Top Risks to Guard Against for Clinical Research Billing Compliance

By Ryan Meade | Managing Director, Aegis Compliance & Ethics Center
April 5th, 2017

Summary: Communication is key to successful clinical research billing (CRB). Learn the top risks associated with billing compliance when communication breaks down.

Estimated reading time: 4 minutes

This article was originally published on March 25, 2013.

Clinical research billing (CRB) continues to present challenges to health care providers. Getting it “right” requires coordination of study information among people who may have never worked with each other before. The key to compliant clinical research billing is exchange of information. The more the parts of a research enterprise can communicate with each other, the better chance the organization has to safeguard the accuracy of the claims.

One of the first questions an organization needs to tackle in its CRB initiative is what clinical research billing entails and who it involves.

What is CRB?

CRB compliance involves any charge for a service that could be directed to a third-party payor. Even small services, such as blood draws, could be charged erroneously. Many parts of a research enterprise may not understand how charges are captured. Understanding the charge capture system is an important first step.

Who is involved in CRB?

The short answer is: just about everyone. Charges are captured and directed typically by the provider sites — the hospital and the physician practice. The study may not originate with the hospital or the physician practice, but with a School of Medicine or a research institute. In those instances, the school or the institute must realize that it is the hospital and physician practice that carries the CRB risk. The basic study information for CRB must be transmitted in one way or another to the hospital and physician practices. CRB also involves correctly charging the study funds or sponsor. The same charges that could go to a third-party payor could also be erroneously charged to the study.

What are the Risks?

Clinical Research Billing errors usually occur because communication has broken down. Some part of the research enterprise has not communicated to another part.

Learn how a clinical trial management system (CTMS) can help your organization avoid these risks and maintain compliant CRB. Register for our free webinar.

For example, if a hospital billing office does not know that a patient is enrolled as a subject in a research study, there would be no reason for the billing office to do anything differently with the charges for that patient. Likewise, if a School has taken money for a protocol required service and does not communicate that to the hospital or physician practice, the hospital billing office would likely bill patients or the patient’s insurer for that service. The physician practice would also likely bill for the physician’s professional fees.

CRB compliance hinges on information getting from study documents to the right people managing charges for clinical services. When CRB communication breaks down, there are five general risks.

Risk No. 1 – Billing for services that are paid for by the sponsors

When a research site takes money for a clinical service from the sponsor, that service cannot be billed to the patient or the patient’s insurer. If it is billed, it could be viewed as a “double billing” situation. Double billing occurs when the same service is paid for by two different sources.

Sites should also realize that the legal portions of the clinical trial agreement can be just as important as the budget exhibit. Usually the “budget” is an exhibit to the clinical trial agreement, which makes the budget and the clinical trial agreement all one legal document. What might look like two documents is, in reality, one, and must be read and interpreted as one document.In order to manage this risk, the research site must understand what the sponsor is paying for. The budget should be clear as to what is or is not covered by the sponsor’s payment. Likewise, if the study is funded by a grant, there should be a document or an internal budget which clearly identifies what the grant is or is not paying for.

Even if the budget information is clear, that information must be communicated to the billing process at the hospital and physician practice.

Risk No. 2 – Billing for services promised free in the informed consent

Every research informed consent form must identify any “added costs” for the subject if he or she enrolls in the study. Sometimes this part of the informed consent form lists items and services that will not be charged to the patient or the patient’s insurer.

All parts of the research enterprise must live up to the promises in the financial discussion of the informed consent form. If the informed consent states that no services required by the study will be charged to the patient or the patient’s insurance, that is a promise which must be kept.

It is important to keep in mind that the informed consent form is interpreted from the perspective of the subject and not from the perspective of the investigator or study team.

Learn more about billing compliance

To learn about the risks in Clinical Billing Compliance, download the free eBook, “Building a Successful Clinical Research Billing Initiative.” This resource, by Aegis Compliance & Ethics Center and Forte Research Systems, provides an introduction to the importance of CRB and starting points for developing an effective CRB initiative.

You can also register for our upcoming webinar to learn how an enterprise clinical trial management system (CTMS), such as Forte’s OnCore Enterprise Research, centralizes your organization’s billing designation, helping you maintain accurate and compliant CRB. Click the link below to sign up today.


About the Author

Ryan is a partner in the law firm of Meade, Roach & Annulis, and also a managing director of Aegis Compliance & Ethics Center. Ryan focuses his legal practice and consulting work on regulatory compliance matters for health care organizations, concentrating principally on Medicare/Medicaid billing compliance and clinical research regulatory laws. Ryan was recently appointed to the faculty of Loyola University Chicago School of Law as the Director of Regulatory Compliance Studies. In Ryan's new role he is responsible not only for developing and teaching a new curriculum for law students in health care compliance but is also overseeing Loyola's online masters program in health care compliance and launching its online masters in research regulatory compliance.

Website: Aegis Compliance & Ethics Center

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2 Responses to “Top Risks to Guard Against for Clinical Research Billing Compliance”

  1. Tzipora Kuba says:

    The link to download the Building a Successful Clinical Research Billing Initiative is not working. Can you kindly send to my e mail? Thanks.

    • Hi,

      It seems some internet/cloud providers are currently experiencing difficulties that may interfere with the links on our website. I would recommend trying to download the content again tomorrow once all systems are back up and running. Thank you for your patience.


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