Medicare Coverage Analysis
Industry Sponsored Clinical Research Projects
The CTO provides the MCA for clinical trials funded by both industry and non-industry sponsors, as well as internally sponsored clinical studies and trials.
An MCA determines whether a clinical trial meets the requirements for reimbursement by Medicare or other insurers for routine care costs. The MCA also determines a priori which items or services will be charged to a third party and which items will be charged to the research study. MCAs are required for all clinical research studies in which some items or services will be billed to a third party as part of standard medical care, whether the third party is Medicare or another provider. The MCA must be completed for such studies prior to contracting and prior to enrollment of study participants. Diagnostic or therapeutic patient care costs of a clinical trial include:
- Items or services that are typically provided absent a clinical trial (e.g., conventional care)
- Items or services required solely for the provision of the investigational item or service (e.g., administration of a non-approved chemotherapeutic agent), the clinically appropriate monitoring of the effects of the item or service, or the prevention of complications; and
- Items or services needed for reasonable and necessary care arising from the provision of an investigational item or service – in particular, for the diagnosis or treatment of complications.
Clinical studies and trials in which all charges are billed to the research project do not require an MCA. In such cases, all charges will be billed to the research project and none can be billed to third party payers.
Non-Industry Sponsored Clinical Research Projects with Patient Care
Non-industry sponsored clinical research projects are negotiated and executed by the Department of Contracts and Grants (DCG), Health Sciences Campus.
Currently, every clinical project, regardless of sponsor, involving patient care must be submitted to CTO for a Medical Coverage Analysis (MCA; see below). Once the MCA is completed, costs for clinical procedures and labs chargeable to award/sponsor are identified and attached to the completed MCA. CTO also conducts a consistency review with the approved Informed Consent Form (ICF) from the IRB to make sure that terms included in ICF with respect to payments and subject injury are consistent with the grant or contract terms accepted by the University.
For more information, please see the Non-Industry Sponsored Clinical Trials Workflow
USC Funded Clinical Trials