News & Analysis as of

Life Sciences False Claims Act (FCA) Health Care Providers

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 & Emery

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

Jones Day on

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

Goodwin on

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 & Emery

Healthcare Regulatory Check-up Newsletter | October 2023 Recap

McDermott Will & Emery on

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 & Emery

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

McDermott Will & Emery on

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...

Venable LLP on

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

King & Spalding on

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

The Volkov Law Group on

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

Goodwin on

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

Goodwin on

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

Goodwin on

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

Jones Day on

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

Jones Day

DOJ Announces $2.2 Billion in 2020 FCA Recoveries and Identifies 2021 Priorities

Jones Day on

The Situation: The U.S. Department of Justice ("DOJ") published its annual report regarding False Claims Act ("FCA") recoveries for fiscal year 2020 (ending September 2020) and announced its priorities for 2021. The...more

Manatt, Phelps & Phillips, LLP

[Webinar] What’s Past Is Present: Key Regulatory Trends Impacting Health Care/Life Sciences - March 23rd, 3:00 pm - 4:00 pm ET

From Pricing to Compliance to Coordinated Care, a Wide Range of Critical Areas Saw Regulatory Changes in 2020 That Will Impact the Health Care and Life Sciences Industries in 2021—and Beyond. Find Out How Your Organization...more

Skadden, Arps, Slate, Meagher & Flom LLP

Novartis’ $678 Million Settlement Sets Guideposts for Life Sciences Industry Speaker Programs

Novartis Pharmaceuticals Corporation (Novartis) recently entered into a civil settlement agreement with the Department of Justice (DOJ) to resolve allegations that the company paid health care practitioners (HCPs) who spoke...more

Foley & Lardner LLP

Third Circuit Creates Budding Circuit Split in United States v. Care Alternatives, Ruling That “Objective Falsity” Is Not Required...

Foley & Lardner LLP on

The United States Court of Appeals for the Third Circuit ruled last week that whistleblower relators need not show “objective falsity” to prove their claims, and that a dispute among physician experts about a clinical...more

Robinson+Cole Health Law Diagnosis

DOJ Reaches Settlement with Patient Assistance Foundation Resolving Allegations of FCA Violations

On January 21, 2020, the Department of Justice (DOJ) announced a $3 million settlement with Patient Services, Inc. (PSI) to resolve allegations of False Claims Act (FCA) violations. The DOJ alleged that PSI enabled three...more

Epstein Becker & Green

Health Care Continues to Drive False Claims Act Recoveries: Thought Leaders in Health Law Video Series

Epstein Becker & Green on

$3 billion recovered under the False Claims Act (“FCA”). That’s what the US Department of Justice (“DOJ”) reported collecting in FY2019. The health care and life sciences industries accounted for $2.6 billion of the total...more

Skadden, Arps, Slate, Meagher & Flom LLP

Drug Pricing Concerns Drive Continued DOJ Focus on Life Sciences Companies

In 2019, U.S. Department of Justice (DOJ) enforcement activity targeting drug and device manufacturers jumped sharply over the prior year, reflecting an increased focus on fraud and abuse in the life sciences sector. More...more

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