Pharmaceutical manufacturers, retail pharmacy chains, medical device companies, pharmacy benefit managers and other organisations currently face the challenge of negotiating a Corporate Integrity Agreement (CIA) with the Office of the Inspector General (OIG).
CIAs are complex, multi-year agreements that require an organisation to implement or maintain an effective compliance programme. Additionally, certain circumstances require an organisation to contract with an Independent Review Organisation (IRO) to provide an independent evaluation of their compliance with the CIA.
PricewaterhouseCoopers has developed a portfolio of services that enable pharmaceutical and life sciences industry organisations to comply with regulatory requirements and to prepare for the increased government attention. We work closely with clients to develop compliance programmes that mitigate the impact of a CIA, provide advice on how to effectively negotiate CIAs with the government, and develop and implement anticipated IRO workplans.