News & Analysis as of

False Claims Act (FCA) Healthcare

Burr & Forman

Federal Agency Deference Eliminated, Now What?

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On June 28, 2024, the U.S. Supreme Court issued a decision that overrules the “Chevron doctrine.”  This means that federal agencies are limited in their ability to rely on their own interpretation of the laws they...more

McDermott Will & Emery

Healthcare Regulatory Check-Up Newsletter | July 2024 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for July 2024. We discuss several US Department of Health and Human Services (HHS) agency actions, including a final rule on provider...more

Health Care Compliance Association (HCCA)

Missing COI Program, Fabricated Outreach, Job, Health Records: The Many Types of Falsehoods

Report on Research Compliance 21, no. 9 (September, 2024) - How many types of falsehoods might sully applications for research funds and the studies they support? Unfortunately, the most recent semiannual report to...more

Mitratech Holdings, Inc

DOJ Unveils Whistleblower Rewards Program: What Every Business Needs to Know

The Department of Justice has launched the Corporate Whistleblower Awards Pilot Program to fight corporate crime. See how it impacts your organization. The U.S. The Department of Justice (DOJ) has just rolled out the...more

Kohn, Kohn & Colapinto LLP

DOJ and Whistleblowers Crack Down on Illegal Kickbacks: Major Qui Tam Settlements from July 2024

In July, the U.S. Department of Justice (DOJ) and U.S. Attorneys Offices announced several large False Claims Act (FCA) settlements stemming from qui tam whistleblower suits....more

Mintz - Health Care Viewpoints

Violations for Excessive Physician Compensation

The Department of Justice (DOJ) recently filed a complaint against Erlanger Health System (Erlanger), a county-owned public health system, and two of its Tennessee hospitals alleging that the health system systemically...more

Epstein Becker & Green

Affordable Care Act Overpayments in the CY 2025 Medicare Physician Fee Schedule Proposed Rule: Implications for False Claims

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Stakeholders are continuing to analyze the implications of the mammoth proposed rule on “Medicare and Medicaid Programs: [Calendar Year (CY)] 2025 Payment Policies under the Physician Fee Schedule and Other Changes to Part B...more

Stoel Rives - Health Law Insider®

Antitrust Scrutiny of Health Care Markets Ready to Escalate – Are You Ready?

The Antitrust Division of the U.S. Department of Justice has intensified its scrutiny of health care markets by establishing a dedicated task force: the Task Force on Health Care Monopolies and Collusion....more

Foley & Lardner LLP

DOJ Shows its Commitment to Cybersecurity Enforcement Through the False Claims Act

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At one time, False Claims Act (FCA) investigations and enforcement actions were largely focused on health care and defense contracts. While those two areas continue to dominate the FCA landscape, cybersecurity has emerged as...more

ArentFox Schiff

Investigations Newsletter: Precision Lens Pays $12 Million to Resolve FCA and AKS Violations

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Precision Lens Pays $12 Million to Resolve FCA and AKS Violations - Late last week, Precision Lens and the estate of its former principal agreed to pay $12 million to resolve allegations regarding violations of the False...more

Sheppard Mullin Richter & Hampton LLP

There Are Limits! Reining In FCA Penalties Pursuant to the Excessive Fines Clause

In the high-stakes realm of False Claims Act (FCA) litigation per-claim penalties can reach daunting levels that dwarf even treble damages. A recent ruling from the Eighth Circuit Court provides valuable guidance on the...more

K&L Gates LLP

Private Equity Firms Should Prepare for Increased Scrutiny as DOJ Puts False Claims Violations Under the Microscope

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Private equity investment in health care has grown significantly over the past two decades, and the US government is starting to pay attention. Recent announcements by the US Department of Justice (DOJ) and proposals by...more

Dentons

Ep. 24 – Implementing AI and Mitigating Compliance Risks – Part I

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In the wake of the United States Supreme Court’s decision in U.S. ex rel. Schutte v. SuperValue, Inc., interpreting the False Claims Act’s scienter element – referring to the defendant’s knowledge and subjective beliefs –...more

Cozen O'Connor

Trending Enforcement Targeting Private Equity Healthcare Portfolios Provides Important Compliance Reminder

Cozen O'Connor on

Over the last decade, private equity firms have acquired healthcare companies, hospitals, and clinics at an increasing rate. In fact, in those ten years, private equity firms have spent roughly $1 trillion on an estimated...more

Woods Rogers

Pharmacies and Pharmacists in the Crosshairs: DOJ’s $408 million Settlement with Rite Aid

Woods Rogers on

Last week, the Department of Justice (DOJ) announced that Rite Aid, ten subsidiaries, and affiliate pharmacies agreed to settle allegations that Rite Aid violated the Controlled Substances Act (CSA) and the False Claims Act...more

Arnall Golden Gregory LLP

Wave of the Future: Are AI and Data Mining the Next Generation of “Professional Whistleblowers”?

In the realm of False Claims Act (“FCA”) litigation, the emergence of artificial intelligence (“AI”) and data mining technologies has introduced both opportunities and complexities for defense strategies. Historically, qui...more

Bass, Berry & Sims PLC

Rite Aid and OptumRx Settlements Highlight Enforcement Focus on Pharmacy Corresponding Responsibility for Dispensing Controlled...

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On July 10, the Department of Justice (DOJ) announced a nearly $410 million settlement with Rite Aid Corporation to resolve allegations that Rite Aid and its affiliates ignored red flags and knowingly dispensed unlawful...more

Robinson+Cole Health Law Diagnosis

DOJ Charges 36 Defendants in Connection with Telemedicine and Clinical Laboratory Fraud and Abuse Schemes

On June 27, 2024, the Department of Justice (DOJ) announced its 2024 National Health Care Fraud Enforcement Action, which resulted in criminal charges against 193 defendants for alleged participation in various health care...more

McDermott Will & Emery

Healthcare Regulatory Check-Up Newsletter | May 2024 Recap

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This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for May 2024. We discuss several notable cases and enforcement resolutions, including the US Court of Appeals for the District of...more

Bass, Berry & Sims PLC

Causation Split: First Circuit Pauses Teva Appeal; Regeneron Appeal Going Forward

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False Claims Act (FCA) practitioners have been closely watching cases in which courts address the causation requirement in FCA actions based on Anti-Kickback Statute (AKS) violations....more

Troutman Pepper

Massachusetts AG Secures Landmark $4M Settlement Over Alleged Staffing Violations

Troutman Pepper on

Massachusetts Attorney General (AG) Andrea Joy Campbell announced a $4 million settlement with Next Step Healthcare, LLC (Next Step), a Massachusetts-based long-term care management company, in a deal that the AG described as...more

Jones Day

2023 False Claims Act Enforcement in Health Care and Life Sciences, Part III

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In February 2024, the Department of Justice (“DOJ”) announced the results of its 2023 False Claims Act (“FCA”) enforcement efforts. Through those efforts, it obtained more than $2.6 billion in overall recoveries, and of that...more

Husch Blackwell LLP

False Claims Act Insights - Physician, Refer Thyself: How Stark Law and FCA Intersect

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Jonathan Porter welcomes Raul Ordonez, Vice President & Chief Compliance Officer at Jackson Health System, and Husch Blackwell senior counsel Megan Phillips to the podcast to explore the intersection of the False Claims Act...more

Bass, Berry & Sims PLC

The Tale of a Self-Disclosure

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Last week, the Department of Justice (DOJ) announced a $12 million settlement with spinal device manufacturer, Innovasis Inc. (Innovasis), and senior executives Brent Felix and Garth Felix related to allegations that they...more

Health Care Compliance Association (HCCA)

Cleveland Clinic Pays $7.6M Related to PI Whose Charges Were Dropped; ‘He Was Treated Horribly’

Attorney Peter Zeidenberg was surprised to learn that NIH had successfully clawed back $3.6 million—plus a nearly 100% penalty—from Cleveland Clinic. The Department of Justice (DOJ) claimed the award funds were ill-gotten...more

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