Even for those who’ve been doing it for years, setting up a clinical trial is a lengthy, detail-oriented matter. The last thing researchers need is more complexity, but unfortunately, when it comes to billing sponsors, payers, and patients, that’s exactly what they get.

This fact became abundantly clear when a case against Rush University Medical Center settled for $1 million last year. The first step to avoiding mishaps such as double billing, as happened at Rush, is to take a systematic approach to coverage reviews for each trial, according to Lisa Murtha, managing director in the New York office of Huron Consulting Group.

There are several things that tend to get left out of these reviews, which Murtha said take between eight and 16 hours when conducted by an experienced reviewer. After the schedule of events for the trial is laid out in an Excel spreadsheet and each event is marked by the party being billed for it, it’s important to compare that with the informed consent document.

“All this takes place before any patients are enrolled in the study,” said Murtha. That way, if there are tests or procedures the patient is expected to pay for or contribute a co-pay, that can be disclosed to them in the informed consent.

Another place researchers get into trouble is neglecting to verify that the therapy involved in the trial is considered the routing therapeutic course of action for patients with that condition for each event you expect to bill Medicare for. “We look at medical literature and ask the investigators what they would do normally, absent the clinical trial,” said Murtha.

Often, the healthcare provider will leave this up to the investigator, said Murtha. “They may be cutting edge physicians doing the absolute best clinical care—but because it’s so cutting edge, Medicare and the other insurers haven’t caught up to them and consider what they’re doing experimental. For billing purposes, it would not meet Medicare’s routine care standard.”

Murtha said the majority of investigators could use more education about the need for proper reviews. “It’s more work on top of their incredibly busy schedules, but to bill payers, particularly Medicare, you have to write your protocols so they clearly document each step for both clinical/scientific and billing purposes. If it’s not documented, it didn’t happen, and there will be no payment.”

Finding workarounds
Ironically, conducting a thorough coverage review is the easy part when it comes to billing issues, Murtha said. Because scheduling and billing systems are often from different vendors and were not built to accommodate clinical trial information, healthcare providers are left with kludgy workarounds.

“Research participants need to be identified in the scheduling, registration, and billing systems to segregate things that are only being done for research (items that get charged against the study budget) from routine things that can be billed to Medicare and other payers,” Murtha said.

Some providers simply flag research participants in all systems and automatically suspend any charges. Each day, a research coordinator looks at the charges for people in their studies and sorts them according to the research grid.

This approach eliminates the need for a large, costly IT project, but it requires considerable manpower from research coordinators, which Murtha noted are typically some of the busiest people in a healthcare organization. “They’re nurses, not trained in billing, and they don’t want to be responsible for that,” she said. Still some of Murtha’s clients have told her that given the complexity of their registration and billing system, this is their only option.

Providers with more open systems (or a larger IT budget) may choose to modify them so individual tests or procedures can be automatically identified as a research task or clinical task, based on the grid. The upfront cost is considerably higher, but the end result is a system that requires less human intervention and has less opportunity for error.

Murtha said organizations that do a lot of research are certainly recognizing the need to adjust their processes. “They need to get on the bandwagon and at least start doing coverage reviews so they can know what charges are billable where,” she said. “In the short run, they can certainly workaround their software by doing bill holds and sorting through the charges manually.”