Callan G. Stein, a partner in the Health Sciences Department and the White Collar Litigation and Investigations Practice Group of Pepper Hamilton, was quoted in the December 24, 2019 PreCheck Blog article, "Three Strategies for Compliance Program Annual Reviews."
Guidance issued by the Department of Justice and the Department of Health and Human Services Office of the Inspector General is the best starting point when conducting a compliance review, says Callan Stein, Partner at Pepper Hamilton LLP. Some items these departments are looking for in a compliance program are responsive updating, customization to the organization and risk assessment, Stein says.
As your organization changes and grows, it’s critical to keep tabs on your compliance department and to have sufficient resources. “You want to make sure that you have enough employees whose job is dedicated to compliance and that the department is commensurate and proportional with your operations,” Stein says.
When compliance issues arise, you need enough resources to be able to take disciplinary action to deter recurrence, which is a practice that the DOJ and HHS OIG will be watching for. Discipline should be consistent across all organizational levels and proportionate to the violation. “The government wants to see significant consequences for compliance violations,” Stein says. “They want to see it across the board, whether the violation comes from the bottom or the top.”
Your healthcare organization generates huge volumes of data every year, and it’s precisely that data that the government mines when conducting investigations. Monitoring that data for trends in noncompliance can help you identify and head off potential violations, Stein says. “If you identify something amiss, you can investigate it using counsel,” he says. “You can then take preemptive action to correct it, if need be.”
Mining your own organizational data throughout the year is a good practice to stay ahead of violations. When problems do arise, the data tells the story. Use it to conduct a root-cause analysis and determine where the problem started. Once you know the cause, Stein says, you can pinpoint why it happened. Then, you can take disciplinary action to ensure that it doesn’t recur.