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, in collaboration with OMB, solicit input from FBI, IRS, SSA, and state agency stakeholders on revisions to its security policy to ensure that cybersecurity requirements for state agencies are consistent with other federal agencies and NIST guidance to the greatest extent possible and document CMS's rationale for maintaining any requirements variances.(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 revise its assessment policies to maximize coordination with other federal agencies to the greatest extent practicable. (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 ensure that the Medicare & You publication includes explicit information on the services covered by the Medicare program for beneficiaries with a SUD. (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 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 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 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 incorporate the use of additional information, such as quality measures or other information that could identify potential quality of care issues, into its survey process for overseeing hospice providers. (Recommendation 1)

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

Comments: HHS concurred with this recommendation. In May 2020, HHS said CMS is evaluating ways in which the Hospice Consumer Assessment of Health Providers and Systems (CAHPS) survey data can be used to inform surveys of hospice providers. HHS also said CMS intends to incorporate use of the current Hospice Quality Reporting Program (HQRP) measurement data into the survey process to provide additional items that inform a surveyor's evaluation of a hospice provider. HHS noted that these changes would be incorporated into a more comprehensive update to the survey process to target providers and areas where risk of noncompliance is greatest. HHS projected the updated process would be implemented by the end of the first quarter of calendar year 2021. In order for us to close the recommendation, CMS has to implement an updated survey process that incorporates the use of additional information that could identify potential quality of care issues, such as that described above.

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, to the extent feasible, maintain more complete information on both the total amount of funding allocated for quality measurement activities and the extent to which this funding supports each of its quality measurement strategic objectives. (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 develop and implement procedures to systematically assess the measures it is considering developing, using, or removing in terms of their impact on achieving CMS's strategic objectives and document its compliance with those procedures. (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 develop and use a set of performance indicators to evaluate the agency's progress towards achieving its quality measurement strategic objectives. (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 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 Centers for Medicare & Medicaid Services (CMS) should create and implement a policy for standard posting requirements regarding comments and their identity information, particularly for duplicate comments, and should clearly communicate this policy to the public on the CMS website. (Recommendation 2)

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

Comments: In January 2020, the Department of Health and Human Services stated that CMS already has policies for standard posting requirements, and noted that they would update their policy and communicate it on the CMS website. However, while CMS provided us with an excerpt of the updated language, as written, it does not include information about how the agency posts duplicate comments. Further, CMS did not provide us with this policy, and our review of the website does not indicate any changes have been made. HHS stated it would provide additional follow up actions by 7/23/2020. Given that we found significant variation in the way that CMS posts comments, even within a single docket, we continue to believe that it is important for CMS to develop and implement a standard policy for posting duplicate comments and their identity information, in addition to communicating this policy to the public on the CMS website.

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 the Centers for Medicare and Medicaid Services should develop a plan with time frames and milestones to discontinue knowledge-based verification, such as by using Login.gov or other alternative verification techniques. (Recommendation 1)

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

Comments: HHS, on behalf of CMS, did not concur with this recommendation. In its February 2020 response to GAO, HHS stated that current NIST guidance to agencies was insufficient and that CMS would look forward to future guidance from NIST and OMB to help guide consideration of non-knowledge-based verification options. We continue to believe that our recommendation is valid because a variety of alternative methods to knowledge-based verification are available that CMS can consider to address the diverse population it serves. Further, NIST has agreed with our recommendation to develop additional guidance for agencies, and CMS may be able to use that guidance to identify a verification approach that does not really on knowledge-based techniques. We will continue to monitor the actions CMS may take to address the recommendation.

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: CMS should evaluate state survey agency processes in all states to ensure all state survey agencies are meeting federal requirements that state survey agencies are responsible for investigating complaints and facility-reported incidents alleging abuse in nursing homes, and that the results of those investigations are being shared with CMS. (Recommendation 1)

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

Comments: HHS concurred with this recommendation. As of November 2019, HHS officials have not informed us of actions taken to complete implementation of this recommendation. We will update the status of this recommendation when we receive additional information.

Recommendation: CMS should identify options for capturing information from Oregon's APS investigations of complaints and facility-reported incidents of abuse and incorporate this information into oversight of Oregon nursing homes. (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 November 2019, HHS officials have not informed us of actions taken to complete implementation of this recommendation. We will update the status of this recommendation when we receive additional information.

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 take steps to collect all of the data from all laboratories that are required to report. If only partial data can be collected, CMS should estimate how incomplete data would affect Medicare payment rates and address any significant challenges to setting accurate Medicare rates. (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 phase in payment-rate reductions that start from the actual payment rates Medicare paid prior to 2018 rather than the national limitation amounts. CMS should revise these rates as soon as practicable to prevent paying more than necessary. (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 use bundled rates for panel tests, consistent with its practice prior to 2018, rather than paying for them individually; if necessary, the Administrator of CMS should seek legislative authority to do so. (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 ensure that the Office of the CIO and other offices, as appropriate, develop and implement policies and procedures that include the CIO in the planning and budgeting stages for all programs that are fully or partially supported with IT resources. (Recommendation 26)

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

Comments: CMS agreed with our recommendation. 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 the Office of the CIO and other offices, as appropriate, develop and implement policies and procedures that document the processes by which program leadership works with the CIO to plan an overall portfolio of IT resources. (Recommendation 27)

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

Comments: CMS agreed with our recommendation. 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 the Office of the CIO and other offices, as appropriate, develop and implement policies and procedures that document the CIO's role in reviewing IT resources that are to support major program objectives and significant increases and decreases in IT resources. (Recommendation 28)

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

Comments: CMS agreed with our recommendation. 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 direct the Office of the CIO and other offices, as appropriate, to take steps to ensure that the actions taken to comply with OMB's common baseline for implementing FITARA on individual investments are adequately documented. (Recommendation 29)

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

Comments: CMS agreed with our recommendation. 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 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 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 subject accessories essential to the group 3 power wheelchairs in the permanent DMEPOS program to prior authorization. (Recommendation 1)

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

Comments: In August 2018, the Department of Health and Human Services reported that it concurs with this recommendation and that CMS is exploring available options to subject accessories essential to the group 3 power wheelchairs in the permanent DMEPOS program to prior authorization. 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 take steps, based on results from evaluations, to continue prior authorization. These steps could include: (1) resuming the paused home health services demonstration; (2) extending current demonstrations; or, (3) identifying new opportunities for expanding prior authorization to additional items and services with high unnecessary utilization and high improper payment rates. (Recommendation 2)

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

Comments: In August 2018, the Department of Health and Human Services reported that it concurs with this recommendation. CMS has recently taken steps to evaluate and continue its prior authorization programs. In June 2019, CMS issued a final report on the independent evaluation of the non-emergency hyperbaric oxygen therapy demonstration. While the agency does not plan to conduct additional demonstrations on this service, CMS officials reported in December 2019 that the agency may consider this service for the new prior authorization process for certain hospital outpatient department services, established in a 2019 final rule. In April 2019, CMS issued a Federal Register notice that added 12 items-seven power wheelchairs and five pressure reducing support surfaces-to its required prior authorization list for the permanent program. CMS officials said in December 2019 that the agency was in the process of determining cost savings from this action and that additional items would be added to the list in early 2020. CMS resumed the home health services demonstration with changes in one state in June 2019 and in another state in September 2019. The agency plans to extend the demonstration to three additional states in 2020. In September 2019, CMS extended the repetitive scheduled non-emergency ambulance service demonstration for 1 year, through November 2020. GAO will continue to monitor issued agency guidance on the home health services demonstration and to evaluate additional steps CMS takes to evaluate and continue prior authorization in Medicare, such as determining cost savings from its actions and identifying new opportunities for prior authorization.

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 issue written criteria for when CMS will allow limited evaluation of a demonstration or a portion of a demonstration, including defining conditions, such as what it means for a demonstration to be longstanding or noncomplex, as applicable. (Recommendation 2)

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

Comments: HHS agreed with this recommendation. In November 2019, HHS reported that it was applying limited evaluation requirements to certain demonstration types, including routine family planning demonstrations. In July 2020, CMS stated that it continues to work with states as they apply for new or extensions of approved demonstrations to determine whether the demonstrations as a whole or certain components would qualify for limited evaluation. The agency, however, reiterated that it needs more experience before developing generalized guidance and that was not a priority for 2020. We will continue to monitor CMS's progress and will review whether to close the recommendation when these criteria are issued.

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: The Administrator of CMS should require plan sponsors to report to CMS on investigations and other actions taken related to providers who prescribe high amounts of opioids. (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. As of September 2019, HHS had not provided information on actions taken to implement it. We will update its status when we receive additional information.

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: The Administrator of CMS should evaluate the possible costs and savings of using disposable devices that could potentially substitute for DME, including options for benefit categories and payment methodologies that could be used to cover these substitutes, and, if appropriate, seek legislative authority to cover these devices.

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

Comments: In March 2019, HHS included in its fiscal year 2020 budget a legislative proposal to extend Medicare coverage to disposable devices that could potentially substitute for DME in treating and managing diabetes. As of March 2020, CMS has not provided documentation of the evaluation of possible costs and savings that we recommended and that we believe underpins the legislative proposal. We will review this documentation once provided.

Recommendation: To ensure that the HVBP program accomplishes its goal to balance quality and efficiency and to ensure that it minimizes the payment of bonuses to hospitals with lower quality scores, the Administrator of CMS should revise the formula for the calculation of hospitals' total performance score or take other actions so that the efficiency score does not have a disproportionate effect on the total performance score.

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

Comments: HHS indicated that it would examine the formula used for calculating hospitals' total performance scores and consider revisions, which would be subject to notice and comment rulemaking. In September 2018, HHS indicated that it had been examining alternatives and considering revising the formula for the calculation of hospitals' total performance scores (TPS) consistent with relevant statutory guidance, and in a way to reduce the effect of the efficiency domain on the TPS. In the Fiscal Year 2019 Inpatient Prospective Payment System proposed rule, CMS proposed to remove the safety domain weighted at 25 percent of the TPS and, in connection, increase the weight of the clinical care domain from 25 percent to 50 percent, which was estimated to reduce the effect of the efficiency domain on the TPS. According to CMS, stakeholders were concerned about the safety domain removal and adverse impacts to rural and smaller hospitals due to increasing outcome measure relative weights. CMS indicated that it analyzed current data in the fall of 2018 and found a similar trend, where rural and small hospitals' payment would be adversely impacted from increasing outcome measure weights. CMS decided to keep measure weights to avoid adversely impacting rural and small hospitals. However, CMS did not take actions so that the efficiency score would not have a disproportionate effect on the total performance score and bonus payments to hospitals with lower quality scores. As of January 2020, the recommendation remains open.

Recommendation: To ensure that the HVBP program accomplishes its goal to balance quality and efficiency and to ensure that it minimizes the payment of bonuses to hospitals with lower quality scores, the Administrator of CMS should revise the practice of proportional redistribution used to correct for missing domain scores so that it no longer facilitates the awarding of bonuses to hospitals with lower quality scores.

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

Comments: HHS indicated that it would explore alternatives to the practice of proportional redistribution, and any changes to the distribution of weights for missing domains would be evaluated for potential negative impacts and would be subject to notice and comment rulemaking. In September 2018, HHS indicated that it was exploring alternatives and considering revising the practice of proportional redistribution used to correct for missing domain scores while also being mindful of any potential unintended consequences. In the Fiscal Year 2019 Inpatient Prospective Payment System proposed rule, CMS proposed to remove the safety domain and, in connection, to require scores for the remaining three domains in order to calculate the total performance score, but CMS did not finalize the weighting revision. CMS reported that stakeholders were concerned about the safety domain removal and any adverse impact to rural and smaller hospitals due to increasing outcome measure relative weights. CMS reported that it analyzed data and found that rural and small hospitals' payment would be adversely impacted from changing proportional redistribution to assign greater relative weight to outcomes. As a result, CMS decided to keep proportional redistribution. However, CMS's actions did not revise the practice of proportional redistribution, and, as a result, the practice may continue to facilitate the awarding of bonuses to hospitals with lower quality scores. As of January 2020, the recommendation remains open.

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 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: CMS should periodically verify the sales price data submitted by a sample of drug manufacturers by requesting source documentation from manufacturers to corroborate the reported data, either directly or by working with the HHS Office of Inspector General as necessary.

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

Comments: In September 2018, HHS officials reiterated that they believe the agency has addressed our recommendation because CMS works with HHS's Office of Inspector General (OIG) as appropriate to collect source documentation from drug manufacturers and takes action as warranted. HHS stated that CMS has continued to provide information regarding problematic ASP submissions to OIG for evaluation of misreporting and continues to use AMP and other benchmarks as comparisons for pricing determinations. They further stated that they do not believe that additional collection of detailed sales information about ASP, such as invoices, is authorized under Part B drug payment provisions in section 1847A or under section 1927(b). As of June 2020, CMS did not provide any additional updates. While we recognize that CMS conducts routine checks to assess the completeness of ASP data submitted by drug manufacturers, we do not believe these activities are enough to close the recommendation. Specifically, CMS only collects source documentation from manufacturers under very limited circumstances (e.g., when there are obvious inconsistencies in the data submitted by manufacturers). CMS does not periodically verify the accuracy of ASP data for a sample of manufacturers by tracing the data to and from drug manufacturers' source documents, such as sales invoices. Because CMS does not routinely verify the accuracy of the underlying data used to determine Medicare payment rates, the resulting payment rates may be inaccurate if drug manufacturers do not report accurate data. With regards to CMS's authority to collect additional information, such as invoices, we believe the agency could work through OIG to collect such information.

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: As CMS continues to implement and refine the contract-level RADV audit process to improve the efficiency and effectiveness of reducing and recovering improper payments and to improve the accuracy of CMS's calculation of coding intensity, the Administrator should modify that calculation by taking actions such as the following: (1) including only the three most recent pair-years of risk score data for all contracts; (2) standardizing the changes in disease risk scores to account for the expected increase in risk scores for all MA contracts; (3) developing a method of accounting for diagnostic errors not coded by providers, such as requiring that diagnoses added by MA organizations be flagged as supplemental diagnoses in the agency's Encounter Data System to separately calculate coding intensity scores related only to diagnoses that were added through MA organizations' supplemental record review (that is, were not coded by providers); and (4) including MA beneficiaries enrolled in contracts that were renewed from a different contract under the same MA organization during the pair-year period.

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

Comments: CMS is working to improve the accuracy of its calculation of coding intensity, as GAO recommended in April 2016. In October 2017, CMS officials told GAO that the agency is reevaluating the design of the risk adjustment data validation audits to ensure their rigor in the context of all the payment error data acquired since the original design of the audits. As part of this work, CMS officials told GAO that the agency will examine whether coding intensity is the best criterion to use to select contracts for audit. As a result, in October 2018, CMS told GAO that rather than coding intensity, it plans to implement a new methodology using payment error as the key sampling driver beginning with audits for payment year 2014. Additionally, CMS was taking steps to modernize its audit system to improve reliability. For example, it initiated a project to explore how to directly receive electronic medical record documentation. As of January 2020, the agency is continuing to reevaluate the design of these audits. Unless CMS takes this and other actions to improve the risk adjustment data validation contract-level audit process, it will fail to recover improper payments of hundreds of millions of dollars annually.

Recommendation: As CMS continues to implement and refine the contract-level RADV audit process to improve the efficiency and effectiveness of reducing and recovering improper payments. The Administrator should modify CMS's selection of contracts for contract-level RADV audits to focus on those contracts most likely to have high rates of improper payments by taking actions such as the following: (1) selecting more contracts with the highest coding intensity scores; (2) excluding contracts with low coding intensity scores; (3) selecting contracts with high rates of unsupported diagnoses in prior contract-level RADV audits; (4) if a contract with a high rate of unsupported diagnoses is no longer in operation, selecting a contract under the same MA organization that includes the service area of the prior contract; and (5) selecting some contracts with high enrollment that also have either high rates of unsupported diagnoses in prior contract-level RADV audits or high coding intensity scores.

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

Comments: CMS is working to modify the selection of MA contracts for audit, as GAO recommended in April 2016. In October 2017, CMS officials told GAO that the initial RADV audit design was based on a limited set of payment error data available at the time. As part of efforts to improve the audits, CMS officials told GAO that the agency will examine whether coding intensity is the best criterion to select contracts for audit. In October 2018, CMS told GAO that it plans to implement a new methodology using payment error as the key sampling driver-rather than coding intensity-beginning with audits for payment year 2014. As of January 2020, the agency is using the revised methodology on the 2014 and 2015 payment year audits. They expect to conclude this process in late fiscal year 2020 and 2021, respectively. Unless CMS completes actions to improve the RADV contract-level audit process, it will fail to recover improper payments of hundreds of millions of dollars annually.

Recommendation: As CMS continues to implement and refine the contract-level RADV audit process to improve the efficiency and effectiveness of reducing and recovering improper payments. The Administrator should enhance the timeliness of CMS's contract-level RADV process by taking actions such as the following: (1) closely aligning the time frames in CMS's contract-level RADV audits with those of the national RADV audits the agency uses to estimate the MA improper payment rate; (2) reducing the time between notifying MA organizations of contract audit selection and notifying them about the beneficiaries and diagnoses that will be audited; (3) improving the reliability and performance of the agency's process for transferring medical records from MA organizations, including assessing the feasibility of updating Electronic Submission of Medical Documentation for use in transferring medical records in contract-level RADV audits; and (4) requiring that CMS contract-level RADV auditors complete their medical record reviews within a specific number of days comparable to other medical record review time frames in the Medicare program.

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

Comments: HHS concurred with this recommendation in its fiscal year 2021 budget justification. HHS reaffirmed its commitment to identifying and correcting improper payments in the MA program. It has begun taking steps to improve the timeliness of the contract-level RADV audit process, such as aligning the time frames in CMS's contract-level RADV audits with those of the national RADV audits. Once completed, CMS needs to provide evidence that the actions taken by the agency have enhanced the timeliness of CMS's contract-level RADV process.

Recommendation: As CMS continues to implement and refine the contract-level RADV audit process to improve the efficiency and effectiveness of reducing and recovering improper payments. The Administrator should improve the timeliness of CMS's contract-level RADV appeal process by requiring that reconsideration decisions be rendered within a specified number of days comparable to other medical record review and first-level appeal time frames in the Medicare program.

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

Comments: CMS is working to improve the timeliness of the agency's contract-level risk adjustment data validation appeals process, as GAO recommended in April 2016. In October 2017, CMS officials told GAO that the agency is actively considering options for expediting the appeals process. For example, CMS is considering the appropriate number of days for rendering reconsideration decisions while allowing for a complete and thorough adjudication. In December 2019, CMS officials told GAO they expect to issue a final rule in January 2021 that will establish uniform timelines to expedite the appeals process. Specifically, they plan to require that a findings determination be made within 60-90 days of an arbiter's receipt of each party's arguments at each stage of an appeal. Unless CMS takes such actions to improve the risk adjustment data validation contract-level audit process, it will fail to recover improper payments of hundreds of millions of dollars annually.

Recommendation: As CMS continues to implement and refine the contract-level RADV audit process to improve the efficiency and effectiveness of reducing and recovering improper payments. The Administrator should ensure that CMS develops specific plans and a timetable for incorporating a RAC in the MA program as mandated by the Patient Protection and Affordable Care Act.

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

Comments: CMS has attempted to incorporate a recovery audit contractor in the Medicare Advantage program, as GAO recommended in April 2016. After failing to receive any proposals when CMS first issued a request for proposals (RFP) in 2014, CMS issued a request for information to industry in December 2015, which included a draft Statement of Work to solicit feedback, gauge interest, and conduct market research regarding CMS entering into a contract with a recovery audit contractor to identify underpayments and overpayments associated with diagnosis data submitted to CMS by Medicare Advantage Organizations. CMS reported that it subsequently issued another RFP in 2016 and did not receive any proposals for a second time. In December 2019, CMS officials told GAO that the functions of the Part C recovery Audit programs are being performed through other program integrity mechanisms. CMS subsequently reported in its fiscal year 2021 budget justification that CMS believes the proposed scope of the Part C RAC has been subsumed by RADV and CMS will demonstrate that the RADV program satisfies this recommendation. Until CMS completes efforts to improve the risk adjustment data validation contract-level audit process and demonstrates that it has satisfied the requirement to incorporate a recovery audit contractor in the MA program, CMS will fail to recover improper payments of hundreds of millions of dollars annually.

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 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 determine the extent to which Medicare payments are aligned with costs for specific types of dialysis treatment and training, the Administrator of CMS should take steps to improve the reliability of the cost report data for treatment and training associated with specific types of dialysis.

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

Comments: As of February 2020, CMS has not implemented this recommendation. HHS agreed with this recommendation and stated in February 2020 that CMS was exploring ways to clarify the cost report instructions in an effort to improve the accuracy of the information submitted. We will update the status of this recommendation when we receive additional information.

Recommendation: To ensure that patients with chronic kidney disease receive objective and timely education related to this condition, the Administrator of CMS should examine the Kidney Disease Education benefit and, if appropriate, seek legislation to revise the categories of providers and patients eligible for the benefit.

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

Comments: As of February 2020, CMS has not implemented this recommendation. HHS did not agree with this recommendation and stated in June 2016 that CMS continuously works to pay appropriately for ESRD services and must prioritize its activities to improve care for dialysis patients. While we acknowledge the need for CMS to prioritize its activities to improve dialysis care, it is important for CMS to help ensure that Medicare patients with chronic kidney disease understand their condition, how to manage it, and the implications of the various treatment options available, particularly given the central role of patient choice in dialysis care. The limited use of the Kidney Disease Education benefit that we noted in our report suggests that it may be difficult for Medicare patients to receive this education and underscores the need for CMS to examine and potentially revise the benefit. We will update the status of this recommendation when we receive additional information.

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 help improve CMS's process for establishing relative values for Medicare physicians' services, the Administrator of CMS should better document the process for establishing relative values for Medicare physicians' services, including the methods used to review RUC recommendations and the rationale for final relative value decisions.

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

Comments: To help improve the Centers for Medicare & Medicaid Service's (CMS) process for establishing relative values for Medicare physicians' services, in May 2015 we recommended that the Administrator of CMS better document the process, including the methods used to review recommendations from the American Medical Association/Specialty Society Relative Value Scale Update Committee (RUC) and the rationale for final relative value decisions. CMS concurred with this recommendation, stating that CMS establishes relative values for new, revised, and potentially misvalued physicians' services based on its review of a variety of sources of information, including the RUC. At that time, CMS officials told us the agency was working to improve the transparency of its process by proposing and finalizing changes to the process in the annual rule for the Physician Fee Schedule. Officials estimated that this process would take several years to complete. In order to close this recommendation as implemented, CMS will need to demonstrate that it has improved its internal and external documentation of its process for establishing relative values. As of June 2020, GAO was still waiting on confirmation from CMS that it had completed its enhancement process for establishing relative values for Medicare physicians' services in a way that would allow for greater transparency and documentation. CMS will need to demonstrate that it has improved its internal and external documentation for establishing relative values in order for GAO to close the recommendation. CMS officials agreed the recommendation should remain open as progress continues.

Recommendation: To help improve CMS's process for establishing relative values for Medicare physicians' services, the Administrator of CMS should develop a process for informing the public of potentially misvalued services identified by the RUC, as CMS already does for potentially misvalued services identified by CMS or other stakeholders.

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

Comments: To help improve the Centers for Medicare & Medicaid Service's (CMS) process for establishing relative values for Medicare physicians' services, in May 2015 we recommended that the Administrator of CMS develop a process for informing the public of potentially misvalued services identified by the American Medical Association/Specialty Society Relative Value Scale Update Committee (RUC), as CMS already does for potentially misvalued services identified by CMS or other stakeholders. CMS did not concur with this recommendation, asserting that the RUC is completely independent of CMS, and as such CMS has no authority to set the RUC's agenda for which services are reviewed. As of June 2020, CMS had not changed its position on the recommendation. We continue to believe that CMS needs to inform the public of potentially misvalued services identified by the RUC, as it does for potentially misvalued services identified by other stakeholders. We acknowledge that in 2017 CMS changed its process for establishing relative values by including proposed values for almost all services in the annual proposed rulemaking for the Physician Fee Schedule, which means that the changes in values for potentially misvalued services identified by the RUC are open for public comment before they become effective. However, we continue to believe CMS should inform stakeholders of these potentially misvalued services before CMS receives RUC recommendations for them and subsequently publishes the values in the proposed rule. Doing so would give stakeholders the same amount of time they have to provide input on potentially misvalued services identified by other stakeholders.

Recommendation: To help improve CMS's process for establishing relative values for Medicare physicians' services, the Administrator of CMS should incorporate data and expertise from physicians and other relevant stakeholders into the process as well as develop a timeline and plan for using the funds appropriated by the Protecting Access to Medicare Act of 2014.

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

Comments: To help improve the Centers for Medicare & Medicaid Service's (CMS) process for establishing relative values for Medicare physicians' services, in May 2015 we recommended that the Administrator of CMS incorporate data and expertise from physicians and other relevant stakeholders into the process, as well as develop a timeline and plan for using the funds appropriated by the Protecting Access to Medicare Act of 2014 (PAMA). CMS concurred with this recommendation, stating that stakeholders have the opportunity each year to nominate potentially misvalued services for review through a public nomination process. In August 2017, CMS officials reported that the final rulemaking for the 2017 Physician Fee Schedule included a data collection effort using PAMA funds and other authorities that will help furnish data to help in valuations for more than half of physician services. However, this effort pertains to global services, which are a specific type of service under the Physician Fee Schedule that include global, professional, and technical components, and does not apply to non-global services, which encompass almost half of physician services. Officials also reported that they had awarded a contract to explore data collection on practice expense and methodologies for using such data when valuing services in the Physician Fee Schedule. However, CMS did not indicate a specific timeline and plan for using the PAMA funds, just that the agency would continue to use these funds to explore more ways to gain improved data. In March 2018, CMS reported that it now incorporates data and expertise from relevant stakeholders-apart from the RUC-into its process for establishing relative values by including any new, revised, or potentially misvalued values in the annual proposed rulemaking, instead of establishing them on an interim final basis in the final rule. This means that the changes in values for services will be open for public comment prior to the implementation of changes to payment. We acknowledge that CMS has made progress towards meeting our recommendation by changing its process to allow for public comments on proposed changes to relative values before they go into effect. CMS has also made progress by beginning to use PAMA funds to assist with valuing global services and exploring avenues for collecting practice expense data. To close this recommendation, we need documentation that CMS has started to incorporate data more broadly into its process for establishing relative values and that it has a documented timeline and plan for how it will use the funds appropriated by the Protecting Access to Medicare Act of 2014. As of June 2020, we had not received this documentation.

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: To ensure that MA encounter data are of sufficient quality for their intended purposes, the Administrator of CMS should establish specific plans and time frames for using the data for all intended purposes in addition to risk adjusting payments to MAOs.

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

Comments: HHS generally agreed with this recommendation. Although CMS reports using MA encounter data for purposes other than risk adjustment, as of February 2020, it has not fully developed specific plans and time frames with dates for all uses. CMS reports that it has begun testing the use of MA encounter data for public health purposes, such as identifying beneficiaries with a history of opioid-related overdose and with other conditions, such as cancer and sickle cell. Further, CMS uses MA encounter data to help identify beneficiaries at risk in areas affected by public health emergencies. CMS reports that its Office of the Actuary (OACT) has used MA encounter data to analyze MA beneficiary utilization of certain Part B drugs. Further, OACT reports that it intends to assess other areas where it could use MA encounter data, such as analyses comparing Medicare fee-for-service and MA. As of February 2020, the agency has not developed specific plans and time frames for this and other intended purposes. For example, although CMS intends to use MA encounter data for program integrity purposes, it has not yet developed specific plans and time frames to do so. We will continue to monitor CMS's progress in developing specific plans and time frames with dates for all intended purposes of MA encounter data.

Recommendation: To ensure that MA encounter data are of sufficient quality for their intended purposes, the Administrator of CMS should complete all the steps necessary to validate the data, including performing statistical analyses, reviewing medical records, and providing MAOs with summary reports on CMS's findings, before using the data to risk adjust payments or for other intended purposes.

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

Comments: HHS generally agreed with this recommendation, however, HHS did not commit to completing data validation before using MA encounter data for risk adjustment. As of February 2020, CMS has continued to make progress in examining the completeness and accuracy of MA encounter data, but more work remains to fully validate these data. CMS has developed and is implementing an MA Encounter Data Integrity and Monitoring plan, which includes data analysis, guidance, and monitoring. As part of this plan, CMS has established preliminary performance metrics for MA encounter data completeness and accuracy. CMS is also conducting analyses related to accuracy and completeness, but has not established performance benchmarks for these analyses. While the agency plans to communicate findings from the analyses to Medicare Advantage organizations, it has not yet done so. Finally, CMS has not verified MA Encounter data by reviewing medical records. While these steps are encouraging, without fully validating the completeness and accuracy of MA encounter data, CMS would be unable to confidently use these data for risk adjustment or other program management or policy purposes.

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: The Administrator of CMS should insert a self-referral flag on its Medicare Part B claims form, require providers to indicate whether the IMRT service for which a provider bills Medicare is self-referred, and monitor the effects that self-referral has on costs and beneficiary treatment selection.

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

Comments: In August 2013, we recommended that the Administrator of the Centers for Medicare & Medicaid Services (CMS) insert a self-referral flag on its Medicare Part B claims form, require providers to indicate whether the intensity-modulated radiation therapy (IMRT) service for which a provider bills Medicare is self-referred, and monitor the effects that self-referral has on costs and beneficiary treatment selection. The Department of Health and Human Services (HHS) did not concur with this recommendation, noting that CMS does not believe that this recommendation will address overutilization that occurs as a result of self-referral, would be complex to administer, and may have unintended consequences. We continue to believe that such a flag on Part B claims would likely be the easiest and most cost-effective way for CMS to identify self-referred IMRT services and monitor the effects of self-referral. As of June 2020, CMS has not provided any additional information about actions it has taken to address this recommendation.

Recommendation: In order to improve CMS's ability to identify self-referred anatomic pathology services and help CMS avoid unnecessary increases in these services, the Administrator of CMS should insert a self-referral flag on Medicare Part B claim forms and require providers to indicate whether the anatomic pathology services for which the provider bills Medicare are self-referred or not.

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

Comments: In June 2013, we recommended that the Administrator of the Centers for Medicare & Medicaid Services (CMS) insert a self-referral flag on Medicare Part B claim forms and require providers to indicate whether the anatomic pathology services for which the provider bills Medicare are self-referred or not. The Department of Health and Human Services (HHS) did not concur with this recommendation, noting that CMS does not believe that this recommendation will address overutilization that occurs as a result of self-referral. Although CMS has taken initial steps relevant to self-referral, the steps do not require a provider to indicate whether anatomic pathology services billed to Medicare are self-referred or not. Specifically, CMS has noted that Section 6409(a) of the Patient Protection and Affordable Care Act required the Secretary of the Department of Health and Human Services, in cooperation with the Inspector General of the Department of Health and Human Services, to establish a Medicare self-referral disclosure protocol that sets forth a process to enable providers of services and suppliers to self-disclose actual or potential violations of the physician self-referral statute. However, the protocol is voluntary and specific to actual or potential violations regarding self-referral, which is not relevant to our recommendation. As of January 2020, CMS has not provided any additional information about actions it has taken to address our recommendation. We continue to believe that inserting a flag on Part B claims to indicate whether an anatomic pathology service is self-referred would improve CMS's ability to monitor self-referred services, which in turn may help them take action to avoid unnecessary increases in these services.

Recommendation: In order to improve CMS's ability to identify self-referred anatomic pathology services and help CMS avoid unnecessary increases in these services, the Administrator of CMS should determine and implement an approach to ensure the appropriateness of biopsy procedures performed by self-referring providers.

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

Comments: In June 2013, we recommended that the Administrator of the Centers for Medicare & Medicaid Services (CMS) implement an approach to ensure the appropriateness of biopsy procedures performed by self-referring providers. The Department of Health and Human Services (HHS) did not concur with this recommendation and does not believe it would address overutilization that occurs as a result of self-referral. In November 2017, CMS officials noted that the agency does not have the ability to identify self-referred anatomic pathology services during medical reviews. As of January 2020, CMS has not provided any additional information about actions it has taken to address the recommendation. We continue to believe that it is important for CMS to monitor the self-referral of anatomic pathology services on an ongoing basis and determine if those services are inappropriate or unnecessary.

Recommendation: In order to improve CMS's ability to identify self-referred anatomic pathology services and help CMS avoid unnecessary increases in these services, the Administrator of CMS should develop and implement a payment approach for anatomic pathology services that would limit the financial incentives associated with referring a higher number of specimens--or anatomic pathology services--per biopsy procedure.

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

Comments: In June 2013, we recommended that the Administrator of the Centers for Medicare & Medicaid Services (CMS) develop and implement a payment approach for anatomic pathology services under the Physician Fee Schedule that would limit the financial incentives associated with referring a higher number of specimens--anatomic pathology services--per biopsy procedure. Although health care providers have discretion in determining the number of tissue samples from biopsy procedures that become specimens (anatomic pathology services), CMS's current payment system under the Physician Fee Schedule provides a financial incentive for providers to refer more specimens per biopsy procedure. Specifically, CMS pays for each specimen that a provider submits to be analyzed. HHS indicated that it concurred with our recommendation and that it had addressed this recommendation by reducing payment for the most commonly furnished anatomic pathology service (Current Procedural Terminology [CPT] code 88305) by approximately 30 percent in calendar year 2013. However, CMS's payment reduction did not change the financial incentive providers have to refer more specimens per biopsy procedure because they will still be paid separately for each specimen submitted. As of January 2020, CMS has not provided any additional information about actions it has taken to limit the financial incentives associated with referring a higher number of specimens. We continue to believe that CMS should develop a payment approach that addresses this incentive.

Recommendation: To help ensure that ADI suppliers provide consistent, safe, and high-quality imaging to Medicare beneficiaries, the Administrator of CMS should determine the content of and publish minimum national standards for the accreditation of ADI suppliers, which could include specific qualifications for supplier personnel and requiring accrediting organization review of clinical images.

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

Comments: In June 2019, HHS officials informed us that they plan to implement this recommendation in March 2020. We will update the status of this recommendation when we receive additional information.

Recommendation: To help ensure that ADI suppliers provide consistent, safe, and high-quality imaging to Medicare beneficiaries, the Administrator of CMS should develop an oversight framework for evaluating accrediting organization performance, which could include collecting and analyzing information on accreditation results and conducting validation audits.

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

Comments: In June 2019, HHS officials informed us that they plan to implement this recommendation in March 2020. We will update the status of this recommendation when we receive additional information.

Recommendation: To help ensure that ADI suppliers provide consistent, safe, and high-quality imaging to Medicare beneficiaries, the Administrator of CMS should develop more specific requirements for accrediting organization mid-cycle audit procedures and clarify guidance on immediate-jeopardy deficiencies to ensure consistent identification and timely correction of serious care problems for the duration of accreditation.

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

Comments: In June 2019, HHS officials informed us that they plan to implement this recommendation in March 2020. We will update the status of this recommendation when we receive additional information.

Recommendation: To reduce the incentive for facilities to restrict their service provision to avoid reaching the LVPA treatment threshold, the Administrator of CMS should consider revisions such as changing the LVPA to a tiered adjustment.

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

Comments: As of February 2020, CMS had not implemented this recommendation. CMS stated in February 2020 that the agency had extensive discussions with the Medicare Payment Advisory Commission regarding the Commission's suggestions for modifying the LVPA. CMS also stated that the agency was analyzing the design of the LVPA as part of its evaluation of the ESRD Prospective Payment System. This recommendation remains open because CMS has not provided documentation of steps such as those described above that the agency has taken to consider revisions to the LVPA. We will update the status of this recommendation upon receipt of additional information from CMS.

Recommendation: In order to improve CMS's ability to identify self-referred advanced imaging services and help CMS address the increases in these services, the Administrator of CMS should insert a self-referral flag on its Medicare Part B claims form and require providers to indicate whether the advanced imaging services for which a provider bills Medicare are self-referred or not.

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

Comments: HHS did not concur with this recommendation. CMS believes that a new checkbox on the claim form identifying self-referral would be complex to administer and providers may not characterize referrals accurately. We continue to believe that such a flag on Part B claims would likely be the easiest and most cost-effective way for CMS to identify self-referred advanced imaging services and monitor the behavior of those providers who self-refer these services, even though the agency has no plans to take further action. As of January 2020, CMS continues to indicate it will not take additional actions to address this recommendation.

Recommendation: In order to improve CMS's ability to identify self-referred advanced imaging services and help CMS address the increases in these services, the Administrator of CMS should determine and implement a payment reduction for self-referred advanced imaging services to recognize efficiencies when the same provider refers and performs a service.

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

Comments: HHS did not concur with this recommendation, noting that CMS did not believe that a payment reduction would address overutilization that occurs as a result of self-referral and that the agency's multiple procedure payment reduction policy for advanced imaging already captures efficiencies inherent in providing multiple advanced imaging services by the same physician. Further, CMS does not think a payment reduction for self-referred services would be effective. For example, the agency believes that providers in self-referring arrangements could avoid this reduction by having one provider refer an advanced imaging service while having another perform the service. Finally, CMS questioned whether implementing our recommendation would violate the Medicare statute prohibiting paying a differential by physician specialty for the same service. Our recommendation, however, refers to specific self-referral arrangements in which the same provider refers and performs an imaging service, and therefore would not be addressed by CMS's multiple procedure payment reduction policy. As noted in our report, this payment reduction would affect about 10 percent of advanced imaging services referred by self-referring providers. In addition, while CMS raised questions about whether implementing our recommendation would violate Medicare's prohibition on paying a differential by physician specialty for the same service, our report shows that self-referring providers generally referred more MRI and CT services, regardless of differences in specialties, and CMS did not indicate how this recommendation would implicate the prohibition on paying a differential by specialty. We continue to believe that CMS should determine and implement a payment reduction to recognize efficiencies for advanced imaging services referred and performed by the same provider. As of January 2020, the agency has no plans to take further action regarding this recommendation.

Recommendation: In order to improve CMS's ability to identify self-referred advanced imaging services and help CMS address the increases in these services, the Administrator of CMS should determine and implement an approach to ensure the appropriateness of advanced imaging services referred by self-referring providers.

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

Comments: HHS did not concur with this recommendation, according to its fiscal year 2021 budget justification. To fully implement this recommendation, CMS should determine and implement an approach to ensure the appropriateness of advanced imaging services referred by self-referring providers.

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: The Administrator of CMS should take steps to better align Medicare beneficiary use of preventive services with Task Force recommendations, including providing coverage of services with an 'A" or 'B" grade for the recommended population and at the recommended frequency, as she determines is appropriate considering cost-effectiveness and other criteria.

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

Comments: CMS has noted that it extended Medicare coverage for several additional preventive services, and that it continues to review the Task Force's recommendations. Specifically, the agency noted that it closely monitors Task Force updates and attends relevant meetings so that alignment with the Medicare population can be considered. However, until CMS implements a systematic process within routine coverage determination steps to regularly consider Task Force guidelines, beneficiaries remain at risk for unnecessary coverage limitations. As of October 2019, CMS officials have not implemented this recommendation and GAO considers it to be open. We will update the status of this recommendation when we receive additional information.

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 information entered into CMS's complaints database is reliable and consistent, the Administrator of CMS should identify issues with data quality and clarify guidance to states about how particular fields in the database should be interpreted, such as what it means to substantiate a complaint.

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

Comments: HHS concurred with this recommendation. In November 2014, CMS officials reported that the agency's Survey and Certification Group was in the early stages of a planned multi-year review of all of its business processes, including those related to nursing home complaint investigations. Officials stated that, as part of that review, agency staff would seek to provide clarification on all aspects of the complaint process, including what it means to substantiate a complaint. In July 2019 CMS officials said some actions have been taken and that they would forward us information. We will update the status of this recommendation when we receive additional information.

Recommendation: To strengthen CMS's assessment of state survey agencies' performance in the management of nursing home complaints, the Administrator of CMS should conduct additional monitoring of state performance using information from CMS's complaints database, such as additional timeliness measures.

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

Comments: In November 2014, CMS officials reported that the fiscal year 2014 protocol for assessment of state agency performance includes a new measure that tracks how soon after the completion of a complaint investigation a state agency uploads data from that investigation to CMS's complaint tracking system. However, the protocol does not call for assessment of the number of days by which state survey agencies miss the deadlines for some complaint investigations--a measure that we suggested could provide a more comprehensive picture of state agency performance. In July 2019 CMS officials said some actions have been taken and that they would forward us information. We will update the status of this recommendation when we receive additional information.

Recommendation: To strengthen and increase accountability of state survey agencies' management of the nursing home complaints process, the Administrator of CMS should clarify guidance to the state survey agencies about the minimum information that should be conveyed to complainants at the close of an investigation.

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

Comments: HHS agreed that CMS needed to take steps to strengthen and increase accountability of state survey agencies' management of nursing home complaints. In November 2014, CMS officials reported that while they believed the CMS State Operations Manual, which specifies procedures for addressing complaints, provides significant guidance regarding the information that state agencies should convey to complainants at the close of an investigation, they would review the guidance to identify any needed changes. In July 2019 CMS officials said some actions have been taken and that they would forward us information. We will update the status of this recommendation when we receive additional information.

Recommendation: To strengthen and increase accountability of state survey agencies' management of the nursing home complaints process, the Administrator of CMS should provide guidance encouraging state survey agencies to prioritize complaints at the level that is warranted, not above that level.

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

Comments: HHS agreed that CMS needed to take steps to strengthen and increase accountability of state survey agencies' management of the nursing home complaints process and stated that CMS would provide clarification and guidance to states to ensure complaints were prioritized at the appropriate level. However, in CMS's fiscal year 2014 protocol for assessment of state agency performance, the prioritization standard still required only that complaints be assigned a priority level at or above the level assigned by CMS reviewers. We remain concerned that defining the standard this way may create an incentive for survey agencies to prioritize some complaints at a higher level than is warranted--which could increase workload and potentially jeopardize the timeliness of investigations that warrant the higher priority level. In July 2019 CMS officials said some actions have been taken and that they would forward us information. We will update the status of this recommendation when we receive additional information.

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

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

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

Recommendation: To 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: 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.