News & Analysis as of

Whistleblowers Anti-Kickback Statute Department of Health and Human Services (HHS)

Venable LLP

Defense-Friendly Anti-Kickback Statute and False Claims Act Marketing and Advertising Decisions

Venable LLP on

On April 14, 2025, the Seventh and Second Circuits each issued opinions narrowing the scope of advertising, marketing, and booking fee activities that run afoul of the federal Anti-Kickback Statute (AKS). See United States v....more

Patterson Belknap Webb & Tyler LLP

The First Circuit Requires But-For Causation in False Claims Act Cases Predicated on Violations of the Anti-Kickback Statute,...

On February 18, 2025, in United States v. Regeneron Pharmaceuticals, the First Circuit held that to establish civil liability under the False Claims Act (“FCA”) premised on violations of the Anti-Kickback Statute (“AKS”), the...more

McDermott Will & Emery

Healthcare Regulatory Check-Up Newsletter | January 2025 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for January 2025. This month features long-awaited proposed and final rules regarding the Health Insurance Portability and Accountability...more

Baker Donelson

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

Baker Donelson on

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

Foley Hoag LLP

False Claim Act Liability Under Anti-Kickback Statute Requires But-For Causation: First Circuit Narrows Liability in Growing...

Foley Hoag LLP on

On February 18, 2025, the First Circuit Court of Appeals issued its decision in U.S. v. Regeneron Pharmaceuticals, ruling that the Anti-Kickback Statute (“AKS”) requires the government to prove that an AKS violation was the...more

ArentFox Schiff

Investigations Newsletter: Pfizer Settles Its Subsidiary’s Kickback Allegations for Nearly $60 Million

ArentFox Schiff on

Pfizer Settles Its Subsidiary’s Kickback Allegations for Nearly $60 Million - Pfizer Inc. agreed to pay over $59,746,277 to resolve allegations that its wholly owned subsidiary, Biohaven Pharmaceutical Holding Company...more

Morrison & Foerster LLP

True Facts About False Claims: MoFo's FCA Newsletter - January 2025

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

ArentFox Schiff

Investigations Newsletter: Federal Government Urges Court of Appeals to Uphold Constitutionality of FCA Qui Tam Provisions

ArentFox Schiff on

Federal Government Urges Court of Appeals to Uphold Constitutionality of FCA Qui Tam Provisions - In a brief filed earlier this week, the US federal government has urged the Eleventh Circuit Court of Appeals to uphold 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

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

Dickinson Wright

Sixth Circuit Defines False Claims Standards

Dickinson Wright on

The Federal False Claims Act (“FCA”) imposes civil liability for presenting a false claim to the government for payment. The Federal Anti-Kickback Statue (“AKS”) prohibits medical providers from making referrals in return for...more

Bass, Berry & Sims PLC

False Claims Act Settlements to Know from Q2 2022

Bass, Berry & Sims PLC on

The second quarter of 2022 brought a number of noteworthy False Claims Act (FCA) settlements, including several of $20 million or more. This post summarizes key settlements of interest to healthcare providers....more

ArentFox Schiff

Investigations Newsletter: SEC Adopts Aggressive Approach to COVID-19 Fraud

ArentFox Schiff on

SEC Adopts Aggressive Approach to COVID-19 Fraud - The US Securities and Exchange Commission has already initiated multiple investigations into companies seeking to illegally profit from the global coronavirus pandemic...more

Bass, Berry & Sims PLC

DOJ Announces 2019 FCA Recovery, Majority Came from Healthcare Industry

The Department of Justice (DOJ) announced this month that it obtained over $3 billion in settlements and judgments from civil fraud and false claims cases during the fiscal year ending September 30, 2019 (FY 2019). Of this...more

ArentFox Schiff

Investigations Newsletter: Home Health Care Employees Plead Guilty in Multi-Million Dollar Medicaid Fraud Scheme

ArentFox Schiff on

Home Health Care Employees Plead Guilty in Multi-Million Dollar Medicaid Fraud Scheme - Two individuals pled guilty in Pennsylvania federal court to conspiracy to defraud the Pennsylvania Medicaid program and commit...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

ArentFox Schiff

Investigations Newsletter: Pharmaceutical Company Agrees to Pay $15.4 Million to Resolve Alleged False Claims Act Violations

ArentFox Schiff on

NY Ambulette Owners Plead Guilty to $8.6 Million Health Care Kickback Scheme - On September 5, the Department of Justice announced that two New York ambulette owners pleaded guilty to one count of conspiracy to offer 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

Holland & Knight LLP

Healthcare Law Update: September 2018

Holland & Knight LLP on

Regulation - CMS Contemplating Telemedicine Changes - The Centers for Medicare & Medicaid Services (CMS) recently published what it described as a "major proposed rule" that covers a number of topics that could have...more

The Volkov Law Group

Healthcare Compliance: Juggling Risk Mitigation Strategies

The Volkov Law Group on

Healthcare organizations – ranging from physician practice groups to large, multi-state hospital systems – face a variety of risks, including fraud and abuse, as well as HIPAA privacy issues. Starting from a baseline risk...more

Polsinelli

Millennium Health to Pay $256 million in False Claims Act Settlement

Polsinelli on

Millennium Health, one of the nation’s largest urine drug testing laboratories, has agreed to pay the government $256 million to resolve claims that it violated the Federal False Claims Act (“FCA”). The Settlement...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

Ballard Spahr LLP on

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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