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Error-free billing: A best practice model
Key is proactive analysis of charges
Aurora Health Care of Milwaukee, WI, has had a very good track record in research billing compliance in recent years, and its success can be attributed to its billing compliance best practice model.
"Aurora Health Care's research billing compliance program is as much about analysis done before services are ever delivered as the correct process afterwards," says Geoffrey Schick, MBA, director, clinical trials research for Aurora Health Care.
"We invest considerable time and effort in mapping out and determining all services and whether they're billed and billable," he says. "That's key to our system, and the time and effort invested keeps us comfortable that we're abiding by guidelines and rules."
Also, the health system errs on the side of caution since research, although considerable, is a small piece of the organization's overall revenues, he adds.
The 15-hospital health system has an average of 250 open clinical trials.
"The backbone of our research billing compliance program is Medicare coverage analysis," Schick says. "We take the protocol and break down all the services into components by CPT code or charge code, and we have trained staff analyze the code and services, sifting through a mountain of data to see if services are billable by Medicare."
This task is handled by the medical audit department.
"They ultimately make a determination if something is billable or not," Schick says.
The medical audit department is comprised of specially-trained staff, typically that have a decade or more of experience in nursing, he says.
The hospital developed the system after receiving recommendations from a consulting firm.
"We have one medical auditor who was originally trained by the consultants, so when we add a new medical auditor we are able to train internally," Schick says.
The medical auditors are very thorough in their proactive assessment. Here are the chief ways they ensure that every potential protocol charge is correctly assessed:
Medical auditors review available guidelines, coverage decisions.
The auditors look at investigative procedures or interventions to see what's already available and to get an idea of the patient population.
Then they look at the Medicare guidelines, local coverage decisions that apply to the region, and they look at medical society Web sites to see if any of the published guidelines might apply, Schick says.
"They want to see if published guidelines could be used for justification that a service should be standard of care," he says. "If there's published evidence-based justification behind it, then it helps us make a decision that this should be done."
It's particularly helpful when medical societies have up-to-date guidelines, he adds.
"But if there's some period of time where people have not updated their Web pages, or if certain services are done routinely, then it's different," Schick says. "If the medical society hasn't updated its Web pages, then we don't have the documentation we need to say we agree that this is okay to bill as routine care."
Teach difference between routine care and what Medicare covers as standard of care in research.
Physicians sometimes mistake the two.
"There are many cases where what a physician does as standard of care may be perfectly reasonable and billable for insurance programs, but it doesn't mean that it's standard of care for research purposes," Schick says. "They might bill for this many times and it's always accepted, but once you get into the research world, there's a higher level standard."
Physicians have to support what they consider routine care in research, providing a reason why this is routinely done and documenting this explanation, he adds.
"It's the science of medicine, but we have to abide by all the rules and regulations," he says.
For instance, investigators need to document the research participant's clinical indications, signs and symptoms.
It's also wise to teach clinical trial coordinators about the difference between what is routine practice in clinical medicine and what is considered standard of care for Medicare billing in research.
"Since 85% of our physician investigators' day is routine clinical care, we need clinical coordinators who assist in the delivery of care to be just as aware," Schick says.
"Our philosophy is to provide the service, document the reason behind it, and we'll either bill or not bill depending on what's there," he says.
Medical auditors use checklist as guide.
Aurora's medical auditors use a clinical trials coverage analysis checklist to guide their decisions.
"The checklist is a process of following stipulations spelled out in Medicare national coverage decision," Schick says. "We collect information, including the IND number, different steps, protocol-specific questions, and information about gaps in identifying Medicare coverage."
For example, the checklist has a section in which the medical auditor can write about billing issues, spelling out specific precedents and concerns.
Also there are a number of questions that can be answered with a "yes" or "no," including these:
- Is this a Medicare Deemed Qualifying Trial?
- Does the coverage analysis outcome indicate proceeding with trial?
- Does an approved Medicare benefit category exist for the services to be provided in this trial?
- Does this trial have therapeutic intent?
- Will this trial enroll healthy patients?
- Is this a diagnostic intervention enrolling healthy patients as a control group only?
- Federally funded?
- Conducted by Centers or Cooperative Groups and the trial is funded by a Federal agency?
- Drug trial with an Investigational New Drug (IND) number assigned by the FDA?
- Does a specifically applicable National Coverage Decision (NCD) exist?
- Is the specific NCD a non-coverage decision?
"Once you identify these things, then the next step is making a decision and moving forward," Schick says. "These decisions aren't low dollar costs, so you might not feel it's ethical to ask subjects to bear the cost of it."
Explain decisions to sponsors and negotiate changes in budget.
"Some sponsors are extremely knowledgeable and very good and practical in terms of what the initial budget offers," Schick says. "But a majority of sponsors typically offer a low rate, gravitating toward the Medicare reimbursement level, and often they don't understand the Medicare billing rules in terms of standard of care."
Sponsors frequently rely on national principal investigators to define standard of practice, although these decisions might not match with what Medicare allows.
"I had a conversation with a sponsor at a conference, and I said, 'Why don't we talk more? Why don't you hire our medical audit team to look at your contracts to see what's billable and what's not?'" Schick recalls. "He said, 'What's in it for us? If we offer low dollars, and everyone takes it, we win. If they don't take it, then no sponsor is called on the carpet for this.'"
The lesson is that sponsors do research as part of their business and treat it as such. So it's up to clinical trial sites to carefully assess protocols and budgets and ask for more money when they know they won't be reimbursed by Medicare for particular interventions.
Keep communication lines open and checks and balances.
It's important to have layers of checks and balances, so any thorough compliance program should have clear, open lines of communication between all parties involved in research and research compliance.
"We've evolved into a very strong research billing compliance program based on prospective analysis," Schick says.
"And the other part is having good communication between hospitals and clinics and the research billing team," he adds. "We make sure we catch all research subjects' accounts for final review and processing to make sure [nothing that should be billed to research] is paid by third-party payers."
Research billing staff review all research subjects' accounts before the accounts are processed by the regular billing staff, he says.
The four medical auditors work primarily on prospective analysis, although they're available to handle a resolution when there's a research billing question or when something did not work according to the protocol or needs further analysis.
Another four employees handle research billing for a total of eight people dedicated to research billing, Schick says.
"They all work with the department of clinical research, but they don't work for the department of clinical research," he says. "It's part of the checks and balances, and their findings are independent and not influenced by what I think might be a good study."