December 3, 2021

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Kaléo Inc. Agrees to Pay $12.7 Million to Resolve Allegations of False Claims for Anti-Overdose Drug

9 min read
<div>kaléo Inc., a Virginia-based pharmaceutical manufacturer, has agreed to pay the United States $12.7 million to resolve allegations that kaléo caused the submission of false claims for the drug Evzio, an injectable form of naloxone hydrochloride indicated for use to reverse opioid overdose. Evzio was the highest-priced version of naloxone on the market, and insurers frequently required the submission of prior authorization requests before they would approve coverage for Evzio.</div>
kaléo Inc., a Virginia-based pharmaceutical manufacturer, has agreed to pay the United States $12.7 million to resolve allegations that kaléo caused the submission of false claims for the drug Evzio, an injectable form of naloxone hydrochloride indicated for use to reverse opioid overdose. Evzio was the highest-priced version of naloxone on the market, and insurers frequently required the submission of prior authorization requests before they would approve coverage for Evzio.

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As a result of the urgent need to move cargo in containers, the Army awarded a contract in August 2010 for 3,227 flatracks.In February 2012, the Army issued the Distribution Enablers Study, which revisited the capabilities needed for “break bulk” and containerized cargo distribution. This study included the E-CHU in its analysis, because more E-CHUs had been fielded to units, and the CTE, which completed testing in 2011. The Distribution Enablers Study recommended using the E-CHU paired with the CTE, because this combination provides three times more capacity to distribute cargo than flatracks alone. As a result, in June 2012, the Army ordered 180 CTEs.Requirements for container handling equipment are continuing to be updated and may change due to DOD's plans to reduce the size of the Army. A Capability Production Document—expected to be issued in late summer 2013 to update the 1998 Operational Requirements Document—is to provide updated requirements to include current technologies for CROPs, E-CHUs, and CTEs and is expected to add the flatrack capability for Army Corps of Engineers bridge units.Army officials said thatplans are also being completed for each piece of container handling equipment—based on the 2012 Distribution Enablers Study—that will identify the quantity and type of equipment to be sent to units.Additionally, Army officials said that the Army is conducting a tactical wheeled vehicle reduction study, due to be completed in late 2013 or early 2014 that could affect requirements for container handling equipment.To increase its ability to move containerized cargo, the Army plans to increase its June 2013 inventory of 1,241 E-CHUs and no CTEs to a fiscal year 2018 inventory of 6,035 E-CHUs and 6,324 CTEs. To move “break bulk” cargo, the Army had 47,228 CROPs and 4,342 flatracks as of June 2013. There is no future funding programmed for CROPs or flatracks, but the inventory is expected to increase because some CROPs and flatracks have been procured but have not yet been provided to units. By fiscal year 2018, the Army expects to have 48,397 CROPs and 7,241 flatracks.Why GAO Did This StudyContainer handling equipment provides Army commanders with the flexibility to respond to rapidly shifting operations by supplying the capability to transport critical cargo. To support a versatile and expandable distribution system, the Army has five types of container handling equipment to carry both containerized and non-containerized (or "break bulk") cargo: flatracks, CROPs, CHUs, E-CHUs, and CTEs. Flatracks, which can carry both containerized and "break bulk" cargo, and CROPs, which can carry only "break bulk" cargo, are structural steel frames. CHUs and E-CHUs attach to the lifting arm of a truck and allow for upload and offload of containers. The CTE is a modification to a trailer which allows the container to roll onto the trailer while being pushed by the CHU/E-CHU.GAO was mandated to provide a report to the congressional defense committees on the acquisition plan, requirement, and inventory for container handling equipment in the Army. Objectives for this report were to describe (1) how the requirements for container handling equipment have changed since 1998 and when the corresponding contracts were awarded or delivery orders issued and (2) the current and projected inventories of container handling equipment.For more information contact Zina D. Merritt at (202) 512-5257 or merrittz@gao.gov.
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For fiscal year 2008, DOD requested $1.2 billion to fund CERP projects in Iraq and Afghanistan and plans to request an additional $507 million, primarily for CERP in Iraq. Furthermore, DOD's reported obligations for Iraq and Afghanistan have grown from about $179 million in fiscal year 2004 to more than $1.1 billion in fiscal year 2007. In addition, over the same period of time, the number of projects in both countries has grown from about 6,450 to about 8,700. According to DOD regulations, CERP is intended for small-scale, urgent humanitarian relief and reconstruction projects for the benefit of Iraqi people. The guidance issued by the Undersecretary of Defense (Comptroller) establishes 19 authorized uses for CERP funds, including transportation, electricity, and condolence payments. CERP funds can be used for both construction and non-construction projects. In Iraq, commanders follow Multinational Corps-Iraq (MNC-I) standard operating procedures for CERP, which expand upon DOD regulations. MNC-I guidance states that the keys to project selection are to (1) execute quickly, (2) employ many Iraqis, (3) benefit the Iraqi people, and (4) be highly visible. DOD regulations identify the roles and responsibilities that different offices play in managing CERP. The Secretary of the Army serves as the executive agent and is responsible for ensuring that commanders carry out CERP in a manner that is consistent with applicable laws, regulations and guidance. The Commander of U.S. Central Command (CENTCOM) is responsible for allocating CERP resources. Public Law No. 108-106 and subsequent laws require DOD to provide Congress with quarterly reports on the source, allocation, and use of CERP funds. 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CERP is intended to provide commanders a source of funds that allow them to respond to urgent, small-scale humanitarian relief and reconstruction needs that will immediately assist the local Iraqi population. However, DOD guidance provides no definition for small-scale or urgent, which leaves commanders with the responsibility of developing their own definitions. Commanders we interviewed had varying definitions for small-scale. Our review of the quarterly reports to Congress demonstrated the wide spectrum in size and costs of projects. For instance, projects ranged from a waterline repair costing slightly more than $100 to an electrical distribution system costing more than $11 million. In addition, during our visit to Iraq, we observed three projects: a multimillion-dollar sewage lift station, a several hundred thousand dollar sports center and community complex, and a fruit and vegetable stand that had been renovated with a $2,500 grant. Commanders typically defined urgent as restoring a basic human need, such as water and electricity, or projects identified by the local Iraqi government as its most pressing requirement for the area. As a result, the scale, complexity, and duration of projects selected vary across commands. While the majority of CERP projects have cost less than $500,000, the number of projects costing more than $500,000 has increased significantly. According to DOD officials, factors contributing to the increasing number of CERP projects costing more than $500,000 include the lack of other available reconstruction money, improved security in the region and the fact that many of the immediate needs of the Iraq people were addressed during the initial phases of CERP. Commanders reported that they generally coordinated projects with the appropriate U.S. and Iraqi officials, as required by guidance. The officials include Iraqi government personnel as well as military and nonmilitary U.S. officials. MNC-I guidance further states that coordination with local officials is critical to ensure that a project meets a need and will be maintained and that numerous projects have been built that did not meet their intended purpose because of lack of coordination. MNC-I guidance notes that coordination efforts may include synchronizing CERP projects with complementary programs funded by United States Agency for International Development or other nongovernmental organizations within the commander's area of responsibility. While the MNC-I project approval process provides some oversight, the Offices of the Under Secretary of Defense (Comptroller), the Army and MNC-I have limited oversight of CERP in Iraq because they (1) do not require units executing projects to monitor them, (2) have not established performance metrics, and (3) have limited knowledge of projects under $500,000. Neither DOD nor MNC-I guidance establishes a requirement for units executing projects to monitor them. MNC-I guidance has a broad requirement for the MNC-I engineer to monitor reconstruction projects, but does not include a requirement for units executing projects to monitor them. No performance metrics exist for CERP. As we have previously reported, federal agencies should develop plans that establish objective, quantifiable, and measurable performance goals that should be achieved by a program. Although MNC-I officials have some visibility over projects costing more than $500,000 because they approve these projects, they have limited visibility and oversight for projects costing less than $500,000. The quarterly reports do not provide information about the number of projects completed during a quarter, the number of projects that have been started but not completed, or the number of projects that have not been sustained or maintained by the Iraqi government or the local population.
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    In U.S GAO News
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    In U.S GAO News
    What GAO Found Key federal agencies, including the Departments of Homeland Security (DHS), Defense (DOD), Health and Human Services (HHS), and Agriculture (USDA), developed a range of interagency response plans to prepare for nationally significant biological incidents. These strategic, operational, and tactical level plans address responding to a broad spectrum of biological threats, including those that are intentional, accidental, or naturally occurring. DHS, DOD, HHS, and USDA conducted numerous interagency exercises to help prepare for and respond to a wide variety of biological incidents, such as anthrax attacks, influenza pandemics, and diseases affecting plants and animals. Specifically, GAO identified 74 interagency biological incident exercises conducted from calendar years 2009 through 2019. Number of Interagency Biological Incident Exercises Conducted, Calendar Years 2009 through 2019 GAO's analysis of after-action reports for selected interagency biological incident exercises and real-world incidents, as well as the COVID-19 response, identified long-standing biodefense challenges. GAO found that the nation lacked elements necessary for preparing for nationally significant biological incidents, including a process at the interagency level to assess and communicate priorities for exercising capabilities. Further, it determined that agencies do not routinely work together in monitoring results from exercises and real-world incidents to identify patterns and root causes for systemic challenges. Assessing and communicating exercise priorities and routinely monitoring the results of the exercises and incidents will help ensure the nation is better prepared to respond to the next biological threat. Why GAO Did This Study The COVID-19 pandemic shows how catastrophic biological incidents can cause substantial loss of life, economic damage, and require a whole-of-nation response involving multiple federal and nonfederal entities. The 2018 National Biodefense Strategy outlines specific goals and objectives to help prepare for and respond to such incidents. The CARES Act includes a provision for GAO to conduct monitoring and oversight of federal efforts to prepare for, respond to, and recover from COVID-19. This report addresses: (1) interagency plans key federal agencies developed, and exercises they conducted, to help prepare for biological incidents; and (2) the extent to which exercises and real-world incidents revealed opportunities to better achieve National Biodefense Strategy objectives. GAO reviewed biological incident plans and after-action reports from exercises and real-world incidents from calendar years 2009 through 2019, including a non-generalizable sample of 19 reports selected based on threat scenario and other factors. GAO interviewed federal and state officials to obtain their perspectives on plans, exercises, and the COVID-19 response.
    [Read More…]

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