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Regulatory Requirements False Claims Act (FCA)

Holland & Hart LLP

Correcting Stark Violations: 90-Day Grace Period

Holland & Hart LLP on

Physicians and entities to which physicians refer may violate the Ethics in Patient Referrals Act (“Stark”) by mistakenly overpaying or underpaying amounts due under a compensation arrangement. For example, a hospital may...more

Gardner Law

Cybersecurity and the FCA: Illumina Signals "No Breach" Enforcement Risks

Gardner Law on

A $9.8 million False Claims Act (FCA) settlement between Illumina Inc. and the U.S. Department of Justice (DOJ) is unique among cybersecurity enforcement actions because it didn’t result from a data breach, but, according to...more

StoneTurn

Tariffs Meet COSO: A Two-Way Street to Risk & Opportunity Management

StoneTurn on

In today’s global trade environment, tariffs have become a company-wide concern—impacting legal, compliance, finance, and operations alike. This article introduces how the COSO Internal Control Framework can serve as a...more

Foley & Lardner LLP

Another FCA Cybersecurity Settlements Highlight DOJ’s Enforcement Priorities

Foley & Lardner LLP on

The United States Department of Justice (DOJ) recently announced another settlement agreement showing that DOJ continues to prioritize cybersecurity enforcement under the False Claims Act (FCA). According to the press...more

Paul Hastings LLP

CMS Proposes Major ASP Reporting Overhaul — Implications for Fair Market Value and Bona Fide Service Fees

Paul Hastings LLP on

The Centers for Medicare & Medicaid Services (CMS) recently published its Proposed 2026 Physician Fee Schedule Rule (Proposed Rule), with extensive implications for drug pricing, Average Sales Price (ASP) calculations, and...more

Thomas Fox - Compliance Evangelist

Compliance into the Weeds: Two Cyber Security Cases for the Compliance Professional

The award winning, Compliance into the Weeds is the only weekly podcast which takes a deep dive into a compliance related topic, literally going into the weeds to more fully explore a subject. Looking for some hard-hitting...more

Paul Hastings LLP

At the Crossroads: Illumina Settlement Reflects the Intersection of Cybersecurity and Healthcare Law

Paul Hastings LLP on

On July 31, the U.S. Department of Justice (DOJ) announced a settlement in United States ex rel. Lenore v. Illumina, Inc, the first case in which underlying cybersecurity issues formed the basis of a settlement under the...more

Maynard Nexsen

Work This Way: A Labor & Employment Law Podcast | Compliance Clarity for Federal Contractors with Joan Moore and Mim Munzel of...

Maynard Nexsen on

In this episode, hosts Tina and Jennie welcome back Joan and Mim of Arbor Consulting Group to unpack critical updates affecting federal contractors and subcontractors. From changes to the OFCCP’s Federal Contractor Portal to...more

Mintz - Health Care Viewpoints

“False” Sense of Security: DOJ Announces False Claims Act Settlements Related to Failure to Comply with Cybersecurity Requirements

On July 31, 2025, the United States Department of Justice (DOJ) announced a pair of settlements with companies accused of having violated the False Claims Act (FCA) by falsely representing their compliance with certain...more

Ropes & Gray LLP

[Podcast] Patient Assistance Programs: Enforcement Trends and Regulatory Challenges

Ropes & Gray LLP on

On this Ropes & Gray podcast, health care partner Michael Lampert and counsel Sam Perrone, and litigation & enforcement partner Andrew O’Connor, rejoin to discuss patient assistance programs, recent enforcement actions, and...more

Husch Blackwell LLP

OIG Announces 2025 Work Plan Review: What Clinical Laboratories Need to Know About Medicare Payments for Diagnostic Lab Tests

Husch Blackwell LLP on

In June 2025, the U.S. Department of Health and Human Services Office of Inspector General (OIG) announced a new item in its Work Plan: “Medicare Payments for Clinical Diagnostic Laboratory Tests in 2024.” This annual review,...more

Proskauer - Health Care Law Brief

DOJ Targets Gender‑Affirming Care under FDCA and FCA: Scrutinizes Off‑Label Drug Use and False Diagnosis Codes

Last month, the United States Department of Justice (“DOJ”) issued its “Civil Division Enforcement Priorities” memorandum, memorializing a shift from its predecessor administration’s policy on gender‑affirming healthcare...more

Clark Hill PLC

Key lessons on the False Claims Act for government contractors after Raytheon’s $8.4 million settlement

Clark Hill PLC on

Government contractors should be on high alert following the recent announcement that Raytheon Company, its parent RTX Corporation, and Nightwing Group, LLC, have agreed to pay $8.4 million to resolve allegations of violating...more

Morgan Lewis

AI in Healthcare: Opportunities, Enforcement Risks and False Claims, and the Need for AI-Specific Compliance

Morgan Lewis on

The risks associated with the growth of AI in the healthcare and life sciences industries, as well as recent federal and state activity and enforcement actions, emphasize the importance of understanding and implementing a...more

Arnall Golden Gregory LLP

When DEI Meets the FCA: What Employers Need to Know About the DOJ’s Civil Rights Fraud Initiative

In this episode, AGG Employment partner and co-chair, Ashley Kelly, speaks with leaders of the firm's new Civil Rights & False Claims Act Risk & Response Team, Gabe Scannapieco and Sara Lord, about the DOJ’s recent move to...more

Quarles & Brady LLP

DOJ Uses Successor Liability as a Civil Cybersecurity Enforcement Tool: Comprehensive Diligence Now May Save Millions Later

Quarles & Brady LLP on

The United States Department of Justice (DOJ) recently settled a qui tam suit with a defense contractor and its successor company for $8.4 million, resolving allegations that the contractor and successor company violated the...more

Wiley Rein LLP

GSA Announces Expansion of “Transactional Data Reporting” Program, Reducing Compliance Obligations for GSA Schedule Contractors

Wiley Rein LLP on

WHAT: The U.S. General Services Administration (GSA) recently announced its planned expansion of the Transactional Data Reporting (TDR) program, which will make TDR mandatory for GSA Schedule contractors whose contracts...more

DCI Consulting

Department of Justice Launches Civil Rights Fraud Initiative

DCI Consulting on

Federal contractors who have been waiting to find out how Executive Order (EO) 14173 would be implemented now know at least one piece of the federal government’s enforcement plan....more

Cooley LLP

NIH Announces New Antidiscrimination Certification Heightening FCA Risk for Some Life Sciences Companies

Cooley LLP on

On April 21, 2025, the National Institutes of Health (NIH) announced a new civil rights term and condition of award for NIH grants, cooperative agreements and other transaction awards. The new term states that recipients of...more

PilieroMazza PLLC

Cybersecurity Compliance in the Crosshairs: Raytheon’s $8.4 Million FCA Settlement and What It Means for Defense Contractors

PilieroMazza PLLC on

Government contractors regularly handle sensitive federal data, and cybersecurity compliance is no longer optional—it’s mandatory. A recent settlement between the Department of Justice (DOJ) and defense contractor Raytheon...more

Greenbaum, Rowe, Smith & Davis LLP

Legal Risks and Challenges for Private Equity in Healthcare Acquisitions

Private Equity (PE) firms continue to be significant players in U.S. healthcare, acquiring assets across various sectors such as physician practices, home health, behavioral health, and urgent care. However, recent legal...more

Foley & Lardner LLP

Another FCA Cybersecurity Settlement Reinforces the Enforcement Trend

Foley & Lardner LLP on

A recent United States Department of Justice (DOJ) announcement highlights the fact that the government’s emphasis on cybersecurity enforcement under the False Claims Act (FCA) is not slowing down. According to the press...more

Kilpatrick

DOJ Announces Plans to Use False Claims Act to Target Anti-Semitism and DEI Policies

Kilpatrick on

In the first five months of this administration, it is clear that one of the foremost concerns of President Trump’s agenda is its focus on Diversity, Equity, and Inclusion (“DEI”) initiatives. Issued in January 2025,...more

Dickinson Wright

Cyber Risk, Real Consequences: DOJ Steps Up Enforcement

Dickinson Wright on

Government efforts to enforce cybersecurity control requirements have moved forward in the opening months of the Trump administration. Regardless of the changes coming to other areas of contracting and the Federal Acquisition...more

Bass, Berry & Sims PLC

DOJ’s New Civil Rights Fraud Initiative – The Investigations are Coming!

Bass, Berry & Sims PLC on

On May 19, the Department of Justice (DOJ) announced the launch of the Civil Rights Fraud Initiative (the Civil Rights Fraud Initiative), which will use the federal False Claims Act (FCA) to pursue claims against recipients...more

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