Health Care Informatics Standards Activities of Selected Federal Agencies (continued)

A Compendium

U.S. Department of Health and Human Services
Centers for Disease Control and Prevention, National Center for Health Statistics (NCHS)

Contact

Marjorie Greenberg
HHS/CDC/NCHS
6525 Belcrest Road, Room 1100
Hyattsville, MD 20782
Phone: (301) 436-4253
Fax: (301) 436-4233
E-mail: msg1@cdc.gov

Data-Related Programs

The agency serves as the World Health Organization (WHO) Collaborating Center for the Classification of Diseases for North America and is responsible for coordination of all official disease classification activities in the United States relating to the International Classification of Diseases (ICD) and its use, interpretation, and periodic revision. This includes maintenance of the ICD-9 for mortality and ICD-9-CM for morbidity. Maintenance for the latter is carried out through the ICD-9-CM Coordination and Maintenance Committee, which was established in 1985 as a forum to discuss possible updates and revisions and is co-chaired by NCHS and HCFA.

NCHS will be responsible for the implementation of ICD-10 for mortality records in 1999 and for the modification of ICD-10 (ICD-10-CM) for morbidity applications. The Collaborating Center is also responsible in North America for the family of ICD classifications, which includes the International Classification of Impairments, Disabilities, and Handicaps (ICIDH); the ICIDH is currently under international revision with strong North American input.

NCHS continues to work with the States to develop standard certificates for vital events which include births, deaths, fetal deaths, marriages, divorces, and abortions. These certificates are revised approximately every 10 years, with the next revision planned for implementation in 2002. Evaluation of the current certificates began in September 1997. NCHS also develops, with State participation, a model law for State registration systems. The standard certificates and model law are the principal means of implementing standardization in the national vital statistics system. Currently, a National Steering Committee convened by NCHS is developing minimum content and transmission standards for the electronic death certificate. Information on these classifications may be found at the NCHS Web site at http://www.cdc.gov/nchs/icd9.html.

NCHS also participates in developing a number of core health data sets in conjunction with interagency task forces and NCVHS. NCVHS is the external advisory committee to HHS; NCHS serves as executive secretary to the committee. The two most prominent core data sets are the Uniform Hospital Discharge Data Set (UHDDS), which is the basis of the hospital discharge data systems in 34 States, and the Uniform Ambulatory Care Data Set (UACDS). Uniform bills, UB-92 and HCFA-1500, respectively, are major vehicles for collecting the UHDDS and UACDS. Building on this history of uniform data set development, in 1996, NCVHS completed a report and recommendations on standardizing 42 core health data elements for enrollment and encounter in 1996; this report was submitted to the HHS Data Council on August 21, 1996, and continues to be under review within HHS in the context of adopting standards under the Health Insurance Portability and Accountability Act of 1996. Information about NCHVS may be found at its Web site: http://www.ncvhs.hhs.gov.

NCHS is responsible for numerous national surveys, including the National Health Intervention Survey (NHIS), the National Health and Nutrition Examination Survey, and national provider surveys. NHIS is serving as the sampling frame for MEPS and, under HHS's integrated survey plan, will serve as the core sampling frame for several departmental surveys. Through this and related mechanisms, NCHS is trying to promote standardized reporting and coding in NCHS surveys, and by example, in similar surveys conducted elsewhere.

Standards Employed

ICD is the official medical classification for disease reporting in the United States. The standard certificates for vital records are adopted by all registration areas in the United States. Of the core data sets, only UHDDS has been officially promulgated by HHS.

Purpose of Standards

The standards are intended to facilitate data collection and analysis by ensuring comparability across geographic areas and sites of care and by enhancing data quality.

Subject Areas Covered

Subject areas are the classification of diseases, causes of death, vital events, and reporting of morbidity data, health events, and other health-related information from individuals, providers, and households.

Standards Activities

NCHS personnel participate in activities of the WHO Collaborating Centers for the Classification of Diseases and in development and revision of international classification standards under WHO. NCHS personnel also function as one of the four cooperating parties in the United States for development of standard morbidity coding guidelines and, with HCFA, as co-chair of the ICD-9-CM Coordination and Maintenance Committee.

Links With Other Agencies

These activities are coordinated extensively within HHS, as well as with a broad range of public and private sector organizations.

Data Dictionaries

The automated systems used in mortality classification are referred to as "dictionaries," translating from medical terms into medical codes. The definitions developed for data elements in the core data sets also represent a type of data dictionary.

Publications and Other Dissemination

NCHS publishes numerous reports, professional papers by staff members, coding instructions for disease classifications, and World Wide Web documents. The annual update of the ICD-9-CM and coding guidelines are made available on CD-ROM. Guidelines are also published in conjunction with private sector organizations such as the American Hospital Association. The sentinel NCHS report, "Health, United States," is published annually and contains trend data on health status, health care resources, health care expenditures, and utilization of health resources. Natality and mortality data are published in annual volumes and through monthly reports and have recently been included on the NCHS home page. The NCVHS Core Health Data Elements report is on the HHS home page.

Participation in ANSI-accredited and Other Standards Development Organizations

NCHS is a member of ANSI HISB, HL-7, and the ANSI Accredited Standards Committee (ASC) X12. NCHS also is a member of and represents public health and research interests on the National Uniform Billing Committee.

HIPAA 1996-Related Activities

  • Key Personnel Assigned to HIPAA Implementation:

    Donna Pickett serves as one of the three co-chairs (with NLM and HCFA) for the Coding and Classification Implementation Team. The team's area of responsibility is codes and classifications for diseases, injuries, impairments, or other health-related problems, and their manifestations; causes of injury, disease, impairment, or other health-related problems; and actions taken to prevent, diagnose, treat, or manage diseases, injuries, and impairments and any substances, equipment, supplies, or other items used to perform these actions.

    Jane Harman serves as co-chair of the Claims and Encounter Implementation Team. This team recommends formats and data content for health insurance claims, encounters, coordination of benefits, remittance advice, and claim status inquiry.

    Phyllis Doulaveris serves as co-chair of the Claims Attachment Team, which is recommending standards for 275 and 277 transactions.

    Charles Rothwell and Michael Kremer serve on the Infrastructure Implementation Team, which is coordinating the work of the other teams, addressing crosscutting issues, and developing the data dictionary.

    Marjorie Greenberg and Lynnette Araki serve as principal and alternate, respectively, on the departmental Health Data Standards Committee, which oversees the HIPAA implementation teams for the HHS Data Council. Ms. Greenberg also serves as executive secretary of NCVHS and head of the WHO Collaborating Center for the Classification of Diseases for North America.

  • Reviews of HIPAA-Related Transaction Standards Needs and Efforts:

    On November 2-3, 1998, NCHS/CDC, in conjunction with AHCPR and NCVHS, sponsored an invitational workshop, "Implications of HIPAA's Administrative Simplification Provisions for Public Health and Health Services Research." In response to recommendations from that workshop, NCHS is working with workshop participants to establish a consortium for representing health and health services research data needs in the standards process and ensuring that priority information needs are addressed in ongoing standards maintenance efforts. Information about the workshop proceedings is available at http://www.lewin.com/hipaa.

  • Plans or Planning Groups Established to Implement HIPAA Changes: N/A

Comments

N/A

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U.S. Department of Health and Human Services
Food and Drug Administration

Contact

Charles S. Furfine, Ph.D.
FDA/CDRH, Mail Code HFZ-143
12720 Twinbrook Parkway
Rockville, MD 20852
Phone: (301) 443-2536, ext. 16
Fax: (301) 443-9101
E-mail: csf@cdrh.fda.gov

Data-Related Programs

The Food and Drug Administration (FDA) is responsible for ensuring that foods are safe, wholesome, and sanitary; human and veterinary drugs, biological products, and medical devices are safe and effective; and cosmetics and electronic products that emit radiation are safe. Regulatory decisions must be based on information that is complete, accurate, and readily available, so that large amounts of data that are collected from premarket approval submissions and postmarket surveillance activities must be maintained and available for analysis whenever and wherever required. To that end, FDA designs administrative, scientific, and technical information systems in support of its regulatory programs.

Standards Employed

FDA utilizes standards developed "in-house" that it promulgates and enforces, such as the quality standards under the Mammography Quality Standards Act of 1992 and Section 204 of the FDA Modernization Act of 1997 that adds a system for recognizing national and international standards in product reviews. FDA may recognize all or part of an appropriate standard established by a nationally or internationally recognized standards development organization. Examples include the utilization of the Coding Symbols for a Thesaurus of Adverse Reaction Terms (COSTART) developed and maintained by FDA's Center for Drug Evaluation and Research, the World Health Organization Adverse Reaction Terminology (WHOART), developed and maintained by WHO, and the International Electrotechnical Commission (IEC) 60601 series of standards.

Purpose of Standards

Standards are used as a basis for regulatory assessments, providing measures for compliance with regulatory requirements, providing guidelines of practice where formal regulations have not been promulgated, and for developing consensus on approaches for producing safe products in new and emerging technical areas.

Subject Areas Covered

FDA participates in standards development activities on standardizing terminology, development of consensus for measuring performance characteristics of medical devices, and standards that provide metrics for quality assurance that can provide less onerous approaches to ensuring the safety and/or effectiveness of regulated products.

Standards Activities

FDA participates in the development of national and international consensus standards and voluntary guidelines through interaction with appropriate national and international standards committees. Emphasis is placed on efforts aimed at avoiding or minimizing redundancies in standards development activities, developing uniform terminology, and developing standards where conformance with the standard enables less onerous regulatory requirements.

Data Dictionaries

N/A

Publications and Other Dissemination

FDA maintains an updated record of draft and final documents at its Web site at http://www.fda.gov.

Participation in ANSI-accredited and Other Standards Development Organizations

FDA participates in activities of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and the Global Harmonization Task Force (medical devices). FDA is a member of the ANSI Medical Device Standards Board, the ANSI Management Board, and many of the ANSI-accredited standards development organizations. These activities are described in an FDA annual report.

HIPAA 1996-Related Activities

  • Key Personnel Assigned to HIPAA Implementation: N/A
  • Reviews of HIPAA Related Transaction Standards Needs and Efforts: N/A
  • Plans or Planning Groups Established to Implement HIPAA Changes: N/A

Comments

Many of FDA's medical, scientific, and regulatory staff participate in standards-setting bodies as either representatives of their professional organizations or as representatives of FDA. Participation varies as to the level of pertinence and potential impact on either a program area within the agency or FDA as a whole.

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U.S. Department of Health and Human Services
Health Care Financing Administration

Contact

CDR Robert Mayes
Office of Clinical Standards and Quality
Health Care Financing Administration
7500 Security Boulevard, Bldg. S3-02-01
Baltimore, MD 21244-1850
Phone: (410) 786-6872
Fax: (410) 786-8532
E-mail: rmayes@hcfa.gov

Data-Related Programs

HCFA is involved in a number of national health data initiatives. These cover the development of core data sets as well as quality measures, financial indicators, measures of beneficiary satisfaction, and measures of access to care for several settings of care, including long-term care, home health, end-stage renal disease, managed care, and fee-for-service acute care. Data are collected both electronically from providers as well as through medical record abstractions. HCFA is currently moving toward the development of significant online analytic processing capabilities to provide greater utility to the Medicare and Medicaid program data bases it maintains.

Standards Employed

HCFA employs standards developed by several SDOs, including ASC X12N, HL7, ASC X3, and others. Currently these standards are focused primarily on data transmission, but there is an increasing interest in data models and data administration standards.

Purpose of Standards

HCFA utilizes standards in its data acquisition activities, in development of its Conditions for Coverage for participation in Medicare by providers, and as part of its reimbursement process.

Subject Areas Covered

These standards cover all aspects of medical care and health status for the 37 million Medicare beneficiaries. This includes reimbursement activities from providers who are paid by HCFA for Medicare services and selected submission under States' Medicaid claims. This includes over 1.2 million providers, their agents, and vendors.

Standards Activities

HCFA personnel participate in ASC X12N, HL7, ICD-10-PCS (Provider Coding System), ICD-9-CM Committees (partnering with NCHS), ASC X3, ISO Technical Committee 215/Health Informatics, ISO/JTC1 Subcommittee 32/Data Management, and several other groups involved in health data standards. Standards are coordinated extensively with HHS, by formal policy-setting processes, and with other agencies, States, insurers, providers, and vendors.

Data Dictionaries

HCFA currently provides a number of clinical data dictionaries, developed by the Office of Clinical Standards and Quality, on its Internet site.

Publications and Other Dissemination

HCFA promulgates its standards through several media, including print, magnetic, and the World Wide Web.

Participation in ANSI-accredited and Other Standards Development Organizations

HCFA is active in standards-setting initiatives, as described in the "Standards Activities" section.

HIPAA 1996-Related Activities

HCFA is the lead agency in the development of HIPAA regulations and co-chairs all of the Federal workgroups in this area. HCFA also has a significant staff presence on the workgroups, and, as a major payer, is working internally to implement the proposed standards. HCFA also has staff on each of the NCHVS workgroups in support of HIPAA.

  • Key Personnel Assigned to HIPAA Implementation: N/A
  • Reviews of HIPAA-Related Transaction Standards Needs and Efforts: N/A
  • Plans or Planning Groups Established to Implement HIPAA Changes: N/A

Comments

N/A

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U.S. Department of Health and Human Services
Health Resources and Services Administration (HRSA)

Contact

Mike Millman
Office of Planning, Evaluation, and Legislation
Health Resources Services Administration
Room 14-33, Parklawn Building
5600 Fishers Lane
Rockville, MD 20857
Phone: (301) 443-0368
Fax: (301) 443-9270

Data-Related Programs

HRSA promotes primary care and other services to vulnerable populations, principally through grants to States, localities, academic institutions, and community-based organizations. Grantees report aggregate data on clients served and services provided.

HRSA sponsors the Area Resource File (ARF), a county-specific health resources information system. The existing data elements from the externally provided data sources are used and include geographic descriptors, health professions information (including training), health facilities information, utilization levels for hospitals, health care expenditures, and population characteristics and economic data. HRSA also maintains the Practitioner Data Bank established by Congress to direct discrete inquiries into and scrutiny of specific areas of a practitioner's license, professional society memberships, medical malpractice payment history, and record of clinical privileges.

HRSA is very interested in the current work on standardizing encounter and enrollment data, which will facilitate monitoring access to care. HRSA has participated as a commenter on a number of data standardization initiatives, including the Healthplan Employers Data and Information Set (HEDIS) indicators; the identification of a consensus-based set of ICD-9 codes that can be used to measure inadequate primary care; and the current HHS study of State and local public health expenditures and capacity for personal health services.

Standards Employed

HRSA is a user but not a setter of data standards. In the development of grantee reporting requirements and other data systems, HRSA reviews coding schemes and adopts them as appropriate. For example, the National Practitioner Data Bank uses the Harvard University Foundation Allegation of Negligence coding scheme. In reviewing and selecting existing coding systems, HRSA consults widely with relevant parties before implementing reporting formats.

Purpose of Standards

N/A

Subject Areas Covered

N/A

Standards Activities

N/A

Data Dictionaries

N/A

Publications and Other Dissemination

N/A

Participation in ANSI-Accredited and Other Standards Development Organizations

N/A

HIPAA 1996-Related Activities

  • Key Personnel Assigned to HIPAA Implementation: N/A
  • Reviews of HIPAA-Related Transaction Standards Needs and Efforts: N/A
  • Plans or Planning Groups Established to Implement HIPAA Changes: N/A

Comments

N/A

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U.S. Department of Health and Human Services
Indian Health Service (IHS)

Contact

Jim Garvie, Acting Director
Office of Information Resources Management
Indian Health Service
Room 5-A-21, Parklawn Building
5600 Fishers Lane
Rockville, MD 20857
Phone: (301) 443-0750
Fax: (301) 443-7279
E-mail: jgarvie@hqe.ihs.gov

Tony D'Angelo
Principal Statistician, Office of Public Health
Indian Health Service
Suite 450, Twinbrook Metro
12300 Twinbrook Parkway
Rockville, MD 20852
Phone: (301) 433-1180
Fax: (301) 433-1522
E-mail: adangelo@hqe.ihs.gov

Data-Related Programs

IHS has a number of efforts in progress to develop health status and care indicators, which it then encourages tribes to adopt.

Standards Employed

The agency generally follows HHS standards (e.g., departmental ambulatory medical data and discharge data sets) and molds its forms and processes to follow HCFA's model in most cases. Tribes are encouraged, but not required, to use the core data set IHS has adopted. Tribes have considerable flexibility and variability in what services they receive, how they pay, and how they report.

Purpose of Standards

The standards developed by IHS are used as part of its usual processing and related functions. External standards are applied as deemed useful. The legislative and regulatory mandates for this activity are the authorization acts for IHS, but this legislation does not mention standards; it simply directs IHS to ensure services.

Subject Areas Covered

The subject areas covered are various aspects of the health status of, and medical care provided to, members of Indian tribes, either directly by IHS or tribes, or under contract by private providers and insurers. Community health and infrastructure as well as clinical care are affected.

Standards Activities

IHS personnel do not participate in standards-setting bodies, although they serve on HHS workgroups. IHS generally tries to follow standards and guidelines developed elsewhere, especially within HHS.

Data Dictionaries

None. IHS has developed a core data set that tribes are encouraged, but not required, to use.

Publications and Other Dissemination

The standards are promulgated by publication in the Federal Register, by inclusion in manuals, and by less formal communication with providers and tribal leaders. To promote the use of standards or guidelines by tribes, IHS holds meetings with tribes and usually sends out letters to tribes and regional officials soliciting review and comments. Such solicitations are sometimes published in the Federal Register as well. Information on the health care data systems is available at http://www.ihs.gov.

Participation in ANSI-Accredited and Other Standards Development Organizations

N/A

HIPAA 1996-Related Activities

N/A

  • Key Personnel Assigned to HIPAA Implementation: N/A
  • Reviews of HIPAA-Related Transaction Standards Needs and Efforts: Participate on HHS Data Council and on HHS standards workgroups.
  • Plans or Planning Groups Established to Implement HIPAA Changes: N/A

Comments

Measures the agency takes to enforce or encourage compliance with standards: IHS enforces compliance with standards by declining requests for contract renewal from providers and vendors who do not follow its requirements.

Measures the agency takes to assess the effects of standards: IHS assesses the effects of standards by developing baseline measures and performance indicators and encouraging their adoption by IHS providers and by tribal contractors. These measures include health status, health practices, community involvement, some financial elements, some Healthy People 2000 objectives, some HEDIS indicators, and some community-specific elements.

IHS's Office of Public Health has focused more on NCHS reporting than on HCFA reporting; many payment data HCFA would collect are not collected for IHS beneficiaries.

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U.S. Department of Health and Human Services
National Institutes of Health, National Cancer Institute, International Cancer Information Center

Contact

Susan M. Hubbard, Director
International Cancer Information Center
9030 Old Georgetown Road
Bethesda, MD 20814
Phone: (301) 496-1773
E-mail: su@icic.nci.nih.gov

Data-Related Programs

The International Cancer Information Center's (ICIC's) mission is to effectively disseminate state-of-the-art information about cancer treatment and research worldwide. The major long-term goal of the ICIC is to provide appropriate information about cancer treatment and research to all persons and organizations with a need for the information. Strategies for achieving the program goals include removing technological, cost, and language barriers to obtaining ICIC information products; defining the universe of potential users of information about cancer treatment and research and the needs of groups within that universe; and developing a plan for reaching groups within that universe.

Toward this end, the ICIC disseminates the Journal of the National Cancer Institute bimonthly and provides two data bases containing information about cancer research and treatment: the Physician Data Query (PDQ) and the CANCERLIT database. The ICIC provides electronic access to these data in a variety of ways, including online access, facsimile access, and access via the Internet. The ICIC is currently building a universal database server that will contain and disseminate all scientific information collected by or created in the ICIC.

Standards Employed

Medical data standards are not used in creating the ICIC information collection, but are useful in accessing that collection. They include a wide variety of standards such as ICD-9, CPT-4, the Systematized Nomenclature of Human and Veterinary Medicine (SNOMED), American College of Radiology/National Electrical Manufacturers Association (ACR/NEMA), and HL7.

Purpose of Standards

The standards described above, and others, will allow individual users or automated medical information systems to interface directly with ICIC data using native nomenclatures.

Subject Areas Covered

The standards cover data including health status, the use and cost of health services, laboratory and imaging standards, and general clinical data for use in computer-based patient record systems.

Standards Activities

ICIC staff monitor standards activities through the Health Information Standards Planning Panel, the White House Information Infrastructure Task Force—Health Information Applications Working Group, and through G7 activities.

Data Dictionaries

The ICIC universal data base will support retrieval using a wide range of standard nomenclatures as stored in the National Library of Medicine's Unified Medical Language System (UMLS).

Publications and Other Dissemination

N/A

Participation in ANSI-accredited and Other Standards Development Organizations

N/A

HIPAA 1996-Related Activities

  • Key Personnel Assigned to HIPAA Implementation: N/A
  • Reviews of HIPAA-Related Transaction Standards Needs and Efforts: N/A
  • Plans or Planning Groups Established to Implement HIPAA Changes: N/A

Comments

N/A

Page last reviewed December 1999
Internet Citation: Health Care Informatics Standards Activities of Selected Federal Agencies (continued): A Compendium. December 1999. Agency for Healthcare Research and Quality, Rockville, MD. http://www.ahrq.gov/research/findings/final-reports/1999-compendium/infostd2.html