Abstract P4-15-02: Lessons learned: Implementing the WISDOM study using private payors to cover study services and generate evidence
Authors: Huilgol Yash S , Wimmer Kenneth , Lin Erick , Thygeson Marcus , Fiscalini Allison S , DiGiorgio Karyn , Kraus David , Latts Lisa M , Tauber Laura , Haywood Trent T ,   Athena Breast Health Network Investigators and Advocate Partners, Esserman Laura J 
Published: March 2020

Abstract
Background: Generating real world evidence in support of value-based healthcare solutions has traditionally been difficult due to the nature of funding and reimbursement mechanisms. Pragmatic, comparative effectiveness studies need additional funding to cover study costs, and systems are not in place to incorporate evidence generation into improving health outcomes. In 2005, the Centers for Medicare and Medicaid Services (CMS) identified the need to broaden access to innovative therapies and practices, and implemented a Coverage with Evidence Development (CED) model. This model has not been adapted by private payers.
Methods: The WISDOM (Women Informed to Screen Depending on Measures of risk) Study in collaboration with the Patient-Centered Outcomes Research Institute (PCORI), addressed this challenge by co-developing a private payer coverage with evidence progression (CEP) model, based upon Medicare’s CED policy. Since the study began in 2016, numerous payers cover the WISDOM Study using CEP, including private, Medi-Cal, and self-insured employer groups, across six states (California, Illinois, Iowa, New Jersey, North Dakota and South Dakota). The payers helped cover study services used for risk assessment and high-risk counseling in the WISDOM Study.
Results: The first barrier was the payer’s fiscal concerns over adopting CEP, which was overcome by establishing the case for evidence generation as a route to better outcomes, cost savings and overall healthcare value. The second barrier was that health insurance companies may only control benefits for a fraction of their members. To overcome this barrier, WISDOM Study Investigators extended CEP to self-insured employers, who have been enthusiastic proponents in covering and recruiting participants. In implementing CEP, a third significant barrier was billing for individual services on a national scale. In response, WISDOM investigators established a scalable and replicable billing infrastructure for pre-approving and submitting claims for study services.
Discussion: The WISDOM Study is a pragmatic, comparative effectiveness trial that provides a framework for future research studies to adopt and build upon. For CEP to be scalable, an established simple mechanism is essential. For every limitation, we have identified important lessons that have been learned during the study’s implementation to address what started as insurmountable barriers and ended as a critical demonstration of feasibility.
Conclusion: These obstacles may inform subsequent implementations of coverage for evidence generation purposes as a means to promote value-based improvements in care.
Citation Format: Yash S Huilgol, Kenneth Wimmer, Erick Lin, Marcus Thygeson, Allison S Fiscalini, Karyn DiGiorgio, David Kraus, Lisa M Latts, Laura Tauber, Trent T Haywood, Athena Breast Health Network Investigators and Advocate Partners, Laura J Esserman. Lessons learned: Implementing the WISDOM study using private payors to cover study services and generate evidence [abstract]. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr P4-15-02.