Including the Integrity Accords (IAs) and the CIA, the U.S. Department of Health and Human Services` Office of Inspector General has concluded 37 in 2018, the lowest number since 2012. However, this is by no means an indication of a more relaxed regulatory environment, but vice versa. Skadden warned that companies could expect tighter oversight in the future and called 2018 an « important year on the political front, » with HHS OIG implementing new fraud monitoring instruments and transparency initiatives. An important element of this activity has been the development of a fraud risk indicator for companies that refuse to operate under a CIA. While the number of CIAs may decrease, these new developments on the political front show a clear need for vigilance in monitoring compliance and in-depth knowledge of the CIA. Below is an alphabetical list of the major pharmaceutical and medical device manufacturer, concluded by the Office of the Inspector General (OIG) for the U.S. Department of Health and Health Services (HHS). For readings, most CIAs generally refer to five (5) years, so the deadline is about five years from the launch date, unless the manufacturer has breached the terms of its CIA or entered into a second or third CIA. The CIA can be used to address issues of quality of care or corporate integrity.  The IRO and its experts must have a thorough understanding of life sciences and the pharmaceutical/biotech industry, and in particular federal health programs, rules and regulations.
They must also be aware of the requirements that a CIA imposes on a company. Ideally, the IRO should have a mix of professionals with backgrounds such as compliance professionals, medical accountants and accountants, investigators, lawyers with previous government experience, professionals with internal experience, etc. In addition, the IRO should have technology and data science experts capable of selecting and analyzing test samples. A knowledge of how the RAT-STATS iv statistics software, recommended by oIG, is essential. Some CLAs ask an independent organization to verify and monitor compliance with CIA conditions. Most CLAs require harm checks to identify errors and their underlying causes.  The government authority can verify compliance through on-site visits.  If a company violates the agreement, the Agency can fine it and, if the problems cannot be resolved, the supplier may be excluded.  This article contains public domain material from the U.S. Department of Health and Health Services` Corporate Integrity Agreements (PDF) document.
Call on April 14, 2018.