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Health Care Providers › False Claims Act (FCA) › Regulatory Violations

Orrick, Herrington & Sutcliffe LLP

Medical Devices, Cybersecurity & The False Claims Act: What are the Key Takeaways from the Illumina - DOJ Settlement?

Orrick, Herrington & Sutcliffe LLP on

Illumina, Inc., a publicly-traded biotechnology company, agreed to a $9.8 million settlement with the U.S. Department of Justice (DOJ) in response to alleged violations of the False Claims Act (FCA). DOJ alleged that Illumina...more

Bass, Berry & Sims PLC

False Claims Act Settlements to Know from Q1 2024

Bass, Berry & Sims PLC on

Despite the recent downward trend in DOJ healthcare industry settlements, the first quarter of 2024 saw many noteworthy False Claims Act (FCA) and civil healthcare fraud settlements related to alleged kickbacks, medically...more

Dentons

DOJ Reports Record False Claims Act Settlements & Judgments in FY 2023

Dentons on

Fiscal year 2023 saw record recoveries and the highest number of settlements and judgments ever under the Federal False Claims Act. According to a new report released by the United States Department of Justice (“DOJ”), the...more

Robinson+Cole Health Law Diagnosis

DOJ Announces $3.8 Million Settlement to Resolve Allegations of False Claims Act and Anti-Kickback Statute Violations

Robinson+Cole Health Law Diagnosis on

On February 9, 2022, the United States Department of Justice (DOJ) announced a $3.8 million settlement with Catholic Medical Center (CMC) of Manchester, New Hampshire. This settlement resolves allegations that CMC violated...more

Jones Day

Fourth Circuit Limits Who Can Act "Knowingly" Under False Claims Act

Jones Day on

Health care industry participants frequently operate under nuanced legal frameworks that apply to the receipt of government funds. A breach of these regulations can open the door to draconian liability under the FCA even when...more

ArentFox Schiff

FDA Proposes to Revise “Intended Use” Regulations (Again) to Clarify that Knowledge Alone Is Not Sufficient to Establish Intent

ArentFox Schiff on

Last week FDA published a proposed rule that would revise the agency’s “intended use” regulations to clarify that a manufacturer’s knowledge of off-label use of its drug or device is, by itself, not sufficient to establish a...more

McDermott Will & Schulte

Healthcare Enforcement Quarterly Roundup - Q4 2019

McDermott Will & Schulte on

In this installment of the Healthcare Enforcement Quarterly Roundup we cover several topics that have persisted over the past few years and identify new issues that will shape the scope of enforcement efforts in 2020. In this...more

Bricker Graydon LLP

Recent Stark Act decision could have significant impact for employed physicians compensated based on personal productivity

Bricker Graydon LLP on

On September 17, 2019, the Third Circuit Court of Appeals issued a decision with potentially far-reaching consequences involving the Stark Act. The case, United States ex rel. Bookwalter v. UPMC, involves allegations that a...more

Farrell Fritz, P.C.

Kickback Arrangements – Cause for Alarm Beyond Federal Healthcare Programs

Farrell Fritz, P.C. on

Few, if any, in the medical industry are unfamiliar with the federal Anti-Kickback Statute (“AKS”). Under AKS, those giving or receiving compensation for referrals for items or services reimbursed by the federal healthcare...more

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