News & Analysis as of

Fraud Department of Health and Human Services (HHS)

Fraud is the making of false representations or engaging in deceptive behavior in order to unlawfully secure financial or personal gain. 
Foley & Lardner LLP

Unpacking the Federal Anti-Kickback Statute’s Application to Payments to Medicare Advantage Agents and Brokers

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On December 11, 2024, the U.S. Department of Health & Human Services’ Office of Inspector General (OIG), issued a Special Fraud Alert (Alert) focusing on financial arrangements involving Medicare Advantage (MA) Organizations...more

Goodwin

The Impact of Trump’s Executive Order on Eliminating Information Silos

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Hello, everyone. My name is Allan Medina. I am a partner in Goodwin’s Washington, DC, office, with a practice focus on government investigations. I’m here with Liza Craig, who is also a partner in the DC office. We are...more

Clark Hill PLC

Right To Know - April 2025, Vol. 28

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Welcome to your monthly rundown of all things cyber, privacy, and technology, where we highlight all the happenings you may have missed. ...more

Foley & Lardner LLP

Key Takeaways: 7th Annual “Let’s Talk Compliance” Conference

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Editor’s Note: PYA and Foley & Lardner hosted the 7th Annual “Let’s Talk Compliance” two-day virtual conference on January 23 and 24, 2025. Panelists included Foley attorneys and PYA subject matter experts. The event was...more

Wiley Rein LLP

DOJ Affirms Aggressive False Claims Act Enforcement, Highlights Use Against Illegal Trade Practices

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The head of the U.S. Department of Justice (DOJ) branch that oversees False Claims Act (FCA) investigations affirmed the Trump Administration’s commitment to pursue civil fraud cases as part of its focus on achieving...more

Pietragallo Gordon Alfano Bosick & Raspanti,...

Hidden Dangers Lurking in Corporate Integrity Agreements

When I litigated False Claims Act (FCA) cases at the U.S. Department of Justice (DOJ), it was common practice for settlements to require Corporate Integrity Agreements (CIAs) setting forth ongoing duties and responsibilities...more

Bass, Berry & Sims PLC

Fourth Circuit Holds that Violation of CIA Can Support Reverse False Claims and Adopts Relaxed Rule 9(b) Presentment Requirement

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On February 3, the U.S. Court of Appeals for the Fourth Circuit reversed a district court’s grant of a motion to dismiss, holding in relevant part that: - Violations of a Corporate Integrity Agreement (CIA) can create an...more

Sheppard Mullin Richter & Hampton LLP

2025 Top-of-Mind Issues for Life Sciences Companies

DTC Telehealth Platforms - Arrangements involving telemedicine and direct-to-consumer (“DTC”) business services are expected to be a source of major regulatory scrutiny. In 2024, such arrangements were the focus of proposed...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

Pietragallo Gordon Alfano Bosick & Raspanti,...

Private Equity Throws FCA Enforcement Off-Kilter

Over the last 15 years, private equity (“PE”) firms have invested hundreds of billions of dollars in the healthcare sector, infiltrating every corner of the industry from emergency rooms and labs to billing providers and...more

Mintz - Health Care Viewpoints

EnforceMintz — Long Tail of Pandemic Fraud Schemes Will Likely Result in Continued Enforcement for Years to Come

In last year’s edition of EnforceMintz, we predicted that 2024 would bring an increase in False Claims Act (FCA) enforcement activity related to COVID-19 pandemic fraud. Those predictions proved correct. The COVID-19 Fraud...more

Bass, Berry & Sims PLC

Athira Pharma Inc. Agrees to Settle False Claims Act Allegations

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On January 6, the Department of Justice (DOJ) announced that Athira Pharma Inc., a Washington-based biopharmaceutical company, agreed to pay over $4 million to settle allegations it violated the False Claims Act (FCA). The...more

Foley Hoag LLP

Health Care Fraud Enforcement in 2025

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We kick off our annual Year in Preview series with a comprehensive look at health care fraud enforcement in 2025. This post proceeds in three parts. First, we explore what the second Trump administration might bring, looking...more

Kilpatrick

Recent Changes in Appropriations Legislation May Have Given "Baby False Claims Act" New Teeth

Kilpatrick on

On December 23, 2024, President Biden signed into law H.R. 5009 - “Servicemember Quality of Life Improvement and National Defense Authorization Act for Fiscal Year 2025.” (2025 NDAA). First passed in 1961, the NDAA is a...more

ArentFox Schiff

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

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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

Pietragallo Gordon Alfano Bosick & Raspanti,...

The Medicare Advantage Program: Public Money & Private Insurance Companies

When I investigated and litigated False Claims Act (FCA) cases at the U.S. Department of Justice (DOJ) over the last 10 years, I was often surprised by just how little I knew about the broad array of government agencies and...more

Polsinelli

The OIG’s Concerns with Potentially Fraudulent Medicare Advantage Marketing

Polsinelli on

The HHS Office of Inspector General (“OIG”) released a Special Fraud Alert to inform health care professionals (“providers”) and Medicare Advantage Organizations (“MAOs”) about the OIG’s view of potentially abusive marketing...more

Robinson & Cole LLP

Legal Update: Key Takeaways: HHS and DOJ’s Health Care Fraud and Abuse Control Program Report

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On December 6, 2024, the Department of Health and Human Services (HHS) and the Department of Justice (DOJ) released the Health Care Fraud and Abuse Control Program Annual Report for Fiscal Year 2023 (the Report). The Report...more

ArentFox Schiff

FCA Enforcement & Compliance Digest — Fall 2024 False Claims Act Newsletter

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Welcome to the Fall 2024 issue of “FCA Enforcement & Compliance Digest,” our quarterly newsletter in which we compile essential updates on False Claims Act (FCA) enforcement trends, litigation, agency guidance, and compliance...more

Bass, Berry & Sims PLC

HHS-OIG Set To Intensify Scrutiny of Grants and Contract Compliance: How to Prepare

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As we detailed in a previous blog, on October 3, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) published a strategic plan to “safeguard[] the integrity of HHS grants and contracts.” The...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

Health Care Compliance Association (HCCA)

In This Month’s E-News: September 2024

Report on Research Compliance 21, no. 9 (September, 2024) - Based on their review of public data on ClinicalTrials.gov, a bipartisan quartet of U.S. representatives has asked the Food and Drug Administration (FDA) to...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

Hinch Newman LLP

FTC Chair Testifies Before House Subcommittee to Discuss Ongoing Work

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On May 15, 2024, the Federal Trade Commission Chair Lina M. Khan appeared before the House Appropriations Subcommittee on Financial Services and General Government to discuss the agency’s FY 2025 budget request and ongoing...more

Davis Wright Tremaine LLP

March 2024 UDAAP Bulletin

Editor's Note The following document provides a monthly roundup summarizing enforcement actions, guidance, rulemakings, and other public statements from the Consumer Financial Protection Bureau, the Federal Trade Commission,...more

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