The National Committee on Vital and Health Statistics was convened on Tuesday and Wednesday, June 16-17, in the Hubert H. Humphrey Building in Washington, D.C. The meeting was open to the public. Present:
Don E. Detmer, M.D., Chair
Jeffrey Blair
Simon P. Cohn, M.D.,
M.P.H.
Kathryn L. Coltin, M.P.H.
Kathleen Frawley, J.D., M.S.,
RRA
Daniel Friedman, Ph.D.
Kathleen Fyffe, M.H.A.
Robert M.
Gellman, J.D.
Richard Harding, M.D.
Lisa Iezzoni, M.D., M.S.
John R. Lumpkin, M.D., M.P.H.
Clement Joseph McDonald, M.D.
Vincent Mor, Ph.D.
Paul Newacheck, Ph.D.
Barbara Starfield,
M.D.
M. Elizabeth Ward, M.N.
Marjorie Greenberg, National Center for Health Statistics (NCHS),
Executive Secretary
James Scanlon, HHS, Executive Staff Director
Lynnette Araki, NCHS
J. Michael Fitzmaurice, Ph.D., Agency for
Health Care Policy and Research liaison
Stewart Streimer, Health Care
Financing Administration liaison
William Braithwaite, M.D., ASPE
Barbara Hetzler, NCHS
Jackie Adler, NCHS
Edith Altice, Gordon &
Barnett
Harriet Starr, IPRO
Christi Bowen, BCBS/FL
Roy
Bussewitz, NACDS
Roberta Dean, NWDA
Lesly Hallman, Bureau of
National Affairs
Helene Guilfoy, Catholic Health Initiatives
Robert
Beck, MultiState Associates
Carole Stephens, Medic Computer Systems
Timothy McNamara, Multi... Information Services
Brian Say, NCHS
Stacey Long, NAHDO
Teresa Cendrowska, ASTM
Leon Gue, HCFA
Karen Trudel, HCFA
Sandra Haydock, HCFA
Melinna Giannini,
Alternative Link
David Brown, CMHS
Kristen Robinson, NIH
Chuck
Meyer, HBO & Co.
William Kirby, Health Management Services.
Janet
Spinks, AQUAS
Henry Heffernan, EDPNS
Michael Tate, American
Dental Assn.
Clare Rodriguez, Fordham University
Gary Friend,
IMS America
Carolyn Rimes, HCFA
Diedra Abbott, College of Amer.
Pathologists
Robert Bolan, McLean Group
Nannette Loeberberg,
Georgetown Law
Richard Klein, NCHS
Jane Harmon, NCHS
Miryam
Granthon, ODPHP
Kathryn Serkes, Assn. of Amer. Physicians &
Surgeons
Loes Schein, HCFA
Daniel Staniec, NCPDP
Linda
Lawrence, NCHS
Donna Shelton, NACHRI
Christopher Bergsten, AAHP
Robert Kolodner, M.D., Veterans Health Admin.
Stanley Edinger,
DHHS
The Committee made the following decisions during its two-day meeting:
1. They authorized Dr. Detmer to send letters of appreciation to outgoing Committee member George Van Amburg and former HCFA liaison Bob Moore.
2. Dr. Detmer asked that all members be supplied with a copy of the Vice President's May NYU speech on privacy.
3. They approved the Committee reorganization plan recommended by the Executive Subcommittee, as outlined in the document in the agenda book. They authorized each subcommittee or workgroup chair to decide whether to have a vice chair, and authorized the Subcommittee on Populations to decide the status of the Workgroup on Population-Based Data.
4. They asked Dr. Elstein for suggestions on how the Committee could help improve data quality. They also agreed to consider making a recommendation to the Department about the need for more trained analysts.
5. They approved a letter to Secretary Shalala and Secretary Herman with comments on the final report of the President's Advisory Commission on Consumer Protection and Quality in the Health Care Industry, with minor modifications. (1 abstention)
6. They approved letters with the Committee's comments on the following NPRMs:
7. They approved the recommendations of the Subcommittee on Standards and Security regarding claims attachments -- specifically, that the standard for the transaction include only HL7 formatted text. (1 abstention)
8. They declined to approve a motion "that all Committee and Subcommittee hearings intended to focus on the subject of unique patient identifiers be postponed until 2 weeks after the Department of Health and Human Services has published in the Federal Register the planned notice of intent on that subject." (Vote: 2 in favor; 10 opposed; 2 abstentions)
9. After initially tabling it from day 1 to day 2 of the meeting, they addressed the following motion: "That all NCVHS committee and subcommittee documents that address the subject of the unique patient identifier or that relate to any committee or subcommittee activities about the unique patient identifier be exempt from the secrecy rules for documents in the committee's ground rules for dealing with the media and other external organizations (paragraphs 1, 2 and 3 from the document section) and that these documents be made available to the public at the same time they are circulated to members of the committee or any of its subcommittees."
The motion was divided to apply 1) to paragraph 1 of the document section, concerning HHS documents, and 2) to paragraphs 2 and 3, NCVHS documents. After discussion, the motion concerning HHS documents (part 1) was defeated (vote: 1 in favor, 7 opposed, 1 abstention).
A motion was passed to table part 2 of the motion, concerning NCVHS-generated documents, and to take it up at the September NCVHS meeting. The tabling motion also directed the staff and Executive Subcommittee to prepare the relevant background documents for the Committee. (Vote on this motion: 5 in favor, 3 opposed, 1 abstention)
10. The group agreed to send their comments on the proposed questions for the hearings on the unique individual identifier to Dr. Lumpkin and Ms. Frawley.
11. They approved the general approach in the draft "vision statement" on the national health information infrastructure, suggested some revisions, and asked Dr. Friedman to contribute language to two sections. The revised draft will be reviewed at the September meeting. They agreed to defer development of a proposed Committee document on objectives for health and health care, pending further interest by the Executive Subcommittee.
12. They agreed to publish a report on 1997-1998 NCVHS activities and accomplishments in early 1999. There was support for subsequently publishing a 50-year report updating the 45-year history published in 1995.
13. They approved charges for the Subcommittee on Standards and Security and the Workgroup on Computer-based Patient Records.
14. They approved a letter to Secretary Shalala on identifiability of health information and confidentiality considerations for health registries. (1 abstention)
15. They approved a document prepared by the Subcommittee on Privacy and Confidentiality providing information requested by the House Ways and Means Committee, Subcommittee on Health.
16. They asked Ms. Maiese for a summary of the criteria used for deciding on socioeconomic categories and for the direction given to Healthy People 2010 workgroups regarding age, gender and disability status.
The following new agency liaisons were introduced: Dr. Michael Fitzmaurice for AHCPR, and Stewart Streimer for HCFA. Dr. Peggy Hamburg was welcomed as the new Data Council Co-Chair. The Committee was briefed by Mr. Fanning, Dr. Braithwaite, and Dr. Hamburg on the Department's privacy and data activities.
Dr. Detmer announced that George van Amburg has completed his tenure on the Committee, Dr. David Takauchi has been appointed, and Drs. Iezzoni and McDonald have been reappointed. The Committee expressed appreciation for the outgoing members and liaisons.
Dr. Detmer then presented the Executive Subcommittee's recommendations for a reorganization of the Committee to accommodate new HIPAA mandates. The Committee discussed and approved the reorganization. Major concerns related to coordinating the large number of subgroups. Dr. Detmer announced the names of Subcommittee and Workgroup chairs and asked members to volunteer for the groups.
Dr. Paul Elstein of HCFA reported on the findings of the agency's 1997 audit of HEDIS data. He noted that the 1998 audit will be better because of the lessons from the first one and new practices such as a sample of medical record review and the auditing of data prior to their submission. The 1997 audit focused on four domains, finding instances of both under reporting and over reporting but no evidence of fraud. He described the major data issues encountered. Because of the limitations with the audit, Dr. Harding urged HCFA to include caveats with the data on its Website, to avoid misinterpretations by consumers and the media.
Dr. Detmer stressed the Committee's desire to help with this effort for better data quality. He suggested some testing of the widespread assumption that better data systems generate more accurate information, to justify spending on information systems. Dr. Elstein said he would work with colleagues to compile data on this subject for policymakers. He suggested an update on the second audit in about 6 months. Ms. Coltin suggested that the Committee consider calling the Secretary's attention to the scarcity of trained analysts and recommending measures to train new people.
Ms. Coltin and Dr. Starfield presented a draft commentary that supplements the Committee's previous letter on the Consumer Bill of Rights and Responsibilities. (The letter is posted on the NCVHS Web site.) The Committee approved the comments, which will be finalized and sent to the Secretary. They agreed to use the problematic term "post-acute care" in this document but to ask the Subcommittee on Populations to look for a more descriptive term and ways to promote its use.
Mr. Blair introduced this inventory, which he prepared for ANSI with the assistance of many volunteers and the support of the Medical Records Institute.
Dr. Lumpkin presented the Standards and Security Subcommittee's recommendations for NCVHS comments on the published NPRMs and on claims attachments. Following discussion and some modifications, all proposed documents and recommendations were approved. The Subcommittee will present recommendations for implementing the claims attachment standard when issues about pretesting the standard have been resolved.
Dr. Lumpkin announced that the first hearing on the unique individual identifier is scheduled for July 20-21 in Chicago. Because the Notice of Intent will not be ready in time, the Department plans to release a white paper outlining alternative approaches to the individual identifier. Mr. Gellman introduced a series of motions concerning the process surrounding hearings on this subject. The discussion and actions are outlined in items 8 and 9 above.
The Committee reviewed a draft document on building the health dimension of the national information infrastructure, a concept paper on framing a statement on national health and health care objectives, and plans for a 1997-1998 report. (See items 11 and 12 above.)
The Committee agreed to have the next report cover the period since the last annual report. It will include some references to the Committee's history in the context of specific topics, and refer to supporting materials on the Website. A draft report is scheduled for review at the November meeting, with the final draft to be circulated to all members for comment and Executive Subcommittee action in early 1999.
Dr. Christopher Chute reported on the program, major issues raised, and follow-up to the November 1997 CPRI conference on terminology, in which several NCVHS members participated. Dr. Detmer and others affirmed the Committee's interest in these activities and their relevance to the work of the CPR Workgroup.
The Committee approved new charges for the Standards and Security Subcommittee and the CPR Workgroup, and Dr. Cohn related the thinking of the new CPR group.
For the Subcommittee on Populations, Dr. Iezzoni emphasized the challenge of integrating the perspective of the new Workgroup on Quality and of achieving productivity in this area. Dr. Friedman reported on a project he and Dr. Starfield will coordinate on developing a vision of health statistics for the next decade or more. He described a series of preliminary activities, to culminate in one or more workshops organized by the Committee on National Statistics. The first is to focus on the 21st Century vision of health statistics. A second workshop, if held, would focus on the implications of the first for NCHS. Dr. Friedman will advise the Committee on what role it might play in advising Dr. Sondik and the National Center for Health Statistics over time.
Ms. Frawley introduced new staff to the Subcommittee on Privacy and Confidentiality and presented two draft documents for the Committee's approval: a letter summarizing the Subcommittee's findings on identifiable data and health data registries, and answers to a set of questions from a Congressional subcommittee. These were approved with minor modifications. Ms. Frawley also presented the Subcommittee's workplan.
Ms. Greenberg reported on plans for an invitational workshop on the implications of HIPAA for public health and health services research. NCHS and CDC will host it in Washington, D.C. on November 2-3. She encouraged the Committee to advise the meeting planners on whom to invite, and to send representatives to the meeting.
The Committee heard three presentations on Healthy People 2010. Deborah Maiese reported that the public comment period (using the Website) closes around December 15, with a final set of objectives expected next summer. A three-volume set covering the objectives, policy, and data details is planned in the year 2000. She and her colleagues urged the Committee to participate in the consultation process. A major development in the objectives is the creation of a "developmental objective" category to push data development in weak areas, with the aim of having baselines by 2005. The other major development is the virtual elimination of differential targets for racial and ethnic minorities. Olivia Carter-Pokras discussed planning in the latter area, and Richard Klein discussed the data issues surrounding the entire process, including efforts to identify a few "leading health status indicators" for the nation.
The Committee expressed strong support for these efforts, with Dr. Starfield pressing for clear and visible objectives reflecting the links between socioeconomic status and health. Ms. Maiese promised to provide further information on work underway in this area.
Dr. Detmer introduced and welcomed Dr. Michael Fitzmaurice, who has replaced Dr. Harvey Schwartz as AHCPR liaison, and Stewart Streimer, replacing Bob Moore as HCFA liaison. He announced that NCVHS member George van Amburg has completed his extended service on the Committee, Dr. Iezzoni and Dr. McDonald have been reappointed, and Dr. David Takauchi has been newly appointed. The Committee approved sending letters of appreciation to Mr. Van Amburg and Mr. Moore. A letter has already been sent to Dr. Schwartz. Dr. Detmer also noted that Dr. Peggy Hamburg is the new Assistant Secretary for Planning and Evaluation and, in that capacity, co-chair of the Data Council.
The Department is starting to consider its options on privacy regulation in the absence of movement on confidentiality bills in Congress. Vice President Gore referred to the need for such legislation in a May commencement speech at NYU. Dr. Detmer asked that members be supplied with a copy of the speech. A Presidential directive to the heads of executive agencies called for actions to enhance privacy. A privacy summit will be held June 23-24, primarily focusing on the Internet and personal information on children.
In response to a question, Mr. Fanning said the Department is not ready to make a statement on the scope of possible confidentiality regulations. He and Dr. Detmer commented on the remarks of Bill Lowrance to the Data Council regarding a European Union directive requiring all member states to have data protection laws in effect by October, and not to permit the export of personal data to countries lacking such protections. This is the subject of ongoing discussion in the administration and with the EU. Various solutions are possible. Dr. Lowrance is urging the U.S. administration to work on specific data exchanges.
The Department is publishing proposed regulations to implement national standards for health care EDI in six areas. The first NPRMs were published May 7, with the comment period closing July 6. The comment period on the employer identifier closes August 17. Dr. Braithwaite acknowledged the "incredible effort" involved in producing the NPRMs.
After being welcomed by Dr. Detmer, Dr. Hamburg expressed appreciation to the Committee for its work with the Department. She noted the strong support for good information systems on the part of the Secretary and her Data Council co-chair, Dr. John Eisenberg. Privacy issues will be among the Council’s priorities until legislation or regulations are in place. The Council also continues its work on survey integration, and it will be building new capacity for data on youth tobacco use.
The Data Council's activities are being coordinated with the Vice President's reinventing government efforts and the President's initiative on race. In the latter area, the Department is focused on its initiative to eliminate racial and ethnic disparities in six critical health status areas: cancer, cardiovascular disease, diabetes, immunization, infant mortality, and HIV-AIDS. This campaign highlights many data deficiencies as well as the links between socioeconomic status and health status. She welcomed the Committee's input on these issues. Finally, she reported that the Data Council is involved in reviewing data initiatives in the Year 2000 budget, and its analysis will reflect Departmental priorities.
Dr. Lumpkin asked whether the Department, under the Data Council's aegis, might implement the large data dictionary being generated by the Data Subcommittee's work on administrative simplification. The goal would be to have all state, local and federal programs using the same definitions. Dr. Hamburg said this would depend on the quality of the work. She commented that such consistency would be a big improvement over the current fragmented system, and also that HIPAA offers the chance to make such changes. In this vein, Ms. Greenberg noted that CDC and HRSA have agreed to work on integrated systems at the state level.
Dr. Detmer expressed appreciation for Dr. Hamburg's enthusiasm for the Committee's priorities, and for her support in getting more budget and staffing. She noted the "true partnership" between the Committee and the Department.
Dr. Detmer explained that the Executive Subcommittee recommends a reorganization of the Committee because of the new tasks and expanded roles mandated by HIPAA. The proposed new structure is as follows:
Members' comments on the proposal were generally positive, with some suggestions for optimizing the new structure and some cautionary notes. There were expressions of concern about the number of proposed subgroups (subcommittees and workgroups) for a Committee of 18. There was considerable support for the new, consolidated Subcommittee on Populations and the creation of a stronger capacity for dealing with population-based issues. The creation of new workgroups (CPR, quality of care, and NHII) was applauded. Members stressed that the groups must work closely together on overlapping concerns, such as the population-based data implications of HIPAA. It was agreed that each Committee subgroup would decide whether to have a vice-chair.
A motion was offered but not seconded to consider a name change for the Committee.
The Committee passed a motion approving the new structure. They asked the Executive Subcommittee to consider which group should monitor the core data element recommendations. The Subcommittee on Populations will decide whether to recommend a separate workgroup on population-specific issues, reporting at the next Committee meeting.
Members were asked to sign up for at least one subcommittee and one workgroup. Dr. Detmer reviewed current staffing arrangements and needs. (Staff assignments are listed on the NCVHS roster.) He announced the following chairs:
In 1997, HCFA performed the first audit, or validation, of HEDIS data. The audit had some limitations in that only 78 contracts (one-fourth of the total, representing 60 percent of the beneficiaries) were visited. There was no medical record review, and plans were not permitted to correct the rates. The 1998 audit will be better because of what HCFA learned on the first one.
The audit looked at four HEDIS measures: breast cancer screening, beta blockers, medical examination for patients with diabetes, and follow-up for hospitalization for mental illness. Each of these domains had unique limitations, and the last had the most data problems.
The IPRO and subcontractors found that a major problem area was the use of proprietary coding and forms. Also, many plans did not differentiate between primary and secondary diagnosis codes. Low cohorts were another problem, and Dr. Elstein agreed with Dr. Fitzmaurice that a statement from NCVHS that this is a national problem would be helpful to HCFA. The IPRO did not find intentional miscoding. The most frequent problem in the effectiveness area was over-reporting, while with frequency of procedures insufficient information usually led to understatements.
Answering a question from Dr. Iezzoni, Ms. Coltin said that the NCQA report card pilot project in 1993 encountered some of the same problems. Asked about possible remedies through system solutions or education, Dr. Elstein responded that this is a major concern that must be addressed so that consumers can expect reliable data for comparing plans. The data are to be used for system-wide quality improvement, internal plan QI, and plan-to-plan comparisons. Currently, having better data may actually work to the detriment of plans because of the comparisons. He invited the Committee's recommendations on these problems.
Dr. Harding made a strong appeal for caveats when the HEDIS data are posted on the Internet, so that consumers and the media understand the limitations of the data and do not draw inappropriate conclusions from them. Dr. Elstein invited him to submit suggested language. He stressed that the 1998 data will be better, thanks to measures such as a sample of medical record review and the auditing of data prior to their submission.
Ms. Coltin observed that there are three sources of data problems: problems with the underlying data, problems with the experience of staff in applying the specifications, and new measures (e.g., the beta-blocker measure). She predicted that HCFA's one-year learning period and tightening of the measures will indeed lead to improvements.
Dr. Elstein commented that HCFA must decide whether to automatically adopt measures recommended by the CPM or wait a year. On another subject, he said the agency is working on improving data completeness, which was a serious problem last year. Also, HCFA intends to require plans to fund the audit starting next year. In response to a question, he said there are as yet no consumer satisfaction measures among the indicators. There is, however, a major effort underway to merge CAPS and HEDIS satisfaction surveys, so it may be included with HEDIS Medicare in the future.
Dr. Detmer stressed the Committee's desire to help with this effort for better data quality. He suggested some testing of the widespread assumption that better data systems generate more accurate information, to justify spending on information systems. Dr. Elstein said he would work with colleagues to compile data on this subject for policymakers. He suggested an update on the second audit in about 6 months. Ms. Coltin suggested that the Committee consider calling the Secretary's attention to the scarcity of trained analysts and recommending measures to train new people.
Ms. Coltin and Dr. Starfield presented a draft commentary that supplements the Committee's previous letter on the Consumer Bill of Rights and Responsibilities. (The letter is posted on the NCVHS Web site.) The document endorses several Quality Commission recommendations (e.g., strengthening the evidence basis for health practices while noting the need for flexibility in defining what this means). It also discusses the direct relevance of the Committee's activities and work plan to many of the Commission's recommendations.
Dr. Starfield observed that the Committee has an opportunity to articulate how the data- dependent objectives can best be supported -- e.g., measuring and reporting on care for vulnerable populations.
Dr. Lumpkin commented that the impact of quality assessment on administrative burden is another reason the Committee needs to be involved with the responses to the Commission's recommendations. Dr. Detmer asked him to draft some language to include in the NCVHS commentary.
Dr. Starfield raised the recurring issue of the correct terminology for what is called "post- acute" care in the Commission reports and NCVHS commentary. The Committee accepted Dr. Iezzoni's suggestion that the terminology remain in this document because it is the standard usage in the field. The Subcommittee on Populations will take up the question of how to "move the ocean liner" toward more appropriate terminology.
The Committee, with one abstention, approved the draft letter with minor modifications.
Mr. Blair acknowledged the hundreds of volunteers who worked on this inventory with him, Dr. Fitzmaurice for suggesting a follow-up and Dr. Fitzmaurice and Jim Scanlon for garnering the support of their agencies, and the Medical Records Institute for releasing his time for preparing this ANSI document. He described the contents and stressed that it contains unaudited data, although they did encourage completeness and relevance.
Both Dr. Detmer and Dr. Cohn commended Mr. Blair and HISB for producing this key document that should move things forward.
Dr. Lumpkin presented draft letters on the published NPRMs, prepared and recommended by the K2 Workgroup and the Subcommittee on Standards and Security. The documents are:
He explained the comments and recommendations in each letter. Following discussion, suggestions for modifications, and some redrafting (over the course of both days of this meeting), the Committee passed motions approving each of these letters, which are posted on the NCVHS Website. The comments on HCFA 0149-P include recommendations on the methodology for the data content committees and data maintenance.
Dr. Lumpkin then presented the Subcommittee's recommendation that the standard for the claims attachment transaction include the requirement only for HL7 formatted text, and not ASCII text as well. The intent is to streamline the messages by having everything sent in one way. The Committee passed a motion to this effect, with one abstention.
The Workgroup plans to address the issue of the timetable for implementing the standards for claims attachments. HIPAA requires that an NPRM be issued this summer. However, HCFA has not had funding to test the transaction standard, and the Workgroup feels it is inappropriate to recommend an untested standard. When they have addressed this issue, they will bring a recommendation to the Committee.
Dr. Lumpkin reported that the first hearing on the unique patient identifier will be held in Chicago on July 20-21. The Department's Notice of Intent (NOI) will list several alternate methodologies for uniquely identifying an individual for purposes of connecting that person with his/her health information. The NOI will be followed by a comment period, after which HHS plans to prepare an NPRM. The NOI is still going through clearance, so the Department plans to prepare a white paper listing the options, for discussion at the July hearing.
The Subcommittee hopes to hear from a varied group of people at the hearing, including providers, payers, SDOs, plans, and more than one panel of consumers. Other hearings will be held in Washington, D.C. (with international spokespersons present) and elsewhere in the U.S.
Mr. Gellman offered the following motion: "that all Committee and Subcommittee hearings intended to focus on the subject of unique patient identifiers be postponed until 2 weeks after the Department of Health and Human Services has published in the Federal Register the planned notice of intent on that subject." It was seconded.
Mr. Gellman asserted that a patient identifier would become a de facto national identifier that would be used for "every purpose," much as the uses of the Social Security Number have far exceeded the government's intent. He stressed the breadth and significance of this issue and the need to be as fair, open and complete as possible.
He then cited several factors that could undermine perceptions of the Committee's fairness and that are reasons for "bend[ing] over backwards to be procedurally fair." First, he asserted that the Committee is "very unbalanced" on this issue because nearly all of its members come out of "the health care establishment." While reasonable as individuals, collectively they do not encompass the scope of concerns and perspectives on the identifier issue. Moreover, the Committee has already taken a position on the patient identifier issue (from which he dissented). He pointed out that the NCVHS Website does not cross-reference the Committee's letter to the Secretary on the health identifier and the dissenting letter from him and Dr. Harding. In conclusion, he asserted that it is unfair to start hearings before the core document (the NOI) is available.
The Committee discussed this matter at great length. It was noted that HIPAA requires HHS to adopt a patient ID; that the Committee's role is to advise the Secretary, not decide on the patient identifier; and that it intends to hold several hearings on the subject, including at least one during the NOI comment period. There was broad agreement that hearings are important for raising public understanding of the issue and informing the Committee about the range of views on the subject. However, members considered the costs and benefits of delaying the first hearing until the NOI is available and people can comment on the alternatives outlined by the government. They weighed these against the benefits of having the maximum amount of time to air views on the basic issue of a unique patient identifier. Several members viewed the promised HHS white paper as an adequate substitute for the NOI, but Mr. Gellman declined to accept an amendment adding the words "white paper or" to "notice of intent." He also expressed doubt that OMB would approve release of the white paper.
Ms. Frawley reminded the Committee of its careful past deliberations and process in regard to the patient identifier, and of its stated desire to get input from industry and people outside the industry before making any recommendations. She noted that the Committee did not initially link its plans for hearings to the publication of the NOI. Mr. Gellman reiterated that although it has not recommended a specific approach, the Committee has already decided that there should be an identifier, something he regards as an open question.
Following the discussion, a vote was taken on the motion and it was defeated (1 in favor, 10 opposed, 2 abstentions).
Mr. Gellman then offered a second motion, as follows: "that all NCVHS committee and subcommittee documents that address the subject of the unique patient identifier or that relate to any committee or subcommittee activities about the unique patient identifier be exempt from the secrecy rules for documents in the committee's 'Groundrules for Dealing with the Media and Other External Organizations' (paragraphs 1, 2 and 3 from the document section), and that these documents be made available to the public at the same time they are circulated to members of the committee or any of its subcommittees."
Ms. Greenberg read the relevant section from the Committee's Groundrules. To accommodate the rest of the agenda, a motion was then passed to table Mr. Gellman's motion until the following day. The remainder of day 1 was spent in breakout sessions. [Note: Day 2 discussion follows, to complete this agenda item.]
When the Committee returned to this subject the following day, Mr. Gellman's motion on documents was reread and seconded. A friendly amendment was accepted to divide the motion into two parts: 1) concerning paragraph 1 of the document section, on HHS documents, and 2) concerning paragraphs 2 and 3, on NCVHS documents. Discussion ensued.
Speaking in support of the motion, Mr. Gellman charged that the policy in question results in conducting the hearings "under an aura of secrecy," when the Committee should be making every effort to inform the public about its thoughts and actions. He challenged the notion that any serious harm or misunderstanding could come from releasing all documents on this topic that are available to or produced by the Committee. He added that it would be worth losing access to predecisional HHS documents to be able to make all documents on which the Committee is deliberating available to the public. He pointed out that the current motion pertains only to documents on the unique patient identifier, "so that the Committee's hearings and activities in this area can't be questioned."
There was general support for having as much openness as possible, and for making an effort to educate the public on this sensitive issue. It was noted that all NCVHS meetings are open, many documents are read aloud during meetings, and no request for a document has ever been denied. Dr. Lumpkin and others predicted that if the Committee failed to protect predecisional HHS documents, it would no longer be given access to them and would lose its collaborative, consultative relationship with the Department that now affords early input into Departmental deliberations. Mr. Scanlon affirmed that this was the likely outcome. Another concern expressed -- one dismissed by Mr. Gellman -- was that documents produced in the early stages of the Committee's thinking on an issue could be taken out of context and misinterpreted as decisions.
After discussion, the sub-motion concerning HHS documents (part 1) was defeated (vote: 1 in favor, 7 opposed, 1 abstention).
The Committee then turned to the sub-motion concerning Committee documents, raising many of the same arguments pro and con. Questions were raised about the definition of "document" and other matters. As an alternative to the current policy, it was proposed that documents be released once they are approved by workgroups or subcommittees. However, Mr. Gellman argued that qualified openness is not true openness. He noted that documents written by NCVHS members expressing personal views could be identified as such so they would not be construed as official documents.
Because of the complexity of this matter, several members expressed discomfort about voting on it in the absence of background information. The Committee passed a motion to table part 2 of Mr. Gellman's motion and to take it up at the September NCVHS meeting. The tabling motion directs the staff and Executive Subcommittee to prepare the relevant background documents for the Committee on relevant policies and procedures. (Vote on this motion: 5 in favor, 3 opposed, 1 abstention.)
Mr. Gellman reiterated that the hearings on the patient identifier are very important and likely to generate considerable public attention. He cautioned against any hastiness or unfairness in the full airing of the issue through the Committee's hearings. He has provided a list of people and organizations with interests in the privacy implications of this subject who should be invited to participate.
Members were given a draft list of questions for those testifying at the Chicago hearing and were asked to give their comments on the questions to Dr. Lumpkin or Ms. Frawley after the meeting. Dr. Starfield expressed hope that the questions can be pared down and made "more publicly relevant and industry relevant." Ms. Greenberg suggested putting the questions under consideration on the Web site and asking for comments and other questions as well as suggestions of groups that might testify. Mr. Gellman asserted that this violates the existing rule. It was moved and seconded that the decision about posting the questions be referred to the Executive Secretary for action. In the absence of a quorum, the staff was asked to poll Committee members by e-mail. (This was the day's last item of business. A quorum was present for all other business.)
Dr. Detmer explained that the Executive Subcommittee and staff have been working on a paper on the health dimension of the National Information Infrastructure. The Data Council has expressed interest in the Committee's recommendations for a strategy to build the health dimension of the NII. The Executive Subcommittee also has worked on a statement of objectives for national health and health services that could serve as a guide and context for the work on the NHII. The latter could be published as a separate document, a section of the NHII document, or not at all. The Committee was asked to consider these draft documents and alternative approaches.
Most of the discussion focused on the paper on the NII. Dr. Friedman suggested some additions relating to population-based data, and he was asked to provide this language to the contractor. Members approved the general contents of the paper, but suggested sharpening the framing language at the beginning and end to explicitly recommend that the Secretary and Data Council take a leadership role in articulating a detailed vision of the health information infrastructure and working out an integrated approach with the private sector. Mr. Blair noted that a "roadmap" for the HII produced by the Council on Competitiveness might be a good resource.
Committee members agreed not to go forward at this time with a paper on objectives for the nation's health and health services. The Executive Subcommittee will determine whether to revisit this idea.
Ms. Greenberg explained that the Committee produced annual reports from 1949 through 1995 (also covering the first months of 1996). Although its new charter requires only annual reports on the implementation of HIPAA and not an overall annual report, the former leaves out many important NCVHS activities and accomplishments.
The Executive Subcommittee therefore recommends producing a report covering the period since the last annual report. They favor including some references to the Committee's history in the context of specific topics. Supporting materials on the Web site will be referenced. A draft report is scheduled for review at the November meeting, with the final draft to be circulated to all members for comment and Executive Subcommittee action in early 1999.
Because 1999 is the Committee's 50th anniversary, the group discussed whether the report on 1997 and 1998 should be embedded in a broader document updating the 45-year NCVHS history that was published several years ago. In this way, a single report would serve a dual purpose. After considering this possibility, members decided that the 50-year review and the Committee's yearly reports should be kept separate, maintaining the continuity of annual or bi- annual reports for the archive. Thus, the 1997-1998 report will go forward as described above, and the Committee may produce a separate document updating the history to encompass 50 years.
This discussion generated a query about changing the Committee's name to reflect its broader mandate. Despite some agreement that the current name does not do it justice, members concluded that it would not be prudent to ask Congress to change it.
Dr. Christopher Chute, co-chair of the terminology conference with Dr. Simon Cohn, gave this report. In addition to CPRI, the sponsors and planners included a spectrum of payers, providers, organized medicine and organized health care. The meeting, held in November 1997, grew out of a summit meeting held a year earlier that emphasized three priorities for health care: patient identifiers, confidentiality, and terminology. The 1997 meeting succeeded in gathering large numbers of providers, practitioners, users, vendors and developers.
The meeting converged around a philosophy of interlocking terminologies, rejecting the notion of creating anything from scratch. The idea of a continuum was a central theme, recognizing that detailed nomenclatures and refined descriptions of patient events are not in conflict with the goals and needs of broader-level classifications; rather, they exist along a continuum, co-evolve, and can be coordinated.
Dr. Chute reviewed the format and content of the conference, at which Dr. Detmer and Dr. Braithwaite provided keynotes and several other NCVHS members and staff made contributions. Extensive documents on the conference are available on the CPRI Website: http://www.cpri.org/terminology/
The terminology meeting reached conclusions regarding:
Dr. Chute showed a schematic of a way to integrate terminologies. It depicts "stove pipes of clinical classification" that arise collectively from a patient-centered clinical base and become specialized and differentiated from each other. A basic premise is that "mapping can occur at the root level." He proposed a model in which clinical terminologies are linked to common underlying servers that share a reference terminology model. The functional role of their access to the server would determine the appearance of the terminology as delivered. A "common interlocking terminology suite" can accommodate this model.
In addition to the importance of communicating and publishing these concepts, the meeting decided on the need for a follow-on conference to revise and update the consensus achieved at previous meetings. Related tasks are establishing a mechanism for interlocking development along the continuum, defining a coordination process, and recommending the proposed public-interest entity. Such a meeting is planned for January 1999 in the D.C. metro area.
Dr. Cohn praised Dr. Chute's summary and observed that the conference provided important beginnings for the Workgroup on Computer-based Patient Records. Dr. Detmer hailed the Committee's involvement in the terminology meeting because of its relevance to Committee charges. Asked about current thinking on who "the entity" might be, Dr. Chute said the question is far from resolution but the candidates include NCVHS, the National Library of Medicine, and CPRI.
Mr. Blair applauded CPRI for helping people "put together something that terminologies can converge to." Dr. Chute agreed with him that progress must be made on multiple axes and development of the reference terminology model requires the cooperation of independent terminology developers. Dr. Chute said this process is starting to happen, despite the lack of "a home for the coordinating process." He agreed that the work of HL7 is an important facet.
Dr. Cohn commented that the new ground broken by the conference was the awareness of a continuum and the need for mapping. Ms. Humphreys of the NLM has already initiated mapping efforts, as she reported at the latest Data Subcommittee meeting.
The Committee approved a new Subcommittee charge, as recommended by the Subcommittee, with a revision to refer to working with the Subcommittee on Populations on population-based data issues related to HIPAA standards.
The proposed charge for the new Workgroup on Computer-based Records, as recommended by the Workgroup and the Data Subcommittee, was presented by Dr. Cohn, who co-chairs the Workgroup with Mr. Blair. The charge states that meeting HIPAA requirements on the CPR will be a primary focus of the group. The Committee approved the charge, with a few modifications. It was noted that the recommendations of all Workgroups should be processed through their respective Subcommittees.
Dr. Cohn then shared a document on the proposed focus, scope and deliverables of the CPR Workgroup, for which seven Committee members (including the co-chairs) have volunteered to date. The group will focus on the issues around uniform data standards for patient medical record information, and the electronic exchange of such information. Such issues include those posed by collaborative health care and patient mobility. The development of a common vision will be an early task of the Workgroup, which plans to leverage HIPAA standards whenever possible.
The Workgroup will develop recommendations and legislative proposals in three areas:
The Workgroup will also track data security issues. Mr. Blair explained that they do not expect to articulate standards as much as trying to understand the evolution of standards and to facilitate interoperability and the greater clinical specificity of data.
Dr. Iezzoni reported that a new charge will be drafted within a week and circulated to Subcommittee members for comment. She expressed delight that seven or eight Committee members already have volunteered for the Subcommittee. In addition to consolidating the responsibilities of two or three previous NCVHS groups, it has a new dimension due to the addition of Ms. Coltin's Workgroup on Quality. Some work is needed to make sure the Subcommittee is productive in the quality area.
On past activities, she reported that the series of hearings on Medicaid managed care was completed in Boston in April. She thanked Carolyn Rimes and other staff for their work on this project. A contractor is now conducting an analysis, and a report is expected by late summer.
The Subcommittee will hold a hearing on health data issues for the insular territories, the American Virgin Islands, and Puerto Rico on July 14-15.
On June 16 they heard a report from the Census Bureau about implementation of the new OMB Directive 15 guidelines. The Subcommittee will continue to track this issue and its implications for longitudinal perspectives.
The focal activity for next year will be an exploration of the continuum of care, with a focus on post-acute care, with Dr. Mor taking the lead. She asked Dr. Friedman to report on a project he and Dr. Starfield will coordinate, concerning developing a vision of health statistics for the next decade or more and the NCVHS role in that vision.
Dr. Friedman explained that the thinking has shifted from the workshops that were the original focus of discussions with Dr. Sondik (Director, National Center for Health Statistics and Senior Advisor to the Secretary on Health Statistics). To develop a vision of health statistics, the plan is to begin a series of small facilitated focus groups aimed at defining health statistics and determining how to evaluate progress in the next 10 to 15 years. A series of papers may be commissioned, one compiling past reports and recommendations on the topic and assessing progress on them; others focusing on specific policy issues such as children's health insurance and on best practices in the U.S. and abroad.
All of these activities will feed into one or more workshops organized by the Committee on National Statistics. The first is to focus on the 21st Century vision of health statistics. A second workshop, if held, would focus on the implications of the first for NCHS. Dr. Sondik hopes to hold the first workshop in early 1999.
Dr. Iezzoni added that Dr. Friedman will advise the Subcommittee on how it can advise Dr. Sondik over time. She also reiterated the Subcommittee's view that HIPAA and standardization issues have a strong impact on the ability to look at the health of populations, and it hopes for a continuing interface with the Data Subcommittee on issues of common concern.
With respect to the continuum of care, Dr. Mor commented that the Subcommittee will have to grapple with the fact that as Medicare moves toward managed care, important data are being lost. Dr. Iezzoni noted that the Quality Workgroup will be addressing this issue.
Ms. Frawley welcomed three new Subcommittee staffers: Wendy Liffers, Lois Schoen, and John Burke. She presented for the Committee's consideration and approval a letter to the Secretary summarizing the findings and recommendations from two round-table discussions hosted by the Subcommittee in January. They concern the nature of identifiable/non-identifiable data and of health registries.
The comments on identifiability include a call for more substantive definitions and procedural mechanisms to protect individuals against identification. On registries, the Subcommittee recommends that health data be provided only to registries that conduct research, public health, and related activities. The Committee, with one abstention, passed a motion approving the draft letter for sending to the Secretary. They authorized Ms. Frawley and staff to make minor modifications to the language based on members' comments.
Ms. Frawley then presented a second document providing follow-up information to the House Ways and Means Committee, Subcommittee on Health, pursuant to a March 1998 hearing on health information privacy. The document answers a series of questions that were sent to NCVHS via Dr. Detmer. The answers reference HIPAA, the Committee's written recommendations on privacy and confidentiality, and the Secretary's September 1997 testimony to Congress, as well as the Committee's work plans (e.g., those of the CPR Workgroup).
Ms. Frawley reviewed each question and proposed answer, which address such topics as audit trails, preemption, the EU directive, enforcement, and discrimination. On the latter, the document urges the Secretary to propose legislation expanding HIPAA's anti-discrimination provisions to cover all aspects of discrimination based on health status and condition. The Committee unanimously passed a motion approving these responses, which Dr. Lumpkin noted are consistent with past Committee positions.
Finally, Ms. Frawley reported on the Subcommittee's work plan. It will hold a hearing or round-table on pharmacy benefit management and use of prescription information. The Subcommittee wishes to co-sponsor the hearings on unique health identifier, and it has recommended some additional questions for the hearing. With Ms. Fyffe in the lead, the Subcommittee plans to address the relationship between health information confidentiality and health care anti-fraud activities. After this, probably in early 1999, the group will investigate health privacy in employment.
Ms. Greenberg reported on plans for an invitational workshop on the implications of HIPAA for public health and health services research. NCHS and CDC will host it in Washington, D.C. on November 2-3. The National Committee has supported the planning through the participation of Dr. Friedman.
Because of HIPAA's important implications for public health and health services research, the Data Council has accepted the recommendation of Dr. Sondik and the CDC administrator to establish a process to broaden input into the maintenance and revision of the HIPAA standards. A major aim is to strengthen the voice of public health and health services research.
Now, what is needed is for the communities in question to recognize the relevance of HIPAA and to be in a position to provide needed input. The workshop is intended to inform people about HIPAA and help them reach a united position about what data needs in this sector might be met through administrative and financial standards and the CPR. Another thing to be determined is how the public health and services research communities should be represented in the standards development organizations and what kind of infrastructure is needed.
Ms. Greenberg welcomed the Committee's recommendations on what organizations should be invited to participate, and she expressed hope that at least three NCVHS members would participate. She added that the education function will continue after the meeting, with several papers commissioned. Dr. Detmer commented that the workshop will be worthwhile for the Committee.
Dr. Friedman noted that the possible uses of identifiers for public health, e.g., for surveillance systems, is one of the important issues to be addressed. Dr. Iezzoni observed that the health services research community needs better representation than that indicated by the current list. She agreed to advise the staff in this area. Several Committee members suggested people and organizations to invite.
(Healthy People Website: http://web.health.gov/healthypeople/)
Ms. Maiese, the Senior Prevention Policy Advisor of the Office of Disease Prevention and Health Promotion (ODPHP), noted that Healthy People is the United States' contribution to the World Health Organization's call for health for all. The planners hope to release Healthy People 2010 in January of 2000, before the Presidential race. A Secretary's Council on National Health Promotion and Disease Prevention Objectives for the Year 2010 meets annually, supported by a Departmental steering committee. These two groups guide the policy for the initiative.
A consultation on a complete set of draft objectives will take place in Fall 1998. There will be five regional meetings, each with a formal hearing. Ms. Maiese issued the first of several appeals for NCVHS to participate in the consultation process. The public comment period (using the Website) closes around December 15, with a final set of objectives expected next summer. Publication of a three-volume set covering the objectives, policy, and data details is planned in the year 2000. About 62 percent of the 700 comments thus far have come from people listing no official affiliation.
Healthy People 2010 will have two types of objectives: 1) measurable ones for which baseline data are available and 2) about 200 "developmental objectives" for which there is no baseline. The "high hurdle" set for the latter is to be able to measure them by the year 2004 so that a 2010 target can be set in 2005. Since work began on the objectives for the current decade, the number without baseline data has been reduced from 91 to 11 because the objectives have driven the development of new data systems -- e.g., on school health practices. The same role is expected for the 2010 objectives.
Audio conferences with the states have begun, focusing on data development and getting started for 2010. States are being encouraged to support healthy community and healthy city initiatives. In addition, to expand the audience beyond the public health community, the Robert Wood Johnson Foundation has funded the formation of a business advisory council for Healthy People 2010.
Another major and "audacious" characteristic of the 2010 objectives is the elimination of differential targets. Dr. Carter-Pokras took up that topic.
By setting the goal of eliminating racial and ethnic disparities, the Department has taken on tough issues it has not addressed before. With respect to the year 2000 objectives, major racial and ethnic disparities remain and in some cases have worsened. There are major problems in monitoring these disparities because of the absence of national data for racial and ethnic minority groups and/or subgroups. One result has been the mistaken assumption that SES differentials account for all the disparities, when research shows that this is not the case.
The demonstrable link between the existence of Healthy People objectives and NIH funding makes it essential to set objectives relevant to all racial and ethnic groups. The developmental objectives now provide a way of pushing for data in new areas. One area where more data are needed is for racial/ethnic subgroups. Aggregate data mask huge disparities within broad racial or ethnic classifications -- e.g., births among Asian-American teenage mothers. The population-specific objectives are expected to shed light on areas of missing data.
Dr. Carter-Pokras described a nuanced approach to these public health and data issues. The President has embraced the elimination of health disparities in six focal areas (mentioned above by Dr. Hamburg). The Surgeon General's guidelines for the priority area work groups call for a single 2010 target for those objectives that can be influenced by public health interventions or improvements in access to health services, and for those amenable to short-term behavioral change. For objectives that are unlikely to be influenced by interventions in the next decade, the target should represent an improvement for a substantial proportion of the population.
Stressing that these approaches are open to public comment, Dr. Carter-Pokras urged the Committee to participate. Finally, she noted that the success in eliminating the differential between black and white women in their rate of mammography use demonstrates the real possibility of eliminating disparities.
Mr. Klein noted the interesting interplay between data and policy issues surrounding Healthy People 2010. One practical issue is simply the size of the next iteration: the number of objectives may be double the number for 2000. The plan is to use electronic dissemination, allowing people to pull out what they are interested in.
One data issue stems from having multiple measures for an objective. NCHS is advocating for a single measure. Also, duplicate objectives in different areas have created "a numbering nightmare" in the past, and there is now agreement to use a single unique number.
The developmental objectives present several challenges. There are hundreds in the current document, and they present serious data collection problems with no clear strategy for how they will be collected. Another issue concerns comparability and consistency: for example, the change to ICD-10 will cause discontinuities in mortality statistics, and a new standard population for age adjustment will affect racial comparisons. Changes in OMB 15 guidelines, particularly the direction to check more than one race, create other complications. Mr. Klein observed that generally, Healthy People "assumes a comparability over time that really doesn't always exist...."
He then described the Institute of Medicine's work on "leading health indicators," aimed at finding a few core indicators that encapsulate or represent the nation's health status. The model is the leading economic indicators. The IOM is considering the criteria for such measures, one of which is regular availability. He noted that such regularity depends in part on dependable funding, and NCHS staff are working with the Data Council on a data development plan for the next decade aimed at assuring a consistent funding stream -- something that has not existed in the past.
IOM is considering three models: a health status model, a health disparities model, and a summary measures/leading contributors approach. None of these is satisfactory to Dr. Sondik, who wants a tight analytic connection between risk factors and outcomes. NCHS is getting involved in summary measures such as quality-adjusted life years and disability-adjusted life years. These can yield a single number with which the health of the population can be summarized. NCHS will hold a conference with international experts in September, looking for two or three measures that can be used over a decade. The issue Dr. Sondik raises is, what does a change in years of healthy life mean? Considerable research is planned over the next decade to tighten the analysis in this area.
Dr. Detmer opened the discussion, which Dr. Starfield launched with a "Wow." She then asked whether Healthy People 2010 would frame the issues to give adequate visibility to the disparity in socioeconomic status and its effect on health status, in contrast with the year 2000 objectives. Noting Dr. Carter-Pokras' comment that "money follows objectives," she offered to work with the planners to frame the objectives so that this dimension receives attention.
Ms. Maiese said a work group is focusing on SES, and she would relay the Committee's comments.
Mr. Scanlon asked for some clarification of the thinking about "leading indicators," and was told that the idea is to find current or recent data that have predictive value. Mr. Klein agreed that the analogy to the economic sphere is imperfect, in that in that context "leading" means "in advance of the business cycle." Naming the indicators was a challenge for the planners. Dr. Mor noted that current data collection and reporting make it possible to provide ongoing data by restructuring some federal-state relationships. Mr. Klein agreed, noting that some outcomes don't change much in the short term. Similarly, Dr. Lumpkin cautioned that in some areas little would be gained by frequent reporting, and in others the data would be misleading.
Dr. Friedman hailed the plan to report data by subgroup, and he recommended that the data include place of birth. The Office of Minority Health has pushed for this as well.
Returning to Dr. Starfield's point about economic equity issues, Dr. Carter-Pokras said that the guidelines for priority area work groups call for SES indicators.
Dr. Detmer noted that the IOM recently decided to look at the health of the nation's poorest 20 percent as one of its priorities. He asked about the prospects for tieing the Healthy People metrics into the delivery system's incentive structures. Ms. Maiese noted that NCQA adopted the clinical preventive service targets in Healthy People 2000, and HEDIS may eventually introduce 2010 measures. In conclusion, she repeated the request for NCVHS participation in the consultation process -- for example on the public health infrastructure objectives, many of which are developmental. At Dr. Starfield's request, she said the Committee would be supplied with the guidance to work groups regarding SES presentation and the criteria for determining classes.
Ms. Greenberg reviewed current plans for the September meeting, as follows:
Dr. Friedman asked for a presentation on the surveillance and data systems objectives for Healthy People 2010.
Ms. Greenberg asked Subcommittees to be thinking about how they want future meetings to be structured.
Dr. Detmer then adjourned the meeting, with thanks to the staff for all their hard work.
I hereby certify that, to the best of my knowledge, the foregoing summary of minutes is accurate and complete.
Don E. Detmer September 15, 1998
Chair Date