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Highlights

What GAO Found

Clinical data registries (CDR) have demonstrated a particular strength in assessing physician performance through their capacity to track and interpret trends in health care quality over time. Studies examining results reported by several long-established CDRs demonstrate the utility of CDR data sets for analyzing trends in both outcomes and treatments. CDR efforts to improve outcomes typically involve a combination of performance improvement activities including feedback reports to participating physicians, benchmarking physician performance relative to that of their peers, and related educational activities designed to stimulate changes in clinical practice. Studies GAO reviewed provided less insight on ways to improve the efficiency of care.

The Department of Health and Human Services' (HHS) plans for implementing the qualified CDR program offer little specificity and provide substantial leeway for CDRs seeking to become qualified. According to officials, HHS plans to have its program requirements and structure evolve over time, and a key question is the extent to which this evolutionary process will focus on harnessing the potential of CDRs to promote quality and efficiency. GAO's synthesis of input from experts and from other relevant sources identified several key requirements that would make it more likely that qualified CDRs promote improved quality and efficiency, which HHS's current plans for the program would do little to address. These requirements include directing CDRs to focus data collection on performance measures that address the key opportunities for improvement in quality and efficiency for each CDR's target population and requiring CDRs to demonstrate improvement over time on the quality and efficiency measures that they collect. In addition, effective oversight of these requirements depends on expert judgment to take account of variation among CDRs in their circumstances and opportunities for improvement.

Experts indicated that HHS can also help qualified CDRs to improve the quality and efficiency of care provided to Medicare patients by taking actions that could reduce potential barriers to the development of qualified CDRs, such as concerns about complying with privacy regulations and the difficulty of funding CDRs. GAO's synthesis of input from experts and from other relevant sources identified several specific actions that HHS could take. They include developing guidance to clarify federal privacy requirements for physicians participating in CDRs and testing one or more models of shared savings between Medicare and qualified CDRs that achieve reduced Medicare expenditures with improved quality of care.

In addition, input from experts and other relevant sources suggests that HHS can take actions to facilitate CDRs' use of health information technology (IT). According to CDR officials, some CDRs have developed approaches to electronically capture and transmit large amounts of detailed clinical data from a wide variety of electronic health record (EHR) systems. CDRs could benefit from new IT standard setting that focuses on data elements needed for the measures that CDRs collect. One way HHS can influence whether EHR vendors use IT standards to design EHR systems that are compatible with CDR needs is through its setting of meaningful use requirements in its EHR incentive programs.

Why GAO Did This Study

The American Taxpayer Relief Act of 2012 instructed HHS to establish a new program to designate "qualified" CDRs--entities that would work with physicians treating Medicare patients to collect clinical information and use it to improve the quality and efficiency of care. The act also mandated GAO to report on the potential for CDRs to improve quality and efficiency.

This report examines (1) improvements demonstrated by CDRs in quality and efficiency of care, (2) HHS's plans for requirements and oversight for qualified CDRs, (3) actions HHS could take to facilitate the development of qualified CDRs, and (4) actions HHS could take to facilitate CDRs' use of health IT. GAO reviewed relevant studies and documents, and interviewed HHS and CDR officials. GAO also convened an expert meeting with the assistance of the Institute of Medicine and synthesized input from experts and other sources to assess the likely effect of potential program requirements, approaches to oversight, and other actions HHS could take.

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Recommendations

GAO recommends that HHS (1) focus its requirements for qualified CDRs on improving quality and efficiency, (2) require qualified CDRs to demonstrate improvement in quality and efficiency, (3) draw on expert judgment to monitor qualified CDRs, (4) reduce barriers to the development of qualified CDRs, and (5) include, if feasible, key data elements needed by qualified CDRs in its requirements under the EHR incentive programs. HHS agreed with GAO's recommendations.

Recommendations for Executive Action

Agency Affected Recommendation Status
Department of Health and Human Services To help ensure that qualified CDRs promote improved quality and efficiency of physician care for Medicare beneficiaries, the Secretary of Health and Human Services should direct Centers for Medicare & Medicaid Services (CMS) to establish key requirements for qualified CDRs that focus on improving quality and efficiency. These requirements could include, for example, having CDRs (1) identify key areas of opportunity to improve quality and efficiency for their target populations and collect additional measures designed to address them, (2) collect a core set of measures established by CMS, and (3) demonstrate that their processes for auditing the accuracy and completeness of the data they collect are systematic and rigorous.
Closed - Implemented
As GAO recommended, CMS has recently taken steps to establish requirements for qualified CDRs that that focus on improving quality and efficiency. Specifically, beginning in CY 2020, CMS will require qualified CDRs to demonstrate that they have clinical expertise in medicine and quality measurement development. This requirement should help to ensure that qualified CDRs have the technical capability needed to focus their efforts where they are likely to have the greatest impact on quality and efficiency.
Department of Health and Human Services To help ensure that qualified CDRs promote improved quality and efficiency of physician care for Medicare beneficiaries, the Secretary of Health and Human Services should direct CMS to establish a requirement for qualified CDRs to demonstrate improvement on key measures of quality and efficiency for their target populations.
Open
As of October 2020, HHS officials reported that they had implemented new requirements for qualified CDRs to provide performance feedback to participating clinicians at least 4 times a year. However, these requirements did not call on qualified CDRs to demonstrate improved performance on their measures of quality and efficiency, as GAO recommended.
Department of Health and Human Services To help ensure that qualified CDRs promote improved quality and efficiency of physician care for Medicare beneficiaries, the Secretary of Health and Human Services should direct CMS to establish a process for monitoring compliance with requirements for qualified CDRs that draws on relevant expert judgment. This process should assess CDR performance on each requirement in a way that takes into account the varying circumstances of CDRs and their available opportunities to promote quality and efficiency improvement for their target populations.
Open
In October 2020, CMS officials updated the agency's response to this recommendation, which calls on CMS to establish a process for monitoring compliance with requirements for qualified CDRs that draw on relevant expert judgment. We noted, in making this recommendation, that expert judgment would enable CMS to assess qualified CDR performance in a way that took account of differences in their circumstances and in the available opportunities for improvement in quality and efficiency for their specific target populations. Based on the materials CMS has provided, our understanding is that the process for monitoring qualified CDRs focuses on ensuring qualified CDR compliance with expectations such as delivering required reports on time and not submitting false or inaccurate data, and does not draw on expert judgment to account for these different circumstances and opportunities for improving quality and efficiency.
Department of Health and Human Services To help ensure that qualified CDRs promote improved quality and efficiency of physician care for Medicare beneficiaries, the Secretary of Health and Human Services should determine and implement actions to reduce barriers to the development of qualified CDRs, such as (1) developing guidance that clarifies Health Insurance Portability and Accountability Act requirements to promote participation in qualified CDRs; (2) working with private sector entities to make relevant multipayer cost data available to qualified CDRs; (3) testing one or more models of shared savings between Medicare and qualified CDRs that achieve reduced Medicare expenditures with improved quality of care, and (4) providing technical assistance to qualified CDRs.
Open
In October 2020, CMS officials updated the agency's response to this recommendation. CMS included documentation of technical assistance provided between April and June 2019 to groups seeking to set up qualified CDRs. The assistance covers topics such as program requirements, how to construct different types of quality measures, and assistance with measure concepts and feedback on self-nomination to be a qualified CDR. This technical assistance is consistent with GAO's recommendation to reduce barriers in the development of qualified CDRs, but it is not clear if the assistance has continued past June 2019, or if other similar technical assistance is being provided on an ongoing basis.
Department of Health and Human Services To help ensure that qualified CDRs promote improved quality and efficiency of physician care for Medicare beneficiaries, the Secretary of Health and Human Services should determine key data elements needed by qualified CDRs--such as those relevant for a required core set of measures--and direct Office of the National Coordinator for Health Information Technology and CMS to include these data elements, if feasible, in the requirements for certification of EHRs under the EHR incentive programs.
Open
In October 2020, CMS officials updated the agency's response to this recommendation.. This recommendation is focused on achieving two key objectives that are specific to qualified CDRs: 1) identifying a set of clinical data elements that are needed for the particular quality measures used by qualified CDRs, and 2) incorporating these data elements into federal requirements for EHRs, where feasible. CMS provided information on steps taken to promote the development of electronic clinical quality measures in general, but has not provided information on steps taken to address either of those qualified CDR-focused objectives.

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