News & Analysis as of

False Claims Act (FCA) Medical Research

Holland & Knight LLP

New Requirements for Research Security Programs Raise the Stakes for Compliance

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The National Security Presidential Memorandum-33 (NSPM-33), issued in January 2021, directed federal agencies that fund research and development (R&D) projects to require certain "Covered Institutions" to certify that the...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

Society of Corporate Compliance and Ethics...

[Event] Higher Education & Healthcare Research Compliance Conference - June 10th - 12th, New Orleans, LA

Don’t miss our annual conference devoted to higher education and research compliance - Attend the Higher Education & Healthcare Research Compliance Conference June 10–12, 2024 and hear from experienced professionals on a...more

Health Care Compliance Association (HCCA)

Moffitt Center’s FCA Settlement is First of 2024; Questions Surround Nature of Billing Errors

Moffitt Cancer Center’s recent $19.5 million settlement with the U.S. Department of Justice (DOJ) and the state of Florida resolving allegations that billing errors violated the False Claims Act (FCA) triggered a “fully...more

BakerHostetler

Healthcare Industry Team 2023 Year in Review

BakerHostetler on

As we approach the conclusion of another transformative year, we are excited to present our comprehensive year-end review, shedding light on the trends shaping the healthcare market in 2023. Our team’s keen insights and...more

Health Care Compliance Association (HCCA)

DOJ: Stanford FCA Case Involved Failures to Disclose Foreign Support From Seven Countries

Report on Research Compliance 20, no. 11 (November, 2023) It wasn't just China. China is among the countries whose support for Stanford University investigators wasn’t reported to five federal research funding agencies,...more

Health Care Compliance Association (HCCA)

[Virtual Event] Healthcare Enforcement Compliance Conference - November 7th - 9th, 8:55 am - 3:30 pm CST

Hear directly from the enforcement community - Want to gain insight into properly monitoring, detecting, investigating, and managing violations? Join us virtually at HCCA’s Annual Healthcare Enforcement Compliance...more

Benesch

Dialysis & Nephrology Digest - March 2022

Benesch on

CMS calls for applications for second cohort of KCC Model; deadline set for Mar. 25 - The Center for Medicare and Medicaid Innovation says performance period participation agreements for the CMS Kidney Care First Option...more

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 18, Number 11. In This Month’s E-News: November 2021

Report on Research Compliance 18, no. 11 (November, 2021) - A professor in the University of Washington (UW) College of Engineering allegedly falsified award documents submitted to the National Science Foundation (NSF)...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

Akin Gump Strauss Hauer & Feld LLP

NIH Continues to Focus on Foreign Influence Issues: Updated Biosketch & Other Support Disclosure Forms

Key Points - Notice reflects NIH’s continued concerns regarding foreign influence and imposes significant new compliance obligations on both grantees and individual researchers. - Obligates grantees to provide NIH...more

Health Care Compliance Association (HCCA)

Lehigh U. Compliance Plan Provides Blueprint for Oversight, Audit Schedule

Report on Research Compliance 17, no. 9 (August 20, 2020) - As part of its recent settlement with the Department of Justice regarding allegations of False Claims Act (FCA) violations, Lehigh University of Pennsylvania is...more

Health Care Compliance Association (HCCA)

Report on Research Compliance 17, no. 8: In This Month's E-News: August 2020

Report on Research Compliance 17, no. 8 (August 2020) - Higher education groups and others are hailing a decision by the administration to rescind planned rules that would have required students in the United States on...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

Morgan Lewis

Higher Education Community Faces Federal Scrutiny of Financial Ties to China

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Both individuals and higher education institutions could face criminal and civil liability if they are not in compliance with federal law in the administration of federal grants and expenditure of federal research dollars, as...more

King & Spalding

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

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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

Bricker Graydon LLP

Clinical trials and Medicare billing: Avoiding false claims liability

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Participating in clinical trials can leave health care providers vulnerable to false claims liability if Medicare rules are not closely followed. This publication reviews settlements involving clinical trials, provides an...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

Troutman Pepper

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

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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

Bricker Graydon LLP

Duke University to pay $112 million in research fraud settlement

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On March 25, 2019, the Department of Justice (DOJ) announced that Duke University agreed to settle a qui tam False Claims Act case for $112.5 million. The whistleblower, who pursued the case on the government’s behalf when...more

Foley & Lardner LLP

Scientific Research Misconduct vs. Fraud: How to Tell the Difference

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For years, misconduct in scientific research was policed primarily by the Office of Research Integrity (ORI) at the U.S. Department of Health and Human Services. After a lengthy and confidential review, an institution...more

Carlton Fields

Expect Focus – International, Summer 2015

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In This Issue: - TTIP’s Impact on U.S. and EU Trade Relations - Proposed Innovation Box Legislation - Justice Department Recovers Nearly $6 Billion From False Claims Act Cases in 2014 - Rules...more

Carlton Fields

Justice Department Recovers Nearly $6 Billion From False Claims Act Cases in 2014

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The U.S. Department of Justice (DOJ) obtained a record $5.69 billion in settlements and judgments from civil cases involving fraud and false claims against the government in fiscal year 2014. This marks the first time the DOJ...more

King & Spalding

Northwestern University Settles Cancer Research False Claims Act Lawsuit

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On July 30, 2013, the United States Attorney’s Office for the Northern District of Illinois announced that Northwestern University entered a settlement agreement to pay the United States $2.9 million to settle False Claims...more

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