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January 14, 2005 DRAFT 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. While our standards and terminologies are far from comprehensive, the primary problem is not the lack of standards but the failure of existing systems to comply with these standards. The NHIN will be the impetus to address that shortcoming. The American College of Emergency Physicians recommends following the methods used by the HL-7 organization to achieve success in getting multi-stakeholder input to generate a useful standard that is not unduly influenced by a single faction or group. The NLM has successfully integrated and disseminated more than 100 standards, and ACEP believes the NLM should be charged with the diffusion of the NHIN standards and protocols, as well as the identification of needs and gaps in that standards repository. 15. Open standards A standards-creation process protected from undue proprietary influence can be achieved by following the examples of existing successful not-for-profit standards-making organizations, such as HL-7 and the College of American Pathologists (developer of SNOMED). HIPAA itself defines a number of standards that healthcare institutions should use to be compliant with the rule, and these standards should be adopted by the NHIN. Given emergency medicine’s broad clinical base and special connection to the goals of the NHIN, the involvement of the American College of Emergency Physicians in the development and diffusion of the standards is critical to the success of the NHIN and its real-world implementation. 16. Existing Standards Development Organizations (SDO) Carefully defining the scope of standards will help to ensure that multiple SDOs do not create competing standards for the same content or purpose. The not-for-profit standards-making organizations will certainly be willing to work to meet the needs of the NHIN, but the standards-making process is a slow and deliberative one, particularly when multiple stakeholders are involved. Maximizing the use and development of the NLM Meta-thesaurus will rapidly facilitate the interoperability of existing systems with overlapping content. Too many standards can be a bad thing, and as noted earlier, the need to adopt, incorporate, and extend the standards that exist is greater than the need for entirely new standards. 17. Standards requirements The health care information market is primarily driven by legislative mandates, medicolegal concerns, and payment policy. If federal payers reimburse health care providers who use the NHIN at a higher rate, a strong market incentive will be created to offer products that can take advantage of the NHIN. Mandating healthcare institutions to participate in the NHIN will also drive the rapid diffusion and widespread adoption of these standards. Much of this is already occurring due to the HIPAA requirements. The American College of Emergency Physicians believes that widespread adoption of these standards will be achieved if the resulting NHIN system is data rich, easy to use, and fast. Clinicians will support access to such a system once it is available, but only if it can be seamlessly used in their busy clinical practice. 18. The Federal Role The federal government transformed the medical informatics landscape when the NLM created the Meta-thesaurus to serve as a repository of standards mapped to one another. By licensing standards such as SNOMED-CT, the federal government took the healthcare industry another leap forward. Expanding these efforts by licensing other existing standards so that they can be freely used, and then mapping them in the Meta-thesaurus would greatly facilitate the development of the NHIN and benefit the entire healthcare information industry. Financial/Regulatory Incentives and Legal Considerations 19. Incentives needed Given the complexities and costs associated with initial data sharing with a NHIN, it seems intuitive that incentives will be needed to drive participation. While nearly every healthcare entity will require some degree of re-tooling of their IT infrastructure to share data, it is unlikely that significant immediate financial rewards for participation will be realized. At first glance it might seem that significantly more effort will be required to share data upstream with a NHIN than it will be to use downstream data. However, the American College of Emergency Physicians believes that ultimately, the most effective presentation of NHIN data to clinicians will be at the point of care, and will likely be maximized by seamless integration and presentation of NHIN data as a key feature of clinical systems of the future. If delivered and executed properly, incentives for using the NHIN to obtain patient data at the point of care should not be required. However, incentives will be required at the beginning to drive the process change, hardware and software implementation, and behavior change inherent to initial participation in the NHIN by clinicians and health care enterprises. 20. Incentive types Individual clinicians and smaller health care organizations may need financial support to offset initial investment to comply with system requirements. Initially, all participants should receive a small direct add-on payment for services rendered for public program patients through CMS in the context of upstream data sharing with the NHIN. Alternatively, for entities not participating after a specific deadline, the federal government could mandate that specific, highly structured, NHIN critical data elements be required within the body of all bills submitted to CMS. However, if true convenience, cost savings, or efficiencies can be realized through access to NHIN data, any and all premiums can be phased out over time once use of NHIN data downstream shows value to end users. Ultimately, once the healthcare IT industry adopts recommendations for data sharing with the NHIN, downstream access may simply become predicated on upstream data sharing for all health care entities. 21. Legal impediments The American College of Emergency Physicians believes that two major legal impediments must be addressed if the NHIN is to be successful. The first involves liability for breaches of security, and the other involves liability for failure to notice or correctly interpret issues hidden in the vast volume of newly available results for tests that may have been ordered by another clinician. According to a 2001 Evans Data poll, roughly 27 percent of developers surveyed in the banking and financial services industries said they had experienced a security breach in the prior year. According to the New York Times, nearly ten million people were victims of identity theft and fraud in a recent 12-month period. Ongoing fraud and identity theft has been reported as costing businesses and financial institutions about $48 billion and consumers $5 billion annually. When the NHIN exists, breaches of security will be inevitable. Hospitals recognize this and will not participate without strong protection from litigation, HIPAA-mandated penalties, and penalties from other local and federal laws. A common cause of malpractice suits relates to the failure of a clinician to notice or properly interpret a test result, even if that test was not ordered by the clinician or related to the patient visit. Physicians and hospitals are well aware of many cases in which lawsuits are brought against physicians who have seen an x-ray on a patient and allegedly have failed to recognize some subtle finding unrelated to the reason for treatment. There is a credible fear that with an NHIN in place, clinicians will be held responsible for every test at every institution the patient has ever visited. To be successful, the liability for test result management should be limited to the clinician who actually ordered the test. The costs of litigation are high and are increasing. Successfully defending a frivolous case can bankrupt a small practice. The NHIN should provide some mechanism, such as binding arbitration, by which issues may be resolved without costly litigation. 22. Organizational mechanisms Enabling legislation and regulation for RHIOs and the NHIN must address the concerns listed above and provide appropriate liability protections for all participants in the system. Other Issues 23. Technical architecture Emergency departments provide critical care to patients 24 hours a day in a fast-paced and challenging environment. In an emergency department, clinical information must be constantly available in a manner that is fast and intuitively simple. Each component of an NHIN must be designed for 100% up time, using parallel redundancy and hot-plug hardware and software techniques to ensure that access is never interrupted for longer than is required for a server reboot. An appropriate technical infrastructure must be easily maintained and inexpensive, but these issues are secondary. Speed and reliability are crucial; if the system is not fast and always available, it will not meet the needs of clinicians and patients. Comprehensive multi-center systems currently exist that have reliably achieved subsecond access times for multi-terabyte datasets containing every known type of clinical data – including all image types as well as all ASCII data within an entire healthcare system. Such systems have demonstrated 99.9997 percent up time and a very low staff overhead by exploiting the intrinsic modularity and strong encapsulation of stringently object-oriented designs and metadata-driven data-centric architectures. Designs that depend upon a rigid hierarchical or highly defined relational data structure have not been shown to meet minimum clinical performance measures in any live emergency care environment. Thus, we are concerned that systems based on this approach might fail to provide the performance and reliability critical to quality emergency care. One architecture that is popular for political reasons has been a fully federated model in which each producer of data is solely responsible for maintaining and providing access to that data. The viability of this architecture is suspect for several reasons. The majority of data producers are small clinical entities that cannot provide 24 x 7 support for a data system. Many small entities have no physical space that is appropriately conditioned for “always on” computing equipment. Connectivity and bandwidth may not be adequate to serve any significant number of users. Building and staffing thousands of small 24-hour data centers is likely not an economically attractive approach. At the opposite end of the spectrum, a fully centralized regional data store model as described above is technically reasonable, but politically unappealing to many stakeholders. The American College of Emergency Physicians believes a hybrid model may be technically robust, politically palatable, and much more likely to meet the needs of the emergency care environment. In this model, each creator of data has three options, each of which provides constant access to the data with zero scheduled downtime and 24 x 7 support to resolve unanticipated problems. Larger institutions may elect to provide external access to data that is maintained within a compatible on-site data repository managed around the clock by their own staff. Mid-size providers may elect to maintain a local repository of data with a replicated copy in a dedicated database hosted at some central exchange. Queries may be auto-directed to either copy of the data, so that if the local copy is unavailable at any time, the centrally replicated version remains accessible. Those who choose this option would be considered to own the hosted (replicated) database as well as their on-site database. Smaller care providers may simply prefer to export their data directly into a central exchange, with no need for the cost and difficulty of managing a locally stored data store. Those who choose this option would be considered the owners of their data as it exists within the regionally hosted data store. As noted earlier, ACEP is concerned that the constant up-time, high speed, and reliability needed for emergency care cannot be assured with a totally decentralized infrastructure (data always residing with the creator). To an unacceptable degree, such a system would be at the mercy of the speed and uptime of each participant and of each hardware and software component at every data storage location. Centrally-cached systems routinely provide sub-second access to all components of a patient’s record across entire regions; fully distributed data stores, in which a central collator merely stores pointers to data wherever it resides, have not been shown to approach this needed level of performance and reliability. The requirement to collate data from many different locations multiplies the potential points of failure in a decentralized system, reducing reliability at the same time that it reduces speed. A more comparable architecture is that utilized by “Google”, which centrally caches web pages to speed searching and provides a reliable way to obtain the page data even when the originating system is temporarily or permanently down. Google could not begin to approach any acceptable level of performance if it contained no cached copies of any data, and was forced to read each and every web page from the original site whenever a query was performed. 24. Measuring success Important metrics of success should include: The speed of the system as measured by the average access time for common queries. The reliability and uptime of the system as a whole, of its various nodes, and the percentage of queries for which some or all of the data is inaccessible. The frequency of use in clinical practice by the full spectrum of clinicians whose patients would benefit from the ready availability of NHIN data. The frequency of use by emergency physicians, whose patients are at the highest short-term clinical risk and who have the highest need for immediate access to historical information from other sites. Measurement of real clinical outcomes such as mortality reduction, morbidity reduction, medical error reduction, and other objective quality metrics. At least some of the metrics should be measured using integrated, real-time survey mechanisms that are part of the NHIN. It is very important to note that any outcomes metrics should represent real clinical outcomes rather than pseudo-outcome metrics (e.g. reductions in test utilization) that are not directly based on clinical outcomes. Cost savings should not be used as a primary measure of success, because although cost savings is an important goal of the NHIN, it is not necessarily a good outcome measure. Cost savings analyses are complex. There may be times in which the NHIN provides the data that guides the clinician to order an expensive but decisively diagnostic test. While the short-term cost for that visit might have been increased by the NHIN, the long-term effect on the system of that focused diagnostic plan might be a net cost savings. To provide a “real-life” context for the importance of EHRs, an ACEP member shared the following true anecdote that demonstrates a tremendous benefit of an improved NHII on safety, quality, and costs. A 78 year- old woman, presented to the emergency department with symptoms of a urinary tract infection. Both the nurse and physician asked her about allergies, and she claimed she was allergic only to penicillin. She was prescribed a sulfa-based antibiotic and discharged. The next day the patient developed a severe reaction which progressed to StevensJohnson Syndrome (a potentially life-threatening, drug-induced disorder in which a patient’s skin blisters and peels off). Over an excruciating thirty-day period, the patient was hospitalized in the intensive care unit where she required multiple skin grafts. Her course was also complicated by multiple infections and blindness. Her medical costs exceed $500,000, and her pain and suffering were extraordinary. Subsequently it was discovered that the patient’s primary care physician's record clearly documented a past allergy to sulfa drugs. Tragically, the emergency care providers who initially treated her did not have access to these records. Had a National Health Information Network been in existence, the scenario would have been much different: The local Health Information Exchange would have connected to the patient’s primary physician’s electronic health record and added allergies to both penicillin and sulfa to her emergency department electronic medical record. She would have been treated with ciprofloxacin as an alternative antibiotic and recovered uneventfully. Over $500,000 in medical expenses, plus legal expenses, and pain and suffering would have been averted. We appreciate the opportunity to offer these comments and we look forward to working cooperatively with your office in order to address these crucial issues. If you have any questions about our comments and recommendations, please contact Barbara Marone, ACEP’s Federal Affairs Director at (202) 728-0610, ext. 3017. Sincerely, Robert E. Suter, DO, MHA, FACEP President