Guest post by Marti Arvin, vice president of audit strategy, CynergisTek.
The myriad of regulations associated with clinical research can be daunting. In addition to complex regulations, most research entities have the added challenge of coordinating the process across multiple stakeholders that may be spread across different organizations. One way to begin to get a handle on this is to look at integration between the EHR and other systems used in the process. The research enterprise can leverage the availability of electronic systems to the reduce duplicate effort, increase researcher satisfaction and improve compliance.
By integrating the EHR and the clinical trials management system (CTMS), an organization can create a single source of truth, consolidate efforts in teams that have the appropriate expertise and decrease the overall timeline to get a study up and running. A typical research project has multiple processes that must occur for it to get approval from the Institutional Review Board (IRB), gain appropriate funding from the sponsor, and receive any necessary approvals from committees such as biosafety or radiation safety. Traditionally, the researcher has been responsible for assuring all of the necessary approvals have been obtained, the study is appropriately budgeted and all other steps are completed to help ensure compliance, despite the fact that the researcher is the scientific expert on the project, and is often the least experienced in ensuring the study meets all the regulatory requirements.
Creating a process where the CTMS and the EHR are integrated to capture necessary information at both the study initiation phase and throughout the study can help improve the process and ensure all necessary actions are completed.
System integration can offer improved efficiency and effectiveness in a number of areas. This discussion will focus on just two examples: Clinical trial billing and HIPAA compliance.
How can system integration help with these two issues?
Clinical Trial Billing
It is necessary to evaluate the proposed budget for the clinical trial to ensure services which can be legitimately billed to the patient/subject’s third-party insurance are identified as such and services that must be covered by another source are identified– also known as the coverage analysis. The rules around what can be billed to insurance, particularly to Medicare, are complex.
The process requires someone with expertise in not only general billing and coding, but the specifics of the rules in this area and the ability to read a study protocol. The language of the study’s informed consent document is also critical. The wrong wording in the informed consent can render a service otherwise billable to third-party insurance non-billable, meaning the cost of the service must be covered by another source and makes the initial coverage analysis extremely important. Equally important is a process to ensure the services are in fact billed in the manner anticipated by the original budget and coverage analysis. This helps ensure the organization does not submit a potential false claim by billing insurance when the study should be covering the cost.
By integrating the systems (CTMS, EHR), a process can be developed to trigger certain steps to happen contemporaneously. The researcher’s initial submission to the IRB system can trigger an alert that the study needs to be established in the CTMS. The establishment of the study in the CTMS then triggers the initiation of the process to develop a coverage analysis. The development of the coverage analysis can be built in to the CTMS so that all services provide to the participant are identified on a structured calendar with the corresponding payer source identified.