Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 247: Reimagining Cell Therapy for Solid Tumors with Ming-Wei Chen and Fangheng Zhou of RephImmune
HHS Policy Changes, Supreme Court Rulings, and the DOJ-HHS False Claims Act Working Group
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 246: The Next Generation of Treatment for Alzheimer's and Parkinson’s with Neal Goodwin and Pawel Krysiak of Jaya Bio
AI Today in 5: August 11, 2025, The ACHILLES Project Episode
False Claims Act Insights - Bitter Pills: DOJ Targets Pharmacies for FCA Enforcement
Key Discovery Points: BYOD Case Law Covering Subpoenas and Employee Handbooks
Daily Compliance News: June 23, 2025, The Is Walmart Cool Edition
Taking the Pulse: A Health Care & Life Sciences Video Podcast | Episode 239: Understanding the 340B Pricing Program with Chuck Melendi of Disruptive Dialogue
Unexpected Paths to IP Law with Dan Young and Colin White
Navigating Legal Strategies for Covering GLP-1s in Self-Insured Medical Plans — Employee Benefits and Executive Compensation Podcast
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 234: Life-Saving Collaboration in the Life Sciences Industry with John Crowley, President & CEO of BIO
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
How Life Sciences Companies Can Create a Culture of Compliance When Expanding to the U.S. Market
Podcast - Hot Topics in FDA Regulation: GLP-1s, LDTs, AI and More
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 231: Advancing the Life Sciences Industry with Kendalle O’Connell of MassBio
Compliance Program Effectiveness: Keep it Streamlined and Strategic
AGG Talks: Cross-Border Business Podcast - Episode 26: U.S. Enforcement Trends Targeting Foreign Pharmaceutical and Medical Device Manufacturers
Podcast — Drug Pricing: 2025 J.P. Morgan Healthcare Conference Takeaways and Outlook
Prescribing GLP-1 Medications: Be Aware of Legal Limitations
Podcast — The Growth Rocketship: How BridgeBio’s Hub and Spoke Portfolio Strategy Set the Market for the Future of Biotech — Then, Now, and What’s Next?
This issue of McDermott Will & Schulte’s Healthcare Regulatory Check-Up highlights regulatory activity for July 2025, including the results of the US Department of Justice’s (DOJ) 2025 National Health Care Fraud Takedown, DOJ...more
On April 29, 2025, a pharmaceutical company filed the latest constitutional challenge to the qui tam provision of the False Claims Act (“FCA”) when it appealed in the United States Court of Appeals for the Third Circuit a...more
In a significant ruling, the Second Circuit Court of Appeals recently expanded the scope of the Anti-Kickback Statute (AKS).The Court joined other circuit courts across the country in adopting, for the first time, the...more
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
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
On June 1, 2023, the Supreme Court issued a unanimous decision holding that the scienter element of the False Claims Act (“FCA”) is met if a defendant subjectively knew his or her claims were false and submitted them anyway....more
We are pleased to bring you our 11th 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
On Monday September 26, the Department of Justice announced a settlement resolving a lawsuit filed by former employee Michael Bawduniak (the “Plaintiff”) against Biogen Inc. (the “Company”) under the qui tam provisions of the...more
This is the sixth in our First 100 Days series examining important trends in white collar law and investigations in the early days of the Biden administration. Our previous entry discussed ESG initiatives by the SEC. Up next...more
A LOOK BACK.... A LOOK AHEAD - Perhaps the single most appropriate word to describe the current state of the civil and criminal healthcare fraud enforcement environment is uncertainty. From changes in personnel and policy...more
Prompt Payment Discounts Not an Anti-Kickback Statute Violation - In United States of Am. et al. ex rel. Ruscher v. Omnicare, No. 15-20629, 2016 WL 6407128 (5th Cir. Oct. 28, 2016), the court of appeals affirmed summary...more
In the public relations battle following the issuance of the Yates Memo, the Justice Department can now cite one example for the new policy – the recent arrest and charging of Carl Reichel, former President of Warner...more
A recent settlement by retailer Kmart Corp. illustrates the breadth of practices in the healthcare space that the government considers to be illegal kickbacks that violate the False Claims Act (FCA). The U.S. Department of...more
Trends & Analysis - Between our last Qui Tam Update and the end of June, 65 health care–related qui tam cases were unsealed (28 in April, 18 in May, and 19 in June). Within those 65 cases...more
Last year continued the trend of robust False Claims Act (FCA) enforcement by the U.S. Department of Justice (DOJ) and proliferating qui tam lawsuits brought by whistleblowers on behalf of the United States. In 2012, DOJ...more
Mintz Levin’s most recent Qui Tam Update authored by our Health Care Enforcement Defense Practice provides focused analysis of four health care-related qui tam cases in which the government declined to intervene, including...more
Trends and Analysis: ..We have identified 21 health care–related qui tam cases unsealed since last month’s Qui Tam Update. Of those, two were filed in 2013, 15 were filed in 2011 or 2012, and four were filed in 2010 or...more
Trends and Analysis - ..We have identified 24 health care-related qui tam cases unsealed since last month’s Qui Tam Update. Of those, only 2 were filed in 2013. Nearly half were filed before 2011. ..Among the 24...more
Trends and Analysis: ..We have identified 20 health care-related qui tam cases unsealed in July 2013. About a quarter of those were filed in 2013. ..Among the cases unsealed in July, the government has declined to...more