Hubert H. Humphrey Building
Washington, D.C.
The National Committee on Vital and Health Statistics was convened on September 19-20 at the Quality Hotel Courthouse Plaza in Arlington, Virginia. The meeting was open to the public. Present:
UPDATE FROM THE DEPARTMENT
Data Council: Mr. Scanlon
Mr. Scanlon reported on several World Health Organization requests being addressed by the Data Council, notably those related to summary health status measures and ICIDH-2 revision. He described several activities of the Data Strategy Group, which is pulling together an analysis and plan for the Department's data needs, particularly with respect to the data needed to measure progress on the two overarching goals of Healthy People 2010. Finally, he gave status reports on several recent NCVHS letters and recommendations to the Department-those concerning ICIDH-2 revision, PMRI standards, and data needs of the islands and territories. He said the Data Standards Committee would serve as the receiving point for future NCVHS recommendations. In the discussion period, he mentioned some of the priorities for the FY2002 budget, and Dr. Mary Emerson gave a status report on pending HIPAA regulations.
Update on SCHIP Evaluation Plan: Dan Gaylin, ASPE
An HHS project to evaluate the State Children's Health Insurance Program, SCHIP, is in its pre-award phase. It was mandated by Congress in the legislation creating the program. It is the first such study to involve primary data collection, and its purposes are to take stock of the program, indicate any need for course corrections, and provide guidance for policy in this area. Ten states will be studied. Congress will receive the first of a series of reports at the end of 2001. There will be a major effort to synthesize and integrate the findings rather than to put forward information piecemeal. The final report to Congress is scheduled (tentatively) for December 31, 2003.
The evaluation questions cover eight main areas, including benefit design and eligibility levels and their impact on enrollment and enrollee satisfaction. One issue of concern is the barriers to enrollment that contribute to the somewhat disappointing total number of children being reached. The study will also try to get at the complex interactions among SCHIP, Medicaid, employee sponsored insurance, private insurance, and uninsurance. Research activities include surveys of new enrollees, oversampling of priority subgroups, a piggy-back on the NCHS state and local area integrated telephone survey (SLAITS), case studies, and focus groups. The challenges include the large scope of the evaluation, the large number of "moving parts," the short time frame, and the fact that the target population has never been substantially surveyed. One design decision was to focus on short-term outcomes, in view of the newness of SCHIP.
Committee members raised questions about coordination with other evaluation projects, reaching hard-to-reach children, and opportunities for states and researchers to derive knowledge from the project.
BRIEFING FROM NCHS DIRECTOR
Edward J. Sondik, Ph.D.
Dr. Sondik gave a broad overview of NCHS, the designated statistical agency in the health area and a part of the Centers for Disease Control and Prevention. Its current budget is $145 million, with which it carries out a broad array of programs in the areas of vital statistics, surveys, research and methodology, and extramural and international activities. (NCVHS members later marveled at all the Center accomplishes on its very small budget.) He described large changes in the last decade in the relative proportions of its funding sources (PHS-1 percent evaluation funds, funds from other agencies for collaborative projects, and direct appropriations, listed in their current order of magnitude).
In the discussion period, Dr. Starfield raised concerns about the lack of integration between ICD and ICIDH, and Dr. Sondik said the interagency committee needs to develop the research agenda for this effort. He encouraged the Committee to help outline this agenda. He said he shared Dr. Mays' concern about diminishing funds for minority health extramural programs, and he welcomed her suggestion about publicizing NCHS resources for researchers on the Web and invited more suggestions.
50TH ANNIVERSARY SYMPOSIUM SUMMARY; NCVHS 50-YEAR HISTORY
The Committee passed two motions, approving the Symposium summary and authorizing the Executive Subcommittee to accept the next draft of the 50-year history. (See Action Items.)
REPORT FROM W.H.O. COLLABORATING CENTER FOR THE CLASSIFICATION OF DISEASES FOR NORTH AMERICA
Marjorie Greenberg
Ms. Greenberg gave a broad overview of the World Health Organization's classification activities. WHO carries out its agenda in cooperation with Collaborating Centers throughout the world. NCHS houses the headquarters of the North American Collaborating Center, in which it works closely with Statistics Canada and the Canadian Institute for Health Information.
Maintenance and revision of the International Classification of Diseases (ICD) is a major WHO activity (and one of several for which its resources are inadequate). The international mechanisms for updating ICD-10 are the Mortality Reference Group and the Update Reference Committee. The main goal is to balance the need for a clinically current and credible classification with the need for stability over time. Major changes are approved every year but implemented every three years; minor changes are implemented annually.
Another member of the WHO family of classifications is ICIDH (International Classification of Impairments, Disabilities and Handicaps). It is designed to complement ICD by classifying outcomes or components of health not captured by ICD, applicable to all persons and across the life span. (The applicability to children is still under development.) ICIDH has been undergoing a decade-long revision process. There have been several drafts, one of which was field tested in 1999; a pre-final draft was released in October, and there was a final revision meeting in November, which Ms. Greenberg attended. Resolutions on ICIDH-2 will be presented to the WHO executive board in January, and to the World Health Assembly in May 2001. She described problems identified in the pre-final draft, the NCVHS and HHS response, and an alternative proposal developed and proposed by the Collaborating Centers. This proposal was well received at the November meeting in Madrid, where people coalesced around it. A new title was approved: The International Classification of Functioning, Disability and Health. For the sake of continuity, the old acronym will be retained, modified by a number: ICIDH-2. Ms. Greenberg stressed that it will need further testing and piloting before it is ready for wide use in the U.S.
In the discussion section, Dr. Iezzoni said the Populations Subcommittee has reviewed the ICIDH-2 with respect to functional status reporting, and will have comments on it at a future NCVHS meeting. Dr. Cille Kennedy of ASPE, Chair of the International Mental Health Task Force, reported that since the 1980 version, mental health has been "well entrenched and embellished" to the point that mental health and its ensuing disabilities and functional status now have parity with other conditions. Mr. Blair expressed concern about the existence of two separate coding sets and expressed hope that they would be synthesized.
ACKNOWLEDGMENT OF NEW AND OUTGOING MEMBERS
Mr. Scanlon welcomed the following new members appointed by the Secretary:
Vickie Mays, Ph.D., UCLA; Ted Shortliffe, Ph.D., Columbia University; Paul Schwartz, Brooklyn Law School; and Gene Lengerich, V.M.D., Pennsylvania State University. He conveyed the Secretary's appreciation to these outgoing members for their contributions: Kathleen Frawley, Robert Gellman, Lisa Iezzoni, Andrew Kramer, and Elizabeth Ward.
PANEL ON HIPAA IMPLEMENTATION DATA ISSUES
WEDI's Strategic Natl. Implementation Process (SNIP): Lee Barrett, Chair, WEDI
SNIP is under the auspices of WEDI, a consensus-based, industry-based coalition from the private and public sector health care industry. WEDI has leveraged its broad consensus-based capabilities to implement HIPAA. SNIP has three workgroups: transaction, security and privacy, and education and awareness. Mr. Barrett focused his remarks on the Transaction Workgroup, which is trying to define the transaction deployment plan. SNIP has been "very aggressive" in its outreach to get stakeholders involved. It is creating base studies and looking for best practices from what has already been learned, in addition to identifying the issues to be resolved. All issues are put in an issues database. SNIP's work is being coordinated with industry experts from the DSMOs as well as HCFA, state organizations, and other bodies. Mr. Barrett described the work of each of the five sub-workgroups-on sequencing, data review, translations, testing, and business issues. He asked NCVHS to help spread the word about this process.
Data Gaps: Helene Guilfoy, Phoenix Health Systems
Ms. Guilfoy's presentation is based on a series of readiness assessments of about 300 systems in about 200 institutions, mostly hospitals. She used slides to present her findings on the readiness of institutions to implement HIPAA. After showing generally poor readiness to implement HIPAA standards, she offered these recommendations for getting from the current state of affairs to HIPAA implementation:
Catherine Schulten, New Era of Network/AFEHCT
Within AFEHCT, Ms. Schulten works with the Workgroup on Administrative Simplification Print Image Research Effort, or ASPIRE, which came into being because NUCC asked AFEHCT to do a demonstration project on data contact gaps between the HCFA 1500 and the 837. The question was whether the 1500 contains all the information needed to create a HIPAA-compliant version 4010 837 professional claim. The group has found data gaps in mandatory data content, ambiguity within data element crosswalks, and non-standard uses of the paper claim form. After describing examples of these problems, she noted that some adaptations and "walk-arounds" are possible. ASPIRE has completed an analysis of the HCFA 1500 crosswalk and posted it on the AFEHCT website, where results of an analysis of UB92 will also be posted.
ANALYSIS OF STATE PRIVACY LAWS
Joy Pritts, Senior Counsel, Health Privacy Project
Ms. Pritts said it is difficult to summarize state privacy laws because "they are all over the place" in state codes, licensing provisions, FOI provisions, evidentiary codes, etc. In all, the legislation is "a patchwork with a lot of gaps," with variations among states in what is addressed and what is neglected. None of these laws was intended to be comprehensive. Generally, states have not kept pace with the changes in health care delivery and technology. Only California, Hawaii and Maine have passed fairly comprehensive medical privacy laws, and Vermont and New York have proposed comprehensive laws. Many states are putting their activity in this area on hold until the HIPAA privacy regulations are finalized. Ms. Pritts discussed the Gramm-Leach-Bliley (Financial Services Modernization) Act of 1999, which she said raises concerns among people concerned about health information privacy because health information on individuals is now in the hands of banks that are affiliated with health insurers.
Bruce Munson, National Conference of Commissioners on Uniform State Laws
NCCUSL is 110 years old and is composed of delegates from all 50 states-typically law professors, judges, private practice lawyers and legislative lawyers, and sometimes legislators. The Conference examines areas where state laws are inconsistent and in such instances establishes a drafting committee to get testimony and devise a uniform act for adoption by all states. Mr. Munson chairs the drafting committee appointed to revise the 1985 Uniform Health Care Information Act (UHCIA), which was enacted by only two states. He noted that enforcement of federal statutes will not be as "thorough" as for state statutes, because of both the limited number of federal agents and the entanglement with state laws and practices. The Conference believes that even in the presence of new national regulations, there is good reason for having uniform state law. The current plan is for the revised UHCIA to be reviewed (have its "first reading") in 2001 and passed in 2002 by NCCUSL. Mr. Munson reviewed the act and proposed revisions, noting where the issues are and how the drafting committee plans to address them. The drafting group hopes to bring the proposed revisions into conformity with the federal privacy rules in time to have their first reading at the August Conference meeting.
NCVHS members remarked on the multiplicity of groups working on model legislation. Mr. Munson stressed the track record and credentials of NCCUSL. Asked to predict the future of a comprehensive health privacy statute, Ms. Pritts predicted a gradual and controversial, but important, process at the federal level. Mr. Munson said he was not optimistic about the prospects for federal law; he argued the benefits of state laws, which he noted have historically governed the practice of medicine.
ELIMINATING DISPARITIES AND LEADING INDICATORS INITIATIVES
Nicole Lurie, M.D., Principle Deputy Assistant Secretary for Health
Dr. Lurie began with a general update on two major HHS projects that she said are "well launched": leading indicators for Healthy People 2010, and initiatives aimed at eliminating health disparities. HHS selected ten leading indictors for Healthy People 2010, to focus the nation's attention and energy. In addition, the HHS initiative to eliminate disparities is focusing on six health conditions. All HHS agencies are involved in that initiative, which also sets 2010 as its target date, and the Department is also working with other Federal agencies and with groups in the private sector and non-governmental organizations. There are major data issues involved in having both baseline data and data for tracking progress with respect to disparities.
Dr. Lurie commented on the implications of these activities for NCVHS and noted the Data Council's work on a long-term strategy to fill data gaps, for which she acknowledged Mr. Scanlon's leadership. Finally, she reviewed the Data Council recommendations regarding investments in data systems for 2001. The first priority is to fund the Department's current commitments and maintain its capacity to collect racial and ethnic data; the next level is funding enhancements to improve data for the two overarching Healthy People 2010 goals; and the third tier is investments to improve general HHS capacity for racial/ethnic data.
In the discussion period, Committee members raised questions about providers' concerns about not having the time in encounters to deal with language issues, research to create survey instruments for linguistic minorities, issues surrounding the transition to new OMB race/ethnicity categories, and the need for data continuity to track the health of subpopulations.
SUBCOMMITTEE AND WORKGROUP REPORTS
Subcommittee on Standards and Security: Dr. Cohn
The Subcommittee on November 28 discussed the themes that emerged from that day's presentations on HIPAA implementation. It is working on digital signatures, under Dr. Zubeldia's leadership. The Subcommittee is also finetuning its work plan with respect to PMRI. The Committee discussed questions about the implementation guides and the timetable for HIPAA implementation.
Workgroups on the NHII and 21st Century Health Statistics: Dr. Lumpkin
The NHII and the 21st Century Health Statistics Workgroups held a joint hearing in North Carolina, and will hold a meeting in early December to coordinate their activities.
Subcommittee on Privacy and Confidentiality: Ms. Frawley
The Subcommittee recommends that a standing Subcommittee remain in place to pursue privacy and confidentiality concerns, rather than using other means such as those discussed at the Executive Subcommittee retreat. The group is now working on a revised charge and a work plan for the coming year. The Subcommittee heard on November 28 from Cynthia Pelegrini, legislative director to Congresswoman Louise Slaughter, about genetic discrimination issues. Ms. Frawley, whose term has ended, thanked her fellow Subcommittee members and her predecessor, Bob Gellman, and announced that Dr. Harding would become Acting Chair.
Subcommittee on Populations: Dr Iezzoni
Dr. Iezzoni, whose term is also ending, began by thanking her Subcommittee members for their hard work. She reported that the Subcommittee hopes to have a draft report on functional status and ICIDH-2 for the Committee to review at its February meeting. The central point is that functional status information is important. She urged the Standards and Security Subcommittee to look at ICIDH-2 as a possible code set, and to consider how to get functional status information into the computerized patient medical record.
Ms. Frawley called attention to the fact that the Privacy Subcommittee reviewed the ICIDH at its June meeting and "raised no concerns regarding any criteria in that classification." She noted the importance of recording that NCVHS looked at the privacy issues early on in this process.
Dr. Lumpkin reported that Dr. Iezzoni has agreed to continue to lead the work on the functional status report, and that Dr. Friedman will serve as interim Chair of the Populations Subcommittee. He concluded the meeting by thanking Dr. Iezzoni, Ms. Frawley, and Ms. Ward for their many contributions to the Committee.
CALL TO ORDER, WELCOME, INTRODUCTIONS
Dr. Lumpkin welcomed new member Dr. Vickie Mays, and noted that the terms of Ms. Frawley, Ms. Ward and Mr. Gellman were ending as of this meeting. (The outgoing members were honored later in the meeting.)
UPDATE FROM THE DEPARTMENT
Data Council : Mr. Scanlon
Mr. Scanlon reported on several requests of member nations from the World Health Organization (WHO) that the Data Council is now studying. The first concerns WHO's 1999 World Health Report. (See Dr. Starfield's review in the September 2000 NCVHS minutes.) Among other things, WHO is asking for advice on measures of health status and inequality. In addition to this request, the Data Council was asked to look at how HHS might approach several classification and measurement issues in which WHO is involved, including the ICIDH-2. (See summaries of presentations by Dr. Sondik and Ms. Greenberg, below.) Other areas that the Data Council workgroup will look at concern summary measures of population health and the harmonization across member states of the measurement of health status (AKA "health states"). Ultimately, but not initially, the goal is a common instrument to use in periodic assessments of the health status of member countries.
The Data Council is also looking at substance abuse surveys-how the various ones relate to each other, where they overlap, how to interpret the information, how to coordinate them better.
In addition, the Data Council's data strategy group is at work in several areas. One is to develop a comprehensive framework for addressing all the data needs that have been identified in various sectors. The group is also working on a long-term data strategy, and studying critical data needs for eliminating health disparities. (Dr. Lurie will talk about this later in the meeting.) In addition, the strategy group is assisting with the FY-02 budget process, reviewing and coordinating input from all the agencies on their needs in order to improve data and information for decision making. The Data Council expects to complete some analysis, priorities and recommendations by December 2000.
On the status of NCVHS recommendations to the Department, Mr. Scanlon said the letter on the ICIDH-2 revision process had an immediate effect and resulted in communications between HHS and WHO staff. The Committee's letter detailing concerns about HIPAA implementation has been referred to the health data standards committee. The Data Council asked all agencies plus DoD and VA to review the NCVHS letter on PMRI standards (on which Dr. Lumpkin and Mr. Blair briefed the Data Council in August), partly with an eye to where it is possible to move forward, including budget implications. The delays in passing a FY-01 budget have held up that process. The 80 percent of the agencies that have responded are very supportive of many of the recommendations, tempered by concerns about the need to have a privacy/confidentiality protection framework in place. Mr. Scanlon predicted that he could give the Committee a more detailed report on responses to that letter at the next meeting.
Finally, HHS agencies were asked to report on their actions with respect to the NCVHS/Population Subcommittee's recommendations on the information needs of the insular areas and trust territories. Some (e.g., NCHS and HRSA) have made "a fair amount of progress on them. The Data Council's working group on racial and ethnicity data has been asked to pull together a progress report, which will be sent to the participants from these areas.
The Data Standards Committee will serve as the receiving point for future NCVHS recommendations.
Discussion
At Dr. Newacheck's request, Mr. Scanlon described a few of the initiatives planned for in the 2002 budget, cautioning that nothing is assured and that the opportunities for increased resources are limited. A general emphasis is to begin a multi-year strategy to provide the data to do such things as monitor Healthy People, monitor trends in the health system, and improve the racial/ethnic database. The standards infrastructure is another focus, as is analysis and dissemination of information. These general goals are interpreted in the context of the mission of each agency. Dr. Lumpkin applauded the effort to work in a coordinated fashion.
Dr. Mary Emerson gave a brief status report on the privacy regulations, which are in clearance in the Department and still are scheduled for publication before the end of this administration. The unique provider and employer identifiers are also in clearance, and the security reg is being delayed to be sure it is harmonized with the privacy regs. The plan ID and attachments regulations are almost ready for HCFA clearance. The enforcement reg has not yet been drafted. Regarding electronic signatures, she said it is being considered separately from the security final rule, and awaits industry consensus.
Update on SCHIP Evaluation Plan: Dan Gaylin, ASPE
HHS will evaluate the State Children's Health Insurance Program, SCHIP. The project is currently in its pre-award phase; the draft statement of work was issued in August. Mr. Gaylin said his comments would be general because the contractor has not yet been selected. (That should be completed by early January 2001.)
He first gave background on the program, which was created as Title 21 of the Social Security Act in 1997 to provide money to states for health insurance for children younger than 19 and within 200 percent of the federal poverty line. He stressed that this is a state program, and states have considerable flexibility in the design, implementation, targets, and benefits of the program. All 50 states and 6 territories have programs, covering more than 2 million children.
DHHS is embarking on its first large-scale evaluation of the program entailing primary data collection, as directed by Congress. The purposes are to take stock of the program, to indicate any need for course corrections, and to provide guidance for policy in this area. Ten states will be evaluated, representing a diverse mix (in all, a stratified sample size of between 18,000 and 24,000). The target population will be surveyed. The deadline set by Congress (12/31/01) is incompatible with the ambitious nature of the evaluation, which requires OMB clearance. Therefore Congress has been informed, and approved, that they will receive a preliminary report in 2001 with follow-up reports thereafter.
The evaluation questions cover eight main areas, including benefit design and eligibility levels and their impact on enrollment and enrollee satisfaction. Another is the impact on the uninsured. One issue of concern is the barriers to enrollment that contribute to the somewhat disappointing total number of children being reached. The study is designed to help answer this with questions about access, utilization, satisfaction, infrastructure, and so on. The study will also try to get at the complex interactions among SCHIP, Medicaid, employee sponsored insurance, private insurance, and uninsurance.
The research activities to explore these questions include surveys of new enrollees, some oversampling of priority subgroups, a piggy-back on the NCHS state and local area integrated telephone survey (SLAITS), case studies, a small survey across all 50 states that will lead to a synthesis report, a lot of secondary data analysis using Medicaid and MSIS data and others, focus groups, and construction of a programmatic database to inform policy making and serve as a basis for research. Some funds are reserved for focus studies in areas of particular interest.
Mr. Gaylin then described which research activities would be used to address which evaluation questions, either as a primary or secondary strategy. Describing the challenges, he noted the large scope of the evaluation, the large number of "moving parts," the short time frame, and the fact that the target population has never been substantially surveyed. The evaluation design contains redundancy and multiple layers in an effort to meet these challenges. Elaborating on the challenges and strategies to meet them, he noted that the variability of the programs makes it difficult to generalize the data. The strategy for addressing this include a broad range of data collection, advance knowledge of state data systems, and incentive payments to states to defray the cost of participation in the evaluation. Another challenge is the use of comparison groups.
HHS convened a design conference in February 2000 with most of the stakeholders at which they "hashed through" many issues. One recommendation was to focus on short-term outcomes, because SCHIP is a young program and it would be premature to consider long-term outcomes. Also, there will be a major effort to synthesize and integrate the findings rather than to put forward information piecemeal. The final report to Congress is scheduled (tentatively) for December 31, 2003.
The main contract (80 percent of funding) will handle the surveys, state case studies, secondary data analysis, and the integrative function. Other elements will be done under smaller contracts. The large contract will also integrate research being done elsewhere in the Department, by states, and by other health services researchers. Also included in the contract is routine ongoing dissemination of results.
Dr. Newacheck was the first of several Committee members to praise Mr. Gaylin's report and the planned evaluation. Asked to say more about the coordination activities in view of the multitude of other evaluations underway, Mr. Gaylin said a major approach will be "getting some people around the table" through informal conferences of stakeholders. Another approach is to establish connections with other researchers and try to tie the research together. The project was designed to avoid overlap as much as possible. Finally, there will be coordination with state evaluators.
To a question from Dr. Lumpkin, Mr. Gaylin said one of the goals of the evaluation is to produce information that will be useful for states that are not in the survey sample. He noted that this goal is to some degree in tension with the primary goal or mandate, which is to produce a scientifically valid evaluation covering the questions Congress laid out.
Dr. Starfield talked with Mr. Gaylin about sampling and reaching hard-to-reach children. She observed that the biggest payoff would come from identifying the geographic areas with a high proportion of eligible children.
Dr. Mays observed that researchers and others would benefit from any methodological products produced by this evaluation, and Mr. Gaylin said he was sure the "blue ribbon researchers" doing this evaluation would be eager to talk about their innovative methodologies. Funds are set aside to create a set of products, including "methodological and data-nerdy" ones as well as ones for Congressional health staff.
BRIEFING FROM NCHS DIRECTOR
Edward J. Sondik, Ph.D.
Dr. Sondik observed that NCHS is one of the federal agencies designated as a federal statistics agency, along with the Bureau of the Census, Bureau of Labor Statistics, et al. These agencies are charged with taking an independent look at their areas and producing information useful for evaluation. NCHS is part of The Centers for Disease Control and Prevention.
Reviewing the program structure of NCHS, he outlined these elements:
The NCHS budget (which totals $145 million in FY2000) has three components: 1) PHS 1 percent evaluation funds, 2) funds obtained from other agencies for collaborative efforts, and 3) direct appropriations. The mix of funding has changed greatly over the last decade, with direct appropriations moving from the largest to the smallest source and PHS-1 percent funds doing just the opposite. Overall, the budget has grown since 1996, but resources are still very tight. (The HHS budget is about $400 billion, much of it not discretionary.)
In the vital statistics program area, Dr. Sondik said there had been great progress on implementing ICD-10, including training. Other activities include introducing a new base for age adjustment, producing research on trends in unwed births (they are dramatically lower), many international activities, and a CD on multiple birth data 1995-1997.
Regarding health status assessment, he focused first on HIS and its use of supplements, which he said are critical to Department activities including evaluating progress for Healthy People. The 2000 survey is looking at cancer control. Future supplements will look at Healthy People and children's mental health, among other topics. Resource limitations make it impossible to meet all the demands for the HIS. However, major changes are underway, such as changing the basic software. Dr. Sondik described SLAITS, which collects detailed information related to the HIS in 78 areas of the U.S. The SLAITS will be used to help produce state-level estimates regarding children with special health care needs.
The HANES, the primary national clinical assessment of health status, completed a cycle in the field in 1999. It has changed considerably and now does a representative sample of the U.S. every year. It now also meets the needs of USDA by inclusion of a diet component. Dr. Sondik noted that the logistics for HANES, which uses trailer trucks, are very interesting and exemplify the complexity of the work involved. A future extension is moving forward: DP (defined population) HANES, using a single trailer that can go to more places. Data for 1999 were released in mid-2000, representing a major change in HANES made possible by automatic coding and other technological advances.
The NCHS national health care surveys cover information on health care utilization. Dr. Sondik noted the need to be sure they are keeping up with the changes taking place in health care delivery, financing, and so on. This involves both filling the gaps (e.g., alternative medicine) and capturing "system dynamics" - how people progress through the health care system - as well as characterizing health care providers and their interrelationships. Various approaches to these questions are being tested and addressed in working papers.
NCHS works with the other statistical agencies to develop a profile of information that goes beyond health, something Dr. Sondik considers very important because solving health-related problems requires information that goes beyond health-e.g., housing, work, education. He cited the reports America's Children: Key National Indicators of Well-Being and Older Americans, 2000 as examples.
Health U.S. 2000 included a chart book on adolescent health; the 2001 volume will have a book on urban and rural health. NCHS, with support from APHA and other agencies, last year began briefing Congressional staff on findings published in Health U.S. The resources available to Congress for policy analysis and decision making were stressed.
NCHS also produced the technical supplement to Healthy People, analyzing the objectives and the data required to track them. Dr. Sondik touched on other NCHS activities: the research data center, the data users conference, and HIPAA implementation. He announced with pleasure that Larry Cox would join NCHS staff in January 2001 as Director of the Office of Research and Methodology, and with regret that Reynard Pincton has left NCHS for NIH. Major challenges the Center is facing include "recruitment, retirements, and recruitment"; research support; privacy and confidentiality; and tight resources.
Finally, Dr. Sondik discussed three World Health Organization efforts in which NCHS and HHS in general are involved - concerning ICIDH-2, operational systems of data collection on health status, and summary measures of population health. He distributed draft language for proposed WHO resolutions endorsing data collection and/or specific instruments in each of these three areas. Dr. Sondik participated in a June 2000 meeting in Ottowa, sponsored by EEC and WHO, that focused on issues related to implementing these measurements and comparisons, and he came away "resolved to do more in terms of international assessment of health status."
Dr. Starfield remarked on all that NCHS does on a very small budget, calling it "really impressive." (Other members later agreed.) She noted that while it is easy to get a summary measure of health, the other areas mentioned above depend on ICD and the disability classification, which are not useful because of their focus on diseases and conditions. There is no effort to put the ICD or ICIDH into a single measure of health conditions or disability, and without that no summary measure is possible. Asked if there is movement in that direction, Dr. Sondik said the interagency committee needs to develop the research agenda for this effort, and he encouraged the Committee to help outline this agenda. The approach must be Department-wide, and the research community in general must be involved. The best outcome would be a single measure that can be easily divided into "a vector of critical components."
To other questions, he said the 1 percent PHS set-aside is not automatic. That amount combined with the direct appropriation has increased by 30 percent in recent years, although the latter has decreased. Progress is being made on the Board of Scientific Counselors, with support from key staffer Linda Blankenbaker. NCHS is part of the NEDS process in CDC (reported on below); he praised the initiative and its underlying thinking, which has useful implications for vital statistics. He agreed with Dr. Lumpkin that it would be useful to look at the privacy issues related to birth and death certificates.
Dr. Mays noted that the budget for minority health extramural programs has gone down, and she asked about the healthiness of this funding. Dr. Sondik said NCHS funds three centers of excellence; he wishes it could fund 15 to nurture research in this area, but the funds don't exist. Indeed some funds have had to be shifted to other efforts, such as fielding HIS. He expressed hope that CDC would make research in this area a priority use of its extramural research funds. Dr. Mays also urged that NCHS use the Internet more to publicize the resources available to researchers. Dr. Sondik welcomed this suggestion and asked for more. He reminded people to visit the NCHS Web page.
A motion was passed to approve the summary of the 50th Anniversary Symposium with no further revisions.
Dr. Lumpkin proposed that the Executive Subcommittee be authorized to (in a January conference call) accept draft 3 of the 50-year history of NCVHS, which will incorporate edits recommended by Committee members. Any final changes can then be made before final adoption at the February full Committee meeting. A motion stating this proposal was passed. It was noted that all Committee members will receive the draft accepted by the Executive Subcommittee prior to the February meeting. Dr. Lumpkin thanked Susan Kanaan for her work on this and other NCVHS reports.
REPORT FROM W.H.O. COLLABORATING CENTER FOR THE CLASSIFICATION OF DISEASES FOR NORTH AMERICA
Marjorie Greenberg
Ms. Greenberg said that at its peak, there were nearly 2,000 WHO Collaborating Centers, on a host of topics. WHO works with member countries, research organizations, and others through this mechanism to carry out its agenda. There is an active network of Collaborating Centers on the international classification of diseases. The North American Collaborating Center, representing the U.S. and Canada, is housed at NCHS and, like other such centers, works on mortality and morbidity applications of ICD and on revision of the ICIDH. There are other Collaborating Centers for Spanish- and Portuguese-speaking countries. English-speaking Caribbean countries will probably affiliate with the North American one. This is currently one of several gaps in coverage, e.g., Africa, Southeast Asia, and Arabic-speaking countries. An effort is underway to reorganize and reduce the number of such centers, although there is concern about not undercutting the good work being done in the current structure. A major issue is WHO's lack of resources, both for supporting the collaborating centers and for supporting the classifications.
In the North American Collaborating Center, U.S. representatives (NCHS staff) work closely with those of the Canadian Institute for Health Information and Statistics Canada. This Collaborating Center, which works around a work plan and priorities developed a few years ago, met in October. Its priorities are implementing ICD-10 worldwide (including training and credentialing); developing mechanisms to update ICD incrementally; and defining the parameters of the family of international health classifications, to prioritize work on the "family members." Ms. Greenberg stressed the need to find, train and credential more classification professionals, and to raise the status of this profession. She chairs a subgroup on this priority, which is developing a credentialing program for mortality and morbidity coders that has been approved by the International Federation of Health Records Organizations.
The international mechanisms that have been established for updating ICD-10 are the Mortality Reference Group and the Update Reference Committee. The first is chaired by Harry Rosenberg and includes representatives from most Collaborating Centers. It addresses issues identified by a mortality forum, an open electronic news group. A major goal is to improve the comparability of the information collected and to interpret the rules in a single way across all countries and languages, using input from all countries that use the classification. The U.S. is disseminating abroad the software it has developed for the ICD-10 rules. The Reference Committee's recommendations are made to the Update Reference Committee, which is chaired by the Australia Collaborating Center. Other Collaborating Centers can also make recommendations, especially with respect to morbidity coding. The main goal is to balance the need for a clinically current and credible classification with the need for stability over time. Recommendations of this Committee are made to the Center Heads, and then on to the WHO secretariat for implementation. Major changes are approved every year but implemented every three years; minor changes are implemented annually.
Ms. Greenberg named the components of the family of classifications, which encompasses ones on external causes of injury, primary care, and surgical procedures and interventions as well as the ICD and ICIDH. Some (e.g., surgical procedures and interventions) are still under development, in an effort to get comparable information cross-nationally.
ICIDH was first developed in the 1970s and published in the 1980s as the International Classification of Impairments, Disabilities and Handicaps. It has been undergoing revision for a decade, spearheaded by the collaborating centers. There have been several drafts, one of which was field tested in 1999. A pre-final draft was released in October, and there was a final revision meeting in November, which Ms. Greenberg attended. Resolutions on the revised classification, ICIDH-2, it will be presented to the WHO executive board in January, and to the World Health Assembly in May 2001.
ICIDH-2 is designed to work collaboratively with ICD to classify outcomes or components of health not captured by ICD. The goals are to establish a common language to improve communications, provide a systematic coding scheme for health information systems, and permit comparison of data across countries, disciplines, services and time. The classification is intended for all people, not just those with disabilities, and it integrates medical and social models as well as the environment. It intends to cover the lifespan, although this version is not adequate for children and an adaptation will be developed.
The beta-2 draft of ICIDH-2 had three dimensions: body functions and structures (impairment); activities-functioning at the person level (limitation); and participation-functioning at societal level (restriction). Major issues were raised by the Populations Subcommittee about overlaps between the second and third dimensions, and the North American Collaborating Center has also looked at this issue. In late October, a pre-final draft was released that, in an attempt to address problems in the beta-2 draft, introduced other problems stemming from a reconceptualization of several key concepts. The draft was strongly criticized by the collaborating centers, and prompted a letter from NCVHS to WHO and to the HHS Office of International Health. The unrealistic timeline for reviewing the new draft and the need for testing were additional concerns.
The collaborating centers proposed an alternative to the pre-final draft, which Ms. Greenberg described. It combined the strengths of both previous versions and allowed flexibility for multiple applications. This proposed alternative was well received at a November meeting in Madrid, where people coalesced around it. A new title was approved: The International Classification of Functioning, Disability and Health. For the sake of continuity, the old acronym will be retained, modified by a number: ICIDH-2. WHO subsequently revised its pre-final draft and circulated it to participants for comments. The draft must be translated into six languages and distributed to the WHO executive board by December 15, for consideration in January.
Ms. Greenberg stressed that the ultimate product of this process will still need further testing and piloting in the U.S. before being put into use; nevertheless, it represents a lot of progress and now will benefit from an ongoing updating and modification process.
On the question of pilot testing, Dr. Iezzoni said the Populations Subcommittee has reviewed this matter and will have comments on it at a future NCVHS meeting. Ms. Frawley observed that use of ICIDH-2 would require substantial documentation in the patient health record that does not exist at present. Ms. Greenberg noted that several professional associations have looked at how to incorporate ICIDH into their documentation of patient care and rehabilitation.
Dr. Cille Kennedy of ASPE, Chair of the International Mental Health Task Force, reported that since the 1980 version, mental health has been "well entrenched and embellished" to the point that mental health and its ensuing disabilities and functional status now have parity with other conditions. The American Psychological Association worked with WHO to develop a clinical assessment version for application and use in clinical assessments, which she believes "begins to provide a base" for entering something into the administrative record. Now what is needed is an assessment manual to guide use of the tool, and training sessions, as well as other manuals for use in research.
Mr. Blair praised the classification but expressed concern about the existence of two separate coding sets. He asked about the possibility that ICIDH might be more tightly coupled with ICD in the future, and whether any entities are looking at automating the coding. Ms. Greenberg agreed that both are desirable. Dr. Iezzoni said the Populations Subcommittee is looking at all of these issues and would report on them. Ms. Greenberg said she hoped the full Committee would continue to be interested.
INTRODUCTION OF NEW MEMBERS, PRESENTATIONS TO OUTGOING MEMBERS
Mr. Scanlon announced and welcomed the following new members that the Secretary has appointed to the National Committee:
He also conveyed the Secretary's appreciation to the outgoing members for their contributions, which are acknowledged in letters and certificates that he presented to each of those present. The outgoing members are:
Ms. Greenberg announced the retirement of Dr. Gerry Hendershott, who has staffed the Subcommittee on Populations and the Work Group on 21st Century Health Statistics. He also played a major role in the U.S. involvement in the ICIDH revision process from its beginning. In addition, Patrice Upchurch of the NCVHS staff is taking another position at NCHS. Ms. Greenberg expressed appreciation to these two individuals.
PANEL ON HIPAA IMPLEMENTATION DATA ISSUES
WEDI's Strategic Natl. Implementation Process (SNIP): Lee Barrett, Chair, WEDI
The Strategic National Implementation Process, or SNIP, is under the auspices of WEDI. WEDI is a consensus-based, industry-based coalition from the private and public sector health care industry, including other stakeholders. WEDI leveraged these broad consensus-based capabilities to implement HIPAA. There are three workgroups: transaction, security and privacy, and education and awareness.
Mr. Barrett said his remarks would focus on the Transaction Workgroup, which is trying to define the transaction deployment plan, covering such things as data content issues, deployment, and sequencing. The goal is a consistent and orderly industry-wide implementation. SNIP has been "very aggressive" in its outreach to get stakeholders involved. It is creating base studies and looking for best practices from what has already been learned, in addition to identifying the issues to be resolved. For the latter, people can submit an issue form to SNIP. SNIP also uses audiocasts in which listeners can ask questions and raise issues. All issues are put in an issues database.
SNIP's work is being coordinated with industry experts from the DSMOs (designated standards maintenance organizations) to ensure that the solutions it finds to issues are supported by those organizations. SNIP is also working with state organizations as well as HCFA, vendors, Medicaid programs, clearinghouses, payers, and others, all in an effort to be inclusive.
There are five sub-workgroups: on sequencing, data review, translations, testing, and business issues. The deliverables include the issues database, which is a key tool, as well as a template for collecting and reporting issues. Resolution of issues will be documented, with the rationale explained. Sub-workgroups may develop position papers or proposals on significant issues, for discussion in a written open discussion forum and during the audiocasts.
The idea behind sequencing is to allow time for development, testing, and migration to the new standards. SNIP feels that the business side will drive HIPAA because people are looking for a quantifiable return on their investment (ROI). Thus, SNIP is collecting case studies with an eye toward documenting the ROI. The sequencing plan, which took many factors into consideration, divides the transactions into five groups and identifies three phases: beta/pilot testing, health plan readiness, and migration/completion. For the different groups of transactions, the first two phases are timed differently, but they are all slated for completion on October 16, 2002. The industry reaction to this plan was varied, but there was general acceptance after the rationale was explained and people were assured that everything had been considered and there was a logic to the timeline.
The Data Review Sub-Workgroup is reviewing the implementation guides for each transaction, with special attention to issues related to data ambiguities and inconsistencies. It is trying to assign specific data values. This subgroup is working in conjunction with X12N through formal liaison mechanisms being set up for many SDOs and others. A database and tracking mechanism will be in place, and an effort is being made to promote industry consensus.
The Translations Sub-Workgroup is watching the early implementers and identifying probably translation issues during the transition period, when some trading partners will have converted and others will not. Mapping strategies and other tools should help reduce the impact of translation problems. One set of problems will arise with paper forms, and the work group is looking at that.
The SNIP Testing Sub-Workgroup is providing a common testing strategy and methodology and looking at what to test and how to avoid redundancy. It is also identifying beta-testers in the industry and figuring out how to link this to certification programs.
The business issues group, working closely with X12N, is identifying data gaps that could prevent an organization from performing required business functions. It will produce white papers on data content and code sets, front end edits, public infrastructure funding, and other topics.
In conclusion, Mr. Barrett said WEDI is encouraged by people's ability and desire to work together on these common goals, and it hopes more organizations will get involved. He asked NCVHS to help disseminate these messages.
Data Gaps: Helene Guilfoy, Phoenix Health Systems
Ms. Guilfoy's presentation is based on a series of readiness assessments of about 300 systems in about 200 institutions, mostly hospitals. She used slides to present her findings on the readiness of institutions to implement HIPAA.
For application security guidelines, eight percent of the systems had everything in the guidelines; fifty percent were conditional (they could do some but not all of the functions); and thirty-four percent have no functionality in this area. For policies and procedures, there was an 18 percent overall compliance with HIPAA; for technical security, the number was 11 percent. For transactions, data were missing from about 50 percent of the institutional claims and an average of about 60 to 80 percent for the five other transactions.
For claims, 51-70 percent of the data were missing; and 94 percent of the data on referral and certification were missing, i.e., there is no place to store the data in the existing systems. There was a 73 percent compliance rate on having the data to fill all the claims. Only 33 percent of the data are available electronically to file home health claims.
Ms. Guilfoy noted that these findings were not a surprise, and the HIPAA rules are still new. She observed that in many cases the information is collected by hospitals; it just is not available electronically. In response to a question, she explained that "compliance" in her study means the percentage of data available electronically. Dr. Zubeldia pointed out that without all the data, it could be said that the compliance rate is zero.
For identifiers, the questions were whether the HIS currently collects some kind of identifier and whether the bills include the information. For the national provider ID, 34 percent of institutions can currently store the information in the new size and format; that number is 42 percent for the national employer ID.
On medical data code sets, Ms. Guilfoy found that as of now, 25 to 43 percent would be able to collect ICD 10-CM, and 32 to 75 percent would be able to collect ICD 10-PCS. She said she is advising her clients to plan for ICD-10. She then showed data on non-medical code sets, noting the differences between X-12 and UB-92. She then discussed some problems associated with the NDC code.
She offered these recommendations for getting from the current state of affairs to implementation of HIPAA:
Catherine Schulten, New Era of Network/AFEHCT
Within AFEHCT, Ms. Schulten works with the Workgroup On Administrative Simplification Print Image Research Effort, or ASPIRE, which came into being because NUCC asked AFEHCT to do a demonstration project on data contact gaps between the HCFA 1500 and the 837. The question was whether the 1500 contains all the information needed to create a HIPAA-compliant version 4010 837 professional claim. Project participants have included providers, payors and clearinghouses. Similar questions concern the UB-92. Both paper forms contain some data that are on the 837, and some that are not. Translation between the two formats is the issue.
The group has found data gaps in mandatory data content, ambiguity within data element crosswalks, and non-standard uses of the paper claim form. Examples of data content gaps are the provider taxonomy code and payor responsibility sequence, neither of which resides on the HCFA 1500. An example of ambiguities in crosswalks is that the 1500 has four categories for relationships of the patient/covered person, while the 837 has 25. One data specificity issue is that the 837 distinguishes between the providers "billed to, paid to, and rendering," while the 1500 does not; nor does the 1500 distinguish between individuals and entities.
Despite problems such as these, Ms. Schulten said "there is hope." She cited the work of the Utah Health Information Network, which is instructing trading partners on how to complete the HCFA 1500 so it is compatible with the 837. Another "work-around" is to produce industry-wide-accepted crosswalks, probably through the auspices of WEDI/SNIP. Other solutions are trading partner agreements and having practice management vendors help providers by providing data enrichment.
ASPIRE has completed an analysis of the HCFA 1500 crosswalk, posted on the AFEHCT website. A demonstration phase of the project is underway. An analysis of UB-92 began in October. Results will be posted on the AFEHCT website.
Discussion
Mr. Rothstein noted that in response to requests for information, hospitals tend to send entire files, which has serious privacy implications. He asked if this would be addressed by the work of any of the panelists' groups, with the effect that providers can segregate information and send only that. Mr. Barrett said the SNIP security and privacy work group will be looking at those issues. It is feasible to do what Mr. Rothstein suggests, he added. Ms. Guilfoy noted that the information requested may not be electronic to begin with. Dr. Lumpkin observed that the Committee's NHII vision paper/interim report addresses some of these issues, while taking the long view as to when such things will be accomplished.
The Committee then recessed for subcommittee meetings, to reconvene the following day as a full Committee.
ANALYSIS OF STATE PRIVACY LAWS
Joy Pritts, Senior Counsel, Health Privacy Project
The Health Privacy Project released a report entitled "The State of Health Privacy" in July 1999 (available at www. healthprivacy.org). Ms. Pritts said it is difficult to summarize state laws because "they are all over the place" in state codes, licensing provisions, FOI provisions, evidentiary codes, etc. None of these laws was intended to be comprehensive; they are ad hoc responses to specific issues, sometimes in "condition-specific" regulations and laws specific to TB or AIDS, for example.
Generally, states have not kept pace with the changes in health care delivery and technology. For example, they assume a one-to-one doctor-patient relationship that hardly exists any more. The laws are also based on paper recordkeeping and do not take electronic information storage and transfer into account. In all, the legislation is characterized as "a patchwork with a lot of gaps," with variations among states in what is addressed and what is neglected. Ms. Pritts cited the variations on patients' right of access to their medical records as an example-a matter of concern when some health care providers see medical information as proprietary. She noted three exceptions, which have fairly comprehensive medical privacy laws: California, Hawaii and Maine (although the last two have suspended theirs for a year).Vermont and New York have proposed comprehensive laws; other than these, the typical state approach is to "nibble at the edge," addressing specific problems. Genetic information and domestic violence are getting a lot of attention now. States are in charge of implementing the insurance provisions of HIPAA, so these requirements are having some impact. Some states use this as a springboard to do more.
Ms. Pritts turned to the Gramm-Leach-Bliley (Financial Services Modernization) Act of 1999, which she said raises concerns among people concerned about health information privacy. The Act removes longstanding restriction and encourages affiliations between banks, insurers including health insurers, and securities firms. The goal was one-stop-shopping for financial services, and this requires the sharing of financial information, defined in such a way as to include information used to apply for health or life insurance, and also including any credit card payments for medical services. Thus, health information is now in the hands of banks if they are affiliated with health insurers. In response to expressions of concern about this, Title 5 was included in Gramm-Leach-Bliley.
Finally, Ms. Pritts said that many states are putting their activity in this area on hold until the HIPAA privacy regulations are finalized.
Bruce Munson, National Conference of Commissioners on Uniform State Laws
NCCUSL is 110 years old and is composed of delegates from all 50 states - typically law professors, judges, private practice lawyers and legislative lawyers, and sometimes legislators. The Conference examines areas where state laws are inconsistent and in such instances establishes a drafting committee to get testimony and devise a uniform act for adoption by all states. One of its products, the Uniform Commercial Code, was enacted by 49 states; others, such as the 1985 Uniform Health Care Information Act (enacted by two states), are less successful. The Conference meets annually, in between which the drafting committees do their work. Proposed acts are not passed until they have been read line by line at two annual meetings, at a minimum.
Mr. Munson chairs the drafting committee appointed to revise the Uniform Health Care Information Act (UHCIA). He noted that enforcement of federal statutes will not be as "thorough" as for state statutes, because of both the limited number of federal agents and the entanglement with state laws and practices. The Conference believes that even in the presence of new national regulations, there is good reason for having uniform state law. The Conference decided not to have the first reading of the proposed revisions of the UHCIA at its July/August 2000 meeting because of last-minute concerns; so the earliest that the act could be promulgated would be Fall 2002. (As a result, Mr. Munson noted that he is speaking as an individual and not representing the Conference.)
He reviewed the act and proposed revisions for the Committee, noting where the issues are and what the Conference is looking at. For example, health care would be redefined to include dealing with genetic materials. Also, Section 103, Scope, is an important provision of the act, designed to prompt state legislatures to find all the disparate state health care provisions, see if they make sense in the light of these provisions, and pull them into order. The act is designed both to be general and to authorize individual states to draft and adopt appropriate regulations concerning the form and dissemination of the notice of information practices and the nature and sufficiency of safeguards. Mr. Munson acknowledged that this militates against uniformity, but he argued that a degree of variety will be a necessity.
The act addresses disclosure in a stringent manner. One subsection tries to create a "long-arm statute" giving jurisdiction over someone outside the state to whom information is disclosed. The Conference "feels very strongly about the sale and marketing of health care information," and it requires separate and "conspicuous" authorization by the patient. Patients may revoke authorization for disclosure. The limited instances where patient's authorization is not required are identified, on the premise that "too much confidentiality can kill you."
Patients are given broad access to their records, with provisions for contesting refusals. They also have broad authority to request corrections and amendments. There are provisions, too, for notice of information practices. Security safeguards are broad and general, for fine-tuning by regulatory agencies. The act also covers civil remedies and criminal penalties.
Discussion
Asked how the state health privacy laws are impacted by ERISA, Ms. Pritts said this is complicated and cannot be generalized about, except to say that there may be an impact.
Asked if the Conference will go back to the drafting table when the HHS final privacy rule is published, Mr. Munson said it would, starting at a meeting in February 2001. The drafting group hopes to bring the proposed revisions into conformity with the federal rules in time to have their first reading at the August Conference meeting.
To another question, he said the NCCUSL has "attempted to open a dialogue" with the National Association of Insurance Commissioners. They were invited to attend drafting meetings, along with other health insurance organizations, but the response to this effort was disappointing.
Dr. Harding asked about states' approaches to sensitive illnesses, and Ms. Pritts said states generally have higher information privacy protections for such conditions than for other conditions, even as they require reporting of many of them. Mr. Munson noted that the proposed uniform act treats all medical information in the same stringent fashion, reasoning that the embargoing of information raises a red flag. He added that what information is sensitive is very situational; a bad heart could keep someone from getting a CEO job.
Ms. Fyffe noted that an organization called NCOIL also has put out a model state privacy law. She suggested doing an inventory of organizations with model privacy laws.
Dr. Starfield asked about the prospects of these organizations coming together to produce one model of legislation. Mr. Munson responded that the health information model notwithstanding, his organization has a good record of getting its products enacted, and it works hand in hand with the American Law Institute and has ABA advisors.
Ms. Pritts noted the range among states, from those that "pride themselves on being consumer-oriented" to those where the issue "has never been on their radar screen." A uniform act with a high-enough standard might work very well; the concern of her Health Privacy organization has been that most models don't set the bar high enough.
Dr. McDonald noted the value of separate independent efforts, and wondered if any of these by states might influence federal regulations or legislation. He then asked for comments on the possibility of "regulations gridlock." He also cautioned against giving consumers so much discretion over what medical information is revealed that their physicians are deprived of the information they need to care for them. Ms. Pritts pointed out the potential for abuse due to broad access to electronic information. Mr. Munson said the proposed uniform state law expects the person safeguarding the records to have policy standards and procedures for managing the information that limit access and disclosure.
Asked to predict the future of a comprehensive health privacy statute, Ms. Pritts predicted a gradual and controversial but important process at the federal level; Mr. Munson said he was not optimistic about the prospects for federal law, and he argued the benefits of state laws, which he noted have historically governed the practice of medicine. Finally, he invited input to his organization's work on the Health Care Information Act.
ELIMINATING DISPARITIES AND LEADING INDICATORS INITIATIVES
Nicole Lurie, M.D., Principle Deputy Assistant Secretary for Health
Dr. Lurie recalled that the last time she visited the Committee, the Department was in the formative stages of identifying leading indicators for Healthy People 2010 and still thinking about how to shape the disparities initiative. Both projects are now "well launched." Noting these initiatives' implications for data and thus for NCVHS, she said her talk would focus on relevant data needs and data issues.
Healthy People 2010 was formally launched in January 2000, with two overarching goals: increasing the years of healthy life and eliminating health disparities. Disparities exist with respect to race/ethnicity, education or income, geographic location, sexual orientation, disability, and gender. Dr. Lurie noted that in its entirety, Healthy People is massive. In order to focus the nation's energy and attention, HHS, with advice from the Institute of Medicine, selected ten leading health indicators: physical activity, overweight and obesity, tobacco use, substance use, responsible sexual behavior, mental health, injury and violence, environmental quality, immunization, and access to health care.
When possible, Healthy People starts with baseline data and aims for two data points in the course of the decade to track progress. However, many areas relevant to the overarching goals have no baseline data, especially for the priority groups in the eliminating disparities initiative. One constraint for some groups is concern about cell sizes and protecting privacy.
A related activity is the HHS Initiative to Eliminate Racial and Ethnic Disparities in Health, announced in February 1998. It shares the goal of eliminating disparities by 2010. There are six focal areas: CVD, cancer, diabetes, infant mortality, immunizations, and HIV/AIDS. They were selected because they account for the bulk of morbidity and mortality in minority communities; baseline data were available; and interventions exist. All HHS agencies are significantly involved in this effort. The approaches include expanding access, leveraging the existing health care system (with attention to quality of care), community demonstrations, research, civil rights enforcement, and an intersectoral approach.
The VA also has a parallel effort on disparities in care and access. The Department also intends to go beyond the federally funded health care system to the private sector, and is working with insurance companies, MCOs, and others about the ways in which they own "part of the problem and part of the solution." The effort has been well received. Dr. Lurie noted the interesting finding from talking with health plans that some plans cannot imagine that their providers would treat members of racial and ethnic minorities or low SES groups differently from those in other groups; yet they have no systems and data for finding out if this is the case.
The Department has formed a partnership with APHA to kick off a broad intersectoral approach and national plan aimed at eliminating disparities. Also, Dr. Lurie chairs a group involving representatives of the Education, Labor, and other cabinet-level departments.
She commented on the implications of these activities for NCVHS, noting the Data Council's work on a long-term strategy to fill data gaps, for which she acknowledged Mr. Scanlon's leadership. There is a budget shortfall for funding this effort. She described a recent meeting of the Secretary's Council for Healthy People, composed of all the former Assistant Secretaries for Health and agency representatives and "a very bipartisan group." The group stressed the priority of addressing data inadequacies, calling this a scientific and public health issue. The former Assistant Secretaries for Health went on record as wanting to work together to move forward funding for data. Dr. Lurie said "we ought to take advantage of that opportunity." Implementation of the new OMB race/ethnicity standards is another activity to plan for.
Finally, she reviewed the Data Council recommendations regarding investments in data systems for 2001. The first priority is to fund the Department's current commitments and maintain its capacity to collect racial and ethnic data, particularly in the NCHS survey infrastructure and for the selected Healthy People 2010 indicators. The next level is funding enhancements to improve data for the two overarching Healthy People 2010 goals, e.g., by enhancing the NHIS. The third tier is investments to improve general HHS capacity for racial/ethnic data. She pointed out that improvements for these purposes at the national level will also involve improving state data, which will be beneficial to states.
The Department also has been examining the real and perceived legality issues around collecting race/ethnicity data. The Office of Civil Rights is working on a national guidance on this subject, and the Department has sent letters providing a legal foundations for health plans. Aetna has expressed interest in doing so, on business grounds.
Discussion
Ms. Ward commented on the need for a "problem-solving atmosphere" to address the concerns of providers in her State (Washington) about handling language interpretation issues and reporting, given the 15 minutes they are allotted for encounters. Dr. Lurie said HCFA is looking at some of these issues and ways to pay for the services. She noted that promising practices are beginning to emerge around the country - e.g., language banks. Dr. Lois Perone, Deputy Assistant Secretary for Planning and Evaluation, said the regional Offices of Civil Rights are good resources on these questions.
Dr. Iezzoni pointed out that NCVHS has recommended that Medicaid managed care data be collected by race and ethnicity. She asked how data will be tracked over time given the new OMB race/ethnicity categories and rules, and also whether NCHS has the funds to do the linguistic work to create survey instruments that work for linguistic minorities. On the first point, Dr. Lurie said Medicaid managed care collection of race/ethnicity data is slowly starting, although it is not yet a requirement. In contrast, race/ethnicity data are required in SCHIP reporting. On the second point, she said it is being worked on by "a lot of very smart people." She noted that understanding the cultural nuances and variations within these big categories is an equivalent challenge. Helping health care providers understand the disparities among their beneficiaries and how to serve all of them is another challenge.
Dr. Sondik commented that the results of the California Health Interview Survey will give some insight into current thinking about race/ethnicity, as well as into the logistics for adequate translation services.
In response to a question from Dr. Cohn, Dr. Lurie said that race/ethnicity data are now collected in several venues, such as the Census and Social Security, but the sources are not connectible and often not linkable to health care information, partly because of privacy constraints. Within the health care system, the data are not being collected by and large. Dr. Sondik commented further on the complexity of getting and linking this information in ways that are meaningful and useful.
Dr. Mays commented on the need for continuity over time in data collection in order to do analysis on subpopulations. Dr. Lurie said that is what is intended through the enhancements she described. In departing, she thanked the Committee for its "hard work and deliberation." Dr. Sondik commented on efforts to address another concern expressed by Dr. Mays, finding the methods and resources to have large enough sample sizes to address race/ethnicity health issues. He said progress is finally starting to be made in this area.
SUBCOMMITTEE AND WORKGROUP REPORTS
Subcommittee on Standards and Security: Dr. Cohn
Dr. Cohn said that at its session the previous day, the Subcommittee discussed themes related to the foregoing presentations on HIPAA implementation. One theme to emerge was the value to industry of the transition occasioned by the administrative and financial transaction rule. This was tempered by another point, concern that the implementation guides may be too stringent. The Subcommittee will be eliciting more views on this when it meets with DSMOs in February.
On the digital signature, on which Dr. Zubeldia has been taking the lead, the Subcommittee held hearings earlier in the Fall, and discussions are now underway that will also be reported on in February. The search is on for suitable and acceptable standards in this area. The Committee will see a draft year 2000 HIPAA report to Congress in February.
On patient medical record information, Mr. Blair said the Subcommittee is working to develop consensus on what to focus on and criteria for selecting standards. All of these topics will be on the Subcommittee's February 1-2 agenda.
Dr. Starfield urged that the language applied to administrative transactions include both financial and administrative information, rather than just the former, because some essential information (e.g., related to quality) is not financial. Dr. Lumpkin commented that the question of what information is and is not required in these transactions must be adjudicated in a deliberative fashion, and some things may have to be phased in.
Dr. McDonald noted that requiring too many data elements that are not on current electronic forms could cause a backlash against HIPAA. He suggested encouraging the SDOs to streamline the implementation guide as much as possible, and asking payors to take a look at what information they really need.
Ms. Guilfoy questioned whether some timetables are realistic. Dr. Zubeldia cautioned against asking X12 to change the implementation guides in any significant way, as that would be "changing tracks" and would be detrimental to the process. Dr. Cohn suggested hearing from the DSMOs before concluding that there is a problem. There was support for this conclusion.
Workgroups on the NHII and 21st Century Health Statistics: Dr. Lumpkin
The NHII and the 21st Century Health Statistics Workgroups held a joint hearing in North Carolina, and will hold a meeting in early December to coordinate their activities.
Subcommittee on Privacy and Confidentiality: Ms. Frawley
The Subcommittee discussed the question, raised at the Executive Subcommittee retreat, of whether privacy issues should be addressed by a Subcommittee or in some other manner. The group agreed that there should indeed be a subcommittee. It will propose a revised charge to reflect the new work plan it is working on. One item on the work plan is examining the impact of privacy regulations on the health care industry. Another is considering, in consultation with the Populations Subcommittee, how the Privacy Subcommittee can address the issue of disparities that all Subcommittees have been asked to look at. The group will prioritize the topics on its current work plan.
The Subcommittee heard from Cynthia Pelegrini, legislative director to Congresswoman Louise Slaughter, about genetic discrimination issues and the legislation introduced by the Congresswoman.
With Ms. Frawley's departure from NCVHS, Dr. Harding becomes the interim Chair. Ms. Horlick will continue as lead staff. Ms. Frawley thanked the Subcommittee members and also acknowledged the previous leadership of Mr. Gellman, the first Chair of the Privacy/Confidentiality Subcommittee.
Subcommittee on Populations: Dr Iezzoni
Dr. Iezzoni, whose term is also ending, began by thanking her Subcommittee members for their hard work. She reported that the Subcommittee hopes to have a draft report on functional status and ICIDH-2 for the Committee to review at its February meeting. The central point is that functional status is important. She urged the Standards Subcommittee to remember ICIDH-2 (which is a classification system, not an assessment or measurement tool) when it is thinking about code sets. She also urged the Standards Subcommittee to include functional status in the data to be recorded in the computerized patient record. She agreed with Dr. Zubeldia that ultimately this issue needs to be taken up with the SDOs like X12.
Ms. Frawley called attention to the fact that the Privacy Subcommittee reviewed the ICIDH at its June meeting and "raised no concerns regarding any criteria in that classification." She noted the importance of recording that NCVHS looked at the privacy issues early on in this process.
Dr. Lumpkin reported that Dr. Friedman will serve as interim Chair of the Populations Subcommittee, and that Dr. Iezzoni has agreed to continue to lead the work on the functional status report.
FINAL BUSINESS
The Committee briefly discussed items for its February agenda. In conclusion, Dr. Lumpkin expressed appreciation to Dr. Iezzoni, Ms. Frawley, and Ms. Ward for the unique perspectives, wisdom, and leadership each of them brought to NCVHS.
He then adjourned the meeting.
I hereby certify that, to the best of my knowledge, the foregoing summary of minutes is accurate and complete.
/s/ John R. Lumpkin, M.D. 4/9/01