Request a Prospective Reimbursement Analysis
Prospective Reimbursement Analysis (PRA) is the process of systematically reviewing all study-related documentation including, but not limited to: the study protocol; investigator’s drug brochure; informed consent form; and contract or grant to determine whether items and services provided during the performance of the study should be covered by study account or billed as routine care costs. This analysis is performed using Medicare regulations as a guideline.
Every protocol performed under the authority of the Johns Hopkins Institutional Review Board (IRB) will go through initial review to determine if a PRA is required. Generally speaking, all protocols involving human subjects and an investigational item or service will require a PRA. Typical exclusions from this process include retrospective chart reviews, observational studies, surveys, outcomes analyses of FDA-approved and marketed items/services, and head-to-head comparisons of FDA-approved and marketed items/services. However, some studies previously exempt from the PRA process may require an EPIC Billing Grid to ensure research services are directed to the study account.
The PRA process is initiated when a new study application is submitted through the electronic IRB (eIRB) system. A request may be submitted directly to Clinical Research Support Services prior to eIRB submission by sending a message to CRSS@jhmi.edu. If the study is determined to need a PRA, it is assigned to an analyst who begins the process by gathering all available study-related documents as listed above. Once the analysis is complete, a draft PRA document is uploaded to the eIRB system and sent to the Principal Investigator (PI) to accept or decline with comments. When the PI has accepted the draft PRA, it is sent through to the IRB committee for use during their review of the study. The PRA process occurs concurrently with the IRB review process. When the study is approved by the IRB, and when the contract is fully executed if applicable, or a notice of grant award is received, the PRA is finalized and posted back to the eIRB system.
If a study requires a PRA, there are two things the study team must do. First, a Patient Financial Responsibility Sheet is uploaded to the eIRB system and must be used during the consent process of study participants. Second, participant recruitment and enrollment MUST BE logged into the Clinical Research Management System (CRMS) to ensure that appropriate billing can take place. These steps have been put in place to ensure that patients do not end up with unexpected or unintended out-of-pocket costs.
Request Clinical Trial Budget Development Assistance
Clinical Trial Budget development and negotiation are upon request and should be sent to CRSS@jhmi.edu.
CRSS staff have access to approved charges for health system services. The budget is drafted from the PRA and is forwarded to the Principal Investigator and study team for review and approval. Upon internal budget approval, negotiations will begin with the PI and study team copied on all correspondence to the sponsor. Please review the Budget Checklist and CRSS Budget Template.
Questions and/or concerns related to Prospective Reimbursement Analyses and/or budget development should be directed to Clinical Research Support Services at 410-361-8372 or CRSS@jhmi.edu.