Halloween Day 2013 added a new CIA to the list….and renewed focus on oversight of medical education. As we all know, on October 31, 2013, J&J entered into a CIA with the OIG and will pay fines of $2.2 Billion to the DOJ. This is the third largest CIA settlement in history and also brings back a familiar area of scrutiny – “Third Party Educational Activities”.
The J&J CIA includes familiar areas of oversight, which we have seen in CIA’s past; including,
1. Development of Policies and Procedures which must address:
- funding and /or sponsorship and participation complies with all applicable federal health care program and FDA requirements
- disclosure of financial support and any financial relationships with faculty, speakers or organizers
- faculty disclosure of any relationship with J&J
- educational focus of the activity
- J&J independence from content, organization and operations of educational activity
- program must be non-promotional in tone/nature
- J&J support be contingent on the providers commitment to provide information that is fair, balanced, accurate and not misleading
2. Establishment of controls which ensure:
- all funding requests are reviewed, tracked and evaluated by Compliance
- funding is based on objective criteria such as qualifications and quality of program
- there is a written agreement with the educational organization and payment complies with, and is consistent with, the written agreement
- J&J staff are not involved in development or implementation of the program
J&J’s CIA indicates that all “Third Party Educational Activities” need to be included in J&J’s annual monitoring plan in order to ensure that controls are operating as designed and that policies and procedures are actually being followed. It goes on to indicate parameters by which that monitoring must happen (e.g. 20 educational programs per year). The life sciences compliance industry typically looks to CIAs when fashioning their compliance programs. It is an effective way to gauge what the government is currently looking at and where it will focus in the coming years. Therefore, it behooves all of us to heed the OIGs Halloween Day warning: It is not enough just to have controls and policies in place. Companies must now prove that they are effective and show that they are actually being compliant.