Healthcare Terminologies and Classifications:
An Action Agenda for the United States
American Medical Informatics Association and American Health Information Management Association Terminology and Classification Policy Task Force Acknowledgements
AHIMA and AMIA Terminology and Classification Policy Task Force Members
Keith E. Campbell, MD, PhD The American Health Chair, AHIMA and AMIA Terminologies and Classifications Policy Task Force Information Management Chief Technology Officer, Informatics, Inc., and Assistant Clinical Professor; Association (AHIMA) is the Department of Medical Informatics and Clinical Epidemiology, Oregon Health and premier association of health Science University information management Suzanne Bakken, RN, DNSc, FAAN (HIM) professionals. AHIMA’s Alumni Professor of Nursing and Professor of Biomedical Informatics School of 51,000 members are dedicated to Nursing and Department of Medical Informatics, Columbia University the effective management of personal health information Sue Bowman, RHIA, CCS needed to deliver quality Director of Coding Policy and Compliance, American Health Information healthcare to the public. Management Association Founded in 1928 to improve the quality of medical records, Christopher Chute, MD, PhD AHIMA is committed to Professor and Chair of Biomedical Informatics, Mayo Foundation advancing the HIM profession in an increasingly electronic and Don Detmer, MD, MA President and Chief Executive Officer, American Medical Informatics Association global environment through leadership in advocacy, Jennifer Hornung Garvin, PhD, RHIA, CPHQ, CCS, CTR, FAHIMA education, certification, and Medical Informatics Postdoctoral Fellow Center for Health Equity Research and lifelong learning. To learn more, Promotion, Philadelphia Veterans Administration Medical Center go to www.ahima.org. Kathy Giannangelo, MA, RHIA, CCS, CPHIMS Director, Practice Leadership, AHIMA
Gail Graham, RHIA The American Medical Director, Health Data and Informatics Department of Veterans Affairs Informatics Association (AMIA) Stanley M. Huff, MD is the premier organization in Professor of Medical Informatics, University of Utah Senior Medical Informaticist, the United States dedicated to Intermountain Healthcare the development and application of medical informatics in the Linda Kloss, MA, RHIA, FAHIMA support of patient care, teaching, Chief Executive Officer, AHIMA research, and healthcare administration. AMIA links Margaret Skurka, MS, RHIA, CCS developers and users of health Professor and Director of Health Information Programs, Indiana University Northwest information technology, creating Mary Stanfill, RHIA, CCS, CCS-P an environment which fosters Vice President, Practice Resources, AHIMA advances that revolutionize healthcare. To learn more, go to Valerie Watzlaf, PhD, RHIA, FAHIMA www.amia.org. Associate Professor, Department of Health Information Management, School of Health and Rehabilitation Sciences, University of Pittsburgh Healthcare Terminologies and Classifications: An Action Agenda for the United States
Table of Contents
Executive Summary ...... 4 Background ...... 5 Magnitude of the Problem ...... 7 The Vision and Goals for the US ...... 9 What to Do Next ...... 15 Role of AHIMA and AMIA ...... 18 Conclusion ...... 19 Table 1: Governance of Various Terminology Systems ...... 20 Table 2: Development and Maintenance of Various Terminology Systems ...... 23 Appendix A: Australia, the United Kingdom, and Canada ...... 27 Appendix B: Terminology Services and Tools ...... 29 Table 3: Terminology Services and Tools in Four Organizations ...... 30 Glossary ...... 32
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This white paper is a revised version of a paper originally released by AHIMA and AMIA in 2006.
©2007 Healthcare Terminologies and Classifications: An Action Agenda for the United States
Executive Summary committed to the development of the emerging national health information system. But both Terminologies and classifications form the organizations recognize that additional foundations of information content in the resources and appropriate funding are needed electronic health record (EHR) and are the to build on initial work for healthcare basis for research, public health reporting, and terminologies and classifications strategy, healthcare payment.1 They are integral to governance, and development and interoperability and, thus, a successful national maintenance processes. health information system that promises To address these issues, AHIMA and AMIA increased patient safety and reduced costs. convened a Terminology and Classification Although there has been significant progress in Policy Task Force composed of experts in the United States to better understand the role medical and nursing informatics (a field that terminologies play in our health information studies the support of medicine by information systems, and to make terminologies more systems), health information management broadly available in machinable forms, more professionals, experts in nosology (the branch must be done to ensure that this progress of medicine that deals with the classification of serves as a robust foundation for the diseases), and educators. The group’s goal was information content of the EHR. to develop recommendations for the major challenges that would help establish a process The healthcare industry–including the that results in interoperability. The Task Force government, professional organizations, public has formulated a vision and associated goals and private institutions, and health informatics and recommendations that it hopes will be and information management professionals– used to frame a public-private dialogue about must address the issues before the US how to redesign the US approach to healthcare healthcare system is marginalized. To not do so terminologies and classifications against a would mean continued reliance on poor- backdrop of international approaches and quality data for decision making and the achievements. spending of dollars to retrofit a system that is 4 obviously broken. The vision consists of the following: This report describes challenges that require • US governance occurs from a national action. It proposes the formation of a perspective against a backdrop of centralized terminology authority, and other international agendas. steps, to address these challenges. • US policy coordinates with other countries, and the US actively collaborates Task Force Vision and and shares costs. Recommendations • Coordination and collaboration occurs The American Medical Informatics Association with international terminology and (AMIA) and the American Health Information classification development and Management Association (AHIMA) are pleased maintenance initiatives. with the progress made thus far and are
1. For purposes of this report, an EHR is defined as an information system designed to provide access to complete and accurate clinical data, practitioner alerts and reminders, clinical decision support systems, and links to medical knowledge. Giannangelo, K. (Ed). Healthcare Code Sets, Clinical Terminologies, and Classification Systems. AHIMA. [Note: Within this definition, a personal health record (PHR) only qualifies as an EHR if it is part of an EHR having the identified capabilities.] Healthcare Terminologies and Classifications: An Action Agenda for the United States
• Terminologies, classifications, and maps terminology and classification form a coherent set of policies and development and maintenance, including procedures for openness and ensured the supporting systems. performance. • Develop a governance model for the • Transparency of process exists even when central authority that is accountable to the the development organization maintains needs of the end users and implementers, the system within its own organization. and also has accountability for the funding of the central authority. • Infrastructure for development and maintenance of the terminology is subject • Commit to the adoption of sound to an open process. principles for operation of a terminology and classification standards development • Business process automation is organization. implemented, allowing organizations to participate and track the terminology and The Task Force believes that the items on this classification development processes, agenda must be accomplished. To this end, reducing cost, and automating many AHIMA and AMIA are ready to lead, in aspects of the system release cycles. concert with the appropriate government agencies, the US effort for terminologies and To implement this vision, the Task Force classification reform. They recognize the US recommends that the healthcare industry— agenda for health information reform will government, public and private institutions, require strong public and private collaboration. and professional organizations— In the months to come, AHIMA and AMIA collaboratively undertake the following tasks: will convene stakeholders to build a broader • Create a publicly funded research and understanding of the current problems, development project to prepare generate wide support for, and begin to specifications for coordinated solutions construct a road map for change. and where possible, consolidate terminology. • Secure funding for the planning and 5 development of a centralized authority, representing both public and private stakeholders, to manage the funding and be responsible for overseeing US Healthcare Terminologies and Classifications: An Action Agenda for the United States
Healthcare Terminologies and Classifications: An Action Agenda for the United States
Background How Terminologies and Classification Systems Are Used Healthcare classifications (systems that arrange Clinical terminologies and classification together similar diseases and procedures and systems have been in use for many years—for organizes related entities for easy retrieval) and example, the International Classification of clinical terminologies (standardized terms and Disease (ICD) was created in the 19th century their synonyms that record patient findings, as a way to identify the causes of death. The circumstances, events, and interventions) are Systematized Nomenclature of Medicine the systems that describe, organize, and (SNOMED) began as an enhancement to the standardize the rapidly evolving language of Standard Nomenclature of Diseases and medicine. In addition, terminologies and Operations, first published in 1965 and used classifications form the information content in to organize information from surgical the electronic health record (EHR) and the pathology reports. personal health record. They are the basis for public health reporting, performance In ad d i ti on to their len g t hy history, term i n o l ogi e s measurement and quality reporting, research, and cl a s s i f i c a ti ons can be used in different ways . and billing and payment for healthcare For ex a m p l e , term i n o l ogies are used pri m a ri ly to services. They are integral to interoperability, c a ptu re clinical inform a ti on . As su ch , t h ey are and thus, to deployment of a nationwide health h i gh ly det a i l ed and have su b s t a n tial gra nu l a ri ty, information network (NHIN) capable of but at the same time they lack reporting ru l e s delivering on the promise of safer and more and guidel i n e s . cost-effective results. Classification systems are intended for An NHIN and the interoperable exchange of secondary data use, including quality of care health information between standard EHRs of measurement, reimbursement, statistical and 6 healthcare data depend on: public health reporting, operational and • Clinical content identified with clinical strategic planning, and other administrative terminologies, which maintain highly functions. While reporting rules and guidelines specific and descriptive patient care data for administrative code sets exist, not everyone and classifications for aggregate reporting is following them. that can be reliably captured, encoded, In the United States, the most commonly used exchanged, and interpreted systems are the International Classification of • Common information models Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) and the Current Procedural • Management and coordination of the Terminology (CPT®). These systems are used various terminology and classification to organize specific diseases and procedures in systems in a synchronized fashion for a a general classification schema. This allows the streamlined life cycle specific diseases and procedures to be grouped into more broad-based categories and then used for reimbursement (ICD-9-CM codes to Healthcare Terminologies and Classifications: An Action Agenda for the United States
Diagnosis-Related Groups), quality of care codes alone. For clinical data representation, a measures (ICD-9-CM codes to patient library of shared models linked to value sets satisfaction rankings), or resource utilization drawn from standard coded terminologies and measures (CPT codes to cost of care). Because classifications is needed. This means resolving classification systems are considered broader issues related to the interface between ways to classify specific diseases and information models. procedures, they are not the most appropriate Both the National Committee on Vital and system to use to identify and capture the Health Statistics (NCVHS) and the Institute of clinical aspects of an episode of care. Medicine have noted that standard For example, in ICD-9-CM and its 10th representation of the full meaning of patient revision, ICD-10-CM, a hospital stay for a medical data requires integrating terminology newborn is represented by codes identifying models with models of context and other the type of birth (that is, live-born infant, structural relationships.3, 4 The NCVHS has also single or multiple births, born in hospital or concluded when patient medical record outside of hospital, and vaginal versus cesarean information standards do not include a delivery) and medical conditions or risk factors comprehensive information model and the infant may have. In contrast, SNOMED terminology model, mapping is made more CT® codes provide the complete clinical detail difficult. for a healthcare encounter. The Apgar score (an assessment of the physical condition of a Terminologies, Classifications, and newborn infant), for example, would be Mapping represented by separate SNOMED CT® codes Mapping is a process that links the content for the cardiac score, respiratory score, muscle from one terminology or classification scheme tone, reflex response, and color.2 to another.5 Together, terminologies, such as SNOMED Many factors within the healthcare industry are CT®, and classification systems, such as ICD-9- driving mapping technology, including the CM, ICD-10-CM, and ICD-10-PCS, provide movement to adopt EHRs and create a NHIN.6 the common medical language necessary for Efforts to control increased administrative 7 the EHR and for population health reporting, costs within healthcare are also a factor. The quality reporting, personal health records, shortage of qualified coders increases costs and safety, clinical trials, biosurveillance, and inefficiencies. These issues exacerbate the need reimbursement. for computer-assisted coding (the automatic Terminologies, Classifications, and generation of codes based on clinical documentation) and the use of mapping Information Models technologies to increase productivity and But simply having a list of relevant words is coding consistency. Today, computer-assisted not the same as representing all the relevant coding and mapping systems are an achievable data in a computable form. The process of data vision for the future, but there is still some way or information representation begins with to go. information models, not just the terms and
2. Dougherty, M. “Standard Terminology Helps Advance EHR.” Journal of AHIMA 74, no. 10 (2003): 59-60. 3. National Committee on Vital and Health Statistics. Patient medical record information terminology analysis reports. 2002. 4. Institute of Medicine. “Key Capabilities of an Electronic Health Record System.” Letter Report of the Committee on Data Standards for Patient Safety, Board on Health Care Services, Institute of Medicine, 2003. 5. Available at www.nlm.nih.gov/healthit.html. 6. Available at www.nlm.nih.gov/healthit.html. Healthcare Terminologies and Classifications: An Action Agenda for the United States
An EHR that can map from a reference authoring environments that are not terminology to a classification system is rare. sufficiently responsive to improve the creation There are currently no nationally or and revision of terminologies. The outcome is internationally recognized standards for map the creation of content in the system based on development and validation. In addition, there a defined need rather than desirable is a lack of coordination among terminology characteristics of a controlled clinical and classification development organizations, terminology.8 Current terminology efforts which inhibits the development of maps. There typically do not meet rudimentary is also no standard definition of a “valid” map. development practices considered routine for Iterative research and development is needed, software development in other industries or along with testing in real environments, to subject domains. Terminology systems also achieve a usable map. probably do not meet Food and Drug Administration standards9 for embedded The NLM has taken a lead in this important software—yet many should. area and has made maps from SNOMED CT® to ICD-9-CM, SNOMED CT® to CPT, and a The situation is complicated by the lack of LOINC to CPT preliminary draft available. business process automation10 across These maps can serve as a starting point for the organizations or departments for updating or development of standards and for testing the maintaining the terminology. Even a single utility of different mapping approaches. organization is required to use multiple tools if it is to function today. Appendix A illustrates this complexity for four healthcare Magnitude of the Problem organizations. Adoption and implementation are in The terminologies and classifications life themselves complicated issues, with many cycle—in particular, development, distribution, governing bodies determining what system and maintenance—is complex. This should be adopted and implemented. In complexity causes problems for all who deal in addition, while there have been discussions some form or another with them. There are a 8 about the basic principles for maintenance and relatively small number of vendors, and what the ideal process should look like, existing systems are not able to seamlessly attributes and standards for terminology exchange information with other systems. This development and maintenance processes have makes commercial offerings challenging and not been brought forth, discussed, or agreed to 7 creates a high risk of vendor lock in and by the principal stakeholders—that is, the significant susceptibility to vendor failure. In owners of the terminologies and classifications addition, no comprehensive open source and the users of the systems. Simply finding development environment exists, resulting in out what systems already exist, what they are
7. Wikipedia states vendor lock-in is a situation in which a customer is so dependent on a vendor for products and services that he or she cannot move to another vendor without substantial switching costs, real and/or perceived. 8. Cimino, J. “Desiderata for Controlled Medical Vocabularies in the Twenty-First Century.” Methods of Information in Medicine 37 (1998): 394-403. 9. Many of the regulations enforced by the Food and Drug Administration (FDA) with regard to medical devices can be found in Title 21 Code of Federal Regulations (CFR) Part 800 to Part 1299. The information required in a 510(k) submission is defined 21 CFR 807.92. Among the list of 510(k) submission requirements is software development, verification and validation information. 10. Wikipedia states business process automation is the process of integrating enterprise applications, reducing human intervention wherever possible, and assembling software services into end-to-end process flows. Healthcare Terminologies and Classifications: An Action Agenda for the United States
used for, when they were adopted and The Vision and Goals for implemented, who maintains them, and what the US the release cycles are can be an onerous task. Today’s proprietary standard development The American Medical Informatics Association models hamper development and maintenance (AMIA) and the American Health Information of terminology standards by prohibiting open Management Association (AHIMA) are pleased publication of content. Terminology systems with the progress made thus far and are are significantly lacking in any principled committed to the development of the emerging approach to validation and quality assurance. national health information system. But both organizations recognize that additional Despite its essential need, insufficient funding resources and appropriate funding are needed has also plagued the development and to build on initial work for healthcare maintenance of clinical terminologies and terminologies and classifications strategy, classifications for years. The bulk of the work is governance, and development and done by volunteers—experts in medical and maintenance processes. health informatics, health information managers, and experts in nosology (the branch To address these issues, AHIMA and AMIA of medicine that deals with the classification of convened a Terminology and Classification diseases). Policy Task Force composed of experts in medical and nursing informatics (a field that Other widely acknowledged problems include: studies the support of medicine by information • The lack of sufficient incentives to systems), health information management cooperate professionals, experts in nosology, and educators. The group’s goal was to develop • Systems are seen as independent when they recommendations for the major challenges that are highly interdependent would help establish a process that results in • A general lack of understanding of how interoperability. The Task Force has formulated encoded data can support initiatives such a vision and associated goals and recommendations that it hopes will be used to as quality or patient safety in the 9 healthcare environment frame a public-private dialogue about how to redesign the US approach to healthcare terminologies and classifications against a backdrop of international approaches and achievements. The Vision: The Task Force’s vision of the ideal state for terminologies and classifications takes into account key issues including governance, licensing, and the methods used in the terminologies and classifications life cycle—specifically, development, distribution, and maintenance. It consists of the following: • US governance occurs from a national perspective against a backdrop of international agendas. Healthcare Terminologies and Classifications: An Action Agenda for the United States
• US policy coordinates with other licensing restrictions that may require countries, and the US should actively commercial organizations to disclose collaborate and share costs. their proprietary source code. A license that requires a vendor to open • Coordination and collaboration occurs their source code, such as the GNU with international terminology and (free software) style licenses, is classification development and inappropriate. maintenance initiatives. • Terminologies, classifications, and maps - Any fees associated with mandated form a coherent set of policies and infrastructure necessary to implement procedures for openness and assured the standard are under regulatory performance. control to assure that fees to support the infrastructure are not diverted. • There is transparency of process even if the development organization maintains the • Business process automation that allows system within its own organization. organizations to participate and track the terminology development process, • The infrastructure for development and reducing cost and automating many maintenance of the terminology is subject aspects of the terminology release cycle is to an open process. The characteristics of put in place. this process include: The Goals: The goals of a coordinated policy - Any classification algorithms required for the US that enables the Task to transform terminology stated forms Force vision builds upon lessons from into inferred forms are publicly national and international efforts in three described and free of patent royalties areas: (1) governance, (2) development and so that any party may implement a maintenance, and (3) acquisition, licensing, terminology-capable classifier and implementation issues. unencumbered. - Interfaces to the terminology 10 development infrastructure Governance (automated term submission process, automated update services, The Task Force recommended the terminology configuration establishment of a centralized oversight management services, and authority to accomplish these governance terminology authoring services) are goals: publicly described and licensed under • Ensure consistency in processes, system an open source agreement such as the coordination, responsiveness to end users 11 Apache 2 license. An open source (vendors and those who use their systems), license is meant to ensure that any and the availability of robust, valid maps. party can freely develop software that can interact with or replace • Adopti on of u n i form ru l e s , reg u l a ti on s , a n d components of the terminology g u i delines for standard i zed term i n o l ogy development infrastructure and up-to - d a te cl a s s i f i c a ti on sys tems ac ro s s unencumbered by licensure fees, the co u n try. patent royalties, or from other
11. Available at http://www.apache.org/licenses/LICENSE-2.0.html. Healthcare Terminologies and Classifications: An Action Agenda for the United States
• Ensure that the organizations authorized to formation of a new SNOMED SDO outside of develop, deploy, and maintain such CAP most likely will resolve this important standards and guidelines assume ongoing governance issue. responsibility to provide clarity with a Fragmentation of the governance process is specific standard or guideline as required, also illustrated by the current situation with publish and disseminate the standards or the ICD. While the National Center for Health guidelines in a manner that is generally Statistics (NCHS) maintains the US clinical understood, and respond in a timely modification if ICD-9-CM and ICD-10-CM manner to all requests for clarification of for diagnosis coding, the Centers for Medicare standards or guidelines. and Medicaid Services (CMS) are responsible Simplifying Governance for development and maintenance of the Meeting this goal will require changes in the procedure coding systems. While subject to a way in which the US governs terminologies single coordination and maintenance and classifications. In the US, there is no committee, coordination of these two essential centralized oversight of terminologies and dimensions could and should be strengthened. classifications. Terminologies and Recognizing that the US could learn mu ch from classifications have their own governance o t h er co u n tries that have alre ady rede s i gn ed process dictated by the organization who t h eir govern a n ce and su pport processes for “owns” the system. Table 1 provides a summary term i n o l ogies and cl a s s i f i c a ti on s , the Task Force of the owners and governance processes for s tu d i ed the approaches taken by Ca n ad a , various terminology systems currently used in Au s tra l i a , and the Un i ted Ki n gdo m . Details for the US. In many cases, the governance process e ach co u n try are found in Appendix B. is strictly an internal function of the terminology development organization with Development and Maintenance little detail available publicly. In a few cases, the The Task Force identified the following goals governance process includes oversight by a for terminologies and classifications committee composed of users and other development and maintenance: stakeholders. The fragmentation illustrated in • The infrastructure for development and 11 Table 1 prohibits interoperability. The number maintenance of the terminology is subject of systems in existence and the resulting to an open process. The characteristics of acronym alphabet soup make apparent the this process include: existing complexity of governance. - Any classification algorithms required An important consideration when choosing to to transform terminology stated forms integrate a component such as a terminology is into inferred forms are publicly to understand the governance model of the described and free of patent royalties organization providing the component, either so that any party may implement a via license or through contribution to the terminology-capable classifier public domain. For example, the problem with unencumbered. third-party control is particularly challenging for SNOMED CT® because the governance of - Interfaces to the terminology SNOMED CT® development and licensing development infrastructure policies has been subject to approval by the (automated term submission process, CAP board of governors, not by the end users automated update services, or licensees of the SNOMED CT® terminology terminology configuration standard. In contrast, HL7’s board of directors management services, and is elected by the HL7 members and is fiducially terminology authoring services) are bound to serve their interests. The proposed Healthcare Terminologies and Classifications: An Action Agenda for the United States
publicly described and licensed under Many systems are developed by professional an agreement at least as open as the associations and academic institutions, while Apache 2 license. others are developed by government agencies. Some organizations follow relatively formal - Any fees associated with mandated sets of processes for developing and refining infrastructure necessary to implement concepts, such as reliance on an editorial board the standard are under regulatory for approval, whereas other organizations’ control to assure that fees to support processes may be informal. In addition, the infrastructure are not diverted. developers may create new terms at will • Robust methods for certifying terminology without a formal or open process with input systems for use in patient-care applications from the users of the system. are developed. These robust methods are Each organization or developer determines patterned after those developed for other their own maintenance process, and update software components, whose failure may schedules vary considerably. The level of result in loss of life, such as the DO-178B resource commitment to ongoing system “Software Considerations in Airborne maintenance also varies, which in turn Systems and Equipment Certification.” influences the maintenance process and the Adapting that specification for terminology frequency of updates. In some cases, requires the terminology development maintenance is handled entirely by the system organization to provide at least the developer, while in other cases, a committee of following: industry experts oversees the maintenance - Certification plan process. - Development plan Meetings to address maintenance issues may be open to the public or may be private. For those - Verification plan processes that include open meetings, final - Configuration management plan decisions regarding system modifications may be made privately rather than during the open - Requirements standards 12 meeting. Some processes allow submission of - Design standards requests for modifications from any source, whereas others place restrictions on requesters. - Verification cases and procedures As shown by the variability in the level of detail - Verification results outlined in Table 2, terminologies even vary in the level of transparency regarding their - Problem reports maintenance processes. - Configuration management records There is also considerable variability in the timing of the release of terminology or - Quality assurance records classification system modifications and their Need for a Standard Process effective dates. As Table 2 shows, some In com p a ri s on to the above goa l s , pre s en t ly the terminologies do not have an established US healthcare indu s try has no standard proce s s update schedule. And variability in the method for the devel opm ent of term i n o l ogies and of publicizing the modifications is an issue as cl a s s i f i c a ti on s . Typ i c a lly, the processes for well. For example, some systems are updated term i n o l ogy and cl a s s i f i c a ti on devel opm ent annually, others biannually, and still others are va ry, gen era lly depending on the size of t h e updated quarterly or even more frequently. devel opm ent or ga n i z a ti on and the purpose of Even for those systems that are updated the standard . This va ri a bi l i ty is evi dent in Ta ble 2. annually or biannually, the effective dates still Healthcare Terminologies and Classifications: An Action Agenda for the United States
differ. The variability in maintenance schedules Acquisition, Licensing, and is not purposeful or useful, as it increases the Implementation cost and complexity of using terminology and classification systems and keeping them up-to- The Task Force identified the following goals date. for terminologies and classifications In some cases, a change in the system update acquisition and implementation: schedule would require legislation. For • A licensing model that embraces the instance, federal law mandates the following: implementation of ICD-9-CM updates on October 1 and CPT updates on January 1 for - More inventiveness, not the the use of these systems in the Medicare promulgation of monopolies (even program. There is no central Web site for nonprofit or regulatory ones) that accessing system updates or an established, stifle innovation and hamper standardized process for notifying the collaboration healthcare industry of an update release. - Open standards to overcome the The “official” source of clarification for using a challenges and standards development particular terminology or classification and the organizations that better serve the process for obtaining an “official” answer are healthcare community needs by not always clear. The integrity of coded data providing open standards and the ability to turn it into functional • Business process automation that allows information require the use of uniform organizations to participate and track the standards, including consistent application of terminology development process, standard codes, code definitions, and reporting reducing cost, and automating many requirements. In Table 2, the system developer aspects of the terminology release cycle is is generally listed by default as the official put in place. source for clarification because there is no • Establishment of funds for healthcare other identified source. standards in ways that do not rely on In many cases, there is no clearly defined revenue generated by selling the standards 13 process for obtaining clarification. As a result, themselves. obtaining guidance on the proper use of a terminology or classification is sometimes Acquisition and Licensing difficult, time-consuming, and expensive. To The way in which licensing is done today is a add to the complexity, there may be more than far cry from the goal. Similar to the systems one official source for a system—for example, discussed in the previous section, healthcare the American Medical Association is standards that structure terminologies and recognized as the source for information on classifications are developed by various the proper use of CPT codes for physician organizations. These organizations are typically providers; however, the American Hospital not for profit; however, the standards they Association is the official clearinghouse for produce are almost always released under hospital providers12 proprietary licenses13 along with fees—even though the efforts to produce those standards are often provided by resources external to the standards organization itself.
12. Available at www.ahacentraloffice.org/ahacentraloffice/html/coding_advice/hcpcs/index.html. 13. Wikipedia states that proprietary indicates that a party, or proprietor, exercises private ownership, control or use over an item of property, usually to the exclusion of other parties. Healthcare Terminologies and Classifications: An Action Agenda for the United States
Ta ke the case of s t a n d a rds devel opm en t linkages in this way is a barrier to creating true or ga n i z a ti on Health Level Seven (HL7). It has interoperability between LOINC and other p l aced all intell ectual property of its standard s important clinical terminologies. i n to the public dom a i n ; h owever, it retains the The SNOMED CT® license is not standard i zed , copyri ghts to publ i s h ed standards and sells the and different or ga n i z a ti ons have different ri gh t s doc u m ents as a revenu e - gen era ting mech a n i s m and re s pon s i bi l i ties depending upon thei r to help sustain the or ga n i z a ti on . The HL7 p a rticular licen s e . The NLM vers i on of t h e l i cense requ i res that the spec i f i c a ti on SNOMED license pro h i bits distri buti on of doc u m ents must ei t h er be purch a s ed or be SNOMED con tent out s i de the US, and it also ava i l a ble on ly to mem bers who have limited pro h i bits mod i f i c a ti on of SNOMED “core a bi l i ty to red i s tri bute them to their custom ers . con ten t .” These re s tri cti ons make open This inabi l i t y to red i s tri bute spec i f i c a ti ons has co ll a bor a ti on around SNOMED-based con ten t h ad a direct influ en ce on the devel opm ent and ch a ll en ging for some and unten a ble for others . d i s tri buti on of open source implem en t a ti ons of Ma ny or ga n i z a ti ons are relu ctant to en g a ge in HL7 spec i f i c a ti on s , s i n ce the spec i f i c a ti ons of su ch co ll a bora ti on wh en a third party is able to those implem en t a ti ons cannot be distri buted to exercise unilateral con trol over con tent they may a group of po ten tial implem en ters who are not devel op a depen dency upon —even wh en that HL7 mem b ers . Open po s ting of devel opm en t co n tent is ba sed upon their own wo rk. The new con tent is thereby not all owed . S DO may rem ove some of the barri ers to Even Logical Observation Identifiers, Names, broader com mu n i ty parti c i p a ti on in the and Codes (LOINC), a database protocol en h a n cem ent and ex p a n s i on of SNOMED CT®. aimed at standardizing laboratory and clinical There are two types of CPT licenses, depending codes,14 charges no license fee for allowed uses upon whether CPT codes will be used in a but has specific use restrictions. The LOINC product that will be sold or distributed to Committee has retained the copyright to its others or whether CPT will only be used content so that it maintains editorial control of within a company and will not be the content. It prohibits LOINC content to be redistributed. In both types, the license fee used to make a competing coding system for structure is per user. A user is defined as an 14 observations.15 These restrictions prevent individual who directly accesses CPT data in a development or enhancement of other product or, in the case where CPT is embedded products in ways that may promote in a product and not directly accessible, relies interoperability because the other products on embedded CPT data to perform his or her may be regarded as “promulgating a different intended function with the product or its standard” and therefore is prohibited by the output. These license requirements increase the LOINC license. For example, it would be a cost of products containing CPT content and violation of the LOINC license to map LOINC inhibit widespread use of CPT. Also, into an existing terminology by assigning a determining the number of CPT users for the new identifier to the LOINC code and creating purposes of license fee calculation can be the appropriate linkages to the concepts in the difficult. existing terminology. The inability to create
14. See www.regenstrief.org/medinformatics/loinc/. 15. Available at www.regenstrief.org/loinc/license/. To prevent the dilution of the purpose of the LOINC codes and LOINC table of providing a definitive standard for identifying clinical information in electronic reports, users shall not use the RELMA program, RELMA Users' Manual, RELMA database, LOINC Users’ Guide, LOINC database, LOINC table or related files, or the LOINC codes for the purpose of developing or promulgating a different standard for identifying laboratory test results, diagnostic study reports, clinical measurements and observations or orders for these entities in electronic reports and messages. Healthcare Terminologies and Classifications: An Action Agenda for the United States
Even the NLM’s Unified Medical Language had invented and locked up, but invent in the System (UMLS) Metathesaurus, which serves way that inventing was done in the great spurt as an official distribution vehicle for HIPAA of 19th-century inventiveness.”18 standard code sets and US government target The recent dispute between two SDOs, HL7 clinical vocabulary standards, requires a and ASTM International, over ownership of license. While content may be used with few ideas contained within the ASTM Continuity restrictions, some vocabularies require separate of Care Record (CCR) and the HL7 Clinical agreements, which may involve fees, with the Document Architecture (CDA) is an example individual vocabulary producers.16 of challenges that are created when standards There are various justifications for resorting to organizations do not publish their works under proprietary licenses. These justifications range open licenses. Organizations should focus on from “we must get revenue to support innovation and building on the foundations development of the standard” to “we must provided by others. They should not be prevent fragmentation of the standard.” permitted to compete with each other for Unfortunately, consequences of relying on proprietary advantage.19 proprietary licenses include deliberate or inadvertent creation of monopoly positions by Implementation standards development organizations and Implementing terminologies and classifications licenses that stifle opportunities for innovation. is not an easy task. Distribution is part of what makes it difficult. Terminologies are usually Experience with open source software and the distributed through the developer or a middle- World Wide Web development have shown ware software or system application vendor. that licensing restrictions are not helpful—and With more than 100 terminology and are also not necessary to prevent fragmentation classification systems, the communication of of the standard. The HTTP protocol and the releases and updates affects the ease with which success of the World Wide Web consortium vendors can incorporate them into products (W3C) are successful and compelling for distribution. demonstrations of the potential of alternative approaches. All W3C documents are under an For example, the NLM’s UMLS has been 15 open license that provides permission to copy designated as the central coordinating body or distribute, in any medium, for any purpose, within the US Department of Health and without fee or royalty.17 W3C operations are Human Services for patient medical record supported by a combination of member dues, terminologies.20 Coordination means the research grants, and other sources of public following: and private funding. W3C operations do not • Uniform distribution of designated rely on revenue from the specifications of the standard vocabularies through the UMLS standard itself. Metathesaurus Eben Moglen, professor of law at Columbia • Reducing peripheral overlap and Law School, states that open source software establishing explicit relationships between provides a “freedom to invent, not reinvent— standard clinical vocabularies (for example, not invent over again something someone else SNOMED, LOINC, RxNorm)
16. Available at www.nlm.nih.gov/pubs/factsheets/umlsmeta.html. 17. Available at www.w3.org/Consortium/Legal/2002/copyright-documents-20021231. 18. Available at http://news.com.com/Open-source+politics+are+American+as+apple+pie/2100-7344_3-6079401.html. 19. Available at www.healthcareitnews.com/story.cms?id=1292 and http://www.healthcareitnews.com/story.cms?id=3076. 20. Available at www.ncvhs.hhs.gov/040922lt.pdf. Healthcare Terminologies and Classifications: An Action Agenda for the United States
• Aligning standard clinical vocabularies standards adoption, legal issues including with standard record and message formats licensing, technology, data integrity requirements, maintenance, education and • Mapping between standard clinical conformance testing, and a road map for vocabularies and administrative code sets change so public and private industry sectors and/or other important vocabularies21 understand the goals, target, and the required While the UMLS was envisioned as a actions. distribution mechanism for clinical The main objectives of this work would be to terminologies and classifications, it is not a continue the work of the Task Force in major distributor because of publication delay partnership with the Office of the National and difficulty in extracting data formats. In Coordinator for Health Information addition, the UMLS is not governed by a Technology (ONC). AHIMA and AMIA will mechanism that is directly accountable to also coordinate with Healthcare Information implementers and EHR developers, which may Technology Standards Panel (HITSP) to help explain why they are going elsewhere for harmonize work. The work will initially focus terminology content. Implementation therefore on research to identify a governance model and is made complicated as most vendors go to the funding sources for the central authority. Thus, source, or owner of the system, because of a significant part of the plan would be the delay and complexity of user formats. development of a governance model for the central authority that is accountable to the needs of the end users and implementers, and What to Do Next also has accountability for the funding of the central authority. It will pursue The Task Force’s recommendations call for recommendations that emerge from the funding to support the planning and research and development project outlined development of an entity that would serve the above. Australia’s model has a number of public interest. This centralized authority, desirable features. However, governance must representing both public and private also formally include care providers and other 16 stakeholders, is expected to manage funding end users. It need not be a government and be responsible for overseeing US responsibility—a quasi-governmental entity terminology and classification development might meet this need quite adequately if and maintenance policies. permanence of the structure can be ensured. There are many challenges for the healthcare In addition, moving from the current industry—government, public and private ineffective and fragmented strategy for institutions, and professional organizations— adoption and maintenance of terminologies with regard to moving forward. A collaborative and classifications to a more efficient system undertaking will be the key to success with the will require a series of actions and long-range following: change strategies. Therefore, an additional 1. Create a publicly funded research and outcome will be a road map for change so development project to prepare specifications public and private industry sectors understand for coordinated solutions and where possible, the goals, target, and required actions. consolidate terminology. The critical elements for the plan include policy, governance,
21. Available at www.nlm.nih.gov/nichsr/2005_NCVHS_July.ppt. Healthcare Terminologies and Classifications: An Action Agenda for the United States
2. Secure funding for the planning and certi f i c a ti on standards for term i n o l ogies and development of an entity that would serve the cl a s s i f i c a ti ons in the EHRs and EHR sys tem s public interest.22 A centralized authority and overs ee the devel opm ent of i m p l em en t a ti on responsible for overseeing US terminology and g u i de s . It must have su f f i c i ent aut h ori ty to classification development and maintenance, coord i n a te ef forts among the va r ious agen c i e s including the supporting systems, is critical. and stakeh o l ders to en su re con gru ency and Such an entity would represent both public co ll a bor a ti on , not com p eti ti on . and private stakeholders, manage funding, and Roles and Responsibilities of the Centralized be responsible for overseeing US terminology Authority and classification development and The Task Force applauds the recent formation maintenance policies. of the IHTSDO and is fully supportive of this Funding development. However, US involvement as a Structuring a public-private effort to charter member of the IHTSDO will require an adjudicate and set policy for various entity responsible for overseeing US interests. stakeholders will require financial support The Task Force believes the central authority (estimated to be between $5 and $50 million). would best serve this role. The central These funds should be placed in one location authority would define the governance to do ongoing monitoring, research, and structure for the US role in the IHTSDO and evaluation results to address: would oversee the SNOMED national release center in the US, where questions regarding the • Quality of encoded data process for requesting of new terms or • Quality of encoding systems establishing regional extensions would be • Value of encoding data resolved. With the aid of funds mentioned below, the US participation process in the • Patient safety issues pertaining to encoded IHTSDO will be defined. data The central authority, which will coordinate • Reproducibility of encoded data the funding of research, standards, grant • Quality, reproducibility, value, and patient review, and contracts, will also have 17 safety pertaining to mapping and to responsibility for the stewardship of the different versions of encoded data in the funding noted above. This authoritative body same system will focus on processes for governing, maintaining, and distributing the • Development and recommendations of terminologies and classifications. Its standards for coded data (that is, for responsibility will be to align funding with computer-assisted coding) policy and guide the contracts and grants • Biosurveillance process toward long-term goals. • Use health informatics data to improve Central Authority Commitment public health practices as well as medical The entity will commit to the adoption of readiness sound principles for operation of a terminology and classification standards Pa r t of the funds would be used to su pport development organization. Primary among h e a l t h c a re standards in ways that do not rely on the principles is an infrastructure for revenue gen era ted by selling the standard s development and maintenance that includes a t h em s elve s . The aut h ori t y wi ll iden tify the
22. Available at www.jamia.org/cgi/content/abstract/5/6/503. Healthcare Terminologies and Classifications: An Action Agenda for the United States
transparent process with policies and as necessary for ridding the development, procedures that can support open standards implementation, and maintenance process of and ensure that those who build content are its complexity and to structure governance in a engaged in any consolidation or integration of coordinated fashion. their products. This commitment would These criteria were developed to screen the include: potential candidate standards, including • Simplified coding guidelines and terminologies and code sets. They are used by reimbursement regulations so that HITSP and its technical committees for mapping rules can be more readily evaluating standards for possible use in the developed and maintained. HITSP Interoperability Specifications. Tier 2 23 • Use case maps from reference terminology criteria are placed into the following to administrative code sets (for instance, categories: SNOMED CT® to ICD-9-CM, SNOMED • Suitability: the standard is named at a CT® to CPT, and LOINC to CPT) that are proper level of specificity and meets validated with an easy, no-cost distribution technical and business criteria of use mechanism. case(s) • Educational resources to train healthcare • Compatibility: the standard shares professionals on the use and interpretation common context, information exchange of coded data and its relationship with structures, content or data elements, clinical terminologies, classification security, and processes with other HITSP systems, and mapping technologies. Since harmonized standards or adopted much of this relationship is still frameworks as appropriate misunderstood and somewhat difficult to • Preferred Standards Characteristics: fully grasp, educational resources that approved standards, widely used, readily clearly and succinctly describe the mapping available, technology neutral, supporting process and the importance of reference uniformity, demonstrating flexibility and terminologies and classification systems are international usage are preferred 18 truly needed. • Standards Development Organization Centralized Authority Relationships and Process: meet selected criteria, The Task Force recommends creating a including balance, transparency, developer terminology group made up of both public due process, stewardship, and others and private organizations to assist the central authority. This group would be contracted and • Total Costs and Ease of Implementation therefore not dependent on “voluntary” commitment. It will be responsible for establishing the standards used for certification Role of AHIMA and AMIA of terminologies and tools. AMIA and AHIMA are committed to a global The Task Force supports the Healthcare approach to health-related terminologies and Information Technology Standards Panel classifications and seeing the recommendations (HITSP) basic standards readiness criteria as a in this report move forward. Both starting point for the work of this centralized organizations are prepared to engage with authority. HITSP’s Tier 2 criteria take into others to accomplish the following next steps: consideration issues the Task Force identified
23. Standards Readiness Criteria, Tier 2, Version 1.0 Healthcare Terminologies and Classifications: An Action Agenda for the United States
• Develop a planning grant. The grant professional organizations, public and private would continue the work of the Task Force institutions, and health informatics and in partnership with the ONC. AHIMA and information management professionals – must AMIA will also coordinate with the HITSP respond to the chaos and address the issues to harmonize work. before the US healthcare system is marginalized. To not do so would mean • Engage informatics and information continued reliance on poor-quality data for management leaders in increasing the decision making and the spending of dollars to awareness of the interdependencies of retrofit a system that is obviously broken. If the encoding data with terminologies, changes outlined in this paper are not made, it classifications, and with issues of is unlikely the goals of the national health reimbursement. It is important to information agenda can be achieved. understand how encoded data can support other initiatives such as quality or patient Moreover, without question there is a need for safety in the healthcare environment. worldwide comparability of healthcare data to • Enlist the support of other key improve the effectiveness of global public organizations in these efforts, such as the health policies and programs. To meet this HHS/Centers for Medicare and Medicaid need a variety of health-related terminologies Services (CMS), including the ONC, large and classifications identifying the clinical data integrated healthcare organizations like is required. However, just having these systems Kaiser Permanente, Veterans Health available does not mean the data can be used Administration, National Institutes of and exchanged. The various systems must be Health, including the National Cancer coordinated and managed in a synchronized Institute and the National Library of fashion. Processes for developing, releasing, Medicine, foundations such as the implementing, and maintaining terminologies California Healthcare Foundation, large and classifications must be streamlined. They insurance organizations such as Blue must have an effective life cycle infrastructure Cross/Blue Shield, and others such as the to improve quality and simplify reliable and Certification Commission for Healthcare maintainable health data. The recent global 19 Information Technology. progress with SNOMED gives special urgency to this matter for the US. We must get our • Create educational resources to train collective house in order; the lack of a coherent healthcare professionals on the use and healthcare system in the US and the lack of interpretation of coded data and its prospects anytime soon for a coherent system relationship with clinical terminologies, cannot be allowed to prevent progress in this classification systems, and mapping extremely important domain. technologies. Achieving the goal of a well-organized, • Broadly publicize these recommendations coordinated health-related terminologies and to those whose support is needed to adopt classifications governance structure and them. efficient development, implementation, and maintenance processes will take time. The industry is challenged to continue forward Conclusion while new approaches are being designed, The members of the Task Force believe the tested, and funded. An industry dedicated to state of terminologies and classifications in the prompt response and collaborative work can US is ineffective and in disarray and build solutions for today’s turmoil and ensure necessitates immediate action. The healthcare better health information management for the industry – including the government, nation and the world. Healthcare Terminologies and Classifications: An Action Agenda for the United States
Table 1. Governance of Various Terminology Systems in the United States
Name of Terminology Owner Governance Process
ABC Codes Foundation for Terminology development is coordinated through Integrative Healthcare the Foundation for Integrative Healthcare (FIHC) and its practitioner association constituents (called member associations).
Clinical Care Virginia Saba Terminology updates are vetted through an Advisory Classification Board.
CDT ADA ADA manages and provides staff to coordinate the technical review and revision process. A Code Revision Committee composed of re p res entatives from the ADA, America’s Health Insurance Plans, the Blue C ross/Blue Shield Association, Centers for Medicare & Medicaid Services, Delta Dental Plans Association, and National Purchaser of Dental Benefits.
CPT AMA AMA oversees a CPT Editorial Panel that is responsible for development and maintenance. The Panel is composed of 15 physicians and two non- physician healthcare professionals appointed by the AMA Board of Trustees.
DSM APA APA Division of Research manages the DSM revision process.
Global Medical CEN The European Committee for Standardization body Device (CEN) owns the copyright, but has delegated Nomenclature administration to the Maintenance Agency Policy Group (MAPG). MAPG includes representatives from 20 the FDA as the US regulatory body, the European Community, the Japanese Ministry of Health, Labour, and Welfare, and five nominees approved to represent CEN, five nominees approved to represent ISO interests, and a representative of the Global Harmonization Task Force.
HCPCS Level II CMS The CMS HCPCS Workgroup is responsible for development and maintenance.
ICD-0 WHO WHO Collaborating Centres govern development and maintenance.
ICD-10 WHO WHO Collaborating Centres govern development and maintenance.
ICD-10-CM NCHS NCHS governs development and maintenance.
ICD-10-PCS CMS The Division of Acute Care within the Center for Medicare Management of CMS governs development and maintenance. ICD-10-PCS was developed by 3M HIS under a CMS contract. Healthcare Terminologies and Classifications: An Action Agenda for the United States
Table 1. Governance of Various Terminology Systems in the United States continued
Name of Terminology Owner Governance Process
ICD-9-CM NCHS and CMS NCHS governs development and maintenance of Diseases and ICD-9-CM diagnoses; the Division of Acute Care Procedures within the Center for Medicare Management of CMS governs development and maintenance of ICD-9-CM procedures; American Health Information Management Association, American Hospital Association, CMS, and NCHS (known as the Cooperating Parties) are responsible for development of official coding guidelines for proper use of ICD-9-CM codes.
ICF WHO WHO Collaborating Centres govern development and maintenance.
International Wonca International World Organization of Family Doctors governs Classification of Classification development and maintenance. Primary Care Committee
LOINC Regenstrief Institute Regenstrief Institute and LOINC Committee govern development and maintenance process. The LOINC Committee is composed of representatives from a number of organizations representing both the public and private sectors.
MEDCIN Medicomp Systems Medicomp Systems is responsible for maintenance and development.
MedDRA ICH MedDRA Maintenance and Support Services MSSO Organization (MSSO) serves as the repository, maintainer, and distributor of MedDRA as well as the source for the most up-to-date information regarding MedDRA and its application within the biopharmaceutical industry and regulators. The 21 MSSO includes a group of internationally based physicians who review all proposed subscriber changes and provide a timely response directly to the requesting subscriber.
NANDA NANDA International NANDA is responsible for development and maintenance.
NDF-RT VA Ongoing development and maintenance is supported under the VA’s Enterprise Reference Terminology project.
NDC FDA The Center for Drug Evaluation and Research within the FDA is responsible for ongoing development and maintenance.
NIC University of Iowa University of Iowa College of Nursing, Center for Nursing Classification and Clinical Effectiveness is responsible for ongoing development and maintenance.
NOC University of Iowa University of Iowa College of Nursing, Center for Nursing Classification and Clinical Effectiveness is responsible for ongoing development and maintenance. Healthcare Terminologies and Classifications: An Action Agenda for the United States
Table 1. Governance of Various Terminology Systems in the United States continued
Name of Terminology Owner Governance Process
Omaha System Karen Martin Karen Martin is responsible for ongoing development and maintenance with updates and feedback from the Omaha System users group.
Perioperative Association of AORN is responsible for ongoing development and Nursing Data Set Perioperative Nurses maintenance. (AORN)
RxNorm NLM NLM is responsible for ongoing development and maintenance.
SNODENT ADA The Advisory Committee on Dental Electronic Nomenclature, Indexing, and Classification (ACODENIC) processes requests for modifications and Council on Dental Benefit Programs have final approval. ACODENIC is composed of representatives from all of the recognized dental specialty organizations, payers, and the ADA.
SNOMED CT® CAP Within the governance structure of CAP, SNOMED International manages the ongoing maintenance and continuing evolution of SNOMED CT®. It accomplishes this through the SNOMED International Authority, SNOMED International Editorial Board, and Working Groups. The SNOMED International Authority has direct responsibility for terminology- related activities. The SNOMED International Editorial Board is responsible for scientific direction, editorial processes, and scientific validity. The Board is composed of voting members and organizational liaisons. This process is under revision; currently the process is private and the editorial board is closed. 22 Universal Medical ECRI ECRI governs ongoing development and Device maintenance. Nomenclature System (UMDNS) Healthcare Terminologies and Classifications: An Action Agenda for the United States
Table 2. Development and Maintenance of Various Terminology Systems in the United States
Name of Developer Development and Official Source Release Terminology (private, govt., Maintenance Process for Clarification Schedule nonprofit, etc.)
ABC Codes Foundation FIHC validates requests for Alternative Link Updated for Integrative new codes or code annually. Healthcare modifications and Alternative Link makes final decision.
Clinical Care Virginia Saba Terminology updates are Virginia Saba There is no Classification vetted by Advisory Board. specific schedule for updates and revisions. Content is revised as clinical requirements change.
CDT ADA Open meetings, changes ADA U p d a t e d voted on by the Code biannually at Revision Committee. the beginning of odd- n u m b e re d years.
CPT AMA Open meetings, changes AMA, AHA Category I: voted on by CPT Editorial provides January 1 Panel. clarification for Category II: use of CPT codes biannually under hospital Category III: outpatient PPS. January and July 23
DSM APA Open process for input, final APA No schedule. decisions are made by APA. Current version is DSM-IV-TR and was published in July 2000. Last major revision was in 1994.
Global CEN Open process for input, Updated at Medical final decisions are made least annually. Device by Maintenance Agency N o m e n c l a t u re Policy Group.
HCPCS level II CMS Open meetings, Individual payers, Some codes are open process for input. AHA pro v i d e s updated CMS makes the final clarification for annually decisions. use of HCPCS (January 1), codes in hospital others are OPPS. updated quarterly. Healthcare Terminologies and Classifications: An Action Agenda for the United States
Table 2. Development and Maintenance of Various Terminology Systems in the United States continued
Name of Developer Development and Official Source Release Terminology (private, govt., Maintenance Process for Clarification Schedule nonprofit, etc.)
ICD-0 WHO Current edition was WHO No schedule developed through collaboration between WHO and the International Agency for Research on Cancer (IARC).
ICD-10 WHO Changes must be sponsored WHO Minor–annually by one of the WHO Major–up to Collaborating Centres for three years Classification of Disease.
ICD-10-CM NCHS Similar to that for ICD-9- Undetermined Undetermined CM. Must conform to constraints imposed by WHO for use of ICD.
ICD-10-PCS CMS Undetermined Undetermined Undetermined
ICD-9-CM NCHS and CMS Open process for submitting The AHA central October 1; Diseases and requests for modifications office on ICD-9- potential exists P r o c e d u re s and for providing public CM for second input on code pro p o s a l s ; update to occur NCHS and CMS have final on April 1, but a p p roval. Four cooperating this has not p a rties (AHA, AHIMA, CMS, occurred yet. NHCS) develop uniform guidelines for application of 24 c o d e s . ICF WHO WHO Collaborating Centres WHO No schedule
International Wonca Developed and maintained Wonca 11-year cycle Classification International by World Organization of of Primary Classification Family Doctors (Wonca) Care Committee International Classification Committee (WICC).
LOINC Regenstrief Open Lab LOINC and Regenstrief No set schedule, Institute Clinical LOINC meetings; Institute three to four maintained times a year. by LOINC Committee. Healthcare Terminologies and Classifications: An Action Agenda for the United States
Table 2. Development and Maintenance of Various Terminology Systems in the United States continued
Name of Developer Development and Official Source Release Terminology (private, govt., Maintenance Process for Clarification Schedule nonprofit, etc.)
MEDCIN Medicomp Developed and maintained Medicomp Twice per year Systems by Medicomp Systems based Systems on recommendations of a g roup of consulting editors f r om Cornell, Harv a rd, Johns Hopkins, and other major medical centers, with substantial input from user c o m m u n i t y - b a s e d physicians.
MedDRA ICH Core subscribers may MSSO Twice a year— MSSO submit requests for new March 1 and terms; MSSO makes final September 1 decision.
NANDA NANDA Anyone may submit a NANDA Every two years request to add a nursing diagnosis; member input sought at NANDA conference; NANDA makes final decision.
NDF-RT VA VA plans to maintain NDF- VA Unknown RT so that it remains fully integrated with RxNorm.
NDC FDA Drug manufacturers submit FDA Quarterly 25 requests for changes; FDA makes final decision
NIC University of Content is added as University of Every four years Iowa requested or needed Iowa College of Nursing, Center for Nursing Classification and Clinical Effectiveness
NOC University of Content is added as University of Every four years Iowa requested or needed Iowa College of Nursing, Center for Nursing Classification and Clinical Effectiveness
Omaha Karen Martin Content is added as Karen Martin No published System requested or needed. schedule
Perioperative AORN Content is added as AORN No published Nursing Data requested or needed. scheduled Set Healthcare Terminologies and Classifications: An Action Agenda for the United States
Table 2. Development and Maintenance of Various Terminology Systems in the United States continued
Name of Developer Development and Official Source Release Terminology (private, govt., Maintenance Process for Clarification Schedule nonprofit, etc.)
RxNorm NLM NLM adds new clinical NLM Weekly, drugs and links to cumulative additional drug monthly terminologies and to refine the model in response to feedback.
SNODENT ADA Open process for input and ADA Unknown submitting requests for modification; Advisory Committee on Dental Electronic Nomenclature, Indexing, and Classification (ACODENIC) of the ADA processes suggestions concerning changes to SNODENT and forwards recommendations for modifications to the Council on Dental Benefit Programs of the ADA for approval.
SNOMED CT® CAP A documented scientific SNOMED Biannually p rocess is followed International –January and that focuses on July u n d e r s t a n d a b i l i t y, re p ro d u c i b i l i t y, and usefulness. Content is 26 defined and reviewed by multiple clinical editors, with additional expert s consulted as necessary to review the scientific integrity of the content. The quality control process is continuously supplemented by feedback from users.
UMDNS ECRI Open process for ECRI Updated daily, requesting changes. but officially, it is updated annually. Healthcare Terminologies and Classifications: An Action Agenda for the United States Appendix A: Terminology Services and Tools
Te r m i n o l o g y Examples (multiple terminologies): LexGrid D e v e l o p m e n t / E d i t i n g / M a i n t e n a n c e (Mayo); Open GALEN; Health Level 7 Term i n o l ogy devel opm en t / ed i ti n g / m a i n ten a n ce Common Terminology Services services support the formal representation of concepts and typically include functions such Concept-based Indexing and Retrieval as provision of a reference model or set of These services support content tagging, reference models using some type of indexing and retrieval of document sets. description logic or frame-based approach, Examples: Unified Medical Language System automated classification of new terms through (particularly MeSH), Concept-based Indexing formal subsumption, and data to support & Retrieval Solution (Apelon); Open GALEN; version control. Some tools (for example, Infobutton Manager (Cimino) Galapagos) support distributed development and resolution of inconsistencies across Terminology Import modelers. These services should support not Terminology import services support the only atomic-level concepts and molecular import of terminologies in a variety of expressions but also other formal structures formats, e.g., UMLS, SQL, SQL Lite, Health such as clinical document architectures. Level 7 Version 3, Protégé. Examples: LexGrid, Medical Entities Dictionary Examples: LexGrid (Mayo) (MED) editor, SNOMED CT® development tools, Terminology Development Environment Terminology Export (Apelon), Protégé (ontology development in Terminology export services support the either frames or OWL) export of terminologies in a variety of formats, (for example, XML, OWL, RDF). Terminology Browsers Terminology browsers support the viewing Examples: LexGrid (Mayo) (and sometimes editing) of a single terminology or a set of terminologies. Natural Language Processing Natural language processing tools parse natural Examples (single terminology): Regenstrief language into syntactic and/or semantic 27 LOINC Mapping Assistant (RELMA), Medical structures and may map parsed terms to a Entities Dictionary (MED) browser, CLUE standardized terminology. (SNOMED CT®) Examples: MedLEE (Friedman) Examples (multiple terminologies): LexGrid (Mayo); Knowledge Source Server (Unified Translation to Natural Language Medical Language System); Open GALEN; Natural language translation services support Mycroft (Apelon), Health Level 7 Common the transformation of a formally represented Terminology Services concept into one or more natural language lexical expressions. For example, the same Terminology Mapping concept may be expressed in American English, Terminology mapping tools support the UK English, and Spanish. mapping of terms from a source terminology (typically local terminology) to a target Examples: Open GALEN terminology. Examples (single terminology): Regenstrief LOINC Mapping Assistant (RELMA); SNOMED CT® development tools Healthcare Terminologies and Classifications: An Action Agenda for the United States
Appendix A: Terminology Services and Tools continued
Clinical Terminology Server http://med.dmi.columbia.edu/ Chute identified a set of nine desideratum MedLEE - A Medical Language Extraction and for a clinical terminology server: word Encoding System: normalization, word completion, target http://lucid.cpmc.columbia.edu/medlee/ terminology specification, spelling correction, lexical matching, term completion, semantic OpenGALEN Foundation: locality, term composition, and term www.opengalen.org/index.html decomposition. The Protégé Ontology Editor and Knowledge Relevant Links Acquisition System: Apelon, Inc.: www.apelon.com/products http://protege.stanford.edu/ Columbia University Biomedical Informatics: SNOMED International: www.snomed.org www.dbmi.columbia.edu/ Unified Medical Language System Knowledge HL7: www.hl7.org Source Server: http://umlsks.nlm.nih.gov/kss/servlet/Turbine/ The Lexical Grid: template/admin,user,KSS_login.vm http://informatics.mayo.edu/LexGrid/index.ph p?page Medical Entities Dictionary:
Table 1. Terminology Services and Tools in Four Organizations
Service CUMC2 IHC3 Mayo4 VAMC5
28 Terminology MED 3M HDD LexGrid Apelon TDE/SDS Development/ Maint. App. Editing/Maintenance Terminology
Browser MED IHC Search LexGrid Apelon DTS/SDS Maint. App.
Terminology Mapping MED (1:1 only) IHC Match LexGrid Apelon TermWorks
Concept-based Infobutton IHC Infobutton LexGrid VETS/SDS Indexing and Retrieval Manager Read-Only APIs
Terminology Import MED 3M HDD LexGrid VETS
Terminology Export MED 3M HDD LexGrid VETS/Database Replication
Natural Language MedLEE IHC NLP UIMA/LexGrid Processing
Clinical Terminology MED 3M HDD LexGrid VETS Server1 (word completion only) Healthcare Terminologies and Classifications: An Action Agenda for the United States
Appendix A: Terminology Services and Tools continued
1. Word normalization, word completion, target terminology specification, spelling correction, lexical matching, term completion, semantic locality, term composition, and term decomposition. 2. At Columbia University Medical Center of New York Presbyterian Hospital, terminology services are supported through the Medical Entities Dictionary (MED), the Infobutton Manager, and the Medical Language Extraction and Encoding (MedLEE) system. The MED, a concept-oriented terminology, serves as the institutional data dictionary and uses a semantic network model that includes a classification hierarchy. MED-related applications support browsing, development, editing, and maintenance of the MED as well as terminology import and export. Terminology server functionality of the MED is limited. The Infobutton Manager is built upon the foundation of semantic relationships in the MED and provides context-specific links to information resources from within the clinical information systems (for example, at the time of order entry or when viewing laboratory results). MedLEE provides natural language processing for a variety of functions including decision support. These tools provide a rich foundation upon which to build a broader set of terminology services throughout the enterprise. 3. At Intermountain Healthcare the run time services, terminology database, and basic import and export programs are based on the Healthcare Data Dictionary (HDD) application provided by 3M Healthcare. The initial design of the software was described by Roberto Rocha (see “Designing a Controlled Medical Vocabulary Server: The VOSER Project,” Computers and Biomedical Research, 1994.) Intermountain has built search programs and terminology matching programs that extend the original HDD functionality. Intermountain’s Infobutton technology has been written locally, but is based largely on the model created by Cimino at Columbia. Natural language processing software has been created by Peter Haug and associated researchers at Intermountain. 4. At Mayo Clinic, production terminology services remains largely done through vendor products (for example, GE/IDX/LastWord). However, the research community is fully supported by LexGrid (http://informatics.mayo.edu). NLP tools were developed in collaboration with IBM and mounted on the Unstructured Information Management Architecture, though the entire suite remains open source. The LexGrid tools underpin vocabulary maintenance and support at HL7, the National Cancer Institute’s Biomedical Informatics Grid, and the CDC Public Health Information Network. 5. At the Department of Veterans Affairs, Apelon is used for clinical terminology, but administrative terminology is homegrown. Terminology services are provided by a combination of VA-developed and commercial products. Currently, clinical and administrative (nonclinical) terminology are modeled, maintained, and deployed separately. Clinical terminology is modeled and maintained in the Apelon Terminology Development Environment. The VA-developed VHA Enterprise Terminology Services (VETS) tools to allow analysts to review and deploy terminology to VA sites as well as providing a real- time terminology server. Development and utilization of the terminology services are still in the early stages. Administrative terminology is developed and maintained in the VA-developed solution called Standard Data Service (SDS) maintenance application. SDS data is stored in a central Oracle database. Applications access the data via read-only APIs, and cache the data locally in either Oracle or Cache databases. Nightly replication keeps the databases in sync, should any changes occur in the SDS central database. Synchronization with Legacy files will be achieved through HL7 messaging. 29 Healthcare Terminologies and Classifications: An Action Agenda for the United States Appendix B: Australia, the United Kingdom, and Canada
Australia by the National Centre for Classification in The organization principally involved in the Health (NCCH). NEHTA, the NCCH, and the identification and development of clinical data Australian Health Ministers' Advisory Council standards for use at the point of care in are all aware of, and are proceeding toward, a Australia is the National E-Health Transition cooperative rationalization of the development, Authority (NEHTA). NEHTA is a not-for- management, and governance of terminologies profit company jointly funded by Australian and classifications in Australia. state, territory, and national governments. The board of NEHTA Limited is composed of chief United Kingdom executives from the health departments in each In April 2002, several key recommendations of these jurisdictions,24 and NEHTA has were identified for IT in the National Health received funding of $AUD130M from the Service (NHS). These included increased and Council of Australian Governments to establish protected funding for IT, stringent, centrally the national infrastructure required to support managed national standards for data, and a national approach to clinical terminologies better management of IT implementation in and unique health identifiers. As part of its the NHS. Following this, NHS Connecting for broader e-health agenda to accelerate the Health was established in 2005 with the adoption of IT in the health sector, NEHTA is primary goal of delivering the National tasked with recommending and where Program for IT . necessary developing standards for clinical use. NHS Data Standards & Products (NHS DS&P) NEHTA has recommended SNOMED CT® is part of the Technology Office of NHS (developed by the College of American Connecting for Health and is responsible for Pathologists) as the most appropriate and the introduction, development, and delivery of comprehensive clinical terminology capable of coding system products used in the patient supporting a national approach to records of the NHS Care Records Service. The terminologies in Australia. NEHTA intends to products that NHS DS&P are responsible for customize SNOMED CT® where necessary to include SNOMED CT®, the Read Codes, meet Australian needs.25 Dictionary of Medicine & Devices, ICD-10, 30 OPCS4, and the NHS Data Dictionary. As part Classifications for statistical reporting have of the delivery and ongoing development, NHS been developed by a number of organizations DS&P also provides a number of other services (including the Australian Health Information delivering codes and data and quality standards Council , and the National Health Information to the NHS incorporating the National Group, which report to the Australian Health Administrative Codes Services, the Spine Ministers Advisory Council). The use of Directory Service (SDS), and the Information classifications is prescribed through national Quality Assurance Programme.26 minimum datasets for reporting, as published in the National Health Data Dictionary. An advantage of the organizational structure in Supporting classifications include an Australian the United Kingdom is that it is centrally extension of ICD-10, designated as ICD-10- managed, which allows Connecting for Health AM, which includes the Australian to inform the NHS about the use of Classification of Health Interventions, which terminologies and classifications that serve the has been developed and is actively maintained needs of the health system.
24. National E-Health Transition Authority, www.nehta.gov.au/content/view/1/103. 25. Available at www.govhealthit.com/article94797-06-12-06-Print). 26. Connecting for Health, www.connectingforhealth.nhs.uk/technical/standards/. Healthcare Terminologies and Classifications: An Action Agenda for the United States Appendix B: Australia, the United Kingdom, and Canada continued
Canada The National ICD-10-CA/CCI Electronic The Canadian Institute for Health Information Products Advisory Group provides advice on (CIHI) is an independent, not-for-profit the ongoing development of new and organization. CIHI is a focal point for enhancement of existing ICD-10-CA and CCI collaboration among major health players— electronic products. This advisory group from provincial governments, regional health reviews proposals and provides feedback on authorities, and hospitals to the federal the potential impact of changes on coding, government, researchers, and associations data capture, and data quality and shares representing healthcare professionals. information and solicits feedback related to Governance of the organization is made up of ICD-10-CA and CCI electronic products with a board of directors that provides strategic provincial/territorial end users. guidance to both CIHI and the Health Canada Health Infoway, established in 2001, is Statistics Division at Statistics Canada. a not-for-profit corporation, whose Members CIHI facilitates data quality and the consistent are Canada’s 14 federal, provincial, and use of Coding Standards for ICD-10-CA and territorial Deputy Ministers of Health. the Canadian Classification of Health Infoway’s mission is to foster and accelerate the Interventions (CCI) (developed to accompany development and adoption of electronic health the ICD-10-CA) and is advised on these topics information systems with compatible standards by several committees.27 The National Coding and communications technologies on a pan- Advisory Committee provides CIHI with Canadian basis. Among its many standards- advice on the development and ongoing related initiatives, Infoway is currently leading enhancement of coding standards. The a project to evaluate SNOMED CT® as the Classification Advisory Committee also Canadian standard for reference terminology provides CIHI with advice on the maintenance for use in the pan-Canadian Electronic Health and enhancement of ICD-10-CA and CCI. Record.
31
27. Ibid. Healthcare Terminologies and Classifications: An Action Agenda for the United States
Glossary ASTM is the largest nongovernment source of standards in the US, comprised of more than ABC Codes: A registered vocabulary of HL7 130 committees that publish 10,000 standards incorporated into the National Library of annually. Medicine’s Unified Medical Language System Computer-assisted coding (CAC): The use in 1998, describing the procedures, treatments, of computer software that automatically and services provided during an encounter generates a set of medical codes for with a complementary and alternative review/validation and/or use based upon medicine, nursing, and other integrative clinical documentation provided by healthcare healthcare provider. practitioners. American Dental Association (ADA): A CEN (European Committee for professional dental association dedicated to the Standardization): A set of standards from the public’s oral health, ethics, science, and voluntary work of participants representing all professional advancement. interests concerned (industry, authorities, and American Hospital Association (AHA): The civil society) contributing mainly through their national trade organization that provides national standards bodies. education, conducts research, and represents Centers for Medicare and Medicaid the hospital industry’s interests in national Services (CMS): The division of the legislative matters. Department of Health and Human Services American Medical Association (AMA): The that is responsible for developing healthcare national professional membership organization policy in the US and for administering the for physicians that distributes scientific Medicare program and the federal portion of information to its members and the public, the Medicaid program; called the Health Care informs members of legislation related to Financing Administration prior to 2001. health and medicine, and represents the Classification: A system that arranges medical profession’s interests in national together similar diseases and procedures and legislative matters. 32 organizes related entities for easy retrieval. American National Standards Institute College of American Pathologists (CAP): A (ANSI): The agency that coordinates the medical specialty organization of board- development of voluntary standards to increase certified pathologists that owns and holds the global competitiveness in a variety of copyright to SNOMED CT®. industries, including healthcare. Current Dental Terminology (CDT): A American Psychiatric Association (APA): A coding system developed to report services medical specialty society with more than performed by the dental profession; formerly 35,000 member physicians in the United States called the Uniform Code on Dental Procedures and abroad who work together to ensure and Nomenclature. humane care and effective treatment for all persons with mental disorders. Current Procedural Terminology (CPT®): A comprehensive list of descriptive terms and ASTM (American Society for Testing and codes published by the American Medical Materials): a scientific and technical Association and used for reporting diagnostic organization for the development of standards and therapeutic procedures and other medical on characteristics and performance of services performed by physicians. materials. The charter includes products, systems and services, as well as materials. Healthcare Terminologies and Classifications: An Action Agenda for the United States
Consolidated Health Informatics (CHI): A healthcare, reduce healthcare costs, and government initiative that adopts standards for guarantee the security and privacy of health domains related to health information for information. federal health data systems, facilitating Health Level Seven (HL7): An organization communication among all federal health that develops standards regarding clinical and agencies. administrative data and is accredited by the Diagnosis-related Group (DRG): A unit of American National Standards Institute. case mix classification adopted by the federal Healthcare Common Procedure Coding government and some other payers as a System (HCPCS): A three-level classification prospective payment mechanism for hospital system introduced in 1983 to standardize the inpatients in which diseases are placed into coding systems used to process Medicare and groups because related diseases and treatments Medicaid claims. tend to consume similar amounts of healthcare resources and incur similar amounts of cost. Healthcare Information Technology Standards Panel (HITSP): A cooperative Diagnostic and Statistical Manual of partnership between the public and private Mental Disorders (DSM): A nomenclature to sectors for the purpose of achieving a widely standardize the diagnostic process for patients accepted and useful set of standards specifically with psychiatric disorders; includes codes that to enable and support widespread correspond to ICD-9-CM codes. interoperability among healthcare software ECRI: An independent nonprofit health applications. services research agency established to promote Hypertext transport protocol (HTTP): The safety, quality, and cost-effectiveness in communications protocol that enables use of healthcare to benefit patient care through hypertext linking. research, publishing, education, and consultation; formerly called the Emergency International Classification of Diseases— Care Research Institute. Oncology (ICD-O): A classification system used for reporting incidences of malignant Food and Drug Administration (FDA): disease. 33 Federal agency responsible for protecting the public health by ensuring the safety, efficacy, International Classification of Diseases, and security of human and veterinary drugs, Ninth Revision, Clinical Modification (ICD- biological products, medical devices, the 9-CM): A classification system used in the nation’s food supply, cosmetics, and products United States to report morbidity information. that emit radiation. International Classification of Diseases, Foundation for Integrative Healthcare Tenth Revision (ICD-10): The most recent (FIHC): A nonprofit foundation established in revision of the disease classification system 1999 that, along with its practitioner developed and used by the World Health association constituents, coordinates Organization to track morbidity and mortality terminology development in ABC codes. information worldwide. Free for use: The material is not copyrighted International Classification of Function, and no license is needed. Disability, and Health (ICF): A classification system released by the World Health Health Insurance Portability and Organization in 2001 that describes how Accountability Act (HIPAA): The federal people live with their health conditions. legislation enacted to provide continuity of health coverage, control fraud and abuse in Healthcare Terminologies and Classifications: An Action Agenda for the United States
International Organization for National Committee on Vital and Health Standardization (ISO): The world’s largest Statistics (NCVHS): A public policy advisory developer of standards whose principal activity board that recommends policy to the National is the development of technical standards that Center for Health Statistics and other health- often have important economic and social related federal programs. repercussions. Nationwide Health Information Network Logical Observation Identifiers, Names, (NHIN): The United States’ vision for a and Codes (LOINC®): A database protocol national health information infrastructure that developed by the Regenstrief Institute for makes secure transmission of person-specific Healthcare aimed at standardizing laboratory health information from one location to and clinical codes for use in clinical care, another. NHIN is synonymous with the outcomes management, and research. national health information infrastructure. MEDCIN®: A proprietary clinical terminology Drug File Reference Terminology (NDF- developed as a point-of-care tool for electronic RT): A nonproprietary drug reference medical record documentation at the time and terminology that includes drug knowledge and place of patient care. classifies drugs, most notably by mechanism of action and physiologic effect. Medical Dictionary for Regulatory Activities (MedDRA): A vocabulary Nursing Interventions Classification (NIC): developed as a pragmatic, clinically validated A standardized classification of interventions medical terminology with an emphasis on that nurses do on behalf of patients in all care ease-of-use data entry, retrieval, analysis, and domains. display, with a suitable balance between National Library of Medicine (NLM): The sensitivity and specificity, within the regulatory world’s largest medical library and a branch of environment. the national institutes of health. NANDA: A classification of nursing diagnoses Nursing Outcomes Classification (NOC): adopted by the North American Nursing A standard i zed cl a s s i f i c a ti on of o utcom e s Diagnosis Association. This system describes 34 devel oped for use in all set ti n gs and with all patients’ reactions to diseases rather than p a ti ent pop u l a ti on s . It was devel oped to classifying the conditions of diseases and eva lu a te the outcomes of nu rsing interven ti on s . disorders. Prospective Payment System (PPS): A type National Center for Health Statistics of reimbursement system based on preset (NCHS): The federal agency responsible for payment levels rather than actual charges billed collecting and disseminating information on after a service has been provided; specifically, health services utilization and the health status one of several Medicare reimbursement of the population in the United States. systems based on predetermined payment rates National Drug Code (NDC): A code set used or periods and linked to the anticipated for medical codes maintained and approved by intensity of services delivered as well as the the FDA; the code set designated by the beneficiary’s condition. Department of Health and Human Services for RxNorm: A nonproprietary terminology reporting drugs and biologics on standard developed by the National Library of Medicine retail pharmacy transactions. that represents drugs at the level of granularity needed to support clinical practice. Healthcare Terminologies and Classifications: An Action Agenda for the United States
Systematized Nomenclature of Dentistry Unified Medical Language System (UMLS): (SNODENT): A comprehensive taxonomy that A mu l ti p u rpo se re s o u rce that inclu des con cept s contains codes for identifying not only diseases and terms from many different devel oped and diagnoses, but also anatomy, conditions, s o u rce voc a bu l a ri e s . morphology, and social factors that may affect Universal Medical Device Nomenclature health or treatment. System (UMDNS): A standard international Systematized Nomenclature of Medicine nomenclature and computer coding system for Clinical Terms (SNOMED CT®): A medical devices; developed by ECRI. systematized, multi-axial, and hierarchically World Health Organization (WHO): The organized controlled terminology developed by United Nations specialized agency created to the College of American Pathologists. ensure the attainment by all peoples of the Standards development organization highest possible level of health; the (SDO): A private or governmental organization international organization responsible for a involved in the development of healthcare number of international classifications, informatics standards at a national or including The International Statistical international level. Classification of Diseases & Related Health Problems (ICD-10) and The International Terminology, clinical: A set of standardized Classification of Functioning, Disability & terms and their synonyms that record patient Health (ICF). findings, circumstances, events, and interventions with sufficient detail to support clinical care, decision support, outcomes research, and quality improvement.
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