Billing compliance is one of the most important and complicated processes researchers deal with on a day-to-day basis. The consequences of inaccurate billing can be severe, and ensuring workflows are being followed by all teams across an institution can be a difficult process.
More than a dozen individuals and groups can be involved in clinical research billing, and communication is key to ensuring billing procedures are being followed from start to finish. When communication breaks down or processes aren’t followed, it can leave the institution (as well as key individuals) at risk. For example, these breakdowns can include billing a trial participant’s insurance for items paid for by sponsors or accidentally billing for services that are promised free during the consent process. Other risks could include billing for services that only pertain to the research itself or billing for non-covered services during a non-qualifying trial.
Taking steps toward compliance
One way to overcome these challenges is to implement a clinical trial management system (CTMS) that centralizes billing information to help ensure accuracy. Combined with solid billing compliance processes, these systems help alleviate many of the concerns regarding communication and standardization across teams. Systems like Forte’s OnCore Enterprise Research System allow staff to build a coverage analysis, which is a protocol-specific billing list of items and services provided as part of the trial. The billing summaries (also called billing grids) mirror the protocol calendar and provide documentation of billing decisions, including an assessment of routine costs and why the study is believed to be qualifying. These are a valuable tool, and an important step toward compliant billing.
In addition to ensuring charges are routed accurately, using a coverage analysis can bring further benefits to your research organization. For example, the ability to reference a clear list of what items are and aren’t billable early in the study startup process can be valuable when building your budget and negotiating with sponsors. The coverage analysis can also be used by compliance officers to monitor and audit the ongoing compliance of trials.
If you’ve already implemented a CTMS, another step towards billing compliance is integration with your electronic medical record (EMR) system. For example, OnCore is able to send complex study billing definitions to an EMR system through the IHE Clinical Research Process Content (CRPC) profile. This means all applicable team members involved in the research and/or billing process can leverage the same billing designations. If a patient is also a subject enrolled on a study, that status will be visible to the organization’s billing office, ensuring charges are routed properly and potential billing issues are avoided.
A version of this blog post was previously published on February 14, 2017.