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?
Texas AG Ken Paxton has sued pharmaceutical manufacturer Eli Lilly for allegedly bribing and illegally inducing medical providers to prescribe and continue prescribing several Lilly drugs—including GLP-1 medications Mounjaro...more
On July 16, 49 attorneys general (AGs) announced that they joined a $202 million settlement with Gilead Sciences, Inc. (Gilead). Previously announced by the Department of Justice in April, the settlement resolved allegations...more
New York AG Letitia James, along with a bipartisan coalition of 48 other AGs and in coordination with the U.S. DOJ, announced a $202 million settlement in principle with Gilead Sciences, Inc. (“Gilead”), to resolve...more
Last month, the United States Department of Justice (“DOJ”) issued its “Civil Division Enforcement Priorities” memorandum, memorializing a shift from its predecessor administration’s policy on gender‑affirming healthcare...more
The U.S. Department of Health and Human Services (HHS) and the Department of Justice (DOJ) have jointly announced the launch of a reinvigorated DOJ-HHS False Claims Act Working Group aimed at enhancing interagency...more
On June 11, 2025, Assistant Attorney General Brett A. Shumate issued an internal memorandum (the “Shumate memo”) to all Civil Division employees of the U.S. Department of Justice (“DOJ”), describing the Division’s enforcement...more
On May 12, 2025, President Trump signed the most recent Executive Order on drug pricing, Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients. ...more
A couple of recent large-scale enforcement actions suggest that the U.S. Department of Justice (DOJ) may be placing increased emphasis on targeting black market prescription drug diversion. This is when pharmaceutical...more
The U.S. Department of Justice (DOJ) and 18 state attorneys general (AG) announced a settlement with Boston-based QOL Medical, LLC (QOL) and its CEO, Frederick Cooper, to resolve allegations that the company provided unlawful...more
In honor of Rare Disease Day on February 28, 2025, we will publish a series of posts throughout the month on As Prescribed and Health Law Scan, focusing on issues impacting the rare disease community....more
A recent Securities and Exchange Commission (“SEC”) settlement with DMK Pharmaceuticals Corporation (“DMK Pharmaceuticals”) and its Chief Financial Officer (“CFO”) serves as a good reminder that SEC-regulated entities...more
Looking for compliance education and networking in your area? HCCA’s Regional Healthcare Compliance Conferences offer practitioners convenient, local compliance education on a wide variety of current and emerging topics...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
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
The following is a summary of selected federal Department of Health and Human Services’ Office of Inspector General (OIG) reports of fraud and abuse enforcement activity across the country. The enforcement actions reported...more
Hear directly from the enforcement community - Want to gain insight into properly monitoring, detecting, investigating, and managing violations? Join us at HCCA’s Annual Healthcare Enforcement Compliance Conference to...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
Litigation involving drug price reporting under the Medicaid Drug Rebate Program (MDRP) has been very active in 2022. Most recently, on August 3, 2022, an Illinois federal jury levied a $61 million verdict against Eli...more
The 340B Program has gained national attention over the last decade, in part due to the opportunities it provides to generate revenue for participating entities without risk of significant enforcement penalties for...more
The owner of Brooklyn Chemists in Gravesend, Brooklyn and Lucky Care Pharmacy in Flushing, Queens was recently indicted on charges of conspiracy to commit health care fraud, conspiracy to defraud the United States by paying...more
Please join us for our annual healthcare compliance seminar to discuss current developments in healthcare regulation and hospital compliance... Registrants will have the option of selecting the sessions they would like to...more
Donald Trump extended two directives restricting the admission of certain immigrants and nonimmigrants to the U.S. Specifically, Presidential Proclamation (PP) 10014 restricting the admission of first-time immigrants and PP...more