Compliance Corner: Quality indicator for CR billing helps keep compliance on track
Quality indicator for CR billing helps keep compliance on track
One key is front-end billing system
When M.D. Anderson Cancer Center Orlando in Orlando, FL, experienced a steep -- 96%-- rise in people enrolled in clinical trials within a few years, leaders decided that some compliance changes were needed.1
"Between 2005 and 2008, we increased from 64 patients to 117 patients and also increased our number of sponsored studies," says Allisun Feazell, CIP, CCRP, manager of the office of protocol regulations at M.D. Anderson Cancer Center Orlando.
The center's industry-sponsored studies more than doubled within the same time period of 2005 to 2008.1
"In order to continue with our growth, it was very important for us to measure that we were actually within compliance," Feazell notes. "We knew we wanted to take on more industry-sponsored studies, and we knew that to grow we would need to have a good system in place to take on more work."
So the research organization began to use a quality indicator that gives a quick snapshot look at the organization's level of billing compliance.
The billing indicator is measured monthly. It divides the total number of new patients on industry studies whose visits were billed correctly with the total number of new patients on industry studies, says Meghan J. Cadwell, MPH, CCRP, project coordinator in the office of protocol regulations at M.D. Anderson Cancer Center Orlando.
The goal is to achieve 100%, and the site's average overall compliance rate has been fairly close to that, she says.
From August, 2007, to September, 2008, most months were 100% or nearly 100%, but there was one outlier month in which only two new participants were counted, and one of these two cases was not in compliance, Cadwell explains.
This resulted in an overall compliance rate of 93%, she adds.
"When we don't have 100%, I look at a specific patient screening visit from that month and see why it wasn't billed correctly, and then we make process improvements," Cadwell explains.
For the first year of measurements from the quality indicator, the organization is doing very well, Feazell says.
"And I fully expect this to go much closer to 100% over the years," she adds.
The research organization has a proactive billing compliance program. A research business coordinator uses the study contract and protocol's schedule of events to identify which procedures should be billed to research and which should be billed to third party payers.1
In establishing a billing compliance program, it's critical to have highly trained personnel, including investigators, study coordinators, clinical nurses, regulatory staff, and even phlebotomists, says Ana Victoria Bendetowicz-Hajdenberg, PhD, a research compliance consultant in Orlando and co-author of a poster abstract on billing compliance.1
"A billing specialist and contract specialist should be part of the team, and we need a well-established process flow," Bendetowicz-Hajdenberg says.
"When we start any new study, we highlight the items that are considered billed to research," Cadwell says.
Cadwell speaks with principal investigators to determine which procedures are standard of care and which are not and to learn of any specific line items in the budget that are intended to be billed to research.
Then Cadwell works with research nurse coordinators and others on the CR staff to educate them about which items need to be billed to research.
"The clinical research coordinator and nurses have that information, and when it's time to bill for research, it's entered in as 'billed to research.'" Cadwell says. "We have a hybrid system that's mainly electronic, and it's entered into the electronic medical system."
Then the information is transmitted to the scheduling and registration department where the order is updated and a research department insurance code is assigned, ensuring that the UB92 will be sent to the research department for payment, Cadwell says.1
The research business coordinator audits the bill-to-research patient study visits to ensure the UB92 has been sent to the research department and the patient's insurance is not billed for research procedures.1
"We basically use human auditing," Cadwell says. "I check the UB92s to make sure they list the correct patient and procedure and that they should be paid for by the study."
Cadwell also works closely with research nurses to make sure nothing is missed.
"I see every visit, and I know if something is supposed to be billed to research or if it isn't," Cadwell says. "We do catch mistakes from time to time, and so that's why we like to do the majority of work on the front end."
Occasionally a mistake will result in a third party payer being billed incorrectly, and the institution will refund the insurance company if that happens, Cadwell says.
"We like to do everything on the front end when the procedures are being scheduled rather than on the back end after the visits have occurred," Cadwell says. "We like to have everything billed up front so there's not a big hold-up in payment."
The quality indicator helps identify weak spots.
For example, there have been a couple of instances when an investigator or clinical research nurse would order a CT scan in the medical record system and order it to be billed to research, Cadwell says.
"When that information was transmitted to the scheduling staff they wouldn't necessarily see it as billed to research, so those items were missed because they didn't transfer them to our insurance code, she explains.
"So we met with the manger of scheduling to discuss the problem, and she went back to her team to re-educate them so they wouldn't miss those items anymore," Cadwell adds.
The scheduling manager also suggested some changes in how the information was written into the electronic medical system, Cadwell notes.
"What might sense for the clinical research nurse is not what works for the scheduler, so we decided to put the information in a section called 'Comments,' which now is where schedulers know to find the information," Cadwell says.
The problem was resolved and no more compliance problems related to this occurred, she adds.
There was an initial educational push when the quality indicator first was used, and now there is continuing education in staff meetings, Cadwell says.
"I present the results of the billing indicator each month and answer questions [from the staff]," she adds. "If anyone is new in the department, we show them the billing indicator, and this keeps the quality indicator fresh in everyone's minds."
- Cadwell M, Bendetowicz-Hajdenberg AV. Establishment of a quality indicator that monitors clinical trials billing compliance. Poster presented at 2008 PRIM&R Advancing Ethical Research Conference, held Nov. 17-19, 2008, in Orlando, FL.
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