Overview
Requirements to track research study participants and events in OnCore and APeX; expectations for compliance with internal control standards to ensure integrity of billing procedures for clinical trials.
Purpose
As of May 7, 2018, UCSF’s single clinical trials management system, OnCore, has been used by research staff to manage study participant enrollment and visit activities for all clinical trials that bill through APeX. OnCore and APeX were integrated to enable research staff to link and track information about studies, participants, and their activities to:
- Provide a centralized system of record for participants who are enrolled in clinical trials
- Support accurate and compliant billing practices for those individuals
- Enable UCSF to be audit ready with OnCore generating reports across all clinical trials
To ensure standardization of accurate, timely, and complete data for all UCSF clinical trials that bill through APeX, this policy defines the requirements to enter and track research study participants and events within OnCore and APeX. Additionally, this policy outlines expectations for compliance with internal control standards to assure the integrity of billing procedures for clinical trials.
Definitions
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A clinical trial management system (CTMS) that supports the management of study activities and participants, research event and visit tracking, Medicare coverage analysis, comprehensive reporting, and electronic data capture.
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(Advanced Patient-Centered Excellence), UCSF’s electronic Epic-based, Medical Record System (EMR) and electronic health record (EHR) system data dating back to 2012.
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The National Institutes of Health defines a clinical trial as "a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes."
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Occurs after a study participant is enrolled in OnCore (and has an active enrollment status in OnCore), an encounter is linked in APeX, and a study participant completes a research event. Once all corresponding Hospital Billing (HB) and/or Professional Billing (PB) charges populate, the charges go to a work queue and are reviewed by the Research Revenue Cycle staff before billing can take place. The charges are validated, routed according to the study’s MCA, and billed accordingly, to either the study account, the study participant, or the appropriate insurer/third-party payor.
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An independent review of a research study to determine which clinical procedures and services are billable to the research participant, the appropriate insurer/third-party payor, or the study account. The MCA includes a review of the clinical trial documents, published practice guidelines, and Local Coverage Determinations (LCD) and National Coverage Determinations (NCD) to determine the billing status of items and services that are documented in the research protocol and/or research plan.
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Effective for items and services furnished on or after July 9, 2007, Medicare covers the 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. Medicare will not cover:
The investigational item or service (unless covered outside of a research study)
Items and services provided solely to satisfy data collection and analysis needs and that are not used in the direct clinical management of the patient (e.g., monthly CT scans for a condition usually requiring only a single scan)
Items and services customarily provided by the research sponsors free of charge for any enrollee in the research study
CMS.gov National Coverage Determination (NCD) Routine Costs in Clinical Trials
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An encounter in APeX is a clinical contact with a study participant. For example, office visits, admissions, and triage calls are encounters or events. If more than one evaluation or procedure takes place at that event, it is still usually considered one encounter. However, study participants can have multiple encounters in a single day if they visit multiple departments, such as an office visit and subsequent visit to the Infusion Center. In billing applications, charges or other transactions can be associated with encounters.
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Associating a study participant encounter with the applicable research study and timeline point in APeX. Linking an encounter indicates that some or all of the billable services in that encounter are related to the study protocol (even if they will be paid for by the study participant or the appropriate insurer/third-party payor). A research timeline must also be generated within APeX for each participant, which will create date ranges for expected encounters based on the study protocol. An encounter can be linked to a research study from the participant’s appointment desk, at registration during scheduling or check-in, during admission, or after events are scheduled (by utilizing research reports in APeX).
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A monthly summary of all study participant charges that were posted to a research study account in the previous month. The Research Statement is sent via email to the Primary Billing Contact for the study. These statements are referred to as “ZZ Statements” (for the West Bay) and “XX Statements” (for the East Bay). The hospital charges (HB) and professional fees (PB) are discounted for research in the statement. The total amount posted to the study account is shown on the top of the document (box titled “Hospital and Professional Research Charge”), along with subtotals for each Account Number (as Acct# in Blue).
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A staff member designated by the Principal Investigator to receive monthly Research Statements for a study. The Primary Billing Contact is identified during the study activation process and is listed as such in the APeX study record.
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A limited period contractually defined by an insurance carrier for receiving and processing an insurance claim.
Policy
The following requirements apply to all UCSF clinical trials that bill through APeX:
- Participant Registration and Enrollment in OnCore
- All study participants must be registered and enrolled on a research study in OnCore within one business day of a scheduled research event.
- All participants in OnCore must have their enrollment status, date of informed consent, and date on the study recorded within one business day of initial study entry. Any future status changes and the date effective must be entered in OnCore within one day of the status change.
- Research Encounter and Order Linking in APeX and Charge Review
- Study participants must be enrolled on a research study in OnCore before any linking in APeX can occur.
- An encounter must be linked to the research study and corresponding timeline point as soon as a research event is scheduled or within one business day of the research event. Once the research event is appropriately linked to a study, a charge review can occur.
- Participant Visit Tracking in OnCore
- All study participants enrolled on a study in OnCore must have their study visits tracked with a corresponding date of occurrence using the OnCore calendar functionality within one business day of a scheduled research event. This tracking must occur for all visits for the duration of the study.
- Visit Tracking in OnCore is a critical area for documentation compliance and must be maintained to ensure compliant billing & invoicing for study participants.
- Research Statement Billing Review
- Once the Research Statement is sent via email from the Research Revenue Cycle unit, the research staff has 30 calendar days to review and reconcile if needed. The research staff’s Primary Billing Contact should review each of the charges detailed for each Account Number to ensure accuracy.
- Upon review, if any charges are in question by the research staff or contain identified errors, a Service Now ticket must be submitted to the Research Revenue Cycle unit to request review and/or charge correction. This ticket must be submitted within those 30 days to ensure prompt review and anticipated compliance with timely filing for any charges billed to an insurer/third-party payor.
- If a charge correction is being requested, the Research Statement and a description of the dispute should be attached to the Service Now ticket. The Research Revenue Cycle unit will re-review the account, make any necessary corrections, notify the Primary Billing Contact of the outcome via Service Now, and close the ticket within 30 days.
- Any potential charge corrections need to be made and reflected correctly in APeX within 30 days from the date of the Research Statement.
- Requests for charge review and/or corrections that are submitted after 30 calendar days will not be reviewed.
Responsibilities
- Office of Clinical Trial Activation (OCTA)
- Build protocol-specific calendars (and updates through subsequent amendments) in OnCore
- Provide and manage role-based access to OnCore to ensure that research staff have appropriate access
- Provide appropriate research staff training (in person and/or through web-based resources) on the OnCore system
- Provide OnCore help desk support
- General oversight of OnCore usage and data
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Principal Investigator (PI)
While responsibility for certain day-to-day management of OnCore utilization may be delegated to administrative or other staff, the PI is responsible for compliance with this policy. For all clinical trials that bill through APeX, it is the responsibility of the PI to:
- Submit all applicable new studies and/or amendments for OnCore activation and modification in accordance with the guidance posted on the UCSF website
- Complete all required APeX and OnCore training prior to scheduling research events
- Enroll study participants in a research study in OnCore
- Record study participant enrollment statuses with corresponding dates during the study
- Ensure that study participant statuses are accurate and up to date during the study
- Record and link all research-related encounters to the timeline in APeX for study participants
- Review applicable APeX reports and research-related encounters (upcoming and past) to ensure that all linking and timeline dates are complete and accurate, including edits if needed.
- Review and verify the billing-related information recorded in the study participant’s electronic health record.
- Track study participants on the OnCore calendar throughout the study
- Review OnCore data and reports to ensure that all mandatory fields are complete and accurate
- Ensure review of Research Statements (by/with the Primary Billing Contact) for billing accuracy and submission of any charge correction requests in a timely and consistent manner.
- Research Revenue Cycle
- Activate study billing accounts (study builds) in APeX.
- Ensure study participant charges are reviewed and routed for billing accurately, according to the MCA.
- Produce and disseminate via email, monthly Research Statements indicating which charges were billed to the study account.
- Provide charge review and correction support
- Office of the Executive Vice Chancellor and Provost, Office of Healthcare Compliance and Privacy, Office of Medical Affairs & Governance, and Audit and Advisory Services are responsible for the enforcement of this policy.
Procedures
The following are detailed procedures for PI and research teams to ensure compliance with this policy:
References
- University of California Policy on Faculty Conduct and the Administration of Discipline (Academic Personnel Manual 016), Office of the President, Rev. 2022.
- University of California Policy on Special Services to Individuals and Organizations (Academic Personnel Manual 020), Office of the President, Rev. 2020.
- University of California Personnel Policies for Staff Members (UC-PPSM) and Personnel Policies for Staff Members 62, 63, and 64