Honoraria - Leveraging Enhanced EDC Integrated CTMS
Functions
Implementation approach two - fully automated process
During 2003, Guidant Corporation implemented enhanced EDC throughout their post-market research program. This program includes a mixture of randomized multi-arm studies, observational single arm studies, and registries ranging in size from 75-200 investigative sites and 500-2000 patients each. At any given point in time, up to 10 of these initiatives are actively enrolling or following patients. Honoraria for data collected and submitted was paid by visit, e.g., screening/enrollment, treatment, follow-up, as well as for conduct of specified testing and upload of resultant data, adverse event reporting, death/LTFU reporting etc., and mailed quarterly.
Guidant had maintained a paper-based reimbursement system for post-market studies prior to 2003. This mirrored, in essence, the process steps described in figure 1. Before 2003 this was manageable as few studies were conducted at relatively few sites - with the significant increase in investment in post-market studies, however, and in anticipation of the rapid enrolment rates and speed of "clean" data acquisition with enhanced EDC, Guidant management determined that maintaining the prior system of reimbursement represented a high-risk of requiring major human resource investment while not decreasing overall error rates.
The specifications delivered to MedNet by Guidant for development of an AutoHonoraria system included -
- Automated reporting of all activities creating payment liability
- Tracking
- All payments due in a given period
- All payments made to date
- Payments becoming due in future periods
- Site, study, multi-study level
- Ability to vary payments from site to site
- Accounting for university overhead etc.
- Milestone achievement payments
- Ability to pay in local currency
- Ability to serve up a single consolidated file to SAP financial accounting system
- Must be in human-readable form for authorization purposes
- Must include payee Tax ID/SSN, cost-center details etc.
- Must integrate directly into SAP without modification
- Automatic cover letter production detailing
- Activities, payments associated with activity, when activity performed
- Activities incomplete/not eligible for payment - with option to not include this data as desired
- e.g. records not locked, data incomplete
The desired outcome of a system conforming to the specifications was reduction in time and human resource burden and increase in error-free production. This was accomplished by further reducing the process steps involved in honoraria fulfillment as can be seen in figure 4, where italics represent a non-human system process.
Figure 4: AutoHonoraria Process
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In essence, the Guidant implementation of AutoHonoraria permitted a single payment file to be produced on demand, authorization of that file, and check generation as a result.
Automated reporting and tracking tools were developed using a variety of color and symbol/icon codes to designate status. while cover-letters that detailed exactly which payments were being made reduced enquiries dramatically as compared to the previous system, phone calls from sites did occur, and quick resolution of concerns could often be achieved utilizing reports of the type shown in figure 5:
Figure 5: Site payments by activity, patient & visit
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Consolidated payment reports by center were also provided, which proved especially useful where a center or investigator participated in more than one research initiative during a reporting period - see figure 6:
Figure 6: Consolidated roll-up reports
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In addition to performing the functions detailed in the specifications sections above, further efficiencies were gained through utilization of mailing address/payee information for auto- generation of mailing labels and/or use of mail-house services (where volume was especially high). In keeping with the core functionality of the AutoHonoraria system, the utilization of this information, already captured within the integrated CTMS function of the enhanced EDC system, took the form of production of a standard comma separated values (CSV) file that can be read by any word-processing/mail-merge program. Additionally, automatic emails were sent to field personnel responsible for given sites with summary level information, dates of payment processing, items outstanding etc.
At time of writing, Guidant has implemented this EDC system throughout all studies. In effect, it disburses multi-million dollar honoraria payments across over a dozen initiatives in a variety of countries with differing local currencies and payment schedules. Where it was estimated that 4.5 FTE was required to manage these payments across the research department and the finance group, the function has been well-executed at a burden of 0.25 FTE - the finance group, recognizing the efficiencies, are actively encouraging other Guidant departments to investigate the technology and implement wherever possible.
© Timothy Pratt 2005
