The National Committee on Vital and Health Statistics was convened on Monday and Tuesday, September 27-28, in the Hubert H. Humphrey Building in Washington, D.C. The meeting was open to the public. Present:
The Secretary has approved the reappointment of Dr. Cohn and Ms. Fyffe and three new appointments to the Committee: Mark Rothstein, J.D., Kepa Zubeldia, M.D., and Andy Kramer, Ph.D. The new HCFA liaison is Gary Christoph, Ph.D.
Dr. Eisenberg reported on developments that grew out of the recommendations of the President's Quality Commission, which released its final report in April 1998. These include the Patients' Bill of Rights, the Quality Interagency Coordinating Task Force (QUIC) and the National Quality Forum. He focused on the two organizations.
The QUIC's mission, carried out through its five work groups, is to enable federal agencies with health care responsibilities to coordinate their quality-related activities and achieve a series of quality goals concerning measurement, information, improvement, infrastructure, personnel, and systems. The Forum's purpose, carried out through its Board and four councils and advised by a Framework Board, is to develop comprehensive quality measurement and public reporting strategies for all stakeholders.
Dr. Eisenberg announced that in collaboration with the 22 states in the Healthcare Cost and Utilization Project (HCUP), AHCPR is making the State Inpatient Databases (SID) more public in order to help improve information on quality of care in hospitals.
Discussion with the Committee focused on coordination with other quality organizations; the relationship with NCVHS, particularly through the Work Group on Quality; and credentialing issues.
The IOM's Quality of Health Care Project started in June 1998, with the objective of putting together a plan to produce a threshold improvement in quality over the next decade. The project, which will last until the end of 2000, has two focal areas: (1) analyzing the major drivers in the health care industry and identifying how to leverage improvement; and 2) determining how to improve the ability of health care organizations and provider groups to improve quality. Each area is the domain of a work group of the IOM Committee.
Dr. Corrigan detailed a series of workshops and reports that are planned by both groups. One workshop examined the lack of media attention to quality issues; another will look at information technology issues. In the second large area listed above, the Committee will synthesize its findings into a description of the critical characteristics of the "21st century healthcare chassis," with the principal report due by late summer, 2000.
The IOM also has a project to evaluate the VA's national formulary system and its impact on quality of care, and it has just released a report on access to specialty care for what the Quality Commission termed "complex or serious" medical conditions.
Discussion with the Committee focused on equity, unanticipatable errors, training for health care personnel, and the need to build consciousness about quality issues and a demand for quality in the market. Dr. Corrigan expressed optimism about the new climate for quality, made possible by public/private collaborations and organizations such as the Forum and the QuIC that can take action on IOM findings and recommendations.
Mr. Scanlon focused on the Data Council's population-based data activities: an updated directory of research data resources just released on the Web; several initiatives on race/ethnicity and discrimination; and an initiative on improving information for decision-making, linked to budget planning for 2001.
On privacy/confidentiality, Mr. Fanning reported that the Department is working on a notice of proposed rulemaking to establish health privacy regulations, pursuant to HIPAA requirements. The NPRM is expected in the Fall. The Department is also advising on a proposed change in OMB grants management circular A10 on releasing data from research supported by federal grant money. A formal revision of the circular by OMB is expected.
Dr. Braithwaite reported that rules on the transaction and code set standards, the employer identifier, the security standards and the national provider identifier are expected by the end of 1999.
Dr. Friedman reported that this project of the Workgroup on a 21st Century Vision for Health Statistics has five components: commissioned white papers, discussion groups, a CNSTAT-sponsored conference in early November, regional meetings and hearings to elicit input from users, and ultimately a vision statement. An edited volume will include the commissioned papers, parts of the CNSTAT workshop, and parts of the vision report.
Dr. Iezzoni presented a revised version of the Medicaid Managed Care report on day one of the meeting, with a request that members review it for action the following day. On day two, she described intended revisions to the report that will explain its emphasis on more rational data management and its goal of improving the ability to monitor the quality of care. The Subcommittee on Privacy and Confidentiality expressed continuing concerns about the level of attention to privacy issues in the report, and Ms. Frawley offered to help draft language to address this concern. In view of these developments, action on the report was deferred until November.
Ms. Freedman introduced Dr. Patricia Potrzebowski of the Pennsylvania Department of Health, Chair of the panel to evaluate the standard certificates, and Dorothy Harshbarger of the Alabama Department of Public Health, who served on the panel and chaired a subgroup. Standard certificates, which are used or adapted voluntarily by states, are revised about once a decade. The current version, implemented in 1989, has been undergoing evaluation and revision for the last two years through a cooperative state-federal effort led by an expert panel.
The panel had four subgroups -- on the birth certificate, death certificate, fetal death report, and standards/designs (including electronic systems). An oversight committee reviewed their recommendations and made final recommendations to NCHS in April 1999. They covered not just the certificates but testing and implementation, including work sheets and training. The Center's goal is to implement the new certificates in January 2003. In the interim, it will do field testing and work with the states to prepare for implementation.
Discussion with the Committee focused on the need to engage the privacy community and get these changes before the public, as well as the resistance of clinicians to more questions and the reasons to avoid the term "traffic accident."
(See also action items above.)
The Population Subcommittee's new initiative is on data- gathering on functional status. Dr. Iezzoni called attention to the implications of this issue for both standard transactions and privacy, and she invited the participation of these Subcommittees. Meetings are planned for October 28-29, 1999, January, April, and July 2000.
Members discussed the challenges of communication and vetting, given deadline pressures and the demands on everyone's time: for all Committee members, the challenge of staying abreast of other subcommittees' activities, and for subcommittees, the challenge of keeping non-members apprised of their activities and outputs. Dr. Lumpkin urged a formal liaison relationship when coordination is critical. The Executive Subcommittee will look again at coordination issues.
Mr. Blair reviewed the work plan and recent activities of the Workgroup on Computer-based Patient Records, noting its efforts to involve and consult with NCVHS members not on the Workgroup. He outlined the stages working up to the report that the Committee must submit to the Secretary in August 2000.
Dr. Cohn reviewed the other activities of the Subcommittee on Standards and Security, which center on past and future NPRMs.
Ms. Frawley reported that the chief task immediately ahead for the Privacy and Confidentiality Subcommittee is commenting on the forthcoming NPRM on health information privacy. Its next major project will concern the use of the Internet for health data.
Ms. Coltin reported that the Workgroup on Quality is focusing on contributing to the Population Subcommittee's project on functional status. It plans a hearing in early November.
Dr. Lumpkin reported that the NHII Workgroup is working on a conceptual model to describe what the NHII will do and how it is put together.
Ms. Greenberg asked for suggestions for the 50th anniversary symposium, which is planned for June 20, 2000.
Dr. Lumpkin called the meeting to order. Mr. Scanlon reported that the Secretary has approved three new appointments to the Committee as well as the reappointment of Dr. Cohn and Ms. Fyffe. The new members are:
Dr. Iezzoni introduced a revised draft of the Populations Subcommittee's report on Medicaid managed care. She reminded the group that this initiative began two years ago and included field visits to Arizona and Massachusetts, as well as a subcontract to consultant Sara Rosenbaum and colleagues to look at state regulations in this area. In response to the Committee's comments at the June meeting, the Subcommittee has separated from the report the draft state contract language being developed by the consultants.
Mr. Gellman stated his continued opposition to the report, which in his view advocates "collecting more data and sharing it with more people" and lacks proper attention to privacy issues and protections. He charged that the drafters failed to consult "the community of people concerned about privacy" and consumer representatives. He acknowledged that the report addresses a genuine problem, but asserted that it is one-sided.
Members were asked to inform Dr. Iezzoni before the afternoon break-outs about any concerns they have about the report and of suggested language. The topic is an action item for day two of this meeting.
On the Subcommittee's report on data in the insular areas, she and Mr. Hitchcock reported that they have received comments on the latest draft from hearing participants and from HRSA, none of which addresses the recommendations. The report was provisionally approved at the last NCVHS meeting, pending receipt of comments; as none addresses the recommendations, that approval stands.
Mr. Blair presented a letter to the Secretary, drafted by the Workgroup on Computer-based Patient Records. Dr. Cohn explained that it serves as a progress report on past work and work plans on uniform standards for patient medical record information. This is a progress letter, not a final report. The intent behind it is to highlight issues of importance to the Committee and to identify major areas of past and future activity. He read the letter, pausing for Committee comments on each paragraph.
Dr. Lumpkin observed that the letter does not adequately reflect the amount of work going on in the industry and the Committee's role in helping to rationalize the process and create consistency among the various activities. He also suggested including a clear statement about the intrinsic privacy and confidentiality issues and the need for a privacy protection framework. There were a few other comments, and Dr. Cohn invited members to share additional ones before the Workgroup revises it and it is acted on in day two of this meeting.
Ms. Greenberg introduced the document, which is a revised version incorporating comments from the June meeting. Dr. Lumpkin asked members to review the document, for discussion the following day.
The recommendations of the President's Quality Commission, which released its final report in April 1998, led to the Patients' Bill of Rights and two groups, the Quality Interagency Coordinating Task Force (QuIC) and the National Quality Forum. The Commission recommended the appointment of a national public/private advisory group to report on the status of health care quality, but the legislation for that has not progressed except for the elements woven into the AHCPR reauthorization. Dr. Eisenberg reported on the two existing bodies.
The QuIC was established by executive order in March 1998 and is co-chaired by the Secretaries of Health and Human Services and Labor, who meet with the group twice a year. The task force meets approximately monthly, with Dr. Eisenberg serving as the Operating Chair. The QuIC's mission is to enable federal agencies with health care responsibilities to coordinate their activities and achieve a series of quality goals concerning measurement, information, improvement, infrastructure, personnel, and systems. There is broad federal participation, including "surprises" like the Federal Trade Commission and the Coast Guard.
The QuIC's approach is to collaborate wherever it can be useful, add value, and minimize confusion for consumers, providers, and patients. One focal area is to develop common measures. There are five work groups, representing the five highest priorities:
Focus: developing a compendium of what's in the "toolbox" and identifying risk adjustment measures and other measures.)
In summary, the following cross-cutting efforts took place in the first year of QuIC:
Another recommendation of the President's Commission was the creation of a non-profit private sector group, which is now called the National Forum for Health Care Quality Measurement and Reporting, AKA the Quality Forum. It was launched and announced by the Vice President after the Commission Report, but it is a private sector program. Its purpose is to develop comprehensive quality measurement and public reporting strategies for all stakeholders.
An early task for the Forum was developing both a coordination framework and a plan for quality measurement and reporting. Other tasks were endorsing sets of quality measures and promoting standardized tools. The hope is that these efforts will bring symmetry in the private sector's approach to quality, aided by the early work of the QuIC. The Forum Board's first meeting with its new director is October 6. Its anticipated budget is $2-3 million a year.
The structure includes a Governing Board, and a Framework Board, which will have about eight members and will develop national aims and look toward the future of health care quality; and four councils -- on consumer, purchaser, provider/health plan, and research/quality improvement. Any organization can join, paying dues of roughly $15,000/year, adjusted as needed. Members choose the council in which they will have primary membership, but can attend meetings of any councils.
The Forum Board has 17 members, who are national leaders in patient/consumer advocacy, business, health care delivery, quality improvement, and health care public policy. Four members are chosen by the councils; the others are selected by the Board itself, with a majority of members (9) representing consumers and purchasers. The Forum is designed to give weight to the perspectives of consumers/patients and purchasers. The federal government also has three positions on the Board: HCFA, AHCPR and an agency designated by the QuIC. The QuIC has a position on the Board. The Forum Director is Ken Kizer, former Undersecretary of the Department of Veterans Affairs.
Dr. Eisenberg used the occasion to announce that AHCPR is launching a new program to make hospital data easier to obtain. In collaboration with the 22 states now participating in the Health Care Cost and Utilization Project, the agency is making the State inpatient databases (SID) more public, with privacy protections. The data are in a uniform format and will supplement NCHS survey data. The database, which will be maintained by Medstat, is expected to improve information on the quality of care in hospitals around the U.S.
Dr. Newacheck asked about the overlap between the work described by Dr. Eisenberg and that of private non-profit groups such as NCQA and the Foundation for Accountability. Dr. Eisenberg said NCQA has a seat on the Forum, but FACCT does not because it does no review or reporting. Other similar groups are possibilities for membership. There are plans for interlocking activities, e.g., around quality measures, and AHCPR will work to link the various organizations. The Performance Measurement Coordinating Council is a parallel mechanism that needs to be coordinated with the Forum. He stressed the value of trying several different approaches to quality and testing their outcomes.
Asked about credentialing, Dr. Eisenberg agreed that it is now a "big hassle" and said the hope is to set up a federal model that the private sector can adapt or adopt if it proves workable. It will be tested and refined in federal delivery systems such as the VA.
Asked about coordination with NCVHS, Dr. Eisenberg said he expected the Committee to be "a beacon, a guiding light." He noted its ability to elicit and transmit ideas from outside government about what the federal government should be doing, and said the Department takes NCVHS recommendations very seriously. The challenge for the Committee is to "stay ahead of the curve," which requires advance notice from the Department, 6 to 18 months out, about its key issues. The Committee also can tell the Department and/or individual agencies what issues they should be dealing with, either directly or through the QuIC. Dr. Lumpkin noted that the Committee's Workgroup on Quality is the natural link to the QuIC.
Ms. Coltin noted that the inadequacies of current data systems forces quality efforts into using patient surveys, which can only be used a limited number of times. The Quality Workgroup wants to identify the key areas of inadequacies in today's data systems in respect to quality measurement and improvement. She noted the potential synergy with the activities described by Dr. Eisenberg, and invited his comments. He agreed, noting in particular the issues of survey integration, access to State and private sector data without violating confidentiality, and a process for presenting a future AHCPR national report on quality.
Dr. Lumpkin expressed the Committee's enthusiastic support for these quality-related activities, and notably the QuIC, which provides a structure for population-based, person-based, and health care-based investigations. He then welcomed the next speaker.
The Institute of Medicine has a long history of working on quality of care, starting with its work on Medicare quality issues. Its Quality Roundtable produced a statement about the urgent need to improve health care quality, published in JAMA in September 1998. That project involved an extensive literature review and brought together high-level experts on this issue. The statement was consistent with the message of the report of the President's Commission on Quality, the core of which is that quality of care is in serious jeopardy today, with millions of people at risk for significant harm.
The Quality of Health Care Project started in June 1998, with the objective of putting together a plan to produce a threshold improvement in quality over the next decade. The Chair is Bill Richardson, CEO and President of the W.K. Kellogg Foundation. The project, which will last until the end of the year 2000, has two focal areas, each with a group working on it: (1) analyzing the major drivers in the health care industry, be they positive or negative, and identifying how to leverage improvement; and 2) determining how to improve the ability of health care organizations and provider groups to improve quality. (Group one is co-chaired by Molly Joel Coye and Chris Bisgard; group two by Don Berwick.)
The IOM Committee will issue a series of reports, the first a long one on patient safety and medical errors to be released in January 2000. It includes close looks at credentialing, medical education, and error reporting, among other topics. For this report, the Committee convened 20 leaders to discuss how professional groups can provide leadership in this area. Another focus group looked at regulatory and legislative factors.
Other, shorter, reports will address critical issues related to policy, communication, and consumer protection. The IOM Committee used an all-day workshop with media leaders to explore the reasons for the limited media attention to quality issues. A white paper will report on this effort. A late-September workshop (which former NCVHS Chair Don Detmer helped to plan) will look at information technology, the impediments to quality care, and relevant policy issues. The proceedings and recommendations from that workshop will be released. Another workshop, in early 2000, will look at payment, cost, and waste, exploring the business case for quality with respect to various payment systems and delivery sites. A workshop planned for March will look at the relationship between volume and outcomes.
In its second major area of study, dubbed "the 21st century healthcare chassis," the IOM Committee has looked at characteristics of exemplary organizations and other industries, using an extensive literature review as well as a telephone interview survey of exemplary "micro-systems" (a term coined by Paul Batald of Dartmouth to describe disease management or primary care programs with a defined patient population). The questions being addressed include the roles of information technology, training, team dynamics, and other factors in the delivery of quality care. The Committee will synthesize its findings into a description of the critical characteristics of the 21st century chassis, with the principal report due by late summer, 2000.
The IOM also has a project to evaluate the VA's national formulary system and its impact on quality of care. David Blumenthal heads the committee, and Roger Herdman staffs it. Another IOM project is a just-released report on access to specialty care for what the Quality Commission termed "complex or serious" medical conditions. Asked by HCFA to look at what regulations are needed to provide guidance to Medicare Plus Choice on how to operationalize the term, the Committee recommended narrowing the definition to "complex and serious." It also identified ways to operationalize the executive order, and advised HCFA to provide general guidance to health plans, with language recommended by the IOM Committee. The Committee recommended more focus on case management and coordination services, and also looked at monitoring issues.
Dr. Starfield commended Dr. Corrigan for the Committee's approach to overuse/underuse/misuse. She asked how it would deal with the unanticipatable errors or safety problems that stem from the inadequacy of the knowledge base. She also asked about attention to the differences in quality of care among population groups, as addressed in the equity goal of the 2010 Health Objectives.
On the second question, Dr. Corrigan said the IOM Committee would not deal extensively with the issue of equity, but the IOM is now putting together two major efforts in that area, one related to communication of clinical information and the other related to the uninsured. An October workshop will address multiple facets of the latter topic.
On the first question, she said the Committee will address various aspects, using a fairly narrow definition of "errors" that does not encompass the up-front issues related to drug safety. She agreed with Dr. Starfield that the literature is scant on the ambulatory side of safety issues.
Ms. Ward noted that the level of education and training of personnel giving medications is one factor. Dr. Corrigan said that the professionalism roundtable identified the importance of involving pharmacists in the effort to reduce errors, and also on the need for a core curriculum on patient safety for professionals and paraprofessionals. The group also looked at systems factors that encourage errors.
Dr. Eisenberg reported that AHCPR has funded and will soon announce four new Centers for Education and Research in Therapeutics (CERTS), which will serve to develop a population base and generate data on errors and adverse events. It hopes to get funding for more such centers. Dr. Corrigan hailed the fact that the Forum, the QuIC, and related programs are taking action on IOM findings and recommendations. She expressed optimism about improving quality in the next decade, thanks to this infrastructure and the bridges being built between the public and private sectors.
Dr. Harding expressed concern about the cut-throat nature of today's health care market that is reflected in Dr. Corrigan's remark that CEOs who spend money on quality do not keep their jobs. He asked how society can make quality a profit center instead of a cost center. She responded that there are indeed areas where increased quality (e.g., eliminating unnecessary services) does reduce cost; the question is why the industry is not seizing on these savings. In other areas, increasing quality may increase cost, and the challenge is to get the market to demand and reward it anyway. The communications workshop tried to get at how to create demand for such changes. She speculated that premiums and cost are what are driving decisions in the industry, along with enrollees' established patterns, rather than quality. The demand for quality does not yet exist, probably because of a lack of awareness of the quality problems.
Dr. Iezzoni called attention to the lack of evidence of the impact of physical and occupational therapy and assistive technologies on the quality of life for people with chronic illness that affects their physical function. Insurers typically refuse to pay for such assistance. Asked if the IOM Committee would look at these issues, Dr. Corrigan said they would not. She characterized this as "an issue just waiting to be done." The IOM Health Care Services Division has a large project of relevance, and it has surfaced the issues raised by Dr. Iezzoni. She agreed that coverage policy is counter-productive in this regard. Dr. Iezzoni expressed hope that the IOM can provide the knowledge base so that when the baby boom generation ages and Congress gets interested, it will be able to make an informed decision.
Dr. Lumpkin introduced and welcomed Dr. Gary Christoph, the new HCFA liaison.
Mr. Scanlon said he would focus on population-based data activities. The Department's Web-based directory of research data resources, which tells what information is available and where to find it, has been completed and is on the Data Council Website. It links to many other sites. The Data Council is working to make the site more user-friendly, and suggestions are welcome both on that and on how to publicize its existence.
On race and ethnicity data, he noted that the initiative to improve the nation's ability to identify and track discrimination is coordinated by OMB and involves several federal agencies. HHS has been asked to take the lead in the health care area. A research conference planned by the National Research Council will be held in late 1999 or early 2000. HHS is working on its data directory, which has extensive information on where to find race and ethnicity data. In addition, the Working Group on Race and Ethnicity Data is reviewing current surveys and administrative data systems to see how they can be enhanced to serve this effort. Also, former NCVHS member Dr. Tom LaViest has been engaged to do a literature review and report on measuring race discrimination in health care. Among other things, he will look at what can be learned from other arenas such as housing and employment.
Regarding the budget planning for FY2001: the Secretary is proposing an initiative on improving information for decision- making, with themes on (1) closing critical data gaps, (2) promoting the next generation of information systems, and (3) improving the delivery of information. This initiative would include not only individual agency activities but also some cross-cutting and unified approaches across the Department, working in partnership with the public health and research communities.
In area (1) above, the key areas are race/ethnicity populations, special populations (e.g., people with disabilities), providers, and outcomes/effectiveness. The initiative will include evaluating and trying to improve methodology. Area (2) links to standards activities and an effort to coordinate them and improve the participation of public health and research communities. In area (3), the Department will take the user's point of view and try to improve access and usability, including supporting training and technical assistance. Policy research on privacy and confidentiality is expected to be one of several cross-cutting activities.
Because of Congress's failure to pass privacy legislation, the Department is working on a notice of proposed rulemaking to establish regulations, pursuant to HIPAA requirements. The NPRM is expected in the Fall. The Committee will consult with NCVHS about the NPRM.
Mr. Fanning briefed the Committee on the Department's views on Congress's "command" that OMB modify the grants management circular A10 on the use of federal grant money, requiring grantees to release underlying data to the public as if it were federal information subject to the Freedom of Information Act (FOIA). The Department favors the release of information, but not based on FOIA. It supports OMB's revision of its prior proposal. The next event expected is the publication by OMB of a formal amendment to that circular.
The four NPRMs published last year related to HIPAA standards will soon be released as final rules. If the clearance process goes as expected, there should be rules on the transaction and code set standards, the employer identifier, the security standards and national provider identifier by the end of 1999. The provider identifier rule will probably have a delayed effective date (e.g., July 2000 at the earliest).
Three other NPRMs are in the hopper, on claims attachments, plan identifier, and health information privacy.
The Workgroup on a 21st Century Vision for Health Statistics has been active for 18 months, with strong support from several NCHS staffers. The project has several components:
More detail of these activities can be found on the NCVHS Website. Following and based on the various meetings, the Department and Workgroup will draft a vision statement that will be vetted both with this Committee and with regional meetings. Ultimately, an edited volume will include the commissioned papers, parts of the CNSTAT workshop, and parts of the vision report.
Dr. Friedman, Ms. Greenberg, and Dr. Lumpkin stressed the importance of integrating this visioning process with the work underway on the national health information infrastructure.
Dr. Lumpkin presented a draft of this process, revised based on the discussion of the previous day. He read the changes aloud. Following a brief discussion and a few suggested modifications that were accepted by the drafters, a motion was unanimously passed, approving the process and the document describing it.
Dr. Cohn described the changes to the draft that was discussed on day one. A motion approving the letter was unanimously passed.
Dr. Iezzoni said a statement would be added to the beginning of this report, providing historical context. It is to explain that considerable information was collected on patients prior to managed care; with the advent of managed care, changes in data collection have made it difficult for Medicaid to monitor the quality of care given to beneficiaries. The report does not propose additional data collection; in fact, it proposes reduced data collection and ways to make it more rational. She moved (and it was seconded) that the report be approved, in anticipation of the addition of the foregoing statement.
Ms. Frawley reported that the Subcommittee on Privacy and Confidentiality remains concerned that the report does not adequately address privacy and confidentiality concerns. On the Subcommittee's behalf she offered to help draft a section on these issues, based on its work in this area, particularly the report to the Secretary.
Comments were made, pro and con, on the extent to which all NCVHS reports should address confidentiality aspects of the specific topic being addressed. On the one hand, the Committee's views on this matter have been publicly stated and a designated Subcommittee is working on these issues on the Committee's behalf. On the other hand, reports need to be free-standing and not depend on the reader's familiarity with the Committee's stand on important related issues.
Concerns were expressed about making a decision on an incomplete report. In view of the Privacy Subcommittee's offer to help address confidentiality issues in this report, Dr. Lumpkin proposed that action on the report be deferred to the November meeting. This was accepted by Dr. Iezzoni, who withdrew her motion. The full report, including the executive summary, will be sent to members in advance of the meeting. The group agreed to a timetable for these steps.
Dr. Iezzoni called the attention of the Subcommittees on Standards and Security and on Privacy and Confidentiality to the Subcommittee's new initiative on information-gathering on functional status. This item, which concerns how people live their daily lives, was targeted for further study in the Committee's core data elements project, with a placeholder designated. The Subcommittee plans to spend the next year studying the feasibility of filling the placeholder and, if feasible, how to do so. This has implications for standard transactions as well as privacy and confidentiality, and she invited their participation. The views of advocates for people with disabilities and other vulnerable populations will be elicited regarding the risks and benefits of a functional status item. Four meetings are planned: October 28-29,1999, January, April, and July 2000. Because of the complexity of this issue, a likely outcome of the project is recommendations for what kind of further study is needed.
Dr. Cohn expressed the Standards Subcommittee's interest in participating. He and Dr. Iezzoni remarked on the challenges of communication and the vetting process, given deadline pressures and the demands on everyone's time: for all Committee members, the challenge of staying abreast of other subcommittees' activities, and for subcommittees, the challenge of keeping non- members apprised of their activities and outputs. Dr. Lumpkin urged a formal liaison relationship when coordination is critical. Referring to the impending report on the 21st century vision, Dr. Friedman noted the additional challenge and importance of collaborating with NCHS and the Data Council.
Dr. Lumpkin said the Executive Subcommittee would pursue these questions, which partly concern the balance between Committee time and subcommittee time at meetings. He thanked Dr. Iezzoni for raising these important issues concerning how the Committee does its business.
(Subcommittee and Workgroup reports resume after the following agenda item.)
Ms. Freedman introduced Dr. Patricia Potrzebowski of the Pennsylvania Department of Health, Chair of the panel to evaluate the standard certificates, and Dorothy Harshbarger, of the Alabama Department of Public Health, who served on the panel and chaired a subgroup. Ms. Freedman reminded the group that the national vital statistics systems is state-based (a designation that covers also seven non-state registration areas). The federal government has issued model standard certificates since 1900, and NCHS periodically issues recommended standards to ensure uniformity, which states adopt voluntarily. These are revised about once a decade.
The current version, implemented in 1989, has been undergoing evaluation and revision for the last two years through a cooperative state-federal effort. The expert panel appointed by NCHS had 24 members, representing a range of stakeholders and types of expertise. The panel was charged with reviewing current certificates and evaluating the utility and quality of current data; identifying unmet data needs; and recommending content, format, and item definitions for new standard certificates. It also undertook to educate data users and providers about the vital registration system and to suggest alternate data sources, as well as to recognize the differing data needs at different levels of government and to identify major users for each data item and the reasons for inclusion or exclusion of an item.
The panel had four subgroups, on the birth certificate, death certificate, fetal death report, and standards/designs (including electronic systems). An oversight committee reviewed their recommendations and made final recommendations to NCHS. The panel took written and oral testimony and surveyed some 1,600 individuals and organizations. It submitted its recommendations last April.
Dr. Potrzebowski said the panel's major objective was to improve the quality of vital statistics data. She outlined the criteria for including or excluding items, adding that for the first time, the panel has recommended further testing for certain items and the development of an implementation plan. It focused not just on data collection instruments but on the entire process, and for the first time designed an electronic data set which provides opportunities for expanded instructions, health screens, and techniques to improve quality. Several recommendations were aimed at improving state vital records systems.
Dr. Potrzebowski reviewed three items that affect all certificates: 1) race/Hispanic origin, redesigned to conform to OMB guidelines; 2) allowing respondents to report more than one race; and 3) questions on education, modeled after 2000 census questions. She then discussed the changes to the death certificate, noting that three items were added: tobacco use, pregnancy, and traffic status. On the fetal death report, she said it resembles the proposed birth certificate with an added section on cause of death, formatted with both check-boxes and additional space for detail. There are new items on pregnancy risk factors, among others, as well. The panel developed standardized worksheets for the mother and hospital staff, to assist with data collection.
Ms. Harshbarger described the fairly extensive changes recommended for the certificate of live birth, noting first the 16 items that remain unchanged, the 6 items deleted, and the dozen modified slightly. Other modifications related to tobacco use as a pregnancy risk factor, mother's weight gain, month when prenatal care began, and elaboration of the 5-minute and possible 10-minute Apgar score. She described the procedures for developing the medical items, which used expert panels, focus groups, and mini-tests of proposed questions. One result of the focus groups was the need for worksheets for clerks. Several items were reworded based on the findings from the mini-tests.
Other changes included these:
Ms. Freedman said the panel has given NCHS an excellent and workable product. The Center's goal is to implement the new certificates in January 2003. In the interim, it will work with the states. Contracts have been let for field tests and development of worksheets and for data specifications for the new data sets. Once these are completed, the certificates will be sent through Departmental clearance, with the revised certificates then released to the states by the Secretary sometime in the year 2000 so states have two years to prepare for implementation. The Department is looking for funding to help states with implementation.
Dr. Starfield asked how the community context, which is known to be an important variable, will be determined, and was told that the mother's address and zip code make that possible. To another question, Dr. Potrzebowski noted that the states can add or modify the certificate questions if they want additional information. States are encouraged to do this because it's a way of testing questions for the next edition of the standard.
Mr. Gellman asked about consultation with patient advocacy and privacy advocacy groups, and was told that they were included in the mailing list for the first round of inquiry. Notices were also posted in scientific journals. He urged NCHS to make a concerted effort to engage the privacy community and to bring the proposed changes before the public. He also questioned what information on the certificate would be made public, noting that privacy standards are becoming more stringent.
In response, Dr. Potrzebowski called attention to statements on the certificates as to restrictions on use of information. Also, in most states, all the information on birth and death certificates is confidential and protected by state law. She stressed that the onus rests with the states to involve the public. Ms. Freedman pointed out that NCHS does not get identifiable data from the records. Mr. Gellman commented that the issues are what happens to the data elements, what protections exist, and how the data are used, particularly regarding birth certificates.
Dr. McDonald commented on the resistance among clinicians to having to answer more questions on the birth certificate. Ms. Freedman said that 90 percent of births are now collected through electronic registration, so the length of the paper certificate is not an issue for most submitters.
Asked about establishing an HL7 standard, Ms. Freedman said there has been talk of this; at a minimum, the standard will be compatible with HL7.
Dr. Lumpkin urged NCHS not to use the term "traffic accident," even if this is ICD-10 terminology and even if using "unintentional injury" might necessitate educating coroners and medical examiners. He also suggested adding an item on injury on the birth certificate, as women are most susceptible to abuse during pregnancy. Dr. Potrzebowski encouraged him to "figure out how to do it in Illinois," as groundwork for the next revision.
Mr. Blair reviewed the past work and future work plan of the CPR Workgroup, noting their efforts to coordinate with other subcommittees. Toward the goal of submitting a report to the Secretary in August 2000, a draft will be presented for action at the June NCVHS meeting, with the first draft of the recommendations to be presented at the February meeting. Hearings are planned for October 14-15 and December 9-10, 1999, and a framework for the recommendations will be developed by late November. The draft report will be vetted with HHS colleagues in March and April.
Mr. Blair and Dr. Cohn invited input from other NCVHS members and sub-groups. Dr. Lumpkin urged the Workgroup to get a draft to the rest of the Committee as soon as it is ready, rather than waiting to send it with meeting books.
Dr. Cohn noted that the work on the CPR is only one of many Subcommittee activities, which include advising on and monitoring implementation of standards and advising on updating the standards. The Subcommittee is also gearing up to respond to the projected NPRM on claims attachments. He predicted that he and Ms. Frawley would at the November meeting propose a process for responding to that NPRM and the one on privacy/confidentiality.
Ms. Frawley reported on the Subcommittee's plans for discussing and commenting on the aforementioned NPRM, which will probably require conference calls because of the limited comment period. The Subcommittee was recently briefed on the European Union directive and national and international privacy activities. In addition, it worked on its work plan, with the use of the Internet for health data planned as the next area of activity, possibly with a hearing in February.
Ms. Coltin said this group is rationalizing its work plan so it can make the maximum contribution to the Population Subcommittee's project on functional status. It plans to work jointly with the Workgroup on the National Health Information Infrastructure (NHII) to ensure the inclusion of quality in the types of information envisioned, and will identify key data categories, e.g., for identifying high-risk patients for intervention. A hearing is planned for November 3, in conjunction with a meeting of the NCQA Committee on Performance Measurement; other hearings will follow, usually in tandem with full NCVHS meetings.
Mr. Blair noted that testimony taken by the CPR Workgroup on data quality and accountability and data integrity is of likely relevance.
Dr. Lumpkin reported that this group is working on a conceptual model to describe what the NHII will do and how it is put together. Components include a national data model and a description of how the model will be used. The latter has raised terminology questions that are not yet resolved. It encompasses several "views": of the patient/consumer/person; of the provider/caregiver; and of the population/community. In addition, cross-cutting "views" that also may be articulated relate to administration and quality.
Ms. Greenberg asked for input by e-mail about the November meeting, which will be held at a Georgetown hotel, as is the CNSTAT workshop. The Executive Subcommittee will plan the November 1999, and February and June 2000 agendas, along with the June 20 50th anniversary symposium, by conference call. She invited suggestions for the symposium. Agenda items for the November, February, and June meetings were noted.
The Executive Subcommittee is meeting the afternoon of December 7 to discuss long-term strategy and budget planning. Inputs are needed for this as well. Mr. Scanlon asked for information on all large special projects by subcommittees and work groups, for budget planning purposes.
Dr. Lumpkin 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. 2/24/00
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Chair Date