The University of Arizona Health Sciences (UAHS) requires a coverage analysis be completed for all human subject research studies prior to subject enrollment. The coverage analysis determines the Medicare qualifying status of the study and appropriate billing designations for all services performed in accordance with the study protocol. Completion of a coverage analysis prior to participant enrollment ensures that the informed consent, budget and clinical care expenses related to an active study are consistent and congruent. For this reason, UAHS Research Administration strongly recommends that study teams wait to receive a completed coverage analysis before submitting a project to the IRB.
The coverage analysis is prepared by UAHS Research Administration with the information provided in the Research Intake Form (RIF). Billing designations are determined using published clinical care guidelines, Local and National Coverage Determinations (NCDs/LCDs), and Principal Investigator input.
As of October 1, 2017, Research Administration will no longer require a reviewed schedule of events for coverage analysis development. Instead, once the coverage analysis has been approved by our medical partner, Research Administration will ask the Principal Investigator to review the coverage analysis and sign the Coverage Analysis Review Memo.
Please note: A schedule of events (table of the sequence of protocol-specified events) will still be considered a required document. This is generally included in the study protocol; however, investigators writing their own protocols will be expected to provide a schedule of events. Investigators may utilize this generic schedule of events template.
Reading the Coverage Analysis
- S = Sponsor-paid item. These items have been deemed “research-specific,” which includes services/procedures provided solely to satisfy data collection as well as services/procedures that would not otherwise be routinely performed for the direct clinical management of the subject. These costs should be absorbed by the study’s sponsor (internal or external).
- M = Medicare billing rules apply. These services/procedures should be billed to the subject or the subject’s insurance as normal, as these have been determined to be routine costs. Per Medicare Guidelines (NCD 310.1), Routine Costs in Clinical Trials may include:
- Items or services that are typically provided absent a clinical trial (e.g., for conventional care/medical necessity);
- Items or services required solely for the provision of the investigational item or service (e.g., administration of a noncovered chemotherapeutic agent);
- Items or services for the clinically appropriate monitoring of the effects of the item or service, or the prevention of complications (e.g., safety labs, pre-meds/supportive medications).
- INV = Invoiceable item. Typically used when a service/procedure could be conducted as standard of care or may have already been conducted as standard of care, but may be invoiced to Sponsor if the service is repeated for research purposes or to satisfy protocol-specific criteria.