Newborn Health: Federal Action Needed to Address Neonatal Abstinence Syndrome

As the opioid crisis has increased in recent years, so has the number of pregnant women who use opioids, which can result in NAS. A recent peer-reviewed study found that cases of NAS have grown nearly five-fold between 2000 and 2012 and that most infants with NAS are covered under Medicaid.

The Comprehensive Addiction and Recovery Act of 2016 includes a provision for GAO to examine NAS in the United States and related treatment services covered under Medicaid. This report 1) describes the hospital and non-hospital settings for treating infants with NAS and how Medicaid pays for services, 2) describes recommended practices and challenges for addressing NAS, and 3) examines HHS's strategy for addressing NAS.

GAO reviewed HHS documentation and interviewed HHS officials. GAO also conducted site visits to four states—Kentucky, Vermont, West Virginia, and Wisconsin—selected based on several factors, including incidence rates of NAS and geographic variation. GAO interviewed stakeholders from 32 organizations, including health care providers and state officials in the selected states.

The prenatal use of opioids or other drugs can produce a withdrawal condition in newborns known as neonatal abstinence syndrome (NAS). Health care providers, state officials, and other stakeholders told GAO that most infants with NAS are treated in the hospital—such as in a neonatal intensive care unit—though some may be referred to a non-hospital setting—such as a neonatal withdrawal center with nursery rooms—to complete their treatment. The table below provides more information on settings for treating infants with NAS and on how Medicaid pays for services in these settings.

According to stakeholders GAO interviewed and literature reviewed, there are several recommended practices and challenges associated with addressing NAS. The most frequently recommended practices included prioritizing non-pharmacologic treatment to infants—treatment that does not involve medications—such as allowing the mother to reside with the infant during treatment; educating mothers and health care providers on treatment of NAS, among other things; and using a protocol in the hospital or non-hospital setting for screening and treating infants with NAS. The most frequently cited challenges included the maternal use of multiple drugs—or polysubstance use—as it can exacerbate NAS symptoms; stigma faced by pregnant women who use opioids; hospital staff burden and limited physical capacity to care for infants with NAS; limited coordination of care for mothers and infants with NAS; and gaps in research and data on NAS, such as research on the long-term effects of the condition.

In May 2017, the Department of Health and Human Services (HHS) published a strategy document that makes key recommendations to address NAS. The Strategy recommends, for example, that health care providers receive continuing education on managing and treating infants with NAS and promote non-pharmacologic treatment. According to HHS officials, these recommendations will inform planning and policy across the department. However, HHS has yet to determine how and when the recommendations will be implemented, including establishing priorities; the roles and responsibilities of other federal, state, and public stakeholders; implementation timeframes; and methods for assessing progress. HHS officials told GAO that they expect to develop an implementation plan sometime in 2017 but had no timeline for doing so. Without a plan that clearly specifies how HHS will implement the Strategy and assess its progress, the department increases the risk that its recommendations for addressing NAS will not be implemented.

HHS should expeditiously develop a plan for implementing the recommendations included in its strategy related to addressing NAS. HHS concurred that it should expeditiously address NAS, but noted implementation of the strategy is contingent on funding.

Opioid misuse, including the use of heroin and misuse of opioids  prescribed for pain management, has been recognized by the federal  government, states, researchers, and others as a growing crisis in the  United States. As opioid misuse has increased in recent years, so has the  number of pregnant women who use opioids. The prenatal use of opioids  by pregnant women—including opioid misuse, use of opioids prescribed  for pain management, and use of certain medications given to treat opioid  addiction—can produce a withdrawal condition in newborn infants known  as neonatal abstinence syndrome (NAS). NAS symptoms range from  excessive crying and irritability to difficulties with breathing and feeding.  NAS is a rapidly increasing public health problem, with the incidence of  NAS in the United States growing nearly five-fold between 2000 and  2012. Specifically, cases of NAS increased from a rate of 1.2 per 1,000  hospital births per year in 2000 to 5.8 per 1,000 hospital births per year in  2012, reaching a total of 21,732 infants diagnosed with NAS. A 2015  study noted that by 2012 one infant was born about every 25 minutes with  NAS.

While experts consider NAS to be an expected and treatable result of  prenatal opioid exposure, infants with NAS require specialized care that  typically results in longer and more complicated and costly hospital stays.  More than eighty percent of the NAS cases identified in the 2015 study  were paid for by Medicaid, the federal-state program that finances health  care coverage for low-income and medically needy populations, including  children and aged or disabled adults.

Due to the growing opioid epidemic and its deleterious effects, including  the effects on infants, Congress has held hearings and passed legislation  aimed at addressing various aspects of this epidemic. For example, the  Protecting Our Infants Act of 2015 directed the Department of Health and  Human Services (HHS) to conduct a study and develop  recommendations for preventing and treating prenatal opioid use  disorders, including NAS. This law also required HHS to review its  planning and coordination related to NAS and to develop a strategy to  address gaps in research and gaps, overlap, and duplication among  federal programs to address NAS. We have previously reported that  HHS has nine agencies involved with addressing NAS and has a council  dedicated to coordinating activities across the department to address  NAS.

The Comprehensive Addiction and Recovery Act of 2016 (CARA)  included a provision for GAO to examine NAS in the United States and  the treatment services for the condition covered under Medicaid in  hospital settings as well as any non-hospital settings. The act required  us to report within a year after passage, and to meet this mandated date,  we briefed your staff on our preliminary findings in July 2017. This report  includes information shared during that briefing and  1.  describes the hospital settings for treating infants with NAS and how  Medicaid pays for services in these hospital settings;  2.  describes the non-hospital settings for treating infants with NAS and  how Medicaid pays for services in these non-hospital settings;  3.  describes the recommended practices and challenges for addressing  4.  examines HHS’s strategy for addressing NAS.

To address our first three audit objectives describing care settings for  treating infants with NAS, Medicaid payment for NAS treatment, and the  recommended practices and challenges for addressing NAS, we did the  following:

We selected 32 stakeholders based on their relevant experience to  cover a range of perspectives on NAS. This included stakeholders  from site visits we conducted in four states—Kentucky, Vermont, West  Virginia, and Wisconsin. We selected these states because they met  the following criteria: (1) high incidence rate of NAS as of 2013; (2)  variation in United States geographic regions with high rates of NAS  as of 2012; (3) more than 40 percent of births in the state were  financed by Medicaid in 2016; and (4) the state has a perinatal quality  collaborative—a state or multi-state network of teams working to  improve health outcomes for mothers and infants—with work related  to NAS. The stakeholders we selected within these states consisted  of four state agencies, including Medicaid officials; officials from the  perinatal collaborative that work on NAS in each state; officials from  one residential treatment facility in each state that provides prenatal  and postpartum care to mothers; and hospital providers, including  physicians or nurses, from eight hospitals (two hospitals in each  state). We also selected 12 additional stakeholders outside of these  four states, including health care providers or administrators in four  non-hospital settings across the United States; officials from five  medical specialty societies, such as the American Academy of  Pediatrics and the American College of Obstetricians and  Gynecologists; and three experts, such as the authors of studies we  identified.

We interviewed each of these 32 stakeholders and requested  information from stakeholders about treating infants with NAS,  including the utilization of available hospital and non-hospital care  settings and associated costs of treatment services. For example, we  requested protocols for screening and treating infants with NAS from  hospital and non-hospital care settings. We reviewed available  protocols provided by hospitals and a non-hospital care setting. We  also reviewed available information reported by state officials, hospital  and non-hospital providers, and state perinatal collaboratives on the  utilization of hospital and non-hospital care settings, the facility’s cost  of treating NAS in hospital and non-hospital settings, length of stay for  treating infants with NAS, or the amount of Medicaid payments for  treating infants with NAS. We discussed the information provided by  stakeholders and examined the information for obvious errors. The  information obtained from these stakeholders is not generalizable to  other states or other hospital and non-hospital settings. In addition, in  some cases, stakeholders collected information differently, including  information on Medicaid payments; as a result, the information  reported by stakeholders is not directly comparable.

We conducted a literature review to identify relevant peer-reviewed  articles published between January 2013 and December 2016. As a  result, we identified and reviewed 40 relevant studies. We examined  the methodologies for each of these studies and determined that the  studies were sufficiently reliable for our audit objectives.

We interviewed officials from HHS, including those from the Centers  for Medicare & Medicaid Services (CMS) and HHS’s Behavioral  Health Coordinating Council—which includes officials from the  Substance Abuse and Mental Health Services Administration  (SAMHSA), the Indian Health Service, the Centers for Disease  Control and Prevention (CDC), and the Food and Drug Administration,  among others—concerning NAS treatment services, settings of care,  Medicaid payment, and recommended practices and challenges  related to addressing NAS.

We conducted a web-based survey administered to Child Welfare  Directors in fifty states and the District of Columbia and included in the  survey questions about whether Child Welfare Directors had received  federal or state guidance related to NAS. All 51 respondents  completed the survey for a response rate of 100 percent.

To examine our last audit objective on HHS’s strategy related to  addressing NAS, we interviewed agency officials and reviewed  documents on the department’s efforts to develop a strategy. Specifically,  we interviewed relevant officials from CMS and HHS’s Behavioral Health  Coordinating Council concerning their efforts to develop a strategy related  to addressing NAS. In reviewing relevant HHS documents, we focused on  HHS’s Protecting Our Infants Act Report to Congress, which includes a  strategy to address identified gaps, challenges, and recommendations  related to NAS and prenatal opioid use. In addition, we reviewed the  relevant standards for internal control in the federal government and the  relevant criteria from GAO’s body of work on effectively managing  performance under the Government Performance and Results Act  (GPRA) of 1993 and the GPRA Modernization Act of 2010. See  appendix I for further details of our methodology related to these  objectives.

We conducted this performance audit from September 2016 to October  2017 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.

NAS is a withdrawal condition within infants that can result from the  prenatal use of opioids by pregnant women. Prenatal opioid use occurs  when a woman, during the course of her pregnancy, uses an opioid- based medication or substance. Prenatal opioid use can take various  forms, including (1) the use of prescriptions for pain management, such  as fentanyl and oxycodone; (2) medication-assisted treatment for opioid  addiction, such as methadone and buprenorphine; (3) prescription drug  misuse or use disorder (such as using an opioid without a prescription,  using a different dosage than prescribed, or continuing to use an opioid  when it is no longer needed for pain); and (4) illicit opioid use, such as  heroin use. These types of prenatal opioid use are not mutually exclusive.  A 2014 study found that almost 22 percent of pregnant Medicaid  beneficiaries filled a prescription for an opioid during their pregnancy.  Medication-assisted treatment—an approach that combines the use of  certain medications and behavioral therapy—is generally considered by  HHS and medical specialty societies to be the standard of care for  treating pregnant women with opioid use disorders, depending on the  individual and her circumstances. SAMHSA and several medical  specialty societies, including the American College of Obstetricians and  Gynecologists and the American Society of Addiction Medicine, have  noted that providing medication-assisted treatment during pregnancy  prevents complications associated with illicit opioid use, encourages  prenatal care, and reduces the risk of obstetric complications. Further,  women may use multiple substances in addition to opioids during  pregnancy—known as maternal polysubstance use—such as tobacco,  alcohol, or anti-depressants, among others.

GAO reported in 2015 that 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. 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. See  GAO-15-203. For more information on factors that can affect access to medication- assisted treatment, see GAO, Opioid Addiction: Laws, Regulations, and Other Factors  Can Affect Medication-Assisted Treatment Access, GAO-16-833 (Washington, D.C.: Sept.  2016). respiratory distress.

There is currently no national standard of care for screening or treating  NAS. There have been a few scoring tools developed to screen the infant  to determine the appropriate course of treatment. Health care 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 College of Obstetricians and Gynecologists recommend that  infants with NAS should not be initially treated with medication, known as  pharmacologic treatment. Instead, these organizations recommend  starting with non-pharmacologic treatment, which includes placing the  infant in a dark and quiet environment, swaddling, breastfeeding,  rooming-in with the mother, and providing high-calorie nutrition, among  other things. For example, rooming-in—allowing the mother to reside with  the infant during the infant’s treatment—may have benefits, such as  helping to develop a bond between the mother and infant and to reduce  the severity of the infant’s NAS symptoms. Pharmacologic treatment,  such as using methadone or morphine, may be necessary only for the  relief of moderate to severe signs of NAS. See figure 1 for more  information on non-pharmacologic and pharmacologic treatment.

Federal Resources on NAS and Prenatal Opioid Use

HHS has published several guidance and educational resources related  to NAS and prenatal opioid use. These documents serve as tools to help  stakeholders, including state entities and health care providers, who work  with this population. For example, SAMHSA published a clinical report for  health care providers in 2016 that provides recommendations to help  them when making decisions regarding the evaluation, care, and  treatment of women with opioid use disorders and infants with NAS. As  of July 2017, SAMHSA is in the process of producing a clinical guide  based on this report and expects to publish an updated report later this  year. In another example, SAMHSA published a guidance document in  2016 that aims to support the efforts of states, tribes, and local  communities in addressing the needs of pregnant women with opioid use  disorders and their infants. Among other things, the document includes  strategies and guidance to promote care coordination among  stakeholders, including child welfare agencies and medical professionals,  when treating infants with NAS. (See app. II for a list of federal  educational resources related to NAS and prenatal opioid use published  by HHS.)

As we previously noted, more than 80 percent of NAS cases are paid for  by Medicaid, which is a federal-state health care program that finances  health care coverage for low-income and medically needy populations,  including children and aged or disabled adults. States administer their  Medicaid programs within broad federal requirements and according to a  state plan approved by CMS, the federal agency within HHS that  oversees Medicaid. The Medicaid program allows states to design and  implement their programs within certain federal parameters, resulting in  more than 50 distinct state-based programs. For example, states  generally determine the type and scope of services to cover, set payment  rates that different health care providers will receive for various covered  services, and pay these providers for claims submitted for services  rendered. In addition, states vary in the extent to which they enroll  beneficiaries in managed care versus delivering care through the more  traditional fee-for-service model. Under a managed care delivery model,  states typically contract with managed care plans to provide a specific set  of Medicaid-covered services to beneficiaries and pay them a set amount  per beneficiary—referred to as capitation payments—to provide those  services. Under fee-for-service, Medicaid pays health care providers a  fee for each service provided to a Medicaid beneficiary. Medicaid’s Early  and Periodic Screening, Diagnostic, and Treatment benefit, which states  are required to provide, covers comprehensive health screenings,  preventive health services, and all medically necessary treatment and  services—for Medicaid eligible-children under the age of 21—to correct or  ameliorate health conditions discovered through screenings.

Most Infants with NAS Complete Treatment in Various Hospital Settings, and in Selected States Medicaid Pays for Services Using Bundled Payments

Hospital Settings for Treating Infants with NAS

According to the literature we reviewed, most infants with NAS in the  United States are treated in a hospital setting, often in the neonatal  intensive care unit (NICU), which has a relatively high daily cost of care.  Stakeholders we interviewed told us that these infants may also be  treated in other hospital settings. According to state and perinatal  collaborative officials in the four selected states we reviewed, infants  diagnosed with NAS begin—and most complete—treatment for the  condition in various hospital settings which provide different levels of  care: a well newborn nursery (level I), special care nursery (level II), or  NICU (level III or IV). For example, according to these officials, most  infants with NAS in Vermont are treated in well newborn nurseries, while  most infants with NAS in Kentucky and Wisconsin are treated in NICUs.  West Virginia perinatal collaborative officials told us that about a third of  infants with NAS are treated in well newborn nurseries, while two-thirds  receive treatment in either a special care nursery or NICU. According to  perinatal collaborative officials and hospital providers in the four selected  states, the severity of the infant’s NAS symptoms or the hospital’s  capability to treat NAS can determine whether the infant receives care in  a nursery or NICU.

Health care providers in the four selected states described the general  clinical approach for treating infants with NAS. According to these  providers, they generally start with non-pharmacologic treatment—for  example, swaddling or placing the infant in a quiet, dark room. Health  care providers may continue to monitor and assess the severity of the  infant’s NAS symptoms using one of the available scoring tools for NAS.  If the infant’s symptoms meet or exceed a certain threshold, these  providers may initiate pharmacologic treatment by administering  morphine or methadone, for example.

Some perinatal collaborative officials that we interviewed in the four  selected states told us that not all hospitals may have the capability to  provide pharmacologic treatment. For example, these officials told us that  level I hospitals—hospitals with only well newborn nurseries—in Kentucky  and Wisconsin may not provide pharmacologic treatment to infants with  NAS because these hospitals may not have the staff expertise to  administer the needed medication and monitor the infants who receive it.  Instead, these hospitals may transfer infants with NAS who require  pharmacologic treatment to hospitals with higher levels of care, such as  those with a NICU. Table 1 provides information on the eight selected  hospitals in our review that provide NAS services.

According to a 2015 study we reviewed, nationwide, infants with NAS  who require pharmacologic treatment generally have longer average  hospital stays (23 days) compared with infants with NAS who do not  require such medication (17 days). Health care providers from our  selected hospitals also indicated a similar trend—the average length of  hospital stay in calendar year 2016 for infants with NAS who received  pharmacologic treatment ranged from 7 to 30 days, while the stays for  infants who did not require such medication ranged from 3 to 7 days.

Medicaid Payments for NAS Treatment Services Provided in Hospital Settings

Medicaid generally pays for NAS treatment services in our four selected  states using a diagnosis-related group (DRG) based payment system, in  which hospitals receive a fixed amount for a bundle of services. In  general, the DRG-based system used in Medicaid pays for the medical  services necessary for treating infants with NAS, such as medication, bed  space, and nursing staff, according to CMS officials. CMS officials said  that the DRG-based system generally does not pay for professional  services, such as physician visits; instead, these services are typically  paid under a fee-for-service payment schedule, in which states or  contracted managed care plans pay health care providers directly for their  services.

Officials in our selected states said information on total Medicaid  payments for hospital-based NAS services was not readily available.  Several DRGs are typically used to bill Medicaid for services provided to  infants. However, these codes alone cannot provide an accurate estimate  of Medicaid payments for NAS treatment services because the codes are  not used exclusively for NAS. For example, according to some health  care providers we interviewed, two DRG codes that may be used to bill  Medicaid and other payers for NAS treatment services are 791  (prematurity with major problems) and 793 (full term neonate with major  problems). However, these codes could be used to bill for over 2,000  diagnoses—for example, pneumonia or measles. One state official said  that while they could provide us with information on Medicaid payments  for these infants, they could not parse out the costs by diagnosis codes,  such as those related to NAS. Thus, estimates of total Medicaid  payments based only on DRG codes likely overstate the amount paid for  NAS hospital-based services.

Officials from two of the four selected states told us that their state has a  public health surveillance system that tracks the incidence of infants  diagnosed with NAS; however, the surveillance systems do not capture  financial information, including Medicaid payments for NAS. At our  request, one of the states cross-referenced their surveillance and  Medicaid data and estimated that in 2016, their state Medicaid program  spent over $22 million to treat 1,565 infants with NAS.

While selected states generally could not provide information on total  Medicaid payments for infants with NAS, some hospitals in our selected  states were able to generate this information at our request using  diagnosis codes that they identified as related to NAS from hospital  claims data. Six of our selected eight hospitals reported that in calendar  year 2016, the average Medicaid payment for treating infants with NAS  ranged from about $1,500 to about $20,200 per infant per stay. The wide  range in Medicaid payment averages may be because the averages  included both infants who did and did not require pharmacologic  treatment and because these hospitals treated infants in various settings,  such as a nursery or a NICU. The literature we reviewed also had limited  information on Medicaid payments for NAS treatment services provided in  hospitals. A recent study reported that from 2009 through 2012—the most  recent data available at the time of the study—Medicaid payments to  hospitals for NAS treatment services increased from about $564 million to  $1.2 billion nationwide.

Some Infants with NAS May Complete Treatment in Non- Hospital Settings Available in Certain States, and in These States Medicaid Pays for a Subset of Services

Non-Hospital Settings for Treating Infants with NAS

While most infants with NAS typically complete treatment in a hospital  setting, stakeholders told us that some of these infants may be  transferred to a non-hospital setting to complete pharmacologic treatment  and continue non-pharmacologic treatment. HHS officials told us that  there is not a comprehensive list of facilities that may treat infants with  NAS outside of the hospital. Based on information from the stakeholders  we interviewed and the literature we reviewed, we identified two types of  non-hospital settings available in certain states that treat infants with  NAS: (1) outpatient clinics and programs and (2) neonatal withdrawal  centers. For the purposes of this report, we defined neonatal withdrawal  centers as facilities that can treat infants who are prenatally exposed to  drugs, including infants with NAS, within the facility.

Outpatient clinics and programs to treat NAS  Through stakeholder interviews and the literature we reviewed, we  identified examples of outpatient clinics and programs in certain states  where infants with NAS can continue pharmacologic treatment after their  discharge from the hospital. For example, some stakeholders we  interviewed told us about a Neonatal Medical Follow-Up Clinic in Vermont  used to follow-up with infants with NAS who have been discharged from  the hospital and are being weaned off methadone on an outpatient basis.  Hospital providers train the infant’s family on how to administer the  infant’s medication at home and provide a referral to the clinic. After  hospital discharge, the infant and family have follow-up visits in the clinic  every 1 to 2 weeks, during which the family discusses with health care  providers the weaning schedule and demonstrate how they administer the  infant’s medication. Health care providers told us that they also  encourage the family to continue providing non-pharmacologic treatment  to the infant. After weaning is complete, the infant continues to follow-up  at the clinic every 1 to 2 months until the infant reaches 12 to 18 months  of age.

Literature we reviewed indicated that other outpatient treatment clinics or  programs such as the one in Vermont have been established or  considered in other states. Specifically, four studies we reviewed  described instances in which infants began their treatment in the hospital  but completed their treatment through a dedicated outpatient program in  Florida, Ohio, and Pennsylvania. Each study noted that the inpatient-to- outpatient approach can result in a shorter hospital length of stay. For  example, one 2015 study found that infants who began treatment in a  hospital and completed their treatment in an outpatient setting stayed in  the hospital an average of 11 days, compared to infants who completed  treatment in the hospital, where the stays averaged about 25 days.  However, the studies also noted that the inpatient-to-outpatient approach  resulted in a longer overall treatment duration across the two settings.

Neonatal withdrawal centers to treat NAS  Some stakeholders we interviewed, including health care providers,  described examples of neonatal withdrawal centers in two states, where  infants with NAS can continue pharmacologic treatment after their  discharge from the hospital. Health care providers in these facilities told  us that in Washington and West Virginia, some infants with NAS who  began treatment in a hospital may be referred to these facilities, where  they reside until they complete treatment and are discharged from the  facility. These providers explained that in these facilities, the infants are  placed in nursery rooms, where health care providers can monitor them  and administer and adjust their medication as needed. In addition,  nursing staff or other caregivers are responsible for providing continuous  non-pharmacologic treatment, and mothers are encouraged to visit and  continue this care. For example, health care providers told us that in  Washington, two to three infants may share a nursery room where trained  caregivers provide them with non-pharmacologic treatment. In West  Virginia, health care providers said infants are typically placed in  individual nursery rooms where nurses provide them with non- pharmacologic treatment. The rooms in the West Virginia facility are also  equipped with a rocking chair to encourage mothers to visit and provide  this care as well. Health care providers told us that the facility currently  offers one nursery room equipped with a bed to help prepare mothers on  what to expect after discharge; they also said that they encourage  mothers to spend the night prior to the infant’s discharge from the facility.  (See text box below).

Treating infants with neonatal abstinence syndrome (NAS) in a neonatal  withdrawal center  One health care provider from a neonatal withdrawal center told us that the practice of  rooming-in helps to facilitate the bond between the mother and infant. He also said  that rooming-in allows health care providers to model care for the mothers and for  mothers to learn how to care for their infants with NAS.   Health care providers told us that the facility currently offers one nursery room  equipped with a bed to help prepare mothers on what to expect after discharge and  that they encourage mothers to spend the night prior to the infant’s discharge from the  facility. One health care provider told us that one mother, after staying overnight with  her infant, realized that she was not prepared to take care of her infant and  consequently gave up custody of the infant. Because of rooming-in, health care  providers were able to ensure that the infant was safe because the mother came to  this realization at the facility, rather than alone at home.   Although the lack of physical space at the facility currently makes it difficult to  accommodate rooming-in for the entire course of the infant’s treatment, these  providers noted the importance of this practice and that they are committed to parental  involvement when treating infants with NAS at their facility.

Figure 2 depicts nursery rooms in the neonatal withdrawal center in West  Virginia. Efforts are also underway to open a neonatal withdrawal center  in Arizona and Ohio, according to stakeholders we interviewed.

Stakeholders we interviewed and the literature we reviewed suggest  some limitations as well as benefits of treating infants with NAS in non- hospital settings, including factors to consider in these settings.

Health care providers from one of the hospitals we visited in Vermont  told us that their hospital is the only one in the state that allows infants  with NAS to complete pharmacologic treatment through the Vermont  outpatient clinic because they have established the necessary  infrastructure to ensure families’ compliance and safe practices at  home. These providers said that they worked with one local pharmacy  to ensure proper dispensing of the medication. Additionally, these  providers measured the amount of medication left over at each follow- up visit with the families.

Some state and perinatal collaborative officials told us that neonatal  withdrawal centers may not be the best environment to treat infants  with NAS because these settings may limit a mother’s access to her  infant, since she may not always be allowed to reside with the infant.  Such limits, according to officials, do not facilitate bonding between  mother and infant.

Another state perinatal collaborative official, as well as health care  providers and staff, told us that neonatal withdrawal centers may be  better for treating infants with NAS because the environment is quieter  and less stimulating than hospital settings, such as NICUs.

Several studies we reviewed also emphasized that the inpatient-to- outpatient approach requires ongoing coordination, communication,  and commitment from multidisciplinary providers, as well as the  families. These studies highlighted instances in which these  approaches reduced the length of the infants’ stay in a hospital,  though the studies emphasized that more work needs to be done to  determine whether these are the optimal approaches for infants with  NAS, as well as the potential long-term benefits of such approaches.

Medicaid Payments for NAS Treatment Services Provided in Non-Hospital Settings

Medicaid pays for NAS treatment services provided in the non-hospital  settings we identified in certain states, according to CMS officials and  other stakeholders we spoke with, but generally pays for these services  separately, in contrast with the single bundled payment paid to  hospitals. State officials and health care providers in the non-hospital  settings we examined described various ways in which Medicaid covered  services they provided to treat infants with NAS. For example:

Outpatient follow-up clinic in Vermont. State officials and staff at  this facility told us that the Vermont Medicaid program pays for an  infant’s outpatient physician visits using a fee-for-service payment  schedule. They added that the Vermont Medicaid program also pays  for the infant’s medication used in pharmacologic treatment and  explained that the pharmacy that dispenses the medication bills  Medicaid for these services.

Neonatal withdrawal center in Washington. Health care providers  at this facility told us that the Washington Medicaid program or their  contracted managed care plans pay for physician visits using a fee- for-service payment schedule, noting that the facility decided to stop  billing Medicaid for medical supplies because of the low  reimbursement. Additionally, these providers suggested that  because the facility does not meet the Medicaid standards required  for receiving payment for hospital inpatient, nursing, or other covered  facility services, the facility is ineligible to receive Medicaid payment  for the costs of room and board. These providers said that they  receive funding for the cost of these services through state  appropriations, foster care payments, city contracts, grants, and  private donations.

Neonatal withdrawal center in West Virginia. State officials and  health care providers at this facility told us that West Virginia pays for  NAS services through two mechanisms, depending on whether the  infant is in foster care. Specifically, if the infant is in foster care, the  facility receives a bundled payment from the state Medicaid program  and the Bureau of Children and Families. However, if the infant is  not in foster care, the state Medicaid program pays for physician visits  using a fee-for-service schedule. Additionally, the facility can receive  payment under a per diem rate that is negotiated with state Medicaid  managed care plans. The health care providers said that they also  receive funding through grants and private donations to help cover the  costs of NAS services.

Stakeholders we interviewed and literature we reviewed suggest that the  costs of treating infants with NAS in non-hospital settings were lower than  treating them in hospital settings. However, supporting data and research  of the costs in different settings are anecdotal or otherwise limited. For  example:

Health care providers from the neonatal withdrawal center in  Washington told us that their facility could treat infants at a lower  average cost per day than could hospitals—at about $700 per infant  per day compared to an average cost of about $1,500-2,500 per infant  per day in a hospital. These providers said that this cost savings is in  part due to their limited staffing of nurses and their ability to leverage  specially trained caregivers to provide infants with non-pharmacologic  treatment and hands-on care, such as feeding and bathing. These  providers also said they use volunteers to help with household duties,  such as laundry and replenishing supplies.

A health care provider from the neonatal withdrawal center in West  Virginia conducted a study that found that the average daily charges  per infant were about $400 in their facility, compared to about $2,600  in a special care nursery and $4,000 in a NICU.

Two studies we reviewed found that inpatient-to-outpatient treatment  approaches reduced hospital costs for NAS treatment; however, these  studies were not generalizable and did not account for the duration of  treatment across the two settings. Specifically, one study found that  an inpatient-to-outpatient treatment approach reduced hospital length  of stay by 55 percent—estimated to save hospitals $396 million  annually—compared with treatment provided solely in a hospital.  The second study found that infants who received care for NAS  through an inpatient-to-outpatient treatment approach had an average  length of stay of 13 days and cost about $14,000, while an inpatient- only approach had an average length of stay of 25 days and cost  about $28,000.

Recommended Practices for Addressing NAS Include Prioritizing Non-Pharmacologic Treatment, While Challenges Include Maternal Use of Multiple Substances

Recommended Practices for Addressing NAS Include Prioritizing Non- Pharmacologic Treatment, Educating Mothers, and Addressing Stigma

The 32 stakeholders we interviewed and the literature we reviewed  identified several recommended practices for addressing NAS—that is,  treating women with opioid use disorders during pregnancy or treating  infants diagnosed with NAS after birth. The most frequently  recommended practices were (1) prioritizing non-pharmacologic  treatment, such as allowing the mother to reside with the infant during  treatment, to facilitate the mother-infant bond; (2) educating mothers on  prenatal care, treatment for NAS, and available resources for after an  infant’s discharge; (3) educating health care providers on the stigma  faced by women who use opioids during pregnancy and on how to screen  for and treat NAS; and (4) using a protocol in a hospital or non-hospital  setting for screening and treating infants with NAS. These  recommended practices are described in more detail below.

Volunteer programs to provide non- pharmacologic treatment for neonatal  abstinence syndrome (NAS)  Some stakeholders told us that some  hospitals have established volunteer cuddler  programs that train volunteers to help provide  some of these non-pharmacologic  treatments—-namely, swaddling, feeding,  soothing, and coddling infants. However,  health care providers at some facilities noted  that volunteers are not necessarily available  during late shifts. indicated that non-pharmacologic treatment may (1) facilitate the mother- infant bond, (2) reduce the severity of NAS symptoms, (3) reduce the  need for pharmacologic treatment, and (4) reduce the length of an infant’s  hospital stay. For example, two of the articles we reviewed noted that  rooming-in has been shown to help decrease the need for pharmacologic  treatment, the number of admissions to the NICU, and the length of an  infant’s hospital stay. Additionally, 17 of the stakeholders we interviewed  and nine articles we reviewed recommended that mothers be allowed to  breastfeed while their infants are treated for NAS, as it helps to build a  bond between the mother and infant. Most of these articles also noted  that breastfeeding has been shown to reduce the severity of NAS.

Educating mothers on prenatal care, treatment for NAS, and  resources for after an infant’s hospital discharge. Most stakeholders  we interviewed and several of the literature articles we reviewed  recommended providing comprehensive, ongoing education to mothers  on prenatal care and treatment for NAS and on the resources that are  available after an infant’s discharge. (See text box below). The  stakeholders and literature indicated that this education may (1) facilitate  a non-combative relationship between the mother and health care  providers; (2) help to reassure and support the mother, who may feel  responsible for the infant’s suffering, in addition to facilitating treatment of  NAS; and (3) help the mother understand her infant’s behavior and  develop greater confidence in her parenting skills. For example, one  article noted that an infant’s withdrawal behavior, such as fisting, back  arching, and jaw clenching, may be misinterpreted by the mother as  dislike of touch, and that educating mothers on these behaviors can help  alleviate feelings of guilt.

Education for mothers on prenatal care, treatment for neonatal abstinence  syndrome (NAS), and resources for after an infant’s hospital discharge

Explaining to the mother during the prenatal period what she can expect when the  infant is born to help ensure she understands the effects of and treatment for NAS;  Informing the mother about non-pharmacologic treatment techniques that can help  reduce the severity of the infant’s NAS symptoms;

Modeling good parenting skills, such as demonstrating how to comfort an infant  who may be crying inconsolably for hours because of withdrawal; and  Informing the mother about contraception for preventing future pregnancies.

Educating health care providers on the stigma faced by women who  use opioids during pregnancy, and how to screen for and treat NAS.  Most stakeholders we interviewed and several of the literature articles we  reviewed recommended educating health care providers, including  providers who are not addiction specialists, on both the stigma faced by  women who use opioids during pregnancy as well as on how to screen for  and treat infants with NAS. The stakeholders and literature indicated that  this education may: (1) improve care so that mothers with opioid use  disorders feel more comfortable seeking and obtaining prenatal care, (2)  help health care providers know how to recognize NAS symptoms to help  ensure infants receive appropriate treatment, and (3) allow for more  consistency among these providers in NAS screening and treatment. For  example, 26 stakeholders told us that educating health care providers  about stigma is important because provider attitudes affect how and if  pregnant women obtain prenatal care and treatment for their opioid use  disorders, which can affect the severity of NAS. Additionally, several  articles we reviewed noted the importance of educating and training  clinicians on how to administer the screening tools used to identify infants  with NAS, which helps ensure infants are identified and receive optimal  care.

Using a protocol for screening and treating infants with NAS. While  there is no single national standard of care for screening and treating  NAS, most stakeholders we interviewed and several of the literature  articles we reviewed recommended that hospital and non-hospital  settings use a protocol to screen for and treat infants with NAS. The  stakeholders and literature indicated that having a protocol can help: (1)  identify infants at risk for NAS, (2) ensure that care is provided  consistently, and (3) reduce the length of stay for infants receiving  pharmacologic treatment. For example, the stakeholders we interviewed  explained that a standard protocol also helps health care providers  understand the tools used to assess the severity of NAS; know the types  of medication used in treatment, including amounts and duration; and  learn how to wean the infant off these medications. Similarly, one article  we reviewed noted that infants who were treated at facilities that adopted  standard treatment protocols experienced shorter durations of  pharmacologic treatment compared with infants who were treated at  facilities that did not use a standard protocol.

Challenges Faced by Health Care Providers in Addressing NAS Include Maternal Use of Multiple Substances and Stigma Faced by Women Who Use Opioids

Stakeholders we interviewed and literature we reviewed identified several  challenges health care providers face in their efforts to address NAS.  The most frequently cited challenges included (1) the use of multiple  substances by pregnant women, which can exacerbate NAS; (2) the  stigma faced by women who use opioids during pregnancy, which may  affect whether they seek prenatal care to address NAS, among other  things; (3) hospital staff burden and limited physical capacity to care for  infants with NAS; (4) limited coordination of care for mothers and infants  with NAS; and (5) gaps in research and data on NAS. These challenges  are described in more detail below.

The use of multiple substances by pregnant women, which can  exacerbate NAS. Most stakeholders we interviewed and some of the  literature we reviewed noted that the use of multiple substances by  pregnant women, including opioids—referred to as maternal  polysubstance use—can be a challenge, and some stated that the use of  these substances can exacerbate NAS symptoms. According to the  stakeholders, the substances can include methamphetamines, nicotine,  alcohol, cocaine, marijuana, benzodiazepines, and Gabapentin. The  stakeholders and literature indicated that maternal polysubstance use can  lead to multiple conditions in the infant—such as prematurity or Hepatitis  C—that can exacerbate NAS symptoms and prolong the length of an  infant’s hospital stay. For example, one expert noted that many women  with opioid use disorders are also heavy cigarette smokers, and the  nicotine typically exacerbates NAS withdrawal symptoms. Additionally,  officials from a hospital and non-hospital setting we visited told us that  they had developed a separate protocol for treating infants exposed to  multiple substances that includes the use of several medications to  address the more severe NAS withdrawal symptoms.

Stigma faced by women who use opioids which may affect whether  they seek prenatal care to mitigate the severity of NAS, among other  things. Most stakeholders we interviewed and several of the literature  articles we reviewed noted that the stigma faced by pregnant women with  opioid use disorders is a challenge in addressing NAS. The stakeholders  and literature indicated that stigma may: (1) prevent pregnant women  from seeking substance use treatment or prenatal care; (2) prevent them  from disclosing their drug use to health care providers during pregnancy;  or (3) cause the women to fear punitive effects, such as losing custody of  their children, being detained, or losing their jobs. For example, officials  from one perinatal quality collaborative told us that these women may fail  to seek care because of stigma, which can ultimately make it more  difficult for health care providers to build relationships with these women  and identify infants at risk for NAS.

Hospital staff burden and limited physical capacity to care for  infants with NAS. According to most stakeholders we interviewed and  some literature we reviewed, staff burden and a limited physical capacity  at facilities can pose challenges for addressing NAS. The stakeholders  and literature indicated that there is increased burden on staff to care for  these infants because they require frequent, personal attention. For  example, the stakeholders explained that a hospital may have to increase  the number of nurses on duty in order to provide the care the infants  need. Health care providers at one hospital said that nurses still struggle  to care for infants with NAS, even with additional staff, because these  infants are overstimulated, cry, and do not eat or sleep well. As a result,  they require much time and one-on-one attention—including cuddling— from nurses. With respect to physical capacity, some stakeholders told us  that limited physical capacity can make it difficult to (1) find space in the  facility where the infants can be protected from high levels of stimulation  and (2) facilitate the mother-infant bond. For example, some stakeholders  told us that hospitals may not have a dedicated space for rooming-in,  making it more difficult to facilitate bonding between mothers and infants.

Limited coordination of care for mothers and infants with NAS. Most  stakeholders we interviewed explained that the lack of coordination  among health care providers and others for the mother and infant with  NAS during the prenatal period, after the infant is born, and following the  infant’s discharge can be a challenge. This coordination includes  organizing patient care activities and sharing information among health  care providers, social workers, and all other participants concerned with  the mother and infant’s care. The stakeholders indicated that this lack of  coordination can make it difficult for families to get the resources or  support they need. (See text box below). For example, some  stakeholders told us that women may miss health care visits because of a  lack of access to enabling services such as transportation or child care.

Limited coordination of care for mothers and infants with neonatal abstinence  syndrome (NAS)   One expert told us that there is a disproportionate number of infants with NAS born in  rural areas. Infants in these areas may be discharged from the hospital without many  follow-up services, such as transportation and care coordination.

Gaps in research and data on NAS. Some stakeholders we interviewed  noted that gaps in research and data on NAS make it challenging to  conduct research on the affected population and fully understand the  magnitude of the problem. The stakeholders indicated that there are gaps  in adequate research and data on (1) the different types of treatment  approaches for NAS; (2) the extent and effects of maternal polysubstance  use among pregnant women; (3) the long-term effects of prenatal drug  exposure, including the effects seen in childhood and adolescence; and  (4) the efforts to ensure more consistent provider diagnosis and  screening, such as through an improved screening tool. For example, the  stakeholders told us that gaps in research and data may contribute to a  lack of a national standard of care for screening and treating infants with  NAS. According to some stakeholders, this may result in missed  opportunities for identifying and treating infants with NAS. Some  stakeholders also told us that because of gaps in research on the long- term effects of prenatal drug exposure, there is limited information on the  types of services that infants with NAS may need in early childhood.  Additionally, some stakeholders noted they found that because NAS was  not consistently diagnosed and coded in medical records using diagnosis  codes, the condition may be under-reported, and researchers may be  limited in their ability to track these infants.

HHS’s Strategy Includes Recommendations Related to Addressing NAS but Lacks Priorities, Timeframes, and Responsibilities for Implementing the Recommendations

In May 2017, HHS published the Protecting Our Infants Act: Report to  Congress, which—among other things—presents a strategy that identifies  key recommendations related to addressing NAS. Specifically, HHS’s  strategy—known as the Protecting Our Infants Act: Final Strategy—made  39 recommendations related to the prevention, treatment, and related  services for NAS and prenatal opioid use. Of the 39 recommendations  HHS made in its report, we found that 28 of them directly relate to the  recommended practices or challenges that we describe above. For  example, the Strategy recommends the following: promoting non-pharmacologic treatment, such as rooming-in; providing continuing medical education to health care providers for  managing and treating infants with NAS, such as on NAS treatment  protocols;  conducting research on the long-term effects of prenatal drug  exposure so that appropriate services can be developed for infants  with NAS; and establishing clear definitions of NAS and standardizing the use of  diagnosis codes to collect more meaningful and actionable data on  NAS.

According to the Strategy, the recommendations will be used to inform  planning and policy across HHS. However, HHS does not include any  information in the Strategy on how the department and other stakeholders  will implement the recommendations. Specifically, HHS does not include  in its Strategy the following:  the explicit priorities among the numerous recommendations and  associated efforts the department has initiated related to NAS;  timeframes for partial or full implementation of these  recommendations;  clear roles and responsibilities for the recommendations, such as the  extent to which HHS will need to rely on the medical community and  federal and public stakeholders for implementation; and  the methods that will be used to assess the department’s progress in  implementing any of these recommendations.

HHS officials told us that they expect to develop a separate plan to guide  implementation of the recommendations and that efforts to develop this  plan were likely to begin in July 2017. However, as of September 2017,  HHS could not provide any documentation that it had started to develop  this implementation plan or establish a timeline for completing the plan;  nor was HHS able to provide any information on what the plan may  include. Having such a plan in place is important to ensure priorities are  known and responsibilities are clear so that agencies and stakeholders  can take appropriate action. Federal internal control standards call for  agencies to have defined objectives clearly as part of their objective- setting process and to assign roles and responsibilities for achieving  these objectives. Objectives defined in specific and measurable terms  allow for the assessment of performance toward achieving objectives.  Furthermore, leading principles on sound planning we have identified in  our prior work call for developing robust plans to achieve agency goals.  Until HHS finalizes an implementation plan that includes specific  priorities, timeframes, responsibilities, and methods for evaluating  progress, it is at risk of not being able to provide reasonable assurance  that it can successfully implement these recommendations in a timely  manner and assess the effectiveness of its efforts.

The rising opioid crisis has caused a significant increase in the number of  infants born and diagnosed with NAS, a condition that affects infants and  their families, hospitals, and other health care providers who are treating  them. The increase in infants born with NAS also increases medical and  other treatment costs experienced by the federal government and states.  HHS recently published a strategy with key recommendations that have  the potential to address some of the challenges related to treating NAS.  However, HHS lacks a sound plan for implementing these recommendations. The absence of such planning raises questions about  whether and when HHS will be able to implement these  recommendations in a timely manner and be able to assess its progress.

The Secretary of HHS should expeditiously develop a plan—that includes  priorities, timeframes, clear roles and responsibilities, and methods for  assessing progress—to effectively implement the NAS-related  recommendations identified in the Protecting Our Infants Act: Final  Strategy. (Recommendation 1)

We provided a draft of this report to HHS for review, and HHS provided  written comments, which are reprinted in appendix III. HHS also provided  technical comments, which we incorporated as appropriate. In its written  comments, HHS concurred with our recommendation to expeditiously  take steps to address NAS and re-stated that its Strategy will be used to  inform planning and policy across HHS. Specifically, HHS said that as  part of its broader initiative to address the opioid crisis, the department  will develop and implement a plan—that will include priorities, timeframes,  roles and responsibilities, and methods for assessing progress—to  address as appropriate and possible, the NAS-related recommendations  in its Strategy. HHS also stated that full implementation would be  contingent on funding, though it provided no information on how much  funding was needed or how the funding would be used. Developing a  plan to guide implementation can help the department determine what  resources, if any, are needed to implement the recommendations in its  Strategy.

We are sending copies of this report to the appropriate congressional  addressees, the Secretary of Health and Human Services, and other  interested parties. In addition, the report will be available at no charge on  GAO’s website at http://www.gao.gov.

If you or your staff have any questions about this report, please contact  me at (202) 512-7114 or at iritanik@gao.gov. Contact points for our Office  of Congressional Relations and Office of Public Affairs can be found on  the last page of this report. GAO staff who made major contributions to  this report are listed in appendix IV.

Appendix I: Detailed Scope and Methodology

To address our first three audit objectives to describe care settings for  treating infants with neonatal abstinence syndrome (NAS), Medicaid  payment for NAS treatment, and the recommended practices and  challenges for addressing NAS, we selected 32 stakeholders based on  their relevant experience to cover a range of perspectives on NAS.  Specifically, these stakeholders included those from site visits we  conducted to four states—Kentucky, Vermont, West Virginia, and  Wisconsin. We selected these states because they met the following  criteria:  1.  the state had one of the top 10 highest incidence rates of NAS,  according to data from the Centers for Disease Control and  Prevention (CDC) for 2013, the most recent year of publicly available  data;  2.  the state provided variation in United States geographic regions with  high rates of NAS, as of 2012;  3.  more than 40 percent of births in the state were financed by Medicaid,  according to a 2016 Kaiser Family Foundation Medicaid Budget  Survey; and  4.  the state has a perinatal quality collaborative—a state or multi-state  network of teams working to improve health outcomes for mothers  and infants—with work related to NAS, which we identified through  the American College of Obstetricians and Gynecologists.

As part of these site visits, we interviewed (1) officials from each of the  four states, including Medicaid officials, Maternal and Child Health  Directors, and Women’s Services Coordinators; (2) representatives from  the four state perinatal collaboratives; (3) health care providers (including  physicians or nurses) from eight hospitals of varying levels of care (two  hospitals in each state), which were selected based on recommendations  from the state perinatal collaboratives because of the hospitals’  experience treating NAS; and (4) officials from a residential treatment  facility in each of the four states that provide prenatal and postpartum  care to mothers, which were also selected based on recommendations  from the state perinatal collaboratives regarding the facilities’ experience  with pregnant women with opioid use disorders and their infants with  NAS.

In addition to our site visits, we selected 12 additional stakeholders that  included health care providers or administrators in non-hospital settings  across the United States; officials from medical specialty societies; and  experts. Specifically, we spoke with (1) health care providers (including  physicians or nurses) or administrators from four non-hospital settings in  Arizona, Ohio, Washington, and West Virginia, which were selected  based on recommendations from stakeholders we interviewed and on the  availability of such settings and their experience treating NAS; (2) health  care providers from five medical specialty societies, including the  American Academy of Pediatrics, the American College of Obstetricians  and Gynecologists, the American Society of Addiction Medicine, MedNAX  (a network of physicians that specialize in neonatal care, including NAS  treatment), and the National Association of Neonatal Nurses; and (3)  three experts, including the authors of published literature we reviewed.

We interviewed each of these 32 stakeholders and requested information  from stakeholders about treating infants with NAS, including the utilization  of available hospital and non-hospital care settings and associated costs  of treatment services. For example, we requested protocols for screening  and treating infants with NAS from hospital and non-hospital care  settings. We reviewed available protocols provided by hospitals and a  non-hospital care setting. We also reviewed available information  reported by state officials, hospital and non-hospital providers, and state  perinatal collaboratives on the utilization of hospital and non-hospital care  settings, the facilities’ cost of treating NAS in hospital and non-hospital  settings, the lengths of stay for treating infants with NAS, or the amount of  Medicaid payments for treating infants with NAS. We discussed the  information provided by stakeholders and examined the information for  obvious errors. The information obtained from these stakeholders is not  generalizable to other states or other hospital and non-hospital settings.  In addition, in some cases, stakeholders used different methods to collect  the information they reported, including information on Medicaid  payments; as a result, the information reported by stakeholders is not  directly comparable.

Additionally, we interviewed officials from HHS, including those from the  Centers for Medicare & Medicaid Services (CMS) and HHS’s Behavioral  Health Coordinating Council—which includes officials from the Substance  Abuse and Mental Health Services Administration (SAMHSA), the Indian  Health Service, the Centers for Disease Control and Prevention (CDC),  and the Food and Drug Administration, among others—concerning NAS  treatment services, settings of care, Medicaid payment, and  recommended practices and challenges related to addressing NAS.

We also conducted a comprehensive literature review to identify relevant  studies on NAS published in peer-reviewed journals from January 2013 to  December 2016. We searched more than 40 databases for research  published in relevant peer-reviewed journals, including BIOSIS  Previews®, Embase®, Gale Group Health Periodicals Database,  MEDLINE®, and New England Journal of Medicine. Key search terms  included “neonatal abstinence syndrome,” “neonatal opioid withdrawal  syndrome,” and “newborn infants.” After excluding duplicates, we  identified and reviewed 325 abstracts. For those abstracts we found  relevant, we obtained and reviewed the full study and selected 40 that  were relevant to (1) hospital and non-hospital settings and related  treatment services for infants with NAS; (2) the costs associated with  treating infants with NAS, including Medicaid payments for services in  these care settings; or (3) recommended practices and challenges for  addressing NAS. We examined the methodologies for each of these  studies and interviewed some of their authors. We determined that the  studies were sufficiently reliable for our audit objectives. For a complete  list of the studies we reviewed, see below.

To examine our last audit objective on HHS’s strategy related to  addressing NAS, we interviewed agency officials and reviewed agency  documents on the agency’s efforts to develop a strategy. Specifically, we  interviewed relevant officials from CMS and HHS’s Behavioral Health  Coordinating Council concerning their efforts to develop a strategy related  to addressing NAS. In reviewing relevant HHS documents, we focused on  HHS’s Protecting Our Infants Act Report to Congress, which includes a  strategy to address identified gaps, challenges, and recommendations  related to NAS and prenatal opioid use. In addition, we reviewed the  relevant standards for internal control in the federal government and the  relevant criteria from GAO’s body of work on effectively managing  performance under the Government Performance and Results Act  (GPRA) of 1993 and the GPRA Modernization Act of 2010.

Allocco, E., M. Melker, F. Rojas-Miguez, C. Bradley, K. A. Hahn, and E.  M. Wachman. “Comparison of Neonatal Abstinence Syndrome  Manifestations in Preterm Versus Term Opioid-Exposed Infants.”  Advances in Neonatal Care, vol. 16, no.5 (2016).

Artigas, V. “Management of Neonatal Abstinence Syndrome in the  Newborn Nursery.” Nursing for Women’s Health, vol. 18, issue 6 (Dec.  2014/Jan. 2015).

Asti, L., J. S. Magers, E. Keels, J. Wispe, and R. E. McLead. “A Quality  Improvement Project to Reduce Length of Stay for Neonatal Abstinence  Syndrome.” Pediatrics, vol. 135, no. 6 (2015).

Busch, D. W. “Clinical management of the Breast-Feeding Mother-Infant  Dyad in Recovery from Opioid Dependence.” Journal of Addictions  Nursery, vol. 27, no. 2 (2016).

Casper, T. and M. Arbour. “Evidence-Based Nurse-Driven Interventions  for the Care of Newborns with Neonatal Abstinence Syndrome.”  Advances in Neonatal Care, vol. 14, no. 6 (2014).

Chau, K. T., J. Nguyen, B. Miladinovic, C. M. Lilly, T. L. Ashmeade, and  M. Balakrishnan. “Outpatient Management of Neonatal Abstinence  Syndrome: A Quality Improvement Project.” The Joint Commission  Journal on Quality and Patient Safety, vol. 42, no. 11 (2016).

Cirillo, C. and K. Francis. “Does Breast Milk Affect Neonatal Abstinence  Syndrome Severity, the Need for Pharmacologic Therapy, and Length of  Stay for Infants of Mothers on Opioid Maintenance Therapy During  Pregnancy?” Advances in Neonatal Care, vol. 16, no.5 (2016).

Clark, L. and A. Rohan. “Identifying and Assessing the Substance- Exposed Infant.” MCN in Advance (2015).

Demirci, J. R., D. L. Bogen, and Y. Klionsky. “Breastfeeding and  Methadone Therapy: The Maternal Experience.” Substance Abuse, vol.  36, no. 2 (2015).

Edwards, L. and L. F. Brown. “Nonpharmacologic Management of  Neonatal Abstinence Syndrome: An Integrative Review.” Neonatal  Network, vol. 35, no. 5 (2016).

Gregory, K. E. “Caring for the Infant with neonatal Abstinence Syndrome  in a Community-Based Setting.” The Journal of Perinatal & Neonatal  Nursing, (2014).

Grim, K., T. E. Harrison, and R. T. Wilder. “Management of Neonatal  Abstinence Syndrome from Opioids.” Clinics in Perinatology, (2013).

Hahn, J., A. Lengerich, R. Byrd, R. Stoltz, J. Hench, S. Byrd, and C. Ford.  “Neonatal Abstinence Syndrome: The Experience of Infant Massage.”  Creative Nursing, vol. 22, issue 1 (2016).

Hall, E. S., S. L. Wexelblatt, M. Crowley, J. L. Grow, L. R. Jasin, M. A.  Klebanoff, R. E. McClead, J. Meinzen-Derr, V. K. Mohan, H. Stein, and M.  C. Walsh. “A Multicenter Cohort Study of Treatments and Hospital  Outcomes in Neonatal Abstinence Syndrome.” Pediatrics, vol. 134, no. 2  (2014).

Hall, E. S., S. L. Wexelblatt, M. Crowley, J. L. Grow, L. R. Jasin, M. A.  Klebanoff, R. E. McClead, J. Meinzen-Derr, V. k. Mohan, H. Stein, and M.  C. Walsh. “Implementation of a Neonatal Abstinence Syndrome Weaning  Protocol: A Multicenter Cohort Study.” Pediatrics, vol. 136, no. 4 (2015).

Holmes, A. V., E. C. Atwood, B. Whalen, J. Beliveau, J. D. Jarvis, J. C.  Matulis, and S. L. Ralston. “Rooming-In to Treat Neonatal Abstinence  Syndrome: Improved Family-Centered Care at Lower Cost.” Pediatrics,  vol. 137, no. 6 (2016).

Jones, H. E., K. Deppen, M. L. Hudak, L. Leffert, C. McClelland, L. Sahin,  J. Starer, M. Terplan, J. M. Throrp Jr., J. Walsh, and A. A. Creanga.  “Clinical Care for Opioid-Using Pregnant and Postpartum Women: The  Role of Obstetric Providers.” American Journal of Obstetrics &  Gynecology, vol. 210, issue 4 (2014).

Jones, H.E., C. Seashore, E. Johnson, E. Horton, K.E. O’Grady, K.  Andringa, M. R. Grossman, B. Whalen, and A.V. Holmes. “Brief Report:  Psychometric Assessment of the Neonatal Abstinence Scoring System  and the MOTHER NAS Scale.” American Journal on Addictions, (2016).

Kraft, W.K., M. W. Stover, and J. M. Davis. “Neonatal Abstinence  Syndrome: Pharmacologic Strategies for the Mother and Infant.”  Seminars in Perinatology, vol. 40, issue 3 (2016).

Krans, E. E., G. Cochran, and D. L. Bogen. “Caring for Opioid Dependent  Pregnant Women: Prenatal and Postpartum Care Considerations.”  Clinical Obstetrics and Gynecology, vol. 58, no. 2 (2015).

Lee, J., S. Hulman, M. Musci Jr., and E. Stang. “Neonatal Abstinence  Syndrome: Influence of a Combined Inpatient/Outpatient Methadone  Treatment Regimen on the Average Length of Stay of a Medicaid NICU  Population.” Population Health Management, vol. 18, no.5 (2015).

MacMullen, N. J., L. A. Dulski, and P. Blobaum. “Evidence-Based  Interventions for Neonatal Abstinence Syndrome.” Pediatric Nursing, vol.  40, no. 4 (2014).

Maguire, D. J., “Mothers on Methadone: Care in the NICU.” Neonatal  Network, vol. 32, no. 6 (2013).

Marcellus, L. “Supporting Women with Substance Use Issues: Trauma- Informed Care as a Foundation for Practice in the NICU.” Neonatal  Network, vol. 33, no.6 (2014).

McKeever, A. E., S. Spaeth-Brayton, and S. Sheerin. “The Role of Nurses  in Comprehensive Care Management of Pregnant Women with Drug  Addiction.” Nursing for Women’s Health, vol. 18, no.4 (2014).

Meyer, M. and J. Phillips. “Caring for Pregnant Opioid Abusers in  Vermont: A Potential Model for Non-Urban Areas.” Preventive Medicine,  vol. 80 (2015).

Newnam, K. M. “The Right Tool at the Right Time: Examining the  Evidence Surrounding Measurement of Neonatal Abstinence Syndrome.”  Advances in Neonatal Care, vol. 14, no.3 (2014).

Orlando, S. “An Overview of Clinical Tools Used to Assess Neonatal  Abstinence Syndrome.” Journal of Perinatal and Neonatal Nursing, vol.  28, no.3 (2014).

Patrick, S.W., M.M. Davis, C.U. Lehman, and W.O. Cooper. “Increasing  Incidence and Geographic Distribution of Neonatal Abstinence Syndrome:  United States 2009 to 2012.” Journal of Perinatology, vol. 35 (2015).

Patrick, S.W., H.C. Kaplan, M. Passarella, M.M. Davis, and S.A. Lorch.  “Variation in Treatment of Neonatal Abstinence Syndrome in U.S.  Children’s Hospitals, 2004-2011.” Journal of Perinatology, vol. 34, no. 11  (2014).

Patrick, S.W., J. Dudley, P.R. Martin, F.E. Harrell, M.D. Warren, K.E.  Hartmann, E.W. Ely, C.G. Grijalva, and W.O. Cooper. “Prescription  Opioid Epidemic and Infant Outcomes.” Pediatrics, vol. 135, no.5 (2015).

Patrick, S.W., R. E. Schumacher, J. D. Horbar, M. E. Buus-Frank, E. M.  Edwards, K. A. Morrow, K. R. Ferrelli, A. P. Picarillo, M. Gupta, and R. F.  Soll. “Improving Care for Neonatal Abstinence Syndrome.” Pediatrics, vol.  137, no. 5 (2016).

Reece-Stremtan, S., and K. A. Marinelli. “ABM Clinical Protocol #21:  Guidelines for Breastfeeding and the Drug-Dependent Woman, Revised  2015.” Breastfeeding Medicine, vol. 10, no.3 (2015).

Shaw, M. R., C. Lederhos, M. Haberman, D. Howell, S. Fleming, and J.  Roll. “Nurses Perceptions of Caring for Childbearing Women Who Misuse  Opioids.” The American Journal of Maternal-Child Nursing, vol. 41, no. 1  (2016).

Sublett, J. “Neonatal Abstinence Syndrome: Therapeutic Interventions.”  The American Journal of Maternal-Child Nursing, vol. 38, no. 2 (2013).

Sutter, M. B., L. Leeman, and A. Hsi. “Neonatal Opioid Withdrawal  Syndrome.” Obstetrics and Gynecology Clinics of North America, vol. 41,  issue 2 (2014).

Teague, A. H., A. J. Jnah, and D. Newberry. “Intraprofessional Excellence  in Nursing: Collaborative Strategies for Neonatal Abstinence Syndrome.”  Neonatal Network, vol. 34, no.6 (2015).

Terplan, M., A. Kennedy-Hendricks, and M. S. Chisolm. “Prenatal  Substance Use: Exploring Assumptions of Maternal Unfitness.”  Substance Abuse: Research and Treatment (2015).

Tolia, V. N., S. W. Patrick, M. M. Bennett, K. Murthy, J. Sousa, P. B.  Smith, R. H. Clark, and A. R. Spitzer. “Increasing Incidence of the  Neonatal Abstinence Syndrome in U.S. Neonatal ICUs.” The New  England Journal of Medicine, vol. 372, no. 22 (2015).

Wiles, J. R., B. Isemann, L. P. Ward, A. A. Vinks, and H. Akinbi. “Current  Management of Neonatal Abstinence Syndrome Secondary to  Intrauterine Opioid Exposure.” Journal of Pediatrics, vol. 165, no. 3  (2014).

Appendix II: Department of Health and Human Services’ Resources Related to Neonatal Abstinence Syndrome and Prenatal Opioid Use

The Department of Health and Human Services (HHS) has published  several guidance and educational resources related to neonatal  abstinence syndrome and prenatal opioid use. According to HHS, these  documents serve as tools to help stakeholders, including state entities  and health care providers, and policymakers. Examples of these  resources are listed below.

Centers for Disease Control and Prevention (CDC), Pregnancy and  Opioid Medications Factsheet, accessed June 8, 2017,  https://www.cdc.gov/drugoverdose/pdf/pregnancy_opioid_pain_factsheet- a.pdf.

CDC Public Health Grand Rounds, Primary Prevention and Public  Strategies to Prevent Neonatal Abstinence Syndrome (Atlanta, GA: CDC,  last updated August 18, 2016), accessed July 19, 2017,  https://www.cdc.gov/cdcgrandrounds/archives/2016/August2016.htm.

CDC, Treating for Two: Safer Medication Use in Pregnancy Initiative  (Atlanta, GA: CDC, last updated May 5, 2016), accessed June 8, 2017,  https://www.cdc.gov/pregnancy/meds/treatingfortwo.

Department of Health and Human Services, Opioids: The Prescription  Drug & Heroin Overdose Epidemic (Washington, D.C., last reviewed  March 24, 2016), accessed June 8, 2017,  https://www.hhs.gov/opioids/index.html.

Department of Health and Human Services, National Center for  Substance Abuse and Child Welfare, Resources & Topics on Neonatal  Abstinence Syndrome, accessed June 8, 2017,  https://www.ncsacw.samhsa.gov/resources/opioid-use-disorders-and-me dication-assisted-treatment/neonatal-abstinence-syndrome.aspx.

Jean Y. Ko. et al., “CDC Grand Rounds: Public Health Strategies to  Prevent Neonatal Abstinence Syndrome,” Morbidity and Mortality Weekly  Report (Centers for Disease Control and Prevention, March 10, 2017),  accessed June 8, 2017,  https://www.cdc.gov/mmwr/volumes/66/wr/mm6609a2.htm.

National Institute on Drug Abuse, Principles of Substance Abuse  Prevention for Early Childhood: A Research Based Guide (last updated  March 2016), accessed June 8, 2017,  https://www.drugabuse.gov/publications/principles-substance-abuse-prev ention-early-childhood/principles-substance-abuse-prevention-early-child hood.

National Institute on Drug Abuse, Substance Use in Women (last updated  September 2016), accessed June 8, 2017,  https://www.drugabuse.gov/publications/research-reports/substance-use-i n-women/summary.

Reddy, Uma M. J. M. Davis, Z. Ren, and M. F. Greene, “Opioid Use in  Pregnancy, Neonatal Abstinence Syndrome, and Childhood Outcomes:  Executive Summary of a Joint Workshop.” Obstetrics and Gynecology,  vol. 130, issue 1 (July 2017).

Substance Abuse and Mental Health Services Administration, A  Collaborative Approach to the Treatment of Pregnant Women with Opioid  Use Disorders. HHS Publications No. (SMA) 16-4978. Rockville, MD:  Substance Abuse and Mental Health Services Administration, 2016.

Substance Abuse and Mental Health Services Administration, “Advancing  the Care of Pregnant and Parenting Women With Opioid Use Disorder  and Their Infants: A Foundation for Clinical Guidance,” Rockville, MD:  Substance Abuse and Mental Health Services Administration, 2016.

Substance Abuse and Mental Health Services Administration,  “Methadone Treatment for Pregnant Women.” HHS Publication No.  (SMA) 14-4124 (Rockville, MD: Substance Abuse and Mental Health  Services Administration, revised 2014).

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

Appendix IV: GAO Contact and Staff Acknowledgments

In addition to the contact named above, Rashmi Agarwal, Assistant  Director; Amy Leone, Analyst-in-Charge; Melissa Duong; Krister Friday;  Jacquelyn Hamilton; Giao N. Nguyen; and Laurie Pachter made key  contributions to this report.

Drug Control Policy: Information on Status of Federal Efforts and Key  Issues for Preventing Illicit Drug Use. GAO-17-766T. Washington, D.C.:  July 26, 2017.

Medicaid Expansion: Behavioral Health Treatment Use in Selected States  in 2014. GAO-17-529. Washington, D.C.: July 21, 2017.

VA Health Care: Actions Needed to Ensure Medical Facility Controlled  Substance Inspection Programs Meet Agency Requirements.  GAO-17-242. Washington, D.C.: February 15, 2017.

Highlights of a Forum: Preventing Illicit Drug Use. GAO-17-146SP.  Washington, D.C.: November 14, 2016.

Opioid Addiction: Laws, Regulations, and Other Factors Can Affect  Medication-Assisted Treatment Access. GAO-16-833. Washington, D.C.:  September 27, 2016.

Drug Enforcement Administration: Additional Actions Needed to Address  Prior GAO Recommendations. GAO-16-737T. Washington, D.C.: June  22, 2016.

Office of National Drug Control Policy: Progress toward Some National  Drug Control Strategy Goals, but None Have Been Fully Achieved.  GAO-16-660T. Washington, D.C.: May 17, 2016.

Veterans Justice Outreach Program: VA Could Improve Management by  Establishing Performance Measures and Fully Assessing Risks.  GAO-16-393. Washington, D.C.: April 28, 2016.

State Marijuana Legalization: DOJ Should Document Its Approach to  Monitoring the Effects of Legalization. GAO-16-1. Washington, D.C.:  December 30, 2015.

Prescription Drugs: More DEA Information about Registrants’ Controlled  Substances Roles Could Improve Their Understanding and Help Ensure  Access. GAO-15-471. Washington, D.C.: June 25, 2015.

Mental Health: Better Documentation Needed to Oversee Substance  Abuse and Mental Health Services Administration Grantees.  GAO-15-405. Washington, D.C.: May 12, 2015.

Prenatal Drug Use and Newborn Health: Federal Efforts Need Better  Planning and Coordination. GAO-15-203. Washington, D.C.: February 10,  2015.

Medicare Program Integrity: CMS Pursues Many Practices to Address  Prescription Drug Fraud, Waste, and Abuse. GAO-15-66. Washington,  D.C.: October 24, 2014.

Office of National Drug Control Policy: Office Could Better Identify  Opportunities to Increase Program Coordination. GAO-13-333.  Washington D.C.: March 26, 2013.

Child Welfare: States Use Flexible Federal Funds, But Struggle to Meet  Service Needs. GAO-13-170. Washington, D.C.: January 30, 2013.

The rising opioid epidemic has contributed to an increase in the number of babies born with neonatal abstinence syndrome—a withdrawal condition with symptoms including excessive crying and difficulty breathing.

The Department of Health and Human Services identified key recommendations to help guide its efforts to prevent and treat this syndrome—such as providing medical education to healthcare providers on how to treat these infants. However, we found that it is unclear how the department will implement these recommendations, if at all.

We recommended that HHS develop a plan to implement these recommendations.