False Claims Act Insights - Reality Checks: How to Approach Healthcare Transactions Without Triggering FCA Liability
Podcast - Discussing a DOJ Lawsuit Under the Civil-Fraud Initiative
False Claims Act Insights - Are the FCA’s Qui Tam Provisions Unconstitutional? One Federal Judge Says “Yes"
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.
Florida Federal Judge Strikes Down FCA’s Qui Tam Provision as Unconstitutional - On September 30, US District Judge Kathryn Kimball Mizelle of the Middle District of Florida held in a historic decision that the federal...more
This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for July 2024. We discuss several US Department of Health and Human Services (HHS) agency actions, including a final rule on provider...more
On May 29, 2024, the U.S. Department of Health and Human Services’ Office of Inspector General (HHS OIG) announced a $12 million settlement with Innovasis Inc., a medical device manufacturer, and two of its senior executives...more
On April 22, 2024, the Office for Civil Rights (OCR) for the United States Department of Health and Human Services issued a Final Rule amending the Privacy Rule of the Health Insurance Portability and Accountability Act...more
Employers must check its employees, contractors and vendors to see if an individual or organization is excluded from participating in federal and/or state programs. While there are a variety of exclusion programs at the...more
Florida Lab Owner Agrees to Pay Over $27 Million to Resolve Three Whistleblower Lawsuits - Daniel Hurt, the prior owner and operator of Fountain Health Services LLC, Verify Health, Landmark Diagnostics LLC, First Choice...more
The government’s continued dedication of resources to investigating and prosecuting fraud against COVID-19 pandemic relief programs appears to have borne fruit according to the results of the COVID-19 Fraud Enforcement Task...more
Prescription drug fraud has long been a focus for government regulators, but it has taken on new significance in the wake of America’s opioid crisis. The U.S. Department of Justice (DOJ), Department of Health and Human...more
Editor’s Note: PYA and Foley & Lardner hosted the 6th Annual “Let’s Talk Compliance” two-day Virtual Conference on January 18 and 19, 2024. Panelists included Foley & Lardner attorneys and PYA experts. The event was hosted by...more
Telemedicine companies are supposed to facilitate medically necessary services to beneficiaries over the telephone via licensed medical professionals. In reality, however, many of these “telemedicine companies” are...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
H. Lee Moffitt Cancer Center & Research Institute Hospital Inc. in Tampa, Florida, has agreed to pay $19.564 million to settle false claims allegations over claims submitted to federal health care programs for items and...more
Medicare Advantage (also known as Medicare Part C) remains a top enforcement priority as evidenced by False Claims Act (FCA) investigations and litigation involving nearly all large Medicare Advantage Organizations (MAOs). As...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
Clinical Laboratory and CEO To Pay Over $13 Million to Settle False Claims Act Allegations - A New Jersey-based laboratory, RDx Bioscience Inc. (RDX), and its owner and CEO, Eric Leykin, agreed to pay $10,315,023 to the US...more
The HHS Office of Inspector General issues a favorable advisory opinion regarding a sponsor’s payment of cost-sharing amounts in a Medicare Category B IDE Clinical Study; the FDA issues guidance regarding the use of Digital...more
Health Care Network Settles False Claims Act Allegations for $345 Million - Community Health Network Inc. (CHN) has agreed to pay $345,000,000 to settle allegations that it violated the False Claims Act (FCA) for knowingly...more
On November 6, 2023, the US Department of Health and Human Services (HHS) Office of Inspector General (OIG) published the General Compliance Program Guidance (GCPG) as a revised reference guide for the healthcare compliance...more
From 1998-2008, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) published compliance program guidelines for various industries in the Federal Register....more
Due diligence properly performed in connection with the purchase and sale of a health care entity is simply different—vastly so—than due diligence performed in other contexts. Failure to recognize this reality can lead to...more
Medical Supplier Agrees to Pay $29 Million for FCA Violations - Earlier this month, the US Department of Justice (DOJ) and medical supplier Lincare Holdings Inc. reached an agreement to settle claims that Lincare violated...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
This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity for May 2023. We discuss several criminal and civil enforcement actions that involve violations of the False Claims Act (FCA)...more