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First Circuit Clarifies FCA Liability Standard for AKS Violations, Deepening Circuit Split

The First Circuit has issued its long-anticipated opinion in United States v. Regeneron Pharmaceuticals, Inc., clarifying the standard for establishing False Claims Act (“FCA”) liability based on Anti-Kickback Statute (“AKS”)...more

OIG Reaffirms Its Concern About “Carving Out” Federal Health Care Program Business

Last month, the Office of Inspector General (OIG) for the U.S. Department of Health and Human Services reaffirmed its longstanding position that an arrangement that “carves out” Federal health care program (FHCP) business is...more

Another Resolution by DOJ Pursuant to its Civil Cyber-Fraud Initiative Highlights Continued Efforts to Hold Companies Accountable...

We previously wrote about the United States Department of Justice’s (“DOJ”) Civil Cyber-Fraud Initiative (“CCFI”), which “aims to hold accountable entities or individuals that put U.S. information or systems at risk by...more

OIG Issues Special Fraud Alert Regarding Telemedicine Arrangements

On July 20, 2022, the Office of Inspector General for the Department of Health and Human Services (“OIG”) issued a special fraud alert (“Alert”) advising “practitioners to exercise caution when entering into arrangements with...more

DOJ’s Civil Cyber-Fraud Initiative Secures More Than $9 Million in Two False Claims Act Settlements for Alleged Cybersecurity...

Last fall, the United States Department of Justice (“DOJ”) launched its Civil Cyber-Fraud Initiative (“CCFI”) as part of its effort to “combat new and emerging cyber threats to the security of sensitive information and...more

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