News & Analysis as of

False Claims Act (FCA) Enforcement Pharmaceutical Industry

Sheppard Mullin Richter & Hampton LLP

DOJ False Claims “Working Group” Update

ICYMI over the holiday week (present company included), the U.S. Department of Justice (DOJ) announced a re-energized partnership with the U.S. Department of Health and Human Services (HHS) to enforce the False Claims Act...more

Cranfill Sumner LLP

Kickbacks and Causation: Supreme Court Could Soon Settle the Question of Anti-Kickback Statute and False Claims Act Causation...

Cranfill Sumner LLP on

A decision by the First Circuit Court of Appeals has deepened the legal debate surrounding False Claims Act (FCA) actions based on violations of the Anti-Kickback Statute (AKS). This decision has increased speculation that...more

Pietragallo Gordon Alfano Bosick & Raspanti,...

Second Circuit Expands Anti-Kickback Statute Liability: “At Least One Purpose” is Enough

In a significant ruling, the Second Circuit Court of Appeals recently expanded the scope of the Anti-Kickback Statute (AKS).The Court joined other circuit courts across the country in adopting, for the first time, the...more

Lowenstein Sandler LLP

In Trump’s Second Term, Healthcare Enforcement May Remain Business as Usual

Compared with other issues, healthcare enforcement during President-elect Donald Trump’s upcoming second term has received little attention. When he takes office again on January 20, should industry actors like pharmaceutical...more

Bass, Berry & Sims PLC

DOJ Brings Nationwide False Claims Act Lawsuit Against CVS for Alleged Violations of Controlled Substances Act

Bass, Berry & Sims PLC on

On December 13, the U.S. Department of Justice (DOJ) intervened in a False Claims Act (FCA) lawsuit alleging that CVS Pharmacy Inc. and its subsidiaries improperly sought federal reimbursement for prescriptions filled in...more

American Conference Institute (ACI)

[Event] FCPA & Anti-Corruption for the Life Sciences Industry - May 9th - 10th, New York, NY

Hosted by the American Conference Institute, the 19th Annual FCPA & Anti-Corruption Conference for the Life Sciences Industry returns for another exciting year with carefully researched programming based on critical findings...more

Sheppard Mullin Richter & Hampton LLP

2024 Top-of-Mind Issues for Life Sciences Companies

As we reflect on 2023 and make predictions for 2024, it is remarkable the number of significant events occurring this past year that will be impactful for the activities of the life sciences industry going forward. Although...more

Skadden, Arps, Slate, Meagher & Flom LLP

The Nucleus: Life Sciences Enforcement and Regulatory Updates

In this issue of our newsletter on developments impacting the life sciences industry, we examine topics including how the increased DOJ and FDA focus on cybersecurity issues could lead to new theories of False Claims Act...more

Goodwin

“Greenfield Fraught with Problems”: District of Massachusetts Holds But-For Causation Required in False Claims Act Cases Based on...

Goodwin on

On September 27, 2023, the Chief Judge of the District of Massachusetts decided that the standard in False Claims Act (“FCA”) cases premised on alleged violations of the Anti-Kickback Statute (“AKS”) is but-for causation....more

Sheppard Mullin Richter & Hampton LLP

2023 Top-of-Mind Issues for Life Sciences Companies

Pharma and Life Sciences Investigations and Prosecutions: The First Two Years of the Biden Administration - With the two-year mark of the Biden presidency looming, the administration’s approach to prosecuting and...more

WilmerHale

Decoupling From China: Part 3 - Oversight And The Election

WilmerHale on

The COVID-19 pandemic and the serious supply chain vulnerabilities it exposed have led to a seismic shift in U.S. policy and regulation, from stepped-up measures to protect U.S. technology, intellectual property and data from...more

Holland & Knight LLP

Healthcare Law Update: May 2018

Holland & Knight LLP on

Enforcement - OIG Issues Advisory Opinion on Provision of Samples by a Device Distributor - On April 30, 2018, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued a...more

Katten Muchin Rosenman LLP

The Sixth Circuit Reins in the Government's Measure of False Claims Act Damages

Pharmaceutical and device companies, financial institutions, government contractors, oil and gas conglomerates, and other public and private entities continue to be in the crosshairs of aggressive federal government...more

Holland & Knight LLP

Commission-Based Sales Agreements for Medical Supplies and Equipment: More Whistleblower Activity on the Horizon? - A Wide Range...

Holland & Knight LLP on

The common industry practice of compensating independent contractor sales representatives on a "percentage of sales" commission basis may be creating an enhanced risk of False Claims Act liability for illegal kickbacks in...more

Mintz - Health Care Viewpoints

Health Care Enforcement in 2012: A Year in Review

Last year was another busy year in health care fraud enforcement. In 2012, the Office of Inspector General for the Department of Health and Human Services (HHS-OIG) reported total expected recoveries of $6.9 billion from all...more

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