Man Convicted of Multiple Obscenity Crimes Involving Children

A Texas man was convicted by a federal jury today for operating a website dedicated to publishing writings that detailed the sexual abuse of children.

More from: January 21, 2021

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    At the state and federal levels, GAO found weaknesses in the oversight of Medicaid managed long-term services and supports (MLTSS), which assist individuals with basic needs like bathing or eating. Through various monitoring approaches, six selected states identified significant problems in their MLTSS programs with managed care organization (MCO) performance of care management, which includes assessing beneficiary needs, authorizing services, and monitoring service provision to ensure quality and access to care. State efforts may not be identifying all care management problems due to limitations in the information they use to monitor MCOs, allowing some performance problems to continue over multiple years. Performance Problems in Managed Care Organization (MCO) Care Management, Identified by Selected States GAO found that the Centers for Medicare & Medicaid Services' (CMS) oversight of state implementation of its 2016 requirements, and of access and quality in MLTSS more broadly, was limited. This hinders the agency's ability to hold states and MCOs accountable for quality and access problems beneficiaries may face. Oversight did not detect quality and access problems. GAO identified cases where CMS learned about problems not through its regular oversight, but instead from beneficiary complaints, media reports, or GAO. CMS officials said that states had not reported these problems to the agency. Lack of national oversight strategy and assessment of problems in MLTSS. Weaknesses in oversight reflect a broader area of concern—namely, that CMS lacks a strategy for oversight. CMS also has not assessed the nature and extent of access and quality problems across states. Without a strategy and more robust information, CMS risks being unable to identify and help address problems facing beneficiaries. As of July 2020, CMS had convened a new workgroup focused on MLTSS oversight, though the goals and time frames for its work were unclear. An increasing number of states are using managed care to deliver long-term services and supports in their Medicaid programs, thus delegating decisions around the amounts and types of care beneficiaries receive to MCOs. Federal guidance requires that MLTSS programs include monitoring procedures to ensure the appropriateness of those decisions for this complex population, which includes adults and children who may have physical, cognitive, and mental disabilities. GAO was asked to review care management in MLTSS programs. Among other things, this report examines state monitoring of care management, and CMS oversight of state implementation of 2016 requirements related to MLTSS quality and access. GAO examined documentation of monitoring procedures and problems identified in six states selected for variation in program age and location. GAO reviewed federal regulations and oversight documents, interviewed state and federal Medicaid officials, and assessed CMS's policies and procedures against federal internal control standards. GAO is making two recommendations to CMS to (1) develop a national strategy for overseeing MLTSS, and (2) assess the nature and prevalence of MLTSS quality and access problems across states. CMS did not concur with the recommendations. GAO maintains the recommendations are warranted, as discussed in this report. For more information, contact at (202) 512-7114 or yocomc@gao.gov.
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    In U.S GAO News
    U.S. Customs and Border Protection (CBP) has made progress testing and deploying facial recognition technology (FRT) at ports of entry to create entry-exit records for foreign nationals as part of its Biometric Entry-Exit Program. As of May 2020, CBP, in partnership with airlines, had deployed FRT to 27 airports to biometrically confirm travelers' identities as they depart the United States (air exit) and was in the early stages of assessing FRT at sea and land ports of entry. Facial Recognition Technology in Use at an Airport CBP has taken steps to incorporate some privacy principles in its program, such as publishing the legislative authorities used to implement its program, but has not consistently provided complete information in privacy notices or ensured notices were posted and visible to travelers. Ensuring that privacy notices contain complete information and are consistently available would help give travelers the opportunity to decline to participate, if appropriate. Further, CBP requires its commercial partners, such as airlines, to follow CBP's privacy requirements and can audit partners to assess compliance. However, as of May 2020, CBP had audited only one of its more than 20 airline partners and did not have a plan to ensure all partners are audited. Until CBP develops and implements an audit plan, it cannot ensure that traveler information is appropriately safeguarded. CBP has assessed the accuracy and performance of air exit FRT capabilities through operational testing. Testing found that air exit exceeded its accuracy goals—for example, identifying over 90 percent of travelers correctly—but did not meet a performance goal to capture 97 percent of traveler photos because airlines did not consistently photograph all travelers. A plan to improve the photo capture rate would help CBP better fulfill the program's mission of creating biometrically confirmed traveler departure records. Further, while CBP monitors air exit's performance, officials are not alerted when performance falls short of minimum requirements. The Transportation Security Administration (TSA) has conducted pilot tests to assess the feasibility of using FRT but, given the limited nature of these tests, it is too early to fully assess TSA's compliance with privacy protection principles. Within the Department of Homeland Security (DHS), CBP is charged with the dual mission of facilitating legitimate travel and securing U.S. borders, and TSA is responsible for protecting the nation's transportation system. For both CBP and TSA, part of their inspection and screening responsibilities includes reviewing travel identification documents and verifying traveler identities. Beginning in 1996, a series of federal laws were enacted to develop and implement an entry-exit data system, which is to integrate biographic and, since 2004, biometric records for foreign nationals. This report addresses (1) the status of CBP's deployment of FRT, (2) the extent to which CBP has incorporated privacy protection principles, (3) the extent to which CBP has assessed the accuracy and performance of its FRT, and (4) the status of TSA's testing and deployment of FRT and how TSA has incorporated privacy protection principles. GAO conducted site visits to observe CBP's and TSA's use of FRT, which were selected to include all three travel environments—air, land, and sea; reviewed program documents; and interviewed DHS officials. GAO is making five recommendations to CBP to (1) ensure privacy notices are complete, (2) ensure notices are available at locations using FRT, (3) develop and implement a plan to audit its program partners for privacy compliance, (4) develop and implement a plan to capture required traveler photos at air exit, and (5) ensure it is alerted when air exit performance falls below established thresholds. DHS concurred with the recommendations. For more information, contact Rebecca Gambler at (202) 512-8777 or gamblerr@gao.gov.
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    In U.S GAO News
    The Department of Veterans Affairs' (VA) Veterans Health Administration (VHA) provides veterans with prosthetic services to assist with their mobility, vision, and hearing needs. The proportion of prosthetics VHA provided to female veterans has been small compared to the share provided to male veterans. However, in fiscal years 2015 to 2019, this proportion grew from 6.8 percent to 7.9 percent and accounted for about $889.1 million of the $15.4 billion total cost of prosthetics. Artificial limbs comprised a relatively small number of the total prosthetics VHA provided to veterans in fiscal years 2015 to 2019; however, veterans who use artificial limbs have complex needs and are significant users of health care services. VHA provided prosthetic services to a small but growing female veteran amputee population (almost 3 percent of veteran amputees in fiscal year 2019), who were generally younger than male veteran amputees. VHA has established an individualized patient care approach in its Amputation System of Care that seeks to address the prosthetic needs of each veteran, including accounting for gender-specific factors. VHA officials said that using a standardized, multidisciplinary approach across VA medical facilities also helps them incorporate the concerns and preferences of female veterans. For example, veterans are provided care by a team that includes a physician, therapist, prosthetist (clinician who helps evaluate prosthetic needs and then designs, fabricates, fits, and adjusts artificial limbs), and other providers as needed. Female veteran amputees GAO spoke with at one VA medical facility said they were satisfied with their VHA care. They also noted a lack of commercially available prosthetic options that VHA providers can use to meet women's needs. Examples of Female Veterans' Artificial Limb Prosthetics Women are generally studied less than their male counterparts in prosthetic and amputee rehabilitation research. VHA designated prosthetics for female veterans a national research priority in 2017, and has funded eight related studies as of May 2020: four pertain to lower limb amputation, three pertain to upper limb amputation, and one pertains to wheelchairs. VHA officials noted the importance of this research priority and the ongoing challenge of recruiting study participants due to the small female veteran population. VHA researchers said they employ various tactics to address this challenge, such as using multi-site studies and recruiting participants from the non-veteran population. Women are the fastest growing veteran subpopulation, with the number of female veterans using VHA health care services increasing 29 percent from 2014 to 2019. Female veterans accounted for an estimated 10 percent of the total veteran population in fiscal year 2019. They are eligible to receive a full range of VHA health care services, including obtaining prosthetics. House Report 115-188 included a provision for GAO to review VHA's prosthetic services for female veterans. This report examines 1) trends in prosthetics provided by VHA to female veterans; 2) characteristics of the female veteran population with limb loss and how VHA provides prosthetic services to these veterans through its Amputation System of Care; and 3) VHA's research efforts and the challenges that exist in studying prosthetics for female veterans with limb loss. GAO analyzed VHA documents, as well as data from fiscal years 2015 to 2019 on prosthetics and veterans with amputations. GAO interviewed agency officials from VHA central office and officials and female veteran amputees at two VA medical facilities selected for expertise in amputation care and prosthetics research activities. In addition, GAO interviewed VHA researchers conducting studies on prosthetics for female veterans. GAO provided a draft of this report to VA. VA provided general and technical comments, which were incorporated as appropriate. For more information, contact Jessica Farb at (202) 512-7114 or farbj@gao.gov.
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  • Aviation Security Technology: TSA Lacks Outcome-oriented Performance Measures and Data to Help Reach Objectives to Diversify its Marketplace
    In U.S GAO News
    The Transportation Security Administration's (TSA) January 2020 TSA Efforts to Diversify Security Technology (strategy) addresses the requirements of the 2018 TSA Modernization Act (the Act) and outlines 12 strategic initiatives to increase small business participation in its marketplace. Moreover, the strategy's initiatives are generally consistent with common practices cited by comparable federal agencies, including vendor outreach and linking small businesses together with bigger contractors. TSA has not developed outcome-oriented performance measures, such as baseline goals or target timeframes to assess the effectiveness of the initiatives in its strategy. While TSA collects some output metrics on its initiatives, leading practices note that outcome-based measures can help track progress in meeting goals. TSA also has not collected data on small businesses' progress across its acquisition phases, such as capturing the overall time, costs, and ability to meet security requirements. Federal standards call for the use of quality information to achieve objectives. Small businesses GAO met with told us they continue to face challenges entering TSA's marketplace—such as navigating it's testing and evaluation process and identifying security requirements—despite TSA's efforts to address them through ongoing and planned initiatives. Developing outcome-oriented performance measures and collecting data, will better position TSA to assess the effectiveness of its initiatives to diversify its security technology marketplace. Examples of Transportation Security Administration (TSA) Security-Related Technologies With the ongoing threat of terrorism, TSA is looking to innovative technologies to improve security. In response to the Act, TSA developed a strategy to promote innovation and increase small business participation in its security technology marketplace. The Act includes a provision for GAO to review this strategy. This report examines, among other things, (1) the extent to which TSA's strategy includes the statutory requirements of the Act and compares to common practices of federal agencies to increase small business participation and (2) the extent to which TSA has performance measures and data to assess the effectiveness of its initiatives. GAO compared TSA's strategy to statutory requirements and practices of comparable federal agencies; interviewed TSA and federal officials from five selected agencies responsible for small and disadvantaged business programs, and a nongeneralizable set of small businesses selected to provide various perspectives on participating in TSA's acquisition processes; and analyzed data from the Federal Procurement Data System–Next Generation. GAO is making two recommendations, including that TSA (1) develop outcome-oriented performance measures and (2) collect data, where appropriate, on small businesses' progress across TSA's acquisition phases. DHS concurred with our recommendations. For more information, contact Triana McNeil at (202) 512-8777 or McNeilT@gao.gov.
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  • Science & Tech Spotlight: Consumer Electronics Recycling
    In U.S GAO News
    Why This Matters Consumer electronics contain critical materials whose supplies are limited, including gold, platinum, and rare earth metals. Domestic recycling of consumer electronics could extend the supply and reduce the current U.S. reliance on imports. New technologies are becoming available, but electronics recycling is complex and faces challenges, such as narrow profit margins. The Technology What is it? Recycling of consumer electronics—including smartphones, televisions, and computers—generally involves separating high-value metals from plastics and other low-value materials. Precious metals and rare earth metals are the economic driving force for consumer electronic recycling technology. These metals have high market values and limited supplies, and they can be reused across many industries, including the defense and energy sectors. Consumer electronic devices can also contain personally identifiable information (PII), including medical and financial data, which could be improperly disclosed if they are not destroyed prior to recycling. According to a study of selected consumer electronics, about 2.8 million tons were disposed of in the U.S. in 2017, of which about 36 percent was recycled. Figure 1. Selected valuable, hazardous, and digital materials contained within consumer electronics that can be recovered, disposed, or destroyed There is no federal standard requiring consumer electronics recycling. Some states have enacted electronics recycling laws requiring electronics producers to pay fees or contract with businesses to ensure electronic waste is collected for recycling. The U.S. recycles electronics domestically and also exports electronics for recycling abroad. How does it work? The high concentration of valuable material in certain consumer electronics is key to the economic viability of recycling these products. Cell phones, as one example, have more precious metal by weight than raw ore does. According to the EPA, 35,274 pounds of copper, 772 pounds of silver, and 75 pounds of gold can be recovered from a million recycled cell phones. Based on commodity market prices on August 12, 2020, these weights of metals are worth approximately $100,000, $290,000, and $2.1 million for copper, silver, and gold, respectively. In contrast, cathode ray tube (CRT) displays in older televisions and computer monitors have little recycling value, but they contain leaded glass and may be considered hazardous waste. In addition, recovery of certain valuable materials from consumer electronics is limited due to the high costs of technology and processing. Electronics recycling companies disassemble devices by shredding, which also destroys PII, or by hand. These companies then separate valuable materials for reuse (including gold, silver, platinum, and rare earth metals) from toxic materials for disposal (including brominated materials and lead). Traditional methods include burning to remove non-metal parts and separation using strong acids. New separation technologies are being used or piloted to recover precious and rare earth metals. For example, robotic disassembly uses machine learning and computer vision to more rapidly pick and sort items. Another new technology uses ultrasound to speed up the chemical removal of gold from cell phone SIM cards. Figure 2. Emerging separation technologies for recycled electronics Other technologies are emerging, like biometallurgy, which uses microorganisms to separate high-value metals from other materials, such as plastics, glass, and glue. For example, naturally occurring bacteria can oxidize gold in acidic solutions, making it soluble and thus easier to separate from other materials. Other advanced techniques, such as magnetic or electrochemical separation, are showing promise in the laboratory with existing technology. For example, in one study, researchers used ultrasound to dissolve nickel and gold within a SIM card. They then used a magnetic field to separate the dissolved nickel, which is magnetic, from the gold, which is not. Similarly, other techniques use electric fields to separate dissolved metals based on their weight and electric charge. How mature is it? Recycling technology is well established for some traditional single-stream processes, such as aluminum recycling. However, electronic devices are more complex and require disassembly and separation. At least one consumer electronics manufacturer is piloting robotic disassembly for its products. Emerging separation technologies such as ultrasound have come to market in the past decade and are being used. Manual disassembly and shredding are decades old. Biometallurgy is being tested in pilot plants, and new microorganisms are being developed in laboratories to treat electronic waste. Opportunities Increase supply and reduce imports. Recycling could increase the domestic supply of precious and rare earth metals and reduce the current U.S. reliance on overseas sources. Grow the green economy. Developing advanced recycling technologies could promote domestic business and employment. Reduce hazardous practices. A significant amount of recycling currently occurs in the developing world, where methods include open-pit burning. New technology could reduce the use of such methods, which are hazardous to the environment and human health. Lessen environmental impacts. Developing advanced recycling technologies could reduce the environmental impacts of raw ore mining and landfill disposal of hazardous materials such as lead and brominated materials. Challenges Market challenges. Markets for recovered materials may be limited, and the value of recovered materials may not be enough to cover the costs of equipment for collection, sorting, disassembly, and separation. Secure destruction of personal information. Many electronic devices contain PII. Shredding them may effectively destroy PII but may also make high-value material harder to recover. Counterfeit electronic parts. Exported used electronics may serve as a source of counterfeit electronic parts, which, as GAO previously reported, could disrupt parts of the Department of Defense supply chain and threaten the reliability of weapons systems. (See GAO-16-236, linked below.) Rapid technological development. As consumer electronics made with new materials get smaller, new technologies for separation may be needed to recycle valuable materials. Policy Context and Questions With the volume of electronic waste expected to grow, questions include: How can programs to support technological innovation, economic development, and advanced manufacturing be leveraged to promote a more robust domestic electronics recycling industry? What efforts can the federal government, states, and others make to incentivize recycling rather than disposal? What are the potential benefits and challenges of such policies? What strategies can the public and private sectors implement to address the risk that exports of used electronics will contribute to unsafe recycling practices, disclosure of PII, and counterfeit electronics? How can reductions in exports bolster job growth? For more information, contact Karen Howard at (202) 512-6888 or HowardK@gao.gov.
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  • Farmworkers: Additional Information Needed to Better Protect Workers from Pesticide Exposure
    In U.S GAO News
    The U.S. Environmental Protection Agency (EPA) and states ensure compliance with the Agricultural Worker Protection Standard (WPS) primarily through inspections of farms. The states collect some information—such as the number of inspections they conduct—and provide that information to EPA as part of cooperative agreements between EPA and the states. The extent of use of the designated representative provision of the WPS, and its effect on the availability of pesticide information, are not known because EPA does not collect information on the use of the provision and does not coordinate with states to do so. EPA's guidance to states for conducting inspections encourages, but does not require, state inspectors to ask farmers and farmworkers about whether a designated representative has been used. EPA officials said that the agency has not asked states to collect information on the provision because the agency has focused on compliance with other aspects of the WPS. By coordinating with states, through the cooperative agreements or some another mechanism, to collect information on the use of the designated representative provision, EPA would be better positioned to determine whether the provision is serving its intended purpose. Some stakeholders have raised concerns about potential misuse of pesticide information, such as other farmers using the information obtained by a designated representative to gain a competitive advantage. However, EPA officials, state officials, and stakeholders told us they did not know of any instance in which a person serving as a designated representative misused the pesticide information obtained from farmers. Neither EPA's guidance nor its website explain the agency's expectations for appropriate use or describe how such information could be misused. EPA officials said that the agency has not explained what constitutes misuse. By explaining, in the agency's guidance, on its website, or through another mechanism, EPA's expectations about appropriate use of pesticide information obtained by designated representatives, including the misuse of such information, the agency could ensure designated representatives understand the importance of the information in reducing the consequences of pesticide exposure. Farmworkers Picking Strawberries at a Farm The use of pesticides contributes to U.S. agricultural productivity by protecting crops against pests or weeds, but this use may pose risks to human health. To reduce the consequences of pesticide exposure to farmworkers' health, EPA revised the WPS in 2015 to include a provision that allows a farmworker to identify a person who can request, for their benefit, certain pesticide information from their employer—this is called the designated representative provision. This report examines (1) what is known about the extent of use and effect of the designated representative provision on the availability of pesticide information and (2) what is known about any misuse of information obtained through the provision. GAO reviewed laws, regulations, and guidance, and interviewed officials from EPA and 13 selected states about how they implement and oversee compliance with the standard. GAO also interviewed stakeholders, such as farmer groups and farmworker advocacy groups. GAO is making two recommendations to EPA to (1) coordinate with states to collect information on the use of the designated representative provision and (2) take steps to explain, in guidance, on its website, or through another mechanism, the agency's expectations about appropriate use of pesticide information obtained by a designated representative and describe potential misuse of such information. EPA agreed, in part, to both recommendations. For more information, contact Steve D. Morris at (202) 512-3841 or morriss@gao.gov.
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    In U.S GAO News
    The Department of Defense (DOD) screens for eating disorders for all applicants entering into the military but does not specifically screen servicemembers for eating disorders after entrance. However, after joining the military, servicemembers receive annual health screenings, and medical personnel may be able to diagnose eating disorders during in-person physical exams. Service branch behavioral health specialists told GAO that DOD medical personnel are trained to notice signs of eating disorders, such as changes in vital signs and emaciated appearance. DOD is examining ways to improve its screening of eating disorders in the military and recently expanded the available research funding for eating disorders in its Peer-Reviewed Medical Research Program (PRMRP). DOD provides health care services to approximately 9.5 million eligible beneficiaries, including services to treat those diagnosed with eating disorders, through TRICARE, DOD’s regionally structured health care system. Servicemembers can obtain these services at military treatment facilities—referred to as direct care—or receive care purchased from civilian providers—referred to as purchased care. DOD officials told us that the specialized level of care necessary to treat eating disorders is available to TRICARE beneficiaries through purchased care, rather than direct care. The Defense Health Agency (DHA), which oversees the TRICARE program, uses two contractors to develop regional provider networks. According to the two TRICARE contractors’ data for purchased care, as of spring 2020, there were 166 eating disorder facilities located in 32 states throughout the country and the District of Columbia. The facilities vary by geographic location, population served, and level of treatment provided: Geography: About half of the 166 facilities (79) are located in the following five states: California (24), Florida (18), Illinois (15), Texas (13), and Virginia (nine).  Population: Of the 166 eating disorder facilities, over three-quarters provide treatment to both adult (132 facilities) and child and adolescent (132 facilities) populations. Level of Treatment: Most facilities provide inpatient hospitalization programs, which are for serious cases requiring medical stabilization (81 facilities); partial hospitalization, which are day programs providing treatment 5 to 7 days a week (133 facilities); or intensive outpatient programs, which are treatment programs providing therapy 2 to 6 days a week (107 facilities). About one-fifth of the facilities (35) provide residential treatment services, which are living accommodations providing intensive therapy and 24-hour supervision. TRICARE contractors have met with some challenges entering into contracts with eating disorder treatment facilities in certain areas of the country, according to DHA officials and both contractors. However, both contractors told GAO they consider it their responsibility to ensure beneficiaries receive the care they need regardless of the location of the facility. No access-to-care complaints related to eating disorder treatment were reported by TRICARE beneficiaries, according to the most recent DHA data for years 2018 through 2019. Eating disorders are complex conditions affecting millions of Americans and involve dangerous eating behaviors, such as the restriction of food intake. They can have a severe impact on heart, stomach, and brain functionality, and they significantly raise the risk of mortality. Many with eating disorders also experience co-occurring conditions such as depression. Research has yielded a range of estimates of the number of servicemembers with an eating disorder, due to differences in research methods. For example, a 2018 DOD study concluded that servicemembers likely experienced eating disorders at rates that are comparable to rates in the general population, while other survey-based research suggested the number of servicemembers with eating disorders may be higher than those with a medical diagnoses of such disorders. The potential effects that eating disorders can have on the health and combat readiness of servicemembers and their dependents underscores the importance of screening and treating this population. GAO was asked to provide information on eating disorders among servicemembers and their dependents. To describe how DOD screens for eating disorders among servicemembers, GAO reviewed DOD policies related to health screening and interviewed behavioral health specialists from the military branches. To understand approaches and challenges with implementing screening in a military environment, any planned or ongoing DOD-sponsored research related to this topic, and available eating disorder treatment, GAO interviewed representatives from the Eating Disorder Coalition, Uniformed Services University of Health Sciences, and the University of Kansas. To describe how DOD provides eating disorder treatment to servicemembers and their dependents, GAO interviewed DHA officials and TRICARE contractors and reviewed the TRICARE policy manual to identify the types of eating disorder diagnoses and treatments that are covered through direct and purchased care. GAO received data from the two TRICARE contractors related to the availability of eating disorder treatment services as of spring 2020. For more information, contact Sharon Silas at (202) 512-7114 or Silass@gao.gov.
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  • Drug Safety: FDA’s Future Inspection Plans Need to Address Issues Presented by COVID-19 Backlog
    In U.S GAO News
    Fiscal year 2015 was the first time that the Food and Drug Administration (FDA) conducted more inspections of foreign drug manufacturers than domestic manufacturers, with the majority conducted in China and India. However, in June 2020, GAO reported that from fiscal year 2016 through fiscal year 2018, both foreign and domestic inspections decreased, in part due to staffing vacancies. While foreign inspections increased in 2019, since March 2020, FDA has largely paused foreign and domestic inspections due to the Coronavirus Disease 2019 (COVID-19) pandemic, conducting only those deemed mission critical. In January 2021, GAO reported that FDA conducted three foreign inspections in fiscal year 2020 following the pause—significantly less than in recent years. Number of FDA-Conducted Foreign Drug Manufacturing Establishment Inspections, Fiscal Years 2019–2020, by Month FDA has used alternative inspection tools to maintain some oversight of drug manufacturing quality while inspections are paused. These tools include relying on inspections conducted by foreign regulators, requesting and reviewing records and other information, and sampling and testing drugs. FDA has determined that inspections conducted by certain European regulators are equivalent to and can be substituted for an FDA inspection. Other tools provide useful information but are not equivalent. In addition, FDA was unable to complete more than 1,000 of its planned fiscal year 2020 inspections and will likely face a backlog of inspections in future years. In January 2021, GAO recommended that FDA ensure that inspection plans for future fiscal years respond to the issues presented by the backlog and that FDA fully assess the agency's alternative inspection tools. FDA concurred with both recommendations. Even before the COVID-19 pandemic, FDA faced persistent challenges conducting foreign inspections. GAO found in December 2019 that there continued to be vacancies among the investigators who conduct foreign inspections. GAO further found that FDA's practice of preannouncing foreign inspections up to 12 weeks in advance could give manufacturers the opportunity to fix problems ahead of the inspection and raised questions about their equivalence to domestic inspections. In light of COVID-19, FDA is now preannouncing both foreign and domestic inspections for the safety of its staff and manufacturers. GAO also found that language barriers can create challenges during foreign inspections as FDA generally relies on the establishment for translation services. The outbreak of COVID-19 has called greater attention to the United States' reliance on foreign drug manufacturers. FDA reports that 74 percent of establishments manufacturing active ingredients and 54 percent of establishments manufacturing finished drugs for the U.S. market were located overseas, as of May 2020. FDA is responsible for overseeing the safety and effectiveness of all drugs marketed in the United States, regardless of where they are produced, and it conducts inspections of both foreign and domestic manufacturing establishments. GAO has had long-standing concerns about FDA's ability to oversee the increasingly global pharmaceutical supply chain, an issue highlighted in GAO's High Risk Series since 2009. This statement is largely based on GAO's Drug Manufacturing Inspections enclosure in its January 2021 CARES Act report, as well as GAO's December 2019 and June 2020 testimonies. Specifically, it discusses (1) the number of FDA's foreign inspections, (2) FDA's response to the COVID-19 pandemic pause in inspections, and (3) persistent foreign inspection challenges. For that work, GAO examined FDA data from fiscal years 2012 through 2020, interviewed FDA investigators, and reviewed documents related to drug oversight during the COVID-19 pandemic, among other things. For more information, contact Mary Denigan-Macauley at (202) 512-7114 or deniganmacauleym@gao.gov.
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  • Crumbling Foundations: Extent of Homes with Defective Concrete Is Not Fully Known and Federal Options to Aid Homeowners Are Limited
    In U.S GAO News
    As of December 2019, at least 1,600 homes in Connecticut had confirmed pyrrhotite but the total number of affected homes is likely higher. According to one estimate, 4,000–6,000 more homes in Connecticut could develop crumbling foundations due to pyrrhotite. Affected homeowners may face total remediation costs of $150,000 or more and drops in property values of 25 percent or more. Connecticut established funding to provide homeowners with up to $175,000 towards the cost of foundation replacement, but affected homeowners are typically responsible for about one-third of total repair costs (which can include costs for replacing driveways and porches damaged during foundation replacement). Current funding is expected to assist 1,034 homeowners. Pyrrhotite Damage to a Basement and a Home Being Repaired Due to Pyrrhotite Damage GAO found that highly affected towns lost more than $1.6 million in tax revenue in 2018 due to lost assessment value of the houses affected by pyrrhotite, but town officials told us the losses have not yet significantly affected their budgets. However, officials were concerned that pyrrhotite could have long-term effects on their towns if the number of affected homes increased or homes were not remediated. GAO also found that homes located in highly affected towns and built when pyrrhotite-containing concrete was used sold for significantly less, on average, than similar homes in less-affected towns. Stakeholders told GAO that defaults and foreclosures related to pyrrhotite have been limited to date. Some federal funds have already been used for pyrrhotite testing and GAO identified eight additional federal programs that could be used to help mitigate financial impacts on homeowners. However, most of these programs have eligibility or funding restrictions that limit their potential for this purpose. Stakeholders with whom GAO spoke suggested other federal responses—in particular, declaring pyrrhotite damage a major disaster or establishing a federally backed insurance product. However, the Federal Emergency Management Agency determined that pyrrhotite damage did not qualify as a natural catastrophe, and a federally backed insurance program may not be feasible since it would serve a small population with high expected costs. Certain homes built in northeastern Connecticut and central Massachusetts between 1983 and 2015 have concrete foundations containing the mineral pyrrhotite. Pyrrhotite expands when it is exposed to water and oxygen and, over time, concrete foundations containing pyrrhotite may crack and crumble. The Explanatory Statement accompanying the Consolidated Appropriations Act, 2019 included a provision for GAO to study the financial impact of pyrrhotite. This report describes (1) what is known about the number of homes affected by pyrrhotite in the region; (2) the financial impact of pyrrhotite on homeowners; (3) the financial effects on towns, local housing markets, and the federal government; and (4) federal options to mitigate pyrrhotite's financial impact on affected homeowners. GAO analyzed data from state, local, and private entities about the extent of pyrrhotite in foundations and associated costs, and federal actions taken in response to pyrrhotite. GAO also interviewed federal, state, and local officials; homeowners; and other stakeholders such as banks and real estate agents. For more information, contact John Pendleton at (202) 512-8678 or pendletonj@gao.gov.
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  • Rural Hospital Closures: Affected Residents Had Reduced Access to Health Care Services
    In U.S GAO News
    GAO found that when rural hospitals closed, residents living in the closed hospitals' service areas would have to travel substantially farther to access certain health care services. Specifically, for residents living in these service areas, GAO's analysis shows that the median distance to access some of the more common health care services increased about 20 miles from 2012 to 2018. For example, the median distance to access general inpatient services was 3.4 miles in 2012, compared to 23.9 miles in 2018—an increase of 20.5 miles. For some of the less common services that were offered by a few of the hospitals that closed, this median distance increased much more. For example, among residents in the service areas of the 11 closed hospitals that offered treatment services for alcohol or drug abuse, the median distance was 5.5 miles in 2012, compared to 44.6 miles in 2018—an increase of 39.1 miles to access these services (see figure). Median Distance in Miles from Service Areas with Rural Hospital Closures to the Nearest Open Hospital that Offered Certain Health Care Services, 2012 and 2018 Notes: GAO focused its analysis on the health care services offered in 2012 by the 64 rural hospitals that closed during the years 2013 through 2017 and for which data were available. For example, in 2012, 64 closed hospitals offered general inpatient services, 62 offered emergency department services, 11 offered treatment services for alcohol or drug abuse, and 11 offered services in a coronary care unit. To examine distance, GAO calculated “crow-fly miles” (the distance measured in a straight line) from the geographic center of each closed rural hospital's service area to the geographic center of the ZIP Code with the nearest open rural or urban hospital that offered a given service. GAO also found that the availability of health care providers in counties with rural hospital closures generally was lower and declined more over time, compared to those without closures. Specifically, counties with closures generally had fewer health care professionals per 100,000 residents in 2012 than did counties without closures. The disparities in the availability of health care professionals in these counties grew from 2012 to 2017. For example, over this time period, the availability of physicians declined more among counties with closures—dropping from a median of 71.2 to 59.7 per 100,000 residents—compared to counties without closures—which dropped from 87.5 to 86.3 per 100,000 residents. Rural hospitals face many challenges in providing essential access to health care services to rural communities. From January 2013 through February 2020, 101 rural hospitals closed. GAO was asked to examine the effects of rural hospital closures on residents living in the areas of the hospitals that closed. This report examines, among other objectives, how closures affected the distance for residents to access health care services, as well as changes in the availability of health care providers in counties with and without closures. GAO analyzed data from the Department of Health and Human Services (HHS) and the North Carolina Rural Health Research Program (NC RHRP) for rural hospitals (1) that closed and those that were open during the years 2013 through 2017, and (2) for which complete data generally were available at the time of GAO's review. GAO also interviewed HHS and NC RHRP officials and reviewed relevant literature. GAO defined hospitals as rural according to data from the Federal Office of Rural Health Policy. GAO defined hospital closure as a cessation of inpatient services, the same definition used by NC RHRP. GAO defined service areas with closures as the collection of ZIP Codes that were served by closed rural hospitals and service areas without closures as the collection of ZIP Codes served only by rural hospitals that were open. GAO provided a draft of this report to HHS for comment. The Department provided technical comments, which GAO incorporated as appropriate. For more information, contact James Cosgrove at (202) 512-7114 or cosgrovej@gao.gov.
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  • General Aviation: Stakeholders Expressed Mixed Views of FAA Policies on Private Pilot Expense Sharing
    In U.S GAO News
    The Federal Aviation Administration's (FAA) primary rationale for its policies on private pilots' sharing expenses with passengers is based on passenger expectations of safety. FAA policies allow private pilots to share the cost of certain flight expenses with passengers but prohibit these pilots from engaging in “common carriage,” which is communicating to the public a willingness to fly in exchange for compensation. These policies generally prohibit pilots from using the internet to find passengers. FAA officials said these policies are in place because they are concerned the public might expect a similar level of safety on private expense-sharing flights as commercial flights. However, the safety record of commercial aviation is better than that of private flying (general aviation). For example, according to data from the National Transportation Safety Board (NTSB), commercial carriers had a fatal accident rate around 30 times lower than general aviation in 2018. FAA officials said their goal for FAA's 2020 guidance on expense sharing was to restate and clarify existing policies. Example of an Aircraft Private Pilots Could Use for Expense-Sharing Flights Stakeholders described benefits of expense sharing but expressed mixed views on FAA's policies and guidance. For example, stakeholders cited potential economic benefits to the general aviation sector and a potential expansion of the pool of future professional pilots as benefits of expense sharing. Most (eight of 13) stakeholders said FAA's 2020 guidance on expense-sharing is clear and provides sufficient information. However, some stakeholders said the guidance could provide more definitive examples of allowed expense-sharing flights, and others disagreed with how FAA defined certain concepts such as how pilots can be compensated for flying passengers. Also, stakeholders split on whether FAA should allow pilots to use the internet to find expense-sharing passengers. Seven of 15 stakeholders, including four representatives from companies with expense-sharing applications, said FAA should allow pilots to use the internet to find these passengers by citing, for example, ongoing positive experiences in Europe. However, eight stakeholders, including six of seven professional organizations, said FAA should not. These stakeholders cited safety-related risks of expense sharing including what they characterized as FAA's limited capacity to enforce current regulations and flights using less experienced pilots. Private flying is expensive, and FAA allows private pilots to reduce their costs by carrying passengers and sharing certain flight expenses with them. However, private pilots cannot engage in common carriage. If pilots do engage in common carriage, they are subject to FAA's more stringent regulations covering commercial air carriers. Some private pilots have sought to use internet applications to find expense-sharing passengers. The FAA Reauthorization Act of 2018 directed FAA to issue advisory guidance clarifying how private pilots may share expenses. In February 2020, FAA released this guidance as an advisory circular. The Act also includes a provision for GAO to review FAA's policies on expense sharing. This report describes: (1) FAA's rationale for its policies on how private pilots may find expense-sharing passengers and (2) selected stakeholder perspectives on FAA's policies and the risks and benefits of arranging these expense-sharing flights online. GAO interviewed FAA officials on how FAA developed its policies and guidance related to expense sharing. GAO also reviewed FAA's data on enforcement actions related to expense sharing and safety data from NTSB. In addition, GAO interviewed a non-generalizable sample of 15 private-sector stakeholders, including professional organizations, such as trade groups representing general aviation pilots, companies that developed expense-sharing internet applications, and flying clubs. For more information, contact Heather Krause at (202) 512-2834 or krauseh@gao.gov.
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  • Justice Department Announces National Response Center and Offer to Bring Assistance to Minneapolis Police Department to Support Law Enforcement and Safe Communities Through Fair Policing
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    The Justice Department, in an announcement by Assistant Attorney General for the Civil Rights Division Eric S. Dreiband, Principal Deputy Assistant Attorney General of the Office of Justice Programs (OJP) Katharine T. Sullivan, and U.S. Attorney for the District of Minnesota Erica H. MacDonald, unveiled a new National Response Center Initiative and offered the assistance to the Minneapolis Police Department (MPD) to support law enforcement, and review, enhance and reform policies and practices to prevent the use of excessive force. The BJA Law Enforcement Training and Technical Assistance Response Center will be a national resource for all state, local, and tribal law enforcement agencies.
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