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United States Government Accountability Office: 
GAO: 

Report to Congressional Committees: 

December 2013: 

Clinical Data Registries: 

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

GAO-14-75: 

GAO Highlights: 

Highlights of GAO-14-75, a report to congressional committees. 

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. 

View [hyperlink, http://www.gao.gov/products/GAO-14-75]. For more 
information, contact Linda T. Kohn at (202) 512-7114 or kohnl@gao.gov. 

[End of section] 

Contents: 

Letter: 

Scope and Methodology: 

Background: 

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

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

HHS Actions Could Reduce 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: 

Conclusions: 

Recommendations for Executive Action: 

Agency Comments and Our Evaluation: 

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

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

Appendix III: GAO Contact and Staff Acknowledgments: 

Abbreviations: 

ACC: American College of Cardiology: 

ATRA: American Taxpayer Relief Act of 2012: 

CDR: clinical data registry: 

CG-CAHPS: Consumer Assessment of Healthcare Providers and Systems-
Clinician & Group Surveys: 

CMS: Centers for Medicare & Medicaid Services: 

CQM: clinical quality measure: 

EHR: electronic health record: 

HHS: Department of Health and Human Services: 

HIPAA: Health Insurance Portability and Accountability Act: 

HITECH: Health Information Technology for Economic and Clinical Health 
Act: 

IOM: Institute of Medicine: 

IRB: institutional review board: 

IT: information technology: 

LOINC: Logical Observation Identifiers Names and Codes: 

NQF: National Quality Forum: 

ONC: Office of the National Coordinator for Health Information 
Technology: 

PQRS: Physician Quality Reporting System: 

RFD: Retrieve Form for Data Capture: 

SNOMED CT: Systematized Nomenclature of Medicine Clinical Terms: 

STS: Society of Thoracic Surgeons: 

[End of section] 

GAO:
United States Government Accountability Office: 
441 G St. N.W. 
Washington, DC 20548: 

December 16, 2013: 

Congressional Committees: 

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,[Footnote 1] 
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.[Footnote 2] 

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.[Footnote 3] 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.[Footnote 4] 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.[Footnote 5] 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.[Footnote 6] 

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.[Footnote 7] 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. 

Scope and Methodology: 

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.[Footnote 8] 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. 

Background: 

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.[Footnote 9] 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.[Footnote 10] Other 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.[Footnote 11] 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. 
[Footnote 12] 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 surgical techniques.[Footnote 13] 
Data from other CDRs have highlighted clinical 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.[Footnote 14] 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.[Footnote 15] 

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.[Footnote 16] 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.[Footnote 17] 

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.[Footnote 18] 

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.[Footnote 19] 
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 
three of the six domains of HHS's National Quality Strategy.[Footnote 
20] The 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.[Footnote 21] 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.[Footnote 
22] 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 (HIPAA) Privacy Rule.[Footnote 23] Under the 
Privacy Rule, protected health 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.[Footnote 24] 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. 
[Footnote 25] However, it has not addressed physician concerns 
regarding the perceived need to meet HIPAA Privacy Rule requirements 
for research uses and disclosures. 

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. 

Limited Ability to Link Patient Data across Sources: CDRs often need 
to supplement the data that they collect themselves with data obtained 
from other sources, but their ability to do so is inhibited by 
limitations in existing processes for matching and linking data on 
individual patients from multiple sources. In order to link patients' 
data from multiple sources into a CDR database, the CDR must first be 
able to identify records for the same patient from each source--a 
process known as matching. Earlier 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.[Footnote 26] 

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.[Footnote 27] 

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.[Footnote 28] 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.[Footnote 29] 
Some EHR 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.[Footnote 30] 

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.[Footnote 31] 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. 

Conclusions: 

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. 

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. 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. 

Agency Comments and Our Evaluation: 

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 [hyperlink, 
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. 

Signed by: 

Linda T. Kohn: 
Director, Health Care: 

List of Committees: 

The Honorable Max Baucus: 
Chairman: 
The Honorable Orrin G. Hatch: 
Ranking Member: 
Committee on Finance: 
United States Senate: 

The Honorable Fred Upton: 
Chairman: 
The Honorable Henry A. Waxman: 
Ranking Member: 
Committee on Energy and Commerce: 
House of Representatives: 

The Honorable Dave Camp: 
Chairman: 
The Honorable Sander M. Levin: 
Ranking Member: 
Committee on Ways and Means: 
House of Representatives: 

[End of section] 

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

Name: Kevin Bozic, MD, MBA; 
Title: William R. Murray Professor and Vice Chair, Department of 
Orthopaedic Surgery; 
Affiliation: University of California, San Francisco; 
Title: Chair, Steering Committee; 
Affiliation: California Joint Replacement Registry. 

Name: Patrick Conway, MD, MSc, SFHM; 
Title: Chief Medical Officer Director, Center for Clinical Standards 
and Quality; 
Affiliation: Centers for Medicare & Medicaid Services. 

Name: Jason Alexander Efstathiou, MD, PhD; 
Title: Assistant Professor of Radiation Oncology; 
Affiliation: Massachusetts General Hospital. 

Name: Richard E. Gliklich, MD; 
Title: President; 
Affiliation: Quintiles Outcome. 

Name: Kate Goodrich, MD, MHS; 
Title: Director, Quality Measurement and Health Assessment Group, 
Center for Clinical Standards and Quality; 
Affiliation: Centers for Medicare & Medicaid Services. 

Name: J. Michael McGinnis, MD, MA, MPP Co-Moderator; 
Title: Senior Scholar and Executive Director, Roundtable on Value & 
Science-Driven Health Care; 
Affiliation: Institute of Medicine. 

Name: Arnold Milstein, MD, MPH Co-Moderator; 
Title: Professor of Medicine and Director, Clinical Excellence 
Research Center; 
Affiliation: Stanford University; 
Title: Medical Director; 
Affiliation: Pacific Business Group on Health. 

Name: Elizabeth Mitchell; 
Title: CEO; 
Affiliation: Network for Regional Health Improvement. 

Name: Peggy E. O'Kane; 
Title: President; 
Affiliation: National Committee for Quality Assurance. 

Name: J. Marc Overhage, MD, PhD; 
Title: Chief Medical Informatics Officer; 
Affiliation: Siemens Medical Solutions, Inc. 

Name: Eric D. Peterson, MD, MPH; 
Title: Fred Cobb, MD, Distinguished Professor of Medicine 
Affiliation: Duke University Medical Center; 
Title: Director; 
Affiliation: Duke Clinical Research Institute. 

Name: Jacob Reider, MD; 
Title: Chief Medical Officer; 
Affiliation: Office of the National Coordinator for Health Information 
Technology. 

Name: David M. Shahian, MD; 
Title: Professor of Surgery; 
Affiliation: Harvard Medical School; 
Title: Vice President, Center for Quality and Safety 
Affiliation: Massachusetts General Hospital; 
Title: Chair, Workforce on National Databases; 
Affiliation: Society of Thoracic Surgeons. 

Name: David Share, MD; 
Title: Senior Vice President, Value Partnerships; 
Affiliation: Blue Cross and Blue Shield of Michigan. 

Source: GAO. 

[End of table] 

[End of section] 

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

Department of Health & Human Services: 
Office of The Secretary: 
Assistant Secretary for Legislation: 
Washington, DC 20201: 

November 22, 2013: 

Linda Kohn: 
Director, Health Care: 
U.S. Government Accountability Office: 
441 G Street NW: 
Washington, DC 20548: 

Dear Ms. Kohn: 

Attached are comments on the U.S. Government Accountability Office's 
(GAO) report entitled, "Clinical Data Registries: ITHS Could Improve 
Medicare Quality and Efficiency Through Key Requirements and 
Oversight" (GAO-14-75). 

The Department appreciates the opportunity to review this report prior 
to publication. 

Sincerely, 

Signed by: 

Jim R. Esquea: 
Assistant Secretary for Legislation: 

Attachment: 

General Comments Of The Department Of Health And Human Services (HHS) 
On The Government Accountability Office's (GAO) Draft Report Entitled, 
"Clinical Data Registries: HHS Could Improve Medicare Quality And 
Efficiency Through Key Requirements And Oversight (GAO-14-75): 

The Department appreciates the opportunity to review and comment on 
this draft report. 

GAO Recommendation 1: 

GAO recommends that the Secretary of HHS 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 data for 
additional measures designed to address them; (2) collect data for 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. 

HHS Response: 

HHS concurs that QCDRs can act as an important tool in our efforts to 
improve health outcomes. We look forward to working with clinical data 
registry stakeholders to evaluate opportunities to ensure that QCDRs 
are improving quality and efficiency. CMS intends to apply the 
experience gained on the QCDR program on an ongoing basis to 
facilitate the changes in QCDRs to improve quality and efficiency, 
including those related to a potential QCDR core measure set. 
Establishing a core measure set across QCDRs of various specialties 
will require experience over time with the different QCDRs to 
determine what measures and types of measures could be potentially 
included in a possible QCDR core measure set. It will be difficult to 
mandate a set of QCDR core measures set, given that QCDRs can cross 
many clinical specialties. 

GAO Recommendation 2: 

GAO recommends that the Secretary of HHS direct CMS to establish a 
requirement for qualified CDRs to demonstrate improvement on key 
measures of quality and efficiency for their target populations. 

HHS Response: 

HHS concurs with this recommendation for a future year. We do see 
value in providing additional specificity on QCDRs demonstrating 
improvement in quality and efficiency; however, a baseline must be 
established built on our experience with the QCDR program for this to 
be a valuable indicator. 

GAO Recommendation 3: 

GAO recommends that the Secretary.of HI-IS direct CMS to establish a 
process for monitoring compliance with requirements for qualified CDRs 
that draws on relevant expert judgment. This process should assess 
qualified CDR performance on each requirement in a way that takes into 
account the varying circumstances of qualified CDRs and their 
available opportunities to promote quality and efficiency for their 
target populations. 

HHS Response: 

HHS concurs with this recommendation and intends to have monitoring 
capabilities for the QCDR program. CMS anticipates that in future 
years the application of relevant and appropriate expert judgment in 
the oversight of QCDRs could be expanded through rulemaking to the 
extent possible while maintaining compliance with appropriate laws and 
regulations. 

GAO Recommendation 4: 

GAO recommends that the Secretary of HHS determine and implement 
actions to reduce barriers in 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 multi-payer 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. 

HHS Response: 

HHS concurs and agrees to reduce barriers for the development of QCDRs 
to the extent possible while maintaining compliance with appropriate 
laws and regulations. 

GAO Recommendation 5: 

GAO recommends that the Secretary of HHS 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 
electronic health records (EHRs) under the EHR Incentive Programs. 

HHS Response: 

HITS concurs and agrees to include, if feasible, in the QCDRs 
requirements, key data elements needed by QCDRs. CMS will continue to 
work closely with ONC in the establishment of criteria for EHR 
certification. To date, HHS has taken steps and initiated activities 
that align with this goal, including the Data Framework Initiative 
[hyperlink, http://www.hhs.gov/open/initiatives/hdi/about.htnil], the 
Structured Data Capture Initiative [hyperlink, 
http://www.healthitgov/buzz-blogielectronic-health-and-medical-
records/ehr-interoperabilitystructured-data-capture-initiative/], the 
Clinical Quality Measure Data Standards Initiative [hyperlink, 
http://www.healthitgov/policy-researchers-implementers/clinical-
quality-measures], and the Supplemental Data File Initiative 
[hyperlink, http://www.healthdata.gov/. CMS and ONC believe that these 
efforts will improve health a systems in general and will benefit QCDR 
efforts going forward. Establishing QCDR key data elements will be a 
matter for future rulemaking. 

[End of section] 

Appendix III: GAO Contact and Staff Acknowledgments: 

GAO Contact: 

Linda T. Kohn, (202) 512-7114 or kohnl@gao.gov: 

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. 

[End of section] 

Footnotes: 

[1] Medicare is the nation's largest health care program, covering 51 
million beneficiaries at a cost of $574 billion in 2012. 

[2] Pub. L. No. 112-240, § 601, 126 Stat. 2313, 2345-2347 (2013). 

[3] R. E. Gliklich and N. A. Dreyer, eds., Registries for Evaluating 
Patient Outcomes: A User's Guide, 2nd ed., AHRQ Publication No.10-
EHC049 (Rockville, MD: Agency for Healthcare Research and Quality, 
September 2010), 10. 

[4] Providers have the option of reporting PQRS data on their selected 
measures to CMS using PQRS registries. These registries differ from 
CDRs in that their sole function is to compile and submit data to PQRS. 

[5] In addition to physicians, other professionals eligible to 
participate in PQRS include nurse anesthetists, nurse practitioners, 
optometrists, physical therapists, and physician assistants. 
Physicians made up approximately three quarters of the eligible 
professionals who received PQRS incentive payments in 2011. 

In 2016 the payment reduction is set to increase to 2.0 percent for 
eligible professionals who do not meet PQRS requirements in 2014. 

[6] Section 601 of ATRA states that for 2014 and subsequent years HHS 
shall treat an eligible professional as satisfactorily submitting data 
on quality measures under PQRS if, in lieu of reporting measures, the 
eligible professional is satisfactorily participating in a qualified 
CDR. Section 601 also requires that HHS establish requirements for an 
entity to be considered a qualified CDR and establish a process to 
determine whether the entity meets those requirements. 

[7] 78 Fed. Reg. 74230 (December 10, 2013). The preamble discussion of 
provisions related to satisfactory participation in a qualified CDR by 
individual eligible professionals begins on 78 Fed. Reg. 74465. 

[8] EHRs are digital versions of patients' medical records that 
contain information about a patient's medical history, diagnoses, and 
treatments including medications, immunization dates, allergies, 
radiology images, and lab and test results. 

[9] For example, the Consumer Assessment of Healthcare Providers and 
Systems-Clinician & Group Surveys (CG-CAHPS) are a set of surveys that 
gather patient input on, for example, the effectiveness of physician 
communication and responsiveness to patient concerns. 

[10] NQF is a nonprofit organization that endorses measures--that is, 
determines which measures should be recognized as the national 
performance standard for a given aspect of care--and encourages their 
use over other measures. NQF has endorsed over 700 measures. 

[11] Beginning in 2015, the Medicare EHR program is to begin applying 
a payment adjustment, or penalty, for professionals that do not meet 
the Medicare EHR program requirements. The Health Information 
Technology for Economic and Clinical Health (HITECH) Act, enacted as 
part of the American Recovery and Reinvestment Act of 2009, among 
other things, provided funding for various activities to promote the 
use of EHRs. The HITECH Act was enacted as title XIII of division A 
and title IV of division B of the Recovery Act. Pub. L. No. 111-5, 
div. A, tit. XIII, 123 Stat. 115, 226-279 and div. B, tit. IV, 123 
Stat. 115, 467-496 (2009). 

[12] E. D. Peterson et al., "Trends in Quality of Care for Patients 
with Acute Myocardial Infarction in the National Registry of 
Myocardial Infarction from 1990 to 2006," American Heart Journal, vol. 
156, no.6 (2008), 1045-1055. 

[13] A. W. ElBardissi et al., "Trends in Isolated Coronary Artery 
Bypass Grafting: An Analysis of the Society of Thoracic Surgeons Adult 
Cardiac Surgery Database," The Journal of Thoracic and Cardiovascular 
Surgery, vol. 143, no. 2 (2012), 273-281. 

[14] M. N. Neuss et al., "Measuring the Improving Quality of 
Outpatient Care in Medical Oncology Practices in the United States," 
Journal of Clinical Oncology, vol. 31, no. 11 (2013), 1471-1477. 

[15] G. C. Lamb et al., "Publicly Reported Quality-of-Care Measures 
Influenced Wisconsin Physician Groups to Improve Performance," Health 
Affairs, vol. 32, no. 3 (2013), 536-542. 

[16] T. B. Ferguson et al., "Use of Continuous Quality Improvement to 
Increase Use of Process Measures in Patients Undergoing Coronary 
Artery Bypass Graft Surgery," Journal of the American Medical 
Association, vol. 290, no. 1 (2003), 49-56. 

[17] D. A. Share et al., "How a Regional Collaborative of Hospitals 
and Physicians in Michigan Cut Costs and Improved the Quality of 
Care," Health Affairs, vol. 30, no. 4 (2011), 636-644. 

[18] Share et al., "Regional Collaborative," 641. 

[19] Lamb et al., "Publicly Reported Measures," 538-540; W. R. Lewis 
et al., "An Organized Approach to Improvement in Guideline Adherence 
for Acute Myocardial Infarction," Archives of Internal Medicine, vol. 
168, no. 16 (2008), 1813-1819. 

[20] The six National Quality Strategy domains are (1) Person and 
Caregiver-Centered Experience and Outcomes, (2) Patient Safety, (3) 
Communication and Care Coordination, (4) Community/Population Health, 
(5) Efficiency and Cost Reduction, and (6) Effective Clinical Care. 

[21] One additional requirement in CMS's plans is that CDR measures 
come from one of the following categories: CG-CAHPS, NQF-endorsed 
measures, current PQRS measures, measures used by medical specialty 
boards or specialty societies, and measures used by regional quality 
collaboratives. As NQF alone has endorsed over 700 measures, having 
the option of selecting measures from any of these sources provides 
CDRs a large number of potential measures to choose from. 

[22] 78 Fed. Reg. 74474 (December 10, 2013). 

[23] Among other things, HIPAA provided for the establishment of 
national privacy and security standards of certain health information. 
Pub. L. No. 104-191, Title II, Subtitle F, 110 Stat. 1936, 2021 
(1996). Under HIPAA, the Secretary of Health and Human Services is 
authorized to promulgate regulations that establish privacy and 
security standards, and HHS implemented these provisions through its 
issuance of the HIPAA Rules--the Privacy Rule, the Security Rule, and 
the Enforcement Rule. The HIPAA Privacy and Security Rules are 
promulgated at 45 C.F.R. Parts 160 and 164 and have recently been 
updated. See 78 Fed. Reg. 5566 (Jan. 25, 2013). The Privacy Rule 
established a category of health information, called "protected health 
information," which may be used or disclosed to others by "covered 
entities" only under specified circumstances or conditions. The 
Privacy Rule establishes different conditions for uses and disclosures 
for quality improvement purposes and for research purposes, and HHS 
has issued guidance concerning the HIPAA research disclosure 
provisions. See Health Services Research and the HIPAA Privacy Rule, 
NIH Publication Number 05-5308, May 2005. 

[24] An IRB is an entity designated to review and monitor biomedical 
and behavioral research in clinical trials involving human subjects, 
with the intended purpose of protecting the rights and welfare of the 
research subjects. Under certain circumstances, the Privacy Rule 
permits a covered entity to use or disclose protected health 
information for research without an individual's authorization. One 
way that a covered entity can use or disclose protected health 
information for research without an authorization is by obtaining 
documentation of IRB approval of a waiver of the individual 
authorization requirement. 

[25] A business associate for a health care provider is a person or 
entity who performs functions or activities on behalf of the provider 
that involve access to protected health information. Federal privacy 
rules generally require that health care providers enter into 
contracts or agreements with their business associates to ensure that 
the business associates appropriately safeguard protected health 
information. This agreement also specifies the permissible uses and 
disclosures of protected health information by the business associate. 

[26] R. Hillestad et al., Identity Crisis: An Examination of the Costs 
and Benefits of a Unique Patient Identifier for the U.S. Health Care 
System (Santa Monica, CA: RAND Corporation, 2008), 7. 

[27] Among the relevant sources that these CDR resource centers could 
draw on are resources produced by the AHRQ-funded Electronic Data 
Methods Forum, whose activities include support for selected CDRs, 
available at [hyperlink, http://www.edm-forum.org]. 

[28] C. J. Hsiao et al., "Office-Based Physicians Are Responding to 
Incentives and Assistance by Adopting and Using Electronic Health 
Records," Health Affairs, vol. 32, no. 8 (2013). 

[29] Data elements are discrete data fields that record a specific 
piece of clinical information, such as primary diagnosis at admission. 

[30] A task force developing clinical standards with representation 
from multiple cardiovascular specialty organizations has stipulated 
the need for common vocabulary and definitions in order to aggregate 
and compare data collected by different EHR systems. C. P. Cannon et 
al., "2013 ACCF/AHA Key Data Elements and Definitions for Measuring 
the Clinical Management and Outcomes of Patients with Acute Coronary 
Syndromes and Coronary Artery Disease," Journal of the American 
College of Cardiology, vol. 61, no. 9 (2013). 

[31] SNOMED CT (Systematized Nomenclature of Medicine Clinical Terms) 
is a comprehensive clinical terminology developed and maintained by 
the International Health Terminology Standards Development 
Organisation based in Denmark. LOINC (Logical Observation Identifiers 
Names and Codes) is a clinical terminology focusing on laboratory 
tests and other clinical observations produced by the Regenstreif 
Institute in Indianapolis, Indiana. 

[End of section] 

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