The National Committee on Vital and Health Statistics was convened on Wednesday and Thursday, June 23 and 24, in the Hubert H. Humphrey Building in Washington, D.C. The meeting was open to the public. Present:
Mr. Scanlon briefed the Committee on the Department's activities in the areas of race/ethnicity data strategy, a government-wide initiative on measuring discrimination, and budget planning for FY2001. A report on the first is expected in July. On the second, HHS has updated a meta-directory of data sources and is beginning a literature review on measuring and tracking discrimination.
Mr. Fanning reported that the Department is working on confidentiality regulations in order to fulfill a HIPAA requirement, should Congress fail to pass legislation by August 20. HHS is still considering the scope of its authority in this area. In another area, the Department is following the process at OMB as it considers amending OMB Circular A-110, which deals with grant activities of federal agencies.
Dr. Braithwaite reported that four rules are being drafted and are slated to be published by the end of 1999, starting with the one on transaction and coding sets. An overall process for revising and maintaining standards will be published at the same time. He also briefed the Committee on the status of the individual identifier, plan identifier, and attachments standards, as well as code sets and enforcement. Discussion with the Committee focused on the importance of keeping the cost of usage fees for code sets low and equitable, and on prospects for the two-year implementation period.
The Committee reviewed a draft process for addressing issues between meetings, agreeing that it would be useful to have such a process in place but that constraints should be imposed on when and how it is used. Staff was asked to redraft the document and circulate it, for action at the next NCVHS meeting.
Members were asked to save June 20-22, 2000, for the 50th anniversary symposium and reception and possible adjunct meetings.
Dr. Meyer described the objectives of AHCPR's quality research, the questions it seeks to answer, and the current limitations in data relative to specific data needs. He noted that quality is now understood as the result of individual-plus-system effort, using knowledge obtained from multiple dynamic sources. Asked to identify the three most important administrative data changes, he specified codes to capture performance measures; standard linkages to lab, pharmacy, facility, provider, and resource data; and a unique code to follow patients across the continuum of care over time and space. His top priorities for additional administrative/enrollment data are a measure of functional status, a short list of tailored lab/radiology results dictated by condition, and standard integrated surveys. Of special interest to the Committee was the National Health Care Quality Report that AHCPR will work on with CDC. Dr. Meyer asked for the Committee's advice on population-based data sources on quality.
Dr. Clauser presented the purchaser's perspective on this topic. HCFA uses performance measurement in its purchasing strategy as well as for quality improvement in both managed care (QISMC) and fee-for-service (the latter through six disease-specific QI programs). A major thrust of efforts to improve data for quality measurement is standardization, with the Diabetes Quality Improvement Project (DQIP) an exemplary project that has produced a core data set used by HCFA and others. HCFA is also creating standardized data collection and reporting tools, based on the MedQuest system, along with analytical tools. HCFA also is auditing performance in both fee-for-service and managed care, working with NCQA in the latter arena. Dr. Clauser noted that capitation poses a threat to data completeness because of the de-linking of quality reporting and reimbursement. Public reporting may provide the needed incentive.
Discussion with the Committee focused on how to achieve health care quality for the non- Medicare population; the need to combine population-based and disease-based perspectives in quality measurement; and including variables related to disparities among sub-populations in quality measurement. The speakers welcomed the Committee's guidance in achieving these objectives. Committee members also raised questions about the business case for and the current backlash against quality measurement.
At Dr. Lumpkin's suggestion, the Committee agreed that NCVHS members will be given 30 days to submit individual comments on the 1996-1998 report, and that all received in that period will be attached when it is published and posted on the Web. Ms. Greenberg will send the final draft and comments already submitted, with the 30 days commencing upon receipt of the draft.
Ms. Coltin said the Subcommittee studied Medicaid managed care data out of a concern about the availability of data for evaluating quality of care in that context. The draft report recommends that HCFA encourage standardization and offers a menu of consistent contractual language for voluntary adoption by states. Its six specific recommendations concern a standardized minimum data set, a standard definition of an encounter, a standard patient survey, consistent reporting for covered and carved-out services (e.g., pharmacy), data sharing, and training.
The Committee discussed each recommendation, with concerns expressed about several specific aspects as well as the general fact that the draft under discussion was not complete. Members encouraged the Subcommittee to revise the report based on this discussion and to present the next draft at the September meeting. The Subcommittee on Privacy and Confidentiality is reviewing the report in the light of privacy/confidentiality issues.
Ms. Ward presented the Subcommittee's report on data needs in the insular areas. The study was undertaken out of an awareness of the inadequate attention by the federal government to these U.S. territories and the challenges of collecting health data there. The thrust of the draft report's recommendations is the need for greater flexibility in the use of federal dollars, and for more direct assistance for improved data collection and analysis.
Ms. Ward asked members to read the report and comment on it. The revised version will be sent to the representatives of the insular areas for their comments. If this results in further revisions, the new draft will be brought back to the Committee for review.
The group discussed the possibility of adding a recommendation that HHS designate a focal point for these issues within the Department.
Nancy Ann Min DeParle briefed the Committee on current HCFA priorities. She called special attention to the issues HCFA is struggling with in the area of tension between progress in monitoring quality and payment, on the one hand, and protecting patients against the misuse of data, on the other. She invited the Committee's guidance in addressing this tension and moving forward, stressing her desire to make confidentiality protections even stronger than they already are, with the Committee's help.
HCFA has had to spend considerable time on Y2K issues, delaying other information system projects. She described current and planned HCFA activities on standardization and administrative simplification and said the agency looks forward to working with NCVHS on using clinically focused data through its computer-based record project. When they have been finalized, the agency will brief NCVHS on plans for resuming deferred information system projects.
Jane Durch of the National Academy of Sciences was Study Director for the Panel on Performance Measures and Data for Public Health Performance Partnership Grants of the Committee on National Statistics (CNSTAT). She presented its April 1999 report, "Performance Measurement in the Public Sector: Principles and Policies for Implementing an Information Network." This report, the second one produced by the CNSTAT panel, addresses broad information issues underlying performance measurement in publicly funded health programs.
Major themes of the report include 1) an emphasis on the appropriate use of performance measurement in a health program context as a tool to guide program management, not a simplistic measure of cause and effect; and 2) the fact that this activity requires continuing attention as knowledge increases and priorities change, implying the need for a way to revise and improve the process over time. The report stresses the need for better information systems and the evolution of a national (as distinct from federal) health information network, bridging public and private sector programs.
Mr. O'Keefe spoke on behalf of the National Association of Health Data Organizations (NAHDO), which supports the collection of race and ethnicity data in administrative data sets and recommends that the information be included in the X12 core standards for claims transactions (on the 837). He noted that states expect to be HIPAA compliant, but at least 16 states are in danger of losing the race and ethnicity data they currently collect if they are lost during standardization.
Dr. Elixhauser represents AHCPR on the Public Health Data Standards Consortium, which is exploring the desirability of integrating race/ethnicity as an optional element in the institutional (hospital) claim for the HIPAA standard. She cited reasons for not collecting the information only in the enrollment record. She also discussed the business reasons for having race/ethnicity information, having to do with improving and being accountable for quality of care.
Dr. Fowles presented a provider's experience in collecting race and ethnicity information, by describing her organization's preparation for and implementation of an extensive collection effort. The information is collected at registration in both ambulatory and hospital settings, but her colleagues say it would not be onerous to include the data element in the claim. She shared eight lessons from her experience that might be useful to others, and she encouraged the agencies interested in receiving this information to help HCOs collect it by developing curriculum and training programs.
The Union Health Center, for which Mr. Cheng is CFO, is a diagnostic and treatment center for the Union of Needletrades, Industrial and Textile Employees. Because of its racially and ethnically diverse patient population, the Center has collected race/ethnicity data for some time, having invested in software and a thorough staff training program. He asserted that despite the business case for collecting this information, it belongs in the enrollment transaction rather than the bill. Doing the latter would impose more burden on providers; patients remain suspicious when asked about race/ethnicity; data validity would suffer; and there are concerns about misuse of the information such as redlining.
Dr. Carrillo reported on a recent federally-sponsored meeting of MCO representatives in Washington, D.C. to discuss performance measurement in managed care and its role in eliminating disparities. Although most MCOs do not currently collect race/ethnicity information and participants raised many philosophical, legal, and technical concerns, they also strongly support the collection of the information. Their recommendations: the data should be collected universally under a federally mandate; legal questions must be addressed and resolved by the Department of Justice; a means of compensation for providers must be found; HCFA should use its leverage as a major purchaser; and OMB Directive 15 and CAHPS provide formats and ways of getting the information. They suggest a model demonstration program at the outset.
Mr. Knettel reported that few ERIC members currently perceive a business need for collecting race/ethnicity information. Indeed, they associate the collection of the information with concerns about legal liability and creating suspicion among employees. Any initiative to collect race/ethnicity data should be federally mandated and accompanied by an extensive educational effort.
Ms. Woo reported that two states, California and Maryland, have laws that might be interpreted to prohibit reporting of race/ethnicity data in administrative data. Overall, this is a grey area, although some states said in an informal survey that a race/ethnicity question raises concerns about discrimination.
Mr. Woo, who works on civil rights enforcement, said he knows of no instance where collection of race/ethnicity information is forbidden by state law. He affirmed that people are concerned about abuses and that confidentiality protections are important, but he also stressed that race/ethnicity data are essential for investigating complaints of discrimination.
Dr. Krieger pointed out that we know there is preventable discrimination and inequality in U.S. society; not gathering information on it is simply a way of not seeing it. She encouraged the Committee to move forward in supporting the collection of data on race/ethnicity in administrative data, to permit ongoing monitoring which is essential. She stressed the importance of seeing race/ethnicity as one axis of social inequality that must be linked with SES, using geocoding or other data sources, for a more complete picture. She noted that concerns about validity can be assessed rationally and empirically, and that usually the bias is in the direction of underestimating discrimination.
The discussion period focused on geocoding, alternatives to the claim as a means of transmission, the implications of recent findings that clinicians discriminate against patients on the basis of race, and concerns about burden and overloading the system.
The Committee passed an amended motion, approving the report on health data in the insular areas, with the addition of a recommendation that the Data Council be asked to identify a single point of accountability and contact for these issues. Ms. Ward thanked Dale Hitchcock for his extensive work on the report.
The Subcommittee will submit a revised report on Medicaid managed care in September.
Dr. Experton noted the unrealized potential in the U.S. for using this technology, which is more advanced in Europe. She described the basic characteristics of Smart Cards, what they contain, how they are read, and some of their functions.
Mr. Maloney noted the need to be able to identify and authenticate where transactions come from. He described several Smart Card projects in Europe as well as a number of initiatives in which the VA is involved in the U.S.
Dr. Kingsland described two pilot projects in the U.S.: the Health Passport Project of the Western Governors' Association, and the Secure Collaboration Technology for Rural Clinical Telemedicine, the latter by West Virginia University.
Mr. Schwartz commented on the privacy/confidentiality pitfalls for consumers if the protections possible in Smart Cards are not fully implemented. He focused on the potential dangers of centralizing all information on individuals, and he raised some questions for policy makers and health care administrators.
Dr. Claire Broome discussed the management commitment at CDC to accelerating movement toward integrated health information systems. She focused her comments on an overview of the CDC mission from the perspective of statistics and health information. CDC has a strong interest in the HIPAA-related work on standards and privacy/ confidentiality, and it is working to ensure that public health data needs are considered. CDC has new resources for developing its systems through funding for preparedness against a bioterrorist episode. The same systems can be used for other purposes such as dealing with emerging infections. She noted CDC's interest in the potential for gathering race/ethnicity information from enrollment and encounter forms, and its growing interest in geocoding.
Ms. Frawley reported that the Privacy/Confidentiality Subcommittee will write Dr. Iezzoni and the contractor a letter with its suggestions for the Medicaid Managed Care report. It will submit its next work plan at the September NCVHS meeting.
Dr. Cohn reported that the Work Group on Computer-Based Patient Records will hold hearings September 16-17 and plans to have an interim report for the Secretary in September and a briefing for the Committee to discuss in November.
Dr. Starfield asked whether the Standards and Security Subcommittee might address the issue of an implementation standard for the transmission of race/ethnicity data. Dr. Cohn suggested that the Executive Subcommittee first decide how to proceed on this matter.
Dr. Friedman reported on the work of the Work Group on Health Statistics for the 21st Century. It tentatively plans three products: a vision document, a "road map," and an edited collection of papers. He observed that how all this fits with the NHII discussions still needs to be worked out.
Dr. Lumpkin reported that the Work Group on the NHII is developing a multidimensional model to guide its planning. It expects to involve external advisors both at the initial conceptual stage and in achieving the goals that are eventually established.
Ms. Greenberg noted that the June 20-21 50th anniversary symposium is the target date for making public the thinking to date on both the NHII and the 21st century vision.
The group met with Debbie Maiese and Linda Bailey of ODPHP, who reported on the status of Healthy People 2010 and the work on a set of leading health indicators. The public comments on the draft published in the Fall are now on the Web. One result of the comments was a decision to add a chapter on chronic kidney disease. New vision and hearing impairment objectives also have been added. The Secretary's Council is examining the question of whether it is feasible to develop data sources and measures for the large number of developmental objectives -- 43 percent of the total.
The launch is planned for January 25, 2000 with an event for which people are encouraged to propose breakout sessions, caucuses, or poster sessions.
The leading health indicators are intended particularly for those constituents who want to work with a smaller number of representative objectives. An Institute of Medicine committee has submitted three reports on this topic, and its health determinants and outcomes model has been selected. A list of 12 possible indicators is being reviewed by the Secretary's Council. The aim is to produce 10 indicators that collectively reflect and represent all 28 chapters of Healthy People. The indicators have been tested in several fruitful focus group sessions.
Dr. Friedman appealed for indicators that are scalable not just to the state but to the local level.
Dr. Lumpkin welcomed Karen Trudel as the acting HCFA liaison, replacing Stewart Streimer.The Committee approved a letter of thanks to Mr. Streimer.
The Department expects in July a major report and recommendations on race and ethnicity data from the Data Council's Working Group on Race and Ethnicity. This report, on which the Committee will be briefed at a future meeting, will lead to a comprehensive data strategy in this area.
The Department is part of a White House initiative to improve the ability to measure and track discrimination in U.S. society, coordinated by OMB and the Council of Economic Advisors. This effort focuses not just on disparities but also on motive. An expert panel convened by the National Academy of Sciences will meet in November to review research questions and methods. Meanwhile, agencies are looking at what they can do in the shorter term to improve measurement and tracking. HHS has updated its "meta-directory" of data resources and systems on race/ethnicity data, and it has asked its Race/Ethnicity Working Group to assess current surveys and administrative data systems in terms of their potential for improvement. The directory, which includes information on how to access the data, will be available publicly.
HHS also will initiate a scientifically-based literature review of knowledge about how to measure and track discrimination. HUD, for example, has developed ways of identifying those engaging in housing discrimination. Mr. Scanlon asked the Committee for suggestions on the literature review or other aspects of this large project.
As part of FY 2001 budget planning with respect to data strategy, the Data Council has reviewed Departmental survey proposals and enhancements in terms of major data gaps and needs.
An analysis and recommendations will be forwarded to the Budget Review Policy Board. The Secretary has identified information for decision-making as a theme of budget planning.
Responding to a question from Dr. Lumpkin, Mr. Scanlon said the Department is exploring the potential of geocoding, with attention to inherent privacy issues.
Because HIPAA requires the Secretary to promulgate regulations on confidentiality of health information if Congress fails to pass legislation by August 20, the Department has been working on regulations. Although there are rumors that Congress will delay some HIPAA deadlines, there is no evidence that this is happening. Senator Leahy has written the President counseling him to veto any bill putting off the deadline or eliminating the Secretary's responsibility in that area.
Mr. Gellman asked if a decision has been made about how to interpret HIPAA on the scope of the Secretary's authority to write privacy regulations--specifically, whether it covers all health information or just electronic transactions. Mr. Fanning said HHS is exploring this question but has reached no conclusion as yet.
HHS is following OMB's process as it considers amending OMB Circular A-110, which deals with grant activities of federal agencies. Congress has directed OMB to make data developed under grants with federal money available to the public. OMB received some 10,000 comments on a proposed amendment, divided evenly between advocates and opponents of using that approach to comply with the Congressional directive. HHS has been assured by OMB that all federal agencies dealing with research grants and resulting data will be consulted before final action is taken. The Department has stressed to OMB the importance of making research data available but not using a "blunt instrument."
HHS has been analyzing the comments on the four rules for HIPAA standards put out in the last year. The four rules are being drafted and are slated to be published by the end of 1999, starting with the one on transaction and coding sets. The X12N Working Group on the implementation guides has updated them and posted the updates on the Washington Publishing Website. There will be more than two years to implement the new rules.
Action on an individual identifier is on hold pending privacy legislation or regulation. The plan identifier ran into difficulty in the clearance process, has been redrafted, and will be put into clearance soon. The plan is to publish an NPRM for the plan identifier by the end of 1999. The attachments standard is in clearance and probably will be published by October.
With the final rules will be published a discussion of how to continue the process of developing and maintaining standards. The process must be smooth and rapid, and must be understood as a continuing process and one that will be refined over time.
The Department is discussing code set issues and working with code set developers to ensure that the code set development is an open public process and that low-cost distribution mechanisms are available. HHS also wants to assist the industry in its efforts to plan and implement standards in a variety of ways, including publicity and education. Monitoring and evaluation is a dimension in which both NCVHS and industry have a role. Although it was not funded to perform any of these functions, the Department is doing them; and the industry is "stepping up to the plate" with education and evaluation initiatives.
The Department will address enforcement in a separate NPRM, to be published in 2000. Because the changes are beneficial to industry, it is expected primarily to police itself, with the Department going after offenders.
In response to a question from Ms. Fyffe, Dr. Braithwaite and Committee members discussed usage fees for code sets. He said private developers need some income to offset their development and maintenance expenses; the idea is to make sure fees are low and only cover costs, and the government will work with private organizations to make sure this happens. Dr. Cohn observed that the Committee would soon be considering the issue of a framework for coding.
Responding to another question, Dr. Braithwaite described some of the variables in the initial two-year implementation period. Asked what kinds of changes will be required by the standards and what this means for the balance between new and adapted systems, he predicted a broad range of responses and needs in the industry.
The Committee reviewed a draft formalizing a process whereby the Committee could address time-sensitive issues between meetings. Members began by discussing whether they should establish a formal process. Mr. Gellman questioned the need for such a policy; the predominant view, however, favored having a procedure in place for occasions when the Committee needs to move quickly on an issue.
Discussion shifted to the contents of such a policy. Members stressed the desire to minimize the potential for misuse or overuse of the process, and the importance of making it consistent with general NCVHS operating principles concerning public access. It was agreed that a distinction between "taking a position" and "commenting" is not necessary. The Committee asked staff to revise the document reflecting this discussion and circulate it in advance of the next NCVHS meeting, for action at that time. Members were asked to submit comments on the current draft to Ms. Greenberg.
Ms. Greenberg announced that the June 2000 NCVHS meeting and 50th-anniversary symposium and reception at the National Academy of Sciences would be held on June 20-21, 2000. Committee members were asked to hold June 20-22 in case adjunct meetings are needed. Other 2000 dates will be confirmed once members have supplied staff with their schedules.
Dr. Meyer is Director of the Center for Quality Measurement and Improvement. This panel was organized by Kathryn Coltin, Chair of the Work Group on Quality, who asked him to address three issues:
AHCPR's quality agenda is contained in the President's Quality Commission Report. Major aims are to expand research on treatments and effectiveness, to reduce health care errors, to improve aspects of quality measurement and reporting, and to build the capacity to improve quality. Information goes to patients, purchasers, and clinicians, who need information for improvement, accountability, and comparison. The sources of information include administrative, clinical, and survey data, each with its own limitations. Surveys are often used to fill the gaps in the other sources, but overuse of them creates problems with response rates and burden.
In its quality research, AHCPR is seeking answers to a few "simple" questions: whether things are getting better or worse, what methods are available to answer that question, how measures for decision-making can be provided, and what must change to drive quality improvement. However, the current organization of data prevents getting the answers to these questions. This is complicated by the fact that quality measurement is shifting from a focus on individual (physician) effort to a focus on the combination of individual and system efforts, using knowledge obtained from multiple dynamic sources. Most data systems are still focused on individuals rather than systems.
Current data are limited partly by the lack of comparability across sectors and geography. Such comparability will be necessary for the forthcoming National Health Care Quality Report that AHCPR will work on with CDC as part of the Secretary's Quality Initiative. Dr. Meyer asked for the Committee's advice on population-based quality data sources. Another gap is the lack of a core measurement set. The Quality Interagency Coordinating Task Force Work Group on Quality Measures has discussed developing a core set of measures, and it is watching the work of the Health Care Forum in this area.
Other gaps include the lack of data elements for use in quality measurement; the inability to integrate patient care data with system data or to cut and reassemble data for new purposes; and the need to integrate data collection into routine work. In addition, getting value from a measurement investment is an acute issue in the public sector, as typified by the Oasis Data Set.
AHCPR is also interested in presentation formats for stakeholders, and Dr. Meyer urged the Committee to "think long and hard" about what the ultimate information products should look like. He described a research project in which two different presentations of the same data comparing health plans resulted in opposite reactions by consumers. (A write-up of this project will be available in a few months.)
He concluded with these "three wishes" for administrative data, the result of an informal poll of AHCPR colleagues:
The wishes for additional administrative/enrollment data are:
Dr. Clauser is Director of Quality Measurement and Health Assessment. He said he would present the purchaser's perspective on performance measurement, which HCFA regards as a foundation for its evolving purchasing strategy. The contexts include nursing homes, dialysis facilities, and management of contracting care oversight.
HCFA uses performance measurement to support quality improvement (QI) initiatives in both managed care and fee-for-service. There are six national QI projects in the latter arena, focused on different conditions (e.g., diabetes and breast cancer). The parallel program in managed care is called QISMC. Medicare Plus Choice health plans choose one priority area for improvement from a list of options. The first project will focus on diabetes. HCFA will also use performance measurement in a public information campaign that is assisting beneficiaries in choosing plans and providers. It hopes to have information on skilled nursing facilities by next summer. Overall, HCFA is trying to create a "clear business case" for the use of quality information to improve programs.
To improve the quality of the data used for performance measurement, HCFA is emphasizing standardizing measures of care rather than developing new ones, to maximize the value of current information. An example is the Diabetes Quality Improvement Project (DQIP). Purchasers and providers reached consensus on a common uniform measure set that was subsequently adopted by NCQA for HEDIS 2000, and also endorsed by the American Diabetic Association. Other federal agencies including the VA have endorsed the measures.
HCFA is also creating standardized data collection and reporting tools, based on the MedQuest system, along with analytical tools. All have been tested for reliability and validity. MedQuest will be required for all PRO performance measurement initiatives in the six national projects mentioned above. They are available free of charge to participants. MedQuest modules are being developed for the MDS for nursing homes, for home health, and for the ESDR core indicator set, among others. Offering these as freeware permits scrutiny of the logic of data collection and also reduces costs.
HCFA is committed to auditing performance measurement data in managed care and fee- for-service. It has worked with NCQA on audit standards. The HEDIS audit findings and feedback to plans have helped improve data quality and reporting.
Looking toward the future, Dr. Clauser acknowledged the National Committee's role in advancing standardization and computerization of patient records, both of which will contribute to data quality. To enhance the value of what HCFA already requires, the agency is trying to enhance the completeness of data reported. One challenge is that new payment methodologies (specifically, capitation) are expected to have an impact on the availability and quality of clinical data because the link between reporting to reimbursement is lost. Another challenge will be improving the completeness of quality of care that is not directly related to payment. Dr. Clauser called for leadership from the Committee as encounter coding systems are built and matched to the fee-for-service system. Attention is also needed to the potential role of public reporting as an incentive for more completeness. In conclusion, he noted the importance of maximizing the investment in the clinical data that are already required.
In response to a request, Dr. Clauser said he would supply the Committee with information on the Diabetes QI data set.
After thanking the presenters, Ms. Coltin noted that HCFA has more data on the Medicare population than are available on other populations and she asked how similar capabilities might be developed elsewhere. Dr. Clauser responded that state Medicaid directors are showing a strong interest in data standardization, although this is complicated by differences in program design. He advised opening a dialogue with state Medicaid representatives to identify the common ground. Dr. Meyer added that this topic of health care quality for the non-Medicare population is a recurring one. The AHCPR project on hospital care that Anne Elixhauser will describe tomorrow is aimed in that direction. AHCPR wants to push in the direction of QI programs for the general population.
Dr. Starfield questioned the "50-year-old" disease-based paradigm for the quality work described, and called for an approach that gets at populations. Most research on treatment effectiveness can only be generalized to about 10 percent of the population. What is needed is a new conceptualization of effectiveness and of harm. Effectiveness should be viewed in terms of impact on people rather than in terms of impact on diseases. One example of need to consider harm is the unanticipated effect of medications, in addition to known adverse effects and error, all of which should be documented as they occur. She referenced her 9/98 JAMA editorial, "Internal Elegance and External Relevance" and called for a shift from elegance to relevance in the work on quality. This would mean, among other things, adding the goal of eliminating disparities to the list of priority quality issues.
Dr. Meyer said these issues are on the agency's radar screen, and it welcomes the Committee's guidance. He noted that his reference to the need to be able to cut and reassemble data was about moving from condition- or procedure-based measures to looking at the entire population, including disparities among racial and ethnic groups. The population perspective will be central to the Health Care Quality Report that AHCPR and CDC will develop.
Dr. Clauser asserted that the disease-based approach has generated important results in reduced mortality; such an approach must be paired with a population-based approach. He agreed that the latter is "the next frontier." One challenge for HCFA as it tries to combine the two is figuring out what it can legitimately hold health plans accountable for.
Dr. McDonald described the merits of moving from ICD-9 or CPT-4 codes to raw clinical data as sources of quality measures.
Dr. Friedman praised the Medicare Compare Website as an exemplar of presenting quality data to the public. He also noted that another rich data source is public health surveillance data.
Asked how AHCPR defines "vulnerable populations" (one focus of quality measurement efforts), Dr. Meyer said it uses the broad definition in the President's Quality Commission Report. He added that the agency looks to the Committee for help in getting these multiple factors into data sets.
Dr. Mor observed that health services research in the nursing home context, which has significant support from HCFA, provides a working model of the multilevel approach described in Dr. Meyer's presentation. Dr. Clauser described some of the other arenas in which HCFA is working with providers and beneficiaries toward detailed clinical automated databases, e.g., end stage renal disease and ESDR.
Mr. Blair asked whether either agency had developed business cases for its quality work. Dr. Meyer remarked that the Malcolm Baldridge Quality Award winners that he has studied did not mention having done a business case analysis before making their investment in quality, which they did for its own sake.
Dr. Lumpkin called attention to the "backlash against quality measurement" in industry and asked about the cost of quality. He also observed that the collection of quality data has not been standardized, adding to the burden on providers. Finally, he noted the difficulty of measuring health in a community under managed care, when some care is not provided by the plan.
Dr. Meyer said AHCPR is funding demonstrations to develop systems in real time; in the meantime, the backlash is a major issue. To measure community, the CAHPS project will try to broaden out to additional populations. Dr. Clauser said HCFA is sensitive to the burden issue and thus uses administrative data to the extent possible and, when necessary, medical records. Both presenters stressed that the strategy must emphasize the inherent importance of quality, especially to consumers. Dr. Clauser described HCFA's population-based approach to Medicare. It has cooperative initiatives with CDC and is working with major purchasers to bring communities together to pursue QI initiatives. Community-based measures are especially promising in the fee- for-service context.
Answering a question from Dr. Fitzmaurice, Dr. Clauser said to his knowledge, HCFA has no plans to change its policy of providing personally identifiable health data for specific research, under conditions that protect confidentiality.
Finally, Ms. Coltin commented on the spillover effect: i.e., changes in provider behavior generally affect all of their patients. She also cautioned against too broad-brush an approach to managed care, given that while HMOs are pushing through many of the quality improvement changes, they cover a minority of managed care enrollees. Most PPOs do not produce quality measures and lack the data capabilities to produce them. Addressing these inconsistencies depends on a voluntary private sector effort.
Dr. Lumpkin proposed that NCVHS members be given 30 days to submit individual comments on the 1996-1998 report, and that all received in that period be attached to it when it is published and posted on the Web site.
Mr. Gellman commented on the importance of giving federal advisory committee members the opportunity to publicly express personal views on committee products, and he urged the Committee to establish a process for giving contrary views "equal time." He supported Dr. Lumpkin's proposal.
No one spoke in opposition to this proposal.
Ms. Greenberg said she would e-mail the final version of the report, together with member views that have already been submitted. Members would then have 30 days to submit any personal comments they wish to have attached to the report.
Ms. Coltin reminded the group that the Subcommittee undertook its study of Medicaid managed care because of concerns that the increased use of managed care would result in inadequate data for evaluating quality of care. It held site visits and took testimony in Washington, D.C., and also commissioned a study of state contracting language. Its draft report reviews the importance of data collection in this context and its legal and operational framework, synthesizes the results of the hearings, and presents the Subcommittee's recommendations.
There are six key recommendations, with two "umbrella recommendations": 1) It suggests that HCFA encourage standardization by specifying the manner and format of data to be routinely collected from MCOs; and 2) it offers a menu of consistent contractual language for voluntary adoption by states. The latter is still undergoing external review.
After describing her concerns about two aspects of the draft report, Ms. Coltin summarized the six recommendations. Among other things, they concern a standardized minimum data set, a standard definition of an encounter, a standard patient survey, consistent reporting for covered and carved-out services (e.g., pharmacy), data sharing, and training. She took exception to the proposition that MCOs should be responsible for enforcing reporting of reportable diseases, which is a state responsibility.
Ms. Coltin explained that the Subcommittee would review the report in its meeting later that day, together with the Committee's comments, and would decide then whether to ask for a general endorsement of the report or to defer any request pending further revisions. Some members commented that they would prefer to take action on a completed document.
Referencing written comments he submitted previously, Mr. Gellman expressed concern that the report does not sufficiently address the rights and interests of patients. He questioned in regard to the draft contractual language "why NCVHS is involved in this effort at all," noting that currently no privacy and confidentiality rules are in place to protect patients. He called for discussion in the report of organizational techniques and technologies to protect confidentiality, and of the gaps in current laws. Ms. Greenberg said that Mr. Gellman's comments had been referred to the Subcommittee on Privacy and Confidentiality, which will review the draft report.
Mr. Zubeldia said the report would be strengthened by a recommendation that managed care organizations be required to handle data electronically, countering a strong trend in the opposite direction as states shift to managed care.
The Committee then reviewed and discussed each of the six recommendations. The suggestions and discussion focused on these areas:
Members agreed that although the report and recommendations are important, the number of revisions suggested by this discussion plus the other unfinished aspects mean that action on the document would best be deferred to the September meeting.
This was deferred until after the meeting with the HCFA Administrator.
Dr. Lumpkin welcomed HCFA Administrator Nancy Ann Min DeParle, noting that since being reconstituted by HIPAA, NCVHS has tried to balance "the two halves of its brain" that focus on standards, security and privacy, on one side, and population issues, on the other.
Ms. DeParle responded that in HCFA, those two aspects are now "at a crossroads or collision point." The agency particularly needs the Committee's help at that crossroads as it develops its information gathering tools to pay providers accurately, protect the Medicare Trust Fund, and oversee the quality of care. Of particular concern are the "tension points" between these efforts and privacy/confidentiality concerns. She referenced HCFA's experience with OASIS, which it developed in response to a Congressional mandate and which has generated "a big explosion" about confidentiality particularly around mental health status assessments. This represents the broader tension between progress in monitoring quality and payment, on the one hand, and protecting patients against the misuse of data, on the other. She invited the Committee's guidance in addressing this tension and moving forward.
Turning to the HCFA's priorities, she noted that it is fundamentally "an operations place" whose first priority is "making sure that claims get paid." In the short run, correcting year 2000 computer problems is the top priority so that claims payment can continue without interruption -- an outcome that she said is now assured insofar as it depends on HCFA. (She said she is less sure whether providers will be ready to bill Medicare, a matter on which HCFA is doing outreach to providers.) The result of the Y2K effort is that other information system projects have been delayed.
HCFA is also working on administrative simplification under HIPAA. Ms. DeParle expressed satisfaction with the way the agency and NCVHS have collaborated on this effort and the resulting "lack of surprises" with the thousands of comments received. Next steps include policies and procedures to enforce standards, examining the Department's role in implementation activities, and monitoring implementation.
The agency looks forward to working with NCVHS on using clinically focused data through its computer-based record project. To make this manageable, its performance measurement strategy is based on the principle and goal of data collection standardization "wherever possible." HCFA is the lead agency for development of HIPAA data standards and participates in standards development organizations. It also is part of an effort to create standardized quality assessment tools.
Ms. DeParle closed by reiterating her request that the Committee help HCFA make its protections for personal medical information even stronger. She also announced that Karen Trudel would serve as the new acting HCFA liaison to NCVHS, now that Steward Streimer has moved to another post in the organization.
Dr. Lumpkin acknowledged the good relationship and results in the joint work between NCVHS and HCFA, both with the liaisons and in the HIPAA-related process. Noting the Committee's vision of developing a national health information infrastructure, he observed that the work on standards and informatics is not an end in itself but a means to the goal of an improved health delivery system and improved health for all Americans.
Referring again to the "surprise" negative reaction to OASIS, Ms. DeParle invited the Committee's guidance on how to help people understand data's potential benefits for everyone, and especially for vulnerable populations.
Dr. Starfield asked about HCFA's perspective on having data for meeting the national goal of eliminating health disparities among population groups. Ms. DeParle said the Government Performance and Results Act includes goals for reducing disparities among beneficiaries in certain areas; and for some benefits, the agency's goal is to "increase the population as a whole." However, HCFA relies on Social Security enrollment data to collect the data necessary for identifying racial and ethnic disparities among Medicare beneficiaries.
Mr. Gellman commented that HCFA was surprised by the reaction to OASIS because it failed to consult anyone with "sensitivity on privacy issues" in its advance research, talking only to "the health data establishment." Also, the public is now paying more attention to the uses of data, making it necessary to "confront the hard issues more carefully."
Dr. Cohn commiserated with Ms. DeParle over the number of Congressional data mandates HCFA must fulfill, plus the Y2K work, and the necessity of deferring other important initiatives (e.g., APCs in the hospital outpatient area). He noted that while inevitable, these delays are "creating a lot of confusion in the health care industry" and he asked for her thoughts. She said HCFA is currently assessing what it can do when, and the Committee would be briefed as soon as plans have been cleared with the Secretary.
Dr. Lumpkin thanked Ms. DeParle and expressed hope for a continuing partnership. She thanked the Committee members for their public service in that capacity.
Jane Durch of the National Academy of Sciences was Study Director of the Panel on Performance Measures and Data for Public Health Performance Partnership Grants of the Committee on National Statistics (CNSTAT). Dr. Lumpkin was a member of the panel. Its April 1999 report is from an HHS-funded project that began in Fall, 1995, in response to GPRA initiatives and proposals for performance partnership grants. The CNStat panel, assembled as a technical advisory body on performance measures, has a mix of academics; people with federal, state and local experience; and content experts in public health, mental health, and substance abuse, among other areas.
The first report, released in 1997, provided an analytic framework for states, communities and the Department in assessing measures for performance partnerships. It offered examples of outcome and intermediate measures but stressed that the specific measures should be selected in the context of the work being done and specific program strategies and goals. It also discussed data sources. The Department extended the life of the panel to address broad data issues turned up by the work in that area. The second phase led to "Performance Measurement in the Public Sector: Principles and Policies for Implementing an Information Network."
The second phase of the study looked beyond the federal/state context to include the local level, and beyond the grant areas on which the first report focused to a wider range of issues. It kept an emphasis on publicly funded health programs. Several themes emerged:
The report lists specific principles for implementing performance measurement -- e.g., they must proceed from clearly defined program goals and must consider the feasibility of data collection and analysis.
The work of the panel pointed to the need for better information systems and the evolution of a national (as distinct from federal) health information network. This would bridge public and private sector programs rather than consolidating them in a single data system. All who would benefit from such an improved system would share responsibility for it. The panel developed recommendations in four areas to promote performance measurement and a broader health information network. The areas: policy actions, operational principles, essential investment, and research. Key features include national collaboration, local-state data system integration, links to other sectors such as criminal justice and transportation, an ongoing review process, and the involvement of federal agencies and foundations in funding research to improve performance measures and the use of performance measurement.
Dr. Friedman remarked on the "millennial epiphenomenon" of people "wandering around visioning" -- something that is happening in health information both nationally and internationally, including within NCVHS. There is high-level agreement on the content of the vision, but little agreement on how to get from here to there. The question for the Committee's NHII Work Group, among other groups, is, "What do we do next?"
Dr. Amaro described a project in Massachussets focused on HIV indicators, and commented on the difficulty of reaching conclusions from the data that have clear implications for prevention. Ms. Durch said the panel shares that view of the difficulty of linking health department activities to outcomes. The first report discussed the need for more than outcome measures. Also, the panel was concerned with the practice of basing resource allocation on performance measurement, given the number of factors that affect outcomes.
Dr. Lumpkin thanked Ms. Durch and predicted many more discussions about quality and performance in the Committee's future.
2) Health Data Needs of the Pacific Insular Areas, Puerto Rico and the U.S. Virgin Islands
Ms. Ward explained that the Subcommittee began this project, with strong encouragement from Dr. Amaro, to look at these areas that have suffered "from a lot of benign neglect." The Subcommittee's hearing last summer was attended by representatives from the Pacific Insular Areas, Puerto Rico and the U.S. Virgin Islands. Members were impressed with the interest expressed by federal agencies in addressing this issue and assisting the areas in question. The services of a federal office formerly designated to serve the Pacific insular areas and the Virgin Islands have been seriously curtailed; one benefit of the hearings was to facilitate communication among federal agencies around these issues.
The draft report on this issue includes recommendations, the thrust of which is the creation of more flexibility in the use of federal dollars in those areas and more direct assistance for improved data collection and analysis.
Ms. Ward asked members to read the report and comment on it. The revised version will be sent to the representatives of the insular areas for their comments. If this results in further revisions, the new draft will be brought back to the Committee for review. She briefly described each of the 14 recommendations, some of which are particular to specific geographic areas. One concerns using the Healthy People 2010 approach as an impetus for expanding assistance; another concerns getting help with denominator data from the Census Bureau and HHS. The Subcommittee also encourages development of a mechanism to help the islands and jurisdictions talk to each other and share concerns and resources.
Mr. Hitchcock explained that the office to which Ms. Ward referred (part of the Department of the Interior [DOI]) still exists but has been significantly downsized. Dr. Lumpkin observed that within HHS, no one is responsible and accountable for the health data needs of these areas; this might warrant a specific recommendation. Ms. Ward said she would take this suggestion to the Subcommittee. Mr. Scanlon added that DOI has responsibility for dealing with governments, but the Committee could recommend that HHS designate a focal point for this set of concerns.
The meeting then recessed for Subcommittee meetings, to reconvene the following day.
Following the customary introductions, Dr. Lumpkin introduced the first panel of the day. He noted that the collection of demographic data on HIPAA transactions had proved to be far more complex than expected.
Mr. O'Keefe spoke on behalf of the National Association of Health Data Organizations (NAHDO). It believes the collection of race and ethnicity data in administrative data sets provides information valuable to providers, policy makers and researchers, and it recommends that the information be included in the X12 core standards for claims transactions. Hospital discharge data give information on the health of a population and the performance of the health care system for diverse users, including purchasers and consumers in addition to those mentioned above.
At least 16 states are in danger of losing the race and ethnicity data they currently collect if they are lost during standardization. It is not adequate to collect the data on the enrollment form because 1) some state organizations lack the statutory authority to obtain enrollment data, and 2) this would provide no information on the uninsured.
Even if it is part of the claims transaction, judgment can still be used about when to collect the information. It would be useful in hospital discharge data for many reasons. As to whether the data are sound, a recent analysis by the Massachusetts Department of Public Health found 90 percent agreement between hospital discharge data and birth certificate data for whites, blacks, and Hispanics.
A uniform national standard for collection will improve data quality and use over time. Such information will permit comparisons and explain variances in cost, quality and access. It will help health care organizations to understand the population they are planning interventions for and to design culturally appropriate interventions, and it will help researchers document disparities.
NAHDO recommends that race/ethnicity data be on the 837.
Dr. Elixhauser represents AHCPR on the Public Health Data Standards Consortium, a public (state/federal)/private body that grew out of last fall's meeting on the implications of HIPAA for public health and health services research. It now has a listserv, through which the Consortium is exploring the desirability of integrating race/ethnicity as an optional element in the institutional (hospital) claim for the HIPAA standard.
She reviewed the reasons why this element is critical for measuring and ultimately eliminating disparities. She referenced a table listing nine studies of state discharge data that document differential use of procedures and other services for whites and members of various non- white populations. That use of administrative data has led to studies to explain the reasons for the differences.
AHCPR obtains data for 22 states for its Healthcare Cost and Utilization Project (HCUP); 16 collect information on race/ ethnicity from hospitals. One problem is non-uniform coding. The states that provide HCUP data plan to be HIPAA compliant, but do not want to lose their race/ethnicity information. Adding this element to the institutional claims standard is facilitated by the fact that it is already a field on the claim; however, the implementation guide specifies the field as “not used.”; also, CDC staff are working with the SDOs to align the code sets in the claims standard with the new OMB Standards for the Classification of Federal Data on Race and Ethnicity.
Dr. Elixhauser cited four reasons for not just collecting race/ethnicity in the enrollment file:
Adding race/ethnicity to the claims standard meets the criterion of fulfilling a business need of the transaction. It has bearing on quality of care, not just on public health-- and quality is "a big part of the business of health care" and one for which providers are being held accountable. A failure to include race/ethnicity in the standard could result in an increase in non-uniform formats as states continue to collect the information; this would add to the reporting burden on providers and making analysis more difficult.
Dr. Fowles was asked to speak of providers' experience in collecting race and ethnicity information. Her organization is an integrated care system employing some 6,000 people, including more than 450 physicians in 16 clinics and a teaching hospital. Although the patient registration form has included a space for race/ethnicity for a decade, systematic collection began in 1999, motivated by the need to qualify for federal funding for research.
She described the steps in implementing this decision:
The organization did not anticipate the negative response the initiative got from physicians; it learned that a more complete and effective training would include outreach to them. Nevertheless, the result was that as of June 1999, race/ethnicity data are available for 210,000 of its 250,000 active patients.
She enumerated eight lessons from which others might learn:
The organization has found that race/ethnicity data can be successfully collected in both hospital and clinic. Although the data are collected on the registration file, Dr. Fowles' colleagues report that reproducing them on claims and encounter files would not be a major issue. This kind of thing is already done for various payer requests.
She stressed that the agencies interested in the data should provide assistance in the process, and recommended that a sponsoring organization pull together curriculum for medical practices that will collect the information. Among other things, seminars could be offered at institutional professional meetings.
The Union Health Center, for which Mr. Cheng is CFO, is a diagnostic and treatment center for the Union of Needletrades, Industrial and Textile Employees (UNITE!). As has always been the case, the Union Health Center serves an ethnically and racially diverse population of garment workers, many of whom are recent immigrants. To address the diverse medical needs of its patients, it has collected race/ethnicity information for several years. The collection of this information remains controversial, especially in terms of its reliability. Information is gathered voluntarily from the patient or ascribed by observation. Multiracial individuals are the most difficult to classify.
The Union Health Center incurred expenses to reprogram software, change work flows, and extensively train workers for collecting race/ethnicity data. Mr. Cheng expressed concern that the new OMB Standards do not allow enough flexibility and should include an "unknown" category.
He asserted that despite the strong business case for collecting this information, the bill is not the right place for transmitting it; rather, it belongs in the enrollment transaction. If necessary, Congress should pass regulations requiring access to these data. Providers who transmit claims are leery of including race/ethnicity in claims, feeling that the requirement would just "give payers another excuse to reject the claim." Mr. Cheng predicted that to avoid this, providers would "just make something up." He also stated his misgivings about potential misuses of the data, such as redlining. He asserted that the issues related to race and ethnicity are public health issues, and the burden should not be placed on providers. They collect the data and are interested in the race and ethnicity of patients; but the information needs to be safeguarded and should be put in its proper place. Furthermore, there is a cost associated with transmitting the information, and it is not clear who will pay for it.
Dr. Carrillo reported on a recent meeting of MCO representatives in Washington, D.C., sponsored by DHHS and the Commonwealth Fund, to discuss performance measurement in managed care and its role in eliminating disparities. He noted that he is not an official spokesperson of the group. The group's overall findings were that 1) most MCOs are not currently collecting these data (as a recent Commonwealth Fund survey determined), and 2) the group was unanimous in wanting to see the data, for the reasons already enumerated by other panelists.
While agreeing on the importance of race/ethnicity data, the MCO representatives raised both conceptual/legal and technical/practical concerns. First, they worried that requiring only MCOs to gather the data could result in the mistaken impression that disparities only exist in managed care. They also were very concerned about the misuse of data to the detriment of patients, including the potential for discrimination. Questions also were raised about whether collecting race/ethnicity data violated any state or federal regulations. Other concerns related to cost and the need for federal requirements to stimulate action.
The technical issues raised included the need for national standardization to facilitate comparisons; the difficulty of generating valid data in the absence of links to SES and acculturation data; other validity issues related to the huge variations within a racial or ethnic group (e.g., Asians, Hispanics, people of the African diaspora); the lack of a standardized, validated method of collection; and issues of comparability of self-reported data.
Reiterating that his colleagues favor the collection of this information and that the foregoing should be regarded as caveats, Dr. Carrillo then offered some possible approaches to collecting the information:
The participants at the MCO meeting suggested a two-step model in which race/ethnicity data are used initially to generate hypotheses for analysis and intervention and then combined with more powerful data on SES, acculturation, etc. to do the analysis and create the intervention. They favored self-report for gathering the data but urged more study of this approach and its validity. They also urged work toward a national policy that applies to both the managed care and fee-for- service environments. They suggested a model program, possibly one aimed at early detection of diabetes among Latinos and thus linking ethnicity data with disease management.
ERIC members are large employers, typically with 50-60,000 employees. The organization does not have a policy position on the present issue, but its general principles are germane. They stress that sensitive data should only be collected pursuant to a specific business need, disclosed only to those with a need to know, and used only for the designated purpose. Currently, few ERIC members perceive a business need for collecting race/ethnicity information. Indeed, they associate the collection of the information with concerns about legal liability and creating suspicion among employees.
Mr. Knettel said these attitudes suggest the need for significant education of employers and employees in the event of an initiative to collect the information; furthermore, employers should be able to cite a government requirement. He concluded by urging caution in moving forward in this area.
Ms. Woo returned to the question of violating state or federal legislation. She and panelist Ed Woo surveyed state laws and found two (California and Maryland) that might prohibit the collection of race/ethnicity data from enrollees by health insurers. A typical response from State Departments of Insurance was that no state law prohibits the collection of such information, but the state does not collect it. Moreover, if they saw such a question on an application form, they would red-line it because it probably violates a section on unfair trade practice or discriminatory practice. Thus, the question is in a grey area.
Mr. Woo, a lawyer, works on civil rights enforcement. He stressed that in that context, race/ethnicity data are very important for investigating complaints of discrimination, e.g., to understand the patient experience in a hospital in order to enforce Title VI. However, he also acknowledged the sensitivity of collecting race/ethnicity data, and the fact that people are suspicious when asked for the information in situations where they might experience discrimination. Further, they tend to blame any subsequent disadvantageous treatment on that request for the information. In employment and education areas, the balance still tips toward collecting the information. It will take education to assure patients the information will not be used against them. There is always a risk that the data will be misused. However, the data also help protect against abuse.
Regarding whether the data collection violates laws, he said that in his experience the collection has never been forbidden by state law. Confidentiality and privacy protections about uses must be worked out at the facility level.
Dr. Krieger, a social epidemiologist, was asked to comment on the themes in the foregoing presentations. She observed that a starting point for the discussion is that preventable discrimination and inequality take place in U.S. society. A basic task of public health is to recognize and minimize such problems; and "not to collect is a way of not seeing that ends up causing injury" by making monitoring impossible. For ongoing monitoring, which is key, administrative data bases are essential.
Race/ethnicity is one of the important axes of inequality in the U.S., although it is not the only one. She urged the Committee to avoid the error of some databases that are "solely racialized" and do not collect information on socioeconomic position. This error contributes to a lack of understanding of heterogeneity, making poor whites disappear and perpetuating stereotypes about people of color. One way to address the need for SES data is to use area-based measures such as geocoding, making it possible to evaluate inequality in terms of race, ethnicity and socioeconomic position rather than just one or the other. Dr. Krieger also stressed that looking only at issues of data misuse overlooks the harm caused by not using data or by "silences in data."
Responding to concerns about validity, she pointed out that the OMB Directive is based on considerable research and there is no need to reinvent the wheel. It is possible to collect more detailed information and then simply collapse to the OMB categories. Also, self-report of race/ethnicity is the standard form of collecting the data, although the SEER cancer registries use an amalgam of data to get that information. Concerns about validity can be assessed rationally and empirically; for example, it is reasonable to assume that with self-report, any bias will be in the conservative direction, meaning that the problem is worse than the data indicate. Finally, she stressed the need for objective data on the consequences of health care actions, based on more than attitudes, because attitudes of both patients and providers tend to understate the extent of discrimination. This again suggests the need for administrative data.
Dr. Krieger summarized her recommendations as follows:
At Dr. Starfield's request, Dr. Krieger described some of her experience with using geocoding. She said she is part of a study to look at what area-based measures of socioeconomic position could be used in the U.S. Generally, the technical capacity is improving and public health interest in this approach is increasing, but more research is still needed.
Dr. Harding was the first of several members to praise the panelists for their lucid and informative presentations. He asked about the incidence of incorrect self-report by registrants (patients) for the purpose of gaming the system. Mr. Cheng said errors are usually introduced by administrative people entering data simply to satisfy a requirement, without regard for accuracy.
To a question from Dr. Cohn, Dr. Krieger said race/ethnicity data are needed in connection with health transactions (rather than being collected in "a completely separate fashion") in order to track health events and their outcomes (access, quality of care, etc.). SES information are needed for the same reason, but can be acquired through geocoding using the address.
Dr. McDonald pointed out that although it lacks the advantage of the reimbursement incentive, race/ethnicity data could be included as an attachment. Dr. Elixhauser said her group considered that but felt the attachments wouldn't be submitted for all patients. Dr. McDonald then commented on concerns about the burden and cost of collection, especially for individual providers. This concern increases with the talk of supplementing race/ethnicity data with other data, such as on SES, language, and so on. Finally, he suggested that coercing the data collection might cause a backlash.
Dr. Lumpkin shared his perspective as an African American, saying he trusted his provider not to discriminate against him but preferred that his insurance company not know his race. He speculated that many people would rather rely on anonymity to protect them instead of relying on the government. Thus, he expressed discomfort with putting race and ethnicity on the claim, even as he acknowledged the public health importance of the information. He wondered about an electronic solution such as one that would send the race/ethnicity data directly to the health data organization along with the bill, bypassing the insurance company.
Dr. Elixhauser and Dr. Amaro both responded by calling attention to Schulman's findings that clinicians themselves discriminate against patients based on race. Dr. Amaro also pointed out that not having the data only creates the inability to track things.
Ms. Coltin agreed, adding that it is known that discrimination occurs but it has not been possible to document exactly where in the health care process it takes place. Adding the data element to the 837 would involve only a one-time programming cost, after which race/ethnicity information could be added to each claim, as is done for date of birth. The biggest problem is that bills only give information for people who use services, and discrimination at the stage of access would not be identified. Thus it is important also to collect race/ethnicity on the enrollment form, to have information on the entire covered population.
Mr. Gellman, Mr. Cheng, and Mr. Zubeldia cautioned against overburdening patients, providers, and the system with mushrooming questions and data collection and reporting requirements.
In conclusion, Dr. Lumpkin thanked the panelists. He reiterated that this issue is far more complicated than it first appeared to be, but it is one the Committee will continue to struggle with.
Ms. Ward amended a motion made the previous day to accept the Subcommittee report on Health Data Needs of the Pacific Insular Areas, Puerto Rico and the U.S. Virgin Islands. She reported that the Subcommittee had added a recommendation (No. 15) requesting the Data Council to identify a single point of accountability and contact for these issues. The amended motion was passed, approving the report with the added recommendation.
Ms. Ward thanked Dale Hitchcock for his extensive work on the report, as she thanked his predecessor, Joan Turek. Dr. Lumpkin thanked the Subcommittee for its work in identifying and addressing these issues.
Dr. Experton noted that information technology is widely accepted in Europe and has unrealized potential in the U.S. She described the Smart Card as an interactive portable tool for immediate and secure offline access to data sets by consumers and providers. It stores a linkage device among the points of care and service and provides a means of secure online transfer of data. The cards have a microprocessor chip embedded in plastic and are read by interfitting to a PC computer system with a $40 Smart Card reader which plugs into the floppy drive. With a laptop, a $10 reader is fitted in the PC MCI slot.
To protect confidentiality, the Smart Card carries an encryption function through the microprocessor, unlike magnetic stripe and laser cards. Health data are typically stored in separate files with restricted access. Smart cards last five to ten years. The contents can be written on or edited and additional functions downloaded to it. There are data lock features; if the card is tampered with, the data will be erased. Additional security such as biometric markers can be added to further restrict access.
The current generation of Smart Card has a memory capacity of 64 kilobytes or 30-60 pages of text.
Mr. Maloney is Director of Emerging Technologies for the VHA. He said he wanted to emphasize the following points:
The "players" in the information system are the patient, provider, medical system, and network. Mr. Maloney noted that the Smart Card is coming into use, and he showed a prototype, Smart Trip, that is now available for use on rapid transit. What is most needed is a better way of identifying and authenticating where transactions come from.
He then discussed PKI systems, noting that they will play a big part in future systems. Two keys or cards are required, those of the patient and the doctor, to access data on the card or the network. The public key is associated with a trusted certification authority. He described how the two work together. The entire system allows open communications and also private and secure communications.
A recent development with Smart Cards is that the French government distributed 42 million family insurance cards ("Vitale") starting in May 1998, doing 5 million cards a month. This is a good example of administrative simplification. They also have issued 50,000 provider cards ("CPS") with PKI keys, mostly to physicians, so they can digitally sign billing documents. They have instituted a health care network to carry the transactions. Another project ("CARDLINK") has been going on in nine countries and nine languages involving 100,000 cards, funded by the European Union. The Germans distributed 80 million Memory Cards in 1994-5 -- less powerful but able to store information digitally. The U.S., a member of the G8 Healthcare Data Card Project, is trying to work out an international agreement on a standard emergency card, and also an international professional card. A NetLink project is just beginning, involving four countries.
The VA upgraded from a dumb card to a smarter one in 1997, and it has been well accepted. It is preparing a small-scale test in the home health care environment. Both Microsoft and IBM are developing support for Smart Cards. The VA is piloting secure access from the Internet, working on a PKI pilot, and has about 50,000 cards in an electronic purse test. It is trying to build a larger initiative with the Department of Defense.
Dr. Kingsland is the NLM's Assistant Director for Applied Informatics and its liaison for Smart Card projects. He described two pilot projects in the U.S.: the Health Passport Project of the Western Governors' Association, and the Secure Collaboration Technology for Rural Clinical Telemedicine, by West Virginia University.
The first is the largest health care demonstration in the U.S. for Smart Cards, involving 25,000 cards in three communities in North Dakota, Wyoming, and Nevada. It enables people to give up-to-date information to physicians, nurses, nutritionists, and early childhood educators. Several state and federal programs are involved in the project (e.g., Medicaid, CDC immunization, WIC, and Head Start), along with private partners including health care providers, clinician groups, and grocery stores. Public kiosks have been put in places like Wal-Mart so that people can check and print out information stored on the card. The project goals are reducing health care costs, improving quality of care, empowering clients, and increasing consumer satisfaction with public health services. The rollout was in June 1999. The project is being rigorously evaluated by an independent entity.
The second project's goal is producing secure collaboration technology for rural clinical telemedicine. The Smart Card is used for identification, authentication and data storage. The partners include a community ambulatory healthcare network and two hospitals. The project's operating hypothesis is that telemedicine can have an especially large impact in rural areas. The project will facilitate information flow between providers. Two types of cards are used, a PIN- protected patient card and a provider card.
The WVU group is testing three application scenarios: providing intensivists with secure remote access to patient data; improving delivery of healthcare through midlevel practitioners; and facilitating secure telemedicine access by county nurses providing home care to a group of diabetes patients. The project is just getting underway.
Mr. Schwartz is a policy analyst who works on privacy issues. He began his remarks by observing that while Smart Cards can enable users to have more control over their data, that is not necessarily the case; they also could be designed to give users less control. His presentation focused on the pitfalls as well as the advantages of this technology. He agreed with Mr. Maloney that the use of Smart Cards for identifying people is the one most needed in the network world.
One pitfall to be concerned about relates to the fact that the Card centralizes all information on a person in a single place. While information on the Smart Card can be protected, this will not happen unless the decision is made to do so. He described a "paranoid" scenario in which a person would be denied health care because of unpaid parking tickets. Also, the disadvantage of having a single key that opens all doors (speaking metaphorically) is the need to change all the locks if that key is lost or corrupted. For that reason, most Smart Card advocates favor using different keys for different purposes.
Mr. Schwartz raised a series of questions for implementers:
Questions for policy makers concern information handling practices and warehousing for third parties, among other things. Also, what happens to data in the event of a merger? What are the internal practices for usage of the card?
In response to a question, Dr. Experton said the French are using a dedicated network, not the Internet. Asked about the cost of a card for the VA, Mr. Maloney said it is about $4-5 per card. Dr. Experton said that a survey of American public showed that about 75 percent welcome Smart Cards and are willing to spend up to $50 per year to realize the benefits from them, particularly related to health care data access. She pointed out that investment in the cards yields a return.
Dr. Broome conveyed greetings and appreciation from the new Director of CDC, Jeff Koplan. She explained that starting July 1, she would be the Senior Advisor to the CDC Director for health information systems, reflecting a management commitment to accelerated movement toward integrated health information systems at CDC. She focused her comments on an overview of the CDC mission from the perspective of statistics and health information.
In addition to infectious disease control, the responsibilities of the Centers for Disease Control and Prevention include preventing chronic diseases, promoting healthy behaviors, and preventing environmental exposures and injuries. Approaches to these areas include basic research, surveillance, and health program implementation in conjunction with state and local partners.
Data systems are essential for carrying out and evaluating each of these activities. NCHS and its surveys and statistics are a centerpiece of CDC's work. Other pieces are surveillance systems and the program management databases used to assess programs, plus secondary sources such as hospital discharge data bases. CDC works closely with the federal agencies responsible for criminal justice and transportation.
CDC regards the work by NCVHS and the Department on implementing HIPAA as a major step forward in its ability to work with its data sources. It has committed large numbers of people to work with HCFA on implementation standards. It is also very engaged in privacy/confidentiality issues. A special concern in these areas is to see that public health uses are considered. CDC is also interested in the emerging work on computerized patient records.
CDC has new resources to motivate change in the system, primarily through funding for building preparedness against a bioterrorist episode. It is developing a capability for two-way communication with local and state partners, and also designing the next generation of its surveillance systems. While preparedness for a bioterrorist episode is a core functionality, the same systems are usable for handling emerging infectious diseases. The new Director has made a commitment that over time, CDC will migrate its legacy systems to use the multi-functional system architecture. The Center is developing data definitions and standards for this system, consistent with those developed by the SDOs. It anticipates adequate funding in the 2000 and 2001 budgets to continue enhancements in the public health data infrastructure.
Dr. McDonald praised CDC for being forward-thinking and effective in its approach to standardization and data gathering. Dr. Broome described the electronic laboratory reporting system with which he has been helping CDC.
Asked about the extent to which CDC's data sources contain information on race/ethnicity, she said they are a core part of the public health data sets although they are not as complete in some of the legacy systems. CDC is very interested in the potential for gathering this information from enrollment and encounter forms, because it is dependent on health care system records for that information. The Center also is working on creative applications of geocoding.
The question of using de-identified data was raised. Dr. Lumpkin observed that while individual identification may not be needed for most CDC research, it is needed for surveillance work. He concluded the session by thanking Dr. Broome and hailing CDC's "thrilling" progress on its information systems.
Ms. Frawley reported that the Subcommittee met earlier this day and reviewed the report on Medicaid Managed Care, in particular the appendix on contract specifications. Members agreed that the report needs to more fully address privacy and confidentiality concerns. A letter will be sent to Dr. Iezzoni suggesting general principles that could be included in the report, along with specific points related to issues Mr. Gellman raised in his letter. Concerns about aspects of the contract language will be raised as well. The Subcommittee also recommends further attention to HIPAA and administrative simplification.
Having completed all of the items in its current work plan, the Subcommittee is now considering a project on Smart Cards. It also will be available to HHS staff on forthcoming privacy recommendations and regulations. Other projects include looking at the use of the Internet for health data and surveying what various agencies are doing about privacy issues. The new work plan will be presented for approval at the September NCVHS meeting. Dr. Lumpkin suggested a session or project on privacy-enhancing technology, with the aim of briefing the entire Committee on this area.
Dr. Cohn said the majority of the Subcommittee's recent work has been in the CPR area. Working toward making recommendations to the Secretary by August 2000, it plans to have draft recommendations for the Committee to review in March. It will hold hearings September 16-17, and plans to have an interim report for the Secretary in September and a briefing for the Committee to discuss in November.
Dr. Cohn noted the potential synergy between the aforementioned project and the Population Subcommittee's work on functional status.
Dr. Fitzmaurice invited members to contact him or one of the co-Chairs with any suggested questions for users of patient medical records standards.
The Subcommittee on Standards and Security is revising its work plan, having completed the items on the current one. It plans to survey preimplementation status in order to then monitor implementation of administrative simplification. This will be a major project in 2000.
Dr. Starfield asked whether the Subcommittee might address the issue of recommending an implementation standard for the transmission of race/ethnicity data. Dr. Cohn suggested that the Executive Subcommittee decide how to proceed on this matter first.
Dr. Friedman predicted that those seeking answers in this area will "roll into the next millennium still visioning." He reported that the first drafts of five commissioned papers are due in early September. Three discussion groups have been held, involving a wide range of perspectives. Reports on those sessions are being prepared. The workshop sponsored by the Committee on National Statistics is scheduled for early November, and work is underway on the agenda. A plan is being developed for formally incorporating professional and public input into the process. A session at a recent National Association of Public Health Statistics and Information Systems meeting was very successful; similar events are planned for other settings, to elicit input from local government, consumers and providers outside Washington, D.C. and state capitals. The public process will include hearings under the auspices of the National Committee.
Three products are tentatively planned: a vision document, a "road map," and an edited collection of papers. How all this will fit in with the NHII discussions still needs to be worked out. One thing to be resolved is definitional issues, e.g., "health statistics" and "surveillance," both of which are becoming obsolescent terms that confuse more than they illuminate.
Ms. Greenberg stressed that the full Committee is invited to the CNStat workshop on November 4-5.
Dr. Lumpkin commented that the NHII activities bring together the Committee's work on standards, populations, and privacy/confidentiality by putting a framework around all of it. The Work Group is developing a multidimensional model that will help it decide how to move forward. It plans to bring in people to advise it on this. The goal by June 2000 is a document describing the process and the ultimate goal; then others will be brought in to help achieve the goal.
Ms. Greenberg noted that the June 20-21 50th anniversary symposium is the target date for making public the thinking to date on the NHII and the 21st century vision.
The Committee met with Debbie Maiese and Linda Bailey of ODPHP. Ms. Maiese reported that a draft of the Healthy People 2010 objectives was published for public comment in the Fall of 1998, generating comments from every state in the U.S. and Puerto Rico. The comments are on the Web [http://web.health.gov/healthypeople] and are word-searchable. One result of the comments was a decision to add a chapter on chronic kidney disease. New vision and hearing impairment objectives have been added, mostly developmental ones because of the absence of baseline data.
In all, the last draft contained 531 objectives, 43 percent of which are developmental. The Secretary's Council is still struggling with the feasibility of committing the resources to developing that many additional measures. The lead agencies are reviewing the state of the data for their chapters and looking at potential sources, sensitive to the limits on expanding surveys. This represents a significant data development agenda still to be worked out in the Department.
One decision has been to include in tables the specific reason for the unavailability of data elements (not collected, not analyzed, or too small to report). The new OMB categories for race and ethnicity will be used, along with measures of socioeconomic status (income and education gradients).
The launch is planned for January 25, 2000 with an event for which people are encouraged to propose breakout sessions, caucuses, or poster sessions. Eliminating health disparities, partnerships for health improvement and the use of technology will be the conference themes.
This summer, the Public Health Foundation is releasing a Healthy People 2010 Toolkit, developed under contract to ODPHP. It will assist with state adaptation and adoption of the national objectives.
Ms. Bailey reported on progress toward leading health indicators, designed particularly for those constituents who want to be able to work with a smaller number of representative objectives. This began as a project of an internal HHS work group, which contracted with the Institute of Medicine, which has delivered three reports (the final of which is on the Web). The IOM identified three possible models--health determinants and outcomes, prevention, and life stages, the first of which resonated best with the Department. One goal has been to make sure that each of the 28 Healthy People chapters is reflected in at least one of the leading health indicators.
Twelve indicator topics were recommended to the Secretary's Council in April; the goal is to reduce the final number to ten. The 12 measures have been tested on several focus groups with diverse compositions. Another project has been data consultations to try and determine what proportion of premature mortality and disability can be addressed through these measures.
The leading indicators will be published in January 2000 along with the 2010 objectives.
Dr. Friedman commented on the merits of having indicators that are scalable to the local level, as is the case with the Consensus Health Indicators for the Year 2000. He asked what would happen to those. Ms. Bailey said ODPHP is working with NCHS on that. Some will continue, and there is considerable overlap in some areas. Ms. Maiese agreed that a cross-walk of some sort is desirable. The intention is to have the leading health indicators measurable at a minimum at the state level. Dr. Friedman said that what is most useful is measures that are scalable up from the city or county. Ms. Maiese said she hoped ODPHP could learn from states about this process and what works for localities.
To another question, she said measures had been developed for all but eight of the 91 developmental objectives for the year 2000. She encourages state and local people to develop new data sources for their objectives.
Dr. Lumpkin noted that there is a natural tie-in with the Turning Point activities of states, 27 of which are doing planning involving performance measurement, with implementation for some slated to begin in December 1999. He then adjourned the meeting.
I hereby certify that, to the best of my knowledge, the foregoing summary of minutes is accurate and complete.
/s/ John R. Lumpkin, M.D. 11/22/99