News & Analysis as of

Department of Health and Human Services (HHS) Healthcare Fraud Corporate Integrity Agreement

Bass, Berry & Sims PLC

Fourth Circuit Holds that Violation of CIA Can Support Reverse False Claims and Adopts Relaxed Rule 9(b) Presentment Requirement

Bass, Berry & Sims PLC on

On February 3, the U.S. Court of Appeals for the Fourth Circuit reversed a district court’s grant of a motion to dismiss, holding in relevant part that: - Violations of a Corporate Integrity Agreement (CIA) can create an...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

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

Harris Beach Murtha PLLC

HHS Office of Inspector General August 2023 Enforcement Activity

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

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

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

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

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

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

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 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

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

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

Skadden, Arps, Slate, Meagher & Flom LLP

HHS OIG Closes 2018 With New Fraud Risk Indicator for Corporate Integrity Agreements

While the number of new corporate integrity agreements (CIAs) declined since last year, and was below the trailing five-year average, 2018 was an important year on the policy front for the Office of Inspector General (OIG),...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

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