Clinical Trials: Understanding Cost, Coverage Implications

July/August 2010, Vol 1, No 3 -


San Diego, CA—Emphasizing the costs and financial reimbursement issues associated with the “everchanging, ever-complex environment” of clinical trial research, a session at the 35th Annual Oncology Nursing Society (ONS) Congress addressed a crowd of both current clinical trial nurses and attendees who may take on this role, discussing how the team responsible for the hours of logistical work and research coordination supporting these trials can work more effectively.

Clinical trials have the obvious benefits of developing new therapies and treatment standards, said Rose Ermete, RN, BSN, a clinical trials nurse at St. Mary Mercy Hospital, Livonia, MI. Another benefit, according to copresenter Denise Friesema, MS, RN, director of clinical research operations at the University of Chicago Medical Center, is that they allow nurses to “leave our fingerprint on science.” Both presenters, however, took care to outline potential pitfalls when conducting clinical research.

According to Ms Ermete, it is extremely important to be in compliance with all billing rules, as the costs of noncompliance range from adverse publicity to Medicare exclusion to criminal penalties. The practices that most commonly lead to noncompliance, she explained, are “double dipping” (when a hospital bills for a service or drug already provided by the sponsor), billing for services that were provided free as part of the trial, and billing for services that would not ordinarily be covered if they were not part of the clinical trial. Illustrating the dangers of noncompliance, Ms Ermete highlighted the situations of several large institutions—such as Johns Hopkins, the Mayo Clinic, and Rush University Medical Center—that have been fined by the US Attorney General’s Office and the Office of Inspector General because of noncompliance issues.

Yet the story of Rush University Medical Center can also be seen as a helpful example for nurses looking to either begin or improve their clinical trial programs, Ms Ermete explained. After being fined $1 million, Rush launched a comprehensive compliance assurance program, which started with—and is centered around—moving from a “siloed” system to a centralized billing process. With one research office handling all paperwork, providing oversight across the organization, and conducting monthly reconciliations, Rush has “set the standard for what the government is looking for when it comes to compliance,” Ms Ermete said. The idea of centralization or “harmonization,” as the presenters explained, was a key theme of the presentation, one to which both Ms Ermete and Ms Friesema repeatedly returned. They stressed that by aligning the multiple departments that work together during a clinical trial under one centralized office, a facility can ensure they are remaining compliant, avoiding fraudulent billing, and conducting research in a consistent manner throughout the institution.

Establish Standard Processes

To establish this centralized system, Ms Ermete noted that institutions can either use a front-end process (identifying the patient before they receive care and then using study-specific charts) or a back-end one (pulling out all bills before they are sent to determine which costs are paid by the study organization). Bringing the relevant departmental teams together is key—especially those people who will be registering patients and billing payers—as is drawing up a flowchart to show how bills should be accurately routed. Regardless of how the system is developed, however, Ms Ermete concluded “there has to be some type of evaluation taking place.” This process should include both active and past accounts, with auditors reviewing invoice details to confirm appropriate billing.

Ms Friesema instructed session participants on the “budget basics” of clinical trial research. Noting that “it’s just not worth the effort” to open a clinical trial that includes only a few patients, she instructed that the first and most important question nurses should ask is whether the facility cares for an adequate patient population. Next, clinical trial nurses should collaborate with the trial physician to determine which parts of the trial would be provided to patients anyway as standard care and what services would be considered additional investigational expense. Finally, clinical trial nurses should examine all 4 components of the study budget: the start-up fees, research-related clinical care expenses, the cost of study implementation and oversight, and indirect costs that go to the facility (such as institutional overhead).

Although burnout is common and high turnover rates among clinical trial nurses have been well documented, Ms Friesema concluded that by considering the strategies outlined in the session and avoiding the pitfalls illustrated by other facilities, clinical trial nurses can help create a successful research program at their institution.