Neonatal risk-appropriate care is the designation of a delivery facility to provide care to infants with a range of complications and risks using established minimum standards [1]. The concept of risk-appropriate care was defined in the March of Dimes 1976 publication of Toward Improving the Outcomes of Pregnancy (TIOP I) [2] and refined in the later versions (TIOP II and TIOP III) [3, 4] with input from clinical membership organizations. The primary clinical membership organization leading neonatal risk-appropriate care guideline development, the American Academy of Pediatrics (AAP), defines levels of care based on infant risk, equipment capabilities, and availability of specialty care. In 2012, the AAP published a policy on neonatal levels of care which provides guidance on the minimum requirements for a facility to function at Levels I, II, III, or IV [1]. Level I facilities are considered birthing centers or community hospitals focused on delivering healthy infants and transferring those in need of more complex services to a higher level facility, while Level IV, the highest level, provides the most comprehensive care to the highest-risk infants. The 2012 AAP policy, first published by the Committee on Fetus and Newborn, was reaffirmed with no change in 2015 [5]. The 2012 AAP policy is concurrently published in the Guidelines for Perinatal Care (GPC), a joint publication by AAP and the American College of Obstetricians and Gynecologists/Society for Maternal-Fetal Medicine (ACOG/SMFM), to provide practicing clinicians the latest guidelines for quality care of pregnant women and newborns [6]. Though the 2012 AAP policy is intended to inform best clinical practices for appropriate, comprehensive care of infants ranging from healthy to high-risk, the 2012 AAP policy may also be used to develop, improve, or augment statewide, state-based policies for neonatal service levels. Designation of risk-appropriate levels to facilities for the provision of care based on neonatal risk, or perinatal regionalization, assures regionalized systems function by transfer of women and neonates to facilities with available capabilities to provide quality care appropriate to patient needs [6].

State policies, often developed by state health departments, identify the regulatory authority and monitoring requirements for health systems within a state [7], provide guidance on minimum standards for neonatal care services such as transport of patients to higher level facilities as appropriate [8], and outline standards for telemedicine services [9]. Previous assessment by Blackmon, Barfield, and Stark of information included in state-level neonatal levels of care policies indicate these policies include regulatory sources, functional criteria for provision of services, utilization criteria, and compliance mechanisms [10]. Findings suggest variability in the structure, content, and reach of neonatal levels of care policies, and attribute such differences to divergent geographic or demographic composition of states. More recent assessments confirm previous findings and identify the transfer of high-risk patients as an action to improve risk-appropriate care in states by targeting measurement of patient volume, or facility utilization, to determine infant survivability [11]. Though informative, these assessments occurred prior to the publication of the 2012 AAP policy.

In 2014, publicly available state neonatal levels of care policies were systematically reviewed to assess consistency with the 2012 AAP policy [12]. Results indicated that two years post-publication of the 2012 AAP policy, 22 state policies included language on at least one level of care, and of those policies, 60% contained language consistent with Level I care, 48% with Level II, 14% with Level III, and 6% with Level IV. The purpose of the current policy review is to assess the proportion of states with language on neonatal levels of care consistent with the 2012 AAP policy, including review for consistency by care criteria (i.e., infant risk, equipment capabilities, and availability of specialty staffing). Additionally, state policy review results from 2014 are compared with results from 2019 to determine changes in consistency by care criteria among states with published policies at both time points.

In 2019, 25 states had a publicly available neonatal levels of care policy, though the number of states with policies available for each level varied (Table 2). For states with policy language defining Level I minimum requirements (n = 24), 88% were consistent with the 2012 AAP policy for the required criteria of infant risk information, specifically gestational age, and 100% for ventilation capabilities. For states with Level II policy language (n = 25), 80% were consistent with infant risk information (i.e., both birth weight and gestational age). For each infant risk criterion, 88% were consistent for birth weight and 88% for gestational age. Examining ventilation capabilities, 92% of states were consistent, and similarly, 92% were consistent with imaging equipment capabilities. For states with Level III policy language (n = 25), 76% of state policies were consistent with infant risk information; specifically, 76% were consistent with the birth weight requirements and 88% with gestational age requirements. For equipment capabilities, 80% were consistent with ventilation requirements, and 88% with imaging requirements. Additionally, 88% were consistent with pediatric surgical specialty requirements and 72% with pediatric surgical subspecialty requirements. For Level IV policies (n = 22), 64% were consistent with infant risk information (64% consistent with birth weight requirements and 73% for gestational age), 82% for ventilation capabilities, and 77% for imaging capabilities. Further, 77% were consistent with pediatric surgery specialty staffing and 73% with pediatric surgical subspecialty staffing requirements. When considering infant risk information, capabilities, and staffing, states were variably consistent by the level of care with the 2012 AAP policy (Fig. 1A–D).

Seven years post-publication of the 2012 AAP policy, state-level policies for neonatal levels of care have been published in half of states in the US. Less states with Levels III and IV criteria in the state policy language were consistent with the 2012 AAP policy than Levels I or II. Though the overall number of states with neonatal levels of care policy only increased by four between 2014 and 2019, the language within existing policies was amended by many more states to be consistent with the minimum requirements of the 2012 AAP policy, an important finding indicating an increase in care consistency standards across many states. Mostly, states included new, amended, or revised language on criteria consistent with the 2012 AAP policy for Levels III and IV, or the highest-level facilities. Our findings are not surprising as the 2012 AAP policy established the highest level of care based on risk assessment and management, Level IV care, representing recent clinical advancements for the most vulnerable infants [1]. Level IV care is separate from the Level III stepped care (i.e., Level IIIA, IIIB, IIIC, and IIID) as defined in previous policies [13]. Though decades since the original TIOP I and the establishment of levels of care [2], developing care standards for Level IV facilities is a necessary next step for updating state policies that designate oversight authority and regulate health systems. To address these changes, many state policies in our study included language referencing the most recent version of the GPC directly for all levels of care, which clearly outlines the requirements for each level of care [6].

Consistency in state neonatal levels of care policies with the 2012 AAP policy may improve the delivery of standardized quality care to address high rates of infant morbidity and mortality as well as disparities in neonatal outcomes. Though neonatal levels of care policies focus on the provision of services rather than patient characteristics, ensuring minimum standards are monitored in all delivery facilities within a state helps assure equitable access to quality care meeting the needs of all patients. However, discordance in available critical care services for high-risk pregnant women and infants may be attributable to differences in geography, demography, or regulatory practices [11], and new studies provide further evidence for disparities in care by geographic location [14, 15]. Nonetheless, geographic location is not the only barrier to accessing quality services [16]; other structural determinants such as race impact quality of care. Profit, Gould, and Bennett et al. (2017) examined racial and ethnic disparities in the provision of Neonatal Intensive Care Unit (NICU) care and found disparities exist in the quality of care, most pronounced in NICUs serving high-risk neonates [17]. Suboptimal and differential care of neonates in NICUs may be influenced by disparate perceptions of families [18], including differential communication and responsiveness of providers [19], and variable or potentially underestimated morbidities of very preterm birth infants by race and ethnicity [20, 21]. Further focus on issues of equity and care standards is warranted to assure neonates receive standardized, comparable treatment and services as outlined in current levels of care policies, regardless of place, race, or ethnicity [22].

In our previous publication on neonatal levels of care regulation, we found that policies with direct oversight by a designated authority (e.g., a state health department) may offer monitoring for provision of services through facility reporting or site visits, though only 20% of states (10 of 50) require site visits for ongoing monitoring [7]. Comprehensive evaluation of existing state levels of care policies requires ongoing monitoring and review, an essential component to ensure the provision of care includes current clinical evidence and best practices to improve systematic, risk-appropriate care in all delivery facilities. Clinical membership organizations offer verification programs to assist states in monitoring the provision of care in facilities. For instance, the AAP NICU Verification Program is designed to review NICU programs and verify the specific standards for a level of care [23].

Similarly, the ACOG/SMFM maternal levels of care verification program, piloted in three states, provides a comprehensive review of maternal services [24]. Additionally, the CDC offers the Levels of Care Assessment Tool (LOCATe^®) to provide a high-level assessment of both neonatal and maternal levels of care. While not comprehensive in assessing all aspects of clinical guidance, CDC LOCATe^® is a tool for states to use for engaging stakeholders in discussion of improvements for risk-appropriate care across hospital systems [25, 26], and has been included in similar policy reviews [27].

Furthermore, state public health programs are essential to support the consistent implementation of neonatal risk-appropriate care policies. For instance, Perinatal Quality Collaboratives (PQCs) are statewide networks of provider teams working to improve the quality of care for mothers and newborns, offering the opportunity to implement quality improvement initiatives that focus on capabilities outlined by levels of care policies in all types of delivery facilities [28, 29]. State PQCs have addressed issues ranging from increasing the use of antenatal steroids among premature neonates [30] and referral of neonates at NICU discharge for high-risk infant follow-up programs [31], to the development of delivery room readiness clinical checklists with communication standards [32] and perinatal outcomes linkage of clinical and administrative data to inform variable reporting within systems [33]. Evidence suggests that PQCs, in partnership with state health departments and other collaborative initiatives such as communities of practice (e.g., Vermont-Oxford Network) or review committees (e.g., Fetal and Infant Mortality Review, Maternal Mortality Review Committees), could offer the stakeholder partnerships necessary to fully implement best clinical practices and levels of care standards statewide [34–36].

Among the 50% of states without publicly available policies, reasons for lack of a policy vary and may include lengthy clinical, statutory or legislative review processes, limited awareness of public health evidence among leadership [37], or de-regionalized, less regulated systems of care [7, 38–40]. Policies focusing on care standards for neonates may require extended review, approval, and implementation timelines as new treatments or pharmaco-logical therapies are limited [41, 42] that impact provision of care, and in turn, revision of standards of care. Yet specific programs targeting care standards, such as the Neonatal Resuscitation Program^® (NRP^®) [43], offer alternative approaches to addressing the lack of a statewide policy for neonatal levels of care. The NRP^® provides training on the most recent evidence-based practice guidelines and education to improve the quality management of care provision and outcomes for newborns [43]. For states with significant rural or frontier geography, training through the NRP^® may increase neonatal stabilization prior to higher level facility transport and decrease unnecessary interventions while increasing odds of survival [44]. Among states with policies, most include training through the NRP^® for Level I facilities, potentially improving neonatal stabilization prior to transfer in areas with limited regionalized systems.

Available service capacity and payment may also affect NICU utilization, resulting in larger rates of admission for lower acuity neonates to sustain revenue [45–47]. Health care financing and reimbursement are driven by costs incurred for provider and hospital services, pharmaceuticals, diagnostic testing, and other administrative fees [48], presenting a barrier for systems changes to standardize care provision beyond negotiated rates or formularies. While knowledge of medical costs and reimbursement for services in the NICU is variable among neonatal providers [49], providers are aware of different payment models such as pay for performance [50, 51], fee-for-service, or bundled payments [38] linked to value-based care [52]. Such payment models utilized by hospital systems function independent of designated authorities responsible for the regulation of statewide policies, driving a disconnect between the provision of services, reimbursement revenue, and levels of care resultant in barriers to quality improvement and systems change. To address challenges in service capacity and reimbursement, grants or enhanced payments have been identified as incentives for participating in regionalized networks [11]. Designated authorities may develop reimbursement payment methodologies by facilitating inter-system transport policies between hospital systems, or negotiating telemedicine policies to augment services in smaller, more isolated facilities. Such agreements between hospital systems may offer reimbursement strategies that support regionalized care and could be scalable among separate hospital systems functioning at variable levels of care.

Limitations exist when interpreting our study findings. We only reviewed publicly available policies, potentially excluding policies unavailable or unpublished publicly. We did not contact all states to confirm that the publicly available policies included in our review were the most current, and therefore, may have missed amended policies not yet available. However, in contacting nine states to validate policy findings, all were confirmed as accurate, an indication that the review was comprehensive and reflected the most recent publicly available information. Additionally, since data collection occurred in 2019, new policies may have been published more recently or amended, which are not included in this study. Finally, although policies are intended to define minimum standards of care by level across states, in practice, capabilities and staffing may not reflect minimum standards, and self-designation of facilities by a level may differ from policy definitions. Despite these limitations, our review presents new information on how state policies have increased in consistency with the 2012 AAP policy, providing evidence of improved policies on standardized capabilities, equipment, and staffing by levels of neonatal care across states.

Neonatal levels of care policies contain the minimum standards for delivery facilities in the US to provide quality care for infants based on risk status. Though existing state policies are variably consistent with the 2012 AAP policy, 50% of states do not have a neonatal levels of care policy, potentially impacting care provision for high-risk neonates. Verification programs, ongoing monitoring and reviews, state public health programs, clinical training programs, and health system reimbursement strategies provide opportunity for states to better establish, review, and monitor neonatal services. Continuing to focus on equitable, standardized care of infants, particularly those born too early or too soon, may have a long-term impact on the morbidity and mortality of the most vulnerable members of the US.