Informatics Now Lives in a HITECH World

The flurry of activity from the Office of the National Coordinator for Health IT (ONC) in late 2009 laid out the implementation plans of the Health Information Technology for Economic and Clinical Health (HITECH) Act of the American Recovery and Reinvestment Act (ARRA, also known as the economic stimulus package). The scope of programs was so immense that few aspects of the biomedical and health informatics field will be unaffected by HITECH. I think we can plainly say that informatics now lives in a HITECH world.

The discipline of biomedical and health informatics has had an increasingly important and visible role in individual health, healthcare, public health, and biomedical research in recent years. But HITECH will impact virtually every aspect of our field. It will certainly define the path and set the implementation priorities for hospitals and physician offices implementing their electronic health records (EHR). HITECH will drive the standards agenda for health data and information. It will also set the bar for privacy and security matters. Finally, HITECH will drive the academic informatics agenda through its impact on research programs (the SHARP program), demonstration projects (the Beacon program), and education (the health IT workforce funding initiatives).

There will, of course, be some activity outside the confines of HITECH. More fundamental research and training of future researchers will continue to be the purview of the National Library of Medicine (NLM). Informatics will continue to play a key role in the Clinical and Translational Science Award (CTSA) program of the National Institutes of Health (NIH). Likewise, the Agency for Healthcare Research and Quality (AHRQ) will likely continue its quality and comparative effectiveness research agendas with the heavy utilization of health IT. But even all of these programs will be impacted by HITECH's provisions and regulations concerning EHR data, its driving of the research agenda, and its influence on curricula in educational programs.

There has been much written in detail about various aspects of HITECH. Probably the best big picture overview is the New England Journal of Medicine article by the National Coordinator himself, Dr. David Blumenthal. This paper lays out the vision of "meaningful use" of health information and the ONC's planned path for achieving it. There are also a number of Web sites and blogs that maintaining ongoing information and commentary about the programs. These include:

• Geek Doctor blog - I have to commend Dr. Halamka for keeping us up to date with a very readable overviews of the emerging programs, regulations, technologies, etc.
  
• HIMSS - Also has a nice site, some of which is limited to members only, that also is kept up to date well
  
• AHIMA - Also starting to provide materials on meaningful use and related topics as well
• HISTalk - this more eclectic blog provides other interesting perspectives
  

There are many other interesting and informative sites, and I am not meaning to slight any of those by not including them. But the above sites are good entry points for those wishing to learn more about how HITECH will drive the EHR implementation agenda in the coming years. Google and other search engines can also be very helpful for finding more information, as can professional organizations to which readers may belong and that provide their perspectives. A nice consultant-style overview is provided by David Classen and Erica Drazen of CSC Corp..

It is important to remember that the goals of HITECH are ultimately rooted in improving individual health, healthcare, and public health. The goal is not adoption for the sake of technology. All HITECH rules, regulations, incentives, programs, etc. are linked to one of five underlying goals for the healthcare system:

1. Improving quality, safety and efficiency
2. Engaging patients in their care
3. Increasing coordination of care
4. Improving the health status of the population
5. Ensuring privacy and security

The financial incentives for EHR adoption are enshrined in two key documents that were released in late December, 2009. Both of these documents are interim documents, with 60-day comment periods before being finalized in the spring. These documents are:

• The Notice of Proposed Rule-Making (NPRM) - the rules for how incentives for meaningful use will be funded through Medicare and Medicaid reimbursement by the Centers for Medicare and Medicaid Services (CMS)
  
• The Interim Final Rule (IFR) standardizing what will be required to achieve meaningful use of EHRs by ONC
  

The NPRM defines eligible professionals and hospitals who can qualify for the meaningful use incentives. It stipulates what these professionals and hospitals must do over what time frame to achieve the incentive payments. Meaningful use is defined to consist of three requirements:

1. Use of certified EHR technology in a meaningful manner
2. Utilize certified EHR technology connected in a manner that provides for the electronic exchange of health information to improve the quality of care
3. Using certified EHR technology, the provider submits information on clinical quality measures

The NPRM defines three phases of increasing criteria and dates by which they must be accomplished to receive incentive payments. These phases were formerly named by the year that providers needed to implement them - 2011, 2013, and 2015 - but are now called stages, with the maximum incentive dollars received by those who implement them by those dates (i.e., stage 1 in 2011, stage 2 in 2013, and stage 3 in 2015). Eligible professionals and hospitals who implement them at later dates receive less funding, and all who do not implement stage 3 by 2015 are assessed a penalty through decreased Medicare or Medicare reimbursement.

The stages of adoption and their key features are as follows:

• Stage 1 - electronically capturing health information in a coded format, using that information to track key clinical conditions, communicating that information for care coordination purposes, implementing some clinical decision support tools, and initiating the reporting of clinical quality measures and public health information.
• Stage 2 - expand on Stage 1 to focus on continuous quality improvement at the point of care and the exchange of information in the most structured format possible.
• Stage 3 - focus on promoting improvements in quality, safety and efficiency by encouraging decision support, patient access to self-management tools, access to comprehensive patient data, and improving population health.

The NPRM presents the requirements for Stage 1 use of an EHR by hospitals and professionals in a meaningful manner. There are 23 criteria, which differ slightly whether for hospitals or professionals (pp. 103-108). Each is tied back to one of the five healthcare outcomes goals listed above. Some of the better known and more widely discussed criteria include:

• Use computerized provider order entry (CPOE) for orders (any type) directly entered by authorizing provider. One of the differences between hospitals and professionals is that the former are required to use CPOE for 10% of all orders whereas professionals are required to use it for 80%.
• Implement drug-drug, drug-allergy, and drug-formulary checks.
• Maintain an up-to-date problem list using ICD-9 or SNOMED.
• (Professionals only) Use electronic prescribing for 75% of all prescriptions.
• Exchange key information electronically among providers of care and other patient-authorized entities.
• Provide summary care record for 80% of care transitions.
• Provide electronic syndromic surveillance data electronically to public health agencies.
• (Professionals only) Provide patients with electronic access to their information for 10% of all patients.
• Protect electronic health information created or maintained by certified EHR technology through the implementation of appropriate technical capabilities.

Some of these criteria are open to interpretation and it is likely some will be modified when the final rule is issued. Many organizations have taken issue with various aspects of these criteria, usually arguing that the definitions are vague and/or they are not likely to be achieved, even for organizations that already have advanced EHR implementations.

The NPRM also lists the quality measures that meaningful users must report on in Stage 1. There are listed 35 clinical quality measures in nine categories for which hospitals must report to meet the meaningful use criteria (pp. 152-162). All of the measures have been endorsed by the National Quality Forum, and 25 have been adopted by the Hospital Quality Alliance. However, only nine of the measures are currently in use in Medicare's pay-for-reporting program, meaning that hospitals may face significant challenges in implementing the new measures if they are all adopted in the final rule. Hospitals will be required to report on all quality measures for which they have any applicable patients, not just for measures applicable to their Medicare patients.

For eligible professionals, the NPRM has a list of 90 quality measures that are grouped into 15 categories by specific medical specialties (pp. 143-151). Professionals must only report on measures for the category of professional in which they fall.

The IFR provides a definition of certified EHRs and an initial set of standards, implementation specifications, and certification criteria for EHRs. It creates standards for certified EHRs in four categories: content, vocabulary, transmission, and privacy/security. Certified EHR Technology is defined by the IFR as consisting of a Qualified EHR that has been certified by an authority designated by the Department of Health & Human Services (in a process to be determined). A Qualified EHR consists of an electronic record of health-related information on an individual that:

• Includes patient demographic and clinical health information, such as medical history and problem lists.
• Has the capacity to provide clinical decision support; support physician order entry; capture and query information relevant to health care quality; and exchange electronic health information with, and integrate such information from other sources.

Of course, as Dr. Blumenthal notes in his New England Journal of Medicine article, achieving the goals of HITECH and meaningful use will not happen with the financial incentives alone. There needs to be an infrastructure that will support the path to getting there. He notes a number of programs that are also funded under HITECH that will help hospitals and professionals reach meaningful use, especially primary care physicians in under-resourced practices. About $2 billion of ARRA funding has been devoted to these programs.

One substantial supporting program will be the Health IT Regional Extension Centers (RECs). About 70 RECs will be funded with $643 million to provide guidance, mainly to small primary care practices, in achieving meaningful use. Because there will be 70 programs, some larger states will have more than one REC while some smaller states will participate in multi-state RECs. These programs will have some similarity to the long-standing agricultural extension service that farmers have relied on for years to improve the capabilities of their farms.

Another key component to achieving meaningful use, likely familiar to readers of this blog, is development of the health IT workforce. The details of these programs have been described in previous postings, but essentially two types of programs will be funded. One will be the funding of five regional community college consortia to achieve 51,000 trained workers over five years (10,500 per year, starting in the fall of 2010) in six specific job roles. The other program will be the funding of universities to train another 1000-1500 individuals per year over three years for six additional higher-level job roles. Also funded under this initiative will be Curriculum Development Centers, mainly to assist community colleges, and a certification examination for graduates of the community college programs. A total of $118 million will be funded under these programs.

Additional funding will go for the following programs (and some additional ones in Dr. Blumenthal's paper and not listed here):

• State-based health information exchange (HIE) - $564 million in grants to the states to develop HIE programs.
• Beacon communities - $235 million to fund up to 15 communities that provide exemplary demonstration of the meaningful use of EHRs to bring out measurable improvement in the quality and/or efficiency of healthcare and/or public health.
• Strategic health information advanced research projects (SHARP) - $60 million for four collaborative research centers in the areas of: Security for Health Information Technology, Patient-Centered Cognitive Support, Healthcare Application and Network Platforms, and Secondary Use of EHR Data
  

I think it is safe to say that ONC and the rest of the government have "played their cards" in the implementation of HITECH, and the above rules and programs will drive the agenda of biomedical and health informatics and related health IT for years to come. These efforts now define what the key functions of EHR systems will be, how hospitals and professionals will fund their use, and what quality measures hospitals and professionals will need to report. The agenda for HIE will now be more clearly defined and very focused at the level of individual states. These programs also define the pathways for various professionals to enter the workforce and provide funding for them. Finally, leadership for both demonstration projects as well as the research agenda will be funded through the Beacon and SHARP programs.

Some ONC leaders have stated that HITECH is a "down payment" on health care reform. Of course, given the state of the health care reform debate as I write this in mid-January, I am not sure what the final payment will be or what healthcare will be in place as these programs are implemented. I do hold the opinion that HITECH is more likely to succeed if we transform our healthcare system to one that better values quality and efficiency, but even under the present system, it is likely to result in some positive improvement.

This is a defining moment for the informatics field. Never before has such money and attention been lavished on it. HITECH provides a clear challenge for the field to "get it right." It will be interesting to look back on this time in the years ahead and see what worked and did not work. Whatever does happen, it is clear that informatics lives in a HITECH world now.