Identifying ways to monitor and mitigate the risk in managing clinical trial billing compliance is a critical element in the success of any research site. It’s important, then, to ensure there is a culture of billing compliance within the organization and that there is a process to evaluate both front- and back-end revenue cycle to uncover opportunities for continuous improvement.
A site’s front-end financial operations focus on anything directly relating to patient interaction, while back-end operations typically involve sponsor claims and reimbursements. While these areas might have distinct teams and operate with only loose connections, efficient front-end processes directly lead to back-end success and, as a result, positive revenue outcomes. Let’s examine how to evaluate both areas, individually and in concert, for more efficient and effective billing processes.
Managing Clinical Trial Billing Compliance
- Feasibility Analysis – Evaluate resource alignment including enrollment numbers, staff, space, and financial ROI
- Medicare Coverage Analysis and Billing – Includes dissecting protocols, evaluating items/fee for services, and determining NCD/LCD
- Budget and Contract – Develop or reevaluate any internal/external templates, understand standard of care and research-related procedures, and become adept at budget negotiations
- Document Alignment – Improve the consistency of mapping costs/billing for each trial and throughout the research organization
- Patient Enrollment Documentation – Ensure consents, registrations, patient documents, research encounters, orders, and admissions to studies are complete
- Billing & Charge Capture – Separate study vs. non study costs, align medical record documentation, and ensure timelines for billing on hold are managed
- Billing & Charge Review: Evaluate payer determination processes, how modifiers/NCT/codes are captured, and implement a clear claims review process
- Financial Reconciliation – Ensure cost centers, project numbers, and EPIC close out procedures are evaluated
Learn more about how a sound fiscal approach can benefit your research organization by viewing our latest webinar “Augment Clinical Trial Billing Initiatives”.