News & Analysis as of October 12, 2024

Settlement Agreements

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The Anti-Kickback Statute is a United States federal criminal statute that prohibits the exchange (or the promise to exchange) of anything of value for referrals of federal healthcare program business. The statute aims to prevent situations where government officials channel federal healthcare dollars towards particular providers, who have offered or given the official a personal benefit. Penalties for violation of the Anti-Kickback statute apply to both sides of a prohibited transaction and can include jail time and steep monetary fines. less -

Health Care Fraud and Abuse 2023 Year in Review

Polsinelli on 4/12/2024

Introduction - Polsinelli proudly introduces the Health Care Fraud and Abuse 2023 Year in Review, a comprehensive examination of the evolving landscape surrounding the False Claims Act (“FCA”) and fraud & abuse enforcement...more

DOJ Continues to Target Lab Sales Arrangements and Ordering Practices

Polsinelli on 4/17/2023

Signaling its continued scrutiny of the laboratory industry, the Department of Justice (DOJ) entered into a settlement agreement with Texas lab Genotox Laboratories Ltd. last month related to compensation Genotox paid to...more

DOJ Announces $900 Million Settlement Tied to Speaker Bureau Payments to Physicians

Robinson+Cole Health Law Diagnosis on 9/28/2022

On September 26, 2022, the United States Department of Justice (DOJ) announced a $900 million settlement with pharmaceutical company Biogen Inc., which arose from alleged violations of the federal False Claims Act (FCA) and...more

Heating Up: Federal Sunshine Act Enforcement on the Rise

Goodwin on 11/5/2021

After several years without any enforcement, the U.S. Department of Justice (“DOJ”) recently penalized medical device and life sciences companies for violating the U.S. Provider Payments Sunshine Act (“Sunshine Act”) (42...more

Healthcare Fraud & Abuse Review 2020

Bass, Berry & Sims PLC on 2/4/2021

Ensuring compliance with the False Claims Act has never been more important for healthcare providers. By March 2020, we saw healthcare professionals standing at the forefront of one of the greatest health crises in a...more

Investigations Newsletter: Department of Justice Announces $8.3 Billion Settlement with Opioid Manufacturer Purdue Pharma and...

ArentFox Schiff on 10/26/2020

Department of Justice Announces $8.3 Billion Settlement with Opioid Manufacturer Purdue Pharma and Members of the Sackler Family - On October 21, the Department of Justice (DOJ) announced that it reached a global resolution...more

Is Your Prior Authorization Program Demonstrably Compliant?

Stinson LLP on 9/23/2020

A recent settlement announced by DOJ serves as a good reminder of the need for device and pharmaceutical manufacturers to periodically revisit their prior authorization assistance programs, to assure that the programs are...more

Novartis’ $678 Million Settlement Sets Guideposts for Life Sciences Industry Speaker Programs

Skadden, Arps, Slate, Meagher & Flom LLP on 8/24/2020

Novartis Pharmaceuticals Corporation (Novartis) recently entered into a civil settlement agreement with the Department of Justice (DOJ) to resolve allegations that the company paid health care practitioners (HCPs) who spoke...more

Novartis’ Simultaneous Settlements Break Records

Akerman LLP - Health Law Rx on 7/22/2020

Novartis Pharmaceuticals Corporation (Novartis) has started July with significant settlements, putting two different fraud and abuse matters behind them. In what has been identified as the largest settlement of an...more

Pharmaceutical company pays $54 million in settlement for FCA violation

Society of Corporate Compliance and Ethics... on 3/24/2020

CEP Magazine (March 2020) - On January 6, Teva Pharmaceuticals agreed to pay $54 million to settle allegations that the company violated the False Claims Act and the Anti-Kickback Statute by providing unlawful compensation...more

EHR vendor Practice Fusion agrees to $145 million settlement to resolve criminal and civil kickback violations

Bricker Graydon LLP on 2/11/2020

On January 27, 2020, the Department of Justice (DOJ) announced a $145 million settlement with electronic health record (EHR) vendor Practice Fusion to resolve civil and criminal allegations that it violated the Anti-Kickback...more

Drug Pricing Concerns Drive Continued DOJ Focus on Life Sciences Companies

Skadden, Arps, Slate, Meagher & Flom LLP on 1/24/2020

In 2019, U.S. Department of Justice (DOJ) enforcement activity targeting drug and device manufacturers jumped sharply over the prior year, reflecting an increased focus on fraud and abuse in the life sciences sector. More...more

Government Continues to Closely Scrutinize Pharmaceutical Marketing Practices

Robinson+Cole Health Law Diagnosis on 9/18/2019

On September 4, 2019 the Department of Justice (DOJ) announced a $15.4 million settlement with pharmaceutical company Mallinckrodt ARD LLC (Mallinckrodt) to resolve alleged violations of the Anti-Kickback Statute (AKS) in two...more

Healthcare Fraud & Abuse Review 2017

Bass, Berry & Sims PLC on 3/13/2018

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

Healthcare Fraud and Abuse Review 2016

Bass, Berry & Sims PLC on 4/13/2017

Bass, Berry & Sims is pleased to announce the release of its fifth annual Healthcare Fraud and Abuse Review 2016. The Review, compiled by the firm’s Healthcare Fraud Task Force, is an industry-leading guide to healthcare...more

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