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Starting a billing compliance program
Train team with all needed players
Clinical research (CR) sites will benefit from implementing a billing compliance program, particularly when handling complex studies, an expert says.
"The risk the institution takes is directly proportional to the complexity of the study," 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 compliance program should start with a well-established process flow, which can be done electronically, she says.
A flow process should clearly identify study procedure and visits versus those that are standard care, Bendetowicz-Hajdenberg says.
"In an ideal world, this flow process is supported by a reliable electronic software and highly-trained personnel," she adds. "In the real world, it is frequent practice that institutions use a variety of electronic programs from different departments, and interface is sometimes a major challenge."
This is why continued training of personnel and established processes of communication are essential, she says.
"The point staff person for billing should be someone who is fully informed of the protocol's schedule of procedures and the clinical trial agreement," Bendetowicz-Hajdenberg says.
The next step is to train staff, beginning with the CR billing coordinator.
"This person should be extremely knowledgeable about the study protocol and the study contract to ensure contractual obligations match the study schedule," Bendetowicz-Hajdenberg says.
"The CR billing coordinator has to train the study coordinator about the billings part of the study," she says. "Once the IRB approves the study, then the billing coordinator gives it to the study coordinator and either meets with the coordinator or sends an email message about which items are billed to the clinical trial."
Face-to-face meetings are preferable, however, she notes.
"The human factor is very important because conditions can change in clinical studies," Bendetowicz-Hajdenberg says.
Training begins when the trial is approved by the IRB, she notes.
"Upon receipt of the drug, the trial is activated, and you're ready to have your first patient," she says. "The billing coordinator needs to hand the trial to the research coordinator, who is by then completely trained in what to do with the medical care."
So the billing coordinator tells the study coordinator what items will be billed and what the schedule looks like and where each will be billed.
Also, CR institutions — both large and small — should have a monthly billing compliance program.
At least monthly, billing coordinators should look at billing indicators to see how many procedures were done and where bills were routed, Bendetowicz-Hajdenberg says.
When mistakes are found, the research billing officer should halt the incorrect billing by communicating with the institution's billing office and re-routing it to the correct clinical trial, she explains.
"Successes and failures to route the billing appropriately should be communicated to the research team in a formal manner and should be part of a standing agenda for a recurrent meeting in order to support improvement," she adds.
Also, the coordinator should communicate to the phlebotomist and others involved how to route CR bills correctly.
And there should be a quality assurance meeting each month to review errors and emphasize billing compliance, Bendetowicz-Hajdenberg says.
"The ultimate goal is to avoid billing insurance for experimental procedures," she adds.