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False Claims Act (FCA) Life Sciences Health Care Providers

White & Case LLP

Life Science & Healthcare Private Equity Risk: Q2 2025 Update

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Private capital firms focused on investment and operations within the Life Science and Healthcare industries face complex compliance, operational, and business risks. To help clients navigate this evolving environment, White...more

Troutman Pepper Locke

State AGs Join $202M Settlement Over HIV Drug Kickback

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On July 16, 49 attorneys general (AGs) announced that they joined a $202 million settlement with Gilead Sciences, Inc. (Gilead). Previously announced by the Department of Justice in April, the settlement resolved allegations...more

Morrison & Foerster LLP

DOJ and HHS Announce Formation of False Claims Act Working Group and Results of National Health Care Fraud Takedown

As we reported in our recent client alert, the Trump administration has made clear that it is committed to using the False Claims Act (FCA) to prosecute healthcare fraud. Two recent Trump administration moves give important...more

DLA Piper

DOJ Memo Identifies False Claims Act and Enforcement Risks Related to Gender Transition Medication and Procedures

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Attorney General (AG) Pam Bondi has issued a memorandum titled “Preventing the Mutilation of American Children” (the Memo) to select Component Heads of the Department of Justice (DOJ). Released on April 22, 2025, the Memo...more

BakerHostetler

Healthcare Industry Team 2024 Year in Review

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As we begin a year that will once again be transformative for the industry, we are excited to present our comprehensive 2024 year-in-review, highlighting all that has happened and the trends that will shape 2025. ...more

Morrison & Foerster LLP

New HHS-OIG Guidance on Sponsored Genetic-Testing Programs

On December 17, 2024, the Department of Health & Human Services, Office of Inspector General (HHS-OIG) issued its second favorable advisory opinion involving an arrangement in which a drug manufacturer sponsors genetic...more

Hinshaw & Culbertson - Health Care

Healthcare Providers, Agents, and Brokers: Please Stop, Look, and Listen Before Entering Into Suspect Medicare Advantage Plan...

The Office of Inspector General (OIG) of the U.S. Department of Health & Human Services (HHS) issues Special Fraud Alerts regarding healthcare fraud and abuse patterns or practices it has recently identified and intends to...more

Skadden, Arps, Slate, Meagher & Flom LLP

The Nucleus: Life Sciences Enforcement and Regulatory Updates - March 2024

Circuit Split Widens Over AKS-Based FCA Causation Element - The Anti-Kickback Statute (AKS) continues to form the basis of hundreds of millions of dollars of annual recoveries for the government under the federal False...more

McDermott Will & Schulte

This Week in 340B: February 27 – March 4, 2024

Find this week’s updates on 340B litigation to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick...more

Jones Day

DOJ Announces Record-Breaking Year for False Claims Act Settlements and Judgments

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Qui tam relators and the U.S. Department of Justice continue to expand usage of the False Claims Act....more

Goodwin

DOJ Renews Focus on Private Equity Amid Record False Claims Act Enforcement

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2023 was another record year for False Claims Act enforcement. On February 22, 2024, the U.S. Department of Justice (DOJ) announced that the federal government and whistleblowers were party to a record number of FCA...more

McDermott Will & Schulte

Healthcare Regulatory Check-up Newsletter | October 2023 Recap

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This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity for October 2023. We discuss several enforcement actions that involve violations of the False Claims Act (FCA) and the...more

Goodwin

A Practical Look at OIG’s New Compliance Guidance

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On November 6, 2023, for the first time in 15 years, HHS OIG issued a new reference guide for the health care compliance community – the General Compliance Program Guidance, or GCPG. While the GCPG does not set new legal...more

American Conference Institute (ACI)

[Event] 11th Annual Advanced Forum on False Claims and Qui Tam Enforcement - January 23rd - 24th, New York, NY

Hosted by American Conference Institute, the 11th Annual Advanced Forum on False Claims and Qui Tam Enforcement returns for another exciting year for lively discussions on FCA enforcement including the ramifications of two...more

McDermott Will & Schulte

[Hybrid Event] Healthcare Litigation, Compliance and Investigations Forum 2023 - November 1st, Chicago, IL

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McDermott’s Healthcare Litigation, Compliance and Investigations Forum is back when you need it the most. Heightened regulatory scrutiny and enforcement activity pose legal, financial and reputational risks for healthcare...more

Venable LLP

[Ongoing Program] Life Sciences Series - Current Trends in Life Sciences and Healthcare Enforcement: Understanding and...

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We are excited to announce Venable’s inaugural Life Sciences Webinar Series. This month-long series will explore the intricacies and latest developments that shape the life sciences industry. Join us as we hear from our...more

Morgan Lewis - Health Law Scan

False Claims Act Breakups Are Harder to Do in the District of Massachusetts

As we at Morgan Lewis pride ourselves on excellent client service, we feel it is our duty to provide critical dispatches from the romantic world of healthcare fraud. Specifically, we want to highlight developments in the...more

Wilson Sonsini Goodrich & Rosati

2022-2023 Medical Product and Service Regulatory Initiatives

The medical product and healthcare service industry is one of the most closely regulated sectors in the U.S. Several agencies actively exercise authority with constantly changing legislation and policies to keep pace with...more

King & Spalding

DOJ Increases Scrutiny of Arrangements with EHR Vendors: What the ModMed Settlement Means for the Life Sciences Industry

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On November 1, 2022, Modernizing Medicine, Inc. (“ModMed”), an electronic health record (“EHR”) technology vendor, entered into a settlement agreement with the Department of Justice (“DOJ”), agreeing to pay $45 million to...more

The Volkov Law Group

False Claims Act Round-Up — DOJ Continues Aggressive Prosecution of Healthcare Fraud

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The Biden Administration warned the healthcare industry that it would aggressively prosecute fraud cases.  The Justice Department is executing on that promise and doing so with great success.  Week after week, we read about...more

Goodwin

Whistleblower Lawyers Use False Claims Act to Target Private Equity Firms Invested In Healthcare and Life Sciences

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Recent developments demonstrate that sponsor-backed companies in the healthcare and life sciences sectors, and in some instances private equity firms and professionals, have entered a new era of heightened regulatory scrutiny...more

Epstein Becker & Green

Video: Record-Shattering Year for FCA Recoveries in Health Care - Thought Leaders in Health Law

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The U.S. Department of Justice (DOJ) collected $5.6 billion in False Claims Act recoveries in fiscal year (FY) 2021. That is over twice as much as 2020, and a record 90 percent of the total was collected from the health care...more

Goodwin

DOJ False Claims Act Recoveries Exceed $5.6 Billion in 2021

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The U.S. Department of Justice (“DOJ”) recently announced that over $5.6 billion in False Claims Act (“FCA”) settlements and judgments had been reached during the 2021 fiscal year, with over $5 billion of those settlements...more

Goodwin

Heating Up: Federal Sunshine Act Enforcement on the Rise

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After several years without any enforcement, the U.S. Department of Justice (“DOJ”) recently penalized medical device and life sciences companies for violating the U.S. Provider Payments Sunshine Act (“Sunshine Act”) (42...more

Jones Day

DOJ Rescinds Limits on the Use of Agencies' Guidance Documents in Civil Enforcement Actions

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A recent action by the Department of Justice ("DOJ") rescinds two prior policies (commonly referred to as the Brand Memo and the Sessions Memo) that had established limits on the federal government's use of agency guidance...more

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