Novartis Corporate Integrity Agreement 2010
Along with the payment of the FCA fees, Novartis entered into an Enterprise Integrity Agreement (CIA) with the Department of Health and Human Services Office of Inspector General (HHS-OIG). Among other things, the CIA requires Novartis to significantly reduce its paid speaker programs and the amount spent on programs. In addition, all remaining speaker programs may only occur in limited circumstances (which may only be available within 18 months of FDA approval of a new state reimbursement product or a new indication of a national reimbursement product previously authorized by the FDA) and in a virtual format (external speakers must be remote and not in the same location as a member of the public). In addition, there is a cap of $100,000 in total compensation for speech and spokesperson training and a total salary cap of $10,000 per spokesperson (without direct payment by Novartis for travel and travel expenses). The new CIA is one of two recent comparisons with the U.S. government. Novartis has agreed to a $678 million settlement to resolve a civil action that originated in the Southern District of New York regarding the loudspeaker programs implemented between 2002 and 2011. Novartis also agreed to a $51.25 million settlement to clarify an investigation in the Massachusetts District into support of some independent non-profit co-paying foundations (ICCFs) from 2010 to 2014. As part of the overall comparison, Novartis also entered into an Enterprise Integrity Agreement (CIA) with the Department of Health and Human Services Office of Inspector General (HHS-OIG) 3 This CIA replaces and replaces the CIA, which Novartis concluded on September 29, 2010 and was subsequently extended for five years due to a Novartis comparison with specialty pharmacies.  The CIA is available at the following time: oig.hhs.gov/fraud/cia/agreements/Novartis_Corporation_06302020.pdf. On Or before March 31, 2011, Novartis must publish on its website an easily accessible and easily accessible list of all U.S.
physicians who received direct or indirect Phase I payments from Novartis in the fourth quarter of 2010, as well as the total value of these payments.