PRENATAL DRUG 

USE AND NEWBORN 

HEALTH

Federal Efforts Need 

Better Planning and 

Coordination

Report to Congressional Requesters

February 2015

GAO-15-203

United States Government Accountability Office
United States Government Accountability Office

Highlights of GAO-15-203, a report to 

congressional requesters

February 2015

PRENATAL DRUG USE AND NEWBORN 

HEALTH 

Federal Efforts Need Better Planning and 

Coordination

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 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.

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.

View GAO-15-203. For more information, 

contact Vijay A. D'Souza at (202) 512-7114 or 

dsouzav@gao.gov.
Page i GAO-15-203 Prenatal Drug Use and Newborn Health

Letter 1 

Background 4

Federally Funded Research Mostly Focused on NAS, and Federal 

Programs and Other Agency Efforts Made Services Available or 

Conducted Activities to Address Prenatal Opioid Use or NAS 6

Most Commonly Cited Gaps Were Related to Treatment of 

Prenatal Opioid Use or NAS 19

ONDCP and HHS Plan and Coordinate to Address Prenatal 

Opioid Use and NAS, but More Documentation and a 

Departmental Focal Point Are Needed 24

Conclusions 31

Recommendations 32

Agency Comments 32

Appendix I Scope and Methodology 34

Appendix II Federally Funded Research Projects on Prenatal Opioid Use 

or Neonatal Abstinence Syndrome 41

Appendix III Federal Programs that Addressed Prenatal Opioid Use or Neonatal 

Abstinence Syndrome 44

Appendix IV Direct Services Made Available and Program Activities Conducted 

by Federal Programs 50

Appendix V Other Agency Efforts to Address Prenatal Opioid Use or Neonatal 

Abstinence Syndrome 54

Appendix VI Comments from the Office of National Drug Control Policy 55

Contents
Page ii GAO-15-203 Prenatal Drug Use and Newborn Health

Appendix VII Comments from the Department of Health and Human Services 57

Appendix VIII GAO Contact and Staff Acknowledgments 59

Related GAO Products 60

Tables

Table 1: Research Gaps Related to Prenatal Opioid Use or 

Neonatal Abstinence Syndrome (NAS) Cited by Federal 

Agency Officials and Experts 20

Table 2: Program Gaps Related to Prenatal Opioid Use or 

Neonatal Abstinence Syndrome (NAS) Cited by Federal 

Agency Officials and Experts 22

Table 3: Other Gaps, Outside of Research and Programs, Related 

to Prenatal Opioid Use or Neonatal Abstinence Syndrome 

(NAS) Cited by Federal Agency Officials and Experts 24

Table 4: List of Federal Agencies with Research, Programs, or 

Other Agency Efforts Related to Prenatal Opioid Use or 

Neonatal Abstinence Syndrome (NAS) through Fiscal 

Year 2014 35

Table 5: Descriptions of Research Projects on Prenatal Opioid 

Use and Neonatal Abstinence Syndrome (NAS) and 

Funding Obligations from Fiscal Year 2008 through 2014 

by Federal Agency 42

Table 6: Federal Programs That Addressed Prenatal Opioid Use 

or Neonatal Abstinence Syndrome (NAS) In Operation in 

Fiscal Years 2013-2014, by Federal Agency 45

Figures

Figure 1: Focus of Federally Funded Research Projects Related to 

Prenatal Opioid Use or Neonatal Abstinence Syndrome 

(NAS), Fiscal Years 2008-2014 8

Figure 2: Federal Programs That Addressed Prenatal Opioid Use 

or Neonatal Abstinence Syndrome (NAS), Fiscal Years 

2013-2014 11
Page iii GAO-15-203 Prenatal Drug Use and Newborn Health

Figure 3: Direct Services Made Available by Eight Federal 

Programs That Addressed Prenatal Opioid Use or 

Neonatal Abstinence Syndrome (NAS), Fiscal Years 

2013-2014 13

Figure 4: Federal Agencies That Made Direct Services Available 

or Engaged in Other Efforts to Address Prenatal Opioid 

Use or Neonatal Abstinence Syndrome Outside of 

Research and Programs, Fiscal Years 2008-2014 15

Figure 5: Other Efforts Conducted by 10 Agencies That 

Addressed Prenatal Opioid Use or Neonatal Abstinence 

Syndrome Outside of Research and Programs, Fiscal 

Years 2008-2014 18

Figure 6: Direct Services Made Available by Federal Programs 

that Addressed Prenatal Opioid Use or Neonatal 

Abstinence Syndrome (NAS), Fiscal Years 2013-2014 51

Figure 7: Other Activities Conducted by Federal Programs that 

Addressed Prenatal Opioid Use or Neonatal Abstinence 

Syndrome, Fiscal Years 2013-2014 52

Figure 8: Other Agency Efforts to Address Prenatal Opioid Use or 

Neonatal Abstinence Syndrome Outside of Research and 

Programs, Fiscal Years 2008-2014 54
Page iv GAO-15-203 Prenatal Drug Use and Newborn Health

Abbreviations

ACF Administration for Children and Families

BHCC Behavioral Health Coordinating Council

BOP Bureau of Prisons

CDC Centers for Disease Control and Prevention

CFDA Catalog of Federal Domestic Assistance 

CMS Centers for Medicare & Medicaid Services

DOD Department of Defense

DOJ Department of Justice

FDA Food and Drug Administration

HHS Department of Health and Human Services

HRSA Health Resources and Services Administration

IHS Indian Health Service

MOTHER Maternal Opioid Treatment: Human Experimental 

 Research

NAS neonatal abstinence syndrome

NIH National Institutes of Health

OASH Office of the Assistant Secretary for Health

OJP Office of Justice Programs

ONDCP Office of National Drug Control Policy

SAMHSA Substance Abuse and Mental Health Services 

 Administration

USDA United States Department of Agriculture

VA Department of Veterans Affairs

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Page 1 GAO-15-203 Prenatal Drug Use and Newborn Health

441 G St. N.W.

Washington, DC 20548

February 10, 2015

The Honorable Lamar Alexander

Chairman

Committee on Health, Education, Labor, and Pensions

United States Senate

The Honorable Bob Corker

United States Senate

Opioid abuse, including the increasing use of heroin and abuse of opioids 

prescribed for pain management, has been recognized by the federal 

government, states, researchers, and others as a burgeoning problem in 

the United States. The prenatal use of opioids by pregnant women—

including opioid abuse, opioids prescribed for pain management, and 

treatment for opioid addiction—can produce a withdrawal condition in 

newborns known as neonatal abstinence syndrome (NAS). Though other 

drugs may cause NAS, opioids are considered the primary cause. NAS 

symptoms range from excessive crying and irritability to difficulties with 

breathing and feeding. The incidence of NAS in the United States has 

nearly tripled over the past decade. A recent study showed that cases of 

NAS increased from a rate of 1.2 per 1,000 hospital births per year in the 

year 2000 to 3.4 per 1,000 hospital births in 2009.1

Newborns with NAS require specialized care—often in a neonatal 

intensive care unit—which results in longer hospital stays and increased 

costs. The same recent study found that treatment costs for newborns 

with NAS are, on average, more than five times the costs of treating other 

newborns at birth. Newborns with NAS stayed in the hospital an average 

of 16 days and incurred average hospital charges of about $53,000, 

compared with an average of 3 days and $9,500 for all other hospital 

births, according to data from 2009.2

 

1

Stephen W. Patrick et al., “Neonatal Abstinence Syndrome and Associated Health Care 

Expenditures: United States, 2000-2009,” JAMA, vol. 307, no. 18 (2012).

More than three-quarters of the NAS 

cases identified in the study were paid for by Medicaid, the federal-state 

program that provides health insurance coverage for certain low-income 

individuals.

2

Patrick et al., “Neonatal Abstinence Syndrome,” p. 1937.
 

Page 2 GAO-15-203 Prenatal Drug Use and Newborn Health

The Office of National Drug Control Policy (ONDCP) within the Executive 

Office of the President is the agency responsible for coordinating drug 

control efforts across the federal government. As part of its efforts, 

ONDCP highlighted maternal addiction and NAS as emerging and critical 

issues in its 2013 and 2014 annual National Drug Control Strategy

reports, and noted that these issues, together with ongoing efforts to 

reduce rates of prescription drug misuse more broadly, require 

coordinated action from public health and safety leaders at the federal, 

state, local, and tribal levels.3 ONDCP also published its prescription drug 

abuse prevention plan in 2011, which focused primarily on prescription 

opioid abuse and included actions in education, monitoring, proper 

disposal, and enforcement to reduce prescription drug abuse in the 

United States.4

Given the health and cost concerns associated with prenatal opioid use 

and NAS, you requested that we provide information on how federal 

agencies have addressed these issues. This report examines (1) federally 

funded research, federal programs, and other federal agency efforts 

related to addressing 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.

To examine federally funded research, federal programs, and other 

federal agency efforts related to prenatal opioid use or NAS, we first 

identified 15 federal departments or agencies (which, for the purposes of 

this report, we refer to collectively as agencies) that reported having 

research, programs, or other efforts related to prenatal opioid use or NAS 

 

3

See Office of National Drug Control Policy, National Drug Control Strategy, (Washington, 

D.C.: 2013 and 2014). The report, published annually, sets forth a comprehensive plan to 

reduce illicit drug use through programs intended to prevent or treat drug use or reduce 

the availability of illegal drugs in the United States.

4

ONDCP’s 2011 prescription drug abuse prevention plan included 13 goals to be achieved 

within 1 to 5 years of the plan’s enactment, subject to the availability of resources. See 

Office of National Drug Control Policy, Epidemic: Responding to America’s Prescription 

Drug Abuse Crisis (2011).
 

Page 3 GAO-15-203 Prenatal Drug Use and Newborn Health

through fiscal year 2014.5,6

• information on research projects, including data on funding 

obligations, from agencies that reported having conducted or funded 

research at any time during fiscal years 2008 through 2014;

We then requested and analyzed information, 

including documents and data, from these agencies, specifically

• information gathered using a Web-based questionnaire on federal 

programs, including data on funding obligations, from agencies that 

reported administering a program in operation during fiscal years 

2013 and 2014; and

• information on other efforts conducted outside of research and 

programs by any agency during fiscal years 2008 through 2014.

To identify gaps in efforts to address prenatal opioid use or NAS, we 

analyzed information gathered from interviews of federal agency officials 

and experts about research, program, and other gaps that may generally 

exist and were not only specific to federal efforts.7

 

5

Federal agencies we identified were ONDCP; nine agencies within the Department of 

Health and Human Services (HHS) (specifically, one staff office—the Office of the 

Assistant Secretary for Health [OASH]—and eight operating divisions: the Administration 

for Children and Families [ACF], Centers for Disease Control and Prevention [CDC], 

Centers for Medicare & Medicaid Services [CMS], Food and Drug Administration [FDA], 

Health Resources and Services Administration [HRSA], Indian Health Service [IHS], 

National Institutes of Health [NIH], and Substance Abuse and Mental Health Services 

Administration [SAMHSA]); two agencies within the Department of Justice (the Office of 

Justice Programs and the Bureau of Prisons); and the Departments of Agriculture, 

Defense, and Veterans Affairs. For the purposes of our study, we collected information on 

research, programs, and other agency efforts through May 31, 2014.

To examine how 

federal efforts to address prenatal opioid use or NAS are planned and 

coordinated, we analyzed information from documents provided by and 

interviews of officials from ONDCP and the Office of the Secretary for the 

Department of Health and Human Services (HHS). We asked ONDCP 

officials about planning and coordination with agencies across the federal 

6

Federal agencies may have broader efforts that address substance use disorders in 

pregnant women or women of childbearing age; however, the scope of this report was 

specific to those efforts that address prenatal opioid use and NAS. States as well as local 

governments may also have efforts to address prenatal opioid use or NAS; however, this 

report focuses only on federal efforts.

7

We interviewed officials from those federal agencies that had funded research or 

administered programs related to prenatal opioid use or NAS, officials from ONDCP, and 

experts (comprising expert organizations as well as individual researchers and clinicians) 

who were selected to include a variety of perspectives.
 

Page 4 GAO-15-203 Prenatal Drug Use and Newborn Health

government and HHS officials about planning and coordination across its 

department since nine of its agencies address prenatal opioid use or 

NAS. As part of our work, we reviewed the data provided by agency 

officials for any outliers, checked for errors and asked for supporting 

documentation as appropriate, and determined that the data were 

sufficiently reliable for our purposes.

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. (See appendix I for a 

more detailed description of our methodology.)

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.8

 

8

Theodore J. Cicero et al., “The Changing Face of Heroin Use in the United States: A 

Retrospective Analysis of the Past 50 Years,” JAMA Psychiatry, vol. 71, no. 7 (2014).

Two recent studies also found that 14 percent of 

pregnant private health insurance beneficiaries, and almost 22 percent of 

Background

Prenatal Opioid Use
 

Page 5 GAO-15-203 Prenatal Drug Use and Newborn Health

pregnant Medicaid beneficiaries filled a prescription for opioids during 

their pregnancy.9

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 offlabel as neither is approved for use during pregnancy.10 Methadone is 

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.

The American Academy of Pediatrics and the American Congress of 

Obstetricians and Gynecologists recommend that newborns with NAS 

should not be initially treated with medication. These organizations 

recommend behavioral treatment as the first approach, including putting 

 

9

Brian T. Bateman et al., “Patterns of Opioid Utilization in Pregnancy in a Large Cohort of 

Commercial Insurance Beneficiaries in the United States,” Anesthesiology, vol. 120, no. 5 

(2014); and Rishi J. Desai et al., “Increase in Prescription Opioid Use During Pregnancy 

Among Medicaid-Enrolled Women,” Obstetrics & Gynecology, vol. 123, no. 5 (2014).

10Off-label use refers to the prescription of a medication for uses other than what the Food 

and Drug Administration has approved.

NAS
 

Page 6 GAO-15-203 Prenatal Drug Use and Newborn Health

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.11

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.12

 

11Stephen W. Patrick et al., “Variation in treatment of neonatal abstinence syndrome in US 

Children’s Hospitals, 2004-2011,” Journal of Perinatology, vol. 34 (2014).

Federal agencies obligated 

$13.6 million for eight projects that included a focus on prevention and 

12Agencies may have obligated additional funding for these projects prior to fiscal year 

2008. Fiscal year 2014 funding obligations were reported through May 31, 2014.

Federally Funded 

Research Mostly 

Focused on NAS, and 

Federal Programs 

and Other Agency 

Efforts Made Services 

Available or 

Conducted Activities 

to Address Prenatal 

Opioid Use or NAS

Federally Funded 

Research Projects Mostly 

Focused on Prevention, 

Understanding, or 

Treatment of NAS
 

Page 7 GAO-15-203 Prenatal Drug Use and Newborn Health

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.13 (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).

14

 

13HHS officials told us that NIH also supported other research projects that did not 

specifically address prenatal opioid use or NAS but may have been related, such as 

prevention research that included pregnant women or women who may become pregnant, 

including those at risk for substance use in general and research on medication 

development or behavioral therapies to treat opioid addiction.

(See appendix II for descriptions 

of all 18 projects.)

14CDC funded three projects and reported total obligations of $1,901 toward travel for one 

study, but was unable to report obligations for the remaining two projects as they involved 

adding one question to a larger CDC questionnaire. FDA funded one project, with 

obligations of $20,000.
 

Page 8 GAO-15-203 Prenatal Drug Use and Newborn Health

Figure 1: Focus of Federally Funded Research Projects Related to Prenatal Opioid Use or Neonatal Abstinence Syndrome 

(NAS), Fiscal Years 2008-2014

Note: We analyzed data provided by NIH, FDA, and CDC. Fiscal year 2014 obligations were reported 

through May 31, 2014.

a

Neither the number of projects nor the amount of funding obligations can be summed across focus 

areas because individual projects sometimes focused on more than one research area.
 

Page 9 GAO-15-203 Prenatal Drug Use and Newborn Health

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.15

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.16

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.17

 

15One-quarter of NIH’s obligations for projects on prenatal opioid use or NAS from fiscal 

years 2008 through 2014 was for the MOTHER study.

Through a Webbased 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 

16Hendree E. Jones et al., “Neonatal Abstinence Syndrome after Methadone or 

Buprenorphine Exposure,” New England Journal of Medicine, vol. 363, no. 24 (2010).

17For the purposes of this report, we defined a program as addressing prenatal opioid use 

or NAS if agency officials reported that (1) the program made relevant direct services 

available—regardless if these services were actually provided—or (2) that the program 

conducted other activities that were relevant to prenatal opioid use or NAS. Programs 

reported information for fiscal year 2013 and for fiscal year 2014 as of May 31, 2014.

Federal Programs Made 

Direct Services Available 

or Conducted Other 

Activities to Address 

Prenatal Opioid Use or 

NAS as Part of Broader 

Objectives
 

Page 10 GAO-15-203 Prenatal Drug Use and Newborn Health

had been in existence for more than 5 fiscal years.18

 

18There were eight additional programs that agency officials identified that did not meet 

our definition of a program that addressed prenatal opioid use or NAS because officials 

reported that they did not make direct services available or conduct activities relevant to 

prenatal opioid use or NAS. Officials from these eight programs either told us that prenatal 

opioid use and NAS were outside the scope of the program, or that while services or 

activities to address prenatal opioid use or NAS were eligible expenses of program funds, 

these issues were either not addressed uniformly by funding recipients, or officials were 

unable to determine if funding was actually used for these purposes in fiscal years 2013-

2014. These programs included six within HHS (Head Start, the Maternity Group Home 

Program, and the Social Services Block Grant Program, run by the Administration for 

Children and Families; Strong Start for Mothers and Newborns, run by the Centers for 

Medicare & Medicaid Services; the Maternal and Child Health Services Block Grant to the 

States, run by the Health Resources and Services Administration; and the Title X Family 

Planning Program, run by the Office of Population Affairs within the Office of the Assistant 

Secretary for Health); as well as two within the Department of Justice (the Joint Adult Drug 

Court Solicitation to Enhance Services, Coordination and Treatment, and the Second 

Chance Act Reentry Program for Adult Offenders with Co-Occurring Substance Abuse 

and Mental Health Disorders, run by the Bureau of Justice Assistance within the Office of 

Justice Programs).

(See appendix III for 

more details on these programs.)
 

Page 11 GAO-15-203 Prenatal Drug Use and Newborn Health

Figure 2: Federal Programs That Addressed Prenatal Opioid Use or Neonatal Abstinence Syndrome (NAS), Fiscal Years 2013-

2014

Note: We analyzed data provided by federal programs through a Web-based questionnaire. Each of 

these 14 programs addressed prenatal opioid use or NAS as part of broader program objectives on 

substance abuse prevention or treatment, maternal and child health, or family and child welfare 

services. Direct services included services for women who use opioids, their newborns, or their 

families, such as screening and referral to treatment, or residential treatment for opioid use disorders. 

Other activities included the provision of training and technical assistance, or public education and 

outreach. All programs but one reported information for fiscal year 2013 and for fiscal year 2014 as of 

May 31, 2014. The Providers’ Clinical Support System for Medication Assisted Treatment only 

reported program information for fiscal year 2014 because SAMHSA officials told us that the program 

started in August 2013, but most of the program’s activity had taken place in fiscal year 2014.
 

Page 12 GAO-15-203 Prenatal Drug Use and Newborn Health

Officials from four programs reported specifically addressing prenatal 

opioid use or NAS as part of their program objectives, but none of the 

14 programs obligated funds specifically to address these issues, as the 

programs were aimed more broadly at addressing substance abuse, 

health, or welfare.

19 For example, the Substance Abuse and Mental 

Health Services Administration’s (SAMHSA) Services Grant Program for 

Residential Treatment for Pregnant and Postpartum Women—which 

included prenatal opioid use and NAS in its program objectives—has an 

overall program purpose of expanding the availability of comprehensive, 

residential substance abuse treatment, prevention, and recovery support 

services for pregnant and postpartum women and their minor children. 

The program looks broadly at prevention and treatment of all substance 

use among pregnant and postpartum women, including those who use 

opioids, as well as alcohol, tobacco, illicit drugs, and other harmful drugs 

(e.g., inhalants). In another example, the Health Resources and Services 

Administration’s (HRSA) Healthy Start program—which did not include 

prenatal opioid use and NAS in its program objectives—broadly aims to 

reduce infant mortality rates and improve perinatal outcomes in 

communities with high annual rates of infant mortality.20

Programs that made direct services available. Officials from 8 of the 

14 programs reported that their programs made direct services available 

to women who used opioids, their newborns, or other members of their 

families. These 8 programs all offered substance use screening, 

assessment, and referral for treatment, as well as case management or 

other recovery support services for women who used opioids, such as 

transportation or child care. The other most frequently reported types of 

Healthy Start 

grantees engage in various types of direct services and activities to 

achieve these goals. Officials reported that the program focuses on 

providing case management services in these communities to pregnant 

and postpartum women and their newborns, and that drug and alcohol 

screening and referral is incorporated into the case management process.

 

19The four programs that reported specifically addressing prenatal opioid use or NAS as 

part of their program objectives were HRSA and ACF’s Maternal, Infant, and Early 

Childhood Home Visiting Program, SAMHSA’s Services Grant Program for Residential 

Treatment for Pregnant and Postpartum Women, and SAMHSA and ACF’s National 

Center on Substance Abuse and Child Welfare, within HHS, along with the Department of 

Justice’s Family Drug Court Program within the Office of Justice Programs’ Office of 

Juvenile Justice and Delinquency Prevention.

20Perinatal generally refers to the weeks immediately prior to and immediately after birth. 
 

Page 13 GAO-15-203 Prenatal Drug Use and Newborn Health

direct services made available by these programs included behavioral 

treatment services for pregnant women with opioid use disorders and 

follow-up case management for newborns diagnosed with NAS. (See 

fig. 3.) (See appendix IV for more information on these 8 programs’ direct 

services.) 

Figure 3: Direct Services Made Available by Eight Federal Programs That 

Addressed Prenatal Opioid Use or Neonatal Abstinence Syndrome (NAS), Fiscal 

Years 2013-2014

Note: We analyzed data provided by federal programs through a Web-based questionnaire. The 

eight programs that reported making direct services available included seven federal programs 

administered by agencies within the Department of Health and Human Services: (1) Abandoned 

Infants; (2) Healthy Start; (3) Maternal, Infant, and Early Childhood Home Visiting Program; 

(4) Regional Partnership Grants; (5) Services Grant Program for Residential Treatment for Pregnant 

and Postpartum Women; (6) Substance Abuse Prevention and Treatment Block Grant; and (7) Tribal 

Maternal, Infant, and Early Childhood Home Visiting Program. One program, the Family Drug Court 

Program, was administered by an agency within the Department of Justice. Programs reported 

information for fiscal year 2013 and for fiscal year 2014 as of May 31, 2014.
 

Page 14 GAO-15-203 Prenatal Drug Use and Newborn Health

Programs that conducted other activities. Officials from 11 of the 14

federal programs reported conducting activities that addressed prenatal 

opioid use or NAS, 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. For example, SAMHSA officials reported that the National Center on 

Substance Abuse and Child Welfare engages in training and technical 

assistance activities to promote interagency collaboration and 

coordination between child welfare agencies, substance abuse treatment 

agencies, and the courts. 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 to various 

groups of pregnant women and women of reproductive age. For example, 

officials reported that the United States Department of Agriculture’s 

(USDA) Special Supplemental Nutrition Program for Women, Infants, and 

Children provides nutrition education to low-income, nutritionally at-risk 

pregnant and postpartum women, and that this education includes 

information on substance use during and after pregnancy. (See appendix 

IV for more information on these 11 programs’ activities.)

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 knowledgesharing groups, while three agencies reported doing both. (See fig. 4.)

Federal Agencies also 

Addressed Prenatal 

Opioid or NAS through 

Their Health Systems or 

Other Efforts Outside of 

Research and Programs
 

Page 15 GAO-15-203 Prenatal Drug Use and Newborn Health

Figure 4: Federal Agencies That Made Direct Services Available or Engaged in Other Efforts to Address Prenatal Opioid Use 

or Neonatal Abstinence Syndrome Outside of Research and Programs, Fiscal Years 2008-2014

Note: We analyzed data provided by federal agencies. Direct services included services for women 

who use opioids, their newborns, or their families, such as screening and referral to treatment, or 

residential treatment for opioid use disorders. Examples of other efforts outside of research and 

programs included participating in knowledge-sharing groups and offering provider education. 

Agencies reported information on efforts outside of research and programs through May 31, 2014.

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 
 

Page 16 GAO-15-203 Prenatal Drug Use and Newborn Health

care to its beneficiaries.21

Officials from 10 of the 11 agencies—including seven within HHS—also 

reported engaging in other efforts that addressed prenatal opioid use or 

NAS. These agencies most frequently reported conducting provider 

education or participating in relevant knowledge-sharing groups, such as 

working groups or expert panels. For example, in September 2012, CDC 

convened an expert meeting on illicit drug abuse during pregnancy, which 

was attended by federal officials, clinicians, and other experts. The 

Centers for Medicare & Medicaid Services also convened an expert panel 

on improving maternal and infant health outcomes in Medicaid and the 

State Children’s Health Insurance Program,

All of these agencies reported that substance 

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.

22

 

21IHS provides health care for American Indians and Alaska Natives who are members or 

descendants of federally recognized tribes through a system of health care facilities 

managed by IHS, tribes, or urban Indian health programs. BOP is responsible for 

overseeing the provision of health care services to federal inmates housed in BOP’s 

institutions or privately managed facilities with which BOP contracts for confinement. DOD 

administers TRICARE, its regionally structured health care program, which offers direct 

services to beneficiaries at military hospitals and clinics, known as military treatment 

facilities. VA’s Veterans Health Administration offers direct services to veterans at VA 

medical facilities. For the purposes of this study, we do not report on direct health care 

services for which the federal government pays but does not provide, such as Medicare, 

Medicaid, or DOD and VA purchased care. In addition, under section 330 of the Public 

Health Service Act, as amended, HRSA awards grants to health centers that provide 

comprehensive primary care services for the medically underserved, including many poor, 

uninsured, and Medicaid patients. While substance abuse services are generally 

considered additional health services, all health centers are required to provide referrals to 

providers for substance abuse services, and a subset of health centers is required to 

provide homeless patients with screening, diagnosis, and treatment services for 

substance use disorders. Because these health centers are funded by grants from HRSA, 

we did not count them as a health system for purposes of this review.

which included a focus on 

substance use during pregnancy, including opioids. Other frequently 

reported agency efforts included conducting relevant training or technical 

assistance to entities other than health care providers, and creating or 

updating written guidance or policies. (See fig. 5.) For example, DOD and 

VA published joint clinical practice guidelines on pregnancy management, 

22The 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.
 

Page 17 GAO-15-203 Prenatal Drug Use and Newborn Health

which include guidance for DOD and VA health care providers on 

screening for drug use and offering treatment during pregnancy.23 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.24

(See appendix V for more information on agency efforts to address 

prenatal opioid use or NAS outside of research and programs.)

 

23See Department of Defense and Department of Veterans Affairs, VA/DOD Clinical 

Practice Guideline for Pregnancy Management, 2009.

24Substance Abuse and Mental Health Services Administration, Center for Behavioral 

Health Statistics and Quality, The TEDS Report: Characteristics of Pregnant Teen 

Substance Abuse Treatment Admissions, May 2013. The source of the data used in this 

publication was the Treatment Episode Data Set, a national census data system of annual 

admissions to substance abuse treatment facilities, maintained by SAMHSA, which 

includes data on the substances for which a client was seeking treatment as well as on 

whether the client was pregnant at the time of admission to treatment.
 

Page 18 GAO-15-203 Prenatal Drug Use and Newborn Health

Figure 5: Other Efforts Conducted by 10 Agencies That Addressed Prenatal Opioid Use or Neonatal Abstinence Syndrome 

Outside of Research and Programs, Fiscal Years 2008-2014

Note: We analyzed data provided by federal agencies. The 10 agencies reporting other efforts were 

(1) Centers for Disease Control and Prevention, (2) Centers for Medicare & Medicaid Services, 

(3) Department of Defense, (4) Department of Veterans Affairs, (5) Food and Drug Administration, 

(6) Indian Health Service, (7) National Institutes of Health, (8) Office of the Assistant Secretary for 

Health, (9) Office of National Drug Control Policy, and (10) Substance Abuse and Mental Health 

Services Administration. Agencies reported information through May 31, 2014.

a

Knowledge-sharing groups refers to agency participation in, or leadership of, such groups, such as 

interagency working groups, advisory committees, or expert panels.

b

Training or technical assistance refers to training other than provider education.

c

”Other” included efforts such as conducting parenting and childbirth classes, or responding to a 

citizen’s petition on opioid labeling.
 

Page 19 GAO-15-203 Prenatal Drug Use and Newborn Health

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.)

Most Commonly 

Cited Gaps Were 

Related to Treatment 

of Prenatal Opioid 

Use or NAS

Research Gaps Cited 

Included Treatment of 

Prenatal Opioid Use and 

Long-Term Effects of 

Prenatal Opioid Exposure 

on Children
 

Page 20 GAO-15-203 Prenatal Drug Use and Newborn Health

Table 1: Research Gaps Related to Prenatal Opioid Use or Neonatal Abstinence Syndrome (NAS) Cited by Federal Agency 

Officials and Experts

Research gap Number that cited gap

Treatment of prenatal opioid use, including medication-assisted treatment 13

Long-term effects of prenatal opioid exposure in children 12

Treatment of NAS 11

Screening and diagnosing of NAS 10

Understanding of NAS and severity of NAS 10

Appropriate research methods or available data (i.e., studies of appropriate size and applied research) 7 

Knowledge of best practices in opioid prescribing 5 

Prevention, including prevention of substance use disorders or pregnancy in women with opioid use 

disorders

4 

Screening for prenatal opioid use 2 

Understanding prenatal opioid use 2 

Source: GAO. | GAO-15-203

Note: We analyzed interviews conducted with 15 federal agency officials and experts. This table 

includes those research gaps cited by at least two agency officials or experts.

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.
 

Page 21 GAO-15-203 Prenatal Drug Use and Newborn Health

• Funding structure. Research funding is typically provided for a 

limited time period, such as 5 years, making research on the longterm 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.)

Program Gaps Cited 

Included Lack of Available 

Treatment Programs and 

Provider Education
 

Page 22 GAO-15-203 Prenatal Drug Use and Newborn Health

Table 2: Program Gaps Related to Prenatal Opioid Use or Neonatal Abstinence Syndrome (NAS) Cited by Federal Agency 

Officials and Experts

Program gap Number that cited gap

Program availability (e.g., availability and appropriateness of opioid use disorder treatment for pregnant 

women and screening and treatment programs for newborns with NAS)

13 

Provider education 10

Prevention, including prevention of pregnancy through family planning and contraceptive services 7 

Public education and outreach, including on addiction 6 

Source: GAO. | GAO-15-203

Note: We analyzed interviews conducted with 15 federal agency officials and experts. This table 

includes those program gaps cited by at least two agency officials or experts. Program availability 

also includes the availability of comprehensive care and enabling services, such as transportation or 

child care.

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.
 

Page 23 GAO-15-203 Prenatal Drug Use and Newborn Health

• 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,25 issues of treatment of prenatal opioid use and NAS, 

prescription drug monitoring programs,26

 

25Safe harbor is a provision in a law or agreement that protects against any liability or 

penalty as long as set conditions have been met. For example, in Tennessee, a safe 

harbor law prevents the state’s department of children’s services from terminating parental 

rights or otherwise seeking protection of the newborn solely because of the patient’s use 

of prescription drugs for non-medical purposes during the term of her pregnancy, as long 

as the patient initiates drug treatment prior to her next regularly scheduled prenatal visit 

and maintains compliance with both drug treatment and prenatal care for the duration of 

her pregnancy.

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 

26A prescription drug monitoring program is a statewide database that collects information 

on substances dispensed in that state. It can be used to support the legitimate medical 

use of controlled substances, such as opioids prescribed for pain, and help prevent drug 

abuse and diversion.

Other Gaps Cited Included 

Lack of Guidance and 

Coordination of Efforts to 

Address Prenatal Opioid 

Use or NAS
 

Page 24 GAO-15-203 Prenatal Drug Use and Newborn Health

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.)

Table 3: Other Gaps, Outside of Research and Programs, Related to Prenatal Opioid Use or Neonatal Abstinence Syndrome 

(NAS) Cited by Federal Agency Officials and Experts

Other Gap Number that cited gap

Guidance on criminalization and “safe harbor” laws for states 7 a

Guidance on screening and treatment practices for prenatal opioid use and NAS 6 

Guidance on opioid prescribing, including prescription drug monitoring programs 6 

Guidance on Medicaid and other health insurance reimbursement structures 5 

Coordination of stakeholders such as states and provider organizations 5 

Source: GAO. | GAO-15-203

Note: We analyzed interviews conducted with 15 federal agency officials and experts. This table 

includes those gaps cited by at least two agency officials or experts.

a

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.

Safe harbor is a provision in a law or agreement that protects against any liability or penalty as long 

as set conditions have been met.

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.

ONDCP and HHS 

Plan and Coordinate 

to Address Prenatal 

Opioid Use and NAS, 

but More 

Documentation and a 

Departmental Focal 

Point Are Needed
 

Page 25 GAO-15-203 Prenatal Drug Use and Newborn Health

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.27 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.28

• 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.

For example, officials told us that ONDCP

• 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.

 

27For an entity to run and control its operations, it must have relevant, reliable, and timely 

communications relating to internal as well as external events. See GAO, Standards for 

Internal Control in the Federal Government, GAO/AIMD-00-21.3.1 (Washington, D.C.: 

Nov. 1999). GAO also previously identified information sharing as one of the purposes for 

interagency collaboration. See Managing for Results: Key Considerations for 

Implementing Interagency Collaborative Mechanisms, GAO-12-1022 (Washington, D.C.: 

Sept. 27, 2012).

28ONDCP has also provided ongoing assistance to states. For example, ONDCP assists 

the Appalachian Regional Commission, a federal-state partnership, to determine the 

extent of prenatal opioid use and NAS in that region of the country on a continuing basis. 

ONDCP has also consulted with state officials from Florida and Tennessee on NAS 

planning. ONDCP also reviewed NAS guidance to states that was being developed by the 

Association for State and Territorial Health Officials.

ONDCP Shares 

Information GovernmentWide, but Does Not 

Document Development of 

National Action Items on 

Prenatal Opioid Use and 

NAS
 

Page 26 GAO-15-203 Prenatal Drug Use and Newborn Health

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,29

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, 

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.

 

29In 2011, ONDCP published Epidemic: Responding to America’s Prescription Drug 

Abuse Crisis. The purpose of this plan was to reduce initiation and misuse of prescription 

drugs, particularly prescription opioids. There are four areas of focus for this plan, 

including public and prescriber education; expansion of prescription drug monitoring 

programs; proper medication disposal; and addressing doctor shopping and illegal 

prescribing and dispensing of prescription opioids through law enforcement. ONDCP 

officials contend that activities in the plan will reduce non-medical prescription drug use 

and in turn will reduce drug use in pregnant women and corresponding NAS rates.
 

Page 27 GAO-15-203 Prenatal Drug Use and Newborn Health

among other goals.30

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.

ONDCP had previously identified prenatal opioid 

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. 

31

 

30We have previously reported on ONDCP efforts to monitor progress made on action 

items in the National Drug Control Strategy. See GAO, Drug Control: Initial Review of the 

National Strategy and Drug Abuse Prevention and Treatment Programs, 

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 

GAO-12-744R

(Washington, D.C.: July 6, 2012); and Office of National Drug Control Policy: Office Could 

Better Identify Opportunities to Increase Program Coordination, GAO-13-333

(Washington, D.C.: Mar. 26, 2013).

31We have previously identified that documentation of meetings and agreements is a key 

feature for successful collaboration. See GAO-12-1022. 
 

Page 28 GAO-15-203 Prenatal Drug Use and Newborn Health

risk of duplication in federal efforts in this area, but have not conducted a 

systematic review of federal efforts.32

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.

 

32GAO previously reported on the need to reduce overlap, duplication, and fragmentation 

across the federal government. See GAO, 2013 Annual Report: Actions Needed to 

Reduce Fragmentation, Overlap, and Duplication and Achieve Other Financial Benefits, 

GAO-13-279SP (Washington, D.C.: Apr. 9, 2013).
 

Page 29 GAO-15-203 Prenatal Drug Use and Newborn Health

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.33 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.34

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.35

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 

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.

 

33The nine agencies that address prenatal opioid use or NAS include one staff office—

OASH—and eight operating divisions, ACF, CDC, CMS, FDA, HRSA, IHS, NIH, and 

SAMHSA. HHS has identified eliminating use of illicit drugs—including heroin and the 

nonmedical use of prescription opioids—by pregnant women as one of its goals for its 

Healthy People 2020 public health initiative which provides science-based, 10-year, 

national objectives for improving health in the United States. One HHS staff office and two 

HHS operating divisions collaborate to oversee progress toward this goal on illicit drug use 

during pregnancy; however, it is not specific to prenatal opioid use.

34One example of this partnership included a review of state policies and practices for 

addressing prenatal substance exposure. See Department of Health and Human Services,

Administration for Children and Families and Substance Abuse and Mental Health 

Services Administration, Substance‐Exposed Infants: State Responses to the Problem, 

HHS Pub. No. (SMA) 09‐4369 (Rockville, Md.: 2009).

35OASH officials told us that they have 13 program offices that coordinate cross-cutting 

HHS initiatives and strategic plans on priority topics with the goal of mobilizing leadership 

in science and prevention for a healthier nation. Through these offices, OASH collaborates 

with other staff offices within the Office of the Secretary and with HHS’s operating 

divisions.

Within HHS, Agencies 

Plan and Coordinate on 

Individual Efforts to 

Address Prenatal Opioid 

Use and NAS, but Do Not 

Have A Focal Point to 

Lead Efforts DepartmentWide
 

Page 30 GAO-15-203 Prenatal Drug Use and Newborn Health

to mental health and substance use and abuse.36 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.37 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.38

Although HHS officials told us about individual agency efforts and 

departmental activities that may address or influence prenatal opioid use 

or NAS, HHS officials indicated that no lead had been established for 

planning and coordination of all efforts related to prenatal opioid use and 

NAS across the department.39

 

36The BHCC was established in 2010, is co-chaired by the Assistant Secretary for Health 

of HHS and the Administrator of SAMHSA, and includes officials across multiple HHS 

agencies.

SAMHSA officials told us that SAMHSA is 

not responsible for planning and coordination across HHS, and OASH 

officials told us their ad hoc workgroup will only involve OASH offices and 

37In a report on prescription drug abuse that primarily focused on opioid analgesics, the 

subcommittee proposed action to support the development and testing of behavioral 

interventions for screening and treating prescription drug abuse, including interventions 

targeting youth and pregnant women. See Department of Health and Human Services, 

Addressing Prescription Drug Abuse in the United States: Current Activities and Future 

Opportunities (Sept. 2013), accessed Jan. 15, 2015, 

http://www.cdc.gov/homeandrecreationalsafety/overdose/hhs_rx_abuse.html. 

38See Food and Drug Administration, FDA Blueprint for Prescriber Education for 

Extended-Release and Long-Acting Opioid Analgesics, Reference ID 3612128, (Aug. 

2014), accessed Nov. 19, 2014, 

http://www.fda.gov/downloads/Drugs/DrugSafety/InformationbyDrugClass/UCM277916.pd

f. 

39We have previously reported that identification of a leader is a key feature for successful 

collaboration. See GAO-12-1022. 
 

Page 31 GAO-15-203 Prenatal Drug Use and Newborn Health

not other HHS agencies.40 Further, the BHCC does not systematically 

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 knowledgesharing 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 

 

40SAMHSA is required to promote the coordination of service programs conducted by 

other departments, agencies, organizations and individuals that are or may be related to 

the problems of individuals suffering from mental illness or substance abuse, including 

liaisons with the Social Security Administration, CMS, and other programs of HHS, as well 

as liaisons with the Department of Education, the Department of Justice, and other federal 

departments and offices, as appropriate. See 42 U.S.C. § 290aa(d)(18).

Conclusions
 

Page 32 GAO-15-203 Prenatal Drug Use and Newborn Health

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, 

Recommendations

Agency Comments
 

Page 33 GAO-15-203 Prenatal Drug Use and Newborn Health

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. 

Vijay A. D’Souza

Director, Health Care
Appendix I: Scope and Methodology

Page 34 GAO-15-203 Prenatal Drug Use and Newborn Health

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 2014.1 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.2 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.)

 

1

For the purposes of our study, we collected information on research, programs, and other 

agency efforts through May 31, 2014.

2

CFDA is a government-wide compendium of federal programs, projects, services, and 

activities that provide federal assistance to the American public. CFDA can be accessed 

at https://www.cfda.gov/. 

Appendix I: Scope and Methodology
Appendix I: Scope and Methodology

Page 35 GAO-15-203 Prenatal Drug Use and Newborn Health

Table 4: List of Federal Agencies with Research, Programs, or Other Agency Efforts 

Related to Prenatal Opioid Use or Neonatal Abstinence Syndrome (NAS) through 

Fiscal Year 2014

Executive Office of the President

1. Office of National Drug Control Policy

Department of Health and Human Services

2. Office of the Assistant Secretary for Health

3. Administration for Children and Families

4. Centers for Disease Control and Prevention

5. Centers for Medicare & Medicaid Services

6. Food and Drug Administration

7. Health Resources and Services Administration

8. Indian Health Service

9. National Institutes of Health

10. Substance Abuse and Mental Health Services Administration

Department of Justice

11. Bureau of Prisons

12. Office of Justice Programs

Other Agencies

13. Department of Agriculture

14. Department of Defense

15 Department of Veterans Affairs

Source: GAO. | GAO-15-203

Note: For the purposes of our study, we collected information on research, programs, and other 

agency efforts through May 31, 2014. Other than the Office of National Drug Control Policy, we did 

not report the individual agencies within each federal department unless there were at least two 

agencies with research, programs, or other agency efforts related to prenatal opioid use or NAS.

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 
Appendix I: Scope and Methodology

Page 36 GAO-15-203 Prenatal Drug Use and Newborn Health

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.3 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.4

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 

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.

 

3

A federal program may include, but is not limited to, (1) grants, cooperative agreements, 

contracts, or funding provided through other mechanisms to state, local, tribal, nonprofit, 

or academic entities, or service providers; and (2) services directly offered or activities 

directly conducted through a program by the federal agency itself. For the purposes of our 

study, we do not report on direct health care services for which the federal government 

pays for but does not provide, such as Medicare, Medicaid, or the Department of Defense 

and the Department of Veterans Affairs purchased care.

4

HHS’s Federal Program Inventory describes each of the programs that HHS administers 

across its agencies as well as how each program supports the department’s broader 

strategic goals and strategic objectives. It can be accessed at 

http://www.hhs.gov/budget/2013-program-inventory/federal-program-inventory.html. 
Appendix I: Scope and Methodology

Page 37 GAO-15-203 Prenatal Drug Use and Newborn Health

use or NAS.5 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.6 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.7

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 

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.

 

5

All programs but one reported information for fiscal year 2013 and for fiscal year 2014 as 

of May 31, 2014. We collected only fiscal year 2014 information on one federal program 

that began in August 2013 because agency officials told us that the program conducted 

most of its activities during fiscal year 2014. All programs that reported information for 

fiscal year 2013 reported that they were still in operation in fiscal year 2014 as of May 31, 

2014, and that no program changes had taken place after fiscal year 2013 that would 

have impacted their questionnaire responses.

6

Our questionnaire asked if programs made relevant direct services available to women 

who used opioids, their newborns, or their families, such as screening and referral to 

treatment, or medication-assisted treatment for opioid addiction. The questionnaire also 

asked if programs engaged in other activities beyond direct services that addressed 

prenatal opioid use or NAS, such as training and technical assistance or public education 

and outreach.

7

To report on the number of years in operation, we asked agency officials if the program 

had been in existence for less than 1 fiscal year, 1 to 2 fiscal years, 3 to 5 fiscal years, or 

more than 5 fiscal years (rounded to the nearest whole fiscal year). For the purposes of 

our report, the term evidence-based refers to direct services and activities that are 

validated by some form of documented scientific data to indicate effectiveness.
Appendix I: Scope and Methodology

Page 38 GAO-15-203 Prenatal Drug Use and Newborn Health

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 2014.8

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 

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.

 

8

Agencies reported information on other efforts to address prenatal opioid use or NAS for 

fiscal year 2014 as of May 31, 2014.
Appendix I: Scope and Methodology

Page 39 GAO-15-203 Prenatal Drug Use and Newborn Health

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.9 We obtained testimonial evidence 

from officials representing nine federal agencies and six experts from 

which we requested information.10

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 

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.

 

9

These experts included officials from the American Academy of Pediatrics; the American 

Congress of Obstetricians and Gynecologists and the American Society of Addiction 

Medicine; the Johns Hopkins Bayview Medical Center, Center for Addiction and 

Pregnancy; the March of Dimes; and two prominent researchers on these topics. Because 

we interviewed experts from the American Congress of Obstetricians and Gynecologists 

and the American Society of Addiction Medicine together in one interview and were 

unable to separate the responses of officials from the two organizations, we count these 

organizations jointly as one expert for our reporting purposes.

10We obtained information on gaps from officials representing seven HHS agencies 

(Administration for Children and Families, Centers for Disease Control and Prevention, 

Centers for Medicare & Medicaid Services, Food and Drug Administration, National 

Institutes of Health, Office of the Assistant Secretary for Health, and the Substance Abuse 

and Mental Health Services Administration), as well as ONDCP and the Department of 

Justice’s Office of Justice Programs.
Appendix I: Scope and Methodology

Page 40 GAO-15-203 Prenatal Drug Use and Newborn Health

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.
Appendix II: Federally Funded Research 

Projects on Prenatal Opioid Use or Neonatal 

Abstinence Syndrome

Page 41 GAO-15-203 Prenatal Drug Use and Newborn Health

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.1 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.)

 

1

Three projects were intramural research, which are projects conducted by agency 

scientists.

Appendix II: Federally Funded Research 

Projects on Prenatal Opioid Use or Neonatal 

Abstinence Syndrome
Appendix II: Federally Funded Research 

Projects on Prenatal Opioid Use or Neonatal 

Abstinence Syndrome

Page 42 GAO-15-203 Prenatal Drug Use and Newborn Health

Table 5: Descriptions of Research Projects on Prenatal Opioid Use and Neonatal Abstinence Syndrome (NAS) and Funding 

Obligations from Fiscal Year 2008 through 2014 by Federal Agency

Project name Project summary

Active or 

completed

Funding obligations 

(dollars in millions)

Research projects funded by National Institutes of Health (NIH)

Maternal Opioid 

Treatment: Human 

Experimental 

Research (MOTHER)

Compared the effects of buprenorphine maintenance treatment to 

methadone maintenance treatment in pregnant women with opioid 

use disorders, for the prevention of, or lessening the severity of, 

NAS in newborns born to the study participants; examined the need 

for dosing changes during late pregnancy and the immediate postpartum period; and assessed the outcome of infants during the first 

36 months of life.

Completed $4.6

Monitoring In Utero 

Drug Exposure

Investigates the presence of drugs in a variety of maternal and fetal 

biological fluids to better detect and understand the process involved 

in the transfer of drugs across the placental membrane. 

Active 2.8 a

Prevention of NAS Determines the effects of prenatal illegal drug exposure on 

consequent health and development of children aged 12-15 years; 

the role of protective factors; and the specific development of 

children growing up in adverse conditions.

Active 2.5

Reinforcement Based 

Treatment for 

Pregnant Drug 

Abusers

Examines reinforcement-based treatment—an integration of 

behavioral treatment with highly individualized treatment plans and 

case management—factors that determine which treatment level is 

best for which patient, and the cost-effectiveness of reinforcementbased treatment. Other outcome measures include neonatal 

measures of length of hospitalization, physical birth parameters, 

neurological integrity, and behavioral functioning.

Active 2.4

Fetal and Infant 

Neurobehavioral 

Effects of Maternal 

Buprenorphine 

Treatment

Examines the neurobehavioral outcomes from the fetal period 

through the first month of life for newborns of opiate-addicted 

mothers treated with buprenorphine during pregnancy. Examines 

sex differences in NAS expression and neurobehavioral functioning 

in breastfed buprenorphine-exposed newborns and determines how 

these differences and concentrations of buprenorphine in breast milk 

affect the risk/benefit ratio of breastfeeding in mothers with opioid 

use disorders treated with buprenorphine.

Active 2.2

Improving Outcome in 

NAS

Compares the efficacy of morphine and methadone in relieving the 

symptoms of NAS.

Active 2.1

A Comparison of 

Buprenorphine Versus 

Methadone in the 

Treatment of NAS

Demonstrates whether buprenorphine is more effective than 

morphine in length of treatment and duration of hospitalization for 

the treatment of NAS in newborns born to women with opioid use 

disorders. 

Active 1.9

Testing the Reliability 

and Validity of Pupil 

Diameter in Opioidexposed Neonates

Tests the reliability and validity of pupil size (a common measure of 

the severity of withdrawal from opioids) in opioid-exposed newborns 

to improve the detection and treatment of withdrawal signs in the 

population.

Active 1.2

Fetal and Infant 

Neurobehavior in 

Opiate Dependent 

Women

Evaluated the variability in fetal functioning related to methadone 

exposure, changes in fetal functioning related to methadone dosing, 

and differences between the effects of methadone and 

buprenorphine on fetal and newborn behavior.

Completed 0.8
Appendix II: Federally Funded Research 

Projects on Prenatal Opioid Use or Neonatal 

Abstinence Syndrome

Page 43 GAO-15-203 Prenatal Drug Use and Newborn Health

Project name Project summary

Active or 

completed

Funding obligations 

(dollars in millions)

Methadone 

Maintenance Therapy: 

a Breastfeeding 

Intervention for 

Pregnant Women

Monitored the proportion of women who breastfed and the length of 

time women breastfed, as well as the impact of breastfeeding on 

substance use and health outcomes for methadone-exposed 

mother-newborn pairs after psycho-educational breastfeeding 

intervention (encouragement to breastfeed).

Completed 0.4

Tobacco Use in Opioid 

Agonist Treated 

Pregnant Women

Examined the role tobacco has on the incidence and severity of NAS 

in methadone-maintained women.

Completed 0.3

Abstinence and Drug 

Withdrawal: Innovative 

Translational Methods 

for Neonates

Quantifies physiological changes due to abstinence and drug 

withdrawal in newborns and investigates whether gentle stimulation 

of a vibrating mattress can improve cardio-respiratory stability in 

these newborns. 

Active 0.2

Buprenorphine 

Treatment of NAS

Evaluated the safety, efficacy, and pharmacokinetics of 

buprenorphine in comparison to morphine in newborns with NAS, 

and examined treatment parameters for NAS with buprenorphine.

Completed 0

Clonidine Treatment 

for NAS

b

Tested the efficacy of different medications for the treatment of NAS 

in newborns born to mothers using heroin or maintained on 

methadone.

Completed 0

Research projects funded by Food and Drug Administration (FDA)

b

Safer Use of Narcotics 

in Pregnant and 

Lactating Women

Examined whether and how narcotics can be used safely in 

pregnant and lactating women to better inform labeling of narcotics 

for use by these populations.

Completed Less than 0.1 million a

Research projects funded by Centers for Disease Control and Prevention (CDC)

c

CDC Epi-Aid 2011 025 

Maternal Drug Use 

and Its Impact on 

Neonates: Washington 

State, 2000-2008

Examined the impact of maternal drug use on newborns in 

Washington state. Annual drug-exposure and NAS rates were 

calculated, types of drugs of exposure identified, and predictors of 

newborns being drug-exposed and born with NAS were examined.

Completed Less than 0.1 million a

National Birth Defects 

Prevention Study

d

Examined causes of birth defects though self-reported exposures, 

including prescription and illicit drug use. One question related to 

prenatal opioid use was added to a maternal questionnaire.

Completed n/a

Birth Defects Study to 

Evaluate Pregnancy 

Exposures

e

Examined causes of birth defects though self-reported exposures, 

including prescription and illicit drug use. One question related to 

prenatal opioid use was added to a maternal questionnaire.

Active n/a

Source: GAO. | GAO-15-203

e

Note: We analyzed information provided by NIH, FDA, and CDC. Information provided was through 

May 31, 2014.

a

These projects were intramural studies conducted by agency scientists. All other studies were 

extramural and were conducted through awards to universities, medical schools, research 

organizations, and private companies.

b

These projects were ongoing without the obligation of new funds from fiscal years 2008 through 

2014.

c

The obligations for this project were $20,000.

d

The obligations for this project were $1,901.

e

CDC was unable to determine the obligations for these projects because they involved adding one 

question to a large CDC questionnaire.
Appendix III: Federal Programs that Addressed 

Prenatal Opioid Use or Neonatal Abstinence 

Syndrome

Page 44 GAO-15-203 Prenatal Drug Use and Newborn Health

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.1

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.)

 

1

For the purposes of our report, we defined a program as addressing prenatal opioid use 

or NAS if agency officials responded that (1) the program made relevant direct services 

available—regardless of whether these services were actually provided; or (2) the 

program conducted other activities that were relevant to prenatal opioid use or NAS.

Programs reported information for fiscal year 2013 and for fiscal year 2014 as of May 31, 

2014.

Appendix III: Federal Programs that 

Addressed Prenatal Opioid Use or Neonatal 

Abstinence Syndrome
Appendix III: Federal Programs that Addressed 

Prenatal Opioid Use or Neonatal Abstinence 

Syndrome

Page 45 GAO-15-203 Prenatal Drug Use and Newborn Health

Table 6: Federal Programs That Addressed Prenatal Opioid Use or Neonatal Abstinence Syndrome (NAS) In Operation in 

Fiscal Years 2013-2014, by Federal Agency

Program name 

(Agency)

Program 

type a

Number of 

fiscal years 

in operation Program description

Types of funding 

recipients

Total program 

funding 

obligations in 

fiscal year 2013

Programs administered by Department of Health and Human Services (HHS) agencies

b

Substance Abuse 

Prevention and 

Treatment Block 

Grantc

Substance 

abuse 

prevention 

 or treatment

(SAMHSA) 

More than 

5 years

Plan, implement, and evaluate activities 

to prevent and treat substance abuse. 

Block grant recipients are required to 

spend at least 5 percent of funds to 

increase the availability of treatment 

services designed for pregnant women 

and women with dependent children, 

either by establishing new programs or 

expanding the capacity of existing 

programs.

State or local health 

departments; state 

or local Medicaid, 

behavioral health, 

and welfare 

services agencies; 

tribes and tribal 

organizations

d

$1.6 billion

Maternal, Infant, 

and Early 

Childhood Home 

Visiting 

Programc,e,f

Maternal 

and child 

health; 

family and 

child welfare 

(HRSA/ACF) services

3-5 years Facilitates collaboration and partnership 

at the federal, state, and community 

levels to improve health and development 

outcomes in at-risk communities through 

voluntary evidence-based home visiting 

programs serving women during 

pregnancy and families with young 

children up to age five. Eligible families 

that have a history of substance abuse or 

need substance abuse treatment are 

identified as a priority population.

State or local health 

departments; 

national, state, or 

local nonprofit 

organizations

377.9 million

Healthy Startg Maternal 

and child 

health

(HRSA) 

More than 

5 years

Provides case management services for 

pregnant and postpartum women and 

their babies. Programs have incorporated 

drug and alcohol screening as a part of 

the case management process and 

women who test positive are referred to 

services as needed. Case managers 

work with women and health providers to 

identify children born to women with drug 

and alcohol problems.

State or local health 

departments; state 

or local behavioral 

health agencies; 

tribes and tribal 

organizations; 

academic 

institutions; public 

nonprofit social 

service agencies 

and hospitals

98.0 million

Services Grant 

Program for 

Residential 

Treatment for 

Pregnant and 

Postpartum 

Womenc,e 

Substance 

abuse 

prevention 

or treatment

(SAMHSA) 

More than 

5 years

Offers comprehensive, residential 

substance abuse treatment, prevention, 

and recovery support services for 

pregnant and postpartum woman and 

their minor children, including services for 

non-residential family members of both 

women and children.

State or local health 

departments; state 

or local behavioral 

health agencies; 

state or local 

nonprofit 

organizations; 

tribes and tribal 

organizations; 

academic 

institutions

15.6 million
Appendix III: Federal Programs that Addressed 

Prenatal Opioid Use or Neonatal Abstinence 

Syndrome

Page 46 GAO-15-203 Prenatal Drug Use and Newborn Health

Program name 

(Agency)

Program 

type a

Number of 

fiscal years 

in operation Program description

Types of funding 

recipients

Total program 

funding 

obligations in 

fiscal year 2013

Regional 

Partnership 

Grants (ACF)

b

Substance 

abuse 

prevention 

or treatment

More than 

5 years

Supports interagency collaborations and 

the integration of programs, services, and 

activities designed to increase the wellbeing, improve the permanency, and 

enhance the safety of children who are 

in, or at risk of, out-of-home placements 

as a result of a parent or caregiver’s 

substance abuse. Partnerships will 

implement varied interventions, such as 

family drug courts, comprehensive 

substance abuse treatment, or in-home 

parenting and child safety support for 

families.

State or local health 

departments; state 

or local behavioral 

health and welfare 

services agencies, 

courts, and 

nonprofit 

organizations; 

tribes and tribal 

organizations; 

academic 

institutions

15.0 million

Tribal Maternal, 

Infant, and Early 

Childhood Home 

Visiting 

Programc,f 

Maternal 

and child 

health; 

family and 

child welfare 

(ACF/HRSA) services

3-5 years Provides funding to tribal organizations to 

develop, implement, and evaluate home 

visiting programs to support children and 

families in American Indian and Alaska 

Native communities.

Tribes, consortia of 

tribes, tribal 

organizations, and 

urban Indian 

organizations

11.5 million

Abandoned 

Infantsh Maternal and child 

health; 

family and 

child welfare 

services

 (ACF) 

More than 

5 years

Provides support for the development, 

implementation and operation of projects 

to demonstrate strategies or approaches 

to prevent abandonment of infants and 

young children with HIV/AIDS, and/or 

drug-exposed infants, and to reunify and 

strengthen families.

State or local 

welfare services 

agencies; state or 

local courts; state 

or local nonprofit 

organizations; 

academic 

institutions

10.8 million

Addiction 

Technology 

Transfer Centersc

Substance 

abuse 

prevention 

(SAMHSA) or treatment

More than 

5 years

Seeks to develop and strengthen the 

workforce that provides addiction 

treatment and recovery support services 

to those in need. In partnership with 

various stakeholders, the ATTCs assess 

the training and development needs of 

the substance use disorders workforce, 

and develop and conduct training and 

technology transfer activities to meet 

identified needs.

Academic 

institutions

9.1 million
Appendix III: Federal Programs that Addressed 

Prenatal Opioid Use or Neonatal Abstinence 

Syndrome

Page 47 GAO-15-203 Prenatal Drug Use and Newborn Health

Program name 

(Agency)

Program 

type a

Number of 

fiscal years 

in operation Program description

Types of funding 

recipients

Total program 

funding 

obligations in 

fiscal year 2013

National Center 

on Substance 

Abuse and Child 

Welfare

b

e,h 

Substance 

abuse 

prevention 

or treatment

(SAMHSA/ACF) 

More than 

5 years

Educates professionals and facilitates 

collaboration across diverse service 

systems to effectively identify and provide 

comprehensive services for substance 

exposed infants and their families, 

including on prenatal opioid use. 

Objective is to improve family recovery, 

safety, and stability by advancing 

practices and collaboration among 

agencies, organizations, and courts 

working with families affected by 

substance use and co-occurring mental 

health disorders and child abuse or 

neglect.

For-profit, small 

business consulting 

agency (otherwise 

activities conducted 

directly by center)

3.9 million

National 

Abandoned 

Infants 

Assistance 

Resource Centerh

Maternal 

and child 

health; 

family and 

child welfare 

(ACF) services

More than 

5 years

Provides state and local, private, nonprofit agencies and organizations serving 

children and families impacted by 

substance abuse and/or HIV/AIDS with 

access to evidence-based information, 

methods, techniques, and strategies for 

establishing an effective, coordinated 

range of comprehensive social and 

health care services.

None (activities 

conducted directly 

by center)

1.1 million

Providers’ Clinical 

Support System 

for the 

Appropriate Use 

of Opioids in the 

Treatment of Pain 

and OpioidRelated 

Addictionc

Substance 

abuse 

prevention 

or treatment

(SAMHSA) 

3-5 years Provides training and education, and 

aims to establish a national mentoring 

network, on the safe and effective 

prescribing of opioid medications in the 

treatment of pain and/or opioid use 

disorders. Training and education 

provided to prescribers and/or 

prescribers-in-training from diverse 

healthcare professions including 

physicians, nurses, dentists, physician 

assistants, pharmacists, and program 

administrators.

National nonprofit 

organizations

0.5 million

Providers’ Clinical 

Support System 

for Medication 

Assisted 

Treatmentc

Substance 

abuse 

prevention 

or treatment

(SAMHSA) 

1-2 years Mentoring program that provides 

guidance, direction, and advice to 

prescribers and key health professionals 

who are new to the field of medicationassisted treatment. Provides waiver 

training for physicians interested in 

providing buprenorphine treatment under 

the Drug Addiction Treatment Act of 

2000, which registers physicians desiring 

to treat addictive disorders outside of 

traditional opioid treatment programs.

National nonprofit 

organizations

n/a (funds were 

not obligated until 

fiscal year 2014)
Appendix III: Federal Programs that Addressed 

Prenatal Opioid Use or Neonatal Abstinence 

Syndrome

Page 48 GAO-15-203 Prenatal Drug Use and Newborn Health

Program name 

(Agency)

Program 

type a

Number of 

fiscal years 

in operation Program description

Types of funding 

recipients

Total program 

funding 

obligations in 

fiscal year 2013

Programs administered by non-HHS agencies

b

Special 

Supplemental 

Nutrition Program 

for Women, 

Infants, and 

Children (USDA)

Maternal 

and child 

health; food 

and nutrition

More than 

5 years

Provides nutritious supplemental food, 

nutrition education, and referrals to health 

and other social services to low-income, 

nutritionally at-risk pregnant, postpartum 

and breastfeeding women, infants and 

children up to age 5.

State or local health 

departments; tribes 

or tribal 

organizations

4.5 billion

Family Drug 

Court Programe,g Substance abuse 

prevention 

or treatment

(OJP within DOJ)

More than 

5 years

Seeks to build the capacity of states, 

state courts, local courts, units of local 

government, and federally recognized 

tribal governments to either implement 

new or enhance pre-existing drug courts. 

The programs must provide services to 

parents in the program and their children. 

The program’s goal is to provide parents 

with substance use disorders who are 

involved in the family judicial system with 

support, treatment, and access to 

services that will protect children, reunite 

families, when safe to do so, and 

expedite permanency.

State or local health

departments; state 

or local behavioral 

health agencies; 

state or local 

courts; tribes or 

tribal organizations

4.9 million

Legend: ACF = Administration for Children and Families; DOJ = Department of Justice; HRSA = Health Resources and Services Administration; OJP = 

Office of Justice Programs; SAMHSA = Substance Abuse and Mental Health Services Administration; USDA = United States Department of Agriculture.

Source: GAO. | GAO-15-203

Notes: We analyzed data provided by federal programs through a Web-based questionnaire. We 

defined a program as addressing prenatal opioid use or NAS if agency officials responded in the 

questionnaire that (1) the program made relevant direct services available—regardless of whether 

these services were actually provided; or (2) the program conducted other activities that were 

relevant to prenatal opioid use or NAS.

a

If multiple agencies are listed, the agency listed first reported that it is the primary administrator of 

the program.

b

We report funding obligations for fiscal year 2013 because fiscal year 2013 was the most recent year 

for which complete obligations data were available. Funding obligations refer to total obligations for 

the entire program in fiscal year 2013 and are not specific to prenatal opioid use or NAS. Officials 

from all of the programs in our scope reported that there were no funds obligated specifically for 

addressing prenatal opioid use or NAS. We do not report 2014 funding obligations because those 

data were not available at the time of our review.

c

Program requires direct services or activities related to prenatal opioid use or NAS to be evidencebased. For the purposes of our report, the term evidence-based refers to direct services and activities 

that are validated by some form of documented scientific data to indicate effectiveness.

d

See 42 U.S.C. §300x-22(b)(1)(C).

e

Agency officials reported that addressing prenatal opioid use or NAS is included in the program’s 

objectives.

f

HRSA and ACF jointly administer the Maternal, Infant, and Early Childhood Home Visiting Program, 

with ACF administering the tribal portion of the program. For the purposes of our report, we provide 

information separately for HRSA’s Maternal, Infant, and Early Childhood Home Visiting Program, and 

ACF’s Tribal Maternal, Infant, and Early Childhood Home Visiting Program.
Appendix III: Federal Programs that Addressed 

Prenatal Opioid Use or Neonatal Abstinence 

Syndrome

Page 49 GAO-15-203 Prenatal Drug Use and Newborn Health

g

Program does not require direct services or activities related to prenatal opioid use or NAS to be 

evidence-based.

h

Program prefers or encourages—but does not require—direct services or activities related to 

prenatal opioid use or NAS to be evidence-based.
Appendix IV: Direct Services Made Available 

and Program Activities Conducted by Federal 

Programs

Page 50 GAO-15-203 Prenatal Drug Use and Newborn Health

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 opioidexposed 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.)

Appendix IV: Direct Services Made Available 

and Program Activities Conducted by 

Federal Programs
Appendix IV: Direct Services Made Available 

and Program Activities Conducted by Federal 

Programs

Page 51 GAO-15-203 Prenatal Drug Use and Newborn Health

Figure 6: Direct Services Made Available by Federal Programs that Addressed Prenatal Opioid Use or Neonatal Abstinence 

Syndrome (NAS), Fiscal Years 2013-2014

Note: We analyzed data provided by federal programs through a Web-based questionnaire. For the 

purposes of our study, we collected information on programs for fiscal year 2013 and for fiscal year 

2014 through May 31, 2014.

a

If multiple agencies are listed, the agency listed first reported that it is the primary administrator of 

the program.

b

Program made direct services available to opioid-exposed newborns.

c

Program made direct services available to family members of pregnant women who used opioids or 

to family members of opioid-exposed newborns.
Appendix IV: Direct Services Made Available 

and Program Activities Conducted by Federal 

Programs

Page 52 GAO-15-203 Prenatal Drug Use and Newborn Health

Figure 7: Other Activities Conducted by Federal Programs that Addressed Prenatal Opioid Use or Neonatal Abstinence 

Syndrome, Fiscal Years 2013-2014

Note: We analyzed data provided by federal programs through a Web-based questionnaire. For the 

purposes of our study, we collected information on programs for fiscal year 2013 and for fiscal year 

2014 through May 31, 2014.

a

If multiple agencies are listed, the agency listed first reported that it is the primary administrator of 

the program.

b

Provided training or technical assistance to entities such as community agencies, hospital staff, and 

multi-disciplinary teams.

c

Provided training or technical assistance to staff from national, state, or local nonprofit organizations.
Appendix IV: Direct Services Made Available 

and Program Activities Conducted by Federal 

Programs

Page 53 GAO-15-203 Prenatal Drug Use and Newborn Health

d

Provided training or technical assistance to tribes or tribal organization staff; staff from national, state 

or local nonprofit organizations; health care providers who provide obstetric or prenatal care; and 

health care providers who provide treatment services for opioid use disorders.

e

Provided training or technical assistance to home visitors such as nurses, social workers, parent 

educators, and community health workers.

f

Provided training or technical assistance to health care providers who may serve women with opioid 

use disorders. 

g

Provided training or technical assistance to officials from state or local health departments and 

Medicaid, behavioral health, or welfare services agencies; state or local courts; national, state, or 

local nonprofit organizations; academic institution staff; health care providers who provide obstetric or 

prenatal care; health care providers who provide treatment services for opioid use disorders; and 

legal professionals. Agency officials reported that this program provided public education and

outreach to health care providers, child welfare professionals, family drug treatment courts, and 

substance abuse professionals, rather than to women who used opioids or their family members.

h

Provided training or technical assistance to health care providers who provide treatment services for 

opioid use disorders; health care providers who provide obstetric or prenatal care; and health care 

providers who prescribe opioids for pain management.

i

Provided training or technical assistance to officials from state or local health departments and 

Medicaid, behavioral health, and welfare services agencies.

j

Provided training or technical assistance to officials from state or local health departments and 

behavioral health agencies, state or local courts, tribes or tribal organizations, and legal 

professionals.

k

Provided training or technical assistance to state or local health department officials and program 

staff.
Appendix V: Other Agency Efforts to Address 

Prenatal Opioid Use or Neonatal Abstinence 

Syndrome

Page 54 GAO-15-203 Prenatal Drug Use and Newborn Health

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.)

Figure 8: Other Agency Efforts to Address Prenatal Opioid Use or Neonatal Abstinence Syndrome Outside of Research and 

Programs, Fiscal Years 2008-2014

Note: We analyzed data provided by federal agencies. For the purposes of our study, we collected 

information on agency efforts outside of research and programs through May 31, 2014.

a

Knowledge-sharing groups included groups such as interagency working groups, advisory 

committees, or expert panels.

b

”Other” included efforts such as conducting parenting and childbirth classes, or responding to a 

citizen’s petition on opioid labeling.

Appendix V: Other Agency Efforts to Address 

Prenatal Opioid Use or Neonatal Abstinence 

Syndrome
Appendix VI: Comments from the Office of 

National Drug Control Policy

Page 55 GAO-15-203 Prenatal Drug Use and Newborn Health

Appendix VI: Comments from the Office of 

National Drug Control Policy
Appendix VI: Comments from the Office of 

National Drug Control Policy

Page 56 GAO-15-203 Prenatal Drug Use and Newborn Health
Appendix VII: Comments from the Department 

of Health and Human Services

Page 57 GAO-15-203 Prenatal Drug Use and Newborn Health

Appendix VII: Comments from the 

Department of Health and Human Services
Appendix VII: Comments from the Department 

of Health and Human Services

Page 58 GAO-15-203 Prenatal Drug Use and Newborn Health
Appendix VIII: GAO Contact and Staff 

Acknowledgments

Page 59 GAO-15-203 Prenatal Drug Use and Newborn Health

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.

Appendix VIII: GAO Contact and Staff 

Acknowledgments

GAO Contact

Staff 

Acknowledgments
Related GAO Products

Page 60 GAO-15-203 Prenatal Drug Use and Newborn Health

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).

Related GAO Products

(291168)
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