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?
Grounded in the OIG’s General Compliance Program Guidance and DOJ’s Evaluation of Corporate Compliance Programs, our immersive, three-and-a-half-day, classroom-style Healthcare Basic Compliance Academy equips compliance...more
On June 11, 2025, the Department of Health and Human Services Office of Inspector General (OIG) issued a favorable advisory opinion on a proposed arrangement where a physician practice managed by a management services...more
Many FDA-regulated companies are exploring ways to support diagnostic testing, especially when early diagnosis can impact treatment options. However, funding diagnostic testing tied to a company’s own product raises important...more
In April, a pharmaceutical manufacturer agreed to pay a $202 million settlement to resolve allegations of Anti-Kickback Statute (AKS) violations. At the heart of the case were speaker programs, where physicians and...more
On April 29, 2025, the U.S. Attorney’s Office for the Southern District of New York (SDNY) announced a $202 million civil False Claims Act (FCA) settlement with Gilead based on allegations that the company’s speaker program...more
In this episode, Mike Burke, AGG Corporate partner and co-chair of the firm’s International practice, is joined by David Blank, AGG Healthcare partner, to discuss how foreign life sciences companies can proactively address...more
Key Insights for Pharma Manufacturers Regarding the AKS - In a series of recent legal challenges initiated by the pharmaceutical industry against the US Department of Health and Human Services Office of the Inspector General...more
In today’s heightened enforcement environment, compliance auditing isn’t just a best practice—it’s a necessity. Federal and state laws and industry guidance, including the Office of Inspector General (OIG) Compliance Program...more
In its first advisory opinion of the year, the Office of Inspector General for the U.S. Department of Health and Human Services (OIG) assessed a pharmaceutical manufacturer’s free product program and found that, although the...more
On February 18, 2025, the United States Court of Appeals for the First Circuit issued its opinion in United States v. Regeneron Pharmaceuticals Inc., finding that, in Anti-Kickback Statute (AKS) cases, the government must...more
On February 18, 2025, a panel of the U.S. Court of Appeals for the First Circuit unanimously decided that in order to transform an Anti-Kickback Statute (AKS) violation into a false or fraudulent claim for purposes of False...more
First Circuit Joins Sixth and Eighth Circuits in Adopting Heightened, But-For Causation Standard for AKS-Based FCA Claims - On February 18, the US Court of Appeals for the First Circuit became the latest court to agree...more
In United States v. Regeneron Pharmaceuticals, Inc., the First Circuit joined the emerging majority view that False Claims Act (FCA) claims based on violations of the Anti-Kickback Statute (AKS) require a showing of “but-for”...more
Key Takeaways - The First Circuit ruled in United States v. Regeneron Pharmaceuticals, Inc., that the government must prove but-for causation to establish False Claims Act (FCA) liability based on violations of the...more
On January 23, 2025, in Pharmaceutical Coalition for Patient Access v. United States, the Fourth Circuit held that a proposed patient assistance program, which would help cancer patients afford certain oncology drugs, would...more
On January 10, 2025, OIG posted a favorable advisory opinion approving a proposed program (Program) to provide patients who meet certain financial need criteria with free access to a pharmaceutical product that has limited...more
The Department of Health and Human Services, Office of Inspector General (“OIG”) recently released a favorable advisory opinion, OIG Advisory Opinion No. 24-12 (the “Opinion”) to a pharmaceutical manufacturer (the...more
The Department of Health and Human Services, Office of Inspector General (“OIG”) recently released a favorable advisory opinion, OIG Advisory Opinion No. 24-11 (the “Opinion”), to a pharmaceutical manufacturer (the...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
The U.S. Department of Health and Human Services Office of Inspector General (HHS OIG) recently issued Advisory Opinion No. 24-04, which primarily addressed a Refund Program offered by a U.S. pharmaceutical company affiliate....more
On 22 February 2024, the US Department of Justice (DOJ) published the statistics for federal civil fraud recoveries in Fiscal Year (FY) 2023. The DOJ announced that the “government and whistleblowers were party to 543...more
Healthcare compliance risks exist even when a company takes steps to structure its business activities to follow the government's own statements. A recent decision by the U.S. District Court for the Eastern District of...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