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BACKGROUND: A myriad of federal, state, and organizational policies are designed to improve access to evidence-based healthcare, but the impact of these policies likely varies due to contextual determinants of, reinterpretations of, and poor compliance with policy requirements throughout implementation. Strategies enhancing implementation and compliance with policy intent can improve population health. Critically assessing the multi-level environments where health policies and their related health services are implemented is essential to designing effective policy-level implementation strategies. California passed a 2019 health insurance benefit mandate requiring coverage of fertility preservation services for individuals at risk of infertility due to medical treatments, in order to improve access to services that are otherwise cost prohibitive. Our objective was to document and understand the multi-level environment, relationships, and activities involved in using state benefit mandates to facilitate patient access to fertility preservation services. METHODS: We conducted a mixed-methods study and used the policy-optimized exploration, preparation, implementation, and sustainment (EPIS) framework to analyze the implementation of California's fertility preservation benefit mandate (SB 600) at and between the state insurance regulator, insurer, and clinic levels. RESULTS: Seventeen publicly available fertility preservation benefit mandate-relevant documents were reviewed. Interviews were conducted with four insurers; 25 financial, administrative, and provider participants from 16 oncology and fertility clinics; three fertility pharmaceutical representatives; and two patient advocates. The mandate and insurance regulator guidance represented two "Big P" (system level) policies that gave rise to a host of "little p" (organizational) policies by and between the regulator, insurers, clinics, and patients. Many little p policies were bridging factors to support implementation across levels and fertility preservation service access. Characterizing the mandate's functions (i.e., policy goals) and forms (i.e., ways that policies were enacted) led to identification of (1) intended and unintended implementation, service, and patient outcomes, (2) implementation processes by level and EPIS phase, (3) actor-delineated key processes and heterogeneity among them, and (4) inner and outer context determinants that drove adaptations. CONCLUSIONS: Following the midstream and downstream implementation of a state health insurance benefit mandate, data generated will enable development of policy-level implementation strategies, evaluation of determinants and important outcomes of effective implementation, and design of future mandates to improve fit and fidelity.

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Background: A myriad of federal, state, and organizational policies are designed to improve access to evidence-based healthcare, but the impact of these policies likely varies due to contextual determinants, re-interpretations of and poor compliance with policy requirements throughout implementation. Strategies enhancing implementation and compliance with policy intent can improve population health. Critically assessing the multi-level environments where health policies and their related health services are implemented is essential to designing effective policy-level implementation strategies. California passed a 2019 health insurance benefit mandate requiring coverage of fertility preservation (FP) services for individuals at risk of infertility due to medical treatments to improve access to services that are otherwise cost-prohibitive. Our objective was to document and understand multi-level environment, relationships, and activities involved in using state benefit mandates to facilitate patient access to FP services. Methods: We conducted a mixed-methods study and used the policy-optimized Exploration, Preparation, Implementation, Sustainment (EPIS) framework to analyze implementation of California's fertility preservation benefit mandate (SB 600) at and between the state insurance regulator, insurer and clinic levels. Results: Seventeen publicly available FP benefit mandate-relevant documents were reviewed, and four insurers, 25 financial, administrative and provider participants from 16 oncology and fertility clinics, three fertility pharmaceutical representatives, and two patient advocates were interviewed. The mandate and insurance regulator guidance represented two "Big P" (system level) policies that gave rise to a host of "little p" (organizational) policies by and between the regulator, insurers, clinics, and patients. Many little p policies were bridging factors to support implementation across levels and FP service access. Characterizing the mandate's functions (i.e., policy goals) and forms (i.e., ways that policies were enacted) led to identification of (1) intended and unintended implementation, service, and patient outcomes; (2) implementation processes by level, EPIS phase; (3) actor-delineated key processes and heterogeneity among them; and (4) inner and outer context determinants that drove adaptations. Conclusions: Following the mid- and down-stream implementation of a state health insurance benefit mandate, data generated will enable development of policy level implementation strategies, evaluation of determinants and important outcomes of effective implementation, and design of future mandates to improve fit and fidelity.

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Background: In 2016, the California Department of Healthcare Services (DHCS) released an "All Plan Letter" (APL 16-014) to its Medicaid managed care plans (MCPs) providing guidance on implementing tobacco-cessation coverage among Medicaid beneficiaries. However, implementation remains poor. We apply the Exploration, Preparation, Implementation, Sustainment (EPIS) framework to identify barriers and facilitators to fidelity to APL 16-014 across California Medicaid MCPs. Methods: We assessed fidelity through semi-structured interviews with MCP health educators (N = 24). Interviews were recorded, transcribed, and reviewed to develop initial themes regarding barriers and facilitators to implementation. Initial thematic summaries were discussed and mapped onto EPIS constructs. Results: The APL (Innovation) was described as lacking clarity and specificity in its guidelines, hindering implementation. Related to the Inner Context, MCPs described the APL as beyond the scope of their resources, pointing to their own lack of educational materials, human resources, and poor technological infrastructure as implementation barriers. In the Outer Context, MCPs identified a lack of incentives for providers and beneficiaries to offer and participate in tobacco-cessation programs, respectively. A lack of communication, educational materials, and training resources between the state and MCPs (missing Bridging Factors) were barriers to preventing MCPs from identifying smoking rates or gauging success of tobacco-cessation efforts. Facilitators included several MCPs collaborating with each other and using external resources to promote tobacco cessation. Additionally, a few MCPs used fidelity monitoring staff as Bridging Factors to facilitate provider training, track providers' identification of smokers, and follow-up with beneficiaries participating in tobacco-cessation programs. Conclusions: The release of the evidence-based APL 16-014 by California's DHCS was an important step forward in promoting tobacco-cessation services for Medicaid MCP beneficiaries. Improved communication on implementation in different environments and improved Bridging Factors such as incentives for providers and patients are needed to fully realize policy goals. Plan Language Summary: In 2016, the California Department of Healthcare Services (DHCS) in California released an "All Plan Letter" (APL 16-014) to its Medicaid managed care plans (MCPs) providing guidance on implementing tobacco-cessation coverage to address tobacco use among Medicaid beneficiaries. We conducted semi-structured interviews with health educators in California Medicaid MCPs to explore the barriers and facilitators to implementing the APL using the Exploration, Preparation, Implementation, Sustainment framework. According to MCPs, barriers included a lack of clarity in the APL guidelines; a lack of resources, including educational materials, infrastructure to identify smokers, and human resources; and a lack of incentives or penalties for providers to provide tobacco-cessation materials to beneficiaries. Facilitators included collaboration between MCPs and state and/or national public health programs. Overall, our findings can provide avenues for improving the implementation of tobacco-cessation services within Medicaid MCPs.

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Importance: 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. Objective: 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). Exposures: State jurisdiction. Main Outcomes and Measures: Main outcomes were the scope and specificity of mandated FP insurance coverage and the role of clinical practice guidelines and insurer regulations in implementation. Results: 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). Conclusions and Relevance: 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.

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INTRODUCTION: In 2016, the California Department of Health Care Services issued All Plan Letter 16-014 to the Medi-Cal Managed Care plans to provide information on requirements for comprehensive tobacco-cessation services. Researchers at the University of California, San Diego set out to (1) examine Medi-Cal's Managed Care plans' progress in implementing each section of All Plan Letter 16-014, (2) understand various factors related to implementation of the All Plan Letter, and (3) make recommendations to improve implementation. METHODS: Researchers surveyed health educators within California's 25 Medi-Cal Managed Care plans to document each one's smoking-cessation services and policies in 2018. Data were collected for 24 of the 25 Medi-Cal Managed Care plans (96%) through 3 methods, including: (1) a web-based survey, (2) an in-depth phone interview, and (3) collection of smoking cessation-relevant documents. RESULTS: Managed Care plans demonstrate low levels of full implementation, with only 1 fully implementing all 20 provisions of the All Plan Letter. On average, Managed Care plans implemented 13 of the 20 provisions. Managed Care plans had the highest implementation rates for provisions related to requirements for coverage of the 7 U.S. Food and Drug Administration-approved medications for tobacco cessation, in which 12 (55%) fully implemented all related required provisions. Managed Care plans had lowest implementation rates for provisions related to data collection, with only 4 (18%) fully implementing all 3 requirements. CONCLUSIONS: Although All Plan Letter 16-014 was successful in creating more comprehensive and consistent benefits across Managed Care plans, 95% of Managed Care plans have not fully implemented it. Further guidance from the Department of Health Care Services and integration with the California Smokers' Helpline may be needed to achieve full implementation.

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INTRODUCTION: Four sections of the Affordable Care Act address the expansion of Medicaid coverage for recommended smoking-cessation treatments for: (1) pregnant women (Section 4107), (2) all enrollees through a financial incentive (1% Federal Medical Assistance Percentage increase) to offer comprehensive coverage (Section 4106), (3) all enrollees through Medicaid formulary requirements (Section 2502), and (4) Medicaid expansion enrollees (Section 2001). The purpose of this study is to document changes in Medicaid coverage for smoking-cessation treatments since the passage of the Affordable Care Act and to assess how implementation has differentially affected Medicaid coverage policies for: pregnant women, enrollees in traditional Medicaid, and Medicaid expansion enrollees. METHODS: From January through June 2017, data were collected and analyzed from 51 Medicaid programs (50 states plus the District of Columbia) through a web-based survey and review of benefits documents to assess coverage policies for smoking-cessation treatments. RESULTS: Forty-seven Medicaid programs have increased coverage for smoking-cessation treatments post-implementation of the Affordable Care Act by adopting one or more of the four smoking-cessation treatment provisions. Coverage for pregnant women increased in 37 states, coverage for newly eligible expansion enrollees increased in 32 states, and 15 states added coverage and/or removed copayments in order to apply for a 1% increase in the Federal Medical Assistance Percentage. Coverage for all recommended pharmacotherapy and group and individual counseling increased from seven states in 2009 to 28 states in 2017. CONCLUSIONS: The Affordable Care Act was successful in improving and expanding state Medicaid coverage of effective smoking-cessation treatments. Many programs are not fully compliant with the law, and additional guidance and clarification from the Centers for Medicare and Medicaid Services may be needed.

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