Four Guideposts to Improve Investigator-Initiated Trials Payment Processes for FMV Compliance
Teams that run investigator-initiated trials (IITs) can play a major part in avoiding (or passing) OIG scrutiny by focusing on improvements in three major areas:The Office of the Inspector General at Health and Human Services (OIG) has been highly focused recently on tracking and publicizing pharmaceutical companies’ payments to thought leader physicians and clinical investigators. A number of companies have found themselves under investigation, and some have had to enter into Corporate Integrity Agreements to ensure their practices are up to the scrutiny.
- Review process for investigator trial proposals
- Documentation of aggregate spend
- Payment triggers and delivery
Guideposts for successfully managing Investigator-Initiated Trials payment processes for fair-market value compliance have emerged in our recent benchmarking studies. Some of them include:
- FMV analysis needs to become a formal milestone in the IIT proposal review process, with FMV analysis performed on all IIT applications that reach serious consideration. IIT teams should cross-reference investigators’ final budget proposals against internal and external databases of post-marketing clinical trial costs. Accurate FMV analysis may require the IIT team to request a greater level of budgeting detail from the investigator.
- IIT teams should monitor aggregate spend on an individual level and site level. IIT leaders must be mindful not to approve studies that would concentrate too high a percentage of their payments to one investigator or academic institution. One tool that some teams have adopted to avoid any such overpayment is the creation of formal compensation limits.
- By paying investigators with milestone payments, rather than flat fees, the team can show clear justification for payments made to investigators. Companies now document consulting and speaking activities for payments to key opinion leader physicians. In much the same way, medical affairs and post-marketing trial teams should require investigators to track milestone activities or completed modules of work in order to receive payment. Interviewed executives note that a hidden benefit of the ‘milestone payment strategy’ is that it keeps investigators motivated. Investigators rarely fail to submit a manuscript for journal publication if the final milestone payment is on the line.
- Finally, to add an extra layer of regulatory compliance, pharmaceutical companies should not pay investigators directly. Payments to physicians and other healthcare specialists conducting IITs should be handled through a third-party vendor.
Making these changes to strengthen investigator payment processes can be difficult, but leaders at the companies that have made these course corrections feel that the results are well worth the effort.
To learn more about Cutting Edge Information’s Investigator-Initiated Trial Management report, download the summary here.