Medicare Coverage Analysis/Separation of Allowable Costs

The primary objective of the Separation of Allowable Costs (coverage analysis) is to ensure that all costs of a clinical trial are billed to the appropriate payer whether it is the sponsor, a third-party payer or the patient. Since clinical research often takes place in conjunction with the routine clinical care of patients, it is important to ensure that billing for both routine and research services/items are allowable by regulations governing medical billing practices; and must be consistent with the informed consent signed by the research subject.

It is the responsibility of the Principal Investigator (PI) or his/her delegate to conduct a systematic review of clinical trial documents including the research protocol, Informed Consent statement, sponsor budget, itemized budget, Clarian Research Registration/Grant Charge form and any other supporting documentation to determine the billing status of items and services to be billed.

The systematic review of clinical trial documents includes determining if the study is a qualifying trial for Medicare and which routine care items are billable to a third party payer.

At this time, the documents that support this review do not need to be submitted to Clinical Trials Services for review. All documentation to support the separation of allowable costs must be retained with the study files.