Body
Title
University of North Carolina at Chapel Hill Policy on Clinical Research Billing
Introduction
Purpose
This policy establishes the framework for billing procedures, items, and tests administered to participants in clinical research studies at the University of North Carolina at Chapel Hill (“UNC-Chapel Hill” or “University”). The policy ensures the University complies with federal, state, and institutional guidelines and supplements existing policies governing how the University conducts clinical research.
Scope
This policy applies to all clinical research projects conducted at the University of North Carolina at Chapel Hill ("UNC-Chapel Hill") where:
- Charges for items, services, and procedures flow through UNC Health hospital or professional (physician) billing systems; and/or
- UNC-Chapel Hill is a party to the research contract or award agreement.
This policy is specifically applicable to:
- Medical items or services provided as part of a clinical research study.
- All clinical research studies conducted at UNC-Chapel Hill, regardless of the funding source, including those funded by external sponsors, internal funds, or other sources.
- Research participants, regardless of whether they have federal, state, or commercial health insurance.
- Covered individuals engaged in clinical research at UNC-Chapel Hill.
However, this policy does not apply to:
- Studies that do not involve human subjects, as defined by University policies and/or federal regulations.
- Studies that do not involve a test article or clinical procedure (e.g., studies limited to surveys or chart reviews).
Policy
Policy Statement
Complex federal, state, and private payer rules govern the conditions under which services, items, and tests associated with a clinical research study can be billed to study sponsors, study participants, and/or their insurers. Accurate clinical research billing depends on planning and collaboration between the study team and a wide variety of individuals and offices before, during, and after the clinical research study is initiated.
Billing Coverage Analysis (BCA) Requirements
Each clinical research study must be:
- Submitted to the Billing Coverage Analysis (BCA) Team: The study must be submitted for review and completion of BCA if deemed necessary.
- Conducted in accordance with the Approved BCA: Ensure that charges are appropriately allocated to the study account, the study participant, or the participant’s third-party payer according to the approved BCA
- Reviewed Before Participant Accrual: The BCA Team must review the study before it is opened to participant accrual to ensure the congruency of the study funding documents, contractual agreements, and informed consent language with the BCA.
Documentation and Compliance
Clinical services, items, or tests billed to study sponsors, study participants, or third-party payers must be fully documented in the medical record. These services must comply with:
- Applicable Billing Rules: Follow the billing rules of the third-party payer being billed.
- UNC Health Safeguards: Follow UNC Health procedures that establish safeguards to prevent billing errors.
- Grant and Contractual Obligations: Follow any grant provisions or contractual obligations entered by UNC-Chapel Hill.
Disclosure of Costs to Study Participants
Potential costs to the study participant or participant’s third-party payer associated with participating in the clinical research study must be:
- Clearly Disclosed and Agreed Upon: Ensure that costs are clearly disclosed and agreed to by the study participant.
- Consistently Represented Across Study Documents: Ensure consistency across all study-related documents, including the protocol, grant, contract, budget, BCA, and Informed Consent Form. The study-related documents must not contain any language that indicates scenarios (including subject injury) in which Medicare, Tricare, or other federally funded health insurance programs will be billed first, and the sponsor will pay any remaining balance that the insurance does not cover. Such language is inconsistent with UNC-Chapel Hill’s position statements on subject injury in clinical trial federal law.
Participant Documentation and Reporting
Study teams must ensure that all study participants:
- Are Recorded in the Clinical Trial Management System: Ensure that all participants are accurately recorded.
- Have Documentation in Their Medical Record: Record appropriate information about research participation in the participant’s medical record according to the study site’s policies.
- Enrollment and Status Reporting: Report initial study enrollment and subsequent enrollment status changes according to procedures established by the Office of the Vice Chancellor for Research (OVCR). The clinical sites of practice where the study is conducted may establish additional specific reporting methods and/or requirements.
Special Considerations for Investigational Device Exemption (IDE) Studies
Clinical research studies involving the use of an Investigational Device Exemption (IDE) device in which any study-related services, items, or tests are billed to study participants and/or study participant’s third-party payers (i.e., the study sponsor is not covering 100% of these costs) must undergo additional review:
- CMS and MAC Approval: the Centers for Medicare and Medicaid Services (CMS) and/or its designated Medicare Administrative Contractor (MAC) must review and approve the study. The MAC must provide written confirmation that the study has been entered into its Medicare claims processing system.
- Pre-Activation Requirements: This review and approval process must be completed before activating the study’s Electronic Health Record System’s Research Account.
Definitions
Billing Coverage Analysis (BCA): detailed review of clinical research items, services, procedures and Medicare billing rules to determine the appropriate payer/funding source for each. It is a systematic review of the research related documents, published practice guidelines and applicable National Coverage Determinations (NCDs) and Local Coverage Determinations (LCDs) to determine the Medicare billing status of the items and services provided to the study participants that are required by the study. A BCA is also a strategy for managing compliance risks associated with clinical research billing.
Clinical Research: For the purpose this policy, the National Institutes of Health (NIH) definition of Clinical Research applies: “Research with human subjects that is:
- Patient-oriented research. Research conducted with human subjects (or on material of human origin such as tissues, specimens, and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects. Excluded from this definition are in vitro studies that utilize human tissues that cannot be linked to a living individual. It includes:
- mechanisms of human disease,
- therapeutic interventions,
- clinical trials, or
- development of new technologies.
- Epidemiological and behavioral studies.
- Outcomes research and health services research"
Clinical Trial Management System (CTMS): comprehensive software platform designed to streamline and centralize the management of clinical trials.
Centers for Medicare and Medicaid Services (CMS): a federal agency within the United States Department of Health and Human Services. It administers the nation’s major healthcare programs including Medicare, Medicaid and CHIP.
Covered Individuals: Individuals engaged in clinical research. This includes faculty, staff (SHRA and EHRA non-faculty), students, guest researchers (e.g., unpaid volunteers, interns, and visiting scholars), collaborators, and consultants.
Medicare Administrative Contractor (MAC): a private health care insurer that has been awarded a geographic jurisdiction to process Medicare Part A and Part B (A/B) medical claims or Durable Medical Equipment (DME) claims for Medicare Fee-For-Service (FFS) beneficiaries.
Investigational Device Exemption (IDE): allows a medical device that has not received marketing clearance or approval to be shipped for use in a clinical study without complying with other regulations of the Federal Food, Drug and Cosmetic Act.
Local Coverage Determination (LCD): a determination by a MAC regarding the coverage of a specific service or item within their jurisdiction.
National Coverage Determination (NCD): a nationwide policy that determines whether Medicare will cover a particular medical service, procedure or device. Medicare coverage is limited to items and services that are reasonable and necessary for the diagnosis or treatment of an illness or injury (and within the scope of a Medicare benefit category). NCDs are made through an evidence-based process, with opportunities for public participation. In the absence of a national coverage policy, an item or service may be covered at the discretion of the Medicare contractors based on an LCD.
Related Requirements
External Regulations and Consequences
University Policies, Standards, and Procedures
Contact Information
Policy Contact
Name: Tara Krieg
Title: Associate Director, Clinical Research Compliance
Unit: Office of Vice Chancellor for Research
Email: tkrieg@unc.edu
Phone: 919-445-9355