Incyte Corporation to Pay $12.6 Million to Resolve False Claims Act Allegations for Paying Kickbacks

A pharmaceutical company headquartered in Delaware has agreed to pay $12.6 million to resolve allegations that it violated the False Claims Act by paying kickbacks.

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    In Crime News
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    In U.S GAO News
    The number of disability claims for veterans living abroad—in foreign countries or U.S. territories—increased 14 percent from fiscal years 2014 to 2019. During this time period, claims processing time frames improved. In fiscal year 2019, the Veterans Benefits Administration (VBA) of the Department of Veterans Affairs (VA) approved comparable percentages of disability claims for veterans living abroad and domestically—63 percent and 64 percent respectively. However, for a subset of these claims—those where veterans likely received a disability medical exam scheduled by Department of State (State) embassy staff—approval rates were often lower. Veterans' access to disability medical exams abroad improved as VBA has increasingly relied on contracted examiners, rather than embassy-referred examiners, to conduct these exams. According to VBA, this shift expanded the pool of trained examiners abroad and increased the frequency and depth of VBA's quality reviews for contract exams. These quality reviews help VBA and its contractor identify and address common errors, according to VBA and contractor officials. However, several factors continue to limit some veterans' ability to access quality disability medical exams (see figure). Factors That Impair the Access of Veterans Living Abroad to Quality Disability Medical Exams Unknown quality of certain exams: A subset of veterans living abroad receive disability medical exams from an embassy-referred provider. VBA does not systematically assess the quality of these exams. Without doing so, VBA cannot determine if such exams affect the approval rates of veterans who receive them or contribute to longer processing times and are unable to make informed decisions about their use. Travel reimbursement: Under current VA regulations, VA is not authorized to reimburse veterans for travel expenses for certain services incurred in foreign countries as it is for those incurred within the United States, including U.S. territories. Consequently, some veterans living in foreign countries may be unable to afford to travel to exams. Examiner reimbursement: The Veterans Health Administration's (VHA) Foreign Medical Program reimburses examiners referred by embassy staff via paper checks in U.S. currency. These checks may be slow to arrive and not accepted by foreign banks, according to State and other officials and staff we interviewed. Such payment issues can deter examiners from being willing to conduct disability medical exams and thus limit veterans' access to these exams in foreign countries. Of the roughly 1 million disability claims VBA processed in fiscal year 2019, 18,287 were for veterans living abroad. Veterans living abroad are entitled to the same disability benefits as those living domestically, but GAO previously reported that veterans living abroad may not be able to access disability medical exams as readily as their domestic counterparts. VBA uses medical exam reports to help determine if a veteran should receive disability benefits. GAO was asked to review the disability claims and exam processes for veterans living abroad. Among other things, this report examines disability claims trends for veterans living abroad and these veterans' ability to access quality disability medical exams. GAO analyzed VBA claims data for fiscal years 2014 to 2019; assessed data reliability; reviewed relevant federal laws, regulations, policies, and contract documents; and interviewed employees of VBA, State, and other stakeholders. GAO is making five recommendations, including that VBA assess the quality of embassy-referred exams, VBA and VHA assess whether to reimburse beneficiaries for travel to disability medical exams in foreign countries, and that VBA and VHA pay examiners located by embassy staff electronically. The Department of Veterans Affairs concurred with GAO's recommendations. For more information, contact Elizabeth Curda at (202) 512-7215 or curdae@gao.gov.
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    In U.S GAO News
    Between January 1980 and July 2020, the United States experienced 273 climate and weather disasters causing more than $1 billion in damages each, according to NOAA. The total cost of damages from these disasters exceeded $1.79 trillion, with hurricanes and tropical storms accounting for over 50 percent of these damages, according to NOAA. Across the regions affected by these hurricanes over the period from 2005 to 2015, CBO estimated that federal disaster assistance covered, on average, 62 percent of the damage costs. GAO has reported that the rising number of natural disasters and reliance on federal disaster assistance is a key source of federal fiscal exposure. GAO was asked to review the costs of natural disasters and their effects on communities. This report examines (1) estimates of the costs of damages caused by hurricanes and hurricanes' effects on overall economic activity and employment in the areas they affected, and (2) actions subsequently taken in those areas to improve resilience to future natural disasters. GAO conducted case studies of Hurricanes Katrina, Sandy, Harvey, and Irma, selected for two reasons. First, they were declared a major disaster by the President under the Robert T. Stafford Disaster Relief and Emergency Assistance Act, which establishes key programs through which the federal government provides disaster assistance, primarily through FEMA. Second, they had sizable effects on the 50 U.S. states and the District of Columbia during the period from 2004 through 2018. GAO analyzed federal agency and other data on costs, economic activity, employment, and recovery and mitigation projects in selected areas affected by these hurricanes. GAO also visited selected recovery and mitigation project sites; interviewed experts and federal, state, and local government officials; and reviewed federal, state, and local government reports and academic studies. Hurricanes Katrina, Sandy, Harvey, and Irma (selected hurricanes) caused costly damages and challenges for some populations in affected communities. In these communities, the National Oceanic and Atmospheric Administration (NOAA) estimated the cost of damages to be approximately $170 billion for Katrina, $74 billion for Sandy, $131 billion for Harvey, and $52 billion for Irma. These estimates include the value of damages to residential, commercial, and government or municipal buildings; material assets within the buildings; business interruption; vehicles and boats; offshore energy platforms; public infrastructure; and agricultural assets. These hurricanes were also costly to the federal government. For example, in 2016, the Congressional Budget Office (CBO) estimated that federal spending exceeded $110 billion in response to Katrina and $53 billion in response to Sandy. GAO analysis suggests that the selected hurricanes were associated with widely varying effects on overall economic activity and total employment in affected metropolitan areas and counties. Economic activity was lower than expected in the month of the hurricane or some of the three subsequent months in three of the affected metropolitan areas GAO analyzed. Within one year, average economic activity in these three metropolitan areas was similar to or greater than what it had been the year before the hurricane. Total employment was lower than expected in the month of the hurricane or some of the three subsequent months in 80 of the affected counties GAO analyzed. Total employment was higher than pre-hurricane employment on average in 47 of those counties within one year but remained below pre-hurricane employment on average in the other 33 counties for at least one year. Finally, state and local government officials said that the selected hurricanes had significant impacts on communities, local governments, households, and businesses with fewer resources and less expertise, and that challenges faced by households may have impacted local businesses. Communities affected by selected hurricanes have been taking actions to improve resilience, but multiple factors can affect their decisions. Actions taken after selected hurricanes include elevating, acquiring, and rehabilitating homes; flood-proofing public buildings; repairing and upgrading critical infrastructure; constructing flood barriers; and updating building codes. A community’s decision to take resilience actions can depend on the costs and benefits of those actions to the community. Multiple factors affect these costs and benefits, including the likelihood, severity, and location of future disasters, as well as the amount of federal assistance available after a disaster. Finally, vulnerabilities remain in areas affected by selected hurricanes. For example, state and local government officials indicated that many older homes in these areas do not meet current building codes. In reports to the Federal Emergency Management Agency (FEMA), states indicate they anticipate that the scope of damages via exposure to weather hazards, such as hurricanes, will likely remain high and could expand across regions affected by the selected hurricanes. In addition, some local governments have projected that population will grow in the regions affected by selected hurricanes. For more information, contact Oliver Richard at 202-512-8424 or richardo@gao.gov.
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  • Information Technology: Federal Agencies Need to Take Urgent Action to Manage Supply Chain Risks
    In U.S GAO News
    Few of the 23 civilian Chief Financial Officers Act agencies had implemented seven selected foundational practices for managing information and communications technology (ICT) supply chain risks. Supply chain risk management (SCRM) is the process of identifying, assessing, and mitigating the risks associated with the global and distributed nature of ICT product and service supply chains. Many of the manufacturing inputs for these ICT products and services originate from a variety of sources throughout the world. (See figure 1.) Figure 1: Examples of Locations of Manufacturers or Suppliers of Information and Communications Technology Products and Services None of the 23 agencies fully implemented all of the SCRM practices and 14 of the 23 agencies had not implemented any of the practices. The practice with the highest rate of implementation was implemented by only six agencies. Conversely, none of the other practices were implemented by more than three agencies. Moreover, one practice had not been implemented by any of the agencies. (See figure 2.) Figure 2: Extent to Which the 23 Civilian Chief Financial Officers Act Agencies Implemented Information and Communications Technology (ICT) Supply Chain Risk Management (SCRM) Practices As a result of these weaknesses, these agencies are at a greater risk that malicious actors could exploit vulnerabilities in the ICT supply chain causing disruption to mission operations, harm to individuals, or theft of intellectual property. For example, without establishing executive oversight of SCRM activities, agencies are limited in their ability to make risk decisions across the organization about how to most effectively secure their ICT product and service supply chains. Moreover, agencies lack the ability to understand and manage risk and reduce the likelihood that adverse events will occur without reasonable visibility and traceability into supply chains. Officials from the 23 agencies cited various factors that limited their implementation of the foundational practices for managing supply chain risks. The most commonly cited factor was the lack of federal SCRM guidance. For example, several agencies reported that they were waiting for federal guidance to be issued from the Federal Acquisition Security Council—a cross-agency group responsible for providing direction and guidance to executive agencies to reduce their supply chain risks—before implementing one or more of the foundational practices. According to Office of Management and Budget (OMB) officials, the council expects to complete this effort by December 2020. While the additional direction and guidance from the council could further assist agencies with the implementation of these practices, federal agencies currently have guidance to assist with managing their ICT supply chain risks. Specifically, the National Institute of Standards and Technology (NIST) issued ICT SCRM-specific guidance in 2015 and OMB has required agencies to implement ICT SCRM since 2016. Until agencies implement all of the foundational ICT SCRM practices, they will be limited in their ability to address supply chain risks across their organizations effectively. Federal agencies rely extensively on ICT products and services (e.g., computing systems, software, and networks) to carry out their operations. However, agencies face numerous ICT supply chain risks, including threats posed by counterfeiters who may exploit vulnerabilities in the supply chain and, thus, compromise the confidentiality, integrity, or availability of an organization's systems and the information they contain. For example, in September 2019, the Department of Homeland Security's Cybersecurity and Infrastructure Security Agency reported that federal agencies faced approximately 180 different ICT supply chain-related threats. To address threats such as these, agencies must make risk-based ICT supply chain decisions about how to secure their systems. GAO was asked to conduct a review of federal agencies' ICT SCRM practices. The specific objective was to determine the extent to which federal agencies have implemented foundational ICT SCRM practices. To do so, GAO identified seven practices from NIST guidance that are foundational for an organization-wide approach to ICT SCRM and compared them to policies, procedures, and other documentation from the 23 civilian Chief Financial Officers Act agencies. This is a public version of a sensitive report that GAO issued in October 2020. Information that agencies deemed sensitive was omitted and GAO substituted numeric identifiers that were randomly assigned for the names of the agencies due to sensitivity concerns. The foundational practices comprising ICT SCRM are: establishing executive oversight of ICT activities, including designating responsibility for leading agency-wide SCRM activities; developing an agency-wide ICT SCRM strategy for providing the organizational context in which risk-based decisions will be made; establishing an approach to identify and document agency ICT supply chain(s); establishing a process to conduct agency-wide assessments of ICT supply chain risks that identify, aggregate, and prioritize ICT supply chain risks that are present across the organization; establishing a process to conduct a SCRM review of a potential supplier that may include reviews of the processes used by suppliers to design, develop, test, implement, verify, deliver, and support ICT products and services; developing organizational ICT SCRM requirements for suppliers to ensure that suppliers are adequately addressing risks associated with ICT products and services; and developing organizational procedures to detect counterfeit and compromised ICT products prior to their deployment. GAO also interviewed relevant agency officials. In the sensitive report, GAO made a total of 145 recommendations to the 23 agencies to fully implement foundational practices in their organization-wide approaches to ICT SCRM. Of the 23 agencies, 17 agreed with all of the recommendations made to them; two agencies agreed with most, but not all of the recommendations; one agency disagreed with all of the recommendations; two agencies neither agreed nor disagreed with the recommendations, but stated they would address them; and one agency had no comments. GAO continues to believe that all of the recommendations are warranted, as discussed in the sensitive report. For more information, contact Carol C. Harris at (202) 512-4456 or harrisCC@gao.gov.
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  • Military Lodging: DOD Should Provide Congress with More Information on Army’s Privatization and Better Guidance to the Military Services
    In U.S GAO News
    What GAO Found Since privatizing its domestic on-base hotels, referred to as lodging, the Army has made a variety of improvements, including the replacement of lodging facilities with newly constructed hotels (see fig.). However, improvements have taken longer than initially anticipated, development plans have changed, and the Office of the Secretary of Defense (OSD) has not included key information about these delays and changes in reports to Congress. If OSD were to provide this additional information, Congress would be better able to determine whether the Privatized Army Lodging (PAL) program has achieved its intended objectives or fully consider whether the other military services should privatize their respective lodging programs. Room at an Army Lodging Facility before Privatizing and Room at the New Candlewood Suites Hotel Built at Yuma Proving Ground, AZ, in 2013 The Army does not estimate cost savings from the PAL program, but instead produces an annual cost avoidance estimate to demonstrate some of the financial benefits resulting from the privatization of its lodging program. Army officials stated that they calculate cost avoidance by comparing the room rate it charges for its lodging—which is limited to 75 percent of the average local lodging per diem rate across its installations—to the maximum lodging per diem that could be charged for that location. However, by using this approach, the Army is likely overstating its cost avoidance, because off-base hotels do not always charge 100 percent of per diem. Until the Army evaluates the methodology it uses to calculate its cost avoidance, decision makers in the Department of Defense (DOD) and Congress cannot be sure that the reported financial benefits of privatization have actually been achieved. OSD's oversight of lodging programs has been limited in some cases. First, OSD and the military services lack standardized data that would be useful for making informed decisions about the lodging programs. Second, DOD requires both servicemembers and civilian employees to stay in on-base lodging when on official travel, with some exceptions. Yet, according to OSD, many travelers are staying in off-base lodging, and OSD has not done the in-depth analysis needed to determine why and how much it is costing the government. Without an analysis that assesses the extent to which travelers are inappropriately using off-base lodging and why it is occurring, as well as a plan to address any issues identified, neither DOD nor Congress can be sure that the department is making the most cost-effective use of taxpayer funds. Why GAO Did This Study In 2009, the Army began to privatize its lodging with the goal of addressing the poor condition of facilities more quickly than could be achieved under continued Army operation. The Navy, Marine Corps, and Air Force currently have no plans to privatize their lodging programs. The Senate Armed Services Committee report accompanying a bill for the Fiscal Year 2020 National Defense Authorization Act included a provision for GAO to review improvements made to Army lodging, among other things. This report examines the extent to which (1) the Army has improved its lodging facilities since privatizing; (2) OSD reported complete information about the Army's development plans to Congress; (3) the Army has reliably determined any cost savings or cost avoidance as a result of its privatized lodging program; and (4) there are limitations in OSD's oversight of the military services' lodging programs. GAO reviewed policies and guidance; analyzed lodging program data for fiscal years 2017 through 2019 (the 3 most recent years of complete and available information); and interviewed DOD officials.
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  • Defense Health Care: Efforts to Ensure Beneficiaries Access Specialty Care and Receive Timely and Effective Care
    In U.S GAO News
    The Department of Defense (DOD) has a general expectation that its health care beneficiaries, upon receiving an urgent referral to see a specialist, will access that specialty care in 3 days or less. GAO's analysis of 16,754 urgent referrals at military treatment facilities (MTF) shows that DOD beneficiaries accessed specialty care services in 3 days or less for more than half of the urgent referrals. About 9 percent of the urgent referrals involved beneficiaries waiting 3 weeks or longer to be seen. According to DOD officials, some beneficiaries may have waited longer than 3 days due to factors such as patient preference, appointment availability, or waiting for lab results. Time to access care varied by specialty, with beneficiaries urgently referred to ophthalmology generally seeing a specialist the fastest, and those urgently referred to mental health and oncology generally waiting the longest. According to DOD officials, MTFs are responsible for monitoring beneficiaries' access to specialty care through urgent referrals. GAO found that the monitoring processes used varied by MTF and specialty care clinic at the five selected MTFs that GAO reviewed. For example, officials from one MTF told GAO they centrally manage all urgent referrals using a daily report to address any delays, while officials from another MTF told GAO that individual specialty care clinics are responsible for managing their own urgent referrals. DOD officials acknowledged such variation and MTFs have been directed to centralize their referral management and monitoring processes—an effort that is currently underway. GAO found that DOD monitors the rates at which beneficiaries receive timely and effective care, in part, through 10 outpatient health care quality measures. These measures allow DOD to make comparisons to civilian health care systems, and they are reviewed by various DOD groups at least quarterly. However, DOD officials told GAO that since October 2017, they have been unable to monitor nine of the 10 measures for MTFs using Military Health System (MHS) Genesis, DOD's new electronic health record system. According to the officials, DOD's current data warehouse—a system that stores some MHS Genesis data and can be used by MTFs to create reports on quality measures—is not capable of producing accurate reports for those measures. DOD officials told GAO they expect to implement a new data warehouse by the end of 2020. DOD officials also said they are importing data related to quality measures into another system used for quality monitoring; however, DOD does not have a targeted date for completing these data imports. Until these actions are fully implemented, groups responsible for monitoring quality care will continue to lack the data needed to offer assurance that the growing number of MTFs using MHS Genesis are providing beneficiaries with timely and effective care that will lead to better health outcomes. A draft of this report recommended that DOD establish a timeline to complete importing the quality measure-related data from MHS Genesis into DOD's system used for quality monitoring. In its review of the draft, DOD concurred with the recommendation and established a timeline for importing the data, to be available in DOD's system no later than May 2021. After reviewing the information DOD provided, GAO removed the recommendation from the final report. DOD is responsible for ensuring that beneficiaries have access to specialty care for conditions that, while not life-threatening, require immediate attention, as well as for ensuring that beneficiaries receive timely and effective care for certain routine or other services. A report accompanying the National Defense Authorization Act for Fiscal Year 2020 included a provision for GAO to review the quality of health care in the MHS. This report examines (1) the timeliness with which beneficiaries access specialty care at MTFs through urgent referrals and DOD's efforts to monitor access, and (2) DOD's use of quality measures to monitor and improve the rates of timely and effective care received by beneficiaries at MTFs. GAO examined relevant policies, national DOD referral data (a total of 16,754 urgent referrals) for a 1-year period ending August 2019, and the most recent available quality measure data (April 2020). GAO interviewed officials from five MTFs, selected for variation in military services, geography, provision of select specialty services, and use of the electronic health record system. For more information, contact Debra A. Draper at (202) 512-7114 or draperd@gao.gov.
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    In Crime News
    Each weekday, the Department of Justice will highlight a case that has resulted from Operation Legend.  Today’s case is out of the District of New Mexico.  Operation Legend launched in Albuquerque on July 22, 2020, in response to the city facing increased homicide and non-fatal shooting rates.
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