On August 28, 2013, the United States Attorneys’ Office announced that Emory University agreed to pay the United States and the State of Georgia $1.5 million to resolve allegations of submitting false claims to Medicare and Medicaid from 2001 through 2010. According to the settlement agreement, Emory’s Winship Cancer Institute was accused of violating the National Coverage Determination (NCD) for Routine Costs in Clinical Trials through:
• Billing Medicare and Medicaid for clinical trial services that should have been billed to the clinical trial sponsors.
• Double-billing the same clinical trial services to clinical trial sponsors and to Medicare and/or Medicaid.
Under this settlement, Emory agreed to identify unallowable costs previously submitted for payment to Medicare, tricare, and Medicaid within 90 days. The federal government is also entitled to recoup these overpayments, plus applicable interest and penalties.
Emory’s settlement illustrates Yale’s need to be proactive in evaluating a research study’s billing compliance. Since February 1, 2013, the OnCore/EPIC interface has been activated to assist investigators and departments with research billing compliance at Yale. Investigators starting a new clinical trial involving clinical services should contact the OnCore team to assess the need to use the interface prior to enrolling their first subject. If the team determines that the study should use the system, subjects must be activated in OnCore/EPIC soon after signing the consent form.