Recommendation: Congress should consider specifying in the IRC what services and activities it considers sufficient community benefit. (Matter for Consideration 1)

Agency: Congress
Status: Open

Comments: When we determine what steps the Congress has taken, we will provide updated information.

Recommendation: The Commissioner of Internal Revenue should update Form 990, including Schedule H and instructions where appropriate to ensure that the information demonstrating the community benefits a hospital is providing is clear and can be easily identified by Congress and the public, including the community benefit factors. (Recommendation 1)

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

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

Recommendation: The Commissioner of Internal Revenue should assess the benefits and costs, including the tax law implications, of requiring tax-exempt hospital organizations to report community benefit expenses on Schedule H by individual facility rather than by collective organization and take action, as appropriate. (Recommendation 2)

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

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

Recommendation: The Commissioner of Internal Revenue should establish a well-documented process to identify hospitals at risk for noncompliance with the community benefit standard that would ensure hospitals' community benefit activities are being consistently reviewed. (Recommendation 3)

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

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

Recommendation: The Commissioner of Internal Revenue should establish specific audit codes for identifying potential noncompliance with the community benefit standard. (Recommendation 4)

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

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

Recommendation: The Director of CDC should take steps to determine participation rates and distribution needed in the AR Option of the National Healthcare Safety Network for conducting regional and national assessments of antibiotic resistance of public health importance. (Recommendation 1)

Agency: Department of Health and Human Services: Public Health Service: Centers for Disease Control and Prevention
Status: Open

Comments: The Department of Health and Human Services concurred with this recommendation. When we confirm any actions the agency has taken to implement the recommendation, we will provide updated information.

Recommendation: The Director of CDC should ensure that CDC's evaluation of its surveillance system for antibiotic-resistant gonorrhea includes measures of its representativeness, such as comparison of the trends in the sample population with those in the overall U.S. population, using specially designed studies if needed. (Recommendation 2)

Agency: Department of Health and Human Services: Public Health Service: Centers for Disease Control and Prevention
Status: Open

Comments: The Department of Health and Human Services and the Centers for Disease Control and Prevention concurred with this recommendation. When we confirm any actions the agency has taken to implement the recommendation, we will provide updated information.

Recommendation: The Director of CDC should provide information on uncertainties for antibiotic resistance estimates in its consolidated Threats Reports, including standard errors or confidence intervals, as appropriate. (Recommendation 3)

Agency: Department of Health and Human Services: Public Health Service: Centers for Disease Control and Prevention
Status: Open

Comments: The Department of Health and Human Services generally concurred with this recommendation. When we confirm any actions the agency has taken to implement the recommendation, we will provide updated information.

Recommendation: The Director of CDC should develop a plan for timely, consolidated reports of antibiotic resistance in priority pathogens at regular intervals. (Recommendation 4)

Agency: Department of Health and Human Services: Public Health Service: Centers for Disease Control and Prevention
Status: Open

Comments: The Department of Health and Human services concurred with this recommendation. When we confirm any actions the agency has taken to implement the recommendation, we will provide updated information.

Recommendation: The Secretary of HHS should identify leadership and clarify roles and responsibilities among HHS agencies to assess the clinical outcomes of diagnostic testing for identifying antibiotic-resistant bacteria. (Recommendation 5)

Agency: Department of Health and Human Services: Office of the Secretary
Status: Open

Comments: The Department of Health and Human Services concurred with GAO's recommendation. When we confirm any actions the agency has taken to implement the recommendation, we will provide updated information.

Recommendation: The Commissioner of FDA should direct the Center for Devices and Radiological Health to conduct additional monitoring and evaluation of the status of FDA-authorized tests that rely on breakpoints, on a regular basis, to determine whether test manufacturers are updating breakpoints, seeking additional resources as needed. (Recommendation 6)

Agency: Department of Health and Human Services: Public Health Service: Food and Drug Administration: Office of the Commissioner
Status: Open

Comments: The Department of Health and Human Services and the Food and Drug Administration concurred with this recommendation. When we confirm any actions the agency has taken to implement the recommendation, we will provide updated information.

Recommendation: The Secretary of HHS should develop a strategic framework to further incentivize the development of new treatments for antibiotic-resistant infections, including through the use of postmarket financial incentives, and, if appropriate, make recommendations to Congress for necessary authority. (Recommendation 7)

Agency: Department of Health and Human Services: Office of the Secretary
Status: Open

Comments: The Department of Health and Human Services did not concur with GAO's recommendation. In commenting on our report, the department noted that it has convened a workgroup to develop a strategic framework that includes proposals to address a variety of challenges facing antibiotic product developers and agreed that additional incentives are needed. However, the department stated it is still analyzing whether postmarket financial incentives should be included in this framework. We believe our recommendation is still warranted, given the importance of antibiotic resistance to public health and the importance of sustaining the antibiotic pipeline, including after antibiotics are brought to market. When we confirm any actions the agency has taken to implement the recommendation, we will provide updated information.

Recommendation: The Secretary of HHS should direct the CARB Task Force to include in its annual updates to the President plans for addressing any barriers preventing full implementation of the National Action Plan and, as appropriate, make recommendations for new or modified actions. Specifically, the CARB Task Force should identify plans to address barriers, such as those related to expanding (1) a CDC program designed to strengthen the U.S. response to resistant gonorrhea; (2) antibiotic stewardship programs across health care settings; and (3) antibiotic use data collection across health care settings, to the extent feasible. (Recommendation 8)

Agency: Department of Health and Human Services: Office of the Secretary
Status: Open

Comments: The Department of Health and Human Services concurred with this recommendation, and stated that beginning in 2020 and continuing annually thereafter, the CARB Task Force's progress reports will include discussion of any barriers preventing full implementation of the National Action Plan, including, as appropriate, barriers that GAO has identified. When we confirm any actions the agency has taken to implement the recommendation, we will provide updated information.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Recommendation: The Administrator of HRSA should issue guidance on the length of time covered entities must look back following an audit to identify the full scope of noncompliance identified during the audit.(Recommendation 4)

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

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

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

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

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

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

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

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

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

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

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

Recommendation: 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 help ensure that its efforts to increase patients' electronic access to health information are successful, the Secretary of HHS should direct ONC to use the information these performance measures provide to make program adjustments, as appropriate. Such actions may include, for example, assessing the status of program operations or identifying areas that need improvement in order to help achieve program goals related to increasing patients' ability to access their health information electronically.

Agency: Department of Health and Human Services
Status: Open

Comments: As of May 2019, ONC is collecting and evaluating information from national surveys, program data, and third-party data sources. As ONC works to implement its evaluations, it should identify how evidence collected from national surveys, program data and third-party data sources has been used to assess the outcomes of key efforts and adjust programs accordingly.

Recommendation: To help determine whether current efforts are effective or if additional action may be needed, such as development of a workplace violence prevention standard for health care employers, the Secretary of Labor should direct the Assistant Secretary for Occupational Safety and Health to develop and implement cost-effective ways to assess the results of the agency's efforts to address workplace violence.

Agency: Department of Labor
Status: Open
Priority recommendation

Comments: According to OSHA officials, the agency had a study underway to review OSHA's workplace violence enforcement cases in health care to better understand the obstacles OSHA compliance officers encountered during these investigations and identify factors which led to citations. The study was intended to help compliance officers develop citations in workplace violence cases. In addition, in December 2016, OSHA published a Request for Information on Preventing Workplace Violence in Healthcare and Social Assistance (RFI) to help identify workplace violence prevention requirements that could be effective and economical if a regulation were to be developed. OSHA reported in June 2018 that it is evaluating the information it received in response to the RFI and is gathering information on best practices in certain industries. As of April 2020, OSHA completed its review of the submissions in response to the RFI, is developing regulatory options, and will obtain additional input from potentially affected small businesses. The agency anticipates completing this process by the end of 2020. To fully implement this recommendation, the agency should complete its process of obtaining input on the regulatory options the agency is developing, and finalize its determination on whether regulatory action is needed.

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

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

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

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

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

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

Recommendation: In order to prevent the shift of services from physician offices to HOPDs from increasing costs for the Medicare program and beneficiaries, Congress should consider directing the Secretary of HHS to equalize payment rates between settings for E/M office visits--and other services that the Secretary deems appropriate--and to return the associated savings to the Medicare program.

Agency: Congress
Status: Open

Comments: The Bipartisan Budget Act of 2015, enacted in November 2015, partially addressed our recommendation as it limits certain providers from billing at higher hospital outpatient department payment rates. Specifically, the legislation excludes services furnished by off-campus hospital outpatient departments from reimbursement under Medicare's hospital outpatient prospective payment system, effective January 1, 2017. According to the Congressional Budget Office, this action saves the Medicare program $9.3 billion over 10 years. However, the Act does not apply to services furnished by providers billing as hospital outpatient departments prior to enactment of the legislation-which includes providers billing as hospital outpatient departments during the study period in our report-as well as hospital outpatient departments located on hospital campuses. This means that, even in 2017 and beyond, many providers will not be affected by the Act, and Medicare will continue to pay more than necessary for certain services. In November 2018, CMS issued a final rule adopting payment changes-that have since been partially overturned under a decision by a federal district court, which CMS has appealed-capping payment rates for certain services furnished by the off-campus hospital outpatient departments that existed or were under construction in 2015 at the physician fee schedule rate. Since these services furnished by these off-campus hospital outpatient departments were paid under a higher rate, the payment cap, which was to be implemented over 2 years, was intended to equalize payment rates for certain clinical visits between settings. In 2019, CMS applied 50 percent of the payment reduction and in 2020 and subsequent years planned to apply 100 percent of the payment reduction. The rule applied to specific clinical visits; and other services would continue to be paid at the higher rate. However, a federal district court overturned the payment cap in September 2019. CMS has appealed that ruling and adopted a final rule in November 2019 that will implement the payment reduction in 2020. A lawsuit challenging the November 2019 final rule has been filed.

Recommendation: To help ensure the financial sustainability of the Medicare program, protect beneficiaries from unwarranted financial burden, and address potential concerns about the appropriateness of the health care provided to Part B beneficiaries, Congress should consider eliminating the incentive to prescribe more drugs or more expensive drugs than necessary to treat Medicare Part B beneficiaries at 340B hospitals.

Agency: Congress
Status: Open

Comments: As of June 2020, Congress had not acted on this Matter for Congressional Consideration.

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

Agency: Department of Health and Human Services
Status: Open

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

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

Agency: Department of Health and Human Services
Status: Open

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

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

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

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

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

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

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

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

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

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

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

Agency: Department of Health and Human Services
Status: Open

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

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

Agency: Department of Health and Human Services
Status: Open

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

Recommendation: To increase beneficiaries' awareness of providers' financial interest in a particular treatment, Congress should consider directing the Secretary of Health and Human Services to require providers who self-refer IMRT services to disclose to their patients that they have a financial interest in the service.

Agency: Congress
Status: Open

Comments: In August 2013, to increase beneficiaries' awareness of providers' financial interest in a particular treatment, we suggested that Congress should consider directing the Secretary of Health and Human Services to require providers who self-refer IMRT services to disclose to their patients that they have a financial interest in the service. As of June 2020, Congress has not implemented this suggestion.

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

Agency: Congress
Status: Open

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

Recommendation: 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: In order to ensure an equitable allocation of CHS program funds, the Congress should consider requiring IHS to develop and use a new method to allocate all CHS program funds to account for variations across areas that would replace the existing base funding, annual adjustment, and program increase methodologies, notwithstanding any restrictions currently in federal law.

Agency: Congress
Status: Open

Comments: As of August 2019, Congress has not acted on this recommendation. We will update the status of this recommendation if Congress takes action.

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

Agency: Department of Health and Human Services
Status: Open

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

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

Agency: Department of Health and Human Services
Status: Open

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