Policy implementation research on health benefit mandates for fertility preservation services to improve access to care in young cancer survivors

在美国，每年有近9万名年龄在15岁到39岁之间的青少年和年轻人被诊断患有癌症。 (阿亚幸存者)。癌症治疗前的保育护理(即不孕症风险咨询和生育 保存服务，如卵母细胞和精子冷冻)是一种以证据为基础的做法，有效地 减少癌症后的不孕不育，这是一个毁灭性的结果。应对有助于降低成本的成本壁垒 使用率、财政负担和困境，11个州最近通过了福利强制法，要求 保险计划包括生育保护福利，其他州和联邦立法尚待通过。 这些卫生政策可能会对预防不孕不育和减轻医疗费用产生重大影响 困难，但诊所和患者利益相关者报告说，强制福利没有惠及癌症患者。在……里面 实施科学，在多个层次内和跨多个层次的背景因素如何存在知识差距 参与实施卫生政策的人可以为设计有意实施的战略提供信息。 因此，目标是对健康保险福利授权进行一项理论知情的调查。 执行情况，以便制定战略，增加对生育力的保护。在EPIS框架的指导下， 本发展方案通过对多个层次进行上下文评估，侧重于探索阶段 (保险监管机构、保险公司、诊所和Aya幸存者)(目标1)和筹备阶段，通过共同 与利益攸关方共同制定福利任务的实施战略需要保持生育能力 (目标2)。在目标1中，我们将检查外部执行、服务和患者结果的决定因素 和内部环境，以及它们之间的桥梁因素。我们将进行调查，文件审查， 访谈和焦点小组，数据将通过快速评估进行分析，以便为随后的数据收集提供信息。 在目标2中，我们将具体说明福利任务的执行战略，并与利益攸关方共同完善这些战略 通过调查、访谈和焦点小组。我们将生成一套完善的实施战略工具包，以 在未来的试验中进行评估。通过对所有通过的州福利授权进行政策扫描，我们选择了加利福尼亚州， 伊利诺伊州和纽约州是可概括的州，因为它们代表着生育环境的关键变化 保全福利授权。跨学科团队拥有现有的、富有成效的协作和 在保育护理、保健政策、定性研究和实施方面的补充专业知识 科学。这项提案是对2018年儿童癌症明星法案的响应，在评估新的生育率方面是及时的 保护福利任务，在将实施科学方法应用于卫生政策方面具有创新性 进程和结果，并扩大关于政策执行战略的经验证据，以及 通过产生新的策略来增加获得生育力保存的机会，从而可能产生高临床影响 并减少AYA幸存者的不良临床结果和经济困难。除了保持生育能力外， 研究结果也将对美国各地目前实施的约2,000项福利任务产生影响。

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.