University of Alabama at Birmingham/UAB Health System
INTEGRATED POLICY FOR CLINICAL RESEARCH BILLING COMPLIANCE
December 10, 2007
This policy establishes uniform requirements for billing clinical services for subjects who participate in research studies that may potentially generate claims to participants or third party payers for any items or services designated as part of a research protocol. It seeks to ensure that UAB and UABHS adhere to laws, regulations, and requirements governing research billing practice.
This policy applies to all operating units of UAB, including those units that furnish clinical services, such as University Hospital; to UAB Highlands; and to the Kirklin Clinic and other clinical facilities owned by the University of Alabama Health Services Foundation that are managed by UAB Health System.
It is the policy of UAB and UABHS that faculty investigators, academic departments, administrative units, healthcare entities and associated staff members coordinate their activities to ensure that clinical services associated with research studies are billed appropriately and in compliance with relevant laws, regulations, and contractual obligations. UAB and UABHS have developed comprehensive processes to communicate information and train the relevant workforce on proper clinical research billing activities and to monitor and reconcile financial information. Individuals involved in the conduct of clinical research, registration of participants, ordering of research items and services, coding research services, and billing for research items and services will comply with this policy and the roles, responsibilities and procedures described herein. Corrective and disciplinary action may be taken for violations of this policy including, but not limited to, suspension of study activities, suspension of billing to participants and third parties and reassignment of claims from billing entities to research accounts, and/or employment action.
Since many departments and units of UAB and UABHS-managed entities provide services which create billing obligations to research participants, it is important to establish the roles and responsibilities of stakeholders in the clinical trials billing process in order to make the process transparent and efficient.
Principal Investigator (PI) and Research StaffThe PI (including research staff designated by the PI) is responsible for project budget development for each study and assuring that steps for accurate billing are taken in the manner described by this policy. The PI is responsible for the following specific steps: 1) providing to the Office of Human Research (OHR) the study protocol (including amendments for addition or deletion of clinical items/services), proposed clinical trial agreement (CTA) (if any), proposed informed consent document (IC) (including amendments related to adding or deleting clinical items/services), schedule of events (i.e. clinical interventions/interactions and research activities designated by the protocol) with each event assigned to a standard treatment or research category to obtain a prospective coverage analysis of billable clinical services, and a copy of the budget request page included in the GCRC application, if applicable; 2) reviewing and accepting the billing matrix generated by OHR for the project; 3) communicating study and participant visit information to the UAB Healthcare entities; and 4) verifying claims from healthcare entities for accuracy and processing payments.
Departments The Department Chair, in collaboration with the Center Director where applicable, and the School Dean, are responsible for establishing and maintaining an environment for clinical research that requires all members of the research team to be both knowledgeable of and compliant with all policies and regulations governing the conduct of research. The approval of a protocol by the Chair acknowledges that the Principal Investigator and research team are both knowledgeable and in compliance. Departments may implement additional procedures to assist the investigator and department in both fiscal and operational management of clinical research projects. A departmental Chair may delegate responsibilities under this policy but the Chair remains ultimately responsible for compliance with this policy.
Office of Human Research (OHR) The Office of Human Research is responsible for performing a prospective coverage analysis for each clinical study, developing a specific billing matrix which utilizes UAB designated research rates, finalizing and approving a billing plan delineating those services which should be billed to the study versus the participant or third party payer as standard care, and communicating the results of the prospective coverage analysis and approved billing plan to the PI, UABHS healthcare entities, OCGA, and IRB as appropriate. In addition the OHR is responsible for the overall operation (coordination, education, and oversight) of the University wide electronic clinical trials management system.
UABHS Healthcare Entities Healthcare entities are responsible for receiving and processing participant visit information and coding and generating claims in accordance with applicable billing regulations and contractual obligations.
Office of Grants and Contracts Administration (OGCA) OGCA is responsible for ensuring no contract is executed without notice of the existence of an approved billing plan and making the executed contract available to the OHR.
Institutional Review Board (IRB) The OIRB is responsible for ensuring that the results of OHR preliminary review of the informed consent documents are incorporated in the IRB review process.
General Clinical Research Center (GCRC) GCRC is responsible for providing the OHR with award information pertaining to payment of items and services for research studies.
Office of Research Compliance (ORC) The ORC advises all stakeholders under this policy (investigators, OHR, healthcare entities, etc.) regarding billing for proposed research studies, assists with establishing procedures for all phases of clinical trial billing, performs monitoring and auditing of the clinical trial billing process to ensure compliance with billing regulations and this policy, and provides research billing compliance training.
UAB is implementing an electronic software product for clinical trials management and currently transitioning from a manual to an electronic process for clinical trials billing. These procedures represent key operational steps in the clinical trials billing process and cover both manual and electronic methods currently in use. All responsible parties are expected to incorporate these operational steps into their current processes and modify processes as necessary to achieve the goals of this policy. Procedural steps for responsible parties may be delegated to other parties by written agreement between the parties and approval by the director of the OHR.
Principal Investigator and Research StaffThe Principal Investigator (or designee:)
Office of Human ResearchThe Office of Human Research:
Healthcare EntitiesHealthcare Entities:
UAB Administrative UnitsUAB Administrative Units:
Forwards contract amendments or otherwise notifies and makes available contract modifications related to provisions of clinical procedures or ancillary services (e.g. radiology, lab, cardiographics, etc.) to OHR.
Expected Time Frames for Completion of Key Procedural StepsIn order to establish consistent performance measures for accomplishing the key procedural steps identified in this policy, the responsible parties will adhere to the expected time frames listed in Table 1 attached to this policy.
The Senior Vice President/Dean of the School of Medicine is responsible for implementation of this policy as it pertains to the OHR and investigators. The Vice President for Research and Economic Development is responsible for implementation of this policy as it pertains to UAB central administration units. The CEO of UABHS is responsible for implementation of this policy as it pertains to UABHS entities. This policy may be modified by concurrence of all individuals responsible for implementation. The Office of Research Compliance and UABHS legal counsel are responsible for ongoing review to ensure that this policy is consistent with current legal and compliance requirements.
Table 1 - Expected Time Frames for Completion of Key Procedural Steps
Expected Time Frame (Working Days)
Prospective Coverage Analysis (FAP)
Confirmation of Billing Plan by Investigator
Study Entry into SiteMinder
Review of Final Budget in SiteMinder
Create Patient Record in SiteMinder
Immediately after consent
Schedule Research Appointment in SiteMinder
At least 1 day before visit or on date of service if enrolled that day.
Transmit manual CTBN
On or before date of service
Create Electronic CTBN (Update Research Appointment in SiteMinder)
1-2 days post visit
Delivery of Claims for Study Services
Payment of Study Claims to Billing Entities