Clarifying and Navigating USPSTF’s Submissions Process

A nonprofit organization was seeking a universal screening recommendation from USPSTF for its indication of interest but had no resident knowledge or experience doing so. The organization sought to understand the process of developing an evidence package for submission to USPSTF as well as the criteria the task force would use to determine whether the evidence package was strong enough to warrant a universal screening recommendation.

We designed a multi-faceted educational program to provide the client with an understanding of USPSTF’s submission processes and evaluation criteria. We led a three-phase approach to assess and develop the client’s strategy for the creation and submission of an effective evidence package.

In phase one, we conducted a thorough review of USPSTF’s evidence framework and recommendation criteria and analyzed three previous USPSTF evidence reviews on similar indications as case studies. We used the findings from these reviews to help guide the client’s strategy for developing and submitting its own evidence package.

In phase two, we reviewed the client’s internal research library to collate relevant studies on screening and monitoring for the indication of interest, assessing the strength of evidence in those studies against USPSTF’s assessment criteria, and proposed reviewing 50 additional research papers to strengthen the evidence package. We then assessed the full evidence package using USPSTF review criteria and concluded that it was strong enough to warrant submission.

In phase three, we held two virtual workshops, one involving USPSTF experts, and one involving several experts on the relevant therapeutic area as well as a former USPSTF chair to answer questions from the medical experts and to help validate the results of our phase two evidence review.

Our work helped the client develop a clear strategy for submitting a strong evidence package to USPSTF. It also set the stage for assembling and submitting that package to maximize the chances of a universal screening recommendation. On the strength of our work, the former USPSTF experts indicated the package was ready for submission, considerably ahead of the client’s expected timeframe.