Corporate Integrity Agreement Examples

For example, in April 2013, Policy and Medicine reported that financial reimbursement programs, known as «clawbacks,» are new compliance rules used to hold current and former executives accountable for their role in compliance violations. At the time, Johnson & Johnson (J&&J) said it agreed in principle with extensive recoveries to deter unethical and inappropriate behavior, but that the company did not have a timeline for adopting a concrete policy. The new CIA J&J, concluded on October 31, 2013, forced the company and J&J is required to establish compensation packages, including recoveries, in accordance with the government`s schedule and under the supervision of HHS-OIG. Arnold & Porter, LLP provided a customer alert analyzing the facts behind the comparison. In addition, companies active in the CIA field should be aware that the provisions of the CIA`s HHS-OIG can be imposed through criminal prosecution, fines, penalties, additional CIA, exclusions and lately forced assignment. When Skadden`s lawyers said HHS-OIG had asked Church Street Health Management to sell one of its dental clinics within 90 days to avoid excluding companies from federal programs, Skadden found that this was «the first time in a healthcare fraud case that OIG has used the forced transfer of a business girl to address deviations from compliance obligations. imposed by the CIA.» Roche appears to be the only pharmaceutical company that has never been subject to the CIA. Nevertheless, a superficial review of the De Roche site, including the company`s Group Code of Conduct, shows that Roche has voluntarily adopted many of the compliance rules required by recent CIA. Roche has a Chief Compliance Officer, a «SpeakUp» hotline for employees to report confidential misconduct, a written «Code of Conduct» formally approved by the CEO and the Board of Directors, electronic compliance and integrity training modules (Roche Behaviour in Business or RoBiB, e-learning program) in which all employees certify their participation in the training and an online notification system for the monitoring and prosecution of alleged infringements from first notification to resolution. In the changing compliance landscape, these measures appear to be examples of good compliance practices.

This article contains public service information from the U.S. Department of Health document: «Corporate Integrity Agreements Snapshot» (PDF). Called April 14, 2018. Recently, parent company Bausch+Lomb entered into a CIA that included a divestiture agreement to transfer all the assets of its subsidiary ISTA Pharmaceuticals within six months, after which ISTA would be excluded for 15 years. Forced assignments are examples of HHS-OIG`s new efforts to enforce the rules without resorting to total exclusion. HHS-OIG also excluded individual executives and indicated that the assignment of a given product or the withdrawal of a company`s patent rights could be future enforcement instruments, which are contractual to combat CIA violations. . . .