March 12, 2019
Opioid Use and Neonatal Abstinence Syndrome
The prevalence of opioid use disorder (OUD)—problematic
opioid use leading to clinically significant impairment or
distress—among pregnant women has gradually increased
as the nation’s opioid epidemic has unfolded. This has led
to increases in several adverse outcomes for infants,
including neonatal abstinence syndrome (NAS). Recent
efforts by both Congress and the U.S. Department of Health
and Human Services (HHS) have focused on addressing the
rising rate of NAS.
NAS is a withdrawal syndrome that often occurs when
newborns no longer receive a substance, such as an opioid,
that was administered in utero. According to a 2014
Pediatrics article focusing on opioid use and NAS, NAS
symptoms can occur within 24 to 72 hours of birth and may
last up to several months, depending on the type of opioid
exposure (e.g., heroin, methadone, or buprenorphine). Such
symptoms can include tremors, feeding and sleeping
difficulties, temperature instability, and hyperirritability.
While other substances (e.g., alcohol) have been associated
with NAS, opioids are one of the most common substances
associated with this syndrome.
According to a 2018 Centers for Disease Control and
Prevention (CDC) analysis, the national prevalence (new
and existing cases) of OUD during pregnancy increased
from 1.5 OUD cases per 1,000 hospital births in 1999 to 6.5
OUD cases per 1,000 hospital births in 2014. New cases
(incidence) of NAS have also increased over a similar time
period. From a national perspective, a 2012 JAMA study
found that the incidence rate of NAS has increased
significantly, from 1.2 cases per 1,000 hospital births per
year in 2000 to 3.4 cases per 1,000 hospital births per year
in 2009. However, the incidence rate of NAS has varied by
state (see Figure 1). These select data are among the most
recent national and state-level estimates available.
Figure 1. Incidence Rate of NAS per 1,000 Hospital
Births in 25 States, 2012 and 2013
Source: Ko et al., 2016, “Incidence of Neonatal Abstinence
Syndrome – 28 States, 1999-2013,” MMWR.
Note: 2013 incidence rates are reported, except 2012 data reported
for four states (Maine, Maryland, Massachusetts, and Rhode Island)
without 2013 data.
NAS Screening and Treatment
No specific NAS screening guideline has been uniformly
endorsed or adopted in clinical practice. Health care
providers typically diagnose NAS using statistically
validated scoring tools (e.g., Finnegan Neonatal Abstinence
Scoring Tool) that score severity based on observed
symptoms in the infant. Medical literature points to the
importance of hospitals and nurseries adopting standard
screening protocols, as well as properly training staff on the
correct use of validated scoring tools.
NAS is a treatable condition that may require both
pharmacologic (e.g., methadone) and non-pharmacologic
care (e.g., gentle handling and feeding on demand).
According to a 2017 Government Accountability Office
(GAO) report, there is no national standard of care for NAS
treatment. However, the American Academy of Pediatrics
(AAP), a professional organization of pediatricians,
recommends that infants with NAS should initially be
treated with non-pharmacologic care, as pharmacologic
treatment may be necessary only for severe cases. In
addition, multiple research studies highlight the importance
of involving mothers during treatment. The AAP further
recommends that case management services (which assist
the infant and caregiver in obtaining necessary medical,
educational, and other services) can ensure that quality care
is provided within each treatment stage.
Gaps in Research on Screening and Treatment
Several recent reports have identified a lack of research on
standardized, uniform screening tools and treatment
protocols. In 2016, the Eunice Kennedy Shriver National
Institute of Child Health and Human Development
(NICHD) at the National Institutes of Health (NIH) held a
workshop with invited experts to review research gaps on
opioid use in pregnancy, NAS, and childhood outcomes.
The workshop proceedings cited gaps specific to NAS,
including the need for more objective screening tools and
the most effective types of non-pharmacologic and
pharmacologic therapies to use in different clinical
scenarios. In 2017, HHS highlighted similar research gaps
in screening tools and treatment protocols, including the
need for further development of objective screening tools
and how exposure to different opioid types and/or other
substances during pregnancy may affect the severity and
treatment of NAS.
According to a 2015 GAO report that examined federally
funded research on prenatal drug use, executive agency
officials and experts also cited NAS screening and
treatment research gaps. Reasons for these gaps included
difficulties conducting research among pregnant women
with substance use disorders, as well as other research areas
beyond prenatal drug use receiving funding priority (the
report did not specify these other areas).
Opioid Use and Neonatal Abstinence Syndrome
Select Health Outcomes Among Infants
At a joint 2016 workshop with invited experts in the field,
NIH found a lack of evidence about the long-term health
effects of prenatal opioid exposure and NAS.
Since that time, a few academic research articles have
examined short- and long-term health outcomes among
infants with and without NAS, respectively. These articles
suggest that infants with NAS are susceptible to
hospital readmission within the first five years of life,
delayed developmental milestones and higher rates of
strabismus (crossed eyes) by the age of two, and
poor academic performance in secondary schooling.
HHS’s Role in Addressing NAS
HHS is addressing NAS through data and surveillance,
research and evaluation, programs and services, and
education activities in its respective agencies. These
agencies include CDC, the Administration for Children and
Families (ACF), the Centers for Medicare and Medicaid
Services (CMS), the Health Resources and Services
Administration (HRSA), and the Substance Abuse and
Mental Health Services Administration (SAMHSA). CDC
generally conducts surveillance of OUD among pregnant
women and NAS. SAMHSA largely focuses on addressing
prenatal substance use among pregnant women and
recovery services for mothers, as evidenced by a recently
released clinical guidance for treating pregnant and
parenting women with OUD. ACF and HRSA largely focus
on services for infants and children affected by prenatal
substance use, including NAS.
CMS oversees Medicaid, a federal-state health care
program that finances health care coverage for diverse
groups of low-income populations, including children,
pregnant women, adults, individuals with disabilities, and
people aged 65 and older. As reported to Congress by the
Medicaid and CHIP Payment and Access Commission
(MACPAC), Medicaid covered almost half of all births in
the United States in 2014, and according to 2018 Pediatrics
article, Medicaid covered 82% of NAS-related births in
2014. In light of Medicaid’s importance in addressing NAS,
CMS released an informational bulletin for states in June
2018 that discusses Medicaid’s role and limitations in NAS
diagnosis and treatment, as well as Medicaid reimbursable
treatment design approaches states may wish to pursue.
HHS’s Strategy to Address NAS
The Protecting Our Infants Act (P.L. 114-91) was enacted
in November 2015. It required HHS, among other things, to
conduct a review of its planning and coordination activities
related to prenatal opioid use (including NAS), develop a
strategy to address gaps in research and federal programs,
and submit a report to Congress on the findings of the
review and the related strategy. After seeking public
comment about its initial strategy, HHS released a final
report in June 2017, Protecting Our Infants Act: Final
Strategy (Final Strategy). This Final Strategy report
provides HHS’s recommendations to address and expand
on NAS prevention, treatment, and services activities
administered by the department.
As required by the Comprehensive Addiction and Recovery
Act of 2016 (CARA; P.L. 114-198), a 2017 GAO report
examined NAS in the United States and related treatment
services under Medicaid. According to GAO, the strategy
HHS outlined in its Final Strategy report does not have a
comprehensive, organized method to address the demands
of treating NAS. Specifically, GAO stated that the strategy
lacks priorities, timeframes, and responsibilities for
implementing HHS’s proposed recommendations for
addressing NAS. While HHS agreed with GAO’s
assessment, it noted that implementation of the strategy was
contingent upon funding.
Provisions in the SUPPORT for Patients
and Communities Act of 2018
In October 2018, Congress enacted the Substance Use–
Disorder Prevention that Promotes Opioid Recovery and
Treatment (SUPPORT) for Patients and Communities Act
of 2018 (P.L. 115-271). The SUPPORT Act is intended to
address extensive overprescribing and misuse of opioids in
the United States, building upon previous legislative efforts
that were also intended to help address, in part, the opioid
epidemic (e.g., CARA and the 21st Century Cures Act [P.L.
114-255]). Provisions in the SUPPORT Act relevant to
NAS took a variety of approaches to address the issue, and
are broadly summarized below.
Section 1005 requires HHS to issue guidance to
improve care for infants with NAS and their families,
and requires GAO to conduct a study addressing gaps in
Medicaid coverage for pregnant and postpartum women
with a substance use disorder.
Section 1007 adds a state option to make Medicaid
inpatient or outpatient services available to infants with
NAS at a residential pediatric recovery center.
Sections 7061-7064 require HHS, among other things,
to conduct and disseminate research on NAS, provide an
update on the implementation of and funding or
additional authorities needed for its strategy to address
NAS, and develop and promote educational materials
about pain management and prevention of substance use
disorders during pregnancy.
Section 7151 allows SAMHSA-funded Building
Communities of Recovery grants to focus outreach
activities on NAS.
Select Issues for Congress
Congress may consider prioritizing research on the
standardization of screening and treatment, as well as longterm health outcomes associated with NAS. Congress may
also consider expanding availability and coverage of
different NAS treatments through Medicaid or other
programs. Finally, Congress may consider monitoring
HHS’s efforts to address NAS, including potential costs
associated with these efforts.
Victoria R. Green, Analyst in Health Policy
Opioid Use and Neonatal Abstinence Syndrome
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