Clinical Research Studies, Including Clinical Trials
Clinical Research is research that either directly involves a particular person or group of people or uses materials from humans, such as their behavior or samples of their tissue and that can be linked to a particular living person.
A clinical trial is a type of clinical research. It is a research study to answer specific questions about vaccines or new therapies or new ways of using known treatments to determine their safety and effectiveness.
Clinical studies can be funded (sponsored) by a variety of organizations—federal agencies, foundations, voluntary health groups, and pharmaceutical companies. Some clinical studies are self-funded (i.e. by the University).
The UR has a “Clinical Research Billing Policy” and “Clinical Research Standard Operating Procedures”. These are accessible in the Clinical Trial Share Point site.
Clinical research and clinical trials, by definition, involve human subjects. The Food and Drug Administration (FDA) and the Department of Health and Human Services (HHS) have regulations that protect human subjects. While there are some differences between the HHS and FDA regulations, the basic regulatory requirements of an institutional assurance approved by HHS, review of research by an institutional review board, the informed consent of subjects and education and training of clinical trial team members are similar.
Federally funded clinical trials must be entered into ClinicalTrials.gov, which provides study participants, family members, health care professionals, and members of the public easy access to information on clinical trials for a wide range of diseases and conditions.
Regulations also exist that govern when the federal government, via Medicare, will pay for costs associated with clinical trials.
There are many other applicable regulations that can be reviewed on the Clinical and Translational Science Institute and Research Subjects Review Board web sites.
General Financial Considerations
To ensure financial sustainability of a clinical trial, a budget should always be prepared independently of the sponsor. Once the budget is complete, the sponsor’s proposed financial terms can be compared against the UR-prepared budget and then the negotiation process begins.
After the negotiations are finalized, there needs to be agreement between the sponsor and the UR regarding which procedures, items and tests are payable by the sponsor and which are payable by insurance or the patient.
The goal of budgeting is to estimate what “per patient” reimbursement is needed from the sponsor to make your study whole financially.
The UR has a Budgeting Workbook and accompanying User’s Manual to assist with budget preparation. The workbook contains worksheets to document the PRA, participant-related costs, non-participant related costs and to compare the UR-prepared budget to the sponsor’s financial offer. The Budgeting Workbook and User’s Manual are accessible in the Clinical Trial Share Point site.
Steps in Budget Preparation
Payment Term Considerations
The ideal situation is where the sponsor’s financial terms include (a) a per patient reimbursement reflective of only the variable costs to be incurred for each individual participant and (b) separately invoice-able amounts for fixed costs and non-participant specific variable costs.
The ideal situation rarely occurs; rather, non-participant-specific costs are often combined in the per participant reimbursement amount. Through the negotiation process, it is best to attempt to have these costs removed from the per participant amount and to include them as separately invoice-able items.
Timing of Reimbursement
Even if care is applied to ensure a clinical trial will be financially self-sustaining, the study could experience a deficit unless disciplined oversight is provided during the life of the study.
Billing errors could also occur without proper oversight. Clinical trial billing errors can have negative consequences for both the UR (which can have fines and penalties and suffer harm to reputation) and to the physician (who can be vulnerable to civil and criminal penalties, including jail sentences).
Examples of billing errors are: (1) services that are not standard of care being billed to insurance and (2) services whose cost are a component of the per patient reimbursement amount yet are also billed to insurance.
There are controls that can help achieve improved financial oversight and mitigate the risk of billing errors. These controls are as follows:
- maintaining participant-level cost information to ensure the respective costs are reflected in the general ledger (as opposed to being billed to insurance);
- monitoring how time of clinical trial team members is spent and ensuring a reasonable approximation of effort is then reflected in the associated general ledger accounts; and
- performing a timely reconciliation of costs anticipated to be reflected in the clinical trial’s general ledger account and transactions that are actually recorded to the general ledger account.
Benefits of these controls for participant specific costs include (1) assurance that bills are charged to the sponsor as expected based upon determination of the proper payer and (2) procedures are valued in accordance with both external regulations and/or internal policies. Sound financial controls will support sound billing controls.
Maintaining a detail of protocol costs incurred is a control to ensure awareness of when a billing milestone is achieved and a bill is to be sent to the sponsor (as per the financial terms of the trial agreement). Such a detail also serves as a control when payments originate with the sponsor (such as when reimbursement is based upon submission of case report forms). Effective oversight of timely receipt of amounts owed requires maintenance of a list of invoices sent and payments received.
When payment is initiated by the sponsor based on completion of visits and submission of case report forms, ensure sponsor remittances provide detail of which participants and specific visits and procedures are being paid.
The UR has a Post-Award Workbook and User’s Manual to assist with monitoring participant-related and non-participant related costs incurred during the life of a trial that are to be paid by the sponsor. The Post-Award Workbook and User’s Manual are accessible in the Clinical Trial Share Point site.
The close out process includes a requirement for a thorough review and explanation of final clinical trial account balances. This requirement serves as a control to ensure an apparent deficit or surplus is not due to billing errors, miscoding of transactions, or lack of payment from sponsor.
The identification of the reasons for the deficit or surplus is achieved with a large degree of accuracy by using the worksheet templates in the Clinical Trial Share Point site.