Clinical Research Billing
In order to comply with federal, state, and institutional regulations and standards for clinical research billing, the University is responsible for establishing effective processes to ensure that all services for a study are billed properly. These processes can be complex because clinical research often involves multiple entities that are responsible for costs incurred during the course of a trial. During a single visit a research participant may receive routine medical care in addition to services or procedures conducted for research purposes.
UNC adheres to the Centers for Medicare and Medicaid (CMS) regulations for billing to the patient (or a third party on the patient’s behalf) in the context of a research protocol. These regulations require that a study be qualifying and that the costs billed to the patient meet specific criteria. You can NEVER bill for items or services that are paid for by the sponsor, promised free in the informed consent, or are part of a non-qualifying protocol.
The OCT has a team dedicated to preparing and conducting a billing coverage analysis (BCA) on all clinical trials conducted at UNC-Chapel Hill and UNC Medical Center. UNC Medical Center includes all UNC Hospitals’ Chapel Hill facilities and, the clinical patient care programs of the School of Medicine of UNC-Chapel Hill (including, UNC Faculty Physicians and the UNC Hillsborough Campus). Concurrently, UNC Health will ensure alignment of billing review processes for the UNC Health Network Entities.
The OCT team will complete a Billing Coverage Analysis (BCA) for all studies with charges processed through Epic, including the following services:
- Conduct Medicare coverage analysis to determine billing status for any studies with study-related billing to patients
- Create billing grid of services related to the study with research costs and codes
- Reconcile final BCA with consent form and any clinical trial agreements
- Build Epic calendar (for non-Oncology protocols)
- Set the Billing Status to active in Epic
All studies MUST be submitted through CRMS or through an OnCore ServiceNow request as soon as the decision has been made to move forward with the clinical trial.
- The OCT Team will review the study to determine the need for a BCA. If it is determined that a BCA is required, the OCT will create the BCA then schedule a time to review with the study team before finalizing.
- CRMS – Create a CRMS record and include the protocol, draft informed consent, investigational brochure and any other relevant study documents. We recommend creating the CRMS record sooner rather than later. Once finalized the study team can use the BCA to complete budget negotiations.
Note: CRMS will still be used for contracting and IDS requests
Note: The BCA and research billing review process differs for the UNC Health entities. For questions and guidance regarding processes within the UNC Health network entities please email ORSC@unchealth.unc.edu
Note: Submitting a CDA to the Industry Contracting Office will not trigger a BCA to be completed since there is no protocol.
To obtain costs in preparation for a proposal the OCT will make the UNC Research Fee schedule available in an ONYEN protected environment. Please email email@example.com for access.
CMS Clinical Trial Policy Overview of Policy Requirements
- The Clinical Trial Policy – The Clinical Trial Policy is a Centers for Medicaid and Medicare Services (CMS) national coverage decision allowing CMS reimbursement of certain costs in clinical trials. These covered costs include:
- “routine costs” in clinical trials that qualify by CMS criteria as a clinical trial
- “reasonable and necessary” items and services used to diagnose and treat complications from participating in CMS-qualified clinical drug trials
- the investigational drug if it is normally covered by CMS outside of a trial
- trial items and services for FDA-required post-approval studies & studies conducted to support CMS “Evidence Development” decisions
- All other Medicare rules apply – Items in a clinical trial that fall under a CMS ‘non-coverage decision’ or that do not fall into a Medicare benefit category are not billable to CMS.
- Determining if the study qualifies for CMS reimbursement – To qualify for CMS-reimbursement of routine care costs, the study must meet ALL 4 criteria:
- The trial must have CMS-required characteristics of a clinical trial (as noted below in item 4))
- Research item/service must fit a Medicare benefit category
- Therapeutic intent must be included in some aspect of the research (does not need to be the primary objective)
- The trial must enroll patients with a diagnosed disease (healthy volunteers may be included as a control group for studies of diagnostic interventions)
- Determining whether a study meets the CMS qualifications – To meet CMS requirements to qualify as a clinical trial, the study should have the following “desirable” characteristics
- A principle purpose of the trial is to test whether the intervention potentially improves the participants’ health outcomes
- The trial is well-supported by available scientific and medical information or it is intended to clarify or establish the health outcomes of interventions already in common clinical use
- The trial does not unjustifiably duplicate existing studies
- The trial design is appropriate to answer the research question being asked in the trial
- The trial is sponsored by a credible organization or individual capable of executing the proposed trial successfully
- The trial is in compliance with Federal regulations relating to the protection of human subject
- All aspects of the trial are conducted according to the appropriate standards of scientific integrity
- Clinical trials that automatically qualify for CMS coverage – Clinical trials with any one of following attributes automatically qualify for consideration of CMS coverage of routine costs:
- Funded by NIH, CDC, AHRQ, CMS, DOD, or the VA
- Supported by centers and/or cooperative groups which are funded by one of the above listed agencies
- Conducted under an IND reviewed by the FDA
- Meet the criteria for exemption from IND regulations
- CMS-covered costs in clinical drug trials – Clinical care costs in a drug trial covered by CMS include items and services that are:
- Typically provided absent a clinical trial (i.e., routine clinical services that are reasonable & necessary)
- Required solely for the provision of the investigational agent, for example:
- administration costs of a non-covered chemotherapeutic agent
- clinically appropriate monitoring of the effects of the investigational agent, or the prevention of complications
- Reasonable and necessary for the diagnosis or treatment of complications from the investigational agent
- Costs not billable to CMS – CMS will not reimburse the following costs:
- The investigational item or service itself unless otherwise covered outside of the clinical trial
- Items and services provided solely to satisfy trial objectives and that are not used in the direct clinical management of the patient
- Items and services customarily provided by the research sponsors free of charge for any trial
ALL protocols require a coverage analysis review by the OCT BCA Team before they can be implemented at UNC. Select “How Do I Request a Coverage Analysis” below for details.