False Claims Act Insights - An FCA Perspective on Artificial Intelligence in the Healthcare Industry
The State of Healthcare Enforcement
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
What’s in Your Operating Agreement? Legal Tips for Healthcare Providers
10 For 10: Top Compliance Stories For the Week Ending, July 26, 2025
Key Discovery Points: Don’t Get Caught with Your Hand in the Production Cookie Jar
Work this Way: An Employment Law Video Podcast | Episode 50: Creating a Competitive Advantage Through Employee Benefits with Connor Shaw of Gallagher
False Claims Act Insights - Will Recent Leadership Changes Lead to FCA Enforcement Policy Changes?
Podcast: Addressing Patient Complaints About Privacy Violations
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 236: Advocating for Accessible Diagnoses with Sydney Severance of Operation Upright
Podcast - Navigating the New Landscape of Private Equity in Healthcare
Taking the Pulse: A Health Care and Life Sciences Video Podcast | Episode 235: Revolutionizing Cancer Care with Eric Perrault of Kiyatec
Evolving AI Legislation: Federal Policies, Task Forces, and Proposed Laws — The Good Bot Podcast
CareYaya: A Revolutionary Approach to Elder Care
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
False Claims Act Insights - Trump DOJ Sharpens Its Focus on Healthcare Fraud
Federal Court Strikes Down FDA Rule on LDTs - Thought Leaders in Health Law®
Breaking Down the Shifting Vaccine Policy Landscape – Diagnosing Health Care Video Podcast
Criminal Health Care Fraud Enforcement: Projections for 2025 and Beyond – Diagnosing Health Care Video Podcast
Healthcare Industry Segment-Specific Compliance Program Guidances (ICPGs)
With the first half of 2025 in the rearview mirror, the government’s continued focus on False Claims Act (FCA) enforcement shows no signs of slowing. In fact, the Department of Justice recently announced the results of a...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
On July 17, the offices of Senators Durbin (D. IL.), Warren (D. MA.), Sanders (I. VT.), and Welch (D. VT.) (collectively, “Senators”) released a report summarizing the results of a nine month investigation into...more
The U.S. Department of Health and Human Services Office of Inspector General (OIG) once again addressed an industry-sponsored genetic testing program, posting a favorable decision on July 2, 2025 in Advisory Opinion (AO)...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
On February 18, 2025, the U.S. Court of Appeals for the First Circuit added its voice to a growing chorus of appellate courts to elevate the standard of proof required to show a violation of the federal False Claims Act in...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
Bass, Berry & Sims is pleased to announce the release of the 13th annual Healthcare Fraud & Abuse Review examining important healthcare fraud developments in 2024. Compiled by the firm's Healthcare Fraud & Abuse Task Force,...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
On December 27, 2024, the United States Court of Appeals for the Second Circuit joined other federal circuit courts in adopting the “at-least-one-purpose” rule (generally shortened to the “one purpose rule”)....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
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
Compared with other issues, healthcare enforcement during President-elect Donald Trump’s upcoming second term has received little attention. When he takes office again on January 20, should industry actors like pharmaceutical...more
This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for November 2024. We discuss several US Department of Justice (DOJ) enforcement actions involving the False Claims Act (FCA) and the...more
This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for September 2024. We discuss several enforcement actions pertaining to healthcare fraud, including alleged violations under the False...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
The third quarter of this year brought numerous high-dollar False Claims Act (FCA) settlements involving a variety of industries and alleged conduct. Below are noteworthy resolutions that reflect recent enforcement trends....more
This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for June 2024. We discuss several US Department of Health and Human Services (HHS) agency actions, including guidance regarding hospital...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
On June 17, the U.S. Department of Health and Human Services Office of Inspector General (OIG) posted Advisory Opinion 24-03, approving an arrangement under which a pharmaceutical manufacturer provides travel, lodging, and...more
This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for May 2024. We discuss several notable cases and enforcement resolutions, including the US Court of Appeals for the District of...more
The Florida Board of Pharmacy permits pharmacies serving residents and patients at long-term care facilities (nursing homes, ALFs, homes for DD residents, etc.) as either Special Closed System Pharmacies or Community...more
Despite the recent downward trend in DOJ healthcare industry settlements, the first quarter of 2024 saw many noteworthy False Claims Act (FCA) and civil healthcare fraud settlements related to alleged kickbacks, medically...more
This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for March 2024. We summarize a US Court of Appeals for the Second Circuit decision interpreting the intent standard under the federal...more