News & Analysis as of

Corporate Integrity Agreement Anti-Kickback Statute

Foley & Lardner LLP

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

Foley & Lardner LLP on

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

The Volkov Law Group

HHS-OIG Issues Comprehensive Compliance Guidance that Underscores the Need for a Robust and Independent Compliance Function (Part...

The Volkov Law Group on

The health care industry has a rich history of commitment and innovation in developing effective compliance  programs.  Going back to the 1990s, HHS elevated compliance program requirements for healthcare companies. Many of...more

Foley & Lardner LLP

HHS OIG: New “General Compliance Program Guidance” Provides Voluntary Steps Towards Increased Effectiveness

Foley & Lardner LLP on

In connection with the November 2023 Health Care Compliance Association’s (HCCA) Healthcare Enforcement Compliance Conference, and with acknowledgment by the Chief Counsel to the Inspector General, Rob DeConti, of the long...more

Health Care Compliance Association (HCCA)

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

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

Health Care Compliance Association (HCCA)

[Event] 2023 Board & Audit Committee Compliance Conference - October 23rd - 24th, Fort Lauderdale, FL

Discover today's best practices for your role in healthcare compliance oversight - The Office of Inspector General of Health and Human Services expects healthcare board members, board audit/compliance committee members,...more

Bass, Berry & Sims PLC

OIG Offers Stakeholders a New Avenue for Informal Fraud and Abuse Guidance

Bass, Berry & Sims PLC on

On March 23, the Office of Inspector General (OIG) for the U.S. Department of Health and Human Services (HHS) announced a new, expanded frequently asked questions (FAQs) process. Although OIG has long maintained FAQs on...more

Dorsey & Whitney LLP

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

Dorsey & Whitney LLP on

​​​​​​​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

Benesch

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

Benesch on

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

Health Care Compliance Association (HCCA)

[Virtual Event] Healthcare Enforcement Compliance Conference - November 7th - 9th, 8:55 am - 3:30 pm CST

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

ArentFox Schiff

Investigations Newsletter: Lens Manufacturer Agrees To Pay $16.4 Million To Resolve Alleged Violations of the False Claims Act and...

ArentFox Schiff on

Lens Manufacturer Agrees To Pay $16.4 Million To Resolve Alleged Violations of the False Claims Act and Anti-Kickback Statute - Essilor International, Essilor of America, Inc., Essilor Laboratories of America Inc., and...more

Rivkin Radler LLP

Fraud Week: Optical Lens Maker Reaches Kickback Settlement

Rivkin Radler LLP on

On August 23, the U.S. Department of Justice announced that Dallas-based optical lens manufacturer Essilor International and its affiliates agreed to pay $16.4 million to settle alleged violations of the federal Anti-Kickback...more

King & Spalding

OIG Updates its Corporate Integrity Agreement Model

King & Spalding on

OIG periodically makes updates to its Integrity Agreement (IA) and Corporate Integrity Agreement (CIA) model language. It is important for healthcare organizations – even those not subject to a CIA – to monitor changes to...more

Bass, Berry & Sims PLC

False Claims Act Settlements to Know from Q2 2022

Bass, Berry & Sims PLC on

The second quarter of 2022 brought a number of noteworthy False Claims Act (FCA) settlements, including several of $20 million or more. This post summarizes key settlements of interest to healthcare providers....more

Rivkin Radler LLP

Texas Hospital Settles Alleged FCA Violations for $18.2 Million

Rivkin Radler LLP on

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

Faegre Drinker Biddle & Reath LLP

HHS-OIG Updates Its Self-Disclosure Protocol

On November 8, 2021, the U.S. Department of Health and Human Services Office of Inspector General (OIG) updated and renamed its Self-Disclosure Protocol (SDP). The OIG had last updated the SDP in 2013. The update changes and...more

Locke Lord LLP

Modifications to OIG’s Health Care ‎Fraud Self-Disclosure Protocol Provides Additional ‎Benefits for ‎Reporting

Locke Lord LLP on

“Houston, we have a problem:” words no in-house counsel ever wants to hear, especially regarding potential compliance issues with federal fraud prevention statutes and regulations. Fortunately, the Office of the Inspector...more

Health Care Compliance Association (HCCA)

[Event] 26th Annual Compliance Institute - March 28th - 31st, Phoenix, AZ

The primary educational and networking event for healthcare compliance professionals - As our flagship healthcare compliance conference, HCCA’s Compliance Institute (CI) has been providing educational resources and...more

Goodwin

Judge Dismisses Pfizer’s Lawsuit Over HHS Limits on Drug Copay Assistance

Goodwin on

In a previous post published on the Washington Legal Foundation’s Legal Pulse blog, Goodwin Partners Matt Wetzel and William Jackson discussed the potential implications of a high-profile recent lawsuit lodged by Pfizer...more

Bricker Graydon LLP

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

Bricker Graydon LLP on

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

Health Care Compliance Association (HCCA)

[Virtual Event] 2021 25th Annual Compliance Institute - April 19th - 22nd, 9:30 am - 4:35 pm CDT

The Compliance Institute is celebrating 25 years! Join us for the Compliance Institute's 25th anniversary, April 19-22, 2021. This year, HCCA is excited to celebrate over two decades of compliance excellence with our...more

King & Spalding

Are Pharma Speaker Programs Facing an Existential Crisis?

King & Spalding on

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

The Volkov Law Group

Merit Medical Systems Settles False Claims Act Case for $18 Million (Part I of II)

The Volkov Law Group on

Medical device maker Merit Medical Systems (“MMS”) agreed to pay $18 million to resolve allegations that the company submitted false claims to Medicare, Medicaid and TRICARE by paying kickbacks to physicians and hospitals to...more

Mintz - Health Care Viewpoints

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

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

Skadden, Arps, Slate, Meagher & Flom LLP

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

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

The Volkov Law Group

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

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

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