News & Analysis as of

Medicare False Claims Act (FCA) Life Sciences

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

Haynes Boone

False Claims Act - 2025 Mid-Year Review

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The False Claims Act continues to be one of the most commonly used weapons in the government’s enforcement arsenal to address various forms of fraud. In addition to our “Year in Review” publication providing an overview of...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

White & Case LLP

DOJ and HHS Relaunch False Claims Act Working Group, Sharpen Healthcare Enforcement Priorities

White & Case LLP on

On July 2, 2025, the U.S. Department of Justice (DOJ) and the Department of Health and Human Services (HHS) jointly announced the reestablishment of the DOJ-HHS False Claims Act (FCA) Working Group. While the two agencies...more

Epstein Becker & Green

DOJ, HHS Announce Revamped False Claims Act Working Group

Now in its sixth month, the second Trump administration has made clear that the False Claims Act (FCA) will remain a central tool in its efforts to combat fraud, waste, and abuse across federal programs....more

Skadden, Arps, Slate, Meagher & Flom LLP

First Circuit Demands ‘But For’ Causation Between Alleged Kickback and Claim Submission

On February 18, 2025, a panel of the U.S. Court of Appeals for the First Circuit unanimously decided that in order to transform an Anti-Kickback Statute (AKS) violation into a false or fraudulent claim for purposes of False...more

Arnall Golden Gregory LLP

Narrowing FCA Cases Based on Kickback Allegations: What Healthcare and Life Sciences Companies Need to Know About the Regeneron...

On February 18, 2025, in a closely watched decision, the United States Court of Appeals for the First Circuit in United States v. Regeneron Pharmaceuticals Inc., No. 23-2086, 2025 U.S. App. LEXIS 3667 (1st Cir. Feb. 18, 2025)...more

Baker Donelson

First Circuit Requires But-For Causation for FCA Liability Based on AKS Violations

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Key Takeaways - The First Circuit ruled in United States v. Regeneron Pharmaceuticals, Inc., that the government must prove but-for causation to establish False Claims Act (FCA) liability based on violations of the...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

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

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

The Volkov Law Group

Alere Agrees to Pay $38.75 Million to Settle False Claims Act Violations (Part II of V)

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Alere, Inc. and its San Diego subsidiary, agreed to pay $38.75 million to resolve False Claims Act charges for billing the Medicare program for defective rapid point-of-care testing devices. ...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

Epstein Becker & Green

DOJ False Claims Act Recoveries FY 2019: Total Collections Rise – Almost 90 Percent Relate to Health Care

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Through a January 9, 2020, press release, the Department of Justice (“DOJ”) reported more than $3 billion in total recoveries from settlements and judgments from fraud-related civil matters brought under the False Claims Act...more

Polsinelli

Genetic Testing Fraud Concerns Confirmed with Charges in One of the Largest Ever Health Care Fraud Schemes

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In one of the largest ever health care fraud schemes charged by the Department of Justice, cancer genetic testing and telemedicine are at the center of the scheme. On September 27, the DOJ announced charges against 35...more

Troutman Pepper Locke

Eleventh Circuit Says Difference Of Opinion Does Not Establish Falsity In False Claims Act Case

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On September 9, in a setback for AseraCare but an overall win for hospice providers, the Eleventh Circuit affirmed a Northern District of Alabama decision to grant a new trial in a False Claims Act (FCA) case against...more

Hogan Lovells

Eleventh Circuit Confirms: Mere Difference of Opinion Between Physicians Does Not Establish Falsity Under the False Claims Act

Hogan Lovells on

More than two years after the Northern District of Alabama granted summary judgment in a False Claims Act (FCA) case in favor of AseraCare Inc., holding that “contradiction based on clinical judgment or opinion alone cannot...more

Troutman Pepper Locke

Court Rejects CMS's Attempt to Broaden False Claims Act Liability in Medicare Overpayment Rule

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The U.S. District Court for the District of Columbia handed down a major victory to Medicare Advantage issuers on September 7, 2018, vacating a 2014 CMS regulation relating to Medicare Advantage overpayments. ...more

Skadden, Arps, Slate, Meagher & Flom LLP

Enforcement and Litigation Strategies: Skadden’s Eighth Annual Pharmaceutical, Biotechnology and Medical Device Seminar

On March 15, 2018, Skadden hosted its Eighth Annual Pharmaceutical, Biotechnology and Medical Device Seminar in Palo Alto, California, which focused on U.S. enforcement issues faced by companies throughout the industry. The...more

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