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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

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

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

FDA Issues Guidance on Prescription Drug Sample Distribution During COVID-19

On June 8, 2020, the Food and Drug Administration (FDA or Agency) issued temporary guidance to address concerns related to distribution of drug samples during the COVID-19 public health emergency....more

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

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

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

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