CIAs: OIG’s Favorite Enforcement Tool
In an attempt to stem health care fraud, the government’s use of Corporate Integrity Agreements (CIAs) is growing. In Professor Zack Buck’s Health Care Fraud and Abuse class here at Seton Hall Law, students were given the benefit of a discussion on the topic by two industry veterans, Tim Grimes and Brett Bissey. Grimes is the Health Care Compliance Officer for the North American Pharmaceuticals branch of Johnson & Johnson, where he oversees the development, improvement and management of health care compliance and government contract compliance systems. Bissey is Senior Vice President, Chief Ethics and Compliance Officer at the University of Medicine and Dentistry of New Jersey (UMDNJ), where he is responsible for the management and direction of all compliance and ethics related programs.
Grimes and Bissey spoke on the proliferation of, and challenges associated with, the use of CIAs in the health care industry. A CIA is a restrictive agreement, usually lasting five years, entered into by the Office of Inspector General of the U.S. Department of Health & Human Services (OIG) and a health care entity alleged to have engaged in fraudulent or abusive practices. CIAs impose numerous compliance obligations, which are intended to stop fraudulent behavior from occurring in the future. These compliance obligations range from requiring employee training, to mandating the appointment of a compliance officer, to implementing a communications hotline. Both Grimes and Bissey have personal experience working under a CIA, as Johnson & Johnson and UMDNJ, like many others in the industry, have or are currently operating under such integrity agreements.
Grimes and Bissey explained that CIAs can be cumbersome because the terms of the agreements are often unclear and the costs of compliance obligations, such as employee training, can be immense. For example, CIAs generally require proper compliance training for any “relevant covered person” within the organization. However, what defines such persons is generally unclear, and the costs and logistics of implementing a training program for all employees who come in contact with a medication, from local pharmaceutical representatives to researchers working in another country, can be expensive and complex.
To help address such issues, Grimes participated in the Pharmaceutical Compliance Roundtable hosted by the OIG in February 2012, which brought together compliance professionals from 23 pharmaceutical manufacturers currently operating under a CIA. By establishing the Roundtable, the OIG sought to foster an open dialogue between private industry and government addressing the implementation and operational challenges of CIAs.
While the difficulties of working under CIAs were mentioned, Grimes and Bissey also acknowledged the benefits that companies can reap by their use. CIAs can also, it was said, be extremely beneficial because they increase the individual responsibility on corporate officers and board members, grabbing the attention of upper-level management who may have previously been less responsive to compliance concerns. Further, the proliferation of CIAs is said to have changed the attitude of some company officers toward compliance initiatives–bringing a level of enthusiasm which may have been absent in the past.
On a parting note, Grimes and Bissey agreed that the government shows no signs of slowing down on its use and enforcement of CIAs in the health care industry. Commenting about the state of the industry, they said the question is not “Who is under a CIA?” Rather, it’s “Who isn’t?”