Accelerating Innovation in Diagnostic Testing for Lyme Disease: HHS Request for Information (RFI)

One tick bite can change your life – or the life of your child.

Diagnostics are just one of the many issues surrounding the multifaceted challenges of Lyme disease. Lyme disease is the most common vector-borne disease and fastest-growing vector-borne disease in the United States, accounting for over 80% of all tick-borne diseases domestically. The CDC estimates that approximately 476,000 Americans are diagnosed and treated for Lyme disease each year.

Lyme disease is a bacterial infection that, if untreated, progressively worsens and can debilitate. The longer one waits to treat Lyme disease, the harder it can be to eradicate. Lyme disease symptoms are similar to other illnesses and vary between patients, making diagnosis challenging. Most clinicians diagnose Lyme disease by using laboratory tests approved by the Food and Drug Administration (FDA) combined with information about a patient’s past exposure risk to ticks and symptoms.

Today’s FDA-approved diagnostic tests for Lyme disease are “indirect” tests, meaning they detect antibodies made by the human body in response to infection. Antibodies can take several weeks to develop, so patients may test negative if infected recently. For example, a patient with a recent tick bite and classic Lyme “bullseye rash” is likely to test negative, even though they have Lyme disease, because their immune system needs several weeks to develop the antibodies detected by the test. The FDA has yet to approve “direct” diagnostic tests for Lyme disease, which would measure active bacterial infection by detecting the presence or absence of Lyme-causing bacteria in the human body. 

For patients and clinicians, this current state of Lyme disease testing and diagnosis can be frustrating at best, and horrifically life-altering at worst.

LymeX: Changing the status quo, together

To address this need, HHS, through its LymeX Innovation Accelerator (LymeX) in partnership with the Steven & Alexandra Cohen Foundation, issued a Request for Information (RFI) on Lyme disease diagnostic tests.

This LymeX RFI aims to gather information on the current state of the science and development of Lyme disease diagnostic tests. The RFI also seeks to answer how technologies developed for COVID-19 diagnostics might be applicable to Lyme disease. The LymeX team expects COVID-19 science and breakthroughs will help usher in the next generation of Lyme disease diagnostic tests.

RFI questions include, but are not limited to:

  • What types of diagnostic technologies are being developed, or could be developed or adapted, to detect Lyme disease, including technologies and breakthroughs adapted from COVID-19 diagnostics with potential applications for Lyme disease (e.g., highly sensitive nucleic acid amplification testing [NAAT])?
  • What challenges exist in the implementation and use of Lyme disease diagnostic testing in clinical practice?
  • What challenges or barriers exist for the development and validation of innovative diagnostic tests for Lyme disease?

Accurate Lyme disease diagnostics are critical to advancing the field and LymeX success. As such, it’s one of our three LymeX focus areas: (1) stakeholder engagement and patient-centered innovation; (2) Lyme disease education and awareness, and; (3) diagnostics to accurately detect all stages of Lyme disease.

The LymeX team invites you to share your expertise related to this LymeX RFI. Your responses will inform the LymeX Diagnostic “Moonshot,” which will be a series of grand-prize challenges launching in 2021. Responses will also augment LymeX market research, which identified the need for improved diagnostic tests for all stages of Lyme disease. HHS will synthesize all LymeX RFI responses and publicly share an anonymized synthesis with the public. Check the HHS LymeX webpage or LymeX.org for updates.

Please submit your RFI responses to LymeInnovation@hhs.gov (subject: RFI RESPONSE) by 5:00 PM ET on March 15th, 2021.

More from: Office of the Assistant Secretary for Health (OASH)

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    GAO identified 59 for-profit college conversions that occurred from January 2011 through August 2020, almost all of which involved the college's sale to a tax-exempt organization. In about one-third of the conversions, GAO found that former owners or other officials were insiders to the conversion—for example, by creating the tax-exempt organization that purchased the college or retaining the presidency of the college after its sale (see figure). While leadership continuity can benefit a college, insider involvement in a conversion poses a risk that insiders may improperly benefit—for example, by influencing the tax-exempt purchaser to pay more for the college than it is worth. Once a conversion has ended a college's for-profit ownership and transferred ownership to an organization the Internal Revenue Service (IRS) recognizes as tax-exempt, the college must seek Department of Education (Education) approval to participate in federal student aid programs as a nonprofit college. Since January 2011, Education has approved 35 colleges as nonprofit colleges and denied two; nine are under review and 13 closed prior to Education reaching a decision. Figure: Example of a For-Profit College Conversion with Officials in Insider Roles IRS guidance directs staff to closely scrutinize whether significant transactions with insiders reported by an applicant for tax-exempt status will exceed fair-market value and improperly benefit insiders. If an application contains insufficient information to make that assessment, guidance says that staff may need to request additional information. In two of 11 planned or final conversions involving insiders that were disclosed in an application, GAO found that IRS approved the application without certain information, such as the college's planned purchase price or an appraisal report estimating the college's value. Without such information, IRS staff could not assess whether the price was inflated to improperly benefit insiders, which would be grounds to deny the application. If IRS staff do not consistently apply guidance, they may miss indications of improper benefit. Education has strengthened its reviews of for-profit college applications for nonprofit status, but it does not monitor newly converted colleges to assess ongoing risk of improper benefit. In two of three cases GAO reviewed in depth, college financial statements disclosed transactions with insiders that could indicate the risk of improper benefit. Education officials agreed that they could assess this risk through its audited financial statement review process and could develop procedures to do so. Until Education develops and implements such procedures for new conversions, potential improper benefit may go undetected. A for-profit college may convert to nonprofit status for a variety of reasons, such as wanting to align its status and mission. However, in some cases, former owners or other insiders could improperly benefit from the conversion, which is impermissible under the Internal Revenue Code and Higher Education Act of 1965, as amended. GAO was asked to examine for-profit college conversions. This report reviews what is known about insider involvement in conversions and to what extent IRS and Education identify and respond to the risk of improper benefit. GAO identified converted for-profit colleges and reviewed their public IRS filings. GAO also examined IRS and Education processes for overseeing conversions, interviewed agency officials, and reviewed federal laws, regulations and agency guidance. GAO selected five case study colleges based on certain risk factors, obtained information from college officials, and reviewed their audited financial statements. In three cases, GAO also reviewed Education case files. Because of the focus on IRS and Education oversight, GAO did not audit any college in this review to determine whether its conversion improperly benefitted insiders. GAO is making three recommendations, including that IRS assess and improve conversion application reviews and that Education develop and implement procedures to monitor newly converted colleges. IRS said it will assess its review process and will evaluate GAO's other recommendation, as discussed in the report. Education agreed with GAO's recommendation. For more information, contact Melissa Emrey-Arras at (617) 788-0534 or emreyarrasm@gao.gov.
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  • Navy Maintenance: Navy Report Did Not Fully Address Causes of Delays or Results-Oriented Elements
    In U.S GAO News
    The Navy's July 2020 report identified two key causes and several contributing factors regarding maintenance delays for aircraft carriers, surface ships, and submarines, but did not identify other causes. For public shipyards, the Navy's report identified the key cause of maintenance delays as insufficient capacity relative to growing maintenance requirements. For private shipyards, the Navy's report identified the key cause as the addition of work requirements after a contract is awarded. These causes and other identified factors generally align with factors that GAO has previously identified as originating during the maintenance process. However, the Navy's report did not consider causes and factors originating in the acquisition process or as a result of operational decisions, as shown below. GAO-Identified Factors Contributing to Maintenance Delays That the Navy Identified in Its July 2020 Report The report identified stakeholders needed to implement action plans, but did not fully incorporate other elements of results-oriented management, including achievable goals, metrics to measure progress, and resources and risks. Some examples from the report: Stakeholders: Identified Naval Sea Systems Command as the primary implementer of most initiatives related to maintenance at shipyards. Goals: Included a goal of reducing days of maintenance delay by 80 percent during fiscal year 2020.The Navy did not achieve this goal based on GAO's analysis of Navy data. Metrics: Included some metrics. The Navy is still identifying and developing other key metrics. Resources: Did not identify costs of the actions in the report. Risks: Identified as risks the coronavirus pandemic, unstable funding, and limited material availability. However, the report did not assess additional risks that GAO previously identified. The Navy generally has been unable to complete ship and submarine maintenance on time, resulting in reduced time for training and operations, and additional costs. The Navy's ability to successfully maintain its ships is affected by numerous factors throughout a ship's life cycle, such as decisions made during acquisition, which occurs years before a ship arrives at a shipyard for maintenance. Others manifest during operational use of the ship or during the maintenance process. The conference report accompanying a bill for the Fiscal Year 2020 Consolidated Appropriations Act directed the Secretary of the Navy to submit a report identifying the underlying causes of maintenance delays for aircraft carriers, surface ships, and submarines and to include elements of results-oriented management. The conference report also included a provision for GAO to review the Navy's report that was released in July 2020. This report evaluates the extent to which the Navy's report (1) identifies the underlying causes of maintenance delays and (2) incorporates elements of results-oriented management. GAO reviewed the Navy's report and interviewed Navy officials. Since 2015, GAO has made 39 unclassified recommendations related to Navy maintenance delays. The Navy or the Department of Defense concurred or partially concurred with 37 recommendations, and had implemented six of them as of September 2020. For more information, contact Diana Maurer at (202) 512-9627 or MaurerD@gao.gov.
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  • Priority Open Recommendations: Nuclear Regulatory Commission
    In U.S GAO News
    What GAO Found In April 2020, GAO identified seven priority recommendations for the Nuclear Regulatory Commission (NRC). Since then, NRC implemented one of these recommendations by issuing a risk management strategy that addresses key elements foundational to effectively managing cybersecurity risks. The remaining six priority recommendations involve the following areas: addressing the security of radiological sources. improving the reliability of cost estimates. improving strategic human capital management. NRC's continued attention to these issues could lead to significant improvements in government operations. Why GAO Did This Study Priority open recommendations are the GAO recommendations that warrant priority attention from heads of key departments or agencies because their implementation could save large amounts of money; improve congressional and/or executive branch decision-making on major issues; eliminate mismanagement, fraud, and abuse; or ensure that programs comply with laws and funds are legally spent, among other benefits. Since 2015, GAO has sent letters to selected agencies to highlight the importance of implementing such recommendations. For more information, contact Mark Gaffigan at (202) 512-3841 or gaffiganm@gao.gov.
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  • Higher Education: IRS And Education Could Better Address Risks Associated with For-Profit College Conversions
    In U.S GAO News
    What GAO Found In its December 2020 report, GAO identified 59 for-profit college conversions that occurred from January 2011 through August 2020. A for-profit college may convert to nonprofit status for different reasons. In about one-third of the conversions, GAO found that former owners or other officials were insiders to the conversion—for example, by creating the tax-exempt organization that purchased the college or retaining the presidency of the college after its sale (see figure). While leadership continuity can benefit a college, insider involvement in a conversion poses a risk that insiders may improperly benefit—for example, by influencing the tax-exempt purchaser to pay more for the college than it is worth. Once a conversion has ended a college's for-profit ownership and transferred ownership to an organization the Internal Revenue Service (IRS) recognizes as tax-exempt, the college must seek Department of Education approval to participate in federal student aid programs as a nonprofit college. GAO also found in its December 2020 report that Education had approved 35 colleges as nonprofit colleges since January 2011 and denied two; nine were under review and 13 closed prior to Education reaching a decision. Figure: Example of a For-Profit College Conversion with Officials in Insider Roles IRS guidance directs staff to closely scrutinize whether significant transactions with insiders reported by an applicant for tax-exempt status will exceed fair-market value and improperly benefit insiders. If an application contains insufficient information to make that assessment, guidance says that staff may need to request additional information. In its December 2020 report, GAO found that for two of 11 planned or final conversions involving insiders that were disclosed in an application, IRS approved the application without certain information, such as the college's planned purchase price or an appraisal report estimating the college's value. Without such information, IRS staff could not assess whether the price was inflated to improperly benefit insiders, which would be grounds to deny the application. If IRS staff do not consistently apply guidance, they may miss indications of improper benefit. Education has strengthened its reviews of for-profit college applications for nonprofit status, but it does not monitor newly converted colleges to assess ongoing risk of improper benefit. In two of three cases GAO reviewed in depth for its December 2020 report, college financial statements disclosed transactions with insiders that could indicate the risk of improper benefit. Education officials agreed that they could develop procedures to assess this risk through its audited financial statement reviews. Until Education develops and implements such procedures for new conversions, potential improper benefit may go undetected. Why GAO Did This Study A for-profit college may convert to nonprofit status for a variety of reasons, such as wanting to align its status and mission. However, in some cases, former owners or other insiders could improperly benefit from the conversion, which is impermissible under the Internal Revenue Code and Higher Education Act of 1965, as amended. This statement—based on GAO's December 2020 report (GAO-21-89)—discusses what is known about insider involvement in conversions and the extent to which IRS and Education identify and respond to the risk of improper benefit. We also requested updates from IRS and Education officials on any agency actions taken to implement the December 2020 report recommendations.
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  • Taxpayer Service: IRS Could Improve the Taxpayer Experience by Using Better Service Performance Measures
    In U.S GAO News
    The Internal Revenue Service's (IRS) mission and strategic plan state expectations for IRS to improve the taxpayer experience and services it provides. However, IRS and its divisions that manage programs serving the largest taxpayer groups—the Wage and Investment (W&I) and the Small Business/Self-Employed (SB/SE) divisions—did not have performance goals to specify the desired improvements. For example, W&I aligned its service programs to IRS's strategic objectives for taxpayer services that state broad types of management activities such as monitoring the taxpayer experience and addressing issues. However, it did not have performance goals that specify outcomes to improve the taxpayer experience, such as reducing taxpayer wait times for telephone assistance. Because IRS and these two divisions do not have performance goals for improving the taxpayer experience, IRS does not have related performance measures. IRS has many performance measures—including more than 80 for W&I and SB/SE—for assessing the services it provides, such as related to timeliness and accuracy of information provided to taxpayers. However, these existing measures do not assess improvements to the taxpayer experience, such as whether tax processes were simpler or specific services met taxpayers' needs. The division-level measures also lack targets for improving the taxpayer experience. Further, the existing measures do not capture all of the key factors identified in Office of Management and Budget guidance for how customers experience federal services, including customer satisfaction and how easy it was to receive the services. As a result, IRS does not have complete information about how well it is satisfying taxpayers and improving their experiences. IRS analyzes its taxpayer service measures to compare performance with targets but the analyses provide few insights and no recommendations to improve the taxpayer experience, such as to provide more timely tax filing guidance. Also, IRS does not have a process to use service measures to guide decisions on allocating resources to improve the taxpayer experience. As a result, IRS is challenged to use performance data to balance resource allocation for efforts to improve the taxpayer experience compared with other IRS efforts. Finally, IRS reports limited information to the public about performance related to the taxpayer experience for transparency and accountability. The table below summarizes important management practices that IRS did not fully follow to provide taxpayers a top-quality service experience. According to IRS, providing top-quality service is a critical part of its mission to help taxpayers understand and meet their tax responsibilities. Congress, the National Taxpayer Advocate, and the administration have recognized the importance of improving how taxpayers experience IRS services. Setting goals and objectives with related performance measures and targets are important tools to focus an agency's activities on achieving mission results. GAO was asked to review IRS's customer service performance measures. This report assesses IRS's (1) goals and objectives to improve the taxpayer experience; (2) performance measures to support improved experiences; and (3) use of performance information to improve the experience, allocate resources, and report performance. To assess IRS's goals, measures, targets, and use of them, GAO compared IRS's practices to key practices in results-oriented management. GAO is making 7 recommendations, including that IRS identify performance goals, measures, and targets; as well as analyze performance; develop processes to make decisions on resources needed; and report performance on improving the taxpayer experience. IRS indicated that it generally agreed with the recommendations, but that details around their implementation were under consideration and would be provided at a later date. For more information, contact Jessica Lucas-Judy at (202) 512-9110 or LucasJudyJ@gao.gov.
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  • Farm Programs: USDA Should Take Additional Steps to Ensure Compliance with Wetland Conservation Provisions
    In U.S GAO News
    What GAO Found The U.S. Department of Agriculture's (USDA) Natural Resources Conservation Service (NRCS) has taken steps to increase the consistency of their determinations about where wetlands exist on farmers' lands. For example, NRCS state offices formed teams to make such determinations in the prairie pothole region (see fig.), which covers parts of Iowa, Minnesota, North Dakota, and South Dakota. These offices also standardized their wetland determination procedures and included more details, such as the types of data that can be used to identify wetland boundaries. Under wetland conservation provisions in federal law, to receive the benefits of certain USDA farm programs, farmers must not convert wetlands to cropland. Wetlands and Cropland in the Prairie Pothole Region NRCS's primary method to ensure compliance with wetland conservation provisions is conducting annual compliance checks of selected tracts of land for farmers in USDA programs. To select tracts, NRCS draws a national random sample. The sample is to include about 1 percent of tracts subject to wetland the provisions nationally, so many tracts are not sampled for years. For 2014 through 2018, NRCS identified fewer than five farmers with wetland conservation violations per year on the approximately 417,000 tracts in North Dakota and South Dakota—the states with the most wetland acres. Agency officials said NRCS has limited resources to conduct more checks. However, some USDA agencies emphasize risk-based criteria, rather than a random sample, in selecting tracts to check for compliance with other provisions. Doing so makes the checks more efficient by targeting the tracts most likely to have violations. If NRCS used a risk-based approach for its compliance checks (e.g., using information on acres cultivated annually on tracts), it could more efficiently ensure compliance with wetland conservation provisions. If NRCS finds violations, USDA's Farm Service Agency (FSA) may withhold program benefits from farmers, or it may grant waivers to farmers who acted in good faith, without intent to commit violations. FSA granted 243 of 301 requests for good-faith waivers from 2010 to 2018, according to FSA data. FSA relies on committees of fellow farmers to decide on waivers by considering factors such as prior violations. GAO found that some committees relied on weak justification to grant waivers even if farmers had prior violations and that FSA had not specified what is adequate justification. By specifying what constitutes adequate justification, FSA could better ensure it provides benefits only to eligible farmers. Why GAO Did This Study Wetlands perform vital ecological functions, and draining them can harm water quality and wildlife habitat. Many wetlands were drained for farming before enactment of wetland conservation provisions in 1985. However, millions of acres of wetlands, known as potholes, remain in the prairie pothole region. NRCS determines where wetlands exist on the land of farmers who participate in USDA farm programs, and it identifies violations of wetland provisions. FSA administers farm program benefits. In 2017, USDA's Office of Inspector General reported that NRCS had implemented wetland determination procedures in the prairie pothole region inconsistently. GAO was asked to review USDA's implementation of wetland conservation provisions in the prairie pothole region. This report examines, among other objectives, the steps NRCS has taken to increase the consistency of wetland determinations and the approaches NRCS and FSA use to ensure compliance with the provisions. GAO reviewed agency manuals, data, and files on wetland determinations and waivers, and interviewed agency officials and stakeholder groups.
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    In U.S GAO News
    GAO reviewed 11 selected committees covered under the Federal Advisory Committee Act (FACA) that serve the Departments of Commerce, Health and Human Services, and the Treasury. GAO found that these committees met many, but not all, selected transparency requirements established by FACA, General Services Administration (GSA) FACA regulations, and the Office of Management and Budget (OMB). FACA committees GAO reviewed published timely notices for 70 of 76 meetings and solicited public comments for all open meetings held by the committees. However, four of the 11 committees did not follow one or more selected requirements to renew charters, decide on proposed recommendations during open meetings, or compile minutes. Five FACA committees GAO reviewed did not always follow requirements in OMB Circular A-130 for federal agencies to make public documents accessible online. GSA encourages agencies to post committee documents online consistent with OMB requirements. However, according to GSA's Office of the General Counsel, GSA's authority under FACA is not broad enough to require agencies to fulfill the OMB requirements. Eight of the nine selected FACA committees in our original sample that make recommendations to agencies attempt to track the agencies' responses to and implementation status of recommendations. However, many committees do not make this information fully available to the public online. Improved public reporting could enhance congressional and public visibility into the status of agencies' responses to committee recommendations. Selected Requirements for Advisory Committees Covered under the Federal Advisory Committee Act (FACA) The selected agencies and FACA committees reported that they implemented a range of practices to help ensure agency officials do not exert inappropriate influence on committees' decisions. These practices include limiting committee members' interactions with agency officials outside committee meetings. GAO also found that about 29 percent of the 11 selected committees' cost data elements in GSA's FACA database for fiscal years 2017 and 2018 were inconsistent with corresponding cost data from selected agency and committee records and systems. In the absence of reliable cost data, Congress is unable to fully rely on these data to inform decisions about funding FACA committees. FACA requires federal agencies to ensure that federal advisory committees make decisions that are independent and transparent. In fiscal year 2019, nearly 960 committees under FACA played a key role in informing public policy and government regulations. GAO was asked to review the transparency and independence of FACA committees and data collected in GSA's FACA database. This report examines (1) selected agencies' and committees' adherence to transparency requirements; (2) their practices to help ensure that agency officials do not exert inappropriate influence on committee decision-making; and (3) the extent to which GSA's FACA database contained accurate, complete, and useful cost information for these committees. GAO selected a non-generalizable sample of 11 FACA committees serving three agencies, based in part on costs incurred and numbers of recommendations made. GAO analyzed documents and interviewed agency officials and committee members. GAO also reviewed FACA database cost data for the 11 committees. Congress should consider requiring online posting of FACA committees' documents. GAO is also making nine recommendations to agencies to improve FACA committee transparency and data accuracy. Agencies agreed with six recommendations, and GSA described steps to address recommendations to it. For more information, contact Michelle Sager at (202) 512-6806 or SagerM@gao.gov.
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    Literature GAO reviewed indicated that private insurance payments for anesthesia services on average were more than 3-1/2 times those of Medicare payments. This payment difference increased from what GAO reported in 2007—average private insurance payments for certain anesthesia services in 2004 were about 3 times those of Medicare. While Medicare rates for anesthesia services are set by the Centers for Medicare & Medicaid Services (CMS), private insurance rates are set through negotiations between providers and private insurers. GAO identified three recent studies with analyses of private insurance and Medicare payments for anesthesia services: Researchers from Yale University calculated that private insurance payments were 3.67 times Medicare payments, on average, for services provided by anesthesiologists for one large private insurer in 2015 operating across all 50 states and the District of Columbia. The Health Care Cost Institute calculated that in 2017 private insurance payments ranged from 2 to 7 times Medicare payments, on average, across six common services provided by anesthesiologists in 33 states. Wide state-to-state variation within specific services was reported. The American Society of Anesthesiologists reported that private insurance payments were 3.46 times Medicare payments, on average, based on a survey of its members in 2019. According to studies GAO reviewed and stakeholders GAO interviewed, market factors likely enhanced anesthesia providers' negotiating position and allowed them to secure higher private payments. For example, several studies and stakeholders cited market concentration as a key factor that increased private payments for anesthesia services. In a market with high provider concentration—or relatively few providers in a given market—there is little competition between providers, enabling the providers within that market to negotiate for higher payments from private insurers. Studies also indicated that specialists, including anesthesia providers, could negotiate higher in-network payment rates because they were able to leave an insurer's network with little risk of losing patients or revenue. In addition, when anesthesia providers are not a part of a private insurer's network, they are typically able to bill for a higher amount than the insurer would pay for an in-network provider, known as out-of-network billing. This dynamic decreases providers' incentives to participate in insurer networks because it creates an attractive alternative to network participation. GAO's interviews with stakeholders, literature review, and review of agency data generally did not indicate that the supply of anesthesia providers was insufficient for Medicare beneficiaries. CMS data indicate that the number of active anesthesia providers per 100,000 Medicare beneficiaries increased from 2010 through 2018 and that a very small number of anesthesia providers opted out of the Medicare program. Furthermore, researchers and stakeholders GAO interviewed were not aware of any issues with access to anesthesia services for Medicare beneficiaries, including those in traditionally underserved rural areas. In 2018, Medicare paid over $2 billion for anesthesia services, such as general anesthesia administered to beneficiaries undergoing surgical or other invasive procedures. The joint explanatory statement for the Further Consolidated Appropriations Act, 2020 included a provision for GAO to update its 2007 report and examine how differences in payment rates for anesthesia services have changed since that time. In 2007, GAO reported that Medicare payments in 2004 for certain anesthesia services provided by anesthesiologists were on average 67 percent lower than private insurance payments in certain geographic areas—indicating that private payments were about 3 times more than Medicare payments at that time. This report describes what is known about (1) recent trends in differences between Medicare and private payments for anesthesia services, and (2) the sufficiency of the supply of anesthesia providers for Medicare beneficiaries. GAO reviewed literature and available published data on payment differences for anesthesia services, published in the United States since 2010. GAO also reviewed data from CMS on the number of anesthesia providers from 2010, 2018, and 2020. GAO also interviewed a nongeneralizable selection of three research groups, two beneficiary advocacy groups, and five stakeholder groups, including those representing anesthesiologists, nurse anesthetists, and hospitals, to obtain their perspectives on these issues. The Department of Health and Human Services provided no comments on this report. For more information, contact Jessica Farb at (202) 512-7114 or farbj@gao.gov.
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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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