News & Analysis as of

Department of Justice (DOJ) National Institute of Health (NIH) False Claims Act (FCA)

Cooley LLP

NIH Announces New Antidiscrimination Certification Heightening FCA Risk for Some Life Sciences Companies

Cooley LLP on

On April 21, 2025, the National Institutes of Health (NIH) announced a new civil rights term and condition of award for NIH grants, cooperative agreements and other transaction awards. The new term states that recipients of...more

Health Care Compliance Association (HCCA)

Delayed Action on Misconduct Costs Firm $4M; FCA Whistleblower Flagged Earlier Application

Scientist and pharmaceutical researcher Andrew P. Mallon—who first reported to NIH and others in 2016 his suspicions that then-Athira Pharma CEO Leen Kawas falsified data in published papers—filed the whistleblower suit...more

ArentFox Schiff

Investigations Newsletter: Federal Government Urges Court of Appeals to Uphold Constitutionality of FCA Qui Tam Provisions

ArentFox Schiff on

Federal Government Urges Court of Appeals to Uphold Constitutionality of FCA Qui Tam Provisions - In a brief filed earlier this week, the US federal government has urged the Eleventh Circuit Court of Appeals to uphold the...more

Health Care Compliance Association (HCCA)

NIH Disavows China Initiative, Offers ‘Trusted Asians’ Support But Cases, Questions Linger

In recent months, NIH signaled that it, in the words of Director Monica Bertagnolli, understands the “difficult climate for our valued Asian American, Asian immigrant and Asian research colleagues who may feel targeted and...more

Morrison & Foerster LLP

True Facts About False Claims: MoFo's FCA Newsletter - July 2024

Designed for busy in-house counsel and compliance professionals, this newsletter seeks to bring you up to speed on key federal and state False Claims Act (FCA) developments, with links to primary resources. Each quarter, we...more

Health Care Compliance Association (HCCA)

Cleveland Clinic Pays $7.6M Related to PI Whose Charges Were Dropped; ‘He Was Treated Horribly’

Attorney Peter Zeidenberg was surprised to learn that NIH had successfully clawed back $3.6 million—plus a nearly 100% penalty—from Cleveland Clinic. The Department of Justice (DOJ) claimed the award funds were ill-gotten...more

Benesch

The “China Initiative” Just Won’t Die - Recent DOJ Settlement Highlights the Lasting Effect of Trump-Era Policy on Health Care...

Benesch on

In 2022, the United States Department of Justice (“DOJ”) announced its decision to shut down the “China Initiative”—the controversial program used to investigate and prosecute academics, health care workers, and...more

Morrison & Foerster LLP

True Facts About False Claims: MoFo's FCA Newsletter - July 2023

Designed for busy in-house counsel and compliance professionals, this newsletter seeks to bring you up to speed on key federal and state False Claims Act (FCA) developments, with links to primary resources. Each quarter, we...more

Health Care Compliance Association (HCCA)

[Virtual Event] 2022 Research Conference - October 6th, 8:25 am - 4:30 pm CDT

Stay on top of the latest in research compliance - Do you want to learn: - Current best practices for building and maintaining a  research compliance work plan? - How to better shift your program’s research focus in...more

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 18, Number 9. In This Month’s E-News: September 2021

Report on Research Compliance 18, no. 9 (September, 2021) - A former Harvard Medical School and Massachusetts General Hospital (MGH) researcher who was the principal investigator on a 2014 NIH award of $939,495.27 and...more

King & Spalding

Heightened Focus on Foreign Influence in Academia

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Department of Education Report Warns that Academic Institutions Are Failing to Meet Compliance Obligations in Fight Against Foreign Influence Last month the Department of Education (“DOE” or “Department”) released an...more

Health Care Compliance Association (HCCA)

Scripps Pays $10M for Alleged FCA Violations; Whistleblower Warned of 'Soft Money Policy'

Report on Research Compliance 17, no. 10 (September 24, 2020) What the federal government—and a whistleblower—allege were False Claims Act (FCA) violations actually resulted from an “accounting discrepancy,” according to the...more

ArentFox Schiff

Investigations Newsletter: Engineering Firm Settles $37 Million False Claims Act Allegations

ArentFox Schiff on

Engineering Firm Settles $37 Million False Claims Act Allegations - As part of a settlement agreement with the Department of Justice, QuantaDyn Corporation has agreed to pay $37,757,713.91 in restitution to resolve...more

Cozen O'Connor

COVID-19 Drug Availability | Federal Banking Rule vs. State Usury Laws | Kickbacks For Pain Meds

Cozen O'Connor on

COVID-19- Bipartisan Group of Attorneys General Seeks to Expand Production of Antiviral Drug- A bipartisan group of 34 AGs, led by California AG Xavier Becerra and Louisiana AG Jeff Landry, sent a letter urging the U.S....more

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 17, Number 6. In This Month's E-News: June 2020

Report on Research Compliance 17, no. 6 (June 2020) - A former assistant veterinary medicine professor at the University of Maryland will retract or correct seven papers published from 2013 to 2016 that contained reused or...more

King & Spalding

DOJ Announces FCA Settlement with NIH-Funded Institute Related to Disclosure of Foreign Influence in Research

King & Spalding on

The Department of Justice (DOJ) recently announced that it reached a $5,500,000 settlement with a biomedical research institute that received NIH grant funding–the Van Andel Research Institute (VARI)–to resolve allegations...more

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 17, Number 3. In This Month's E-News: March 2020

Report on Research Compliance 17, no. 3 (February 20, 2020) - Despite its earlier agreement to repay just $5,442 in costs questioned by the National Science Foundation (NSF) Office of Inspector General, the University of...more

Health Care Compliance Association (HCCA)

After $5.5M FCA Settlement, Institutions Face Bigger Risks for Mishandling Foreign Support

Report on Research Compliance 17, no. 2 (January 23, 2020) - Acting with “deliberate ignorance” and “reckless disregard” are not words that any institution wants to hear associated with its name. But these are at the heart...more

Polsinelli

DOJ’s False Claims Act Recoveries Rise to More Than $3 Billion in FY2019, With Continued Emphasis on Health Care Fraud Cases

Polsinelli on

On January 9, 2020, the Civil Division of the U.S. Department of Justice (DOJ) announced that it recovered over $3 billion from civil False Claims Act (FCA) judgments and settlements in the fiscal year ending September 30,...more

Troutman Pepper Locke

When Research Misconduct Violates the False Claims Act: Lessons from Duke's $112.5M Settlement

Troutman Pepper Locke on

On March 25, the U.S. Department of Justice (DOJ) announced that Duke University agreed to settle a False Claims Act qui tam action alleging widespread misconduct in federally funded research. ...more

McCarter & English, LLP

Universities Are Prime Targets for False Claims Act Liability

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Colleges and universities receive billions of dollars in federal funds, whether through research grants or student financial aid, or even by billing Medicare or Medicaid for services rendered at academic medical centers. As a...more

Dorsey & Whitney LLP

DOJ Files FCA Complaint Against Recipient of Grant Funding

Dorsey & Whitney LLP on

The FCA began as a response to procurement fraud by military contractors during the Civil War. In the intervening years, its reach has extended and increasingly the government is using the FCA as a tool in the context of...more

McGuireWoods LLP

Washington Healthcare Update

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This Week: The President took a victory lap in Wisconsin, announcing that 20 million people have gained health insurance through the Affordable Care Act... That figure includes people newly covered through insurance...more

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