News & Analysis as of

Whistleblowers Compliance Anti-Kickback Statute

Baker Donelson

First Circuit Requires But-For Causation for FCA Liability Based on AKS Violations

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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

ArentFox Schiff

Investigations Newsletter: Massachusetts District Court Judge Applies Heightened Causation Standard in FCA Case

ArentFox Schiff on

Massachusetts District Court Judge Applies Heightened Causation Standard in FCA Case - On January 6, a District Court of Massachusetts judge granted summary judgment for defendants on allegations of violating the...more

Mintz - Health Care Viewpoints

EnforceMintz — Scienter, Causation, and Constitutional Questions: 2024’s Three Key FCA Litigation Issues

In 2024, federal courts issued a number of important decisions in False Claims Act (FCA) cases that are particularly noteworthy for the health care and life sciences industries. We focus here on decisions that further develop...more

Pietragallo Gordon Alfano Bosick & Raspanti,...

Second Circuit Expands Anti-Kickback Statute Liability: “At Least One Purpose” is Enough

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

ArentFox Schiff

FCA Enforcement & Compliance Digest — Fall 2024 False Claims Act Newsletter

ArentFox Schiff on

Welcome to the Fall 2024 issue of “FCA Enforcement & Compliance Digest,” our quarterly newsletter in which we compile essential updates on False Claims Act (FCA) enforcement trends, litigation, agency guidance, and compliance...more

Dentons

Ep. 12 - Working with Valuation Experts to Substantiate Fair Market Value Compensation

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We often work with valuation experts to ensure compensation payments between healthcare organizations and physicians are fair market value and commercially reasonable for purposes of compliance with the Stark Law and the...more

Bradley Arant Boult Cummings LLP

State False Claims and AKS Statutes Keep Case Alive in 2nd Circuit: Underappreciated State Laws May Present Significant Compliance...

Recent years have seen eye-popping judgments and settlements involving cases brought under the federal False Claims Act (FCA) and federal Anti-Kickback Statute (AKS). And healthcare companies have, unsurprisingly, focused...more

Health Care Compliance Association (HCCA)

In Biggest Stark-Based FCA Settlement Ever, Indiana Hospital Pays $345M, Has Unusual CIA

Community Health Network (CHN) in Indiana has agreed to pay $345 million to settle false claims allegations that it paid over-the-top salaries to hundreds of physicians and rewarded them for their referrals in violation of...more

Health Care Compliance Association (HCCA)

[Event] 2023 Healthcare Enforcement Compliance Conference - November 5th - 7th, Washington, DC

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

Health Care Compliance Association (HCCA)

[Event] 2023 Board & Audit Committee Compliance Conference - October 23rd - 24th, Fort Lauderdale, FL

Discover today's best practices for your role in healthcare compliance oversight - The Office of Inspector General of Health and Human Services expects healthcare board members, board audit/compliance committee members,...more

Bass, Berry & Sims PLC

[Virtual Conference] Nashville Healthcare Fraud Conference - December 15th - 16th, 8:00 am - 1:00 pm CST

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Please join us for the 8th Annual Nashville Healthcare Fraud Conference hosted by Bass, Berry & Sims and the Tennessee Hospital Association. Eligible for more than seven hours of CLE credit (including ethics), this...more

Health Care Compliance Association (HCCA)

[Virtual Event] Healthcare Enforcement Compliance Conference - November 7th - 9th, 8:55 am - 3:30 pm CST

Hear directly from the enforcement community - Want to gain insight into properly monitoring, detecting, investigating, and managing violations? Join us virtually at HCCA’s Annual Healthcare Enforcement Compliance...more

Health Care Compliance Association (HCCA)

[Event] Nashville Regional Healthcare Compliance Conference - November 5th, Nashville, TN

Our one-day Regional Compliance Conferences provide attendees with a forum to interact with local compliance professionals, share information about your compliance successes and challenges, and create educational...more

Thomas Fox - Compliance Evangelist

Novartis US Corruption Settlements: Part 3 – Compliance Failures

I have written extensively about the Novartis International AG (Novartis) Foreign Corrupt Practices Act (FCPA) settlement, which was announced in late June. However, the enforcement action paled next to the Stipulation and...more

The Volkov Law Group

Avanir Pharmaceuticals Pays More than $108 Million to Settle Kickback Violations

The Volkov Law Group on

Just to repeat myself – pharmaceutical and medical device firms face extraordinary risks of enforcement under the False Claims Act.  While everyone likes to write and focus on FCPA or anti-corruption risks for global drug and...more

The Volkov Law Group

Focusing on “Payments” to Healthcare Professionals (Part I of III)

The Volkov Law Group on

The United States healthcare industry poses an infinite number of risks when it comes to interactions with healthcare professionals. Given the aggressive regulation and enforcement of prohibitions against kickbacks and...more

Skadden, Arps, Slate, Meagher & Flom LLP

A Dialogue With Corporate Counsel: Skadden’s Eighth Annual Pharmaceutical and Medical Device Seminar

On October 30, 2018, Skadden hosted its Eighth Annual Pharmaceutical and Medical Device Enforcement and Litigation Seminar in New York City, which focused on U.S. enforcement issues faced by companies throughout the industry....more

Skadden, Arps, Slate, Meagher & Flom LLP

Enforcement and Litigation Strategies: Skadden’s Eighth Annual Pharmaceutical, Biotechnology and Medical Device Seminar

On March 15, 2018, Skadden hosted its Eighth Annual Pharmaceutical, Biotechnology and Medical Device Seminar in Palo Alto, California, which focused on U.S. enforcement issues faced by companies throughout the industry. The...more

Hogan Lovells

Government data mining leads to more aggressive investigations

Hogan Lovells on

The government is leveraging its access to big data in order to aggressively pursue healthcare investigations. Maria Durant and Gejaa Gobena, partners in our Boston and Washington, D.C. offices, discuss the steps life...more

Thomas Fox - Compliance Evangelist

Compliance Lessons from the Olympus Corporate Integrity Agreement – Part I

The recent Olympus Corporation and related entities (collectively ‘Olympus’) enforcement action demonstrated a company seemingly dedicated to lying, cheating and stealing its way across the globe in search of almighty dollar....more

Faegre Drinker Biddle & Reath LLP

What’s Scarier than a Compliance Officer Turned Whistleblower? A Whole Association of Them

In U.S. ex rel. Corporate Compliance Assocs. v. N.Y. Society for the Relief of the Ruptured & Crippled the court ruled that the whistleblower failed to meet the False Claims Act’s requirement that allegations be described...more

Mintz - Health Care Viewpoints

Health Care Enforcement in 2012: A Year in Review

Last year was another busy year in health care fraud enforcement. In 2012, the Office of Inspector General for the Department of Health and Human Services (HHS-OIG) reported total expected recoveries of $6.9 billion from all...more

Ballard Spahr LLP

Major New Jersey Health System Pays $12.6 Million To Settle False Claims Act Suit Alleging Physician Kickback Scheme

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Federal prosecutors recently announced a $12.6 million False Claims Act (FCA) settlement with a major New Jersey health system to resolve allegations that the system paid outside physicians in order to increase referrals....more

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