National coverage analyses for NCI clinical trials: A pilot project to reduce participation barriers.

Abstract

6542 Background: Since the implementation of the ACA, many insurers have followed Medicare’s lead in covering routine care costs associated with clinical trials (CTs). However, questions remain on how to distinguish routine care from non-billable research costs, and this has important financial implications for both sites and patients. As a result, many sites individually conduct coverage analyses (CAs) prior to opening CTs to determine billable routine costs. This is a significant duplication of effort for NCI network CTs that are open at hundreds of sites. A 2015 ASCO-NCI initiative identified the centralized creation of CAs for national CTs as a potential solution to reduce site burden, increase CT transparency and billing compliance, and ultimately reduce barriers to CT participation. We provide initial findings from the resulting NCI pilot program. Methods: NCI set up a Coverage Analysis Working Group (CAWG) made up of representatives from NCI’s Cancer Trials Support Unit (CTSU), network groups, NCI, and billing compliance consultants. CAWG created a CA template and development process for NCI network trials. CAWG will survey site users in April 2017 to evaluate the first year of the pilot project. Results: CAs for 7 CTs were first posted to the CTSU website on 4/20/16. As of January 2017, CAs have been posted for 22 CTs: 17 NCTN and 5 NCORP. This represents 14.6% of the 150 large, later-phase network trials available on the CTSU. These CAs had been posted for a mean of 219 days (median 238) as of 1/31/17. In this time, CAs were downloaded an average of 319 times (median 301), for a total of 7,007 downloads. An additional 26 CAs have been posted for MATCH (n = 20) and LUNG-MAP (n = 6) sub-studies and downloaded 7,035 times. Survey results evaluating this CA pilot will be presented in June 2017. Conclusions: Providing centralized CAs to NCI’s national network trials is feasible and well received with sites reporting that this pilot is reducing the time and effort of opening CTs and improving CT funding transparency. Collaboration is needed with CMS and third party payers to enhance clarity around CT coverage policy and billing compliance, along with continued feedback to make further improvements to reduce trial barriers.