News & Analysis as of

Department of Health and Human Services (HHS) Corporate Integrity Agreement Health Care Providers

Pietragallo Gordon Alfano Bosick & Raspanti,...

Hidden Dangers Lurking in Corporate Integrity Agreements

When I litigated False Claims Act (FCA) cases at the U.S. Department of Justice (DOJ), it was common practice for settlements to require Corporate Integrity Agreements (CIAs) setting forth ongoing duties and responsibilities...more

Mintz - Health Care Viewpoints

EnforceMintz — Additional Health Care Provider Joins the OIG’s “Heightened Scrutiny” List in 2024

The HHS Office of Inspector General (OIG), in connection with its enforcement responsibilities, must exclude a party from the federal health care programs if the party is found to have violated certain federal laws. This type...more

Health Care Compliance Association (HCCA)

[Event] 2025 Board & Compliance Committee Conference - February 24th - 25th, Phoenix, AZ

The Board & Compliance Committee Conference is designed specifically to educate board members on best practices and recommendations for establishing and maintaining an effective compliance program. The OIG-HHS will discuss...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

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

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

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

Health Care Compliance Association (HCCA)

Rob DeConti on the Latest Guidance and Insights from the OIG at HHS

In this podcast Rob DeConti, Assistant Inspector General for Legal Affairs within the office of counsel to the Inspector General at HHS, was good enough to share a tremendous amount of insight into what the OIG is seeing,...more

Troutman Pepper Locke

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

Troutman Pepper Locke 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)

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

Skadden, Arps, Slate, Meagher & Flom LLP

HHS-OIG Year in Review: Despite Challenges Posed by the Pandemic, 2020 Saw an Uptick in Enforcement Action

Despite the challenges posed by the COVID-19 public health emergency in 2020, the Office of Inspector General, U.S. Department of Health and Human Services (HHS-OIG) entered into the highest number of corporate integrity...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

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)

DAB Affirms OIG's $1.32M Penalty on Provider for Breaching CIA

Report on Medicare Compliance 29, no. 23 (June 22, 2020): The HHS Departmental Appeals Board (DAB) has upheld the largest stipulated penalty imposed by the HHS Office of Inspector General (OIG) in years. OIG fined...more

Health Care Compliance Association (HCCA)

Report on Medicare Compliance Volume 29, Number 13. News Briefs: April 2020

Report on Medicare Compliance 29, no. 13 (April 6, 2020) - During the coronavirus pandemic, the HHS Office of Inspector General (OIG) is “trying to minimize the burdens on providers,” said Christi Grimm, principal deputy...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)

Report on Medicare Compliance Volume 28, Number 44. News Briefs: December 2019

Report on Medicare Compliance 28, no. 44 (December 16, 2019) - ? Korunda Medical LLC, a Florida-based company that provides primary care and interventional pain management, has agreed to pay $85,000 to settle a potential...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

McDermott Will & Schulte

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

Arnall Golden Gregory LLP

OIG Releases Revised Guidance on Independent Review Organization Independence and Objectivity

On August 22, 2016, the Office of Inspector General of the Department of Health and Human Services (OIG) released updated guidance on Independent Review Organization (IRO) independence and objectivity (the “Guidance”). The...more

Skadden, Arps, Slate, Meagher & Flom LLP

Recent Corporate Integrity Agreements Highlight HHS OIG’s Compliance Program Priorities

Corporate Integrity Agreements (CIAs) are among the most important tools in the U.S. Department of Health and Human Services Office of Inspector General’s (OIG) toolbox for promoting compliance in the health care industry....more

Cooley LLP

Blog: Court Holds Corporate Integrity Agreement May Be Basis for Reverse False Claim Liability

Cooley LLP on

This week, a federal district court denied Cephalon Inc.’s (Cephalon) motion to dismiss a third amended complaint filed under the False Claims Act (FCA) by three qui tam relators in United States ex rel. Boise v. Cephalon,...more

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