Johnson and Johnson Corporate Integrity Agreement: The Progression of Life Science Corporate Integrity Agreements

Conclusion The industry should take note of the expanded enforcement actions CIAs permit as well as the consequences of CIA violations. After the 2012 Pharmaceutical Compliance Roundtable, attended by HHS-OIG officials and representatives of 23 pharmaceutical companies under CIAs, we reported that the government was seeking a middle ground to avoid exclusion (which can leave beneficiaries without needed drugs) but also provide sufficient consequences to deter further misconduct. Gibson Dunn's 2012 Year-End Health Care Compliance Update noted enforcement officials are imposing "increasingly harsh penalties… on companies and individuals alike, 'seeking to disprove the ill-advised notion that health care fraud enforcement is simply the cost of doing business.'" Because of implementation and IRO requirements, a CIA can be very costly, particularly in the first year. To stay ahead of the compliance curve, companies that want to do business with the government should continually utilize existing CIAs as guidance to voluntarily structure rigorous compliance programs in a timetable and manner that works best for each individual company.
Source: Policy and Medicine - Category: Health Medicine and Bioethics Commentators Authors: Source Type: blogs