HI Course Harish C.

Rijhwani

Reference Link: http://www.tmcnet.com/usubmit/2012/05/01/6284446.htm

How the Continuity of Care Document Can

Advance Medical Research and Public Health
[American Journal of Public Health]
Recent federal health information technology incentives adopt an extensible standard, called the
Continuity of Care Document (CCD), as a new basis for digital interoperability. Although this
instrument was designed for individual provider communications, the CCD can be effectively reused
for population- based research and public health.

Three examples in this commentary demonstrate the potential of CCD aggregation and highlight
required changes to existing public health and research practices. Transitioning to the use of this
new interoperability standard should be a priority for public health investment, research, and
development. (AmJ Public Health. 2012;102:e1-e4. doi:10.2105/AJPH.2011. 300640) THE ADOPTION
OF ELECTRONIC health records (EHRs) has focused on enhancing the delivery of individual care, but
the application of digital medical data to widespread population health analysis is critically lacking.
Population analysis empowers public health agencies, disease registries, medical researchers, and
practicing clinicians to monitor care quality and improve disease management beyond face-to-face
patient encounters. Potential applications of EHR technology to population analysis are
straightforward. Health surveillance should rely on automated detection rather than manual
inspection. Quality measures should be calculated and streamed directly to agencies for quality
improvement. Comparative effectiveness should leverage the emerging wealth of digital data to
inform decisions on care appropriateness and provide feedback to clinicians. What limits these
applications is the divergence of how EHRs capture and record medical data without a standard
method to exchange information between these systems. This observation led the President's
Council of Advisors on Science and Technology1 and the Institute of Medicine2 to recently identify
interoperability as the major deficit of current health information technology. From their
perspectives, fluid and secure data exchange has the most immediate potential to improve care
quality and efficiency nationwide.

Achieving robust interoperability requires common language and structures to medical data
so communication is seamless to care providers. This contrasts with current practice. Today,
implementations of medical data exchange force both senders and recipients of medical data to plan
in advance the content and format of exchange. This is akin to installing a unique web browser for
each Web site on the Internet; the complexity and burden of such networking effectively isolates
medical data at the point of care. Health information exchanges confront this same obstacle, where
even successful networks note the challenge of normalizing heterogeneous EHR data.3 Information
exchange is consequently the exception rather than the norm. Recent federal initiatives, however,
are beginning to dismantle these barriers.

In the American Recovery and Reinvestment Act of 2009, Congress approved $27 billion in health
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information technology stimulus and placed standardized information exchange as a leading policy
objective. Specific objectives for this program were released in July 2010, a majority of which focus
on data structure and interoperability. One requirement for all providers is that an EHR must be able
to create, transmit, and receive an electronic document containing key clinical information using
standard terminologies. The 2 standards that may be used for this objective are the Continuity of
Care Document (CCD) and the Continuity of Care Record (CCR). Although both the CCD and CCR are
acceptable in federal regulation, EHR vendors have focused on the CCD because it is the newer
format developed through the harmonization of the CCR with other past standards. THE
CONTINUITY OF CARE DOCUMENT Although it was originally designed to exchange information on
individual patients, the CCD will become a powerful instrument for medical research and public
health. Its enforcement of structured data and language provides the first normalized summary that
can be generated from any of the 600 plus certified EHRs. As such, CCDs can be interpreted without
previous knowledge of the source system, similar to a Web page on the Internet. The CCD uses
extensible markup language to represent medical data in a consistent, tagged format. These tags,
attached to every data element, identify key context descriptors such as the language being used to
encode data . According to federal regulation, the electronic summary must include data on patient
demographics, problems, medications, allergies, laboratory results, and procedures. Although these
sections represent only a fraction of all medical data, standardization makes them available to
systems beyond the originating EHR.

Using the CCD, agencies can create tools to communicate population data that are immediately
compatible with any certified EHR. Although the potential applications are many, the following three
examples illustrate the promise of CCD applications to improve existing systems for population
analysis.

EXAMPLE 1

Extending Public Health to Chronic Diseases More than 20 million people are estimated to have
diabetes in the United States, but only 20% of these patients receive the appropriate preventative
services as recommended by the American Diabetes Association. Many persons with diabetes are
consequently at high risk of complications, comorbidities, and death as a result of the disease. In
2005, the New York City Board of Health approved a novel approach to collect data about the
disease and craft better public health responses. The board requires mandatory reporting of patient
identified glycosylated hemoglobin values from laboratories to the local department of public
health. This collection format is similar to reporting systems for communicable disease, limited to
patient and provider contact information and the lab date and result for glycosylated hemoglobin.
As a result of this program, the city now produces quarterly reports for approximately 1600
providers and mails 400 letters each week to patients with high glucose levels.

Although local pilots demonstrate the public health benefit of this and other initiatives, key data
from these efforts are missing. Relevant information on medications, preventative practices, and
quality performance are not transmitted. An absence of total patient counts and detailed diagnoses
prevents accurate incidence calculations. These limit the comprehensiveness of physician reports
and patient mailings. As certified EHRs are adopted in a public health region, submitting normalized
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data via the CCD would enlarge the analytical power of such initiatives while minimizing the
reporting burden. Moreover, it would allow expansion of such analytics to other chronic conditions,
such as heart failure or hypertension, without increasing the need for new interfaces. Public health
authorities exercising their statutory power to collect such information presents a significant
opportunity to improve the care for chronic diseases.

EXAMPLE 2

Clinical Detail in Death Certificates In 1999, the US Food and Drug Administration approved
rofecoxib, commonly known by its brand name of Vioxx. Within several years, the drug had become
a blockbuster for its ability to treat chronic pain without the adverse effects of gastrointestinal ulcers
and bleeding. Soon after its launch, however, the safety of rofecoxib was questioned because of
postapproval data on the incidence of myocardial infarction. By September 2004, Merck had
voluntarily withdrawn the drug from the market because of mounting evidence of cardiovascular
harm caused by rofecoxib.

In One retrospective study of Kaiser Permanente members examined whether rofecoxib was
associated with increased coronary events. By scanning 2.3 million person years, researchers
observed an adjusted odds ratio of 3.58 for serious coronary heart disease with high-dose rofecoxib
compared with similar drugs. With such a serious increase in risk, the drug clearly caused thousands
of deaths before its withdrawal 5 years after approval. One vocal expert and researcher on the study
from the US Food and Drug Administration said the agency was "incapable of protecting America
against another Vioxx." Transparency through data can be a valuable safeguard in researching
suspected causes of death. One way to increase the power of mortality studies would be to increase
data reported at the time of death. Pairing clinical detail on medications and laboratory results, as
well as other known conditions, would help agencies and epidemiologists better explore vital
statistics data. These data could again be aggregated by CCDs for health facilities by using certified
EHR technology. With such tools, death certificate data could be scanned to test hypotheses of
medication risk, similar to Kaiser's analysis of rofecoxib. Although that may not be feasible for
several years, setting expectations in advance will prepare for an eventual transition to active
adverse event detection.

EXAMPLE 3

Advancing Biosurveillance Currently the Centers for Disease Control and Prevention runs a
nationwide reporting system named the Influenza-like Illness Surveillance Network (ILINet). ILINet
collects information weekly from approximately 1800 outpatient care sites on patients who have a
fever and cough or sore throat in the absence of other known causes. Providers submit weekly
patient counts stratified by age through fax or the Internet to the Centers for Disease Control and
Prevention. Regional information is made publicly available and monitored for potential outbreaks.
The estimated time burden for participants is less than 30 minutes per week, but collection of simple
patient counts limits the depth of analysis. Novel approaches that electronically extract more
comprehensive patient data can improve the depth, speed, and sample size of influenza analytics.
One such system pioneered by the Veterans Administration uses patient diagnosis detail from all
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patient visits documented in its EHR. Using this electronic detail has detected significant shifts in
condition type and patient demographics that could not be revealed through ILINet.

CCD-normalized extracts present an opportunity to rapidly scale electronic surveillance. Rather than
having registries like ILINet manually collect data, simple applications could be distributed to parse
and calculate statistics from certified EHR technology. The flexibility of this approach relies not on
transmitting personal health information, but on locally deploying programs to analyze data within a
practice's existing infrastructure. Then, richer de-identified summaries of influenza- like encounters
could be transmitted weekly, or daily, with minimal effort on the behalf of providers. Although
regional pilots exist using older standards for surveillance, the CCD's common structure and
language reduces implementation cost. Future public health surveillance systems will unlock new
data on health disparity, detailed symptomatology, and therapeutic regimen that will strengthen
national efforts to manage infectious disease and environmental risk.

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FUTURE OF CLINICAL DATA EXCHANGE AND POPULATION ANALYSIS The future challenge of clinical
data exchange will be to create infrastructure where information can be rapidly accessed while
retaining the privacy and security expected of medical records. The previously mentioned examples
illustrate how public health authorities could use the CCD to work within established practices of
identified health data collection, but local CCD aggregation provides an immediate alternative for
data sharing within a provider network. A normalized database that assembles CCD extracts from
heterogeneous EHRs could service quality measurement and internal reporting needs for integrated
group practices and health systems. This avoids privacy restrictions as previous rulings exempt data
sharing among integrated clinicians when engaged in quality improvement and population health.
Emerging models of care, such as the Patient Centered Medical Home, also assume such exchange as
a foundation for care coordination. CCD repositories could additionally serve regional and national
efforts to improve care, such as clinical trial enrollment, disease registries, and comparative
effectiveness research. A prototype of such a system, called popHealth, is being piloted, but more
investment and development will be required for such projects to reach sustainable scale.
Distributed normalized repositories based on the CCD also create opportunities for existing health
information exchanges and public health agencies. Although more than 190 health information
exchanges initiatives exist in the United States as of 2010, the majority do not store aggregate data
because of concerns about patient privacy and data ownership. As consequence, they provide
minimal support for medical researchers or epidemiologists. De-identification of CCD repositories or
distributed queries of the databases could provide valuable information about population health
without compromising patient confidentiality. Regional and national payers may also subsidize such
initiatives if they can demonstrate care coordination improvements that lower overall cost. These
avenues provide strategic alternatives for health information exchanges, many of which are in
financial doubt because of the unwillingness of providers to pay for transactional information
exchange. CCD-based population analysis has clear limitations given the infancy of the standard.
Until a large majority of health providers have adopted certified technology, there may be a
selection bias in using CCD-data from early EHR adopters. In particular, physician practices with EHRs
may underrepresent Medicaid and uninsured populations and not be representative of all providers
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or patients. Fortunately, it is estimated that by 2019, 90%of ambulatory practices will be using EHRs
capable of CCD production. CCDs generated from different EHRs also possess heterogeneity as the
standard was not widely adopted with a robust reference library before EHR developers updated
their software to meet federal interoperability standards. In addition, CCDs do not necessarily
contain standardized information on care plans, immunizations, genomics, imaging procedures, or
advance directives for the first stage of the federal incentive program. The CCD format is extensible,
however, which provides a natural growth trajectory for these and other data as they become
routinely encoded in medical records. Even with these limitations, the CCD provides a strong basis
for population health research.

A logical next step for leaders in public health will be to pilot systems for CCD-based aggregation and
create a facile environment for clinicians to adopt them. This requires consideration for how the CCD
could bolster new efforts for disease management and possibly replace older methods for data
submission. These efforts could kindle new cooperation between public health agencies, health
information exchanges, and other parties involved with medical research. For these future CCD-
based initiatives, however, careful consideration of patient privacy will be required. Although public
health agencies have the statutory power to collect identified medical data, broader access to de-
identified data will be vital to clinical research and comparative effectiveness studies. Public health
and medical informatics professionals should advocate the advancement of pilot programs, de-
identification methods, and that the CCD become a common tool for medical data far beyond
individual provider communications.

CONCLUSIONS Future generations will not judge the adoption of EHRs on the elimination of paper in
medical practice. Instead, they will ask whether the new digital infrastructure was effectively
harnessed to break down barriers to quality improvement, effective information sharing, and the
reuse of medical data. Significant opportunities exist for research and public health personnel to
prepare for this transition, particularly in how CCD data can be most effectively harnessed. When
clinicians can simultaneously reduce the reporting burden for public health programs and develop
new channels for quality improvement, the benefits of CCD-based aggregation will become
transparent. This will require the work of many over coming years, but as David Blumenthal, MD,
MPP, former director of the Office of the National Coordinator for Health Information Technology,
stated, "[I]nformation is the lifeblood of modern medicine. Health information technology is
destined to be its circulatory system." The CCD can be an effective instrument to deliver on this
promise.