Clinical Research Financial Management

Financial management is essential to the success of clinical research. The costs of clinical trials are numerous, and the financial resources required to conduct them must be carefully managed. University of Virginia School of Medicine’s Clinical Trials Unit 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 subject’s insurance provider or the study subject and to make certain that clinical trials are conducted efficiently and effectively.

Clinical Research Financial Management (INTRANET)

• Billing Coverage Analysis Template

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.

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.

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.

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.

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.

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

Please reach out to:

Jessica Morris
Phone: 434-297-5681
jlm6uw@virginia.edu

• To request Medical Center and UVA Physicians Group prices for study paid procedures.
• Issues with subject registration & account reconciliation.
• Investigational device billing.

Courtney Nightengale
Phone: 434-243-1927
cdn4q@virginia.edu

• Study billing coverage analyses.
• Study injury coverage.