Create a prospective fiscal approval process for research trials

Centralized process creates efficiencies

One major academic research institution has developed a process for prospectively checking protocols for fiscal responsibility and compliance.

"We started this process two years ago," says René Jooste, MPharm, CCRP, a clinical trials billing officer at the office of human research at the University of Alabama at Birmingham.

"We piloted this process in the beginning with a high area research group, the oncology department," Jooste says. "As we progressed through it, we added some more units and have a big area of the campus involved with this now."

The prospective fiscal approval process was implemented for two reasons, Jooste says.

"One was to be in compliance and see that all activities performed on clinical trials are performed correctly and to follow all laws and regulations," she explains. "The other reason is to assist investigators in getting budgets properly negotiated."

The key to the latter reason is to create costs of what an institution should be, Jooste says.

Investigators send the fiscal approval office a packet of information, including the following:

  • the protocol;
  • the informed consent document;
  • the clinical trial agreement with the sponsor; and
  • a proposed budget, departmental budget, or sponsor's budget.

"In our office, we review this protocol or research trial, and we tease out all the activities required by the trial, which have the potential of clinical billing," Jooste says. "Those items with the potential of clinical billing are the ones that could go to the patient's insurance or to the sponsor."

Any research procedure that has the potential for billing both a patient's insurer and the sponsor is reviewed by the office, she adds.

Another task the office has tackled involves reaching an agreement with other departments for establishing a research fee schedule, Jooste says.

Jooste negotiated with various departments about their fees, essentially reaching agreements that are very close to Medicare rates, she says.

"So if you were to do some kind of study in one area of the campus, and it's research-related, the cost to a sponsor is the same, and there's no need to negotiate a deal with individual doctors," she says.

For example, the research fee schedule details the cost of a chest X-ray that is done on campus.

"We look at what it costs to get clinical services performed at UAB," Jooste says.

"What we charge the sponsor is something different," she adds. "We don't get involved with the complete budget, such as how much to charge the sponsor for nursing hours and going to meetings."

Jooste's office only is concerned about the items that could be billed to insurance and to the patient.

The prospective fiscal review is conducted on an Excel spreadsheet that lists items, visit by visit in the protocol. The research fees are included.

"Once [the CR team] gets that back they can go back and develop the complete budget," Jooste says. "They can add to our spreadsheet the personnel costs, IRB costs, and other things they need to do, and they also need to decide how much they want to charge the sponsor for doing this."

For example, the typical scenario is that a sponsor will come to the principal investigator to offer X amount for enrolling patients in the study, Jooste explains.

The PI has to decide whether this will cover his or her costs. The prospective fiscal analysis helps the PI make this decision.

"I would say that the contribution we make is basically providing investigators with the research fee costs, but it's only a part of the feasibility assessment," Jooste says. "Then you have to add time and other administrative costs and overhead, and we don't get involved with that."

While the office doesn't assist with the budget negotiations and budget feasibility much beyond the research fee and protocol/informed consent review, there is a possibility that the role will be expanded.

"People are curious of whether we might get involved in a complete budget process in the future," Jooste notes. "We haven't excluded that for future plans."

The spreadsheet analysis also assists the institution with billing compliance, Jooste notes.

"This information is very helpful to people in the billing offices, which have to prepare bills for patients, insurance companies, and sponsors for things going on in clinical trials," Jooste says.

The feasibility office also assists investigators with checking language in the informed consent forms.

"We typically concentrate on making sure information in the document agrees with what the protocol has shown to be the costs of having the patient participate in the trial," Jooste says.

For example, if the protocol mentions possible out-of-pocket costs for patients or their insurance companies, then the informed consent document should have language about these, as well.

"Sometimes when we review the protocol there is a discrepancy between what the protocol states, how things are to be billed and who pays for specific procedures, and these are not consistent with the informed consent document," Jooste explains.

Another part that Jooste checks is that specific items that are billed to a patient's insurance company will not have local coverage issues, excluding a certain drug or procedure from insurance reimbursement.

"So if something like that is an issue on a protocol, then we want to give investigators information about coverage and potential problems," Jooste says. "We'll assist him with feasibility problems that might require a PI to go back to the sponsor and say that we'd planned it this way but will have coverage problems."

Since the institution began prospective fiscal feasibility reviews, PIs have been much more accurate in their budgeting, Jooste notes.

"It still remains a very complicated process to tease out everything on your study, but having it synchronized remains a big help," she says.

Prior to the reviews, each investigator would call the various departments to negotiate his or her own fees. Now they need only make a submission to the feasibility office to obtain the information they need, Jooste says.

"It's centralized the whole request procedure, and that's been very beneficial and cut time for the internal staff," Jooste says.