The National Committee on Vital and Health Statistics was convened on Monday and Tuesday, September 8 and 9, in the Sheraton Hotel in Washington, D.C. The meeting was open to the public. Present:
Don E. Detmer, M.D., Chair
Hortensia Amaro, Ph.D.
Simon P. Cohn,
M.D., M.P.H.
Kathryn L. Coltin, M.P.H.
Kathleen Frawley, J.D., M.S., RRA
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.
Barbara Starfield, M.D.
George H. Van Amburg, M.S., M.P.H.
M.
Elizabeth Ward
Marjorie Greenberg, National Center for Health Statistics (NCHS), Executive
Secretary
James Scanlon, HHS, Executive Staff Director
Lynnette Araki,
NCHS
Harvey Schwartz, Ph.D., Agency for Health Care Policy and Research
liaison
Bob Moore, Health Care Financing Administration liaison
Jackie Adler, NCHS
Mike Goldman, Citibank
Robert Beck, MultiState
Assoc.
Helene Guilfoy, Catholic Health Initiatives
Robert Bolan, McLean
Group
Kristen Pruett, IMSI
Gary Friend, IMS America
William Brunn,
Amer. Psychiatric Assn.
Chris Bergsten, AAHP
Sarah Comley, International
Observers
Jane Harman, NCHS
Bill Sobaski, HCFA
Marian Lowe, Capitol
Associates
Jean Narcisi, AMA
Chris Plaushin, ASCP
Gerry Adler, HCFA
Constance
Percy, National Cancer Institute
Pat Hamby, HBO&Co
Carolyn Rimes,
HCFA
Laura Saul-Edwards, AAFP
Mary Moien
Kim Colman, Amer. Soc.
Cataract & Refractive Surgery
Carol Higgins, NACHRI
Marget
Amatayakul, CPRI
Nellie Bristol, Health News Daily
Dr. Leslie Cooper,
NIH
George Gay, NCHS
Sheila Helbringer, Integrated Management Svces,
Inc.
Kepa Zubeldia, ENVOY-NEIC
Jan Lovern, JL Information Solutions
Stan
Edinger, AHCPR
Kathryn Foxhall, St. Anthony's Publishing
Linda McNish,
NCHS
Gwen Moulton, BNA
Jack Geisser, International Billing Assn.
Howard
Bradley, Social Security Admin.
Steve Lillie, DOD
Lyndalee Korn, TRW
Christine
Stahlecker, Empire BCBS
Deidra Abbott, College of Amer. Pathologists
Stacey
Long, NAHDO
Roy Bussewitz, NACDS
Jack Emery, AMA
Krista Robinson,
EDS
Maria Ward, Blue Cross Blue Shield of IL
Durwin Day,
Mark
Gordon, Thomas Edison State College
Linda Kloss, AHIMA
Kathleen Fyffe,
HIAA
Mary Emerson, HCFA
Joyce Frieden, Internal Medicine News
Jeanne
Gilliland, CDC
William Baughman, Paralyzed Veterans of Amer.
Henry
Heffernan, EDPNS
Eric Stas, MBS
Jeffrey Koshel, National Academy of
Sciences
James Maisel, M.D., ZyDoc
Robert Kolodner, M.D., VA
Michael
Stafford, AHSR
David Smith, HCFA
David Brown, CMHS
Michele Gurzano,
KAI
Jason Goldwater, NCHS
Jeanne Schulte Scott, CIS Technologies
Phyllis
Doulaveris, NCHS
The Committee met for a day and a half in plenary sessions. In addition to hearing status reports from Department representatives, they took action on Subcommittee recommendations on the OMB recommended changes to Directive 15, health data security standards, the Payor ID, and the unique health identifier for individuals. They were also briefed on the Panel on Public Health Performance Measurement and Data, and heard Subcommittee and work group reports on public education plans and work plans. They approved a set of internal guidelines for dealing with external organizations, individuals and groups.
The Department reports from Dr. Braithwaite, Mr. Scanlon and Mr. Fanning concentrated on activities related to HIPAA. Mr. Garrison gave a broad overview of the Data Council's work, highlighting its plans for reviewing provider surveys and improving state data. All representatives stressed their appreciation for the Committee's work.
Dr. Iezzoni and Dr. Amaro presented the response to the OMB recommendations prepared by the Subcommittee on Population Specific Issues. In general, they characterized the OMB position as good. The Subcommittee's response stresses the need to continue to clarify the underlying concepts of race and ethnicity and to study the implications of the changes for health data reporting. It also offers itself as a resource and promises continued involvement in this issue. The Committee approved the response, which was sent immediately to OMB.
The Committee engaged in two discussions of these recommendations, one preceding and one following Subcommittee break-out sessions. At the first, Dr. Lumpkin briefed members on the findings of the August hearing on security. He explained the Subcommittee's decision not to recommend a single standard because of the current state of the industry in this area and its primary need for a set of scalable organizational and technical practices. The Subcommittee's recommendations are based in large part on those of the National Research Council Study Committee, which also testified at the hearing. Several suggestions were offered for revising the report, including explicitly discussing the relationship between privacy, confidentiality and security. The following day, the Committee approved the revised version of the recommendations, for forwarding to the Secretary.
Ms. Ward reported on the Work Group's development of a communications plan, with staffing from the Department's media staff. Presentation materials are being developed for members, and fact sheets (which members were asked to review) are being put on the NCVHS Website. A small-scale media campaign is planned, due to the limited ability to respond to media inquiries.
The Committee discussed proposed guidelines for dealing with external organizations, individuals and groups, including the media. They gave special attention to the question of how to make clear in speeches the distinction between their personal views and Committee positions, as well as to the reasons for keeping Committee and Department documents confidential until they are ready for public release. After modifications were made to the guidelines based on this discussion, the revised guidelines were approved.
Subcommittees were asked to update their work plans, with special attention to unfinished business. The Planning and Implementation Work Group will combine these into the Committee work plan. As items are completed, the Chairs should notify Ms. Coltin. The Committee's rolling work plan will be revised accordingly.
Mr. Scanlon reported that nominations for new Committee members have been submitted to the Secretary, and it is hoped they will be named by November.
Jeffrey Koshel, the panel's study director, briefed the Committee on the panel's report on phase one and its plans for phase two. The report stresses the caution with which outcome measures must be viewed and urges that several different kinds of performance measures be used in conjunction with each other. It also looks at the limitations of current data sources. Phase two of the project, scheduled for completion in June 1998, focuses on recommendations for data system improvements and for research.
The discussion with Mr. Koshel focused on ways the panel and Committee can coordinate their work, cross-fertilize each other, and avoid duplication. Overlaps with each of the Subcommittees were explored, and the groups' shared interest in health data from the private sector was considered.
The Committee will meet in 1998 on the following dates, some of which include a third day for Subcommittee meetings:
Subcommittee chairs reported on their work plans, all of which are published and available on the NCVHS Website.
The Committee devoted a significant amount of time to finalizing its recommendations to the Secretary on this subject. At the outset, members were supplied with two documents:
Although there were large areas of consistency between the two documents, an essential difference lay in the Subcommittee's statement that the Committee continues to support the concept of a unique health identifier for individuals, and Mr. Gellman's assertion that such an identifier may not be a good idea and may not be necessary to accomplish linkages. Much of the Committee's discussion centered on aspects of this basic difference of opinion.
The process of crafting the recommendations had several stages. They began by considering the Subcommittee's recommendations, the several components of which they addressed separately. Once a sense of the group was established, a second draft was prepared, followed by further discussion. The Committee then set aside the revised Subcommittee recommendations to review Mr. Gellman's proposal and explore ways to conflate the two wherever they were complementary. A third draft was prepared based on this discussion. This draft was discussed further, and several amendments and minor editorial changes were approved. Finally, the Committee passed a motion approving the revised version of the third draft, with two members opposed. It was agreed that if the opposing members wished, they could submit dissenting views in a minority letter to the Secretary, provided this precedent-setting action is acceptable to Dr. Detmer (who was absent for this discussion). The final version of the Committee's letter to the Secretary is available on the NCVHS Website.
To summarize the content of the discussion, the Committee members reached fairly easy agreement on the following principles:
The Committee spent considerable time discussing the following questions, which were more controversial:
All members agreed that it was premature to cite leading options before getting more input from the industry. This decision reversed the recommendation of the Subcommittee. The group had several lively discussions of the potential merits and drawbacks of a unique health identifier for individuals, with differing views about whether they are on balance positive or negative. The majority felt that the Committee should affirm its traditional support for a unique identifier; the minority held that historical stances should not bind the group if the reasoning has changed, that in any case this document does not require reiteration of that historic position, and that the Committee should remain silent about the identifier pending further investigation.
After the revised recommendations were approved, the group discussed their expectations about the Committee's role in the process once its recommendations go to the Secretary. They agreed that the introductory and concluding language of the letter would state the Committee's intention to continue receiving public comment and to revisit the issue at its November meeting.
Following introductions, Dr. Detmer reviewed the agenda and welcomed the first speakers.
Dr. Braithwaite said the Committee's recent HIPAA-related recommendations have been very helpful to the Department. All of the recommendations under consideration by the implementation teams are consistent with them. The teams have reduced the number of proposed rules from 12 to five or six. Except for the employer identifier and the individual identifier (the Department is talking with the IRS about the former, and is waiting for the Committee's recommendations on the latter), they will be published by the end of October.
He identified several cross-cutting issues that are being addressed. First, they are trying to define where responsibilities lie for the infrastructure needed to support transaction standards. He described some of the complexities of implementation, and noted that it would be nice to have a trusted third party do compliance testing. The government is working with private sector organizations to set up such a body. Another issue is proprietary standards, which people know will not be valid after the year 2000. Some in the industry are insisting that the standards are voluntary, but the Department has legal and Congressional opinion to the contrary. The Department also continues to work on the universal health identifier, especially around privacy concerns.
There have been complaints about the 24-month time frame for the more complex claim standards, and that is being explored. The teams are also working on the complaint that the standards need more flexibility.
In response to a question, Dr. Braithwaite said they hope to find ways to designate the version in the current implementation guide rather than in the regulation.
Dr. McDonald remarked on the complexity of billing today and the "ugliness" in the way things are constructed and defined at the low level. He lamented that the standards documents talk about preserving things the way they are rather than using this as a chance to clean things up. Dr. Detmer responded that the Committee's charge to track implementation includes a mandate to help things evolve in a positive direction. Mr. Mayes said the infrastructure implementation team is acutely aware of the "fundamental issue" Dr. McDonald highlights, which relates to the master data dictionary issue. The team is seeking ways to apportion responsibility for maintaining the structure, developing data registries, and so on. Dr. Braithwaite noted that standards development is a gradual process in which first the baseline is set, and then it is possible to evolve to something that is "cleaner or prettier."
Jim Klein of EDS pointed out that delaying providers' compliance would force people to work with dual standards and delay the savings promised by the bill.
Mr. Fanning will report briefly tomorrow. In his absence, Mr. Scanlon reported that the Department's recommendations are in the final stages of clearance and will be released September 11. The NCVHS hearings were very helpful. He called attention to the Secretary's recent speech to the National Press Club, outlining principles that form the basis of the privacy recommendations. Dr. Detmer commented that it was an excellent speech.
Dr. Detmer asked about reactions to the Committee's recent recommendations. He said his sense is they were seen as reasonable, and Ms. Ward said they were well received in Washington State. Dr. Starfield expressed concern that confidentiality issues were not more thoroughly addressed, especially given the forthcoming work on the computerized patient record. Mr. Scanlon described some of the letters received by the Department. He said he would see that all members received copies.
Dr. Iezzoni said that at the request of the Subcommittee on Population-Specific Issues, Dr. Amaro prepared a draft letter on the OMB's July recommendations on categorizing race and ethnicity. Dr. Amaro said that overall, the Subcommittee felt the recommendations were good. It stresses the need to continue to clarify the underlying concepts of race and ethnicity and to study the implications of the changes for health data collection. The OMB recommendations did not identify how tabulation would be done, and the Subcommittee offers itself as a resource for continuing work in this area. It also emphasizes that health data should have as much consistency as possible.
In response to a question, Dr. Amaro agreed that there is no recommendation for recording multiple ethnicities. Dr. Iezzoni said that although the Subcommittee agrees that there should be, it is not feasible in the current OMB structure. Further research on ways of looking at ethnicity is recommended. This is also the case for the proposal to add Cape Verde and Arab/Middle Eastern as ethnic categories. The Subcommittee stresses the need to collect information on subgroups, and notes its intention to stay active in this area.
Dr. Lumpkin commented on the need to keep as a reference point the reason for retaining these racial and ethnic designations -- i.e., their usefulness in identifying groups that are at particularly high risk. Dr. Detmer observed that our culture's understanding of race and ethnicity is evolving and receiving increasingly serious attention that may lead to fundamental changes.
Dr. Cohn and others praised the Subcommittee for its good work on this effort. At his suggestion, they agreed to strengthen the letter's references to the reasons for having the classifications. He also urged that in the future, re-drafts use conventions to indicate changes from previous iterations. The group agreed that this was a good idea.
The Committee approved the proposed letter, with minor modifications. It will be sent immediately to OMB. (All NCVHS documents are available on the Website.)
Dr. Lumpkin circulated a draft set of recommendations from the K2 Work Group of the Subcommittee on Data Needs, Standards and Security. The Work Group will consider the Committee's comments at its afternoon meeting. He reported that the Subcommittee's August hearing on security standards revealed both that technology already exists to protect information security, and that generally the industry is not using it. One vendor claimed he could go into any health care institution in the country and walk out with the paper records of ten patients. Thus, the electronic age should be seen as having the potential to enhance the poor state of existing security, even while it increases the public's concern about security. The hearing also revealed the lack of uniformity among various security approaches and the high cost of building systems, especially if security is not part of the initial design. The Subcommittee also heard testimony on the report of the National Research Council, on which it based many of its recommendations.
Because no single standard is sufficient and because the industry is at different levels of implementation, the Subcommittee recommends a phased-in approach. It does not recommend a standard, but may do so in the future, if appropriate. For now, its report offers a set of principles and criteria.
Ms. Frawley reported that the 25 witnesses at the hearing were in general agreement that what the industry needs is a set of scalable organizational and technical practices.
Dr. Starfield urged that the Subcommittee's report more fully reflect the rich discussion at the hearing. Others suggested including definitions of terms and explicitly discussing the relationship between privacy, confidentiality and security.
Mr. Moore said the Department teams as they develop regulations in this area are taking the position that many products can accomplish the specified objectives -- most of which, Ms. Frawley noted, are organizational practices. She added that the vendors, system developers and industry representatives at the hearing stressed their desire for a baseline so people know the ground rules. Dr. Lumpkin explained that in this context, the Committee's role is to influence providers to take action within their organizations.
Mr. Mayes characterized the hearing discussions as addressing three levels: specific technical issues such as encryption, broad security practices and technology that are applicable across industries and generally developed outside health care, and issues that are unique to health care. The task before this group and the implementation teams is to identify the issues and needs that are specific to health care, and to determine how to be most productive without reinventing the wheel.
Dr. Mor called attention to two issues. The first is the lack of boundaries within health care today, which calls into question propositions like firewalls and distinctions between data at rest and data in motion. The second is the need for security in data archiving. He urged that these issues of boundaries and archiving be addressed in the future.
Dr. Lumpkin proposed suggesting that HCFA consider including security as a condition of participation in Medicare and Medicaid. Ms. Ward expressed her view that the pivotal area of security should not be treated as entirely voluntary when other activities under HIPAA are not. Mr. Moore stressed that the Department does not see any of the standards, including security, as voluntary; it simply is not in a position to mandate specific security packages. Ms. Frawley noted that Dr. Lumpkin's idea about HCFA participation was discussed at the hearings; the problem is that organizations are at very different places in their security practices and learning curves. Dr. Detmer noted that the Committee's task is to figure out how best to call attention to the issue. Mr. Moore said the Department's view is that HIPAA applies to all health care information, at rest and moving, including paper records.
Dr. Braithwaite noted that even if the technologies are not specified, the criteria for meeting certain principles can be. Moreover, if the Committee does not do this, the Department will have to, so that the regulations offer some guidance on what behavior is expected. Dr. Detmer observed that the process that is underway is partly addressing the dimensions of values and civility. Dr. Lumpkin noted that as with the quality assurance movement, this one will develop in stages, allowing the Committee to be increasingly specific over time.
Mr. Mayes reminded the group that security is expensive to retrofit, so in that regard the sooner it is specific, the better. Dr. Cohn noted that some speakers at the hearings asked for greater specificity and leadership from the federal government and NCVHS. Dr. McDonald cautioned against thinking that defining technical specs and imposing them on the industry will make "everybody happy": the presence of a human element means it will not be that simple. He suggested staying with what is known to work and taking small steps forward from there. Ms. Frawley added that at present, many organizations do not even have password control and are struggling with questions of access. Mr. Gellman noted that getting people to recognize the need for security is a contribution in itself. He urged a long-term perspective on this complicated issue.
The Subcommittee's recommendations were modified on the basis of this discussion and resubmitted to the Committee on the following day. A motion was passed approving the recommendations, which will be sent to the Secretary.
Ms. Ward said the Committee is playing catch-up in this area, developing plans and materials for member presentations and other components of a public education effort, as well as guidelines for dealing with outside organizations, individuals and groups, including the media. A set of draft guidelines was circulated. The policy that stimulated the most discussion concerned the need to restrict access to Department and Committee documents that have not been finalized.
Dr. Cohn noted the contradiction between the Committee's public discussion of documents in its open meetings and the policy of keeping them secret. It was explained that "pre- decisional" documents tend to take on a life of their own that belies their provisional nature. The goal is to preserve the Committee's practice of open discussion of issues, while also protecting documents until they are ready to be made public. Thus access to the written materials needs to be restricted.
Dr. Lumpkin observed that the collaborative relationship and process between the K2 Work Group and HHS implementation teams, in which NCVHS liaisons were privy to proposals as they were developed, provides a good model. This kind of relationship and access affords early and ongoing input to Department policy. He contrasted this with the recent OMB decision, about which the Committee was kept in the dark until after its public release. It was noted that the Department's recent decision to share documents with the Committee at an early stage depends on members' willingness to keep them confidential. The result is better policy and less confusion for the public.
Mr. Mayes encouraged members with contacts whose expertise would be useful to the Department to put them in direct contact with the implementation teams, which regularly talk with outside experts. He reiterated the importance of not letting non-final documents take on a life of their own.
Mr. Gellman stressed that it is difficult to regulate disclosures of information; the best that can be done is to label documents appropriately and hope people do the right thing. Dr. Detmer commented that the objective of this effort is to clarify for NCVHS members what the right thing is, to help them further the goals of the Committee.
Members discussed other aspects of the guidelines and how to make clear to audiences the distinction between their personal views and those of the Committee. Dr. Detmer said it will also be useful to know when members are making presentations. It was agreed that a revised version of the proposed guidelines would be considered later in the meeting.
Regarding educational materials, Ms. Ward said the goal is to have available by November attractive materials to aid members in making presentations. The Work Group has the help of the Department's media staff in developing a communication plan. Because members and staffers have limited time for responding to media inquiries, they are keeping the plan manageable and small scale. The Committee's slide presentations will be on the Website.
Two Subcommittee chairs said they are receiving a large volume of e-mail queries they do not have time to answer. They were advised to forward these to Ms. Greenberg, so they can be analyzed and a set of boilerplate answers prepared for frequently-asked questions.
Later in the meeting, Ms. Greenberg presented a revised version of the proposed guidelines. She stressed that she would make every effort to see that all documents that are not for public distribution are properly marked. Dr. Lumpkin suggested, in addition, that members assume that all documents received on listservs are not for distribution. The revised guidelines were approved.
Ms. Greenberg asked members to send her their comments on the draft informational documents also circulated, which describe HIPAA and review NCVHS charges and activities.
It was noted that the normal modes of disseminating information on the impact of HIPAA are not effective with many of the nation's health care provider organizations and state entities. These entities do not recognize their interests nor the relevance of the legislation to them. Ms. Ward said this is a major concern and focus of the public education Work Group, which is not only developing materials for the Website but also working with HHS media people to get literature out to a long list of organizations, select media contacts, and conventions. The Department also has a public education awareness group with an outreach plan, and the two groups are coordinating their efforts. Both bodies are trying to tailor their outreach in terms of the specific impact on the target group. More such outreach and honing of the message are needed. Mr. Moore commented that for some organizations and individuals, the issue is not a lack of awareness but a refusal to accept that the legislation applies to them.
Ms. Coltin asked all Subcommittees to update their work plans for the coming year. The Planning and Implementation Work Group will compile them into a Committee work plan and try to assure coordination. She asked for special attention to unfinished business from both the current Subcommittee plans and those of predecessors. Each group will be supplied in the near future with a list of outstanding issues in its area, which can be used to further update work plans, as needed, in time for the November meeting.
Dr. Iezzoni asked about the process for indicating that a given item on the work plan has been addressed. Ms. Greenberg said the rolling work plan that was formerly part of the agenda books will be reinstated, and the staff will try and track the status of work plans. Chairs can also notify Ms. Coltin by e-mail when projects are completed, with cc's to her, Ms. Araki, and Mr. Scanlon.
Dr. McDonald expressed concern that the Department's teams are getting ahead of the Committee, and he wondered whether NCVHS members in touch with those teams could keep other members abreast of developments.
Asked about new NCVHS members, Mr. Scanlon reported that a full set of nominations has gone to the Secretary, and he hopes they will be named before November.
Finally, Ms. Coltin reported that the Executive Subcommittee would be outlining responsibilities for monitoring the impact of the HIPAA standards.
In Dr. Detmer's absence, Dr. Lumpkin chaired the second day of the meeting. Following introductions, he welcomed Data Council co-Chair David Garrison.
Mr. Garrison expressed his appreciation and that of the Secretary for the Committee's good work and for the positive relationship between NCVHS and the Department. He reported that Dr. Bruce Vladeck of HCFA has finished his service as the Council's co-Chair.
He then gave a brief overview of the Council's work on a data collection strategy and on health applications in the national information infrastructure. In the first area, the Council is developing a plan and budget for all surveys between 1996 and 2001. Implementation of the survey integration plan is making good progress, and the survey of employers is also being consolidated. The Data Council is working on a conceptual framework for data on health care resources, capacity and the public health infrastructure, on which it welcomes the Committee's advice. The research planning initiative is in its second phase.
The development of strategies for obtaining state-level data are of special interest to the Secretary, and the Data Council is looking at several possibilities, which he enumerated. In addition, the Council has established a standing work group on race and ethnicity to recommend Department-wide approaches and strategies. One result is the proposal of an HHS-wide policy on including race and ethnicity information in HHS-sponsored data collections.
Mr. Garrison reported that the Council has begun examining opportunities for health sector applications in the National Information Infrastructure. It has established interagency working groups in the four areas that the Vice President directed HHS to spearhead. In the area of enhanced health information for consumers, it has developed a new collaborative Website, called Healthfinder.
In conclusion, Mr. Garrison reiterated the Data Council's desire for advice and counsel from the Committee on all of the aforementioned data policy priorities.
Dr. Lumpkin observed that the Behavioral Risk Factor Survey (BRFSS), one of the best models for state level data, is at risk as its funding is curtailed.
Mr. Fanning reported that on Thursday the Department will unveil its recommendations to Congress for health record confidentiality legislation. He thanked the Committee for its help in the form of hearings and recommendations. The hearings put the Department in touch with the needs and interests of a wide range of people and groups.
He stressed that although the initial rules will cover providers and payors, confidentiality issues are much broader and there is much more to be done. The Department is positioned to be "more expansive and more attentive to the other needs" with the help of the NCVHS Subcommittee on Privacy and Confidentiality. One focus of attention will be the protection of research information.
Dr. Lumpkin welcomed Jeffrey Koshel, the panel's Study Director, who noted that Dr. Lumpkin is a member of the panel. Its members combine technical knowledge and experience administering state-level programs. The panel grew out of interest in a proposed federal block grant program that would give states more flexibility in spending in return for their participation in performance contracts. The panel was created to look at possible methods of constructing performance agreements with state health departments. Early on, it concluded that outcome measures by themselves are inadequate for judging the performance of individual state entities. It looked carefully at the kind of measures that states use to affect outcomes, and it took time to clarify concepts and definitions. It studied administration, capacity, process and outcome indicators and talked about the relationships and distinctions among them.
The report of the first phase is "Assessment of Performance Measures for Public Health, Substance Abuse, and Mental Health" (National Academy Press, 1997). It stresses that when the specific effect of an individual public health intervention is not certain, it is important to be very careful in drawing inferences. This is a message the panel's representatives are working hard to communicate to people in both legislative and executive branches of government.
Mr. Koshel reiterated that the single most important conclusion of the panel is that "one should not look for quick or summary outcomes alone." One should proceed with great caution in using outcomes in performance measurement; furthermore, the process and capacity measures that public agencies have traditionally used to demonstrate performance should be used as adjuncts to the outcome measures. To get a sense of what is being achieved, the panel recommends using as many appropriate measures as possible in conjunction with one another. The report lists several dozen outcome measures that are supported by state level data. It also lists process and capacity measures, but stresses that they are only examples and not a complete universe of relevant measures. The panel discourages the notion of being prescriptive in coming up with process and capacity measures, arguing that this would "put almost a tax on creativity" and skew the appropriate local and state response to given problems. Mr. Koshel expressed hope that this message is getting through and counteracting people's tendency to think that a simple "magic bullet or single outcome measure" exists.
Another of the panel's conclusions concerns the urgent need to invest in data infrastructure to support performance assessments and program evaluations. The report lists the relevant sources of data for the health outcomes it discusses, and suggests the limitations of those data. For example, he agreed with Dr. Lumpkin that the role of the BRFSS as the principal data source for most measures is endangered by its continuing erosion.
The report also stresses the need to promote more research on the relationship between program interventions and outcomes, a matter on which there is a dearth of research evidence at present. This is especially true in the substance abuse and mental health areas, where the panel had a challenge to come up with measures that could be supported by research and that could be used across states. Mr. Koshel noted that the public health community is well ahead of the substance abuse/mental health field in this regard. The panel had to settle for a minimal rule for suggesting outcome measures in these areas; namely, that a measure be used as long as it met the panel's selection criteria and data needed to support that measure be available in at least one state.
The panel is now in its second phase, having completed the phase of identifying the measures that could be part of performance agreements between states and the Department in the next three to five years. The next volume will look at what data are needed to improve the measures, and what research would establish more confidence in a set of accurate and comprehensive measures. The second report is scheduled for release by June, 1998.
In the discussion period, Mr. Koshel acknowledged that Government Performance and Results Act (GPRA) had a major effect on this effort. Although the legislative effort to restructure federal public health block grant programs "went nowhere," all executive agencies are now developing strategic plans with outcome measures and other measures for submission to Congress under GPRA. The panel has said strongly that using performance measures to allocate resources is a poor idea, although they can be used as "crude flags" to signal the need for technical assistance. In effect, the results of this project can be used to support a broader range of management activities than originally were proposed under the Performance Partnership Grant idea.
Mr. Gellman urged that the panel consider a performance measure for confidentiality compliance, particularly in the substance abuse/mental health area where it is a special concern.
Mr. Koshel said he would take this recommendation back to the panel. Dr. Lumpkin said the panel has had to struggle against "scope creep" beyond its original mandate, which was confined to the impact of performance partnership grants by federal programs. Dr. Iezzoni seconded Mr. Gellman's statement about the confidentiality issues with mental health and substance abuse measures, saying it is a special concern of the Subcommittee on Population Specific Issues. Dr. Starfield praised the panel's report and noted its great relevance to the work of NCVHS. She asserted that it is impossible to avoid scope creep because public health cannot be separated from "non-public health." She suggested finding ways for the two bodies to share information in the period prior to the release of the panel report, given their shared interest in data needs. Mr. Koshel said the panel has been concerned about the changes brought about by managed care and the relationship between public and private data needs.
Asked about federal initiatives to support state development of data systems, Mr. Koshel noted that SAMHSA has requested $100 million for that purpose. He questioned whether the money can be put to good use, however, without common definitions across states, something that is particularly lacking in the substance abuse area. He predicted that significant resources will be available to states if state agencies meet the challenge of improving data systems and concepts.
Dr. Iezzoni raised the issue of data systems in the Territories, which Mr. Koshel noted the Department is making an effort to include, along with Indian tribes. She asked for input from the panel in conjunction with the Subcommittee's December meeting on the subject.
Asked about the future of the panel given the extent and rate of change underway in the area it is studying, Mr. Koshel said the Department has already extended the life of the panel. He agreed that it probably should continue indefinitely; but some other entity will have to track the panel's work after its completion. The panel will meet October 21-22 and in late January, and possibly again in May. The final report should be close to completion by March.
Dr. Starfield and Dr. Iezzoni expressed interest in a joint meeting between their Subcommittees and the panel, to share information and find ways to complement rather than duplicate each other's work. It was agreed that they would work through Mr. Scanlon to coordinate activities. Mr. Koshel agreed to brief the Committee again on the panel's work and on gaps where a Subcommittee contribution would be useful.
Ms. Coltin noted the potential for private-public complementarity in performance measurement, if their differing methodologies can be reconciled. She asked if any validation studies were planned. Mr. Koshel said the panel is aware of these issues and will address them in a general way in its report. It lacks both the time and the private sector expertise to develop specific recommendations.
Mr. Van Amburg stressed the importance of methodology development as well as data analysis, presentation and distribution. He noted the methodology problems with BRFSS, notably the low and decreasing response rates, and asked the panel's intentions in this area. Mr. Koshel said the panel is aware of the problem and will address it in the report, but it is hesitant to "get in the middle of very serious differences of opinion" about methodology.
Ms. Ward noted that issues of the scale being raised in this discussion are appropriate ones for the National Committee to address, and she urged that they not be overlooked.
Jim Masel, Chair Elect of HOST, called attention to the costs of the proposed data collection, and expressed hope that the process can be standardized and the items kept to a minimum. Dr. Lumpkin pointed out that one objective of these efforts is to have this kind of reporting be a byproduct of clinical care. He thanked Mr. Koshel for meeting with the Committee.
After considering several alternatives, the group selected the following dates for future full Committee meetings. Three of the meetings have a third day reserved for possible Subcommittee meetings.
Subcommittee work plans are published and available on the NCVHS Website.
Mr. Gellman cited a number of issues that the Subcommittee plans to address: health privacy legislation, the question of what constitutes an "identifiable record," disease registries, prospects of broadening the HHS certificates of confidentiality to apply to more classes of information, provider confidentiality, pharmaceutical marketing, problems with employer use of employee information, and ownership of clinical data. The group has not yet prioritized these issues or organized them into a work plan.
Mr. Scanlon noted that the National Bioethics Advisory Commission is looking into IRBs. Ms. Frawley noted that the President's Commission on Quality will soon issue its consumer bill of rights. Briefings of the full Committee were suggested for both items, and they were placed on the November agenda.
Dr. Starfield reported that the Subcommittee's K2 Work Group has the most fleshed-out work plan. The Committee is participating in the planning of the November conference on terminology, which CPRI is sponsoring. There will be a hearing on claims attachments in January or February, and one later in the spring on procedures for changing standards, new transactions, new codes and new data elements. Subsequently there will be hearings on the computerized patient record.
The Subcommittee is asking that Dr. John Eisenberg, AHCPR Administrator, and Dr. Edward Sondik, NCHS Director, attend the November full Committee meeting to talk about data needs for quality, accountability and population-based health. The Subcommittee will further develop its work plan after new members are added.
A question was raised about the timing of hearings on changing standards and version control. It will be resolved in November.
Dr. Iezzoni reported that the Subcommittee has responded to the OMB recommendations on race and ethnicity, an area it will continue to review. Starting with a September 29-30 meeting, it will focus on Medicaid managed care for the next year, with two site visits planned. Its December meeting will focus on data systems to support public health and other health care initiatives in the Territories.
At its meeting the previous day, the Subcommittee reviewed five of the federal government's 45 ways of defining disability. It is particularly concerned about how the Year 2000 Census will treat disability, in the first Census since implementation of the Americans with Disabilities Act. The draft questions, which are still under development, will be published in the Federal Register, and the Subcommittee plans to respond. It also plans to monitor OASIS and is concerned about how HCFA is looking at post-acute care.
In this regard, Ms. Frawley informed the group that HCFA has started a technical advisory group to develop a post-acute care standardized assessment tool. It has already met, and plans to have a tool out by January. She noted that there is a limit to how much the industry can absorb. Dr. Iezzoni remarked on the implications of this development for data standards and privacy, and suggested that the Committee be briefed on it in November.
Next, she reported that the Subcommittee wants to have joint hearings with the Subcommittee on Data Needs, Standards and Security on the data standards being developed by SAMHSA and other federal agencies dealing with mental health and substance abuse. There are also privacy and confidentiality concerns, suggesting that all three Subcommittees have an interest in this issue. This topic generated a long discussion in which members expressed alarm that some agencies are developing standards outside those mandated through HIPAA and possibly contrary to administrative simplification. Mr. Mayes commented that the infrastructure implementation team is studying how to impress on federal agencies that HIPAA applies to everyone. He pointed out, however, that agencies such as SAMHSA some have legitimate concerns about how they will continue to collect important information if the content structure is reduced. He encouraged the Committee to look at how to structure claims and attachments to meet public health needs. The group discussed the most appropriate forum for addressing this matter. To expedite discussion and action on it, they agreed to ask SAMHSA for a briefing document on data standards prior to the November meeting, at which time they will decide how to move forward. One option is to look at this in the context of code sets.
Dr. Iezzoni said the Subcommittee is also concerned about the coding of functional status and "things beyond the acute medical model of disease." In this context, it wants to learn more about the ICIDH-2. This is relevant to the data Subcommittee as well. Dr. Starfield added that the core data elements are another "generalizable issue" related to data standards. The group agreed to look at functional status, including ICIDH, next spring or early summer, probably at a full Committee meeting.
Ms. Frawley urged that the Committee make a regular practice of getting briefing documents ahead of its meetings, to make the best use of meeting time.
On another subject, Ms. Greenberg asked that the staff be informed as to whether the Committee wants a presentation on the clinical modification of ICD-10, which goes out for public comment in November or December.
The Subcommittee has reserved these meeting dates in 1998:
Dr. Starfield reported that the Subcommittee on Health Data Needs, Standards and Security concurs with the Data Council's plans to send its recommendations out for comment. The recommendation is for development of a 9-digit Payor ID, initially numeric and with the capacity to be alpha numeric in the future, with the proviso that consideration for internal routing of sub-organizational units be considered.
A motion to this effect was approved and the recommendation will be sent to the Subcommittee.
Committee members were initially supplied with two documents on this subject:
It was noted that the HHS implementation team is recommending one identifier, but that the Subcommittee is not comfortable making such a recommendation at this time. There are two reasons for this: 1) a privacy and confidentiality framework should be in place first; and 2) the Committee needs to get public comment before making such a recommendation.
Responding to this proposition, Bob Mayes noted some problems with the master patient index (MPI) in respect to claims processing. Dr. Lumpkin said this and other concerns would be considered at a later time. At Ms. Frawley's request, Mary Emerson explained the reasoning behind the implementation team's recommendation. Ms. Emerson agreed with Dr. Lumpkin that the ASTM criteria serve only as a rough screen because they have not been weighted or ranked. She also noted that they are only relevant to the unique identifier (not to other linkage methods), and she explained that the "hybrid VA model" recommended by the Implementation Team combines the ASTM identifier with the MPI.
Ms. Frawley observed that the Secretary's privacy principles, as outlined at the Press Club in July, suggest that she does not want information to be linked. Ms. Frawley questioned why the Committee is working so hard on a unique health identifier when the effort runs counter to the Secretary's privacy principles.
Following this preliminary discussion, the group turned to the Subcommittee's recommendations. They agreed to disaggregate the several issues embedded in the recommendations so as to discuss them separately. It was noted that the Subcommittee's recommendation takes issue with the Congressional directive to the Committee to recommend a specific unique health identifier for individuals to the Secretary.
The group talked several times about the potential merits and dangers of having a unique identifier, and about whether there are any viable alternatives. Mr. Gellman stressed the abuses to which such a number would be subjected, and Dr. Lumpkin outlined the clinical benefits that can only be accomplished with a unique identifier. Mr. Gellman's argument that technology is evolving rapidly and it is premature to take action pending new developments was met with the objection that technology is always changing, and any mechanism adopted will need ways to evolve.
The first stage of the discussion established the Committee's universal agreement that linkage of medical records for health purposes is desirable (leaving aside the question of how it is to be done), and that the objective of this process is a unique health identifier or other method of linking records for health purposes. Members also agreed that the HIPAA mandate in regard to the health identifier for individuals extends beyond the nine transactions specified in the legislation. This position is consistent with that taken by the Department. In addition, the group affirmed the principle that a unique health identifier or other methodology accomplishing the same purpose should not be enacted without a legislative structure to assure confidentiality.
They then briefly discussed a methodology for evaluating alternatives -- namely, ASTM criteria, cost-benefit analysis, and public comment. There were differing views about the usefulness of the ASTM criteria for this purpose: Mr. Gellman stressed their lack of weighting and the incomplete representation in their development, while others pointed out that they were balloted in an open process by an ANSI-accredited body.
Finally, they considered whether the Committee recommendations should cite the current leading options -- an enhanced social security number, another unique number, and a combination of a unique number and an MPI. Because of uncertainty about the Department's reasons for its recommendation and because of a desire to get more industry input, they agreed not to limit the consideration of options by specifying any candidates.
The meeting then recessed for lunch, during which the Subcommittee recommendations were redrafted based on the foregoing discussion. Following lunch, Dr. Lumpkin read the revised version and reinstated an earlier motion to approve the recommendations. Several amendments were offered, some of which passed and some of which failed. An amendment to delete mention of continuing support for an identifier was defeated.
Mr. Gellman reiterated his opposition to stating the Committee's continued support for the concept of a health identifier, and also to stating in advance the criteria by which a health identifier would be evaluated. He agreed with other members, however, that developmental and evaluative efforts should continue and not wait for passage of privacy legislation.
Dr. Cohn questioned why the Committee would bother to inform the Secretary that it is continuing to do what it is already doing -- i.e., evaluating options for accomplishing linkage. However, the group agreed with Ms. Greenberg that many bodies are or should be involved in this process, including ones in the private sector.
Mr. Gellman expressed his intention to submit dissenting views to the Secretary on behalf of those who do not support the recommendations. His fellow Committee members and the staff agreed that this would be appropriate. They agreed to review the idea, which would set a precedent, with Dr. Detmer, who was absent for this discussion.
Ms. Frawley urged the group to review Mr. Gellman's document, which articulates many of the key issues, and to make an effort to integrate it with the Subcommittee's draft recommendations insofar as they are complementary. The next portion of the discussion focused on this effort. Each paragraph was reviewed and decisions made on whether, and how, to conflate it with the recommendations. One point stressed by Mr. Gellman was the importance of having the decisions about this highly political issue made through the regular legislation process. This would give Congress an active and explicit role rather than the passive and silent one by which regulations could be ratified. Most others on the Committee did not support this view, however.
A break was taken, during which a new draft was prepared integrating selected portions of the two documents in keeping with the foregoing discussion. The first amendment to the new document, to delete mention of the Committee's continuing support of the concept of a unique identifier, was again defeated. Mr. Van Amburg expressed concern about reconciling this statement of support with a later statement recommending that a variety of other methods be considered, but the group let both stand. The majority of members agreed that a probabalistic linkage mechanism is not adequate for clinical or administrative purposes, and tentative language referring to this option was deleted. Ultimately, the arguments that the Committee has historically supported the concept of a unique health identifier and that there may be no alternative prevailed.
Following further discussion and minor editing, the motion to approve the revised recommendations was passed, with two opposed. Mr. Gellman reiterated the reasons for his opposition, as outlined above.
The group then discussed their expectations about the Committee's role in the process after its recommendations go to the Secretary. They agreed that the introductory and concluding language of the letter will state the Committee's intention to continue receiving public comment and to revisit the issue at its November meeting.
Following an opportunity for public comment, the meeting was adjourned.
I hereby certify that, to the best of my knowledge, the foregoing summary of minutes is accurate and complete.
/s/ Don Detmer December 18, 1987
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Chair Date