As noted in a recent article from Policy and Medicine, we have now received our first definitive indication that the OIG and CMS are moving to enforce the Sunshine Act reporting requirements. According to Mary Riordan, senior counsel at the Health and Human Services’ Office of Inspector General, life sciences companies can expect to see enforcement actions beginning next year. Speaking at the Pharmaceutical Compliance Congress and Best Practices Forum in October, Ms. Riordan urged companies “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.” For her, that meant companies should:
- Establish meaningful controls around relationships with physicians and teaching hospitals
- Use the Open Payments system as a compliance tool (e.g., mine the data), and
- Weave Compliance into everyday business operations, and
- Establish robust monitoring and risk assessment programs.
If companies haven’t looked beyond just reporting the data to CMS, now is the time do so before the Government knocks on the door.