October 4, 2017 Congressional Addressees Opioid misuse, including the use of heroin and misuse of opioids prescribed for pain management, has been recognized by the federal government, states, researchers, and others as a growing crisis in the United States. As opioid misuse has increased in recent years, so has the number of pregnant women who use opioids. The prenatal use of opioids by pregnant women—including opioid misuse, use of opioids prescribed for pain management, and use of certain medications given to treat opioid addiction—can produce a withdrawal condition in newborn infants known as neonatal abstinence syndrome (NAS).1 NAS symptoms range from excessive crying and irritability to difficulties with breathing and feeding. NAS is a rapidly increasing public health problem, with the incidence of NAS in the United States growing nearly five-fold between 2000 and 2012.2 Specifically, cases of NAS increased from a rate of 1.2 per 1,000 hospital births per year in 2000 to 5.8 per 1,000 hospital births per year in 2012, reaching a total of 21,732 infants diagnosed with NAS.3 A 2015 study noted that by 2012 one infant was born about every 25 minutes with NAS.4 While experts consider NAS to be an expected and treatable result of prenatal opioid exposure, infants with NAS require specialized care that 1 See Mark L. Hudak and Rosemarie C. Tan, American Academy of Pediatrics, “Neonatal Drug Withdrawal,” Pediatrics, vol. 129, no.2 (2012). Though other drugs may cause NAS, opioids are considered the primary cause. When it is possible to determine that the withdrawal symptoms are unique to opioids, the more precise term “neonatal opioid withdrawal syndrome” is used. However, because opioid use often does not occur in isolation from other risk factors or other substance use—such as alcohol, barbiturates, and selective serotonin reuptake inhibitors—it can be difficult to identify neonatal opioid withdrawal syndrome. For purposes of this report, we refer to these withdrawal symptoms as neonatal abstinence syndrome, or NAS. 2 Stephen W. Patrick et al., “Increasing Incidence and Geographic Distribution of Neonatal Abstinence Syndrome: United States 2009-2012,” Perinatology, vol. 35 (2015). 3 See Stephen W. Patrick et al., “Neonatal Abstinence Syndrome and Associated Health Care Expenditures: United States, 2000-2009,” JAMA, vol. 307, no.18 (2012) and Patrick et al., “Increasing Incidence and Geographic Distribution of Neonatal Abstinence Syndrome: United States 2009-2012.” 4 Patrick et al., “Increasing Incidence and Geographic Distribution of Neonatal Abstinence Syndrome,” 652. Letter Page 2 GAO-18-32 Newborn Health typically results in longer and more complicated and costly hospital stays. More than eighty percent of the NAS cases identified in the 2015 study were paid for by Medicaid, the federal-state program that finances health care coverage for low-income and medically needy populations, including children and aged or disabled adults.5 Due to the growing opioid epidemic and its deleterious effects, including the effects on infants, Congress has held hearings and passed legislation aimed at addressing various aspects of this epidemic. For example, the Protecting Our Infants Act of 2015 directed the Department of Health and Human Services (HHS) to conduct a study and develop recommendations for preventing and treating prenatal opioid use disorders, including NAS. This law also required HHS to review its planning and coordination related to NAS and to develop a strategy to address gaps in research and gaps, overlap, and duplication among federal programs to address NAS.6 We have previously reported that HHS has nine agencies involved with addressing NAS and has a council dedicated to coordinating activities across the department to address NAS.7 The Comprehensive Addiction and Recovery Act of 2016 (CARA) included a provision for GAO to examine NAS in the United States and the treatment services for the condition covered under Medicaid in hospital settings as well as any non-hospital settings.8 The act required us to report within a year after passage, and to meet this mandated date, 5 Patrick et al., “Increasing Incidence and Geographic Distribution of Neonatal Abstinence Syndrome,” 653-654. 6 Pub. L No. 114-91, §§ 2, 3, 129 Stat. 723, 724-725 (2015). In May 2017, HHS published the Protecting Our Infants Act: Report to Congress, which—among other things—includes a review of planning and coordination activities relating to NAS; recommendations for identifying, preventing, and treating NAS; and a strategy for addressing gaps, overlap, and duplication among federal programs to address NAS. See Substance Abuse and Mental Health Services Administration (SAMHSA), “Protecting Our Infants Act: Report to Congress,” May 2017. 7 The nine agencies we identified were one staff office—the Office of the Assistant