What is a Coverage Analysis, and why do I need it?
Coverage Analysis is a prospective review of all items and services provided in an NIH-defined clinical trial, to determine how each item should be funded. The process involves a detailed review and application of Medicare’s National and Local Coverage Determinations (NCDs and LCDs), as well as specialty guidelines. The process informs your study team of which items can be billed to the patient/their insurance, and which will need to be funded by the study. The CA should be done before your budget is finalized, to ensure all research-related items can be negotiated with the sponsor.
At what point in my study start-up process should I submit for a coverage analysis? Once I submit, what does the process look like?
As soon as you have a final protocol and a draft version of your consent form, you can submit your CA request here: cctsdata.uky.edu/membership. As a reminder, this should always occur before your budget is finalized. Once your request is submitted, our CTMS team will build a protocol calendar, and the coverage analysis will then be applied to the calendar. Once the CA is completed and approved by your team, the budget can be finalized and entered into OnCore as well. (Note: there may be specific instances when an OnCore calendar is not required, so the CA may be processed in Excel. For questions about this, please contact a CRSO Coverage Analyst.)
Are there fees associated with the coverage analysis?
Yes, for any study submitted to the CRSO on, or after, August 1, 2020, there are fees for all industry-sponsored, qualifying, trials, and any significant amendments. The start-up coverage analysis is $3,200 and any significant amendment will be $1,000. Questions on if your study or amendment will be charged? Contact the CRSO at CRSOstudyassist@uky.edu.