Clinical Research Budgeting & Billing Compliance Program
BUSINESS DEVELOPMENT PROCESS
The objectives of the Clinical Research Budgeting and Billing Compliance Program of the University of Texas Health Science Center-Houston (UTHSC-H) 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 UTHSC-H budget template. UTHSC-H Clinical Trial Budget Template.
In studies where services or professional fees are provided in UTHSC-H facilities and/or by UTHSC-H 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. UTHSC-H 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
