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.
Once the coverage analysis is set-up and the calendar specified, this then can trigger a record in the integrated EHR that allows for subjects/patients to be associated with the study. If available in the EHR, this can then be set-up to allow for some of the charge analysis to be automated, which means certain charges can automatically be billed to a third-party insurance, the study or another source and eliminates the need for human intervention to ensure appropriate billing for a significant number of charges. While it is unlikely the entire process can be automated, the integration of the systems allows for an increased number to be. If the set-up is done correctly, this not only frees up people and resources, it increases the level of compliance with proper billing, which in turn reduces the potential for improper billing, the potential re-work of a claim and/or submission of a false claim.
If the coverage analysis is performed by individuals with the expertise in this area it also avoids the mistakes made by the often well-intentioned, but non-expert researcher who does not understand the rules. Instead, researcher can focus on the scientific process of research, which is their primary role for the research project, thus increasing researcher satisfaction.
For a researcher to obtain protected health information (PHI) from a covered entity about a research study participant they must either obtain an authorization from the subject or meet another HIPAA exception. For a clinical trial, an authorization is the most common way data is obtained in a HIPAA compliant manner.
If the systems are integrated it can also increase the HIPAA compliance. If the IRB approval of the study triggers events in the CTMS, which serves as the gatekeeper functions for the study to actually be initiated, it can ensure the researcher has all the right documentation in place prior to initiating the study. For example, if the study cannot begin until the research team uploads a copy of the authorization to be used in the study, it serves as a reminder that an authorization from the subject is needed. If a subject cannot be added to the study CTMS record without someone verifying the authorization was obtained from that subject, this serves as second check to ensure it was obtained before PHI is released by the covered entity. The systems can be set-up to preclude the release of information, such as laboratory results, back to the subject record in the CTMS if the check box indicating the authorization was obtained is not completed.
For both clinical trial billing and HIPAA, having integrated systems allows for easier compliance audits as well. The auditors can look in two systems for most of the information necessary to conduct an audit rather than contacting each research team. Additionally, having the coverage analysis in the CTMS and the billing documentation in the EHR makes it easier to auditing the billing.
Having the study subject identified in the CTMS allows for easier identification in the EHR which in turn makes it easier to track down the actual authorization to ensure it was signed by the subject.
A process to integrate systems is no small undertaking as it is necessary to gather all the interested stakeholders and consider the process from all angles. The goal of integration should be to make the process more efficient and effective by balancing the desire for ease of use against the requirements of the various oversight parties. But if the process is open and transparent, and has input from all the stakeholders, it is possible to achieve the goal.