The primary objective of the Separation of Allowable Costs coverage analysis is to document that an allocation of costs analysis has been completed and all costs of a clinical trial are allocated to the appropriate payer whether it is the sponsor, a third party payer or the patient/subject. Since clinical research often takes place in conjunction with the routine clinical care of patients/subjects, it is important to ensure that billing for both routine, standard of care and research services/items are allowable by regulations governing medical billing practices. Additionally, the cost allocation plan must be consistent with the informed consent signed by the research subject. Sample Separation of Allowable Costs formats are located in the Tool Kit at the right side of the page.
The Principal Investigator (PI) is responsible for compliance with all billing rules for billing Medicare, Medicaid and third party insurers for services provided in the context of clinical research. The PI or his/her delegate is responsible for conducting a systematic review of clinical trial documents including the research protocol, Informed Consent, sponsor budget, itemized budget, and any other supporting documentation to determine the consistency of cost allocation of items and services to be billed. This internal analysis is required regardless of the funding source and cost allocation.
The Separation of Allowable Costs must be completed and maintained with the study budget files for research billing purposes.