Clinical Research Billing Compliance

All human subject research subject to HRPP Manual 4-1, Applicability, that may generate a billable event, regardless of funding source, must be billed appropriately and in compliance with relevant billing laws and regulations. Any research related billing must be documented, coded, and charged based on actual services rendered; must be allowable by regulations governing medical billing practices; must be consistent with any applicable contractual provisions; and must be consistent with the informed consent signed by the research subject.

MSU requires that all studies with a billable event follow the Compliance office review process to ensure that clinical research expenses are prospectively allocated appropriately, a coverage analysis is performed and that third party payers are not billed for services for which the study Sponsor is responsible and/or that are provided free of charge.  See HRPP Manual 7-8-A, Clinical Research Billing Compliance Coverage Analysis and 8-10, Research Site Visits.

For more information, please also view the Clinical Research Billing Compliance FAQs.