Leveraging CIAs as a compliance tool: Analyzing trends to identify and mitigate compliance risks for pharmaceutical and medical device manufacturers

Samantha Groden (samantha.groden@dentons.com) is a Senior Managing Associate in the San Francisco office, Jordan Jackson (jordan.jackson@dentons.com) is an Associate in the Birmingham office, and Tisha Schestopol (tisha.schestopol@dentons.com) is Counsel in the Washington, DC, office of Dentons.

Identifying, monitoring, and addressing potential risk areas is a critical component of an effective compliance program. Indeed, the Office of Inspector General (OIG) within the U.S. Department of Health & Human Services recommends that healthcare organizations participating in federal healthcare programs conduct periodic risk assessments and engage in internal review processes with the aim of identifying and prioritizing risks, developing and implementing internal auditing and monitoring work plans related to such risks, and developing and implementing corrective action plans in response to the findings, as applicable.[1]

This article is the last in a series designed to equip compliance personnel with data—derived from recent government enforcement activity—that can help them better understand the government’s current enforcement priorities and, thus, inform how they rank potential risks to their organization.

Recent corporate integrity agreements (CIAs) and integrity agreements (IAs) imposed by the OIG,[2] as well as associated settlement agreements and litigation filings, provide a wealth of information regarding the agency’s priorities, areas of focus, and compliance expectations. (IAs are similar to CIAs but typically have a shorter term and contain fewer compliance obligations.) By understanding the circumstances under which the OIG has imposed a CIA or IA, federal healthcare program participants can better understand the agency’s enforcement emphasis and identify internal practices that may require closer scrutiny.

Unfortunately, while the OIG maintains a publicly available database of its active CIAs and IAs (and associated materials),[3] the data is not organized in a way that easily allows for quantitative and qualitative analysis. Each article in this series is designed to provide targeted data analysis of recent CIA and IA enforcement activity related to a specific type of provider or supplier. This article focuses on recent CIAs involving pharmaceutical and medical device manufacturers.

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