Quality Hotel Courthouse Plaza
Arlington, Virginia
The National Committee on Vital and Health Statistics was convened on September 19-20 at the Quality Hotel Courthouse Plaza in Arlington, Virginia. The meeting was open to the public. Present:
Committee members
Staff and liaisons
Others
Mr. Scanlon reported on the status of three NCVHS reports on PMRI, data in the territories, and Medicaid managed care all of which are under review in the Department. He also described the activities of the new Data Strategy Committee of the Data Council, which will be ready to report to NCVHS in a few months.
Dr. Braithwaite reported that the release date for the privacy rule is still not known. The transaction rule was released on August 17. He reviewed the status of the other proposed rules and reported that in the next year, the Department plans to publish a notice of proposed rulemaking on the enforcement rules for administrative simplification, covering privacy and security and all other enforceable standards.
LETTER TO THE SECRETARY ON EARLY IMPLEMENTATION OF HIPAA TRANSACTIONS AND CODE SET STANDARDS (Action Item)
Dr. Cohn reviewed a draft letter to the Secretary, prepared by the Subcommittee on Standards and Security to distill the issues and concerns about implementation that it heard in July testimony. The Committee reviewed the draft letter in detail and offered a number of suggestions and comments. The letter was referred to the Subcommittee for revision, for action on the revised draft the following day. (See Action Items.)
In discussion, a question arose as to the extent to which each of the Committee’s documents should be self-contained and self-explanatory, for the benefit of readers unfamiliar with the subject. Dr. Lumpkin made a general process suggestion that documents on the Committee’s Website contain hypertext that connects to background materials.
DISCUSSION OF EXECUTIVE SUBCOMMITTEE RETREAT (Action Item)
Dr. Lumpkin reported on the deliberations of the Executive Subcommittee at its August planning retreat, and members reviewed the report on the retreat. After discussion, they approved a slightly revised mission statement drafted by the Executive Subcommittee (see Action Items). Dr. Lumpkin briefed members on recent discussions with Dr. Sondik about the relationship between the Center and NCVHS, which was also discussed at the retreat.
The group reviewed the substantive and operational issues raised at the retreat, and considered the possible approaches entertained by the Executive Subcommittee. The Subcommittee will be developing a strategic plan based on its August retreat and this meeting’s discussion, for future consideration by the full Committee.
BRIEFING FROM IOM COMMITTEE ON THE NATIONAL QUALITY REPORT ON HEALTH CARE DELIVERY
Margarita P. Hurtado, Ph.D., Institute of Medicine
Dr. Hurtado is the Study Director of the Committee on the National Quality Report on Health Care Delivery. A final report is expected in Spring 2001. The purpose of the national health care quality report is to inform Congress, policy makers at all levels, and the general public. It will serve as a barometer of quality of health care delivery. The IOM committee has been asked to define the questions the report should address, define the domains it should include, provide examples of measures, and make recommendations on production of the report. It has completed nine of its eighteen months and held three of its four meetings. It is chaired by Dr. William Roper of the University of North Carolina. The vice-chair is Dr. Arnold Epstein from Harvard University. The study’s website URL is http://nationalacademies.org/iom/hcs/nqr.
Dr. Hurtado invited suggestions from NCVHS. Ms. Frawley said the Committee would be interested in “what falls off the table” in the IOM committee’s list of things to measure, as this may suggest data gaps.
BRIEFING ON IOM REPORT, PROTECTING DATA PRIVACY IN HEALTH SERVICES RESEARCH Dr. Lee Zwanziger, Institute of Medicine
The reason for this ASPE- and AHRQ-supported study is that privacy bills and rules generally assume that human subjects are well enough protected if an IRB has looked at a protocol and deemed the release adequately protective. The question is whether IRBs are actually in a position to do that and whether they are adequately supported to carry out this role. The IOM committee was thus charged with gathering information about current IRB practices and principles for protecting confidentiality and identifying ones with superior efficacy, as well as identifying other organizations without IRBs that are doing similar things and, if appropriate, recommending a set of best practices for protecting confidentiality.
The final report was issued in August, and on September 11 the Chair moderated a follow-up symposium on next steps. The thrust of the report is that a commitment to privacy and confidentiality and to reaping the benefits of good research requires support for the institutions that help enhance privacy. This includes supporting IRB practices favoring confidentiality, and punishing improprieties. Resources must be invested in the IRB process, as well as in technical infrastructure and assistance from IT professionals and other experts.
DISCUSSION OF THE WORLD HEALTH REPORT 2000 HEATH SYSTEMS: IMPROVING PERFORMANCE Barbara Starfield, M.D.
Dr. Starfield began by discussing her commentary in JAMA, July 26, 2000, “Is US Health Really the Best in the World?” The commentary reviews the data of the U.S. and 12 other industrialized countries and shows poor U.S. performance on most indicators. It considers the possible reasons for this poor performance (which is most notable for the young) and suggests that it stems from income disparities, the high rate of errors and adverse effects of health care, and, especially, the underinvestment in primary care in the U.S.
Dr. Starfield then briefed the Committee on the World Health Report 2000, which also reveals the poor health status of the U.S. population as a whole, relative to other countries. Asked to comment on the effect of uninsurance and underinsurance on these results, she said the greatest significance of a lack of insurance is that it deprives people of access to good primary care.
Finally, Dr. Starfield discussed the implications of this work for data and thus for future NCVHS efforts, emphasizing four priorities: distinguishing types of health care received, detecting adverse effects, using E-codes consistently, and improving data on equity.
In the discussion, the Committee focused on the potential of geocoding and the need to track the Department’s work on summary measures (which Dr. Starfield said it must be possible to disaggregate to be useful). The Committee agreed to follow up on both of these issues, with an eye to advising the Department on both. Also, Dr. Zubeldia was asked to follow up on concerns he expressed about the ability to collect E-codes in the HIPAA professional transaction.
UPDATE ON GOVERNMENT COMPUTER-BASED PATIENT RECORD (GCPR) PROJECT David Camacho, Dr. Steve Brown, and Dr. William York, GCPR Board of Governors and Executive Committee
The goal of this project, called the Framework Project, which was established by Presidential order, is to provide clinical information at the point of service and create a lifelong virtual medical record. The program goals are to create a secure, encrypted, patient-focused national architecture with interoperability. This is a joint venture of VA, DoD and the Indian Health Service. Congress and the GAO are following it closely. Its functional requirements are to access multiple levels of data, support point of care clinical decision-making, enhance population epidemiology, meet or exceed HIPAA requirements, prevent inappropriate access, and provide accurate and complete data. Terminology mediation plays a critical role, and the speakers described the current short-term model (STM) and longer-term plans for a Reference Terminology Model (RTM).
Rigorous pilot testing will go through June, with a field test in Alaska planned for September 2001 involving pharmacy, radiology, demographics and laboratory “partitions.” That will be followed by a more robust beta test with 10 partitions, including immunizations and physical exams. The speakers also described the project’s privacy protection structures and practices.
Committee questions primarily focused on state applications and privacy implications. Dr. Fitzmaurice observed that the GCPR has the potential to help reduce adverse events, and he encouraged the developers to watch for the information that will be critical for doing so.
For the Subcommittee on Populations, Dr. Iezzoni moved that the full Committee authorize the Subcommittee to work on a letter via a conference call, to be reviewed by a full Committee conference call and sent to Secretary Shalala. The letter will probably call for due process so that the final version of ICIDH-2 reflects research findings. NCVHS members unanimously approved this motion. (See Action Items.)
Dr. Friedman reported on recent activities and plans by the Workgroup on 21st Century Health Statistics, and Dr. Lumpkin on the same by the NHII Workgroup. The two groups are coordinating their efforts to elicit feedback and develop more detailed recommendations.
Dr. Cohn reported that the Subcommittee on Standards and Security has reabsorbed the Workgroup on Computer-based Patient Records, and Mr. Blair will be Vice Chair of the Subcommittee.
Ms. Frawley reported that the Subcommittee on Privacy and Confidentiality is preparing to monitor the forthcoming privacy rules, after they are published, and to advise the Secretary on issues related to those regulations.
All Subcommittees are working on their work plans and priorities for the coming year.
Chairman John Lumpkin, M.D., called the meeting to order and invited all present to introduce themselves.
On the status of NCVHS recommendations on patient medical record information: Dr. Lumpkin and Mr. Blair presented them to the Data Council in August, and the report and recommendations were well received. The Data Council has asked all HHS agencies to look at relevant recommendations and identify the actions they are taking or plan to take related to them. Agencies are also asked for their view of the top priority areas for HHS. These responses are starting to come in. However, actions in this area will be limited until a privacy framework is in place. The Health Data Standards Committee of the Data Council will evaluate the NCVHS recommendations related to the HIPAA process.
In response to a question about the effects of budgeting process and the election, Dr. Fitzmaurice said that the recommendations of NCVHS will be helpful in the transition, whoever the new administration is. Mr. Scanlon added that the lack of a 2001 budget is stressful, but there are opportunities in these transitions, as well. The fact that new budgets are under development is advantageous in terms of responding to new recommendations. It was noted that the Committee hopes for bipartisan support for all its recommendations, and that the first priority is to get privacy protections in place. Ms. Greenberg noted that the Committee’s PMRI report will be referenced in the next report to Congress on HIPAA implementation.
Regarding the Committee’s earlier recommendations on data for the insular territories, this report was circulated and several agencies appear to be acting on the recommendations. (Mr. Scanlon described these as “unsung activities.”) HHS agencies have been asked to report on progress. Once all their responses are in, the Department will send a letter to the territorial representatives who participated in the NCVHS hearing on this subject, inviting their further comment to the Subcommittee on Populations. HHS does not plan to follow up with the Department of the Interior.
The NCVHS report on Medicaid managed care is being reviewed by HCFA and the Center for Medicaid and State Operations. HCFA will decide whether to send the report to state Medicaid agencies. In addition, the HHS Data Strategy Committee is considering the recommendations in the context of its work. The Data Strategy Committee is also looking at the insular area recommendations.
The Data Council devoted an entire meeting in June to a review of data collection, analysis and dissemination initiatives. This produced a decision to “pull all the strands together” into an overall framework and data strategy with multi-year frameworks and budgetary implications. The Council replaced the survey integration work group with a Data Strategy Committee whose goal is to review all HHS data needs and pull together an overall framework for them. Their work, which is already well underway, has three prongs: a multi-year data strategy, a link to the FY2002 budget process that focuses on funding for data priorities, and similarly motivated links to the initiative to eliminate disparities and the initiative on leading health indicators for Healthy People 2010.
In response to a question from Dr. Cohn, Mr. Scanlon said the Department will be ready to report to NCVHS when the data strategy is ready, which should be in “several months.” HHS also has an overall strategic plan and an IT plan; perhaps the CIO could brief the Committee.
Dr. Starfield noted that the U.K.’s National Health Service is holding a conference on November 27 on “Information: The Key to Delivering Our Health Agenda.”
Privacy Regulation And Data Standards: William Braithwaite, M.D., Ph.D.
For Mr. Fanning, Dr. Braithwaite reported that the timing of the release of the final rule for privacy and health care is still unknown, due to the complexity of the rule and the huge number of comments to be addressed. The President has promised that it will be out by the end of the (calendar) year.
The final transaction rule was published on August 17. Feedback from the industry is generally very positive. A few errata in the rule are being corrected and published in the Federal Register. The public can send questions and comments on the final rules via the Department’s Web page. Also, the designated SDOs have a Website for questions and suggestions. Major concerns can be brought to NCVHS, which could choose to address them in recommendations to the Secretary for the next annual revision.
Three other final rules are waiting to be finalized and cleared for publication: those on employer identification, national provider identifier, and security. The latter is interconnected with the privacy rule and will not be finalized until that is complete. These rules, too, are expected by the end of the year.
In the next year, the Department plans to publish a notice of proposed rulemaking on the enforcement rules for administrative simplification, covering privacy and security and all other enforceable standards. A public comment period will follow the NPRM. The final enforcement rules are expected to go into effect on the compliance date for each published standard.
Asked by Ms. Frawley about a new “office of E health” within HHS, Dr. Braithwaite said its emphasis is on heightening security relative to internal IT and E.GOV. He added that the CIO and Deputy CIO are now on the Data Council.
Dr. Braithwaite answered a series of questions about the details of the rulemaking and revision process and other matters e.g., multi-facility health plans with both payer and provider functions. (For these technical issues, the reader is directed to the transcript, posted on the NCVHS Website.)
Dr. Zubeldia asked about the federal government’s thinking on preempting state law on such things as transactions, identifiers, code sets and security. Dr. Braithwaite said his understanding of HIPAA is that state laws that conflict with it will be rendered null and void, but non-conflicting ones will not be preempted.
LETTER TO THE SECRETARY ON EARLY IMPLEMENTATION OF HIPAA TRANSACTIONS AND CODE SET STANDARDS (Action Item)
Dr. Cohn reviewed a draft letter to the Secretary, prepared by the Subcommittee on Standards and Security to distill the issues and concerns about implementation that it heard in July testimony. The Subcommittee believes there is a need for ways to hear from the health care industry and the public about implementation on an ongoing basis, and also that it will be useful to provide the Secretary with written information on the concerns heard to date.
Members made a few suggestions for revisions and clarifications to this letter without challenging its basic substance or intention. The letter addresses six topics. The bulk of the discussion was on the first two items. The first recommendation concerns code sets that are implicit in the standards but not named in the regulations or maintained by any SDO e.g., code sets maintained by HCFA. The letter recommends a deliberative process for responding to qualified business needs. The second recommendation concerns HCPCS codes and the revision process. For recommendation two, NCVHS members asked for more language to clarify what aspects and levels of HCPCS are being addressed, and Ms. Frawley was asked to supply this language. Dr. Zubeldia was asked to contribute language on the need for the federal government to promptly inform industry of coding changes, and also possibly to help industry cover the expenses necessitated by such changes.
In discussion of recommendation two, a question arose as to the extent to which each of the Committee’s documents should be self-contained and self-explanatory, for the benefit of readers unfamiliar with the subject. Dr. Lumpkin made a general process suggestion that documents on the Committee’s Website contain hypertext that connects to background materials.
Dr. Cohn said the Subcommittee on Standards and Security would revise the letter per the foregoing discussion and present the revised draft the following day for action.
DISCUSSION OF EXECUTIVE SUBCOMMITTEE RETREAT (Action Item)
Dr. Lumpkin referred members to the minutes of the retreat in the agenda book. He invited discussion on the proposed mission statement. Members praised the brevity and emphasis of the statement. After discussion, and by unanimous vote, they then approved a slightly revised version, as follows: The mission of the National Committee on Vital and Health Statistics is to advise on shaping a national information strategy for improving the population’s health.
The group turned to the section of the retreat summary entitled “roles and customers.” Some members expressed discomfort with the word “customers,” suggesting instead that the various groups to which the Committee relates be called “audiences” in future documents.
Ms. Greenberg explained that the goal of the retreat was to initiate a process for developing a strategic plan for the Committee. The substantive areas discussed in the retreat summary will become the focus of a draft strategic plan that will be reviewed by the Committee in the future. Those substantive areas are as follows:
Dr. Lumpkin briefed members on recent discussions with Dr. Sondik about the relationship between the Center and NCVHS, a subject discussed at length at the Executive Subcommittee retreat. He noted that especially since HIPAA, NCVHS primarily advises the Secretary rather than any sub-unit of the Department, leading to some neglect of the historically close relationship to NCHS. This has created something of an advisory vacuum that Dr. Sondik has proposed be filled in two ways: by creating a Board of Scientific Counselors (BSC) for NCHS, and by strengthening and clarifying the relationship between NCHS and NCVHS. The exact nature and mechanics of these relationships will be worked out after the new body is established. Dr. Iezzoni stressed that Dr. Sondik strongly hopes that NCVHS will have a liaison on the BSC.
The full Committee then reviewed the eight organizational concerns discussed at the Executive Subcommittee retreat. They are:
Dr. Lumpkin said the Executive Subcommittee spent a good bit of time discussing the first topic, especially with reference to the substantive priority of operationalizing the population health focus. The Subcommittee concluded that any structural change should flow from a deliberate review of issues and Committee priorities. The goal is to have more flexibility to deal with issues as they arise, while also keeping the focus on top NCVHS priorities. Related goals are to be most effective given the Committee’s huge work load and the multiple demands on the time of members and staff. Dr. Lumpkin added that the Executive Subcommittee considered various structural options, e.g., using more ad hoc groups focused on specific issues. The Subcommittee also looked at whether privacy concerns would be better served if specialists on this topic were distributed among other subcommittees and workgroups instead of being “sequestered” in a single subcommittee.
On the last topic, Mr. Rothstein said he favored keeping the Privacy Subcommittee but also having some expertise on this topic present on other groups. He recommended recruiting new NCVHS members who combine interests in privacy and in other subjects. Mr. Blair urged that breakout meetings be scheduled so that members of other subcommittees can attend the meetings of the Privacy Subcommittee.
On the subject of operationalizing the population health focus, Dr. Iezzoni commented that “the basic bottom line is that it is not working very well right now.” She asserted that it would be a disservice to the NCVHS mission and history to focus solely on HIPAA legislative mandates. She noted the difficulty NCVHS has had in retaining members from academia with specific interests in population health; this raises questions about recruitment and how to define the Committee’s work in this area.
In general, the Committee agreed on the need for a solution to the problems outlined by Dr. Iezzoni. However, members did not favor the ones identified at the Executive Subcommittee retreat i.e., making population issues the responsibility of the full Committee, and/or using targeted ad hoc work groups. Dr. Lumpkin observed that a major priority of the Department is to eliminate health disparities, and that as organized, the Committee is not able to play a significant role in advising on this priority. One question to be addressed in looking at these issues is “Where do we go next with HIPAA?”
Ms. Fyffe stimulated a lively discussion with her observations that there are no full-time practicing physicians on the Committee and that this perspective is therefore missing from its deliberations. Some of the MDs on the Committee cited their current or recent clinical work. Dr. Lumpkin noted that national professional medical associations have trouble finding physicians “in the trenches” who are senior enough to serve in national bodies; or, conversely, the ones who are senior enough to do so no longer work full time in the trenches. Dr. Starfield observed that in any case, the Committee’s populations focus calls for a different perspective than that involved in working solely with individual patients. Finally, Ms. Greenberg reminded the group that “associations are not represented on this Committee” and that NCVHS was not created with that intention.
In conclusion, Dr. Lumpkin said that the Executive Subcommittee would follow up on the topics just discussed and eventually bring recommendations to the full Committee.
The meeting then recessed for lunch and a joint workgroup meeting, to reconvene thereafter.
BRIEFING FROM IOM COMMITTEE ON THE NATIONAL QUALITY REPORT ON HEALTH CARE DELIVERY
Margarita P. Hurtado, Ph.D., Institute of Medicine
Dr. Hurtado is the Study Director of the Committee on the National Quality Report on Health Care Delivery (Website: http://nationalacademies.org/iom/hcs/nqr). The Committee’s work continues, with a final report expected in Spring 2001. She acknowledged the presence of Tom Riley of AHRQ, which sponsored the IOM study.
The study came about as a byproduct of the 1998 recommendations of the President’s Advisory Commission on Consumer Protection and Quality, and also of the legislation reauthorizing AHRQ in 1999 and calling for an annual report on the quality of care, starting in 2003. The purpose of the national health care quality report is to inform Congress, policy makers at all levels, and the general public. It will serve as a barometer of quality of health care delivery. (Health U.S. and the Healthy People 2010 Objectives serve complementary functions.)
The IOM committee has been asked to define the questions the report should address, define the domains it should include, provide examples of measures, and make recommendations on production of the report. It has completed nine of its eighteen months and held three of its four meetings. It is chaired by Dr. William Roper of the University of North Carolina. The vice-chair is Dr. Arnold Epstein from Harvard University.
The committee looked at the work of the IOM Committee on the Quality of Health Care in America (their first report was To Err Is Human, and they are preparing another one on the future of the US health care system) for suggestions about possible approaches to this topic. Another framework of interest based on consumer research was outlined by the Foundation for Accountability.
The committee sponsored a workshop in May 2000 on envisioning a national quality report on health care. Dr. Starfield was one of the presenters. The committee also heard presentations on how quality is measured in the education sector and in other countries (the U.K. and Australia). Speakers discussed measures for safety, effectiveness, patient-centeredness, and efficiency. It was stressed that the quality report should provide a stable set of measures from year to year, with supplements on special topics with policy relevance. All the presentations are on the study Web site, along with the preliminary selection criteria for measures. Dr. Hurtado said the committee intends to include equity in the categories to be measured. It regards equity as an issue that cuts across the categories listed above.
After the workshop, the committee issued a call to the private sector for suggested measures in the categories of safety, effectiveness, patient-centeredness, and timeliness. (AHRQ will issue a call for measures among federal agencies later this year.) Several organizations submitted a total of 138 measures, the large majority of which (66%) were measures of effectiveness. In terms of care needs, the largest number concerned living with illness; none related to coping with changing needs (also called care at the end of life).
In response to questions, Dr. Hurtado said that in preliminary discussions the committee suggested that the report include both national and state measures, and the goal should be to provide information at both levels. The report should go beyond hospitals to cover a variety of health care settings. The committee did not consider cost to be a part of quality in their work thus far. The committee is considering the need for using both survey data and patient records as data sources.
Asked whether the committee is looking for actionable measures so that something can be done about problems that are identified, she said actionability is one of the criteria for the measures. However, the link between the indicator and the remedy is often not very clear or very close for national data so actionability will be more in the national policy arena. Asked about age-appropriate measures, she said that some of the measures the committee is considering are targeted to different age groups.
Dr. Lumpkin thanked Dr. Hurtado for the Committee and said they eagerly await the final report. Dr. Hurtado invited specific suggestions from NCVHS.
Ms. Frawley said the Committee would be interested in “what falls off the table” in the IOM committee’s list of things to measure, as this may suggest data gaps. Mr. Reilly said that AHRQ plans to identify measures for all the cells in the framework that will be laid out by the IOM committee in their upcoming report. The empty cells, i.e., the ones for which data are lacking, will help to guide the research agenda.
The Committee then recessed into subcommittee working sessions, to reconvene the following day.
BRIEFING ON IOM REPORT, PROTECTING DATA PRIVACY IN HEALTH SERVICES RESEARCH Dr. Lee Zwanziger, Institute of Medicine
Dr. Lumpkin welcomed Dr. Zwanziger, noting that AHRQ and ASPE funded the study she directed. Dr. Iezzoni served on the IOM committee that conducted the study, The Committee on the Role of Institutional Review Boards and Health Research Data privacy Protection, which is chaired by Dr. Bernard Lowe.
The reason for the study is that privacy bills and rules generally assume that human subjects are well enough protected if an IRB has looked at a protocol and deemed the release adequately protective. The question is whether IRBs are actually in a position to do that and whether they are adequately supported to carry out this role. The IOM committee was thus charged with gathering information about current IRB practices and principles for protecting confidentiality and identifying ones with superior efficacy, as well as identifying other organizations without IRBs that are doing similar things and, if appropriate, recommending a set of best practices for protecting confidentiality.
The first meeting was a conference call in January 2000. A call was posted on a listserve inviting IRB professionals and others to submit practices and suggestions. The committee also held a public workshop and commissioned two background papers, one on special issues related to research subjects who are minors and the other on international standards of privacy. The final report was issued in August, and on September 11 the Chair moderated a follow-up symposium on next steps.
Turning to the key points of the report, Dr. Zwanziger noted that practices do exist that can enhance privacy protections while allowing good research to proceed; but the enhancements will require investments. Thus, a commitment to privacy and confidentiality and to reaping the benefits of good research requires support for the institutions that help enhance privacy. A thorough institutional commitment to confidentiality is needed, instantiated in policies and procedures and reflecting a culture that respects privacy. This would include supporting IRB practices favoring confidentiality, and punishing improprieties. Resources must be invested in the IRB process, as well as in technical infrastructure and assistance from IT professionals and other experts. There are additional issues and need for protection when children are involved.
The IOM committee argued strongly that the PI for and subjects of any sort of research would benefit from an outside look at the protocol by “an uninvolved eye,” to make sure that all possible protections are in place. This can be either an IRB or another mechanism.
Ms. Coltin raised the issue of IRB liability, and Dr. Zwanziger said the committee did not look at this issue, although it is an important one.
Dr. Friedman praised the IOM report for differentiating between health services research and clinical research and for encouraging the former. He asked why the committee recommended that guidance and examples on interpreting federal regulations should come from individual IRBs. Dr. Zwanziger said the committee wanted to encourage local sources to think ahead and think judiciously about giving guidance to PIs, because not everything can be anticipated. It did not mean to preclude guidance from central human protection office.
Ms. Ward asked about follow-up studies. Dr. Fitzmaurice said AHRQ initiated this project because little is known about how IRBs protect the privacy of health services research data, an issue that has become increasingly important to policy-makers. He called the IOM “a great first start.” Now the agency will consider what steps are needed to improve protections. Mr. Fanning added that the privacy NPRM says the Department will re-examine the rules for protection of research subjects with a special eye to the confidentiality requirements. He noted that the Office of Protection from Research Risks has been elevated to an office of the Secretary unit, now called the Office of Human Research Protections, and confidentiality is a high priority.
Asked to characterize research practices not subject to federal regulations, Dr. Zwanziger said there is wide variation. Some organizations were not willing to talk publicly about their activities in this area. Asked about industry self-governance, she said some groups have issued recommendations. These tend to focus on problems that have arisen or might arise, rather than on ongoing practices.
DISCUSSION OF THE WORLD HEALTH REPORT 2000 HEATH SYSTEMS: IMPROVING PERFORMANCE Barbara Starfield, M.D.
Dr. Starfield began by discussing her commentary in JAMA, July 26, 2000, “Is US Health Really the Best in the World?” This, she said, was not written in response to the World Health Report; it was stimulated by a query from NCVHS member Jeff Blair. In it, she reviewed the data of the U.S. and 12 other industrialized countries and found that the U.S. did poorly on most indicators (e.g., low birth weight, neonatal and infant mortality, potential years of life lost, life expectancy, and age-adjusted mortality).
Overall, the population grows less disadvantaged as it gets older, belying the common misconception that poor health in the U.S. is the result of behavioral factors such as poor eating habits. In fact, none of this country’s poor standing, she said, can be explained by the behavior of the population. For example, the U.S. has lower rates of smoking and drinking than the other countries. She speculated that the country’s poor ranking relative to its fellow industrialized nations was partly due to disparities in wealth, which are greater in the U.S. than in other countries. Another possible explanation is the rate of error and adverse effects in health care, although data on these factors cannot be analyzed in terms of age variations. Another important factor is the impact of the kind of services being received, i.e., primary care versus specialty services. However, this information, too, is difficult to obtain because the data do not make a clear distinction in ambulatory care between primary and specialty care. The data do suggest, she said, that on average, more strongly oriented primary care systems do better. This finding is supported by The World Health Report.
The major author of The World Health Report, Dr. Christopher Murray, uses econometrics in much of his work. He came up with five main measures of health of all of the world’s countries: disability-adjusted life expectancy (DALE), child survival to age 5 (including a disparities component), two measures of responsiveness (responsiveness of the health system to those with contact with it, and responsiveness distribution), and “fair financing.” There are also two summary measures, an overall health indicator and overall performance. Dr. Starfield noted that the WHO report suggests that she was “too generous” in her rankings, and it confirms that younger people in the U.S. are at special disadvantage.
Asked about what role the presence or absence of insurance plays in these disparities, Dr. Starfield said having insurance clearly contributes to better health, but her analysis suggests that having strong primary care is even more important. In other words, insurance facilitates access to a primary care source, but without good primary care, the difference between the insured and uninsured is less significant. Her study also shows that the presence of primary care physicians reduces the ill effect of income inequality.
Mr. Blair commented that Dr. Starfield’s article had corrected some of his misconceptions about health in the U.S. He added that the article could help NCVHS focus its thinking and work for the future. Dr. Starfield took that cue to talk about the implications of her work for data, and thus for future NCVHS efforts. She called attention to four priorities:
Mr. Blair asked what we could learn from countries that did better than the U.S. in Dr. Starfield’s analysis. She noted in particular the Canadian efforts over several decades to understand equity issues and improve equity in that country.
Dr. Friedman agreed with Dr. Starfield that geocoding is “the way for us to go.” He noted that Canada has taken steps that facilitate both geocoding and analyses of economic status: specifically, asking permission on the census to link census data with other data sets, and using a system of postal codes that roll up into census block groups.
Mr. Scanlon said the Department would be interested in any recommendations the Committee cared to make about geocoding. He described a new research data center at NCHS where in-house research involving linkages can be done under conditions of privacy and confidentiality.
Ms. Greenberg commented that an HHS interagency working group chaired by Dr. Sondik is looking at summary health measures, which are likely to drive data collection in the future. Asked for her view of this emphasis, Dr. Starfield replied that unless they can be disaggregated, summary measures can obscure important differences and interfere with the ability to aggregate and thus to attribute responsibility. She agreed that NCVHS should follow the HHS work in this area.
Dr. Lumpkin suggested sending a letter to those preparing the summary health statistics that makes this point, among others the Committee deems important.
Dr. Friedman reiterated that the Committee should follow up on both geocoding and summary measures. In addition, he suggested inviting Nancy Krieger to update the Subcommittee on Populations on her work on infant and child health and development.
On E-codes, Dr. Zubeldia commented that HIPAA standards on the professional side do not support the use of E-codes. He recommended requesting that the DSMO website add E-codes for the next release. There was considerable discussion of this issue. Dr. Starfield agreed that it would be important to do as Dr. Zubeldia suggested. Dr. Cohn, however, said he disagrees with Dr. Zubeldia’s view that E-codes are not supported, and he cautioned that providers will not report E-codes unless payers pay for adding it.
SECURITY AND STANDARDS SUBCOMMITTEE ACTION ITEM
Dr. Cohn reviewed with members the revised draft of the letter to the Secretary on early implementation of HIPAA transactions and code sets standard, which the Committee discussed the previous day and the Subcommittee revised in accordance with that discussion. Members discussed the new draft and suggested a few minor changes. The Committee then unanimously passed a motion approving the revised letter and authorizing the Subcommittee to make any needed editorial changes for improved readability before sending it to the Secretary.
UPDATE ON GOVERNMENT COMPUTER-BASED PATIENT RECORD (GCPR) PROJECT¾ David Camacho, Dr. Steve Brown, and Dr. William York, GCPR Board of Governors and Executive Committee
Mr. Camacho noted that this project began with a Presidential Review Directive in November 1997 calling for a comprehensive patient medical record for “every soldier, sailor, airman and marine” in the Departments of Defense and Veterans Affairs. The project has added the modifier “virtual” after “comprehensive” because the task is to get disparate legacy systems to talk to each other. The goal is to provide clinical information at the point of service and create a lifelong virtual medical record. The program goals are to create a secure, encrypted, patient-focused national architecture with interoperability. NCVHS members are invited to visit the GCPR program office in Skyline.
This is a joint venture of VA, DoD and the Indian Health Service. Congress and the GAO are following it closely. Mr. Camacho described what is envisioned for the framework. Its functional requirements are to:
The framework was developed using a heritage system integration, on the basis of which generic security standards were developed. The plan is to create a federated master patient index and then build an environment for testing the framework.
Continuing the story, Dr. Brown said that terminology mediation plays a critical role for GCPR because of the need to interchange information among the information systems of three agencies. They began with a short-term model (STM), a low-cost “partial meta data registry” of terms to meet immediate needs. It contains roughly 650,000 terms (linked to reference information model attributes) from 8,000 code sets.
The Reference Terminology Model (RTM) is the planned long-term approach to terminology mediation. It will be concept-based and have 40 definitions. A demonstration project is nearing completion, to help operationalize the RTM process. Information about medications is a first step. GCPR is working with Kaiser Permanente, NCI and other federal agencies on terminology. Dr. Brown noted that the project has made significant progress towards the National Reference Terminology for Medications called for in the NCVHS Report on Uniform Data Standards for Patient Medical Record Information.
Mr. Camacho said rigorous pilot testing will go through June, with a field test in Alaska planned for September 2001, involving pharmacy, radiology, demographics and laboratory “partitions.” That will be followed by a more robust beta test with 10 partitions, including immunizations and physical exams. He then described the “common sources architecture” concept that is emerging from the GCPR work.
Dr. York then discussed the privacy protection and security aspects of the Framework Project. The stringent Department of Defense security standards are being used as the guideline. The privacy issues will be considerable in a system that can “move records from many sites all at once and then glue them back together again seamlessly.” In addressing them, allowance must be made for the fact that the privacy and security fields are evolving, and new policies can be expected to emerge from a variety of sources. He described the system of structures and practices under development, which involve a “user region,” a “trusted extension of the heritage system,” and a gatekeeper between the two as well as a policy evaluator.
Mr. Camacho noted the possible benefits and uses of the GCPR framework that extend beyond what it was designed for e.g., providing the foundation for lifelong medical records and connecting to rural health areas. The project is looking for partners to share development costs and possibly provide services; two examples are Kaiser Permanente in Oakland, CA and Guard and Reserve Support. Other federal agencies have been in contact. Other possible initiatives include medical readiness and providing support for medical research and education. The project hopes to be the genesis of the federated master patient index. Benefits to patients will include always-available information at the point of service, reduced risk, improved continuity of care, and increased involvement in their own care.
Mr. Gellman discussed the Privacy Act publication requirement of a system of records notice, and then questioned the Project’s interpretation that the requirement does not apply to its GCPR activities because no permanent record is stored. He and others discussed the implications of the Boxer Amendment.
In response to a question from Mr. Blair, Dr. Brown explained why GCPR created its own pharmacy terminology model. He invited advice and help in sorting through this complex area. In general, the project intends to avoid “re-inventing the wheel” and will look at existing terminologies. Dr. Kolodner added that the VA recently held a meeting, attended by FDA representatives, to discuss internal information needs regarding adverse drug events.
Answering a question from Dr. Lumpkin, Dr. Kolodner said the Framework project currently has no data exchange with State long-term care facilities for veterans, but it expects that the new system will provide a vehicle for getting clinical information on all patients whose care the VA helps to pay for. Dr. Lumpkin also asked how the project would be evaluated and the extent to which error reduction is part of its activities. Dr. York pointed out that the system is designed to move information and is not involved in applications.
In response to Dr. Cohn, Dr. Brown said the GCPR project would not make an effort to replace other terminologies.
To a question from Mr. Rothstein, Dr. York said the project will impose none of its own rules on the use of information, but instead will apply the rules promulgated elsewhere. In other words, all policy issues are outside the framework. Mr. Rothstein asked follow-up questions to clarify the implications of this premise. Dr. York agreed with his conclusion that “if [NCVHS is] concerned about the substantive privacy and confidentiality rules, [the GCPR] system is really not the place to focus our efforts.” Dr. Kolodner added, however, that feedback from NCVHS about implementation will be important. He stressed that “privacy and security is fundamental to the whole framework.”
Returning to comments by Dr. Starfield and Dr. Lumpkin, Dr. Fitzmaurice observed that the GCPR has the potential to help reduce adverse events, and he encouraged the developers to watch for the information that will be critical for doing so. He also asked them to point out to NCVHS where informatics need to be pushed to achieve these benefits.
The Subcommittee has been considering the International Classification on Functioning and Disability (ICIDH-2) as the placeholder for the core data element of functional status. It has just learned that the World Health Organization process for finalizing it has been changed with limited consultation. The Subcommittee would like the full Committee to weigh in on this process. Dr. Iezzoni therefore moved that the full Committee authorize the Subcommittee to work on a letter via a conference call, to be reviewed by a full Committee conference call and sent to Secretary Shalala. The letter will probably call for due process so that the final version of ICIDH reflects research findings. NCVHS members unanimously approved this motion.
Dr. Iezzoni also reported that the Subcommittee will be considering its priorities, to provide input to the Committee’s planning. Finally, she said the Subcommittee had cancelled its October 24 meeting.
The Workgroup is working to generate feedback to the interim report via public hearings, a forthcoming CDC briefing, and presentations at professional forums. The task that lies ahead is developing the final report and coming up with a more specific planning document. The Workgroup is also developing a model of the determinants of population health, for use in evaluating data gaps and data needs at local, state and national levels. It plans to work on identifying privacy and confidentiality issues that are specific to health statistics, possibly commissioning a paper on this subject. In addition to these three primary activities, the Workgroup is exploring the development of an edited volume reflecting this process.
The Subcommittee has reabsorbed the Workgroup on Computer-based Patient Records. Mr. Blair will serve as Vice Chair of the Subcommittee and will continue to focus on PMRI, and former Workgroup staff will also focus on PMRI, with Dr. Fitzmaurice as lead staff for that effort.
The Subcommittee will hold public hearings on October 26-27 on issues related to electronic and digital signatures, with the aim of ultimately advising the Secretary on this subject. Other issues that the Subcommittee is working on include tracking implementation of HIPAA standards, considering enforcement and compliance, identifiers, new standards, code sets, and ICD-10-CM. Some items on this long list, Dr. Cohn said, may have to be elevated to the full Committee. The Subcommittee will finalize its PMRI work plan at either its November or February meeting.
Dr. Starfield asked that the Subcommittee look at the issue Dr. Zubeldia raised earlier about E-codes. Dr. Lumpkin suggested that the Subcommittee frame the discussion, which could then be held by the full Committee.
The Subcommittee is awaiting publication of the privacy regulations and considering its responsibilities for monitoring the regulations and advising the Secretary on their implementation. It is looking to its own report to the Secretary for issues raised by industry with regard to implementation. It also will be watching for unintended consequences. It will review and revise its work plan before the November meeting.
The full Committee accepted the Subcommittee’s suggestion that the Committee be briefed on privacy activities in state legislatures. Ms. Frawley reported that the Georgetown University Health Privacy Project has done a state-by-state analysis of privacy legislation and regulations, and she suggested that this be included in the same briefing.
The Workgroup has been holding joint meetings and joint hearings with the Workgroup on 21st Century Health Statistics. Dr. Lumpkin agreed with Dr. Friedman that more detail is needed in both visions in order to elicit more pointed input. The two workgroups will meet in an extended joint session in December to discuss coordination between the groups and their products.
Finally, the Committee briefly discussed possible topics for the November meeting, and Dr. Lumpkin 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 01/29/01
Chair Date