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: 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 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 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 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: 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 ensure that savings are realized from the implementation of an MPPR or other policies that reflect efficiencies occurring when services are furnished together, Congress may wish to consider exempting these savings from budget neutrality.

Agency: Congress
Status: Open

Comments: Congress has exempted savings from the implementation of multiple procedure payment reductions (MPPR) for certain diagnostic imaging and therapy services from the budget neutrality requirement, as GAO suggested in July 2009. However, as of January 2020, other policies that may result in a reduction in payments for the professional component for imaging services remained subject to budget neutrality; "savings" from these services are redistributed to other services and do not accrue to the Medicare program. The Consolidated Appropriations Act of 2016 revised the payment reduction for the professional component of multiple diagnostic imaging services from 25 percent to 5 percent beginning on January 1, 2017, and exempted the reduced expenditures attributable to this MPPR from the budget neutrality provision. MPPRs or other policies that may result in a reduction to payments for the technical component for diagnostic cardiovascular and ophthalmology services continue to be subject to budget neutrality for 2020. Unless Congress exempts from the budget neutrality requirement savings realized from the implementation of all MPPRs or other policies that reflect efficiencies occurring when services are furnished together, these savings will not accrue to the Medicare program.