News & Analysis as of

Department of Justice (DOJ) Anti-Kickback Statute Compliance

Health Care Compliance Association (HCCA)

[Event] Healthcare Basic Compliance Academy - July 21st - 24th, Nashville, TN

Grounded in the OIG’s General Compliance Program Guidance and DOJ’s Evaluation of Corporate Compliance Programs, our immersive, three-and-a-half-day, classroom-style Healthcare Basic Compliance Academy equips compliance...more

Skadden, Arps, Slate, Meagher & Flom LLP

Speaker Program Settlement Highlights Compliance Risks for Life Sciences Companies

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

White & Case LLP

Life Science Private Equity Risk

White & Case LLP on

Private Equity focused on investment and operations within the Life Science industry faces significant compliance, operational and business risk due to the heavily regulated nature of the investment targets and portfolio...more

Polsinelli

A Deepened Divide: Appellate Court Joins False Claims Act Circuit Split in Favor of Health Care Defendants

Polsinelli on

On February 18, 2025, the United States Court of Appeals for the First Circuit issued its opinion in United States v. Regeneron Pharmaceuticals Inc., finding that, in Anti-Kickback Statute (AKS) cases, the government must...more

Skadden, Arps, Slate, Meagher & Flom LLP

First Circuit Demands ‘But For’ Causation Between Alleged Kickback and Claim Submission

On February 18, 2025, a panel of the U.S. Court of Appeals for the First Circuit unanimously decided that in order to transform an Anti-Kickback Statute (AKS) violation into a false or fraudulent claim for purposes of False...more

ArentFox Schiff

Investigations Newsletter: First Circuit Joins Sixth and Eighth Circuits in Adopting Heightened, But-For Causation Standard for...

ArentFox Schiff on

First Circuit Joins Sixth and Eighth Circuits in Adopting Heightened, But-For Causation Standard for AKS-Based FCA Claims - On February 18, the US Court of Appeals for the First Circuit became the latest court to agree...more

Mintz - Health Care Viewpoints

First Circuit Adopts “But-For” Causation Standard for False Claims Act Cases Based on Anti-Kickback Statute Violations

In United States v. Regeneron Pharmaceuticals, Inc., the First Circuit joined the emerging majority view that False Claims Act (FCA) claims based on violations of the Anti-Kickback Statute (AKS) require a showing of “but-for”...more

Arnall Golden Gregory LLP

Government Investigations Team Insights - February 2025

AGG’s Government Investigations Team Insights provides periodic updates covering legal and regulatory topics. Our team, which includes former federal prosecutors and federal agency attorneys, has successfully represented...more

Pietragallo Gordon Alfano Bosick & Raspanti,...

The Emergency Room—The Front Door to the Hospital (Fraud Schemes)?

Fraud related to hospital services – both inpatient and outpatient – has led to over $511 million in damages and hundreds of millions of dollars in False Claims Act (FCA) settlements over the past 15 years. The ER has been...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 — FCA Enforcement in Value-Based Care Arrangements Heated Up in 2024 and Likely to Remain a Priority in 2025

Value-based care (VBC) is a health care delivery model that has grown increasingly common in recent years. Perhaps unsurprisingly, this growth seems to have attracted the attention of government enforcement agencies...more

Mintz - Health Care Viewpoints

EnforceMintz — 2024’s Key False Claims Act Settlements Involving Hospitals and Health Systems: Continued Focus on Stark Law and...

In 2024, the Department of Justice (DOJ) resolved several noteworthy False Claims Act (FCA) cases against hospitals and health systems. In particular, DOJ obtained a number of large recoveries in cases where Stark Law and...more

Proskauer - Health Care Law Brief

OIG Releases Special Fraud Alert About Suspect Payments in Marketing Arrangements Related to Medicare Advantage and Providers

On December 11, 2024, the Office of Inspector General for the U.S. Department of Health and Human Services (“OIG”) issued a special fraud alert warning about certain marketing schemes that involve questionable payments and...more

Mintz - Health Care Viewpoints

Key Takeaways from the OIG’s New Compliance Program Guidance for Skilled Nursing Facilities

As part of its Modernization Initiative, the Department of Health and Human Services’ Office of Inspector General (OIG) recently published its first industry-segment specific Compliance Program Guidance, which focuses on...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

Foley & Lardner LLP

Compliance Compass: The Erlanger Complaint – A Cautionary Reminder About the Importance of FMV

Foley & Lardner LLP on

Although most health care lawyers and compliance officers who review and analyze physician compensation understand that fair market value (FMV) is important, the nuances around FMV are sometimes missed....more

ArentFox Schiff

Investigations Newsletter: FCA Enforcement & Compliance Digest — Summer 2024 False Claims Act Newsletter

ArentFox Schiff on

Welcome to the Summer 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...more

NAVEX

The Supreme Court Made Its Rulings; Corporate Compliance Needs March On

NAVEX on

At the end of June, the U.S. Supreme Court issued major decisions on the enforcement power of the Securities and Exchange Commission, what does or doesn’t qualify as a bribe of government officials, and on federal judges’...more

K&L Gates LLP

The False Claims Act and Health Care: 2023 Recoveries and 2024 Outlook

K&L Gates LLP on

On 22 February 2024, the US Department of Justice (DOJ) published the statistics for federal civil fraud recoveries in Fiscal Year (FY) 2023. The DOJ announced that the “government and whistleblowers were party to 543...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

Foley & Lardner LLP

Health-Care Fraud Scrutiny Heats Up For Companies, Providers

Foley & Lardner LLP on

This year will see a continued proliferation of enforcement against health-care fraud, with old and new theories. Some hot spots for enforcement will involve cases about new technologies; data outliers; entities perceived as...more

Morrison & Foerster LLP

True Facts About False Claims: MoFo's FCA Newsletter - December 2024

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: Binance to Pay Historic $4 Billion Fine

ArentFox Schiff on

Binance to Pay Historic $4 Billion Fine - Binance Holdings Limited, the operator of the world’s largest cryptocurrency exchange, agreed to pay $4.3 billion to resolve allegations that it violated the Bank Secrecy Act (BSA)...more

McDermott Will & Emery

OIG Issues General Compliance Program Guidance Updates

McDermott Will & Emery on

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

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

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