News & Analysis as of

Department of Health and Human Services (HHS) False Claims Act (FCA) Corporate Integrity Agreement

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

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

Harris Beach PLLC

HHS Office of Inspector General August 2023 Enforcement Activity

Harris Beach PLLC on

The following is a summary of selected federal Department of Health and Human Services’ Office of Inspector General (OIG) reports of fraud and abuse enforcement activity across the country. The enforcement actions reported...more

ArentFox Schiff

Investigations Newsletter: Medical Supplier Agrees to Pay $29 Million for FCA Violations

ArentFox Schiff on

Medical Supplier Agrees to Pay $29 Million for FCA Violations - Earlier this month, the US Department of Justice (DOJ) and medical supplier Lincare Holdings Inc. reached an agreement to settle claims that Lincare violated...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

Proskauer - Health Care Law Brief

Another Unique Integrity Agreement Signals a Trend towards HHS-OIG’s Comfort with a Belt and Suspenders

In recent years, there have been only a handful of corporate integrity agreements (“CIAs”) and integrity agreements (“IAs”) that have included a “conditional exclusion release” of the Office of the Inspector General for the...more

Foley & Lardner LLP

Compliance Officers Lookout! DOJ and OIG Tag Team Corporate Integrity Agreements

Foley & Lardner LLP on

The Office of Inspector General of the U.S. Department of the Health and Human Services (OIG) recently changed the language describing a compliance officer’s role in relation to other responsibilities he or she may have...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

Health Care Compliance Association (HCCA)

Sanford Settles Telehealth Case Over One Physician; It Disclosed Reportable Event

Report on Medicare Compliance 31 no. 29 (August 15, 2022) - Sanford Health, Sanford Clinic and Sanford Medical Center in South Dakota have agreed to pay $25,842 in a settlement about telemedicine services with the HHS...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

ArentFox Schiff

Investigations Newsletter: Physician Partners of America Agrees To Pay $24.5 Million To Resolve False Claims Act Allegations

ArentFox Schiff on

Physician Partners of America Agrees To Pay $24.5 Million To Resolve False Claims Act Allegations - Physician Partners of America LLC (PPOA), its founder, and its former chief medical officer agreed to pay $24.5 million to...more

Skadden, Arps, Slate, Meagher & Flom LLP

Corporate Integrity Agreements: A Year in Review

In 2021, the Department of Health and Human Services Office of Inspector General (HHS-OIG) entered into 30 new corporate integrity agreements (CIAs) with companies and individuals to resolve exclusion authority arising out of...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

Health Care Compliance Association (HCCA)

Hospital Settles FCA Case Filed by CO Over Modifiers; Make Sure People ‘Feel Heard’

Report on Medicare Compliance 30, no. 32 (September 13, 2021) - John Peter Smith (JPS) Hospital in Fort Worth, Texas, agreed to pay $3.3 million to settle false claims allegations in a case with a hot risk area, a...more

Sheppard Mullin Richter & Hampton LLP

Sutter Health Settles Medicare Fraud Case For $90 Million: The Largest Settlement For Medicare Advantage Fraud

A major California-based health care system, Sutter Health, and several of its medical practice foundation affiliates have agreed to pay a total of $90 million to settle allegations that they violated the False Claims Act...more

ArentFox Schiff

Investigations Newsletter: Nursing Home Chain Agrees to Pay $11.2 Million to Resolve False Claims Act Allegations

ArentFox Schiff on

On May 21, 2021, SavaSeniorCare LLC and several of its affiliates, which own and operate skilled nursing facilities across the country, agreed to pay $11.2 million to resolve claims that the companies billed Medicare for...more

Miles & Stockbridge P.C.

Disregard Compliance at Your Peril: Compliance Officer Paid As Whistleblower

Miles & Stockbridge P.C. on

A medical device manufacturer learned what might seem an obvious lesson when it paid $18 million to settle a False Claims Act lawsuit brought by its former Compliance Officer: don’t ignore your compliance officer. The federal...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

Health Care Compliance Association (HCCA)

DOJ Is Trying to 'Incentivize Higher-Quality Compliance,' Former Official Says

Report on Medicare Compliance 28, no. 44 (December 16, 2019) - One way to find out whether compliance and integrity have seeped into the bones of an organization is asking people who would know. There may be a compliance...more

The Volkov Law Group

Avanir Pharmaceuticals Pays More than $108 Million to Settle Kickback Violations

The Volkov Law Group on

Just to repeat myself – pharmaceutical and medical device firms face extraordinary risks of enforcement under the False Claims Act.  While everyone likes to write and focus on FCPA or anti-corruption risks for global drug and...more

Jones Day

D.C. Circuit Rejects Novel Theory of Reverse False Claims Liability for Reporting Violations

Jones Day on

The Situation: In U.S. ex rel. Kasowitz Benson Torres LLP v. BASF Corporation, the relator alleged reverse false claims liability under the False Claims Act ("FCA") for the defendants' purported failure to comply with...more

Mintz - Health Care Viewpoints

Insys Bankruptcy Filing Immediately After Global Settlement Triggers Powerful Remedies

Over the last two years, much of the healthcare world has been watching the government’s prosecution of Insys Therapeutics for its sales and marketing practices related to its Subsys spray. Subsys is powerful and highly...more

King & Spalding

Vanguard Healthcare Agrees to Pay More Than $18 million to Resolve FCA Lawsuit

King & Spalding on

On February 27, 2019, the Department of Justice announced that Vanguard Healthcare, LLC and related Vanguard companies agreed to pay more than $18 million to resolve claims made by the United States and the State of Tennessee...more

King & Spalding

Electronic Health Records Vendor Agrees to $155 Million Settlement to Resolve FCA Allegations, Required to Make Free Upgrades to...

King & Spalding on

On May 31, 2017, the DOJ announced a $155 million settlement with eClinicalWorks (ECW), one of the nation’s largest electronic health records (EHR) vendors, to resolve a False Claims Act lawsuit brought by a whistleblower. ...more

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