Kelly Willenberg, R.N., M.B.A.
New tools streamline billing for clinical trials
Warren Beck
Vanderbilt University Medical Center's Department of Finance is partnering with the Informatics Center on the development and implementation of a new application that will result in more accurate charging and billing of patient services in clinical trials.
This is being in done in conjunction with the Office of Grants and Contracts Management, the Institutional Review Board (IRB) and Research Support Services in the Office of Research.
A goal is to avoid compliance issues that have resulted in multi-million-dollar settlements paid by several academic medical centers across the country for inappropriate billing of patient services to Medicare, said Kelly M. Willenberg, R.N., M.B.A., manager of clinical research financial compliance.
The new Vanderbilt system was developed in collaboration with Informatics under the direction of the center's assistant director, Cass Fagan, and key people in the Department of Finance, including Director Warren Beck.
“One of the most significant improvements … is Subject Tracker, which is an automated intelligence tool,” Beck said. “This tool will help us ensure that charges are posting to appropriate study D&H accounts or standard-of-care accounts.”
D&H (doctors and hospital) accounts are used for posting the cost of items such as investigational drugs, medical devices and research-related procedures that are covered by granting agencies, including the federal government, corporations and foundations.
Standard-of-care or conventional care charges include costs of other clinical services provided during the study that are not covered by granting agencies but which are eligible for reimbursement by Medicare or by the research subject's private insurance coverage.
On the Finance department's Web site is another recently developed tool called “Clinical Research Budget Template” that can help researchers build their budgets for the clinical components of their studies, and appropriately separate costs that can be charged to the granting or sponsoring agencies from those charged to Medicare or private insurance.
The template can be accessed by clicking “Clinical Trials Billing Compliance” under the “Research” toolbar on the lower left corner of the Medical Center home page. The intent is that it should be filled out for every clinical study, regardless of whether there is external research funding or a D&H account, Willenberg said.
Information from the forms in this template, including the Clinical Trial Registration Form and a cost analysis worksheet for each research subject, will be integrated into the Subject Tracker tool. “It's working behind the scenes to make sure that we're charging services appropriately to the correct account,” Willenberg said.
“Medicare has actual codes that we are required to use for clinical trials patients,” she added. “This tool is enabling us to do that with more efficiency.”
Willenberg and Alison Culley, R.N., research billing compliance coordinator, also are entering into the medical center's EPIC billing system the names of the research subjects who are currently participating in the estimated 400 clinical studies with a D&H account.
When that work is completed, the department will begin entering the more than 2,000 clinical studies that don't have a D&H account because they aren't supported by an outside funding agency. That work should be completed by mid-summer.
With the help of the Informatics Center and the Office of Research, the Finance Department has begun to generate reports from the database that can catch inappropriate charges and research subjects who haven't been entered into the system.
“Once we get all the patients in and all the studies in, we'll actually be able to watch the charges that are going on the patients' bills on a daily basis,” Willenberg said.
The department also is working with the Institutional Review Board, which evaluates and approves every clinical research proposal, so that whenever a new study is approved, “we will get an alert and we will work with the team to make sure it's in the system,” she said.
Finally, Willenberg and Culley have begun training study coordinators to enter the names of subjects — as soon as they've given consent to participate in a study — into a new research patient registration form in StarPanel, Vanderbilt's advanced electronic medical record application. That information then is entered into the EPIC billing system and into Vanderbilt's Medipac admissions and discharges database.
Eventually the Medical Center will either buy a system to handle the new compliance requirements, “or they'll decide to design the system here and go with it,” Willenberg said. Currently, “there's not a product on the market that does this.”
“This is a team effort,” she added, noting that it is endorsed and supported by Associate Vice Chancellor for Research Jeffrey Balser, M.D., Ph.D., Assistant Vice Chancellor for Research Gordon Bernard, M.D., and Medical Center Compliance Officer James Snell, M.D.
“Our hope is that we can accomplish an organized, intuitive, compliant system for handling clinical research billing in tandem with continuing support for excellence in clinical investigation,” said Bernard, whose responsibilities include Research Support Services and the IRB.
Staff from the Office of Research, Grants and Contracts Management, the IRB, Research Support Services and the Finance Department will work together to integrate this process into the normal flow of work for investigators and study coordinators in order to reduce redundancy and the overall burden of establishing a compliant program for each study.
These staff will become trained in the new skills needed to provide a supportive role in this process as they have for other institutional areas related to clinical research.
“Finance is the sponsor behind this piece of work because we are the department with the responsibility for compliant charging and billing,” Willenberg said, “but we're all working together to make the research enterprise better in billing compliance. Everything we do here is going to help us in the future.”
Willenberg can be reached at 3-3653 or kelly.willenberg@vanderbilt.edu.