AGG Talks: Cross-Border Business Podcast - Episode 28: How Life Sciences Companies Can Create a Culture of Compliance When Expanding to the U.S. Market
False Claims Act Insights - Swamp Things: A Post-Election Look at DOJ’s False Claims Act Enforcement, Part I
False Claims Act Insights - Reality Checks: How to Approach Healthcare Transactions Without Triggering FCA Liability
False Claims Act Insights - Are All Healthcare “Kickbacks” Subject to FCA Liability?
The Latest on Healthcare Enforcement
Episode 303 --- Deep Dive into the HHS-OIG Compliance Program Guidance
Litigating Elder Financial Exploitation Cases: Defending Banks in a Tough Spot — The Consumer Finance Podcast
UPIC Report Card: The OIG’s Evaluation of the UPICs Provides Insight Into the Future of Hospice Audits
Health Care Fraud and Abuse Control Program FY 2021 Report
Forecast for Telehealth Fraud and Abuse Risk in 2021 - Diagnosing Health Care Podcast
Fraud and Abuse Enforcement Priorities in the Wake of COVID-19 - Diagnosing Health Care Podcast
Nota Bene Episode 37: How to Prevent or Defend Against Business Crimes with Chuck Kreindler
Value-based health care: fraud & abuse laws
Value-based health care: issues for pharmaceutical companies
Private Equity focused on investment and operations within the Life Science industry faces significant compliance, operational and business risk due to the heavily regulated nature of the investment targets and portfolio...more
This issue of McDermott’s Healthcare Regulatory Check-Up highlights key regulatory and enforcement activity for March 2025. This month features: - Noteworthy enforcement actions demonstrating that the Anti-Kickback Statute...more
Teva Pharmaceuticals USA Inc. (Teva USA) and Teva Neuroscience Inc. (“Teva”) agreed to pay $450 million to resolve two matters that allege Teva violated the Anti-Kickback Statute (AKS) and the False Claims Act (FCA). Teva is...more
Walking away from the American Health Law Association’s annual conference, I’m feeling energized from (re)connecting with friends and colleagues, inspired by the complex and transformational work being done throughout the...more
OIG Warns That Proposed Drug Discounts May Warrant Sanctions - On October 5, the US Department of Health and Human Services’ Office of Inspector General (OIG) issued an advisory opinion assessing a proposal that involved...more
In a previous post published on the Washington Legal Foundation’s Legal Pulse blog, Goodwin Partners Matt Wetzel and William Jackson discussed the potential implications of a high-profile recent lawsuit lodged by Pfizer...more
On August 12, 2021, a panel of the Seventh Circuit voting 2-1 endorsed the existence of an “objective reasonableness” defense under the FCA. United States ex rel. Schutte v. SuperValu, Inc., No. 11-cv-3290, 2021 WL 3560894...more
On November 20, 2020, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) finalized its previously abandoned 2019 proposal to exclude certain rebates paid by drug manufacturers from the...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 2019, U.S. Department of Justice (DOJ) enforcement activity targeting drug and device manufacturers jumped sharply over the prior year, reflecting an increased focus on fraud and abuse in the life sciences sector. More...more
In this week's episode, Lindsey Rogers-Seitz forecasts a number of critical issues spanning the health care industry that are likely to be points of focus in the coming year. Among these issues, Ms. Rogers-Seitz discusses the...more
• The OIG issued an unfavorable advisory opinion on a proposed program by which a marketer would provide free drugs to hospitals to utilize in an inpatient setting to treat infantile epilepsy. • Contrary to the typical...more
In the midst of the ongoing federal conversation surrounding the 340B Drug Pricing Program, individual states are implementing a number of regulatory efforts related to the 340B Program at an increasingly fast pace. These...more
We expect 2018 to be another year of rapid change within the health care industry. In this episode, Mary Beth Johnston highlights some of the key topics that the health care practice group will monitor in the coming year,...more