Clinical Data Registries: HHS Could Improve Medicare Quality and Efficiency through Key Requirements and Oversight

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.

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.

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.

Both the federal government and private entities are attempting to  enhance the quality and efficiency of health care by shifting from  rewarding physicians and other providers based on the volume of their  services to rewarding them based on the value of those services—quality  and efficiency of care. However, finding a practical way to accurately and  credibly identify and then promote high quality and efficient care is a  complex task. An approach adopted by some groups, such as medical  specialty societies and regional health improvement collaboratives, has  been to develop clinical data registries (CDR). CDRs are entities that  collect and analyze detailed information on the therapies that patients  receive and changes in their clinical condition over time in order to  evaluate and improve care practices and outcomes. In recognition of the  potential of CDRs to promote the quality and efficiency of care in the  Medicare program, the American Taxpayer Relief Act of 2012 (ATRA)  instructed the Department of Health and Human Services (HHS) to  establish a new program to designate “qualified” CDRs. This program  could encourage more physicians treating Medicare beneficiaries to  participate in CDRs and thereby engage in the process of collecting  detailed clinical information and using it to improve the quality and  efficiency of care.

CDRs can analyze variations in treatment and outcomes; examine factors  that influence prognosis and quality of life; describe care patterns,  including appropriateness of care and disparities in the delivery of care;  assess effectiveness; measure the quality of care; and study quality  improvement. Proponents contend that qualified CDRs would generate data of greater relevance, depth, and credibility to physicians— particularly specialist physicians—than current federal performance  assessment programs, and thereby improve quality and efficiency. The  new qualified CDR program will provide physicians with an alternative to  participation in HHS’s existing Physician Quality Reporting System  (PQRS). PQRS allows physicians to report quality data on services they  provide to Medicare beneficiaries using measures that physicians select  from a menu of HHS-defined quality measures. HHS provides incentive  payments to physicians who satisfactorily report quality data to PQRS,  and has announced that physicians who do not satisfactorily meet PQRS  submission requirements in 2013 will have their Medicare payments  reduced by 1.5 percent for services provided in 2015. Under the new  CDR program, physicians who satisfactorily participate in a qualified CDR  would also receive the incentive payments and would avoid the penalties  without submitting data to PQRS.

HHS issued a final rule and preamble on December 10, 2013, that  included information on how the qualified CDR program will function. In  the preamble, HHS set out plans for implementing the ATRA  requirements and the definition of, requirements for, and process for  being designated a qualified CDR. The program is scheduled to take effect in January 2014. ATRA mandated that GAO report on the potential  of CDRs to improve the quality and efficiency of care in the Medicare  program and the role of health information technology (IT) in facilitating  CDRs. For this report, we examined  1.  Ways CDRs have demonstrated the capacity to improve the quality  and efficiency of physician care;  2.  HHS’s plans for requirements and oversight of qualified CDRs to  maximize CDRs’ potential impact on the quality and efficiency of care;  3.  Barriers, if any, to the development of qualified CDRs, and actions  HHS can take to minimize their potential impact; and  4.  The potential of health IT to enhance CDR operations and actions  HHS can take to facilitate CDR use of health IT.

To examine ways CDRs have demonstrated the capacity to improve the  quality and efficiency of physician care, we conducted internet searches  and reviewed literature to identify studies assessing the impact of CDRs  on quality and efficiency of physician care. We synthesized the results of  these studies in terms of the type, scope, and magnitude of changes in  quality and efficiency attributed to CDRs, and assessed the strength and  limitations of the evidence produced by those studies. We also  interviewed officials from seven organizations that operate existing CDRs,  including regional health care collaboratives, and officials from a major  health plan. These interviews generally included discussion of the type,  scope, and magnitude of any changes in quality and efficiency of  physician care that they have observed stemming from the activities of  CDRs. We selected CDRs that cover patient care across a range of  medical conditions, focusing on those that have operated for a number of  years and on organizations that have extensive experience using CDR  data.

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. In addition, we convened an expert meeting with the  assistance of the National Academies’ Institute of Medicine (IOM) to  discuss potential requirements for qualified CDRs, the advantages and  disadvantages of these requirements, and the oversight that HHS could  provide to qualified CDRs to promote the quality and efficiency of care.  We worked with staff at IOM to identify experts to participate in the  meeting. Generally, participants were chosen for their expertise in  operating or launching a CDR, as health plan officials or other users of  CDR data, as health IT professionals, or as clinical researchers.

Representatives from the Centers for Medicare & Medicaid Services  (CMS)—the HHS agency charged with implementing the program—and  HHS’s Office of the National Coordinator for Health Information  Technology (ONC) also attended the meeting. To ensure that participants  represented a broad range of views and interests and that we fully  understood those interests, we required that participants complete a  conflict of interest form. See appendix I for a list of experts who  participated in the meeting. We synthesized the experts’ comments at the  meeting together with other relevant sources, including related published  literature, to assess the potential impact of different program  requirements and approaches to providing oversight of those  requirements on the effectiveness of qualified CDRs in promoting quality  and efficiency of care.

To identify barriers, if any, to the development of qualified CDRs and  actions HHS can take to minimize their impact, we interviewed officials  and reviewed documents from CMS on its plans for implementing the  qualified CDR program. We also obtained input from participants during  the expert meeting on barriers to the development of qualified CDRs and  on what support HHS could provide to reduce these barriers. We  synthesized the experts’ comments at the meeting together with other  relevant sources, including related published literature, to assess the  potential impact of selected actions HHS could take on overcoming the  identified barriers to the development of qualified CDRs.

To examine the potential of health IT to enhance CDR operations and  actions HHS can take to facilitate CDR use of health IT, we reviewed  documents and interviewed officials from CMS and ONC on the agencies’  plans related to IT for the qualified CDR program. We also interviewed  officials to determine how CDRs interact with electronic health record  (EHR) systems used by many providers. In addition, we obtained input  from participants during the expert meeting on the potential of health IT to  facilitate CDR operations. In addition to receiving input from meeting  participants, we also interviewed health IT experts who have been  involved in applying health IT to the operations of existing CDRs.

We conducted this performance audit from March 2013 to December  2013 in accordance with generally accepted government auditing  standards. Those standards require that we plan and perform the audit to  obtain sufficient, appropriate evidence to provide a reasonable basis for  our findings and conclusions based on our audit objectives. We believe  that the evidence obtained provides a reasonable basis for our findings  and conclusions based on our audit objectives.

Over the past 25 years, a broad range of entities—encompassing the  federal Medicare and Medicaid programs, private health insurers, and  various provider organizations—have created different systems for  assessing physician performance, of which PQRS and CDRs are  examples. Early efforts largely focused on the quality of care (i.e., the  extent to which patients received care that was likely to improve their  health status). More recently, the focus of many of these systems has  expanded to include the efficiency of care (i.e., the extent to which high- quality care was provided without using more resources than necessary).  In concert with these performance assessment systems, some public and  private payers have begun to provide incentives to physicians based on  their performance to stimulate improvement over time.

These physician performance assessment systems have developed a  wide range of performance measures. Some are process measures,  which assess the extent to which physicians effectively implement clinical  practices (or treatments) that have been shown to result in high-quality or  efficient care. Others are outcome measures, which track the results of  physician care, such as mortality, infections, and how patients experience  that care. To assess performance on such measures, these systems  have collected information from administrative data sets, including billing  data, as well as from patient medical records and patient surveys.  Measures used to assess physician performance are composed of a  number of clinical data elements, or pieces of data, that must be collected  in order to determine performance. For example, the performance  measure endorsed by the National Quality Forum (NQF) for acute stroke  mortality rate comprises two data elements—the number of stroke  patients treated and the number of deaths among those patients.measures are more complex and require more data elements.

Many of these assessment systems evolved independently and therefore  are very different from one another. For example, there is great variability  among existing CDRs, which range from those developed by medical  specialty societies to those developed by regional health care  improvement collaboratives. One of the longest-standing CDRs focused  on physician care is the Society of Thoracic Surgeons’ (STS) Adult  Cardiac Surgery Database, which was established in 1989 in response to  HHS’s publication of mortality rates for individual thoracic surgery  programs. According to the STS, HHS’s published rates were misleading  because they had not been adjusted adequately for variations in the  complexity of patients treated by different programs. The most  complicated and highest-risk cases typically have the highest mortality  rates, independent of the quality of the surgeon’s performance. So the  STS developed nationally benchmarked performance data with  empirically tested risk adjustment models based on detailed clinical  variables. Since then, additional CDRs have been developed by medical  specialty societies, such as the American College of Cardiology (ACC)  and the American College of Surgeons, as well as by regional health care  improvement collaboratives, such as Minnesota Community  Measurement and the Wisconsin Collaborative for Healthcare Quality.

The profusion of these different systems has created difficulties for those  involved in using and maintaining them. For example, physicians, along  with other providers, have found it burdensome to provide data on  multiple performance measures to multiple public and private physician  performance assessment systems, which has led to efforts to align these  systems. For example, CMS has announced its intention to maximize the  extent to which physicians can satisfy its different performance  assessment programs by submitting one set of data. There have also  been efforts to develop a consensus among public and private groups  concerning top priority objectives for improvement. For example, in 2011  the Secretary of HHS issued a National Quality Strategy based on input  from major health care stakeholders, which established six broad priority  domains. However, efforts to bring various systems into greater alignment  based on specific national priorities are complicated by the diversity of  care that physicians provide. For example, primary care physicians treat  patients with conditions that fall under nearly 400 different diagnostic  categories, making it difficult to assess their performance appropriately  with a limited number of measures. Collectively, specialist physicians also  encompass a broad range of conditions and treatments. While some  dimensions of quality and efficiency may apply broadly across most  physicians, such as the extent to which they coordinate their care  effectively with a patient’s other care providers, other important aspects of  physician performance are distinct for different medical conditions.

Physicians are increasingly using EHRs to collect and report the data  needed for performance assessments, in part as a result of direct  governmental encouragement. HHS’s Medicare and Medicaid EHR  programs provide incentive payments to eligible participants as they  adopt, implement, or upgrade certified EHR technology and demonstrate  its meaningful use. To receive these incentives, eligible providers,  including physicians, must first adopt EHR technology that is certified  specifically for the EHR Incentive Programs. Certified EHR systems must  meet specific criteria, including having the ability to store data in a  structured format to facilitate retrieval and use of the data by other  systems, and having the capability to collect and report data on a large  number of clinical quality measures defined by HHS. Physicians must  then demonstrate that they are using their certified EHR systems in  meaningful ways that can positively affect the care of their patients,  including conducting quality assessments using some of the clinical  quality measures. The EHR incentive programs, which began in 2011, are  scheduled to be implemented in three stages. Stage 1 is focused  primarily on data capture and sharing. Stage 2 is scheduled to begin in  2014 and will focus on improving selected clinical processes. Stage 3 is  expected to begin in 2016 and to focus on improving quality, safety, and  efficiency outcomes.

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. This strength derives from the fact that CDRs  typically collect extensive, standardized clinical data on large numbers of  patients that provide more clinical detail than can be obtained from  administrative data. Those clinical data provide the basis for developing  sophisticated risk models, which enable CDRs to compare physician  performance with appropriate adjustments for variations in the severity  level and other attributes of the patients they treat. CDRs also collect  extensive, standardized data on treatments provided to large numbers of  patients over extended periods of time, which permits CDRs to explore in  depth how treatment variations affect patient outcomes. Moreover, CDRs  collect information about many different types of patients encountered by  physicians, including those with complex combinations of medical  conditions, who are often excluded from clinical research studies. This  enables CDRs to analyze trends for the full population of patients that  participating physicians actually treat, and examine variations across  many different subgroups of patients.

Studies examining outcomes reported by several long-established CDRs  demonstrate the utility of CDR data for analyzing trends in both outcomes  and treatments. For example, CDR data on treatment of acute myocardial  infarction over 15 years show major increases in guideline-recommended  treatment and a 39 percent reduction in overall mortality. Similarly,  results from the STS Adult Cardiac Surgery Registry show substantial  improvements in mortality and morbidity rates for coronary artery bypass  graft surgery—24.4 percent lower mortality and 26.4 percent lower  postoperative stroke over 10 years—that were linked to refinements in   Data from other CDRs have highlighted clinical  surgical techniques.areas where quality improvements have been more mixed, such as a  medical oncology CDR that showed marked improvements over 5 years  only on measures of whether providers had adopted new clinical  practices, while other measures of clinical quality remained relatively high  on some dimensions and low on others. Another study presented  comparable results for a state-based CDR assessing primary care. It  found major improvements over 6 years on some measures, such as  kidney function monitoring for diabetic patients, but considerably less  improvement on others, such as lipid testing and control for patients with  coronary artery disease.

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. Officials of the CDRs from which these  results were reported described to us a range of educational materials  and related activities that they have developed targeted to physicians who  do relatively poorly on specific measures. They generally view these  additional education activities as essential to achieving improved  performance. Using a within-registry, national-level randomized controlled  trial, one study of the STS registry demonstrated a positive impact from  providing surgeons with educational materials targeted to key process  measures related to cardiac surgery. Another study used CDR  performance data to assess the effectiveness of a health plan’s  interventions to promote changes in practice. Specifically, it found that  physician groups participating in the health plan’s regional collaboratives  had lower risk-adjusted mortality and better composite quality scores over  time than physician groups in other states who participate in these  CDRs.

Compared with their efforts related to quality, CDRs have typically  provided less insight on ways to improve the efficiency of care. For  example, none of the studies of CDR results that we examined addressed  changes in the cost of care directly. However, studies of CDRs focusing  on surgical care reported improvements on several measures related  directly or indirectly to the use of resources, such as rates of  complication. The potential to draw inferences about costs from rates of  complications was demonstrated by researchers affiliated with Michigan  Blue Cross and Blue Shield. They used CDR data to estimate that their  regional surgical collaborative had led to 2,500 fewer patients with  surgical complications per year, which—when considered with the  average cost of those complications—translated to annual savings of  about $20 million.

One reason why CDRs have not typically assessed the cost of care is  that their data have usually been limited to information available from  patient medical records recorded during the course of treatment, including  patient risk factors, process measures concerning the treatments  provided, and short-term outcomes such as inpatient mortality and  morbidity. These data do not typically include information on costs as well  as other information relevant to assessing longer term outcomes and  changes in patient functioning (e.g., patient-reported outcomes). To  obtain this information, CDRs need to turn to other data sources, as some  have started to do. For example, the STS has begun, for specific  research projects, to obtain Medicare claims data and merge those data  with its own CDR data to examine costs and long-term outcomes.

The results reported to date from existing CDRs are also limited in terms  of their scope and capacity to determine the independent impact of CDRs  on physician performance. Most of the studies examining the outcomes of  CDRs that we found come from a relatively small number of CDRs run by  certain medical specialty societies—including the STS for cardiac  surgery, the American College of Surgeons for general and vascular  surgery, and the American Society for Clinical Oncology for medical  oncology—plus one ambulatory care CDR run by a regional health care  improvement collaborative, the Wisconsin Collaborative for Healthcare  Quality. Most of these are CDRs that have been in operation for close to  a decade or more, and therefore have substantial longitudinal data from  which to analyze trends over time. Even within the given specialty or  region targeted by the CDR, the scope of care addressed by the studies  we examined were typically limited. For example, the study of cardiac  surgery focused on one procedure—coronary artery bypass graft  surgery—while the study of ambulatory care in Wisconsin examined  diabetes, coronary artery disease, and hypertension management plus  three cancer screenings and a vaccine.

Moreover, CDRs by design collect observational data with no  predetermined designation of treatment and control groups, as would be  done in a randomized controlled trial. Therefore, it is difficult to use CDR  data to assess the independent effect of the CDR on physician  performance, relative to other factors. A few studies have compared CDR  results to control groups and found that the CDRs had at least a modest  impact on outcomes relative to the controls. However, these analyses  were limited to measures where the same data were available from other  sources for both CDR patients and control groups, which means that the  data used in those analyses did not have the clinical detail (or validation)  of the CDR-collected data. Moreover, patients in the control groups also  differed to some extent from patients in the CDRs in ways that may affect  the results reported.

HHS’s Plans for Requirements and Oversight for Qualified CDRs Need to Focus on Quality and Efficiency

HHS’s plans for CMS’s implementation of the qualified CDR program  include little specificity on how CDRs will improve quality and efficiency.  Setting key requirements, with greater specificity, for CDRs to become  qualified could help promote improved quality and efficiency of care. 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. CMS’s  plans include certain minimal attributes for entities to be considered, such  as having been in existence with at least 50 participants for no less than  one year. In addition, CMS’s plans include a number of largely procedural  performance requirements that qualified CDRs would have to satisfy.  Among the most important are

Data collection: A qualified CDR must collect and report to CMS data  for at least nine quality measures, at least one of which must be an  outcome measure. Collectively, these measures must cover at least   The  three of the six domains of HHS’s National Quality Strategy.measures should include patient data from multiple payers and be  risk-adjusted, where appropriate.

Data validation: A qualified CDR must attest to CMS that all the data it  submitted were accurate and complete, submit a data validation  strategy for verifying the accuracy and completeness of data it  collected, perform the steps described in its validation strategy and  provide CMS with evidence of successful results, and make available  to CMS samples of patient data that CMS could use for its own audits  of data validity.

Data security: A qualified CDR must have a plan to maintain data  security and privacy, have appropriate business associate  agreements with participating physicians to satisfy federal patient  privacy requirements, and use specified methods to transmit quality  data to CMS in one of two specified data formats.

Transparency: A qualified CDR must make publicly available  information about its measures, including their supporting evidence or  rationale, data elements, and criteria for including and excluding  patients.

Improvement activities: A qualified CDR must provide feedback  reports to participating physicians on their performance at least four  times a year, with benchmarks derived from the CDR’s own database  or external sources.

As a whole, CMS’s plans provide substantial leeway in key areas  regarding what could constitute satisfactory CDR performance. For  example, CMS’s plans grant CDRs wide latitude in selecting which  measures they will collect, as long as they cover three of six National  Quality Strategy domains and at least one is an outcome measure.

Similarly, CMS’s plans state that CDR feedback to participating  physicians should include benchmark information, but CDRs will have  discretion to determine the appropriate benchmark, either derived from  the CDR’s own data or drawn from an external source.

The extensive leeway in CMS’s plans would allow diverse registries to  become qualified. Because registries are typically designed to focus on a  particular set of patients, defined by medical condition, type of treatment  received, or geographical location, they will inevitably vary substantially in  their opportunities to promote quality and efficiency of care. Therefore,  the broad parameters in CMS’s plans are compatible with a wide range of  CDRs potentially addressing diverse types of physician care. However,  the flexible approach for qualifying CDRs may at the same time provide  minimal impetus to CDRs to take full advantage of their specific  opportunities to promote the quality and efficiency of care. For example,  CMS’s plans do not include a process or criteria for assessing the extent  to which the measures selected by a CDR in fact address the key  opportunities that could result in improved care for its particular target  population.

In addition, CMS has not provided any details on how it plans to interpret  or enforce program requirements for CDRs. For example, CMS has not  described what CDRs would need to do to make their data validation  strategies acceptable to CMS. Nor has it described the minimal  thresholds of accuracy and completeness that CDRs would need to  attain, which could help CMS to audit CDR data as necessary in the  future. CMS has also not described how it intends to provide oversight to  ensure that CDRs comply with the requirements, beyond having CDRs  submit a self-nomination statement, initially on an annual basis.

Greater specificity in both the requirements for CDRs and the  mechanisms for enforcing them is likely to develop with time. CMS has  not yet implemented the qualified CDR program, but in the preamble that  accompanied its final rule, CMS stated that, as it gains programmatic  experience, it anticipates making changes in future rulemaking to the  requirements for becoming a qualified CDR. However, CMS has not yet  articulated the direction or ultimate goals that it seeks to accomplish  through this evolution, except that, to the extent possible, it will seek to  align the requirements for CDRs more closely over time with  requirements for other federal quality programs.

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.  Such requirements could affect quality and efficiency both by determining  which entities are designated as qualified CDRs and by encouraging  certain activities by CDRs after they are designated as qualified. We  identified the following key requirements and assessed the extent to  which they are addressed by CMS’s plans for implementing the qualified  CDR program:  1.  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. Input from experts and other  relevant sources indicates that appropriate performance measures  would encompass broadly defined measures of patient outcomes,  such as patient experience and function, and consider the  appropriateness of the chosen treatment, compared to available  alternatives.

Rationale: For any given patient population, defined by medical  condition, treatments received, geographic location, or other  attribute, there are a wide range of existing or potential  performance measures on which a CDR could focus. If those  measures are not well selected, they may divert the attention of  participating physicians to clinical issues that are overly narrow or  fail to uncover actual differences in quality and efficiency. Every  CDR faces the choice of where it should focus its data collection  and analytical resources, though the specific clinical issues that  offer the greatest opportunity for improved quality and efficiency  will vary from one CDR to another, depending on their target  populations and the depth of the evidence base currently  established for its field of clinical practice. CDRs need to make  strategic choices that make the most of existing knowledge and  strategies for improving quality and efficiency while also helping to  incrementally expand that evidence base over time.

Comparison to CMS plans: CMS plans to leave measure selection  to the discretion of each CDR, within the broad parameters of  covering three National Quality Strategy domains and including at  least one outcome measure. CMS has not described expectations  regarding how well targeted those measures are relative to the  specific quality or efficiency deficiencies of that CDR’s target  population. Nor has CMS required that CDRs collect information  on patient experience and functional outcomes or address the  appropriateness of treatments provided.  2.  Core set of measures: Input from experts and other relevant sources  indicates that having qualified CDRs collect data for a minimum set of  core performance measures with standardized definitions and  specifications as part of their overall data collection effort would  enable CDRs to address broad, shared objectives regarding both  quality and efficiency.

Rationale: While CDRs are free to collect a wide range of  measures reflecting quality and efficiency opportunities in their  particular target populations, there are certain measures that  apply across the patient populations covered by different CDRs.  Some of these relate to national-level quality improvement  objectives such as improving care coordination. In order for CDRs  to contribute to these broader national priorities, CDRs could  collect the relevant data for their patients in a standardized fashion  that permits sharing and aggregating of the data across CDRs and  other sources of quality data. A core measure set would align  CDRs with key national level priorities on quality and efficiency,  while still allowing for innovation and permitting CDRs to collect  other data that address regional or specialty-specific concerns.

Comparison to CMS plans: CMS has not established common  measures across qualified CDRs. To the extent that registries  report on different measures within the six National Quality  Strategy domains, they would not produce results that could be  aggregated to assess progress overall. In addition, results could  not be compared across different CDRs, which may be useful, for  example, to examine cardiac patients receiving medical or surgical  treatments.  3.  Data accuracy and completeness: Input from experts and other  relevant sources indicates that the credibility of CDR results relies on  having CDRs implement a systematic and rigorous process for  ensuring the accuracy and completeness of the data they collect and  analyze.

Rationale: Assessing physician performance with inaccurate or  incomplete data is likely to produce misleading and invalid results.  Therefore several existing CDRs have instituted regular external  audits of the data submitted to their databases. However, the  appropriate form of systemic and rigorous checking of the data  may vary depending on the CDR’s focus and method of data  collection. For example, one long-standing CDR has annual  external audits conducted of the data it collects, auditing 8 percent  of participating physicians in 2013, to ensure that reported data  are accurate compared to the original records from which the data  were collected. Auditors also check hospital logs to make sure  that data on all eligible cases were submitted. By contrast, an  official for a different CDR that relies on electronic data extraction  from EHRs described the use of statistical methods to identify  outliers in the data that may indicate a data collection error.

Comparison to CMS plans: CMS’s plans state that CDRs must  submit a data validation strategy that is acceptable to CMS, but  CMS has not described either the approach or the intensity of the  CDR efforts expected. CMS has also not detailed how it would  evaluate the strategies for acceptability, or how it might evaluate  CDR data for validity. Because data validation tends to be a labor- intensive and expensive activity for CDRs, the absence of specific  validation requirements once the program is implemented may  cause some CDRs to curtail their validation efforts.  4.  Participation levels: Input from experts and other relevant sources  indicates that CDRs need to achieve a substantial level of  participation to ensure that their results represent the physicians that  make up their target population, but for newly established CDRs it  often takes time to achieve this level of participation.

Rationale: Registries that recruit a relatively low proportion of  physicians within their target population may not have the data  needed to support accurate risk adjustments and benchmarking.  However, historically it has taken time for registries to become  well established. Rather than setting a minimum proportion, a  requirement to disclose the level of participation in a CDR may  partially compensate for low levels of participation by alerting  potential users of the data to take those limitations into account.

Comparison to CMS plans: CMS has not addressed the issue of  how well a CDR represents physicians treating its targeted patient  population. The planned required minimum of 50 participants may  constitute only a very small fraction of those physicians. However,  CDRs may use benchmarks developed with data from external  organizations, such as the National Committee for Quality  Assurance, which could help registries with low participation to  achieve more accurate benchmarking.  5.  Performance improvement: Input from experts and other relevant  sources indicates that CDRs improve quality and efficiency by  supplementing timely feedback on physician performance with  information that targets needed practice changes.

Rationale: The potential for CDRs to promote quality and  efficiency improvements depends in large part on their ability to  provide physicians with “actionable information” that identifies not  only where performance is deficient but also specific changes in  behavior that a physician could take to improve their outcomes.  For example, one CDR official told us that in addition to  performance feedback and benchmarking, the CDR teaches,  provides leadership, and supports hospitals and providers in  quality improvement and change management. Another CDR  official explained that they use CDR data to determine where  additional tools are needed for physician development. The CDR  provides virtual education programs and develops improvement  tools for providers. The CDR officials we spoke with generally  agreed that it is vital for CDRs to use data to inform quality  improvement initiatives, rather than simply collecting the data.

Comparison to CMS plans: CMS’s plans would require that  qualified CDRs provide participating physicians at least four  feedback reports per year with benchmarks of some kind, but they  do not require qualified CDRs to undertake any quality initiatives  beyond feedback reports.  6.  Public reporting: Input from experts and other relevant sources  indicates that having CDRs provide some form of public reporting can  promote greater quality and efficiency. However, to avoid unintended  adverse effects the public reporting may be limited to selected  measures that are particularly useful to patients and/or be phased in  over time.

Rationale: Public reporting can often help to motivate quality and  efficiency improvement, but under some circumstances may also  diminish physicians’ receptivity to negative information and their  willingness to participate in CDRs. For example, a CDR may  encourage competing providers to collaboratively examine their  performance data to identify patterns and sources of suboptimal  care. Some of these providers may not be willing to participate in  such quality improvement efforts if doing so involves publicly  reporting data that could put them at a competitive disadvantage.  In this way, differences across CDRs in the kind of data they  collect and how they use them may affect the results available to  be shared with the public and the possible ramifications of doing  so.

Comparison to CMS plans: CMS initially proposed that qualified  CDRs have a plan to publicly report results for individual  physicians, with benchmarks. In response to public comments that  raised concerns about the cost and time associated with public  reporting, CMS did not adopt this requirement. Instead, the  preamble to the final rule states that CMS encourages qualified  CDRs to move toward public reporting, and that it will revisit this  proposed requirement in the future.  7.  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.

Rationale: Both the financial incentives that CDRs will extend to  participating physicians and the flexibility allowed in how they  choose to operate are intended to promote improved quality and  efficiency of care. Therefore, successful CDRs will begin to realize  their potential to improve care by demonstrating results on key  improvement opportunities for the CDR’s target population.  Because those opportunities vary across CDRs, the magnitude of  improvement that can be expected of different CDRs will also  vary. At a minimum, each CDR has the ability to identify its key  targets for improvement and begin to make incremental progress  toward them.

Comparison to CMS plans: CMS has not described any  expectations regarding the results of qualified CDR activities.

Effective Oversight of CDRs Depends on Expert Judgment to Account for Variation among Them

To effectively implement requirements for qualified CDRs that focus on  improving quality and efficiency, expert judgment is needed to interpret  those requirements in accordance with the CDRs’ differing circumstances  and opportunities for improvement. In particular, according to experts and  other relevant sources, assessing both potential and actual effects of  individual CDRs on quality and efficiency of care requires an  understanding of what those particular CDRs could do to change  physician practice and achieve improved performance. This will depend  on the state of clinical research and other factors that affect what is  currently known about opportunities to improve quality and efficiency in  each CDR’s area of medical practice. For example, expert judgment is  needed to determine whether the particular set of measures adopted by a  CDR effectively addresses the key quality and efficiency opportunities for  improvement for the target population of that CDR. In addition, expert  judgment could help to determine what adjustments to make in  performance expectations for CDRs that have only recently been  established, which compared to CDRs that have been in operation over a  longer period and have achieved a higher level of physician participation,  may need time to build their capacity to promote improvements in quality  and efficiency.

Experts and other sources we consulted suggest a range of potential  sources that CMS could draw on to provide this expert judgment for  assessing qualified CDRs. They include relying on staff within CMS,  contracting with outside experts, and delegating certain aspects of  oversight to independent organizations. For example, one variation of the  latter option might be to set up a deeming process to select one or more  outside entities that meet CMS-determined criteria for carrying out all or  part of this oversight function. Each of those options has strengths and  limitations in terms of, for example, its resource requirements, adaptability  to varying situations, and responsiveness to agency priorities (such as  promoting alignment with other quality programs). CMS could consider  these different strengths and limitations in building an organizational  structure for monitoring qualified CDRs that draws on expertise from one  or more of these sources.

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. Reducing  these barriers would make it easier for qualified CDRs to get started and  expand the scope of their activities and thereby improve the quality and  efficiency of physician care provided to Medicare beneficiaries, according  to the input from experts and other relevant sources.

Concerns about Complying with Privacy Regulations: Some CDR officials  report that the recruitment of new participants is made more difficult by  widespread concerns among physicians that submission of data to a CDR  risks violation of the Health Insurance Portability and Accountability Act   Under the Privacy Rule, protected health  (HIPAA) Privacy Rule.information may be used or disclosed only for specified permitted  purposes. Because CDR data are often used for the purposes of both  quality improvement activities and clinical research, it may often not be  clear whether, or which, permitted use or disclosure applies. This lack of  clarity can make it more difficult for CDRs to collect and analyze clinical  data for either purpose. CDR officials stated that a particular concern of  potential CDR participants is the perceived need for individual patient  authorization or approval by an Institutional Review Board (IRB) to ensure  compliance with HIPAA requirements. CMS has indicated that CDRs  must enter into an appropriate business associate agreement with  participating physicians that provides for receipt of patient data and public  disclosure of quality measure results.physician concerns regarding the perceived need to meet HIPAA Privacy  Rule requirements for research uses and disclosures.

However, it has not addressed  The HHS Office for Civil Rights monitors compliance with HIPAA  requirements and issues various types of guidance to explain how those  requirements apply under different circumstances. Input from experts and  other relevant sources suggests that physicians and CDRs could benefit  from guidance that provides a detailed explanation of what CDRs need to  include in their business associate agreements with participating  physicians and what activities would trigger the need for individual patient  authorization or IRB approval of their data collection and analysis  activities.  attempts to implement a unique personal identifier as part of patients’  records to enable matching were abandoned due to concerns about its  potential impact on patient privacy. Alternative methods exist for matching  patient data without using a unique patient identifier, including algorithms  that make probabilistic matches based on several discrete data elements.  However, these approaches often fall short of matching data from multiple  sources for all patients, due in part to variations in the algorithms  themselves and the data elements they use for performing these  matches.

Input from experts and other relevant sources suggests that HHS could  work on developing a standardized process for matching and linking  patient data that does not require the use of a unique patient identifier,  including a uniform algorithm and associated data specifications. HHS  could then work with other health care entities to adopt this standardized  approach across the spectrum of relevant data sources to better address  the need of CDRs to link data from other sources in order to perform a  more complete assessment of physician performance.

Lack of Patient Cost Data: Because CDRs derive most of their data from  patient medical records, they typically lack information about the cost of  patient care needed to address questions about the efficiency of care.  The most fundamental problem with obtaining cost data is that cost data  are fragmented among the various public and private payers for health  care, including private health insurers as well as Medicare and Medicaid.  Even when CDRs limit their focus to the Medicare population, they have  had to negotiate with CMS for access to Medicare claims data for each  particular research project.

To facilitate and encourage CDR analysis of the efficiency of physician  care, input from experts and other relevant sources suggests that CMS  could make its cost data for Medicare and Medicaid patients generally  available to qualified CDRs. In addition, although HHS has less direct  control over the cost data collected by private health insurers, some  health insurers have begun to work with states, HHS, and others to  assemble “all-payer” claims databases that combine public and private  health care spending data. HHS could examine the potential for making  these “all-payer” claims databases available to qualified CDRs.

Difficulty of Funding CDRs: CDRs frequently have difficulty finding a  sustainable flow of funding from the participating physicians to maintain  the resource-intensive activities necessary for their work, including  collecting and validating detailed clinical data, which requires highly  trained staff. Under the new program, participation in a qualified CDR will  entitle physicians to receive benefits of the same incentive payments and  exemption from penalties provided to PQRS participants, which could  help to encourage physicians to participate in CDRs and to fund their  operations. However, experts report that participation in PQRS remains a  cheaper and easier way to obtain those benefits. HHS is looking into  expanding incentives for physician participation in CDRs by coordinating  with additional federal programs, such as the EHR incentive program, as  well as possible coordination with related nongovernmental activities,  such as maintenance of certification requirements established by various  boards of medical specialties.

An alternative approach for providing additional funding to qualified CDRs  raised at our expert meeting would be to share with them some of the  financial benefits that the CDRs may generate for the Medicare program.  Doing so could benefit CDRs that are successful in producing these  benefits while promoting program savings for Medicare. For example,  HHS could consider testing models of “shared savings” programs— possibly through CMS’s Center for Medicare and Medicaid Innovation— that would provide CDRs or their participating providers with a portion of  any cost savings for the Medicare program that resulted from their  activities. To do this, CMS would have to develop a credible methodology  for determining the extent of savings that a qualified CDR’s activities had  produced for Medicare.

Need for Technical Assistance: The first CDRs established by medical  specialty societies reported taking many years to work out how best to  accomplish the complex technical tasks needed to get a new CDR up and  running. These include procedures for deciding what measures to collect,  appropriate and feasible data collection and submission processes,  implementation of risk adjustment, provisions for maintaining data  security and protecting patient privacy, and effective data validation  procedures. Several CDRs that have followed have turned to those first  CDRs for informal guidance, to learn from their experience. Input from  experts suggests that HHS could consider creating or facilitating the  development of a CDR resource center that would offer qualified CDRs,  or CDRs seeking to become qualified, technical assistance in the initial  phases of setting up a CDR. Such a CDR resource center could draw on  expertise from existing CDRs or other relevant sources and could help  new registries launch successfully and more quickly achieve an adequate  level of physician participation.

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.

CDRs Can Benefit from Using Health IT to Electronically Collect and Transmit Data, but Face Limits in Implementation

Health IT applications, including EHRs, could offer CDRs substantial  support in collecting and transmitting large amounts of detailed clinical  data from participating physicians’ medical records. CDR officials report  that, without such IT support, data collection is a time-consuming process  where data must be manually abstracted from medical records by  specially trained staff and formatted for transmission to the CDR, a  process that includes training staff to synthesize information from patient  charts and other records. These trained data abstractors must often make  judgments on how to interpret certain information in the record to meet  the CDR’s data specifications and definitions. For example, the word  “pneumonia” may not appear in the medical record for all patients with the  condition. Therefore, an abstractor may need to interpret the record’s  data on patient encounters, chest x-ray results, or stethoscope breath  sounds to determine whether a patient had pneumonia as defined by the  CDR. In addition, most data collection is performed days or weeks after  care is provided, rather than at the time of the care, which can  substantially delay feedback to physicians.

Input from experts and other relevant sources suggest that EHR systems,  if appropriately designed and implemented, have the potential to greatly  increase the efficiency of extracting data from patient records and  transmitting these data to CDRs. The use of EHR systems across the  country is growing; the proportion of office-based physicians using any  type of EHR system increased from 51 percent in 2010 to 72 percent in  2012. If CDRs could receive and aggregate electronically extracted data  from EHR systems, the need for manual abstraction by trained  professional staff could be reduced or eliminated. Reducing the burden of  manual data abstraction could have a number of long-term benefits,  including reducing costs for physicians to participate in the CDR, reducing  the amount of time a practice spends on CDR data collection activities,  and increasing overall participation of physicians in CDRs. Health IT  experts also note that automated data collection from EHR systems  makes it possible for CDRs to provide physicians with more timely  feedback on care they have recently provided, compared to manual data  collection. In addition, EHR systems as well as other health IT  applications have the potential to facilitate information sharing among  CDRs and other potential users of health care quality and efficiency data,  allowing for comparison across CDRs and providing a more  comprehensive and long-term view of the outcomes of patient care.

Some CDRs have adopted IT approaches that allow them to  automatically extract at least some information from their participating  members’ EHR systems into the CDR’s database. However, these  approaches have some important limitations. For example, experts  reported that some CDRs use a method called Retrieve Form for Data  Capture (RFD), which informs the physician through a trigger in their EHR  system when a patient may be eligible for inclusion in the CDR database.  The RFD uses data from the EHR system to automatically prepopulate  the CDR’s web-based data collection form. However, the RFD then  requires that the physician interrupt work to enter the remaining  information that was not automatically captured from the EHR. The RFD  also works only with EHR systems from a few different vendors. Another  example was described by an official from the ACC’s Pinnacle registry,  which has implemented a more comprehensive system for electronically  capturing data from a wider variety of EHR systems. Within each  physician practice, system integration software is installed on the same  server that hosts the EHR system. The software is designed, developed,  and implemented to automatically extract data directly from the  physician’s EHR system for transmission to the CDR database. After a  period of testing and adjustment to adapt the software to the EHR  system’s specific data structure, it can automatically capture 75 to   90 percent of the desired information. The ACC has determined that this  electronic data collection results in higher levels of physician participation,  and therefore is worth the tradeoff of doing without the portion of data that  cannot be captured electronically. However, according to an ACC official,  the system does not work with EHR systems produced by certain  vendors, has been costly to implement, and may not be feasible for CDRs  in other fields of medicine, where there is less consistent use of clinical  terminology than in cardiology.

Variation among EHRs Affects CDR Ability to Use Health IT and Could Be Addressed through Health IT Standards and HHS Adjustments to the EHR Incentive Programs

Experts and other relevant sources indicate that variation in EHR systems  on several key dimensions impairs CDRs’ ability to collect electronic data  from participating physicians.

EHRs can differ in which data elements they collect.systems collect more information on some topics than others,  because physicians in different specialties have different needs and  interests.

EHR systems can differ in how they store data. In order to  automatically extract data from the EHR, CDRs must develop  methods for converting the data in each EHR to a format that the  CDR’s IT system can accept and accurately interpret. For example,  an ACC official told us that one reason why their system has been  costly to implement and does not work with EHR systems from certain  vendors is because of differences in how data are stored in different  EHR systems.

Finally, even if EHR systems collect the same basic content and use  compatible storage methods, their data elements may be specified or  defined differently. For example, an EHR may identify a smoker based  on whether a person smoked any number of cigarettes in the last  year, while another may count as a smoker anyone who has smoked  at least 100 cigarettes in the past and still currently smokes. While  both of these definitions may serve various purposes, the information  collected from each EHR on smoking would not be fully comparable.

These variations in EHR data content, storage, and specifications can  impact a CDR’s ability to extract data electronically from physician EHR  systems. In order to assess physician performance, CDRs have to collect  all the data elements needed for their performance measures and ensure  that those data elements are consistent with the CDR’s data  specifications. Consequently, CDRs cannot take full advantage of EHR  systems to facilitate data collection and transmission unless they can  overcome these variations in content, storage, and specifications across  existing EHR systems.

One way to reduce variation across health IT applications, including EHR  systems, and thereby facilitate collection and transmission of clinical data,  is to develop and implement relevant health IT standards. 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. Where such standards are in place, they are  available for vendors to use in designing and implementing EHR systems.  As a result, different vendors would be more likely to develop EHR  systems with consistent clinical data, in terms of their content and  specification. Such consistency could make it easier for CDRs to collect  these data from different EHR systems, as long as the standards aligned  with the CDR’s own data specifications and needs.

However, standards may not always align with CDR needs. For example,  one CDR official reported that the existing health IT standard for cancer  staging does not provide the level of detail needed by the oncology CDR,  Quality Oncology Practice Initiative, to assess physician compliance with  treatment guidelines targeted by the CDR. Several independent  organizations play a role in setting the health IT standards that apply to  physician EHR systems. They include international standards setting  groups, each of which creates detailed coding systems, such as  SNOMED CT and LOINC, designed to provide a standard way to  electronically record one or more categories of clinical information.  According to agency officials, while HHS interacts with these groups and  may be able to influence the development of new or revised health IT  standards, the process for doing so can be long, taking as long as   2 years. Therefore, at any given time, the extent of existing health IT  standards largely constrains what developers of EHR systems can do to  implement standardized data elements.

A second major factor that experts report affects the design and  implementation of EHR systems used by physicians is the meaningful use  requirements established by HHS for its EHR incentive programs. HHS  establishes two sets of requirements for the EHR incentive programs that  potentially affect CDRs: (1) a list of specific clinical quality measures  (CQM) that physicians are required to collect using EHR-collected data  elements, and (2) certification criteria that specify certain capabilities that  EHR systems are required to demonstrate, including the ability to collect  the data needed for physicians to report the specified CQMs. To receive  an incentive payment, physicians must demonstrate, among other things,  that they have used a certified EHR system to collect data for a minimum  number of the specified CQMs.

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. According to IT experts at our expert meeting, EHR vendors  place a high priority on developing EHR systems that are able to collect  CQMs prescribed by meaningful use requirements, without which the  systems would not qualify for EHR incentive payments. The current set of  64 CQMs focuses predominantly on primary care and generally does not  include measures relevant to CDRs, many of which focus on assessing  specialty care. HHS has stated its intention to consider revisions to the  meaningful use requirements under Stage 3 of the EHR incentive  program implementation, scheduled to take effect in 2016. These  revisions would give qualified CDRs greater flexibility in meeting the EHR  programs’ quality reporting requirements. By also including the data  needed by CDRs in its revised meaningful use requirements, HHS could  increase the motivation for vendors to include the capacity to collect data  elements for measures relevant to CDRs in their EHR systems.

Qualified CDRs have the potential to improve the quality and efficiency of  care for Medicare beneficiaries by encouraging physicians to submit  extensive, standardized data to CDRs, enabling the CDRs to provide  feedback to physicians on their performance relative to that of their peers.  Studies show that CDRs have great potential to improve quality, and to a  lesser extent efficiency, but often that potential is not realized. 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. The  extent to which HHS’s new program can help CDRs realize their potential  to improve quality and efficiency will depend in large part on the content  and oversight of the requirements that HHS sets for qualified CDRs and  the support that HHS provides.

To date, HHS plans have focused on largely procedural requirements for  CDRs that collectively would do little to base qualification of CDRs on  their potential to affect quality and efficiency or hold them accountable for  achieving improvements in those domains. Our analysis identified certain  key requirements that HHS could adopt that would make it substantially  more likely that qualified CDRs actually would improve quality and  efficiency. Some of these key requirements are more important than  others to have in place as the program is implemented. From the  beginning, the effectiveness of CDRs will depend on their selecting  measures that focus the CDRs’ assessment and performance  improvement activities on the specific opportunities for improvement that  exist for their particular target populations. At the same time, CDRs can  also collect a limited core data set that contributes to achieving national  quality and efficiency objectives. The credibility of those data depends on  CDRs establishing from the start systematic and rigorous processes to  validate their accuracy and completeness. HHS can most clearly ensure  that each qualified CDR focus on improvements in quality and efficiency  by requiring that each CDR demonstrate improvements in key measures  of quality and efficiency for its target population. Effective monitoring of  these requirements will depend on applying expert judgment that can take  account of the variation across CDRs in their target opportunities for  improvement.

HHS can also enhance the effect of qualified CDRs on quality and  efficiency by taking steps to reduce barriers to their development and, in  particular, taking account of CDRs in its ongoing efforts to promote health  IT. Certain steps would be particularly useful as the program gets under  way, including clarifying the application of HIPAA privacy requirements to  physicians participating in qualified CDRs, addressing the lack of access  to multipayer cost data, expanding potential sources of funding to support  sustained CDR operations, and providing technical assistance to newly  established CDRs. Meanwhile, efforts by some CDRs to adapt health IT  to make their data collection less costly and more timely have run into  significant barriers related both to gaps in existing health IT standards  and to the failure of many current EHRs to apply existing standards to  collect data needed by CDRs in a structured format. Changes to EHR  capabilities that would enable them to collect such data within existing  standards are clearly feasible, but are not high priorities for providers and  IT vendors because they are not included in the current set of meaningful  use requirements for the EHR incentive program. As HHS determines  what the next cycle of meaningful use requirements should comprise,  identifying data elements for measures commonly needed by CDRs and  including them in meaningful use requirements could substantially assist  qualified CDRs in adapting health IT to make data collection less costly  and more timely.

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. 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.

Direct CMS to establish a requirement for qualified CDRs to  demonstrate improvement on key measures of quality and efficiency  for their target populations.

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.

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.

Determine key data elements needed by qualified CDRs—such as  those relevant for a required core set of measures—and direct ONC  and CMS to include these data elements, if feasible, in the  requirements for certification of EHRs under the EHR incentive  programs.

We provided a draft of this report to HHS for review, and HHS provided  written comments, which are reprinted in appendix II. In its comments,  HHS concurred with our recommendations and stated its intention to  apply the experience it gains in implementing the qualified CDR program  to facilitate changes that lead to improved quality and efficiency. For  example, HHS stated that it saw value in providing greater specificity in  the expectations it sets for qualified CDRs, in particular with respect to  having them demonstrate improvement in quality and efficiency, once  HHS has sufficient experience with the program to establish a baseline  against which to assess their performance. HHS also stated its intention  to establish a process to monitor the qualified CDR program that would  draw on relevant and appropriate expert judgment and to do what it could  to reduce barriers to the development of qualified CDRs. In addition, HHS  agreed to have CMS and ONC work together to consider the inclusion of  key data elements for qualified CDRs as they develop enhanced health IT  criteria for the next stage of the EHR incentive programs. Meanwhile,  HHS noted several other efforts that it currently has under way to improve  health IT systems in general, which can also provide assistance to  qualified CDRs attempting to use health IT to facilitate their operations.  While HHS concurred with each of our recommendations, its comments  also noted some challenges that it expects to face. For example, HHS  stated that it will examine the possibility of establishing a core measure  set for qualified CDRs, but it observed that doing so could prove difficult  given the number of different clinical specialties on which qualified CDRs  may focus. As noted in the draft report, a minimum set of core  measures—even if small—could help CDRs to promote national-level  quality improvement objectives such as improving care coordination by  permitting the sharing and aggregating of the data across CDRs and  other sources of quality data. HHS also provided us with technical  comments, which we incorporated as appropriate.

We are sending copies of this report to the Secretary of Health and  Human Services, the Administrator of the Centers for Medicare &  Medicaid Services, the National Coordinator for Health Information  Technology, and other interested parties. In addition, the report is  available at no charge on the GAO website at http://www.gao.gov.

If you or your staffs have any questions about this report, please contact  me at (202) 512-7114 or at kohnl@gao.gov. Contact points for our Offices  of Congressional Relations and Public Affairs may be found on the last  page of this report. GAO staff who made key contributions to this report  are listed in appendix III.

Appendix I: List of Participants at GAO’s Expert Meeting Hosted by the Institute of Medicine, June 10–11, 2013

Pacific Business Group on Health  Network for Regional Health  Improvement  National Committee for Quality  Assurance  Siemens Medical Solutions, Inc.

Appendix II: Comments from the Department of Health and Human Services

Appendix III: GAO Contact and Staff Acknowledgments

In addition to the contact named above, Will Simerl, Assistant Director;  Emily Binek; Monica Perez-Nelson; Eric Peterson; and Roseanne Price  made key contributions to this report.

Question: Why are CDRs effective for assessing physician performance?

Answer: 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.

Question: What have studies examining long-established CDRs revealed about their utility?

Answer: Studies examining results reported by several long-established CDRs demonstrate the utility of CDR data sets for analyzing trends in both outcomes and treatments.

Question: What have studies reviewed by the GAO revealed about improving the efficiency of healthcare?

Answer: Studies GAO reviewed provided less insight on ways to improve the efficiency of care.

Question: What do CDR efforts to improve outcomes typically involve?

Answer: 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.

Clinical Data Registries Have Enabled Sophisticated Assessments of Quality of Care, but Have Less to Report on Efficiency and Have Other Limitations

Question: How specific are the HHS plans for implementing the qualified CDR program?

Answer: 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.

Question: Why have HHS defined their plans this way?

Answer: 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.

Question: What did GAO synthesize in order to facilitate the improvement of the CDR program?

Answer: 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.

Question: What requirements did the GAO identify for qualified CDR's to promote quality and efficiency?

Answer: 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.

Question: What will effective oversight of these requirements depend on and why?

Answer: 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.

HHS’s Plans for Requirements and Oversight for Qualified CDRs Need to Focus on Quality and Efficiency

CMS’s Plans for Implementing the Qualified CDR Program Include Little Specificity on How CDRs Will Improve Quality and Efficiency

Key Requirements Could Improve the Quality and Efficiency of Care through Qualified CDRs

Question: How might HHS help CDR's improve the quality and efficiency of care provided to Medicare patients?

Answer: 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.

Question: What was the result of GAO's synthesis of findings?

Answer: GAO's synthesis of input from experts and from other relevant sources identified several specific actions that HHS could take.

Question: What actions could HHS take based on GAO's findings?

Answer: 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.

HHS Actions Could Reduce Barriers to the Development of Qualified CDRs

Question: What have experts suggested HHS can take actions to facilitate?

Answer: In addition, input from experts and other relevant sources suggests that HHS can take actions to facilitate CDRs' use of health information technology (IT).

Question: What have some CDR's developed that are an example of this?

Answer: 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.

Question: What new IT standards could CDRs benefit from?

Answer: CDRs could benefit from new IT standard setting that focuses on data elements needed for the measures that CDRs collect.

Question: How might HHS influence the adoption of these standards?

Answer: 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.

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

Variation among EHRs Affects CDR Ability to Use Health IT and Could Be Addressed through Health IT Standards and HHS Adjustments to the EHR Incentive Programs

Question: What does this report examine?

Answer: 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.

Question: What did the GAO review in order to make this report?

Answer: GAO reviewed relevant studies and documents, and interviewed HHS and CDR officials.

Question: How did the GAO assess the likely effects of potential program requirements?

Answer: 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.