The Training Challenges in Billing and Research Compliance

Clinical Researcher—March 2019 (Volume 33, Issue 3)


Kelly M. Willenberg, DBA, RN, CCRP, CHRC, CHC

Clinical trial billing is the process of ensuring that, from the coverage analysis to a claim reimbursement, you have revenue integrity. From the negotiation of a budget and contract against the coverage analysis to the revenue charge review and adequately coding claims, a site must ensure teamwork and communication for all stakeholders.

However, billing compliance is sometimes an overlooked component at clinical operations sites. What are the challenges with the process of billing compliance, and how do you train team members adequately? This article focuses on how determining when training is necessary and when it is lacking is a successful component of a compliant research billing process.

Challenges Ahead

A research billing compliance professional faces challenges every day, and sometimes they are insurmountable. Understanding why a coverage analysis is necessary, and its importance to the development of the contract, budget, and informed consent is key. Although some sites have this process designated to someone on the research team, the necessity for having the proper training cannot be overstated.

Asking study coordinators to perform this task is truly difficult without the proper training and clinical expertise. Analyzing a protocol’s study procedures from the billing perspective is not an easy task for anyone, least of all someone who has no idea what a coverage analysis is. However, their knowledge base from the clinical side in evaluating a study calendar and protocol for the clinical services can be extremely valuable to the process. Can they make an adequate evaluation and perform the necessary steps?

In some ways, having little or no training can be riskier, because once you start documenting using a bad process, you open the door for mistakes to be recorded and replicated. To be successful in research billing compliance, all staff need to accomplish many things, including an investment of time into professional development activities around the billing process.

Validation and Evaluation

How do you validate and evaluate your process of billing compliance? First, you must know all the types of clinical trials open at your site and whether they are considered “deemed and qualifying” under the National Coverage Decision of the Center for Medicare and Medicaid Services. Beyond the more familiar types of drug trials, understanding what types of device trials, if any, your site has open (including those carried out under Category A or B Investigational Device Exemptions [IDEs]) and if they have approval from Medicare is vital to your success in reimbursement.

Recognizing the types of studies and promoting awareness of them among all participants at every visit will set you up for success. Identifying each study with a coverage analysis is best practice, and should be implemented to procedurally process claims in a compliant manner. This does not occur without dedication and knowledge on many levels in the billing compliance spectrum.

While training is important, staff turnover for the billing compliance team can lead to big issues if there is not a hand off of information. The consequences can impact accrual and compliance with the protocol. There are many steps to ensure that ultimately, a claim is submitted correctly; the regulations are intense and cannot be learned overnight. Each state Medicaid plan varies, and all commercial payers have different medical management policies that can cover or not cover clinical trials. Accepting that Medicare is the payer that you should follow with intention from the beginning will make the process smoother.

Targeting Training Needs

What training is necessary for success? The first part of the billing compliance process is the coverage analysis. Training on a coverage analysis is absolutely necessary for best practice with a review of the protocol services against National Guidelines, National Coverage, and Local Coverage Decisions. This justification is documented and serves as justification when a claim is processed for a study participant with billable services.

The coverage analysis is the basis for a solid budget, contract, and informed consent. Knowing that the patient should be told what services their insurance or payer is going to be covering for a trial is part of the consent process, as they may end up with outstanding balances. This is why the person doing the consent should be trained on the coverage analysis so they can describe correctly to the participant what their expected cost will be in the consent form, and ensure that this description is understandable to a person with an 8th grade education.

Another area that is important to the billing compliance process is ensuring that all coordinators receive education on how the coverage analysis impacts the consent. Explaining that something is covered by a sponsor is easy, but when it is documented as a routine cost in the coverage analysis, the consent process is marred by disagreement with the financial documents. Participants will be confused when they receive an explanation of benefits that shows something itemized that they thought was provided by the study sponsor. By building appropriate infrastructure around this process, everyone is informed about what is expected to be paid by Medicare or insurance and what the sponsor is paying for or providing for free, and ultimately the transparency helps the participant to understand their financial responsibility.

Another problematic area for billing compliance is claims processing, when the research coordinator is contacted to help segregate charges on a participant claim. If the coordinator does not understand how the coverage analysis directly impacts submission of the claim, they can direct charges to the wrong payer. When they are not trained adequately, they may not order the services correctly. Asking one if something is “standard of care” might get an incorrect answer, thus a wrong claim is processed.

If the services are set as billable under the rules to a payer as a “routine” costs, the claim should be processed in that matter. Without the ability to track these visits, some sites find themselves overwhelmed and coordinators are relied on to make decisions on segregating charges with no knowledge or training of the billing compliance process. Making the wrong decision can separate hospital and physician billing into two different methods for one visit. Research staff must understand that how a service is ordered and documented can be the reason for a denial.

These types of services can be just as important in an inpatient device study and an outpatient drug trial. The government wants to know that you are billing both drug and IDE device studies correctly; both have unique challenges that must be understood. Anyone who deals with the claim at the patient care level needs information on the coverage analysis regardless the type of study you are dealing with when there is treatment. The communication flow is sometimes the biggest challenge for billing compliance teams, and often a lack of training can cause many discrepancies.

Considering the Three C’s

The “three C’s” of billing compliance can be described as meeting the Challenges, fostering Collaboration, and accepting a spirit of Compromise.{1} Once you decide to meet the challenges of billing compliance, collaborating with colleagues will help in answering questions that arise. Keeping training on the agenda for all team members and encouraging them to attend conferences that have billing compliance, revenue cycle, and reimbursement on the agenda is key. There are many conferences that have sessions on these topics.

There also are many opportunities for training. Finding opportunities where all staff—including coders, study coordinators, billing compliance managers, regulatory compliance experts, and accounting team members—can learn together is recommended. Having everyone work together and collaborate on how to face the challenges in billing is gratifying for billing compliance personnel.

Compromise involves reaching an understanding of how each department’s procedures can impact others. Working together to face simple process issues with compromise for who is responsible can make the difference within a compliant billing process.


Put training on your team’s calendar and you will reap the benefits! Delving into networking opportunities, mentoring programs, and training will help staff to achieve career goals and make research billing compliance programs stellar. Attending clinical trial billing compliance conferences will strengthen your team members’ abilities to meet the challenges that come with this important aspect of clinical trial management.


  1. Meade R, Willenberg K. 2010. The 3 C’s of research billing compliance: collaboration, challenges and compromise. J Healthcare Comp 12.

Kelly M. Willenberg, DBA, RN, CCRP, CHRC, CHC, ( is Manager of Kelly Willenberg, LLC in Greenville, S.C.