National Coordinator, Health Information Technology

January 14, 2005DRAFT

David J. Brailer, MD, Ph.D.

National Coordinator, Health Information Technology

Department of Health and Human Services

517-D, Hubert H. Humphrey Building

200 Independence Avenue, SW

Washington, DC 20201

RE: Request for Information: Development and Adoption of a National Health Information Network

Dear Dr. Brailer:

On behalf of the American College of Emergency Physicians (ACEP), I am pleased to respond to your Request for Information on the Development and Adoption of a National Health Information Network. ACEP is a national medical specialty society with more than 23,000 members. ACEP is dedicated to improving the quality of emergency care through continuing education, research, and public education. We appreciate the opportunity to provide the Department with our comments on developing the infrastructure, standards, and proposed use of information technology in healthcare, particularly as it affects the delivery of emergency medicine services.

ACEP members are actively involved in research and development projects that contribute significantly to the evolving National Health Information Network (NHIN). In 1994, ACEP developed and first presented the “Emergency Department of the Future” project which includes many of the concepts now planned for implementation as part of the national health information infrastructure. More recently, in cooperation with the Society for Academic Emergency Medicine, ACEP members coordinated an Emergency Medicine Information Technology Consensus Conference in May 2004. The results of that meeting were published in the November 2004 issue of Academic Emergency Medicine (Vol 11, No 11) as a special issue devoted to medical informatics. This consensus document represents a landmark publication in the field of medical information management technology, and we would be pleased to share it with you and your staff.

The emergency department is one of the most complex and challenging practice environments in all of medicine, making emergency medicine one of the specialties most in need of an improved national health information infrastructure. According to the CDC’s estimates for 2003, the nation’s emergency departments care for more than 114 million patients per year of all ages; for undifferentiated acute medical and traumatic conditions; in rural, urban, and suburban areas; 24 hours a day, 7 days a week, 365 days a year. Due to the very nature of emergency care, it is often delivered without the benefit of a patient’s vital past medical information. Nevertheless, emergency care providers perform admirably as the safety net for a healthcare system that is chronically overcrowded and poorly supported. Clearly, all patients will benefit from improved healthcare information technology, but none will benefit as much as those cared for in emergency situations.

The American College of Emergency Physicians is actively participating in and endorses the Collaborative OCNHIT RFI response developed by the Connecting for Health workgroup. In addition, we offer our own comments to address issues specific to emergency medicine and to clarify the impact that the implementation of a national network will have on the practice of emergency medicine.

Background

1. National Health Information Network (NHIN) definition

The value of NHIN, as defined in the Collaborative Response, includes several capabilities that American College of Emergency Physicians believes are so important to emergency medicine that they must be highlighted. The NHIN must:

• Provide the connectivity necessary for high quality healthcare by allowing individuals and their authorized health professionals to access necessary health information about a person exactly when, where, and how it is needed, in real time.
• Support the creation of distilled datasets that are useful for quality measurement and reporting, product effectiveness monitoring, research and other purposes.
• Enhance quality, safety, and professionalism by providing physicians with the ability to look at aggregate outcomes of care and benchmarks of performance.

2. The overall NHIN model

The American College of Emergency Physicians believes improvements in emergency care information systems are vital to the interests of the more than 114 million Americans who seek care in EDs each year. Emergency care providers interact with all other medical specialties, and the ED frequently serves as the hub of patient care by bridging inpatient and outpatient services. Use-case analyses in medical informatics and information exchange frequently are based upon emergency medical encounters. Because of our unique position as the health care system’s safety net and our organization’s unique position in the house of medicine, we believe ACEP should and must play a leadership role in the pursuit of a NHIN.

ACEP agrees conceptually with the vision of developing a series of regional health information networks that are integrated to form a coordinated national system. An important component that should not be neglected is the development of specialty-based communication and secondary datasets to support research, benchmarking, and health policy. Specialty societies such as ACEP are uniquely positioned to play an important role in facilitating these capabilities. Also, ACEP is a non-profit organization whose role is to promote high quality emergency care, as opposed to the sometimes-conflicting priorities of insurance companies or other commercial stakeholders.

Consistent with this vision, ACEP is already pursuing projects leading to a national emergency medicine web-based communication and preparedness network, and a national emergency medicine encounter registry. These projects will create additional significant

benefits for the other specialists that interact with emergency medicine every day. We urge and seek funding for these projects in the near future as key components of NHIN.

3. National vs. local/regional aspects of NHIN

The American College of Emergency Physicians concurs that both local and national strategies are necessary with two areas of particular importance to emergency medicine:

While interoperable regional exchange organizations remain a sensible model on which building blocks can be created for a national system, policy supporting national capabilities is vital. An interoperable national routing service is imperative for innumerable patients who travel among multiple geographic regions. It is of paramount importance that all regional systems share their information to support the national communication and preparedness and benchmarking initiatives previously described.

Emergency medicine, more than any other specialty, is affected by the speed of system response and requires information in real time and with 24 x 7 dependability. If multiple local regions build their own solutions, specific criteria must be developed that define acceptable system performance for each Regional Health Information Organization (RHIO) in order to meet the critical demands of busy emergency departments nationwide.

Organizational and Business Framework

4. NHIN organizational framework

a. Development b. Operational policies c. Acceleration d. Operations

The American College of Emergency Physicians strongly supports capitalization assistance to establish additional RHIOs, evaluation studies, and models for sustaining operations. From our experience with disaster preparedness funding, ACEP believes that federal funding directed only to state governments achieves less than optimal results. A more effective funding mechanism to support development and operation of RHIOs should be provided directly to RHIOs that are already working to achieve articulated results.

5. Financial model for building NHIN

At this early stage of NHIN development, funding is most likely to come from a combination of federal sources, private foundations, and enlightened companies that foresee the future benefits. An important requirement for this early funding must include systematic evaluation, preferably with formal return on investment studies.

6. Financial model for sustaining NHIN

Various communities are considering transaction fees, subscription, or utility models for supporting ongoing operations. The American College of Emergency Physicians believes that the “transaction fee model” is ill advised for a variety of reasons. Transaction fees create a strong disincentive for providers to access the NHIN system. This is particularly true in emergency medicine, which provides a disproportionate share of charity care to uninsured and otherwise disadvantaged patients. Therefore, EDs would have few means to recover extra costs associated with use of the NHIN system. Further, it is those that pay for health care (government and employers) who will benefit financially from a more cost-

effective health information-sharing environment. We believe that the most reasonable funding mechanism is one that aligns both the return and the investment and thus favors either a public utility model or a payer-supported system.

7. Privacy and security considerations

The American College of Emergency Physicians supports the general statements in the Collaborative Response, and believes network operation should be consistent with current HIPAA rules and with provisions that facilitate access for continuing care and emergency situations.Given the nature of emergency medicine, cumbersome or onerous authorization requirements must be avoided. Moreover,it is vitally important that a "break the glass" policy be included, whereby authorized emergency clinicians are able to gain access to critical information with a doctrine of presumed consent when patients have emergency conditions and are unable to provide consent.

8. Support for public policy

The overriding reason for creation of a NHIN must be improvement in the quality and efficiency of healthcare for all Americans. Quality can be defined in many ways, including improvements in morbidity and mortality, cost effectiveness, patient satisfaction, and access to care. Secondary use of NHIN data should support improvements in public health through surveillance, benchmarking, and policy support initiatives. The Collaborative Response recommends the establishment of a Standards and Policy Entity (SPE) that defines the standards and policies that underpin the Common Framework.The American College of Emergency Physicians believes that medical specialty societies should be provided representation within such an entity.

Management and Operational Considerations

9. Encouraging competition

As noted above in Section 4, the American College of Emergency Physicians believes funds should be made available to a variety of local, regional, and state-based initiatives, including public and private partners, in order to stimulate innovation at many levels.

10. Infrastructure that encourages: a. Private investment b. Nonproprietary control c. Interoperability d. Innovation

The American College of Emergency Physicians is concerned that reliance on private investment as the primary funding source will result in undesirable and unintended consequences. Propriety stakeholders that invest in the infrastructure may bias development in favor of their business needs. This could result in an unfair advantage in the marketplace and disrupt the usual competitive forces that drive innovation. It could also result in an infrastructure optimized for the needs of private investors rather than one optimized for the needs of our healthcare system as a whole.

The banking industry is a frequently cited example of a system funded by private investment that uses data standards to achieve interoperability. However, this privately

funded system succeeds because banks are free to turn away non-paying customers, impose fines on those who do not comply with their rules, and manage their financial risk under legal contracts. By altruistic mission and by federal law, emergency departments cannot

turn away patients. Further, hospital emergency departments go well beyond the requirements of federal law and provide the full spectrum of care to patients regardless of their ability to pay. Because of its ability to provide a virtual continuum of care across

facilities, one of the beneficiaries of a NHIN will be patients without a regular source for medical care who utilize a variety of healthcare settings. Therefore, a public utility model would best serve the needs of the NHIN by providing a system that is fiscally responsible, yet not unduly influenced by corporate profit motive. By establishing standards by which all systems must interact, the health information technology industry will be free to innovate and compete on features and functionality rather than holding customers hostage with proprietary data formats and structure.

11. Broad based use

In 1998, the American College of Emergency Physicians ACEP adopted a policy recommending that every emergency department provide access to the Internet as a clinical resource. The recent Society for Academic Emergency Medicine Information Technology Consensus Conference re-stated this policy in its final recommendations. Virtually every hospital emergency department in America now has Internet access making it the logical means for data exchange. Limiting the NHIN to a non-standard or proprietary system has the potential to limit its access and usability.

Ensuring broad-based use will also depend on minimizing the effort and expense each healthcare entity must commit to participate. Rather than requiring healthcare entities to make every data element available to the NHIN, data elements should be prioritized based on the needs of the various specialties. The highest value data elements for the various specialties should be carefully chosen and required for the initial NHIN implementations.

When prioritizing the data, objective data is of primary importance.ACEP believes that the highest value objective data elements for emergency medicine include discharge summaries, patient medications, allergies, problem lists, reasons for previous encounters, EKGs, and the results of major tests such as CT scans and angiograms. (This is basically a subset of the Continuity of Care Record (CCR) HL-7 specification). Limiting the data elements required for participation to those with the highest value will lower the cost for smaller healthcare entities, particularly those in low-income areas.

12. Community and Regional Information Organization Effects

The NHIN will impact CHINs and RHIOs by ensuring that they develop local infrastructures that will meet the national need. The nascent RHIOs and CHINs have helped to break the traditional data barriers that sequester patient data within each healthcare entity. It is critical that these organizations recognize that their existence is not an end, but a means to an end. The goal is to ensure that healthcare providers have access to critical patient information no matter where that patient might present for care, even if that happens to be outside of the patient’s community or region. A NHIN will help CHINs and RHIOs to think beyond their local agreements and standards and build an infrastructure that can seamlessly interact with other CHINs and RHIOs to better meet patient needs.

One issue that is likely to arise is data mapping among various standards and protocols already in use to ensure that systems can communicate with one another. Even with common standards, there are issues with integration at the application and institutional level. For instance, hospitals may use different units or different methodologies for the

same lab test. For example, a D-dimer test done at Hospital A may use the latex agglutination method while the same test at Hospital B uses the ELISA method. The two

tests have the same name but different reference ranges and different uses in clinical care. Such issues may lead to errors if not addressed.

Another issue likely to arise is the ability of RHIOs and CHINs to manage the various data-sharing concerns. The Society for Academic Emergency Medicine Information Technology Consensus Conference concluded that, when caring for the emergency patient, “Electronic clinical records should be released immediately upon the certification of a clinician that there is an immediate clinical need for the release of those records.” The issues of security, identification and authentication should facilitate that process rather than hinder it.

13. Impact on Health Information Technology Industry

The American College of Emergency Physicians believes that the impact of a NHIN on the Health Information Technology (HIT) industry will be powerful and positive. Companies will form to help institutions meet the needs of the NHIN, and the existing members of the industry will be forced to reconfigure their systems to be inter-operative and standards-based. These changes have been recommended by the informatics community for decades. The NHIN will create the market forces necessary to make change a reality.

This environment also presents an opportunity for powerful players in the industry to manipulate the system to their own ends.Whenever appropriate, the standards and protocols adopted should be those already proposed by governmental and not-for-profit organizations such as the National Library of Medicine, HL-7, the National Committee on Vital and Health Statistics, and medical societies. The Society of Academic Emergency Medicine’s recent consensus document makes very specific recommendations on many of the standards and protocols that should be used for emergency medicine purposes and we would be pleased to share it as a resource document for the NHIN.

Standards and Policy Requirements for Inter-Operability

14. Standards oversight entities

Several standards have been developed and are in active use today. The organizations that exist, such as HL-7, have been very effective in creating useful and widely used standards and protocols. The National Library of Medicine (NLM) has done an outstanding job of collating various terminology standards and even licensing standards to make them available to the general public. They have also done much of the necessary work to map the terminologies from one to another so that data in one format can be “translated” to another format.