MSU HRPP Manual Section 7-8

7-8, Clinical Research Billing Compliance

All human subject research subject to HRPP Manual Section 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. A billable event is an event that could generate a charge (e.g., clinic visits, procedures, blood draws, labs, or radiology) to a patient or their insurance carrier. 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 Section 7-8-A, Clinical Research Billing Compliance Coverage Analysis and 8-10, Research Site Visits

Individuals (e.g. faculty, providers and staff) must work together to ensure that clinical services associated with a research study are billed appropriately and in compliance with relevant laws and regulations. 

This policy and procedure supersedes those previously drafted.

Approved By: Vice President of Research and Graduate Studies, 12-9-2015. Revision 1 approved by Assistant VP Regulatory Affairs on 4-14-2016.

Related HRPP Manual Sections

Approved PDF Version

Please note that hyperlinks have been added to the web version of this document for ease of use. View approved PDF version of Section 7-8, Clinical Research Billing Compliance.