Prenatal opioid use can take various forms, including (1) using prescriptions for pain management, such as fentanyl and oxycodone; (2) medication-assisted treatment for opioid addiction, such as use of methadone and buprenorphine; (3) prescription misuse or abuse (such as using without a prescription, using a different dosage than prescribed, or continuing to use a drug when no longer needed for pain); and (4) illicit opioid use, such as heroin. These types of prenatal opioid use are not mutually exclusive. Women can use opioids in different ways during the course of a pregnancy. A recent study of heroin-dependent individuals in treatment showed most people reported their first regular opioid was a prescription drug. Two recent studies also found that 14 percent of pregnant private health insurance beneficiaries, and almost 22 percent of pregnant Medicaid beneficiaries filled a prescription for opioids during their pregnancy. Medication is considered the standard of care for pregnant women with opioid use disorders. Medications used for such addiction treatment are typically other opioids, such as methadone and buprenorphine, used off- label as neither is approved for use during pregnancy. administered daily as part of a registered, comprehensive substance abuse treatment program that can include prenatal care, counseling, family therapy, nutrition counseling, and other supportive services. Buprenorphine is the only opioid approved for the treatment of opioid use disorders for which physicians can write a prescription outside of a licensed treatment program. It is generally associated with a lower risk of overdose and fewer drug interactions than methadone and does not require daily visits to a treatment program. Experts consider NAS to be an expected and treatable result of pregnant women’s prenatal opioid use. Newborns with NAS may exhibit withdrawal signs and symptoms such as irritability, high-pitched crying, stiffness, sweating, vomiting, diarrhea, poor feeding, seizures, and respiratory distress. NAS is also associated with premature birth and lower birth weight, and can interfere with the mother-infant bonding process. Symptoms of NAS usually develop within 72 hours of birth, but may develop anytime in the first 2 weeks of life, including after hospital discharge. Providers predominantly diagnose NAS using the Finnegan Neonatal Abstinence Scoring Tool, which calculates a score based on a variety of central nervous, metabolic, respiratory, and gastro-intestinal symptoms that might be observed. Off-label use refers to the prescription of a medication for uses other than what the Food and Drug Administration has approved. the infant into a dark and quiet environment, swaddling, rooming with the mother, and providing high-calorie nutrition, among other things. Medication, such as methadone or morphine, may be necessary only for the relief of moderate to severe signs of NAS. Regardless of the type of treatment, a recent study found inconsistency in treatment both across and within particular settings of care. Specifically, the study found that the medications primarily used to treat NAS from 2004 to 2011 varied across hospitals, and that the type of medication used was associated with variations in length of treatment, length of stay, and hospital charges. Even within hospitals, only 5 of the 14 hospitals examined used the same treatment more than 80 percent of the time. Fourteen out of 18 federally funded research projects included a focus on NAS prevention, understanding, or treatment. Fourteen federal programs made direct services available or conducted other activities to address prenatal opioid use or NAS as part of broader program objectives. Eleven federal agencies also addressed prenatal opioid use or NAS through their health systems or other efforts outside of research or programs. From fiscal years 2008 through 2014, federal agencies obligated almost $21.6 million for 18 research projects related to prenatal opioid use or NAS, 14 of which included a focus on prevention and understanding of NAS, treatment of NAS, or both, as individual projects sometimes focused on more than one research area.$13.6 million for eight projects that included a focus on prevention and Federal agencies obligated understanding of NAS and $6 million for seven projects that included a focus on treating NAS. Other topics covered by these 18 projects included the treatment of prenatal opioid use (4 projects), incidence or prevalence of NAS, incidence or prevalence of prenatal opioid use, and costs related to NAS (3 projects each). No projects focused on the prevention or understanding of prenatal opioid use or any costs associated with such use. (See fig. 1.) All of the 18 projects were funded by agencies within HHS. Specifically, 14 of the 18 projects were funded by the National Institutes of Health (NIH) and the remaining 4 were funded by the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA). (See appendix II for descriptions of all 18 projects.) Projects that included a focus on prevention and understanding of NAS examined, for example, the transfer of drugs from the mother to the fetus or how different drugs used to treat addiction in the mother affected the newborn. Projects that included a focus on treatment of NAS examined, for example, different approaches to treatment such as gentle stimulation of newborns or comparisons of different medications to treat NAS. The project that was provided the largest amount of funds (nearly $4.6 million during the period we reviewed) was the Maternal Opioid Treatment: Human Experimental Research (MOTHER) study, which included a focus on prevention and understanding of NAS as well as treatment of NAS. This eight-site randomized clinical trial compared the effects of pregnant women’s use of buprenorphine to methadone on the severity and duration of NAS. It found that newborns born to women who received buprenorphine for opioid addiction treatment during pregnancy required significantly less morphine to treat withdrawal symptoms, had significantly shorter hospital stays, and required a significantly shorter duration of treatment for NAS, compared to newborns born to women who received methadone during pregnancy. Agency officials identified 14 federal programs on substance abuse prevention or treatment, maternal and child health, or family and child welfare services that addressed prenatal opioid use or NAS in fiscal years 2013 or 2014 as part of broader program objectives. Through a Web- based questionnaire, officials from 8 of these 14 programs reported making direct services available to women, infants, or their families, and 11 reported conducting other activities such as public education or providing technical assistance, with 5 reporting both. (See fig. 2.) These 14 programs were run by five different agencies, with 12 of these programs administered by agencies within HHS. Nine of the 14 programs had been in existence for more than 5 fiscal years.more details on these programs.) Outside of research and programs, officials from 11 federal agencies— mostly within HHS— reported that their agencies made direct services available through their health systems or engaged in other efforts that addressed prenatal opioid use or NAS during fiscal years 2008 through 2014. Four of the 11 agencies reported making relevant direct services available through their health systems and 10 agencies reported engaging in other efforts, such as provider education and knowledge- sharing groups, while three agencies reported doing both. (See fig. 4.) Officials from four of the 11 agencies—the Indian Health Service (IHS) within HHS, the Bureau of Prisons (BOP) within the Department of Justice (DOJ), the Department of Defense (DOD), and the Department of Veterans Affairs (VA)—reported that their health systems made direct services available to women who use opioids, their newborns, or their families, as part of each agency health system’s broader efforts to provide care to its beneficiaries.abuse screening and referral, medication-assisted treatment for opioid use disorders, behavioral treatment services, and case management or recovery support services may be available through their health systems, among other services. The State Children’s Health Insurance Program is a federal-state program that provides coverage to low-income children whose household incomes are above the threshold for Medicaid eligibility. which include guidance for DOD and VA health care providers on screening for drug use and offering treatment during pregnancy. Some agencies also published relevant reports or fact sheets that included information on prenatal opioid use or NAS. For example, SAMHSA recently published a fact sheet on pregnant teenagers admitted to substance abuse treatment facilities that, in part, discusses opioid use.(See appendix V for more information on agency efforts to address prenatal opioid use or NAS outside of research and programs.) The research and program gaps most commonly cited by federal agency officials and other experts were related to treatment of pregnant women with opioid use disorders or newborns with NAS. Research gaps cited focused on treatment of opioid use during pregnancy, including the effectiveness of various drugs, and the long-term effects of prenatal opioid exposure on children. The program gap most frequently cited was the lack of available treatment programs for both pregnant women and newborns with NAS. Other gaps cited included a lack of guidance and coordination in efforts to address prenatal opioid use or NAS. Agency officials and other experts we interviewed most often cited research gaps on treatments of opioid use during pregnancy and understanding the long-term impact on children exposed to opioids prenatally. Specific research gaps related to the treatment of prenatal opioid use included a lack of knowledge about best practices for initiating medication-assisted treatment during pregnancy, and an understanding of the barriers to accessing opioid use disorder treatment for pregnant women. Agency officials and experts said that there has not been adequate research comparing different types of treatment approaches and that research is needed on how best to treat a pregnant woman with an opioid use disorder so that the treatment is most effective for the woman while offering minimal risk to the fetus. The other research gap most frequently cited by agency officials and experts was research on the long-term effects of prenatal drug exposure, which officials and experts said is needed to understand the impact of prenatal exposure to opioids on children through adolescence. Other research gaps cited by agency officials and experts were related to studies of the treatment of NAS, screening and diagnosis of NAS, and understanding of NAS, such as the impact of opioid exposure on infants and severity of NAS. For example, officials and experts noted that the Finnegan Neonatal Abstinence Scoring Tool, which is used by health care providers to screen for and diagnose NAS, can be long and complex, and that a more objective NAS screening tool is needed. They also noted that there is not enough information to know what medications work best for what kinds of patients when behavioral therapies do not work for newborns with NAS. Agency officials and experts told us that as a result of these research gaps, providers often do not know how best to treat patients, which in turn leads to variation in the length and quality of treatment. (See table 1.) Agency officials and other experts cited several reasons for these research gaps, some of which are similar to those we have found for other public health issues. The most frequently cited reasons were Difficulty conducting research. Agency officials and experts noted difficulties in identifying and retaining pregnant women with substance use disorders for research studies due to the low number of such women and their reluctance to participate in such studies, sometimes out of fear of criminal charges or other repercussions from their use of opioids. Further, due to the use of multiple substances and variation in the expression of NAS, studies on this topic require a large number of participants, according to agency officials and experts. Research priorities. Agency officials and experts told us that prenatal opioid use and NAS had not been prioritized compared to other areas of research. For example, one expert suggested that there is a priority now on studying marijuana use and pregnancy. Lack of funding. Agency officials and experts cited a lack of research funds in general and specifically for NAS-related studies. They commented that there are many competing priorities for limited research funds. Funding structure. Research funding is typically provided for a limited time period, such as 5 years, making research on the long- term effects of prenatal opioid use particularly challenging according to experts. Experts also noted that funding for individual studies is often capped at a level too small to conduct the multi-site studies necessary in this area since it is difficult to find enough study participants at a single research site. Lack of capacity to conduct research. Agency officials and experts expressed concern that there may not be adequate expertise in this area to conduct this type of research. When asked about program gaps related to prenatal opioid use or NAS, agency officials and other experts we interviewed most frequently cited the lack of available programs, including treatment programs for pregnant women and for newborns with NAS. Such gaps in treatment programs included a lack of comprehensive care (i.e., the coordinated provision of obstetric care and addiction treatment), culturally appropriate care (particularly for the tribal community), and enabling services (e.g., transportation and child care). For example, agency officials and experts said that there were not enough services available that allow women to keep their children with them while in residential substance abuse treatment. They also cited program gaps in provider education—such as how to recognize substance abuse in patients, and how to appropriately prescribe and dispense opioids to prevent addiction—noting that many health care providers receive only limited training on these topics. Agency officials and experts told us that these program gaps can result in women not getting the addiction treatment they need while pregnant and the continuation of substance use during pregnancy. This may result in poor health outcomes for infants because they may be exposed to more than one substance or at risk for increased severity of NAS, according to agency officials and experts. (See table 2.) Agency officials and other experts cited several reasons for these program gaps, some of which are similar to those we have found for other public health issues. The most frequently cited reasons were Stigma and criminalization of pregnant women who use drugs. Some state laws require health care providers to report substance use during pregnancy to state or local officials, which officials and experts said could result in women not getting substance abuse treatment or prenatal care out of fears of criminal charges, their children being taken away, or being stigmatized as a drug user. Officials told us that providers are reluctant to recommend screening, treatment, or counseling when there are serious potential legal consequences, and as a result, pregnant women may not have access to appropriate programs that do not present legal consequences. Gaps in current research. Agency officials and experts attributed program gaps to the limited evidence base specific to prenatal opioid use or NAS, particularly around screening and medication safety during pregnancy. Officials and experts told us, for example, that because of the gaps in scientific knowledge, there is limited training for providers on how to treat substance use or prescribe pain medication during pregnancy. Awareness of NAS as a public health problem. Officials noted that the development of treatment programs lags behind the awareness of the existence of a problem, and issues such as prenatal opioid use and NAS have become more critical in the last 5 to 10 years. Lack of funding. Agency officials and experts said that funding for programs to address prenatal opioid use or NAS is challenging for many states and localities. This may result in a lack of available treatment programs. In addition to research and program gaps, agency officials and other experts cited other gaps in guidance, particularly around “safe harbor” laws for states, issues of treatment of prenatal opioid use and NAS, prescription drug monitoring programs, and development of Medicaid reimbursement policies. For example, agency officials and experts noted that there is no national or federal guidance for states on how to best draft laws and policies that would remove the possibility of criminalization so that pregnant women could more freely obtain needed treatment without facing the risk of criminal penalties or removal of their children from the home. They also cited a lack of national or federal guidance for health care providers in approaches to screening and treatment of prenatal opioid use and NAS. Specifically, they noted that there are not a lot of data to inform best practices, so there are no standards for care. Similarly, they cited a lack of federal guidance to assist states in the regulation and oversight of opioid use and prescribing through prescription drug monitoring programs, which also vary across states. They noted that while most states have prescription drug monitoring programs, their capacity and utility vary. Agency officials and experts noted that one effect of these other gaps is that states have varying policies related to prenatal opioid use or NAS. For example, officials and experts have noted that state policies on criminalization can result in women not having access to appropriate programs. In addition, agency officials and experts said some states have not seen much success with their prescription drug monitoring programs, possibly because they are not used by providers. One official commented that without effective prescription drug monitoring programs, it is difficult to catch “doctor shopping,” which is when a patient obtains controlled substances (such as opioids prescribed for pain management) from multiple health care providers without the providers’ knowledge of other similar prescriptions. (See table 3.) Agency officials and other experts did not frequently cite reasons for these other gaps. Among the few reasons cited, one official said that one reason for these gaps is that some states may have more established programs with a greater financial investment, particularly regarding prescription drug monitoring programs. ONDCP plans and coordinates by sharing information and developing national action items to address prenatal opioid use and NAS, but does not document the development of these action items. HHS relies on its agencies to plan and coordinate individual efforts, and has established a council that identifies activities that may influence, but are not targeted specifically at, prenatal opioid use and NAS. However, HHS lacks a focal point to lead planning and coordination of efforts related to prenatal opioid use or NAS across the department. As part of ONDCP’s efforts to plan and coordinate the federal government’s approach to prenatal opioid use and NAS, officials told us that they have shared information on these issues with federal agencies, states, and other organizations and experts. ONDCP officials told us that the office has been both a leader and participant at various conferences and meetings that focus on sharing information in this area.For example, officials told us that ONDCP gave presentations on NAS in May 2012, July 2014, and August 2014 as part of a webinar hosted by the Association for State and Territorial Health Officials and other organizations. hosted a leadership meeting in August 2012 that brought together scientists and policymakers to share knowledge on these issues. ONDCP shared the results of this leadership meeting at a subsequent September 2012 meeting that included federal agency officials as well as the American Academy of Pediatrics and the American Congress of Obstetricians and Gynecologists. participated in the April 2014 annual National Rx Drug Abuse Summit, where ONDCP officials led a presentation entitled, “Solutions Discussion Impacting Neonatal Abstinence Syndrome.” led a June 2014 White House Summit on the Opioid Epidemic which focused on heroin and prescription drugs, and during which NAS was briefly discussed. helped SAMHSA plan its August 2014 Prescription Drug Abuse Policy Academy, which included presentations on prenatal opioid use and NAS. Officials told us that ONDCP also shares information through two interagency groups—the Prescription Drug Abuse Prevention Interagency Working Group and the Treatment Coordination Group—comprising officials from at least 15 federal agencies. These interagency groups are broad in scope, but may raise prenatal opioid use or NAS during group meetings. Specifically, the Prescription Drug Abuse Prevention Interagency Working Group coordinates implementation of ONDCP’s 2011 prescription drug abuse prevention plan, and officials told us group members have discussed presentations on prenatal opioid use and NAS. The Treatment Coordination Group is focused on evidence-based substance abuse treatment services and ONDCP officials told us that members are working to plan and implement three to five activities aimed at improving access to medication-assisted treatment for people with opioid use disorders. Officials said that in discussing medication-assisted treatment, prenatal opioid use or NAS may have been raised. ONDCP officials also told us that the agency plans to develop an informal subgroup of the Prescription Drug Abuse Prevention Interagency Working Group that will focus specifically on NAS, but had not done so as of November 2014. They said that the purpose of this subgroup will be for staff from agencies involved in NAS-related issues to meet periodically and exchange information on the subject. In addition to these interagency working groups, ONDCP officials told us that in September 2014 they initiated the process and are coordinating with federal agencies to develop national action items related to prenatal opioid use and NAS for inclusion in the 2015 National Drug Control Strategy report, which outlines the federal government’s action items aimed at reducing illegal drug use and drug-related health consequences, among other goals.use and NAS as emerging issues in its 2013 and 2014 National Drug Control Strategy reports, but officials said that they had not yet developed action items, in part, because it is challenging to determine goals and targets in the absence of extensive research on NAS. Officials also said that they plan to follow the same method used to develop all action items by consulting with federal officials, state and local governments, health experts, and other stakeholders, and that federal agencies would be identified to take the lead on implementing and monitoring the action items once they are developed. Officials told us they anticipate having three to five action items related to prenatal opioid use and NAS that will be finalized by the end of 2014 in order to be included in the 2015 National Drug Control Strategy. ONDCP had previously identified prenatal opioid While developing these action items could potentially help the federal government address issues related to prenatal opioid use and NAS, ONDCP did not provide information on the potential action items being considered, the content of the discussions with federal agencies in developing these action items, or potential agency leads for implementation. Officials said they used information gathered from meetings and conversations with federal, state, and local officials and experts on prenatal opioid use or NAS to identify potential action items and have had separate discussions with officials from various federal agencies to develop specific action items and discuss any issues with implementation. However, ONDCP does not formally document the information used or the discussions with federal agency officials, including the extent to which gaps were considered, to develop specific action items. ONDCP officials said they do not document this information since the process followed in developing action items is generally informal.Additionally, ONDCP officials told us that the agency has not examined issues of duplication, overlap, or fragmentation related to prenatal opioid use or NAS. ONDCP officials told us that they believe that there is little risk of duplication in federal efforts in this area, but have not conducted a systematic review of federal efforts. Given the large number of federal agencies and stakeholders with whom ONDCP coordinates on prenatal opioid use and NAS, ONDCP’s lack of documentation of items such as meeting discussions and potential issues with implementation as they develop action items related to prenatal opioid use and NAS could limit its ability to systematically and effectively plan and coordinate these activities. Specifically, ONDCP may be less effective in ensuring clarity in the steps agencies need to take to implement the action items. Furthermore, as the challenges of prenatal opioid use and NAS are unlikely to be resolved in one year, documentation of the process—including information considered and discussions used to develop the action items—will be helpful as ONDCP considers modifying existing action items or adding additional action items in the future. HHS officials told us that those HHS agencies that conduct or fund research, administer programs, or conduct other efforts related to prenatal opioid use or NAS, plan and coordinate on individual efforts when working toward broad goals and objectives related to opioid abuse and overdoses. For example, SAMHSA officials told us that they have a long partnership with the Administration for Children and Families (ACF) to address issues of prenatal substance exposure, including opioids. Additionally, officials from the Office of the Assistant Secretary for Health (OASH) said they plan to convene an ad hoc workgroup of representatives from OASH offices to identify resources and opportunities for dissemination and expansion of public health awareness, education, and prevention efforts to address prenatal opioid use and NAS. As of November 2014, officials told us that the group will meet to identify key strategic initiatives that will take place within the next 18 months, but the first meeting was in the planning stages and no members had been identified. HHS officials also told us that the department broadly plans and coordinates across the department on opioid abuse through its Behavioral Health Coordinating Council (BHCC), which identifies activities that may influence, but are not are specifically targeted to address, prenatal opioid use or NAS. The Office of the Secretary—which oversees the activities of HHS—established the BHCC to coordinate departmental activities related to mental health and substance use and abuse. HHS officials told us that one of the subcommittees of the BHCC, the prescription drug and opioid abuse subcommittee, identifies activities to address the overall prescription opioid epidemic and reduce the rates of death and other adverse public health effects, which may include prenatal opioid use and NAS. HHS officials told us that the activities the BHCC identifies can influence the use and abuse of opioids by pregnant women, which is the primary cause of NAS. For example, HHS officials said one such activity is FDA’s requirement for manufacturers of certain opioid analgesics to make training on proper prescribing practices available to health care professionals that prescribe these medications, including the potential risk of NAS. We have previously reported that identification of a leader is a key feature for successful collaboration. See GAO-12-1022. not other HHS agencies.plan and coordinate department-wide on efforts specifically related to prenatal opioid use or NAS. The lack of a focal point may limit HHS’s ability to efficiently and effectively plan and coordinate efforts across the nine HHS agencies that conduct or fund research, administer programs, or conduct other agency efforts related to prenatal opioid use or NAS. Additionally, there is risk of duplication, overlap, or fragmentation of HHS’s research, programs, and other agency efforts to address these issues. HHS officials also indicated that they had not reviewed any potential gaps in existing efforts at this time. Federal agencies have recognized prenatal opioid use and NAS as emerging public health issues facing pregnant women and newborns and have several ongoing efforts to address these issues. Specifically, we found that federal agencies fund research projects focused primarily on NAS; administer programs or have health systems that make direct services available to women who use opioids and newborns with NAS; and engage in other efforts, such as provider education and knowledge- sharing groups. However, federal agency officials and experts we interviewed cited several gaps in efforts to address prenatal opioid use and NAS, most commonly gaps related to treatment, as well as lack of guidance to states and health care providers. While ONDCP is coordinating with federal agencies to develop action items to address prenatal opioid use and NAS, improved documentation could help make the process more systematic and effective. Further, HHS does not have a focal point to lead planning and coordination of efforts across its nine agencies that address these issues. These limitations in planning and coordination by ONDCP and HHS may limit the effectiveness of federal efforts to reduce prenatal opioid use among pregnant women and rates of NAS. Additionally, there is a risk that efforts may be duplicated, overlapping, or fragmented. Given the increasing use of heroin and abuse of opioids prescribed for pain management, as well as the increased rate of NAS in the United States, it is important to improve the efficiency and effectiveness of planning and coordination of federal efforts on prenatal opioid use and NAS. In order to ensure that efforts to address prenatal opioid use and NAS are systematically and effectively planned and coordinated across the federal government, the Director of ONDCP should document the process, including discussions held and information considered, of developing action items on prenatal opioid use and NAS. This may include documenting gaps that were considered in developing action items. In order to ensure that efforts to address prenatal opioid use and NAS are systematically and effectively planned and coordinated across HHS’s agencies, the Secretary of HHS should designate a focal point, such as the BHCC or another entity, to lead departmental planning and coordination related to prenatal opioid use and NAS, including consideration of gaps in research, programs, and other efforts. We provided a draft of this report to ONDCP, HHS, DOJ, USDA, DOD, and VA. ONDCP and HHS concurred with our recommendations and provided written comments, which are reprinted in appendixes VI and VII, respectively. In its written comments, ONDCP noted its efforts in working with federal agencies, states, and other stakeholders to focus attention on opioid addiction and NAS, and concurred with our recommendation that ONDCP document its process for developing action items on prenatal opioid use and NAS. In its written comments, HHS stated that it has focused efforts on reducing opioid use disorders with some emphasis on special populations, including pregnant women, and concurred with our recommendation that HHS designate a focal point to lead departmental planning and coordination related to prenatal opioid use and NAS. HHS noted that it plans to conduct a departmental review to designate such a focal point. ONDCP and HHS also provided technical comments, which we incorporated as appropriate. In addition, USDA provided one technical comment, which we incorporated. We are sending copies of this report to the Director of the Office of National Drug Control Policy, the Secretary of the Department of Health and Human Services, the Attorney General, the Secretary of the Department of Agriculture, the Secretary of the Department of Defense, the Secretary of the Department of Veterans Affairs, and other interested parties. In addition, the report is available at no charge on the GAO website at http://www.gao.gov. If you or your staff have any questions about this report, please contact me at (202) 512-7114 or dsouzav@gao.gov. Contact points for our Offices of Congressional Relations and Public Affairs may be found on the last page of this report. Major contributors to this report are listed in appendix VIII. Our objectives were to examine (1) federally funded research, federal programs, and other federal agency efforts related to prenatal opioid use or neonatal abstinence syndrome (NAS); (2) gaps identified by federal agency officials and experts in efforts to address prenatal opioid use or NAS; and (3) how federal efforts to address prenatal opioid use or NAS are planned and coordinated. To examine federally funded research, federal programs, and other federal agency efforts related to prenatal opioid use or NAS, we first identified federal departments or agencies (collectively referred to as agencies) that reported having research, programs, or other agency efforts related to prenatal opioid use or NAS through fiscal year 2014. To identify these agencies, we created a list of preliminary agencies based on a review of our recent work, as well as a review of the 2013 Catalog of Federal Domestic Assistance (CFDA) and discussion with officials from the Office of National Drug Control Policy (ONDCP), which is responsible for coordinating federal drug control efforts. We then screened these agencies to identify those with research, programs, or other agency efforts related to prenatal opioid use or NAS. Based on our screening, we identified 15 relevant agencies that we included in our review. (See table 4.) To examine federally funded research, each of the 15 agencies in our review identified whether they had conducted or funded research on prenatal opioid use or NAS during fiscal years 2008 through 2014 through our initial screening. We selected these timeframes in order to provide information on the body of research funded in recent years. Three of the 15 agencies in our review—the Centers for Disease Control and Prevention, Food and Drug Administration, and National Institutes of Health—reported that they had funded or conducted relevant research during this time period. Using a data collection instrument, we collected information from these three agencies on the details of this research— such as the target populations, focus of the research, and funding obligations data by fiscal year. We received completed responses from the three agencies and followed up to clarify the agencies’ responses if their responses were unclear or incomplete. In addition, to assess the reliability of the obligations data, we requested information on the agencies’ data systems and if there were any limitations to reporting the data. We also conducted internal checks to identify any outliers, and followed up with agency officials as appropriate. We determined that the research data provided by the agencies were sufficiently reliable for our purposes. To examine federal programs that addressed prenatal opioid use or NAS, we took a two-part approach. We first identified potentially relevant federal programs by reviewing the 2013 CFDA and the Department of Health and Human Services (HHS) Federal Program Inventory for fiscal year 2013, the latest available data at the time of our review, and by interviewing federal agency officials. We then requested that each of the 15 agencies in our review confirm if the programs that we initially identified addressed prenatal opioid use or NAS, and if they were in operation in fiscal years 2013 or 2014. We selected these time frames to provide information on current programs that address these issues, and we included fiscal year 2013 because it was the most recent fiscal year for which complete program data were available. We also asked each agency to identify any additional programs that we had not identified that were relevant to prenatal opioid use or NAS. As a result, seven federal agencies identified a total of 22 federal programs that addressed prenatal opioid use or NAS in fiscal years 2013 or 2014. We then developed and administered a Web-based questionnaire to collect information on each of these 22 programs—such as types of direct services made available and other activities conducted related to prenatal opioid use or NAS—and used the information provided to determine if each of the programs met our definition for addressing prenatal opioid use or NAS. We defined a program as addressing prenatal opioid use or NAS if (1) the program made relevant direct services available— regardless if these services were actually provided—or (2) the program conducted other activities that were relevant to prenatal opioid use or NAS. We also collected other types of information on each program, such as the program description and objectives, number of years in operation, funding mechanisms, funding obligations, and whether available services and activities were required to be evidence-based. During the development of our questionnaire, we pretested it with federal agency officials representing four programs across three agencies to ensure that our questions and response choices were clear, appropriate, and answerable. To obtain a variety of perspectives on our questionnaire, we selected the four programs for pretesting based on the types of services offered or activities conducted, funding mechanisms, and federal agency responsible for program administration. We then made changes to the content of the questionnaire based on feedback obtained from the pretests. We administered the questionnaire from June 2014 through October 2014. Officials from all 22 programs completed the questionnaire. The results from our questionnaire are not subject to sampling error because we sent the questionnaire to the universe of potential respondents. However, the practical difficulties of conducting any questionnaire may introduce errors, commonly referred to as nonsampling errors. For example, difficulties in how a particular question was interpreted, in the sources of information that were available to respondents, or in how the data were entered into a database or were analyzed could introduce unwanted variability into the questionnaire results. We encountered instances of nonsampling error in analyzing the questionnaire responses, such as respondents providing conflicting, vague, or incomplete information. We generally addressed these errors by performing automated checks to identify inappropriate answers, and also contacted agency officials for clarification and to request additional documentation as appropriate. However, we did not independently verify all of the information and data provided by the questionnaire respondents. In addition, to assess the reliability of obligations data reported in the questionnaire, we requested supporting documentation, and incorporated questions about the programs’ data systems and if there were any limitations to reporting the data. On the basis of our application of recognized survey design practices and follow-up procedures, we determined that the data provided by the agencies on programs were sufficiently reliable for our purposes. To examine other agency efforts that addressed prenatal opioid use or NAS in recent years outside of research and programs, we used a data collection form through which the 15 agencies in our review identified any other agency efforts that took place from fiscal years 2008 through 2014.We received completed responses from all 15 agencies. In some instances, respondents provided conflicting, vague, or incomplete information. We generally addressed these errors by contacting agency officials for clarification and requesting additional information or documentation as appropriate. However, we did not independently verify all of the information provided by the respondents. We determined that the data provided by the agencies on other agency efforts were sufficiently reliable for our purposes. To examine gaps in efforts to address prenatal opioid use or NAS, we obtained testimonial evidence from federal agency officials and experts on any research, program, and other gaps that exist in efforts to address prenatal opioid use or NAS. Specifically, we requested information from federal officials representing the agencies that had funded or conducted research in fiscal years 2008 through 2014, the agencies with relevant programs in fiscal years 2013 or 2014, and ONDCP. In addition, we selected experts (comprising expert organizations as well as individual researchers and clinicians) in order to include perspectives from health care professionals, advocates, and researchers with expertise in women’s health, pediatric health, and addiction. We obtained testimonial evidence from officials representing nine federal agencies and six experts from which we requested information. We then conducted preliminary content analyses of the information provided by agency officials and experts on: (1) research, program, and other gaps; (2) the reasons for these gaps; and (3) the effects of these gaps. We created preliminary categories based on these analyses. Two GAO analysts then independently conducted formal analyses, reviewed each other’s work, and discussed any discrepancies to ensure that both agreed on the assigned categorization of all information provided by agency officials and experts. For reporting purposes, we counted each federal agency and each expert (whether an individual or an expert organization) as one unit in our analysis. The results of this analysis are not generalizable because we selected the agency officials and experts from whom we obtained testimonial information. We did not independently verify the information provided by agency officials and experts. To examine how federal efforts to address prenatal opioid use or NAS are planned and coordinated, we collected documents and interviewed officials from ONDCP about planning and coordination across the federal government. We also collected documents and interviewed officials from HHS’s Office of the Secretary about planning and coordination across HHS’s nine agencies that fund research, conduct programs, or engage in other agency efforts to address prenatal opioid use or NAS. We conducted this performance audit from January 2014 to February 2015 in accordance with generally accepted government auditing standards. Those standards require that we plan and perform the audit to obtain sufficient, appropriate evidence to provide a reasonable basis for our findings and conclusions based on our audit objectives. We believe that the evidence obtained provides a reasonable basis for our findings and conclusions based on our audit objectives. Federal agencies obligated almost $21.6 million for 18 research projects that focused on prenatal opioid use or neonatal abstinence syndrome (NAS) from fiscal year 2008 through 2014. The six research projects that were provided the highest amount of funding each received more than $2 million from fiscal years 2008 through 2014, with five of these projects including a focus on prevention and understanding of NAS or treatment of NAS. Additionally, half of the 18 projects were completed by May 2014, while the remaining half were ongoing. All but three of the 18 projects were funded for extramural research, which were grants, contracts, or cooperative agreements awarded to universities, medical schools, research organizations, and private companies. Fourteen of the 18 projects were funded by the National Institutes of Health (NIH) and the remaining four were funded by the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA). (See table 5.) Federal agency officials identified 14 programs that addressed prenatal opioid use or neonatal abstinence syndrome (NAS) in fiscal years 2013 or 2014 by making relevant direct services available or conducting other activities as part of broader programs on substance abuse prevention and treatment, maternal and child health, or family and child welfare services.Officials from four of these 14 programs reported specifically addressing prenatal opioid use or NAS as part of their program objectives: (1) the Maternal, Infant, and Early Childhood Home Visiting Program, run by the Health Resources and Services Administration (HRSA); (2) the Services Grant Program for Residential Treatment for Pregnant and Postpartum Women, run by the Substance Abuse and Mental Health Services Administration (SAMHSA); (3) the National Center on Substance Abuse and Child Welfare, run by SAMHSA and the Administration for Children and Families (ACF), all within the Department of Health and Human Services; and (4) the Family Drug Court Program within the Department of Justice’s Office of Justice Programs. (See table 6.) Officials from eight of the 14 programs that addressed prenatal opioid use or neonatal abstinence syndrome (NAS) in fiscal years 2013-2014 reported that their programs made various direct services available to women who used opioids, such as women in medication-assisted treatment for opioid use disorders; those who misused, abused, or were addicted to opioids; and/or those who were prescribed opioids for pain management. Some programs also made services available to newborns who had been exposed to opioids during pregnancy, to family members of pregnant women who used opioids, or to family members of opioid- exposed newborns. (See fig. 6.) Officials from 11 of the 14 federal programs that addressed prenatal opioid use or NAS reported that the programs had conducted activities relevant to these issues, other than, or in addition to, direct services. All of these programs reported providing training or technical assistance that addressed prenatal opioid use or NAS to various stakeholders, most frequently health care providers, officials from state or local health departments or behavioral health agencies, and nonprofit organization staff. In addition to training and technical assistance, officials from five programs reported that their programs conducted public education or outreach related to prenatal opioid use or NAS. (See fig. 7.) Officials from 10 out of 11 federal agencies reported engaging in other efforts outside of research and programs to address prenatal opioid use or neonatal abstinence syndrome (NAS) from fiscal years 2008 through 2014. These 10 agencies most frequently reported conducting provider education or participating in relevant knowledge-sharing groups, such as working groups or expert panels. (See fig. 8.) Vijay A. D’Souza, (202) 512-7114 or dsouzav@gao.gov. In addition to the contact name above, Rashmi Agarwal, Assistant Director; Sarah Abou-El-Seoud; Jennie Apter; Carolyn Fitzgerald; Linda Galib; Jackie Hamilton; Carolyn Feis Korman; and Hannah Locke made key contributions to this report. Office of National Drug Control Policy: Office Could Better Identify Opportunities to Increase Program Coordination, GAO-13-333 (Washington, D.C.: Mar. 26, 2013). Drug Control: Initial Review of the National Strategy and Drug Abuse Prevention and Treatment Programs, GAO-12-744R (Washington, D.C.: July 6, 2012). Prescription Pain Reliever Abuse: Agencies Have Begun Coordinating Education Efforts, but Need to Assess Effectiveness, GAO-12-115 (Washington, D.C.: Dec. 22, 2011). Methadone-Associated Overdose Deaths: Factors Contributing to Increased Deaths and Efforts to Prevent Them, GAO-09-341 (Washington, D.C.: Mar. 26, 2009). Prescription Drugs: OxyContin Abuse and Diversion and Efforts to Address the Problem, GAO-04-110 (Washington, D.C.: Dec. 23, 2003). Drug Exposed Infants: A Generation at Risk, HRD-90-138 (Washington, D.C.: June 28, 1990).

Summary: The prenatal use of opioids, including heroin and opioids prescribed for pain management, can produce a withdrawal condition in newborns known as NAS. A recent study found that cases of NAS have tripled over the last decade and that treatment costs for newborns with NAS—most of which are paid by Medicaid—are more than five times the cost of treating other newborns at birth. GAO was asked to provide information on how federal agencies have addressed prenatal opioid use and NAS. In this report, GAO examines (1) federally funded research, federal programs, and other federal agency efforts related to prenatal opioid use or NAS; (2) gaps identified by federal agency officials and experts in efforts to address prenatal opioid use or NAS; and (3) how federal efforts to address prenatal opioid use or NAS are planned and coordinated. GAO analyzed information from federal agencies, including documents and data, on research, programs, and other agency efforts; interviewed federal agency officials and experts about gaps; and interviewed federal agency officials about planning and coordination of federal efforts. Federally funded research mostly focused on neonatal abstinence syndrome (NAS), and federal programs and other agency efforts made services available or conducted activities to address prenatal opioid use or NAS. From fiscal years 2008 through 2014, federal agencies obligated almost $21.6 million for 18 research projects related to prenatal opioid use or NAS, most of which focused on preventing, understanding, or treating NAS. Fourteen federal programs on substance abuse, health, and welfare—12 of which were administered by agencies within the Department of Health and Human Services (HHS)—made direct services available (such as screening and referral for treatment) or conducted other activities (such as training or technical assistance) to address prenatal opioid or NAS in fiscal years 2013 or 2014 as part of broader objectives. Outside of research and programs, 11 federal agencies made direct services available through their health systems or engaged in other efforts during fiscal years 2008 through 2014. The gaps in efforts to address prenatal opioid use and NAS most commonly cited by federal agency officials and experts were related to the treatment of prenatal opioid use and NAS. With regard to research, the most commonly cited gaps were inadequate research on treatment of prenatal opioid use and the long-term effects of prenatal opioid exposure on children. Reasons cited for these research gaps included difficulties in conducting research, such as identifying and retaining pregnant women with substance use disorders for studies, and prenatal opioid use and NAS not being as high a priority as other research areas. With regards to programs, agency officials and experts most commonly cited the lack of available treatment programs for pregnant women and newborns with NAS, including the availability of comprehensive care and enabling services, such as transportation and child care. Reasons cited for these program gaps included the stigmatization and criminalization of pregnant women who use drugs. In addition to research and program gaps, other gaps cited by agency officials and experts included a lack of guidance on criminalization policies for states, screening and treatment practices, and opioid prescribing. The Office of National Drug Control Policy (ONDCP)—the agency responsible for coordinating drug control efforts across federal agencies—plans and coordinates with other agencies by sharing information and developing national action items to address prenatal opioid use and NAS. However, ONDCP does not document its process for developing action items, including the information considered or discussions with agency officials. Within HHS—which has nine agencies that address prenatal opioid use or NAS—the department relies on its agencies to plan and coordinate individual efforts, and also has established a council that identifies activities that may influence, but are not targeted specifically at, prenatal opioid use and NAS. However, HHS lacks a focal point to lead planning and coordination of efforts related specifically to prenatal opioid use or NAS across the department. These limitations in planning and coordination by ONDCP and HHS may limit the effectiveness of federal efforts to reduce prenatal opioid use among pregnant women and rates of NAS. Additionally, there is a risk that federal efforts may be duplicated, overlapping, or fragmented. GAO recommends that ONDCP document the process for developing action items on prenatal opioid use and NAS and that HHS designate a focal point to lead departmental planning and coordination on these issues. ONDCP and HHS concurred with GAO's recommendations and provided technical comments that GAO incorporated as appropriate.