News & Analysis as of September 26, 2024

Corporate Integrity Agreement

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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 -

Compliance Compass: The Erlanger Complaint – A Cautionary Reminder About the Importance of FMV

Foley & Lardner LLP on 8/13/2024

Although most health care lawyers and compliance officers who review and analyze physician compensation understand that fair market value (FMV) is important, the nuances around FMV are sometimes missed....more

[Event] 2023 Healthcare Enforcement Compliance Conference - November 5th - 7th, Washington, DC

Health Care Compliance Association (HCCA) on 8/8/2023

Hear directly from the enforcement community - Want to gain insight into properly monitoring, detecting, investigating, and managing violations? Join us at HCCA’s Annual Healthcare Enforcement Compliance Conference to...more

Recent DOJ Settlements Involving DME Manufacturers Highlight Important Anti-Kickback Considerations

Dorsey & Whitney LLP on 10/20/2022

The Department of Justice (“DOJ”) recently announced two settlement agreements, both involving durable medical equipment (“DME”) companies, following allegations that the companies had violated the Anti-Kickback...more

Modern Vascular is the Latest Defendant in a Growing Trend of Qui Tam Relator Cases against Office-based Lab Companies

Benesch on 9/29/2022

Earlier this month a federal judge unsealed a federal qui tam relator complaint originally filed in January 2020 by Dr. Jay Radhakrishnan and Dr. William Julien against Arizona-based Modern Vascular and certain of its...more

Texas Hospital Settles Alleged FCA Violations for $18.2 Million

Rivkin Radler LLP on 12/16/2021

The U.S. Department of Justice (DOJ) announced that Flower Mound Hospital Partners LLC, a partially physician-owned hospital in Flower Mound, Texas, agreed to pay $18.2 million to settle its alleged violations of the False...more

Recent kickback cases yield almost $20 million in settlements for the United States

Bricker Graydon LLP on 2/15/2021

The Department of Justice (DOJ) and U.S. Attorney’s Offices have been quite busy settling False Claims Act (FCA) cases during the first month and a half of 2021. Two recent FCA lawsuits based, at least in part, on allegations...more

Are Pharma Speaker Programs Facing an Existential Crisis?

King & Spalding on 11/25/2020

Exploring the Implications of HHS-OIG’s Special Fraud Alert and Groundbreaking Novartis CIA Requirements on Compliance Program Policies and Controls that Govern Speaker Programs - A Special Fraud Alert issued by the U.S....more

West Virginia Hospital Enters into a $50 Million Settlement to Resolve Allegations over Excessive Compensation Paid to Referring...

Mintz - Health Care Viewpoints on 9/16/2020

On September 9, 2020, the Department of Justice (DOJ) announced a $50 million settlement with Wheeling Hospital, Inc. of West Virginia to resolve False Claims Act allegations that Wheeling Hospital violated the Anti-Kickback...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

Oklahoma City Hospital, Management Company, And Physician Group To Pay $72.3 Million To Settle Federal And State False Claims Act

The Volkov Law Group on 7/31/2020

The Justice Department’s enforcement programs are resuming – False Claims Act, FCPA and other programs will continue. The rate of enforcement, however, is subject to change once again from the impact of the pandemic....more

Drug Testing Lab Pays Nearly $12 Million to Settle False Claims Act Allegations

ArentFox Schiff on 7/27/2020

Drug Testing Lab Pays Nearly $12 Million to Settle False Claims Act Allegations - On July 20, 2020, the Department of Justice (DOJ) announced a civil settlement with Sterling Healthcare Opco, LLC d/b/a Cordant Health...more

Novartis US Corruption Settlements: Part 4 – CIA Structural Requirements

Thomas Fox - Compliance Evangelist on 7/23/2020

I have written extensively about the Novartis International AG (Novartis) Foreign Corrupt Practices Act (FCPA) settlement, which was announced in late June. However, the enforcement action paled next to the Stipulation and...more

CIA Imposes Requirements for Pharmaceutical Speaker Programs and Events

Arnall Golden Gregory LLP on 7/22/2020

On July 1, 2020, the United States Department of Justice (DOJ) announced two settlements with Novartis Pharmaceuticals Corporation (“Novartis”), resolving allegations that the company had paid illegal kickbacks to physicians...more

Novartis Settles False Claims Act Cases and Pays $729 Million for Domestic Bribery Schemes

The Volkov Law Group on 7/8/2020

We have a new poster-child for a defective corporate culture of wrongdoing. Novartis has joined the exclusive club, along with Siemens, General Motors, Wells Fargo, and others in the misconduct Hall of Fame. ...more

The Role of Compliance in Government Enforcement

WilmerHale on 3/18/2019

As reflected in recent remarks by Deputy Attorney General Rod Rosenstein, the United States Department of Justice (DOJ) is “reinforcing its relationship with good corporate citizens” by coordinating with, and considering, the...more

Department of Justice Announces Significant False Claims Act Settlements Tied to Electronic Health Records Arrangements

Robinson+Cole Health Law Diagnosis on 2/21/2019

The Department of Justice (DOJ) recently announced two high-dollar False Claims Act (FCA) enforcement actions involving allegedly fraudulent arrangements tied to the implementation and use of electronic health record systems...more

2018 Digital Health Year in Review: Focus on Care Coordination and Reimbursement

McDermott Will & Emery on 2/6/2019

In 2018, even more than in recent years, federal lawmakers and regulators continued the push toward modernizing the existing legal framework to support and encourage digital health adoption in the context of care coordination...more

$24 million settlement resolves False Claims and Stark Law violations involving improper physician arrangements

Bricker Graydon LLP on 11/29/2018

The Department of Justice (DOJ) recently announced that Montana’s Kalispell Regional Healthcare System (KRH) and six subsidiaries and related entities agreed to pay $24 million to resolve allegations that they violated the...more

Health Management Associates Pays Over $260 Million in Criminal and Civil Penalties for Pervasive False Billing and Kickback...

The Volkov Law Group on 10/25/2018

Healthcare Management Associates (HMA) settled criminal and civil charges with the Justice Department for illegal fraud and kickback schemes. HMA billed federal government healthcare programs for inpatient services that...more

Enforcement and Litigation Strategies: Skadden’s Eighth Annual Pharmaceutical, Biotechnology and Medical Device Seminar

Skadden, Arps, Slate, Meagher & Flom LLP on 3/30/2018

On March 15, 2018, Skadden hosted its Eighth Annual Pharmaceutical, Biotechnology and Medical Device Seminar in Palo Alto, California, which focused on U.S. enforcement issues faced by companies throughout the industry. The...more

A Dialogue With Corporate Counsel: Skadden’s Seventh Annual Pharmaceutical and Medical Device Seminar

Skadden, Arps, Slate, Meagher & Flom LLP on 12/5/2017

Panelists examined major enforcement actions from 2017 and identified key trends. Aggressive Enforcement With a Decrease in High-Dollar Settlements. Panelists noted that the Department of Justice (DOJ) continues its...more

The Federal Government Holds Individuals Responsible for Involvement in Corporate Healthcare Fraud and Abuse

Sherman & Howard L.L.C. on 11/29/2016

In September 2016, three corporate officers in two healthcare fraud and abuse cases settled allegations that they were personally liable for violations of federal fraud and abuse laws. These settlements come one year after...more

When Outside Compliance Monitors May Be a Blessing: Companies Subjected to Corporate Integrity Agreements May Be Undone by Rogue...

Eversheds Sutherland (US) LLP on 10/12/2016

Companies face ever-increasing pressures to implement mechanisms designed to prevent or effectively address employee malfeasance. In today’s environment, even companies who appear to be cooperating with investigative and...more

OIG Issues New Exclusion and CIA Guidance

McDermott Will & Emery on 4/29/2016

On April 18, 2016, Inspector General Daniel R. Levinson announced the publication of updated guidance on how the Office of Inspector General (OIG) makes decisions about using its permissive exclusion authority and requiring...more

Olympus Settles FCPA Charges with DOJ

Dorsey & Whitney LLP on 3/4/2016

The Department of Justice resolved another FCPA investigation centered on payments made to health officials. Olympus Corporation of the Americas, a wholly owned subsidiary of Olympus Corporation, Tokyo, Japan, and Olympus...more

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