Are You Leaving Billing Money on the Table?

Study sites that fail to conduct adequate billing coverage analysis are “leaving money on the table,” says Kelly Willenberg, owner of Kelly Willenberg LLC.

“We see people who don’t do a coverage analysis at all, so they have no justification or backup for anything that they’re billing out to Medicare or any other payers that would be considered conventional care, or what physicians like to call standard care,” Willenberg says. That inability to “translate” information from the clinical team to the budget and billing and claims processing teams “can really hinder the process,” she adds.

Willenberg warns about another common, and big, billing snafu: Failing to use “any codes and modifiers—no [National Clinical Trial Identifier], no notation, no revenue code—nothing to show a payer that the patient is participating in a trial and you are [providing] what is considered the care to them that would have been done minus the study, or it is considered a routine cost in a qualifying trial.”


A Clinical Trial Financial Management Review: A Paradigm of Front End and Back End Revenue

Join Kelly Willenberg at ACRP 2019 this April for this deep-dive, interactive workshop exploring the entire financial process of a clinical trial. Gain insights into how to manage budgets, evaluate the budgeting process, and more. If you have personnel doing coverage analysis for your site, you won’t want to miss this workshop.

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This workshop is nearly sold out, so sign up today!


“The third big area we see is the Medicare Advantage piece, [where] you have to know what type of trial the patient is on and if they are on a drug clinical trial,” Willenberg says. Medicare Advantage was not set up to cover the routine costs in a drug clinical trial, she explains. “You have to manually process those claims.”

ACRP 2019

It gets increasingly tricky, she says, “even to the point that Medicare pays as the normal payer for the patient for anything in the clinical trial calendar, but Medicare Advantage is supposed to pay for the gap, or to make the patient whole.” In a typical scenario, the patient would owe 20% as a conventional Medicare fee for service. “What’s left, Medicare Advantage is supposed to [cover, and] you’re supposed to be able to back bill them for the outstanding balance,” Willenberg notes.

However, the landscape is anything but clear and consistent. “Not all Medicare Advantage plans play by the rule,” Willenberg explains, “and it’s very challenging for sites to get it right and for the patient not to end up owing a balance that they shouldn’t necessarily have owed.”

Willenberg will provide an overview of the basics of billing compliance on February 13 in this free webinar for ACRP Members, Clinical Trial Billing Basics.

Author: Michael Causey