Washington, D.C.
The National Committee on Vital and Health Statistics was convened on February 26-27, 2003 at the Hubert H. Humphrey Building in Washington, D.C. The meeting was open to the public. Present:
Committee members
John R. Lumpkin, M.D., M.P.H., Chair
Jeffrey Blair, M.B.A.
Simon P. Cohn, M.D., M.P.H., FACP
John Danaher, M.D.
Peggy B. Handrich
Richard K. Harding, M.D.
John Paul Houston, Esq.
Stanley M. Huff, M.D.
Robert W. Hungate
Eugene Lengerich, V.M.D.
A. Russell Localio, Esq., M.A., M.P.H., M.S.
Vickie Mays, Ph.D.
Mark A. Rothstein, J.D.
Donald M. Steinwachs, Ph.D.
Kepa Zubeldia, M.D.
Absent:
Clement Joseph McDonald, M.D.
Edward M. Shortliffe, M.D., Ph.D.
Staff and liaisons
Marjorie Greenberg, NCHS/CDC, Executive Secretary
James Scanlon, ASPE, Executive Staff Director
Judith Berek, CMS liaison
Virginia Cain, NIH liaison
J. Michael Fitzmaurice, Ph.D., AHRQ liaison
Ed Sondik, Ph.D., NCHS liaison
Steve Steindel, Ph.D., CDC liaison
Others
Jackie Adler, NCHS
Debbie Jackson, NCHS
Katherine Jones, NCHS
Anita Epstein, JCAHO
Suzie Burke-Bebee, NCHS
Jorge Ferrer, CMS
Shelley Haworth, Unicor Medical
Stan Edinger, AHRQ
Philip Aspden, IOM
Olivia Carter-Pokras, Ph.D., University of Maryland School of Medicine
Carol Bickford, American Nurses Assn.
Melissa Bartlett, AAHP
Arthur Ciarkowski, FDA
Dan Rode, AHIMA
Tom Rhodes, NIST
Debra Bass, Alternative Link
Marietta Squire, NCHS
Deanna Jang, OCR
Eduardo Ortiz, AHRQ
Harvey Schwartz, Ph.D., AHRQ
Gracie White, NCHS
Michelle Williamson, NCHS
CONSOLIDATED HEALTH INFORMATICS (CHI) BRIEFING -- Jared Adair, CMS
The CHI Initiative is an effort to adopt message and vocabulary interoperability standards for the federal government. Ms. Adair reported on the government's plans for developing a portfolio of vocabulary domains in which it would like to adopt standards.
DEPARTMENTAL UPDATES
Mr. Scanlon reported on positive developments since the Committee's November meeting that indicate the Department's recognition of the importance and potential of the NHII. For example, the President's FY2004 budget includes an increase of $3 million for the NHII Initiative. He stressed the particular importance of the Department's policy commitment, noting that the amount of the allocation can change. The Department is planning a national meeting on the NHII from June 30 to July 2, in Washington, DC.
Ms. Kaminsky described OCR's national privacy conferences, routine outreach, and development of targeted technical assistance materials. NCVHS members stressed the need for targeted guidance to small ambulatory providers, large integrated delivery systems and academic medical centers, and the research community (in the last case, so they can educate fearful potential participants).
Ms. Trudel noted that the final rules for security and modifications to the transactions and code sets had been published on February 20, to which the Committee responded with applause. Three other regulations are in process - for provider and plan identifiers and for attachments. She discussed plans for outreach and complaint handling.
UPDATE ON NCHS ACTIVITIES - Dr. Ed Sondik, Director
Dr. Sondik hailed the publication Shaping a Health Statistics Vision for the 21st Century, a joint project of NCHS, NCVHS, and the Data Council. He then briefly reported on the Center's move to a new building, progress on its various reengineering projects, and the creation of a bridge file between the data collected under the old OMB race and ethnicity standards and those using the categories in the 2000 Census. The application for a Board of Scientific Counselors has been approved. He said that although the budget has been relatively constant over the last several years (representing a reduction, given inflation), the last year has been one of the most productive ever for the Center. In 2003 and 2004, NCHS will take a "hard look" at its data priorities, in consultation with NCVHS and others. Members discussed with Dr. Sondik the repercussions and possible remedies for the tight NCHS budget.
SUBCOMMITTEE ON POPULATIONS: COLLECTION AND USE OF HEALTH DATA IN RACIAL AND ETHNIC POPULATIONS - Dr. Mays
On day one of the meeting, Dr. Mays circulated a letter and recommendations to the Secretary, drafted by the Subcommittee on Populations, concerning health data collection needs related to racial and ethnic minorities in the U.S. and the Territorial Regions. She read the letter aloud, and members suggested edits. Members with further suggestions were invited to the Subcommittee's afternoon breakout session. At that session, the letter and recommendations were revised. The revised document was reviewed by the Committee on day two, further edits were put forward, and the revised letter and recommendations were approved.
Ms. Handrich, a new member, stimulated a lively discussion by asking whether it is Committee practice to recommend changes that would impose new costs on states, regardless of whether adequate funds are available to support that activity. She expressed concern about the prospect of unfunded mandates.
DRAFT 2000-2002 REPORT
Ms. Greenberg explained that this is a general report of the Committee's activities and accomplishments, continuing a tradition of annual and multi-year NCVHS reports that began in 1949. It is intended as a vehicle for education about the Committee's priorities and activities. No substantive changes were suggested; members were asked to give their edits to Ms. Greenberg or Ms. Kanaan. On day two, the Committee voted to approve the report and authorize the Executive Subcommittee to give final approval when it is finalized.
ETHICS ISSUES BRIEFING ON ADVISORY COMMITTEE MEMBERSHIP - John Condray, HHS Office of General Counsel, Ethics Division
Mr. Condray began with a 20-minute videotape made by the Office of Government Ethics, concerning the ethics standards that apply to special government employees serving on advisory committees. He then reviewed the structure of the ethics program and answered members' questions. In general, he stressed that members should consult with an ethics official or Ms. Greenberg if they have specific questions or think something might be a problem.
ORGANIZATIONAL ISSUES
Members discussed several alternatives for handling overlapping areas among subcommittees and workgroups, and agreed on "a menu of options."
POPULATION HEALTH: A CANADIAN PERSPECTIVE ON OPPORTUNITIES AND CHALLENGES FOR DEVELOPING HEALTH STATISTICS AND HEALTH INFORMATION - Charlyn Black, M.D., Sc.D., Centre for Health Services and Policy Research, University of British Columbia
Dr. Black presented by telephone while the Committee viewed her slides. She praised the Committee's recent report, Shaping a Health Statistics Vision for the 21st Century, which she said "moves the notch a lot higher." She reviewed the landmarks of Canadian work on population health, starting in 1974, and shared key definitions and approaches that inform Canada's approach to population health and health information. The provincial administrative data systems have a population-based (research) registry at their hub, fed by multiple specific data bases. She discussed the uses of the data to develop information on key indicators (need, health status, service utilization, and supply of resources) to support policy and planning. She explained that the population health perspective has health improvement as a fundamental goal, defines populations by characteristics other than their interactions with the medical care system, encompasses a broad range of determinants of health, and encourages consideration of the marginal contributions of investments in health.
Dr. Black then turned to provincial health information systems, the focus of her work, noting that the provincial settings provide the "foundational understanding of what is possible" with health statistics and health information. The hub of the information systems provides a base for population-based analysis, including longitudinal person-specific information. The population-based system links key indicators for a defined population and enables comparisons across subpopulations, thus giving a larger picture of how investments in health care align with health. Using these concepts and data from the Province of Manitoba, she showed a series of slides showing "the paradoxical investments we're making in health." After enumerating the limitations and benefits of population-based administrative data systems, she said the next stage of development involves adding depth and breadth to administrative data systems related to educational attainment, environmental conditions and exposures, social circumstances, and other factors that influence health.
She discussed the major information infrastructure issues in Canada, noting that while there is great potential to build capacity within provinces, there is no national integrative hub. She also identified threats to the development of provincially based information systems in Canada. After mentioning other factors to be considered so that future information systems can be used for population based analysis and policy, she said she hoped to work with NCVHS to help realize its vision for health statistics.
SUBCOMMITTEE AND WORKGROUP REPORTS
Each of the Chairs summarized the recent activities and plans of their groups.
Mr. Rothstein followed his report by expressing his personal disappointment in the Secretary's letter responding to the Committee's September and November letters about outreach on the privacy rule.
(See detailed meeting summary below for these brief agenda items.)
-DAY ONE-
The details of all presentations can be found in the meeting transcript posted on the NCVHS Web site, www.ncvhs.hhs.gov
CALL TO ORDER, WELCOME, INTRODUCTIONS, REVIEW OF AGENDA
Dr. Lumpkin called the meeting to order, asked all present to introduce themselves, and welcomed the first speaker.
CONSOLIDATED HEALTH INFORMATICS (CHI) BRIEFING -Jared Adair, CMS
The CHI Initiative is an effort to adopt message and vocabulary interoperability standards for the federal government. Ms. Adair described the government's approach, saying it plans to develop a portfolio of vocabulary domains in which it would like to adopt standards. It will share these with the Committee and others. Representatives of HHS, DOD and VA are taking a structured approach to looking at vocabularies and existing standards, in order to form opinions on the best course of action for the government. These will be presented to the CHI Council. She stressed that if no standard proves to be mature enough for adoption, the Council will work with industry on a solution. CHI is one of several e-Gov initiatives, and it is preparing a business case for OMB, which will soon be completed.
Dr. Cohn expressed appreciation to Ms. Adair for "leading up very good work." He added that status reports on the CHI would be a standing agenda item of all forthcoming Standards Subcommittee meetings.
DEPARTMENTAL UPDATE: DATA COUNCIL - Jim Scanlon, ASPE
There have been positive developments since the Committee's November meeting that indicate the Department's recognition of the importance and potential of the NHII.
The President's FY2004 budget includes an increase of $3 million for "the NHII Initiative," to accelerate the development and adoption of the technology and standards necessary for electronic health record systems and their use by the health care and public health sectors, as well as support for the NHII. The focus on the voluntary adoption of standards is part of the initiative. Mr. Scanlon stressed the particular importance of the policy commitment, noting that the amount of the allocation can change. AHRQ and ASPE have asked for $12 million to support standards efforts. The AHRQ budget has a patient safety focus, which is a big part of the Secretary's theme in the 2004 budget. One initiative focuses on improving patient safety through hospital information technology, with special attention to helping small and rural hospitals. A $10 million increase has been proposed for the public health information network, which includes NEDSS. Mr. Scanlon noted other budget details, as well.
Turning to other activities, he said the Department is planning a national meeting on the NHII from June 30 to July 2, in Washington, DC. The idea is to identify the consensus and come up with a national action agenda, with recommendations in eight areas including homeland security, patient safety, standards, data architecture, and privacy. The Data Council is compiling an inventory of all NHII-related activities in HHS.
In other news, the HHS Strategic Plan is going through its final revision, which will incorporate NCVHS recommendations. Also, the searchable Web gateway to HHS data is now operational, at www.aspe.hhs.gov/statinfo. It includes access to the policy information center and some two dozen major data systems, plus links to published literature via NLM PubMed. The metadirectory of HHS data systems also has been updated.
Regarding NCVHS recommendations, Mr. Scanlon noted that the Vision for 21st century Health Statistics would be presented to the Data Council in March.
Discussion
Committee members praised Mr. Scanlon and his office for the items they had gotten included in the 2004 budget. Mr. Scanlon stressed that many of the themes and ideas "came out of the Committee's work." He acknowledged that the timing and nature of Congressional approval is unknown. He also agreed with Mr. Localio that the $50 million budgeted for patient safety is not a significant amount, relative to the magnitude of the problem, adding that it is for a demonstration project.
DEPARTMENTAL UPDATE: OCR ACTIVITIES ON PRIVACY RULE -Stephanie Kaminsky, OCR
With the April 14 compliance deadline fast approaching, Ms. Kaminsky said OCR is sponsoring four large-scale, broad-based national privacy conferences around the U.S., two in February and two in March, with CMS participation. OCR is also continuing routine outreach and developing targeted technical assistance materials, and it is coordinating activities related to the enforcement rule with CMS. It is "bulking up" its staff in anticipation of the complaints expected starting on April 15. A privacy rule complaint form was published in the Federal Register for those wishing to submit paper complaints, and information on how to submit exception determination requests will be published soon. The Federal Register and the Web site will soon have information on the address for submitting complaints. The combined reg text will be updated soon to reflect changes from the security rule.
Discussion
Dr. Cohn expressed pleasure that things are progressing, and asked how OCR and CMS would avoid confusion in their respective enforcement roles. Ms. Kaminsky said the two agencies are working closely on that. Dr. Cohn said joint hearings by the Standards and Privacy Subcommittees on enforcement issues might be in order.
Asked how OCR was helping small ambulatory providers prepare to comply with the privacy regs, Ms. Kaminsky said the privacy conferences and targeted technical assistance materials were the main approaches. Dr. Danaher said the roundtables were very useful, but he questioned whether many small providers had attended. He also asked for OCR's help in "demystifying the state preemption analysis piece." He noted the merits of enlisting the state medical societies.
Mr. Houston expressed concern that large integrated delivery systems and academic medical centers might need their own targeted guidance.
Mr. Localio said "there is panic in the research community" because potential participants are refusing to participate in research for fear of litigation. He suggested that OCR provide guidance to the research community on "how those people can get their work done," including educating covered entities on what information they can release with impunity. Ms. Kaminsky said NIH staff working on privacy are very tuned into this problem, and are working on special materials for the research community. OCR is also aware of this anxiety. Dr. Lumpkin suggested that OCR ensure that its name is on any guidance materials developed by NIH, to strengthen the weight of the guidance.
Ms. Kaminsky agreed with Dr. Danaher that the educational campaign would need to continue well past April 14. She added that OCR Director Rick Campanelli stresses voluntary compliance as the preferred approach, with OCR providing assistance to help covered entities understand their obligations. Dr. Danaher suggested that OCR have a triage system for processing complaints.
DEPARTMENTAL UPDATE: DATA STANDARDS - Karen Trudel, CMS
Ms. Trudel noted that the final rules for security and modifications to the transactions and code sets were published on February 20, to which the Committee responded with applause. The modifications final rule will go into effect on October 16, 2003, so covered entities will not have to implement two different versions of the standards. Three other regulations are in process - for provider and plan identifiers and for attachments.
The security rule goes into effect on April 21, making the compliance date April 21, 2005 or a year later for small health plans. A PDF version is on the CMS/HIPAA Web site. The purpose of the security rule is to protect electronic health information against reasonably anticipated threats or hazards and improper use or disclosure. It covers all electronic (and only electronic) protected health information, both at rest and in motion, and applies to all covered entities. It is closely linked to the privacy rule, and enables the implementation and enforcement of the privacy rule. It addresses not just the confidentiality but also the integrity and availability of data. Ms. Trudel noted that the privacy and security rules can be represented by a Venn diagram, with overlapping and non-overlapping areas.
The rule is designed to be flexible, scaleable, comprehensive, and technology-neutral. She described the ways in which the rule departs from the NPRM-the major ones being consolidated and tightened requirements, additional flexibility, and coordination with the privacy rule. She then explained the distinction between standards and implementation specifications. The latter are specific measures pertaining to a standard. They may be either required or "addressable" (i.e., the covered entity must consider whether it makes sense to do it, with documentation if it does not). Covered entities have been given maximum flexibility in figuring out the most effective way to implement the requirements and addressable specifications. The bottom line is that all standards must be implemented using a combination of required and addressable implementation specifications and other security measures, and choices must be documented. She gave some examples of different applications.
CMS is doing a lot of outreach, especially to small providers, and will develop technical assistance materials and a video. Ms. Trudel added that she expects that whatever complaints CMS receives will be linked to a privacy complaint, and they will work closely with OCR on complaints.
Discussion
Mr. Houston urged CMS to have "an extremely aggressive communication plan" and to focus on the big providers, who otherwise can be expected to have a lot of technical questions for CMS. Ms. Trudel said there will be outreach to both large and small providers.
Several NCVHS members praised the clarity of the security rule. Asked if the rule might change between now and the effective date in 2005, Ms. Trudel said that while she could not predict, she believed the standards were flexible enough not to require modification.
UPDATE ON NCHS ACTIVITIES - Dr. Ed Sondik, Director
For the benefit of new members, Dr. Sondik gave some general background about NCHS. It is one of the designated federal statistics agencies, with a long list of information it is required to collect and report. Noting that Committee members had asked that he apprise NCVHS of major issues for the Center, he said he would do that as well as giving salient news of the last year. He began by hailing the publication of Shaping a Health Statistics Vision for the 21st Century, a joint project of NCHS, NCVHS, and the Data Council. The report fits well within the NHII and offers useful recommendations that should be revisited periodically to assess progress. A more scholarly book on the same topics is under development, with the manuscript scheduled for completion this summer. It is to be published by Oxford University Press.
NCHS is moving into a new building in Hyattsville, and he encouraged the Committee to visit and to hold a meeting there sometime. He acknowledged the pivotal role of NCHS Chief Administrative Officer Doug Zinn in achieving the move to the new building.
NCHS has been especially busy in the past year with its multi-year reengineering project. One focus is getting vital statistics off legacy (including DOS-based) systems and onto the internet, an effort about which state offices and their national organization are enthusiastic. This involves networking the process from birth registration to death registration.
A new sample has been developed for the National Health Interview Survey; this project, like the changes in vital statistics, is expensive. There have been other redesigns, notably of NHANES, which is now on a two-year cycle and generates some data on an annual basis. NCHS wants to take another look at what is being collected, a matter it is discussing with the Institute of Medicine. It will also consult NCVHS. Another significant development in the last year was the creation of a bridge file between the data collected under the old OMB race and ethnicity standards and those using the categories in the 2000 Census. It is on the NCHS Web site, along with the new standards for information quality, among other things.
Dr. Sondik reported that after three years of consideration and discussion with NCVHS, the Center's application for a Board of Scientific Counselors has been approved. Members have not yet been appointed. He then turned his attention to the budget, noting that the funds now available to NCHS are considerably lower than the 1994 level, allowing for inflation. The net available to NCHS is just over $100 million. The budget has been relatively constant over the last several years. Nevertheless, the last year has been one of the most productive ever for the Center. Limited budgets require "judicious changes" - e.g., a reduced sample for NHIS, depending on additional support from collaborators in order to continue NHANES, modifying state contracts for vital statistics, and fielding fewer health care surveys.
In 2003 and 2004, NCHS will take a "hard look" at its data priorities, a process for which it will want help from NCVHS. It will also search for greater efficiencies and identify data systems for less frequent collection. Dr. Sondik stressed the importance of support for every step of what the health statistics vision report calls the health statistics cycle. This includes research and development and evaluation, which tend to get sacrificed when funds are tight.
He briefly described high points in NCHS programs in the previous year. NHANES had excellent response rates and released data within a year, thanks to "the zeal of the staff" and new technology. NHANES trailers will be set up at HHS and the old FDA building this Spring. The NHIS also has speeded up data release to within six months of collection. Its data include measures of the percent of the population with health insurance. The last NHIS had a supplement on complementary and alternative medicine as well as children's mental health. Vital statistics data are also being released more rapidly. New population estimates are being used for analyses. The Health Care Survey has generated many publications, journal articles, and electronic releases. A redesigned nursing home survey will be fielded in the Fall. Dr. Sondik gave some statistics on dissemination, noting that the Web site has grown from 6500 user sessions in 1995 to 550,000 in 2002.
In summary, Dr. Sondik said, NCHS is producing more data and the data are being distributed more widely and in a more timely fashion. They need more R&D and to continue reengineering, even if it is at the expense of more data when budgets are tight.
Discussion
Dr. Steinwachs congratulated Dr. Sondik on the Center's accomplishments. He asked if there were ways to increase people's awareness that the data they are using come from NCHS, noting that this concerned both branding and access. Dr. Sondik said he had found that "the reporters know where the data come from," and HHS press releases make this clear. NCHS has tried to educate users about what NCHS does, and it sends a regular newsletter. (NCVHS members will be added to the mailing list.)
Asked if NCHS works with others to get data on special populations, Dr. Sondik said they are considering doing so. He described some of the methodology issues involved.
He said he shared Mr. Localio's concern about "the size of the pixels" as a result of the reduction of NHIS sample sizes, adding that there may be other ways than national surveys to get information on small population groups. This is less preferable, however, because of the loss of the many related variables gained through NHIS or NHANES.
Noting that cutting the NHIS sample reduces the ability to do research on vulnerable populations, Dr. Mays asked what plans NCHS has for compensating for that. Dr. Sondik said he would seek the Committee's advice on this question. The inevitable choices and trade-offs will be discussed with NCVHS and in "wider forums," as well as the new Board of Scientific Counselors. Eventually, the reengineering should result in efficiencies that will free up funds for other uses, but not enough or soon enough to address this short-run problem. NCHS will also look to other funding sources for things like an Hispanic HANES, which would be designed like a community HANES. To a follow-up question, Dr. Sondik said it might be possible for foundations to buy survey time for special purposes, provided they served the broad public health interest. He added that NCHS has "always been open to that." Another possibility is to define a cycle of information-gathering on, for example, a once-a-decade basis for targeted populations, and to use that to build on. Dr. Lumpkin encouraged Dr. Sondik to consult the Populations Subcommittee on issues deriving from its forthcoming report.
In conclusion, Dr. Sondik thanked the NCHS staff supporting NCVHS for their excellent work, adding that the Center's support of the Committee is "absolutely critical to the Department."
SUBCOMMITTEE ON POPULATIONS: COLLECTION AND USE OF HEALTH DATA IN RACIAL AND ETHNIC POPULATIONS - Dr. Mays
Dr. Mays circulated a letter and recommendations to the Secretary, drafted by the Subcommittee on Populations, concerning health data collection needs related to racial and ethnic minorities in the U.S. and the Territorial Regions. She explained that the Subcommittee had been holding a series of hearings on the subject, in the light of the new OMB guidelines on race and ethnicity. Some issues emerged that were deemed "dire enough" to warrant immediate communication rather than waiting until the end of the hearings process, when a report will be produced. The timing of the budget process was one motivation for acting now. The recommendations reflect what the Subcommittee heard in the hearings. The letter focuses on measurement issues, the standards issue of guidance for measuring and monitoring the standard race and ethnicity categories, and the broad question of whether or not there are sufficient data to determine and address health disparities. She began by reading the letter aloud and inviting comments from the Committee. Members offered editorial suggestions and discussed some of the underlying issues.
The decision was made to address the information infrastructure issues regarding American Indian/Alaska Native populations in a separate letter.
Dr. Mays then read the Subcommittee's preliminary recommendations. Again, members discussed the draft recommendations and their scope and applications, and suggested revisions. Dr. Steindel asked that the recommendations reference the findings in the hearings, to give them substance and context. Dr. Berek cautioned against recommending changes (e.g., in Medicare data collection) that are prohibitively expensive and burdensome.
In view of the large number of draft recommendations and the shortness of time for discussing them, Dr. Mays suggested that Committee members with comments participate in the afternoon Subcommittee session, during which the letter and recommendations will be revised, for action by the Committee on day two of this meeting.
Ms. Handrich, a new member, asked if it is Committee practice to recommend changes that would impose new costs on states, regardless of whether adequate funds are available to support that activity. She expressed concern about the prospect of unfunded mandates.
Mr. Scanlon stated that while he believed the Committee should consider whether the benefits outweigh the costs, there is no standard Committee practice on this matter. The Committee can, and sometimes does, recommend additional federal funding for recommended actions. Ms. Berek offered to help the Committee draft a recommendation on language collection that "doesn't get tangled in the potential costs of it," to get the topic on the table.
Dr. Mays posited that it is the Committee's responsibility to "shine a light" and stimulate discussion about how its recommendations can be implemented. Ms. Greenberg added that as an advisory committee, the Committee's role is to identify needs in national health information policy, to weigh priorities across needs, and to determine whether meeting those needs is feasible. It should frame its recommendations in terms of why certain information is important and the costs of not having it. It is the Department's responsibility to look at the implications of implementing the recommendations.
COMMENTS ON DRAFT 2000-2002 REPORT
Ms. Greenberg noted that this is a general report of the Committee's activities and accomplishments, continuing a tradition of annual and multi-year reports that goes back to the beginning of the Committee in 1949. It is intended as a vehicle for education about the Committee's priorities and activities. It is posted on the NCVHS Web site and provided in print form to various constituencies, including the Department and people on the Hill, and the Committee's mailing list. It is supplemented by the annual report to Congress on HIPAA implementation. Mr. Blair suggested that those appointed by the House or Senate might provide a copy to the people who appointed them. There were no substantive objections to the report. Members were asked to give their edits to Susan Kanaan, the author of the report. The Committee will vote on the draft on day two. Ms. Greenberg commended Ms. Kanaan for her continued excellence in chronicling the work of the Committee.
The group then recessed, to reconvene in Subcommittee breakout sessions.
-DAY TWO-
BRIEFING ON ETHICS ISSUES FOR ADVISORY COMMITTEE MEMBERS - John Condray, HHS Office of General Counsel, Ethics Division
After a short introduction, Mr. Condray showed a 20-minute videotape made by the Office of Government Ethics. The videotape consisted of a number of vignettes showing situations that commonly arise for special government employees serving on advisory committees. These vignettes dramatized various situations in which ethical issues might arise and explained the relevant provisions of the law.
Following the videotape, Mr. Condray reviewed the structure of the ethics program. Mr. Condray discussed the financial disclosure reports required of all NCVHS members, and the rationale for the financial disclosure system. He also reviewed the conflict of interest statutes and regulations that apply to advisory committee members, including gifts from outside sources, use of official position, post-employment restrictions and the requirement that members recuse themselves from discussions and decisions in which they have a potential conflict of interest, unless they receive a waiver from the agency. He also distributed handouts on these subjects. In general, he stressed that members should consult with an ethics official or Ms. Greenberg if they have specific questions or concerns.
Dr. Lumpkin raised a question about provisions for travel expense reimbursement for teaching, speaking, and writing related to official duties, given that members are asked to make many presentations involving travel expenses. Mr. Condray said he would work with the Committee officers to resolve this matter. He concluded by discussing the restrictions on political activities under the Hatch Act.
Dr. Lumpkin informed new members that the Committee has officially identified spokespersons on specific subjects, e.g., standards, generally the subcommittee chairs or vice chairs.
SUBCOMMITTEE ON POPULATIONS ACTION ITEMS - Dr. Mays
At the request of Dr. Mays, the Committee unanimously voted to approve an addition of a final paragraph to a letter recently approved by the Executive Subcommittee concerning the budget for NCHS, and especially for the NHIS.
Dr. Mays reported that the Populations Subcommittee had changed its charge to include attention to language.
She then circulated the revised version of the letter and recommendations discussed the previous day. She read aloud the revised letter, and members offered minor edits. It was agreed that the newly condensed and prioritized recommendations would be incorporated into the body of the letter.
The Committee unanimously passed a motion approving the letter and recommendations, as revised. The final version of the letter and recommendations, as approved by the Committee, is posted on the NCVHS Web site.
APPROVAL OF 2000-2002 REPORT
The Committee passed a motion approving the 2000-2002 report, with final editorial revisions to be submitted to and approved by the Executive Subcommittee.
NCVHS ORGANIZATIONAL ISSUES
Dr. Lumpkin said he would ask the Committee at its next meeting to consider making the Quality Workgroup a freestanding Subcommittee rather than a sub-group of the Subcommittee on Populations, as it is now.
Dr. Mays noted that at the last meeting she had identified common issues between the Subcommittee on Populations and other subcommittees and workgroups. She noted a suggestion by Dr. Cohn that chairs regularly give each other lists of issues being considered by their groups, commending this to the group as an efficient way for chairs to identify overlapping areas that might call for joint action such as joint hearings.
Dr. Lumpkin suggested, as well, that members be allowed to participate as corresponding members in groups in which they have an interest but are unable to serve as full members. This would enable them to receive materials and emails and thus keep track of issues being addressed. Dr. Cohn suggested that the Committee watch for issues needing joint action and joint hearings. Dr. Mays pointed out that sometimes, all that will be needed is an informal consultation. The group discussed several alternatives for handling overlapping areas and agreed that there would be "a menu of options." Ms. Greenberg noted that security is an issue that bridges the Privacy and Standards subcommittees, a topic that might be discussed at the next meeting.
POPULATION HEALTH: A CANADIAN PERSPECTIVE ON OPPORTUNITIES AND CHALLENGES FOR DEVELOPING HEALTH STATISTICS AND HEALTH INFORMATION - Charlyn Black, M.D., Sc.D., Centre for Health Services and Policy Research, University of British Columbia
Dr. Lumpkin noted that Dr. Black's presentation continues a series addressing issues related to population health.
Dr. Black spoke by telephone while the Committee viewed her slides. She began by praising the Committee's recent report, Shaping a Health Statistics Vision for the 21st Century, which she said "moves the notch a lot higher."
Canada has profoundly influenced the population health agenda, starting with a 1974 document called "A New Perspective on the Health of Canadians," which set the agenda for the population health movement. One of the most influential works is the 1994 book, Why Are Some People Healthy and Others Not? edited by Greg Stoddard and Bob Evans.
In 1994, a committee of provincial, territorial and federal deputy ministers of health worked on strategies for population health, based on the concepts in the aforementioned book. Then the Prime Minister convened the National Forum on Health, which articulated a strategy and new direction for Canada that focused on health instead of illness, disease, and health care. In 1999, another influential book was published with the support of the Canadian Institute for Advanced Research: Developmental Health and the Wealth of Nations: Social, Biological and Educational Dynamics, emphasizing the importance of early childhood development.
The planners used a definition that is key to the strategies: "'Population health' refers to the health of a population as measured by health status indicators and as influenced by social, economic and physical environments, personal health practices, individual capacity and coping skills, human biology, early childhood development, and health services." (ACPH 1997). As an approach, this moves beyond measurement to analysis, the application of resulting knowledge for policies and actions to improve health and wellbeing, and the evaluation of results.
Statistics Canada, the national statistics agency, has been a big influence in this area, introducing new survey instruments focused on health. The Canadian research agency that is equivalent to the NIH has been reformulated as The Canadian Institutes of Health Research, working closely with Statistics Canada. A Population Health Initiative also has been formed.
Dr. Black then turned to provincial health information systems, the focus of her work, noting that the provincial settings provide the "foundational understanding of what is possible" with health statistics and health information. She explained that in Canada, the main activity around health takes place at the provincial level, where constitutional authority for health care resides. This presents challenges for information systems. Because of universal health care in Canada, the provinces are responsible for more than 98 percent of their populations. The hub of the information systems provides a base for population-based analysis, including longitudinal person-specific information. She described the structure of the provincial administrative data systems, with the population-based registry as the hub, around which are arrayed specific data sources such as hospital, home care, and vital statistics. The challenge is to translate the "crude data" into information (for populations, not individuals) regarding need, health status, utilization of services, and supply of resources, in order to support policy and planning.
She illustrated this process using a five-level pyramid, with "data acquisition, maintenance and enhancement" as the base and "applied research to answer specific questions and monitor changes" as the top level. A population-based system has been developed that links indicators about need, health status, and so on for a defined population and enables comparisons across subpopulations, thus giving a larger picture of how investments in health care align with health. She noted that many of her themes also appear in the NCVHS health statistics vision report.
What is different about the population health perspective is its emphasis on:
Using these concepts and data from the Province of Manitoba, Dr. Black showed a series of slides showing "the paradoxical investments we're making in health." She showed graphs of premature mortality rates, the supply of set-up hospital beds, hospital separation rates, and childhood immunization rates, broken out by health authority and smaller units. One observation from the data is the importance of having small-area data within health authorities, as the larger geographic groupings can obscure significant health variations within them. Among other things, the slides show a mismatch in the way hospital resources are used, and a positive correlation between income and childhood immunization rates.
From using administrative data systems for research, Dr. Black said, researchers have learned, on the one hand, that population-based administrative data systems lack depth and standardization, are missing critical pieces, and can be difficult to access and use. On the other hand, these systems have great breadth and a "surprising" ability to provide perspective on health and health care; the population registry provides a critical hub for more specific data; and, most importantly, they provide an infrastructure for development, addition, and triangulation of other data systems. They can be used to watch entire populations mature and change, and to understand the different influences affecting different cohorts.
To illustrate these points, she showed slides correlating 1) brain development, age, and health investments; and 2) literacy and SES gradients for youth, by province.
The next stage of development of population health information systems, she said, involves adding depth and breadth to administrative data systems related to educational attainment, environmental conditions and exposures, social circumstances, and other factors that influence health.
While Canada has great potential to build capacity within provinces, she said, it has no national integrative hub. She identified threats to the development of provincially based information systems in Canada: first, the privacy agenda; second, the privatization of service delivery, payment for health services, and data collection and data stewardship; and finally, provincial variations in system development, making it impossible to do comparative work across the provinces.
In conclusion, Dr. Black described what has been learned from using administrative data systems. She stressed the need to separate research holdings and real-time systems. Research holdings must maximize anonymity while maximizing researchers' ability to link data to put the pieces together; in contrast, real-time systems need identifiable information and must be highly accurate. So these systems must be separated, while maximizing interactions across the two domains. Researchers also have learned that a population registry is critical, that researchers need similar registries to track populations of providers; and that they need state-of-the-art, standardized data collection tools. They also need comprehensive data collection for all health-related services provided to Canadians, and to be able to develop anonymized person-oriented longitudinal data, plus approaches that are both privacy-sensitive and quality-enhancing.
Finally, she stressed the importance of understanding the possibilities and designing systems that benefit from the advantages of population-based analysis in the next generation of IT applications. She reiterated that the Vision for 21st Health Statistics has "set a new standard for developing a vision to move forward," and she expressed hope that she could work with the Committee in implementing its population-based vision.
Discussion
Asked whether the provinces are attempting to standardize their data, Dr. Black said that this discussion is "fraught with political and technical difficulties." To another question, she said the country's academic institutions have good working relationships with the Canadian Institute for Health Information and with Stats Canada.
Asked if her institute's products demonstrate the practical utility of population-based health information (e.g., on worker productivity and health care costs), she said, by way of example, that they are proposing research to compare the health and health care related to "new-economy" and "old-economy workers." This is expected to be of interest to both employers and politicians.
Dr. Lumpkin thanked Dr. Black for helping the Committee advance the population health dimension of its agenda.
REPORT FROM SUBCOMMITTEE ON STANDARDS AND SECURITY - Dr. Cohn
The Subcommittee will have hearings on March 25-26, May 21-22, and in the last half of the year. It continues to work on PMRI terminology recommendations (with a final report and recommendations slated for September), on advising the CHI initiative, and on HIPAA implementation. The contract for a cost-benefit study on migrating to ICD-10-CM and ICD-10-PCS is under development, with a report to the Committee expected in June or September. There also may be a joint hearing on security. A rough draft of the 2003 report on HIPAA progress is also targeted for June.
REPORT FROM NHII WORKGROUP - Dr. Lumpkin
The Department is holding a conference on the NHII on June 30-July 2. The Workgroup is planning a meeting in Atlanta in April or May, with another hearing on June 6, focusing on the personal health record. It plans to submit a letter to the Secretary at the June NCVHS meeting, focusing on follow-up to the NHII recommendations.
REPORT FROM SUBCOMMITTEE ON POPULATIONS - Dr. Mays
The Subcommittee is pulling together reports on its hearings. A report on population based data may be ready for presentation in June. A hearing on American Indians/Alaska Natives is tentatively planned for mid-May in Los Angeles.
REPORT FROM SUBCOMMITTEE ON PRIVACY AND CONFIDENTIALITY - Mr. Rothstein
At its breakout session earlier this day, the Subcommittee planned its hearings and projects for the coming months and decided to work on two issues: first, a joint hearing with the Subcommittee on Standards and Security on enforcement and implementation of the privacy and security rules, along with design of a HIPAA evaluation strategy; and, second, study of the issue of redisclosure of information following a HIPAA authorization.
Emphasizing that he was expressing his personal views, Mr. Rothstein stated his disappointment in the Secretary's response to the Committee's September 27 and November 25 letters urging that HIPAA privacy rule compliance be made a top priority and that resources for compliance assistance be significantly increased. The Secretary's response essentially advised the Committee not to worry because good progress was being made and more would follow. Mr. Rothstein said the specific measures described in the Secretary's letter "are necessary but not sufficient to address the problems" outlined by the Subcommittee in its letters; and the Department's efforts are "not nearly enough and they are much too late." In addition, the Secretary's response does not address two overarching concerns of the November letter, the lack of sufficient resources and the lack of a sense of urgency.
Mr. Rothstein praised OCR for its efforts related to the HIPAA conference in Atlanta, but suggested it had limited value because it was too close to the compliance deadline and its content is too basic for most covered entities that have attempted compliance and not basic enough for those that haven't. He recommended specialized courses in the future, offered through partnerships with relevant organizations.
Mr. Rothstein said the Subcommittee would continue to monitor HIPAA compliance. It may hold hearings a few months after the April 14 deadline. Dr. Lumpkin suggested asking OCR to supply the Subcommittee with information on the types and volume of complaints it receives.
REPORT FROM WORKGROUP ON QUALITY - Mr. Hungate
Dr. Lumpkin thanked Mr. Hungate for accepting the Chairmanship of the Quality Workgroup.
Mr. Hungate said he wanted to "reset expectations" about what the Workgroup would do, given the lack of institutional crossover from prior membership and the fact that the Workgroup's past work has primarily happened through panel presentations to the full Committee. He said the Workgroup would produce an interim report summarizing findings to date; the report would provide a basis for repositioning the Workgroup's objectives and work plan for the future. There is interest in broadening the scope from health care quality to health quality. The Workgroup (which Dr. Steinwachs is joining) will hold a planning meeting in April, to which Kathy Coltin, the previous Chair, will be invited. Mr. Hungate said the Workgroup would try to clarify the relationship between its domain and the Committee's other work and recommendations, such as on the NHII. It expects to continue the discussion about future directions with the full Committee at the June NCVHS meeting.
Various members expressed their views about how the Workgroup could make the greatest contribution, and in what conceptual context. Mr. Scanlon noted that approaches to quality and patient safety are currently very fluid and developmental; he suggested "at a minimum" monitoring the multiple activities of other bodies, inside and outside the Department.
As factors to be kept in mind in the planning process, Ms. Greenberg pointed out that the Executive Subcommittee had affirmed the importance of quality to the full Committee; that the Committee had received a good "deal of valuable testimony on the subject over the last several years; and that the Committee had made a commitment to advise AHRQ on the National Healthcare Quality Report.
FUTURE AGENDAS
The following topics were mentioned for the forthcoming meeting:
The Executive Subcommittee will hold a conference call to plan the June meeting.
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 06/02/2003 _____________________________________________________________________
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