Grant Number:	5R21CA271184-02 Interpret this number
Primary Investigator:	Su, Hui-Chun
Organization:	University Of California, San Diego
Project Title:	Policy Implementation Research on Health Benefit Mandates for Fertility Preservation Services to Improve Access to Care in Young Cancer Survivors
Fiscal Year:	2023

Nearly 90,000 adolescents and young adults ages 15 to 39 are diagnosed with cancer each year in the U.S. (AYA survivors). Fertility preservation care before cancer treatment (i.e., infertility risk counseling and fertility preservation services such as oocyte and sperm freezing) is an evidence-based practice that effectively decreases infertility after cancer, a devastating outcome. In response to cost barriers that contribute to low utilization and financial burden and distress, 11 states recently passed benefit mandate laws requiring health insurance plans to include fertility preservation benefits, with additional state and federal legislation pending. These health policies may have substantial impact on preventing infertility and mitigating medical financial hardship, but clinic and patient stakeholders report that mandated benefits are not reaching cancer patients. In implementation science, there is a knowledge gap about how contextual factors in and across the multiple levels that are engaged in implementing a health policy can inform the design of deliberate implementation strategies. Thus, the objective is to conduct a theory-informed investigation of health insurance benefit mandate implementation, in order to derive strategies to increase fertility preservation care. Guided by the EPIS framework, this developmental proposal focuses on the exploration phase via a contextual assessment of multiple levels (insurance regulators, insurers, clinics and AYA survivors) (Aim 1) and the preparation phase through co- developing with stakeholders implementation strategies for benefit mandate required fertility preservation care (Aim 2). In Aim 1, we will examine determinants of implementation, service and patient outcomes in the outer and inner contexts, as well as bridging factors between them. We will conduct surveys, document reviews, interviews and focus groups, and data will be analyzed by rapid assessment to inform subsequent data collection. In Aim 2, we will specify implementation strategies for benefit mandates and refine them with stakeholders through surveys, interviews, and focus groups. We will generate a toolkit of refined implementation strategies to evaluate in a future trial. Through a policy scan of all passed state benefit mandates, we selected California, Illinois, and New York as generalizable states because they represent key variations in environments for fertility preservation benefit mandates. The transdisciplinary team has existing, productive collaborations and complementary expertise in fertility preservation care, health policy, qualitative research and implementation science. This proposal is responsive to the Childhood Cancer STAR Act of 2018, timely in assessing new fertility preservation benefit mandates, innovative in applying implementation science methods to health policy processes and outcomes and expanding the empirical evidence on policy implementation strategies, and of potential high clinical impact through generation of novel strategies to increase access to fertility preservation and decrease adverse clinical outcomes and financial hardship in AYA survivors. Beyond fertility preservation, study results will also have implications for the ~2,000 current benefit mandates implemented across the U.S.





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