Coverage Analysis

The University of Arizona Health Sciences requires that a coverage analysis be completed for all human subject research studies prior to subject enrollment regardless of the funder. The coverage analysis determines the Medicare qualifying status of the study and the 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. The analysis is required even if a study will cover the cost of all procedures in a study. 

The coverage analysis is prepared by the U of A Health Sciences Research Administration with the information provided in the research administration portal. Billing designations are determined using published clinical care guidelines, local and national coverage determinations (NCDs/LCDs), and principal investigator input. To maintain compliance, billing designations cannot be directed by a study sponsor. 

The completed coverage analysis will be approved by our medical partner, and then reviewed by the Principal Investigator.  The principal investigator will then sign the coverage analysis review memo.

Reading the Coverage Analysis

• S = Sponsor-paid item. These items have been deemed “research-specific,” which includes services or procedures provided solely to satisfy data collection as well as services or 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 or 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, premeds/supportive medications).
• INV = Invoiceable item. Typically used when a service or procedure could be conducted as standard of care or may have already been conducted as standard of care, but may be invoiced to the sponsor if the service is repeated for research purposes or to satisfy protocol-specific criteria.