Sites Leverage Coverage Analysis as Roadmap to New Revenue

Kelly Willenberg, Manager, Willenberg & Associates Inc.

Kelly Willenberg, Manager, Willenberg & Associates Inc.

Foodies are sometimes surprised to find their favorite popular bistro shutting the doors for good and going out of business. It makes no sense, they’ll say, because the place was always so crowded. However, grizzled restaurateurs will tell you crowds don’t always equal success if the business isn’t being run properly.

Same thing goes for clinical trial sites, says Dr. Kelly Willenberg, DBA, MBA, CCRP, CHC, CHRC, manager of Kelly Willenberg & Associates. Too many sites struggle with identifying workload—especially before and during a trial—and have difficulty identifying the true costs in personnel and dollars for trial-related tasks, she notes.

“How can you know you are maximizing revenue from front to back” if you don’t truly know how much a service costs to provide and whether or not it is billable or otherwise reimbursable, Willenberg asks. “We’ve seen most sites underbudgeting without a coverage analysis,” she adds.

Willenberg is a big advocate of conducting a thorough coverage analysis and producing a detailed budget at the very beginning of the trial gestation process. “If you get it right at the beginning, your end product should be correct, too,” she says. Translation: No more billing surprises or getting stuck with absorbing a cost the site thought was covered elsewhere.

Coverage analysis is the “roadmap to maximizing revenue,” Willenberg says. Yes, it takes some time, and yes, it costs some money to do properly, but it more than pays for itself across the life of the trial project, she maintains.


An End to End Clinical Trial Financial Management Review – A Deep Dive into the Front End and Back End Revenue Stream

Join Willenberg and industry consultant Deena Bernstein at ACRP 2020 in Seattle this May for a thorough review of the entire financial process of a clinical trial site operation. This intensive, full-day workshop will cover how to manage the budget so you know how to effectively cover your costs, how to evaluate your budget process while analyzing the paradigm of clinical research billing compliance, and more. If you have personnel doing coverage analysis for your site, you don’t want to miss this workshop.

View Details and Sign Up >


Sites without solid coverage analysis and budgeting parameters struggle on a number of fronts, Willenberg says. For example, it can be “tough to translate between the clinical team and the billing team” when submitting claims to payers, she notes. Even a term such as “standard of care” is not officially recognized in some areas of trial reimbursement as a determinant of what is covered and what isn’t.

Minus robust coverage analyses, “some sites lean too heavily on the principal investigator or the study team to tell them what should be billed,” Willenberg says.

Bottom line: Sites without coverage analysis and budgeting that is under control are “leaving money on the table,” Willenberg says.

Author: Michael Causey