The U.S. Department of Justice has collected upwards of $17 billion in settlements from the healthcare industry since 2009, including more than $2 billion from a single life sciences company. As part of those settlements, more than half of Fortune 500 pharmaceutical and medical device companies are operating under corporate integrity agreements (CIA) with the U.S. government.
A CIA outlines the ethical obligations a company agrees to in exchange for being allowed to continue participating in federal healthcare programs. CIAs are lengthy contracts—50 to 100 pages—detailing new procedures and protocols that must be meticulously adhered to in order to avoid further penalties. New procedures include the establishment of new regulatory roles and committees, comprehensive quarterly and annual reports, exhaustive record keeping, cumbersome review processes, and seemingly endless approvals.