The US Department of Justice Antitrust Division (DOJ or Division) recently released a revised Evaluation of Corporate Compliance Programs in Criminal Antitrust Investigations (Guidance). The Guidance reflects how the Division assesses the effectiveness and adequateness of a company’s antitrust compliance program. The Guidance offers insight into the Division’s evaluations of antitrust compliance programs at the charging and the sentencing stages of a criminal prosecution but is equally applicable to civil compliance. Adherence to the Guidance improves the chances a company can receive leniency and reduces the risk of prosecution should a violation occur.Continue Reading Antitrust Corporate Compliance Programs: Late 2024 Changes Mean Companies Should Revisit Their Programs Early in 2025

In United States ex rel. Silver v. Omnicare, Inc., et al. (D.N.J. No. 11-cv-01326), a whistleblower relator consistently alleged that certain pharmaceutical service providers have engaged in an illegal kickback arrangement and defrauded the government by offering unreasonably low prices to nursing homes for Medicare Part A patients’ prescription drugs in exchange for the opportunity to provide the same drugs at much higher costs to the nursing homes’ Medicaid and Medicare Part D patients for reimbursement. In a recent Order, the federal district court in New Jersey revived previously dismissed claims and permitted the relator to file a new, and fourth, amended complaint that asserts a new theory of liability to buttress the core kickback scheme allegations. The new complaint asserts that prescription drug event (PDE) data and enrollee encounter data are “claims for payment” under the False Claims Act (FCA)—and that even accurate PDE data can be a “false claim” under the FCA in cases where a pharmacy is alleged to pay kickbacks to its customers.
Continue Reading How the Truth Is False: Accurate Prescription Drug Event Data Can Trigger False Claims Act Liability