Integrate best compliance practices in CR operations

Assess, educate, monitor billing compliance

Clinical trial (CT) sites need to do system-wide risk assessments of the CT process to see where they need to improve policies, procedures, and operations, says Kelly Willenberg, BSN, MBA, president of Synergism, LLC of Chesnee, SC. Willenberg works with sites to improve research compliance, including billing and program compliance services.

"From my experience, I see that different things work for different places," she says. "It can be challenging to assess the state of your operational engine."

CT sites sometimes have a vague sense that they have a billing compliance risk, but they don't realize how big the risk is, she says.

"I see the biggest problems in billing compliance," Willenberg notes.

But sites also might have conflict of interest and human subjects protection issues.

"They don't have a solid informational infrastructure to build on," she says. "And they're just kind of muddling along with no standard operating procedures (SOPs), plan for the future, or an effective self-monitoring plan because they don't know what they have."

Willenberg suggests sites follow these steps to improve their compliance practices:

• Establish effective billing compliance practices: Sites often fail to realize that it takes a multidisciplinary team to do billing coverage analysis and the budget process, Willenberg says.

"They sometimes don't know they have problems because they don't know how to set it up to start out," she explains. "Their first priority should be to have someone in a position who is designated to be responsible for research billing."

This person needs to be very knowledgeable about the regulations and the institution's rules, as well as understanding key compliance principles.

The billing compliance point person also should have the authority to make decisions and changes as needed.

If a site is unable to hire a billing compliance manager, then it would be a good idea to contract with an expert to provide risk assessment and auditing services.

• Provide adequate investigator and staff training: Sites often fail to provide adequate and ongoing staff training.

If investigators and study coordinators do not understand the regulations then it is difficult for them to ensure complete compliance.

"Maybe they never had the proper education and training to even know what they should be doing," Willenberg says.

This training should include human subjects protection, best practices, good clinical practices (GCP), clinical trial billing compliance, and other compliance issues.

• Define your institution's specific compliance needs: "Some places will find their need is billing compliance; some will need better consent form documentation, and other people might find their need is consistency and integrating compliance into their research operations," Willenberg says.

A CT site might need a process improvement action plan that is communicated to all staff.

"A lot of times what's lacking is communication," Willenberg says.

Most CT sites would benefit from making certain all policies and procedures are written down and defined.

"Then assess and document what educational training is required for all personnel involved in research," she says. "When people are well-trained and receive education on a routine basis, then role delineation and responsibilities are carefully and better outlined for people."

P&Ps can explain who has the authority and responsibility for various research tasks.

"There's a price to pay if you're not doing all this," Willenberg says. "You have potential financial risk and regulatory problems, and the institution's values might be compromised."

• Conduct self-monitoring and risk assessments: Sites need to monitor their open studies and look for trends.

"Some institutions will do random self-monitoring, working with a compliance department or internal audit department," Willenberg says. "They'll interview key principal investigators and personnel and assess where they are at that point in time."

If they're assessing the billing process, here are some questions to ask:

— Is the institution charging Medicare for research activities?

— Did the institution bill appropriately to other payers?

— Did the institution bill the sponsor for screening failures or items and services done for research purposes only?

— Were the proper codes and modifiers put on bills that went to Medicare?

"There's a process research sites have to follow at the beginning of a trial to see which activities qualify for Medicare and should be billed," Willenberg says.

"Ninety percent of the time what I see is the accounts receivable are lower than they should be because sites are not billing appropriately," she says. "They're not collecting their accounts receivable and monitoring what should be coming in and what is not billed appropriately."

Before a study begins, a CT site should determine which payer is responsible for each activity, and this information needs to be included in the informed consent form that the patient signs, she adds.

Sites might do a careful coverage analysis before opening a study. This will help them identify holes in their compliance program, especially in billing.

Self-monitoring also means that the site will conduct random review of bills, segregating charges and matching these with what was included on the patient's informed consent.

"In the standard review process, this will ensure you are doing billing compliance in the way you should be," Willenberg says. "You can have a great system, but if someone is not checking how you're segregating charges then who knows if it is being billed correctly."