In total, 17 documents were reviewed, and 4 insurers, 16 oncology and fertility clinics (contributing 25 participants: 2 clinical administrators, 6 financial counselors, 13 clinicians, and 4 patient navigators), 3 fertility pharmaceutical representatives, and 2 patient advocates participated. Findings are organized according to Crable’s six policy-relevant implementation science recommendations [1].

Specify dimensions of a policy’s function: goals, policy type, contexts, and resources/capital exchangedPolicy goal

As stated by bill author Senator Portantino, the goal of the benefit mandate was to improve access to fertility preservation services for patients undergoing cancer treatment [21]. Specifically, the policy aimed at reducing denials of coverage for fertility preservation services and any related delays in providing cancer treatment to these patients by clarifying that fertility preservation services are basic health care services and thus required to be covered by all health insurance products regulated by California’s Department of Managed Health Care. Excluding insured individuals not subject to the mandate (Medi-Cal and self-insured) and uninsured individuals, the mandate applies to 42% of California’s overall population [12].

Policy type and context

Treating the mandate as the EPIS innovation, its implementation occurs across three levels to ultimately reach patients: regulator, health insurers, and clinics (Fig. 1); each level needs to implement policies related to the benefit mandate. The benefit mandate represents a “Big P,” macro-level policy to insurance regulators because it arises from a legislative body and requires compliance. Regulators then are responsible for issuing guidance to the insurers for how to implement the mandate, another Big P policy. Downstream, in response to “Big P” implementation, “little p” policies arise from regulators, insurers, and clinics and are implemented in level-specific contexts (Fig. 1). For example, in response to SB 600 and the related regulator guidance, insurers design fertility preservation benefits to include in benefit arrays. In response, clinics then generate new policies on additional benefit verification, pre-authorization, claims, and appeal efforts to seek coverage for patients.

Fig. 1

The multi-level active implementation zone for the fertility preservation benefit mandate. The implementation zone includes the state insurance regulator, insurers, and clinics. Downstream of the Big P fertility preservation benefits mandate policy, and both Big P and little p policies arise in regulator, insurer, and clinic implementation to enable patient access to these insurance benefits. Through multi-level implementation, these downstream policies reshape and dilute the policy package. P Big P, p little p, E exploration, P preparation, I implementation, S sustainment, O outer context, In inner context, B bridging

Resources or capital exchanged

After SB 600 was signed into law in 2019, the regulator issued regulation in January, 2020, to detail compliance and filing requirements [22]. The regulation defined applicable populations, affirmed coverage of “standard fertility preservation services,” and required that insurers submit documentation stating that all of their documents (current evidence of coverage, summary of benefits, schedules of benefits, infertility riders, subscriber agreements, and disclosure forms) did not specifically exclude fertility preservation benefits. If an insurer’s pre-mandate coverage policies were not in compliance as described above, the regulation required insurers to submit plans detailing future amendments to plan documents that would ensure timely compliance with SB 600 [22]. No resources were specifically allocated to the regulator or insurers for policy implementation. No financial support to comply with SB 600 was exchanged from state regulators to insurers. However, the policy created an opportunity for health insurers to reimburse contracted medical providers for the delivery of fertility preservation services to eligible members.

Specify dimensions of a policy’s form: origin and creators, structural components, and dynamismInnovation developers

In February 2011, California State Assembly member Portantino introduced the first known legislation, Assembly Bill (AB) 428, to require California health insurers to cover fertility preservation services [12]. This policy innovation was further developed with information submitted by regulators, insurer groups, clinical groups, and patient advocacy groups. This bill was also supported by the American Society of Reproductive Medicine, California Medical Association, California National Organization for Women, Fertile Action, Medical Oncology Association of Southern California, and RESOLVE: The National Infertility Association. AB 428 failed in the assembly and was reintroduced in California three more times as AB 912 (2013), SB 172 (2017), and ultimately as SB 600 (2019). California eventually passed SB 600 as a fertility preservation mandate with a democratic legislature and governor, similar to the political environment in the other states to pass fertility preservation mandates. More recent passage of fertility preservation mandates has occurred in states with a Republican-controlled legislature and/or governor [8].

Innovation characteristics

The earlier versions of the benefit mandate were similar in that they would have required that fertility preservation services be added as a covered benefit for designated health insurance plans. They either failed in committee (i.e., proposed policy was rejected) or were vetoed by the governor amid concerns that they exceeded the essential health benefit ceiling set by the national Affordable Care Act [23]. SB 600, on the other hand, defined “standard fertility preservation services” as “basic healthcare services,” which are required to be covered in all relevant health plans per the pre-existing state law Knox-Keene Health Care Service Plan Act of 1975 [24]. It also clarified that “standard fertility preservation services” are defined as “procedures consistent with the established medical practices and professional guidelines published by the American Society of Clinical Oncology (ASCO) or the American Society for Reproductive Medicine (ASRM).” Furthermore, the language stated that SB 600 would not apply to Medicaid enrollees.

We assessed the innovation’s dynamism (i.e., potential for permanence). SB 600 defined fertility preservation services as “basic healthcare services” required to be covered under current law, thereby improving the potential for permanence of the fertility preservation benefit mandate. Conversely, when a benefit mandate is added as a stand-alone statute (as opposed to part of current law), it is easier for policy makers to introduce future legislation removing fertility preservation services from the list of state mandates or to include a sunset date for the policy. The policy developers wrote SB 600 specifically in this way to try to prevent noncompliance from impacted insurers. In addition, the reference to external guidelines from the ASCO and ASRM to define “standard fertility preservation services” allows for the policy to evolve as additional treatments become standard of care.

Fertility preservation policy outcomes

Policy developers delineated the service outcomes (access to fertility preservation services, reduce denials of coverage for services, and any related delays in providing cancer treatment) and long-term health outcomes (quality of life based on family building ability) but did not specify implementation outcomes [25]. As researchers, we identified implementation outcomes and several additional service outcomes of SB 600 from the perspectives of stakeholders at each level (Table 1).

Table 1 Implementation, service, and patient outcomes from stakeholder perspectivesIdentify and define the (nonlinear) phases of policy D&I

We identified key implementation processes across levels in nearly all EPIS phases (sustainment activities were rarely reported; Table 2). At the outer context regulator level, key processes included gathering stakeholder feedback in drafting regulator guidance, implementation via issuing the guidance and conducting independent medical reviews from consumers who were denied fertility preservation benefits, and assessment of compliance with regulations during sustainment. In an iterative loop, stakeholder feedback during implementation and sustainment has driven preparation of additional regulator guidance on benefit specifics and populations covered. As of January 2024, these additional guidelines have not been open to public feedback or publicly issued.

Table 2 Mandate implementation processes by level, EPIS phase and domain, and key actors

At the inner context insurer level, implementation activities were documented across all four phases of EPIS. During the exploration phase, insurers reported monitoring potential legislation; gathering legal, medical, and actuarial expertise within the organization to shape insurer-level policies that would comply with the mandate; assessing compliance of existing contracts with purchasers/members, providers, and facilities; and evaluating capacity to administer the benefits. During the preparation phase, insurers reported (1) designing and selling fertility preservation benefits to purchasers, (2) ensuring adequate providers and facilities to deliver fertility preservation services, and (3) configuring staff and systems to administer fertility preservation benefits. Implementation phase activities included educating stakeholders about new benefits, performing benefit verification and pre-authorization, and processing claims and appeals. Sustainment activities such as monitoring and evaluation of patient utilization of fertility preservation benefits were less often mentioned.

Clinics reported engaging in exploration activities mainly through their participation in professional societies, whom they relied on to scan the environment and inform them of potential future policy changes. Clinic-level preparation activities included the following: (1) contracting with insurers to deliver fertility preservation services, (2) determining patient payment processes, and (3) configuring financial processes for interacting with insurers and patients. Contracting is time- and resource-intensive for clinics and does not occur when adequate reimbursement for services cannot be negotiated or patient volumes are expected to be low. The implementation processes that centered around accessing benefits were extremely complex. Thus, in iterative loops after initial development, patient payment processes between the clinic and patient and financial processes between the clinic and insurer (benefit verification, prior authorization, claims, and appeals) were continually adapted in response to the many barriers encountered during attempts to utilize fertility preservation benefits. No sustainment-level activities were reported.

Temporally, the insurance regulator and insurers had nearly synchronous EPIS phases because regulator guidance was issued close to legislation passage (approximately 3 months), with the legislation going into effect immediately. In contrast, some clinics reacted to mandate passage at a later point as insurers reached out regarding establishing contracts, while most reacted even later as patients presented with fertility preservation service needs.

Describe the temporal roles that stakeholders play in policy D&I over time

Actor roles across EPIS phases and domains are summarized in Table 2. Most actors have roles in more than one phase, and most of their actions span multiple levels. Across levels, exploration phase activities were primarily conducted by government relations personnel or external professional organizations that were relied on to monitor the environment and report on any significant proposed policy changes. This occurs in the inner context at the regulator level, at both the inner context and bridging context through professional societies at the insurer level, and through bridging activities only at the clinic level.

It was clear from interviews with stakeholders that the individual characteristics of implementers in one level influenced implementation efforts across other levels. For example, clinic financial navigator expertise not only facilitated implementation at the clinic level but also was responsible for transfer of information to insurer benefit verification teams. In addition, expertise, relationships with other actors, and job tenure were noted as extremely important factors for implementation activities occurring across multiple levels (e.g., benefit determination, member education).

Consider policy-relevant outer and inner context adaptations

Preparation activities primarily occurred in the inner context, while implementation activities took place in the inner context and through bridging factors between the inner and outer contexts. Data support that there are contextual factors within regulator, insurer, and clinic levels that impact implementation (Fig. 2).

Fig. 2

EPIS framework of contextual factors important to fertility preservation benefit mandate implementation. The policy innovation is the fertility preservation (FP) benefit mandate. Contextual factors within and between outer context (legislature, governor, and insurance regulator) and inner context (insurer and clinic) levels impact benefit mandate implementation

At the outer context regulator level, the most relevant construct that influenced implementation is competing priorities. Most of the time, no resources are allocated specifically for the implementation of state benefit mandates; therefore, the regulator may be under-resourced and unable to thoroughly engage in implementation activities. In California, implementation activities related to SB 600 compete with other preexisting responsibilities, and the regulator may not have the ability to thoroughly evaluate, monitor, and enforce policies. Some states have started to explicitly allocate funds for implementation of benefit mandates to provide regulators with adequate resources to prioritize implementation activities [13].

Insurer

The most relevant construct at the insurer level is also related to competing priorities. Insurers registered opposition to fertility preservation benefit mandate legislation but then needed to implement the policy after it became law. Therefore, it is unlikely that effective and efficient implementation is a top priority for the insurer. This may be even more pronounced for insurers that are for-profit and may have financial profits as a higher priority than ensuring patients have efficient and effective access to new treatments. In addition, as fertility preservation services are used by a small proportion of the population, promotion of the new benefit will be a lower priority than promotion of services used by a larger share of the population.

Clinics

Available clinic resources and culture influenced fertility preservation financial practices with insurers and patients and ultimately fertility preservation benefit utilization. Nearly all participants discussed that the clinic’s financial team’s expertise is a key resource and the rate-limiting factor. Person power and experience are needed for contracting with insurers, benefit verification/billing coordinators, prior authorization, and billing/claims. These present significant financial costs to the clinic. When the amount of work to accept insurance is too high, clinics do not contract with insurers, do not advise patients that there may be fertility preservation benefits, or do not provide enough support to utilize benefits.

Some clinics are motivated by a culture that “puts the patient first” or prioritizes patients who need medically indicated fertility preservation. These clinics actualize this culture through staffing for financial counseling and fertility preservation navigation, identification of an oncofertility team, creation and dissemination of educational cheat sheets about the insurance process, and policies such as absorption of costs of fertility preservation consultations. In smaller clinics, staff often have larger and overlapping roles. For example, a financial counselor may also be the head of finance for the clinic, meaning they pay clinic bills, order lab supplies, etc., or may also be the IVF coordinator, making them have less time to perform the role of financial counselor.

Experiences during implementation fueled tension for change by clinic financial teams, leading to modifying policies for patient payment and counseling and financial team training for fertility preservation patients. Some clinics changed patient payment policies. One clinic implemented a protocol to learn whether a patient’s insurance plan is subject to the mandate. If subject, even without benefit verification, the clinic required a small partial payment up front, relying on the ability to appeal after services are completed. Very few clinics had the ability to do so and defer collections until all appeals are completed, while most clinics required full payment up front if there is no insurer benefit or insurer-clinic contract. The timing and frequency of financial communication may be important for helping patients make timely decisions on whether care is feasible while not overwhelming them. For clinics that accept insurance, benefit verification and financial counseling were often moved from after the initial medical visit to before the visit, due to the financial responsibility expected of the patients. Here, patients who do not have verified benefits will often drop out of care.

Larger financial counseling teams invested in training new team members, as turnover is frequent. Most experienced financial counselors discussed training on the job because responses within and between insurers on individual cases are so heterogeneous that training materials are difficult to generate. Only one clinic generated a spreadsheet that summarized benefit verification processes by common insurers. Instead, one-on-one mentoring communicated tips such as using cancer diagnosis rather than the fertility preservation code, because the latter is more likely to be treated as infertility, for which there is no mandated insurance coverage.

Identify and describe bridging factors necessary for policy D&I success

Key bridging factors were identified between all levels (Fig. 2). Bridging factors were identified as relationships between the outer and inner contexts, often reciprocal, which functioned to transfer knowledge between outer and inner context actors, contest the mandate’s scope across contexts, and ultimately promote policy transfer (clinic and insurance plan compliance with the mandate) and access to benefits. Two Big P’s (mandate, regulator guidance) give rise to many little p’s (e.g., independent medical review, bidirectional legal actions between the regulator and insurers, contracts) that served to bridge implementation and compliance with SB 600 across multiple levels and within the health care system. Clinical society guidelines represented another bridging factor that influenced regulator (outer context) and insurer (inner context) implementation.

Consistency of communicating benefit design to clinics and patients across different platforms — plan handbook, member services, provider services, and web portals — was not met. Often, one or more of these bridging documents and resources lacked specificity regarding if and to what extent there is coverage of fertility preservation benefits. Often, two sources would provide discrepant information. This resulted in clinic financial staff undertaking time-consuming interrogation of all sources when such staff is a limited resource. One observed determinant of plan handbook accuracy is the timing of implementation. If mandates are signed late in a calendar year, plan handbooks for members may have already been written for the following year. The number of years since enactment may be a determinant of effective implementation.

Education about the benefit mandate was generated by insurers and some clinics, targeting insurers, clinics, and patients. Template letters to the insurer from clinics and patients included copies of the law and ASRM clinical guidelines that fertility preservation is standard of care. Provider bulletins and educational sessions were undertaken by insurers to both the clinic’s provider and administrative teams.