Recommendation: The Administrator of HRSA should ensure that the information it uses to verify nonprofit status for all nongovernmental hospitals that participate in the 340B Program is reliable—for example, by requiring and reviewing the submission of official documentation hospitals must already maintain or by ensuring the reliability of the data the agency uses. (Recommendation 1)

Agency: Department of Health and Human Services: Public Health Service: Health Resources and Services Administration
Status: Open

Comments: HHS concurred with this recommendation and in June 2020, reiterated that HRSA believes that the information it uses to determine nonprofit status is reliable, because hospital administrators attest to its accuracy. However, as discussed in our report, neither HRSA nor the agency that collects the data has evaluated the reliability of the data for verifying nonprofit status. Without ensuring it is using reliable information, HRSA cannot effectively determine if nongovernmental hospitals participating, or seeking to participate, in the 340B Program meet the statutory eligibility requirements.

Recommendation: The Administrator of HRSA should implement a process to verify that every nongovernmental hospital that participates in the 340B Program has a contract with a state or local government as required by statute. (Recommendation 2)

Agency: Department of Health and Human Services: Public Health Service: Health Resources and Services Administration
Status: Open

Comments: HHS did not concur with this recommendation and, as of June 2, 2020, did not plan to take any actions to implement the recommendation. HHS noted that requiring all covered entities to submit a state or local government contract would create a significant burden for covered entities. However, as we noted in our report, HRSA already requires hospitals to maintain copies of their state or local government contracts. Therefore, it is unclear how implementing a process to verify the existence of those contracts would represent a significant burden. Without this information, HRSA does not have reasonable assurance that nongovernmental hospitals have the statutorily required contracts to participate in the 340B Program.

Recommendation: The Administrator of HRSA should provide more specific guidance for 340B Program auditors on how to determine if nongovernmental hospitals' contracts with state and local governments require the provision of health care services to low-income individuals not eligible for Medicaid or Medicare. (Recommendation 4)

Agency: Department of Health and Human Services: Public Health Service: Health Resources and Services Administration
Status: Open

Comments: HHS concurred with this recommendation and in June 2020, indicated that HRSA had updated its audit guidance and procedures to more clearly specify that contracts must contain requirements for the provision of health care services to low-income individuals. However, these documents do not contain any specific guidance on how auditors are to evaluate whether contracts require these services. Without more specific guidance for auditors' review of contracts, HRSA lacks reasonable assurance that the audits are appropriately identifying deficiencies in nongovernmental hospitals' contracts with state or local governments.

Recommendation: The Administrator of HRSA should require nongovernmental hospitals participating in the 340B Program to demonstrate that they have contracts with state or local governments in effect prior to the beginning of their audits' periods of review and should apply consistent and appropriate consequences for hospitals that are unable to do so. (Recommendation 6)

Agency: Department of Health and Human Services: Public Health Service: Health Resources and Services Administration
Status: Open

Comments: HHS concurred with this recommendation. As noted in our report, HRSA updated its draft audit procedures for fiscal year 2020 audits in September 2019 to specify that auditors should look for effective dates that cover the entire audit period. While this is an important step, HRSA must also show that it has ceased accepting retroactive contract documentation, and has applied consistent and appropriate consequences when auditors find that nongovernmental hospitals did not have contracts in effect prior to the beginning of their audit periods. As of June 2020, HHS indicated that HRSA had not taken these actions. Allowing hospitals that are unable to demonstrate that they have contracts in place that cover their audits' periods of review to continue to participate without consequences undermines the effectiveness of HRSA's audit process and increases the risk that ineligible hospitals will receive discounts under the program.

Recommendation: To improve VA's ability to plan for and align its facilities with estimated changes to veterans' needs and expectations, we recommend that the Secretary of Veterans Affairs ensure the appropriate offices and administrations develop and implement a process to assess veterans' changing expectations and disseminate this information to VAMCs. (Recommendation 1)

Agency: Department of Veterans Affairs
Status: Open

Comments: VA concurred with this recommendation, but noted that it had already developed and implemented effective systems for obtaining Veterans' input in facility planning. However, we found that the information VA collects through these efforts may be limited based on our review of VA's surveys, including VSignals and the Survey of Enrollees, as well as our discussions with several Veterans Service Organizations. For example, we found that VA's efforts were limited because they either focused on overall veteran expectations without a means of assessing how they differed by demographics, or they focused on veteran satisfaction with their past experiences. Moreover, satisfaction with past experiences, as operationalized by VA for the surveys we reviewed, measured how someone is with what they received--while "expectations," as defined by VA, would measure or gain insight into what it is that someone would want, and which may or may not be what they are receiving. Thus, while satisfaction, as operationalized by VA, can be an indicator of an expectation, as defined by VA, the two are not synonymous. Although VA considers this recommendation closed, we are working with them to identify ways that expectations, as VA has defined the term, can be measured.

Recommendation: To improve VA's ability to plan for and align its facilities with estimated changes to veterans' needs and expectations, we recommend that the Secretary of Veterans Affairs ensure the appropriate offices and administrations instruct VAMCs on how to meet VA's strategic goal of incorporating veterans' changing needs and expectations into facility planning, such as by identifying certain resources or tools and directing VAMCs to use them. (Recommendation 2)

Agency: Department of Veterans Affairs
Status: Open
Priority recommendation

Comments: VA agreed with the recommendation and indicated that it would instruct users on what data to use in planning and updates, which would help ensure veterans' input is incorporated where appropriate. As of its fiscal year 2021 budget justification, VA still had not provided this guidance to the VAMCs, but noted that it would provide it in scheduled facility planning calls that were expected to start in the second quarter of fiscal year 2020.

Recommendation: To improve VA's ability to plan for and align its facilities with estimated changes to veterans' needs and expectations, we recommend that the Secretary of Veterans Affairs ensure the appropriate offices and administrations provide additional instruction to VAMCs on how to incorporate the concept of foundational health services into facility planning. (Recommendation 3)

Agency: Department of Veterans Affairs
Status: Open

Comments: VA concurred with this recommendation and noted that it would clarify prior guidance on the foundational health services for VAMCs, which it expected to complete in June 2019. In November 2019, VA told us that it had reviewed this prior guidance from August 2017 that had defined foundational services, and has rescinded it. However, we are working with VA to determine if this decision to rescind the prior guidance was distributed to VAMCs.

Recommendation: To improve VA's ability to plan for and align its facilities with estimated changes to veterans' needs and expectations, we recommend that the Secretary of Veterans Affairs ensure the appropriate offices and administrations systematically gather feedback from facility planners and address (as necessary) their concerns with the reliability of the SCIP process, including providing additional information on how SCIP's space estimates are derived. (Recommendation 4)

Agency: Department of Veterans Affairs
Status: Open
Priority recommendation

Comments: VA agreed with this recommendation and indicated that it would update its training instructions to facility planners by adding an explanation of how SCIP space estimates are derived. In addition, VA noted that it would survey facility planners about their concerns with the SCIP space estimates, and use these results to either address the concerns or make improvements to SCIP. As of November 2019, VA had not completed the training or the survey, but noted that they are in the process of updating training materials for the FY22 SCIP planning process--which was targeted to start 2019. We will work with VA to obtain relevant documentation of these efforts.

Recommendation: As MHS governing bodies conduct their recurring reviews of quality measures selected for MHS's Core Dashboard and Purchased Care Dashboards, the Assistant Secretary of Defense for Health Affairs should direct those bodies to prioritize, as appropriate, the selection of measures that apply to both direct and purchased care at the provider level and that expand the range of quality measure types and medical conditions that are assessed. (Recommendation 1)

Agency: Department of Defense: Office of the Assistant Secretary of Defense (Health Affairs)
Status: Open

Comments: As of January 2020, DOD officials described proposed actions to address key elements of our recommendation. Specifically, DOD officials described compiling a comprehensive library of existing inpatient and outpatient quality measures for both direct and purchased care; categorizing those measures by type and medical condition; and identifying 8 measures that are common across direct and purchased care. DOD stated it is considering expanding those 8 common measures to 12 measures. The new measures would cover three cancer screening measures and an additional inpatient satisfaction measure. However, DOD officials noted these 12 measures are not reported at the provider level for purchased care given current contract reporting requirements and would require contract modifications. DOD officials also said they are participating in an interagency partnership to use a common set of quality measures across federal programs, including under the Department of Veterans Affairs. Once those quality measures are determined, DOD may expand the range of quality measures common across direct and purchased care to be consistent with other federal programs. We will keep this recommendation open until DOD provides additional information on actions taken to select and expand quality measures across direct and purchased care.

Recommendation: The Assistant Secretary of Defense for Health Affairs should establish, as appropriate, performance standards related to the Purchased Care Dashboard measures that are consistent with the MHS's performance standards for direct care; ensure they are applied to individual purchased care providers; and take steps, such as amending its managed care support contracts, if necessary, to require corrective actions to be taken when providers do not meet those standards. (Recommendation 2)

Agency: Department of Defense: Office of the Assistant Secretary of Defense (Health Affairs)
Status: Open

Comments: As of January 2020, DOD officials said that once a common set of quality measures is adopted to the extent possible across direct and purchased care (as discussed in Recommendation 1), DOD plans to establish consistent performance standards applied to individual providers and plans to develop processes to issue corrective actions for individual direct and purchased care providers who do not consistently meet established standards. We will update this recommendation as DOD provides progress updates on the implementation of these plans.

Recommendation: The Under Secretary for Health should specify in VHA policy that reviews of providers' clinical care after concerns have been raised should be documented, including retrospective and comprehensive reviews. (Recommendation 1)

Agency: Department of Veterans Affairs
Status: Open

Comments: VA agreed with the recommendation and indicated plans to revise policy to codify requirements to document reviews. As of April 2020, VA estimates completing these and other revisions to the policy in August 2020.

Recommendation: The Under Secretary for Health should specify in VHA policy a timeliness requirement for initiating reviews of providers' clinical care after a concern has been raised. (Recommendation 2)

Agency: Department of Veterans Affairs
Status: Open

Comments: VA agreed with the recommendation and indicated plans to revise policy to incorporate timeline expectations for initiating reviews after clinical care concerns have been raised. As of April 2020, VA estimates completing these and other revisions to the policy in August 2020.

Recommendation: The Director of the MSPV-NG program office should, with input from the Strategic Acquisition Center (SAC), develop, document, and communicate to stakeholders an overarching strategy for the program, including how the program office will prioritize categories of supplies for future phases of requirement development and contracting. (Recommendation 1)

Agency: Department of Veterans Affairs
Status: Open
Priority recommendation

Comments: The Department of Veterans Affairs (VA) agreed with GAO's November 2017 recommendation. VA planned to implement a new Medical-Surgical Prime Vendor (MSPV) program, called MSPV 2.0, by March 2020; however, this program has been delayed to at least January 2021. MSPV 2.0 includes a process where clinicians review requirements for a set list of products. As of August 2020, VA is beginning the national rollout of this clinician review process, but the results of this process won't be implemented until after MSPV 2.0 begins. VA's strategy for its MSPV program depends on full implementation of this clinician review process.

Recommendation: The Director of the MSPV-NG program office should provide complete guidance to medical centers for matching equivalent supply items, which could include defining the roles of clinicians and local Clinical Product Review Committees. (Recommendation 4)

Agency: Department of Veterans Affairs
Status: Open

Comments: The Department of Veterans Affairs (VA) agreed with GAO's November 2017 recommendation. VA implemented a tool-the Medical Product Data Bank's eZSAVE application-to improve the matching of equivalent supply items. In November 2018, VA reported that it holds monthly meetings with selected clinical and logistics staff to obtain their input on the matching process. However, as of August 2020, VA has not provided documentation showing how it has defined the role of clinical staff, including Clinical Product Review Committees, in this process. Without documentary support, GAO cannot assess the extent of the clinical staff role in the matching process. If the roles of clinicians are not clearly defined, it increases the risk of inconsistent involvement in the matching process.

Recommendation: The VHA Chief Procurement and Logistics Officer should use input from national clinical program offices to prioritize its MSPV-NG requirements development and standardization efforts beyond Phase 2 to focus on supply categories that offer the best opportunity for standardization and cost avoidance. (Recommendation 8)

Agency: Department of Veterans Affairs
Status: Open

Comments: The Department of Veterans Affairs (VA) agreed with GAO's November 2017 recommendation. VA's planned Medical-Surgical Prime Vendor (MSPV) 2.0 program includes engaging selected clinicians in its requirement development for a set list of products, known as Clinician-Driven Strategic Sourcing. In April 2019, VA began a pilot for this clinician review process, including input from national clinical program offices. As of August 2020, VA is beginning the national rollout of this process. VA does not plan to incorporate the results of this clinician review process in the list of available supplies until after MSPV 2.0 is implemented, which has been delayed until at least January 2021. Until VA implements MSPV 2.0 and incorporates the results of the Clinician-Driven Strategic Sourcing process, it will not be able to achieve its goals of cost savings and improved clinical consistency.

Recommendation: The VHA Chief Procurement and Logistics Officer should direct Veterans Integrated Service Network (VISN) Network Contracting Offices to work with medical centers to identify any opportunities to more strategically purchase goods and services frequently purchased on an emergency basis. For example, offices could do this by analyzing existing data. (Recommendation 9)

Agency: Department of Veterans Affairs
Status: Open

Comments: The Department of Veterans Affairs (VA) agreed with GAO's November 2017 recommendation. In August 2019, senior VA acquisition officials agreed to conduct an analysis of its spending to identify items that the department frequently purchases on an emergency basis and to develop plans to purchase those goods and services more strategically, such as by issuing a national contract or adding the items to the formulary as needed. As of August 2020, these officials indicated they would provide this analysis to GAO by the end of 2020.

Recommendation: VHA Chief Procurement and Logistics Officer should analyze data on items that are frequently purchased on an emergency basis, determine whether such items are suitable to be added to the MSPV-NG formulary, and work with SAC to make any suitable items available via MSPV-NG. (Recommendation 10)

Agency: Department of Veterans Affairs
Status: Open

Comments: The Department of Veterans Affairs (VA) agreed with GAO's November 2017 recommendation. VA reported that it added thousands of items to the Medical-Surgical Prime Vendor (MSPV) formulary from June 2018 through December 2018, some of which had previously been purchased on an emergency basis. VA also reported in June 2018 and updated in March of 2020 that it is tracking items purchased on an emergency basis. However, as of August 2020, VA has not provided documentation showing whether and how this analysis has informed its selection of which products to add to the formulary. Without documentary support, GAO cannot assess the extent to which items that VA added to the formulary were previously purchased on an emergency basis. If VA does not use analysis of emergency procurements to help inform which items should be added to the MSPV formulary, it will miss opportunities to avoid emergency procurements and increase efficiency.

Recommendation: The Undersecretary for Health should develop and implement a process to accurately count all physicians providing care at each medical center, including physicians who are not employed by VHA. (Recommendation 1)

Agency: Department of Veterans Affairs: Veterans Health Administration
Status: Open
Priority recommendation

Comments: As of January 2020, VHA continues to disagree with the recommendation and has not taken any action. Although VA responded to our report by stating that the ability to count physicians does not affect its ability to assess workload, we maintain that an accurate count of all physicians providing care at each medical center is necessary for accurate workforce planning. To implement the first recommendation, VHA needs to develop a system-wide process to collect information on all physicians providing care at VAMCs, including physicians that are not employed by VHA. This information should be available at the local level for workforce planning purposes.

Recommendation: The Undersecretary for Health should develop and issue guidance to the VAMCs on determining appropriate staffing levels for all mission-critical physician occupations. (Recommendation 2)

Agency: Department of Veterans Affairs: Veterans Health Administration
Status: Open

Comments: VHA concurred with this recommendation. In November 2017, VHA's Executive in Charge chartered the Specialty Care Provider Staffing and Network Model Workgroup to develop a methodology for determining the scope and complexity of specialty care services. The Workgroup also developed an analytical tool to support local decision-making around specialty staffing levels. According to VHA, the Specialty Care Services Staffing model has been validated across some VHA regions. The Workgroup was directed to develop an Executive Decision Memorandum for an official determination as to implementation of the model. As of January 2020, VHA was awaiting the results of the Governing Board's decision on the Executive Decision Memorandum, the guidance documents, and analytical template. VHA reported the target date for completion is March 2020.

Recommendation: The Undersecretary for Health should establish a system-wide method to share information about physician trainees to help fill vacancies across VAMCs. (Recommendation 4)

Agency: Department of Veterans Affairs: Veterans Health Administration
Status: Open

Comments: VHA concurred with this recommendation. VHA is working to develop the necessary capacity to enable a system-wide method for sharing information about physician trainees to help fill vacancies. In April 2019, VHA anticipated having this system in place by the end of fiscal year 2019. However, VHA has not submitted any additional information since April 2019. VHA has also created a VHA-Trainee Recruitment and Hiring Workgroup (the Workgroup). The Workgroup serves as the advisory group on trainee recruitment and hiring, for the purpose of developing a permanent Trainee Recruitment and Hiring Function. The Workgroup is holding Virtual Trainee Recruitment Events for critical occupations. Until GAO sees evidence of a system-wide method for sharing information about physician trainees, this recommendation will remain open.

Recommendation: The Undersecretary for Health should take additional steps to ensure that VA's website reports health care quality measures that cover a broad range of health care services, highlights key differences in the clinical quality of care, and presents this information in an easily accessible and understandable way (Recommendation 1).

Agency: Department of Veterans Affairs
Status: Open

Comments: As of January 2020, VA provided information that they had updated information on its website to include more quality measures, particularly as they relate to outpatient care. While VA has made progress in reporting on additional measures, we reviewed VA's website-specifically, their Access and Quality webpage which is the primary webpage for veterans to access information on quality-as of February 2020 and found that VA has still yet to report on a broad range of quality measures that would assist veterans in making health care decisions for inpatient care. For example, VA does not report any quality measures related to readmissions and mortality; length-of-stay; or efficiency. VA also continues to report only one timely and effective care measure for inpatient care. With regards to presentation of its quality measures, VA no longer links its Access and Quality webpage to the homepage of VA's website, making it more difficult to find. Additionally, for the new outpatient measures that VA has added to its website, VA has not presented these measures in an easily understandable way as there is little explanation of what they are measuring and how veterans can use these measures to make healthcare decisions. We will keep this recommendation open until VA has made further updates to its website.

Recommendation: The Undersecretary for Health should direct VA Central Office to conduct a systematic assessment of the completeness and accuracy of patient clinical information across VAMCs that is used to calculate the health care quality measures VA reports and address any deficiencies that affect the accuracy of these measures (Recommendation 2).

Agency: Department of Veterans Affairs
Status: Open

Comments: As of January 2020, VA has said they have focused on three main efforts as it relates to documenting information on VA quality of care, including: timeliness of access information (e.g., wait times) to health care within VA facilities; timeliness and accuracy of payments to community care providers; and accuracy of coding and documentation within VA and from community providers. In particular, VA has conducted several efforts to improve education and training on clinical documentation and coding, particularly for providers. VA has also said it has made efforts in requiring programs across regional networks aimed at improving clinical documentation and coding. While these efforts can help with improving documentation of care to veterans, it is unclear how VA Central Office has assessed whether these efforts have actually achieved its goals and improved the accuracy of its quality measures. As we stated in our report, VA Central Office has not conducted a systematic assessment of the completeness and accuracy of the clinical data recorded in VA patient medical records across all VAMCs. The results of such a systematic analysis could help identify the deficiencies, if any, in the recording of patient clinical information and what steps, if any, VA Central Office may need to take to address them. We will keep this recommendation open until VA provides information on a systematic assessment of clinical documentation.

Recommendation: The Secretary of Veterans Affairs should direct the Under Secretary for Health to monitor the full amount of time newly enrolled veterans wait to be seen by primary care providers, starting with the date veterans request they be contacted to schedule appointments. This could be accomplished, for example, by building on the data collection efforts currently being implemented under the "Welcome to VA" program.

Agency: Department of Veterans Affairs
Status: Open
Priority recommendation

Comments: In March 2016, GAO recommended that VA monitor the full amount of time newly enrolled veterans wait to be seen by primary care providers, starting with the date veterans request they be contacted to schedule appointments. VA concurred with this recommendation, and in June 2017, reported to GAO that it had taken actions to address it. Specifically, VA indicated that it revised an internal report to help identify and document all newly enrolled veterans and monitor their appointment request status. The report is intended to enable VHA and its medical centers to oversee the enrollment and appointment process by tracking the following timeframes: (1) application to enrollment, (2) enrollment to initial contact, (3) initial contact to primary care appointment, and (4) total time from application to primary care appointment. However, VA also indicated in its response that it did not have data that captures application dates for all newly enrolled veterans. As such, the report could not be used to consistently monitor the full amount of time these veterans wait to be seen by primary care providers. In January 2018, VA reported developing and implementing technical enhancements to its electronic systems that will enable it to capture the application date for all newly enrolled veterans. In April 2018 and December 2018, VA reported making continued efforts to implement technical enhancements to its electronic system. In its February 2020 update, VA identified several steps that the agency was completing to fully implement the revised internal report and noted that following a successful piloting of the report, the agency would implement it system-wide. VA reported that it expects to fully address this recommendation by October 2020.

Recommendation: The Secretary of Defense should direct the Secretary of the Army to implement processes to review and monitor the Army military treatment facility prescribing practices for medications discouraged under the PTSD guideline and address identified deviations.

Agency: Department of Defense
Status: Open

Comments: DOD concurred with this recommendation and stated that any policy that it may issue related to the monitoring of prescribing practices would be directed toward all of the military services. In May 2018 DOD stated that it planned to (1) conduct a comprehensive review of existing prescribing practices for the treatment of PTSD; (2) develop policy guidance for addressing prescribing practices for the management of PTSD that deviate from the clinical practice guideline; and (3) implement an automated dashboard that will flag medications that the PTSD guideline discourages from use. In its February 26, 2020 response, DOD stated that July 30, 2020 is the estimated completion date for these planned actions. To close this recommendation, DOD needs to implement its planned actions and provide documentation showing that the Department is monitoring medications discouraged from use under the PTSD guideline and addressing identified deviations.