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    Results:

    Subject Term: Diseases

    9 publications with a total of 21 open recommendations including 1 priority recommendation
    Director: Kathryn A. Larin
    Phone: (202) 512-7215

    8 open recommendations
    Recommendation: To ensure expedited processing of disability claims through CAL is consistent and accurate, the Acting Commissioner of Social Security should develop a formal and systematic approach to gathering information to identify potential conditions for the CAL list, including by sharing information through SSA's website on how to propose conditions for the list and by utilizing research that is directly applicable to identifying CAL conditions.

    Agency: Social Security Administration
    Status: Open

    Comments: SSA agreed with this recommendation. In November 2017, SSA reported that it had revised the CAL website to provide an explanation of how to suggest a Compassionate Allowance initiative (CAL) condition and how the agency will evaluate suggestions. SSA also planned to sponsor a National Disability Forum in November 2017 to provide experts and patient organizations in the field of rare and debilitating diseases another opportunity to share research and suggestions for new CAL conditions. We will consider closing this recommendation when the agency provides evidence that it has utilized research that is directly applicable to identifying CAL conditions.
    Recommendation: To ensure expedited processing of disability claims through CAL is consistent and accurate, the Acting Commissioner of Social Security should develop formal procedures for consistently notifying those who propose conditions for the CAL list of the status of their proposals.

    Agency: Social Security Administration
    Status: Open

    Comments: SSA agreed with this recommendation and updated its Compassionate Allowance initiative (CAL) website to describe how the agency will keep stakeholders informed of their status in evaluating suggestions. Further, SSA reported in November 2017 that it plans to update the website to include information on process timeframes, including when stakeholders who have submitted a potential CAL condition for agency consideration can expect to hear from SSA. We will consider closing this recommendation once the agency has completed these website updates.
    Recommendation: To ensure expedited processing of disability claims through CAL is consistent and accurate, the Acting Commissioner of Social Security should develop and communicate internally and externally criteria for selecting conditions for the CAL list.

    Agency: Social Security Administration
    Status: Open

    Comments: SSA agreed with this recommendation and stated that it has several relevant activities underway. SSA reported that it completed a survey of the disability determination services staff regarding several aspects of CAL in October 2017. SSA also plans to begin a quality review process to obtain feedback on CAL conditions and other issued raised by GAO's review. In addition, SSA plans to revise its website based on feedback from the survey and its quality reviews.
    Recommendation: To ensure expedited processing of disability claims through CAL is consistent and accurate, the Acting Commissioner of Social Security should take steps to obtain information that can help refine the selection software for CAL claims, for example by using management data, research, or DDS office feedback.

    Agency: Social Security Administration
    Status: Open

    Comments: SSA agreed with this recommendation and reported that it completed a survey of disability determination services staff in October 2017 that included several questions about CAL policy, process, and conditions. SSA plans to analyze the survey results to identify opportunities to further refine its CAL selections. We will consider closing this recommendation when the agency provides evidence that it has used this disability determination services office feedback or other management data or research to refine the selection software for CAL claims.
    Recommendation: To ensure expedited processing of disability claims through CAL is consistent and accurate, the Acting Commissioner of Social Security should clarify written policies and procedures regarding when manual addition and removal of CAL flags should occur on individual claims.

    Agency: Social Security Administration
    Status: Open

    Comments: SSA agreed with this recommendation and stated that it has two activities underway to assess opportunities to improve CAL procedures. SSA completed a survey of disability determination services staff in October 2017. The survey included several questions focused on how adjudicators understand and implement procedures for manually adding or removing CAL case flags. In addition, in fiscal year 2018, SSA plans to begin a special quality review process that focuses on CAL flag use. SSA reported that it will use results of the survey and quality reviews to improve CAL procedures.
    Recommendation: To ensure expedited processing of disability claims through CAL is consistent and accurate, the Acting Commissioner of Social Security should assess the reasons why the uses of manual actions vary across DDS offices to ensure that they are being used appropriately.

    Agency: Social Security Administration
    Status: Open

    Comments: SSA agreed with this recommendation. SSA plans to use results from its October 2017 disability determination services survey and fiscal year 2018 quality reviews of CAL flag use to assess why manual actions vary across disability determination services offices. SSA stated that these results may prompt the agency to conduct further data analysis or modify CAL procedures and training.
    Recommendation: To ensure expedited processing of disability claims through CAL is consistent and accurate, the Acting Commissioner of Social Security should develop a schedule and a plan for updates to the CAL impairment summaries to ensure that information is medically up to date.

    Agency: Social Security Administration
    Status: Open

    Comments: SSA agreed with this recommendation and stated that the agency has drafted an internal business process document to ensure all impairment summaries are current. The business process identified how and when SSA will complete and document its review of an revisions to the CAL impairment summaries. SSA reported that it will implement the process once it has been finalized.
    Recommendation: To ensure expedited processing of disability claims through CAL is consistent and accurate, the Acting Commissioner of Social Security should develop a plan to regularly review and use available data to assess the accuracy and consistency of CAL decision-making.

    Agency: Social Security Administration
    Status: Open

    Comments: SSA agreed with this recommendation and stated that it has drafted a protocol for an ongoing review of CAL allowances and denials. The plan is currently under review, and once finalized, SSA said they will review a nationally valid sample of CAL determinations on an ongoing basis. SSA said that it will share study results with policy and other internal stakeholders, as needed.
    Director: Persons, Timothy M
    Phone: (202) 512-6412

    4 open recommendations
    Recommendation: The Secretary of Health and Human Services should direct the Commissioner of the Food and Drug Administration to consolidate information from individual diagnostic test labels and make this information available in a form that enables users to more readily compare information across tests.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: In August 2017, officials from the Department of Health and Human Services told us that the Food and Drug Administration is working to consolidate and make available on its website information for Zika virus diagnostic tests that have emergency use authorization.
    Recommendation: The Secretary of Health and Human Services should direct the Commissioner of the Food and Drug Administration to require manufacturers to list the identity of comparator assays on their diagnostic test labels.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: In August 2017, officials from the Department of Health and Human Services told us that the Food and Drug Administration plans to recommend to sponsors of Zika virus diagnostic tests that they provide a description of the comparator assay.
    Recommendation: The Secretary of Health and Human Services should direct the Director of Centers for Disease Control and Prevention to establish a transparent process to provide CDC diagnostic tests, upon request, to manufacturers that are in the final stages of diagnostic test authorization.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: In August 2017, officials from the Department of Health and Human Services told us that the Centers for Disease Control and Prevention (CDC) Technology Transfer Office is working to establish a transparent process that ensures CDC diagnostic tests can be provided to manufacturers.
    Recommendation: The Secretary of Health and Human Services should direct the Director of Centers for Disease Control and Prevention to include information on CDC-developed tests distributed to or shared with public health laboratories on CDC's website, including laboratory developed tests.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: In August 2017, officials from the Department of Health and Human Services told us the Centers for Disease Control and Prevention (CDC) provides information on CDC-developed diagnostic tests on the Food and Drug Administration?s (FDA) website. CDC stated that their website will feature a direct link to FDA information on CDC-developed tests. CDC will continue to explore additional outlets for publication of information on CDC-developed diagnostic tests.
    Director: Kathleen King
    Phone: (202) 512-7114

    1 open recommendations
    including 1 priority recommendation
    Recommendation: To help ensure that timely primary care is available and accessible to AI/AN people, the Secretary of HHS should direct the Director of IHS to monitor patient wait times in its federally operated facilities and ensure corrective actions are taken when standards are not met.

    Agency: Department of Health and Human Services
    Status: Open
    Priority recommendation

    Comments: As of June 2017, according to IHS, the implementation of an agency-wide standard for patient wait times will be accomplished as follows: A decision will be made on the standard to be used, by the IHS Director no later than July 2017. Using a pilot sample of facilities (two to four facilities), the standard will be assigned to the Area Directors over the selected pilot facilities in October 2017. Systems of measurement will be decided and communicated to the Area Directors for the pilot facilities. By December 31, 2017, three months of activity will be analyzed and evaluated against the standard. Between January and March, 2018, adjustments to the necessary systems of measure, or adjustments to the reasonably expected performance standard will be made. A final evaluation will be performed not later than September 2018, and final adjustments will be made to either the measurement system or the standard to allow for full implementation of the standard across all IHS Areas by October, 2018.
    Director: Andrew Sherrill
    Phone: (202) 512-7215

    1 open recommendations
    Recommendation: To enhance consistency with DOL policy and procedures in adjudicating EEOICPA Part E claims, the Secretary of Labor should strengthen internal controls by requiring district offices to take steps to ensure that all claimant correspondence for Recommended and Final Decisions receives supervisory review.

    Agency: Department of Labor
    Status: Open

    Comments: The Department of Labor agreed with our recommendation that a second level review will provide a higher degree of internal quality control. However, upon evaluating our recommendation, Labor determined that given its current staffing levels it would not be possible to conduct a supervisory review of all Recommended and Final Decisions without having an adverse impact on the issuance of timely decisions for claimants. Instead, Labor is implementing a process to review a sample of decision letters - initially 10 percent - and make procedural adjustments based on the results of those reviews. We will revisit the status of this recommendation pending the results of Labor's supervisory reviews of selected decision letters.
    Director: Gerald Dillingham, Ph.D
    Phone: (202) 512-2834

    1 open recommendations
    Recommendation: To help improve the U.S. aviation sector's preparedness for future communicable disease threats from abroad, the Secretary of Transportation should work with relevant stakeholders, such as the Department of Health and Human Services, to develop a national aviation-preparedness plan for communicable disease outbreaks. Such a plan could establish a mechanism for coordination between the aviation and public health sectors and provides clear and transparent planning assumptions for a variety of types and levels of communicable disease threats.

    Agency: Department of Transportation
    Status: Open

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Director: Linda Kohn
    Phone: (202) 512-7114

    3 open recommendations
    Recommendation: To ensure effective implementation of the Inclusion Policy in a manner consistent with the Revitalization Act's provisions regarding the design of certain clinical trials, the NIH Director should examine approaches for aggregating more detailed enrollment data at the disease and condition level, and report on the status of this examination to key stakeholders and through its regular biennial report to Congress on the inclusion of women in research.

    Agency: Department of Health and Human Services: Public Health Service: National Institutes of Health
    Status: Open

    Comments: NIH agreed with our recommendation and began discussions in November 2015 regarding conducting these types of analyses. In April and May 2016, NIH officials identified a preliminary strategy for summarizing inclusion data at the disease and condition level. As of August 2017, NIH officials said that due to potential data limitations, NIH will continue to refine methods of reporting at this level, and the agency plans to report enrollment data at the disease and condition level in its next triennial NIH report to Congress, covering fiscal years 2015-2017, to be drafted in fiscal year 2018.
    Recommendation: To ensure effective implementation of the Inclusion Policy in a manner consistent with the Revitalization Act's provisions regarding the design of certain clinical trials, the NIH Director should, on a regular basis, systematically collect and analyze summary data regarding awardees' plans to conduct analyses of potential sex differences, such as the proportion of trials being conducted that intend to analyze differences in outcomes for men and women.

    Agency: Department of Health and Human Services: Public Health Service: National Institutes of Health
    Status: Open

    Comments: In August 2017, NIH reiterated that the agency has established a number of policies and processes to ensure that sex differences are considered in the design of research, but has not taken action specific to this recommendation. We continue to believe that thoughtful, useful analysis and summary reporting would improve NIH's oversight of this aspect of the Inclusion Policy.
    Recommendation: To ensure effective implementation of the Inclusion Policy in a manner consistent with the Revitalization Act's provisions regarding the design of certain clinical trials, the NIH Director should report on this summary data and the results of this analysis in NIH's regular biennial report to Congress on the inclusion of women in research.

    Agency: Department of Health and Human Services: Public Health Service: National Institutes of Health
    Status: Open

    Comments: NIH agreed with our recommendation in commenting on our report. In August 2017, NIH reiterated that the agency has established a number of policies and processes to ensure that sex differences are considered in the design of research, but has not taken action specific to this recommendation. We continue to believe that thoughtful, useful analysis and summary reporting would improve NIH's oversight of this aspect of the Inclusion Policy.
    Director: Currie, Christopher
    Phone: (404)679-3000

    1 open recommendations
    Recommendation: In order to help build and maintain a national biosurveillance capability in a manner that accounts for the particular challenges and opportunities of reliance on state and local partnerships, we recommend the Homeland Security Council direct the National Security Staff to take the following action as part of its implementation of our previous recommendation for a national biosurveillance strategy: Ensure that the national biosurveillance strategy (1) incorporates a means to leverage existing efforts that support nonfederal biosurveillance capabilities, (2) considers challenges that nonfederal jurisdictions face in building and maintaining biosurveillance capabilities, and (3) includes a framework to develop a baseline and gap assessment of nonfederal jurisdictions' biosurveillance capabilities.

    Agency: Executive Office of the President: Homeland Security Council
    Status: Open

    Comments: In June 2010, GAO recommended a national biosurveillance strategy to provide a framework for building and maintaining a national biosurveillance capability. In October 2011, building on that recommendation, we called for such a strategy to address key challenges we identified in state and local biosurveillance by accounting for the need to leverage nonfederal resources. In July 2012, the White House released the National Strategy for Biosurveillance. A strategic implementation plan was to be published within 120 days of strategy issuance. The July 2012 strategy did not adequately address the issues we raised related to state and local biosurveillance and acknowledged but did not meaningfully address the need to leverage nonfederal resources. As of March 14, 2013 the implementation plan has not been released.
    Director: Currie, Christopher
    Phone: (404)679-3000

    1 open recommendations
    Recommendation: In order to help build and maintain a national biosurveillance capability---an inherently interagency enterprise---the Homeland Security Council should direct the National Security Staff to, in coordination with relevant federal agencies, charge this focal point with the responsibility for developing, in conjunction with relevant federal agencies, a national biosurveillance strategy that: 1) defines the scope and purpose of a national capability; 2) provides goals, objectives and activities, priorities, milestones, and performance measures; 3) assesses the costs and benefits associated with supporting and building the capability and identifies the resource and investment needs, including investment priorities; 4) clarifies roles and responsibilities of leading, partnering, and supporting a national capability; and 5) articulates how the strategy is integrated with and supports other related strategies' goals, objectives, and activities.

    Agency: Executive Office of the President: Homeland Security Council
    Status: Open

    Comments: In July 2012, the White House released the National Strategy for Biosurveillance to describe the U.S. government's approach to strengthening biosurveillance. A strategic implementation plan was to be completed within 120 days of the strategy issuance. As we testified in September 2012, the strategy did not fully meet the intent of our recommendation; however, when the implementation plan is complete, it may meet our recommendation. Specifically, the strategy did not provide the mechanism GAO recommended to identify resource and investment needs, including investment priorities. As of September 2015, GAO has not received a copy of the implementation plan for review and has not been able to confirm that it has been finalized and is considered operational by the White House and the key interagency partners.
    Director: Cosgrove, James C
    Phone: (202)512-7029

    1 open recommendations
    Recommendation: To help ensure that changes in Medicare payment methods for dialysis care do not adversely affect beneficiaries, the Administrator of CMS should monitor the access to and quality of dialysis care for groups of beneficiaries, particularly those with above average costs of dialysis care, under the new bundled payment system. Such monitoring should begin as soon as possible once the new bundled payment system is implemented and be used to inform potential refinements to the payment system.

    Agency: Department of Health and Human Services: Centers for Medicare and Medicaid Services
    Status: Open

    Comments: In March 2010, we recommended that the Administrator of CMS monitor the access to and quality of dialysis care for groups of beneficiaries, particularly those with above average costs, under the new bundled payment system to help ensure that changes in the Medicare payment methods for dialysis care do not adversely affect. We further specified that such monitoring begin as soon as possible once the new bundled payment system is implemented. CMS implemented the expanded bundled payment system for dialysis care in January 2011. As of August 2011, CMS is collecting data on dialysis care utilization that could be used to examine access to and quality of dialysis care by groups of beneficiaries. Although CMS anticipates using these data to identify potential problems in dialysis care, the agency has not begun using these data to examine access to and quality of care by groups of beneficiaries, nor has finalized plans to do so.