A blog about insurance billing! I know you’ve all been waiting for this day. Before your eyes gloss over and you move on, what if I told you that completing a single coverage analysis for just one clinical trial takes an estimated six hours of site staff time, at a cost of about $270? Now project these figures out to the scale of our network. If 15 trials were activated in one year at 500 sites, coverage analysis costs would exceed $2 million.

Save time on that one step in the cancer clinical trial process, and we save a lot of both time and money. Reduce that paperwork burden and, likely, you’d see more hospitals and clinics opening trials – which means more patients enrolling onto our studies.

I’m proud to report that SWOG has played a leadership role in improving the way the National Cancer Institute handles coverage analysis in a unique partnership with ASCO and three NCI programs – the National Clinical Trials Network (NCTN), the NCI Community Oncology Program (NCORP), and the Clinical Trials Support Unit (CTSU). SWOG member Connie Szczepanek, director of the Cancer Research Consortium of West Michigan NCORP and a member of our survivorship, symptom control and quality of life, and oncology research professionals committees, is lead author on an article published this week in the Journal of Oncology Practice. The article, which was co-authored by SWOG Assistant Director of Administration Casey Dawson, shows the impact of coverage analysis on sites and on the trial process, and explains a new system to improve how these documents are completed.

After hearing widespread concerns through member surveys and directly from researchers, ASCO’s Research Community Forum took on the issue of insurance billing. All clinical trial sites must properly charge either a health care insurer or the trial sponsor for trial-related goods and services – drugs, office visits, lab tests, etc. – and budget for those expenses. If sites don’t, they could be out of compliance with federal billing guidelines or risk passing on unbudgeted costs to patients – or eat those costs themselves and lose money by opening trials.

To reduce these risks, research staff at sites develop a coverage analysis before the start of a trial. A coverage analysis is essentially a spreadsheet that lists all procedures required under a trial, determines if they are part of standard care or solely required for the study, and assigns a price tag and payer for each. But for sites that run a lot of trials, producing a coverage analysis for each one is unwieldy – and often results in redundancies, inconsistencies, trial delays, and potential costs to sites and patients. This is not an effective, efficient process.

So the ASCO team, led by Connie, had an idea: What if coverage analysis for all NCI trials was done centrally, using a single template? This is an idea similar to that underlying the NCI’s Central Institutional Review Board – an initiative that has significantly speeded up trial times. It also reflects the sentiment of the Institute of Medicine report which led to the consolidation of the cooperative groups – consolidate common functions. In 2015, the ASCO group held a symposium organized in partnership with our long-time NCI partners Andrea Denicoff, head of operations for the NCTN, and Marge Good, a nurse consultant with NCORP. Nearly 50 staff from ASCO, the NCTN, NCORP, and the CTSU gathered at ASCO headquarters, and quickly endorsed the idea of a centralized process – using a coverage analysis template created by SWOG’s own Casey Dawson.

As the Journal of Oncology Practice article notes, this pilot project is up and running. A CTSU working group refined the SWOG template, and CTSU staff are now using it to centrally complete coverage analyses for new NCTN Phase III multi-site treatment trials, as well as select Phase II trials and NCORP cancer control and prevention trials activated after May 1, 2016. Under the pilot, those coverage analyses are available to all sites that open NCI trials. Andrea Denicoff continues to lead the work of this group, and she will present a poster presentation on their results at ASCO in June.

Like I said, clinical trial billing isn’t, may I say it, sexy. But these results are. This collaborative project between ASCO and the NCI may wind up saving taxpayers millions and speeding new cancer treatments and prevention strategies to patients. It doesn’t get more compelling than that. Thanks to Connie, Casey, Andrea, Marge and the entire coverage analysis team. To read their article, go here. 

A reminder: The San Antonio Breast Cancer Symposium (SABCS) abstract submission deadline is Monday, June 12, 2017 at 11:59 pm (CDT). Please submit your abstracts to SWOG publications manager Pat Arlauskas at neynhfxc/ng/bufh/qbg/rqh for processing two weeks prior to the deadline.