HHS Initiative on Substance Exposure in the Mother-Infant Dyad

With the publication of clinical recommendations for standardizing the definition of opioid withdrawal in the neonate, one important next step for this initiative is implementation of the clinical definition – with an overarching aim of improving care for mother-infant dyad and families. Recognizing both challenges and opportunities that may present with implementation, this viewpoint article outlines specific applications of this clinical definition in informing discussions on treatment protocols, administrative coding, surveillance, and research criteria. Ranging from maternal preconception health to family-centered programs and policies, using a common diagnostic language to standardize the way we identify opioid-exposed neonates, can inform critical discussions along the spectrum of care for the mother-infant dyad.

This effort brought together clinicians, researchers, and policy experts specializing in maternal-child health to begin discussions on understanding and addressing care gaps. Though our discussion started on NAS, based on feedback received from national experts, we broadened the scope to include an overarching emphasis on the mother-infant dyad and family-centered approaches. Our 2020 report highlights four major findings from discussions on leveraging a health information technology-centered approach to develop a data-driven national policy approach for improving long-term care for the dyad.

Together with state public health leaders and CDC experts, we developed a study to identify and evaluate state-mandated public health reporting of NAS. Our 2019 report shows that state-mandated reporting helps quantify NAS incidence, and inform programs and services in impacted communities. This work illustrates that NAS public health reporting is important for identifying opportunities for prevention and facilitating linkages to care for infants and their mothers.

As a continued collaboration with state public health leaders, CDC experts, and the Office of the Assistant Secretary for Planning and Evaluation (ASPE), we conducted a follow-up evaluation of state-mandated NAS public health reporting. Our 2022 report shows that although mandated NAS case reporting offers continued advantages in determining NAS incidence and community exposure patterns, continued case reporting and infrastructural challenges limit the breadth of short- and long-term surveillance. This work illustrates that persistent data collection issues, such as a lack of a standard clinical definition for NAS, and infrastructural gaps are important areas for resource- and capacity-building assessments and responding actions.

Partnering with national maternal-child specialists and NIH experts, we conducted an expert literature review to identify criteria used to define NAS in clinical studies of the mother-infant dyad to-date. Our 2021 report shows that most clinical studies used subjective NAS scoring or treatment algorithms, and administrative coding to define NAS, and notably did not consistently incorporate opioid exposure into their inclusion criteria. This project illustrates the need for a more refined and standardized definition of NAS and marked the first of two phases of HHS’ strategic effort to establish a standard clinical definition.

As a continuation of our efforts on improving long-term care for the dyad, this convening brought together clinicians, researchers, policy experts and bioethicists to discuss a priority care gap – the lack of a standard clinical definition for substance withdrawal in neonates. This two-day convening held March 2021, elicited feedback on design, development, and results from an HHS two-phased strategy for developing a standard clinical definition for opioid withdrawal in the neonate. Integration of national expert input has been the centerpiece not only of discussions on standardization of clinical approaches, but also, of bioethical considerations for the mother-infant dyad. This convening illustrated the importance of social determinants and health equities for the dyad when examining downstream policy and program development.

As a collaboration between HHS interagency partners, an expert advisory board of six leading national experts in maternal-child health, and using modified-Delphi methodologies, we developed and conducted expert panels of clinicians, researchers, and policy experts to explore which clinical elements are essential to defining NAS, also referred to as neonatal opioid withdrawal syndrome (NOWS), and other terminologies. With an emphasis not on terminology, but on understanding fundamental clinical elements, our evidence-based findings revealed clinical criteria necessary for the diagnosis of NAS and NOWS. Together, in our 2021 report, we put forth a set of clinical recommendations for standardization of the definition of opioid withdrawal in the neonate. Accompanied with a set of bioethical principles, we propose this standardized clinical definition for use by clinicians, researchers, and public health advocates to improve not only scientific discovery, but also, clinical needs assessment and care delivery for mother-infant dyads and families.