025, HHS and DOJ announced a new working group focused on enforcement of the False Claims Act (“FCA”). According to the announcement, the DOJ-HHS False Claims Act Working Group (“Working Group”) is a...more
Designed for busy in-house counsel, compliance professionals, and anti-corruption lawyers, this newsletter summarizes some of the most important international anti-corruption law and enforcement developments from the past...more
In 2025, whistleblower regulations are poised for major evolution, reflecting a renewed commitment to transparency and accountability. The Ethics and Compliance Initiative (ECI) 2023 survey revealed a startling statistic:...more
On September 30, 2024, Judge Kathryn Mizelle of the U.S. District Court for the Middle District of Florida issued a noteworthy decision in United States ex rel. Zafirov v. Florida Medical Associates, LLC, holding that the qui...more
US Supreme Court Declines to Consider AKS ‘Willfulness’ Question - On October 7, the US Supreme Court denied a petition in which a whistleblower asked the Court to decide whether a “willful” act under the federal...more
A valuable tool in filing whistleblower claims against companies related to government fraud took a potentially major hit this week when a federal judge in Florida ruled that a significant portion of the statutory scheme...more
August was another robust month in international trade that further signifies the need for corporations to invest in effective compliance programs. For starters, the DOJ unveiled a new program that incentivizes corporate...more
Earlier this year, as described in a previous client alert, the Department of Justice (“DOJ”) Criminal Division announced a landmark pilot program to pay monetary awards to whistleblowers (the “Program”). At that time, Deputy...more
Designed for busy in-house counsel and compliance professionals, this newsletter seeks to bring you up to speed on key federal and state False Claims Act (FCA) developments, with links to primary resources. Each quarter, we...more
On February 1, 2022, the U.S. Department of Justice (DOJ) announced that it collected more than $5.6 billion in False Claims Act (FCA) settlements and judgments in fiscal year 2021. This is the largest annual total since...more
Just to repeat myself – pharmaceutical and medical device firms face extraordinary risks of enforcement under the False Claims Act. While everyone likes to write and focus on FCPA or anti-corruption risks for global drug and...more
If you work in compliance in the healthcare industry, you have a tough job. The number and variety of risks that healthcare providers face is daunting. The False Claims Act is a mighty weapon in the hands of federal...more
On March 31, 2014, in U.S. ex rel. Nathan v. Takeda Pharmaceuticals North America, the Supreme Court of the United States declined to review a decision by the U.S. Court of Appeals for the Fourth Circuit upholding a district...more