Is Your Clinical Research Revenue Cycle Too Slow?

Creating an efficient process for billing and identification of study-related procedures is a process in itself. Additionally, at large institutions where research is a small percentage of revenue, optimizing cash flow and compliance of the research revenue cycle may not be as big of a priority as it is for small institutions. Still, the absolute money value and risk in play can be substantial no matter your size. This blog details how partnerships between study teams and billing specialists can build accuracy and efficiency into your encounter identification and billing processes, mitigating risk and enhancing your revenue cycle.

Factors That Slow Your Revenue Cycle (and why they need to be addressed)

Before conducting a clinical research study, many institutions develop a coverage analysis, which usually generates a billing grid. Once procedures have been performed and corresponding charges have been accrued, this can serve as a guide for payer identification. Even with a billing grid on hand, institutions conducting clinical research can experience delays in the process of identifying payers, which can lead to losing hundreds of thousands of dollars. 

Way too often, institutions fall victim to timely filing limitations for claims submission– that is, claims will not be reimbursed by payers (such as insurance companies) if they are submitted after a contracted number of days from the date of service. Even when procedures are reimbursed by payers, the institution may be subject to slower cash inflow due to delays in processing.  In addition, the cost of charging an incorrect payer can be disastrously high, and without a solid process in place, determining the correct payer can be tricky.

For example, there are certainly occasions when it is appropriate to bill the research subject’s insurance for procedures performed as part of a clinical trial. As we have discussed in a previous post, per Medicare’s National Coverage Determination (NCD) 310.1, procedures that would be performed for the subject’s routine care regardless of participation in the trial can be billed to Medicare.  On the other hand, under the False Claims Act, it is illegal to bill Medicare for other procedures, such as those funded by the study’s sponsor (this is known as “double billing” or “double dipping”). Penalties for these violations can be hefty, including treble damages and civil penalties of up to $21,916 per violation.

It is therefore imperative for an institution conducting clinical research to identify the appropriate payer for each procedure performed before billing is processed. 

Things to Consider in Your Research Revenue Cycle Workflow

If you are a small research institution, it may be feasible to train study teams to review the corresponding charges to identify the appropriate payer. The coordinators, nurses, and investigators who are in direct contact with patients are often the personnel in the best position to indicate whether a procedure is related to the study and can often most easily determine the protocol visit number. Even so, the intricacies of billing and payer determination are time-consuming, and time spent figuring them out can slow your revenue cycle and leave members of your study team less time to focus on their specialized roles.

And what if you’re a larger institution, with multiple departments across campus, or across different campuses? Is it practical to expect study teams, who are often focused on other aspects of research, to know to use the billing grid and consistently interpret it accurately to route claims to the appropriate payer? How much consistent training and oversight would it take? How do you handle study team turnover?

Some institutions have processes that indicate encounters as either research-related or not at the time of scheduling. The challenge with relying only on this “linking” at the time of scheduling is that study-related visits/procedures can be scheduled without the involvement of the study teams – for example, a patient might go to an emergency room or primary care physician for a study-related adverse event, or for lab work scheduled by the patients with the labs directly. Relying on other personnel such as front desk staff, schedulers, or the patients themselves to identify study-related encounters often leads to inaccurate linking of encounters, or worse, leads to study-related encounters going unlinked.

It may be much more effective to partner with a specialized central team to review charges and identify the payers rather than expect all the different study teams at the institution to consistently and accurately follow the process. Services such as PFS Clinical’s Revenue Guard can help your institution boost revenue and compliance, generating positive effects for your institution, your trials, and your patients.

The Study Team’s Role in the Revenue Cycle

While centralizing this responsibility can result in many benefits for your institution, studies and patients, such a partnership is only efficient if your internal process is working for you. Regardless of your size, there are pieces of information that should be obtained from study teams. Namely, study teams should be given the responsibility to:

1)     Identify when patients enroll and dis-enroll from a study in order to capture their charges for review. Often, this is done in a system such as Velos, Epic, Cerner, Clinical Conductor, etc.

2)     Identify to which research study an encounter/charge is related (if any)

3)     For many studies, especially oncology trials, identify the protocol visit number or treatment cycle to which the procedure corresponds

Institutions should have a reliable process for obtaining this information from study teams for every charge reviewed. If central bill reviewers find themselves in a position that requires too much time spent asking for clarification from study teams, delays in submitting charges to the payer can occur. Moreover, lack of clarity can cause preventable oversights.

For example, a central reviewer may have reason to assume that a procedure is not part of the study if it has not been identified as research-related and is not indicated in the billing grid. This procedure might actually be an unscheduled visit to treat an adverse event related to the study, and would be paid by the study’s sponsor. In other words, when a reliable process is lacking, the compliance risk to the institution increases.

The most efficient and effective process, therefore, may be one that routes each of the enrolled patients' potentially research-related procedures to the study team for review after the procedure has been performed and before charges are routed to central bill reviewers. In institutions where study teams do not review the encounters/charges after the scheduling stage, the study teams may not necessarily rush to update statuses of disenrolled study patients. In those institutions, central bill reviewers may find themselves chasing after study teams to update study statuses so that claims are not held unnecessarily. If a process is in place for routing encounters to the study teams for review before billing, study teams will be incentivized to update the statuses of disenrolled patients so that they do not continue to unnecessarily review those patients' charges.


For each institution, the specifics of your process will vary depending on factors such as your current process, culture, size, technological platforms and resources. No matter your situation, the substantial revenue and risk involved means that a strong partnership between study teams and billing review specialists can really go a long way toward optimizing efficiency and compliance in your revenue cycle.