While the CIA model approach may offer welcome predictability, HHS OIG should consider adopting one or more provisions of the Model Corporate Integrity Agreement presentation, designed by Skadden, published last year in Law360. The Skadden CIA model includes modern business design conventions, maintains the CIA`s core requirements, and provides companies with greater flexibility in implementing these obligations and strengthens provisions for risk assessment and monitoring. In recent years, OIG CIAs has concluded with many health organizations, including pharmaceutical manufacturers, hospitals, doctors` offices, clinical laboratories, nursing homes, home health services and medical equipment and sustainable pharmacy providers. While civil comparisons between the DOJ and a healthcare provider or provider often contain terms that have been developed or adapted to address specific issues that have been the subject of controversy, the aforementioned standard terms, which are normally included in these transaction agreements20 i „Corporate Integrity Agreements“. Order of business| Reports and publications | Office of the Inspector General | Department of Health and Human Services. Available at: oig.hhs.gov/compliance/corporate-integrity-agreements/index.asp. The Company Integrity Agreement governs all agreements with healthcare providers (HCP`s), including wire transfer agreements. DEA requirements, CCO reporting rules. The CIA of AmerisourceBergen Corporation (ABC) appears to be the second open CIA (and so far only the second CIA) to explicitly abide by the rules of the DEA (i.e.
the requirements of the Controlled Substance Act). 5 The requirements of the DEA are broad and must be considered throughout the company`s compliance program. It should also be noted that the ABC CIA provides that the Chief Compliance Officer reports „directly“ to the Audit Committee of the Board of Directors and only „administratively“ to the Chief Executive Officer. 10 In certain circumstances, the IGO will provide an exclusion authorisation permitted without an appropriate CIA, for example. B if the company discloses the conduct in question itself or if it undertakes with the United States to comply with integrity obligations. . . .