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Office of Research AdministrationClinical Research Support Services1629 S. Thames Street, Suite 200Baltimore, Maryland 21213
410-502-6001/office410-502-6004/[email protected]
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Objectives
• Become familiar with our office staff, roles, and responsibilities.
• Understand a Prospective Reimbursement Analysis, how it can benefit your studies, and other documents related to the PRA process
• Gain tools and information to help in your budget development process
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Office Organization
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Office of Research AdministrationClinical Research Support Services
• Primary Function– Prospective Reimbursement Analysis
• Multiple Secondary Functions– Study Budgeting– Initiate JHH Research Account through Patient
Financial Services (PFS)– Patient Financial Responsibility Sheet– Clinical Research Insurance Clearance
determination– Etc. etc. etc…
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Prospective Reimbursement Analysis (PRA)
• Complex process
• Simultaneous with – IRB review– Contract negotiations
• Constantly changing– Changes to regulations/coverages/care
standards– Changes in institutional processes
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• Highlights– Therapeutic Intent
• Phase I studies• Consent form benefit statement
– Must use• Patient Financial Responsibility Sheet• CRMS
– Communicate, Communicate, Communicate
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• Summary– The PRA is the internal tool developed to document
how each study meets the NCD criteria for billing routine costs to Medicare.
– A systematic review of clinical trial related documents to determine the billing status of items and services that are documented within the research protocol
– A method for ensuring that all the documents pertaining to a research protocol are consistent with each other
Prospective Reimbursement Analysis (PRA)
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Budget Developmentand Negotiations
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Budget Development
• Concurrent with PRA development
• How CRSS can help:– Identify “hidden” costs– Identify and document “routine” vs.
“research”– Provide completed budget template– Negotiate with your sponsor
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Budget Development
• Study Team must:– Provide salary information– Identify amount of effort for all personnel– Identify cost amounts (i.e. cost of special
labs, radiology procedures)– Maintain timely communication with CRSS– Process proposal through standard methods
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Budget Negotiations
• Service offered by CRSS
• Benefits– Maintain rapport with sponsor– Removed from “business” aspect of
research– Institutional backing
• By request only– Some PIs prefer to be “hands-on” with the
negotiation process
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Questions?
Thank you