Health Terminologies and Vocabularies Environmental Scan findings as of September 1, 2017

Findings from June 21 hearing, research, and interviews NCVHS Charges Related to Data Standards

•“Study the issues related to the adoption of uniform data standards for patient medical record information and the electronic exchange of such information and report to the Secretary of Health and Human Services (HHS) recommendations and legislative proposals for such standards and electronic exchange.” •“Advise the Department on health data collection needs and strategies; review and monitor the Department's data and information systems to identify needs, opportunities, and problems.” Health Terminologies and Vocabulary Project Goals, Scoping document, 6/20/17

Take a contemporary look at the health terminology and vocabulary landscape in order to advise the Secretary regarding 1. The changing environment and implications for timing and approach to health terminology and vocabulary standards adoption, 2. Needs, opportunities, and problems with development, dissemination, maintenance, and adoption of health terminology and vocabulary standards, 3. Actions that HHS might take to improve development, dissemination, maintenance, and adoption of standards. NCVHS Terminology and Vocabulary Milestones

Report: Information for Health: A Letter to Secretary Principles for guiding Strategy for Building the National recommending adoption of choices for the standards Health Information Infrastructure PMRI Standards. to be adopted by the (2001)https://aspe.hhs.gov/report/infor https://www.ncvhs.hhs.gov/wp- Secretary. mation-health-strategy-building-national- content/uploads/2014/05/031105lt3.p https://www.gpo.gov/fdsys/pkg/F health-information-infrastructure df R-1998-05-07/pdf/, p. 25274

2012-14 1998 2000 2001 2003 2003

Letter to Secretary recommending Letters to the Secretary Report: Uniform Data that HHS initiate the regulatory pertaining to ICD-10 Standards for Patient process for the concurrent adoption implementation Medical Record https://www.ncvhs.hhs.gov/wp- of ICD-10-CM and ICD-10-PCS content/uploads/2014/05/120302lt4.pdf Information https://www.ncvhs.hhs.gov/recommendation https://www.ncvhs.hhs.gov/wp- (2000) https://www.ncvhs.hhs.g s-reports-presentations/november-5-2003- content/uploads/2014/05/130920lt.pdf ov/wp- letter-to-the-secretary-icd-10- https://www.ncvhs.hhs.gov/wp- content/uploads/2014/08/hipaa00 recommendations/ 0706.pdf content/uploads/2014/05/140515lt3.pdf

Health Terminologies and Vocabularies Defined (NCVHS, 2000)* • Terminology - a collective term • Vocabulary - a set of specialized used to describe the continuum terms that facilitates precise of code set, classification, and communication by minimizing or vocabulary. eliminating ambiguity. (e.g. SNOMED-CT)

• “Controlled vocabulary” indicates only • Code - a representation assigned the set of individual terms in the to a term so that it may more vocabulary. • “Structured vocabulary” or “reference readily be processed. In general, terminology,” relates terms to one most terminologies incorporate a another (with a set of relationships) and qualifies them (with a set of attributes) to coding system for computer promote precise and accurate processing. interpretation. These relationships and attributes may be represented in some type of an information model. • Classification- arranges or • Vocabularies are mapped to standard organizes like or related terms for terminologies easy retrieval (e.g. ICD-10) • Nomenclature – synonym of vocabulary

*NCVHS “Uniform Data Standards for Patient Medical Record Information (PMRI) as required by the Administrative Simplification Provisions of the Health Insurance Portability and Accountability Act of 1996” July 6, 2000, p. 24

Terminologies and Vocabularies Developed, Maintained and/or Disseminated by the Federal Government

CDC/National Center CMS National Library of for Health Statistics Medicine • The Collaborating •ICD-10-PCS • Designated as the central Center for the WHO •HCPCS – Levels I and II coordinating body for Family of International PMRI (Patient Medical Classifications for North Record Information) America Terminology Standards • ICD-10-CM • SNOMED CT • ICF (International Classification of Functioning, Disability and • LOINC Health • RxNorm • Classification of Death and Injury Resulting from Terrorism • UMLS • ICD-O

Named Standards

Name Purpose Ownership/Gover Development and Release nance Maintenance SNOMED-CT Clinical terminology with Owned and International Advisory Groups for editorial, terminology US Editions released (Systematized global scope enabling maintained by the releases, and content; Clinical reference groups expand in March and Nomenclature of automation of reasoning SNOMED dialogue with specialists and address emerging uses such as September; Medicine -- Clinical and analytical approaches International precision medicine. Extensive partnerships and Mapping files and Terms) to process EHR data (IHTSDO); NLM is the collaborations with AMA, LOINC, WHO, LOINC, etc. other derivatives Named standard for US member. Formal change request process; throughout the year Meaningful Use Mappings to ICD-10- CM, ICD-10, LOINC, ICPC and others; US releases available through UMLS; LOINC Universal standard for Owned and LOINC Committee defines overall naming conventions and June and December (Logical identifying health maintained by policies for the development process; Committee has releases Observation measurements, Regenstrief Institute, laboratory, clinical, and nursing subgroups. Identifiers Names observations and Inc. Change request process; Each release contains about 1,400 and Codes) documents. new terms. Named standard for To advance use, RELMA software helps users map their local Meaningful Use terms or lab tests to LOINC codes. Apps aid use of LOINC by developers. RxNorm Drug terminology for the Developed and Derived from other commonly used public and private drug Full release each US that presents drugs maintained by NLM. terminologies including FDA structured product labeling month through from prescribers’ point of (NDC); major editorial policy changes informed by user UMLS; new drug view (ingredient + strength feedback. updates weekly; API + dose form) Changes compiled from data sources received monthly queried over 800 Named standard for except FDA NDC codes which are updated daily. million times in 2016 electronic exchange in by 20K unique users. government systems Named Standards System Purpose Ownership/Gover Development and Release nance Maintenance

ICD-10 Cause of death World Health WHO Update and Revision Steering Committee (URC) assesses URC responsible for (International coding from Organization holds the need to update ICD and the need to revise particular areas revisions annually Classification of death copyright. of the classification. Once the plan is approved, the URC or less frequently; Diseases and certificates; in oversees the revision effort. Changes must be sponsored by Major revisions related health use in US since one of the WHO Collaborating Centers for Classification of approximately problems, 10th rev) 1999 (statutory Disease. NCHS serves as US Center. every decade. basis) ICD-10-CM Classification of World Health CDC/NCHS participates in development of ICD versions and Annual updates (International Diseases and Organization holds develops conforming Clinical modification (CM) for US use. effective October 1 Classification of Related Health copyright. Maintenance through the Coordination and Maintenance (C & of each year; Official Diseases, clinical Problems CDC/NCHS develops M) Committee which receives and considers code change output files posted modification, 10th Named HIPAA and maintains proposals through an open process. CDC/NCHS is final on NCHS and via revision) standard for Clinical Modification authority for changes to ICD-10-CM. The Cooperating Parties NLM UMLS. morbidity in for use in the U.S. comprised of NCHS, CMS, AHA and AHIMA advise on changes outpatient, and develop coding guidelines. Cooperating Parties serve as inpatient and Editorial Advisory Board (EAB) to Coding Clinic sponsored by other care AHA. AHA maintains the central office on ICD-10-CM for settings. handling coding questions from the field. ICD-10-PCS Classification of Centers for 10-PCS is a totally redesigned system for coding procedures Annual updates (ICD-10 Procedure inpatient Medicare and developed by CMS as a complete replacement for ICD-9-CM effective October 1 Coding System) procedures Medicaid Services Volume 3. of each year; official Named HIPAA CMS co-chairs C & M Committee with CDC/NCHS as described output files posted standard for above and CMS has final authority for changes to PCS. Public on CMS and via inpatient comments and requests for changes are handled by C & M NLM UMLS. procedures process. CMS serves as a member of the Cooperating Parties for guideline development and the EAB to oversee coding questions from the field. Named Standards Name Purpose Ownership/Governan Development and Release ce Maintenance CDT Achieve uniformity, American Dental Multi-stakeholder Code Maintenance Annual update, effective (Code on Dental consistency and specificity in Association. Committee accepts, amends, or rejects January 1 of each year documenting dental Council on Dental code change requests. Procedures and treatment; used to process Benefit Programs Nomenclature) dental claims, and populate (CDBP) an EHR. Named HIPAA standard CPT Terminology used to American Medical Work of the CPT Editorial Panel aided by Annual update, effective (Current uniformly and consistently Association (AMA) CPT Advisory Committee medical specialty January 1. Early fall release to Procedural report ambulatory and Board of Trustees and health professional advisors; a public support implementation Terminology) hospital outpatient medical appoints the CPT request process for changes suggested by planning and training. Certain procedures and services by Editorial Panel who has medical specialty societies or individual category I codes are “early physicians and other health final authority for practitioners. Agenda and reports of released” to become effective care professionals. updates. Editorial Panel meetings are publically 6 months subsequent to Named HIPAA Standard as available; a formal process in place for release date (e.g., vaccine HCPCS Level I public comments and appeals of Panel products, Molecular decisions. Pathology); other category codes may be early released to capture reporting for evaluation.

HCPCS–Level National codes used to CMS with participation CMS HCPCS Workgroup responsible for Quarterly with annualized II identify products, supplies, from other federal decisions about additions, revisions, and compilation and services such as agencies and private deletions. Workgroup comprised of (Healthcare ambulance and durable health plans. representatives of CMS, CMS contractors, Common medical equipment and consultants from Federal agencies and Procedure Coding supplies when used outside a Medicaid, private insurance, and the System) physician's office. Department of Veteran’s Affairs. Codes Named HIPAA Standard used by all private and public health insurers. Named Standards System Purpose Ownership/Governa Development and Release nce Maintenance NDC A universal FDA assigns codes FDA publishes electronic NDC Directory. NDC Directory is (National Drug product based on information Available via FDA and UMLS. Also available via mobile apps. updated daily. Codes) identifier for submitted by part of drugs intended drug listing CMS’s 11-digit NDC derivative format adopted by data standards for human use. requirements. selected pursuant to HIPAA regulation. Code denotes labeler, product and packaging. Named HIPAA Standard Other WHO International Classifications Name Purpose Ownership/Governance Development and Release Maintenance

nd ICPC (International Classification of primary care World Organization of Family International Classification Committee, 2 nd Classification of problems and related Physicians (WONCA); revision (1998) ICPC-2 revision updated in rd Primary Care) conditions; captures reason a related classification within 2015; 3 revision under development but for encounter, symptoms, the WHO Family of experienced challenges of a largely relevant social problems; International Classifications volunteer effort episode based; interoperable with standard terminologies and classifications ICD-O-3 Used in tumor or cancer WHO; A derived classification The classification is based on ICD-10 but (International registries for coding the site within the WHO Family of provides greater site detail for some types Classification of (topography) and the International Classifications. of tumors. Diseases for histology (morphology) of Last update is 2000; Work is underway on Oncology, 3rd Ed. neoplasms, usually from a version 4 with no published release date. pathology report. Used in NIH research. ICF Classification for measuring WHO; A reference WHO adopted a standardized method for health and disability at both classification within the WHO measuring health and disability across (The International individual and population Family of International cultures based on the ICF that can be Classification of levels. A version for children Classifications applied before and after intervention to Functioning, Disability ICF-CY is also available measuring the difference made by a given & Health) intervention.

ICHI Under-development and WHO; to be a new reference Based on ICD-9 Volume 3 so less complex (International intended as a common tool classification than ICD-10-PCS. Classification of for reporting and analyzing Includes public health related procedures. Health Interventions) health interventions for statistical purposes. Other Specialized Systems Available through UMLS*

Name Purpose Ownership/Governanc Development and Release e Maintenance Schedule DSM Defines and classifies mental American Psychological Thirteen (13) workgroups including representatives 5th edition is first (Diagnostic and disorders that also defines Association from 16 countries participated in this edition. full revision since Statistical Manual of disorders in order to improve Scientific review and Clinical and Public Health 1994; no Mental Disorders, 5th diagnoses, treatment, and Committees oversaw the workgroups. National published ed) research Institutes of Mental Health, Drug Abuse and schedule for Alcoholism and Alcohol Abuse and the American updates Psychiatric Institute for Research and Education supported underlying research. Corrections and additions through web portal.

ICNP A terminology for nursing International Council of Participation open to individuals and groups; (International practice and a framework Nurses (ICN); Individual researchers and organizations, such as ICN into which existing a related classification accredited ICNP R&D Centers, are encouraged to Classification of vocabularies and within the WHO Family collaborate closely with ICN through their national Nursing Practice) classifications can be cross- of International nurses associations. mapped to enable Classifications “at risk conditions” comparison of nursing practice. Limited use in US. MedDRA Standardized medical International Council for MedDRA Maintenance and Support Services Twice a year, terminology to facilitate Harmonization (ICH) of Organization (MSSO) manages the maintenance March and (Medical Dictionary sharing of regulatory Technical Requirements process September for Regulatory information internationally for Pharmaceuticals for activities, v20) for medical products used by Human Use (ICH) is the humans. convener)

*UMLS includes a number of other systems relating to nursing practice, drugs, devices, clinical research and genomics. Other Specialized Systems Available through UMLS*

Name Purpose Ownership/Governanc Description Release e Schedule

The GO Project is a collaborative Produced by the GO Three structured, controlled vocabularies (ontologies) that Updated regularly The Gene effort to address the need for Consortium. Vocabularies describe gene products in terms of their associated throughout the year Ontology consistent descriptions of gene and gene product biological processes, cellular components and molecular products in different databases. annotations available to all functions in a species-independent manner. GO includes (GO) Intended for use by system public and private sector cross-links between the ontologies and the genes and gene developers who need consistent users with no licensing products in the collaborating databases, and tools that descriptions of gene products in requirements. facilitate the creation, maintenance and use of ontologies. different databases.

An electronic medical record Created and is maintained MEDCIN contains more than 300,000 clinical data elements Updated files are MEDCIN engine for entry, retrieval and by Medicomp Systems, Inc., encompassing symptoms, history, physical examination, released at least correlation of clinical tests, diagnoses, and therapies. twice per year. information at the point of care, Includes concepts, descriptions, a hierarchy, and SNOMED and to store medical information CT® mappings. and produce narrative reports from the same data.

The goal of CDISC is to develop The Clinical Data The CDISC consists of a series of standards to support the The CDISC CDISC platform independent standards Interchange Standards research process such as Study Data Tabulation Model Terminology is Terminology that aid interoperability of Consortium (CDISC) is an (STDM), Questionnaire (QS) and Functional Test (FT) updated annually as healthcare information systems international non-profit Terminology, Clinical Data Acquisition Standards part of the NCI to support clinical research. organization that develops Harmonization (CDASH) and Analysis Data model (ADaM). Thesaurus. data standards for medical In addition, CDISC maintains a Clinical Data Element research and other Glossary, a controlled terminology to support the healthcare areas. therapeutic area standards of CDISC.

*UMLS includes a number of other systems relating to nursing practice, drugs, devices, clinical research and genomics. Key Issues

Governance

Uses Coordination

Research and Development evaluation Processes

Supporting Maintenance technologies Processes Governance and Coordination

WHO AMA

Governing & CPT/HCPCS Coordinating ICD Bodies?

CDC/NCHS CMS CMS

1. Is current level of directional and operational coordination IHTSDO Regenstrief across named standards adequate?

2. Are the paths for SNOMED- LOINC sustainability adequate? CT

3. Is there research on how best to measure validity and fitness for use? NLM NLM Development Maintenance Process (ICD-11 as example)

Steering Group Design Final Authority for Changes

Clinical Advisory Process for public Panel(s) input Release Build Review and Comment Change requests

Guideline Communication & Development Training Q & A Services group Web based and in person Accurate and (including commercial consistent application Official guidance services) Test Configure 1. Are maintenance processes regularly reviewed for improvement? 1. Is ICD-11 version being designed so that 2. Is use of technology and major redesign won’t be needed for analytics optimized? version 12? 3. Are there any steps missing? 2. What is the “predictability roadmap” for moving from ICD-10 to ICD-11? Dissemination

1. Is UMLS as platform AMA and licensed for dissemination Sources optimized? SNOMED- Commerci 2. Could redundant CT licensed Sources al Sources channels for web UMLS as dissemination by Unified federal agencies be Source reduced? LOINC 3. Are there ways to Source NCHS e- files optimize the use of technology for CMS e-files dissemination? Next steps January Committee Q-1 & 2 2018 Q-3 & 4 2018, Q 1 2019 Meeting 1. Deeper dive what we’ve 1. Finalize environmental 1. Reserve possibility of learned about the ICD-10- scan report as input for one additional CM and PCS results to Stakeholder Roundtable hearing in fall 2018 date. 2. Host Stakeholder 2. Draft final report and 2. Deeper dive into design Roundtable to consider of ICD-11 and vision for opportunity areas, frame letter to the Secretary its use in conjunction models and 3. Present to Committee with SNOMED-CT. recommendations. for preliminary 3. Governance models from 3. Standards Subcommittee discussion in first other countries. considers integration into meeting of 2019 Predictability Roadmap 4. Present for final approval in June 2019