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Under the guidance of Toya Campbell, Senior Director, staff in the offices of Clinical Research Billing Compliance, Clinical Trials Financial Clearance and Clinical Research Revenue Cycle provide support to ensure correct and compliant billing related to patient participation in research studies. Our goal is for this web page to provide relevant, up-to-date communication links and information for investigators, study coordinators and other research team personnel regarding clinical research billing for hospital and professional fee charges across the collective Johns Hopkins Medicine entities (JHU School of Medicine, JHHS Hospitals and Clinical Practice sites)
A brief description and contact information for the leadership of each office follows. Helpful documents and weblinks associated with each group are available by clicking here: Additional Resources
SOM Compliance and Training
Research Compliance Operations
Clinical Research Billing Compliance (CRBC)
CRBC ensures that patient care services for study participants are billed as either “routine care” [e.g., to the participant or his/her insurer] or “research only” [e.g., to be paid by the study budget / sponsor], using the Prospective Reimbursement Analysis as a roadmap. This “adjudication process” is carried out for hospital inpatient/outpatient and professional fee charges. CRBC is also responsible for regulatory monitoring related to clinical research billing and the association of research participant consent forms within the Epic EHR application.
Clinical Research Financial Clearance (CRFC)
CRFC staff verify insurance coverage of potential participants for outpatient studies and coordinate alongside JHM Access Services to obtain inpatient services clearance. Participants with Medicare have a defined clinical trial coverage benefit. Some insurers will refuse to pay for routine care provided in the context of a clinical trial. The Informed Consent Form of a study with a PRA explains “what will it cost” to participate in the study by referencing the Patient Financial Responsibility Information Sheet. As a result, verification prior to enrollment whether a participant’s insurance will authorize coverage is an essential element of the clinical research financial clearance process. CRFC also provides guidance for the appeal of clearance denials for routine services associated with clinical trials.
Last updated 5/26/2020
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