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United States Government Accountability Office: 
GAO: 

Report to Congressional Requesters: 

February 2015: 

Prenatal Drug Use and Newborn Health: 

Federal Efforts Need Better Planning and Coordination: 

GAO-15-203: 

GAO Highlights: 

Highlights of GAO-15-203, a report to congressional requesters. 

Why GAO Did This Study: 

The prenatal use of opioids, including heroin and opioids prescribed 
for pain management, can produce a withdrawal condition in newborns 
known as NAS. A recent study found that cases of NAS have tripled over 
the last decade and that treatment costs for newborns with NAS-—most 
of which are paid by Medicaid—-are more than five times the cost of 
treating other newborns at birth. 

GAO was asked to provide information on how federal agencies have 
addressed prenatal opioid use and NAS. In this report, GAO examines 
(1) federally funded research, federal programs, and other federal 
agency efforts related to prenatal opioid use or NAS; (2) gaps 
identified by federal agency officials and experts in efforts to 
address prenatal opioid use or NAS; and (3) how federal efforts to 
address prenatal opioid use or NAS are planned and coordinated. GAO 
analyzed information from federal agencies, including documents and 
data, on research, programs, and other agency efforts; interviewed 
federal agency officials and experts about gaps; and interviewed 
federal agency officials about planning and coordination of federal 
efforts. 

What GAO Found: 

Federally funded research mostly focused on neonatal abstinence 
syndrome (NAS), and federal programs and other agency efforts made 
services available or conducted activities to address prenatal opioid 
use or NAS. From fiscal years 2008 through 2014, federal agencies 
obligated almost $21.6 million for 18 research projects related to 
prenatal opioid use or NAS, most of which focused on preventing, 
understanding, or treating NAS. Fourteen federal programs on substance 
abuse, health, and welfare-—12 of which were administered by agencies 
within the Department of Health and Human Services (HHS)—-made direct 
services available (such as screening and referral for treatment) or 
conducted other activities (such as training or technical assistance) 
to address prenatal opioid or NAS in fiscal years 2013 or 2014 as part 
of broader objectives. Outside of research and programs, 11 federal 
agencies made direct services available through their health systems 
or engaged in other efforts during fiscal years 2008 through 2014. 

The gaps in efforts to address prenatal opioid use and NAS most 
commonly cited by federal agency officials and experts were related to 
the treatment of prenatal opioid use and NAS. With regard to research, 
the most commonly cited gaps were inadequate research on treatment of 
prenatal opioid use and the long-term effects of prenatal opioid 
exposure on children. Reasons cited for these research gaps included 
difficulties in conducting research, such as identifying and retaining 
pregnant women with substance use disorders for studies, and prenatal 
opioid use and NAS not being as high a priority as other research 
areas. With regards to programs, agency officials and experts most 
commonly cited the lack of available treatment programs for pregnant 
women and newborns with NAS, including the availability of 
comprehensive care and enabling services, such as transportation and 
child care. Reasons cited for these program gaps included the 
stigmatization and criminalization of pregnant women who use drugs. 
In addition to research and program gaps, other gaps cited by agency 
officials and experts included a lack of guidance on criminalization 
policies for states, screening and treatment practices, and opioid 
prescribing. 

The Office of National Drug Control Policy (ONDCP)-—the agency 
responsible for coordinating drug control efforts across federal 
agencies-—plans and coordinates with other agencies by sharing 
information and developing national action items to address prenatal 
opioid use and NAS. However, ONDCP does not document its process for 
developing action items, including the information considered or 
discussions with agency officials. Within HHS-—which has nine agencies 
that address prenatal opioid use or NAS—-the department relies on its 
agencies to plan and coordinate individual efforts, and also has 
established a council that identifies activities that may influence, 
but are not targeted specifically at, prenatal opioid use and NAS. 
However, HHS lacks a focal point to lead planning and coordination of 
efforts related specifically to prenatal opioid use or NAS across the 
department. These limitations in planning and coordination by ONDCP 
and HHS may limit the effectiveness of federal efforts to reduce 
prenatal opioid use among pregnant women and rates of NAS. 
Additionally, there is a risk that federal efforts may be duplicated, 
overlapping, or fragmented. 

What GAO Recommends: 

GAO recommends that ONDCP document the process for developing action 
items on prenatal opioid use and NAS and that HHS designate a focal 
point to lead departmental planning and coordination on these issues. 
ONDCP and HHS concurred with GAO’s recommendations and provided 
technical comments that GAO incorporated as appropriate. 

View [hyperlink, http://www.gao.gov/products/GAO-15-203]. For more 
information, contact Vijay A. D'Souza at (202) 512-7114 or 
dsouzav@gao.gov. 

[End of section] 

Contents: 

Letter: 

Background: 

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: 

Most Commonly Cited Gaps Were Related to Treatment of Prenatal Opioid 
Use or NAS: 

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

Conclusions: 

Recommendations: 

Agency Comments: 

Appendix I: Scope and Methodology: 

Appendix II: Federally Funded Research Projects on Prenatal Opioid Use 
or Neonatal Abstinence Syndrome: 

Appendix III: Federal Programs that Addressed Prenatal Opioid Use or 
Neonatal Abstinence Syndrome: 

Appendix IV: Direct Services Made Available and Program Activities 
Conducted by Federal Programs that Addressed Prenatal: 

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: 

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

Appendix VIII: GAO Contact and Staff Acknowledgments: 

Related GAO Products: 

Tables: 

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

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

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: 

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: 

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: 

Table 6: Federal Programs That Addressed Prenatal Opioid Use or 
Neonatal Abstinence Syndrome (NAS) In Operation in Fiscal Years 2013-
2014, by Federal Agency: 

Figures: 

Figure 1: Focus of Federally Funded Research Projects Related to 
Prenatal Opioid Use or Neonatal Abstinence Syndrome (NAS), Fiscal 
Years 2008-2014: 

Figure 2: Federal Programs That Addressed Prenatal Opioid Use or 
Neonatal Abstinence Syndrome, Fiscal Years 2013-2014: 

Figure 3: Direct Services Made Available by Eight Federal Programs 
That Addressed Prenatal Opioid Use or Neonatal Abstinence Syndrome 
(NAS), Fiscal Years 2013-2014: 

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: 

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: 

Figure 6: Direct Services Made Available by Federal Programs that 
Addressed Prenatal Opioid Use or Neonatal Abstinence Syndrome (NAS), 
Fiscal Years 2013-2014: 

Figure 7: Other Activities Conducted by Federal Programs that 
Addressed Prenatal Opioid Use or Neonatal Abstinence Syndrome, 
Fiscal Years 2013-2014: 

Figure 8: Other Agency Efforts to Address Prenatal Opioid Use or 
Neonatal Abstinence Syndrome Outside of Research and Programs, Fiscal 
Years 2008-2014: 

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: 

[End of section] 

United States Government Accountability Office: 
GAO:
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. 
[Footnote 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.[Footnote 2] 
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. 

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.[Footnote 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. 
[Footnote 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 through fiscal year 2014.[Footnote 5][Footnote 6] We then 
requested and analyzed information, including documents and data, 
from these agencies, specifically: 

* 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; 

* 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. 
[Footnote 7] 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 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.) 

Background: 

Prenatal Opioid Use: 

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.[Footnote 6] Two 
recent studies also found that 14 percent of pregnant private health 
insurance beneficiaries, and almost 22 percent of pregnant Medicaid 
beneficiaries filled a prescription for opioids during their 
pregnancy.[Footnote 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 
off-label as neither is approved for use during pregnancy.[Footnote 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. 

NAS: 

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 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.[Footnote 11] 

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: 

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. 

Federally Funded Research Projects Mostly Focused on Prevention, 
Understanding, or Treatment of NAS: 

From fiscal years 2008 through 2014, federal agencies obligated almost 
$21.6 million for 18 research projects related to prenatal opioid use 
or NAS, 14 of which included a focus on prevention and understanding 
of NAS, treatment of NAS, or both, as individual projects sometimes 
focused on more than one research area.[Footnote 12] Federal agencies 
obligated $13.6 million for eight projects that included a focus on 
prevention and 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.[Footnote 13] (See figure 
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).[Footnote 14] (See appendix II for descriptions 
of all 18 projects.) 

Figure 1: Focus of Federally Funded Research Projects Related to 
Prenatal Opioid Use or Neonatal Abstinence Syndrome (NAS), Fiscal 
Years 2008-2014: 

[Refer to PDF for image: illustrated table] 

Research projects funded by National Institutes of Health (NIH): 

Research project: Maternal Opioid Treatment: Human Experimental 
Research (MOTHER); 
Focus of research project: 
Prevention and understanding of NAS; 
Treatment of prenatal opioid use. 

Research project: Monitoring In Utero Drug Exposure; 
Focus of research project: 
Prevention and understanding of NAS; 
Incidence or prevalence of NAS; 
Incidence or prevalence of prenatal opioid use. 

Research project: Prevention of NAS; 
Focus of research project: 
Treatment of prenatal opioid use. 

Research project: Reinforcement Based Treatment for Pregnant Drug 
Abusers; 
Focus of research project: 
Prevention and understanding of NAS; 
Treatment of prenatal opioid use. 

Research project: Fetal and Infant Neurobehavioral Effects of Maternal 
Buprenorphine Treatment; 
Focus of research project: 
Prevention and understanding of NAS. 

Research project: Improving Outcome in NAS; 
Focus of research project: 
Treatment of NAS. 

Research project: A Comparison of Buprenorphine Versus Methadone in 
the Treatment of NAS; 
Focus of research project: 
Treatment of NAS; 
Costs related to NAS. 

Research project: Testing the Reliability and Validity of Pupil 
Diameter in Opioid-exposed Neonates; 
Focus of research project: 
Treatment of NAS; 
Incidence or prevalence of NAS. 

Research project: Fetal and Infant Neurobehavior in Opiate Dependent 
Women; 
Focus of research project: 
Prevention and understanding of NAS; 
Treatment of prenatal opioid use. 

Research project: Methadone Maintenance Therapy: a Breastfeeding 
Intervention for Pregnant Women; 
Focus of research project: 
Prevention and understanding of NAS; 
Treatment of NAS. 

Research project: Tobacco Use in Opioid Agonist Treated Pregnant Women; 
Focus of research project: 
Prevention and understanding of NAS. 

Research project: Abstinence and Drug Withdrawal: Innovative 
Translational Methods for Neonates; 
Focus of research project: 
Treatment of NAS. 

Research project: Buprenorphine Treatment of NAS; 
Focus of research project: 
Treatment of NAS; 
Costs related to NAS. 

Research project: Clonidine Treatment for NAS; 
Focus of research project: 
Treatment of NAS; 
Costs related to NAS. 

Research projects funded by Food and Drug Administration (FDA): 

Research project: Safer Use of Narcotics in Pregnant and Lactating 
Women; 
Focus of research project: 
Prevention and understanding of NAS. 

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

Research project:CDC Epi-Aid 2011 025 Maternal Drug Use and Its Impact 
on Neonates: Washington State, 2000-2008; 
Focus of research project: 
Incidence or prevalence of NAS. 

Research project:National Birth Defects Prevention Study; 
Focus of research project: 
Incidence or prevalence of prenatal opioid use. 

Research project:Birth Defects Study to Evaluate Pregnancy Exposures; 
Focus of research project: 
Incidence or prevalence of prenatal opioid use. 

Total number of research projects by focus[A]: 	
Focus of research project: 
Prevention and understanding of NAS: 8; 
Treatment of NAS: 7; 
Treatment of prenatal opioid use: 4; 
Incidence or prevalence of NAS: 3; 
Incidence or prevalence of prenatal opioid use: 3; 
Costs related to NAS: 3. 

Funding obligations (in millions) by focus[A]: 
Focus of research project: 
Prevention and understanding of NAS: $13.6 million; 
Treatment of NAS: $6.0 million; 
Treatment of prenatal opioid use: $10.3 million; 
Incidence or prevalence of NAS: $4.0 million; 
Incidence or prevalence of prenatal opioid use: $2.8 million; 
Costs related to NAS: $1.9 million. 

Source: GAO. GAO-15-203. 

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. 

[End of figure] 

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.[Footnote 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.[Footnote 16] 

Federal Programs Made Direct Services Available or Conducted Other 
Activities to Address Prenatal Opioid Use or NAS as Part of Broader 
Objectives: 

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. 
[Footnote 17] Through a Web-based questionnaire, officials from 8 of 
these 14 programs reported making direct services available to women, 
infants, or their families, and 11 reported conducting other 
activities such as public education or providing technical assistance, 
with 5 reporting both. (See figure 2.) These 14 programs were run by 
five different agencies, with 12 of these programs administered by 
agencies within HHS. Nine of the 14 programs had been in existence for 
more than 5 fiscal years.[Footnote 18] (See appendix III for more 
details on these programs.) 

Figure 2: Federal Programs That Addressed Prenatal Opioid Use or 
Neonatal Abstinence Syndrome (NAS), Fiscal Years 2013-2014: 

[Refer to PDF for image: illustration of overlapping spheres] 

Made Direct Services Available: 
1) Regional Partnership Grants (ACF)[A]; 
2) Healthy Start (HRSA)[A]; 
3) Services Grant Program for Residential Treatment for Pregnant and 
Postpartum Women (SAMHSA)[A]. 

Made Direct Services Available and Conducted Other Activities: 
1) Abandoned Infants (ACF)[A]; 
2) Tribal Maternal, Infant, and Early Childhood Home Visiting Program 
(ACF/HRSA)[A]; 
3) Maternal, Infant, and Early Childhood Home Visiting Program 
(HRSA/ACF)[A]; 
4) Substance Abuse Prevention and Treatment Block Grant (SAMHSA)[A]; 
5) Family Drug Court Program (OJP within DOJ). 

Conducted Other Activities: 
1) National Abandoned Infants Assistance Resource Center (ACF)[A]; 
2) National Center on Substance Abuse and Child Welfare 
(SAMHSA/ACF)[A]; 
3) Addiction Technology Transfer Centers (SAMHSA)[A]; 
4) Providers’ Clinical Support System for the Appropriate Use of 
Opioids in the Treatment of Pain and Opioid-Related Addiction 
(SAMHSA)[A]; 
5) Providers’ Clinical Support System for Medication Assisted 
Treatment (SAMHSA)[A]; 
6) Special Supplemental Nutrition Program for Women, Infants, and 
Children (USDA). 

[A] Program administered by HHS agency. 

ACF: Administration for Children and Families; 
DOJ: Department of Justice; 
HHS: Department of Health and Human Services; 
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. 

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. 

[End of figure] 

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.[Footnote 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.[Footnote 20] 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. 

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 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 figure 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: 

[Refer to PDF for image: vertical bar graph: 

Available direct service: Screening, assessment, and referral for 
treatment; 
Number of programs: 8. 

Available direct service: Case management and other recovery support 
services; 
Number of programs: 8. 

Available direct service: Follow-up case management for newborns with 
NAS; 
Number of programs: 6. 

Available direct service: Behavioral treatment services; 
Number of programs: 5. 

Available direct service: Medication-assisted treatment; 
Number of programs: 4. 

Available direct service: Residential treatment; 
Number of programs: 4. 

Available direct service: Family planning services; 
Number of programs: 2. 

Available direct service: NAS diagnosis or treatment; 
Number of programs: 1. 

Source: GAO. GAO-15-203. 

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. 

[End of figure] 

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.) 

Federal Agencies also Addressed Prenatal Opioid or NAS through Their 
Health Systems or Other Efforts Outside of Research and Programs: 

Outside of research and programs, officials from 11 federal agencies--
mostly within HHS--reported that their agencies made direct services 
available through their health systems or engaged in other efforts 
that addressed prenatal opioid use or NAS during fiscal years 2008 
through 2014. Four of the 11 agencies reported making relevant direct 
services available through their health systems and 10 agencies 
reported engaging in other efforts, such as provider education and 
knowledge-sharing groups, while three agencies reported doing both. 
(See figure 4.) 

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: 

[Refer to PDF for image: illustration of overlapping spheres] 

Made Direct Services Available through Health System: 
1) Department of Justice Bureau of Prisons. 

Made Direct Services Available through Health System and Engaged in 
Other Efforts: 
1) Indian Health Service[A]; 
2) Department of Defense; 
3) Department of Veterans Affairs. 

Engaged in Other Efforts: 
1) Centers for Disease Control and Prevention[A]; 
2) Centers for Medicare & Medicaid Services[A]; 
3) Food and Drug Administration[A]; 
4) National Institutes of Health[A]; 
5) Office of the Assistant Secretary for Health[A]; 
6) Substance Abuse and Mental Health Services Administration
7) Office of National Drug Control Policy. 

[A]: HHS Agency. 

Source: GAO. GAO-15-203. 

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. 

[End of figure] 

Officials from four of the 11 agencies--the Indian Health Service 
(IHS) within HHS, the Bureau of Prisons (BOP) within the Department of 
Justice (DOJ), the Department of Defense (DOD), and the Department of 
Veterans Affairs (VA)--reported that their health systems made direct 
services available to women who use opioids, their newborns, or their 
families, as part of each agency health system's broader efforts to 
provide care to its beneficiaries.[Footnote 21] 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. 

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[Footnote 22] 
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 figure 5.) For example, DOD and VA published joint clinical practice 
guidelines on pregnancy management, which include guidance for DOD and 
VA health care providers on screening for drug use and offering 
treatment during pregnancy.[Footnote 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.[Footnote 24] (See appendix V for 
more information on agency efforts to address prenatal opioid use or 
NAS outside of research and programs.) 

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: 

[Refer to PDF for image: vertical bar graph] 

Agency effort: Provider education; 
Number of federal agencies: 8. 

Agency effort: Knowledge-sharing groups[A]; 
Number of federal agencies: 7. 

Agency effort: Training or technical assistance[B]; 
Number of federal agencies: 6. 

Agency effort: Written policies or guidance; 
Number of federal agencies: 5. 

Agency effort: Public education or outreach; 
Number of federal agencies: 4. 

Agency effort: Reports, fact sheets, or other written publications; 
Number of federal agencies: 4. 

Agency effort: Surveillance or monitoring; 
Number of federal agencies: 4. 

Agency effort: Strategic planning; 
Number of federal agencies: 2. 

Agency effort: Regulation and oversight of opioid labeling, marketing, 
or prescribing; 
Number of federal agencies: 1. 

Agency effort: Other[C]; 
Number of federal agencies: 4. 

Source: GAO. GAO-15-203. 

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. 

[End of figure] 

Most Commonly Cited Gaps Were Related to Treatment of Prenatal Opioid 
Use or NAS: 

The research and program gaps most commonly cited by federal agency 
officials and other experts were related to treatment of pregnant 
women with opioid use disorders or newborns with NAS. 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. 

Research Gaps Cited Included Treatment of Prenatal Opioid Use and Long-
Term Effects of Prenatal Opioid Exposure on Children: 

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.) 

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

Research gap: Treatment of prenatal opioid use, including medication-
assisted treatment; 
Number that cited gap: 13. 

Research gap: Long-term effects of prenatal opioid exposure in 
children; 
Number that cited gap: 12. 

Research gap: Treatment of NAS; 
Number that cited gap: 11. 

Research gap: Screening and diagnosing of NAS; 
Number that cited gap: 10. 

Research gap: Understanding of NAS and severity of NAS; 
Number that cited gap: 10. 

Research gap: Appropriate research methods or available data (i.e., 
studies of appropriate size and applied research); 
Number that cited gap: 7. 

Research gap: Knowledge of best practices in opioid prescribing; 
Number that cited gap: 5. 

Research gap: Prevention, including prevention of substance use 
disorders or pregnancy in women with opioid use disorders; 
Number that cited gap: 4. 

Research gap: Screening for prenatal opioid use; 
Number that cited gap: 2. 

Research gap: Understanding prenatal opioid use; 
Number that cited gap: 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. 

[End of table] 

Agency officials and other experts cited several reasons for these 
research gaps, some of which are similar to those we have found for 
other public health issues. The most frequently cited reasons were: 

* Difficulty conducting research. Agency officials and experts noted 
difficulties in identifying and retaining pregnant women with 
substance use disorders for research studies due to the low number of 
such women and their reluctance to participate in such studies, 
sometimes out of fear of criminal charges or other repercussions from 
their use of opioids. Further, due to the use of multiple substances 
and variation in the expression of NAS, studies on this topic require 
a large number of participants, according to agency officials and 
experts. 

* Research priorities. Agency officials and experts told us that 
prenatal opioid use and NAS had not been prioritized compared to other 
areas of research. For example, one expert suggested that there is a 
priority now on studying marijuana use and pregnancy. 

* Lack of funding. Agency officials and experts cited a lack of 
research funds in general and specifically for NAS-related studies. 
They commented that there are many competing priorities for limited 
research funds. 

* Funding structure. Research funding is typically provided for a 
limited time period, such as 5 years, making research on the long-term 
effects of prenatal opioid use particularly challenging according to 
experts. Experts also noted that funding for individual studies is 
often capped at a level too small to conduct the multi-site studies 
necessary in this area since it is difficult to find enough study 
participants at a single research site. 

* Lack of capacity to conduct research. Agency officials and experts 
expressed concern that there may not be adequate expertise in this 
area to conduct this type of research. 

Program Gaps Cited Included Lack of Available Treatment Programs and 
Provider Education: 

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.) 

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

Program 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); 
Number that cited gap: 13. 

Program gap: Provider education; 
Number that cited gap: 10. 

Program gap: Prevention, including prevention of pregnancy through 
family planning and contraceptive services; 
Number that cited gap: 7. 

Program gap: Public education and outreach, including on addiction; 
Number that cited gap: 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. 

[End of table] 

Agency officials and other experts cited several reasons for these 
program gaps, some of which are similar to those we have found for 
other public health issues. The most frequently cited reasons were: 

* Stigma and criminalization of pregnant women who use drugs. Some 
state laws require health care providers to report substance use 
during pregnancy to state or local officials, which officials and 
experts said could result in women not getting substance abuse 
treatment or prenatal care out of fears of criminal charges, their 
children being taken away, or being stigmatized as a drug user. 
Officials told us that providers are reluctant to recommend screening, 
treatment, or counseling when there are serious potential legal 
consequences, and as a result, pregnant women may not have access to 
appropriate programs that do not present legal consequences. 

* Gaps in current research. Agency officials and experts attributed 
program gaps to the limited evidence base specific to prenatal opioid 
use or NAS, particularly around screening and medication safety during 
pregnancy. Officials and experts told us, for example, that because of 
the gaps in scientific knowledge, there is limited training for 
providers on how to treat substance use or prescribe pain medication 
during pregnancy. 

* Awareness of NAS as a public health problem. Officials noted that 
the development of treatment programs lags behind the awareness of the 
existence of a problem, and issues such as prenatal opioid use and NAS 
have become more critical in the last 5 to 10 years. 

* Lack of funding. Agency officials and experts said that funding for 
programs to address prenatal opioid use or NAS is challenging for many 
states and localities. This may result in a lack of available 
treatment programs. 

Other Gaps Cited Included Lack of Guidance and Coordination of Efforts 
to Address Prenatal Opioid Use or NAS: 

In addition to research and program gaps, agency officials and other 
experts cited other gaps in guidance, particularly around "safe 
harbor" laws for states,[Footnote 25] issues of treatment of prenatal 
opioid use and NAS, prescription drug monitoring programs,[Footnote 
26] 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 guidance for health 
care providers, including federal guidance, in approaches to screening 
and treatment of prenatal opioid use and NAS. Specifically, they noted 
that there are not a lot of data to inform best practices, so there 
are no standards for care. Similarly, they cited a lack of federal 
guidance to assist states in the regulation and oversight of opioid 
use and prescribing through prescription drug monitoring programs, 
which also vary across states. They noted that while most states have 
prescription drug monitoring programs, their capacity and utility 
vary. Agency officials and experts noted that one effect of these 
other gaps is that states have varying policies related to prenatal 
opioid use or NAS. For example, officials and experts have noted that 
state policies on criminalization can result in women not having 
access to appropriate programs. In addition, agency officials and 
experts said some states have not seen much success with their 
prescription drug monitoring programs, possibly because they are not 
used by providers. One official commented that without effective 
prescription drug monitoring programs, it is difficult to catch 
"doctor shopping," which is when a patient obtains controlled 
substances (such as opioids prescribed for pain management) from 
multiple health care providers without the providers' knowledge of 
other similar prescriptions. (See table 3.) 

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: Guidance on criminalization and "safe harbor" laws for 
states[A]; 
Number that cited gap: 7. 

Other Gap: Guidance on screening and treatment practices for prenatal 
opioid use and NAS; 
Number that cited gap: 6. 

Other Gap: Guidance on opioid prescribing, including prescription drug 
monitoring programs; 
Number that cited gap: 6. 

Other Gap: Guidance on Medicaid and other health insurance 
reimbursement structures; 
Number that cited gap: 5. 

Other Gap: Coordination of stakeholders such as states and provider 
organizations; 
Number that cited gap: 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] 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. 

[End of table] 

Agency officials and other experts did not frequently cite reasons for 
these other gaps. Among the few reasons cited, one official said that 
one reason for these gaps is that some states may have more 
established programs with a greater financial investment, particularly 
regarding prescription drug monitoring programs. 

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

ONDCP plans and coordinates by sharing information and developing 
national action items to address prenatal opioid use and NAS, but does 
not document the development of these action items. HHS relies on its 
agencies to plan and coordinate individual efforts, and has 
established a council that identifies activities that may influence, 
but are not targeted specifically at, prenatal opioid use and NAS. 
However, HHS lacks a focal point to lead planning and coordination of 
efforts related to prenatal opioid use or NAS across the department. 

ONDCP Shares Information Government-Wide, but Does Not Document 
Development of National Action Items on Prenatal Opioid Use and NAS: 

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.[Footnote 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.[Footnote 28] For example, officials told us 
that ONDCP: 

* gave presentations on NAS in May 2012, July 2014, and August 2014 as 
part of a webinar hosted by the Association for State and Territorial 
Health Officials and other organizations. 

* hosted a leadership meeting in August 2012 that brought together 
scientists and policymakers to share knowledge on these issues. ONDCP 
shared the results of this leadership meeting at a subsequent 
September 2012 meeting that included federal agency officials as well 
as the American Academy of Pediatrics and the American Congress of 
Obstetricians and Gynecologists. 

* participated in the April 2014 annual National Rx Drug Abuse Summit, 
where ONDCP officials led a presentation entitled, "Solutions 
Discussion Impacting Neonatal Abstinence Syndrome." 

* led a June 2014 White House Summit on the Opioid Epidemic which 
focused on heroin and prescription drugs, and during which NAS was 
briefly discussed. 

* helped SAMHSA plan its August 2014 Prescription Drug Abuse Policy 
Academy, which included presentations on prenatal opioid use and NAS. 

Officials told us that ONDCP also shares information through two 
interagency groups--the Prescription Drug Abuse Prevention Interagency 
Working Group and the Treatment Coordination Group--comprising 
officials from at least 15 federal agencies. These interagency groups 
are broad in scope, but may raise prenatal opioid use or NAS during 
group meetings. Specifically, the Prescription Drug Abuse Prevention 
Interagency Working Group coordinates implementation of ONDCP's 2011 
prescription drug abuse prevention plan,[Footnote 29] and officials 
told us group members have discussed presentations on prenatal opioid 
use and NAS. The Treatment Coordination Group is focused on evidence-
based substance abuse treatment services and ONDCP officials told us 
that members are working to plan and implement three to five 
activities aimed at improving access to medication-assisted treatment 
for people with opioid use disorders. Officials said that in 
discussing medication-assisted treatment, prenatal opioid use or NAS 
may have been raised. ONDCP officials also told us that the agency 
plans to develop an informal subgroup of the Prescription Drug Abuse 
Prevention Interagency Working Group that will focus specifically on 
NAS, but had not done so as of November 2014. They said that the 
purpose of this subgroup will be for staff from agencies involved in 
NAS-related issues to meet periodically and exchange information on 
the subject. 

In addition to these interagency working groups, ONDCP officials told 
us that in September 2014 they initiated the process and are 
coordinating with federal agencies to develop national action items 
related to prenatal opioid use and NAS for inclusion in the 2015 
National Drug Control Strategy report, which outlines the federal 
government's action items aimed at reducing illegal drug use and drug-
related health consequences, among other goals.[Footnote 30] 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. 

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.[Footnote 31] Additionally, ONDCP officials told us 
that the agency has not examined issues of duplication, overlap, or 
fragmentation related to prenatal opioid use or NAS. ONDCP officials 
told us that they believe that there is little risk of duplication in 
federal efforts in this area, but have not conducted a systematic 
review of federal efforts.[Footnote 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. 

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 Department-Wide: 

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.[Footnote 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.[Footnote 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.[Footnote 35] As of November 2014, 
officials told us that the group will meet to identify key strategic 
initiatives that will take place within the next 18 months, but the 
first meeting was in the planning stages and no members had been 
identified. 

HHS officials also told us that the department broadly plans and 
coordinates across the department on opioid abuse through its 
Behavioral Health Coordinating Council (BHCC), which identifies 
activities that may influence, but are not are specifically targeted 
to address, prenatal opioid use or NAS. The Office of the Secretary--
which oversees the activities of HHS--established the BHCC to 
coordinate departmental activities related to mental health and 
substance use and abuse.[Footnote 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.[Footnote 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.[Footnote 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.[Footnote 39] 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 not other HHS agencies. 
[Footnote 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. 

Conclusions: 

Federal agencies have recognized prenatal opioid use and NAS as 
emerging public health issues facing pregnant women and newborns and 
have several ongoing efforts to address these issues. Specifically, we 
found that federal agencies fund research projects focused primarily 
on NAS; administer programs or have health systems that make direct 
services available to women who use opioids and newborns with NAS; and 
engage in other efforts, such as provider education and knowledge-
sharing groups. However, federal agency officials and experts we 
interviewed cited several gaps in efforts to address prenatal opioid 
use and NAS, most commonly gaps related to treatment, as well as lack 
of guidance to states and health care providers. While ONDCP is 
coordinating with federal agencies to develop action items to address 
prenatal opioid use and NAS, improved documentation could help make 
the process more systematic and effective. Further, HHS does not have 
a focal point to lead planning and coordination of efforts across its 
nine agencies that address these issues. These limitations in planning 
and coordination by ONDCP and HHS may limit the effectiveness of 
federal efforts to reduce prenatal opioid use among pregnant women and 
rates of NAS. Additionally, there is a risk that efforts may be 
duplicated, overlapping, or fragmented. Given the increasing use of 
heroin and abuse of opioids prescribed for pain management, as well as 
the increased rate of NAS in the United States, it is important to 
improve the efficiency and effectiveness of planning and coordination 
of federal efforts on prenatal opioid use and NAS. 

Recommendations: 

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. 

Agency Comments: 

We provided a draft of this report to ONDCP, HHS, DOJ, USDA, DOD, and 
VA. ONDCP and HHS concurred with our recommendations and provided 
written comments, which are reprinted in appendixes VI, and VII, 
respectively. In its written comments, ONDCP noted its efforts in 
working with federal agencies, states, and other stakeholders to 
focus attention on opioid addiction and NAS, and concurred with our 
recommendation that ONDCP document its process for developing action 
items on prenatal opioid use and NAS. In its written comments, HHS 
stated that it has focused efforts on reducing opioid use disorders 
with some emphasis on special populations, including pregnant women, 
and concurred with our recommendation that HHS designate a focal 
point to lead departmental planning and coordination related to 
prenatal opioid use and NAS. HHS noted that it plans to conduct a 
departmental review to designate such a focal point. ONDCP and HHS 
also provided technical comments, which we incorporated as 
appropriate. In addition USDA provided one technical comment which we 
incorporated. 

We are sending copies of this report to the Director of the Office of 
National Drug Control Policy, the Secretary of the Department of 
Health and Human Services, the Attorney General, the Secretary of the 
Department of Agriculture, the Secretary of the Department of Defense, 
the Secretary of the Department of Veterans Affairs, and other 
interested parties. In addition, the report is available at no charge 
on the GAO website at [hyperlink, 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. 

Signed by: 

Vijay A. D'Souza: 
Director, Health Care: 

Appendix I: Scope and Methodology: 

Our objectives were to examine (1) federally funded research, federal 
programs, and other federal agency efforts related to prenatal opioid 
use or neonatal abstinence syndrome (NAS); (2) gaps identified by 
federal agency officials and experts in efforts to address prenatal 
opioid use or NAS; and (3) how federal efforts to address prenatal 
opioid use or NAS are planned and coordinated. 

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.[Footnote 41] 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.[Footnote 42] 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.) 

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. 

[End of table] 

To examine federally funded research, each of the 15 agencies in our 
review identified whether they had conducted or funded research on 
prenatal opioid use or NAS during fiscal years 2008 through 2014 
through our initial screening. We selected these timeframes in order 
to provide information on the body of research funded in recent years. 
Three of the 15 agencies in our review--the Centers for Disease 
Control and Prevention, Food and Drug Administration, and National 
Institutes of Health--reported that they had funded or conducted 
relevant research during this time period. Using a data collection 
instrument, we collected information from these three agencies on the 
details of this research--such as the target populations, focus of the 
research, and funding obligations data by fiscal year. We received 
completed responses from the three agencies and followed up to clarify 
the agencies' responses if their responses were unclear or incomplete. 
In addition, to assess the reliability of the obligations data, we 
requested information on the agencies' data systems and if there were 
any limitations to reporting the data. We also conducted internal 
checks to identify any outliers, and followed up with agency officials 
as appropriate. We determined that the research data provided by the 
agencies were sufficiently reliable for our purposes. 

To examine federal programs that addressed prenatal opioid use or NAS, 
we took a two-part approach.[Footnote 43] 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.[Footnote 
44] We then requested that each of the 15 agencies in our review 
confirm if the programs that we initially identified addressed 
prenatal opioid use or NAS, and if they were in operation in fiscal 
years 2013 or 2014. We selected these time frames to provide 
information on current programs that address these issues, and we 
included fiscal year 2013 because it was the most recent fiscal year 
for which complete program data were available. We also asked each 
agency to identify any additional programs that we had not identified 
that were relevant to prenatal opioid use or NAS. As a result, seven 
federal agencies identified a total of 22 federal programs that 
addressed prenatal opioid use or NAS in fiscal years 2013 or 2014. 

We then developed and administered a Web-based questionnaire to 
collect information on each of these 22 programs--such as types of 
direct services made available and other activities conducted related 
to prenatal opioid use or NAS--and used the information provided to 
determine if each of the programs met our definition for addressing 
prenatal opioid use or NAS.[Footnote 45] 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.[Footnote 46] 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.[Footnote 47] During the 
development of our questionnaire, we pretested it with federal agency 
officials representing four programs across three agencies to ensure 
that our questions and response choices were clear, appropriate, and 
answerable. To obtain a variety of perspectives on our questionnaire, 
we selected the four programs for pretesting based on the types of 
services offered or activities conducted, funding mechanisms, and 
federal agency responsible for program administration. We then made 
changes to the content of the questionnaire based on feedback obtained 
from the pretests. We administered the questionnaire from June 2014 
through October 2014. Officials from all 22 programs completed the 
questionnaire. 

The results from our questionnaire are not subject to sampling error 
because we sent the questionnaire to the universe of potential 
respondents. However, the practical difficulties of conducting any 
questionnaire may introduce errors, commonly referred to as 
nonsampling errors. For example, difficulties in how a particular 
question was interpreted, in the sources of information that were 
available to respondents, or in how the data were entered into a 
database or were analyzed could introduce unwanted variability into 
the questionnaire results. We encountered instances of nonsampling 
error in analyzing the questionnaire responses, such as respondents 
providing conflicting, vague, or incomplete information. We generally 
addressed these errors by performing automated checks to identify 
inappropriate answers, and also contacted agency officials for 
clarification and to request additional documentation as appropriate. 
However, we did not independently verify all of the information and 
data provided by the questionnaire respondents. In addition, to assess 
the reliability of obligations data reported in the questionnaire, we 
requested supporting documentation, and incorporated questions about 
the programs' data systems and if there were any limitations to 
reporting the data. On the basis of our application of recognized 
survey design practices and follow-up procedures, we determined that 
the data provided by the agencies on programs were sufficiently 
reliable for our purposes. 

To examine other agency efforts that addressed prenatal opioid use or 
NAS in recent years outside of research and programs, we used a data 
collection form through which the 15 agencies in our review identified 
any other agency efforts that took place from fiscal years 2008 
through 2014.[Footnote 48] We received completed responses from all 15 
agencies. In some instances, respondents provided conflicting, vague, 
or incomplete information. We generally addressed these errors by 
contacting agency officials for clarification and requesting 
additional information or documentation as appropriate. However, we 
did not independently verify all of the information provided by the 
respondents. We determined that the data provided by the agencies on 
other agency efforts were sufficiently reliable for our purposes. 

To examine gaps in efforts to address prenatal opioid use or NAS, we 
obtained testimonial evidence from federal agency officials and 
experts on any research, program, and other gaps that exist in efforts 
to address prenatal opioid use or NAS. Specifically, we requested 
information from federal officials representing the agencies that had 
funded or conducted research in fiscal years 2008 through 2014, the 
agencies with relevant programs in fiscal years 2013 or 2014, and 
ONDCP. In addition, we selected experts (comprising expert 
organizations as well as individual researchers and clinicians) in 
order to include perspectives from health care professionals, 
advocates, and researchers with expertise in women's health, pediatric 
health, and addiction.[Footnote 49] We obtained testimonial evidence 
from officials representing nine federal agencies and six experts 
from which we requested information.[Footnote 50] We then conducted 
preliminary content analyses of the information provided by agency 
officials and experts on: (1) research, program, and other gaps; (2) 
the reasons for these gaps; and (3) the effects of these gaps. We 
created preliminary categories based on these analyses. Two GAO 
analysts then independently conducted formal analyses, reviewed each 
other's work, and discussed any discrepancies to ensure that both 
agreed on the assigned categorization of all information provided by 
agency officials and experts. For reporting purposes, we counted each 
federal agency and each expert (whether an individual or an expert 
organization) as one unit in our analysis. The results of this 
analysis are not generalizable because we selected the agency 
officials and experts from whom we obtained testimonial information. 
We did not independently verify the information provided by agency 
officials and experts. 

To examine how federal efforts to address prenatal opioid use or NAS 
are planned and coordinated, we collected documents and interviewed 
officials from ONDCP about planning and coordination across the 
federal government. We also collected documents and interviewed 
officials from HHS's Office of the Secretary about planning and 
coordination across HHS's nine agencies that fund research, conduct 
programs, or engage in other agency efforts to address prenatal opioid 
use or NAS. 

We conducted this performance audit from January 2014 to February 2015 
in accordance with generally accepted government auditing standards. 
Those standards require that we plan and perform the audit to obtain 
sufficient, appropriate evidence to provide a reasonable basis for our 
findings and conclusions based on our audit objectives. We believe 
that the evidence obtained provides a reasonable basis for our 
findings and conclusions based on our audit objectives. 

[End of section] 

Appendix II: Federally Funded Research Projects on Prenatal Opioid Use 
or Neonatal Abstinence Syndrome: 

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.[Footnote 51] 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.) 

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: 

Research projects funded by National Institutes of Health (NIH): 

Project name: Maternal Opioid Treatment: Human Experimental Research 
(MOTHER); 
Project summary: Research projects funded by National Institutes of 
Health (NIH): 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 post-partum 
period; and assessed the outcome of infants during the first 36 months 
of life; 
Active or completed: Research projects funded by National Institutes 
of Health (NIH): Completed; 
Funding obligations: Research projects funded by National Institutes 
of Health (NIH): $4.6 million. 

Project name: Monitoring In Utero Drug Exposure; 
Project summary: Research projects funded by National Institutes of 
Health (NIH): 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 or completed: Research projects funded by National Institutes 
of Health (NIH): Active[A]; 
Funding obligations: Research projects funded by National Institutes 
of Health (NIH): $2.8 million. 

Project name: Prevention of NAS; 
Project summary: Research projects funded by National Institutes of 
Health (NIH): 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 or completed: Research projects funded by National Institutes 
of Health (NIH): Active; 
Funding obligations: Research projects funded by National Institutes 
of Health (NIH): $2.5 million. 

Project name: Reinforcement Based Treatment for Pregnant Drug Abusers; 
Project summary: Research projects funded by National Institutes of 
Health (NIH): 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 reinforcement-based 
treatment. Other outcome measures include neonatal measures of length 
of hospitalization, physical birth parameters, neurological integrity, 
and behavioral functioning; 
Active or completed: Research projects funded by National Institutes 
of Health (NIH): Active; 
Funding obligations: Research projects funded by National Institutes 
of Health (NIH): $2.4 million. 

Project name: Fetal and Infant Neurobehavioral Effects of Maternal 
Buprenorphine Treatment; 
Project summary: Research projects funded by National Institutes of 
Health (NIH): 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 or completed: Research projects funded by National Institutes 
of Health (NIH): Active; 
Funding obligations: Research projects funded by National Institutes 
of Health (NIH): $2.2 million. 

Project name: Improving Outcome in NAS; 
Project summary: Research projects funded by National Institutes of 
Health (NIH): Compares the efficacy of morphine and methadone in 
relieving the symptoms of NAS; 
Active or completed: Research projects funded by National Institutes 
of Health (NIH): Active; 
Funding obligations: Research projects funded by National Institutes 
of Health (NIH): $2.1 million. 

Project name: A Comparison of Buprenorphine Versus Methadone in the 
Treatment of NAS; 
Project summary: Research projects funded by National Institutes of 
Health (NIH): 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 or completed: Research projects funded by National Institutes 
of Health (NIH): Active; 
Funding obligations: Research projects funded by National Institutes 
of Health (NIH): $1.9 million. 

Project name: Testing the Reliability and Validity of Pupil Diameter 
in Opioid-exposed Neonates; 
Project summary: Research projects funded by National Institutes of 
Health (NIH): 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 or completed: Research projects funded by National Institutes 
of Health (NIH): Active; 
Funding obligations: Research projects funded by National Institutes 
of Health (NIH): $1.2 million. 

Project name: Fetal and Infant Neurobehavior in Opiate Dependent Women; 
Project summary: Research projects funded by National Institutes of 
Health (NIH): 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; 
Active or completed: Research projects funded by National Institutes 
of Health (NIH): Completed; 
Funding obligations: Research projects funded by National Institutes 
of Health (NIH): $0.8 million. 

Project name: Methadone Maintenance Therapy: a Breastfeeding 
Intervention for Pregnant Women; 
Project summary: Research projects funded by National Institutes of 
Health (NIH): 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); 
Active or completed: Research projects funded by National Institutes 
of Health (NIH): Completed; 
Funding obligations: Research projects funded by National Institutes 
of Health (NIH): $0.4 million. 

Project name: Tobacco Use in Opioid Agonist Treated Pregnant Women; 
Project summary: Research projects funded by National Institutes of 
Health (NIH): Examined the role tobacco has on the incidence and 
severity of NAS in methadone-maintained women; 
Active or completed: Research projects funded by National Institutes 
of Health (NIH): Completed; 
Funding obligations: Research projects funded by National Institutes 
of Health (NIH): $0.3 million. 

Project name: Abstinence and Drug Withdrawal: Innovative Translational 
Methods for Neonates; 
Project summary: Research projects funded by National Institutes of 
Health (NIH): 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 or completed: Research projects funded by National Institutes 
of Health (NIH): Active; 
Funding obligations: Research projects funded by National Institutes 
of Health (NIH): $0.2 million. 

Project name: Buprenorphine Treatment of NAS; 
Project summary: Research projects funded by National Institutes of 
Health (NIH): Evaluated the safety, efficacy, and pharmacokinetics of 
buprenorphine in comparison to morphine in newborns with NAS, and 
examined treatment parameters for NAS with buprenorphine; 
Active or completed: Research projects funded by National Institutes 
of Health (NIH): Completed; 
Funding obligations: Research projects funded by National Institutes 
of Health (NIH): 0[B]. 

Project name: Clonidine Treatment for NAS; 
Project summary: Research projects funded by National Institutes of 
Health (NIH): Tested the efficacy of different medications for the 
treatment of NAS in newborns born to mothers using heroin or 
maintained on methadone; 
Active or completed: Research projects funded by National Institutes 
of Health (NIH): Completed; 
Funding obligations: Research projects funded by National Institutes 
of Health (NIH): 0[B]. 

Research projects funded by Food and Drug Administration (FDA): 

Project name: Safer Use of Narcotics in Pregnant and Lactating Women; 
Project summary: Research projects funded by National Institutes of 
Health (NIH): 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; 
Active or completed: Research projects funded by National Institutes 
of Health (NIH): Completed[A]; 
Funding obligations: Research projects funded by National Institutes 
of Health (NIH): Less than $0.1 million[C]. 

Project name: Research projects funded by Centers for Disease Control 
and Prevention (CDC). 

Project name: CDC Epi-Aid 2011 025 Maternal Drug Use and Its Impact on 
Neonates: Washington State, 2000-2008; 
Project summary: Research projects funded by National Institutes of 
Health (NIH): 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; 
Active or completed: Research projects funded by National Institutes 
of Health (NIH): Completed[A]; 
Funding obligations: Research projects funded by National Institutes 
of Health (NIH): Less than $0.1 million[D]. 

Project name: National Birth Defects Prevention Study; 
Project summary: Research projects funded by National Institutes of 
Health (NIH): 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 or completed: Research projects funded by National Institutes 
of Health (NIH): Completed; 
Funding obligations: Research projects funded by National Institutes 
of Health (NIH): n/a[E]. 

Project name: Birth Defects Study to Evaluate Pregnancy Exposures; 
Project summary: Research projects funded by National Institutes of 
Health (NIH): 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 or completed: Research projects funded by National Institutes 
of Health (NIH): Active; 
Funding obligations: Research projects funded by National Institutes 
of Health (NIH): n/a[E]. 

Source: GAO. GAO-15-203. 

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. 

[End of table] 

[End of section] 

Appendix III: Federal Programs that Addressed Prenatal Opioid Use or 
Neonatal Abstinence Syndrome: 

Federal agency officials identified 14 programs that addressed 
prenatal opioid use or neonatal abstinence syndrome (NAS) in fiscal 
years 2013 or 2014 by making relevant direct services available or 
conducting other activities as part of broader programs on substance 
abuse prevention and treatment, maternal and child health, or family 
and child welfare services.[Footnote 52] 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.) 

Table 6: Federal Programs That Addressed Prenatal Opioid Use or 
Neonatal Abstinence Syndrome (NAS) In Operation in Fiscal Years 2013-
2014, by Federal Agency: 

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

Program name (Agency)[A]: Substance Abuse Prevention and Treatment 
Block Grant[C] (SAMHSA); 
Program type: Substance abuse prevention or treatment; 
Number of fiscal years in operation: More than 5 years; 
Program description: 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[D]; 
Types of funding recipients: State or local health departments; state 
or local Medicaid, behavioral health, and welfare services agencies; 
tribes and tribal organizations; 
Total program funding obligations in fiscal year 2013[B]: $1.6 billion. 

Program name (Agency)[A]: Maternal, Infant, and Early Childhood Home 
Visiting Program[C,E,F] (HRSA/ACF); 
Program type: Maternal and child health; family and child welfare 
services; 
Number of fiscal years in operation: 3-5 years; 
Program description: 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; 
Types of funding recipients: State or local health departments; 
national, state, or local nonprofit organizations; 
Total program funding obligations in fiscal year 2013[B]: $377.9 
million. 

Program name (Agency)[A]: Healthy Start[G] (HRSA); 
Program type: Maternal and child health; 
Number of fiscal years in operation: More than 5 years; 
Program description: 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; 
Types of funding recipients: State or local health departments; state 
or local behavioral health agencies; tribes and tribal organizations; 
academic institutions; public nonprofit social service agencies and 
hospitals; 
Total program funding obligations in fiscal year 2013[B]: $98.0 
million. 

Program name (Agency)[A]: Services Grant Program for Residential 
Treatment for Pregnant and Postpartum Women[C,E] (SAMHSA); 
Program type: Substance abuse prevention or treatment; 
Number of fiscal years in operation: More than 5 years; 
Program description: 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; 
Types of funding recipients: State or local health departments; state 
or local behavioral health agencies; state or local nonprofit 
organizations; tribes and tribal organizations; academic institutions; 
Total program funding obligations in fiscal year 2013[B]: $15.6 
million. 

Program name (Agency)[A]: Regional Partnership Grants (ACF); 
Program type: Substance abuse prevention or treatment; 
Number of fiscal years in operation: More than 5 years; 
Program description: Supports interagency collaborations and the 
integration of programs, services, and activities designed to increase 
the well-being, 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; 
Types of funding recipients: State or local health departments; state 
or local behavioral health and welfare services agencies, courts, and 
nonprofit organizations; tribes and tribal organizations; academic 
institutions; 
Total program funding obligations in fiscal year 2013[B]: $15.0 
million. 

Program name (Agency)[A]: Tribal Maternal, Infant, and Early Childhood 
Home Visiting Program[C,F] (ACF/HRSA); 
Program type: Maternal and child health; family and child welfare 
services; 
Number of fiscal years in operation: 3-5 years; 
Program description: 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; 
Types of funding recipients: Tribes, consortia of tribes, tribal 
organizations, and urban Indian organizations; 
Total program funding obligations in fiscal year 2013[B]: $11.5 
million. 

Program name (Agency)[A]: Abandoned Infants[H] (ACF); 
Program type: Maternal and child health; 
family and child welfare services; 
Number of fiscal years in operation: More than 5 years; 
Program description: 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; 
Types of funding recipients: State or local welfare services agencies; 
state or local courts; state or local nonprofit organizations; 
academic institutions; 
Total program funding obligations in fiscal year 2013[B]: $10.8 
million. 

Program name (Agency)[A]: Addiction Technology Transfer Centers[C] 
(SAMHSA); 
Program type: Substance abuse prevention or treatment; 
Number of fiscal years in operation: More than 5 years; 
Program description: 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; 
Types of funding recipients: Academic institutions; 
Total program funding obligations in fiscal year 2013[B]: $9.1 million. 

Program name (Agency)[A]: National Center on Substance Abuse and Child 
Welfare[E,H] (SAMHSA/ACF); 
Program type: Substance abuse prevention or treatment; 
Number of fiscal years in operation: More than 5 years; 
Program description: 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; 
Types of funding recipients: For-profit, small business consulting 
agency (otherwise activities conducted directly by center); 
Total program funding obligations in fiscal year 2013[B]: $3.9 million. 

Program name (Agency)[A]: National Abandoned Infants Assistance 
Resource Center[H] (ACF); 
Program type: Maternal and child health; 
family and child welfare services; 
Number of fiscal years in operation: More than 5 years; 
Program description: Provides state and local, private, non-profit 
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; 
Types of funding recipients: None (activities conducted directly by 
center); 
Total program funding obligations in fiscal year 2013[B]: $1.1 million. 

Program name (Agency)[A]: Providers' Clinical Support System for the 
Appropriate Use of Opioids in the Treatment of Pain and Opioid-Related 
Addiction[C] (SAMHSA); 
Program type: Substance abuse prevention or treatment; 
Number of fiscal years in operation: 3-5 years; 
Program description: 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; 
Types of funding recipients: National nonprofit organizations; 
Total program funding obligations in fiscal year 2013[B]: $0.5 million. 

Program name (Agency)[A]: Providers' Clinical Support System for 
Medication Assisted Treatment[C] (SAMHSA); 
Program type: Substance abuse prevention or treatment; 
Number of fiscal years in operation: 1-2 years; 
Program description: Mentoring program that provides guidance, 
direction, and advice to prescribers and key health professionals who 
are new to the field of medication-assisted 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; 
Types of funding recipients: National nonprofit organizations; 
Total program funding obligations in fiscal year 2013[B]: n/a (funds 
were not obligated until fiscal year 2014). 

Programs administered by non-HHS agencies: 

Program name (Agency)[A]: Special Supplemental Nutrition Program for 
Women, Infants, and Children (USDA); 
Program type: Maternal and child health; food and nutrition; 
Number of fiscal years in operation: More than 5 years; 
Program description: 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; 
Types of funding recipients: State or local health departments; 
tribes or tribal organizations; 
Total program funding obligations in fiscal year 2013[B]: $4.5 billion. 

Program name (Agency)[A]: Family Drug Court Program[E,G] (OJP within 
DOJ); 
Program type: Substance abuse prevention or treatment; 
Number of fiscal years in operation: More than 5 years; 
Program description: 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; 
Types of funding recipients: State or local health departments; 
state or local behavioral health agencies; state or local courts; 
tribes or tribal organizations; 
Total program funding obligations in fiscal year 2013[B]: $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 evidence-based. 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. 

[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. 

[End of table] 

[End of section] 

Appendix IV: Direct Services Made Available and Program Activities 
Conducted by Federal Programs: 

Officials from eight of the 14 programs that addressed prenatal opioid 
use or neonatal abstinence syndrome (NAS) in fiscal years 2013-2014 
reported that their programs made various direct services available to 
women who used opioids, such as women in medication-assisted treatment 
for opioid use disorders; those who misused, abused, or were addicted 
to opioids; and/or those who were prescribed opioids for pain 
management. Some programs also made services available to newborns who 
had been exposed to opioids during pregnancy, to family members of 
pregnant women who used opioids, or to family members of opioid-
exposed newborns. (See figure 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 
figure 7.) 

Figure 6: Direct Services Made Available by Federal Programs that 
Addressed Prenatal Opioid Use or Neonatal Abstinence Syndrome (NAS), 
Fiscal Years 2013-2014: 

[Refer to PDF for image: illustrated table] 

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

Program name (Agency)[A]: Abandoned Infants[B,C] (ACF); 
Screening, assessment, and referral for treatment; 
Case management and other recovery support services; 
Follow-up case management for infants treated for NAS; 
Behavioral treatment services; 
Medication-assisted treatment; 
Residential treatment; 
Family planning services. 

Program name (Agency)[A]: Regional Partnership Grants[B] (ACF); 
Screening, assessment, and referral for treatment; 
Case management and other recovery support services; 
Follow-up case management for infants treated for NAS; 
Behavioral treatment services; 
Medication-assisted treatment; 
Residential treatment; 
NAS diagnosis or treatment. 

Program name (Agency)[A]: Tribal Maternal, Infant, and Early Childhood 
Home Visiting Program{B,C] (ACF/HRSA); 
Screening, assessment, and referral for treatment; 
Case management and other recovery support services; 
Follow-up case management for infants treated for NAS. 

Program name (Agency)[A]: Healthy Start[B] (HRSA)
Screening, assessment, and referral for treatment; 
Case management and other recovery support services; 
Follow-up case management for infants treated for NAS. 

Program name (Agency)[A]: Maternal, Infant, and Early Childhood Home 
Visiting Program{B,C] (HRSA/ACF); 
Screening, assessment, and referral for treatment; 
Case management and other recovery support services; 
Follow-up case management for infants treated for NAS; 
Family planning services. 

Program name (Agency)[A]: Services Grant Program for Residential 
Treatment for Pregnant and Postpartum Women (SAMHSA); 
Screening, assessment, and referral for treatment; 
Case management and other recovery support services; 
Follow-up case management for infants treated for NAS; 
Behavioral treatment services; 
Medication-assisted treatment; 
Residential treatment. 

Program name (Agency)[A]: Substance Abuse Prevention and Treatment 
Block Grant (SAMHSA); 
Screening, assessment, and referral for treatment; 
Case management and other recovery support services; 
Behavioral treatment services; 
Medication-assisted treatment; 
Residential treatment. 

Program name (Agency)[A]: Title X Family Planning Program[D] 
(OPA within OASH); 
Screening, assessment, and referral for treatment; 
Family planning services. 

Program administered by non-HHS agency: 

Program name (Agency)[A]: Family Drug Court Program[B,C] (OJP 
within DOJ); 
Screening, assessment, and referral for treatment; 
Case management and other recovery support services; 
Behavioral treatment services. 

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. 

[End of figure] 

Figure 7: Other Activities Conducted by Federal Programs that 
Addressed Prenatal Opioid Use or Neonatal Abstinence Syndrome, 
Fiscal Years 2013-2014: 

[Refer to PDF for image: illustrated table] 

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

Program name (Agency)[A]: Abandoned Infants[B] (ACF); 
Types of other program activities: 
Provided training or technical assistance to health care providers; 
Provided training or technical assistance other than to health care 
providers; 
Conducted public education and outreach to women who used opioids 
and/or their families. 

Program name (Agency)[A]: National Abandoned Infants Assistance 
Resource Center[C] (ACF); 
Types of other program activities: 
Provided training or technical assistance other than to health care 
providers. 

Program name (Agency)[A]: Tribal Maternal, Infant, and Early Childhood 
Home Visiting Program[D] (ACF/HRSA); 
Types of other program activities: 
Provided training or technical assistance to health care providers; 
Provided training or technical assistance other than to health care 
providers; 
Conducted public education and outreach to women who used opioids 
and/or their families. 

Program name (Agency)[A]: Maternal, Infant, and Early Childhood Home 
Visiting Program[E] (HRSA/ACF); 
Types of other program activities: 
Provided training or technical assistance other than to health care 
providers. 

Program name (Agency)[A]: Addiction Technology Transfer Centers[F] 
(SAMHSA); 
Types of other program activities: 
Provided training or technical assistance to health care providers. 

Program name (Agency)[A]: National Center on Substance Abuse and Child 
Welfare[G] (SAMHSA/ACF); 
Types of other program activities: 
Provided training or technical assistance to health care providers; 
Provided training or technical assistance other than to health care 
providers; 
Conducted public education and outreach to women who used opioids 
and/or their families. 

Program name (Agency)[A]: Providers’ Clinical Support System for the 
Appropriate Use of Opioids in the Treatment of Pain and Opioid-Related 
Addiction[H] (SAMHSA); 
Types of other program activities: 
Provided training or technical assistance to health care providers. 

Program name (Agency)[A]: Providers’ Clinical Support System for 
Medication Assisted Treatment[H] (SAMHSA); 
Types of other program activities: 
Provided training or technical assistance to health care providers. 

Program name (Agency)[A]: Substance Abuse Prevention and Treatment 
Block Grant[I] (SAMHSA); 
Types of other program activities: 
Provided training or technical assistance other than to health care 
providers; 
Conducted public education and outreach to women who used opioids 
and/or their families. 

Programs administered by non-HHS agencies: 

Program name (Agency)[A]: Family Drug Court Program[J] (OJP within 
DOJ); 
Types of other program activities: 
Provided training or technical assistance other than to health care 
providers. 

Program name (Agency)[A]: Special Supplemental Nutrition Program for 
Women, Infants, and Children[K] (USDA); 
Types of other program activities: 
Provided training or technical assistance other than to health care 
providers; 
Conducted public education and outreach to women who used opioids 
and/or their families. 

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. 

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. 

[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. 

[End of figure] 

[End of section] 

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

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 figure 
8.) 

Figure 8: Other Agency Efforts to Address Prenatal Opioid Use or 
Neonatal Abstinence Syndrome Outside of Research and Programs, Fiscal 
Years 2008-2014: 

[Refer to PDF for image: illustrated table] 

Other agency efforts: 

Department of Health and Human Services (HHS) agencies: 

Federal agency: CDC; 
Provider education; 
Knowledge-sharing groups[A]; 
Reports, fact sheets, or other written publications; 
Surveillance or monitoring. 

Federal agency: CMS; 
Provider education; 
Knowledge-sharing groups[A]; 
Training or technical assistance other than provider education; 
Written policies or guidance; 
Reports, fact sheets, or other written publications; 
Strategic planning. 

Federal agency: FDA; 
Provider education; 
Knowledge-sharing groups[A]; 
Public education or outreach, including media or advertising campaigns; 
Surveillance or monitoring; 
Regulation and oversight of opioid labeling, marketing, or prescribing; 
Other[B]. 

Federal agency: IHS; 
Provider education; 
Knowledge-sharing groups[A]; 
Training or technical assistance other than provider education; 
Written policies or guidance; 
Reports, fact sheets, or other written publications; 
Public education or outreach, including media or advertising campaigns; 
Surveillance or monitoring; 
Other[B]. 

Federal agency: NIH; 
Knowledge-sharing groups[A]; 
Training or technical assistance other than provider education. 

Federal agency: OASH; 
Knowledge-sharing groups[A]. 

Federal agency: SAMHSA; 
Provider education; 
Training or technical assistance other than provider education; 
Reports, fact sheets, or other written publications; 
Public education or outreach, including media or advertising campaigns; 
Surveillance or monitoring; 
Other[B]. 

Non-HHS agencies: 

Federal agency: DOD; 
Provider education; 
Written policies or guidance. 

Federal agency: ONDCP; 
Provider education; 
Knowledge-sharing groups[A]; 
Training or technical assistance other than provider education; 
Written policies or guidance; 
Public education or outreach, including media or advertising campaigns; 
Strategic planning; 
Other[B]. 

Federal agency: VA; 
Provider education; 
Written policies or guidance. 

CDC: Centers for Disease Control and Prevention; 
CMS: Centers for Medicare & Medicaid Services; 
DOD: Department of Defense; 
FDA: Food and Drug Administration; 
IHS: Indian Health Service; 
NIH: National Institutes of Health; 
OASH: Office of the Assistant Secretary for Health; 
ONDCP: Office of National Drug Control Policy; 
SAMHSA: Substance Abuse and Mental Health Services Administration; 
VA: Department of Veterans Affairs. 

Source: GAO. GAO-15-203. 

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. 

[End of figure] 

[End of section] 

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

Executive Office of The President: 
Office of National Drug Control Policy: 
Washington, D.C. 20503: 

January 13, 2015: 

Vijay A. D'Souza: 
Director, Health Care: 
Government Accountability Office: 
441 G. Street, NW: 
Washington DC 20548: 

Subject: GAO Report on Prenatal Drug Use and Newborn health (GAO-15-
203): 

Dear Mr. D'Souza: 

ONDCP appreciates the work which GAO has done examining the issue of 
Prenatal Drug Use and Newborn Health. GAO's report has the potential 
to help increase awareness of this serious public health concern in 
Congress and amongst the American people. 

ONDCP has worked to focus national attention on the growing problem of 
opioid addiction resulting from the misuse of prescription drugs. In 
2011, ONDCP developed a plan entitled "Epidemic: Responding to 
America's Prescription Drug Abuse Crisis." The growth in the rates of 
neonatal abstinence syndrome (NAS) is closely linked to the dramatic 
increase in the non-medical use of prescription opioids over the last 
fifteen years. As GAO recognized in its report, ONDCP "highlighted 
maternal addiction and NAS as emerging and critical issues in its 2013 
and 2014 annual National Drug Control Strategy reports." Most of the 
women whose babies are born with NAS had a preexisting condition of 
either pain for which an opioid had been prescribed or an opioid use 
disorder prior to their pregnancy. Reducing the number of babies born 
with NAS depends in large measure on reducing the prevalence of 
nonmedical prescription opioid use. ONDCP has worked extensively with 
other Federal agencies, State governments, medical organizations, the 
public health community, and law enforcement to address the opioid 
addiction crisis through a broad range of public health and public 
safety initiatives. This comprehensive effort includes prescriber 
education, public prevention efforts, prescription drug monitoring 
programs, abuse deterrent formulations of pain medicine, controls to 
prevent drug diversion, expanded access to treatment for opioid use 
disorders, overdose prevention, and safe drug disposal. 

In 2012, the Administration convened a White House national leadership 
meeting bringing together Federal agencies, State officials, key 
stakeholders and Congressional staff to discuss solutions to the 
growing NAS problem. ONDCP has played a leading role in disseminating 
information about prenatal opioid use and NAS, and coordinating 
efforts to respond to it across the Federal Government. The Office has 
also provided technical assistance to state governments and public 
health organizations. For example, we have worked extensively
with the Appalachian Regional Commission to address the problem of NAS 
in a region particularly hard hit by the opioid crisis. 

There are additional steps that should be taken to address the issue 
of NAS. Medical care needs to be standardized for infants with NAS and 
best practices for their care need to be disseminated. Women at risk 
of giving birth to a drug exposed baby should be encouraged to seek 
prenatal care and treatment for their substance use disorders. Fear of 
losing custody of their children, and in some states even facing 
criminal penalties, can deter women from seeking medical assistance. 
More family based treatment is needed for women with substance use 
disorders, including access to medication assisted therapy. 

ONDCP is committed to continuing work with our Federal partners to 
respond effectively to the serious problem of prenatal opioid use and 
NAS. As we proceed, we will heed GAO's recommendation for better 
documentation of the process for developing action items. 

Signed by: 

Jeffrey J. Teitz: 
General Counsel: 
Office of National Drug Control Policy: 

[End of section] 

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

Department of Health and Human Services: 
Office of The Secretary: 
Assistant Secretary for Legislation: 
Washington, DC 20201: 

January 15, 2015: 

Vijay A. D'Souza: 
Director, Health Care: 
U.S. Government Accountability Office: 
441 G Street NW: 
Washington, DC 20548: 

Dear Mr. D'Souza: 

Attached are comments on the U.S. Government Accountability Office's 
(GAO) report entitled, "Prenatal Drug Use and Newborn Health: Federal 
Efforts Need Better Planning and Coordination" (GA0-15-203). 

The Department appreciates the opportunity to review this report prior 
to publication. 

Sincerely, 

Signed by: 

Jim R. Esquea: 
Assistant Secretary for Legislation: 

Attachment: 

General Comments Of The Department Of Health And Human Services (HHS) 
On The Government Accountability Office's (GAO) Draft Report Entitled: 
Prenatal Drug Use And Newborn Health: Federal Efforts Need Better 
Planning And Coordination (GAO-15-203): 

The U.S. Department of Health and Human Services (HHS) appreciates the 
opportunity to review and comment on this draft report. 

GAO Recommendation: 

The Government Accountability Office (GAO) recommends that in order to 
ensure that efforts to address prenatal opioid use and neonatal 
abstinence syndrome (NAS) are systematically and effectively planned 
and coordinated across HHS's agencies, the Secretary of HHS should 
designate a focal point, such as the Behavioral Health Coordinating 
Council 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. 

HHS Response: 

HHS concurs with this recommendation. HHS has focused coordinated 
efforts on reducing opioid use disorder and these activities/policies 
are aimed at reducing the potential for misuse and abuse across the 
U.S. with some emphasis on special populations, including pregnant 
women. HHS will conduct a departmental review to designate a focal 
point to lead planning and coordination efforts to address the issue 
of NAS and possible departmental duplication. 

[End of section] 

Appendix VIII: GAO Contact and Staff Acknowledgments: 

GAO Contact: 

Vijay A. D'Souza, (202) 512-7114 or dsouzav@gao.gov. 

Staff Acknowledgments: 

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. 

[End of section] 

Related GAO Products: 

Office of National Drug Control Policy: Office Could Better Identify 
Opportunities to Increase Program Coordination, [hyperlink, 
http://www.gao.gov/products/GAO-13-333] (Washington, D.C.: Mar. 26, 
2013). 

Drug Control: Initial Review of the National Strategy and Drug Abuse 
Prevention and Treatment Programs, [hyperlink, 
http://www.gao.gov/products/GAO-12-744R] (Washington, D.C.: July 6, 
2012). 

Prescription Pain Reliever Abuse: Agencies Have Begun Coordinating 
Education Efforts, but Need to Assess Effectiveness, [hyperlink, 
http://www.gao.gov/products/GAO-12-115] (Washington, D.C.: Dec. 22, 
2011). 

Methadone-Associated Overdose Deaths: Factors Contributing to 
Increased Deaths and Efforts to Prevent Them, [hyperlink, 
http://www.gao.gov/products/GAO-09-341] (Washington, D.C.: Mar. 26, 
2009). 

Prescription Drugs: OxyContin Abuse and Diversion and Efforts to 
Address the Problem, [hyperlink, 
http://www.gao.gov/products/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). 

[End of section] 

Footnotes: 

[1] Stephen W. Patrick et al., "Neonatal Abstinence Syndrome and 
Associated Health Care Expenditures: United States, 2000-2009," JAMA, 
vol. 307, no. 18 (2012). 

[2] Patrick et al., "Neonatal Abstinence Syndrome," p. 1937. 

[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). 

[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. 

[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. 

[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). 

[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).

[10] Off-label use refers to the prescription of a medication for uses 
other than what the Food and Drug Administration has approved. 

[11] Stephen W. Patrick et al., "Variation in treatment of neonatal 
abstinence syndrome in US Children's Hospitals, 2004-2011," Journal of 
Perinatology, vol. 34 (2014). 

[12] Agencies may have obligated additional funding for these projects 
prior to fiscal year 2008. Fiscal year 2014 funding obligations were 
reported through May 31, 2014. 

[13] HHS 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. 

[14] CDC 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. 

[15] One-quarter of NIH's obligations for projects on prenatal opioid 
use or NAS from fiscal years 2008 through 2014 was for the MOTHER 
study. 

[16] Hendree E. Jones, et al., "Neonatal Abstinence Syndrome after 
Methadone or Buprenorphine Exposure," New England Journal of Medicine, 
vol. 363, no. 24 (2010). 

[17] For 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. Programsreported information for fiscal year 2013 
and for fiscal year 2014 as of May 31, 2014. 

[18] There 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). 

[19] The 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. 

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

[21] IHS 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, the Health Resources and 
Services Administration (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. 

[22] The State Children’s Health Insurance Program is a federal-state 
program that provides coverageto low-income children whose household 
incomes are above the threshold for Medicaid eligibility. 

[23] See Department of Defense and Department of Veterans Affairs, 
VA/DOD Clinical Practice Guideline for Pregnancy Management, 2009. 

[24] Substance 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. 

[25] 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. 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. 

[26] A 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. 

[27] For 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, [hyperlink, 
http://www.gao.gov/products/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, [hyperlink, http://www.gao.gov/products/GAO-12-1022] 
(Washington, D.C.: Sept. 27, 2012). 

[28] ONDCP 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. 

[29] In 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. 

[30] We 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, [hyperlink, 
http://www.gao.gov/products/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, [hyperlink, 
http://www.gao.gov/products/GAO-13-333] (Washington, D.C.: Mar. 26, 
2013). 

[31] We have previously identified that documentation of meetings and 
agreements is a key feature for successful collaboration. See 
[hyperlink, http://www.gao.gov/products/GAO-12-1022]. 

[32] GAO 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, [hyperlink, 
http://www.gao.gov/products/GAO-13-279SP] (Washington, D.C.: Apr. 9, 
2013). 

[33] The 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. 

[34] One example of this partnership included a review of state 
policies and practices for addressing prenatal substance exposure. See 
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). 

[35] OASH 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. 

[36] The 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. 

[37] In 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, [hyperlink, 
http://www.cdc.gov/homeandrecreationalsafety/overdose/hhs_rx_abuse.html]

[38] See 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, [hyperlink, 
http://www.fda.gov/downloads/Drugs/DrugSafety/InformationbyDrugClass/UCM
277916.pdf]. 

[39] We have previously reported that identification of a leader as a 
key feature for successful collaboration. See [hyperlink, 
http://www.gao.gov/products/GAO-12-1022]. 

[40] SAMHSA 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). 

[41] For the purposes of our study, we collected information on 
research, programs, and other agency efforts through May 31, 2014. 

[42] 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 [hyperlink, 
https://www.cfda.gov/]. 

[43] 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. 

[44] 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 [hyperlink, 
http://www.hhs.gov/budget/2013-program-inventory/federal-program-
inventory.html]. 

[45] 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. 

[46] 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. 

[47] 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. 

[48] Agencies reported information on other efforts to address 
prenatal opioid use or NAS for fiscal year 2014 as of May 31, 2014. 

[49] 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. 

[50] We 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. 

[51] Three projects were intramural research, which are projects 
conducted by agency scientists. 

[52] 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. 

[End of section] 

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