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Billing poses problems: how to avoid mistakes
Bigger the institution, the more challenges
The hospital billing system typically has limitations when it comes to research management systems, according to an expert.
To start, there's a different focus than the typical patient care billing focus, and everything in the hospital is designed to meet the patient care model and needs, says Jennifer Leigh Lanter, RN. CCRC, MSPH, a clinical research billing compliance manager with the Ohio State University (OSU) Medical Center in Columbus, OH. Lanter gave a well-received talk about clinical trial billing at the Association of Clinical Research Professionals (ACRP) Global Conference and Exhibition, held April 20-24, 2007, in Seattle, WA.
For example, the normal billing process is designed to bill primary insurance first, then secondary insurance, and then the patient, Lanter says.
"Research billing doesn't work that way," Lanter says. "The bills have to be split between research and patient charges, and many providers have to manually manipulate these claims."
The challenge is for institutions to create a way to make research billing work within their system, and this outside-the-norm approach is, by nature, hard to institutionalize, Lanter says.
Lanter offers these examples of the challenges institutions face when billing for research:
1. Research has a different focus.
"Hospitals are focused on standardized clinical care, and research is focused on unique, cutting-edge treatment with unknown outcomes," Lanter says. "So when you look at a hospital setting, all of their work flow processes and systems are designed to deal with normal care processes."
Anything related to research has to be handled outside of that box, she adds.
"It's difficult to handle, even when hospitals have research in their mission statements," Lanter says. "They're still focused on patient care, and research typically is a small part of their overall operations."
2. The systems are limited.
"Hospital systems are designed to manage normal patient care processes, and sometimes they don't even meet the normal processing needs," Lanter says.
Large institutions have the challenge of needing bolt-on technology to patch gaps and get systems to work together, she says.
"They don't have one system from the same company," Lanter explains. "There are multiple companies, systems that talk different languages, different platforms, and these are all designed to deal with patient care issues."
If an institution tries to automate for research billing with these issues, then it would have to deal with each system separately and figure out a way to make a change that would work for all of them, she adds.
"It isn't an easy fix," Lanter says. "Every institution is different with different processes."
3. There are communication problems.
"There's a disconnect between hospital and research staff. Hospital staff lack an understanding of research," Lanter says.
Likewise, research professionals often do not understand hospital processes, she adds.
"A lot of research staff are left out of the relevant training on registration processes, documentation processes, and reimbursement principles," Lanter says. "This education is directed at physicians, physician assistants, or nurse practitioners."
So research professionals often do not understand the steps needed to get paid, and they have to start from scratch when trying to get a research patient through the system, she adds.
There are many different ways to resolve these challenges, and here are some of Lanter's suggestions:
• Start with contracting: "Hospitals negotiate many different types of contracts, and these determine who is covered and what and how services are paid," Lanter says.
"A lot of times research contracts want us to bill insurance, and some payers have strict exclusions for anything that's experimental," Lanter explains. "So research professionals need to learn what has been negotiated with payers, and what the Medicare and Medicaid requirements for billing are."
Institutions need to teach clinical research staff that it can be challenging and that third party payers may not follow the lead of Medicare and pay for research services, Lanter says.
• Work on scheduling and pre-certification: "Once the patient hits the system, you can start with scheduling and pre-certification and the financial aid process," Lanter says.
"Depending on the institution and how it's set up, there can be many different problems," she says.
When scheduling subjects, it's important to get as much information up front as possible and to try to get the pre-certification completed, Lanter says.
"If the provider doesn't have a good system for identifying research subjects, then they can sometimes be entered as clinical patients, which means they'll get billed," Lanter says. "And sometimes when they're identified as research patients, the pre-certification area doesn't know that they are supposed to pre-certify them."
There are split billing cases where some of the patient care is research and some is standard of care, and so the patient has to go through the normal processes, Lanter says.
On the financial aid side, a patient often will be scheduled, information will be collected, and the pre-certification staff will call to identify the need for financial aid," Lanter says.
"This way the billing office can identify the process for some kind of charity application or write-off, but if the patient isn't properly identified, this won't be done," Lanter says.
Patients who are registered incorrectly might be assigned to self-pay, so the challenge is to make sure the accounts are tagged appropriately, Lanter notes.
• Registration issues also should be handled up front: "Registration could pose the same issues as scheduling and pre-certification, depending on what area the patient comes from," Lanter says.
"Also, hospitals may have limitations on the number of registrations they can create," Lanter says.
"I've been at institutions where they can create a research registration and patient registration for the same encounter," she explains. "But there are downstream effects to that because you can't always ensure people will pick the right account when entering the charges."
On the other hand, some institutions won't allow more than one registration to be entered into the system for the same patient, she adds.
• Clinical care challenges also occur: Billing problems can occur when a patient subject's treatment deviates from the protocol, Lanter says.
"So I've had some billing challenges where the patient came in for a research procedure, and then they did something that was considered standard of care, and it was billed to the research account because that's how it was registered," Lanter says.
Often the only way to find these system limitations is to rely on someone telling the billing department about them, she notes.
"Either a provider flags all accounts, and we review everything one by one, which can be overwhelming, or they rely on researchers to tell them when their patients present to the hospital," Lanter says.
Most researchers will map out research procedures up front and come up with a billing plan on how to register the patients and how to track them, Lanter says.
But problems can arise when it comes to subject notification, she says.
"So when a subject is presented or enrolled, most institutions require a principal investigator to email or fax something saying which patients are in the study," Lanter says. "This is necessary because of all the different limitations that can occur within a system with paperwork flow and processes."
For instance, someone could send in the order with correct information, such as the research number, and an order to not bill a third party payer, and then the information is lost, Lanter says.
"So many different people work on these accounts, and the accounts are so highly electronic that sometimes information gets buried within the system," Lanter explains.
• Handle charge capture challenges: It's always challenging to figure out which charges are supposed to be standard of care and which are for research, Lanter says.
"There is no good systematic way to segregate these procedures as they are occurring," she says.
"So if a patient comes in for a regular visit, we won't know which charges to separate," Lanter says. "Then there are medical records and coding challenges where sometimes we won't know which code to use."
For example, if a procedure is done for investigational purposes, it may not have a CPT code, or clinical staff might not know which one to pick, she says.
"It's possible also that if charges are pulled after a claim has been coded, it might affect the coding," she says.
All of these issues require manual overview and are very time consuming, Lanter notes.
• Develop policies and procedures: It's important to have policies and procedures in place to help make sense of research billing, Lanter says.
Then the principal investigator can go through the protocol and document which procedures are research and which are not, so the institution can compare these original information with what is later billed, Lanter says.
"Principal investigators should do the checklist because they're the ones who have most knowledge about patients," Lanter says. "Research coordinators should know which procedures are referred to as standard of care, and the hospital needs someone from a quality assurance perspective to make sure everyone is on track."
Also, research coordinators need to respond when called by billing offices about clarifications and issues that arise.
"Sometimes customer service staff will get a call that a patient was billed for a research visit, but they can't tell us the name of the researcher or number of the case," Lanter says. "So the research coordinators end up with the responsibility to tell the provider who is in what study and which patients they have so we can go back and make sure there aren't any claims being sent to the patients."
Finally, an institution's policies and procedures could include self-audits, which would help everyone feel comfortable that the billing system is working well, and charges are being sent to the proper payers, Lanter adds.