Beth Israel’s billing and budget grids work
Compliance, quality, finances all improved
Beth Israel Deaconess Medical Center of Boston has developed a clinical trial tracking system that has improved trial efficiency, compliance, and the bottom line.
The system includes a billing grid and budget worksheet, which give research staff and others a very simple and direct way to monitor trial recruitment, invoicing, visit dates, and other information, reports Ramesh Gunawardena, operations manager of the clinical trials office in research and academic affairs.
"From an efficiency standpoint, it’s real-time data of a patient’s milestones; and from an auditing perspective, if the study were to close, the information is right there, and we can verify if we received all payments for work completed," he notes.
Here’s how the system works:
1. Establish budget using worksheet.
"With clinical trials, based on patient payment, there are a lot of assumptions made when a budget is developed," Gunawardena says. "One aspect we cannot make assumptions on is the allocation of charges for procedures required on the protocol. We have to predetermine what the charge allocation is going to be."
So Gunawardena developed a budget worksheet that details charges for each step of a clinical trial. The worksheet has been modified through use and input from other experts, he says. (See sample budget worksheet, inserted in this issue.)
The institution’s central office creates the budget, and once it’s finalized, it is used to create a billing grid that will be put into a shared electronic drive and used by study coordinators, Gunawardena says.
The worksheet includes the listing of CPT-4 codes, unit costs, baseline cost information, which typically is the unit cost except in the cases where it’s designated a standard of care (SOC) cost.
Then there are columns for carrying the costs forward during each weekly visit and follow-ups. Likewise, the budget worksheet includes estimated costs for baseline and other visits or the principal investigator, the research nurse, study coordinator, and miscellaneous administrative personnel.
At the worksheet’s end are rows totaling direct costs per visit, indirect costs, and total cost per visit. The last total budget number is the total cost of baseline, treatment, and follow-up for each patient. And the worksheet also includes a list of one-time, nonrefundable costs for the IRB submission and review, research pharmacy fee, clinical trials office fee, division start-up fee, and storage fee.
"We consult with the PI and study team at the time the study is developed and determine whether the screening is grant specific or whether it can be billed to the patient’s insurance company," says Gunawardena.
Items that would be routine care costs under Medicare guidelines are billed to the patient’s insurance company, and they are listed as "SOC" on the budget worksheet, he adds.
Alternately, items that should be charged to the sponsor are budgeted with a dollar amount that the sponsor will need to reimburse, Gunawardena says.
2. Turn budget numbers into billing grid.
"When we finalize the budget, we negotiate with the sponsor, agree on all charge allocations and costs, and then we take the template and turn it into a billing grid, which shows only the procedures that are going to be charged," says Gunawardena.
The purpose of the billing grid is to illustrate precisely which items at which visits will be charged to SOC and which will be charged to the sponsor, which is listed as GRANT.
Only CPT-4 code numbers are listed on the grid. The other items are simply the visits and to whom they will be charged, and the timeline, Gunawardena says. (See sample billing grid worksheet, inserted in this issue.)
"We have study coordinators access this billing grid and use it as a charge allocation guide," says Gunawardena. "So when a patient comes in, we ask the study coordinator to create a billing grid, put the patient’s name on it, and follow the predetermined allocations."
Study coordinators complete the worksheet by placing patient names and dates of service, he says.
Using the grid as a guide, they find that it answers the main questions they have when patients return for visits, Gunawardena says.
"So when the patient comes to visitd, the study coordinator looks at the billing grid and sees that it has to be charged to the grant," he explains. "Then the study coordinator will fill out the requisition, showing the item, like an ECG, and puts the grant number on it so we can bill the sponsor based on that."
Then a grant number is created in the accounting system for each activated study where all grant related transactions are charged to and monitored, Gunawardena says.
3. Train study coordinators to use grid.
"Once the contract has been finalized and the billing grid is posted, we hand the study coordinator a folder summarizing it," Gunawardena says. "There’s a copy of the budget, the contract, and we also issue fluorescent green stickers that are put on the requisitions to show that it’s a grant charge.
"One problem we had in the past with requisitions is when we had a handwritten grant number on them, the person on the back end would miss out on the grant number, and the charge was automatically made to the insurance company," Gunawardena says. "So we created the green stickers so the persons processing the form would see it and see the grant number clearly delineated there and process it."
Gunawardena and other managers meet with study coordinators to explain what they need to do with regard to a particular study’s grid.
4. Use grids for monitoring and auditing.
"On a monthly basis, we get patient care reports under the specific accounting numbers for each study, and they delineate what charges hit with that account," Gunawardena says.
"Then we send these to the study coordinator, and they verify against the billing grid for each patient to make sure the charges hit the specific account number appropriately based on the allocation delineated on the grid," he explains. "If there is a misallocation, the study coordinator notifies us of the variance, and we track that charge and make sure it wasn’t billed inappropriately."
Six months after the institution began using the grids, managers ran an error report to determine the number of billing reversals that were made, Gunawardena says.
"We saw a substantial improvement in that," he says.
The clinical trial tracking process depends on a reconciliation, which is checked at the end of the month, Gunawardena notes.
The patient care reports are a critical part of the fiscal compliance program, he adds.
"We print out those reports and hand deliver them to each study coordinator. We give them a time period of 15 days to get back to us on whether they are correct or incorrect," Gunawardena says. "And we keep close track of the distribution, tracking the date we sent it to them and making sure we receive a response that it’s OK."
If an error is made, it would be corrected immediately, and the breakdown identified; if necessary, the study coordinator is retrained, he says.
Beth Israel Deaconess Medical Center of Boston has developed a clinical trial tracking system that has improved trial efficiency, compliance, and the bottom line.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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