Recommendation: The Administrator of CMS should develop formal procedures that include specific steps to be taken in the APD review process, including how CMS will document the review (including the name of the reviewer, date of review, and what was reviewed); what documentation should be retained after the review; as well as decision-making criteria for approval or denial decisions for state Medicaid IT funding requests. (Recommendation 1)

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

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

Recommendation: The Administrator of CMS should, as part of the APD review process and prior to approval, verify that all of the required information (e.g. alternatives analysis, feasibility study, and cost benefit analysis) is included in the funding request. (Recommendation 2)

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

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

Recommendation: The Administrator of CMS should ensure that all APD-related artifacts are retained within the designated CMS document management system, including documentation of key information from meetings and email communications with the states, the MITA self-assessment and independent verification and validation reports, when creating APD decision packages. (Recommendation 3)

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

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

Recommendation: The Administrator of CMS should require analysts to maintain relevant MMIS and E&E system artifacts based on the entire system life cycle instead of individual APDs. (Recommendation 4)

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

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

Recommendation: The Administrator of CMS should, in consultation with the HHS and CMS CIOs, develop a documented, comprehensive, and risk-based process for how CMS will select IT projects for technical assistance and provide recommendations to states to assist them in improving the performance of the systems, with consideration to those that are high-cost and performing poorly. (Recommendation 5)

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

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

Recommendation: The Administrator of CMS should encourage state Medicaid program officials to consider involving state CIOs in overseeing Medicaid IT projects. (Recommendation 6)

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

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

Recommendation: The Administrator of CMS should establish a timeline for implementing the outcome-based certification process for MMIS and E&E systems. (Recommendation 7)

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

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

Recommendation: The Administrator of CMS should establish documented procedures for how the results of the outcome-based certification process will be used for conducting oversight and making funding decisions. The procedures should include specific steps that CMCS will take to oversee individual state MMIS and E&E projects and how it will demonstrate that the steps have been taken. (Recommendation 8)

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

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

Recommendation: Prior to approving funding for MMIS and E&E systems, the Administrator of CMS should identify areas of duplication or common functionality, such as core MMIS modules, in order to facilitate sharing, leveraging, or reusing Medicaid technologies. CMS should share the results of the review with the state or territory requesting federal funding for a duplicative or similar project and take steps to encourage states to share, leverage, or reuse Medicaid technologies, where possible. (Recommendation 9)

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

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

Recommendation: The Administrator of CMS should take steps to obtain quality information on the experiences of dual-eligible beneficiaries who have been default enrolled into D-SNPs, such as by obtaining information about the extent to which and reasons that beneficiaries disenroll from a D-SNP after being default enrolled. (Recommendation 1)

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

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

Recommendation: The Commissioner of Internal Revenue should assess options for updating Publications 590-A and 590-B to either include more information or direct taxpayers to other resources for IRA owners with investments in unconventional assets. Such information could include: storage requirements for IRA investments in certain precious metals; valuation methods for hard-to-value IRA assets; the Department of Labor's process for granting exemptions to IRA prohibited transactions rules; and IRA investments with the potential to create unrelated business income tax liabilities. (Recommendation 1)

Agency: Department of the Treasury: Internal Revenue Service
Status: Open

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

Recommendation: The Commissioner of Internal Revenue, building on forthcoming compliance research using new IRA asset data, should evaluate the feasibility of requiring disclosure for high-risk IRA asset types associated with abusive schemes as transactions of interest. (Recommendation 2)

Agency: Department of the Treasury: Internal Revenue Service
Status: Open

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

Recommendation: The Commissioner of Internal Revenue should develop resources (such as training materials or job aids) for Small Business/Self-Employed examiners conducting IRA owner audits that explain how IRAs with unconventional assets can generate unrelated business income tax liability, and how examiners can refer cases to unrelated business income experts in IRS for assistance. (Recommendation 3)

Agency: Department of the Treasury: Internal Revenue Service
Status: Open

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

Recommendation: The Administrator of CMS should determine the extent to which state Medicaid programs are in compliance with federal requirements to cover MAT medications in all formats and take actions to ensure compliance, as appropriate. (Recommendation 1)

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

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

Recommendation: The Administrator of CMS should ensure that state Medicaid programs have written policies and procedures that specify the extent to which covered entities can use 340B drugs for Medicaid beneficiaries, are designed to effectively identify if 340B drugs were used, and if so, how they should be excluded from Medicaid rebate requests. The policies and procedures should be made publically available and cover FFS, managed care, and all of the dispensing methods for outpatient drugs. (Recommendation 1)

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

Comments: HHS concurred with this recommendation and in August 2020 stated that it is developing guidance to state Medicaid programs directing them to strengthen policies and procedures related to 340B drugs for Medicaid beneficiaries.

Recommendation: The Administrator of HRSA should incorporate assessments of covered entities' compliance with state Medicaid programs' policies and procedures regarding the use and identification of 340B drugs into its audit process, working with CMS as needed to obtain states' policies and procedures. (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 August 2020, did not plan to take any actions to implement the recommendation. As noted in our report, covered entities' compliance with state Medicaid programs' policies and procedures is fundamental to preventing duplicate discounts. Thus, we continue to believe that HRSA's audit process should include an assessment of covered entities' compliance with state Medicaid programs' policies and procedures related to 340B drugs as it is necessary to identify potential duplicate discounts and to ensure covered entities' compliance with 340B Program requirements.

Recommendation: The Administrator of HRSA should require covered entities to work with affected drug manufacturers regarding repayment of identified duplicate discounts in Medicaid managed care. (Recommendation 3)

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 August 2020, did not plan to take any actions to implement the recommendation. As noted in our report, HRSA officials told us that covered entities' obligations for preventing duplicate discounts are the same for Medicaid fee-for-service and managed care. Thus, we continue to believe that when duplicate discounts related to Medicaid managed care have been identified, the agency should require covered entities to work with manufacturers to remedy them as they do for duplicate discounts related to Medicaid fee-for-service to help ensure compliance with 340B Program requirements.

Recommendation: The Commissioner of the Social Security Administration should clarify policies and procedures to remind staff that a diagnosis of a substance use disorder is not necessary to conduct a Drug Addiction and Alcoholism evaluation. (Recommendation 1)

Agency: Social Security Administration
Status: Open

Comments: SSA agreed with this recommendation. The agency stated that it had revised related policies in February 2020, and had planned to issue guidance and video-on-demand training to further clarify policies and procedures in this area. However, SSA said its efforts to maintain mission critical activities amid the COVID-19 pandemic have delayed further implementation of this recommendation and a specific implementation date could not be provided at this time.

Recommendation: The Commissioner of the Social Security Administration should ensure that staff document their rationale for decisions involving the Drug Addiction and Alcoholism evaluation process. (Recommendation 2)

Agency: Social Security Administration
Status: Open

Comments: SSA agreed with this recommendation. The agency said it had planned to issue guidance reinforcing its policy on properly documenting decisions involving the Drug Addiction and Alcoholism evaluation process. However, SSA said its efforts to maintain mission critical activities amid the COVID-19 pandemic have delayed implementation of this recommendation and a specific implementation date could not be provided at this time.

Recommendation: The Assistant Secretary of Labor for the Employee Benefits Security Administration should evaluate whether targeted oversight in response to information received is effective for ensuring compliance with MH/SU parity requirements. If this evaluation determines the current targeted oversight approach results in significant program risks, the Employee Benefits Security Administration should develop a plan to more effectively enforce MH/SU parity requirements and if necessary seek additional oversight authority, as warranted. (Recommendation 1)

Agency: Department of Labor: Employee Benefits Security Administration
Status: Open

Comments: DOL agreed with this recommendation. In February 2020, DOL reported that its Employee Benefits Security Administration plans to evaluate its targeted approach to MH/SU parity enforcement. When we confirm what actions DOL has taken in response to this recommendation, we will provide updated information.

Recommendation: The Administrator of CMS should evaluate whether targeted oversight in response to information received is effective for ensuring compliance with MH/SU parity requirements for non-federal governmental plans. If this evaluation determines the current targeted oversight approach results in significant program risks, CMS should develop a plan to more effectively enforce MH/SU parity requirements and if necessary seek additional oversight authority, as warranted. (Recommendation 2)

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

Comments: HHS agreed with this recommendation. In August 2020, HHS reported that CMS has developed a two-part evaluation to determine whether targeted oversight of non-federal governmental plans is effective for enforcing MH/SU parity requirements. According to HHS, this evaluation will include (1) a review of non-federal governmental plan documents for compliance with MH/SU parity requirements and (2) a survey of state enforcement authority and regulatory best practices for ensuring MH/SU parity compliance. As of August 2020, HHS reported that the first part of the CMS evaluation is underway.

Recommendation: The Administrator of CMS should expand its review of states' implementation of the provider screening and enrollment requirements to include states that have not made use of CMS's optional consultations. Similar to CMS's contractor site visits, such reviews should include any necessary steps to address areas of noncompliance for all types of enrolled providers, including those under contract with managed care organizations. (Recommendation 1)

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

Comments: CMS concurred with our recommendation. In February 2020, CMS told us that it plans to reach out to states that have not yet participated in its optional consultations to discuss their progress towards implementing provider screening and enrollment requirements, and outline steps that the states should take to come into full compliance with them. In order to fully address this recommendation CMS would need to review all states' implementation of the provider screening and enrollment requirements, including states that have not made use of CMS's optional consultations. As such, this recommendation remains open until CMS provides evidence that it has assessed the compliance of all states; we will continue to monitor CMS's progress.

Recommendation: The Administrator of CMS should annually monitor progress toward addressing any areas of noncompliance related to the provider screening and enrollment requirements for any state with one or more corrective action plans. (Recommendation 2)

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

Comments: As of February 2020, HHS officials have not informed us of any actions taken to implement this recommendation. We will update the status of this recommendation when we receive additional information

Recommendation: The Administrator of CMS should require states to submit and make public projections of administrative costs when seeking approval of demonstrations, including those with work requirements and all other demonstrations. (Recommendation 1)

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

Comments: HHS did not concur with this recommendation in its September 2019 comments on the report. We maintain that the recommendation is valid because requiring states to make public information about administrative costs would help to ensure that demonstration proposals provide sufficient information to ensure meaningful public input.

Recommendation: The Administrator of CMS should account for the administrative costs of demonstrations, including those with work requirements and all other demonstrations, when assessing whether demonstrations are budget neutral. (Recommendation 2)

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

Comments: HHS did not concur with this recommendation in its September 2019 comments on the report. We maintain that the recommendation is valid because including administrative costs in its assessments will help HHS ensure that demonstrations are budget neutral.

Recommendation: The Administrator of CMS should assess the risks of providing federal funds for costs to administer work requirements that are not allowable and should respond to risks by improving oversight procedures, as warranted. This assessment should consider risks related to costs for information systems, beneficiary supports, and managed care. (Recommendation 3)

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

Comments: HHS did not concur with this recommendation in its September 2019 comments on the report. We maintain that the recommendation is valid and that assessing these risks of providing federal funds for costs that are not allowable and improving oversight, as warranted, would help HHS to ensure the integrity of the Medicaid program.

Recommendation: The Administrator of CMS should work with states and relevant federal agencies to collect accurate and complete data on blood lead screening for Medicaid beneficiaries in order to ensure that CMS is able to monitor state compliance with its blood lead screening policy, and assist states with planning improvements to address states' compliance as needed. (Recommendation 1)

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

Comments: In June 2020, Centers for Medicare & Medicaid Services (CMS) officials said that obtaining complete data on blood lead screenings for children enrolled in Medicaid will not be possible, but that the agency is committed to improving the accuracy and completeness of the data. For example, in February 2020, CMS reported that the agency is planning to use a new data system-as states meet certain data quality and completeness benchmarks for the system-to generate the report that includes states' blood lead screening data. CMS stated that this will improve the agency's and states' ability to assess gaps in blood lead screening data. This is a positive step, yet any new data system will also need to consider how to help address known limitations in the current blood lead screening data, such as the under-counting of blood lead screening tests not paid for by Medicaid. To implement this recommendation, CMS should address limitations in blood lead screening data to better monitor compliance with the agency's blood lead screening policy.

Recommendation: The Administrator of CMS should regularly assess the appropriateness of performance measures and targets for the EPSDT benefit, and take any necessary actions to ensure their relevance and use, including adding, changing, or removing measures, or targets, and regularly communicating performance measures and targets to states. (Recommendation 2)

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

Comments: In June 2020, CMS officials reiterated that they do not concur with this recommendation, in part because the agency does not have the authority to set binding targets for every EPSDT measure. As we stated in our report, our recommendation does not assume that targets should be set for every measure--rather, that CMS needs to regularly assess the appropriateness of performance measures and targets for the EPSDT benefit and communicate them to states. This includes assessments of the CMS-416 performance measures, such as the participant and screening ratios. which CMS officials acknowledge have limitations.

Recommendation: The Administrator of CMS should conduct regular evaluations of state performance by comparing states' performance measurement data with CMS's EPSDT targets to identify gaps in states' performance and areas for improvement. (Recommendation 3)

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

Comments: In June 2020, CMS officials reiterated that they do not concur with this recommendation, in part because the agency provides states with information about their performance on ESPDT measures reported on the Child Core Set, including a state's performance relative to other states' performance. We noted the limitations of this approach in our report; descriptions of a state's performance relative to other states is subject to change over time. For example, because the median is the midpoint of all states' performance, it ensures that half of states will not meet it, regardless of their individual performance. A fixed target--or targeted improvement goal, such as the one developed as part of the Oral Health Initiative--would provide states with the opportunity to measure performance over prior years' results, which is a more meaningful measure that all states can strive to achieve.

Recommendation: The Administrator of CMS should assist states with planning needed improvements, including providing focused assistance, to resolve gaps in states' performance in meeting CMS's EPSDT targets. (Recommendation 4)

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

Comments: In June 2020, CMS officials reiterated that they do not concur with this recommendation, in part because the agency does not believe that it is productive or appropriate to set targets for every EPSDT measure. As we stated in our report, our recommendation does not assume that targets should be set for every measure. However, developing additional targets on performance measures critical to beneficiaries' health and well-being could help improve oversight of EPSDT. Targeted technical assistance could be valuable for CMS to provide to states after identifying gaps in states' performance relative to EPSDT targets. Doing so would allow CMS to share additional strategies to help states plan and implement needed improvements.

Recommendation: The Administrator of CMS should develop a plan with time frames and interim milestones for using T-MSIS data to generate the necessary data from the Child Core Set to improve EPSDT oversight and streamline state reporting. (Recommendation 6)

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

Comments: In June 2020, CMS officials said that they are currently exploring the feasibility of using T-MSIS data to generate certain Child Core Set measures. Specifically, the agency is conducting a pilot with five Child Core Set measures. CMS officials said that they will use the pilot's results to determine the timeline for generating the additional Child Core Set measures through T-MSIS. GAO will continue to follow the agency's progress on this activity.

Recommendation: The Administrator of CMS should ensure the agency's Medicaid third-party liability guidance is consistent with federal law related to

• the requirement for states to apply cost avoidance procedures to claims for labor, delivery, and postpartum care services,
• the requirement for states to make payments without regard to potential third-party liability for pediatric preventive services unless the state has made a determination related to cost-effectiveness and access to care that warrants cost avoidance for 90 days, and
• state flexibility to make payments without regard to potential third-party liability for pediatric services provided to child support enforcement beneficiaries. (Recommendation 1)

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

Comments: On November 14, 2019, CMS issued an Informational Bulletin providing further guidance to Medicaid Bipartisan Budget Act (BBA) of 2018 and changes to Medicaid Provisions Passed in April 2019-Third Party Liability in Medicaid and CHIP. The intent of the information Bulletin is to further clarify CMS guidance issued in the agency's June 2018 Bulletin on key provisions related to third party liability in Medicaid and CHIP. The Bulletin also addresses April 2019 changes to the Bipartisan Budget Act of 2013. The bulletin clarifies CMS guidance on two of the three issues we identified in our 2019 report. The bulletin notes that (1) effective February 9, 2018 a state is required to use standard coordination of benefits cost avoidance when processing claims for prenatal services which now includes labor and delivery and postpartum care claims, and (2) effective October 1, 2019, a state is required to make payments without regard to third party liability for pediatric preventive services unless the state has made a determination related to cost-effectiveness and access to care that warrants cost avoidance for 90 days. However, with regard to the third issue, the bulletin notes that, effective April 18, 2019, a state is allowed 100 days to pay claims related to child support enforcement, but does not note that states may choose to make payment within 30 days, if the state determines doing so is cost-effective and necessary to ensure access to care. We will continue to monitor CMS guidance on payments related to child support enforcement to assess whether the recommendation is fully implemented.

Recommendation: The Administrator of CMS should determine the extent to which state Medicaid programs are meeting federal third-party liability requirements and take actions to ensure compliance as appropriate. Such actions can include ensuring that state plans reflect the law. (Recommendation 2)

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

Comments: As of February 2020, we are unaware of any actions taken by CMS to implement this recommendation.

Recommendation: The administrator of CMS should require that abuse and perpetrator type be submitted by state survey agencies in CMS's databases for deficiency, complaint, and facility-reported incident data, and that CMS systematically assess trends in these data. (Recommendation 1)

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

Comments: HHS concurred with this recommendation. In February 2020, HHS said CMS is developing the ability to review survey trends related to alleged perpetrator and alleged abuse types and aims to implement this recommendation by December 2020.

Recommendation: The administrator of CMS should develop and disseminate guidance—including a standardized form—to all state survey agencies on the information nursing homes and covered individuals should include on facility-reported incidents. (Recommendation 2)

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

Comments: HHS concurred with this recommendation. In February 2020, HHS said CMS will list the elements that all nursing homes should report to state agencies and aims to implement this recommendation by December 2020.

Recommendation: The administrator of CMS should require state survey agencies to immediately refer complaints and surveys to law enforcement (and, when applicable, to Medicaid Fraud Control Units (MFCU)) if they have a reasonable suspicion that a crime against a resident has occurred when the complaint is received. (Recommendation 3)

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

Comments: HHS concurred with this recommendation. In February 2020, HHS said CMS will require state survey agencies to immediately refer complaints upon receipt and surveys to law enforcement (and, when applicable, to Medicaid Fraud Control Units) if they have a reasonable suspicion that a crime against a resident has occurred and aims to implement this requirement by December 2020.

Recommendation: The administrator of CMS should conduct oversight of state survey agencies to ensure referrals of complaints, surveys, and substantiated incidents with reasonable suspicion of a crime are referred to law enforcement (and, when applicable, to MFCUs) in a timely fashion. (Recommendation 4)

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

Comments: HHS concurred with this recommendation. In February 2020, HHS said CMS will revise guidance to ensure state survey agencies will investigate and track incidents of abuse and neglect and report substantiated findings to local law enforcement. CMS aims to implement this recommendation by December 2020.

Recommendation: The administrator of CMS should develop guidance for state survey agencies clarifying that allegations verified by evidence should be substantiated and reported to law enforcement and state registries in cases where citing a federal deficiency may not be appropriate. (Recommendation 5)

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

Comments: HHS concurred with this recommendation. In February 2020, HHS said CMS will provide clarification to the state survey agencies regarding the definition of substantiated and when cases need to be referred to law enforcement. CMS aims to implement this recommendation by December 2020.

Recommendation: The administrator of CMS should provide guidance on what information should be contained in the referral of abuse allegations to law enforcement. (Recommendation 6)

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

Comments: HHS concurred with this recommendation. In February 2020, HHS said it will provide guidance to state agencies and nursing homes on identifying and reporting potential abuse and neglect of residents and will develop a list of standardized elements that should be included when reporting an abuse allegation to law enforcement. HHS aims to implement this recommendation by July 2020.

Recommendation: The Administrator of CMS should develop and communicate a policy that defines when changes to a pending section 1115 demonstration application are considered major and should prompt a new review of the application against the transparency requirements applicable to the pending application. (Recommendation 1)

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

Comments: In response to this recommendation, HHS stated that existing regulations permit CMS at its discretion to direct an additional public comment period when states make a modification to an application that substantially changes the design. In July 2020, CMS officials said the agency would continue to exercise its regulatory discretion as needed and planned no further action in response to this recommendation. In light of past CMS decisions to not require states to first seek public comment before submitting major changes to their demonstration applications, we maintain that a policy is needed defining when changes are considered major and should prompt a new review of the application against transparency requirements. We will continue to monitor CMS's actions in this area.

Recommendation: The Administrator of CMS should develop and communicate a policy whereby applications for section 1115 demonstration amendments that may have significant impact are subject to transparency requirements comparable to those for new demonstrations and extensions. (Recommendation 2)

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

Comments: HHS stated that it plans to implement a policy applying state public input processes and application criteria to amendments proposing significant or substantial changes in the same manner as for new demonstrations. In July 2020, CMS stated the agency plans to develop criteria for determining whether an amendment application proposes a substantial change to an existing demonstration and to include this in guidance by early 2021. We will continue to monitor CMS's actions in this area and will close this recommendation once this policy guidance is issued.

Recommendation: The Administrator of CMS should institute a process to routinely assess, and take steps to ensure, as appropriate, that Medicare and Medicaid documentation requirements are necessary and effective at demonstrating compliance with coverage policies while appropriately addressing program risks. (Recommendation 1)

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

Comments: The Department of Health and Human Services concurred with this recommendation. In February 2020, the Centers for Medicare & Medicaid Services (CMS) noted that it had clarified and amended several Medicare documentation requirements as part of an agency initiative to assess such requirements. CMS further stated that Medicaid documentation requirements are generally established at the state level, and that the agency has taken steps to identify best practices for documentation requirements and share them with states. However, we believe that CMS still needs to take steps to assess documentation requirements in both programs to better understand how the variation in the programs' requirements affects estimated improper payment rates. Without an assessment of how the programs' documentation requirements affect estimates of improper payments, CMS may not have the information it needs to ensure that Medicare and Medicaid documentation requirements are effective at demonstrating compliance and appropriately address program risks.

Recommendation: The Administrator of CMS should take steps to ensure that Medicaid medical reviews provide robust information about and result in corrective actions that effectively address the underlying causes of improper payments. Such steps could include adjusting the sampling approach to reflect state-specific program risks, and working with state Medicaid agencies to leverage other sources of information, such as state auditor and the Department of Health and Human Services' Office of the Inspector General findings. (Recommendation 2)

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

Comments: The Department of Health and Human Services (HHS) did not concur with this recommendation. As of September 2020, HHS has stated that it does not plan to implement this recommendation because the agency believes the resource requirement is not justified based on the potential improper payment findings. HHS further stated that the agency already uses a variety of sources to identify and take corrective actions to address underlying causes of improper Medicaid payments. However, we found that the Centers for Medicare & Medicaid Services (CMS) and state Medicaid agencies are expending time and resources developing and implementing corrective actions that may not be representative of the underlying causes of improper payments in their states. Without robust information to effectively identify the underlying causes of improper payments, CMS and state Medicaid agencies may not develop corrective actions that effectively address Medicaid program risks.

Recommendation: The Administrator of CMS should take steps to minimize the potential for Payment Error Rate Measurement (PERM) medical reviews to compromise fraud investigations, such as by directing states to determine whether providers selected for PERM medical reviews are also under fraud investigation and to assess whether such reviews could compromise investigations. (Recommendation 3)

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

Comments: The Department of Health and Human Services (HHS) concurred with this recommendation. In October 2019, the Centers for Medicare & Medicaid Services (CMS) updated Medicaid Payment Error Rate Measurement (PERM) program guidance to strongly encourage state Medicaid agencies to proactively review providers selected for the state's PERM review; determine whether any of the selected providers are subjects of current or impending fraud investigations; and assess whether a PERM review could compromise the fraud investigation. CMS included this clarification in updated contractor guidance and in information provided to state Medicaid agencies. CMS plans to include the updated guidance in the fiscal year 2019 PERM program manual, which CMS anticipates completing by the end of 2019. Such revisions to the PERM manual will further codify and encourage state efforts to prevent PERM reviews from potentially compromising ongoing fraud investigations. As of September 2020, CMS has not informed us of any additional actions taken to implement this recommendation, including of any revisions to the PERM manual; we will update the status of this recommendation when we receive additional information.

Recommendation: The Administrator of CMS should address disincentives for state Medicaid agencies to notify the PERM contractor of providers under fraud investigation. This could include educating state officials about the benefits of reporting providers under fraud investigation, and taking actions such as revising how claims from providers under fraud investigation are accounted for in state-specific FFS improper payment rates, or the need for corrective actions in such cases. (Recommendation 4)

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

Comments: The Department of Health and Human Services (HHS) concurred with this recommendation. In October 2019, the Centers for Medicare & Medicaid Services (CMS) noted that the agency updated Medicaid Payment Error Rate Measurement (PERM) guidance regarding state Medicaid agencies' corrective action plans for providers under fraud investigation. If a state Medicaid agency opts to remove a provider from the state's PERM review due to a fraud investigation, claims associated with the provider are determined to be improper, due to no documentation. Under the updated guidance, states are no longer required to develop a corrective action plan for such claims, since the state is already addressing the issue through a fraud investigation. CMS included this updated guidance in the fiscal year 2017 PERM corrective action plan template, and plans to include the updated guidance in the fiscal year 2019 PERM program manual, which CMS anticipates completing by the end of 2019. Such revisions to the PERM manual will remove a disincentive for state Medicaid agencies to notify the PERM contractor of providers under fraud investigation. As of September 2020, CMS has not informed us of any additional actions taken to implement this recommendation, including of any revisions to the PERM manual; we will update the status of this recommendation when we receive additional information.

Recommendation: CMS should take action to ensure South Dakota's Medicaid state plan provides coverage for abortions in cases of rape and in cases of incest, in addition to life endangerment, to comply with federal law, which currently requires such coverage. (Recommendation 1)

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

Comments: In June 2019, HHS officials reported they were reviewing agency processes and would determine the best course of action moving forward. Officials said they would provide an update on actions by 12/20/2019. As of April 6, 2020, this recommendation remains open.

Recommendation: CMS should determine the extent to which state Medicaid programs are in compliance with federal requirements regarding coverage of Mifeprex and take actions to ensure compliance, as appropriate. (Recommendation 2)

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

Comments: In June 2019, HHS officials reported they were reviewing agency processes and would determine the best course of action moving forward. Officials said they would provide an update on actions by 12/20/2019. As of April 6, 2020, this recommendation remains open.

Recommendation: CMS should determine the extent to which state Medicaid programs are accurately reporting fee-for-service abortions on line 14 of the CMS-64 and take actions to ensure accuracy, as appropriate. (Recommendation 3)

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

Comments: In June 2019, HHS officials reported they were developing written instructions for states to reiterate fee-for-service reporting requirements for abortions provided in their Medicaid programs. Officials said they would provide an update on actions by 12/20/2019. As of April 6, 2020, this recommendation remains open.

Recommendation: The Administrator of CMS should provide states with more information on how to fulfill the requirement for independent encounter data audits, including information on the required audit scope and methodology, and what should be described in the resulting report. (Recommendation 1)

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

Comments: HHS agreed with our recommendation, noting that CMS would provide states with additional information on how to fulfill the requirement for independent encounter data audits. HHS also noted in January 2019 that CMS was developing voluntary guidance that will include information on best practices for validating encounter data. To implement this recommendation, the Administrator of CMS should inform states of the required audit scope and methodology as well as the resulting report. As of January 2020, HHS officials have not informed us of any additional actions taken to implement this recommendation. We will update the status of this recommendation when we receive additional information.

Recommendation: The Administrator of CMS should provide states information on the required content of the annual assessment of encounter data reporting. (Recommendation 2)

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

Comments: HHS agreed with our recommendation, noting that CMS would provide states further information on the required content of the annual assessment. In January 2019, HHS noted that CMS continues to develop guidance to states on how to fulfill the annual assessment requirement. As of January 2020, HHS officials have not informed us of any additional actions taken to implement this recommendation. We will update the status of this recommendation when we receive additional information.

Recommendation: The Administrator of CMS should provide states with information on the circumstances under which CMS would defer or disallow matching funds in response to noncompliant encounter data submissions. (Recommendation 3)

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

Comments: HHS neither agreed nor disagreed with our recommendation and noted steps it has already taken to remind states of their obligation to submit timely, quality encounter data, and prioritize data quality. In January 2019, HHS identified a possible step CMS could take in the event it finds deficiencies in states' encounter data reporting that cannot be resolved through informal monitoring and discussions with state Medicaid agencies. In particular, HHS noted that CMS would issue guidance on the parameters by which the agency would impose financial penalties on states for noncompliant encounter data submissions, if necessary. In February 2020, CMS officials told us that they continue to monitor state encounter data submissions and would issue guidance to states if they identify deficiencies in the data that cannot be resolved through informal monitoring and disccussions with state Medicaid agencies. To implement this recommendation, the Administrator of CMS should provide states with this information. We will update the status of this recommendation when we receive additional information.

Recommendation: The Administrator of CMS should complete a comprehensive, national risk assessment and take steps, as needed, to assure that resources to oversee expenditures reported by states are adequate and allocated based on areas of highest risk. (Recommendation 1)

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

Comments: CMS has taken steps to conduct a comprehensive national risk assessment. As of October 2019, CMS had developed a standard tool to assess risk and staff capacity. The agency indicated that once the assessment is complete, CMS will identify opportunities to increase resources, review the current allocation of financial staff, and determine the appropriate allocation of staff by state. We will continue to monitor CMS's action to complete this assessment.

Recommendation: The Administrator of CMS should clarify in internal guidance when a variance analysis on expenditures with higher match rates is required. (Recommendation 2)

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

Comments: In October 2019, CMS indicated that the agency held meetings to clarify internal guidance on the variance analysis and is the process of drafting updated guidance for the CMS-64 review. We will continue to monitor CMS's actions to update the guidance.

Recommendation: The Administrator of CMS should revise the sampling methodology for reviewing expenditures for the Medicaid expansion population to better target reviews to areas of high risk. (Recommendation 3)

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

Comments: In October 2019, CMS indicated that given their current resources, they believe the sampling methodology is sufficient and have no plans to revise it. The agency noted that the current methodology requires a minimum sample size but gives reviewers the flexibility to expand the size of the sample if warranted by risk and as resources permit. We continue to believe that the current methodology does not sufficiently target areas of high risk.

Recommendation: The Administrator of CMS should eliminate impediments to collaborative audits in managed care conducted by audit contractors and states, by ensuring that managed care audits are conducted regardless of which entity--the state or the managed care organization--recoups any identified overpayments. (Recommendation 2)

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

Comments: CMS agreed with and has taken some steps to address this action, as recommended by GAO in July 2018. In September 2019, CMS reported that in July 2019 CMS held a meeting with states and collaborative audit contractors to discuss coordination of managed care audits, including a wide range of challenges with managed care audits. As result of the feedback and recommendations received, CMS is evaluating several process improvements and reiterated that audit contractors will continue to work with states to provide support and assistance in Medicaid managed care, and that Medicaid managed care audits should not be limited by MCO contract language. Although CMS has communicated to states the need to increase audits in managed care and address identified issues, it is unclear if these actions will remove known impediments to managed care audits or result in an increase in the number of collaborative audits. Implementing GAO's July 2018 recommendation is needed because few audits of Medicaid managed care have been conducted and overpayments can be significant based on the findings from federal and state audits and investigations that have been completed. .

Recommendation: The Administrator of HRSA should require covered entities to register contract pharmacies for each site of the entity for which a contract exists. (Recommendation 1)

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

Comments: HHS does not concur with this recommendation and, as of July 2020, did not plan to take any actions to implement the recommendation. As noted in our report, without complete information on contract pharmacy arrangements--including information on with sites of a covered entity have contracts with a contract pharmacy--HRSA cannot ensure that it is optimally targeting the limited number of audits done each year. Additionally, manufacturers lack important information to help ensure that 340B discounted drugs are only provided to pharmacies with a valid 340B contract with the covered entity site for which the drug is being dispensed.

Recommendation: The Administrator of HRSA should issue guidance to covered entities on the prevention of duplicate discounts under Medicaid managed care, working with CMS as HRSA deems necessary to coordinate with guidance provided to state Medicaid programs.(Recommendation 2)

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

Comments: HHS concurred with this recommendation. In July 2020, HHS indicated that it believes that guidance does not provide HRSA appropriate enforcement capability and that this recommendation can only be accomplished after policy is issued. HRSA has requested regulatory authority for all aspects of the 340B Program in the FY 2021 President's Budget.

Recommendation: The Administrator of HRSA should incorporate an assessment of covered entities' compliance with the prohibition on duplicate discounts, as it relates to Medicaid managed care claims, into its audit process after guidance has been issued and ensure that identified violations are rectified by the entities. (Recommendation 3)

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

Comments: HHS concurred with this recommendation. In July 2020, HHS indicated that it believes that guidance does not provide HRSA appropriate enforcement capability and that this recommendation can only be accomplished after policy is issued. HRSA has requested regulatory authority for all aspects of the 340B Program in the FY 2021 President's Budget.

Recommendation: The Administrator of HRSA should issue guidance on the length of time covered entities must look back following an audit to identify the full scope of noncompliance identified during the audit.(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. In July 2020, HHS indicated that it believes that guidance does not provide HRSA appropriate enforcement capability and that this recommendation can only be accomplished after policy is issued. HRSA has requested regulatory authority for all aspects of the 340B Program in the FY 2021 President's Budget.

Recommendation: The Administrator of HRSA should require all covered entities to specify their methodology for identifying the full scope of noncompliance identified during the audit as part of their corrective action plans, and incorporate reviews of the methodology into their audit process to ensure that entities are adequately assessing the full scope of noncompliance. (Recommendation 5)

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

Comments: HHS does not concur with this recommendation and, as of July 2020, did not plan to take any actions to implement the recommendation. HHS noted that requiring all covered entities subject to an audit to specify their methodology for identifying the full scope of noncompliance identified during the audit would create a significant burden for covered entities. However, as noted in our report, HRSA already requires covered entities with audit findings to determine the full scope of noncompliance and requires entities subject to a targeted audit to provide their methodology for such assessments to HRSA. Thus, it is unclear how requiring covered entities subject to risk-based, as opposed to targeted, audits to provide HRSA with a written description of methodologies that they are already required to formulate and implement would create a significant additional burden. Without this information, HRSA does not have reasonable assurance that the majority of covered entities have adequately identified all instances of noncompliance.

Recommendation: The Administrator of HRSA should require all covered entities to provide evidence that their corrective action plans have been successfully implemented prior to closing audits, including documentation of the results of the entities' assessments of the full scope of noncompliance identified during each audit.(Recommendation 6)

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

Comments: HHS does not concur with this recommendation and, as of July 2020, did not plan to take any actions to implement the recommendation. HHS stated that requiring all covered entities with audit findings to provide evidence that their corrective action plans have been successfully implemented would create an undue burden for covered entities. However, HRSA already requires such evidence from covered entities subject to targeted audits, and it is unclear how providing evidence of implementation of corrective actions that entities developed and are required to implement would create significant additional burden for these entities. Additionally, without such evidence HRSA does not have a reasonable assurance that the majority of covered entities audited have corrected the issues identified in the audit, and are not continuing practices that could lead to noncompliance.

Recommendation: The Administrator of HRSA should provide more specific guidance to covered entities regarding contract pharmacy oversight, including the scope and frequency of such oversight. (Recommendation 7)

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

Comments: HHS concurred with this recommendation. In July 2020, HHS indicated that it believes that guidance does not provide HRSA appropriate enforcement capability and that this recommendation can only be accomplished after policy is issued. HRSA has requested regulatory authority for all aspects of the 340B Program in the FY 2021 President's Budget.

Recommendation: The Administrator of CMS should consider and take steps to mitigate the program risks that are not measured in the PERM, such as overpayments and unallowable costs; such an effort could include actions such as revising the PERM methodology or focusing additional audit resources on managed care. (Recommendation 1)

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

Comments: CMS concurred with this recommendation. In October 2018, it reported that it was developing a plan to address the recommendation. CMS also reported that it has published several guidance documents and is in the process of finalizing others. In addition, it reported that it continues to develop educational strategies (such as a recent course managed care offered by CMS' Medicaid Integrity Institute) and oversight and audit strategies and mechanisms related to managed care. CMS communicated that it initiated 32 audits involving Medicaid managed care network providers in 6 states and an audit of a managed care plan in another state in FY 2018. For FY 2019, CMS stated that it will be establishing a medical loss ratio examination process and initiating such audits of managed care organizations in California. CMS also stated that it will be developing guidance for states and managed care plans on managed care delivery and oversight to develop program integrity capacity and reduce program risks. As of December 2019, CMS has not taken any additional steps; we will continue to monitor CMS's progress to mitigate the managed care program risks not measured in the PERM.

Recommendation: The Administrator of CMS should ensure that CMS has complete data on terminations of enrollee coverage for nonpayment of premiums by requiring issuers to report these data. (Recommendation 1)

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

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

Recommendation: The Administrator of CMS should provide a transparent process for issuers and CMS to systematically reconcile discrepancies in their data on terminations of enrollee coverage for nonpayment of premiums. (Recommendation 2)

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

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

Recommendation: The Administrator of CMS should provide guidance and clarify requirements regarding the monitoring and reporting of deficiencies that states using home and community-based services (HCBS) waivers are required to report on their annual reports. (Recommendation 1)

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

Comments: CMS concurred with this recommendation and indicated the agency would provide guidance and clarify requirements regarding the monitoring and reporting of deficiencies in states' annual reports. According to CMS's fiscal year 2021 Budget Justification the agency expects to issue sub-regulatory guidance pertaining to health and welfare of Medicaid beneficiaries in residential facilities by the close of 2020.To fully implement this recommendation, the sub-regulatory guidance should clarify requirements for states' monitoring and reporting of deficiencies in HCBS annual reports. GAO will continue to monitor CMS actions in response to this recommendation.

Recommendation: The Administrator of CMS should establish standard Medicaid reporting requirements for all states to annually report key information on critical incidents, considering, at a minimum, the type of critical incidents involving Medicaid beneficiaries, and the type of residential facilities, including assisted living facilities, where critical incidents occurred. (Recommendation 2)

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

Comments: HHS neither agreed nor disagreed with this recommendation. According to CMS' fiscal year 2021 Budget Justification, the agency expects to issue sub-regulatory guidance pertaining to health and welfare of Medicaid beneficiaries in residential facilities by the close of 2020. To fully implement this recommendation, the sub-regulatory guidance should establish standard Medicaid reporting requirements for all states to report critical incidents annually. GAO will continue to monitor CMS actions in response to this recommendation.

Recommendation: The Administrator of CMS should ensure that all states submit annual reports for HCBS waivers on time as required. (Recommendation 3)

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

Comments: CMS concurred with this recommendation and stated that it will review and update its communications with states to reaffirm reporting requirements and ensure that all HCBS annual reports are submitted on time. According to CMS' fiscal year 2021 Budget Justification, the agency expects to issue sub-regulatory guidance pertaining to the health and welfare of Medicaid beneficiaries in residential facilities by the close of 2020. To fully implement this recommendation, the sub-regulatory guidance should ensure that all states submit annual reports on time. GAO will continue to monitor CMS actions in response to this recommendation.

Recommendation: The Administrator of CMS should ensure that all types of Medicaid HCBS programs have requirements for states to avoid or mitigate potential conflicts of interest on the part of entities that conduct needs assessments that are used to determine eligibility for HCBS and to develop HCBS plans of service. These requirements should address both service providers and managed care plans conducting such assessments. (Recommendation 1)

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

Comments: HHS concurred with our recommendation. However, in an April 2018 update, HHS noted that the recommendation should be closed based on existing Medicaid regulations. GAO disagrees. The existing regulations--which GAO reviewed at the time of this study--do not address all types of Medicaid HCBS programs. For example, specific conflict of interest requirements are generally not in place for needs assessments that are used to inform HCBS eligibility determinations. Similarly, managed care plans may have a financial interest in the outcome of HCBS assessments used for both determining eligibility and service amounts. GAO maintains that states should be required to avoid or mitigate potential conflicts of interest on the part of entities-including both service providers and managed care plans-that perform the needs assessments that states use for eligibility determinations and to develop plans of service. As of December 2019, HHS officials have not informed us of any additional actions taken to ensure that states avoid or mitigate potential conflict of interests in needs assessments for all types of Medicaid HCBS programs. We will update the status of this recommendation when we receive additional information.

Recommendation: The Administrator of CMS, in partnership with the states, should take additional steps to expedite the use of T-MSIS data for program oversight. Such steps should include, but are not limited to, efforts to (1) obtain complete information from all states on unreported T-MSISdata elements and their plans to report applicable data elements; (2) identify and share information across states on known T-MSIS datalimitations to improve data comparability; and (3) implement mechanisms, such as the Learning Collaborative, by whichstates can collaborate on an ongoing basis to improve thecompleteness, comparability, and utility of T-MSIS data.(Recommendation 1)

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

Comments: HHS concurred with this recommendation. As of February 2020, CMS has taken steps to improve T-MSIS data quality, but further efforts are needed to expedite the data's use in oversight. With regard to obtaining complete information from all states, CMS released additional guidance in March 2019, on state compliance with T-MSIS requirements. This guidance includes the need to resolve data issues associated with 12 top priority items and missing data elements, both of which are key for using T-MSIS data. Further, CMS identified an additional 11 top priority items, noting it also expected states to resolve data issues with these items. CMS reports that it has helped resolve data issues related to these 23 top priority items by sending states summary data on compliance with associated reporting requirements. CMS has notified states of their compliance status and asked non-compliant states to submit corrective action plans. However, CMS reports that the level of states' T-MSIS data completeness varies and agency state liaisons and technical assistants continue to work individually with states to identify, prioritize, and resolve key missing data elements. With regard to identifying and sharing information, CMS has made some T-MSIS data available for use through five T-MSIS analytical files, which include data on Medicaid and CHIP enrollment, demographics, service utilization, and payments. Further, CMS has created resources to support researchers in their use of these analytical files, including information on the completeness and accuracy of certain data elements. With regard to implementing mechanisms for collaboration across states, additional CMS action is needed. In particular, CMS's efforts to create a mechanism for states to disseminate information about T-MSIS data and its comparability across states remain limited and the agency has not launched its proposed Learning Collaborative to facilitate ongoing feedback and collaboration. While progress has been made, additional actions, such as establishing mechanisms for ongoing feedback and collaboration across states, are needed to consider this recommendation implemented.

Recommendation: The Administrator of CMS should articulate a specific plan and associated time frames for using T-MSIS data for oversight. (Recommendation 2)

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

Comments: HHS concurred with this recommendation. As of February 2020, CMS has taken steps to articulate guidance to states, but has not outlined a specific plan and associated time frames for using T-MSIS data for oversight. Until CMS takes these actions, the recommendation remains open.

Recommendation: The Administrator of CMS should provide fraud-awareness training relevant to risks facing CMS programs and require new hires to undergo such training and all employees to undergo training on a recurring basis. (Recommendation 1)

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

Comments: The agency agreed with this recommendation. In July 2018, CMS reported that it is strengthening its efforts to ingrain fraud risk management principles throughout the Agency and is developing a training video, module, and curriculum to train staff agency-wide on fraud risks. In November 2019, CMS provided fraud-awareness training videos for new and current CMS employees. GAO requested and is awaiting documentation to show mandatory nature and annual frequency of the training in order to assess the extent to which the training is consistent with leading practices in fraud risk management.

Recommendation: The Administrator of CMS should conduct fraud risk assessments for Medicare and Medicaid to include respective fraud risk profiles and plans for regularly updating the assessments and profiles. (Recommendation 2)

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

Comments: Agency agreed with this recommendation. In July 2018, CMS reported that it has initiated the fraud risk assessment for some programs in Medicare, including the Medicare Diabetes Prevention Program expanded model. CMS also reported that it is also continuing to draft fraud risk profiles for the Comprehensive End-Stage Renal Disease (ESRD) Care model, the Comprehensive Primary Care Plus model, the permanent Medicare Shared Savings Program, and the new Medicare Beneficiary Identifier. Additionally, CMS reported that it is assessing the Quality Payment Program, established by the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA), utilizing the GAO fraud risk assessment framework. We will continue to monitor CMS's progress in this area. In November 2019, CMS provided a diagram depicting CMS approach to assessing fraud risks and a document for Home Health Request for Anticipated Payment, stating that fraud risk assessments on Medicare Diabetes Prevention Program and Quality Payment Program are under development. We requested and are awaiting additional information on CMS's approach and plans for conducting fraud risk assessments in Medicare programs, including the reasoning for program selection, overall order, and anticipated timeframes.

Recommendation: The Administrator of CMS should, using the results of the fraud risk assessments for Medicare and Medicaid, create, document, implement, and communicate an antifraud strategy that is aligned with and responsive to regularly assessed fraud risks. This strategy should include an approach for monitoring and evaluation. (Recommendation 3)

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

Comments: Agency agreed with this recommendation. In November 2019, CMS reported on activities to conduct fraud risk assessments in Medicare programs (see Recommendation 2), however this work is ongoing and the recommendation remains open. Because completion of a fraud risk assessment is necessary before developing an antifraud strategy, this recommendation also remains open. We will continue to monitor CMS's progress in this area.

Recommendation: To improve CMS's oversight of states' MLTSS programs, the Administrator of CMS should take steps to identify and obtain key information needed to oversee states' efforts to monitor beneficiary access to quality services, including, at a minimum, obtaining information specific to network adequacy, critical incidents, and appeals and grievances.

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

Comments: The Department of Health and Human Services (HHS) agreed with this recommendation. In December 2017, HHS communicated its intent to review regulations and enhance its capacity to measure, monitor, and improve care and quality across a number of domains, including MLTSS. As of February 2020, HHS stated that it is developing guidance related to reporting on key information needed to oversee beneficiary access to care. GAO will continue to monitor the department's actions and any steps taken to address this recommendation.

Recommendation: To improve consistency in CMS oversight of federal spending under section 1115 demonstrations, the Secretary of Health and Human Services should require the Administrator of CMS to develop and document standard operating procedures for monitoring spending under demonstrations that (1) require setting reporting requirements for states that provide CMS the data elements needed for CMS to assess compliance with demonstration spending limits; (2) require consistent enforcement of states' compliance with financial reporting requirements; and (3) require consistent tracking of the amount of unspent funds under demonstration spending limits.

Agency: Department of Health and Human Services
Status: Open

Comments: The Department of Health and Human Services (HHS) has taken steps to improve the consistency of oversight of federal spending under section 1115 demonstrations. In November 2018, HHS officials reported that they have developed draft guidance, including a standard reporting tool for states, to better ensure consistent reporting of the elements needed to assess compliance with demonstration spending limits and was in the process of testing the tool with two states. In addition, the agency is developing standard operating procedures for agency staff to require consistent tracking of unspent funds under the spending limit. As of November 2019, HHS has not provided any updates. GAO will continue to monitor HHS's actions and once procedures are in place, GAO will assess whether they address our recommendation.

Recommendation: To improve the collection of complete and consistent personal care services data and better ensure CMS can effectively monitor the states' provision of and spending on Medicaid personal care services, CMS should better ensure that personal care services data collected from states through T-MSIS and MBES comply with CMS reporting requirements.

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

Comments: The Centers for Medicare & Medicaid Services (CMS) concurs with GAO's recommendation. In December 2017, CMS cited ongoing efforts related to claims data submitted by states through T-MSIS, CMS's new claims reporting system. Efforts included validation checks of personal care service claims to ensure that key data are not missing or incorrect. In addition, CMS stated it was working with the states to address concerns that are identified with the quality of claims data submitted. However, as of March 2020, CMS had not reported that it had addressed inaccurate state reporting of expenditures through CMS's expenditure reporting system, Medicaid Budget and Expenditure System (MBES). Complete implementation of the recommended action will better ensure state reporting of claims and expenditures is accurate and will allow CMS to effectively perform key management functions.

Recommendation: To improve the collection of complete and consistent personal care services data and better ensure CMS can effectively monitor the states' provision of and spending on Medicaid personal care services, CMS should develop plans for analyzing and using personal care services data for program management and oversight.

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

Comments: The Centers for Medicare & Medicaid Services (CMS) concurred with this recommendation. However, as of March 2020, CMS had not developed a plan for analyzing and using personal care services data as GAO recommended in January 2017. Developing a plan for analyzing and using personal care services data for program management and oversight is an important step CMS needs to take to improve the oversight and management of personal care services.

Recommendation: To improve oversight of states' payment structures for MLTSS, the Administrator of CMS should require all states to collect and report on progress toward achieving MLTSS program goals, such as whether the program enhances the provision of community-based care.

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

Comments: As of June 2020, CMS has not informed us of any additional actions taken to implement this recommendation. CMS previously reported that it is working to develop guidance on how states report on progress towards achieving MLTSS program goals, such as the extent to which the program enhances the provision of community-based care. CMS has contracted with a vendor to produce recommendations for what would be included in the state reporting. We will update the status of this recommendation when we receive additional information.

Recommendation: To improve oversight of states' payment structures for MLTSS, the Administrator of CMS should establish criteria for what situations would warrant exceptions to the federal standards that the data used to set rates be no older than the three most recent and complete years.

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

Comments: As of June 2020, CMS has not informed us of any additional actions taken to implement this recommendation. CMS previously reported that it has monitored rate certifications and the data used for rating periods starting on or after July 1, 2017. CMS said that it has not had any states set rates that do not meet the federal standards for the data being no older than the three most recent and complete years and, therefore, does not believe that it should publish guidance on what situations would warrant exceptions. In order to better determine whether there is a need for such guidance, we believe that CMS should continue to monitor rate certifications and assess the data being used, particularly as additional states are developing or considering implementation of MLTSS programs. We will update the status of this recommendation as CMS conducts reviews of other states' payment structures and data used to establish them.

Recommendation: To improve oversight of states' payment structures for MLTSS, the Administrator of CMS should provide states with guidance that includes minimum standards for encounter data validation procedures.

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

Comments: As of June 2020, CMS has not informed us of any additional actions taken to implement this recommendation. CMS previously reported to GAO that it has convened a workgroup to develop an Encounter Data Toolkit, which will provide best practices for encounter data submissions and validation procedures. The workgroup is also discussing minimum standards for states to determine if the encounter data are complete and accurate for purposes of rate setting. The workgroup met in June and July 2018, and two additional workgroup meeting are planned prior to the drafting of the toolkit. We will update the status of this recommendation when we receive additional information.

Recommendation: To achieve a better understanding of the effect of certain Personal care services (PCS) services on beneficiaries and a more consistent administration of policies and procedures across PCS programs, the Acting Administrator of CMS should collect and analyze states' required information on the impact of the Participant-Directed Option and Community First Choice programs on the health and welfare of beneficiaries as well as the state quality measures for the Participant-Directed Option and Community First Choice programs.

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

Comments: The Centers for Medicare & Medicaid Services (CMS) concurred with GAO's recommendation. On December 30, 2016, the agency issued guidance on the Community First Choice program to assist states in submitting information to CMS on the health and welfare of beneficiaries. In March 2019, CMS officials stated that the agency is currently developing the process for states to report this information to CMS. Agency officials also stated they are exploring the value of collecting this information for the Participant-Directed Option program given the limited number of states currently operating under this authority. In February 2020, CMS officials stated that the agency continues to develop policy related to this recommendation.

Recommendation: To help improve the Five-Star System's ability to enable consumers to understand nursing home quality and make distinctions between high- and low- performing homes, the Administrator of CMS should add information to the Five-Star System that allows consumers to compare nursing homes nationally.

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

Comments: HHS did not concur with this recommendation. CMS officials told us in July 2019 that they do not plan to implement this recommendation. We maintain that adding national comparison information is important.

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 improve the accessibility and reliability of SNF expenditure data, the Acting Administrator of CMS should take steps to improve the accessibility of SNF expenditure data, making it easier for public stakeholders to locate and use the data.

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

Comments: In September 2016, GAO recommended that CMS improve the accessibility and reliability of SNF expenditure data, thereby making it easier for public stakeholders to locate and use the data. The agency concurred with this recommendation in 2016 and stated that it would review the feasibility of increasing the accessibility of this data. However, in August 2017, HHS told GAO that it now believes that the cost of implementing this recommendation would outweigh its benefits. HHS confirmed in July 2019 that its position on this recommendation has not changed. GAO continues to hold that data on SNFs' relative expenditures should be readily accessible to the public to ensure transparency in SNF expenditures.

Recommendation: To improve the accessibility and reliability of SNF expenditure data, the Acting Administrator of CMS should take steps to ensure the accuracy and completeness of SNF expenditure data.

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

Comments: In September 2016, GAO recommended that CMS take steps to ensure the accuracy and completeness of SNF expenditure data. However, the agency did not concur with this recommendation. HHS reported in 2016 that the amount of time and resources to verify the accuracy and completeness of SNF expenditure data could be substantial, without assurance of benefit to the agency and the public. However, during the course of our work, GAO found that CMS uses this expenditure data to update overall SNF payment rates, in addition to more general purposes. GAO continues to believe that CMS should take steps to ensure reliable expenditure data are accurate and complete. As of July 2019, the agency continues to non-concur with this recommendation.

Recommendation: To ensure efficient use of federal resources, the Administrator of CMS should account for Medicaid payments a hospital has received that offset uncompensated care costs when determining hospital uncompensated care costs for the purposes of making Medicare UC payments to individual hospitals.

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

Comments: No executive action taken as of March 2020. CMS initially agreed with GAO's June 2016 recommendation. However, in October 2018, and again in December 2019 , CMS indicated that it was reconsidering whether to offset Medicare Uncompensated Care (UC) payments by Medicaid's uncompensated care payments. CMS stated that because Medicare UC payments are distributed based on hospitals' relative (not actual) uncompensated care costs, it would not be appropriate to account for Medicaid payments that reduce hospital uncompensated care. However, in some states Medicaid payments reduce or even eliminate hospital uncompensated care costs, which can result in an inequitable distribution of payments. Because the total amount of Medicare UC payments is capped, not accounting for Medicaid payments will result in hospitals that have little or no uncompensated care costs receiving a higher proportion of Medicare UC payments than warranted, resulting in in less funding for hospitals that actually have uncompensated care costs. Implementing GAO's recommendation would ensure that Medicare UC payments are based on accurate levels of uncompensated care costs and result in CMS better targeting billions of dollars in Medicare UC payments to hospitals that do have with the most uncompensated care costs, while avoiding making payments to hospitals with little or no uncompensated care costs.

Recommendation: The Secretary of Health and Human Services should direct the Administrator of CMS to assess the feasibility of updating the agency's study on the effect of VA-provided Medicare-covered services on per capita county Medicare FFS spending rates by obtaining VA utilization and diagnosis data for veterans enrolled in Medicare FFS under its existing data use agreement or by other means as necessary.

Agency: Department of Health and Human Services
Status: Open

Comments: In December 2017, the U.S. Department of Health and Human Services (HHS) indicated that it had further reviewed our recommendation and determined that updating the agency's study on the effect of VA-provided Medicare-covered services on per capita county Medicare fee-for-service (FFS) spending rates using the Department of Veterans Affairs' (VA) utilization and diagnosis data was not feasible. Challenges cited by HHS included (1) pricing each VA encounter using Medicare payment rules; (2) determining which Medicare provider would have treated each beneficiary; and (3) the resources required to have an ongoing data feed with VA and to protect VA utilization and diagnosis data. While we acknowledge that there may be challenges associated with incorporating VA utilization and diagnosis data into HHS's analysis, we believe that HHS needs to do additional work before it can determine whether such an approach is feasible. For example, while HHS noted resource concerns related to sharing and storing sensitive VA data, the agency already receives and stores some VA data. It remains unclear whether HHS has assessed what additional resources would be needed to store VA utilization and diagnosis data and whether such data would need to be shared via an ongoing data feed-another challenge mentioned by HHS. As of June 2020, HHS has not provided us with any additional information about actions it has taken to address this recommendation. We continue to believe that HHS should assess the feasibility of implementing a methodology for estimating the effect of VA-provided Medicare-covered services on per capita county Medicare FFS spending rates that incorporates VA data.

Recommendation: If CMS makes an adjustment to the benchmark to account for VA spending on Medicare-covered services, the Secretary of Health and Human Services should direct the Administrator of CMS to assess whether an additional adjustment to MA payments is needed to ensure that payments to MA plans are equitable for veterans and nonveterans.

Agency: Department of Health and Human Services
Status: Open

Comments: In December 2017, the U.S. Department of Health and Human Services (HHS) indicated that there are a number of limitations that would impede the Centers for Medicare & Medicaid Services' (CMS) ability to conduct an analysis of veteran versus nonveteran payments to MA plans. HHS indicated that in order to conduct a thorough assessment, CMS would need utilization and diagnosis data from the Department of Veterans Affairs (VA), which would take several years to collect and analyze. In addition, HHS indicated that if CMS determined an adjustment was needed, the agency would have to overcome other data, operational, and financial challenges related to making the adjustment. As a result, HHS indicated that implementing such an adjustment would be infeasible. However, CMS currently adjusts the benchmark to account for VA spending on Medicare-covered services without VA utilization and diagnosis data. While we agree that VA utilization and diagnosis data may improve the accuracy of an adjustment to MA payments to ensure that payments to MA plans are equitable for veterans and nonveterans, it is unclear why CMS could not make an adjustment without VA utilization and diagnosis data. As of June 2020, HHS has not provided us with any additional information about actions it has taken to address this recommendation. In order for us to close this recommendation, CMS would need to assess whether an additional adjustment to MA payments is needed.

Recommendation: To promote consistency in the distribution of supplemental payments among states and with CMS policy, the Administrator of CMS should issue written guidance clarifying its policy that requires a link between the distribution of supplemental payments and the provision of Medicaid-covered services.

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

Comments: CMS issued a proposed rule in November 2019 that may address this issue. According to the agency, the rule will promote state accountability, improve federal oversight, and strengthen the fiscal integrity of Medicaid. Specifically, the agency said the rule would require states to report to CMS a comprehensive description of the methodology used to calculate the amount and distribution of supplemental payments and the provider metrics used to calculate payment amounts, such as Medicaid utilization or costs. We will assess the extent to which the final rule addresses our recommendation when it is issued.

Recommendation: To promote consistency in the distribution of supplemental payments among states and with CMS policy, the Administrator of CMS should issue written guidance clarifying its policy that payments should not be made contingent on the availability of local funding.

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

Comments: CMS issued a proposed rule in November 2019 that may address this issue. According to the agency, the rule will promote state accountability, improve federal oversight, and strengthen the fiscal integrity of Medicaid. Specifically, the proposed rule clarifies the agency policy that Medicaid payments may not be contingent on the availability of local funding, according to agency officials. We will assess the extent to which the final rule addresses our recommendation when it is issued.

Recommendation: To ensure states have appropriate and current guidance to assist them in designing and administering Medicaid NEMT, the Secretary of HHS should direct CMS to assess current Medicaid NEMT guidance and update that guidance as needed.

Agency: Department of Health and Human Services
Status: Open

Comments: As of July 2019, HHS officials reported that they are waiting for a policy decision from leadership concerning non-emergency medical transportation. GAO will continue to monitor and update the status of this recommendation.

Recommendation: To improve the effectiveness of its oversight of eligibility determinations, the Administrator of CMS should conduct reviews of federal Medicaid eligibility determinations to ascertain the accuracy of these determinations and institute corrective action plans where necessary.

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

Comments: The Department of Health and Human Services (HHS) has taken some steps to improve the accuracy of Medicaid eligibility determinations, as GAO recommended in October 2015, but has not yet conducted a systematic review of federal eligibility determinations. In July 2017, HHS issued its final rule on the Payment Error Rate Measurement (PERM) program, and stated that it would include reviews of federal eligibility determinations in states that have delegated that authority. In December 2017, HHS provided information noting that the first cycle of the revised PERM includes two states where there were federal eligibility determinations. However, as HHS confirmed in December 2019, the random sample of eligibility determinations reviewed in the first cycle of the revised PERM did not include any federal eligibility determinations. As such, the PERM has not systematically reviewed federal determinations, and we maintain that further reviews are needed to help ensure that only individuals eligible for Medicaid are receiving benefits. We will continue to monitor HHS to determine if HHS is ascertaining the accuracy of federal eligibility determinations and taking corrective action where necessary.

Recommendation: To improve its oversight of network adequacy in MA, the Administrator of CMS should augment MA network adequacy criteria to address provider availability.

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

Comments: HHS concurred with this recommendation, and noted in a February 2018 update that CMS requires MAOs to identify provider availability in certain circumstances, such as in granting exceptions to the agency's network adequacy criteria. CMS also stated that it would consider augmenting MA network adequacy criteria to address provider availability in future years. However, CMS's 2018 MA network adequacy guidance stated that the agency does not currently consider provider availability when reviewing an organization's network adequacy, and this guidance was not updated in 2019. As a result, as of September 2019, agency officials have not implemented this recommendation.

Recommendation: To improve its oversight of network adequacy in MA, the Administrator of CMS should verify provider information submitted by MAOs to ensure validity of the Health Services Delivery data.

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

Comments: HHS concurred with this recommendation, and noted in a February 2018 update that the agency has standardized existing protocols to ensure the validity of the Health Services Delivery data submitted by MAOs with regards to exceptions requests and partial county justifications. However, CMS's 2018 MA network adequacy guidance stated that MAOs remain responsible for conducting validation of Health Services Delivery data. Unless CMS verifies provider information submitted by MAOs, the agency cannot be confident that MAOs are meeting network adequacy criteria. As of September 2019, agency officials have not implemented this recommendation.

Recommendation: To improve its oversight of network adequacy in MA, the Administrator of CMS should set minimum requirements for MAO letters notifying enrollees of provider terminations and require MAOs to submit sample letters to CMS for review.

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

Comments: HHS concurred with this recommendation. In a September 2017 update, the agency stated that it had met the spirit of our recommendation by adding its best practice suggestions of what should be included in the written termination notice to the Medicare Managed Care Manual. However, as we noted in our report, those practices are not required, nor are the letters regularly reviewed. As of September 2019, agency officials have not yet implemented this recommendation.

Recommendation: To improve the transparency and accountability of HHS's section 1115 Medicaid demonstration approval process, and to ensure that federal Medicaid funds for the demonstrations do not duplicate other federal funds, the Secretary of Health and Human Services should issue criteria for assessing whether section 1115 expenditure authorities are likely to promote Medicaid objectives.

Agency: Department of Health and Human Services
Status: Open

Comments: The Department of Health and Human Services (HHS) partially concurred with this recommendation and has taken some steps to address the problems GAO identified. Initially, in August 2015, HHS posted on its website general criteria for assessing whether Medicaid section 1115 demonstration expenditure authorities are likely to promote Medicaid objectives, but GAO found the general criteria were not sufficiently specific. HHS later removed these criteria from its website and replaced them with six broad areas of reform that HHS encourages states to consider. As of January 2020, HHS does not have specific criteria for approving section 1115 expenditure authorities, but officials noted that the agency had begun including in approval letters the agency's rationale for approving specific expenditure authorities. GAO considers this a positive step towards improving the transparency of HHS's approval decisions, and if implemented consistently would address the intent of GAO's recommendation. HHS officials indicated that this step would be included in written protocols the agency is drafting but did not have a date for their completion. If these protocols are completed and consistently implemented, HHS's bases for its approvals of expenditure authorities, which can amount to billions of dollars in federal spending, will be more transparent. We will continue to monitor HHS's actions in response to this recommendation.

Recommendation: To improve the transparency and accountability of HHS's section 1115 Medicaid demonstration approval process, and to ensure that federal Medicaid funds for the demonstrations do not duplicate other federal funds, the Secretary of Health and Human Services should ensure the application of these criteria is documented in all HHS's approvals of section 1115 demonstrations, including those approving new or extending or modifying existing expenditure authorities, to inform internal and external stakeholders, including states, the public, and Congress, of the basis for the agency's determinations that approved expenditure authorities are likely to promote Medicaid objectives.

Agency: Department of Health and Human Services
Status: Open

Comments: HHS agreed with this recommendation and, as of January 2020, had taken some steps to ensure that the bases for its approval decisions are documented in all approvals of section 1115 demonstrations. In December 2017, HHS's Centers for Medicare & Medicaid Services (CMS) issued a letter to state Medicaid officials, stating it had begun requesting additional documentation of the demonstration purposes being served by certain types of previously approved funding in demonstration proposals. Additionally, the agency noted it was taking certain steps to ensure that only allowable costs were matched by federal Medicaid funds. In April 2018, CMS officials stated that the agency had begun addressing in approval documents how each intervention proposed by the state was determined to be likely to promote Medicaid objectives. Officials reported that this step would be included in formal written protocols that outline the agency's procedures for application review and preparation of approval documents for section 1115 demonstrations, but as of January 2020, the agency did not have time frames for the completion of these protocols. If CMS completes and implements the written protocols, stakeholders should be able to more easily and consistently assess the agency's decisions. We will continue to monitor CMS's efforts in this area.

Recommendation: To improve CMS's oversight of Medicaid payments, the Administrator of CMS should take steps to ensure that states report accurate provider-specific payment data that include accurate unique national provider identifiers (NPI).

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

Comments: In November 2019, CMS issued a proposed rule that the agency said would promote state accountability, improve federal oversight, and strengthen the fiscal integrity of the Medicaid program. Among other things, the proposed rule would require states to report supplemental payments made to individual providers; furthermore, it would require states to include the National Provider Identifier (NPI) number-a unique 10-digit identification number assigned to health care providers. GAO will continue to monitor the status of the proposed rule and will review a final rule, if one is issued, to determine the extent it addresses the recommendation.

Recommendation: To improve CMS's oversight of Medicaid payments, the Administrator of CMS should develop a policy establishing criteria for when such payments at the provider level are economical and efficient.

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

Comments: In November 2019, CMS issued a proposed rule that the agency said would require states to demonstrate to CMS that supplemental payments to individual providers are economical and efficient and also require states to end and then seek CMS approval to renew supplemental payments every three years. GAO will monitor the status of the proposed rule and will review a final rule, if one is issued, to determine the extent to which it addresses the recommendation.

Recommendation: To improve CMS's oversight of Medicaid payments, the Administrator of CMS should, once criteria are developed, develop a process for identifying and reviewing payments to individual providers in order to determine whether they are economical and efficient.

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

Comments: In November 2019, CMS issued a proposed rule that the agency said would require states to demonstrate to CMS that supplemental payments to individual providers are economical and efficient and also require states to end and then seek CMS approval to renew supplemental payments every three years. GAO will monitor the status of the proposed rule and will review a final rule, if one is issued, to determine the extent to which it addresses the recommendation.

Recommendation: Depending on the outcome of the litigation, the Secretary of Labor should take steps to ensure the agency will be positioned to conduct a meaningful retrospective review consistent with the Executive Order at an appropriate time. These steps should be taken in consultation with the Centers for Medicare & Medicaid Services, and could include, for example, identifying metrics that could be used to evaluate the rule, and implementing a plan to gather and analyze the necessary data.

Agency: Department of Labor
Status: Open

Comments: The Department of Labor's Wage and Hour Division (WHD) agreed with this recommendation and reported that it is working to develop data collection plans and explore a potential evaluation that is focused on the Home Care Rule. As part of this effort, WHD noted that it will continue to work with HHS and other federal partners. In FY16, WHD reported that such an evaluation of how stakeholders and affected industries have responded to the rule would be beneficial. However, litigation has delayed implementation and enforcement of the rule significantly, and WHD believes an evaluation at this stage would be premature and would be unlikely to fully and accurately capture stakeholders' responses to the rule and the resulting impacts. Delaying the evaluation would allow WHD to monitor the results of its own investigations and the effects of ongoing compliance assistance, both of which would be extremely difficult to measure at this early stage. In 2017, WHD reported that it will continue to monitor early implementation to determine the appropriate start for any evaluation and lay the groundwork for future assessment, including a plan for how to identify data that would inform such as an assessment. In 2018, WHD reported that it is too early in the implementation phase of the rule to conduct an evaluation of the rule's impact. The Department and WHD continue to engage with HHS to understand stakeholders' responses to the rule. WHD also continues to lay the groundwork for any future assessment by working to identify data sources that would inform such as an assessment.

Recommendation: To promote and enhance federal, state, and local NEMT coordination activities, the Secretary of Transportation, as the chair of the Coordinating Council, should convene a meeting of the member agencies of the Coordinating Council and complete and publish a new or updated strategic plan that, among other things, clearly outlines a strategy for addressing NEMT and how it can be coordinated across federal agencies that fund NEMT service.

Agency: Department of Transportation
Status: Open

Comments: The Federal Transit Administration (FTA) concurred with this recommendation. The Department of Transportation (DOT), which chairs the Coordinating Council on Access and Mobility (Coordinating Council) and provides administrative support and staff, has made some progress to enhance coordination of NEMT programs through the development of a new or updated strategic plan, as GAO recommended in December 2014, but coordination at the federal level remains limited. In October 2019, the Coordinating Council adopted a new strategic plan as recommended by GAO. However, DOT indicated that strategies for coordinating NEMT across federal agencies would not be fully articulated until November 2020 when it plans to issue a report to the President and Congress. Until the report is finalized, the Coordinating Council may be missing an opportunity to identify and align goals and strategies for increased NEMT coordination with the benefits of coordination, such as increased program efficiency or reduced costs.

Recommendation: To promote and enhance federal, state, and local NEMT coordination activities, the Secretary of Transportation, as the chair of the Coordinating Council, should convene a meeting of the member agencies of the Coordinating Council and finalize and issue a cost-sharing policy and clearly identify how it can be applied to programs under the purview of member agencies of the Coordinating Council that provide funding for NEMT.

Agency: Department of Transportation
Status: Open

Comments: FTA concurred with this recommendation. The Department of Transportation (DOT), which chairs the Coordinating Council and provides administrative support and staff, has made minimal progress to develop and issue a cost-sharing policy, as GAO recommended in December 2014, which would allow agencies to identify and allocate costs among programs. In October 2019, the Coordinating Council adopted a new strategic plan. DOT plans to include a cost sharing policy as part of a report to the President and Congress in September 2020. According to DOT officials, they have begun the process of soliciting and including input from Coordinating Council agencies to develop the elements of the report, including the cost sharing policy, as of December 2019. The development of a cost sharing policy would provide federal guidance on how to address cost sharing issues across agencies and help facilitate ride and vehicle sharing. Until the Coordinating Council develops federal cost allocation principles for transportation providers, federal agencies may be unable to address cost-sharing issues across agencies such as ride and vehicle sharing.

Recommendation: To promote and enhance federal, state, and local NEMT coordination activities, the Secretary of Transportation, as the chair of the Coordinating Council, should convene a meeting of the member agencies of the Coordinating Council and using the on-going work of the Health, Wellness, and Transportation working group and other appropriate resources, (1) identify the challenges associated with coordinating Medicaid and VA NEMT programs with other federal programs that fund NEMT, (2) develop recommendations for how these challenges can be addressed while still maintaining program integrity and fraud prevention, and (3) report these recommendations to appropriate committees of Congress. To the extent feasible, the Coordinating Council should implement those recommendations that are within its legal authority.

Agency: Department of Transportation
Status: Open

Comments: FTA said they concurred in part with this recommendation. The Fixing America's Surface Transportation (FAST) Act requires the Coordinating Council on Access and Mobility (Coordinating Council) to develop and publish a strategic plan. The Department of Transportation (DOT), which chairs the Coordinating Council and provides administrative support and staff, has made some but minimal progress to address the challenges associated with coordinating Medicaid and VA NEMT programs and other federal programs, as GAO recommended in December 2014. In October 2019, the Coordinating Council adopted a new strategic plan. According to DOT, it has made progress identifying challenges associated with coordinating Medicaid and VA NEMT programs, in part through the use of focus groups and a survey conducted by the National Center for Mobility Management. DOT expects it will include recommendations for addressing the challenges identified in a November 2020 report to the President and Congress. As of December 2019, DOT had begun the process of soliciting input from Coordinating Council agencies into these recommendations. Until DOT's assessment to identify and address coordination challenges is completed, agencies will be limited in coordinating Medicaid and VA NEMT programs with other federal programs that fund NEMT.

Recommendation: To improve consumers' access to relevant and understandable information on the cost and quality of health care services, the Secretary of HHS should direct the Administrator of CMS to include in the CMS Compare websites, to the extent feasible, estimated out-of-pocket costs for Medicare beneficiaries for common treatments that can be planned in advance.

Agency: Department of Health and Human Services
Status: Open

Comments: As of September 2019, HHS officials have not informed us of any actions taken to implement this recommendation. We will update the status of this recommendation when we receive additional information.

Recommendation: To improve consumers' access to relevant and understandable information on the cost and quality of health care services, the Secretary of HHS should direct the Administrator of CMS to organize cost and quality information in the CMS Compare websites to facilitate consumer identification of the highest-performing providers, such as by listing providers in order based on their performance.

Agency: Department of Health and Human Services
Status: Open

Comments: As of September 2019, HHS officials have not informed us of any actions taken to implement this recommendation. We will update the status of this recommendation when we receive additional information.

Recommendation: To improve consumers' access to relevant and understandable information on the cost and quality of health care services, the Secretary of HHS should direct the Administrator of CMS to include in the CMS Compare websites the capability for consumers to customize the information presented, to better focus on information relevant to them.

Agency: Department of Health and Human Services
Status: Open

Comments: As of September 2019, HHS officials have not informed us of any actions taken to implement this recommendation. We will update the status of this recommendation when we receive additional information.

Recommendation: To improve consumers' access to relevant and understandable information on the cost and quality of health care services, the Secretary of HHS should direct the Administrator of CMS to develop specific procedures and performance metrics to ensure that CMS's efforts to promote the development and use of its own and others' transparency tools adequately address the needs of consumers.

Agency: Department of Health and Human Services
Status: Open

Comments: As of September 2019, HHS officials have not informed us of any actions taken to implement this recommendation. We will update the status of this recommendation when we receive additional information.

Recommendation: The Administrator of CMS should develop a data collection strategy that ensures that states report accurate and complete data on all sources of funds used to finance the nonfederal share of Medicaid payments. There are short- and long-term possibilities for pursuing the data collection strategy, including (1) in the short-term, as part of its ongoing initiative to annually collect data on Medicaid payments made to hospitals, nursing facilities, and other institutional providers, CMS could collect accurate and complete facility-specific data on the sources of funds used to finance the nonfederal share of the Medicaid payments, and (2) in the long-term, as part of its ongoing initiative to develop an enhanced Medicaid claims data system (T-MSIS), CMS could ensure that T-MSIS will be capable of capturing information on all sources of funds used to finance the nonfederal share of Medicaid payments, and, once the system becomes operational, ensure that states report this information for supplemental Medicaid payments and other highrisk Medicaid payments.

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

Comments: The Centers for Medicare & Medicaid Services (CMS) acknowledged that it lacks adequate data on state financing methods for overseeing compliance with a certain federal requirement related to the nonfederal share and that it will examine efforts to improve data collection toward this end. In November 2019, CMS issued a proposed rule that the agency said would promote state accountability, improve federal oversight, and strengthen fiscal integrity of the Medicaid program. The proposed rule would establish new policies and codify existing policies related to reporting the sources of funds used to finance the nonfederal share of Medicaid payments. For example, the proposed rule would require states to report, at the aggregate and provider level, contributions to the state or local governments used as a source of the nonfederal share for Medicaid supplemental payments. GAO will continue to monitor the status of the proposed rule, as well as review a final rule, if one is issued, to determine the extent to which it addresses the recommendation. GAO maintains it is important that CMS and federal policymakers have more complete information about how increasing federal costs are impacting the Medicaid program, including beneficiaries and the providers who serve them and plans to continue to monitor CMS's actions to help ensure that states report accurate and complete data on all sources of the nonfederal share.

Recommendation: To assist states that rely on or are planning to contract with an MCO to administer Medicaid prescription benefits, and to help provide effective oversight of psychotropic medications prescribed to children in foster care, the Secretary of Health and Human Services should issue guidance to state Medicaid, child-welfare, and mental-health officials regarding prescription-drug monitoring and oversight for children in foster care receiving psychotropic medications through MCOs.

Agency: Department of Health and Human Services
Status: Open

Comments: In an October 2018 written response, Health and Human Services (HHS) noted that they released 2017-2018 Drug Utilization Review Summaries for Prescription Drug Fee-For-Service Programs as it relates to national statistics on state oversight of psychotropic medications, as well as new state requirements to report on their Medicaid managed care organizations. However, as of August 2019, HHS confirmed they have not issued any guidance to state Medicaid, child-welfare, and mental-health officials regarding prescription-drug monitoring and oversight for children in foster care receiving psychotropic medications through MCOs, as we recommended. We continue to believe that additional HHS guidance that helps states implement oversight strategies within the context of a managed-care environment is needed to help ensure appropriate monitoring of psychotropic medications prescribed to children in foster care.

Recommendation: To ensure that CMS and ONC can effectively monitor the effect of the EHR programs and progress made toward goals, the Secretary of Health and Human Services should direct the agencies to develop performance measures to assess outcomes of the EHR programs--including any effects on health care quality, efficiency, and patient safety and other health care reform efforts that are intended to work toward similar outcomes.

Agency: Department of Health and Human Services
Status: Open

Comments: HHS neither agreed nor disagreed with our recommendation. In July 2015, CMS noted that the agency is working to align the programs to better enable monitoring using outcome-oriented performance measures and noted that the agency is collecting data that will help them to develop such measures. CMS did not indicate when HHS plans to develop such measures as GAO recommended. In June 2016, CMS also noted that it analyzed the results of the EHR programs as of October 2015, but did not indicate that it used performance measures that assess outcomes. In September 2017, HHS officials provided us a variety of publically available reports, which they indicated show how program participants are progressing in the EHR programs and the related impacts. In 2018, CMS changed the name of these programs to the Promoting Interoperability programs to focus on improving interoperability and patients' access to health information, and officials noted that the agency is working to develop related outcome-based measures. To fully implement this recommendation, CMS needs to develop performance measures that enable the agency to assess whether the Promoting Interoperability programs are improving outcomes, such as health care quality, efficiency, and patient safety, as we recommended.

Recommendation: To ensure that CMS and ONC can effectively monitor the effect of the EHR programs and progress made toward goals, the Secretary of Health and Human Services should direct the agencies to use the information these performance measures provide to make program adjustments, as appropriate, to better achieve program goals.

Agency: Department of Health and Human Services
Status: Open

Comments: In written responses provided by HHS in February 2014, on a draft of the report, the agency indicated that it agrees that outcome-oriented performance measures will be useful to evaluating the extent that the EHR programs--enacted through legislation--achieve the expected results. However, HHS did not identify any specific actions that it might undertake to address our recommendation. In July 2015, CMS indicated that the agency is still working to develop additional performance measures, which is a necessary first step towards implementing our recommendation to HHS that CMS and ONC use the outcome-oriented performance measures to make program adjustments, as appropriate. In September 2017 and March 2018, HHS officials provided us documents, which they indicated show how information gathered through monitoring activities was used to inform the EHR programs. In November 2018, HHS officials noted that CMS is actively working to use data submitted for the Promoting Interoperability Programs to improve upon the outcomes of patients, and also indicated (as noted above) that CMS is collaborating with stakeholders to develop outcome-based measures for the Promoting Interoperability Programs. To fully implement this recommendation, CMS needs to develop outcome-oriented performance measures and then demonstrate it is using them to make appropriate program adjustments. We will update the status of this recommendation when we receive additional information.

Recommendation: To improve the transparency of the process for reviewing and approving spending limits for comprehensive section 1115 demonstrations, the Secretary of Health and Human Services should reconsider adjustments and costs used in setting the spending limits for the Arizona and Texas demonstrations, and make appropriate adjustments to spending limits for the remaining years of each demonstration.

Agency: Department of Health and Human Services
Status: Open

Comments: As of January 2020, the Department of Health and Human Services (HHS) has taken steps to address GAO's 2013 recommendation, but more actions are needed for GAO to consider this recommendation implemented. Beginning in May 2016, the Centers for Medicare & Medicaid Services (CMS) began implementing a new budget neutrality policy. The new policy was outlined in a Letter to State Medicaid Directors in 2018, and it addressed certain problems GAO identified regarding states' allowed methods for determining budget neutrality of their demonstrations. CMS has begun phasing in the methods established under this new policy for all states, including the two states (Arizona and Texas) for which GAO recommended adjustments. One portion of the policy--under which spending limits will be updated to reflect more recent spending data--will be implemented beginning in 2021 and will address concerns GAO identified in Arizona's spending limit once its demonstration is renewed. In January 2019, CMS officials told GAO that the agency continues to allow states to include hypothetical costs when determining demonstration spending limits, an action GAO identified as a concern in Texas' demonstration. While CMS officials provided documentation on changes the agency made in the spending limit approved for Texas' new demonstration period beginning in January 2018, GAO reviewed these changes and found that further adjustments are needed to remove additional hypothetical costs from the Texas' spending limit.

Recommendation: To improve transparency of and accountability for Medicaid non-DSH supplemental payments, Congress should consider requiring the Administrator of CMS to (1) improve state reporting of non-DSH supplemental payments, including requiring annual reporting of payments made to individual facilities and other information that the agency determines is necessary to oversee non-DSH supplemental payments; (2) clarify permissible methods for calculating non-DSH supplemental payments; and (3) require states to submit an annual independent certified audit verifying state compliance with permissible methods for calculating non-DSH supplemental payments.

Agency: Congress
Status: Open

Comments: No legislation enacted as of February 2020. However, CMS has taken some administrative actions, which are underway, to improve its oversight of non-DSH supplemental payments. In November 2019, CMS issued a proposed rule that the agency said would promote state accountability, improve federal oversight, and strengthen fiscal integrity of the Medicaid program. Among other things, the proposed rule would require states to report on non-DSH supplemental payments on a facility-specific basis, as well as specify data sources, data standards, and acceptable methods for demonstrating compliance for non-DSH supplemental payment calculations. GAO plans to continue to monitor congressional action and the status of the proposed rule, as well as review a final rule, if one is issued, to determine the extent to which they improve state reporting of non-DSH supplemental payments, clarify permissible methods for calculating non-DSH supplemental payments, and require audits to verify that states use permissible methods to calculate non-DSH supplemental payments.

Recommendation: To improve the effectiveness of the MSP program and process for NGHPs, and to improve the agency's communication regarding the MSP process for situations involving NGHPs, the Acting Administrator of CMS should develop guidance regarding liability and no-fault set-aside arrangements.

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

Comments: As of March 2019, CMS officials reported that the agency was still in the process of implementing this recommendation about developing guidance regarding liability and no-fault set-aside arrangements. Since April 2012, the month the recommendation was made, CMS officials have reported at various times that the agency was planning to issue either regulatory or sub-regulatory guidance on this topic. In March 2019, officials said that the agency now planned to issue regulatory guidance, and that a Notice of Proposed Rulemaking was expected to be posted in October 2019. We will continue to update the status of this recommendation as new information is available.

Recommendation: To help ensure appropriate payments to MA plans, the Administrator of CMS should take steps to improve the accuracy of the adjustment made for differences in diagnostic coding practices between MA and Medicare FFS. Such steps could include, for example, accounting for additional beneficiary characteristics, including the most current data available, identifying and accounting for all years of coding differences that could affect the payment year for which an adjustment is made, and incorporating the trend of the impact of coding differences on risk scores.

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

Comments: CMS indicated in January 2020 that it has no plans to take further action regarding our recommendation. CMS stated that, given the complexity of measuring coding changes attributable to plan behavior and the difficulty of measuring countervailing factors, there is not a single correct factor within the viable range of adjustment factors. In addition, the agency noted that there is policy discretion with respect to the appropriate adjustment factor for the payment year. In the Medicare Advantage Call Letter of April 2019, CMS stated that it will apply the statutory minimum adjustment of 5.90 percent for calendar year 2020. As of February 2020, CMS had not provided any documentation of its analysis and the basis for its determination. Although the application of the 5.90 percent adjustment and other recent changes CMS has made to its methodology for calculating the diagnostic coding adjustment (i.e., the exclusion of diagnosis codes that were differentially reported in Medicare fee-for-service and Medicare Advantage) likely brings CMS's adjustment closer to what GAO's analysis projects to be an accurate adjustment, a modified methodology that incorporates more recent data, accounts for all relevant years of coding differences, and incorporates the effect of coding difference trends would better ensure an accurate adjustment in future years. Until CMS shows the sufficiency of the diagnostic coding adjustment or implements an adjustment based on analysis using an updated methodology, payments to Medicare Advantage plans may not accurately account for differences in diagnostic coding between these plans and traditional Medicare providers.

Recommendation: To ensure that federal funding efficiently and effectively responds to the countercyclical nature of the Medicaid program, Congress may wish to consider enacting an FMAP formula that is targeted for variable state Medicaid needs and provides automatic, timely, and temporary increased FMAP assistance in response to national economic downturns.

Agency: Congress
Status: Open

Comments: As of September 2020, no legislation had been enacted. GAO has testified on at least one bill that had been introduced in the Congress that would implement this Matter for Congressional Consideration. On February 10, 2016, GAO testified on considerations related to the Medicaid funding formula. See Medicaid: Changes to Funding Formula Could Improve Allocation of Funds to States GAO-16-377T January 26, 2016. We also cited this report in our discussion on Medicaid funding during economic downturns in Medicaid: Key Policy and Data Considerations for Designing a Per Capita Cap on Federal Funding (GAO-16-726). We cited this Matter in Opportunities to Improve the Federal Recovery and Response Efforts (GAO-20-625) and in COVID-19: Brief Update on Initial Federal Response to the Pandemic (GAO-20-708).

Recommendation: PPACA contained several important program integrity provisions for the 340B program, and additional steps can also ensure appropriate use of the program. Therefore, the Secretary of HHS should instruct the administrator of HRSA to finalize new, more specific guidance on the definition of a 340B patient.

Agency: Department of Health and Human Services
Status: Open

Comments: In January 2017, HRSA withdrew proposed guidance that included further specificity on the definition of 340B patient in response to the new administration's January 20 memorandum directing agencies to withdraw regulations that were pending before the Office of Management and Budget but had not yet been published in the Federal Register. In March 2018, HRSA told GAO that it continues to assess next steps with the Administration on the proposed omnibus guidance, which included the patient definition. In June 2019, HRSA reported that it is still working with the Department to determine next steps for this recommendation. In July 2020, HRSA reported that it conducted an evaluation of its audit process and other program integrity efforts and determined that guidance does not provide the agency with appropriate enforcement capability. Therefore, HRSA is not pursing new guidance under the Program at this time. The FY 2021 President's Budget includes a proposal to provide HRSA comprehensive regulatory authority.

Recommendation: PPACA contained several important program integrity provisions for the 340B program, and additional steps can also ensure appropriate use of the program. Therefore, the Secretary of HHS should instruct the administrator of HRSA to issue guidance to further specify the criteria that hospitals that are not publicly owned or operated must meet to be eligible for the 340B program.

Agency: Department of Health and Human Services
Status: Open

Comments: In January 2017, HRSA withdrew proposed guidance that included additional specificity regarding hospital eligibility in response to the new administration's January 20 memorandum directing agencies to withdraw regulations that were pending before the Office of Management and Budget but had not yet been published in the Federal Register. In March 2018, HRSA reported that it believes it is unable to implement this recommendation without additional legislative authority because the statute does not speak to the issue raised in the recommendation. HRSA also noted that the FY19 President's Budget includes a proposal to provide HRSA comprehensive regulatory authority, and that if this proposal is enacted, it could regulate on hospital eligibility. In June 2019, HRSA reported that it is still unable to implement this recommendation without additional legislative authority, though the President's FY 2020 Budget includes a proposal to provide HRSA with such authority. In July 2020, HRSA reported that it conducted an evaluation of its audit process and other program integrity efforts and determined that guidance does not provide the agency with appropriate enforcement capability. Therefore, HRSA is not pursing new guidance under the Program at this time. The FY 2021 President's Budget includes a proposal to provide HRSA comprehensive regulatory authority.

Recommendation: In light of the need for accurate and complete information on children's access to health services under Medicaid and CHIP, the requirement that states report information to CMS on certain aspects of their Medicaid and CHIP programs, and problems with accuracy and completeness in this state reporting, the Administrator of CMS should work with states to identify additional improvements that could be made to the CMS 416 and CHIP annual reports, including options for reporting on the receipt of services separately for children in managed care and fee-for-service delivery models, while minimizing reporting burden, and for capturing information on the CMS 416 relating to children's receipt of treatment services for which they are referred.

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

Comments: In August 2019, CMS stated that the agency's long-term plan is to use the Transformed Medicaid Statistical Information System (T-MSIS) to analyze information on children's receipt of Early and Periodic Screening, Diagnostic and Treatment (EPSDT) services. As of June 2020, CMS had developed a new CMS-416 reporting form that gives states the option of having CMS calculate the measures for the report using T-MSIS. CMS stated that it intends to implement this option for states for fiscal year 2020 CMS-416 reports, which are due in April 2021. As of August 2020, the new CMS-416 form was undergoing Paperwork Reduction Act review. CMS is also exploring using T-MSIS to generate the Core Set of Children's Health Care Quality Measures for Medicaid and CHIP, some of which are included in the CHIP annual report. As of June 2020, CMS had begun a pilot test to generate five of the Core Set measures using 2018 T-MSIS data. GAO considers this recommendation open and will continue to monitor CMS's progress towards its long-term goal of using T-MSIS to monitor children's receipt of EPSDT services.

Recommendation: To enhance the provision of dental care to children covered by Medicaid and CHIP, and to help ensure that HHS's Insure Kids Now Web site is a useful tool to help connect children covered by Medicaid and CHIP with participating dentists who will treat them, the Secretary of HHS should require states to verify that dentists listed on the Insure Kids Now Web site have not been excluded from Medicaid and CHIP by the HHS-OIG, and periodically verify that excluded providers are not included on the lists posted by the states.

Agency: Department of Health and Human Services
Status: Open

Comments: As of September 2020, CMS has not indicated taking steps to require states to ensure excluded providers are not listed on the Insure Kids Now website, nor has it indicated taking steps to periodically verify that providers excluded from Medicaid and CHIP are not on the list. CMS has said that it relies on states to provide accurate lists of eligible dentists and that data issues prevent the agency from independently verifying that excluded providers are not included on the Insure Kids Now website. We continue to believe that CMS should require states to ensure that excluded providers are not listed on the website and periodically verify that excluded providers are not included on the lists posted by the states, so that the website does not present inaccurate information about providers available to serve Medicaid-covered children.

Recommendation: To help states identify and address quality-of-care concerns among individuals with developmental disabilities receiving Medicaid HCBS waiver services, the Administrator of CMS should encourage states to (1) include death as a critical incident and conduct mortality reviews if they do not already do so and (2) broaden their mortality review processes if they already include death as a critical incident and conduct mortality reviews.

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

Comments: As of August 2020, CMS had taken some steps to address this recommendation but additional actions are needed to fully implement it. In June 2018 CMS issued a Medicaid update to states explaining that CMS strongly encourages them to include unexpected deaths in their definition of reportable critical incidents. CMS also stated in the update that states should conduct a preliminary review of all beneficiary deaths and investigations should focus on those deaths determined to be unexpected. Further, CMS has shared with states best practices for state mortality reviews that include, for example, the use of an interdisciplinary review committee and taking actions to address identified quality of care problems. CMS also developed a webinar training (Incident Management 101) to help states improve their incident management systems for the Medicaid HCBS waiver. The webinar outlines the key elements of building a comprehensive incident management system (e.g., establishing a process for conducting investigations of incidents, tracking and trending incidents to help prevent and mitigate incidents from occurring) and reiterates CMS's expectation that states identify and address unexplained deaths on an ongoing basis in order to meet the waiver's health and welfare assurance. In late 2018, CMS planned to include in its revised waiver application questions to determine practices regarding states' review and evaluation of unexpected deaths. In September 2019, CMS officials notified us that it will provide an updated status report on this recommendation in November 2019. As of August 2020, CMS officials have not provided us information regarding its revised waiver application and technical guide. We will update the status of this recommendation when we receive this information.

Recommendation: Congress may wish to consider requiring increased attention to fiscal responsibility in the approval of section 1115 Medicaid demonstrations by requiring the Secretary of HHS to improve the demonstration review process through steps such as (1) clarifying criteria for reviewing and approving states' proposed spending limits, (2) better ensuring that valid methods are used to demonstrate budget neutrality, and (3) documenting and making public material explaining the basis for any approvals.

Agency: Congress
Status: Open

Comments: As of April 2020, there had been no legislation introduced to require HHS to improve the Medicaid demonstration review process. However, HHS has taken some action to address some aspects of GAO's recommendation. CMS established new policies that addressed certain problems GAO had identified and issued written guidance on the process and criteria used to approved states' proposed spending limits. Not all problems identified by GAO were addressed by the new CMS policy, thus legislation to require HHS to improve the Medicaid demonstration review process, as GAO recommended in January 2008, continues to be a viable matter for consideration.

Recommendation: Congress may wish to consider addressing whether demonstrations that allow states to operate public managed care organizations and retain excess revenue to support programs previously funded by the state--including the Vermont demonstration--are within the scope of the Secretary of HHS's authority under section 1115 of the Social Security Act.

Agency: Congress
Status: Open

Comments: As of April 2020, Congress had not passed legislation in response to our matter for congressional consideration.

Recommendation: To enhance the transparency of CMS oversight and clarify and communicate the types of allowable state financing arrangements, the Administrator of CMS should provide each state CMS reviews under its initiative with specific and written explanations regarding agency determinations on the allowability of various arrangements for financing the nonfederal share of Medicaid payments and make these determinations available to all states and interested parties.

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

Comments: CMS has taken steps to provide states with specific and written explanations regarding agency determinations on whether various arrangements for financing the nonfederal share of Medicaid payments are allowable and making those determinations available to states and interested parties. In November 2019, CMS issued a proposed rule that the agency said would promote state accountability, improve federal oversight, and strengthen fiscal integrity of the Medicaid program. The proposed rule would establish new policies and codify existing policies related to the sources of funds that states use to finance the nonfederal share of Medicaid payments. For example, the rule is intended to provide CMS and states with better information and guidance to identify existing and emerging state financing issues, provide more clarity on allowable financing arrangements and promote state accountability. GAO will continue to monitor the status of the proposed rule, as well as review a final rule, if one is issued, to determine the extent to which it addresses the recommendation.

Recommendation: To help further the progress toward meeting the goals of IPIA and determining states' role in assisting federal agencies to report a national improper payment estimate on federal programs, the Director, Office of Management and Budget, should expand IPIA guidance to provide criteria that federal agencies should consider when developing a plan or methodology for estimating a national improper payment estimate for state-administered programs, such as criteria that address the nature and extent of data and documentation needed from the states to calculate a national improper payment estimate.

Agency: Executive Office of the President: Office of Management and Budget
Status: Open

Comments: The Office of Management and Budget (OMB) concurred with this recommendation. Since the issuance of the GAO report, OMB has made several revisions to its OMB Circular No. A-123, Appendix C "Requirements for Effective Measurement and Remediation of Improper Payments." The latest revision is dated June 26, 2018. The intent of OMB Circular No. A-123, Appendix C, is to ensure that federal agencies focus on prevention and have the proper incentives to improve their improper payment rates. In August 2020, OMB provided us its improper payment guidance on sampling and estimation in place at the time of the GAO audit. Based on this documentation, we sent a follow-up request to OMB for additional information. We are currently waiting to hear back from OMB so we can continue with our review. We will continue to monitor the agency's actions to address this recommendation.

Recommendation: To meet its fiduciary responsibility of ensuring that section 1115 waivers are budget neutral, the Secretary of Health and Human services should better ensure that valid methods are used to demonstrate budget neutrality, by developing and implementing consistent criteria for consideration of section 1115 demonstration waiver proposals.

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

Comments: As of January 2020, the Department of Health and Human Services (HHS) had taken some action to address GAO's 2002 recommendation. In August 2018, HHS issued written guidance through a State Medicaid Directors Letter documenting four key changes it made in 2016 to its budget neutrality policy. These changes addressed some, but not all of the questionable methods GAO identified in its reports. To fully address this recommendation, HHS should also address these other questionable methods, such as setting demonstration spending limits based on hypothetical costs-what the state could have paid-rather than payments actually made by the state. GAO has found that the use of hypothetical costs has the potential to inflate spending limits and thus threatens budget neutrality of demonstrations