St. Jude Agrees to Pay $27 Million for Allegedly Selling Defective Heart Devices

St. Jude Medical Inc. (St. Jude) has agreed to pay $27 million to settle allegations under the False Claims Act that, between November 2014 and October 2016, it knowingly sold defective heart devices to health care facilities that, in turn, implanted the devices into patients insured by federal health care programs. St. Jude was acquired by Abbott Laboratories in January 2017.

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    In U.S GAO News
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To reach the full potential of 5G, new technologies will need to be developed. International bodies that have been involved in defining 5G network specifications will need to develop additional 5G specifications and companies will need to develop, test, and deploy these technologies. GAO identified the following challenges that can hinder the performance or usage of 5G technologies in the U.S. GAO developed six policy options in response to these challenges, including the status quo. They are presented with associated opportunities and considerations in the following table. The policy options are directed toward the challenges detailed in this report: spectrum sharing, cybersecurity, privacy, and concern over possible health effects of 5G technology. Policy options to address challenges to the performance or usage of U.S. 5G wireless networks Policy Option Opportunities Considerations Spectrum-sharing technologies (report p. 47) Policymakers could support research and development of spectrum sharing technologies. Could allow for more efficient use of the limited spectrum available for 5G and future generations of wireless networks. It may be possible to leverage existing 5G testbeds for testing the spectrum sharing technologies developed through applied research. Research and development is costly, must be coordinated and administered, and its potential benefits are uncertain. Identifying a funding source, setting up the funding mechanism, or determining which existing funding streams to reallocate will require detailed analysis. Coordinated cybersecurity monitoring (report p. 48) Policymakers could support nationwide, coordinated cybersecurity monitoring of 5G networks. A coordinated monitoring program would help ensure the entire wireless ecosystem stays knowledgeable about evolving threats, in close to real time; identify cybersecurity risks; and allow stakeholders to act rapidly in response to emerging threats or actual network attacks. Carriers may not be comfortable reporting incidents or vulnerabilities, and determinations would need to be made about what information is disclosed and how the information will be used and reported. Cybersecurity requirements (report p. 49) Policymakers could adopt cybersecurity requirements for 5G networks. Taking these steps could produce a more secure network. Without a baseline set of security requirements the implementation of network security practices is likely to be piecemeal and inconsistent. Using existing protocols or best practices may decrease the time and cost of developing and implementing requirements. Adopting network security requirements would be challenging, in part because defining and implementing the requirements would have to be done on an application-specific basis rather than as a one-size-fits-all approach. Designing a system to certify network components would be costly and would require a centralized entity, be it industry-led or government-led. Privacy practices (report p. 50) Policymakers could adopt uniform practices for 5G user data. Development and adoption of uniform privacy practices would benefit from existing privacy practices that have been implemented by states, other countries, or that have been developed by federal agencies or other organizations. Privacy practices come with costs, and policymakers would need to balance the need for privacy with the direct and indirect costs of implementing privacy requirements. Imposing requirements can be burdensome, especially for smaller entities. High-band research (report p. 51) Policymakers could promote R&D for high-band technology. Could result in improved statistical modeling of antenna characteristics and more accurately representing propagation characteristics. Could result in improved understanding of any possible health effects from long-term radio frequency exposure to high-band emissions. Research and development is costly and must be coordinated and administered, and its potential benefits are uncertain. Policymakers will need to identify a funding source or determine which existing funding streams to reallocate. Status quo (report p. 52) Some challenges described in this report may be addressed through current efforts. Some challenges described in this report may remain unresolved, be exacerbated, or take longer to resolve than with intervention. GAO was asked to assess the technologies associated with 5G and their implications. This report discusses (1) how the performance goals and expected uses are to be realized in U.S. 5G wireless networks, (2) the challenges that could affect the performance or usage of 5G wireless networks in the U.S., and (3) policy options to address these challenges. To address these objectives, GAO interviewed government officials, industry representatives, and researchers about the performance and usage of 5G wireless networks. This included officials from seven federal agencies; the four largest U.S. wireless carriers; an industry trade organization; two standards bodies; two policy organizations; nine other companies; four university research programs; the World Health Organization; the National Council on Radiation Protection and Measurements; and the chairman of the Defense Science Board's 5G task force. GAO reviewed technical studies, industry white papers, and policy papers identified through a literature review. GAO discussed the challenges to the performance or usage of 5G in the U.S. during its interviews and convened a one-and-a-half day meeting of 17 experts from academia, industry, and consumer groups with assistance from the National Academies of Sciences, Engineering, and Medicine. GAO received technical comments on a draft of this report from six federal agencies and nine participants at its expert meeting, which it incorporated as appropriate. For more information, contact Hai Tran at (202) 512-6888, tranh@gao.gov or Vijay A. D’Souza at (202) 512-6240, dsouzav@gao.gov.
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    In response to the Department of Labor's Home Care Rule—which extended Fair Labor Standards Act (FLSA) minimum wage and overtime protections to more home care workers—some states made changes in their Medicaid programs, according to studies and GAO interviews with stakeholders and selected state officials. Many stakeholders said the rule led some states to limit home care workers' hours in their Medicaid programs to avoid overtime costs. For example, in Oregon, newly hired home care workers provided through Medicaid were generally limited to 40 hours per week, according to state documentation. Some states also budgeted additional funds for overtime pay. In addition, according to a few stakeholder groups, some states changed service delivery in their Medicaid programs, for example, by discontinuing services such as live-in care. In contrast, several stakeholders said some states did not make any major changes to their Medicaid programs' home care services. Provider agencies, workers, and consumers experienced changes after the Home Care Rule took effect. Specifically, some provider agencies restricted workers' hours to limit overtime costs, though this can result in the need to hire more workers, leading to increased costs of recruiting, training, and scheduling, according to several stakeholders. GAO's analysis of national survey data found that home care workers, when compared to occupations with similar education and training requirements, were more likely to work full-time but did not earn significantly higher earnings following the Home Care Rule (see figure). Many stakeholders GAO spoke with described ongoing challenges consumers face in obtaining home care services, such as difficulty finding workers to hire. Estimated Median Weekly Earnings of Employed Workers, 2010 through 2019 Note: The margins of error at the 95 percent confidence level are within plus or minus 7.2 percent of the estimate itself. Employment in home care is projected to grow nearly 40 percent over the next decade to meet demand from an increasing population of older adults and people with disabilities. Home care workers help those who need assistance with activities of daily living such as dressing, eating, or bathing. State Medicaid programs may allow home care for eligible individuals as an alternative to institutional care. The Department of Labor's (DOL) Home Care Rule, which went into effect in 2015, extended FLSA protections to more home care workers. GAO was asked to review the implementation and effects of the Home Care Rule. This report examines what is known about (1) changes states made to their Medicaid programs in response to the Home Care Rule; and (2) the Home Care Rule's effect on home care provider agencies, workers, and consumers. To address these objectives, GAO analyzed 2010 through 2019 national survey data on workers' hours and wages; interviewed stakeholders from 15 organizations that represent the different groups affected, DOL officials, and home care program officials from three states selected based on variation in their Medicaid programs and minimum wage levels; and reviewed studies on state strategies to implement the Home Care Rule. For more information, contact Melissa Emrey-Arras at (617) 788-0534 or emreyarrasm@gao.gov.
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    In Justice News
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  • Colorado Man Charged with Hate Crime After Unprovoked Stabbing of Black Man
    In Crime News
    A Colorado man has been charged with a hate crime after stabbing a Black man from Ontario, Oregon while the man was sitting in a fast food restaurant, announced Assistant Attorney General Eric Dreiband of the Justice Department's Civil Rights Division and U.S. Attorney Billy J. Williams of the District of Oregon.
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  • Covid-19 Contracting: Observations on Federal Contracting in Response to the Pandemic
    In U.S GAO News
    Government-wide contract obligations in response to the COVID-19 pandemic totaled $17.8 billion as of June 11, 2020. Four agencies accounted for 85 percent of total COVID-19 contract obligations (see figure). This report provides available baseline data on COVID-19 federal contract obligations. Contract Obligations in Response to COVID-19 by Department, as of June 11, 2020 About 62 percent of federal contract obligations were for goods to treat COVID-19 patients and protect health care workers—including ventilators, gowns, and N95 respirators. Less than half of total contract obligations were identified as competed (see figure). Top Five Goods and Services and Percentage of Obligations Competed, as of June 11, 2020 According to the Centers for Disease Control and Prevention, as of June 30, 2020, the United States has documented more than 2.5 million confirmed cases and more than 125,000 deaths due to COVID-19. To facilitate the U.S. response to the pandemic, numerous federal agencies have awarded contracts for critical goods and services to support federal, state, and local response efforts. GAO's prior work on federal emergency response efforts has found that contracts play a key role, and that contracting during an emergency can present unique challenges as officials can face pressure to provide goods and services as quickly as possible. The Coronavirus Aid, Relief, and Economic Security Act (CARES Act) included a provision for GAO to provide a comprehensive review of COVID-19 federal contracting. This is the first in a series of GAO reports on this issue. This report describes, among other objectives, key characteristics of federal contracting obligations awarded in response to the COVID-19 pandemic. Future GAO work will examine agencies' planning and management of contracts awarded in response to the pandemic, including agencies' use of contracting flexibilities provided by the CARES Act. GAO analyzed data from the Federal Procurement Data System-Next Generation on agencies' reported government-wide contract obligations for COVID-19 through June 11, 2020. GAO also analyzed contract obligations reported at the Departments of Health and Human Services, Defense, Homeland Security, and Veterans Affairs—the highest obligating agencies. For more information, contact Marie A. Mak at (202) 512-4841 or MakM@gao.gov.
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  • Lake Ontario-St. Lawrence River Plan: Improved Communication and Adaptive Management Strategy Could Help Address Stakeholder Concerns
    In U.S GAO News
    The International Joint Commission's (IJC) process for developing and selecting the Lake Ontario-St. Lawrence River Plan 2014 (Plan 2014) was generally consistent with relevant essential elements of risk-informed decision-making. During the 18-year process, IJC took steps to define objectives and performance measures to be used in its decision-making, identify various options, assess uncertainties like climate change, and engage with stakeholders, among other steps. These steps are all essential elements of risk-informed decision making. Plan 2014 Affects Various Users of Lake Ontario and the St. Lawrence River, Including (from Left to Right) Commercial Navigation, Coastal Development, and Recreational Boating, Including Marinas IJC uses two mechanisms—a communications committee and a strategic communication plan—and a variety of methods—such as its website, social media, and public meetings—to communicate with stakeholders about its implementation of Plan 2014. Nevertheless, 12 of the 14 stakeholders GAO interviewed expressed concerns about IJC's communication. GAO found that IJC's strategic communication plan and related documents partially align with best practices. For example, the communication plan and related documents do not comprehensively identify target audiences or include mechanisms to monitor and evaluate the effectivness of their communication efforts. Updating its strategic communication plan to align with best practices and principles for risk communication could help IJC ensure improved stakeholder communication. Of the 14 stakeholders interviewed, nine expressed concerns about the rules and criteria in Plan 2014 and 10 expressed concerns about its implementation. For example, seven stakeholders told us that they do not believe that the Plan allows IJC to act proactively in anticipation of future water conditions. IJC has taken initial steps to develop an adaptive management process that may help address stakeholder concerns and approved a long-term adaptive management strategy in March 2020. However, the document does not fully incorporate the key elements and essential characteristics of an adaptive management process that could help IJC transparently and effectively assess Plan 2014 and adjust future actions to achieve the plan's objectives. For example, the Plan does not fully incorporate a communication strategy for engaging stakeholders throughout the process or information on how IJC will determine if adjustments to the Plan's rules and criteria are warranted. Water releases from Lake Ontario into the St. Lawrence River are determined by a set of regulatory rules and criteria called Plan 2014—issued pursuant to IJC's Supplementary Order of Approval and the Boundary Waters Treaty of 1909. The IJC—a binational commission—developed and issued the Plan and Order with the concurrence of the United States and Canada. The rules affect a variety of users of the waterway, including ecosystems, hydropower, and municipal and industrial water use. After flooding from the lake and river in 2017, GAO was asked to examine the process IJC used to develop and evaluate Plan 2014 and how IJC has addressed stakeholder concerns. This report examines (1) the extent to which IJC's process to develop and select Plan 2014 was consistent with essential elements of risk-informed decision-making, (2) actions IJC has taken to communicate with stakeholders about its implementation of Plan 2014 and stakeholder concerns regarding IJC's communication, and (3) stakeholder concerns about Plan 2014 and the extent to which IJC has developed a process to assess and adjust Plan 2014. GAO reviewed Plan 2014 and other IJC documents, interviewed IJC and federal officials and a nongeneralizable sample of 14 stakeholders, selected for a variety of user interests and stakeholder types. GAO is making three recommendations, including that the U.S. Section of the IJC work with its Canadian counterpart to ensure that the communication plan aligns with best practices and the adaptive management strategy fully incorporates key elements. IJC agreed with our recommendations. For more information, contact J. Alfredo Gómez at (202) 512-3841 or gomezj@gao.gov.
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  • The United States Sanctions Venezuelan Officials Involved in Unjust Sentencing of the Citgo 6
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  • Eastern Kentucky Doctor and Assistant Plead Guilty to Unlawfully Distributing Opioids
    In Crime News
    A Kentucky doctor and his former office assistant pleaded guilty on Aug. 7 for their roles in unlawfully distributing opioids and other controlled substances during a time when the defendants did not have a legitimate medical practice.
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  • Justice Department Sues to Shut Down Florida Tax Return Preparers
    In Crime News
    The United States has filed a complaint in the U.S. District Court for the Southern District of Florida seeking to bar three Miami Gardens-area tax return preparers and their businesses and franchises, from owning or operating a tax return preparation business and preparing tax returns for others, the Justice Department announced today. The United States has simultaneously filed a request for a preliminary injunction that would immediately prohibit defendants from further preparing taxes during the pendency of the suit.
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  • SavaSeniorCare LLC Agrees to Pay $11.2 Million to Resolve False Claims Act Allegations
    In Crime News
    SavaSeniorCare LLC and related entities (Sava), based in Georgia, have agreed to pay $11.2 million, plus additional amounts if certain financial contingencies occur, to resolve allegations that Sava violated the False Claims Act by causing its skilled nursing facilities (SNFs) to bill the Medicare program for rehabilitation therapy services that were not reasonable, necessary or skilled, and to resolve allegations that Sava billed the Medicare and Medicaid programs for grossly substandard skilled nursing services. Sava currently owns and operates SNFs across the country.
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  • U.S. Leadership on Human Rights and Ending Systemic Racism
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  • Former Tennessee County Official Indicted for Kidnapping and Sexual Assault
    In Crime News
    Today, the Justice Department announced the unsealing of a nine-count indictment charging Michael Harvel, 59, of Crossville, Tennessee, with civil rights violations for kidnapping and sexually assaulting women that he supervised during his tenure as the Cumberland County, Tennessee, Solid Waste Director. FBI agents arrested Harvel at his home earlier today, and he will appear before a U.S. Magistrate Judge later this afternoon.
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  • Operation Legend: Case of the Day
    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 Western District of Missouri.  Operation Legend launched in Kansas City on July 8, 2020, in response to the city facing increased homicide and non-fatal shooting rates.
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  • Final four sentenced in $189M Health Care Fraud Scam
    In Justice News
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