Handbook of Operating Procedures

I. POLICY AND GENERAL STATEMENT

Principal Investigators (“PIs”) at The University of Texas Health Science Center at Houston (“University”) conduct clinical research to fulfill the University’s missions to discover and translate advances in the biomedical and social sciences and to model best practices in clinical care and public health. Clinical research at the University often takes place in conjunction with routine clinical care of patients, and thus, it is necessary to ensure that billing for both routine and research services/items is handled appropriately. This policy explains the need to identify clinical research patients, delineate the routine costs versus research charges, and ensure that appropriate billing occurs.

The process of ensuring clinical research costs are applied appropriately involves a coordinated effort between the PI, research study staff, department administrators, and the Office of Sponsored Projects Administration's Clinical Research Finance (CRF) team. All clinical services or items must be: 1) billed in accordance with all applicable federal, state, and third-party payer regulations (see list); 2) billed in accordance with the grant or contract funding guidelines; 3) consistent with all study related material including informed consent; and 4) in compliance with all applicable University policies and procedures. 

II. DEFINITIONS

ClinicalTrials.gov: a registry and results database of publicly and privately supported clinical research studies conducted around the world.

Coverage analysis: a systematic review of a study to determine whether the “patient billable” services are eligible and/or approved to be billed out to third party payers. A coverage analysis also delineates all procedures listed in the study protocol’s schedule.

CPHS: Committee for the Protection of Human Subjects. Can also be referred to as “IRB” (Institutional Review Board). All human subjects research, funded and unfunded, must be reviewed and approved by the University’s CPHS before it is initiated if it falls in one of the following categories:

• Human subjects research conducted by any University employee, student, or other trainee in any facility/location (e.g. MHHS, HCPC, or Harris Health System); or
• Human subjects’ research conducted by non-University investigators that involves subjects/patients from any University facility.

CRF team: The Clinical Research Finance and Administration team is a division of the Office of Sponsored Projects Administration (SPA).

EHR/EMR:  electronic health/medical record system.

National Clinical Trial Number (NCT#): a unique identification code given to each clinical study registered on ClinicalTrials.gov. The format is the letters "NCT" followed by an 8-digit number (for example, NCT00000999).

National coverage determination (NCD):  a nationwide determination by the Centers for Medicare and Medicaid Services (CMS) of whether Medicare will pay for an item or service. Medicare coverage is limited to items and services that are considered "reasonable and necessary" for the diagnosis or treatment of an illness or injury and are within the scope of a Medicare benefit category.

NCD 310.1: an NCD that outlines the Medicare policy for coverage of routine costs of qualifying clinical trials as well as reasonable and necessary items and services used to diagnose and treat complications arising from participation in all clinical trials.  A copy of this document can be accessed at CMS.gov.

Qualifying clinical trial (QCT): a clinical trial that meets mandatory requirements set forth by Medicare to be eligible for reimbursement.

Research services: services provided to a participant in a clinical trial that are performed for research purposes and are billed to and paid for by the study sponsor.

Routine cost services (also called standard of care or conventional care): services that are provided to an individual for a diagnosed disease regardless of whether he or she is participating in a clinical trial.

START system:   the University’s institutional Research Project Management System. START is the central repository for coverage analyses. All coverage analysis records must be recorded and uploaded into this system. The agreement module is utilized for coverage analysis records.

III. PROCEDURE

The CRF team will document clinical research billing policies/procedures, provide education for clinical research staff, oversee the coverage analyses process, and monitor clinical research billing and research study expenses.

A.        Operational Responsibilities

It is the responsibility of the PI to ensure that the clinical research billing of his or her studies is in compliance with all laws and regulations and adheres to University policy. The PI, his or her research staff, department administrators, and the CRF Team must work together to ensure the components of accurate billing are in place. Specifically, refer to the Coverage Analysis Procedure and the Clinical Research Billing Procedure.  

• The CRF team must review all studies submitted to CPHS to identify studies that include clinical patient care to evaluate for possible billing risk.­­­­­­­­­­­
• The CRF team must ensure a coverage analysis is created for all clinical studies that pose a potential billing risk.

• The coverage analysis should be consistent with the study protocol and informed consent and should accurately and appropriately allocate the costs associated with the performance of the clinical study to the responsible payer.
• The CRF team must ensure all coverage analyses are recorded and uploaded within START system. (This will ensure the PI and applicable study team members have access.)
• The CRF team must ensure all applicable clinical studies are entered into the appropriate EHR/EMR.
• The PI and study staff must ensure that there is an outlined plan to identify research patients prior to providing services.
• The PI and study staff must ensure that the services for study subjects enrolled in the clinical research project are billed in accordance with the coverage analysis and that the bills are based on actual services rendered and consistent with the informed consent.
• The PI and study staff must ensure that study subjects are linked/associated to the clinical study within the appropriate EHR/EMR.
• The PI and study staff must ensure that research visits are linked/associated to the clinical study within the appropriate EHR/EMR.
• After services are provided, study staff must coordinate with the appropriate billing personnel to ensure that proper billing information is provided.
• When research visit charges are entered into the appropriate EHR/EMR, the study staff must review appropriate reports in the system to ensure proper billing information is entered.  In Epic, this is the Research Billing Queue Report.  Each department and clinic must follow clinical research billing procedures specific to its unit or practice in order to ensure that clinical research billing is conducted appropriately and accurately.
• Study staff must conduct periodic reconciliation of clinical research billing charges.

Additional information may be found on the Clinical Research Finance website.  

IV. CONTACTS

• • Sponsored Projects Administration, Clinical Research Finance
  • 713-500-3999
  • CRF@uth.tmc.edu

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