CTU Service Spotlight – Clinical Research Financial Management

The UVA School of Medicine Clinical Trials Unit is a multi-tier resource for the entire UVA research community that is optimized to reinforce the “enabling discoveries for better health” goal of UVA Health’s strategic plan. In each edition of CTU Currents we will explore one of the various services offered by the CTU and in this edition we take a look at the Clinical Research Financial Management team.

Financial management is essential to the success of clinical research. The costs of clinical trials are numerous, and require significant funding for staff, equipment, supplies, and participant recruitment. Proper budget development and sponsor billing ensures clinical trials are able to enroll and support the study team throughout the life of the study. The UVA CTU Clinical Research Financial Management team provides billing coverage analysis, site budget development and negotiation (fee for service), research billing assistance, and sponsor invoicing and payment reconciliation (fee for service) to ensure proper billing of services to the sponsor of the study, study participant’s insurance provider or the study participant and to make certain that clinical trials are conducted efficiently and effectively with proper management of study funds.

“The goal of the Financial Management team is to give clinical researchers at UVA the strongest possible foundation on which to build their projects”, says Jennifer Richards, Senior Compliance Manager of the CTU Financial Management team. “Understandably the PI and study team are laser-focused on patient care and the science behind the project. Having a team of experienced finance professionals on hand to navigate the budgeting, billing and payments, as well as integrating with our clinical trial management system (CTMS), OnCore, and existing financial systems at UVA, allows them to rest easy knowing that the financial health of the study will not be an issue.”

Examples of services provided by the Clinical Research Financial Management team include:

Billing Coverage Analysis (BCA) – Required for all clinical trials

Coverage Analysis is the review of study documentation to determine who will be paying the costs of each item, service, and activity required by the protocol. This analysis and determination results in a study-specific billing plan which is recorded on a billing grid in CRConnect and Epic (as applicable).

The CTU supports the BCA process by:

• Generating and maintaining the BCA based upon study documents.

• For studies that will have services billed to study subjects/insurance, Coverage Analysis is a three-step process:

1. Confirm that the study meets the definition of a Qualifying Clinical Trial.
2. Determine which study-related items/services may be considered to be Routine Costs.
3. For each Routine Cost, document the Medicare rule(s) that allows reimbursement for that item/service and any other rules that disallow or reduce coverage for that item/service.

Epic Research Billing Review – Required for all clinical trials

Research billing is a process in which technical and professional charges for research participants are being billed appropriately and in compliance with the BCA, relevant laws, regulations, and contractual agreements

Research billing review in Epic allows for the review and routing of charges to be billed to the sponsor or patient/insurance, in accordance with the generated BCA.

The CTU supports research billing by:

• Providing research pricing for services, agents, and devices administered as part of a qualifying clinical trial.
• Activating research studies in Epic for associating patients, linking encounters/orders, and performing research billing review.
• Completing 2^nd tier review of research accounts to verify billing charges, ensuring changes have been appropriately directed to patient/insurance or study based off of the study Billing Coverage Analysis (BCA).
• Collaborating with billing teams to audit billed research services.

Budget Development and Negotiation – Fee for service

A detailed budget will help ensure that the Principal Investigator and the UVA are reimbursed sufficiently and will assist in defining the scope of work anticipated.

A detailed budget lists all the services and activities necessary for conducting the study and the cost of each service/activity to be paid by the study.

The CTU can:

• Work with investigators, department business staff, and sponsors to develop and negotiate budgets in support of UVA’s mission and in accordance with both internal and external policy.
• Develop study budgets (including internal budgets with break-even costs for use in red-lining the sponsor budget).
• Work with the Principal Investigator (PI)/Study Coordinator for approval of the budget prior to sending the budget to the sponsor for negotiation.
• Negotiate the budget with the sponsor.
• Work in collaboration with your departmental financial administrator or independently.

Sponsor Invoicing and Payment Reconciliation – Fee for service

Managing revenue and expenses for clinical trials is crucial to ensure the effective allocation of resources, adherence to budget and billing compliance, and successful execution of the study.

The CTU can:

• Invoice sponsors for services, including tracking ACH/auto payments generated by EDC or other sponsor system.
• Provide reconciliation support, including receipt tracking of invoiced sponsor payments.

Payment and Fees:

SOM CTU Financial Management services such as budgeting and invoicing are available as fee for service support. These services can be used by any UVA investigator who needs financial management support.

• Financial management support for budgeting and invoicing is charged at an hourly rate.
• All project specific time is tracked in Oncore and the PI will be invoiced monthly.

Contact Us

Inquiries regarding budgeting and invoicing services or questions about research billing, research billing review or scheduling training should be directed to somctufinsupport@uvahealth.org