by: David Blumenthal and Don Berwick
On July 13, with the issuance of two regulations defining and supporting “meaningful use” of electronic health records (EHRs), our nation began in earnest its journey toward ubiquitous and effective use of health information technology. In considering the significance of this moment, it is useful to remember the events and energies that have brought us to this starting point, and to understand the many different elements that will support this initiative.
The proximate event leading us to the July 13 announcement was the enactment of the Health Information Technology for Economic and Clinical Health (HITECH) Act, in February 2009. This act makes available unprecedented resources to support the nation’s transition to EHRs. In the months since its enactment, extensive preparations have been made. These constitute the operational supports for a multiyear, multiphase campaign of EHR adoption and use. But behind these preparations lies a longer and deeper history that has prepared us to seize this moment.
It was six years ago that the Office of the National Coordinator for Health Information Technology (ONC) was created. The recognition of the need for a federal leadership role reflected a growing professional and bipartisan consensus regarding the potential benefits of health information technology (IT). In the intervening years, we have also seen an increasing understanding of both the opportunities and the barriers to the dissemination of electronic health information systems.
Of even greater importance, it was a decade ago that the Institute of Medicine (IOM) published findings regarding safety and quality of health care in America in a pair of groundbreaking studies: To Err Is Human and The Quality Chasm. Those findings altered the nation’s understanding of its health care system and the results it was achieving, as well as highlighting the great potential for improvement. The IOM reports played an important part in illustrating both the need for improved information systems in health care and the potential for electronic data to help fill that need.
Finally, it has been more than 20 years since pioneering health care institutions began developing early digital systems to support clinicians and improve patient care. Some of the successes and the failures along that road are well-known; others made their contribution with less notice. All of them deserve our appreciation. Both of the authors are beneficiaries of those efforts; both of us are able to testify now to the potential of health IT because we benefited in our practice of medicine from the efforts of early adopters and EHR technology developers.
This brief history demonstrates that our nation has undergone a long learning process in preparation for the initiative we are now undertaking. A review of the pages of Health Affairs itself would reveal a layered progression of discovery and understanding. For some years, we have reviewed the evidence and considered the questions: “Is the technology ready for significant national investment?” and “How is such investment to be made?”
HITECH: Answering The Questions
Congress answered those questions in HITECH, not only by providing significant new resources, but equally importantly by creating a multifaceted structure of standards, supports, and protections that reflect the learning of many years. Since enactment of HITECH, the ONC, the Centers for Medicare and Medicaid Services (CMS), other federal and state agencies, and a myriad of stakeholders have been working to assemble and launch the many elements of a national EHR initiative.
First, Congress found that universal adoption and meaningful use of EHRs can indeed yield unique and substantial benefits that are urgently needed in our health care system—to improve individual and public health, support providers in the delivery of care, empower patients, and improve cost-effectiveness. At the same time, the implementation of health IT must be synergistic with other efforts. A modernized health IT system will be a resource for the innovation, spread of ideas, rewards for excellence, patient empowerment, and transparency that are all envisioned in the Patient Protection and Affordable Care Act.
To help achieve those benefits, HITECH authorized significant federal expenditure over a ten-year period: up to an estimated $27 billion in incentive payments through Medicare and Medicaid to support clinicians and hospitals in the adoption and use of EHRs. This projected federal spending recognizes both the real financial challenges that providers face in acquiring EHR systems, as well as the potential benefits to the nation as a whole from such investment.
Second, Congress made clear that HITECH’s incentive payments are not intended merely to support acquisition of EHR technology for its own sake. Simple digitalization of information does not produce the benefits we seek. Instead, as outlined by the law, it is the “meaningful use” of EHR systems that creates new value—including the capacity to make a patient’s information available when and where it is needed, and the capacity to improve patient safety and quality of care. To achieve those goals for the meaningful use of EHRs, the Department of Health and Human Services (HHS) developed three companion regulations:
- A CMS regulation defining the meaningful use objectives that providers must meet in the initial years to qualify for incentive payments (announced July 13);
- An ONC regulation specifying the standards, implementation specifications, and certification criteria that EHR systems must meet in order to be certified as capable of supporting the meaningful use requirements (announced July 13); and
- An additional ONC regulation initiating a rapid certification process, so that qualified EHR systems can be made available quickly, and providers can have confidence that the systems they acquire will successfully perform the functions required to obtain incentive payments (announced June 18.) A permanent certification process will be put in place shortly.
Third, HHS continues to build the protections necessary for an EHR-based health care system. Privacy and security are the bedrock of building trust, a “must-have” component for the success of health IT. On July 8, the HHS Office for Civil Rights announced a proposed rule strengthening protections under the Health Insurance Portability and Accountability Act of 1996 (HIPAA).
The proposed rule would expand individuals’ right to access their information and restrict certain disclosures of protected health information to health plans; extend the application of important privacy and security requirements to the business associates of entities already covered under HIPAA; establish new limitations on the use and disclosure of protected health information for marketing and fund-raising purposes; and prohibit the sale of protected health information without patient authorization.
Finally, Congress provided a variety of supports to assist providers in adopting and using EHRs, and to help enable EHR technology to keep moving forward:
- The Health Information Technology Extension Program ($643 million). A nationwide network of Regional Extension Centers (RECs) will provide technical assistance to clinicians, especially those who provide primary care services in smaller practices. Clinicians in such practices deliver the majority of primary care services but have the lowest rates of EHR adoption and the least access to resources to help them implement and use EHRs. The RECs’ goal is to provide outreach and support services to at least 100,000 high-priority primary care providers within two years. A Health IT Research Center will also provide support materials, especially to clinicians serving patient populations with special needs.
- The State Health Information Exchange Cooperative Agreement Program ($564 million). This grant program is helping states to rapidly build capacity for exchanging health information. The ability to exchange information is vital to realizing the benefits of EHRs, and state leadership is essential to achieving this.
- The Health IT Workforce Training Program ($118 million). There is a national shortage of health IT professionals who can help clinicians and hospitals achieve meaningful use. The workforce training program will support education of health IT personnel, including curriculum development, funds for community college programs, and competency examinations.
- The Beacon Community Program ($235 million). This grant program has identified leading communities where health and IT goals are being combined to demonstrate improved health and care results. They will focus on achieving measurable health and efficiency improvements over a compressed time frame, and they will provide lessons that can be transferred to other communities in the United States.
- The Strategic Health IT Advanced Research Projects (SHARP) Program ($60 million). This grant program will fund research to address key issues for health IT use that could impede progress in adoption and meaningful use.
In addition, the ONC continues to develop a National Health Information Network, a secure means for exchanging health information to ensure that the information follows the patient.
Thus, since enactment of HITECH, a constellation of efforts has been assembled and coordinated to carry out a national initiative on EHR adoption. These go well beyond the simple authorization of bonus payments through Medicare and Medicaid. They focus on achieving health results through meaningful use of EHRs. They address the bedrock issues of privacy, security, and public trust in health IT. And they include new programs to support providers in adopting and using EHR systems.
July 13: Beginning The Journey In Earnest
July 13 marked the beginning of a national EHR initiative. On that day, with the many other elements in place, the final CMS regulation on incentive payments and meaningful use was announced, as was the final ONC regulation on standards and certification.
In the final CMS regulation, significant changes were made from the rule published last January, to better enable providers to meet the requirements of meaningful use and qualify for incentive payments. The total number of objectives to be met in Stage 1 (2011-12), as well as the thresholds associated with those objectives, were reduced.
Other changes were also made in response to the more than 2,000 comments received. We recognize the challenge that providers face in making the transition to EHRs. Our goals for EHR adoption and use remain high, but they must be attainable by the average clinician and hospital. We have sought to make our objectives for meaningful use both ambitious and achievable.
The issuance of these two final rules and the launch of a national incentive campaign affirm and carry out the goals set by Congress and the President. After many years of discussion and learning, the time for action is here. EHR systems will not be perfect as we embark on this transformation. We will learn and adjust as we move through this multiyear process. And for smaller practices and hospitals especially we want to offer assistance.
But we believe the time for waiting is over. EHR adoption and meaningful use hold the promise of safer, higher-quality care for patients. They will enable health care professionals to serve with greater effectiveness and confidence. They will enhance public health and make more cost-effective use of our nation’s unparalleled health care resources.
It is our privilege to be able to help our health care colleagues bring about these improvements. It is our pledge to work closely and productively with them to achieve these goals.
Virtual Global, a West Virginia corporation, is a provider of cloud-enabled enterprise IT solutions, including the TeamHost™ cloud platform for creating and deploying SaaS systems without programming; HealthCapsule™, a toolkit for creating secure Health IT solutions; TeamLeader™, a project management 2.0 software for tracking and reporting on virtual teams in real-time; and cloudipedia.com, a website that brings cloud computing information to the masses. Since 1995, Virtual Global’s platform technologies have served commercial and federal customers worldwide with enterprise-class IT needs.