Improve clinical trial billing through systematic process
Compliance quickly improves
Before Emory University in Atlanta completely revamped its clinical trials billing process, most of the CT budgeting and analyses were done by individual departments.
Since centralizing billing, the research institution has made the process more consistent and efficient and has improved CT payments, says Kris West, JD, an associate vice president and director of the office of research compliance at Emory.
"We're actually doing much better at getting more money for trials from sponsors," West says.
A CT site can capture more revenue once the billing process is made more efficient with documentation of what various tasks actually cost and precisely which procedures are covered by insurance, West notes.
"We can say, 'Here are the things that you said Medicare would pay for, but an analysis under the Medicare rules shows they won't pay for this, so you'll have to pay more,'" West explains.
One central clinical trials office is responsible for looking at all of the clinical trials and their budgets and performing Medicare coverage analysis for each of those trials, West says.
The implementation of the revamped billing and compliance process worked this way:
1. Committee examined current process from top down.
"We've been working on this project for quite a while, a number of years," West says. "We assembled a committee of users, including research administrators, researchers, technical people to take a top-to-bottom look at our systems."
They concluded the solution would be to go from a decentralized to centralized approach, West says.
"Before, most of the budgeting and analysis of clinical trials in terms of budget for the trial and what was appropriate for third-party payers was done on an individual department basis," West explains. "Now what we've done is transferred most of those functions to be centralized in a beefed-up office."
2. Obtain institution-wide buy-in.
"During the committee process we involved people from all aspects of the university, including user groups, research investigators, upper-level administration from information technologies, hospital billing and revenue, and the health sciences center," West says.
"We tried to get everybody's input up front and have them buy into the necessity for making changes to the system," West says. "I think it helped having people involved on the front end because it helped them have a stake in the system."
During the buy-in process, the institution had a one-year, voluntary implementation period, which later was rolled into a hard deadline, West adds.
The chief challenge to staff buy-in was habit.
"People get engrained in their own departmental systems and ways to do things, and they don't want to change those systems," West explains.
3. Educate staff.
The first step was to select a major clinical trials group that worked in cardiology and kick off the education sessions with this group, West says.
"We gave them specific education sessions with their research coordinators and principal investigators, and they were a pilot group," West says. "Then we had large-scale educational sessions with all of the research coordinators."
The office of clinical research office conducts popular lunch and learn sessions, and the CR staff made presentations to describe the new billing system, West adds.
CR staff used the CR office's Web site to provide follow-up information.
"We put together a clinical trials manual posted on the Web site that describes the various processes involved," West says.
4. Walk staff through new process.
"When an investigator has a proposed trial, he contacts the clinical trial office and provides the office with the trial protocol, the informed consent, and the clinical trial agreement, as proposed by the sponsor," West explains. "Then the clinical trials office reviews the contract and informed consent and makes a grid that shows all of the items and services required as part of that protocol."
The CT office identifies the items that the sponsor will pay for and then analyzes the remaining items to see what can be billed appropriately to Medicare and Medicaid, West adds.
"Then, once they break that down, they look at the budget for the trial to see if the budget is actually covering everything that needs to be done, either in terms of sponsors paying for it or something that can be legitimately billed to Medicare or Medicaid," West says.
That information is used as a baseline for the study.
5. Improve budget negotiations.
The clinical trials organization then works with the sponsor on the budget negotiations to see if there's a difference or gap in the funds needed to cover the trial, West says.
"They take into account what administrative things they do on our end," West says. "Will they need administrative work to get the trial up and running?"
Those costs need to be included in the budget, as well, she says.
For example, how much time will it take the nurse to fill out the clinical research organization forms?
"You need to make sure those are included, as well as the actual medical items and procedures," West says.
Other costs include time spent at investigator meetings and research coordinator training, she adds
6. Use grid to clarify the budget.
The budget grid shows every step of the clinical trial and how it can be appropriately billed.
"Then you take that information to negotiate the budget with the sponsor," West says. "After that's done then you provide that to the office of sponsored programs folks so they can make sure the CT agreement incorporates that budget."
There are standardized templates that show whether the informed consent document matches with the contract. This way, there won't be a contract that says the trial participant's own insurance will pay for this item and that, only to have this contradicted in the informed consent.
"That's one of the keys to the whole success of this process," West says. "You can't have an informed consent document saying you don't have to pay for anything when the contract says you're going to submit these things to the subject's insurance."
7. Create standard informed consent language.
"We came up with some very standard informed consent language," West says.
The language includes options for having the sponsor pay for the subject's injury and for the alternative of the sponsor not paying for it, she says.
"The clinical trials office looks at those documents to make sure they line up with the budget," West explains. "And we've tried to get the IRB to be in tune to any changes that are made to that consent language."
Initially, the clinical trials staff found that there were mistakes where the language in the IC document did not match the budget. But soon, clinical trial sites were compliant, West notes.
"It's working very nicely now," she adds.
8. The protocol and budgeting are processed sequentially.
To avoid delays, the protocol approval from the IRB and budgeting process are processed sequentially, West says.
"The clinical trials office sees the protocol and the sponsored research office sees the protocol on a parallel process," she explains. "The informed consent and contract are developed at the same time."
After the clinical trials agreement is signed and the IRB approves the protocol, then the next step is to train research coordinators on how to fill out billing forms to reflect Medicare coverage and what's on the contract, she adds.
"We let the billing people know up front about the forms we've developed, the codes, and how to bill for these," West says.
9. Review billing.
"We have a post-award group that reviews the accounts for first and third subjects enrolled in the clinical trial to make sure the billing works the way it's supposed to," West says. "If there are problems then we'll do more reviews, but if the system works for the first and third subjects then it means the forms are filled out right and things are routed appropriately."
Before Emory University in Atlanta completely revamped its clinical trials billing process, most of the CT budgeting and analyses were done by individual departments.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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