Clinical trial regulations constantly expand and evolve. These changes are put in place to benefit health systems and patients. Still, maintaining compliance with ever-changing rules can challenge even the most organized sites—and lead to costly errors. This is especially true when handling the billing for clinical trials.
Clinical trial billing mistakes come in many forms; a site may accidentally charge Medicare for a non-routine service, or it may bill a patient and sponsor for the same item. But even if errors are innocent, they can lead to serious penalties, including fines, imprisonment, or both. Clinical trial management software (CTMS) can take the guesswork out of billing to ensure compliance.
Shared Documents and Definitions
To best comply with the 13 core principles of Good Clinical Practice (GCP), clinical trials need consistency. Unfortunately, this can be difficult for research organizations to achieve across multiple sites—or even across multiple departments. Since many areas of an organization can touch the billing process, avoiding communication breakdowns (and the problems they create) is necessary.
One way a CTMS helps ensure compliance is through document-sharing features, which your billing department can use to its advantage. For instance, at the beginning of a study, they can broadly distribute a coverage document. This would list what is and isn’t billable, as well as who is responsible for payment. That way, all your sites and departments can easily find and comply with the appropriate billing information.
But what if your site doesn’t have a centralized billing office, or just instituted one? Billing and budgeting offices are a relatively new development for many organizations. And in such instances, their processes may still be fractured or struggling due to their infancy. This is a recipe for compliance-related issues.
Depending on the study, billing can include multiple steps (validating charges, designating payees, invoicing sponsors, etc.) with sub-tasks involving many areas of an organization—from principal investigators to IRB members and others. A good CTMS can establish an efficient billing review workflow; this lets you manage these connections and ensure everyone is included accordingly.
Centralized Billing Information
In addition to GCP, health organizations must also perform a Medicare Coverage Analysis (MCA) before beginning any clinical trial that includes medical procedures. As part of the MCA process, sites must maintain records of a study’s payment and billing information. The best way to document all of this in a clear and detailed manner is via a single billing or cost allocation grid.
With a centralized billing grid, you can summarize decisions around MCA costs and their justifications in one location. And while you may be able to use an internal solution for documenting these, a good CTMS will offer features that add efficiency and reduce compliance-related risks—like seamlessly integrating billing grid information with an electronic medical record (EMR) system.
Want to learn more about how a CTMS can help ensure billing compliance? Request a free demo of Clinical Conductor today.