HHS OIG Enforcement Actions on the Horizon Utilizing Open Payments, Advises Companies on Compliance

Pharmaceutical and device companies can expect federal agencies to begin pursuing enforcement actions against companies that fail to comply with Open Payment reporting requirements within the next year, according to Mary Riordan, senior counsel at the Health and Human Services' Office of Inspector General. The Affordable Care Act provides for penalties for manufacturers who fail to timely, accurately or completely report the information and for those who knowingly fail to timely, accurately or completely fail to report financial arrangements. Moreover, Riordan, the keynote speaker at this year's Annual Pharmaceutical Compliance Congress and Best Practices Forum in October, noted for the audience, the Open Payments system is a very easily searchable public database with information that will be of interest to the public, law enforcement, the media, researchers, and many others. It's important for companies to be aware of and have controls around financial relationships the company has to ensure it can provide appropriate answers to questions that will inevitably come its way. To ensure compliance with reporting requirements, Riordan advised the audience to set up meaningful controls around relationships and arrangements that could implicate kickback regulations, use the information collected about these relationships as a tool to improve compliance efforts, integrate compliance efforts into business operations, and develop monitoring and risk-assessment programs. Here's what...
Source: Policy and Medicine - Category: American Health Authors: Source Type: blogs