Federally Funded Research Projects Mostly Focused on Prevention, Understanding, or Treatment of 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, 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. Federal Agencies also Addressed Prenatal Opioid or NAS through Their Health Systems or Other Efforts Outside of Research and 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. Most Commonly Cited Gaps Were Related to Treatment of Prenatal Opioid Use or NAS

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. The program gap most frequently cited was  the lack of available treatment programs for both pregnant women and  newborns with NAS. 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. The most frequently cited reasons were
Stigma and criminalization of pregnant women who use drugs. Other Gaps Cited Included Lack of Guidance and Coordination of Efforts to Address Prenatal Opioid Use or NAS

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. ONDCP and HHS Plan and Coordinate to Address Prenatal Opioid Use and NAS, but More Documentation and a Departmental Focal Point Are Needed

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. 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. 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. 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. ONDCP and HHS also provided technical comments, which  we incorporated as appropriate. Appendix I: Scope and Methodology

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. We did not independently verify the information  provided by agency officials and experts. Appendix III: Federal Programs that Addressed Prenatal Opioid Use or Neonatal Abstinence Syndrome

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.
Why GAO Did This Study

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.

What GAO Found

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.

What GAO Recommends

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.