A circuit split over the causation standard under the federal Anti-Kickback Statute (AKS) could grow wider after a recent Northern District of Illinois (NDIL) decision. In United States ex rel. Jeffrey Wilkerson & Larry...more
As detailed in Part I of our three-part series on Minimizing Customs Enforcement and False Claims Act Risks, the combination of the new high-tariff environment, the heightened ability of Customs (and the general public) to...more
4/25/2025
/ Anti-Dumping Duty ,
Classification ,
Compliance ,
Countervailing Duties ,
Country of Origin ,
Customs and Border Protection ,
Duty Free ,
Enforcement Actions ,
False Claims Act (FCA) ,
Free Trade Agreements ,
Imports ,
International Trade ,
Misclassification ,
Misrepresentation ,
Penalties ,
Risk Management ,
Tariffs ,
Valuation
As detailed in our prior article on “What Every Multinational Company Should Know About … The Rising Risk of Customs False Claims Act Actions in the Trump Administration,” the Department of Justice (DOJ) is encouraging the...more
4/10/2025
/ Customs and Border Protection ,
Department of Justice (DOJ) ,
Enforcement ,
False Claims Act (FCA) ,
Imports ,
International Trade ,
Multinationals ,
Penalties ,
Risk Management ,
Settlement ,
Tariffs
President Trump’s January 21 Executive Order targeting Diversity, Equity, and Inclusion Programs (DEI) (the “January 21 Executive Order”) and, specifically, § 3(b)(iv)) (the Certification Provision) cannot be the basis for...more
On February 20, 2025, the Deputy Assistant Attorney General for the Commercial Litigation Branch at the U.S. Department of Justice (DOJ), Michael Granston, emphasized using the False Claims Act (FCA) to address U.S. Customs &...more
3/7/2025
/ Compliance ,
Customs and Border Protection ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Globally Harmonized System ,
Imports ,
International Trade ,
Misclassification ,
Section 301 ,
Supply Chain ,
Tariffs ,
Trump Administration ,
US Enforce and Protect Act (EAPA) ,
Whistleblowers
In our July 15, 2024 post, we analyzed the Supreme Court’s landmark case Loper Bright Enterprises v. Raimondo and the opportunities the decision might offer False Claims Act (FCA) defendants. As a brief reminder, Loper Bright...more
On September 17, 2024, the Office of Research Integrity (ORI) issued a final rule adopting changes to federal regulations governing research misconduct involving federally funded research (Final Rule). The regulations have...more
9/25/2024
/ Appeals ,
Confidential Information ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Documentation ,
False Claims Act (FCA) ,
Final Rules ,
Fraud ,
HHS Office of Research Integrity (ORI) ,
Investigations ,
New Regulations ,
Plagiarism ,
Public Health Service (PHS) ,
Statute of Limitations ,
Transcripts ,
Willful Misconduct
The demise of Chevron opens up new potential defenses in False Claims Act (FCA) cases.
On June 28, 2024, the Supreme Court, in Loper Bright Enterprises v. Raimondo, put an end to Chevron deference to agency interpretation...more
The Department of Justice’s (DOJ) annual False Claims Act (FCA) press release revealed that it increased self-initiated investigations for the federal fiscal year ending September 30, 2023, by 1.5 times over the prior year....more
On October 5, 2023, the Office of Research Integrity (ORI) of the Department of Health and Human Services (HHS) issued a notice of proposed rulemaking to update the Public Health Service (PHS) Policies on Research Misconduct...more
On June 16, 2023, the Supreme Court of the United States issued an 8–1 decision in United States ex rel. Polansky v. Executive Health Resources, Inc., pertaining to the government’s authority to dismiss False Claim Act (FCA)...more
The Supreme Court today issued its ruling on one of the most significant False Claims Act (FCA) cases it has considered in the last several years. In the consolidated cases of United States ex rel. Schutte et al. v. SuperValu...more
The Supreme Court has agreed to review Seventh Circuit rulings in a critical pair of False Claims Act (FCA) cases that will have a significant impact on whether FCA defendants can continue to argue that an objectively...more
On December 27, 2022, the Centers for Medicare & Medicaid Services (CMS) published a proposed rule which, in part, seeks to amend the existing regulations for Medicare Parts A, B, C, and D regarding the standard for when an...more
1/3/2023
/ Affordable Care Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Civil Monetary Penalty ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Medicare Advantage ,
Medicare Part A ,
Medicare Part B ,
Medicare Part C ,
Medicare Part D ,
OIG ,
Overpayment ,
Proposed Rules
The Office of Inspector General of the U.S. Department of the Health and Human Services (OIG) recently changed the language describing a compliance officer’s role in relation to other responsibilities he or she may have...more
The Eighth Circuit Court of Appeals’ recent ruling in United States ex rel. Cairns v. D.S. Med., LLC is a significant win for defendants facing False Claims Act (FCA) claims based on alleged violation of the Anti-Kickback...more
On June 7, 2022, Governor Jared Polis signed into law the Colorado False Claims Act (CFCA) at Colo. Rev. Stat. Ann. § 24-31-101 et seq. The CFCA is largely based on the Federal False Claims Act (FCA), but is not an exact...more
We invite you to enjoy a review of the food and beverage industry with bite size articles ranging from regulatory and real estate trends to litigation and M&A happenings.
The past two years have seen significant changes...more
6/2/2022
/ American Rescue Plan Act of 2021 ,
Beverage Manufacturers ,
Coronavirus/COVID-19 ,
Department of Justice (DOJ) ,
Enforcement ,
False Claims Act (FCA) ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Food Manufacturers ,
Investigations ,
Paycheck Protection Program (PPP) ,
Putative Class Actions ,
SBA ,
Whistleblowers
In a 2-1 opinion issued on April 5, the Seventh Circuit Court of Appeals again held that an objectively reasonable interpretation of a relevant statute or regulation precludes the required finding of intent under the False...more
The Fourth Circuit Court of Appeals is now the latest in a growing number of courts holding that an objectively reasonable interpretation of governing law defeats the requisite element of intent or “scienter” under the False...more
On February 1, 2022, the Department of Justice (DOJ) issued its annual release touting its latest accomplishments in the False Claims Act field, advertising another multibillion-dollar year in recoveries; $5.6 billion makes...more
When a company decides to self-disclose misconduct (or conduct that may be construed as such) to the government, that decision triggers a stream of additional questions. In the weighty deliberations about whether and what to...more
12/2/2021
/ Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Disclosure Requirements ,
False Claims Act (FCA) ,
Health Care Providers ,
Healthcare ,
Healthcare Fraud ,
Legal Representatives ,
Liability ,
OIG ,
Self-Disclosure Requirements ,
Suppliers
In a much-awaited Seventh Circuit decision, the court joined four other circuits in endorsing the “objective reasonableness” defense under the federal False Claims Act (FCA). In a 2-1 panel decision, the court not only upheld...more
8/30/2021
/ Centers for Medicare & Medicaid Services (CMS) ,
Corporate Counsel ,
Drug Pricing ,
Fair Credit Reporting Act (FCRA) ,
False Claims Act (FCA) ,
Medicaid ,
Medicare Part D ,
Price Match Guarantees ,
SCOTUS ,
Summary Judgment ,
Wal-Mart
On July 1, 2021, United States Attorney General Merrick Garland rescinded the Brand Memorandum and the Sessions Memorandum, which directed Department of Justice (DOJ) attorneys to refrain from using agency guidance to bring...more
On Monday February 22, 2021, the U.S. Supreme Court declined to grant certiorari in CareAlternatives v. United States (CareAlternatives), a case on appeal from the Third Circuit that could have assessed the issue of...more