Is Coverage Analysis Required for ALL New and Legacy Clinical Studies?
Yes. All new and legacy clinical studies, including Investigator-Initiated studies, (whether funded or unfunded, and regardless of the funding source) that may include any clinical or research items, tests, procedures, interventions or other services on study subjects performed at any UCLA Health System location, must be submitted to the Clinical Trial Administration Office to complete required Coverage Analysis Process under UCLA Policy 915.
UCLA Policy 915: http://www.adminpolicies.ucla.edu/pdf/915.pdf
Clinical Trials Administration Office (CTAO): http://clinicaltrials.ucla.edu/
Office of Compliance Services FAQ: Identifying when research services can be billed to Medicare or insurance. http://compliance.uclahealth.org/body.cfm?id=189#faq151