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HHS Corporate Integrity Agreements: A Year in Review

In 2022, the Department of Health and Human Services Office of Inspector General (OIG) entered into 31 new corporate integrity agreements (CIAs) with companies and individuals in lieu of exercising its permissive exclusion...more

Deputy Attorney General Monaco Announces Additional Measures Targeting Corporate Criminal Conduct: The Impact for Life Sciences...

In a speech on September 15, 2022, Deputy Attorney General (DAG) Lisa Monaco announced several important updates to the U.S. Department of Justice’s (DOJ’s) approach to investigating and prosecuting corporate crimes. These...more

DOJ-Initiated False Claims Act Activity on the Rise

Key Points The volume of new False Claims Act (FCA) case filings remained high in 2021, and the Department of Justice (DOJ) collected more than $5.6 billion in settlements and judgments — the second-largest annual total in...more

HHS-OIG Signals Increasing Skepticism of Speaker Programs, Identifies Practices That Raise Compliance Red Flags

On November 16, 2020, the Office of the Inspector General of the Department of Health and Human Services (HHS-OIG) issued a Special Fraud Alert regarding the inherent fraud and abuse risks associated with...more

"Trends in Corporate Integrity Agreements Reflect New HHS OIG Guidance on Use of Exclusion Authority"

2016 was a year of change for the Department of Health and Human Service's Office of Inspector General's (OIG) approach to corporate integrity agreements (CIA). The OIG began to use its new model CIA format and applied its...more

"FDA Publications Double Down on Agency’s Ability to Prohibit Off-Label Communications, but Narrow Scope of Debate"

On the eve of a change in administration, the U.S. Food and Drug Administration (FDA or the Agency) released a flurry of documents regarding off-label communications and FDA’s ability to regulate such communications within...more

Supreme Court Holds That Violations of the False Claims Act’s Seal Requirements Do Not Require Automatic Dismissal

On December 6, 2016, the Supreme Court of the United States ruled unanimously in State Farm Fire and Casualty Co. v. United States ex rel. Rigsby that violations of the False Claims Act’s (FCA) seal requirement do not require...more

"Escobar and the Implied Certification Theory: Initial Cases Raise the Bar on Materiality in False Claims Act Litigation"

On June 16, 2016, the U.S. Supreme Court in Universal Health Services, Inc. v. United States ex rel. Escobar1 (Escobar) unanimously upheld the implied certification theory of False Claims Act (FCA) liability and strengthened...more

Insights Conversations: How Government Health Care Investigations May Be Shifting

The Department of Justice (DOJ) has long had the advantage when investigating False Claims Act (FCA) cases against health care companies. However, recent changes in the courts, including a unanimous U.S. Supreme Court...more

"In Escobar, Supreme Court Upholds False Claims Act’s Implied Certification Theory"

On June 16, 2016, the U.S. Supreme Court in Universal Health Services v. United States ex rel. Escobar unanimously upheld the implied certification theory of False Claims Act (FCA) liability. The Court ruled that a party can...more

"New HHS OIG Criteria to Guide Resolution of Health Care Investigations"

The Office of Inspector General of the Department of Health and Human Services (OIG) has issued updated guidance on the use of its so-called permissive exclusion authority under Section 1128(b)(7) of the Social Security Act...more

"One-Two Punch: Amarin Settlement Order and Vascular Solutions Acquittal Further Erode Off-Label Promotion Enforcement Regime"

In an apparent first, the U.S. Food and Drug Administration (FDA) has conceded that a pharmaceutical company may engage in truthful and nonmisleading speech promoting the off-label use of a prescription drug. This concession...more

"Financial Relationships Likely to Be a Focus in Life Sciences Enforcement and Litigation"

For more than a decade, the Department of Justice (DOJ) has zealously pursued enforcement actions against the health care industry. Given the continued growth in government spending on health care and the billions of dollars...more

"The Future of Government Regulation, Enforcement of Off-Label Promotion"

Three years ago, in United States v. Caronia, the U.S. Court of Appeals for the Second Circuit held that the Federal Food, Drug and Cosmetic Act (FDCA) neither prohibits nor criminalizes truthful, nonmisleading speech that...more

"Department of Justice Issues Guidance to Criminal and Civil Prosecutors to Facilitate Individual Prosecutions in Corporate...

On September 9, 2015, the Department of Justice (the Department) publicly announced that it had issued guidance to its criminal and civil prosecutors that purports to change, at least in part, the Department’s approach to...more

"U.S. v. Novartis: Reaffirming the Importance of Updating and Adhering to Corporate Policies"

A recent decision in a false claims act case, United States ex rel. Bilotta v. Novartis Pharmaceuticals Corporation (Novartis), underscores the importance of policing employee adherence to corporate policies and industry...more

"Is the DOJ FCPA Enforcement Hegemony Dead?"

For nearly 15 years, the United States has had the worldwide corruption enforcement stage to itself, reaping billions of dollars in fines and settlement payments from companies that have acknowledged engaging in bribery in...more

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