Recommendation: The Secretary of Veterans Affairs should ensure that the role and responsibilities of the Interagency Program Office are clearly defined within the governance plans for acquisition of the department's new electronic health record system. (Recommendation 1)

Agency: Department of Veterans Affairs
Status: Open
Priority recommendation

Comments: The Department of Veterans Affairs (VA) concurred with our recommendation to ensure that the role and responsibilities of the Interagency Program Office (IPO) were clearly defined within the governance plans for acquisition of the department's new electronic health record system. As of December 2019, VA and the Department of Defense (DOD) have replaced the IPO with a new joint governance body. Specifically, the Federal Electronic Health Record Modernization (FEHRM) program office has been established to serve as the single point of accountability in the delivery of a common health record between the departments and the advancement of interoperability with the private sector. In its charter, the FEHRM was described as a single decision-making authority to manage issues in support of the departments' integrated electronic health record objectives and its leadership is responsible for, among other things, working to formulate, oversee, de-conflict, and ensure adherence to electronic health record-related VA and DOD policies. However, the corresponding Implementation Plan that is intended to document how the FEHRM executes its full responsibilities has yet to be issued. To fully implement this recommendation, VA needs to document the role and responsibilities of the FEHRM with respect to VA's acquisition of its new electronic health record system, explaining the role, if any, the FEHRM will have in the governance process. We will continue to monitor the departments' incorporation of the FEHRM into the plans for the ongoing acquisition.

Recommendation: To better understand the available opportunities for collecting inmate health care utilization data, BOP should conduct a cost-effectiveness analysis of potential solutions, and take steps toward implementation of the most effective solution.

Agency: Department of Justice: Bureau of Prisons
Status: Open

Comments: BOP agreed with GAO's June 2017 recommendation and has begun to take steps to address it. In 2018, BOP contracted with a management consulting firm to improve organizational alignment and strengthen data analytics capabilities. This firm is also examining data analytics solutions and by late March 2020 is expected to make recommendations to BOP to support a request for purchase (RFP) for the most cost-effective one. BOP anticipates the RFP will then follow within the subsequent three months. This contracting work is a positive step that should help BOP identify the most cost-effective solution to collect health care utilization data. BOP is still in the early stages of implementing this action, therefore it is too soon to assess whether its efforts will fully address GAO's recommendation. However, once these actions are completed, BOP could be better positioned to find a solution for collecting the needed data.

Recommendation: To better understand the available opportunities for controlling health care costs, BOP should implement its guidance to conduct "spend analyses" of BOP's health care spending, using data sources already available

Agency: Department of Justice: Bureau of Prisons
Status: Open

Comments: BOP agreed with GAO's June 2017 recommendation and has begun to take steps to address it. In 2018, BOP contracted with a management consulting firm to identify opportunities to improve organizational alignment and strengthen data analytics capabilities. As part of this effort, BOP also contracted with a health care finance expert, who began working with BOP Health Services Division in June 2019. The expert has met with subject matter experts across disciplines to identify reliable sources for medical cost data, including medical activities data, staffing data, and medical cost data to support conducting spend analyses. BOP expects this effort to be completed by late spring 2020. This contracting work is a positive step toward implementing BOP's spend analysis guidance; however, since BOP has not yet completed this effort, it is too soon to assess whether BOP's efforts will fully address GAO's recommendation. Once BOP has completed this effort, it could be better positioned to identify opportunities for controlling health care costs.

Recommendation: To determine the actual or likely effectiveness of its ongoing or planned health care cost control initiatives, BOP should evaluate the extent to which its initiatives achieve their cost control aim.

Agency: Department of Justice: Bureau of Prisons
Status: Open

Comments: BOP agreed with GAO's June 2017 recommendation and has begun to take steps to address it. In 2018, BOP contracted with a management consulting firm to identify opportunities to improve organizational alignment and strengthen data analytics capabilities. As part of this effort, BOP also contracted with a health care finance expert, who began working with BOP Health Services Division in June 2019. BOP is working with this expert to validate existing financial data sources and apply a standardized cost accounting model to evaluate the cost effectiveness of key health care cost control initiatives. According to BOP, the model is being developed in phases with the initial phase expected to be completed by late March 2020. The second phase of the model is scheduled to launch in October 2020. This is a positive step that will better position BOP to evaluate its health care cost control initiations. Since BOP has not yet completed this effort, it is therefore too soon to assess whether its efforts will fully address GAO's recommendation. However, once BOP has completed this effort, it could help BOP evaluate the effectiveness of its health care cost control initiatives.

Recommendation: To enhance its strategic planning for and implementation of health care cost control efforts, BOP should incorporate elements of a sound planning approach and (1) establish a means of measuring progress toward and effectiveness of its activities for its current strategic objectives and goals related to controlling health care costs; and (2) identify the resources and investments necessary for implementation of its planned health care cost control initiatives.

Agency: Department of Justice: Bureau of Prisons
Status: Open

Comments: BOP agreed with GAO's June 2017 recommendation and has begun to take steps to address it. In October 2018, BOP initiated a contract with an external group of public administration experts to examine BOP's organizational structure and its lines of authority. The group completed its study and issued a report in October 2019, which included recommendations for BOP. According to BOP, the Health Services Division is in the process of creating a Strategic Plan Advisory Group, which will implement recommendations in the October 2019 report, and will establish a 2020-2025 Strategic Plan. The Strategic Plan Advisory Group will also evaluate metrics, including those related to financial performance that will, according to BOP, enable it to identify the resources and investments to help control health care costs. This action is a positive step that could help BOP enhance its strategic planning for and implementation of health care cost control efforts. However, BOP is in the early stages of implementing this recommendation; thus it is too soon to assess if BOP will find the most effective method for enhancing its strategic planning.

Recommendation: To improve the reliability and utility of its Federal Medical Center mission analyses, BOP should document the analyses and findings that underlie its recommendations.

Agency: Department of Justice: Bureau of Prisons
Status: Open

Comments: In June 2017, BOP agreed with GAO's recommendation. However, BOP decided to end the Federal Medical Center mission analyses process. Instead, in September 2018 BOP established a Medical Referral Center (MRC) Executive Advisory Board, made up of BOP's Health Services Division leadership and wardens from all seven MRCs. According to BOP, the Board plans to develop and implement dashboard metrics by the end of calendar year 2020 to monitor essential functions at the centers, which it hopes will improve management of the inmate health care system. In the meantime, BOP reports that the Board has already developed and implemented the MRC pipeline patient dashboard, which permits the MRC wardens to monitor incoming patients in advance of arrival and to maximize the best patient care and housing until treatment is complete. In addition, the Board has developed and implemented the Memory Disorder Unit at one if its MRCs. This resulted in BOP making more efficient use its inpatient beds, as inmates that were housed in community hospitals could return to a BOP inpatient setting. While these steps might not fulfill the recommendation as worded, they have already resulted in some improvements to the utility of the MRCs, and therefore the intent of the recommendation. We will continue to monitor progress on this effort to ensure BOP develops and implements the metrics as planned.

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. When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: To make it more likely that HHS will achieve its goals to reduce quality measure misalignment and associated provider burden, the Secretary of HHS should direct CMS and the Office of the National Coordinator for Health Information Technology to prioritize their development of electronic quality measures and associated standardized data elements on the specific quality measures needed for the core measure sets that CMS and private payers have agreed to use.

Agency: Department of Health and Human Services
Status: Open

Comments: In January 2019, HHS told us that CMS completed an analysis to determine which measures-from the core measure sets that CMS and private payers have agreed to use-are feasible to develop as electronic clinical quality measures. Further, in April 2019, CMS officials told us they will consider developing new electronic clinical quality measures where appropriate and feasible to fill future measure needs or gaps identified by the Core Quality Measures Collaborative (CQMC). However, we determined that the actions did not fully address the recommendation because they do not include efforts to work with ONC to prioritize their development of electronic clinical quality measures for the CQMC core measure sets. We will update the status of this recommendation when we receive additional information.

Recommendation: To make it more likely that HHS will achieve its goals to reduce quality measure misalignment and associated provider burden, the Secretary of HHS should direct CMS to comprehensively plan, including setting timelines, for how to target its development of new, more meaningful quality measures on those that will promote greater alignment, especially measures to strengthen the core measure sets that CMS and private payers have agreed to use.

Agency: Department of Health and Human Services
Status: Open

Comments: In April 2019, HHS told us that CMS had conducted an assessment of the impact of selected measures used in its quality programs and has linked key component of that assessment to some meaningful measure areas that CMS has identified as priorities. However, this document did not include elements of a comprehensive plan--such as setting timelines-for how to target its development of new, more meaningful quality measures that will promote greater alignment. We will update the status of this recommendation when we receive additional information.

Recommendation: To ensure that HHS workforce efforts meet national needs, the Secretary of Health and Human Services should develop a comprehensive and coordinated planning approach to guide HHS's health care workforce development programs--including education, training, and payment programs--that (1) includes performance measures to more clearly determine the extent to which these programs are meeting the department's strategic goal of strengthening health care; (2) identifies and communicates to stakeholders any gaps between existing programs and future health care workforce needs identified in the Health Resources and Services Administration's workforce projection reports; (3) identifies actions needed to address identified gaps; and (4) identifies and communicates to Congress the legislative authority, if any, the Department needs to implement the identified actions.

Agency: Department of Health and Human Services
Status: Open

Comments: In December 2016, HHS indicated that the agency had not yet taken steps to implement a comprehensive workforce planning effort. Officials said that for the FY2018 cycle, HHS had planned to expand its group developing legislative proposals to include budget issues and gaps that warrant attention. While it did not do so during that cycle, officials indicated that they would recommend this broader approach to workforce planning for future budget and legislative cycles. In an update presented in HHS's FY2021 budget justification, HHS did not address efforts to develop a comprehensive and coordinated planning approach to guide HHS's health care workforce development programs. Instead, it described its current legislative and budget development effort and proposal to restructure CMS Graduate Medical Education (GME) programs into a discretionary grant program. It noted that such a restructuring would allow the Department to set expectations for program performance in CMS GME and allow the kind of tracking HRSA has been able to implement in the Children's Hospital GME program and its Teaching Hospital GME program. It noted that Congress had not responded to this request. However, this recommendation stands on its own and is separate from any legislative efforts to modify how federal GME funds are distributed. Whether or not legislation is enacted to implement a consolidated federal GME grant program, HHS should take action to develop a comprehensive and coordinated planning approach. Such action is important for HHS to assure that federal programs fully meet workforce needs. Further, the CARES Act of 2020 requires HHS to develop a comprehensive and coordinated strategic plan for HHS health workforce programs. We will be monitoring HHS's implementation of this requirement to determine if it satisfies the intent of this recommendation.

Recommendation: To help ensure that HHS is adequately and comprehensively assessing HPP and PHEP awardees' performance and progress in meeting the medical and public health preparedness goals of the cooperative agreements, the Secretary of Health and Human Services should direct ASPR and CDC to develop objective and quantifiable performance targets and incremental milestones that correspond to the new HPP and PHEP performance measures, against which HHS can gauge progress toward the medical and public health preparedness goals of the cooperative agreements and direct technical assistance, as needed.

Agency: Department of Health and Human Services
Status: Open

Comments: Since we examined the HPP and PHEP cooperative agreements in 2012, ASPR had developed few targets for the HPP program measures or their corresponding indicators that were contained in the HPP performance measurement guidance documents issued for Budget Periods (BP) 2-5, ending June 30, 2017. Additionally, the new HPP performance measure implementation guidance for the 5-year project cycle from 2017-2022 introduces 28 performance measures, with few having targets; the guidance notes that corresponding goals or targets may be set at a later date after data from the first budget period of this new project cycle has been reviewed. Regarding PHEP, CDC had developed performance targets for about half of the performance measures as of the PHEP BP5 performance measurement guidance (BP5 ended June 30, 2017). These performance measures generally remain the same, with existing targets, for BP1 (July 1, 2017-June 30, 2018) of the new 5-year budget cycle. GAO recognizes that it may not be appropriate to develop performance targets for every performance measure depending on the desired process or outcome; however, both agencies still have work to do in this area. In November 2017, both ASPR and CDC officials noted that they could not commit to setting consistent targets with incremental milestones over a budget cycle and therefore could not implement the recommendation. As of August 2018, there was no change from the agencies' position that they do not have plans to fully implement the recommendation at this time.

Recommendation: To help ensure that HHS is adequately and comprehensively assessing HPP and PHEP awardees' performance and progress in meeting the medical and public health preparedness goals of the cooperative agreements, the Secretary of Health and Human Services should ensure that performance measures and targets remain consistent across the 5-year project cycle and that any future measures be comparable to determine whether awardees are making progress toward meeting short- and long-term medical and public health preparedness goals of the cooperative agreements.

Agency: Department of Health and Human Services
Status: Open

Comments: Since we first examined the HPP and PHEP cooperative agreements in 2012, ASPR and CDC had made efforts to maintain consistency in their performance measures, particularly in the last 3 years of the prior project cycle which ended June 30, 2017. However, because part of the recommendation includes consistency of performance measures into future project cycles, we also examined whether both cooperative agreements continued to use basically the same performance measures into the current 5-year cycle, which began July 1, 2017. ASPR's HPP has made a significant change in its performance measures, introducing a new set of 28 performance measures for this new 5-year cycle. CDC's PHEP performance measures generally remained consistent in the last two budget periods of the prior 5-year cycle, and remained generally the same for the first year of the new 5-year cycle (some measures were "retired," though key components from a measure may continue to be used by CDC in other types of reviews). Additionally, in November 2017, both CDC and ASPR officials noted that they may need to continue to adjust the performance measures during the new 5-year cycle. As of August 2018, as a result of the change to HPP's measures and the agency statements in November 2017, GAO anticipates keeping this recommendation open at least for the next few budget periods, in order to determine whether the agencies maintain consistency with the performance measures during the new project cycle.

Recommendation: To help ensure that Medicare beneficiaries have access to high-quality dialysis care, the Administrator of CMS should assess the extent to which the bundled payment for dialysis care will be sufficient to cover an efficient dialysis organization's costs to provide such care when the bundled payment expands to cover oral-only ESRD drugs. The Administrator should conduct this assessment before implementing this expanded bundled payment.

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

Comments: CMS, as required by the Protecting Access to Medicare Act of 2014 (PAMA), delayed until 2024 when the bundled payment for dialysis care is expanded to cover oral-only ESRD drugs. Because PAMA requires CMS to use the most recent year of data available to implement this payment change, CMS has been unable to implement our recommendation. We will update the status of this recommendation upon receipt of additional information from CMS.

Recommendation: To better account for physicians practicing in underserved areas through the use of J-1 visa waivers, the Secretary of Health and Human Services should collect and maintain data on waiver physicians--including information on their numbers, practice locations, and practice specialties--and use this information when identifying areas experiencing physician shortages and placing physicians in these areas.

Agency: Department of Health and Human Services
Status: Open

Comments: HHS concurred with our recommendation, commenting that the department's goal was to assure that the limited resources of the J-1 visa waiver program and other programs addressing areas and populations with limited access to health care professionals are targeted most effectively. In 2013, HHS indicated that it was considering the best approach to collect information to identify J-1 visa physicians practicing in underserved areas. As of February 2018, however, HHS reported that it does not have the capacity to track physicians practicing in underserved areas through the use of J-1 visa waivers, citing reasons such as the number of federal entities and states involved in the process. While we recognize that collecting and maintaining these data requires coordination with other agencies, we continue to believe that without data on waiver physicians, HHS--the federal agency with primary responsibility for addressing physician shortages--will lack the information needed to consider waiver physicians working in underserved areas when placing providers in these areas under other programs. As of August 2019, HHS officials have not informed us of actions taken to implement this recommendation. We are leaving this recommendation open until the department collects and maintains data on waiver physicians and considers those physicians in its efforts to address physician shortages.