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Corporate Integrity Agreement Department of Justice (DOJ) Department of Health and Human Services (HHS)

Foley & Lardner LLP

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

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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

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

Harris Beach PLLC

HHS Office of Inspector General August 2023 Enforcement Activity

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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

King & Spalding

DOJ Corporate Enforcement Policy Revisions Target Executive Compensation, Following Multi-Agency Trend

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On March 2, 2023 and March 3, 2023, in a pair of speeches by Deputy Attorney General (DAG) Lisa Monaco and Criminal Division Assistant Attorney General (AAG) Kenneth Polite, the U.S. Department of Justice (DOJ) announced...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

Dorsey & Whitney LLP

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

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​​​​​​​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

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

Rivkin Radler LLP

Texas Hospital Settles Alleged FCA Violations for $18.2 Million

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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

Foley & Lardner LLP

OIG’s Revised Self-Disclosure Protocol: Top Takeaways

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On November 8, 2021, the Department of Health & Human Services (HHS) Office of Inspector General (OIG) released a revised and renamed Provider Self-Disclosure Protocol: the OIG “Health Care Fraud Self-Disclosure” protocol...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

Skadden, Arps, Slate, Meagher & Flom LLP

HHS-OIG Signals Increasing Skepticism of Speaker Programs, Identifies Practices That Raise Compliance Red Flags

On November 16, 2020, the Office of the Inspector General of the Department of Health and Human Services (HHS-OIG) issued a Special Fraud Alert regarding the inherent fraud and abuse risks associated with...more

King & Spalding

Are Pharma Speaker Programs Facing an Existential Crisis?

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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

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

Skadden, Arps, Slate, Meagher & Flom LLP

HHS-OIG Year in Review: Pharma and Medical Device CIAs Increase, Include Novel Provisions

Corporate integrity agreements (CIAs) continued to be an important tool for the Office of Inspector General, U.S. Department of Health and Human Services (HHS-OIG) in 2019. Notably, pharmaceutical and device manufacturers saw...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

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

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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

McDermott Will & Emery

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

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

Skadden, Arps, Slate, Meagher & Flom LLP

Health Care Investigation Trends: Corporate Integrity Agreements No Longer a Given

2017 was slightly above average for new corporate integrity agreements (CIAs), with 46 entered into by the Department of Health and Human Services’ (HHS) Office of Inspector General (OIG) and companies and individuals...more

Skadden, Arps, Slate, Meagher & Flom LLP

"Trends in Corporate Integrity Agreements Reflect New HHS OIG Guidance on Use of Exclusion Authority"

2016 was a year of change for the Department of Health and Human Service's Office of Inspector General's (OIG) approach to corporate integrity agreements (CIA). The OIG began to use its new model CIA format and applied its...more

Sherman & Howard L.L.C.

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

Sherman & Howard L.L.C. on

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

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