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Investigations False Claims Act (FCA)

Holland & Knight LLP

Final Medicare Overpayment Rules a Mixed Bag for Providers

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The Centers for Medicare & Medicaid Services (CMS) released highly anticipated updates this month to the Medicare regulations interpreting the federal 60-day overpayment refund requirement (the Overpayment Statute). 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

Health Care Compliance Association (HCCA)

In This Month’s E-News: November 2024

On the heels of a $7.6 million payment by Cleveland Clinic to settle allegations of False Claims Act (FCA) violations and unallowable sharing of passwords, Michael Lauer, NIH deputy director for extramural research, penned a...more

ArentFox Schiff

Investigations Newsletter: San Diego Physician and Medical Practice Pay $3.8 Million to Resolve FCA Allegations

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San Diego Physician and Medical Practice Pay $3.8 Million to Resolve FCA Allegations- San Diego-based physician Dr. Janette J. Gray and her former medical practice, The Center for Health & Wellbeing, agreed to pay $3.8...more

Mintz - Health Care Viewpoints

Federal District Court Holds FCA’s Private Whistleblower Provisions Unconstitutional

On September 30, 2024, a federal district court judge held that the qui tam provisions of the False Claims Act (FCA) violate the Appointments Clause of Article II of the Constitution. U.S. ex rel. Zafirov v. Fla. Med....more

Foley & Lardner LLP

Stung by Cybersecurity Noncompliance: DOJ Unveils its False Claims Act Complaint Against Georgia Tech

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Share on Twitter Print Share by Email Share Back to top As reported in our August 2024 client alert, earlier this year the U.S. Department of Justice (DOJ) intervened in a False Claims Act (FCA) matter initiated by two...more

Foley & Lardner LLP

Research Misconduct: ORI Issues Final Rule with Modernized and Streamlined Regulations

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On September 17, 2024, the Office of Research Integrity (ORI) issued a final rule adopting changes to federal regulations governing research misconduct involving federally funded research (Final Rule). The regulations have...more

Gardner Law

Kickbacks and Consequences: Lessons from the Innovasis Settlement

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On May 29, 2024, the U.S. Department of Health and Human Services’ Office of Inspector General (HHS OIG) announced a $12 million settlement with Innovasis Inc., a medical device manufacturer, and two of its senior executives...more

Holland & Hart LLP

Key Compliance Takeaways for Companies from the DOJ's New Corporate Whistleblower Program

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On August 1, 2024, the U.S. Department of Justice (“DOJ”) announced its new “Corporate Whistleblower Awards Pilot Program” (“DOJ Program”), a three-year initiative managed by DOJ’s Money Laundering and Asset Recovery Section....more

Womble Bond Dickinson

The Company You Keep: FCA Investigations of 8(a) Program Contractors

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Federal government contracts are routinely awarded to companies supplying goods and services to U.S. government agencies. According to the Government Accountability Office, in 2023, the federal government committed about $759...more

Proskauer - Health Care Law Brief

CMS Proposes Additional Modifications to the Overpayment Rule Relating to the Deadline for Reporting and Returning Overpayments

In the context of Medicare Advantage (“MA”) reform initiatives, we previously addressed the Centers for Medicare & Medicaid Services’ (“CMS”) December 27, 2022 proposal to amend its regulations set forth at 42 C.F.R. §...more

Benesch

Engaging in Activities that Violate Federal Law? DOJ Scrutiny of PPP Loan Recipients Turns to Ancillary Companies Supporting the...

Benesch on

Since its inception, the cannabis industry has always existed alongside significant regulatory and compliance challenges. These largely stem from the fact that the manufacture, distribution and possession of marijuana remains...more

Bradley Arant Boult Cummings LLP

FCA Settlements with Companies on Government Cybersecurity Concerns Continue

On Monday, June 17, 2024, the Department of Justice (DOJ) announced settlements involving $11.3 million in payments for consulting companies failing to comply with cybersecurity requirements in federally funded contracts. The...more

PilieroMazza PLLC

[Webinar] Common Scenarios Triggering False Claims Act Violations, Part 3: Claims and Investigations - July 2nd, 2:00 pm - 3:00 pm...

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In the highly regulated world of government contracting, strict adherence to compliance obligations and the ability to identify and manage associated risks are essential. This is the third and final webinar in PilieroMazza’s...more

Mintz - Health Care Viewpoints

DOJ Releases COVID-19 Fraud Enforcement Task Force Report Touting Its Successes and Urging Lawmakers to Enact New Legislation

The government’s continued dedication of resources to investigating and prosecuting fraud against COVID-19 pandemic relief programs appears to have borne fruit according to the results of the COVID-19 Fraud Enforcement Task...more

McDermott Will & Emery

[Webinar] 2024 Enforcement Outlook | Hot Topics and Emerging Trends in False Claims Investigations and Litigation - April 25th,...

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Join us for the next webinar in our Enforcement Outlook series, which will focus on the latest trends and hot topics surrounding the False Claims Act (FCA). Members of our White-Collar Practice Group will dive into how the...more

Bass, Berry & Sims PLC

The United States Intervenes in its First False Claims Act Cybersecurity Case

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The United States notified the U.S. District Court for the Northern District of Georgia that it plans to intervene in a False Claims Act case filed against Georgia Tech Research Corporation (Georgia Tech) by its Associate...more

Akin Gump Strauss Hauer & Feld LLP

Courts Should Finally Rule That the False Claims Act Qui Tam Provisions Are Unconstitutional

Last term, in U.S. ex rel. Polansky v. Exec. Health Res., Inc., three Justices noted that there are “substantial arguments” that the False Claims Act’s (FCA) qui tam provisions do not conform with Article II of the...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

Jenner & Block

Government Contracts Legal Round-Up – 2024 Issue 5

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False Claims Act Update - The Department of Justice reported sharply increased False Claims Act recoveries for government fiscal year 2023. Settlements and judgements dramatically increased from the fiscal year 2022...more

Perkins Coie

DOJ-Initiated False Claims Act Cases Reached Record High in Fiscal Year 2023

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The U.S. Department of Justice (DOJ) announced that it initiated a record-high 500 new False Claims Act (FCA) cases in Fiscal Year 2023. The government and whistleblowers (qui tam relators) were party to 543 settlements and...more

Dickinson Wright

6 Key Steps to Respond to a Health Care Investigation (and Related Issues)

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Originally published in Healthcare Michigan, Volume 41,  No. 2 - The United States Department of Justice (“DOJ”) and state law enforcement agencies have robust teams investigating and prosecuting health care fraud. Law...more

Mintz

EnforceMintz — COVID-19 Fraud Enforcement Unlikely to Slow Down in 2024

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The government continued to dedicate enormous resources to investigating and prosecuting fraud against COVID-19 pandemic relief programs in 2023. While we observed some civil False Claims Act settlements, criminal enforcement...more

Torres Trade Law, PLLC

Trade Violations Under the False Claims Act

On February 7, the U.S. Department of Justice (DOJ) announced that settlements and judgements under the False Claims Act (FCA) exceeded $2 billion for the 2022 fiscal year. The 2022 fiscal year also had the second-highest...more

Sheppard Mullin Richter & Hampton LLP

2024 Top-of-Mind Issues for Life Sciences Companies

As we reflect on 2023 and make predictions for 2024, it is remarkable the number of significant events occurring this past year that will be impactful for the activities of the life sciences industry going forward. Although...more

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