The objectives of the Clinical Research Budgeting and Billing Compliance Program of UT Health are to bill clinical research services accurately, to recover all costs of research studies and to follow all federal and local regulations, guidelines, policies and processes relating to clinical research billing.

Process

The principal investigator develops an internal budget for clinical research studies that documents the services required for the study, the costs of the study and the party responsible for payment of the services on the appropriate budget template.

In studies where services or professional fees are provided in UT Health facilities and/or by UT Health physicians, a unique billing account is established to identify the research study, billing information, research services, procedural codes and costs of the research services on the designated form.  Research Account Setup Form

To ensure accurate billing, at the time of service, the research study, subject, services and/or professional fees provided are identified on the research charge document and entered into the research account. UT Health Clinical Trials Services Form

Applicable Regulations and Guidelines

• USC Title 31 (False Claims Act),
• Social Security Act -Section1862 (a)(1)(E), Section1852 (a)(1)(A)
• Medicare Coverage Issues Manual, Sections 30-1
• Medicare Carriers Manual, Part III, sections 910-4912
• Medicare NCD 30-1
• 45 CFR 46 (http://www.access.gpo.gov/nara/cfr/waisidx_04/45cfr46_04.html )
• 42 CFR 405.203
• OIG