Billing Compliance Basics: What Clinical Researchers Should Know

Meghan Hosely
September 3rd, 2019

For many clinical trials, their operational goals are relatively similar: ensure compliance with regulations, minimize patient billing errors and patient dissatisfaction, and minimize claims processing errors. There are many facets of a clinical trial that work together to meet these three goals, including billing compliance.

Billing compliance makes sure all services in a trial are paid for by helping to reduce double billing and preventing billing for services that are not covered by the trial or are not medically necessary for the participant.

Billing Compliance’s Role in a Clinical Trial

There are more benefits to billing compliance than simply avoiding double billing. Adhering to billing compliance standards leads to reduced errors, consistent billing practices, increased revenues and improved budget negotiation. Not only does this streamline the billing process, it simplifies the entire trial process.

Before the trial begins, it’s best to start collecting all billable information in the protocol. Not all of the information will be easily accessible – look at the study’s footnotes or the visit documentation to find everything considered billable. Gathering all necessary information in the beginning helps designate who is paying for what, because it reduces the urgency of determining billing responsibility at the last minute.

It’s also helpful for the research department to connect with the billing department. Having an established relationship with billing makes it easier for the research staff to approach them with any questions or concerns. Establishing a relationship also helps billing understand the research staff’s thought processes as they start to bill services.

Risks of Being Non-Compliant

While there are many benefits to compliant billing, there are equally as many risks to not following billing compliance regulations: damage to the reputation of the institution and/or principal investigator (PI), fines, audits and false claims. Damage to the institution’s or PI’s reputation due to non-compliant billing practices can hinder an institution’s ability to obtain funding for current and/or future clinical trials.

Establishing guidelines for billing is the key to reducing risk around billing non-compliance, and it also helps standardize the entire process. There is no right or wrong way to establish guidelines, however, it’s imperative to do so, so that staff can refer to it if they have any questions. It also helps keep the research department on the same page as your institution’s billing department.

Coverage Analysis and Billing Compliance

If billing compliance ensures all services in a clinical trial are paid for, coverage analysis designates who is billed for what services – the sponsor or the participant’s insurance. Policies dictate that bills should only be sent to payers if they are directly related to patient care or have not been paid elsewhere.

Coverage analysis prepares the way for billing compliance; through it, a study can account for a solid budget, contract and informed consent process. It’s considered best practice to conduct coverage analysis of a study as it justifies why a service is being billed. Coverage analysis is performed by a chosen research team member with proper training and industry knowledge.

Through coverage analysis, two questions are asked: Is it ok to bill any part of this protocol to the subjects’ insurance providers? If yes, which items can be billed to insurance, and which items will the sponsor have to provide or pay for?

By answering these questions and ensuring your coverage analyst is properly trained and educated in industry knowledge, everyone involved in the trial will know what the sponsor is paying for and what the insurer is paying for. In turn, this also helps the participants understand their financial responsibility as they move through the phases of the trial. While it is the first step, coverage analysis is critical in ensuring the overall success of billing compliance

Our Budgeting and Coverage Analysis Checklist helps you analyze your billing compliance risk and highlights key budget-related aspects of your study that can also go overlooked.