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Statutory Interpretation Anti-Kickback Statute

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

ArentFox Schiff

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

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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...

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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

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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

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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

Burr & Forman

Federal Agency Deference Eliminated, Now What?

Burr & Forman on

On June 28, 2024, the U.S. Supreme Court issued a decision that overrules the “Chevron doctrine.”  This means that federal agencies are limited in their ability to rely on their own interpretation of the laws they...more

Stevens & Lee

Welcome to the Post-Chevron World: HHS on the Defensive

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The Supreme Court’s recent ruling in Loper Bright Enterprises v. Raimondo (and its companion case, Relentless v. Department of Commerce), in which it overruled the Chevron doctrine, has received a great deal of attention...more

Robinson+Cole Health Law Diagnosis

OIG Issues Favorable Advisory Opinion Regarding Home Health Agency’s Proposal to Pay Tuition Costs for New Employees

On February 14, 2022, the Office of Inspector General (OIG) issued Advisory Opinion No. 22-03 (Advisory Opinion) regarding a home health agency’s (Requestor) proposal to pay nurse aide certification tuition costs on behalf of...more

Arnall Golden Gregory LLP

OIG’s First Advisory Opinion of 2022 Allows for Expansion of Discount Programs

On January 19, 2022, the Department of Health and Human Services, Office of Inspector General (“OIG”) released a favorable advisory opinion, OIG Advisory Opinion No. 22-01 (the “Opinion”), analyzing a proposed expansion of...more

Robinson+Cole Health Law Diagnosis

OIG Advisory Opinion No. 19-02 Allows Pharmaceutical Manufacturer to Temporarily Loan Smartphones to Financially Needy Patients to...

On January 24, 2019, the Office of Inspector General (“OIG”) issued a favorable advisory opinion allowing a pharmaceutical manufacturer (“Manufacturer”) to temporarily loan limited-functionality smartphones to financially...more

Robinson+Cole Health Law Diagnosis

OIG Issues Favorable Advisory Opinion for Trust Donations to Public-Private Research Institute Affiliated with a Health System...

On November 6, 2018, the Office of Inspector General (OIG) of the Department of Health and Human Services published a favorable Advisory Opinion regarding a proposed arrangement comprised of substantial donations that were...more

Ballard Spahr LLP

D.C. Circuit Rules CFPB’s View of RESPA Was Wrong But its Structure is Constitutional

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On January 31, 2018, the en banc D.C. Circuit handed down its opinion in the PHH v. CFPB case, which we’ve discussed at length. It held, 7 to 3, that the CFPB’s single-director-removable-only-for-cause structure is...more

Bricker Graydon LLP

PHH’s hidden gem

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The long-awaited en banc decision in PHH Corp., v. CFPB has finally been issued. The Court of Appeals for the D.C. Circuit upheld the constitutionality of the Consumer Financial Protection Bureau (CFPB) and reversed a prior...more

Poyner Spruill LLP

CFPB Declared Unconstitutional

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The United States Court of Appeals for the District of Columbia Circuit today ruled on a critical case “about executive power and individual liberty.” In the matter of PHH Corporation, et. al., v. the Consumer Financial...more

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