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



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

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:  Because the military services have different descriptors for similar data fields, DOD cannot ensure that the services are categorizing similar types of sexual harassment in the same way  In addition, we found that the Army is more detailed in characterizing different types of sexual harassment  Specifically, as shown in table 4, the Army has an additional data field that provides more detailed descriptions of three types of sexual harassment; the other military services’ respective databases do not have this level of detail  Because the Army has this additional data field, it can capture information on multiple types of harassment that may occur in a single incident  The other military services, in contrast, do not have this capability in their respective databases  To illustrate, if one case of sexual harassment involved both verbal and nonverbal forms of sexual harassment, the Army could choose a more specific characterization to describe the incident, while the other military services would characterize the incident in more general terms  ODMEO officials are considering adapting an existing system to track instances of sexual harassment department-wide  That system, called Force Risk Reduction (FR2), is currently used to track safety issues like military injuries, civilian workers’ compensation claims, and casualty notifications at DOD  ODMEO recently completed a pilot of the system with the Marine Corps, the Navy, and the Army to test whether it would be useable for adaptation for sexual harassment data, and is planning a second pilot to include the Air Force and the National Guard Bureau  According to ODMEO officials, their adaptation of FR2 is intended to collect aggregate-level sexual harassment data from the military services, and the military services will continue to operate and rely on their individual databases to maintain more detailed case-level information on incidents  For example, ODMEO’s adaptation of FR2 would not have details such as descriptions of specific incidents, or information on dates associated with investigations or appeals  These types of data will continue to be maintained in the service systems  ODMEO officials told us that their new data system, if implemented, is not designed to collect case-level details in order to avoid personally identifiable information  Federal internal control standards state that management should define the identified information requirements at the relevant level and requisite specificity for appropriate personnel  Management should also process the obtained data into quality information  Consistency of information meets the identified information requirements when relevant data from reliable sources are used  While DOD is exploring implementing a system to track instances of sexual harassment department-wide, as currently planned this system will not collect case-level details and individual military service systems will continue to be relied upon for this type of information  Inconsistencies in data elements and definitions among the military services generally mean that one military service may be maintaining sexual harassment data that are more or less detailed than sexual harassment data maintained by other military services, or that is simply different from the data maintained by other military services  Additionally, inconsistent data elements and definitions may create difficulties in reporting sexual harassment data from the military services to OSD for a department-wide report, since ODMEO has to adapt data from the services to fit reporting requirements  Without standard data elements and definitions for sexual harassment data, DOD will continue to lack assurance about the consistency of these data across the military services  DOD has several overarching efforts to address unwanted sexual behaviors across the continuum of harm  Specifically, the department established an office to oversee the integration and coordination of unwanted sexual behaviors in 2015 and is in the process of developing an overarching prevention strategy  However, because the strategy is under development, it is unclear whether it will contain key elements for long-term and results-oriented strategic planning  DOD also has ongoing collaborative efforts to address unwanted sexual behaviors along the continuum of harm  Specifically, we identified 15 collaborative efforts, including regular meetings, Integrated Product Teams, and working groups that involve multiple entities that address unwanted sexual behaviors  DOD has taken steps to integrate activities related to the continuum of harm and is in the process of developing an overarching prevention strategy  Based on its research, DOD has sought to understand and define the continuum of harm, including the shared characteristics that contribute to increased unwanted sexual behaviors along the continuum and implications for prevention and response efforts  Also, in November 2015, DOD established a new entity—the Office of the Executive Director for Force Resiliency, within the Office of the Assistant Secretary of Defense for Readiness—to oversee policies and initiatives related to the continuum of harm  Specifically, the Executive Director for Force Resiliency was expected to provide senior leader policy guidance and oversight on high visibility departments that include SAPRO and ODMEO  In November 2016, the Office of the Executive Director for Force Resiliency was absorbed under the Assistant Secretary of Defense for Readiness  According to the Assistant Secretary of Defense for Readiness, the functions of the Office of the Executive Director for Force Resiliency remain and coordination of the efforts of several offices that address the continuum of harm continues  Officials from the Assistant Secretary of Defense for Readiness and SAPRO told us that they are drafting an overarching prevention strategy to encompass behaviors along the continuum of harm  However, because the strategy is still under development, its contents and timelines are unclear  We have previously identified six elements of strategic management planning that are key for establishing a long-term, results- oriented strategic planning framework: (1) a mission statement, (2) long- term goals, (3) strategies to achieve goals, (4) external factors that could affect goals, (5) the use of metrics to gauge progress, and (6) evaluations of the plan to monitor goals and objectives  By incorporating the elements of a comprehensive and results-oriented strategy into its overarching prevention strategy, the department will be better positioned to effectively coordinate and integrate prevention activities and reduce unwanted sexual behaviors  A mission statement, along with long-term goals and strategies to achieve those goals, should help to focus efforts in integrating prevention activities, and metrics and evaluations will allow the department to gauge progress and make changes as necessary, while also accounting for external factors that may impact progress towards goals  Our review identified 15 collaborative efforts that DOD has used to address behaviors along the continuum of harm, including sexual harassment, sexual assault, and domestic violence involving sexual assault  Three of these efforts are cross-cutting between all three of the key OSD stakeholders—ODMEO, FAP, and SAPRO—and five involve cross-cutting efforts by at least two of the key stakeholders  Figure 1 lists DOD’s 15 collaborative efforts  Regarding the three cross-cutting efforts involving all three of the key stakeholders, The Sexual Assault Prevention and Response Integrated Product Team provides a forum for OSD, the military departments, and the National Guard Bureau to address sexual assault prevention efforts  The team meets bimonthly and serves as the implementation and oversight arm for DOD’s Sexual Assault Prevention and Response (SAPR) program  The team also coordinates new policies; reviews existing SAPR policies and programs to ensure they are consistent with applicable instructions; and monitors the progress of program elements including DOD’s SAPR strategic plan tasks, DOD’s sexual assault prevention strategy tasks, and implementation of NDAA- related sexual assault issues  SAPRO leads this effort  The Prevention Collaboration Forum and working group develops coordinated prevention approaches that address factors impacting personnel readiness such as sexual harassment, sexual assault, and domestic violence involving sexual assault  According to its proposed charter, the focus of the forum is on enhancing the health of military unit and family climates as well as strengthening and promoting the resiliency and readiness of the total force through a coordinated effort around integrated policies, collaborative direction of research, alignment of resources, analysis of gaps, and synchronization of activities  The Assistant Secretary of Defense for Readiness leads this effort with SAPRO providing administrative and facilitation support  The Victim Assistance Leadership Council advises the Under Secretary of Defense for Personnel and Readiness on policies and practices related to victim assistance across DOD  According to its charter, the council provides a forum for senior leaders to exchange information and collaborate on issues affecting victims of all forms of crime and harassment within DOD, including but not limited to victims of sexual harassment, sexual assault, and domestic violence involving sexual abuse  Leadership rotates between SAPRO, FAP, and ODMEO and other offices  Regarding the cross-cutting efforts involving two of the three key stakeholders, the Sexual Harassment Prevention and Response Working Group is led by ODMEO and includes SAPRO  The group was established to evaluate how to best position sexual harassment prevention and response policy and oversight and to leverage technology to automate annual reporting requirements  The four other cross-cutting efforts are (1) the hazing and bullying working group, (2) retaliation working groups created under the SAPR Integrated Process Team, (3) domestic abuse rapid improvement events, and (4) ODMEO and SHARP meetings  The remaining collaborative efforts we identified are specific to FAP, SAPRO, and ODMEO  For example, the Sexual Assault Prevention Roundtable is a forum for representatives from OSD, the military departments, and the National Guard Bureau to share information on sexual assault prevention efforts and requirements  According to its charter, the roundtable’s activities include, among other things, sharing promising practices and prevention updates; discussing challenges in prevention program implementation, including servicemember training, and identifying approaches to address them; identifying metrics to assess the impact and effectiveness of prevention efforts, and opportunities to collaborate on research projects; and tracking the implementation of prevention tasks identified in the DOD SAPR strategy  SAPRO leads this effort  The Defense Diversity Working Group is an ODMEO-specific group that collaborates with various OSD and military service offices on military and civilian diversity and inclusion issues and implements mandated diversity plans and programs  Studies by DOD and others have shown that unwanted sexual behaviors do not exist in isolation but are part of a range of interconnected, inappropriate behaviors that are connected to the occurrence of a sexual assault  While DOD has policies and procedures to prevent and respond to these types of unwanted behaviors, some of the policies do not include key elements like anonymous reporting of sexual harassment and principles in the CDC framework for sexual violence prevention  Fully including these elements in the department’s policies can help ensure that the military services are interpreting and applying prevention and response efforts consistently and may also decrease the risk of perpetration or victimization related to instances on unwanted sexual behaviors  Further, DOD has developed reliable data systems for collecting and reporting data on some of the unwanted sexual behaviors including sexual assault and instances of domestic violence with sexual assault  However, inconsistencies in sexual harassment data elements and definitions may be creating difficulties in developing department-wide reports on unwanted sexual behaviors  Improving and standardizing data collection efforts will not only improve the quality of data that DOD and the military services collect but may also increase the ability for DOD to further develop its understanding of the connection between unwanted sexual behaviors  Finally, DOD officials have stated that they are in the early stages of developing an overarching strategy to address the interconnected nature of the range of unwanted sexual behaviors  To ensure that the department is appropriately concentrating its efforts to prevent and respond to the full range of unwanted behaviors, it is important that DOD include elements of a long-term, results-oriented strategy into its overarching prevention strategy  In doing so, DOD will be in a better position to effectively coordinate and integrate prevention activities and ultimately reduce instances of unwanted sexual behaviors  We are making the following four recommendations to DOD: The Under Secretary of Defense for Personnel and Readiness should fully include in the new policy for sexual harassment the principles in the Centers for Disease Control’s framework for sexual violence prevention, including risk and protective factors, risk domains, and tertiary strategies  (Recommendation 1) The Under Secretary of Defense for Personnel and Readiness should include in the new policy for sexual harassment mechanisms for anonymous reporting of incidents consistent with section 579 of the National Defense Authorization Act for FY 2013  (Recommendation 2) The Under Secretary of Defense for Personnel and Readiness should (1) direct the Office of Diversity Management and Equal Opportunity to develop standard data elements and definitions for maintaining and reporting information on sexual harassment incidents at the military service level, and (2) direct the military services to incorporate these data elements and definitions into their military service-specific databases  (Recommendation 3) The Under Secretary of Defense for Personnel and Readiness should direct the Assistant Secretary of Defense for Readiness to incorporate in its continuum of harm prevention strategy all the elements that are key for establishing a long-term, results-oriented strategic planning framework  The elements are (1) a mission statement, (2) long-term goals, (3) strategies to achieve goals, (4) external factors that could affect goals, (5) use of metrics to gauge progress, and (6) evaluations of the plan to monitor goals and objectives  (Recommendation 4) We provided a draft of this report to DOD and CDC for review and comment  In its written comments, DOD concurred with three recommendations and partially concurred with one, noting planned actions to address this recommendation  DOD’s comments are reprinted in their entirety in appendix II  DOD and CDC also provided technical comments, which we incorporated into the report as appropriate  DOD concurred with our three recommendations that DOD fully include in the new policy for sexual harassment the principles in the CDC's framework for sexual violence prevention, that DOD also include in the new sexual harassment policy mechanisms for anonymous reporting, and that DOD incorporate in its continuum of harm strategy all the elements that are key for establishing a long-term, results-oriented strategic planning framework  With regard to our recommendation that DOD develop standard data elements and definitions for maintaining and reporting information on sexual harassment incidents and direct the military services to incorporate these into their databases, DOD partially concurred and stated that while a 2013 policy memorandum provides standard data elements and definitions, the services collect other data elements based on their unique needs  DOD stated that ODMEO will conduct a review to determine compliance with DOD reporting requirements and identify emerging policy modifications or changes/additions to standard definitions  We are sending copies of this report to the appropriate congressional committees, the Secretary of Defense, the Under Secretary of Defense for Personnel and Readiness, and the Director, Centers for Disease Control and Prevention  In addition, the report is available at no charge on the GAO website http://www gao gov  If you or your staff have any questions about this report, please contact me at (202) 512-3604 or farrellb@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 III  To determine the extent to which the Department of Defense (DOD) has policies on sexual harassment that include Centers for Disease Control and Prevention (CDC) principles and relevant legislative elements, we obtained and reviewed Office of the Secretary of Defense (OSD) and service-level sexual harassment policies  We compared the policies with a framework developed by the CDC for preventing sexual violence, which CDC defines as including non-contact unwanted sexual behaviors, sexual harassment, and physical sexual assault  CDC’s model is based on the concept of addressing the health of a given population based on common risk and protective factors and effective, tested strategies  We reviewed CDC’s framework for preventing sexual violence as well as our report on DOD’s sexual assault prevention strategy to identify six principles that an organization can include in a sexual violence prevention strategy or policy: Risk factors: Factors that may put people at risk for sexual violence perpetration or victimization, such as an organizational climate that either explicitly or implicitly condones sexual harassment; Protective factors: Factors that may protect high-risk people from harm, such as an organizational climate that promotes respect among personnel at all levels; Primary strategies for prevention: Strategies that occur before sexual violence takes place to prevent initial perpetration, such as sexual harassment prevention training; Secondary strategies for prevention: Immediate responses after sexual violence has occurred to address the early identification of victims and the short-term consequences of violence, such as reporting mechanisms and immediate interventions; Tertiary strategies for prevention: Long-term responses after sexual violence has occurred to address the lasting consequences of violence and sex-offender treatment interventions, such as the long- term treatment of the victim and perpetrator; and Risk domains: Levels at which risk and protective factors should be categorized, including: individual, relationship, community, and society  DOD has previously adapted risk domains to the military population, using the levels of: individual, relationship, leaders at all levels, military community, and society  DOD previously used CDC’s framework for preventing sexual violence in the department’s 2014-2016 Sexual Assault Prevention Strategy  In addition, we reviewed the OSD and service-level sexual harassment policies to determine the extent to which they included three elements identified in the National Defense Authorization Act (NDAA) for FY 2013, which directed DOD to develop a comprehensive policy that includes sexual harassment prevention training for the armed forces; mechanisms for reporting incidents, including mechanisms for anonymous reporting; and mechanisms for responding to and resolving instances of sexual harassment, including for the prosecution of perpetrators  Two GAO analysts independently reviewed the policies and determined whether or not each element was included  Any discrepancies were resolved through discussion and consultation with a third analyst  We interviewed officials in the Under Secretary of Defense for Personnel and Readiness’ Office of Diversity Management and Equal Opportunity, who oversee department- wide policy on sexual harassment, to obtain an understanding of their roles and processes regarding sexual harassment as well as the status of policy development in that area  We also interviewed officials from military equal opportunity offices in the Air Force, the Navy, and the Marine Corps, as well as officials from the Army’s Sexual Harassment/Assault Response and Prevention Office to obtain an understanding of the service sexual harassment offices and roles, as well as the status of updates to their respective policies  To determine the extent to which DOD has processes for maintaining and reporting consistent data on incidents of unwanted sexual behaviors, we reviewed DOD reports to Congress that provide incident data regarding unwanted sexual behaviors, including DOD’s most recent annual report on sexual assault in the military  We identified the databases that generate the reported data and evaluated the processes for assuring the quality and consistency of data in those databases—including the Defense Sexual Assault Incident Database, which maintains sexual assault data; the Central Registry database, which maintains data on domestic violence involving sexual assault; and various military service- level databases that maintain sexual harassment data  To evaluate DOD’s reported data we reviewed pertinent statutory provisions, DOD guidance, and the Standards for Internal Control in the Federal Government that address agencies’ use of quality data and our prior reports evaluating sexual assault data  In evaluating the reported data, we obtained and reviewed statutory provisions with reporting requirements, as well as DOD guidance on data collection for sexual harassment, sexual assault, and domestic violence involving sexual abuse  With regard to DOD efforts to collect and maintain sexual assault data, we met with OSD, Navy, Air Force, and Marine Corps officials in their respective Sexual Assault Prevention and Response offices as well as officials in the Army’s Sexual Harassment/Assault Response and Prevention office  We also reviewed our prior report on DOD’s Defense Sexual Assault Incident Database and our prior report that evaluated sexual assault data across agencies  To determine whether DOD has processes for collecting and maintaining consistent data for domestic violence with sexual assault, we obtained and compared data elements and processes from DOD’s Central Registry database, which contains data for domestic violence throughout the department  We also obtained and reviewed policies that outline processes for collecting and reporting domestic violence involving sexual abuse data, and interviewed officials from Family Advocacy Program offices in OSD and the Army, Navy, Marine Corps, and Air Force to determine data reliability and comprehensiveness  To determine the extent to which reports of sexual assault, including reports of sexual assault among servicemembers and reports of domestic abuse involving sexual assault, meet statutory requirements for reporting, we reviewed DOD reports to Congress that provide sexual assault incident data, including DOD’s most recent annual report on sexual assault in the military and compared those reports with requirements in the NDAA for FY 2011, which directs DOD to report the total number of substantiated and unsubstantiated sexual assault incidents, among other things  With regard to sexual harassment data, we interviewed officials in the Under Secretary of Defense for Personnel and Readiness’ Office of Diversity Management and Equal Opportunity, as well as officials from the Military Equal Opportunity offices in the Air Force, Marine Corps, and Navy, and officials from the Army Sexual Harassment/Assault Response and Prevention office  We collected and compared data fields and data definitions from the Army, Navy, Marine Corps, and Air Force offices that address sexual harassment  We compared the data elements to determine whether the data elements and definitions across the services are consistent  To identify the extent to which DOD has overarching efforts, including a prevention strategy, to address unwanted sexual behaviors across the continuum of harm, we met with officials in the Office of the Assistant Secretary of Defense for Readiness and DOD’s Sexual Assault Prevention and Response office  We reviewed our prior work and provisions from the Government Performance and Results Act to identify key elements that should be included in strategic plans as well as standards for coordinating within agencies  Key elements include (1) mission statement, (2) long-term goals, (3) strategies to achieve goals, (4) external factors that could affect goals, (5) use of metrics to gauge progress, and (6) evaluations of the plan to monitor goals and objectives  We identified and reviewed coordinating mechanisms used by OSD and the service offices that guide and oversee efforts to address unwanted sexual behaviors  We reviewed DOD, RAND Corporation, and CDC reports that addressed the continuum of harm and the relationship between the various forms of unwanted sexual behaviors  We interviewed officials from OSD and service-level Sexual Assault Prevention and Response, Family Advocacy, and Military Equal Opportunity offices and the Army’s Sexual Harassment/Assault Response and Prevention to identify the various efforts in which they participate  We also collected and reviewed charters and meeting notes for integrated product teams and working groups to identify their intended purposes, their activities, their membership, and whether they involved multiple offices addressing unwanted sexual behaviors  In identifying DOD’s collaborative efforts, we also reviewed our prior work on collaboration among federal agencies but we did not assess the effectiveness of department’s collaborative efforts  We conducted this performance audit from August 2016 to December 2017 in accordance with generally accepted government auditing standards  Those standards require that we plan and perform the audit to obtain sufficient, appropriate evidence to provide a reasonable basis for our findings and conclusions based on our audit objectives  We believe that the evidence obtained provides a reasonable basis for our findings and conclusions based on our audit objectives  In addition to the staff named above, key contributors to this report include Thomas Gosling (Assistant Director); Isabel Band; Matthew Bond; Vincent Buquicchio; Caroline DeCelles; Mae Jones; Kirsten Lauber; and Brian Pegram  Sexual Assault: Better Resource Management Needed to Improve Prevention and Response in the Army National Guard and Army Reserve  GAO-17-217  Washington, D C : February 27, 2017  Military Personnel: DOD Has Processes for Operating and Managing Its Sexual Assault Incident Database  GAO-17-99  Washington, D C : January 10, 2017  Sexual Violence Data: Actions Needed to Improve Clarity and Address Differences Across Federal Data Collection Efforts  GAO-16-546  Washington, D C : July 19, 2016  DOD and Coast Guard: Actions Needed to Increase Oversight and Management Information on Hazing Incidents Involving Servicemembers  GAO-16-226  Washington, D C : February 9, 2016  Sexual Assault: Actions Needed to Improve DOD’s Prevention Strategy and to Help Ensure It Is Effectively Implemented  GAO-16-61  Washington, D C : November 4, 2015  Military Personnel: Actions Needed to Address Sexual Assaults of Male Servicemembers  GAO-15-284  Washington, D C : March 19, 2015  Military Personnel: DOD Needs to Take Further Actions to Prevent Sexual Assault during Initial Military Training  GAO-14-806  Washington, D C : September 9, 2014  Military Personnel: DOD Has Taken Steps to Meet the Health Needs of Deployed Servicewomen, but Actions Are Needed to Enhance Care for Sexual Assault Victims  GAO-13-182  Washington, D C : January 29, 2013  Preventing Sexual Harassment: DOD Needs Greater Leadership Commitment and an Oversight Framework  GAO-11-809  Washington, D C : September 21, 2011  Military Justice: Oversight and Better Collaboration Needed for Sexual Assault Investigations and Adjudications  GAO-11-579  Washington, D C : June 22, 2011  Military Personnel: DOD’s and the Coast Guard’s Sexual Assault Prevention and Response Programs Need to Be Further Strengthened  GAO-10-405T  Washington, D C : February 24, 2010  Military Personnel: Additional Actions Are Needed to Strengthen DOD’s and the Coast Guard’s Sexual Assault Prevention and Response Programs  GAO-10-215  Washington, D C : February 3, 2010  Military Personnel: DOD’s and the Coast Guard’s Sexual Assault Prevention and Response Programs Face Implementation and Oversight Challenges  GAO-08-924  Washington, D C : August 29, 2008  Military Personnel: The DOD and Coast Guard Academies Have Taken Steps to Address Incidents of Sexual Harassment and Assault, but Greater Federal Oversight Is Needed  GAO-08-296  Washington, D C : January 17, 2008 

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 2: The Department of Defense (DOD) obligates more than $300 billion annually to pay for goods and services (including research and development)  Most of these acquisitions are governed by numerous statutes and regulations found in Title 10 of the United States Code, the Federal Acquisition Regulation (FAR), and the Defense Federal Acquisition Regulation Supplement (DFARS)  DOD can also enter into certain transactions without triggering most of the standard acquisition statutes and regulations by using other transaction (OT) authorities  In recent years, Congress has expanded these authorities and DOD is increasingly using OTs for research, prototyping, and production  This report examines (1) how OTs work, (2) why they were established, (3) potential benefits and risks of using OTs, and (4) whether there are data available against which to measure their effectiveness  Appendix A provides a legislative history of DOD's other transaction authorities  On October 4, 1957, the Soviet Union triggered a space race with the United States when it successfully launched Sputnik I into orbit, becoming the first nation to send a man-made satellite into space  Congress, concerned that the United States was falling behind in space, held a series of hearings on an "emergency" effort to respond to the Soviet launch of Sputnik  At the same time, a bill was introduced in the Senate to create an agency with the means to quickly and efficiently develop a national space program  These efforts led to passage of the National Aeronautics and Space Act of 1958 (Space Act, P L  85-568) in July 1958, which established the National Aeronautics and Space Administration (NASA)  In an effort to give the new agency "the necessary freedom to carry on research, development, and exploration     to insure the full development of these peaceful and defense uses without unnecessary delay," the Space Act granted NASA broad authority to "enter into and perform such contracts, leases, cooperative agreements, or other transactions as may be necessary" to accomplish its mission of research and exploration (emphasis added)  Congress extended different variations of OT authorities to other select agencies, granting the authority to DOD in the FY1990 & 1991 National Defense Authorization Act (NDAA, P L  101-189 )  For an analysis of which non-DOD agencies can use OTs and how the authorities differ by agency, see Appendix B   Other transactions are legally binding contracts that are generally exempt from federal procurement laws and regulations such as the Competition in Contracting Act and the Federal Acquisition Regulation  In contrast, traditional procurement contracts must adhere to the procurement rules set forth in statute and regulation  Generally, DOD can use other transaction authorities for three purposes: 1  conduct research, 2  develop prototypes, or 3  contract for follow-on production of a successful prototype project  DOD's other transaction authorities are found in two sections of law: 10 U   S   C   2371 grants DOD the authority to use other transactions to carry out basic, applied, and advanced research projects  DOD regulations treat these projects as financial assistance instruments, not as contracts  10 U   S   C   2371b permits the use of other transactions to conduct prototype projects and follow-on production  OTs can only be used for prototypes if one of the following applies: at least one nontraditional defense contractor significantly participating in the project; all significant participants are small businesses or nontraditional defense contractors; at least one-third of the total cost of the prototype project is provided by nongovernment participants; or the senior procurement acquisition official provides in writing an explanation of the exceptional circumstances justifying an OT  Follow-on production can only be conducted when the underlying prototype OT was competitively awarded, and the prototype project was successfully completed  10 U   S   C   2373 , while generally not considered an o ther t ransaction authority , allows DOD to buy certain items and designs for experimental or test purposes without having to adhere to the procurement laws set forth in Chapter 137 of Title 10  OT authorities grant government officials the flexibility to include, amend, or exclude contract clauses and requirements that are mandatory in traditional procurements (e g , termination clauses, payments, audit requirements, intellectual property, and contract disputes)  OTs can be structured in numerous ways, including a direct relationship between a single government agency and a single provider; joint ventures; partnerships; multiple agencies joining together to fund an agreement encompassing multiple providers; or through a consortium  One common application of OTs is to forge an agreement with a consortium  A consortium is an organized group— it can consist of nonprofits, academic institutions, or contractors— focusing on a specific technology area  Generally, a lead entity coordinates and directs a consortium's activities  Consortia have consisted of a handful to as many as 1,000 members  Consortia can act to facilitate multiparty agreements whereby each member is akin to its own co-prime contractor with the government  In such a case, the government articulates the need or problem it is trying to solve, and the various members of the consortium can submit white papers for consideration  In this scenario, OTs can serve as an efficient way for all members to send unsolicited technology suggestions and solutions to solve a defined challenge  Consortia can also be used to develop an ecosystem of entities working together on a project, whereby members of a consortium pool resources and collaborate with DOD  A number of analysts argue that using consortia in this way gives the federal government a unique ability to leverage and pool the technological expertise and innovation of multiple entities in a particular sector, thereby strengthening and advancing a sector of the industrial base that may have defense applications  Seen like this, OTs can be considered a mechanism to promote defense technology and the defense industrial base, with the potential added benefit of advancing the domestic commercial technology base  Some analysts, however, have argued that many of today's consortia do not operate as collaborative organizations, but function more like managed multiple award task order contracts  These analysts argue that DOD should seek to foster more collaboration in consortia  Some analysts have argued that consortia reduce competition, since only members of the consortium under contract can participate in the project or submit white papers for consideration and funding  Others counter that even when an OT is signed with a single consortium, competition could be increased, since all members of the consortium are notified of the opportunity (expanding the pool of potential competitors aware of the opportunity), and the OT will foster internal competition among consortium members  OTs are not procurement contracts and thus are exempt from numerous procurement statutes and regulations, including the statutes in Chapter 137 of Title 10 ( Procurement Generally )  They are, however, bound by standard contract and other select laws and regulations  Examples of laws that do not apply include the Truth in Negotiations Act, Competition in Contracting Act, Cost Accounting Standards, Contract Disputes Act, and select intellectual property statutes such as the Bayh-Dole Act  A number of these laws are aimed at oversight and protecting the interests of taxpayers  While the Competition in Contracting Act does not apply, 10 U S C  2371b requires that research and prototype projects be competed "to the maximum extent practicable " DOD policy mirrors the statutory language, stating "[C]ompetition is a good thing  It helps keep prices low, quality high, and gives the government leverage in negotiations " To the extent that OTs induce nontraditional contractors to work with DOD, OTs can be viewed as promoting competition among (and within) entities that would not normally compete for DOD contracts  However, the lack of explicitly defined competition requirements could result in less competition for certain OTs  OTs are not free from all legislative and regulatory requirements  Generally, statutes and regulations that are not procurement-specific apply, including the Trade Secrets Act, (18 U S C  1905); the Economic Espionage Act (18 U S C  1831-39); elements of the Freedom of Information Act (5 U S C  552); and fiscal and property laws, such as the Anti-deficiency Act (31 U S C  1341); and the Tucker Act (28 U S C  1491)  As can be seen by these citations, many of these statutes are not located in the procurement titles of Title 10 or Title 41  The Government Accountability Office (GAO) has held that OTs are not procurement contracts, and therefore it will not review protests of such an award or solicitation  However, GAO will review "a timely protest that an agency is improperly using its other transaction authority " OT contracts can be protested to the Court of Federal Claims, although there is debate as to the extent of the court's jurisdiction  The limited protest jurisdiction of GAO is appealing to many government procurement officials  One senior Air Force official reportedly stated that OTs are "just so much faster and so much more attuned to getting something that we want today and not have to spend a couple of years going through a protest, going through this huge process to get something we wanted two years ago " It generally does not take that long to go through a GAO protest  By statute, GAO must issue an opinion on a protest within 100 days of the protest being filed, and 70% of cases are resolved in less than 60 days  While exempt from GAO bid protests, OTs are not exempt from GAO audits  Generally, OTs that include government payments exceeding $5 million are required to include a clause granting GAO the right to examine the records of any related party  However, this requirement has a number of limitations  Used properly, OTs can provide significant benefits to DOD  Along with the potential benefits come certain risks  Some of the potential benefits to OTs highlighted by analysts and officials include providing a mechanism to pool R&D resources with industry to facilitate development of, and obtain "the latest state-of-the-art, dual use technologies"; attracting nontraditional contractors with promising technological capabilities to work with DOD; lowering costs by eliminating requirements associated with the Federal Acquisition Regulations (i e , costs associated with required reporting and administrative activities) or sharing costs with industry; and "speeding up" the acquisition process  A number of experts argue that OTs provide a unique mechanism for DOD to invest in, and influence the direction of, technology development even when the end result is not directly tied to a military capability  As one observer noted, the real benefit to DOD may be that [t]he R&D has been accomplished and is available to the technical and scientific communities  As a result, a subsequent phase of research can begin or a particular approach can be demonstrated to be of no value  Some argue that OTs have particular import today  Drawing parallels to the space race, these analysts argue that DOD is engaged in a defense technology race  According to the 809 Panel: DoD is now in a period during which the time a particular technology is a dominant force on the battlefield is getting increasingly shorter, disruptive technologies are emerging at a faster pace, and these technologies are more widely dispersed…In a world with rapidly changing technology, time is a valuable resource that must not be taken for granted  It is difficult to predict what capabilities DoD will need 5 to 10 years from now—biotechnology, nanotechnology, artificial intelligence, robotics, or a new technology area not even known today  It also is unclear on what plane the military will conduct warfare—traditional battlefields, space, cyberspace, or some other domain  The current acquisition system lacks the agility needed to adapt to new paradigms  These analysts argue that OTs and similar rapid acquisition authorities are critical for DOD to compete in such a fast-paced global environment where technology and innovation are no longer driven by DOD, but by industry and foreign competitors  In 1960, the United States accounted for 69% of global R&D, with U S  defense-related R&D alone accounting for more than one-third of global R&D  The federal government funded approximately twice as much R&D as U S  business  However, from 1960 to 2016, the U S  share of global R&D fell to 28%, and the federal government's share of total U S  R&D fell from 65% to 24%, while business's share more than doubled from 33% to 67%  As a result of these global, national, and federal trends, federal defense R&D's share of total global R&D fell to 3 7% in 2016  Given the shift in the global R&D landscape, and the diminishing influence of DOD as a market mover, analysts suggest that the current procurement system is overburdened by regulations and bureaucratic processes that slow the system, increase costs, and dissuade companies from doing business with DOD  In contrast, OTs are viewed as faster, attracting companies that would otherwise forgo working with DOD and promoting broader investment in critical defense capabilities  As one analyst wrote: OTAs are currently the only way to remove the barriers necessary to get these nontraditional sources of innovation to do business with the military  Properly constructed, OTAs help speed up the process, respect a company's IP through negotiation rather than regulatory fiat, and result in contracting under commercial terms and conditions  Congress also appears to have shifted its view on appropriate use of other transactions  In the FY1999 conference report, Congress stated that [OT] authority should only be used in the exceptional cases where it can be clearly demonstrated that a normal contract or grant will not allow sufficient access to affordable technologies  By comparison, in the FY2018 NDAA, Congress expanded OT authorities and stated the following: In the execution of science and technology and prototyping programs, the Secretary of Defense shall establish a preference, to be applied in circumstances determined appropriate by the Secretary, for using transactions other than contracts, cooperative agreements, and grants  Along with the potential benefits come potential risks, including that of diminished oversight and exemption from laws and regulations designed to protect government and taxpayer interests  Some analysts, while acknowledging the important role of OTs, raise concerns over transparency and how these agreements are being employed  As one industry official stated, OTs are a contracting method, not a substitute for good acquisition practices  Discussing a particular OT for cloud services that was protested and ultimately cancelled by DOD, one observer argued The cloud contract provides a teachable moment for procurement reform-minded officials in the Pentagon and Capitol Hill  The problem was not with the OTA mechanism, which remains an essential element of reforming Pentagon procurement  Rather, the problem was with a lack of transparency with how the mechanism was employed  Scott Amey, general counsel of the Project on Government Oversight, cautioned We have to seriously consider how we are using [OTs]; whether we are using them as intended, whether we are getting the goods and services that we really want and need, whether we are getting them at the best cost and process, and we are using this procurement vehicle as a way to just circumvent the rules and have contractors not have the administration and oversight they need to hold them accountable  I'm just afraid this is going to result in a lot of waste, fraud, and abuse in the future  Congress has expressed repeated concerns that OTs could be used to circumvent congressional intent  In the FY1999 NDAA, the committees emphasized that the authority should only be used in a limited manner  The conference report stated the following: The conferees are especially concerned that such authority not be used to circumvent the appropriate management controls in the standard acquisition and budgeting process  Congress echoed a similar concern in the FY2019 NDAA  According to the House report: The committee also urges the Department to reiterate through established guidelines that OTA is not a means for circumventing appropriate use of the Federal Acquisition Regulations, and that full and open competition should be used to the maximum extent possible to maintain a sense of integrity, fairness, and credibility in the Federal Procurement process  Other transactions are also exempt from many of the socioeconomic policies put in place by Congress to promote public policies, including some Buy America requirements  Some analysts have raised concerns that OTs are a way to circumvent many of the public policies enshrined in the acquisition process  A number of analysts and officials have raised concerns that if DOD uses OTs in ways not intended by Congress—or is perceived to abuse the authority—Congress could clamp down on the authority  Under Secretary of the Army Ryan McCarthy reportedly stated that the military department is "trying to be very judicious about this authority so we don't lose it " Some analysts argue that Congress is already clamping down on the use of OTs  These analysts point to language in the FY2019 NDAA and FY2019 appropriations legislation ( P L  115-245 ) requiring additional reporting and notification (see Appendix A )  Such notification and reporting requirements, however, are not new; when Congress expanded OT authorities in the past, reporting and notification requirements were commonly included  The reporting requirements may also be a result of congressional frustration with a lack of transparency and data on how DOD uses OTs  DOD lacks authoritative data that can be used to assess OT effectiveness and better understand broader trends associated with these agreements  The most frequently cited source for such data is the Federal Procurement Data System-Next Generation (FPDS-NG), which is the primary source for tracking data on contract obligations, including other transactions for prototypes and follow-on production  FPDS-NG is configured to track data on cost-sharing, other transaction award type, and prevalence of nontraditional contractors  Obligations connected to OTs for research are tracked by the Defense Assistance Awards Data System, which is primarily used to track grants and cooperative agreements  This bifurcation of how OT data are tracked makes it more difficult to get a consolidated view of OT data  According to DOD, all OT data will be reported through FPDS-NG starting in late 2019  The procurement data in FPDS-NG are not fully reliable  There are quality issues relating to accuracy, completeness, and timeliness of data  CRS reviewed FPDS-NG data for prototype OT agreements signed or modified between FY2015 and FY2017 and found similar data inconsistencies  DOD officials acknowledge that they do not have sufficiently reliable data upon which to conduct analysis on the use of OTs and are taking steps to try to improve the data  The analyses below reflect CRS's effort to analyze DOD's use of other transaction authority based on the best available data  According to FPDS-NG, in FY2017, DOD obligated $2 1 billion—and received $360 million in cost-share contributions—on prototype other transaction agreements, representing less than 1% of DOD's total FY2017 contract obligations (approximately $320 billion)  Despite the small percentage of obligations, OTs are growing quickly and are expected to continue to grow at a rapid pace  From FY2013 to FY2017, the number of new prototype agreements increased from 12 to 94, an increase of over 650% (see Table 1 )  DOD's Defense Innovation Unit (DIU, formerly known as the Defense Innovation Unit Experimental, or DIUx) was involved with approximately half of the prototype agreements executed in 2017  DOD officials have stated their intent to further increase the department's use of OTs  Officials say that this increase is due to Congress expanding the statutory authority  The Army executed more than 66% of the prototype OT agreements between FY2013 and FY2017, often on behalf of other military departments and components (see Table 2 )  Army Contracting Command-New Jersey at Picatinny Arsenal executes many of these agreements  DIU currently uses Picatinny Arsenal to execute all of its other transaction agreements  A number of private sector companies do not pursue federal government contracts because they are unwilling to forfeit intellectual property rights or adhere to some of the procurement regulations  One of the goals of OTs is to expand the defense marketplace by creating a mechanism for access to technologies and services of companies that would not otherwise work with DOD, particularly startups and companies developing innovative technology  As one industry representative stated: Because they are "outside" the FAR, OT agreements do not require such cumbersome oversight and audit requirements such as those imposed by the Truth in Negotiations Act, cost and pricing data or an expensive Cost Accounting System (CAS) qualified financial system  CAS compliant financial systems can cost a company millions of dollars to implement and maintain — and are therefore a significant, if not potentially fatal, barrier to government market entry for startups and small, innovative companies  These requirements tend to reinforce the "legacy advantage" of large traditional contractors, who can afford to hire and staff these requirements with large staffs of accountants and lawyers  A number of nontraditional companies told CRS that they are more likely to work with DOD because of the department's other transaction authorities  Despite these claims, some observers question whether OTs are effectively bringing nontraditional contractors into the defense marketplace  A DOD Inspector General report examining other transactions from FY1994 to FY2001 found that OTs did not attract significant numbers of nontraditional defense contractors to do business with DOD  The report found that of the 209 prototype agreements examined, traditional defense contractors received 95% of the $5 7 billion in funds awarded  A recent analysis of FPDS-NG data by Federal News Network had similar findings  According to the report, from FY2015 to FY2017, while nontraditional defense contractors were awarded most of the new OTs (66% vs  33% for traditional defense contractors), the dollar value of the OTs favored traditional contractors ($20 8 billion vs  $7 4 billion for nontraditional contractors)  Some observers have questioned the accuracy of the data published by Federal News Network  According to Charlie McBride, president of Consortium Management Group (which manages two consortia working with DOD through OTs), 88% of the total dollar value of awards to CMG Group has gone to nontraditional prime contractors, and nontraditional entities have participated in the remaining 12%  This debate highlights the lack of authoritative data on OTs  The currently available data may not accurately reflect the extent to which nontraditional contractors are engaged in OT agreements  FPDS-NG does not collect data regarding subcontractors or consortia composition, making it difficult to determine the nature and extent to which nontraditional defense contractors and entities may be working under OT agreements with DOD directly or as subcontractors  When Congress extended OT authority to DOD, it authorized inserting a clause requiring a person or entity to make payments to DOD as a condition of receiving support under the agreement  Such funds were to be merged into an account dedicated to support DARPA advanced research projects  The intent of this provision was to permit DARPA to "recoup the fruits of such arrangements, when there is a 'dual use' potential for commercial application" and reinvest the funds to develop other technologies  In addition to the recoupment authority, DOD can share costs with other parties under an OT  Using this approach, the amount of each party's share is negotiated and incorporated into the agreement  Congress believed that OTs and cooperative agreements were ideal vehicles for promoting DOD-industry collaboration in developing dual-use technologies  For example, the FY1992 & 1993 NDAA ( P L  102-190 ) authorized DOD to enter into cooperative and other transaction agreements to develop critical dual-use technologies as set forth in the Defense Critical Technologies Plan  According to the Senate report:     the United States tends to underinvest in dual-use technologies  National security requirements alone often do not justify major DOD support, and market prospects alone often appear to be too long-term or high risk to justify US industry carrying the entire development burden     The committee encourages use of cooperative agreements and other transactions in lieu of grants or contracts     The provision would require that at least 50 percent of funding over the life of a partnership derive from non-federal sources but would allow for a smaller industry share at the start  In the 1990s, some DARPA OTs required participants to share costs because the types of work completed generally involved R&D that was mutually beneficial to government needs and industry commercial goals  In certain instances, present-day OTs have cost-sharing requirements that foster collaborative research  Some analysts believe that DOD is not always realizing all the benefits that OTs have to offer, such as sufficiently leveraging private capital or forming true consortia of multiple parties pooling resources  Some of these analysts believe that DOD does not sufficiently use consortia to leverage private investment through the pursuit of collaborative, mutually beneficial, dual-use technologies  Some observers argue that as the legislation on OTs has evolved, the cost-sharing provision for prototype projects has come to create an unfair playing field biased against traditional defense contractors  For prototype projects, traditional contractors generally are required to assume one-third of costs whereas nontraditional defense contractors and small businesses generally do not have to cost share  From a fairness perspective, these observers argue that traditional contractors should not have a mandatory cost share  These observers also point out that some nontraditional defense contractors are companies with billions of dollars of revenue that should not be granted a competitive cost advantage  Putting traditional defense contractors at a competitive disadvantage could deny DOD access to those companies with the most experience working on defense products, potentially depriving the military of access to leading defense-related research and technology  Other observers argue that the cost share as currently structured is appropriate: traditional defense contractors hold a significant competitive edge in their understanding of, and have the systems in place to manage, traditional contracts  In contrast, nontraditional and small businesses, which generally cannot compete with the traditional defense contractors, need the exemption from the cost-share requirement to be able to work with DOD  These observers also argue that traditional contractors are awarded the majority of dollars obligated to OTs, proving how difficult it is for nontraditional suppliers to break into the defense marketplace  Additionally, traditional contractors could avoid the cost-sharing requirement by teaming with a nontraditional contractor  DOD has not effectively tracked data on cost sharing  A 2017 report to Congress indicated that in FY2016 DOD obligated $1 billion for prototype agreements and received $68 million in cost-share contributions  A CRS review found numerous concerns with the data underlying the report, and with DOD's analytical conclusions  See Appendix C for further discussion  A number of analysts and industry officials have raised concerns that DOD could use OTs to avoid competitions, as OTs are exempt from the Competition in Contracting Act  According to statute, follow-on production using other transaction authority can only be awarded if the underlying R&D agreement was competed  In addition, 10 U S C  2371b states that "to the maximum extent practicable" OTs must be competed  Determining whether OTs are being used to circumvent competition requires a two-step analysis: 1  Are OTs competed less often that traditional contracts? 2  Is there a benefit to these OTs being competed? Available FPDS-NG data suggest that DOD is broadly complying with 10 U S C  2371b's competition mandate  Between FY2013 and FY2017, approximately 89% of all new OT prototype agreements were competed in some fashion  Many observers and analysts believe that OT agreements can be executed substantially faster, sometimes in a matter of weeks, compared to the months or years it typically takes to execute traditional contracts  Based in part on this belief, some officials and analysts are touting OTs as a new model for conducting acquisitions and the answer to many of the problems in defense acquisition  These analysts argue that in a world of increasingly fast technology development, DOD acquisitions must go faster or risk being left behind  Many acquisition professionals argue that OT contracts are not inherently faster than traditional contracting; instead, they are executed faster because they are not encumbered by the reviews, protests, and bureaucratic layers that have been overlaid on traditional contracting  According to these officials, OTs take just as long as traditional contracts if the same execution and oversight processes are applied  And because all terms are negotiable, complex negotiations could make OTs take longer to execute than traditional contracts that have required, nonnegotiable conditions  The Other Transactions Guide states The OT award process will not always be faster than the traditional procurement processes and sometimes can be as long or longer  The speed of award is tied to many factors, many of which are internal to the organization  DOD has not tracked data on the relative time it takes to execute OTs vs  traditional contracts, making it impossible to objectively assess these claims  Analysts and officials generally agree that the workforce plays a critical role in determining the success or failure of an acquisition  Because there are fewer predefined requirements, OTs can be more difficult to negotiate than traditional contracts, putting DOD at greater risk of not getting what it wants at a reasonable price  The complexity and difficulty of negotiations is particularly high when there are intellectual property/patent rights issues, as is the case with most OTs  Given these challenges, OTs often require more experienced and capable government representatives to ensure implementation of agreements that are in the government's best interest  Some analysts question the extent to which the workforce is sufficiently trained and equipped to negotiate OTs  In response to this concern, in the FY2018 NDAA, Congress required workforce education and training for OTs, and required DOD to establish a cadre of intellectual property experts to advise, assist, and provide resources to program offices that are developing intellectual property strategies for contracts and agreements (see Appendix A )  DOD officials acknowledge that more training and education is required  Given the complexity of OTs and the limited extent to which they are used, some analysts and industry officials suggested that there may be a benefit to establishing a centralized office within DOD responsible for executing or overseeing all other transaction agreements  Such a structure could help ensure that those members of the acquisition workforce engaged in other transactions are sufficiently experienced, trained, and qualified  A number of analysts have argued that DOD should take steps to improve its use of OTs  Many of these analysts have suggested that data are not consistently and accurately tracked, regulations and guidance on when and how to use OTs are vague or insufficient, and the workforce is not sufficiently prepared to effectively use OTs  A number of officials have acknowledged these shortcomings and DOD is reportedly taking steps to address them  For example, in December 2018, DOD issued an updated Other Transactions Guide , a comprehensive guide containing best practices, case studies, and a clarification of myths related to other transaction authorities  In addition, Defense Acquisition University developed new course materials addressing OTs and is working to expand its offerings of relevant training and classes  However, numerous acquisition officials question whether it is possible, or even desirable, to try to quickly implement training aimed at preparing the thousands of DOD acquisition officials to execute OTs  Some of these officials have suggested it might be appropriate to only allow a limited and vetted number of acquisition professionals to be OT agreements officers  Some argue that OTs are just one "tool in the tool box," appropriate for only specific types of contracts, and should not be used to avoid the statutory and regulatory framework or to try to accelerate the process just for the sake of speed  Others have suggested that OTs should be used to cut through bureaucracy, speed up the acquisition process, avoid regulations and bid protests, and perhaps eventually supplant the regular FAR-based contracting process  Given the benefits and risks associated with OTs, questions for Congress include the following: 1  To what extent and in what circumstances do the potential benefits of OTs in terms of cost, schedule, and added capabilities outweigh concerns over potential fraud, waste, abuse, diminished oversight, and other public policy objectives? 2  Should OT authorities be extended further, curtailed, or maintained? The FY2019 NDAA required DOD to submit a report annually through 2021, summarizing DOD's use of OTs, including organizations involved; number of transactions; amounts of payments; and purpose, description, and status of projects  The NDAA also required the Defense Innovation Unit to submit a report to Congress, to include the number of traditional and nontraditional defense contractors with DOD contracts or other transactions resulting directly from the unit's initiatives  The conference report for the FY2019 defense appropriations bill included language expressing the conferees' "[concern] with the lack of transparency surrounding the employment of OTA, particularly for follow-on production " The conferees directed DOD to provide quarterly reports to the House and Senate appropriations committees listing each active OT, and to include additional information for each agreement  The conferees also directed GAO to review DOD's use of OTs to determine whether the "employment of this authority conforms to applicable statutes and guidelines, to include the identification of any potential conflicts " GAO was also required to report on the extent to which OTs have been used since FY2016  The multitude of reporting requirements, and the questionable reliability of the available data, raise a number of questions that Congress may wish to explore, such as the following: 1  To what extent, if any, should the current reporting requirements be consolidated to create a more streamlined and consistent flow of information to Congress? 2  What specific data does Congress need in these reports to effectively conduct oversight? For example, what percentage of research OTs result in prototype projects and follow-on production? 3  To what extent are the data sufficiently reliable, and will such data be easily retrievable in the future, to allow Congress to conduct effective, timely, and ongoing oversight? If the data are not sufficiently reliable or accessible in the future, what other data collection and tracking methods could Congress mandate to ensure ongoing access to reliable data? 4  How are OTs being used? Where and when in the acquisition lifecycle is the authority being used? To what extent is the requirements process being circumvented when DOD awards an OT follow-on production contract for a major system? One analyst suggested that "no efficiency is lost if only the most able personnel are authorized to procure and administer" OT agreements and further argued that expanding the use of OTs would increase the training costs by expanding the number of people who can "weave complex agreements in a relatively unstructured environment " Congress may consider whether DOD should establish an acquisition innovation lab or center of excellence responsible for overseeing, executing, and approving all OTs across the department  Such a lab or center could be staffed and supported by a cadre of professionals with experience across the acquisition lifecycle who have a willingness and ability to embrace new ideas and rethink existing practices  Alternatively, such labs or centers could be established in the military departments  Having centers in each organization could allow for consideration of the different missions and business approaches of the departments and help educate the workforce on a more systematic basis  Proponents argue that such an office would help ensure that only experienced and capable officials, with the appropriate training, use OT authorities  Such an office could also help protect against layering internal DOD policies and bureaucracies onto OTs by placing OTs outside of the traditional bureaucratic acquisition process  Proponents could further argue that such an office could better propagate best practices and ensure that OTs are used appropriately and are consistent with guidance and legislation  Having a single office responsible for executing or approving all OTs could also help ensure more timely and accurate information, giving Congress more visibility into DOD's use of other transaction authorities  To the extent that a single, high-level official is responsible for managing and overseeing all OTs, Congress might wish to consider repealing or modifying existing statutory approval requirements  If such an office was able to provide timely and accurate information, Congress might also consider some of the current reporting requirements unnecessary, and may choose to repeal some of the reporting requirements  Opponents of such a proposal argue that centralizing OTs would have the opposite effect, increasing bureaucracy by adding yet another office within DOD  Opponents also argue that such an office could make it more time-consuming to get a project underway and may discourage program offices from attempting or suggesting OTs  Some also argue that a single office may not have the resources to execute and approve agreements in a timely manner, and would inhibit spreading expertise on how to execute OT agreements more broadly across the acquisition workforce  Even proponents who might in theory support establishing such an office could raise significant concerns regarding how such an office would function in practice  A number of alternative options could be pursued to address concerns raised by opponents of establishing a centralized office  Some of these alternative options include the following: Granting such an office primary, but not exclusive, authority to execute OTs  For example, agreement officers specifically authorized to do so could execute OTs, with the centralized office conducting a peer review  Under this construct, the office could also be charged with providing information and expertise/consulting services on the use of OTs to program offices contemplating using the authorities  Establishing centers within each military department, with a designated office in OSD serving a coordinating function (with nondelegable approval authority residing in the military department office designated for OTs)  Creating the office as a pilot program for three years, to help DOD manage OTs until such time as the workforce becomes more experienced and proficient in using these agreements  Appendix A  Legislative History Other transaction authority first appeared in the National Aeronautics and Space Act of 1958  Since then, Congress has extended OT authorities to 11 federal agencies and a number of other federal offices (see Appendix B for information on other federal entities with similar authorities)  This appendix traces the legislative history of OT authorities and select related statutes applicable to DOD  To read the full text of the three statutory provisions related to OTs (10 U S C  2371, 2371b, and 2373), see Appendix D   National Aeronautics and Space Act of 1958 (P L  85-568) Creation of Other Transaction Authority On July 29, 1958 President Dwight D  Eisenhower signed into law the National Aeronautics and Space Act (P L  85-568), which established the National Aeronautics and Space Administration (NASA)  The purpose of the act included the expansion of human knowledge, preservation of the role of the United States as a leader in space science and technology, and pursuing the most effective utilization of the scientific and engineering resources of the United States  Section 203(b)(5) of the Space Act provided NASA the authority (emphasis added) to enter into and perform such contracts, leases, cooperative agreements, or other transactions as may be necessary in the conduct of its work and on such terms as it may deem appropriate, with any instrumentality of the United States     or with any person, firm, association, corporation, or educational institution  To the maximum extent practicable and consistent with the accomplishments of the purpose of this Act, such contracts, leases, agreements, and other transactions shall be allocated by the Administrator in a manner which will enable small-business concerns to participate equitably and proportionately in the conduct of the work of the Administration  Intellectual Property Rights The Space Act specifically addressed NASA's "property rights in inventions " Section 305 stated that any invention made in the performance of any work under any contract is the exclusive property of the United States "unless the Administrator waives all or any part of the rights " This was true even when the person who created the invention "was not employed or assigned to perform research, development, or exploratory work, but the invention is nevertheless related to the contract" and was made during working hours, or with a contribution of the government  The act granted the Administrator wide latitude to "waive all or any part of the rights of the United States under this section" if doing so was deemed to be in the best interests of the United States  When such rights were waived, NASA retained an irrevocable, nonexclusive, nontransferable royalty-free license by or on behalf of the United States  National Defense Authorization Act for FY1990 & FY1991 ( P L  101-189 ) The FY1990 & FY1991 NDAA granted DARPA temporary authority to enter into "cooperative agreements and other transactions" for the purpose of conducting advanced research projects  The statute clarified that OTs should only be used when "the use of standard contracts or grants is not feasible or appropriate " Congress restricted funding for OTs and cooperative agreements to $25 million of appropriated funds for FY1990 and FY1991, and set the authority to expire on September 30, 1991  Cost Sharing The FY1990 & FY1991 NDAA permitted OTs (or cooperative agreements) to include a clause requiring a person or entity to make payments to DOD as a condition of receiving support under the agreement  Such funds were to be merged into an account dedicated to supporting DARPA advanced research projects using cooperative agreements and other transactions  The act required, to the extent practicable, that funds provided by the government not exceed the total amount provided by the other parties to the project  According to the Senate report, one of the intents of the cost-sharing provision was to permit DARPA to "recoup the fruits of such arrangements, when there is a 'dual use' potential for commercial application" and to reinvest the funds to develop other technologies  Reporting Requirements The FY1990 & FY1991 NDAA required DOD to submit an annual report on the use of OTs and cooperative agreements, to include a description of each agreement and the technologies involved, the potential military and commercial utility of the technology, the reasons a contract or grant was not feasible to support the research, and the amount of payments, if any, received by the federal government under the agreement  National Defense Authorization Act for FY1991 ( P L  101-510 ) Section 244 increased the funds authorized for cooperative agreements and OTs from $25 million to $50 million  However, no such funding was appropriated  Reporting and Notification Requirements The conference report required DOD to submit to Congress a report listing the cooperative agreements and consortia intended to be used in FY1991-1992  The conference report also required DOD to provide the armed services and appropriations committees 30 days' notice prior to DOD signing a cooperative agreement or agreement with a consortia under OT authority  The Senate report focused on consortia as a method to pool resources, share research among numerous participants, and promote critical dual-use technology  Department of Defense Appropriations Act, 1992 ( P L  102-172 ) Limitations on the Use of OTs Section 8113A of P L  102-172 placed temporary limitations on the use of agreements undertaken pursuant to 10 U S C  2371: Section 8113A limited the use of OTs and cooperative agreements exclusively to DARPA (to the exclusion of the rest of DOD) for FY1992  Section 8113A limited DARPA to obligating or expending no more than $37 5 million in FY1992 for cooperative agreements or OTs undertaken pursuant to 10 U S C  2371  Section 8113A further established that no more than $75 million could be obligated or expended by DARPA in FY1992 for DOD dual-use critical technology partnerships  National Defense Authorization Act for FY1992 & FY1993 ( P L  102-190 ) Expanded Authority Section 826 extended other transaction authority to the military departments, and established separate fund accounts in each department for cost sharing  Section 826 also repealed the sunset for cooperative agreements and OTs, making the authorities permanent  Section 821 authorized DOD to enter into cooperative and other transaction agreements to develop critical dual-use technologies as set forth in the Defense Critical Technologies Plan  According to the Senate report     the United States tends to underinvest in dual-use technologies  National security requirements alone often do not justify major DOD support, and market prospects alone often appear to be too long-term or high risk to justify US industry carrying the entire development burden     The committee encourages use of cooperative agreements and other transactions in lieu of grants or contracts     The provision would require that at least 50 percent of funding over the life of a partnership derive from non-federal sources but would allow for a smaller industry share at the start  The conference report stated that the partnerships should focus on programs that fit into the security needs within DARPA  The conference report also stated that OTs are appropriate for those cases where the "regulations applicable to the allocation of patent and data rights under the procurement statutes may not be appropriate to partnership arrangements in certain cases " National Defense Authorization Act for FY1993 ( P L  102-484 ) Cost Sharing Section 4221 established 10 U S C  2511, which required DOD to establish cooperative arrangements with industry, educational institutions, federal labs, and other entities, to pursue research, development, and application of dual-use technologies  The section authorized DOD to use grants, contracts, cooperative agreements, or OTs to create these partnerships, and that the Federal government should not contribute more than 50% of the costs related to projects under this authority  National Defense Authorization Act for FY1994 ( P L  103-160 ) Expanded Authority Section 827 established 10 U S C  2358, which gave the Secretary of Defense and the Secretaries of the military departments the authority to conduct basic, advanced, and applied research through the use of contracts, cooperative agreements, grants, and OTs  Previously, OTs were only authorized for advanced research  Prototype Authorities Section 845 granted DARPA the authority to use OTs for prototype projects directly related to weapons or weapon systems proposed to be acquired by DOD  Section 845 required that "to the maximum extent practicable," prototypes be competitively awarded  This authority was set to terminate after three years  Section 845 remained as a note to 10 U S C  2371 until separately codified as 10 U S C  2371b in the FY2016 NDAA ( P L  114-92 )  Federal Acquisition Streamlining Act of 1994 ( P L  103-355 ) Section 1301 redesignated the language in 10 U S C  2358 (granting the authority to use OTs) to 10 U S C  2371  Reporting Requirements Section 1301 also required DOD to submit an annual report to the armed services committees, to include a general description of the other transactions, including the technologies involved in the research, the potential military and, if any, commercial utility of such technologies, the reasons for not using a contract or grant to provide support for such research, and the amount of payments, if any, received during the fiscal year pursuant to a clause in the other transactions and to what accounts such payments were credited  National Defense Authorization Act for FY1997 ( P L  104-201 ) Section 203 required that a senior DOD official be designated in OSD, and that the officials' sole responsibility be developing policy related to, and ensuring implementation of, DOD's dual-use technology program  This section authorized DOD to use OTs (as well as contracts, cooperative agreements, and grants) for dual-use projects only if the project "is entered into through the use of competitive procedures " Section 743 granted DOD the authority to use OTs to conduct research on Gulf War Syndrome, to determine its relationship to possible exposures of members of the Armed Forces to chemical warfare agents and hazardous materials, and the use of inoculations and new drugs  Expanded Prototype Authorities Section 804 amended Section 845 of the FY1994 NDAA by extending to the military departments and officials designated by the Secretary of Defense, the authority to use OTs for certain prototype projects  This authority, originally granted solely to DARPA and set to expire after three years, was given a new termination date of September 30, 1999  Reporting Requirements Section 267 modified elements of the annual report to the armed services committees  National Defense Authorization Act for FY1998 ( P L  105-85 ) Section 832 amended 10 U S C  2371 by clarifying that certain information submitted to DOD (i e  a proposal, business plan, technical information) be protected from disclosure pursuant to 5 U S C  552 for a period of five years  Strom Thurmond National Defense Authorization Act for FY1999 ( P L  105-261 ) Section 241 extended the sunset day for the authority to use OTs for prototypes from September 30, 1999, to September 30, 2001  Section 817 amended Section 2371 of Title 10, United States Code, clarifying that information submitted by outside parties in cooperative agreements for basic, applied, and advanced research is protected from disclosure under Section 552 of Title 5, United States Code  Department of Defense Appropriations Act, 1999 ( P L  105-262 ) While the enacted FY1999 defense appropriations bill ( P L  105-262 ) did not include legislative language addressing OTs, H Rept  105-591 , which accompanied the House-reported version of H R  4103 , included language expressing the House Appropriations Committee's "serious reservations" regarding the Air Force's then-proposed use of an OT agreement—instead of a contract— to develop the Evolved Expendable Launch Vehicle (EELV) program  The committee noted that "under [OTs] traditional safeguards which protect the government's interest in large acquisition programs are largely absent," and required the Under Secretary of Defense for Acquisition, Technology, and Logistics (now the Under Secretary of Defense for Acquisition and Sustainment) and the DOD Inspector General to certify to the congressional defense committees that the use of an OT was appropriate for the EELV program, and that "adequate safeguards exist[ed] to protect the government's interest and monitor program performance " National Defense Authorization Act for FY2000 ( P L  106-65 ) Section 801 required that for prototypes using OT authorities, DOD ensure that GAO, under its audit authority, have access to records relating to other transaction prototype agreements exceeding $5 million  Section 801 allowed for a waiver to GAO access and exempted entities that over the last year have not entered into an agreement with DOD that provided for audit access by a government entity  According to the Senate report: Senior DOD officials have sought legislation to extend other transaction authority to production contracts  Under current authority, there is some debate about whether GAO has audit access to other transactions  As the size, costs, and complexity of programs being funded using other transactions increases, the committee wants to ensure that the GAO has audit access in relation to the higher levels of spending and added risks  Reporting Requirements The Senate report also addressed reporting requirements and congressional intent to review the use of OTs  The report stated the following: The committee is assessing the utility of other transaction prototype authority  The statement of managers accompanying the Strom Thurmond National Defense Authorization Act of 1999 directed the Secretary of Defense to report on the use of this authority to the congressional defense committees, no later than March 1, 1999  In addition, both the Department of Defense Inspector General and the General Accounting Office are reviewing the use of other transaction prototype authority and will report to Congress in the coming year  The committee is interested in the extent that new commercial firms are entering the DOD marketplace through the use of other transaction authority, as well as the degree of cost sharing between the government and non-federal government parties  The committee is also interested in any lessons learned from the broad exemptions to federal law provided by other transaction authority  For example, other transactions are exempt from the Competition in Contracting Act, Truth in Negotiations Act, Contract Disputes Act, Antikickback Act of 1986, Procurement Integrity Act, Service Contract Act, Buy American Act, and chapter 137 of title 10, United States Code  Questions have been raised about whether the government's interest is adequately protected in the absence of the applicability of these statutes  Conversely, advocates of the view that the government should take advantage of the flexibility of other transactions have championed proposals to extend other transaction authority to production  The committee directs the Secretary of Defense to provide a new report that updates information in the March 1999 report on the use of other transaction prototype authority to the congressional defense committees by February 1, 2000  National Defense Authorization Act for FY2001 ( P L  106-398 ) Limitations on the Use of OTs Section 803 limited the use of OTs for prototype projects to only those circumstances when at least one nontraditional defense contractor significantly participates in the project, one-third of the total cost of the project is paid out of funds provided by parties to the transaction other than the federal government, or the senior procurement executive determines in writing that exceptional circumstances justify use of an OT  Nontraditional defense contractor was defined as an entity that for a period of one year has not entered into or performed "any contract that is subject to full coverage under the cost accounting standards" or "any other contract in excess of $500,000 to carry out prototype projects or to perform basic, applied, or advanced research projects for a Federal agency, that is subject to the Federal Acquisition Regulation '' Section 803 also extended the authority to use OTs for prototypes from September 30, 2001, to September 30, 2004  According to the Senate report, the intent of using OTs for prototypes is to attract companies that typically do not do business with the Department of Defense and encourage cost sharing and experimentation in potentially more efficient ways of doing business with traditional defense contractors  Other transaction authority is an important acquisition tool that can facilitate the incorporation of commercial technology into military weapon systems  In an environment where, in many areas, commercial technology is now more advanced than defense technology, it is imperative that the Department continue to have the flexibility to use innovative contractual instruments that provide access to this technology  There are, however, improvements that can be made in managing and overseeing these contractual arrangements  Section 804 clarified the extent of GAO's access to records in instances where the party in question has only done business with the government in the preceding year through an OT or cooperative agreement  National Defense Authorization Act for FY2002 ( P L  107-107 ) Expanded Authority—Follow-on Production Section 822 of the FY2002 NDAA granted DOD the authority to award a follow-on production contract for prototype projects when at least one-third of the total cost of the prototype project is to be paid out of funds provided by non-federal government sources  Under this authority, such a follow-on contract could be awarded without competition if the prototype project was successfully completed, the number of units in the production contract does not exceed the number of units specified in the underlying prototype agreement, and the price for each unit does not exceed the price specified in the underlying transaction  Department of Defense and Emergency Supplemental Appropriations for Recovery from and Response to Terrorist Attacks on the United States Act, 2002 ( P L  107-117 ) Establishment of Army Venture Capital Initiative (AVCI) Section 8150 designated $25 million of the FY2002 funds made available for Army Research, Development, Test, and Evaluation (RDT&E) to be made available to the Secretary of the Army for the purpose of funding a venture capital investment corporation established pursuant to 10 U S C  2371  A 2014 RAND report stated that OT authorities were used only to form the AVCI, and were not used to acquire products or services: "While OT authorities were used to form [AVCI] itself, any volume of the Army's purchase of products and services from [AVCI] companies is conducted under the FAR " National Defense Authorization Act for FY2004 ( P L  108-136 ) Expanded Authority Section 847 of the FY2004 NDAA extended the authority to use an OT for developing prototypes to improve weapons or weapon systems currently in use by the Armed Forces  Previously, such authority was restricted to prototypes "directly relevant to weapons or weapon systems proposed to be acquired or developed" by DOD  Section 847 also established a pilot program for transitioning prototypes to follow-on contracts for production for nontraditional defense contractors  Under the pilot program, such a follow-on contract could be treated as a commercial item or an item developed with both federal and private sector funds (for purposes of negotiating intellectual property rights)  The pilot program was restricted to contracts with nontraditional defense contractors, where the value of the contract does not exceed $50 million (approximately $70 million in FY2018 dollars), and that are firm-fixed price or fixed price with economic adjustment  The pilot program was set to sunset September 30, 2008  Section 1441 authorized any agency that engages in basic, applied, or advanced research and development projects that facilitated defense against or recovery from terrorism or nuclear, biological, chemical, or radiological attack to exercise the same general authority given to DOD as found in 10 U S C  2371 (including for prototype projects)  Reporting Requirements Section 1031 sunset the annual reporting requirement for OT after the report covering FY2006 was submitted  National Defense Authorization Act for FY2006 ( P L  109-163 ) Restricted Authority and Notification Requirements Section 212 of the FY2006 NDAA directed the Army to procure the Future Combat System using contract procedures set forth in part 15 of the Federal Acquisition Regulation, in lieu of an OT  Section 823 extended ethics requirements to OT prototype authority and required the congressional defense committees be notified in writing at least 30 days before such authority is exercised  Certification Requirements Section 823 also amended Section 845 of the FY1994 NDAA, requiring a written determination by a senior procurement executive for other transaction prototype projects estimated between $20 million and $100 million, and for a written determination by the Under Secretary of Defense for Acquisition, Technology, and Logistics for prototype projects that exceed $100 million  According to the Senate report: Section 845 was intended to be used for limited prototype projects, particularly those in which the Department seeks to engage nontraditional defense contractors that may be averse to the requirements imposed by a standard Department procurement contract  For this reason, the statement of managers accompanying the Strom Thurmond National Defense Authorization Act for Fiscal Year 1999 (Public Law 105–261) states: The conferees continue to believe that the section 845 authority should only be used in the exceptional cases where it can be clearly demonstrated that a normal contract or grant will not allow sufficient access to affordable technologies  The conferees are especially concerned that such authority not be used to circumvent the appropriate management controls in the standard acquisition and budgeting process  …  The committee does not believe that the $20 9 billion agreement entered between the Army and the Lead Systems Integrator for the FCS program is consistent with the language and intent of section 845 authority  Section 845 authority is intended to be used for limited prototype projects, particularly those in which the Department of Defense seeks to engage nontraditional defense contractors that may be averse to the requirements imposed by a standard Department contract  Department of Defense Appropriations Act, 2007 ( H R  5631 ) Reporting Requirement The FY2007 defense appropriations bill ( P L  109-289 ) did not include language addressing OTs  The conference report ( H Rept  109-676 ) included language expressing the conferees' "[concern] with the continued use of OTA contracts by the Missile Defense Agency," as such contracts "lack the customary safeguards found under FAR-based contracts for organizational conflict of interest, truth in negotiations and submission of cost and pricing data " The conferees "strongly encourage[d]" the Missile Defense Agency to convert "large development and procurement contracts using OTA to FAR-based contracts," and directed the Missile Defense Agency to submit a report to the congressional defense committees on the use of OTs, to include the number, value, and justification for the use of such agreements  National Defense Authorization Act for FY2008 ( P L  110-181 ) Section 823 extended the authority for prototype projects for five more years, from September 30, 2008, to September 30, 2013  National Defense Authorization Act for FY2009 ( P L  110-417 ) Section 822 required DOD to issue guidance on rights in technical data under non-FAR agreements, including OTs  Section 822 also required that appropriate provisions relating to rights in technical data be included in non-FAR agreements, consistent with policy guidance  This requirements is in statute at 10 U S C  2320 note  Section 824 expanded the scope of the pilot program for transition to follow-on contracts for certain prototype projects to include research projects carried out under 10 U S C  2371  Authority to use the pilot program, set to expire September 30, 2008, was extended to September 30, 2010  Section 874 required OT data be included in the Federal Procurement Data System  National Defense Authorization Act for FY2011 ( P L  111-383 ) Section 866 changed the definition of nontraditional defense contractor, conforming the definition to that found in 10 U S C  2302(9)  National Defense Authorization Act for FY2013 ( P L  112-239 ) Section 863 extended the authority for using OTs for prototype projects from September 30, 2013, to September 30, 2018  Carl Levin and Howard P  "Buck" McKeon National Defense Authorization Act for FY2015 ( P L  113-291 ) Expanded Authority Section 812 expanded the authority to use OT for prototypes, to include those "directly related to enhancing the mission effectiveness of military personnel and the supporting platforms, systems, components, or materials proposed to be acquired or developed by the Department of Defense, or to improvement of platforms, systems, components, or materials in use by the Armed Forces " Prior to the FY2015 NDAA, OTs could only be used for prototypes relating to weapons or weapon systems proposed to be developed, or for the improvement of weapons or weapon systems currently in use  Reporting Requirements Section 1071 repealed the reporting requirement language found in 10 U S C  2371, relating to OTs for research projects  National Defense Authorization Act for FY2016 ( P L  114-92 ) Until the FY2016 NDAA, the prototyping and follow-on production authority established in Section 845 of the FY1994 NDAA (as amended) was found in 10 U S C  2371 note  Section 815 of the FY2016 NDAA simultaneously repealed Section 845 of the FY1994 NDAA and put the repealed language into the newly created 10 U S C  2371b  The FY2016 NDAA also modified 2371b by making the authority permanent  Expanded Authority and Small Business The authorities in Section 2371b were expanded to allow their use when "all significant participants in the transaction other than the Federal government are small businesses or nontraditional contractors" and when the agency determines that using an OT would expand the defense supply base in a manner that could not be accomplished through a contract  Section 815 eased the restriction on follow-on production contracts or transactions  Section 815 amended the definition of a nontraditional defense contractor found in 10 U S C  2302 to be an entity that is not currently performing, and for one year prior to an OT has not performed on any contract or subcontract that is subject to full coverage under the cost accounting standards pursuant to Section 1502 of Title 41, U S C  Section 815 also required DOD to update its guidance to reflect changes in the statute  The conference report stated that Congress believed OTs are an attractive option for firms and organizations that do not usually participate in government contracting due to typical overhead burdens and the "one size fits all" rules governing defense acquisition  The report also stated that OTs could support DOD's effort to access new sources of technological innovation, specifically with Silicon Valley startup firms and small commercial firms  National Defense Authorization Act for FY2018 ( P L  115-91 ) Expanded Authority Section 216 of the FY2018 NDAA authorized nonprofit research institutions to enter into OTs with DOD for prototype projects  Section 862 amended 10 U S C  2358, granting the Secretary of Defense and the military departments the authority to pursue basic research, applied research, advanced research, and development projects under the OT authorities granted in Sections 2371 and 2371b of Title 10  Workforce Section 802 required DOD to establish a cadre of intellectual property experts to advise, assist, and provide resources to program offices who are developing intellectual property strategies for contracts and agreements  Section 863 required training and education for personnel involved in OTs and other innovative contracting methods  Certification Requirements and Small Business Section 864 adjusted the language of the statute to state that the dollar threshold relates to the specific transaction for a prototype project and not for the value of the entire project  Section 864 defined a transaction for follow-on production to include "all individual prototype sub-projects awarded under the transaction to a consortium of United States industry and academic institutions " Section 864 also increased the dollar thresholds for required approvals and defined the term small business to include small businesses under Section 9 of the Small Business Act to ensure that companies participating in the Small Business Innovation Research and Small Business Technology Transfer programs were considered small businesses for the purposes of the cost-sharing requirements  Miscellaneous Section 867 required the Secretary of Defense to establish a preference for OTs in the "execution of science and technology and prototyping programs " Section 1711 required DOD to carry out a pilot program to "assess the feasibility and advisability of increasing the manufacturing capability of the defense industrial base " Pursuant to the pilot, Section 1711 authorized DOD to use OTs to support production capabilities in small and medium-sized manufacturers  John S  McCain National Defense Authorization Act for FY2019 ( P L  115-232 ) Section 211 of the FY2019 NDAA clarified that follow-on production of a prototype or subproject within a consortium may occur if the individual prototype or subproject is complete; all projects associated with the consortium do not need to be completed before follow-on production of a specific prototype  Expanded Authority The FY2019 NDAA authorized the use of OTs to develop enhanced personal protective equipment (Section 226) and to carry out research under the Explosive Ordnance Disposal Defense Program (Section 311)  Reporting Requirements Section 244 required the Defense Innovation Unit to submit a report to Congress, to include the number of traditional and nontraditional defense contractors with DOD contracts or other transactions resulting directly from the unit's initiatives  Section 873 required DOD to submit an annual report through 2021, summarizing DOD's use of OTs, including organizations involved; number of transactions; amounts of payments; and purpose, description, and status of projects  Department of Defense Appropriations Act, 2019 ( P L  115-245 ) Reporting Requirements While the enacted FY2019 defense appropriations bill did not include legislative language addressing OTs, the conference report included language expressing the conferees' "[concern] with the lack of transparency surrounding the employment of OTA, particularly for follow-on production " The conferees directed DOD to provide quarterly reports to the House and Senate appropriations committees listing each active OT, and to include the following information on each agreement: funding military service or DOD component; major command (if applicable); contracting activity; appropriation title; budget line item; minimum and maximum award value; vendor; obligations and expenditures to date; product service code; period of performance; and indication if the OT agreement included an option for follow-on production (with a description of the scope of anticipated follow-on production)  The conferees also directed GAO to review DOD's use of OTs to determine whether the "employment of this authority conforms to applicable statutes and guidelines, to include the identification of any potential conflicts " GAO was also required to report on the extent to which OTs have been used since FY2016  Notification Requirements The House report to accompany H R  6157 acknowledged OTs as an "important tool to provide flexibility and agility for cutting-edge research and development projects and prototypes " However, the report stated its concern "with the lack of transparency on the use of OTA authority for follow-on production procurements," and directed that no funds could be obligated or expended for a follow-on production contract or a transaction carried out under 10 U S C  2371b, until 30 days after the Secretary of Defense provides the congressional defense committees with a notification of the proposed contract or transaction, to include a justification of why an OT is being used for production  Appendix B  Non-DOD Federal Agencies with Agency-Wide OT or Related Authorities A number of agencies have varying other transaction or similar authorities, as reflected in Table B-1   The table below is not a comprehensive or definitive listing of every federal government entity with OT or related authorities  In some instances, offices, agencies, commissions, and other federal government entities have OT or related authorities that are only associated with certain programs or projects, such as the National Institutes of Health (which has OT authority for such specific activities such as the National Heart, Blood Vessel, Lung, and Blood Diseases and Blood Resources Program [42 U S C  §285b-3] and the Cures Acceleration Network [42 U S C  §287a])  Appendix C  Reliability of Data on Other Transactions All data have imperfections and limitations  FPDS-NG data can be used to identify broad trends and produce rough estimates, or to gather information about specific contracts  Some observers say that despite their shortcomings, FPDS-NG data are substantially more comprehensive than what is available in most other countries in the world  Understanding the limitations of government procurement data—including knowing when, how, and to what extent to rely on data—can help policymakers incorporate FPDS-NG data more effectively into their decisionmaking process  FPDS-NG OT Data Quality and Accuracy Issues Decisionmakers should be cautious when using data from FPDS-NG to develop policy or otherwise draw conclusions, especially with respect to OTs  In some cases, the data themselves may not be reliable  In other instances, a query for particular data may return differing results, depending on the parameters and timing of the analysis  In particular, all DOD data entered into FPDS-NG are subject to a 90-day delay, and updates to "data, including new actions, modifications, and corrections are made on a regular basis," which could result in changes to "data     for current and/or prior fiscal years " Inconsistencies in FPDS-NG Data Within FPDS-NG, two primary collections of obligation data exist: one associated with standard government procurement contracts or modifications to such contracts, and the other associated with prototype OT agreements or modifications to such agreements  FPDS-NG's collection of prototype OT data allows for the input of additional data elements—such as nongovernment dollars associated with cost-share prototype OT agreements—not included in FPDS-NG's collection of standard government procurement contract data  More consequentially, FPDS-NG's prototype OT data include two similar data elements that allow users to identify the fiscal year a prototype OT agreement was signed or modified  One, labeled in the database as "Fiscal Year," appears to allow users entering data into the system to manually assign a fiscal year to a transaction  FPDS-NG users entering data into the system appear to have interpreted this data element in various, conflicting ways  For example, a Department of the Air Force OT agreement was signed in February 2016 for the development of rocket propulsion system prototypes under the Evolved Expendable Launch Vehicle (EELV) program  FPDS-NG records an obligation of $115 million in FY2020 for this agreement  Fiscal law bars DOD from obligating money now for future fiscal years that have not yet occurred  The second, labeled "Contract Fiscal Year," appears to be based on the date the prototype OT agreement was signed or modified  See Table C-1 for a comparison of the "Fiscal Year" and "Contract Fiscal Year" elements for selected new prototype OT agreements signed between FY2013 and FY2017  If a user selects the Fiscal Year data element when attempting to review high-level data on recent trends in the use of prototype OT agreements within DOD—such as the total amount obligated for prototype OT agreements on an annual basis—that user will obtain a substantially different result than if he or she selects the Contract Fiscal Year data element for a similar analysis  See Table C-2 for a comparison of action obligations and nongovernment contributions using the Fiscal Year and Contract Fiscal Year data elements for new prototype OT agreements signed between FY2013 and FY2017  DOD OT Data Analysis Methodological Issues in Congressional Reports A March 2017 report to Congress entitled "An Assessment of Cost-Sharing in Other Transaction Agreements for Prototype Projects," completed by the Office of the Under Secretary of Defense for Acquisition, Technology, and Logistics indicated that In FY2016, DOD obligated (Note: Two outliers in 2016 excluded) $1 billion in section 2371b awards and received $68 million in cost-share contributions after excluding two significant trend outliers  DOD cited FPDS-NG as the source for its analysis, and defined the "significant trend outliers" excluded as "two $40 million OTAs with total cost-share of $270 million," likely referring to two DARPA prototype OT agreements conducted on a cost-share basis initiated in FY2016  However, a CRS analysis of the same FPDS-NG data identified numerous inconsistencies in DOD's methodological approach  Recreation of DOD Methodology Specifically, DOD appears to have conducted its analysis using the "Fiscal Year" data element referenced in this report's discussion of FPDS-NG OT data quality and accuracy issues, which would attribute some prototype OT activities to the wrong fiscal year for the purposes of comparative trend analysis  DOD also compared two disparate transaction types: the reported "$1 billion in Section 2371b awards" includes all action obligations associated with ongoing prototype OT activities in FY2016, including transactions associated with prototype OT indefinite delivery contracts, while the "$68 million in cost-share contributions" includes only cost-share contributions associated with new prototype OT agreements  If DOD used the "Contract Fiscal Year" data element, excluded the identified "trend outliers," and focused on all action obligations and cost-share contributions associated with ongoing prototype OT activities, it would have found instead that the department obligated $1 4 billion for prototype OT agreements in FY2016, with an additional $313 5 million in cost-share contributions from the private sector  On the other hand, if DOD used the "Contract Fiscal Year" data element, excluded the identified "trend outliers," and focused on only action obligations and cost-share contributions associated with new prototype OT agreements, it would have found instead that the department obligated $400 million for prototype OT agreements in FY2016, with an additional $272 1 million in cost-share contributions from the private sector  Appendix D  Other Transaction Authority Statutes 10 U S C  §2371  Research projects: transactions other than contracts and grants (a) ADDITIONAL FORMS OF TRANSACTIONS AUTHORIZED — The Secretary of Defense and the Secretary of each military department may enter into transactions (other than contracts, cooperative agreements, and grants) under the authority of this subsection in carrying out basic, applied, and advanced research projects  The authority under this subsection is in addition to the authority provided in Section 2358 of this title to use contracts, cooperative agreements, and grants in carrying out such projects  (b) EXERCISE OF AUTHORITY BY SECRETARY OF DEFENSE — In any exercise of the authority in subsection (a), the Secretary of Defense shall act through the Defense Advanced Research Projects Agency or any other element of the Department of Defense that the Secretary may designate  (c) ADVANCE PAYMENTS — The authority provided under subsection (a) may be exercised without regard to Section 3324 of Title 31  (d) RECOVERY OF FUNDS — (1) A cooperative agreement for performance of basic, applied, or advanced research authorized by Section 2358 of this title and a transaction authorized by subsection (a) may include a clause that requires a person or other entity to make payments to the Department of Defense or any other department or agency of the Federal Government as a condition for receiving support under the agreement or other transaction  (2) The amount of any payment received by the Federal Government pursuant to a requirement imposed under paragraph (1) may be credited, to the extent authorized by the Secretary of Defense, to the appropriate account established under subsection (f)  Amounts so credited shall be merged with other funds in the account and shall be available for the same purposes and the same period for which other funds in such account are available  (e) CONDITIONS — (1) The Secretary of Defense shall ensure that- (A) to the maximum extent practicable, no cooperative agreement containing a clause under subsection (d) and no transaction entered into under subsection (a) provides for research that duplicates research being conducted under existing programs carried out by the Department of Defense; and (B) to the extent that the Secretary determines practicable, the funds provided by the Government under a cooperative agreement containing a clause under subsection (d) or a transaction authorized by subsection (a) do not exceed the total amount provided by other parties to the cooperative agreement or other transaction  (2) A cooperative agreement containing a clause under subsection (d) or a transaction authorized by subsection (a) may be used for a research project when the use of a standard contract, grant, or cooperative agreement for such project is not feasible or appropriate  (f) SUPPORT ACCOUNTS — There is hereby established on the books of the Treasury separate accounts for each of the military departments and the Defense Advanced Research Projects Agency for support of research projects and development projects provided for in cooperative agreements containing a clause under subsection (d) and research projects provided for in transactions entered into under subsection (a)  Funds in those accounts shall be available for the payment of such support  (g) EDUCATION AND TRAINING —The Secretary of Defense shall— (1) ensure that management, technical, and contracting personnel of the Department of Defense involved in the award or administration of transactions under this section or other innovative forms of contracting are afforded opportunities for adequate education and training; and (2) establish minimum levels and requirements for continuous and experiential learning for such personnel, including levels and requirements for acquisition certification programs  (h) REGULATIONS — The Secretary of Defense shall prescribe regulations to carry out this section  (i) Protection of Certain Information From Disclosure -(1) Disclosure of information described in paragraph (2) is not required, and may not be compelled, under Section 552 of Title 5 for five years after the date on which the information is received by the Department of Defense  (2)(A) Paragraph (1) applies to information described in subparagraph (B) that is in the records of the Department of Defense if the information was submitted to the Department in a competitive or noncompetitive process having the potential for resulting in an award, to the party submitting the information, of a cooperative agreement for performance of basic, applied, or advanced research authorized by Section 2358 of this title or another transaction authorized by subsection (a)  (B) The information referred to in subparagraph (A) is the following: (i) A proposal, proposal abstract, and supporting documents  (ii) A business plan submitted on a confidential basis  (iii) Technical information submitted on a confidential basis  10 U S C  §2371b  Authority of the Department of Defense to carry out certain prototype projects (a) AUTHORITY — (1) Subject to paragraph (2), the Director of the Defense Advanced Research Projects Agency, the Secretary of a military department, or any other official designated by the Secretary of Defense may, under the authority of Section 2371 of this title, carry out prototype projects that are directly relevant to enhancing the mission effectiveness of military personnel and the supporting platforms, systems, components, or materials proposed to be acquired or developed by the Department of Defense, or to improvement of platforms, systems, components, or materials in use by the armed forces  (2) The authority of this section- (A) may be exercised for a transaction (for a prototype project) that is expected to cost the Department of Defense in excess of $100,000,000 but not in excess of $500,000,000 (including all options) only upon a written determination by the senior procurement executive for the agency as designated for the purpose of Section 1702(c) of Title 41, or, for the Defense Advanced Research Projects Agency or the Missile Defense Agency, the director of the agency that- (i) the requirements of subsection (d) will be met; an d (ii) the use of the authority of this section is essential to promoting the success of the prototype project; and (B) may be exercised for a transaction (for a prototype project) that is expected to cost the Department of Defense in excess of $500,000,000 (including all options) only if- (i) the Under Secretary of Defense for Acquisition, Technology, and Logistics determines in writing that- (I) the requirements of subsection (d) will be met; an d (II) the use of the authority of this section is essential to meet critical national security objectives; and (ii) the congressional defense committees are notified in writing at least 30 days before such authority is exercised  (3) The authority of a senior procurement executive or director of the Defense Advanced Research Projects Agency or Missile Defense Agency under paragraph (2)(A), and the authority of the Under Secretary of Defense for Acquisition, Technology, and Logistics under paragraph (2)(B), may not be delegated  (b) EXERCISE OF AUTHORITY — (1) Subsections (e)(1)(B) and (e)(2) of such Section 2371 shall not apply to projects carried out under subsection (a)  (2) To the maximum extent practicable, competitive procedures shall be used when entering into agreements to carry out projects under subsection (a)  (c) COMPTROLLER GENERAL ACCESS TO INFORMATION — (1) Each agreement entered into by an official referred to in subsection (a) to carry out a project under that subsection that provides for payments in a total amount in excess of $5,000,000 shall include a clause that provides for the Comptroller General, in the discretion of the Comptroller General, to examine the records of any party to the agreement or any entity that participates in the performance of the agreement  (2) The requirement in paragraph (1) shall not apply with respect to a party or entity, or a subordinate element of a party or entity, that has not entered into any other agreement that provides for audit access by a Government entity in the year prior to the date of the agreement  (3) (A) The right provided to the Comptroller General in a clause of an agreement under paragraph (1) is limited as provided in subparagraph (B) in the case of a party to the agreement, an entity that participates in the performance of the agreement, or a subordinate element of that party or entity if the only agreements or other transactions that the party, entity, or subordinate element entered into with Government entities in the year prior to the date of that agreement are cooperative agreements or transactions that were entered into under this section or Section 2371 of this title  (B) The only records of a party, other entity, or subordinate element referred to in subparagraph (A) that the Comptroller General may examine in the exercise of the right referred to in that subparagraph are records of the same type as the records that the Government has had the right to examine under the audit access clauses of the previous agreements or transactions referred to in such subparagraph that were entered into by that particular party, entity, or subordinate element  (4) The head of the contracting activity that is carrying out the agreement may waive the applicability of the requirement in paragraph (1) to the agreement if the head of the contracting activity determines that it would not be in the public interest to apply the requirement to the agreement  The waiver shall be effective with respect to the agreement only if the head of the contracting activity transmits a notification of the waiver to Congress and the Comptroller General before entering into the agreement  The notification shall include the rationale for the determination  (5) The Comptroller General may not examine records pursuant to a clause included in an agreement under paragraph (1) more than three years after the final payment is made by the United States under the agreement  (d) APPROPRIATE USE OF AUTHORITY — (1) The Secretary of Defense shall ensure that no official of an agency enters into a transaction (other than a contract, grant, or cooperative agreement) for a prototype project under the authority of this section unless one of the following conditions is met: (A) There is at least one nontraditional defense contractor or nonprofit research institution participating to a significant extent in the prototype project  (B) All significant participants in the transaction other than the Federal Government are small businesses (including small businesses participating in a program described under Section 9 of the Small Business Act (15 U S C  638)) or nontraditional defense contractors  (C) At least one third of the total cost of the prototype project is to be paid out of funds provided by sources other than other than the Federal Government  (D) The senior procurement executive for the agency determines in writing that exceptional circumstances justify the use of a transaction that provides for innovative business arrangements or structures that would not be feasible or appropriate under a contract, or would provide an opportunity to expand the defense supply base in a manner that would not be practical or feasible under a contract  (2) (A) Except as provided in subparagraph (B), the amounts counted for the purposes of this subsection as being provided, or to be provided, by a party to a transaction with respect to a prototype project that is entered into under this section other than the Federal Government do not include costs that were incurred before the date on which the transaction becomes effective  (B) Costs that were incurred for a prototype project by a party after the beginning of negotiations resulting in a transaction (other than a contract, grant, or cooperative agreement) with respect to the project before the date on which the transaction becomes effective may be counted for purposes of this subsection as being provided, or to be provided, by the party to the transaction if and to the extent that the official responsible for entering into the transaction determines in writing that- (i) the party incurred the costs in anticipation of entering into the transaction; and (ii) it was appropriate for the party to incur the costs before the transaction became effective in order to ensure the successful implementation of the transaction  (e) Definitions —In this section: (1) The term "nontraditional defense contractor" has the meaning given the term under Section 2302(9) of this title  (2) The term "small business" means a small business concern as defined under Section 3 of the Small Business Act (15 U S C  632)  (f) FOLLOW-ON PRODUCTION CONTRACTS OR TRANSACTIONS — (1) A transaction entered into under this section for a prototype project may provide for the award of a follow-on production contract or transaction to the participants in the transaction  A transaction includes all individual prototype subprojects awarded under the transaction to a consortium of United States industry and academic institutions  (2) A follow-on production contract or transaction provided for in a transaction under paragraph (1) may be awarded to the participants in the transaction without the use of competitive procedures, notwithstanding the requirements of Section 2304 of this title, if - (A) competitive procedures were used for the selection of parties for participation in the transaction; and (B) the participants in the transaction successfully completed the prototype project provided for in the transaction  (3) Contracts and transactions entered into pursuant to this subsection may be awarded using the authority in subsection (a), under the authority of Chapter 137 of this title, or under such procedures, terms, and conditions as the Secretary of Defense may establish by regulation  (g) AUTHORITY TO PROVIDE PROTOTYPES AND FOLLOW-ON PRODUCTION ITEMS AS GOVERNMENT-FURNISHED EQUIPMENT — An agreement entered into pursuant to the authority of subsection (a) or a follow-on contract or transaction entered into pursuant to the authority of subsection (f) may provide for prototypes or follow-on production items to be provided to another contractor as Government-furnished equipment  (h) APPLICABILITY OF PROCUREMENT ETHICS REQUIREMENTS — An agreement entered into under the authority of this section shall be treated as a Federal agency procurement for the purposes of Chapter 21 of Title 41  10 U S C  §2373  Procurement for experimental purposes (a) AUTHORITY — The Secretary of Defense and the Secretaries of the military departments may each buy ordnance, signal, chemical activity, transportation, energy, medical, space-flight, and aeronautical supplies, including parts and accessories, and designs thereof, that the Secretary of Defense or the Secretary concerned considers necessary for experimental or test purposes in the development of the best supplies that are needed for the national defense  (b) PROCEDURES — Purchases under this section may be made inside or outside the United States and by contract or otherwise  Chapter 137 of this title applies only when such purchases are made in quantities greater than necessary for experimentation, technical evaluation, assessment of operational utility, or safety or to provide a residual operational capability 
Report 2:  Because the military services have different descriptors for similar data fields, DOD cannot ensure that the services are categorizing similar types of sexual harassment in the same way  In addition, we found that the Army is more detailed in characterizing different types of sexual harassment  Specifically, as shown in table 4, the Army has an additional data field that provides more detailed descriptions of three types of sexual harassment; the other military services’ respective databases do not have this level of detail  Because the Army has this additional data field, it can capture information on multiple types of harassment that may occur in a single incident  The other military services, in contrast, do not have this capability in their respective databases  To illustrate, if one case of sexual harassment involved both verbal and nonverbal forms of sexual harassment, the Army could choose a more specific characterization to describe the incident, while the other military services would characterize the incident in more general terms  ODMEO officials are considering adapting an existing system to track instances of sexual harassment department-wide  That system, called Force Risk Reduction (FR2), is currently used to track safety issues like military injuries, civilian workers’ compensation claims, and casualty notifications at DOD  ODMEO recently completed a pilot of the system with the Marine Corps, the Navy, and the Army to test whether it would be useable for adaptation for sexual harassment data, and is planning a second pilot to include the Air Force and the National Guard Bureau  According to ODMEO officials, their adaptation of FR2 is intended to collect aggregate-level sexual harassment data from the military services, and the military services will continue to operate and rely on their individual databases to maintain more detailed case-level information on incidents  For example, ODMEO’s adaptation of FR2 would not have details such as descriptions of specific incidents, or information on dates associated with investigations or appeals  These types of data will continue to be maintained in the service systems  ODMEO officials told us that their new data system, if implemented, is not designed to collect case-level details in order to avoid personally identifiable information  Federal internal control standards state that management should define the identified information requirements at the relevant level and requisite specificity for appropriate personnel  Management should also process the obtained data into quality information  Consistency of information meets the identified information requirements when relevant data from reliable sources are used  While DOD is exploring implementing a system to track instances of sexual harassment department-wide, as currently planned this system will not collect case-level details and individual military service systems will continue to be relied upon for this type of information  Inconsistencies in data elements and definitions among the military services generally mean that one military service may be maintaining sexual harassment data that are more or less detailed than sexual harassment data maintained by other military services, or that is simply different from the data maintained by other military services  Additionally, inconsistent data elements and definitions may create difficulties in reporting sexual harassment data from the military services to OSD for a department-wide report, since ODMEO has to adapt data from the services to fit reporting requirements  Without standard data elements and definitions for sexual harassment data, DOD will continue to lack assurance about the consistency of these data across the military services  DOD has several overarching efforts to address unwanted sexual behaviors across the continuum of harm  Specifically, the department established an office to oversee the integration and coordination of unwanted sexual behaviors in 2015 and is in the process of developing an overarching prevention strategy  However, because the strategy is under development, it is unclear whether it will contain key elements for long-term and results-oriented strategic planning  DOD also has ongoing collaborative efforts to address unwanted sexual behaviors along the continuum of harm  Specifically, we identified 15 collaborative efforts, including regular meetings, Integrated Product Teams, and working groups that involve multiple entities that address unwanted sexual behaviors  DOD has taken steps to integrate activities related to the continuum of harm and is in the process of developing an overarching prevention strategy  Based on its research, DOD has sought to understand and define the continuum of harm, including the shared characteristics that contribute to increased unwanted sexual behaviors along the continuum and implications for prevention and response efforts  Also, in November 2015, DOD established a new entity—the Office of the Executive Director for Force Resiliency, within the Office of the Assistant Secretary of Defense for Readiness—to oversee policies and initiatives related to the continuum of harm  Specifically, the Executive Director for Force Resiliency was expected to provide senior leader policy guidance and oversight on high visibility departments that include SAPRO and ODMEO  In November 2016, the Office of the Executive Director for Force Resiliency was absorbed under the Assistant Secretary of Defense for Readiness  According to the Assistant Secretary of Defense for Readiness, the functions of the Office of the Executive Director for Force Resiliency remain and coordination of the efforts of several offices that address the continuum of harm continues  Officials from the Assistant Secretary of Defense for Readiness and SAPRO told us that they are drafting an overarching prevention strategy to encompass behaviors along the continuum of harm  However, because the strategy is still under development, its contents and timelines are unclear  We have previously identified six elements of strategic management planning that are key for establishing a long-term, results- oriented strategic planning framework: (1) a mission statement, (2) long- term goals, (3) strategies to achieve goals, (4) external factors that could affect goals, (5) the use of metrics to gauge progress, and (6) evaluations of the plan to monitor goals and objectives  By incorporating the elements of a comprehensive and results-oriented strategy into its overarching prevention strategy, the department will be better positioned to effectively coordinate and integrate prevention activities and reduce unwanted sexual behaviors  A mission statement, along with long-term goals and strategies to achieve those goals, should help to focus efforts in integrating prevention activities, and metrics and evaluations will allow the department to gauge progress and make changes as necessary, while also accounting for external factors that may impact progress towards goals  Our review identified 15 collaborative efforts that DOD has used to address behaviors along the continuum of harm, including sexual harassment, sexual assault, and domestic violence involving sexual assault  Three of these efforts are cross-cutting between all three of the key OSD stakeholders—ODMEO, FAP, and SAPRO—and five involve cross-cutting efforts by at least two of the key stakeholders  Figure 1 lists DOD’s 15 collaborative efforts  Regarding the three cross-cutting efforts involving all three of the key stakeholders, The Sexual Assault Prevention and Response Integrated Product Team provides a forum for OSD, the military departments, and the National Guard Bureau to address sexual assault prevention efforts  The team meets bimonthly and serves as the implementation and oversight arm for DOD’s Sexual Assault Prevention and Response (SAPR) program  The team also coordinates new policies; reviews existing SAPR policies and programs to ensure they are consistent with applicable instructions; and monitors the progress of program elements including DOD’s SAPR strategic plan tasks, DOD’s sexual assault prevention strategy tasks, and implementation of NDAA- related sexual assault issues  SAPRO leads this effort  The Prevention Collaboration Forum and working group develops coordinated prevention approaches that address factors impacting personnel readiness such as sexual harassment, sexual assault, and domestic violence involving sexual assault  According to its proposed charter, the focus of the forum is on enhancing the health of military unit and family climates as well as strengthening and promoting the resiliency and readiness of the total force through a coordinated effort around integrated policies, collaborative direction of research, alignment of resources, analysis of gaps, and synchronization of activities  The Assistant Secretary of Defense for Readiness leads this effort with SAPRO providing administrative and facilitation support  The Victim Assistance Leadership Council advises the Under Secretary of Defense for Personnel and Readiness on policies and practices related to victim assistance across DOD  According to its charter, the council provides a forum for senior leaders to exchange information and collaborate on issues affecting victims of all forms of crime and harassment within DOD, including but not limited to victims of sexual harassment, sexual assault, and domestic violence involving sexual abuse  Leadership rotates between SAPRO, FAP, and ODMEO and other offices  Regarding the cross-cutting efforts involving two of the three key stakeholders, the Sexual Harassment Prevention and Response Working Group is led by ODMEO and includes SAPRO  The group was established to evaluate how to best position sexual harassment prevention and response policy and oversight and to leverage technology to automate annual reporting requirements  The four other cross-cutting efforts are (1) the hazing and bullying working group, (2) retaliation working groups created under the SAPR Integrated Process Team, (3) domestic abuse rapid improvement events, and (4) ODMEO and SHARP meetings  The remaining collaborative efforts we identified are specific to FAP, SAPRO, and ODMEO  For example, the Sexual Assault Prevention Roundtable is a forum for representatives from OSD, the military departments, and the National Guard Bureau to share information on sexual assault prevention efforts and requirements  According to its charter, the roundtable’s activities include, among other things, sharing promising practices and prevention updates; discussing challenges in prevention program implementation, including servicemember training, and identifying approaches to address them; identifying metrics to assess the impact and effectiveness of prevention efforts, and opportunities to collaborate on research projects; and tracking the implementation of prevention tasks identified in the DOD SAPR strategy  SAPRO leads this effort  The Defense Diversity Working Group is an ODMEO-specific group that collaborates with various OSD and military service offices on military and civilian diversity and inclusion issues and implements mandated diversity plans and programs  Studies by DOD and others have shown that unwanted sexual behaviors do not exist in isolation but are part of a range of interconnected, inappropriate behaviors that are connected to the occurrence of a sexual assault  While DOD has policies and procedures to prevent and respond to these types of unwanted behaviors, some of the policies do not include key elements like anonymous reporting of sexual harassment and principles in the CDC framework for sexual violence prevention  Fully including these elements in the department’s policies can help ensure that the military services are interpreting and applying prevention and response efforts consistently and may also decrease the risk of perpetration or victimization related to instances on unwanted sexual behaviors  Further, DOD has developed reliable data systems for collecting and reporting data on some of the unwanted sexual behaviors including sexual assault and instances of domestic violence with sexual assault  However, inconsistencies in sexual harassment data elements and definitions may be creating difficulties in developing department-wide reports on unwanted sexual behaviors  Improving and standardizing data collection efforts will not only improve the quality of data that DOD and the military services collect but may also increase the ability for DOD to further develop its understanding of the connection between unwanted sexual behaviors  Finally, DOD officials have stated that they are in the early stages of developing an overarching strategy to address the interconnected nature of the range of unwanted sexual behaviors  To ensure that the department is appropriately concentrating its efforts to prevent and respond to the full range of unwanted behaviors, it is important that DOD include elements of a long-term, results-oriented strategy into its overarching prevention strategy  In doing so, DOD will be in a better position to effectively coordinate and integrate prevention activities and ultimately reduce instances of unwanted sexual behaviors  We are making the following four recommendations to DOD: The Under Secretary of Defense for Personnel and Readiness should fully include in the new policy for sexual harassment the principles in the Centers for Disease Control’s framework for sexual violence prevention, including risk and protective factors, risk domains, and tertiary strategies  (Recommendation 1) The Under Secretary of Defense for Personnel and Readiness should include in the new policy for sexual harassment mechanisms for anonymous reporting of incidents consistent with section 579 of the National Defense Authorization Act for FY 2013  (Recommendation 2) The Under Secretary of Defense for Personnel and Readiness should (1) direct the Office of Diversity Management and Equal Opportunity to develop standard data elements and definitions for maintaining and reporting information on sexual harassment incidents at the military service level, and (2) direct the military services to incorporate these data elements and definitions into their military service-specific databases  (Recommendation 3) The Under Secretary of Defense for Personnel and Readiness should direct the Assistant Secretary of Defense for Readiness to incorporate in its continuum of harm prevention strategy all the elements that are key for establishing a long-term, results-oriented strategic planning framework  The elements are (1) a mission statement, (2) long-term goals, (3) strategies to achieve goals, (4) external factors that could affect goals, (5) use of metrics to gauge progress, and (6) evaluations of the plan to monitor goals and objectives  (Recommendation 4) We provided a draft of this report to DOD and CDC for review and comment  In its written comments, DOD concurred with three recommendations and partially concurred with one, noting planned actions to address this recommendation  DOD’s comments are reprinted in their entirety in appendix II  DOD and CDC also provided technical comments, which we incorporated into the report as appropriate  DOD concurred with our three recommendations that DOD fully include in the new policy for sexual harassment the principles in the CDC's framework for sexual violence prevention, that DOD also include in the new sexual harassment policy mechanisms for anonymous reporting, and that DOD incorporate in its continuum of harm strategy all the elements that are key for establishing a long-term, results-oriented strategic planning framework  With regard to our recommendation that DOD develop standard data elements and definitions for maintaining and reporting information on sexual harassment incidents and direct the military services to incorporate these into their databases, DOD partially concurred and stated that while a 2013 policy memorandum provides standard data elements and definitions, the services collect other data elements based on their unique needs  DOD stated that ODMEO will conduct a review to determine compliance with DOD reporting requirements and identify emerging policy modifications or changes/additions to standard definitions  We are sending copies of this report to the appropriate congressional committees, the Secretary of Defense, the Under Secretary of Defense for Personnel and Readiness, and the Director, Centers for Disease Control and Prevention  In addition, the report is available at no charge on the GAO website http://www gao gov  If you or your staff have any questions about this report, please contact me at (202) 512-3604 or farrellb@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 III  To determine the extent to which the Department of Defense (DOD) has policies on sexual harassment that include Centers for Disease Control and Prevention (CDC) principles and relevant legislative elements, we obtained and reviewed Office of the Secretary of Defense (OSD) and service-level sexual harassment policies  We compared the policies with a framework developed by the CDC for preventing sexual violence, which CDC defines as including non-contact unwanted sexual behaviors, sexual harassment, and physical sexual assault  CDC’s model is based on the concept of addressing the health of a given population based on common risk and protective factors and effective, tested strategies  We reviewed CDC’s framework for preventing sexual violence as well as our report on DOD’s sexual assault prevention strategy to identify six principles that an organization can include in a sexual violence prevention strategy or policy: Risk factors: Factors that may put people at risk for sexual violence perpetration or victimization, such as an organizational climate that either explicitly or implicitly condones sexual harassment; Protective factors: Factors that may protect high-risk people from harm, such as an organizational climate that promotes respect among personnel at all levels; Primary strategies for prevention: Strategies that occur before sexual violence takes place to prevent initial perpetration, such as sexual harassment prevention training; Secondary strategies for prevention: Immediate responses after sexual violence has occurred to address the early identification of victims and the short-term consequences of violence, such as reporting mechanisms and immediate interventions; Tertiary strategies for prevention: Long-term responses after sexual violence has occurred to address the lasting consequences of violence and sex-offender treatment interventions, such as the long- term treatment of the victim and perpetrator; and Risk domains: Levels at which risk and protective factors should be categorized, including: individual, relationship, community, and society  DOD has previously adapted risk domains to the military population, using the levels of: individual, relationship, leaders at all levels, military community, and society  DOD previously used CDC’s framework for preventing sexual violence in the department’s 2014-2016 Sexual Assault Prevention Strategy  In addition, we reviewed the OSD and service-level sexual harassment policies to determine the extent to which they included three elements identified in the National Defense Authorization Act (NDAA) for FY 2013, which directed DOD to develop a comprehensive policy that includes sexual harassment prevention training for the armed forces; mechanisms for reporting incidents, including mechanisms for anonymous reporting; and mechanisms for responding to and resolving instances of sexual harassment, including for the prosecution of perpetrators  Two GAO analysts independently reviewed the policies and determined whether or not each element was included  Any discrepancies were resolved through discussion and consultation with a third analyst  We interviewed officials in the Under Secretary of Defense for Personnel and Readiness’ Office of Diversity Management and Equal Opportunity, who oversee department- wide policy on sexual harassment, to obtain an understanding of their roles and processes regarding sexual harassment as well as the status of policy development in that area  We also interviewed officials from military equal opportunity offices in the Air Force, the Navy, and the Marine Corps, as well as officials from the Army’s Sexual Harassment/Assault Response and Prevention Office to obtain an understanding of the service sexual harassment offices and roles, as well as the status of updates to their respective policies  To determine the extent to which DOD has processes for maintaining and reporting consistent data on incidents of unwanted sexual behaviors, we reviewed DOD reports to Congress that provide incident data regarding unwanted sexual behaviors, including DOD’s most recent annual report on sexual assault in the military  We identified the databases that generate the reported data and evaluated the processes for assuring the quality and consistency of data in those databases—including the Defense Sexual Assault Incident Database, which maintains sexual assault data; the Central Registry database, which maintains data on domestic violence involving sexual assault; and various military service- level databases that maintain sexual harassment data  To evaluate DOD’s reported data we reviewed pertinent statutory provisions, DOD guidance, and the Standards for Internal Control in the Federal Government that address agencies’ use of quality data and our prior reports evaluating sexual assault data  In evaluating the reported data, we obtained and reviewed statutory provisions with reporting requirements, as well as DOD guidance on data collection for sexual harassment, sexual assault, and domestic violence involving sexual abuse  With regard to DOD efforts to collect and maintain sexual assault data, we met with OSD, Navy, Air Force, and Marine Corps officials in their respective Sexual Assault Prevention and Response offices as well as officials in the Army’s Sexual Harassment/Assault Response and Prevention office  We also reviewed our prior report on DOD’s Defense Sexual Assault Incident Database and our prior report that evaluated sexual assault data across agencies  To determine whether DOD has processes for collecting and maintaining consistent data for domestic violence with sexual assault, we obtained and compared data elements and processes from DOD’s Central Registry database, which contains data for domestic violence throughout the department  We also obtained and reviewed policies that outline processes for collecting and reporting domestic violence involving sexual abuse data, and interviewed officials from Family Advocacy Program offices in OSD and the Army, Navy, Marine Corps, and Air Force to determine data reliability and comprehensiveness  To determine the extent to which reports of sexual assault, including reports of sexual assault among servicemembers and reports of domestic abuse involving sexual assault, meet statutory requirements for reporting, we reviewed DOD reports to Congress that provide sexual assault incident data, including DOD’s most recent annual report on sexual assault in the military and compared those reports with requirements in the NDAA for FY 2011, which directs DOD to report the total number of substantiated and unsubstantiated sexual assault incidents, among other things  With regard to sexual harassment data, we interviewed officials in the Under Secretary of Defense for Personnel and Readiness’ Office of Diversity Management and Equal Opportunity, as well as officials from the Military Equal Opportunity offices in the Air Force, Marine Corps, and Navy, and officials from the Army Sexual Harassment/Assault Response and Prevention office  We collected and compared data fields and data definitions from the Army, Navy, Marine Corps, and Air Force offices that address sexual harassment  We compared the data elements to determine whether the data elements and definitions across the services are consistent  To identify the extent to which DOD has overarching efforts, including a prevention strategy, to address unwanted sexual behaviors across the continuum of harm, we met with officials in the Office of the Assistant Secretary of Defense for Readiness and DOD’s Sexual Assault Prevention and Response office  We reviewed our prior work and provisions from the Government Performance and Results Act to identify key elements that should be included in strategic plans as well as standards for coordinating within agencies  Key elements include (1) mission statement, (2) long-term goals, (3) strategies to achieve goals, (4) external factors that could affect goals, (5) use of metrics to gauge progress, and (6) evaluations of the plan to monitor goals and objectives  We identified and reviewed coordinating mechanisms used by OSD and the service offices that guide and oversee efforts to address unwanted sexual behaviors  We reviewed DOD, RAND Corporation, and CDC reports that addressed the continuum of harm and the relationship between the various forms of unwanted sexual behaviors  We interviewed officials from OSD and service-level Sexual Assault Prevention and Response, Family Advocacy, and Military Equal Opportunity offices and the Army’s Sexual Harassment/Assault Response and Prevention to identify the various efforts in which they participate  We also collected and reviewed charters and meeting notes for integrated product teams and working groups to identify their intended purposes, their activities, their membership, and whether they involved multiple offices addressing unwanted sexual behaviors  In identifying DOD’s collaborative efforts, we also reviewed our prior work on collaboration among federal agencies but we did not assess the effectiveness of department’s collaborative efforts  We conducted this performance audit from August 2016 to December 2017 in accordance with generally accepted government auditing standards  Those standards require that we plan and perform the audit to obtain sufficient, appropriate evidence to provide a reasonable basis for our findings and conclusions based on our audit objectives  We believe that the evidence obtained provides a reasonable basis for our findings and conclusions based on our audit objectives  In addition to the staff named above, key contributors to this report include Thomas Gosling (Assistant Director); Isabel Band; Matthew Bond; Vincent Buquicchio; Caroline DeCelles; Mae Jones; Kirsten Lauber; and Brian Pegram  Sexual Assault: Better Resource Management Needed to Improve Prevention and Response in the Army National Guard and Army Reserve  GAO-17-217  Washington, D C : February 27, 2017  Military Personnel: DOD Has Processes for Operating and Managing Its Sexual Assault Incident Database  GAO-17-99  Washington, D C : January 10, 2017  Sexual Violence Data: Actions Needed to Improve Clarity and Address Differences Across Federal Data Collection Efforts  GAO-16-546  Washington, D C : July 19, 2016  DOD and Coast Guard: Actions Needed to Increase Oversight and Management Information on Hazing Incidents Involving Servicemembers  GAO-16-226  Washington, D C : February 9, 2016  Sexual Assault: Actions Needed to Improve DOD’s Prevention Strategy and to Help Ensure It Is Effectively Implemented  GAO-16-61  Washington, D C : November 4, 2015  Military Personnel: Actions Needed to Address Sexual Assaults of Male Servicemembers  GAO-15-284  Washington, D C : March 19, 2015  Military Personnel: DOD Needs to Take Further Actions to Prevent Sexual Assault during Initial Military Training  GAO-14-806  Washington, D C : September 9, 2014  Military Personnel: DOD Has Taken Steps to Meet the Health Needs of Deployed Servicewomen, but Actions Are Needed to Enhance Care for Sexual Assault Victims  GAO-13-182  Washington, D C : January 29, 2013  Preventing Sexual Harassment: DOD Needs Greater Leadership Commitment and an Oversight Framework  GAO-11-809  Washington, D C : September 21, 2011  Military Justice: Oversight and Better Collaboration Needed for Sexual Assault Investigations and Adjudications  GAO-11-579  Washington, D C : June 22, 2011  Military Personnel: DOD’s and the Coast Guard’s Sexual Assault Prevention and Response Programs Need to Be Further Strengthened  GAO-10-405T  Washington, D C : February 24, 2010  Military Personnel: Additional Actions Are Needed to Strengthen DOD’s and the Coast Guard’s Sexual Assault Prevention and Response Programs  GAO-10-215  Washington, D C : February 3, 2010  Military Personnel: DOD’s and the Coast Guard’s Sexual Assault Prevention and Response Programs Face Implementation and Oversight Challenges  GAO-08-924  Washington, D C : August 29, 2008  Military Personnel: The DOD and Coast Guard Academies Have Taken Steps to Address Incidents of Sexual Harassment and Assault, but Greater Federal Oversight Is Needed  GAO-08-296  Washington, D C : January 17, 2008 

ground_truth: The Department of Defense (DOD) obligates more than $300 billion annually to buy goods and services, and to support research and development. Most of these acquisitions are governed by procurement statutes and regulations found in Title 10 (and parts of other select titles) of the United States Code, the Federal Acquisition Regulation (FAR), and the Defense Federal Acquisition Regulation Supplement. Under certain circumstances, DOD can enter into an other transaction (OT) agreement instead of a traditional contract. OT agreements are generally exempt from federal procurement laws and regulations. These exemptions grant government officials the flexibility to include, amend, or exclude contract clauses and requirements that are mandatory in traditional procurements (e.g., termination clauses, cost accounting standards, payments, audit requirements, intellectual property, and contract disputes). OT authorities also grant more flexibility to structure agreements in numerous ways, including joint ventures; partnerships; consortia; or multiple agencies joining together to fund an agreement encompassing multiple providers. Other transaction agreements are legally binding contracts; they are referred to as agreements to distinguish them from the traditional procurement contracts governed by the FAR and procurements laws. Other transaction authorities are set forth in two sections of law: 10 U.S.C. 2371—granting authority to use OTs for basic, applied, and advanced research projects. 10 U.S.C. 2371b—granting authority to use OTs for prototype projects and follow-on production. Under this authority, a prototype project can only be conducted if at least one nontraditional defense contractor significantly participates in the project; all significant participants are small businesses or nontraditional defense contractors; at least one-third of the total cost of the prototype project is provided by nongovernment participants; or the senior procurement acquisition official provides a written justification for using an OT. Follow-on production can only be conducted when the underlying prototype OT was competitively awarded, and the prototype project was successfully completed. OTs have the potential to provide significant benefits to DOD, including attracting nontraditional contractors with promising technological capabilities to work with DOD, establishing a mechanism to pool resources with other entities to facilitate development of, and obtain, state-of-the-art dual-use technologies, and offering a unique mechanism for DOD to invest in, and influence the direction of, technology development. A number of analysts warn that along with the potential benefits come significant risks, including potentially diminished oversight and exemption from laws and regulations designed to protect government and taxpayer interests. In FY2017, DOD obligated $2.1 billion on prototype OT agreements, representing less than 1% of contract obligations for the year. However, the use of OTs is expected to grow at a rapid pace, due in part to recent statutory changes expanding other transaction authorities. A number of analysts and officials have raised concerns that if DOD uses OTs in ways not intended by Congress—or is perceived to abuse the authority—Congress could clamp down on the authority. Generally, DOD lacks authoritative data that can be used to measure and evaluate the use of other transaction authorities.