Compliance Corner

Develop a model CR billing compliance system

Expert outlines steps to follow

Research institutions lose time and efficiency during the typical billing compliance process. The risk of mistakes that could trigger regulatory problems can be high when a Medicare billing process is poorly organized and checks and balances are weak.

A well-designed and executed clinical research billing process can reduce problems, improve compliance, and make the billing process faster. If the process is designed for electronic administration, it has the potential for even better outcomes, an expert says.

"The paper process of paying for procedures took three to five months to complete, and now it can take three to five days," says Johanna Chesley, BA, CCRC, clinical research compliance officer at the University of Utah in Salt Lake City, UT. The university in collaboration with Click Commerce has developed an electronic clinical research billing compliance system, called uTRAC that is a model for CR billing compliance.

"The tool has allowed for centralization within our institution regarding clinical research billing compliance," Chesley says. "Billing compliance can fold into many aspects of clinical research; the first is the budget, whether it is a budget for an externally-sponsored study or an internally-sponsored study."

Clinical research sites can create a best practice in billing compliance by following thorough and important steps when revising their billing process and policies. Here are some of Chesley's suggested steps to follow:

1. Identify a committee to implement processes.

"We have a clinical research oversight committee that approves policy and is included in discussions," Chesley says.

The committee includes physicians, PhDs, and the associate vice president of health sciences, as well as legal counsel, directors of clinical research-related compliance offices, such as research integrity, institutional review board (IRB), and the office of (externally) sponsored projects, hospital and departmental administrators and clinical research managers.

2. Have the legal department interpret regulations.

Research billing compliance needs a legal interpretation of Medicare billing rules, and the institution's legal office should make this determination, Chesley says.

"Ask for an internal and external legal counsel review," she suggests. "Through institutional determined policy and process documentation, align billing decisions with the policy as to why you made that decision, referring to the logic of how Medicare coverage interpretation is created."

The interpretation is essential because different institutions will have different interpretations of the regulations. For example, each institution has its own legal interpretation of what is considered nonqualifying, Chesley says.

3. Create centralized research pricing for the institution.

"We can't make a budget until we have centralized pricing so we know what we'll be expected to pay," Chesley says. "I would urge sites to include representatives from the hospital or facility side, as well as the professional side, to come together to decide how the research pricing proposal should look."

Many institutions have moved toward a centralized price list based on the Medicare allowable rate for the region.

"All non-commercially funded studies receive the Medicare allowable rate at our institution, but others may want to charge non-profit and internal studies more," she notes.

"We've created that," she adds. "Then you can have an upcharge for commercially-sponsored studies because Medicare rates often are at cost or below costs, and may times research increases actual costs."

Placing the price list on the institution's website can lead to problems when investigators mistakenly download an older version.

"So first we created a process for a pricing request, which was an interim process until the electronic system was available," Chesley says. "Now that it's electronic, we have the price list imported via Excel and a bulk importer."

When clinical research staff enters the study's sponsor and name and then types in the codes of procedures, the electronic price list automatically fills in the costs.

"We update the price list every six months, following Medicare updates, or even sooner, if they make an interim change," Chesley says.

If the user selects the National Institutes of Health as the sponsor, then the federal price rates will be pulled up. If the user indicates an industry sponsor, the private sponsor rates pop up, she adds.

One issue to watch out for involves Medicare rates rising during the duration of a study. Because of this inflation, the research institution includes inflation in the rates, Chesley says.

"If your study lasts five years, that rate likely will go up, so we use an inflation multiplier for projected budgeting," she says.

The inflation multiplier is based on the study's length times the expected rate of inflation to come up with an average cost for the procedure.

The inflation multiplier cannot be charged to federally-funded studies, but it is a smart strategy for budgeting purposes, Chesley says.

"We charge the actual Medicare rate for the date of service," she adds.

When sites do not use an inflation multiplier, their charges likely will increase, but many times, their budgets are set and cannot be renegotiated for the increased procedure charge. So it's better to include the inflation percentage up front, she adds.

4. Compare protocol billing plan grid to project and informed consent.

The protocol billing grid plan, the informed consent form, the contract, and the protocol are four essential pieces of information, and research sites should compare these to make sure there are no discrepancies, Chesley advises.

The Centers for Medicare and Medicaid Services (CMS) considers the informed consent document a contract, so if it doesn't match with the sponsor's protocol and contract, then the research site could be out of compliance, she explains.

5. Place patients' bills on hold to verify.

"There needs to be a process to hold patients' bills so they're not released inaccurately," Chesley says. "In parallel with the pricing process, there should be a process by which the participants' records can be held."

The holding process would work something like this: The research participant has an x-ray during the study visit. After the x-ray is done, it is coded, and the code prompts the researcher to review the work queue and decide who to bill for the charges related to that x-ray. Before that bill is sent to the insurance company/Medicare, participant/patient, and/or the sponsor/research organization, the designated payer should be verified, she explains.

"To have those charges released out of the billing system, someone should review them," Chesley says. "If no one is reviewing them to make sure there is a modifier or to make sure there isn't a modifier, then they might be released to the patient inaccurately."

Another potential problem would be if the research site charged the patient's insurance and also charged the sponsor for the same procedure. This is called double-dipping and is fraudulent, she adds.

"So if you don't have an electronic process that automatically flags participants' bills in the billing system, then you need a process where the patient's visit is flagged and charges are reviewed manually," Chesley says.

6. Move to an electronic system for improved accuracy and efficiency.

Once the research billing process has been developed, forming a stable base, a research site is ready to move forward and develop an electronic system. For this to work, the site will need access to an information technologies support system, as well as to billing experts, Chesley says.

"I would try to integrate the process with other compliance offices, and then search for the right product for your organization," she suggests.

"Once the product is purchased, find a project manager who can manage the content and IT staff," she adds.

After purchasing the software, the site should develop and test, focusing on different aspects of the application before the entire application is implemented, she says.

"We did a phased approach with the software," Chesley says. "First, we completed the protocol billing grid and other basic aspects of the system, and, then, as the system grew, we added an automated Medicare coverage analysis that is integrated with our billing plan."

After our primary development tasks were phased into the program, then the institution went live with the billing system and payment reconciliation processes, she adds.

7. Establish weekly reports. The last step is very important because it can help catch problems before they become compliance issues.

"Our team holds weekly meetings to review reports," Chesley says.

These reports help ensure the process is billing accurately and that payments are being made. Plus they can help identify trends and other information that could be used to improve the billing process.

"Oversight is much more fluid with an electronic system because the requisition of those charges is happening more efficiently and is readily at everyone's fingertips," Chesley says.

The uTRAC electronic system has worked so well for the University of Utah that the institution has a copyright pending on the system and plans to market it to other research organizations, she adds.

The annual maintenance of uTRAC would be provided at no charge as it would be handled through a consortium of research institutions, Chesley says.

"We hope to create a collegial process," she concludes.