Herbert Wertheim School of Public Health, University of California, San Diego, La Jolla.
Department of Obstetrics, Gynecology, and Reproductive Services, University of California, San Diego, La Jolla.
JAMA Health Forum. 2021 Dec 3;2(12):e214309. doi: 10.1001/jamahealthforum.2021.4309.
Multiple US states recently passed laws mandating health insurance coverage for fertility preservation (FP) services to improve access to care for patients with cancer, for whom FP service expenses can be prohibitive. Key unanswered questions include how heterogeneous benefit mandate laws and regulations are and how this variation may affect implementation, access, and utilization.
To describe the design of state-level FP health insurance benefit mandate laws and regulations and derive guidance on best practices and implementation needs.
DESIGN, SETTING, AND POPULATION: Legal mapping and implementation science framework-guided analyses were conducted on 11 US state laws that mandate health insurance benefit coverage for FP services for patients at risk of iatrogenic infertility from medical treatments and on related insurer regulations. Design features of laws and regulations and the implementation process were summarized by themes (eg, coverage specification).
State jurisdiction.
Main outcomes were the scope and specificity of mandated FP insurance coverage and the role of clinical practice guidelines and insurer regulations in implementation.
Between June 2017 and March 2021, 11 states passed FP benefit mandate laws. States took a median (range) of 283 (0-640) days to implement mandates, and a majority issued regulatory guidance after the law was in effect. While standard-of-care procedures such as embryo cryopreservation require medical evaluation, medications, ultrasonography and laboratory monitoring, oocyte retrieval, embryo derivation, cryopreservation, and storage, there was variation in which services were specified for inclusion or exclusion in the laws and/or regulator guidance. The majority of state laws and regulator guidance reference medical society clinical practice guidelines and federal policies (Affordable Care Act and Health Insurance Portability and Accountability Act).
In this qualitative assessment of 11 state-level FP benefit mandates, variation that may influence patient access was identified in the design and implementation of the mandates. As clinical stakeholders aim to understand and/or shape these laws and their implementation, key considerations included specificity and flexibility of benefit design to be clinically meaningful, expansion of clinical practice guidelines to inform benefit coverage, inclusion of publicly insured and self-insured populations for universal access, and consistency between state and federal policies.
最近，美国多个州通过了法律，要求医疗保险涵盖生育力保存（FP）服务，以改善癌症患者的护理获取，因为 FP 服务费用可能令患者望而却步。关键的未解决问题包括：福利授权法律和法规的差异有多大，以及这种差异可能如何影响实施、获取和利用。
描述州一级 FP 健康保险福利授权法律和法规的设计，并就最佳实践和实施需求提供指导。
设计、背景和人群：对 11 项要求医疗保险覆盖患者因医疗治疗而面临医源性不孕风险的 FP 服务的美国州法律以及相关的保险公司法规进行了法律映射和实施科学框架指导分析。法律和法规的设计特点以及实施过程按主题（例如，涵盖范围）进行了总结。
州管辖范围。
主要结果是授权 FP 保险覆盖的范围和具体性，以及临床实践指南和保险公司法规在实施中的作用。
2017 年 6 月至 2021 年 3 月期间，11 个州通过了 FP 福利授权法。各州实施授权平均用时（范围）为 283（0-640）天，大多数在法律生效后发布了监管指南。虽然胚胎冷冻等标准护理程序需要医疗评估、药物、超声检查和实验室监测、卵母细胞采集、胚胎衍生、冷冻保存和储存，但在法律和/或监管指南中规定纳入或排除哪些服务存在差异。大多数州法律和监管指南都参考了医学协会临床实践指南和联邦政策（平价医疗法案和健康保险可携带性和责任法案）。
在对 11 项州一级 FP 福利授权的定性评估中，在授权的设计和实施中发现了可能影响患者获取的差异。随着临床利益相关者旨在了解和/或塑造这些法律及其实施，关键考虑因素包括受益设计的特异性和灵活性，以使其具有临床意义，扩大临床实践指南以告知受益覆盖范围，纳入公共保险和自我保险人群以实现普遍获取，以及州和联邦政策之间的一致性。
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