The Legal Tightrope: Surviving Parallel Investigations
Navigating Government Contracts: Diana Shaw on Oversight and Whistleblower Protections
The Presumption of Innocence Podcast: Episode 45 - The Grit, Grace and Gift of Second Chances
The Justice Insiders Podcast - The Ever-Expanding Net: Corporate Compliance in an Era of Increasing Trade Sanctions and Restrictions
False Claims Act Insights - Are All Healthcare “Kickbacks” Subject to FCA Liability?
Episode 333 -- The Boeing Proposed Plea Agreement
DOJ’s New Self-Disclosure Policy and Corporate Whistleblower Awards Pilot Program
False Claims Act Insights - Assessing the Fallout from a Thermonuclear FCA Verdict
FCPA Survival Guide - Step 8 - Investing in Compliance
Exploring the AI and Crypto Intersection
The Justice Insiders Podcast: Jarkesy’s Implications for the Administrative State
The Presumption of Innocence Podcast: Episode 41 - The Dynamics of Decision-Making: Psychology and the Criminal Justice System
INTERPOL and Child Kidnapping Cases. What are INTERPOL’s Abilities and Limitations?
False Claims Act Insights - Eureka! Government Investigators Seek Out Research Misconduct
The Justice Insiders Podcast - AI-Washing: Everything Old Is New Again
The CFPB and State AGs Act Jointly Against Online Educational Company
Will the U.S. Have a GDPR? With Rachael Ormiston of Osano
Episode 328 -- Sanctions Enforcement Risks and Redlines
FCPA Survival Guide: Step 3 - Extensive Remediation
Episode 324 -- Third-Party Risks and Sanctions Compliance
Find this week’s updates on 340B litigation to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick...more
In July, the U.S. Department of Justice (DOJ) and U.S. Attorneys Offices announced several large False Claims Act (FCA) settlements stemming from qui tam whistleblower suits....more
DaVita is a regular target of government enforcement actions involving fraud and illegal kickbacks. It has an extensive history of violations and settlements....more
Healthcare fraud is an ever-growing constant in our economy. It is a battle that presents new and exponential challenges. The U.S. Department of Justice, the HHS-Office of Inspector general and State Attorneys’ General all...more
The Department of Justice announced one if its most aggressive and wide-ranging enforcement actions to date, a coordinated two-week operation spanning 32 federal districts. The orchestrated effort involved the FBI, HHS-OIG,...more
Healthcare enforcement is never quiet. There’s always something, or many things, going on, and compliance teams need to stay on top of the trends to ensure that their programs are staying ahead of the risks. To find out...more
Introduction - Polsinelli proudly introduces the Health Care Fraud and Abuse 2023 Year in Review, a comprehensive examination of the evolving landscape surrounding the False Claims Act (“FCA”) and fraud & abuse enforcement...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 U.S. Food and Drug Administration (FDA) uses warning letters to notify manufacturers that they have violated the FDA’s regulations or federal law. Manufacturers that receive warning letters must respond promptly, and they...more
ACI’s Advanced Forum on Managed Care Disputes and Litigation offers an unparalleled learning experience, specifically designed for the MCO legal community. Attend and develop winning legal strategies and business best...more
We are pleased to bring you our 12th 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
This week, DEA announced it has entered into a settlement agreement with Morris & Dickson Co., LLC (“Morris & Dickson”), resolving the protracted dispute born out of a May 2, 2018 Order to Show Cause (“OTSC”) and Immediate...more
On January 23, the U.S. Court of Appeals for the Second Circuit affirmed a district court ruling that Martin Shkreli, CEO of Vyera Pharmaceuticals (Vyera), violated federal and state laws by engaging in illegal and...more
ACI’s FDA Boot Camp – now in its 42nd iteration – continues to provide the working knowledge of core essentials of FDA law and regulation, including the new amendments under the Food and Drug Omnibus Reform Act (FDORA). This...more
In 2020, over 142 million prescriptions for opioid medications were filled in the U.S. That same year, 16,416 people died from overdoses on prescription opioids—a 376% increase from 1999....more
On December 26, 2023, the Food and Drug Administration (FDA) released a Small Entity Compliance Guide Final Guidance Document: Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a...more
As we wrote about in our prior blog post, on September 29, 2023, John D. Bates of the U.S. District Court for the District of Columbia struck down a federal rule that permitted health plans and pharmacy benefit managers...more
The Louisiana Insurance Department (“Department”) recently fined Express Scripts Administrators, LLC (“ESA”) $275,000 and MedImpact Healthcare Systems, Inc. (“MedImpact”) $250,000 for allegedly failing to pay electronically...more
In a recent speech, a senior official at the U.S. Department of Justice Antitrust Division noted that “in U.S. antitrust enforcement and competition policy, there is no more important question than what can we do to safeguard...more
ACI’s FDA Boot Camp is back in Boston! This essential training course – now in its 41st iteration – continues to provide the working knowledge of core essentials of FDA law and regulation, including the new amendments under...more
The wait is finally over. On June 7, 2023, after remaining silent for over an entire year, the US Food and Drug Administration (“FDA”) Office of Prescription Drug Promotion (“OPDP”) issued its first untitled letter of 2023 to...more
On May 26, 2023, the Drug Enforcement Administration (DEA) published a final decision and order (the “Final Order”) affirming an Administrative Law Judge's (ALJ) August 29, 2019 recommendation (the “ALJ Order”) to revoke DEA...more
Always on the lookout for unapproved drugs and supplements being sold, the U.S. Food and Drug Administration (FDA) has ramped up its enforcement actions against selective androgen receptor modulators (SARMs), which are banned...more
Congress was in session, and it was a busy healthcare week at the committee level, with six hearings focused specifically on health issues. On the House floor, Republicans passed the Limit, Save, Grow Act—a bill that raises...more