prompt_front: You are given two reports by the government agency.



Question: Write a one-page summary of the report 1.

Report 1: For over a decade, each of VA’s 170 medical centers used VHA’s legacy MSPV program to order medical supplies, such as bandages and scalpels  Many of those items were purchased using the Federal Supply Schedules, which provided medical centers with a great deal of flexibility  However, as we reported in 2016, this legacy program prevented VHA from standardizing items used across its medical centers and affected its ability to leverage its buying power to achieve greater cost avoidance  Standardization is a process of narrowing the range of items purchased to meet a given need, such as buying 10 varieties of bandages instead of 100, in order to improve buying power, simplify supply chain management, and provide clinical consistency  In part because of the legacy MSPV program’s limited standardization, VHA decided to transition to a new iteration, called MSPV-NG  The transition to MSPV-NG has been a major effort, involving the MSPV- NG program office, stakeholders from the VHA’s Procurement and Logistics Office and VA’s Strategic Acquisition Center (SAC)—a VA-wide contracting organization—and logistics and clinical personnel at every medical center  The program also includes hundreds of new contracts with individual supply vendors and a new set of prime vendor contracts to distribute the supplies  VA’s goals for the MSPV-NG program include (1) standardizing requirements for supply items for greater clinical consistency; (2) demonstrating cost avoidance by leveraging VA’s substantial buying power when making competitive awards; (3) achieving greater efficiency in ordering and supply chain management, including a metric of ordering 40 percent of medical centers’ supplies from the MSPV-NG formulary; and (4) involving clinicians in requirements development to ensure uniform clinical review of medical supplies  VHA launched the MSPV-NG program in December 2016, but allowed a 4-month transition period  After April 2017, medical centers could no longer use the legacy program  MSPV-NG now restricts ordering to a narrow formulary  VHA policy requires medical centers to use MSPV- NG—as opposed to other means such as open market purchase card transactions—when purchasing items that are available in the formulary  Leading hospital networks we spoke with have similar goals to VA in managing their supply chains, including clinical standardization and reduced costs  These hospital networks reported they analyze their spending to identify items purchased most frequently, and which ones would be the best candidates to standardize first to yield cost savings  The hospitals’ supply chain managers reported establishing consensus with clinicians through early and frequent collaboration, understanding that clinician involvement is critical to the success of any effort to standardize their medical supply chain  By following these practices, these hospital networks have reported they have achieved significant cost savings in some cases, and the potential for improved patient care, while maintaining buy-in from their clinicians  VHA’s implementation of the MSPV-NG program—from its initial work to identify a list of supply requirements in early 2015, through its roll-out of the formulary to medical centers in December 2016—was not executed in line with leading practices  Specifically, VHA lacked a documented program strategy, leadership stability, and workforce capacity for the transition that, if in place, could have facilitated buy-in for the change throughout the organization  Further, the initial requirements development process and tight time frames contributed to ineffective contracting processes  As a result, VHA developed an initial formulary that did not meet the needs of the medical centers and has yet to achieve utilization and cost avoidance goals  VA made some changes in the second phase of requirements development to address deficiencies identified in the initial roll out  Key among these was to increase the level of clinical involvement, that is, to obtain input from the doctors and nurses at VA’s individual medical facilities  Despite changes aimed at improving implementation, the agency continues to face challenges that prevent the program from fully achieving its goals  VA did not document a clear overall strategy for the MSPV-NG program at the start and has not done so to date  About 6 months after our initial requests for a strategy or plan, a VHA official provided us with an October 2015 plan focusing on the mechanics of establishing the MSPV-NG formulary  However, this plan was used only within the VHA Procurement and Logistics Office and had not been approved by VHA or VA leadership  Leading practices for organizational transformation state that agencies must have well-documented plans and strategies for major initiatives (such as MSPV-NG) and communicate them clearly and consistently to all involved—which included VHA headquarters, the SAC, and all 170 medical centers  Without such a strategy, VA could not reasonably ensure that all stakeholders understood VHA’s approach for MSPV-NG and worked together in a coordinated manner to achieve program goals  In our November 2017 report, we recommended that the Director of the MSPV-NG program office should, with input from SAC, develop, document, and communicate to stakeholders an overarching strategy for the program, including how the program office will prioritize categories of supplies for future phases of requirement development and contracting  VA agreed with this recommendation and reported it would have a strategy in place by December 2017  Leadership instability and workforce challenges also made it difficult for VA to execute its transition to MSPV-NG  Our work has shown that leadership buy-in is necessary to ensure that major programs like MSPV- NG have the resources and support they need to execute their missions  Due to a combination of budget and hiring constraints, and lack of prioritization within VA, the MSPV-NG program office has never been fully staffed and has experienced instability in its leadership  As of January 2017, 24 of the office’s 40 positions were filled, and program office officials stated that this lack of staff affected their ability to implement certain aspects of the program within the planned time frames  In addition, since the inception of MSPV-NG, the program office has had four directors, two of whom were acting and two of whom were fulfilling the director position while performing other collateral duties  For instance, one of the acting MSPV-NG program office directors was on detail from a regional health network to fulfill the position, but had to abruptly leave and return to her prior position due to a federal hiring freeze  In our November 2017 report, we recommended that VHA prioritize the hiring of a MSPV- NG program director on a permanent basis  VA agreed with this recommendation and indicated a vacancy announcement will be posted by the end of 2017  The MSPV-NG program office initially developed requirements for items to be included in the formulary based almost exclusively on prior supply purchases, with limited clinician involvement  The program office concluded in its October 2015 formulary plan that relying on data from previous clinician purchases would be a good representation of medical centers’ needs and that clinician input would not be required for identifying which items to include in the initial formulary  Further, rather than standardizing purchases of specific categories of supplies—such as bandages or scalpels—program officials told us they identified medical and surgical items on which VA had spent $16,000 or more annually and ordered at least 12 times per year, and made those items the basis for the formulary  Officials said this analysis initially yielded a list of about 18,000 items, which the program office further refined to about 6,000 items by removing duplicate items or those that were not considered consumable commodities, such as medical equipment  This approach to requirements development stood in sharp contrast to those of the leading hospital networks we met with, which rely heavily on clinician input to help drive the standardization process and focus on individual categories of supplies that provide the best opportunities for cost savings  Based on the requirements developed by the program office, SAC began to issue competitive solicitations for the 6,000 items on the initial formulary in June 2015  Medical supply companies had responded to about 30 percent of the solicitations as of January 2016  As a result, according to SAC officials, they conducted outreach and some of these companies responded that VHA’s requirements did not appear to be based on clinical input and instead consisted of manufacturer-specific requirements that favored particular products instead of broader descriptions  Furthermore, SAC did not solicit large groups of related items, but rather issued separate solicitations for small groups of supply items—consisting of three or fewer items  This is contrary to industry practices of soliciting large groups of related supplies together  Therefore, according to SAC officials, some medical supply companies told them that submitting responses to SAC’s solicitations required more time and resources than they were willing to commit  By its April 2016 deadline for having 6,000 items on the formulary, SAC had been working on the effort for over a year and had established competitive agreements for about 200 items, representing about 3 percent of the planned items  Without contracts for the items on the formulary in place, VA delayed the launch of the MSPV-NG program until December 2016 and SAC began establishing non-competitive agreements in the last few months before the launch of MSPV-NG  As shown in figure 1, these non-competitive agreements accounted for approximately 79 percent of the items on the January 2017 version of the formulary  While this approach enabled the MSPV-NG program office to establish the formulary more quickly, it did so at the expense of one of the primary goals of the MSPV-NG program—leveraging VA’s buying power to obtain cost avoidance through competition


Report 2:  Once VA’s MSPV-NG initial formulary was established in December 2016, each medical center was charged with implementing it  According to logistics officials we spoke with at selected medical centers, they had varying levels of success due, in part, to incomplete guidance from the program office  Without clear guidance, many medical centers reported they were unable to find direct matches or substitutes on the MSPV-NG formulary for a substantial number of items they routinely used, which negatively impacted utilization rates for the initial formulary  In our November 2017 report, we recommended that the Director of the MSPV- NG program office provide complete guidance to medical centers for matching equivalent supply items  VA agreed with this recommendation and indicated it would provide this guidance to medical centers by December 2017  According to SAC, as of June 2017, only about a third of the items on the initial version of the formulary were being ordered in any significant quantity by medical centers, indicating that many items on the formulary were not those that are needed by medical centers  Senior VHA acquisition officials attributed this mismatch to shortcomings in their initial requirements development process as well as with VA’s purchase data  VA had set a target that medical centers would order 40 percent of their supplies from the MSPV-NG formulary, but utilization rates were below this target with a nationwide average utilization rate across medical centers of about 24 percent as of May 2017  Specifically, Chief Supply Chain Officers—who are responsible for managing the ordering and stocking of medical supplies at six selected medical centers—told us that many items they needed were not included in the MSPV-NG formulary  As such, we found that these six medical centers generally fell below VA’s stated utilization target  As shown in figure 2, among the six selected medical centers we reviewed, one met the target, while the remaining five were below 25 percent utilization  Instead of fully using MSPV-NG, the selected medical centers are purchasing many items through other means, such as purchase cards or new contracts awarded by their local contracting office, in part, because they said the formulary does not meet their needs  These approaches run counter to the goals of the MSPV-NG program and contribute to VA not making the best use of taxpayer dollars  Greater utilization of MSPV-NG is essential to VA achieving the cost avoidance goal of $150 million for its supply chain transformation effort  Under the legacy MSPV program, the National Acquisition Center tracked cost avoidance achieved by comparing prices for competitively-awarded MSPV supply contracts with prices available elsewhere  However, VHA officials stated that they are not currently tracking cost avoidance related specifically to MSPV-NG  In our November 2017 report, we recommended that the VHA Chief Procurement and Logistics Officer, in coordination with SAC, should calculate cost avoidance achieved by MSPV-NG on an ongoing basis  VA agreed with this recommendation and reported it would develop a new metric to measure cost avoidance by June 2018  In Phase 2 of MSPV-NG, the program office has taken some steps to incorporate greater clinical involvement in subsequent requirements development, but both its requirements development and SAC’s contracting efforts have been hampered by staffing and schedule constraints  In the fall of 2016, the program office began to establish panels of clinicians to serve on MSPV-NG integrated product teams (IPT) assigned to the task of developing updated requirements for the second phase of the formulary  Program officials said they had difficulty recruiting clinicians to participate  We found that slightly more than half (20 of the 38) of the IPTs had begun their work to review items and develop updated requirements by the time the MSPV-NG program launched in December 2016  Staff on the IPTs had to complete their responsibilities by the end of March 2017 while simultaneously managing their regular workload as physicians, surgeons, or nurses  By early March 2017, the IPTs still had about 4,200 items to review  Faced with meeting this unrealistic time frame, the MSPV-NG program office had 9 IPT members travel to one location—with an additional 10 members participating virtually—to meet for 5 days to review the remaining items  Members told us that this time pressure limited the extent to which they were able to pursue the goal of standardizing supplies, and that their review ended up being more of a data validation exercise than a standardization review  VHA ultimately met this compressed timeline, but in a rushed manner that limited the impact of clinician involvement  In our November 2017 report, we recommended that the VHA Chief Procurement and Logistics Officer use input from national clinical program offices to prioritize its requirements development and standardization efforts beyond Phase 2 to focus on supply categories that offer the best opportunity for standardization and cost avoidance  VA agreed with this recommendation and stated it is in the process of finalizing guidance that will detail the importance of involving the national clinical program offices in MSPV-NG requirements development and standardization efforts  The SAC plans to replace the existing Phase 1 non-competitive agreements with competitive awards based on the Phase 2 requirements generated by the IPTs, but it may not be able to keep up with expiring agreements due to an unrealistic schedule  Because they were made on a non-competitive basis, the Phase 1 agreements were established for a period of 1 year  In order to keep the full formulary available, the SAC director said the staff must award 200 to 250 contracts before the Phase 1 agreements expire later this year  SAC officials acknowledged that it is unlikely that they will be able to award the contracts by the time the existing agreements expire  According to SAC officials, they are in the process of hiring more staff to deal with the increased workload  Further, the SAC division director told us that they canceled all outstanding Phase 2 solicitations in September 2017 due to low response rates, protests from service-disabled veteran-owned small businesses, and changes in overall MSPV-NG strategy  In our November 2017 report, we recommended that the MSPV-NG program office and SAC should establish a plan for how to mitigate the potential risk of gaps in contract coverage while SAC is still working to make competitive Phase 2 awards, which could include prioritizing supply categories that are most likely to yield cost avoidance  VA agreed with this recommendation and indicated it has developed a plan to mitigate the risk of gaps in contract coverage with short- and mid-term procurement strategies to ensure continued provision of medical and surgical supplies to VHA facilities  The department also stated that it plans to replace the current MSPV-NG contract and formulary process with a new approach where the prime vendor would develop the formulary  However, VA will likely face challenges in this new approach until it fully addresses the existing shortcomings in the MSPV-NG program  Chairman Roe, Ranking Member Walz, and Members of the Committee, this concludes my prepared statement  I would be pleased to respond to any questions that you may have at this time  If you or your staff have any questions about this statement, please contact Shelby S  Oakley at 202-512-4841 or OakleyS@gao gov  In addition, contact points for our Offices of Congressional Relations and Public Affairs may be found on the last page of this statement  Individuals who made key contributions to the report on which this testimony is based are Lisa Gardner, Assistant Director; Emily Bond; Matthew T  Crosby; Lorraine Ettaro; Michael Grogan; Jeff Hartnett; Katherine Lenane; Teague Lyons; Roxanna Sun; and Colleen Taylor  This is a work of the U S  government and is not subject to copyright protection in the United States  The published product may be reproduced and distributed in its entirety without further permission from GAO  However, because this work may contain copyrighted images or other material, permission from the copyright holder may be necessary if you wish to reproduce this material separately 

ground_truth: 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.

prompt_front: You are given two reports by the government agency.



Question: Write a one-page summary of the report 2.

Report 1: 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  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  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 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  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 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  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  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  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  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)  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)  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 


Report 2: The Buy American Act of 1933 was enacted during the Great Depression when there was a need to create and preserve jobs for American workers, and it established a preference for the federal government to buy domestic end products  Many of the products the federal government buys—including aircraft engines and medical supplies—are end products that may be subject to the requirements of the Buy American Act  Further, the Buy American Act does not apply to products that are purchased for use outside the United States or obtained through contracts under the micro-purchase threshold, which was generally $3,500 in fiscal year 2017  end products manufactured in the United States provided that (a) the product is a commercially available off-the-shelf item; or (b) the cost of the components mined, produced, or manufactured in the United States exceeds 50 percent of the total cost of all components  End products that are not considered domestic under the Buy American Act are treated as foreign  This characterization is based on the origin of the end product—that is, where the product is manufactured or produced—and not the vendor’s location  For example, a vendor located in Finland may supply end products manufactured in the United States, in which case these products would be treated as domestic products  Conversely, a vendor located in the United States may supply end products manufactured in Finland  In this case, the end products would be considered foreign  Although the Buy American Act establishes a preference for domestic end products, there are situations in which agencies can procure foreign end products through established exceptions to the Buy American requirements  In addition, under the Trade Agreements Act of 1979, the United States has waived domestic purchasing requirements—including the Buy American Act—for certain acquisitions of foreign end products from countries that are party to international trade agreements or are considered designated countries by the U S  Trade Representative  In implementing the Buy American Act, the FAR sets forth several exceptions that permit federal agencies to buy foreign end products  These include situations when a domestic end product is not produced in sufficient quantities or cases where the cost would be unreasonable to buy a domestic end product  The steps that contracting officers must take to determine or document an exception will vary depending on the circumstances of the acquisition  For example, a written determination from the Head of Contracting Activity (HCA) or a delegate may be necessary to determine non-availability in some cases  However, a written determination may not be required when an acquisition is conducted through full and open competition, is synopsized, and no domestic offer is received  Other exceptions to the Buy American Act restrictions on the purchase of foreign products, such as the exception for commercial information technology, are blanket exceptions that do not require a written determination  In addition, some agencies have specified additional considerations that must precede a determination and what level of authority is appropriate for certain determinations  The five Buy American Act exceptions that apply government-wide and the corresponding determination standards in the FAR are listed in Table 1  Individual federal agencies may make blanket determinations of situations in which the Act’s restrictions should not apply to that agency’s procurements, when it is not in the public interest to restrict the purchase of foreign end products  For example, over the years, DOD has entered into reciprocal procurement agreements with 27 foreign counterparts  DOD determined that it would be inconsistent with the public interest to apply the Buy American Act restrictions on products from these 27 qualifying countries  Thus, if an offer includes end products from a qualifying country, those products are not restricted by the Buy American Act and the acquisition of qualifying country end products does not require higher approval  This public interest exception for qualifying countries applies only to contracts awarded by DOD  Federal agencies can purchase eligible foreign end products from designated countries when the Buy American Act’s requirements are waived because of the terms of an international trade agreement or other criteria, such as a designation by the U S  Trade Representative as a least developed country  In accordance with the Trade Agreements Act of 1979, the president has the authority to waive the Buy American Act  For eligible products that come from countries covered by the World Trade Organization’s Government Procurement Agreement, Free Trade Agreements, and the Israeli Trade Act, the Buy American Act has been waived so that these items receive nondiscriminatory consideration and are on equal footing with domestic end products  In total, these agreements cover approximately 60 countries—overlapping with all but two of the DOD qualifying countries  Appendix II highlights the overlap  Unlike DOD’s blanket public interest exception for qualifying countries, the Buy American Act requirements are only waived under a trade agreement if the acquisition is of a certain value set by the U S  Trade Representative  Current trade agreement thresholds, at or above which the requirements are waived, range from $25,000 for contracts for eligible products from Canada to $180,000 for the 45 other parties to the World Trade Organization’s Government Procurement Agreement  Table 2 lists the parties eligible for trade agreements and the associated threshold for supply contracts  The FAR specifies certain conditions in which trade agreements do not apply, even if the acquisition is above the requisite threshold value set by the U S  Trade Representative  In these cases, the Buy American Act would apply  These conditions include, but are not limited to: acquisitions that do not use full and open competition, when the limitation of competition would preclude the procedures applicable to acquisitions covered by trade agreements; certain sole-source acquisitions for commercial items using simplified acquisition procedures; acquisitions set aside for small businesses; acquisition of ammunition, arms, or war materials, or for purchases indispensable for national security or national defense purposes; and acquisitions from federal prison industries or nonprofit agencies employing people who are blind or severely disabled  If the contracting officer determines that a trade agreement applies to a particular acquisition, which waives the Buy American restrictions, that determination does not require additional review at a higher level  This is similar to other circumstances where Buy American Act restrictions do not apply, such as for the acquisition of products for use outside the United States or contracts valued below the micro-purchase threshold  The Buy American Act’s applicability is based on the country of origin of the product being supplied, rather than the country of the vendor offering the product to the government  Vendors who propose to do business with the U S  government are required to certify as to where their products are manufactured or produced—whether in the United States or in a designated country covered by the Trade Agreements Act  Vendors can provide an annual certification applicable to all of their contracts through the federal government’s contractor registry, known as the System for Award Management (SAM)  Through SAM, a vendor identifies the country of origin for foreign products associated with a broad category of products  For example, a vendor could state that it provides aircraft components that originate in France and Mexico  Vendors also have the option not to certify the origin of their products in SAM, but instead provide information about foreign end products in their individual offers for contracts  Contracting officials include the relevant clauses in solicitations and contracts in accordance with regulation to require vendor certification  For example, the clause at FAR 52 225-2, Buy American Certificate, requires the offeror to certify that each end product is a domestic end product, or list any foreign end products and their country of origin  Once a contract is awarded, the awarding agency must enter certain information into FPDS-NG, a government-wide database for contract awards and obligations  The Office of Federal Procurement Policy (OFPP) within the Office of Management and Budget provides the overall direction for FPDS-NG, which is managed by the General Services Administration  FPDS-NG data can be populated through the individual systems agencies use to develop contracts  Agencies are responsible for the quality of the information transmitted to FPDS-NG, including data captured on the contract value and whether the foreign product acquisition is authorized by one of the Buy American Act exceptions or a trade agreement  This information is recorded at the contract level, or at the delivery order level for orders from indefinite delivery contracts  For certain product categories—essentially those that represent end products—FPDS-NG requires that contracting staff enter information in the “Place of Manufacture” drop-down data field, as shown in Figure 1  This field must be populated for all reported manufactured end products, including those valued under the micro-purchase threshold, which at the time of our review was generally $3,500  Options in this field include indicating that the product is made in the United States, or that it is made outside the United States and qualifies under one of the Buy American Act exceptions, or that it is subject to the requirements of a trade agreement instead of the Buy American Act requirements  In 2018, FPDS-NG data on agencies’ historical reporting of the use of Buy American exceptions were added to the website on which agencies post contracting opportunities (www fbo gov)  According to OFPP, this allows vendors selling domestic products to more easily see how agencies acquire foreign goods pursuant to Buy American Act exceptions  In fiscal year 2017, the federal government obligated approximately $7 8 billion for the acquisition of foreign end products, which accounts for less than 5 percent of total federal contract obligations for end products in that year  We observed differences in how civilian agencies and DOD apply Buy American Act exceptions and waivers  In our review of 38 contracts and orders from four agencies—DOD, HHS, DHS, and VA—we found 6 instances where the place of manufacture information was misreported in FPDS-NG  We further identified system limitations in how FPDS-NG captures information  Based on our analysis of FPDS-NG data, almost 40 percent of federal contract obligations in fiscal year 2017—totaling approximately $196 billion—were for domestic and foreign end products, such as aircraft parts, that may be subject to the Buy American Act  Less than 5 percent of these obligations—approximately $7 8 billion—were reported as foreign end products  This is consistent with the information agencies reported in FPDS-NG in the previous 4 years, with foreign end products accounting for approximately 3 to 8 percent of goods subject to Buy American Act restrictions between fiscal years 2013 through 2016  The foreign end products in fiscal year 2017 primarily came from South Korea, the United Kingdom, Afghanistan, Canada, Mexico, and the United Arab Emirates, which together accounted for almost half of the total foreign end products reported  Appendix III shows the federal government’s obligations for foreign end products from various countries for fiscal year 2017  The procurement of foreign end products is permitted by the flexibilities available under the Buy American Act’s exceptions and waivers  Agencies also procured foreign end products through means separate from the exceptions allowed under the Buy American Act, primarily in cases where the Act would not apply  Agencies reported obligating more than $700 million to procure foreign end products by applying one of the five government-wide Buy American Act exceptions—such as domestic non-availability or unreasonable cost—in FPDS-NG for fiscal year 2017  Agencies reported obligating approximately $550 million to procure foreign end products as permitted by the Trade Agreements Act, which waives the Buy American Act’s domestic preference requirements for US trading partners when eligible products are covered by trade agreements and are above certain dollar thresholds  DOD also obligated nearly $2 9 billion to procure foreign products from countries with which it has reciprocal procurement agreements, using what is referred to as the DOD qualifying country exception  This is an exercise of the authority available to agencies under the Buy American Act’s public interest exception  DOD determined that it is not in the public interest to restrict the purchase of foreign end products from 27 countries  All but two of these qualifying countries are also US trading partners, so some of these awards for eligible products may be authorized by a trade agreement  However, the qualifying country exception allows DOD to procure foreign end products without regard to dollar thresholds or other trade agreement eligibility limitations  Agencies also procured foreign end products, such as fuel, to be used outside the United States, in which circumstance the Buy American Act’s requirements do not apply  For fiscal year 2017, these obligations accounted for almost $3 7 billion—about 47 percent of all dollars obligated for foreign end products, as reported in FPDS-NG  Figure 2 highlights fiscal year 2017 obligations, including agencies’ reported spending on foreign end products under the Buy American Act exceptions and other means  DOD accounted for more than 80 percent—roughly $6 4 billion—of the total obligations for foreign end products in fiscal year 2017  Almost all of DOD purchases were either for use outside of the United States, so were not subject to Buy American Act restrictions, or were reported under the public interest exception for DOD qualifying countries  In contrast, civilian agencies report a more varied mix of the exceptions and waivers of the Buy American Act  The civilian agencies—which are unable to apply DOD’s qualifying country exception—were more likely to report buying foreign end products based on trade agreements or another exception to the Buy American Act requirements  Figure 3 shows how DOD and the civilian agencies acquired foreign end products authorized by the various exceptions and waivers of the Buy American Act  From our review of FPDS-NG data, the civilian agencies are more likely to cite one of the five Buy American Act exceptions or a trade agreement waiver when buying foreign end products, and thus take corresponding actions to document or approve the authority cited  For example, in our review of contracts from four agencies, VA obligated $71,000 for medical imaging equipment from Canada, and had to consider whether a trade agreement waiver applied  The manufacturer was determined to be the only source available and the contracting officer determined the acquisition was authorized by a Buy American exception based on domestic non-availability, which can require additional review  In contrast, DOD may make a similar contract award for equipment from Canada based on the qualifying countries exception  DOD acquisitions, then, may be authorized by exceptions such as domestic non-availability when a required item does not come from a qualifying country  For example, we reviewed a $744,000 DOD award for vehicle equipment that was only available from South Africa—which is not one of the DOD qualifying countries and not covered by any of the trade agreements—so the acquisition was authorized by the domestic non-availability exception  In addition, the civilian agencies also reported buying foreign end products for use outside the United States but to a lesser extent than DOD  For example, this included one of the contracts we reviewed, an HHS award for Ebola vaccines manufactured in the Netherlands, with $44 7 million obligated in fiscal year 2017  This contract was reported as used outside the United States because it is primarily stored overseas  FPDS-NG is the primary means for capturing procurement data regarding the Buy American Act, but we found that agencies may not always input reliable information on the extent to which exceptions or waivers authorized the acquisition of foreign end products  In addition, some aspects of how FPDS-NG is structured could lead to additional data reporting errors  In the non-generalizable sample of 38 contracts and orders we examined from DOD, HHS, DHS, and VA, we found 6 awards where information related to the Buy American Act was incorrectly reported in FPDS-NG  In three of the six contracts, agencies recorded the wrong exception or waiver, most often because of an error when reporting the place of manufacture in FPDS-NG  For example, DOD reported a $22,000 contract for vehicle equipment from South Africa as a Buy American Act exception due to unreasonable cost  But the contract file indicated that the exception that applied was domestic non-availability  DOD officials acknowledged the error and corrected it in FPDS-NG during the course of our review  In the three remaining contracts, agencies misreported whether an end product came from the United States or another country  For example, DHS incorrectly recorded that an $18 million contract was for aircraft accessories and other parts manufactured in the United States, even though file documentation showed the contract was for Italian-produced spare parts from the original equipment manufacturer  The Italian- produced spare parts were available from existing inventory maintained by the manufacturer and were needed immediately to meet a mandatory operational requirement  Officials from DHS acknowledged the recording oversight, attributed it to a mistake when entering information in FPDS- NG, and have since corrected the error in response to our observation  Additionally, FPDS-NG has system limitations that could hinder complete and accurate reporting of Buy American Act information: DOD Qualifying Country Exceptions and Trade Agreement Waivers  FPDS-NG requires that information on the type of Buy American Act exception or waiver applied be provided when end products are reported as foreign  But FPDS-NG does not identify errors associated with this process  For example, we reviewed an $8 3 million DHS contract for engines manufactured in Germany that was recorded as a DOD qualifying country exception in FPDS-NG, although this exception is not available to civilian agencies  Contracting officials corrected the data in FPDS-NG during the course of our review  Further, FPDS-NG does not prevent agencies from reporting trade agreement waivers when the contracts are valued below applicable thresholds or waivers do not apply, such as for small business set asides  For example, in the fiscal year 2017 data we reviewed, more than 5 percent of contract obligations reported for trade agreement waivers were for awards set-aside for small businesses, which would not be eligible under the Trade Agreements Act  OFPP officials noted that because of the various dollar thresholds applicable to different trade agreements, adding automatic thresholds in FPDS-NG to guide contracting staff in reporting an applicable trade agreement could lead to additional data errors in the procurement database  Awards under the Micro-purchase Threshold  Although the Buy American Act requirements do not apply to contract awards valued below the micro-purchase threshold—generally $3,500 in fiscal year 2017—the FPDS-NG ‘Place of Manufacture’ field does not have an option to indicate whether a contract is under the threshold  Instead, contracting officers entering information for awards under the micro- purchase amount must still state whether the product is domestic or foreign  If the product is foreign, the officials must select a Buy American Act exception authorizing the purchase, even though no exception is needed at these dollar levels  As a result, when agencies report in FPDS-NG that a Buy American Act exception or waiver applied for a procurement valued at less than $3,500, that information would not be accurate  Based on our review, this may have involved about $16 million in fiscal year 2017 obligations  Awards for both Foreign and Domestic Products  When reporting data for contracts that include multiple end products from both the United States and a foreign country, FPDS-NG only allows for one country of origin to be identified  Contracting officers told us that they typically will report a foreign end product in FPDS-NG when the foreign products account for the preponderance of the contract value  Thus, in cases where a contract includes foreign end products that do not account for the preponderance of the contract’s value, the value of these foreign end products would not be reported in FPDS-NG  We have previously reported that FPDS-NG has similar limitations in other fields, such the type of product or service provided, which prevent contracting officers from identifying more than one condition  According to OFPP, a recent change in the FAR requiring contract reporting at the line item level should provide greater transparency of all products included in a contract  Buy American Act Exceptions and Waivers under Indefinite Delivery Contracts  The way FPDS-NG captures data for Buy American Act exceptions and waivers for some indefinite-delivery contracts results in inaccurate data reporting  When an indefinite- delivery contract is initially awarded, FPDS-NG functionality does not give contracting staff the option to enter information for the ‘Place of Manufacture’ field  Instead, this information is typically captured once an order is placed on the contract  In our review of FPDS-NG data across the four agencies, however, we found that in some cases obligations are reported on the initial indefinite delivery contract so the Buy American Act exceptions or waivers are not recorded  This occurred with multiple agencies, but particularly at HHS, where information for almost 28 percent of HHS obligations for end products in fiscal year 2017 was not captured in FPDS-NG because the obligations were reported in the system through the initial contracts rather than orders  As a result, the applicability of the Buy American Act for HHS contracts totaling almost $1 9 billion in fiscal year 2017 was unreported in FPDS-NG  DOD, DHS, and VA officials told us they identified FPDS-NG reporting as an area of concern  GAO Standards for Internal Controls in the Federal Government state that management should use quality information to support objectives, and that such data should be complete and accurate  In response to the 2017 Executive Order calling for federal agencies to assess their implementation of the Buy American Act requirement, OFPP officials told us they are identifying potential strategies for improving the information agencies submit to FPDS-NG  As OFPP weighs potential options for FPDS-NG reporting, implementing enhancements to reduce data entry errors and ensure that the data collected are complete and accurate would help enable the system to provide the most useful information possible  Ensuring information is correctly reported in FPDS- NG is critical because the data are used to inform procurement policy decisions and facilitate congressional oversight  The four agencies we reviewed—DOD, HHS, DHS, and VA—took different approaches to provide training and guidance for the Buy American Act requirements  Contracting officers faced challenges when procuring products subject to the Buy American Act  For example, we found instances in which contracting officers applied a waiver or exception to contracts where the waiver did not apply and did not have complete guidance for required determinations or reviews  There also were challenges in confirming product origin information when vendors did not provide consistent information  The four agencies we reviewed varied in the mix of training and guidance provided to aid contracting officers in implementing the requirements of the Buy American Act  Three of the four agencies—DOD, DHS and VA— supplemented the federal acquisition regulation, which implements the requirements of the Buy American Act and Trade Agreements Act, with their own acquisition regulations  In addition, DHS and DOD have recently updated existing training or added new training and guidance  VA issued policy memoranda in 2017, emphasizing the importance of meeting Buy American Act requirements, but has not added training or provided specific guidance  HHS does not provide department-level training or guidance related to the Buy American Act  Most of the DHS and DOD contracting officers we spoke to reported that they had attended training and several found the guidance provided by the training to be helpful  HHS and VA contracting officials described confusion due to the lack of resources available at their respective agencies  In 2017, in response to a series of recommendations from the DOD Inspector General to re-emphasize Buy American Act training and guidance, the Defense Acquisition University introduced an updated training course that specifically focuses on the requirements and implementation of the Buy American Act  While not mandatory, a June 2017 memo notified all DOD services and the defense agencies that members of their contracting workforce should complete this training as part of their professional development  At the current pace of enrollment, DOD officials anticipate approximately 18,000 people will have taken this course by the end of September 2018, which is a seven-fold increase over previous graduation rates  Incorporated into these trainings were supplemental on-the-job tools to assist contracting officers when awarding contracts for end products subject to the Buy American Act requirements  One such tool is a flowchart outlining applicable solicitation provisions or contract clauses based upon the awarded contract’s total dollar value  DOD contracting officials we interviewed from Defense Logistics Agency’s (DLA) Land and Maritime division had completed the agency-level Buy American Act training and said it served as a good refresher, with some noting that most of the training they had received on the subject came when they were first hired  DOD provides regulations and guidance on Buy American Act requirements through both the Defense Federal Acquisition Regulation Supplement (DFARS) and the accompanying Procedures, Guidance and Information  DOD contracting officers use the provisions and clauses in DFARS to address the public interest exception for DOD qualifying countries  In addition, as a part of the updated training, the Defense Pricing and Contracting Office developed two documents to provide additional Buy American Act guidance  One outlines a step-by-step approach contracting officers can follow to determine whether the Buy American Act applies to their particular procurement and, if so, whether the use of an exception or waiver is appropriate  The second assists contracting officers with evaluating all offers—foreign and domestic— when price is the determining factor  In addition, we found that DLA supplements the available Defense Acquisition University training and guidance with a robust level of support, including annual training and subject matter expertise  DLA contracting officers told us that while they found the updated training helpful, they also appreciated the training course internal to their agency, as it addresses the types of procurements they typically handle in their day-to- day work, such as buying spare parts  Further, DLA contracting officers noted that they use the job aid provided through the local training  DHS introduced training courses in 2017 that specifically focus on the requirements and implementation of the Buy American Act, including a mandatory training course for DHS contracting officers  DHS reported that 94 percent of contracting staff had taken the required course as of April 2018  DHS developed these courses in response to the 2017 Executive Order to ensure its staff was familiar with the Buy American Act requirements  Incorporated into these training courses are supplemental on-the-job tools to assist contracting officers when awarding contracts for end products subject to the Buy American Act requirements, such as a flowchart outlining applicable solicitation provisions or contract clauses based upon contract dollar value  Contracting officials generally view the training and tools they received as beneficial  For example, several DHS contracting officials we interviewed said that the agency’s new course provided a helpful review on the topic, while one contracting officer specifically noted that the course materials are useful to new staff, to help them understand the Act’s waivers and exceptions  DHS also revised its acquisition manual in December 2017 to add further detail regarding the Buy American Act requirements  Specifically, DHS updated its acquisition manual to provide contracting officers more explicit FPDS-NG reporting instructions for procurements subject to the Buy American Act, as well as discretion to purchase domestic end products at or below the micro-purchase threshold  Additional changes include increasing the documentation and level of managerial review required to use several of the exceptions to the Buy American Act  For example, prior to 2018—which includes the time period in which the DHS contracts and orders we reviewed were awarded—the head of individual contracting offices had the authority to approve domestic non-availability and unreasonable cost exceptions, with a notification made to the DHS Chief Procurement Officer  But under the new policy, the use of these exceptions must have the concurrence of the HCA—who is responsible for contracting activities within individual DHS components—and be approved by the department’s Chief Procurement Officer  Table 3 outlines these changes  In September 2017, VA issued guidance to reinforce existing Buy American Act requirements  The policy memorandum encourages the HCAs within VA to institute reviews of awarded contracts subject to the Buy American Act to ensure compliance  As of September 2018, policy officials did not know how many HCAs had taken this step  Further, the guidance emphasizes the importance of Buy American Act training for its acquisition workforce  VA policy officials explained that the Buy American Act is introduced in several VA training courses, but the agency does not have a specific course on implementing the Buy American Act requirements or provide additional instruction or tools  During the course of our review, VA officials said that some of the HCAs had added internal training on the Buy American Act  In addition, VA contracting staff has the option of taking training offered outside the agency, such as the updated Defense Acquisition University course on the Buy American Act  This training is not required  Contracting officials we spoke to at VA said they struggled with the details of awarding contracts subject to Buy American Act requirements because they are not provided sufficient agency-specific training and guidance on the topic  Moreover, several contracting staff noted an increased need for training due to recent changes in VA contracting practices  Specifically, in response to a 2016 Supreme Court decision, VA has increased contracting efforts with veteran-owned small businesses through the Veterans First Contracting Program  As a result, contracting officials explained they have reduced their use of schedule contracts, in which the determinations related to the Buy American Act requirements were made with the initial awards  As one contracting officer explained, prior to this change, more than 90 percent of her division’s procurements were through VA schedule contracts in which Buy American Act applicability had already been established  However, this shift in contracting practices means contracting officers will more frequently need to consider the applicability of the Buy American Act, but contracting officers have not received specific guidance or training to do so  Noting the significance of this change, one contracting officer stated she approached VA management to obtain Buy American Act training for her division, but such training was not available  Federal internal controls state that agencies should ensure that training is aimed at developing and retaining employee knowledge, skills, and abilities to meet changing organizational needs  In September 2018, we reported that VA was experiencing difficulties implementing multiple aspects of the Veterans First policy, and we recommended that VA provide more targeted implementation training  As VA moves forward to implement this training, incorporating the Buy American Act requirements will be important to provide greater assurance that staff has the knowledge and skills needed to navigate the changing procurement environment  HHS does not have agency-level Buy American training or guidance  The HHS Acquisition Regulation Supplement does not address foreign acquisitions  HHS officials told us that efforts to develop guidance that would address Buy American Act requirements are underway, but they do not know when they will be finalized and made available to contracting officers, and could not describe the extent to which they will address Buy American Act implementation  The HHS contracting officers we interviewed discussed informal Buy American Act training their divisions had developed because department-level training was not available  For example, at HHS’ National Institutes of Health, a contracting official told us about a training course she recently developed because her office was taking on the administration of additional contracts for which the Buy American Act requirements would apply  Contracting officers at HHS’ Office of Biomedical Advanced Research and Development Authority described informal training on the agency’s contract writing system— included as part of their weekly internal staff meetings—that provides additional guidance on how to appropriately complete certain data fields relevant to the Buy American Act  In our analysis of 38 contracts from across the four agencies, we found that agencies faced various levels of challenge in applying the Trade Agreements Act waivers and Buy American Act exceptions to acquire foreign end products  This was particularly apparent in cases where contracting officers had to determine if a trade agreement applied or cases which required a determination that a domestic end product was not sufficiently available, in accordance with the domestic non-availability exception to the Buy American Act requirements  Contracting staff also had difficulty determining the origin of products in light of incomplete or conflicting information  Of the six contracts we reviewed reporting that a trade agreement applied to the foreign end products purchased, we found two cases in which this waiver did not apply to the contracts in question  The value of the contract is one determining factor for whether a trade agreement waives the Buy American Act requirements, although the FAR also states additional factors that would affect applicability under a trade agreement  The two contracts we found, both from VA, had total dollar values at award— $8,435 and $11,950, respectively—that were less than any of the thresholds at which trade agreement waivers of the Buy American Act are applicable  Both contracts were for products from countries that are party to the World Trade Organization Government Procurement Agreement, so the value of the acquisition would have to be equal to or exceed $191,000—the threshold that was in effect at the time of award—for waivers from Buy American requirements to apply  Contracting officials in both cases were generally unaware that the applicable threshold was not met, making the trade agreement waiver inapplicable  Although VA has added Buy American Act guidance since these contracts were awarded early in fiscal year 2017, the information currently available does not provide sufficient detail to assist contracting officers when awarding contracts in these situations  For example, the guidance VA provided contracting officers in September 2017 does not emphasize consideration of the applicable trade agreement thresholds or include information on how contracting officers should determine the applicable waiver or exception  When contracting officers procure foreign end products, the type of waiver or exception used to support the purchase matters—particularly when required additional steps and review are not completed because the wrong waiver or exception was applied  We found that the two VA contracts with foreign end products were incorrectly reported as the Trade Agreements Act waiver having applied  If one of the other Buy American Act exceptions permitting purchases of foreign end products had applied, contracting officers may have been required to obtain higher-level review or complete a written determination  In addition, we reviewed contracts that show some of the complexities contracting officers face beyond applying the dollar thresholds when determining if an award for foreign end products is eligible under the Trade Agreements Act waiver of the Buy American Act  Specifically, we found instances where DHS contracting officials took different approaches for non-competed awards for similar foreign-manufactured products  For example, we reviewed a non-competed $58 million DHS award for acquiring spare aircraft parts from an original equipment manufacturer located in a foreign country that is party to the World Trade Organization Government Procurement Agreement  DHS reported in FPDS-NG that the procurement was waived by the Trade Agreements Act  However, we also reviewed two other sole-source awards from DHS for similar products—spare aircraft parts from two separate manufacturers in foreign countries that are also party to the World Trade Organization Government Procurement Agreement—that were instead reported as subject to the Buy American Act, but excepted due to the non-availability of domestic products  Contracting officers may come to different conclusions for similar products, in part, because of the multiple factors that have to be considered when determining whether an acquisition is subject to the Buy American Act and whether any waivers or exceptions apply  However, available guidance does not always address these complexities  For example, agencies need to decide if other conditions, such as the procurement of products deemed indispensable for national security or national defense purposes apply to an acquisition that would make a trade agreement inapplicable  Further, if the product’s country of origin is considered a designated country under the World Trade Organization Government Procurement Agreement, officials need to determine that the product is eligible under that agreement  DHS updated its training and guidance for the Buy American Act, which includes a job aid outlining at what dollar values solicitation provisions and contract clauses under a trade agreement waiver are applicable  However, it does not address other situations in which contracts may not be eligible under the Trade Agreements Act, such as non-eligible products or products for national defense purposes  For the other agencies in our review, we found that DOD’s updated Buy American Act training and its acquisition supplement both address trade agreement eligibility, but HHS does not yet have Buy American guidance to address this topic  Federal internal control standards state that agencies should communicate quality information internally to achieve their objectives and that they should select the appropriate methods of communication  When written guidance is not available, agencies may miss opportunities to ensure appropriate steps are taken to meet Buy American Act requirements  Our review of 38 contracts also included 8 contracts for foreign end products pursuant to the domestic non-availability exception  In certain situations, such as when contracts are awarded without full and open competition, this exception requires an approved written determination  The FAR establishes requirements for domestic non-availability determinations, but agencies can delegate the level of review required or specify information to be included in the determination  Three of the agencies we reviewed—DOD, DHS, and VA—provide supplemental guidance on the process for making determinations, including who must make the determination when applying a domestic non-availability exception  However, DHS policy officials told us that when the agency uses the domestic non-availability exception for a sole-source acquisition, the written justification that the FAR requires for non- competed awards should suffice as the documentation to support the non-availability determination as well  The practice of using sole-source justifications to support Buy American determinations is not addressed in DHS guidance  According to DHS policy updated in 2018, determinations of domestic non-availability must be concurred with by the HCA and approved by the Chief Procurement Officer  Federal and DHS acquisition regulations, however, state that some justifications can be approved at a lower level  In the absence of further guidance, this difference in approval levels could result in inconsistent application within the department  In addition, as previously noted HHS does not yet have Buy American Act guidance so the department does not provide information on how to make determinations  According to federal internal control standards, agencies should communicate quality information internally to achieve their objectives and that they should select appropriate communication methods  When written guidance is not available, agencies may miss opportunities to ensure that contracting officers take the steps needed to meet requirements when applying a domestic non-availability exception  Knowing the country of origin of the products the federal government buys is necessary to implement the Buy American Act, but contracting officers do not always have access to accurate information on originating countries  The FAR and the DFARS provide various clauses which, when incorporated into contracts, require vendors to certify that the end products they provide to the government are domestic and, if necessary, declare the foreign countries from which they provide products  Vendors frequently certify this information through the System for Award Management (SAM), the government-wide system used to collect vendors’ annual representations and certifications  Contracting officers may rely on the information vendors provide about their product origins, but they are generally expected to take actions to verify incomplete or conflicting information when they have reason to believe that a vendor will be providing a non-compliant product  We found that SAM certifications and offers did not always include accurate information on end products from foreign countries  In 6 of the 38 contracts that we reviewed—from DHS, HHS, and VA—the vendors certified that they only provided domestic end products although the end products provided were foreign  In all of these cases, the contracting officers knew that the acquisitions included foreign end products  For example, we reviewed two DHS awards for spare aircraft parts from an Italian-based company, one of which was reported in FPDS-NG under the domestic non-availability exception to the Buy American Act, and the other which was incorrectly reported as being manufactured in the United States but has since been corrected  Contracting officials said they knew the parts were made in Italy based on extensive experience contracting with the company and, in part, because they had visited the production location  Contracting officials—including some at HHS and VA—said they use SAM as their primary source to determine whether the vendor is offering domestic end products  Others reported some awareness of the limitations of SAM certifications  At all four agencies, contracting officials emphasized that it is important to ask questions when end product origin information is not readily available—or if there is conflicting information—but agency guidance that we reviewed does not address this need or provide information on how to do so  Only the local training offered by DOD’s DLA addresses other sources of information, which officials said was helpful because it is specific to the industries with which they work  Instead, some officials described how they rely on their experience to know how to verify products’ origins but this can be problematic, particularly with newer staff  For example, in one contract we reviewed VA contracting officials acknowledged that a new contracting specialist at VA did not follow-up when the product origin certification was not provided and assumed all of the items procured were domestic  During the course of our review, the contracting specialist’s supervisor said that she contacted the vendor and learned that some of the items provided were in fact foreign end products  The foreign products were not considered to account for the preponderance of the contract so were not reported in FPDS-NG, but the contracting officer was acting with incomplete information at the time of award  Further, in 4 of the 38 contracts that we reviewed, it is not clear how contracting staff took steps to obtain product origin information in situations where it was not provided in SAM  In these cases—which include contracts for both domestic and foreign end products—the vendors had opted not to certify their product origins in SAM, but instead said that they would provide the information with their individual proposals  However, based on the information in the contract files, the proposals did not include this information  For example: Three of the contracts we reviewed from HHS—all reported as purchasing end items manufactured in the United States—did not certify product origin in SAM  The supervising contracting officer for two of the awards explained that his contracting staff regularly check the vendor’s written representations and certifications provided in the offer, because the SAM certifications are general and do not always apply to the specific equipment they buy  However, the three contract files we reviewed did not include manufacturing or origin information  The vendor for a DHS contract that was reported as manufactured in the United States did not certify this information in SAM  The contracting officer said that he checks SAM for product origin information, but in the documents we reviewed there is no evidence of the information in the contract file  Federal internal control standards state that agencies should communicate the necessary quality information needed to achieve the agency’s objectives, thereby enabling personnel to address risks  Providing guidance regarding the situations in which contracting officers should verify product origin information with vendors may help agencies better meet the requirements of the Buy American Act  Although purchases for foreign end products account for less than 5 percent of federal procurement spending in fiscal year 2017, it is important that these purchases be consistent with the domestic- purchasing restrictions in the Buy American Act  This requires that Buy American Act exceptions and trade agreement waivers be used only when applicable, and that agencies report accurate data on the extent to which they are used  However, data reporting errors by contracting staff and FPDS-NG limitations mean that data on the use of exceptions and waivers are not fully captured  The federal agencies all have responsibilities to ensure Buy American Act data are accurate and complete  The lack of good data can hinder congressional oversight of the extent to which foreign end products are procured as authorized by one of the exceptions or waivers of the Buy American Act  Agencies have taken varied approaches for providing information to contracting officers that navigate the complexities and nuances associated with applying the different Buy American Act exceptions or trade agreement waivers  DOD has added such detailed information through its revised training course and policy guidance  Adding these types of targeted information to address challenging areas would help contracting officers at other agencies implement the Buy American Act’s domestic preferences, as well as related exceptions and waivers  Further, to accurately determine how exceptions and waivers apply requires complete product origin information  Although the responsibility to certify the origins of products supplied to the federal government rests with the contractors, contracting officers would benefit from resources that help them identify information that may be inconsistent, to ensure that accurate information is available  We are making four recommendations, one each to the Office of Management and Budget, DHS, VA, and HHS  The Director of the Office of Management and Budget should instruct the Office of Federal Procurement Policy: To facilitate additional training to improve the understanding of the contracting workforce regarding the Buy American Act requirements; and To facilitate clarifying revisions to FPDS-NG, where needed, and provide training and guidance for recording Buy American Act information in FPDS-NG to improve the accuracy of the Buy American data  (Recommendation 1) The Secretary of Homeland Security should clarify existing guidance in the Homeland Security Acquisition Manual or update training to help contracting officials: Identify the factors that should be considered in order to determine the applicability of the Trade Agreements Act and waiver of the Buy American Act; Document determinations of the use of Buy American exception for domestic non-availability and ensure the required approvals are obtained, particularly when such determinations are evidenced through justifications for other than full and open competition; and Identify sources of information available for determining product origin and the steps they should take to verify information that is inconsistent  (Recommendation 2) The Secretary of Veterans Affairs should clarify existing guidance, or provide training or other instruction, to help contracting officials: Address the applicability of the Buy American Act requirements and provide instruction on how to implement the requirements, including in any training developed to implement the Veterans First policy; Identify the factors that should be considered in order to determine the applicability of the Trade Agreements Act and waiver of the Buy American Act; and Identify sources of information available for determining products’ origins and the steps they should take to verify information that is inconsistent  (Recommendation 3) The Secretary of Health and Human Services should provide guidance, training, or other instruction to help contracting officials: Identify the factors that should be considered in order to determine the applicability of the Trade Agreements Act and waiver of the Buy American Act; Document determinations of the use of Buy American exceptions for domestic non-availability and ensure the required approvals are obtained; and Identify sources of information available for determining products’ origins and the steps they should take to verify information that is inconsistent  (Recommendation 4) We provided a draft of this report to DOD, HHS, DHS, VA, and the Office of Management and Budget for review and comment  DOD reviewed the report, but did not offer comments  HHS, DHS, and VA provided written responses, which are reproduced in Appendices IV, V, and VI of this report, respectively  A senior official within the Office of Federal Procurement Policy (OFPP) at the Office of Management and Budget provided a response via email  In addition, HHS, DHS, and OFPP provided technical comments, which we incorporated into the report where appropriate  In their responses, HHS, DHS, VA agreed, and OFPP generally agreed, with our findings and recommendations  The written response from HHS and DHS included information on the steps each agency plans to take to address the recommendations  Specifically, HHS stated that the agency will evaluate ways to provide additional training and guidance to contracting officials  DHS stated that it will provide guidance on the applicability of the Buy American Act and the Trade Agreements Act in certain situations and the documentation and approvals required when awarding non-competed contracts that require an exception  Additionally, DHS plans to update training regarding actions contracting officers should take when there are discrepancies in product origin information  VA concurred with our three-part recommendation and described some of the actions the agency plans to take in response  However, VA’s comments do not fully address our recommendation  Specifically, we recommended that VA clarify guidance or provide training to identify factors that could help contracting officers determine the applicability of Trade Agreements Act waivers of the Buy American Act  The comments from VA, however, only restate the existing Buy American Act exceptions and make no mention of Trade Agreements Act waivers  Further, we recommended that VA identify sources of information regarding product origin and the steps to be taken to verify inconsistent product origin information  VA’s response only noted that contracting officers are responsible for conducting market research and ensuring that all product origin requirements are met  VA did not outline any additional steps the agency would take to help contracting officers navigate the complexities inherent in this area  Going forward, VA will need to develop a more robust and responsive approach in order to fully implement our recommendation  We are sending copies of this report to the appropriate congressional committees; the Secretaries of the Departments of Defense, Health and Human Services, Homeland Security, and Veterans Affairs; the Director of the Office of Management and Budget; and other interested parties  In addition, the report is available at no charge on the GAO website at http://www gao gov  If you or your staff have any questions about this report, please contact me at (202) 512-4841 or woodsw@gao gov  Contact points for our Offices of Congressional Relations and Public Affairs may be found on the last page of this report  GAO staff who made key contributions to this report are listed in appendix VII  The objectives of this report are to assess the extent to which (1) the federal government procures foreign products through Buy American Act exceptions and waivers; and (2) selected agencies provide training and guidance to implement the Buy American Act requirements  To address both of these objectives, we reviewed relevant laws and policies, such as sections of the Federal Acquisition Regulation (FAR); the Buy American Act as amended; the Trade Agreements Act of 1979 as amended; federal acquisition regulation supplements from audited agencies such as the Department of Defense Federal Acquisition Regulation Supplement (DFARS); the Executive Order “Buy American, Hire American” of 2017; the World Trade Organization’s Agreement on Government Procurement; and memorandums, policy, guidance, and instructions related to the Buy American Act  To assess the federal government procurement of foreign products, including those procured through citing exceptions and waivers of the Buy American Act, we analyzed data from the Federal Procurement Data System-Next Generation (FPDS-NG) for fiscal year 2017, which was the most recent and complete data available at the time of our review  We analyzed procurement data in FPDS-NG across the federal government in fields relevant to the Buy American Act’s domestic preference requirements, including the product service code, country of product origin, and place of manufacture, in addition to fields such as the contract value and dollars obligated  We reviewed the place of manufacture field in particular as it contains information on how the Buy American Act applies to the contract, including whether the preponderance of the obligations is for manufactured end products and, if so, whether they are manufactured in or outside of the United States  When manufactured outside of the United States, this field also captures the reason the purchase was permissible, which we analyzed to assess the dollar obligations associated with the various Buy American exceptions or trade agreement waiver reported, as well as when products were used outside of the United States  We also analyzed data from FPDS-NG to identify the countries where foreign end products were reported to be manufactured and the associated dollars obligated in fiscal year 2017  In addition, we met with officials from the Office of Management and Budget, Office of Federal Procurement Policy to better understand ongoing reviews of the data in FPDS-NG that pertains to the Buy American Act  In our analysis of FPDS-NG data, we took steps to minimize issues that might affect data reliability  Specifically, we analyzed FPDS-NG data to identify potential errors and inconsistencies, such as non-eligible agencies reporting the use of exceptions for DOD qualifying countries, or reporting trade agreement waivers for contracts valued less than minimum thresholds for trade agreements  We made minor adjustments to minimize potential data reporting issues, including aggregating the exceptions reported, and where appropriate, limiting our analysis to one year of data, fiscal year 2017  Based on these steps, we determined that FPDS-NG data were sufficiently reliable to allow us to calculate the approximate extent of obligations for foreign end products and the use of the Buy American Act exceptions and the Trade Agreements Act waiver  However, we are unable to precisely determine the amount spent on foreign end products through the use of exceptions and waivers because of the reporting errors and data system limitations we identified in this report  Using FPDS-ND data, we identified four agencies—the Departments of Defense (DOD), Health and Human Services (HHS), Homeland Security (DHS), and Veterans Affairs (VA)—that had the highest fiscal year 2017 obligations in the product codes for manufactured products, which are potentially subject to the Buy American Act restrictions  In addition, to identify trends and determine if there were variations in reported obligations for foreign end products in the past, we reviewed FPDS-NG data on the Buy American exceptions and trade agreement waivers in fiscal years 2013 through 2017  To assess the extent to which selected agencies are providing training and guidance to implement the requirements of the Buy American Act, we reviewed training course materials and regulations, policies, and other guidance available at the four agencies in our review—DOD, HHS, DHS, and VA—to determine the extent to which they address the Buy American Act requirements  In addition, we reviewed training materials available to government employees through sources such as the Federal Acquisition Institute  We interviewed policy officials from the four agencies to understand how training and guidance had been implemented  We further reviewed relevant inspector general reports from the DOD Inspector General issued between 2015 and 2018, which made several recommendations to improve compliance with the Buy American Act, among other requirements  Within the four agencies, we selected contracting offices that reported obligating fiscal year 2017 dollars for awards with foreign end products and awards with US-manufactured end products  We specifically focused on offices that reported a sufficient amount of foreign end product obligations and a sufficient number of contract awards to allow us to select multiple contracts  We also considered offices with a variety of Buy American exceptions and waiver types reported, in order to select a mix of contracts  The contracting offices selected were as follows: DOD: Defense Logistics Agency, Land and Maritime HHS: National Institutes of Health and the HHS Office of the Assistant Secretary for Preparedness and Response DHS: United States Coast Guard VA: Veterans Health Administration From these offices, we selected a non-generalizable sample of 38 contracts and delivery orders awarded in fiscal year 2017  At each agency, we selected awards to include a mix of end items produced by domestic and foreign manufacturers and, when products were reported as foreign manufactured, a mix of the various exceptions and waivers cited  We also include awards across a range of value for dollars obligated above the micro purchase threshold—ranging from approximately $5,000 to more than $100 million—to ensure we reviewed awards both above and below the various thresholds at which the Trade Agreements Act waiver might apply  Additionally, our sample included awards for similar types of end products across agencies, including aircraft parts at DOD and DHS and medical supplies at HHS and VA, to compare practices in different agencies  We originally selected 40 awards for review—10 from each agency—but removed two awards from our sample  One was an HHS award that we determined was awarded using Other Transaction Authority and was not subject to the Buy American Act  The second excluded contract was from DHS, which was modified after award to reflect that it was an information technology service rather than a product  As a service, it would not be subject to the Buy American Act  We reviewed the contract files for each of the 38 awards in our sample, including documentation such as the contract and task order award, solicitations, vendors’ offers or response to proposals, determination and finding memos, and FPDS-NG output documents  In addition, we reviewed the certifications each vendor provided in the System for Award Management (SAM) at the time of contract award  We interviewed contracting officials responsible for each of the 38 contracts and task orders to understand how they addressed the Buy American Act requirements, including how they determined exception or waiver applicability and product origin  We also reviewed any agency-specific or local training and guidance, tools, or job aids available to assist contracting officers in implementing the Act’s requirements We conducted this performance audit from October 2017 to December 2018 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 audit objectives  The United States maintains trade relationships with other countries whose specific negotiated terms results in different levels and types of applicability for waivers and exceptions to the Buy American Act  Figure 4 depicts the range of relationships that the United States maintains with other nations that allow for less restrictive purchasing of foreign end products by the federal government  The federal government purchases foreign end products from various countries  Figure 5 highlights the different amounts of contract obligations for foreign end products from these countries for fiscal year 2017  The highest category, over $500 million, includes 4 countries that account for almost 40 percent of all federal procurement of foreign end products  Countries where the federal government obligated less than $5 million for the procurement of foreign end products are not included  In addition to the contact named above, Candice Wright, Assistant Director; and Jennifer Dougherty, Analyst-in-Charge, managed this review  Skip McClinton; Erin Stockdale; Adam Cowles; Stephanie Gustafson; Julia Kennon; Anne Louise Taylor; and Robin Wilson made key contributions to this report 

ground_truth: The Buy American Act of 1933, as amended, is the main U.S. law promoting domestic purchasing. The Act permits agencies to buy foreign end products only under certain exceptions, such as when domestic items are not available at a reasonable cost. Further, U.S. trade agreements waive the Buy American restrictions for certain products. GAO was asked to review implementation of the Buy American Act. This report assesses the extent to which (1) the federal government procures foreign products through Buy American Act exceptions and waivers; and (2) selected agencies provide training and guidance to implement the Act. GAO reviewed laws, regulations, and policies related to the Buy American Act and analyzed data for fiscal year 2017 from FPDS-NG. GAO also analyzed a non-generalizable sample of 38 contracts from DOD, HHS, DHS, and VA—the agencies with the most obligations for products in fiscal year 2017. The 38 awards selected include a mix of foreign and domestic products, as well as dollars obligated. Finally, GAO interviewed cognizant contracting and policy officials from the selected agencies. According to data reported in the Federal Procurement Data System-Next Generation (FPDS-NG) in fiscal year 2017, foreign end products accounted for less than 5 percent—about $7.8 billion—of federal obligations for products potentially subject to the Buy American Act. Federal agencies procured foreign products using exceptions to Buy American Act requirements, as well as through waivers or when the Buy American Act did not apply, as shown in the figure. The amount of foreign end products purchased could be greater than reported in FPDS-NG, however, due to reporting errors and system limitations. GAO found that 6 of the 38 contracts reviewed from the Departments of Defense (DOD), Health and Human Services (HHS), Homeland Security (DHS), and Veterans Affairs (VA) inaccurately recorded waiver or exception information. FPDS-NG system limitations compound these errors because it does not fully capture Buy American Act data. Among other things, the database does not always enable agencies to report the use of exceptions or waivers on contracts for both foreign and domestic products, reducing data accuracy. The Office of Management and Budget (OMB) is considering strategies to improve Buy American Act data. The four agencies GAO reviewed varied in their approaches to Buy American Act training and guidance. DOD reports that it will have trained more than 18,000 personnel by the end of 2018. DHS reports training almost 1,400 people—approximately 94 percent of its contracting staff—as of April 2018. Some VA courses mention the Act, but none is focused specifically on implementing its requirements. HHS does not have agency-level training or guidance on the Act. GAO found that contracting officers for the contracts it reviewed face challenges implementing Buy American Act requirements. Having specific and targeted Buy American Act guidance and training can better ensure that agencies meet the Act's requirements. GAO is recommending that OMB take steps to improve Buy American Act data and that HHS, DHS, and VA improve agency guidance and training on implementing the Act. All of the agencies either concurred or generally concurred with GAO's recommendations.