To examine HHS’s plans for requirements and oversight of qualified  CDRs to maximize CDRs’ potential impact on the quality and efficiency of  care, we interviewed HHS officials and reviewed HHS documents on the  department’s plans for implementing the qualified CDR program,  including both a proposed and final rule and the accompanying  preambles, which were published in the Federal Register during the  period of our review. Clinical Data Registries Have Enabled Sophisticated Assessments of Quality of Care, but Have Less to Report on Efficiency and Have Other Limitations

CDRs 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 outcomes reported by several long-established CDRs  demonstrate the utility of CDR data 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. 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. CMS’s Plans for Implementing the Qualified CDR Program Include Little Specificity on How CDRs Will Improve Quality and Efficiency

CMS’s plans for implementing the qualified CDR program, when it begins  in 2014, offer little specificity concerning CDR objectives or results and  provide substantial leeway for CDRs seeking to become qualified. Key Requirements Could Improve the Quality and Efficiency of Care through Qualified CDRs

We identified several key requirements for qualified CDRs that, based on  our synthesis of the input from experts at the meeting we convened with  the assistance of IOM together with other relevant sources, would  contribute to improved quality and efficiency of care for Medicare patients. Performance measures to address key opportunities: Having  qualified CDRs focus their data collection on performance measures  that address specific opportunities to improve quality and efficiency for  each CDR’s target population enhances their effectiveness in  promoting quality and efficiency overall. Demonstrating results: Input from experts and other relevant  sources indicates that CDRs are more likely to achieve improvements  in physician performance if they have specific incentives to do so. Therefore, requiring qualified CDRs to demonstrate improvement over  time on the quality and efficiency measures that they collect would  help to focus their attention on achieving results. HHS Actions Could Reduce Barriers to the Development of Qualified CDRs

Based on our synthesis of the input from experts at the meeting we  convened with the assistance of IOM together with other relevant  sources, there are several actions that HHS could take that could help  reduce potential barriers to the development of qualified CDRs. Health IT, Including EHRs, Can Support the Collection and Sharing of CDR Data, and Those Activities Could Be Strengthened by HHS Actions to Align Health IT Policies with CDR Needs

In recent years, some CDRs have developed different approaches to  electronically capture data from a wide variety of health IT applications,  particularly EHR systems. Input from experts and other relevant sources  suggests that HHS could help CDRs overcome barriers that impede the  electronic collection and transmission of clinical data by supporting  standard setting and adjusting meaningful use requirements. According to  experts, CDRs could benefit from health IT standards that reduce  variation across EHR systems on the data elements needed for the  measures used by CDRs. Through its setting of these meaningful use requirements, HHS could  influence the extent to which EHR systems are designed and  implemented to collect data needed by CDRs to assess physician  performance. While  implementation of the program is just getting under way and HHS plans to  have its program requirements and structure evolve over time, a key  question is the extent to which that evolutionary process focuses on  harnessing the potential of CDRs to promote quality and efficiency. Recommendations for Executive Action

To help ensure that qualified CDRs promote improved quality and  efficiency of physician care for Medicare beneficiaries, we recommend  that the Secretary of Health and Human Services take the following five  actions:
Direct CMS to establish key requirements for qualified CDRs that  focus on improving quality and efficiency. Determine and implement actions to reduce barriers to the  development of qualified CDRs, such as (1) developing guidance that  clarifies HIPAA 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.
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.

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.

What GAO Recommends

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.