Life Sciences is among the more highly regulated industries in business today, with pharmaceutical and related firms subject to scrutiny from federal and state-level regulatory agencies regarding their interactions with healthcare professionals (HCPs). Entering into a Corporate Integrity Agreement (CIA) can be a challenge, but it is by no means an uncommon one. This document is intended both for firms operating under a CIA, as well as those that want to enhance efforts to steer clear of compliance issues and hopefully avoid the need to enter into a CIA.
Download this new IQVIA White Paper and learn more about:
- Operational Risk Areas that can Trigger a CIA
- Key Categories of CIA Compliance
- Elements of Compliance-Centric Engagements
- Factors Necessary for Facilitating Compliance-Centric Speaker Programming
- The Final Frontier of Reporting
One of the consequences of such scrutiny is that there is little margin for error in regard to maintaining high standards for both internal and external compliance requirements when interacting with Healthcare Professionals.
A failure in these areas can result in investigations by both state and federal authorities and can be one of the steps along the path that leads a company to enter into a Corporate Integrity Agreement (CIA) with the Office of the Inspector General (OIG) within the Department of Health and Human Services (HHS).
Entering into a CIA can be a challenge for a Life Sciences company, but it is not an uncommon occurrence in this industry: U.S. government records show that hundreds of businesses across the spectrum of the healthcare sector are currently operating under CIAs, and it is has become very typical for dozens of CIAs to be initiated, extended or expanded on an annual basis. As of December 19, 2018, there were a total of 243 open CIAs.
According to research from Skadden, Arps, Slate, Meagher & Flom LLP, the number of new or amended CIAs in 2018 dropped to 38, below the 40 that were introduced in 2017.
Including integrity agreements (IAs) as well as CIAs, the U.S. Department of Health and Human Services’ Office of Inspector General entered into 37 in 2018, the lowest number since 2012. But this is by no means indicative of a more relaxed regulatory environment — in fact, the reverse is actually the case. Skadden cautioned that companies can expect stricter oversight in the future, calling 2018 an “important year on the policy front,” because the HHS OIG implemented new fraud monitoring tools and transparency initiatives. One significant component of this activity was the development of a Fraud Risk Indicator targeting companies that refuse to operate under a CIA. While the number of CIAs might be on the wane, these new developments on the policy front show a clear need for vigilance in monitoring compliance and in-depth knowledge of CIAs.