News & Analysis as of

Statutory Interpretation Healthcare Fraud

Foley Hoag LLP - White Collar Law &...

Federal District Court Upholds HHS Advisory Opinion Blocking Fertility Assistance Program

A recent decision from the United States District Court for the District of Columbia continues to give significant deference to the U.S. Department of Health and Human Services’ (HHS) interpretation of the Anti-Kickback and...more

Arnall Golden Gregory LLP

A Constitutional Perspective on False Claims Act Penalties: District Court Finds That Penalties Conflict With Constitution’s...

In a potential watershed decision issued on February 26, 2025, the United States District Court for the Northern District of Texas ruled, in U.S. ex rel. Taylor v. Healthcare Associates of Texas, that the civil penalties...more

ArentFox Schiff

Vertex’s Attempt to Redefine AKS Falls Short: Key Insights for Pharma Manufacturers

ArentFox Schiff on

In a series of recent legal challenges initiated by the pharmaceutical industry against the US Department of Health and Human Services Office of the Inspector General (OIG), manufacturers have contested the OIG’s...more

McCarter & English, LLP

Federal Courts Decide on FCA Claims Actions

There are still several unsettled legal issues regarding the standards applicable to a False Claims Act (FCA) claim, such as the standard to prove causation when an FCA claim is based on a violation of the Anti-Kickback...more

Epstein Becker & Green

What Does the Phrase “Resulting From” Mean? Circuit Courts Split on Standard for Determining When an AKS Violation Is a False...

Epstein Becker & Green on

Dating back to the 19th century, the U.S. Supreme Court has held that when construing a statute, the courts are to “give effect, if possible, to every clause and word of a statute, avoiding, if it may be, any construction...more

Harris Beach Murtha PLLC

First Circuit Decision Raises Bar on Anti-Kickback Statute-Premised Liability Under the False Claims Act

The United States Court of Appeals for the First Circuit recently joined the Sixth Circuit (2023) and Eighth Circuit (2022) in holding that the term “resulting from” in the Federal Anti-Kickback Statute (“AKS”) (as amended in...more

Lowenstein Sandler LLP

Circuit Split Deepens on Anti-Kickback Statute’s Causation Standard

Lowenstein Sandler LLP on

Introduction: In its recent decision in United States v. Regeneron Pharmaceuticals, Inc., the United States Court of Appeals for the First Circuit deepened an existing federal circuit court split regarding the causation...more

WilmerHale

First Circuit Adopts “But For” Causation Standard under the Anti-Kickback Statute, Paving the Way for Potential Supreme Court...

WilmerHale on

Last week, the First Circuit Court of Appeals issued its long-awaited decision in United States v. Regeneron Pharmaceuticals with significant implications for health care companies facing allegations of violations of the...more

Goodwin

First Circuit Adopts Defense-Friendly “But-For” Causation Standard for AKS-Predicated FCA Claims

Goodwin on

In a unanimous panel opinion filed on February 18, 2025, the First Circuit held that False Claims Act cases predicated on violations of the Anti-Kickback Statute (“AKS”), require proof that alleged kickbacks were the...more

Foley & Lardner LLP

Anti-Kickback Statute Premised False Claims Cases: The “But For” Causation Standard Finds Support from First Circuit

Foley & Lardner LLP on

It’s now 3–1, with the First Circuit (2025) aligning with the Sixth (2023) and Eighth (2022) Circuits finding the meaning of the words “resulting from” — as used in a 2010 amendment to the federal Anti-Kickback Statute (AKS)...more

Foley Hoag LLP - White Collar Law &...

District Court Grants Summary Judgment Win to False Claims Act Defendants, Adopting But-For Causation Standard for Claims Based on...

Courts continue to reject aggressive Anti-Kickback Statute (“AKS”) allegations. Most recently, on January 6, 2025, Judge Patti Saris of the U.S. District Court for the District of Massachusetts dismissed a qui tam action...more

Jones Day

Fourth Circuit Limits Who Can Act "Knowingly" Under False Claims Act

Jones Day on

Health care industry participants frequently operate under nuanced legal frameworks that apply to the receipt of government funds. A breach of these regulations can open the door to draconian liability under the FCA even when...more

Proskauer - Health Care Law Brief

False Claims Act Spotlight (3 of 3): Changing Landscape of the FCA in the Courts

On August 12, 2021, a panel of the Seventh Circuit voting 2-1 endorsed the existence of an “objective reasonableness” defense under the FCA. United States ex rel. Schutte v. SuperValu, Inc., No. 11-cv-3290, 2021 WL 3560894...more

Morgan Lewis

Seventh Circuit Creates Third Standard in FCA Dismissal Authority Circuit Split

Morgan Lewis on

The Seventh Circuit’s novel statutory interpretation of the government’s dismissal authority under 31 USC § 3730(c)(2)(A) may have unintended consequences. ...more

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