Fort Bend County home health owner charged with copying and pasting doctor signatures

A 60-year-old Richmond man is now in custody on charges of making false statements in his scheme to defraud Medicare

Read full article at: https://www.justice.gov April 12, 2021

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Vaccine Platform Technologies Supported by Operation Warp Speed, as of January 2021 As of January 30, 2021, five of the six OWS vaccine candidates have entered phase 3 clinical trials, two of which—Moderna's and Pfizer/BioNTech's vaccines—have received an emergency use authorization (EUA) from the Food and Drug Administration (FDA). For vaccines that received EUA, additional data on vaccine effectiveness will be generated from further follow-up of participants in clinical trials already underway before the EUA was issued. Technology readiness. GAO's analysis of the OWS vaccine candidates' technology readiness levels (TRL)—an indicator of technology maturity— showed that COVID-19 vaccine development under OWS generally followed traditional practices, with some adaptations. FDA issued specific guidance that identified ways that vaccine development may be accelerated during the pandemic. Vaccine companies told GAO that the primary difference from a non-pandemic environment was the compressed timelines. To meet OWS timelines, some vaccine companies relied on data from other vaccines using the same platforms, where available, or conducted certain animal studies at the same time as clinical trials. However, as is done in a non-pandemic environment, all vaccine companies gathered initial safety and antibody response data with a small number of participants before proceeding into large-scale human studies (e.g., phase 3 clinical trials). The two EUAs issued in December 2020 were based on analyses of clinical trial participants and showed about 95 percent efficacy for each vaccine. These analyses included assessments of efficacy after individuals were given two doses of vaccine and after they were monitored for about 2 months for adverse events. Manufacturing. As of January 2021, five of the six OWS vaccine companies had started commercial scale manufacturing. OWS officials reported that as of January 31, 2021, companies had released 63.7 million doses—about 32 percent of the 200 million doses that, according to OWS, companies with EUAs have been contracted to provide by March 31, 2021. Vaccine companies face a number of challenges in scaling up manufacturing to produce hundreds of millions of doses under OWS's accelerated timelines. DOD and HHS are working with vaccine companies to help mitigate manufacturing challenges, including: Limited manufacturing capacity: A shortage of facilities with capacity to handle the vaccine manufacturing needs can lead to production bottlenecks. Vaccine companies are working in partnership with OWS to expand production capacity. For example, one vaccine company told GAO that HHS's Biomedical Advanced Research and Development Authority helped them identify an additional manufacturing partner to increase production. Additionally, the U.S. Army Corps of Engineers is overseeing construction projects to expand capacity at vaccine manufacturing facilities. Disruptions to manufacturing supply chains: Vaccine manufacturing supply chains have been strained by the global demand for certain goods and workforce disruptions caused by the global pandemic. For example, representatives from one facility manufacturing COVID-19 vaccines stated that they experienced challenges obtaining materials, including reagents and certain chemicals. They also said that due to global demand, they waited 4 to 12 weeks for items that before the pandemic were typically available for shipment within one week. Vaccine companies and DOD and HHS officials told GAO they have undertaken several efforts to address possible manufacturing disruptions and mitigate supply chain challenges. These efforts include federal assistance to (1) expedite procurement and delivery of critical manufacturing equipment, (2) develop a list of critical supplies that are common across the six OWS vaccine candidates, and (3) expedite the delivery of necessary equipment and goods coming into the United States. Additionally, DOD and HHS officials said that as of December 2020 they had placed prioritized ratings on 18 supply contracts for vaccine companies under the Defense Production Act, which allows federal agencies with delegated authority to require contractors to prioritize those contracts for supplies needed for vaccine production. Gaps in the available workforce: Hiring and training personnel with the specialized skills needed to run vaccine manufacturing processes can be challenging. OWS officials stated that they have worked with the Department of State to expedite visa approval for key technical personnel, including technicians and engineers to assist with installing, testing, and certifying critical equipment manufactured overseas. OWS officials also stated that they requested that 16 DOD personnel be detailed to serve as quality control staff at two vaccine manufacturing sites until the organizations can hire the required personnel. As of February 5, 2021, the U.S. had over 26 million cumulative reported cases of COVID-19 and about 449,020 reported deaths, according to the Centers for Disease Control and Prevention. The country also continues to experience serious economic repercussions, with the unemployment rate and number of unemployed in January 2021 at nearly twice their pre-pandemic levels in February 2020. In May 2020, OWS was launched and included a goal of producing 300 million doses of safe and effective COVID-19 vaccines with initial doses available by January 2021. Although FDA has authorized two vaccines for emergency use, OWS has not yet met its production goal. Such vaccines are crucial to mitigate the public health and economic impacts of the pandemic. GAO was asked to review OWS vaccine development efforts. This report examines: (1) the characteristics and status of the OWS vaccines, (2) how developmental processes have been adapted to meet OWS timelines, and (3) the challenges that companies have faced with scaling up manufacturing and the steps they are taking to address those challenges. GAO administered a questionnaire based on HHS's medical countermeasures TRL criteria to the six OWS vaccine companies to evaluate the COVID-19 vaccine development processes. GAO also collected and reviewed supporting documentation on vaccine development and conducted interviews with representatives from each of the companies on vaccine development and manufacturing. For more information, contact Karen L. Howard and Candice N. Wright at (202) 512-6888 or howardk@gao.gov or wrightc@gao.gov.
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    In U.S GAO News
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  • Weapon Systems Cybersecurity: Guidance Would Help DOD Programs Better Communicate Requirements to Contractors
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    Since GAO's 2018 report, the Department of Defense (DOD) has taken action to make its network of high-tech weapon systems less vulnerable to cyberattacks. DOD and military service officials highlighted areas of progress, including increased access to expertise, enhanced cyber testing, and additional guidance. For example, GAO found that selected acquisition programs have conducted, or planned to conduct, more cybersecurity testing during development than past acquisition programs. It is important that DOD sustain its efforts as it works to improve weapon systems cybersecurity. Contracting for cybersecurity requirements is key. DOD guidance states that these requirements should be treated like other types of system requirements and, more simply, “if it is not in the contract, do not expect to get it.” Specifically, cybersecurity requirements should be defined in acquisition program contracts, and criteria should be established for accepting or rejecting the work and for how the government will verify that requirements have been met. However, GAO found examples of program contracts omitting cybersecurity requirements, acceptance criteria, or verification processes. For example, GAO found that contracts for three of the five programs did not include any cybersecurity requirements when they were awarded. A senior DOD official said standardizing cybersecurity requirements is difficult and the department needs to better communicate cybersecurity requirements and systems engineering to the users that will decide whether or not a cybersecurity risk is acceptable. Incorporating Cybersecurity in Contracts DOD and the military services have developed a range of policy and guidance documents to improve weapon systems cybersecurity, but the guidance usually does not specifically address how acquisition programs should include cybersecurity requirements, acceptance criteria, and verification processes in contracts. Among the four military services GAO reviewed, only the Air Force has issued service-wide guidance that details how acquisition programs should define cybersecurity requirements and incorporate those requirements in contracts. The other services could benefit from a similar approach in developing their own guidance that helps ensure that DOD appropriately addresses cybersecurity requirements in contracts. DOD's network of sophisticated, expensive weapon systems must work when needed, without being incapacitated by cyberattacks. However, GAO reported in 2018 that DOD was routinely finding cyber vulnerabilities late in its development process. A Senate report accompanying the National Defense Authorization Act for Fiscal Year 2020 included a provision for GAO to review DOD's implementation of cybersecurity for weapon systems in development. GAO's report addresses (1) the extent to which DOD has made progress in implementing cybersecurity for weapon systems during development, and (2) the extent to which DOD and the military services have developed guidance for incorporating weapon systems cybersecurity requirements into contracts. GAO reviewed DOD and service guidance and policies related to cybersecurity for weapon systems in development, interviewed DOD and program officials, and reviewed supporting documentation for five acquisition programs. GAO also interviewed defense contractors about their experiences with weapon systems cybersecurity. GAO is recommending that the Army, Navy, and Marine Corps provide guidance on how programs should incorporate tailored cybersecurity requirements into contracts. DOD concurred with two recommendations, and stated that the third—to the Marine Corps—should be merged with the one to the Navy. DOD's response aligns with the intent of the recommendation. For more information, contact W. William Russell at (202) 512-4841 or russellw@gao.gov.
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  • Organ Transplants: Changes in Allocation Policies for Donated Livers and Lungs
    In U.S GAO News
    The Organ Procurement and Transplantation Network (OPTN) develops allocation policies in the United States to determine which transplant candidates receive offers for organs, such as livers or lungs, that are donated from deceased donors. In July 2018, the Department of Health and Human Services (HHS), which oversees OPTN, directed it to change the liver allocation policy to be more consistent with federal regulations. The liver allocation policy changed in February 2020 from a system that, in general, offered donated livers first to the sickest candidates within the fixed boundaries of a donation service area or region to a system based on a candidate's level of illness and distance from the donor hospital. The current liver allocation policy offers livers first to the sickest candidates within 500 nautical miles of the donor hospital using a series of distance-based concentric circles, called acuity circles. The processes used to develop the liver and lung allocation policies had various similarities and differences. For example, while the current liver allocation policy, the 2017 liver allocation policy, and the current lung allocation policy each had public comment periods, the length of these comment periods varied—25 days for the current liver allocation policy; two separate 62-day and 64-day periods for the 2017 liver allocation policy; and 61 days (retroactive) for the current lung allocation policy. In addition, the current lung allocation policy resulted in part from a federal district court order directing HHS to initiate emergency review of the policy. However, the 2017 liver allocation policy—that was approved but never implemented—resulted from a 2012 OPTN Board directive to reduce geographic disparities in organ allocation. HHS oversight of OPTN's processes were similar for all three allocation policies and included reviewing the proposed changes to the policies to ensure compliance with federal regulations, according to HHS officials. Timeline of Selected Events Related to Three Organ Allocation Policies Organ transplantation is the leading form of treatment for patients with severe organ failure. OPTN, a nonprofit entity that was established in 1984 under the National Organ Transplant Act, manages the nation's organ allocation system. In 2019, 32,322 organs were transplanted from deceased donors in the United States. Nevertheless, as of July 2020, close to 110,000 individuals remained on waiting lists for donor organs. Previously, donated livers and lungs were generally offered first to the sickest candidates in donation service areas. However, livers and lungs are now generally offered first to the sickest candidates based on distance. GAO was asked to review the changes to the liver and lung allocation policies. This report describes (1) changes to the liver allocation policy, and (2) similarities and differences in the processes OPTN used to change the liver and lung allocation policies, and federal oversight of these processes, among other things. GAO reviewed documents, including those related to the current liver and lung allocation policies, and the 2017 liver allocation policy; interviewed HHS officials and OPTN members; reviewed the National Organ Transplant Act and its implementing regulations; and conducted a literature review of studies published from January 2017 through April 2020 in peer-reviewed and other publications. HHS and the United Network for Organ Sharing (the contractor serving as OPTN) provided technical comments on a draft of this report, which GAO incorporated as appropriate. For more information, contact James Cosgrove at (202) 512-7114 or cosgrovej@gao.gov.
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