News & Analysis as of

Health Insurance False Claims Act (FCA) Pharmaceutical Industry

Ankura

Bona Fide Service Fees, Government Price Reporting, and the Inflation Reduction Act

Ankura on

“Manufacturers are responsible for meeting all four parts of the definition of bona fide service fee before a fee can qualify as a bona fide service fee.” ...more

Morgan Lewis - As Prescribed

Patient Assistance Programs – The Dos and Don’ts from HHS OIG

Patient assistance programs (PAPs) emerged to help patients who lack health insurance or prescription drug coverage obtain critical, and often, life-saving medications. This is especially true for rare disease patients, whose...more

Troutman Pepper Locke

DOJ and 18 States Reach False Claims Act Settlement with QOL

Troutman Pepper Locke on

The U.S. Department of Justice (DOJ) and 18 state attorneys general (AG) announced a settlement with Boston-based QOL Medical, LLC (QOL) and its CEO, Frederick Cooper, to resolve allegations that the company provided unlawful...more

McDermott Will & Schulte

Healthcare Regulatory Check-Up Newsletter | September 2024 Recap

McDermott Will & Schulte on

This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for September 2024. We discuss several enforcement actions pertaining to healthcare fraud, including alleged violations under the False...more

The Volkov Law Group

Teva Pharmaceuticals Pays $450 Million to Resolve Anti-Kickback and False Claims Act Violations

The Volkov Law Group on

Teva Pharmaceuticals USA Inc. (Teva USA) and Teva Neuroscience Inc. (“Teva”) agreed to pay $450 million to resolve two matters that allege Teva violated the Anti-Kickback Statute (AKS) and the False Claims Act (FCA). Teva is...more

Epstein Becker & Green

SuperValu’s Effect on the FCA Scienter Standard and Impact to Future Litigation

Epstein Becker & Green on

n June 1, 2023, the U.S. Supreme Court unanimously settled a long-standing dispute over a subjective versus objective standard for scienter under the False Claims Act (FCA), holding that a defendant’s own subjective belief is...more

Akerman LLP - Health Law Rx

Teva FCA Decision Sheds Light on Varying Interpretations of the Elements of an FCA Claim

How could alleged kickbacks threaten to render insolvent a publicly traded company with assets (taken from its latest SEC filing) in excess of $43 billion? The answer stems from a recent decision by the United States District...more

Dickinson Wright

False Claims Act “Knowledge” Is a Subjective Standard

Dickinson Wright on

The Federal False Claims Act (“FCA”) allows private parties to bring lawsuits in the name of the federal government against defendants who allegedly “knowingly” present a false claim to the government for payment. The...more

McDermott Will & Schulte

[Webinar] 2019 Q4 Healthcare Enforcement Roundup - February 5th, 2:30 pm ET

The final quarter of 2019 brought forward new guidance and proposed rules with major implications for healthcare companies, enforcement developments in healthcare private equity investing and opioid litigation matters, among...more

Butler Snow LLP

Pro Te: Solutio – Vol. 12, No. 3

Butler Snow LLP on

Summer is winding down, and Fall texted to say she is on her way. This means that Pro Te: Solutio is returning for its third edition of 2019. As always, our authors have taken the time to research and address current issues...more

Bass, Berry & Sims PLC

Healthcare Fraud & Abuse Review 2017

Bass, Berry & Sims PLC on

A LOOK BACK... A LOOK AHEAD - While the uncertainty associated with legislative efforts to repeal the Patient Protection and Affordable Care Act (PPACA) dominated most of the headlines for the healthcare industry last year,...more

Holland & Knight LLP

Healthcare Law Update: September 2017

Holland & Knight LLP on

OIG Advisory Opinions - Manufacturer's Free Replacement of Spoiled Pharmaceutical Products Authorized - On Aug. 25, 2017, the U.S. Department of Health and Human Services' (HHS) Office of Inspector General (OIG)...more

Bass, Berry & Sims PLC

FCA Issues to Watch: Pharmaceutical and Device Developments | INSIDE THE FCA

Bass, Berry & Sims PLC on

The government’s FCA enforcement efforts have continued to focus on key areas concerning the pharmaceutical and medical device industries. In fact, drug and device manufacturers accounted for nearly half of the enforcement...more

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