Clinical trial sites see benefits of developing patient tracking system
Manual and electronic systems explained
Research institutions looking for ways to improve quality and billing compliance increasingly are turning to clinical trials patient tracking systems, experts say.
"The thing I’m hearing a lot of noise about is the clinical trials patient tracking system," says Lynette M. Schenkel, director of the office for responsible conduct of research at the University of Oregon in Eugene. Schenkel, who previously was the administrative director for research and academic affairs at Beth Israel Deaconess Medical Center in Boston, also is an editorial advisory board member for Clinical Trials Administrator.
"It’s a system designed to be an independent record of study procedures billed to the clinical trial, and it ties in with patient billing," she explains. "Most institutions have no way of knowing who their clinical trial patients are, and it’s not identifiable through the billing system."
However, the old way of handling research patient billing is fraught with regulatory danger, as more than 100 institutions discovered several years ago when they were hit with huge clinical trial settlement costs due to charges of wrongfully billing Medicare. Stemming from a whistle-blower suit, the charges dated back more than a decade and involved investigational devices used in clinical trials, Schenkel says.
Unfortunately, it’s sometimes difficult to convince administrators of the importance of investing in a clinical trial tracking system until they’re hit with compliance repercussions, she notes.
"It’s a compliance issue and a revenue issue," Schenkel explains. "Even larger institutions are strapped for operational finances, and if the budget is going to get cut, this is, unfortunately, where it gets cut because of the lack of understanding of the importance of it."
Beth Israel Deaconess Medical Center paid $3.2 million to settle charges that the hospital wrongfully billed Medicare for experimental treatments in the late 1980s and early 1990s, reports Ramesh Gunawardena, operations manager of the clinical trials office, research and academic affairs at Beth Israel.
As a result of this settlement, Beth Israel centralized its clinical trials office and has created a very thorough clinical trials tracking system that includes a detailed budget grid and a billing grid for each trial, delineating how to bill for each procedure.
"The clinical trials office was created after the settlement and for the primary purpose of compliance and avoiding conflict of interest in budget negotiations," Gunawardena says.
The clinical trials tracking system enables research staff to pull up information on how many patients are enrolled at any given time and which visits they’ve completed, Gunawardena explains.
"The goal is to have real-time data, and we are striving towards that goal," he says.
"We employ Excel spreadsheets and shared drives, but the availability of data is dependent on when the study coordinator enters that information," Gunawardena says. "We track dates of service for procedures completed at each protocol required visit, but it’s basically a poor man’s database."
Beth Israel’s new budgeting and billing grid system resulted in a 70% increase in contracted charges for direct and indirect costs between 2002 and 2003, although the number of new sponsored protocols was level, Schenkel recalls.
"A patient clinical trials tracking system is important because it’s the only way you can ensure the proper billing to third-party payers, including Medicare," she says. "And it enables you to get statistical information, such as how many patients are enrolled in the trial."
Without such a system, it’s fairly easy to make mistakes, such as billing third-party payers for expenses that should be billed to the sponsor and the reverse, Schenkel adds.
The problem is that staff in the patient billing departments may not know enough about clinical trials to capture all of the charges for a sponsor, she says.
"Unless you’re tracking each patient in an exhaustive manner, there’s no way you’ll get everything right," Schenkel says.
Research officials at Vanderbilt University Medical Center in Nashville, TN, are looking for an electronic system that would serve as a clinical trials tracking system, and have found that it’s difficult to find a system that meets all needs, says Kelly Willenberg, RN, MBA, manager of clinical research financial compliance.
"What I’d like is to have a clinical trials management system that is secure, accurate, and an independent record of study procedures that we can reference to appropriately bill charges to the clinical trial, as well as to third-party payers," Willenberg says.
"As a side note, if it was a working electronic system and had the features I feel are necessary to be successful, we could also provide statistical information to the principal investigator and department of finance and know where we are with clinical trial budgets," she says.
"We need this at Vanderbilt to improve the billing process to clinical trials; it’s all done manually now," Willenberg adds.
However, nearly two years after Willenberg assumed her role at the research institution, she has yet to find the ideal electronic clinical trials system.
"Having worked in oncology research for a number of years, I knew there were systems out there that potentially were available, but I haven’t found a good clinical trial management system," she says. "So I started to look at institutions that were tracking clinical trial patients, and, for the most part, they’re doing it manually."
If Willenberg does not find the ideal electronic system, Vanderbilt might find a way to build up its billing systems to serve the needs of tracking clinical trials, Willenberg notes. "We have an IT team working on this," she adds.
Dana Farber Cancer Institute in Boston has a manual clinical trials patient tracking process that is simple and effective, says Jane Russell, director of the quality assurance office for clinical trials.
The institute’s protocol registration process is used to check eligibility and register patients after they’ve signed the informed consent document, she explains.
"The registration occurs by having the clinical research coordinator fax over the eligibility checklist and some basic information about the patient, such as the hospital number," Russell says. "Then the checklist is reviewed by the registrar to make sure it’s complete, and they also send the signed informed consent over."
Clinical trial patients are registered in the system once all the necessary information is collected, she notes.
The system captures the name of the protocol, the chairperson of the protocol, the treatment assignment, the date activated, the date closed, and some of the information is sent to the billing group so the billing department can determine which patients are on a study and make certain the proper party is billed for the costs, Russell explains.
"I think the system is important because it gives you a good overview of what your whole research group is doing," she says. "We can use the registration system to manage compliance through eligibility, auditing, and accrual rates."
Nurses, physicians, pharmacists, and members of the clinical trials office may review the information to keep track of subjects and to check protocol accrual progress, Russell says.
"We have the system so we always know who’s on the protocol, to manage eligibility, and for safety reasons this is linked to our pharmacy systems," she says. "So if the pharmacy is supposed to dispense an experimental drug, it will only do that if the patient is registered on a protocol."
The system’s statistics also are used for grant applications, Russell adds.
"We’ve had discussions about enhancing the system," she says. "And we’re in the process of implementing a clinical trial electronic data capture system for investigator-initiated protocols."
Research institutions looking for ways to improve quality and billing compliance increasingly are turning to clinical trials patient tracking systems, experts say.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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