Washington, D.C.
The National Committee on Vital and Health Statistics was convened on November 19-20, 2002 at the Hubert H. Humphrey Building in Washington, D.C. The meeting was open to the public. Present:
Acting Chair Simon Cohn welcomed six new members and introduced the four who were present. He also acknowledged the impending retirement of four members and the resignation of one. (See Committee roster for all designations.)
Mr. Scanlon reported on positive developments at HHS in response to the Committee’s recommendations on the NHII, clinical data standards, and the HHS Strategic Plan. He offered to brief the Committee on the Department’s information quality guidelines at a future meeting, and also on the new Web-based gateway to HHS statistics.
CMS received about a half-million requests for a one-year extension of the transaction rule under ASCA. The Secretary has assigned responsibility to CMS for enforcing the administrative simplification provisions. Because CMS is also a covered entity, a separate office, the Office of HIPAA Standards, will be established for this purpose, directed by Jared Adair, with Ms. Trudel as her Deputy. It will coordinate outreach on HIPAA with the Office for Civil Rights.
Mr. Campanelli thanked the Committee for its letter on outreach, which OCR has reviewed and which the Privacy Council will discuss with Mr. Rothstein at a November 20 meeting. The Guidance is expected imminently. He described OCR outreach and capacity-development activities. Committee members expressed appreciation for OCR’s hard work despite limited resources.
On behalf of the Privacy Subcommittee, Dr. Harding read a draft letter to OCR and several categories of recommendations for outreach and public education regarding the privacy rule. Members offered comments and suggested edits, which were incorporated into a revised draft that was presented for action on day two of this meeting. After a few additional minor edits, the letter and recommendations were approved by unanimous vote.
CODE SETS: BACKGROUND INFORMATION AND DRAFT RECOMMENDATIONS
The Committee was briefed on the issues concerning the proposed transition from ICD-9-CM¾from volumes 1 and 2 (on diagnoses) to ICD-10-CM and from volume 3 (on procedures) to ICD-10-PCS. The Committee had been supplied with extensive background documents in advance of the meeting. This proposed transition has been contentious, especially regarding procedure codes. Donna Pickett of NCHS reviewed a report and timeline summarizing the major events and issues related to these code sets. She explained the reasons for the development of ICD-10-CM and ICD-10-PCS and their relation to past recommendations from NCVHS and other bodies. Dr. Cohn reviewed the diagnostic coding issues of particular concern to the Subcommittee on Standards and Security. He described the testimony and the Subcommittee’s subsequent discussions and failure to reach consensus. He said the Subcommittee came away feeling the need for a cost-benefit study as well as consideration of whether the Committee should be doing anything else while awaiting the findings of such a study. The salient question regarding diagnostic coding, he said, may be how to move to ICD-10-CM in a way that is “minimally disruptive to the industry.” Dr. McDonald then offered comments on procedure coding, including the results of testing. He observed that it might be advisable to look into other countries’ procedure classification systems.
In the discussion session, Dr. Starfield argued for waiting for a procedure coding system that is internationally compatible. Ms. Greenberg said this will not happen any time soon, and what is needed is the ability to map to a single set of sentinel procedures. Dr. Tom Gustafson, Director of the CMS Hospital and Ambulatory Policy Group, said that as a payor, the agency feels constrained by ICD-9-CM and feels a replacement is inevitable. Another line of discussion concerned the possibility of holding out for a single procedure coding system. Because neither 10-PCS nor CPT is workable for this purpose, and because GAO has given the go-ahead to use dual systems under HIPAA, no one insisted on this course of action.
Ms. Coltin then articulated the questions before the Committee: The Subcommittee on Standards and Security wants to contract for a cost-benefit study to inform its recommendations on these issues. The question is how to frame the study. One option is to limit it to looking at the costs and benefits of transition to systems that are ready to go, i.e., ICD-10-CM and ICD-10-PCS. This led to discussion of how the study should be framed and what it should cover. The Committee referred to the Subcommittee on Standards and Security the task of defining the scope of the study to be conducted.
Ms. Greenberg and Mr. Scanlon read and presented certificates of appreciation from Secretary Thompson to retiring long-term members Kathryn Coltin, Daniel Friedman, Paul Newacheck, and Barbara Starfield. Ms. Greenberg expressed appreciation for the many valuable contributions of each one.
MINORITY HEALTH STATISTICS/DATA AND HEALTH DISPARITIES DATA
Dr. John Ruffin, Director, National Center on Minority Health and Health Disparities
Dr. Ruffin described the purpose and activities of the NIH Office of Research on Minority Health, created in 1990, and the NIH National Center on Minority Health and Health Disparities, created in 2001. The main objective of the first Office was to convince people at NIH and in the nation “that health disparity is real,” with the related objective of calling attention to the paucity of minorities participating in solutions. It used a distinguished 54-member Fact-Finding Team and three regional meetings to identify needs. The regional meetings posed the question, “What is it at NIH as it relates to health disparity that we should be doing but we’re not doing?” The findings led to a report and recommendations. Now that the Office has become the National Center on Minority Health and Health Disparities, it is authorized to award grants and has a broader base. Dr. Ruffin described a number of its activities, including loan repayment programs to build the workforce working on health disparity, an endowment program to strengthen research institutions, and the establishment of Health Disparities Centers of Excellence around the U.S.
In the discussion period, members were interested in the advisory committee’s discussions, the Center’s training activities, and future communications between NCVHS and the Center. Dr. Ruffin welcomed the suggestion of a collaboration between the Subcommittee on Populations and the Center’s advisory committee, and/or an exchange of presentations.
Dr. Nathan Stinson, Deputy Assistant Secretary for Minority Health
Director, Office of Minority Health, DHHS
Dr. Stinson said the OMH has always stressed the need for pertinent information in order to plan and evaluate efforts to eliminate health disparities. Eliminating health disparities is an HHS priority, and the Deputy Secretary looks to the OMH to play a prominent role in this effort. The OMH moves “in lock step” with the Data Council in terms of its recommendations in this area, and it funnels its recommendations and ideas through the Data Council.
In the discussion period, Dr. Mays talked with Dr. Stinson about the impending NCVHS recommendations on race/ethnicity data. Mr. Scanlon stressed that the Department is of one mind about the goals for race and ethnicity data; the limiting factor tends to be resources. Mr. Stinson observed that the country cannot know if it is wasting resources or using them effectively without better and more targeted information.
POPULATION HEALTH
Dr. Barbara Starfield
Dr. Starfield said that in framing a description of population health she seeks to dispel the misconception that population health is merely the sum of individual health. She reviewed the ways population health is currently measured, noting that none of the existing methods adequately represents population health. After describing the continuum from interest in the individual to interest in the population that characterizes different branches of the health field, she said the public health perspective shifts the attention from illness and risk to understanding the influences on health and the clustering of ill health. She reviewed a diagram of the multiple influences on health and noted that in the population health perspective, there is interest not only in the average health level of individuals, but also in equity, the distribution of health across the population.
Dr. Starfield stressed that disease is not randomly distributed in the population, and some sub-populations are more vulnerable to diseases and to multiple diseases. She then commented on the implications of this variability for health statistics. She noted the need to determine new ways to characterize health that are not based on mortality and that take into account the context of health, co-morbidity, disparities (equity), and the need to bridge clinical medicine and public health. After mentioning the limitations of an emphasis on morbidity and the use of DALYs, she offered a third option, profiles of health derived from combinations of separate domains. She described an analysis of self-reported children’s health data, which uses this approach to characterize children’s health. The exercise demonstrates that it is possible to do this form of analysis; the question is whether it is worth working toward expanding this for the rest of the population and other age groups. Dr. Starfield then briefly commented on social and political context, co-morbidity, and understanding disparities, stressing that there are lots of data sets with information on social and political context and that to understand disparities, it is essential to do stratified analysis (separate analyses) rather than statistical adjustment. In conclusion, she reiterated that population health is not the sum of individual measures of health, for two reasons: the latter do not represent health, and health and the influences on health are not distributed randomly across the population.
CALL TO ORDER, WELCOME, INTRODUCTIONS, REVIEW OF AGENDA
In Dr. Lumpkin’s absence, Dr. Cohn called the meeting to order. He welcomed six new members and introduced the four who were present. He also acknowledged the impending retirement of four members (to be honored later in the meeting) and the resignation of member Brady Augustine to take a position at CMS. After all present introduced themselves and he reviewed the agenda, Dr. Cohn said that as a member of the CPT Editorial Panel, he would recuse himself from discussions of CPT and procedure codes. Later in the meeting, Dr. Huff said he, too, would recuse himself from this discussion because of a potential conflict of interest.
The Department is still operating on Continuing Resolutions, so agencies are continuing to work within the levels of last year’s budgets. There have been positive developments on the NHII, the PMRI and clinical data standards, and the Department has begun to implement “at least the spirit of the NCVHS recommendations.” Dr. Bill Yasnoff was appointed as Senior Advisor for NHII initiatives in ASPE. This office will provide a departmental coordinating point for NHII activities. The Department may sponsor a national meeting on the NHII in June. It is updating an inventory on its activities in this sphere and is also developing an interactive Web site in this area.
The CHI Working Group has been evaluating NCVHS recommendations on the first suite of message format standards. They are now making recommendations to the HHS Data Council and the CIO Council, which should result in agreement on a set of standards that HHS would adopt for interoperability of clinical data.
In other areas, HHS is revising its strategic plan based on NCVHS comments. It is completing its guidelines on assuring the quality of information it disseminates to the public, and also monitoring public requests for corrections (none of which have been received so far). Mr. Scanlon offered to brief the Committee on the guidelines at a future meeting, and also on the new Web-based gateway to HHS statistics. The National Academy of Sciences study of the adequacy of race/ethnicity data is well underway and the Committee has good liaison with it through Dr. Lumpkin’s membership on the panel and Dr. Mays’ participation. Finally, the Department is updating its meta-directory of HHS data and statistical resources.
The deadline for requesting a one-year extension of the transaction rule under ASCA was October 15, and CMS received about a half-million requests, 90% via its Web site. Once the paper requests are keyed in, it will run reports for the Committee to review. CMS met its goal of doing outreach sessions on HIPAA in every state in 2002. It has a consolidated outreach plan for 2003, conveying information on how CMS will help people achieve HIPAA compliance by the end of the year. It will coordinate outreach with the Office for Civil Rights. Final rules on modifications to the transactions and on security are still targeted for publication in December, and the final rule on the provider identifier and Notices of Proposed Rulemaking on plan identifiers and attachments are still in review.
The Secretary has assigned responsibility to CMS for enforcing the administrative simplification provisions. Because CMS is also a covered entity, a separate office, the Office of HIPAA Standards, will be established for this purpose, directed by Jared Adair, with Ms. Trudel as her Deputy. The plan is for the enforcement process to be complaint-driven. Discussions are ongoing in the Department about an enforcement regulation.
Asked what the denominator might be for the number of requests for extension, Ms. Trudel said they think they heard from a large percentage of covered entities. Asked if CMS can provide national leadership despite its “conflict of interest,” she asserted that the Center’s familiarity with running a health insurance plan is a benefit to the field at large, not a detriment.
Mr. Campanelli thanked the Committee for its letter on outreach, which OCR has reviewed and which the Privacy Council will discuss with Mr. Rothstein at a November 20 meeting. The Guidance is expected in “a matter of days,” providing technical assistance and replacing (and expanding) a prior document posted on the Web. OCR is also developing targeted technical assistance and is pursuing a contract for that purpose. An integrated copy of the privacy regulations, incorporating the modifications, has been posted on the Web site, along with a set of FAQs that will be updated as OCR becomes aware of new topics of concern.
An effort is underway to build OCR’s capacity to do outreach by training staff, including comprehensive training in the other five regions. Questions are now being referred to the regions. Regarding the new collaborations with CMS, mentioned by Ms. Trudel, he noted that the privacy rule has provided a new opportunity for many elements of the Department to work together. CMS has useful privacy guidance materials on its Web site, including a covered entity chart. OCR is also trying to leverage its “sister agencies.” AHRQ, NIH, CDC, FDA, SAMHSA, and HRSA are all producing materials for their Web sites, in addition to OCR and CMS. In late January or February 2003 the Secretary and Regional Directors are collaborating with universities to provide conferences on privacy, staffed by OCR.
Dr. Cohn and Dr. Harding expressed appreciation for OCR’s hard work despite limited resources. Dr. Danaher suggested that April 14, 2003 be reframed as the start-date or launching date for laying a foundation for privacy, rather than as “the drop-dead date.” Mr. Campanelli said OCR is trying to emphasize that point and the fact that OCR’s philosophy is to promote voluntary compliance.
On behalf of the Privacy Subcommittee, Dr. Harding read a draft letter to OCR and several categories of recommendations for outreach and public education on the privacy rule. The letter and recommendations are an action item for November 20. The Committee offered suggestions on structure, formatting, and content, for consideration by the Subcommittee in revising the letter and recommendations before they are presented to the Committee for action.
Mr. Blair raised a substantive issue about what should be said about the relationship between the new HIPAA Office and the proposed HHS office to coordinate the NHII, given that the latter includes HIPAA standards. Ms. Greenberg observed that the recently appointed Senior Advisor on the NHII should not be burdened with HIPAA issues, and that what the Committee is trying to convey is the need for oversight and policy guidance for both arenas. Members agreed on making explicit the relevance of the NHII but also on keeping HIPAA and NHII operations and oversight separate for the time being.
Dr. Shortliffe stimulated considerable discussion by asking what the Committee might recommend that could dissuade entities from defensive practices such as returning to or staying with paper records to avoid being covered entities. Dr. Lengerich raised a related concern about negative health outcomes resulting from defensive practices related to the privacy rule. Dr. Harding said the Subcommittee is concerned about blowing anecdotal testimony out of proportion. Mr. Localio urged that the Department undertake a formal assessment of the impact of the privacy rules, so that policy is not made on the basis of anecdotes. Further discussion of these issues was deferred to the Subcommittee meeting. The group agreed to add a point about the importance of marshalling the necessary resources for the impact assessment.
The Subcommittee was commended for its productivity in recent months.
Dr. Cohn said this session is primarily designed to bring new members up to speed on “a relatively contentious issue.” Ms. Coltin, who chaired this portion of the meeting, reminded the group that the Committee had decided at its last meeting that it needed a briefing on the issues concerning the proposed transition from ICD-9-CM¾from volumes 1 and 2 (on diagnoses) to ICD-10-CM and from vol. 3 (on procedures) to ICD-10-PCS. The Subcommittee has not been able to reach consensus on procedure codes. The Committee was supplied with extensive background documents in advance of this meeting. (Several of the documents are posted on the NCVHS web site.)
Ms. Pickett reviewed a report and timeline summarizing the major events and issues related to these code sets. ICD-9-CM (the clinical modification) was implemented in the U.S. in 1979 and has been used in the DRG system since 1983. It has been updated annually to capture information on new and emerging diseases and technologies and procedures, but the innovations have outstripped the code set’s capacity to meaningfully accommodate them. NCVHS reported in 1990 that the quality of the ICD was in danger of being compromised.
Responding to a 1993 NCVHS recommendation, NCHS undertook an evaluation of ICD-10 for morbidity purposes. Work on a clinical modification took place in the mid-1990s, and a technical advisory panel recommended that NCHS proceed with implementation of ICD-10-CM. The U.S. implemented ICD-10 for mortality coding in 1999, but decisions about moving to new code sets for morbidity and related reimbursement applications were deferred because of the HIPAA standards implementation and, later, Y2K concerns. The Subcommittee on Standards and Security held hearings on ICD-10-CM in May, 2002. Testimonies are posted on the NCVHS Web site.
As noted, Vol. 3 of ICD-9-CM deals with inpatient procedures. HCFA (now CMS) began developing a replacement in 1990 to address the limitations of vol. 3. A 1995 contract led to the development of ICD-10-PCS. It is not based on an international classification because currently WHO does not have one. It was developed in consultation with a technical advisory panel and 30 specialty groups. Meanwhile, the American Medical Association developed and maintains the Current Procedural Terminology (CPT-4), used for procedures by physicians and (to a lesser extent) other health professionals. NCVHS and other bodies have concluded that there are structural problems with both CPT and ICD-9-CM, vol. 3. Since 1986, NCVHS has emphasized the need for a single procedure code set, across settings and applications, most recently in a 1993 report. However, the GAO in August 2002 issued a report stating that dual code sets for reporting medical procedures are acceptable under HIPAA. The ICD-9-CM Coordination and Maintenance Committee held a hearing in May 2001 at which the AMA was the only one of 11 organizations not to support moving forward with a process leading to implementation of ICD-10-PCS.
Dr. Cohn reviewed the testimony heard by the Subcommittee and its subsequent discussions and failure to reach consensus. He said the Subcommittee came away feeling the need for a cost-benefit study as well as consideration of whether the Committee should be doing anything else while awaiting the findings of such a study. He speculated that the contention around this issue is a function of the cost of the transition. While there is “fairly good consensus that ICD-9-CM is pretty broken,” views differ as to the urgency of moving forward.
He then reviewed a series of questions outlined in a background document prepared for the Committee, concerning testing, the merits of the additional detail in the new version, and the reasons against remaining with ICD-9-CM vols. 1 & 2. On the latter, he reiterated that ICD-9-CM is 25 years old and does not adequately incorporate new medical knowledge. The salient question may be how to move to ICD-10-CM in a way that is “minimally disruptive to the industry.”
Dr. McDonald noted that ICD-10-CM is an expanded version of ICD-10, and he expressed concern that more codes could lead to more mistakes and possibly more opportunities for the appearance of fraud. Ms. Pickett countered that the new codes were requested by medical specialists; Ms. Berek said more information can actually obviate the need for requests for records and the possibility of “false positives”; and Ms. Brooks stressed that coding systems should not be judged on the basis of size when the chief goal is better data.
It was noted that the classification is used not only for reimbursement, but also for quality assessment, research, and other purposes, and some coding structures work better than others for those purposes. Ms. Coltin added the codes are also used in the outpatient setting, where greater specificity is needed.
Dr. McDonald noted that the AHA, among others, would like to see ICD-10-PCS installed as quickly as possible. He explained that ICD-9-CM, vol. 3 is used only in hospitals and for medical procedures while ICD-10-PCS is broader in scope. He noted that the findings of the pilot project were used to revise PCS, and then two groups of coders evaluated the coding time for the old and new code sets. One said there was no significant difference, while the other predicted that people would have difficulty learning the new system. In the Subcommittee’s hearings, those opposed to the transition were primarily insurance carriers concerned about costs. The Subcommittee also was concerned that further study is needed on the efficacy of the new system before it could confidently recommend a transition. Conceptually, Dr. McDonald said, PCS has a sensible structure. He then reviewed the questions and comments in the Committee’s background materials, covering such questions as testing, the need for the greater specificity, the arguments for and against the transition, and whether there should be a single procedure coding system.
Dr. McDonald noted that other countries have developed procedure classification systems that the Committee should hear about. Ms. Greenberg said they have not been systematically looked at by the Committee, something that would be advisable if the idea of a single procedure classification system is going to be pursued.
Responding to a question from Dr. Fitzmaurice, Mr. Beebee from AMA and Ms. Leon-Chisen from AHA said that CPT does not specify who does the procedure, but there are differences in how the codes are applied depending on who performs it.
Dr. Starfield pointed out that the U.S. has high health care costs because it does so many procedures, and to understand that, it is necessary to have coding that is comparable with that of other countries. She argued for waiting for something that is internationally compatible. Ms. Greenberg said this will not happen soon. Australia’s Interventions Classification has been adapted for international use, but countries with their own code sets are unlikely to adopt this. What is needed, she said, is the ability to map to a single set of sentinel procedures, and this is the direction the international community is headed.
Mr. Blair asked about trends toward computerized coding and what impact that would have. Ms. Brooks affirmed that there is a trend toward computerization, with more than half of current coding done that way. Ms. Prophet-Bowman added, however, that auto-coding is still a long way off, and Ms. Leon-Chisen said many small entities will continue to use paper systems.
At Ms. Greenberg’s invitation, Dr. Tom Gustafson, Director of the CMS Hospital and Ambulatory Policy Group, said that as a payor, the agency feels constrained by ICD-9-CM and feels a replacement is inevitable, though it is appropriate to “argue about the timing” of the transition. He expects that CMS will recommend to the Secretary a move to ICD-10 with reasonable flexibility and speed. It is watching NCVHS deliberations “with great care.” Asked to comment on whether CPT could be used in the inpatient environment in place of vol. 3 of ICD-9-CM, he said those who have studied this, including NCVHS, have concluded that CPT, which is designed for use in paying physicians but not facilities, does not work well for other purposes. Among other things, it fails to address procedures that are important to hospitals and to give a complete picture of care. CPT would have to be significantly adapted to fit in a hospital setting, which would take considerable time; it is not ready as a candidate to replace ICD-9-CM, vol. 3. Similarly, ICD-10-PCS is not ready to move into a physician environment, so CMS is recommending that PCS be used to replace ICD-9-CM, vol. 3, and CPT-4 continue to be used for its current purposes.
Asked to comment on why CMS feels so much more urgency about the transition than the largest private health insurers, Dr. Gustafson speculated that the private companies are concerned about the cost of the transition, which is admittedly significant. CMS recognizes the costs but believes it must accommodate innovations in health care in ways that ICD-9-CM does not permit.
Ms. Coltin then articulated the questions before the Committee. The Subcommittee on Standards and Security would like to contract for a cost-benefit study to inform its recommendations on these issues. The question is how to frame the study. One option is to limit it to looking at the costs and benefits of transition to systems that are already ready to go, i.e., ICD-10-CM and ICD-10-PCS.
Dr. Starfield asserted that it’s a waste of time to invest in a system that is not internationally compatible. Ms. Berek stressed that the current system is broken and “we need to get moving”; failing to do so increases the possibility of error and makes research difficult.
From the audience, Carol Bickford of the American Nurses Association urged the Committee to include in its study these criteria: the new system’s ability to account for the role of non-physician providers, to support an evolving health care system, and to look at outcomes.
Dr. Newacheck cautioned the Committee to be careful about who does the analysis and how much leeway they are given, because the results of cost-benefit analyses depend on the assumptions made and the perspective taken.
Ms. Coltin noted that one variable is whether the transition to the replacements for vols. 1&2 and for vol.3 (whatever they are) happen simultaneously or separately. In addition, the study must determine not just the costs and benefits but who would incur the costs and accrue the benefits.
Noting the broad range of factors raised in this discussion, Dr. Sondik suggested that the terminology of “cost-benefit study” focuses the study too narrowly. He proposed “analytic study” or “decision analytic study.” He added that the change in coding systems will have an effect on the entire health care system, and this needs to be analyzed, as well.
Dr. McDonald observed that someone should also “explain all these undercurrents” ¾loyalties and interests that are not made explicit but influence the debate. “No one wants their team to lose, [and] we get caught in the middle of that.”
Returning to Dr. Sondik’s point, Ms. Greenberg said “impact analysis” is another term that has been used, and if/when an NPRM is developed, it will have to include an impact analysis. While acknowledging that the U.S. has a unique health care system, she noted that other G-8 countries transitioned to ICD-10-CM for diagnosis without any cost-benefit analysis, simply because they recognized that the old classification no longer worked and they had to change.
Regarding the proposed analysis, she said two different studies were being discussed. One is a cost-benefit impact analysis of a transition from 9-CM to 10-CM and from 9-CM vol. 3 to 10-PCS. Alternatively, if the NPRM lays out alternatives for replacing 9-CM vol. 3, then the impact analysis would look at all the alternatives. The other study that might be needed is a separate study on moving to a single procedure classification encompassing both 10-PCS and CPT. This study might also look at what it would take to make U.S. procedure coding internationally compatible. It is better to view these as two separate studies than to push them into a single study. She added that while she is very sympathetic to the notion of a single procedure classification system, attempting this would delay the process “perhaps indefinitely.”
The Committee referred to the Subcommittee on Standards and Security the task of defining the scope of the study to be conducted.
Ms. Greenberg and Mr. Scanlon read and presented certificates of appreciation from Secretary Thompson to retiring long-term members Kathryn Coltin, Daniel Friedman, Paul Newacheck, and Barbara Starfield. Ms. Greenberg expressed appreciation for the many valuable contributions of each one.
The Committee then recessed into Subcommittee and Workgroup meetings, to reconvene the following day.
Following introductions and a review of the agenda, Dr. Cohn welcomed Dr. Ruffin, who began his presentation with some history. The Office of Research on Minority Health was created at NIH in 1990, and the NIH National Center on Minority Health and Health Disparities was created in 2001. The former was created in response to research and Healthy People initiatives, and located in the office of the NIH Director. Its main objective was to convince people at NIH and in the nation “that health disparity is real,” with the related objective of calling attention to the paucity of minorities participating in solutions.
The NIH Office was guided by the question, “What is it at NIH as it relates to health disparity that we should be doing but we’re not doing?” They held meetings around the country with a fact-finding team in 1990, asking that question. The breadth of this question meant that a very large fact-finding team (54 members) was needed. It included such notables as Donna Shalala and Ted Cooper as well as representatives of minority institutions and research institutions. After holding meetings in Arlington, VA; San Diego; and Atlanta, with the participation of some 2,000 people, the team then came up with a report and 13 recommendations on what NIH should be doing. (Copies were distributed to NCVHS members.) These recommendations were categorized in terms of which institutes and centers should carry them out, and delegated with accompanying funds to carry them out, in partnership with Dr. Ruffin’s Office.
Now that the Office has become the National Center on Minority Health and Health Disparities, it is authorized to award grants and has a broader base, encompassing all underserved populations including people in isolated geographic regions, minorities, among others. The law mandates it to set up loan repayment programs for use as a “carrot” in recruiting a workforce related to health disparities in particular areas, e.g., AIDS research. The program funded 45 individuals in 2001, its first year, and 153 in 2002. It focuses on all health professionals, not just MDs. Another mandate was to attract institutions into research. An endowment program is being used to strengthen the research infrastructure at institutions that participate in health disparity research.
The third and most significant mandate is the establishment of Health Disparities Centers of Excellence around the U.S. There are three categories: institutions that want to develop as Centers and receive planning grants (R24s); those that enter into Cooperative Agreements with NIH; and full-fledged, research-intensive Centers of Excellence. Minority institutions are affiliated with about two-thirds of the Centers of Excellence.
The NIH Center plans to issue an RFA that would allow agencies to apply for data centers that would be responsible for gathering information on the results coming out of the Centers of Excellence. It is also coordinating the development of a dimension of NIH’s five-year strategic plan that outlines partnerships with the Institutes to work on health disparities. As a result, the Center knows what each institute wants it to do and it can form partnerships to support projects¾e.g., the Jackson Heart Study, a joint project with NHLBI, and cancer research in partnership with Morehouse School of Medicine and other institutions. The next step will be to make the research findings known to people around the country.
Dr. Mays asked Dr. Ruffin about the Center’s advisory group’s discussion of quality issues in the collection of data for racial and ethnic minority groups. She also asked how his Center will coordinate disparity issues across all NIH Institutes. Dr. Ruffin said the Center has two advisory groups¾the advisory body mandated by Congress and a Trans-NIH Coordinating Committee. For the latter, a decision was made not to include representatives of all 27 institutes; instead, initially five or six people representing “the critical disease areas” will serve on the Committee. This may change over time. Regarding the first question, the Advisory Committee is just getting started but Dr. Mays’ topic will certainly be on its agenda.
Asked to discuss minority workforce development, he said that training is at the heart of this issue and many of the Fact Finding Team’s recommendations focused on it. The Center works with and transfers funds for life-sciences education to the National Science Foundation, which deals with K-12 education. One gap that was identified was the difficulty of transitioning from two-year schools to four-year schools, so the Center created the Bridging program to help promising students get into four-year programs. It is also building bridges to facilitate transitions from Masters to Ph.D. programs for students of historically black colleges and universities. Initiatives such as these are starting to build a significant workforce.
Dr. Mays asked how NCVHS can influence the direction of the Center’s activities and share its recommendations about data collection and the elimination of health disparities. Dr. Ruffin said the Center’s plan is outlined in the NIH strategic plan, and he encouraged the Committee to review it and offer input. He welcomed Ms. Greenberg’s suggestion of a collaboration between the Subcommittee on Populations and the Center’s advisory committee, and/or an exchange of presentations. Dr. Cohn thanked Dr. Ruffin and predicted an ongoing dialogue with the Center.
Dr. Stinson said the OMH has always stressed the need for pertinent information in order to plan and evaluate efforts to eliminate health disparities. Eliminating health disparities is an HHS priority, and the Deputy Secretary looks to the OMH to play a prominent role in this effort. An analysis found that the Department does its work through policy development, building the science base, linking people to services, and strategic communications. In each of these areas there is an opportunity to talk within the Department and with state and local officials and private entities about the importance of race and ethnicity data. One focus is disseminating and translating research results and best practices.
The OMH moves “in lock step” with the Data Council in terms of its recommendations in this area, and it funnels its recommendations and ideas through the Data Council. The OMH established an advisory committee two years ago that advises the entire Department on minority health. This group has not yet talked much about data collection. A future agenda will include an update on the status of recommendations to the Department regarding the collection of racial and ethnic data. In conclusion, Dr. Stinson reiterated that advocacy for the collection of racial and ethnic data is regarded as a prime directive of the OMH, carried out through work with Departmental agencies and state and local officials and private entities.
Dr. Mays noted that the Subcommittee on Populations is developing recommendations, and she asked how to ensure that they reach the OMH advisory group and his office and have the best chance of being implemented. Dr. Stinson stressed the importance of directing the recommendations to the Office of the Deputy Secretary as well as to his office, to build awareness of the recommendations. Mr. Scanlon suggested directing the NCVHS recommendations to the Secretary, with copies to the Data Council co-chairs and to Dr. Stinson. He added that the Department is of one mind about the goals for race and ethnicity data; “the limiting factor tends to be resources.” He briefly reviewed the Department’s strong policies regarding race and ethnicity data, noting that the weakest link is in surveys, because special targeted surveys to get adequate data on minorities are expensive.
Using the example of cancer, Dr. Stinson commented that some populations are disproportionately affected by specific diseases, and that intensive, targeted efforts are needed for those populations to reach Healthy People targets and effectively reduce health disparity. Furthermore, the country cannot know if it is wasting resources or using them effectively without better information.
Asked what issues have been prominent in advisory council discussions, Dr. Stinson identified diversification of the health professions, border health (the borders with Mexico and the Northwest as well as immigration from the Caribbean), and assessing whether the public health infrastructure is really being strengthened with respect to bioterrorism.
Dr. Starfield said that the effort to frame a description of population health is motivated by a desire to dispel the misconception that population health is merely the sum of individual health.
Population health is measured in a number of ways, but none of the existing methods adequately represents population health. The current measures include mortality rates, life expectancy, years of potential life lost, disease occurrence or severity, self-reported health, and DALYs (disability-adjusted life years, the measure recommended by WHO). She offered the following definition of health developed by WHO-Euro and incorporated into the 1986 Ottawa Declaration: “Health is the extent to which an individual or group is able, on the one hand, to realize aspirations and satisfy needs and, on the other hand, to cope with the interpersonal social, biological, and physical environments. It is a resource for everyday life, not the objective of living; it is a positive concept embracing social and personal resources as well as physical and psychological capacities.” This definition is gaining wide acceptance and contains elements that are measurable, unlike the 1948 WHO definition.
The distinction between the focus on individuals and populations or sub-populations is at the heart of the distinctions among the branches of medicine. They reflect the tension between the rights of the individual and the needs of the population. Health is just one area in which the failure to resolve this tension is manifested, especially in the U.S. Dr. Starfield outlined a continuum based on this distinction¾from clinical medicine, at the individual end, through clinical epidemiology and social and community medicine, to public health. Each branch addresses a different question: from “What diseases might this patient have?” in clinical medicine, to “What characteristics are most salient in improving overall health and the distribution of health in populations?” in public health.
The public health perspective shifts the attention from illness and risk to understanding influences on health and the clustering of ill health. Dr. Starfield reviewed a diagram of the multiple influences on health. In the population health perspective, there is interest not only in the average health level of individuals, but also in equity, the distribution of health across the population. This dimension has assumed prominence in the discussion of health disparities in the last five years.
She then introduced the genetics concepts of penetrance (causes without disease results), pleiotropism (one cause, many diseases), and etiologic heterogeneity (many causes, one disease) because of their general relevance to the influence on disease. These variables are explained because of the multiple influences on health and their interactions, which together potentiate vulnerability or resilience.
She stressed that disease is not randomly distributed in the population and some sub-populations are more vulnerable to diseases and to multiple diseases. This was illustrated in a graph on “ratios of observed and expected (co-)occurrences of diseases, overall and for different ages.”
Dr. Starfield then asked what all of this bodes for the future of health statistics. She began with the need to determine new ways to characterize health that are not based on mortality and that take into account the context of health, co-morbidity, disparities (equity), and the need to bridge clinical medicine and public health. There are three alternative approaches to characterizing population health. If the focus on diagnosis continues with an emphasis on morbidity, some form of case mix by age will be needed to deal with co-morbidity. DALYs, another alternative, have ethical and technical problems.
The third option is profiles of health derived from combinations of separate domains, and Dr. Starfield described this in detail. The Adjusted Clinical Groups (ACG) method is a way to characterize individuals, sub-populations and populations in terms of the burden of morbidity. (More information at http://acg.jhsph.edu) The ACG system is used to define 13 profiles ranging from excellent health to “worst health” taking into consideration four domains of health. She described an analysis of self-reported children’s health data, using this approach to characterize the health of that sub-population. This demonstrates that it is possible to do it, and the question is whether it is worth working toward expanding this for the rest of the population and other age groups.
Dr. Starfield then briefly commented on social and political context, co-morbidity, and understanding disparities. She noted that there are lots of data sets providing information on social and political context. Data systems are needed that allow for coordination among different providers to capture co-morbidity. To understand disparities, it is essential to do stratified analysis (separate analyses) rather than statistical adjustment, and there are few prototypes for this in the literature. Finally, the boundaries between public health and clinical medicine are increasingly fluid, and data systems are needed to coordinate the activities of both sectors.
In conclusion, she reiterated that population health is not the sum of individual measures of health because the latter do not represent health, and because health and the influences on health are not distributed randomly across the population.
Dr. Cohn remarked on the relevance of the genomic theory of disease, and he proposed that the Committee be briefed on this subject at a future meeting.
Asked about the health policy implications of her findings on child health, Dr. Starfield said that primary care can have a great impact on population health when services are tailored to the needs of specific population groups.
Asked what data and data systems can support the analysis she recommends, she said they include survey data and claims data (in lieu of electronic medical records). She asserted that much of the information is already available, but in sources that health researchers don’t know about or use. She cited data on women’s health, including its political and social context, as an example.
Mr. Rothstein read new and revised sections of the letter read and discussed the previous day. Following discussion and minor editing, the Committee approved the revised letter by a unanimous vote.
Mr. Rothstein said the Subcommittee plans in 2003 to work on the migration of health information beyond the health care system, focusing first on school-based health records. Dr. Cohn added that the Standards and Privacy Subcommittees will work together on monitoring the security regulation when it is released.
Dr. Mays reported that the Subcommittee had learned the previous day about a potential decrease in the NCHS budget that would impact its surveys, notably the sample size of the NHIS, as well as the national vital statistics system. She read a draft letter to the Secretary expressing concern about cuts and urging that these programs have sufficient funding.
The Committee discussed the nature of the problem, who has responsibility for decisions about it, and what wording would be most appropriate, given the current stage of the budget cycle. Several amendments to the letter were suggested. The Committee passed a motion authorizing the Subcommittee to revise the letter and the Executive Subcommittee to act on the final version on behalf of the full Committee.
Turning to another subject, Dr. Mays said that following on the Executive Subcommittee’s decision to elevate the population health mission in all its work and to pay more attention to cross-cutting projects, the Subcommittee has identified several cross-cutting issues. These issues might belong in the workplans of other Subcommittees because of their particular expertise, or they might be addressed through joint hearings or be taken up by the Committee as a whole. She mentioned the following topics and asked the Committee to consider how to address them:
Standards:
Quality:
NHII:
Privacy:
There was agreement that the Executive Subcommittee should look at these issues, set priorities, and determine which should be addressed, and how. Dr. Mays was asked to write up her list of issues for the Executive Subcommittee.
Dr. Newacheck commented that the Committee had for the past five years had a “bias” toward addressing standards and privacy issues in full Committee meetings, and this imbalance could be corrected by greater focus on population issues in full Committee meetings. Dr. Mays said the Subcommittee on Populations would continue to ask other subcommittees and workgroups to identify the population health issues within their domains.
Finally, Dr. Mays reported that the Subcommittee is preparing a letter to present to the Committee at its February meeting on findings from its hearings. She added that she would attend the Institute of Medicine’s December 12-13 meeting on collection of data on race and ethnicity.
Dr. Cohn reported that the Subcommittee is working on the scope of the study discussed the previous day. It is also continuing discussions about clinical terminologies for PMRI. It will hold hearings on December 10-11 and January 29-30, the latter to include a session on alternative and complementary medicine. Hearings are also planned for March 25-26 and May 21-22.
Ms. Coltin reported that the Workgroup is preparing a report on data gaps and recommendations on measuring quality of care. In addition, it has developed seven recommendations for AHRQ on the National Quality Report. She read the recommendations, which will be formalized in a letter that will be submitted to the Executive Subcommittee for action and forwarding to AHRQ.
Dr. Shortliffe reported that the Workgroup plans two sets of hearings, on January 27-28 in Washington, D.C., and in Atlanta about a month later. He called attention to a new IOM report on the NHII that was distributed to members.
Mr. Scanlon asked Chairs to advise ASPE of special projects with budgetary implications for 2003.
Ms. Greenberg reviewed the current thinking about the February meeting agenda, which will be finalized by the Executive Subcommittee.
After reiterating the Committee’s gratitude to retiring members for their service, Dr. Cohn 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. 03/20/03
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Chair Date