ECRI submits the attached comments on coding and classification issues in connection with the requirements of the Health Insurance Portability and Accountability Act of 1996 (P2 104-191).
ECRI is a nonprofit, nongovernmental health services agency and a World Health Organization (WHO) Collaborating Center for Information Transfer on Medical Devices. For more than 25 years, ECRI has developed, maintained, and continuously updated a standard controlled vocabulary and coding system for medical device classification. This nomenclature, the Universal Medical Device Nomenclature System (UMDNS), covers all medical devices, equipment, supplies, disposables, clinical laboratory instrumentation, reagents, test kits, selected hospital furniture, casework, systems, and instruments used to test medical equipment. Medical devices thus include almost any nondrug item used for patient care.
ECRI recommends that UMDNS be considered as an initial standard for administrative transactions under HIPAA, to encode patient record information related to the use of medical technology for preventing, diagnosing, treating, or managing diseases, injuries, and impairments. Below, we present our rationale for this recommendation.
Market Acceptance and Current Scope of Use
UMDNS is in use in thousands of institutions worldwide, including regulatory agencies, other agencies within national Ministries of Health, hospitals, and health systems. UMDNS has been translated into 10 languages, including Spanish, French, and German. It is used to index and structure a wide range of clinical and technical information. Applications utilizing UMDNS range from regulatory databases on medical device incidents to software for medical device inventory control in hospitals to bibliographic databases such as ECRI's Health Devices Alerts and the National Library of Medicine's (NLM's) HealthSTAR (Health Services, Technology, and Administration Research) database. UMDNS is used to index the technology assessment content supplied by ECRI for the HealthSTAR database.
Under a Memorandum of Understanding with CEN, the official standards body of the European Union (EU), ECRI's UMDNS has been adopted as the interim standard for electronic communication among regulatory agencies of EU member nations. This nomenclature will also serve as the basis for the final standard. UMDNS will also become the basis for the international standard currently in development under ISO Technical Committee 210.
Under a partnership agreement between ECRI and the U.S. Food and Drug Administration (FDA), ECRI will assist FDA to harmonize its present nomenclature system with UMDNS to support use by the global community, including health authorities, medical device manufacturers, and healthcare payers and providers.
UMDNS concepts have also been incorporated into NLM's Unified Medical Language System (UMLS). For the past five years, NLM has contracted with ECRI, on a sole source basis, to map and link medical device concepts to other controlled medical nomenclatures in UMLS. Currently UMDNS terms are already linked to MESH, ICD, CPT, SNOMED, and other source vocabularies in UMLS.
Methods of Distribution
ECRI licenses UMDNS (to ensure system integrity) free of charge to healthcare facilities, government agencies, and others. Related data applications developed by ECRI, such as publications, CD-Roms, software, and online databases are available for a fee.
Weaknesses of Current Methods for Coding and Classifications of Encounter Data
Coding systems such as CPT and HCPCS do not, in most cases, explicitly identify devices used in procedures. A procedure may be heavily device-dependent, but this may not be apparent from the CPT or HCPCS code. This has long been a problem, and it is a growing problem as the number of devices continues to increase. The problem is compounded because many of the institutional controls that exist for in-patient care, do not exist in out-patient settings, where increasing amounts of care are delivered.
Hospital admissions in a cost containment and managed care environment are often intended to provide patients with access to a specific technology (medical device). Without device-type-specific coding it is difficult to track the diffusion of devices throughout the healthcare system and ensure payment for their appropriate use.
Implications for the Computer-Based Patient Record
It is essential that data from the Computer-Based Patient Record be retrievable to support analysis for many purposes. For coding encounters involving medical devices, one could theoretically choose from three possible levels of classification:
1. Makes or models applying to only one particular product from a single manufacturer and described by a unique designation supplied by the manufacturer.
There are more than 1 million possible products identified at this lowest level. It is very difficult, if not impossible, to develop a controlled vocabulary for this level.
2. Medical device product categories or groupings, with each grouping applied to a set of medical devices with similar properties and uses. This level is the level which is most useful for coding and controlled vocabularies. UMDNS currently includes approximately 6,000 terms and codes at this middle level.
3. Medical device categories at a higher level, such as electromedical devices, or critical care devices. At this level, each category may include large numbers of lower level groupings. A given medical product may belong to multiple category levels (e.g., general purpose infusion pumps). This level of classification is too broad to capture enough detail about the specific types of devices used in patient care.
While it is important for some applications (such as procurement or inventory control) to retain information at the level of individual manufacturers' products, without a standard nomenclature at the device grouping or generic category level, it is impossible using this level of detail, to build information systems that will support a broad range of needs. In particular, data retrieval for health services research, coding for reimbursement, outcomes studies, technology assessment, postmarket surveillance, or any evaluative purpose where it is necessary to look at administrative data concerning the use of similar products requires this 2nd-level approach. In addition, published reports in the clinical literature databases such as MEDLINE and HealthSTAR rarely provide information at the specific product level. However, emerging applications for database searching based on UMLS and utilizing the ECRI device nomenclature for device-related concepts will offer relevant information retrieval from clinical literature and other types of databases. To support the wide range of analyses utilizing patient outcome information, it also is critical that the standard nomenclature for devices for the computer-based patient record be dynamically linked to other medical concepts, including those for reimbursement, procedures, and diseases. As described previously, this mapping and linking is already in place for UMDNS in the context of the NLM Unified Medical Language System.
In summary, we believe that ECRI's UMDNS would be a valuable standard both for electronic transactions under HIPAA and for the computer-based patient record. It does not substitute for catalog number or bar code product-specific designations, although it is possible to make product-specific designations a subset of broader UMDNS terms and codes.
Respectfully submitted,
Vivian H. Coates, M.B.A.
Vice President
Information Services
andTechnology Assessment
cc: Joel J. Nobel, M.D., ECRI
Jeffrey C. Lerner, Ph.D., ECRI