Abstract: The Meaningful Use Incentive Program from the Centers for Medicare & Medicaid Services (CMS) has successfully driven the adoption of electronic health records (EHRs). However, it has been criticized recently for being too aggressive, ill conceived, poorly implemented, and responsible for fostering the adoption of an immature technology. Some clinicians allege that EHRs disrupt clinical workflows, are too time consuming, and have a negative impact on the quality of physician-patient relationships. Although there may be some truth to a number of these assertions, the authors suggest that an enlarged historical perspective makes apparent the fundamental and positive transformation of health care that has been initiated by the Meaningful Use program. In this light, Meaningful Use has facilitated the advancement of evidence-based medicine and, thus, offers substantial promise of ongoing improvements in patient outcomes and safety. Furthermore, systematic efforts to optimize the untapped clinical value of EHRs have not yet begun. This includes data mining to provide robust analytics in support of needed population health management efforts and precision medicine, which will facilitate the shift from volume- to value-based reimbursement.
As the Meaningful Use Incentive Program launched by the incentives driving the rapid adoption of electronic health records (EHRs) in recent years, providers have articulated concerns about the time expended to document patient information and to manage care orders electronically.1-3 The Health Information Technology for Economic and Clinical Health (HITECH) Act sought to radically accelerate adoption of EHRs in hospitals, clinics, and physician offices across the nation, through a mix of front-loaded incentives and back-loaded penalties. In addition to noting positive impacts of EHRs, such as improved availability of clinical data and evidence-based clinical decision support, providers have reported that EHR inefficiencies are adversely affecting the quality of patient care, and, because fewer patients are purportedly seen each day, provider income may decline.1-3 In addition, physicians have experienced substantial changes in reimbursement, adding cumulatively to an era of unprecedented change and dislocation.
Although physicians approve of EHRs conceptually and appreciate their potential future promise, in many cases, the current state of EHR technology has created physician dissatisfaction.1 Poor EHR usability, time-consuming data entry, reduced patient care time, and inability to exchange health information are central concerns. Physicians emphasize that EHR technology—especially user interfaces—must improve.1
Those responsible for the deployment and management of EHRs have heard frequently from physician end-users that EHRs have transformed them into clerks and that unintuitive organization and onerous navigation of EHRs interfere with clinical thinking and compete with face-to-face patient interaction.1 No EHR product offers a clearly superior resolution of physician concerns, and the American Medical Association issued a report detailing priorities to the industry for improving EHR usability.4
As a result of this high physician dissatisfaction, a new unregulated industry has emerged nationally to provide physicians with medical scribes—unlicensed individuals hired to enter information into the EHR at the direction of a physician or other licensed practitioner and to assist physicians with EHR navigation and electronic documentation. The rise of the medical scribe industry has been a compensatory reaction to EHRs of poorly perceived usability, and the use of medical scribes in lieu of direct, personal engagement of EHRs by physicians has generated its own concerns.5
THE DIGITAL IMPERATIVE IN US HEALTH CARE
Despite criticism, Meaningful Use has greatly advanced implementation of EHRs by providing funding and strategic direction for their acquisition and adoption in the United States. Criticism usually focuses on the reality that all EHR vendors’ products have significant perceived usability problems, and some regard current EHRs as immature or simply bad technology that was not yet ready for national implementation.6 Meaningful Use has not yet realized the full promise of EHRs; however, it is reasonable to ask what program could have done so, given how far the nation needed to progress in this area.
Meaningful Use accelerated EHR adoption from very low levels over a mere 5-year period. Without this injection of substantial material resources and direction, it is unlikely that current levels of EHR adoption would have been possible. Although computerized physician order entry (CPOE) has been perhaps one of the most disruptive health care developments in a generation, its primary purpose is the elimination of errors due to handwriting or the insertion of non-clinical personnel into the ordering management process, as well as the deployment of integrated clinical decision support (CDS) that increases patient safety and improves patient outcomes.7-20
CPOE has been the best means so far of systematically embedding scientific evidence and care standardization into medical practice in order to improve quality and reduce patient risk and the substantial annual mortality associated with preventable harm and errors.7-21 These are foundational changes in the practice of medicine. There was never going to be an immediately satisfying transition from paper to digital in health care. The digitalization of medicine is about much more than new technology adoption or the capture of data for financial utilities; it is our first real opportunity, across the health care system, to ensure that experience and science drive clinical care delivery within almost every care setting, as determined and shaped by the evidence base.
Further, it is critical to recall a key impetus toward the digitalization of health care: a highly unsafe health care environment for patients in the United States. Evidence-based medicine, the rise of EHRs, CPOE and clinical decision support originate in and focus significantly on the urgent imperative to reduce the 210,000 to 440,000 deaths associated with preventable harm and errors occurring in US hospitals each year.21 Medical errors are now the third leading cause of death in the United States —resulting in the deaths of at least 250,000 people every year—trailing only heart disease and cancer.22 Equaling 9–11 mortality events every 3–5 days, this level of mortality is staggering and would not be tolerated in any other US industry. Would the commercial aviation industry be regarded as successful if an aircraft crashed with all passengers and crew perishing every day?
The frustration of physicians with the current state of EHR, CPOE, and digital documentation technology is understandable. Yet, EHRs remain essential to achieving distributed evidence-based medical practice and prevention of errors. As we consider Meaningful Use in our rear view mirror, one must ask: was there a better idea or method to rapidly, pervasively, and sustainably digitize health care processes and insert the evidence base into clinical workflows? To eliminate handwriting illegibility as a cause of error-related morbidity and mortality? To get us to a point where interoperability could even present itself as a key problem demanding resolution? To enable us to begin to strategize and implement the first steps towards analytics-driven precision medicine and population health efforts to intervene earlier in the course of disease and thereby reduce preventable morbidity, suffering, care utilization, and associated expenditure? Without EHRs and MU, would we, at long last, be at the threshold of a fundamental transition from volume to value-based health care?
Almost every new and transformative technology involved first product generations that left much to be desired from the perspective of end-users (or customers). We do not expect aircraft from the 1940s or 1960s to compare favorably to today’s commercial aircraft. Today’s personal computers or smart phones are almost inconceivably more usable, powerful, and prolific in their value delivery than their progenitors were in the 1990s—but a few decades ago. In fact, every major innovation’s first implementations are followed by rapid cycles of new innovations to make the innovation more usable and customer friendly.
ENABLING THE SHIFT FROM VOLUME- TO VALUE-BASED CARE
As the EHR infrastructure is now distributed and utilized across the country, new payment models are being introduced that reward providers for improving health outcomes through this infrastructure. While technology adoption requirements will continue, such adoption is made far more rational when complemented by a focus on using the new functionality within EHRs to improve patient outcomes and measure EHR impact and value.
The Acting Administrator of the Centers for Medicare & Medicaid Services (CMS) stated recently that the end of the Meaningful Use era was imminent, to be replaced with a more narrow regulatory framework that aligns with merit-based alternative payment models promulgated by the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA).23 MACRA is intended to ensure that quality and clinical care improvements will be used to determine Medicare payments to physicians. Health care organizations and physicians with concerns about how to sustain the costs of EHRs and their ongoing optimization are hopeful that such new incentive programs will clarify, rather than obscure, the road to achieving the interrelated goals of EHR adoption and value-based reimbursement.
At present, CMS is driving a natural transition from the early period of Meaningful Use characterized by incentives and penalties driven largely by process metrics to new payment models that reward providers for achieving better health outcomes, utilizing the national EHR infrastructure that MU has established.23 MACRA, in this light, may not have been possible if it were not for the prior capacity-building made possible through Meaningful Use. Without the foundation of national EHR distribution, we cannot envision subsequent refinements to optimize the technology to advance the shift from volume to value-based care.
The new regulatory process will focus less on process metrics such as measuring software use and adoption levels per se and more on the use of EHR technology to improve care quality and outcomes. The US Department of Health and Human Services has articulated a goal of 30% of Medicare payments being linked to value-based care by 2016 and 50% by 2018.24 Measurement of Meaningful Use of EHRs in Stage 3 will remain, but MACRA begins the process of leveraging EHR technology toward improved clinical performance and outcomes. This will be a welcome transition for many practitioners and similar changes are expected for hospitals and the Medicaid program.
The use of EHR data in analytics and clinical outcomes evaluation/demonstration will continue to be a major and expanding focus of EHR value delivery as population health programs become integral to health care and as we move toward precision medicine. Health care systems will need to acquire and deploy new or added domain multidisciplinary outcomes and health services research expertise to mine the appropriate data, ensure metrics measured are the most useful for determining outcomes, drive and quality assure the analytic process, and monitor to validate that the outcomes defined and evaluated are truly clinically beneficial and meaningful.
As the ability to correlate and integrate financial and clinical data has evolved, the utilization of EHRs as an integral component of the billing system for health care services delivered is rapidly expanding. Twenty years ago, much of the data within the clinical and financial systems were housed in disparate systems. Even the larger vendors who offered both clinical and financial systems did so in a split environment, with little to no data passing between them. Consequently, health care organizations had to make significant investments in these disparate systems. It has only been in the last 5-10 years that commercial EHR products began to integrate the billing modules where data could be used to analyze the efficiencies from within the EHR and without having to manipulate the data in an external warehouse. Today, we are seeing ever greater opportunities as the larger EHR vendors are unifying their data architecture and better reporting tools are being placed in providers’ hands.
For the technology to achieve the articulated vision, a focus on interoperability and information sharing among a broad spectrum of systems must occur. The Office of the National Coordinator for Health Information Technology (ONC) has issued a proposed guideline that outlines a 10-year roadmap to achieve full interoperability.23 Completion of the first stage is anticipated by the end of 2017. This first stage only involves a capability for EHRs to send, receive, find, and use priority data domains to improve health care outcomes. This would tie to the initial requirements of Meaningful Use Stage 3 objectives to be in place by 2018 and of MACRA.
There are other challenges facing the adoption of a fully integrated EHR. Physician satisfaction as well as local community standards may have a future impact on adoption. To ensure the continued growth of EHR adoption, it is imperative that the United States achieves full interoperability. The current Meaningful Use framework promotes interoperability, but the challenges to achieving this are many, beginning with EHR vendors who must agree and collaborate to allow data to flow between them efficiently. As we advance EHR refinement and optimization in coming years, it will be prudent to remain aware, much as we do with other technology, that EHRs have a degree of moral hazard and are not infallible, and our dependence on them, as the need for downtime solutions and drills demonstrates, must be accompanied with risk mitigation strategies and processes to ensure patient safety.
CONCLUSION
While it is true that EHR technology remains immature and requires aggressive advancements in clinical usability, Meaningful Use achieved its central objective exceedingly well: it has placed EHRs in a large majority of US hospitals, clinics, and physician practices. The key point is that Meaningful Use was not the end of the journey; rather, it was the beginning. The next phase of optimizing EHR functionality in order to yield greater impact on patient outcomes will help facilitate the shift from a system of perverse incentives favoring volume of care delivered toward those that reward for quality and positive clinical impact.
Now that EHRs are in place, a process of significant usability improvement has already begun, as evidenced from our previews of the next generation products of leading EHR vendors. Moreover, for both CPOE and digital documentation, we now must focus on optimizing these clinical information technologies to deliver even greater clinical value to patients and their providers. This will include provision of data that can be transformed into actionable clinical information and intelligence to drive effective population health programs and to enable the transition to precision medicine. In addition, vendors must dramatically enhance EHR functionality, improve usability, and institute new operating and business models (for example, secure cloud-based services with reduced cost structures, greater interoperability, etc).
However, to achieve these objectives, greater interoperability must exist between the different EHR systems. Our culture will need to evolve along with it. The ONC roadmap has an expected 10-year target of realizing a fully enabled learning health system, with the individual at the center. For this to occur, other enablers must also evolve to continually motivate both the vendors developing the EHR tools and physicians to adopt the technology.
As we identify the shortcomings of Meaningful Use, there is value in recalling where the health care industry has been in recent decades with respect to building and engaging electronic digital infrastructure and applications. Throughout the 1980s and beyond, while other sectors of the US economy implemented electronic digital infrastructure, for various reasons, health care did not. The complexity of contemporary health care, and the imperative to prevent errors and to ensure that scientific evidence serves as the basis of care decisions and delivery, has been a great challenge to our national health care system and to the medical profession. While far from perfect, Meaningful Use has set us upon a positive pathway to achieving these critical objectives.
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