Podcast - Cybersecurity Roundup: Analyzing New and Proposed Rules for Contractors
AGG Talks: Women in Tech Law Podcast - Episode 3: Cybersecurity and FCA Compliance: Essential Insights for Tech Leaders
False Claims Act Insights - Are All Healthcare “Kickbacks” Subject to FCA Liability?
False Claims Act Insights - If Everything Matters, Nothing Does: Parsing Materiality in FCA Disputes
False Claims Act Insights - Assessing the Fallout from a Thermonuclear FCA Verdict
False Claims Act Insights - Eureka! Government Investigators Seek Out Research Misconduct
Common Scenarios Triggering False Claims Act Violations, Part 3: Claims and Investigations
Common Scenarios Triggering False Claims Act Violations, Part 1: Gov. Contracts and Cybersecurity
False Claims Act Insights - Physician, Refer Thyself: How Stark Law and FCA Intersect
False Claims Act Insights - The Art and Science of Corporate Compliance in Managing FCA Risk
The Latest on Healthcare Enforcement
False Claims Act Insights - Railroaded! How to Approach the Twin Tracks of Parallel Proceedings
FCA Uncovered: Mitigating Risk in the Regulatory Spotlight — Regulatory Oversight Podcast
False Claims Act Insights - Are We Done Here? The Unique Dynamics of FCA Settlements
False Claims Act Insights - Help! I Got a Civil Investigative Demand from DOJ. What Do I Do?
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 186: White Collar Crimes in Healthcare with Maynard Nexsen’s White Collar Team
False Claims Act Insights - Think You Know Whistleblowers? Think Again.
PilieroMazza Annual Review What DOJ’s Annual FCA Report Means for Government Contractors
Protecting Our Nation’s Data: Cybersecurity Compliance for Government Contractors
Medical Device Legal News with Sam Bernstein: Episode 19
There are many junctures in the U.S. healthcare system that enable fraudulent activities, and one of the biggest has to do with pharmaceutical companies. The U.S. Food and Drug Administration (FDA) and the Department of...more
Join Gardner Law for a half-day CLE event in person at the Capital Factory in Austin, TX or attend virtually. Prepare for the regulatory rodeo with confidence by learning how to navigate regulatory, compliance, and privacy...more
On March 12, the Second Circuit affirmed in part and reversed in part a district court dismissal of False Claims Act (FCA) claims predicated on alleged Anti-Kickback Statute (AKS) violations. Adam Hart brought the claims...more
Hosted by the American Conference Institute, the 19th Annual FCPA & Anti-Corruption Conference for the Life Sciences Industry returns for another exciting year with carefully researched programming based on critical findings...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
In this issue of our newsletter on developments impacting the life sciences industry, we examine topics including how the increased DOJ and FDA focus on cybersecurity issues could lead to new theories of False Claims Act...more
FDA law firm Gardner Law and EU-based Fieldfisher discuss regulatory, compliance, and privacy matters relevant to high-tech healthcare products. - - Harnessing AI and Connected Devices in Medical Innovation in an...more
This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity for August 2023. We discuss several criminal and civil enforcement actions that involve violations of the False Claims Act...more
A DMEPOS supplier agrees to pay $29M to resolve False Claims Act allegations that it billed Medicare, MA Plans, and beneficiaries for oxygen equipment for which it had already received payment in full; the FDA releases...more
There have been several noteworthy False Claims Act (FCA) settlements in the second quarter of 2023. Four of these settlements have come in over $20 million. This post summarizes key settlements of interest....more
On February 7, the Department of Justice (DOJ) issued a press release indicating that settlements and judgments under the False Claims Act (FCA) exceeded $2.2 billion in the fiscal year ending September 30, 2022. Of this...more
This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity and developments occurring in January 2023, including several criminal and civil enforcement actions related to the federal...more
On February 7, 2023, the U.S. Department of Justice (DOJ) announced its fiscal year (FY) 2022 False Claims Act (FCA) statistics. Utilizing DOJ’s FY 2022 Data Table and comparing back to our FY 2021 coverage, MoFo’s FCA team...more
Bass, Berry & Sims will release its 11th Annual Healthcare Fraud & Abuse Review in early February 2023. As a companion to the Review, we will host a complimentary webinar on Wednesday, February 22, 2023, from 10:00 a.m.-12:00...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
The medical product and healthcare service industry is one of the most closely regulated sectors in the U.S. Several agencies actively exercise authority with constantly changing legislation and policies to keep pace with...more
The third quarter of 2022 brought a number of noteworthy False Claims Act (FCA) settlements, including several over $20 million and one in the high nine figures. This post summarizes key settlements of interest to healthcare...more
The United States’ recent False Claims Act (“FCA”) prosecution in United States v. Prometheus Group, et al., is a reminder that the government will use the FCA to target medical device manufacturers for off-label use of...more
After years of government skepticism and enforcement activity targeting physician-owned medical device companies, a recent favorable advisory opinion by the Office of Inspector General for the U.S. Department of Health &...more
The U.S. Department of Justice (“DOJ”) recently announced that over $5.6 billion in False Claims Act (“FCA”) settlements and judgments had been reached during the 2021 fiscal year, with over $5 billion of those settlements...more
STATISTICAL TRENDS IN FALSE CLAIMS ACT LITIGATION - FCA case activity for 2021 reveals seemingly contrary trends. For the federal fiscal year (FY) that ended September 30, 2021, the DOJ annual report on FCA enforcement...more
Bass, Berry & Sims is pleased to announce the release of the 10th annual Healthcare Fraud & Abuse Review examining important healthcare fraud developments in 2021. Compiled by the firm’s Healthcare Fraud & Abuse Task Force,...more
DOJ Files Complaint in AWP False Claims Act Suit Against Pharmaceutical Ingredient Seller - On November 8, 2021, the Department of Justice (DOJ) announced that it intervened in a qui tam suit and filed a False Claims Act...more
After several years without any enforcement, the U.S. Department of Justice (“DOJ”) recently penalized medical device and life sciences companies for violating the U.S. Provider Payments Sunshine Act (“Sunshine Act”) (42...more
On August 2, 2021, the U.S. Food and Drug Administration (FDA) issued its final rule amending the intended use regulations codified at 21 CFR 801.4 and 21 CFR 201.128, marking the end of an effort FDA began in 2015. While the...more