Research Roundtable: Billing Compliance and the Clinical Research Management System

Published January 12, 2022

Research Roundtable.

If you are conducting a Human Clinical Research Study that involves services at Erie County Medical Center (ECMC), Kaleida Health, Great Lakes Cancer Care Collaborative, or General Physician, PC (GPPC), including radiology services, your study will be registered in the Clinical Research Management System (CRMS).

This system is used to notify our affiliates regarding patients enrolled in a study and to meet the requirements per Centers for Medicare and Medicaid Services. (More information can be found on the

U.S. Dept. of Health & Human Services Guidance Portal “Mandatory Reporting of an 8-Digit Clinical Trial Number on Claims” page.)

Within 24 hours of the procedure or test, the study team will be required to enter the patient demographic information — including the consent — in CRMS so that claims may be coded correctly prior to submitting to a third-party payor. Even if the entire procedure is billed to the patient’s insurance or Medicare, the information is required when the visit is part of the research study.

Once the information is provided, the system will notify the appropriate biller so the charges can be billed to the sponsor or patient’s insurance. The uploaded consent will also be available to the team to be placed in the patient’s medical record.

All invoices or health claim forms that are charged to the research study must be sent to the Clinical Research Office (CRO) for review prior to being processed for payment. This will ensure that the study is paying the contracted amount per the agreement. These transactions are also exempt from obtaining prior approval through Procurement.

Contact Information

Learn more by visiting the Administrative Services Gateway “Confirming Received Guidelines” page. If you have questions or would like further information, contact Dominic LoTempio, Director of Procurement Systems and Compliance, Purchasing and Contract Services, at 716-645-4503 or dsl4@buffalo.edu. And for questions regarding CRMS, contact Pamela Anderson, RN, BSN, Associate Operational Director, Clinical Research Office, at 716-888-4841 or pka2@buffalo.edu.

“Research Roundtable” is a section in the University at Buffalo Clinical and Translational Science Institute (CTSI) Translational Spotlight newsletter. Add your email to the newsletter mailing list here.