presents a strategy that identifies key recommendations related to addressing NAS.57 Specifically, HHS’s strategy—known as the Protecting Our Infants Act: Final Strategy—made 39 recommendations related to the prevention, treatment, and related services for NAS and prenatal opioid use. Of the 39 recommendations HHS made in its report, we found that 28 of them directly relate to the recommended practices or challenges that we describe above. For example, the Strategy recommends the following: • promoting non-pharmacologic treatment, such as rooming-in; • providing continuing medical education to health care providers for managing and treating infants with NAS, such as on NAS treatment protocols; • conducting research on the long-term effects of prenatal drug exposure so that appropriate services can be developed for infants with NAS; and • establishing clear definitions of NAS and standardizing the use of diagnosis codes to collect more meaningful and actionable data on NAS. According to the Strategy, the recommendations will be used to inform planning and policy across HHS. However, HHS does not include any information in the Strategy on how the department and other stakeholders will implement the recommendations. Specifically, HHS does not include in its Strategy the following: • the explicit priorities among the numerous recommendations and associated efforts the department has initiated related to NAS; • timeframes for partial or full implementation of these recommendations; 57HHS’s report also (1) provides background on prenatal opioid exposure and NAS; (2) summarizes HHS activities related to prenatal opioid exposure and NAS, including a summary of published educational resources; and (3) presents clinical evidence and recommendations for preventing and treating NAS. See SAMHSA, “Protecting Our Infants Act: Report to Congress,” May 2017. This report, including the strategy, was mandated in the Protecting Our Infants Act of 2015. Pub. L. No. 114-91, §§ 2, 3, 129 Stat. 723, 724- 725 (2015). HHS’s Strategy Includes Recommendations Related to Addressing NAS but Lacks Priorities, Timeframes, and Responsibilities for Implementing the Recommendations Page 32 GAO-18-32 Newborn Health • clear roles and responsibilities for the recommendations, such as the extent to which HHS will need to rely on the medical community and federal and public stakeholders for implementation; and • the methods that will be used to assess the department’s progress in implementing any of these recommendations. HHS officials told us that they expect to develop a separate plan to guide implementation of the recommendations and that efforts to develop this plan were likely to begin in July 2017. However, as of September 2017, HHS could not provide any documentation that it had started to develop this implementation plan or establish a timeline for completing the plan; nor was HHS able to provide any information on what the plan may include. Having such a plan in place is important to ensure priorities are known and responsibilities are clear so that agencies and stakeholders can take appropriate action. Federal internal control standards call for agencies to have defined objectives clearly as part of their objectivesetting process and to assign roles and responsibilities for achieving these objectives. Objectives defined in specific and measurable terms allow for the assessment of performance toward achieving objectives.58 Furthermore, leading principles on sound planning we have identified in our prior work call for developing robust plans to achieve agency goals.59 Until HHS finalizes an implementation plan that includes specific priorities, timeframes, responsibilities, and methods for evaluating progress, it is at risk of not being able to provide reasonable assurance that it can successfully implement these recommendations in a timely manner and assess the effectiveness of its efforts. The rising opioid crisis has caused a significant increase in the number of infants born and diagnosed with NAS, a condition that affects infants and their families, hospitals, and other health care providers who are treating them. The increase in infants born with NAS also increases medical and other treatment costs experienced by the federal government and states. HHS recently published a strategy with key recommendations that have the potential to address some of the challenges related to treating NAS. However, HHS lacks a sound plan for implementing these 58See GAO-14-704G. 59Specifically, sound plans include such components as what the plan is trying to achieve and how it will achieve these results, as well as priorities, milestones, and performance measures to monitor and gauge the results. For example, see GAO/GGD-96-118, GAO-04-408T, and GAO-17-5. Conclusions Page 33 GAO-18-32 Newborn Health recommendations. The absence of such planning raises questions about whether and when HHS will be able to implement these recommendations in a timely manner and be able to assess its progress. The Secretary of HHS should expeditiously develop a plan—that includes priorities, timeframes, clear roles and responsibilities, and methods for assessing progress—to effectively implement the NAS-related