Clinical trial billing compliance ensures that charges related to research activities are accurately billed and adhere to regulations like Medicare's National Coverage Determination (NCD) for clinical trials. It prevents fraud, ensures proper reimbursement, and maintains ethical standards. As a billing analyst, I ensure that billing aligns with study protocols, sponsor agreements, and regulatory requirements, minimizing risks of audits or penalties.

When discrepancies arise, I first review the study budget, contract terms, and billing records to identify the root cause. I collaborate with study teams and sponsors to resolve issues, ensuring accurate billing and compliance. Clear communication and documentation are key to maintaining transparency and preventing future discrepancies.

I’ve used tools like Epic, Cerner, and specialized billing software such as CTMS. These platforms streamline charge capture, track billing compliance, and generate reports. They help me ensure accurate coding, monitor study progress, and maintain audit trails, which are essential for efficient billing operations and regulatory adherence.

I regularly attend webinars, read industry publications, and participate in professional organizations like ACRP or MAGI. I also review updates from CMS and other regulatory bodies. Staying informed helps me adapt to changes, implement best practices, and ensure compliance in clinical research billing.

In a previous role, I noticed a billing error where routine care costs were incorrectly charged to the sponsor. I reviewed the protocol, identified the mistake, and corrected the charges. I also implemented a checklist to prevent similar errors, ensuring accurate billing and maintaining trust with the sponsor.