DR. LUMPKIN: For those of us who have been in the subcommittee meetings all morning, it hardly seems like we are starting, but I guess this is the first full committee session today. So we will start off, as is our practice, with going around the room to introduce ourselves for those will be listening on the Internet.

[Introductions were made.]

Thank you. I did want to welcome Dr. Gary Christoph, who is our new liaison from HCFA. I do have a confession. He taught physical chemistry. That was my second worst course that I had when I was an undergraduate. The worst course was physical and analytical chemistry, which gave me nightmares. But we're pleased to have you here.

We'll start off with updates from the Department.

Agenda Item: Update from the Department, Data Council Activities - James Scanlon, ASPE

MR. SCANLON: Let me start. It's a pleasure to be here this morning, and I want to update the committee on several items. You are going to hear reports from Bill and Karen and John on where we are in the areas of administrative simplification, standards, and privacy. So I'm going to try to focus on the other perspectives the committee brings to bear, the area for population-based data statistics and so on.

First of all, let me report on our HHS-wide Web-based directory of research data resources. I think at the June meeting I reported that the Department was in the process of updating and expanding on our Web-based directory of virtually all of the research and statistical databases that HHS sponsors, pulling them together into one electronic directory.

This is more or less a meta directory. It tells about what the information is. That's been completed, and it's been placed on our HHS Data Council website. So you can come to the HHS website and the Data Council home page, it's listed there as one of the "what's new" items. This is an attempt to pull together virtually all of the major statistical and resource databases that HHS supports. It includes not only the survey activities, but it includes analytic databases, surveillance information and so on.

There is a description of each one of the data systems, and a contact person. In many cases there is a link on the Web to the sponsoring agency, and in some cases to the statistical information and data itself. So we are encouraging all of our agencies to put all of these statistical and research data resources in that directory.

It is still not as entirely user friendly as we want. I think we are going to be looking at how would you access the data from the point of view of the user, and not necessarily have to know the name of the agency, or the name of the data set itself to be able to do a thorough search. Here we are looking for any ideas I think from the committee. Many of you are users of this kind of information. We would welcome any ideas on how to make this more user friendly.

We are planning to announce in various newsletters and some of our grant announcements that such a resource is available, and we would encourage analysis of some of the data sets that exist in the directory. Again, we welcome any comments from the committee.

Secondly, there are several activities going on in the areas of race and ethnicity data. I gave you a brief report I think at the June meeting on a couple of them, and let me bring you up-to-date now. As I did report in June, the Administration has established an initiative designed to improve the ability of the nation to identify and track discrimination in several sectors of U.S. society.

It is being coordinated by the Office of Management and Budget, and it involves a number of federal agencies -- the Department of Housing and Urban Development housing area, the Department of Education for the area of education, the Justice Department for criminal justice, and so on. HHS has been asked to take the lead in the area of health care.

So there are several parts of this initiative, but the basic focus is to improve the statistical capability to monitor, to track, and to identify race discrimination in these various sectors of society. As part of this effort, I think I reported previously, the OMB has asked the National Research Council to set up a panel that would meet several times, and would begin with a workshop to look at the state-of-the-art and where we are in measuring race discrimination now in these various sectors. And to think about a research agenda and a methodological development agenda for how the federal agencies, at least, could process in the years ahead.

That research conference was tentatively scheduled for November, but clearly it's going to be pushed back now, probably December or January, depending on the budget and appropriations situation. As you know, the federal fiscal year ends this Thursday, and October 1 is the beginning of the next fiscal year. It's not clear what exactly -- well, it looks like there will be a continuing resolution to fund HHS and other agencies. So that may delay in actually whipping money over to the National Research Council to get that project started.

Let me talk a little bit about within HHS what we are doing anyway. We're starting it this year, and will continue into next year, a couple of steps. First, the data directory that I described a minute ago actually has fairly extensive information on what race and ethnicity data is available in that particular data set. It also describes the geographical detail.

So first of all, we're trying to pull together resources of what do we think we have already. Second, we have asked our working group on race and ethnicity data. This is a working group under the Data Council to begin to review our current surveys and our current administrative data systems to see if there may be measures there that would be helpful, to see what might have to be added, or what makes sense to add to these to move forward in this direction. And to potentially come up with a research agenda or a methodological agenda for at least HHS to look at.

And third, we have asked a former member of the committee, Tom Lavis(?) -- I think you all remember Dr. Lavis -- to undertake a literature review in the area of what is the current state-of-art and measurement in measuring race discrimination in the health care setting. This would look at not only what appears to be the state-of-the-art in the health care setting, but what can we learn from other fields.

For example, the housing sector and the employment sector take different tacks in terms of how they assess race discrimination in those areas. And to see what we can learn from other fields, and come up with some recommendations about how we might proceed. We have already asked Dr. Lavis to undertake that, so hopefully by December or January we should actually have some preliminary findings from there.

Then our Office for Civil Rights will be looking at new methodologies as well. Remember here that we're focusing on health care, not necessarily health status alone. Typically in epidemiological research and public health the focus is on identifying disparities in health status or so on according to various subpopulation groups.

The emphasis hasn't been necessarily on looking at the motivation maybe for the disparity. Here we are looking specifically at the health care setting. There has been some research you are familiar with where through simulations or other means there has been an attempt to try to focus on what race differences may occur in treatment settings or for different diseases and so on. So that's the focus I think we would be asking the work group and Dr. Lavis to take. At any rate, we hope to end up with at least the state-of-the-art report on what do we know in the health care setting.

Finally, budget planning for 2001. While we are just about completing one fiscal year, we have already begun to plan for the year 2001. As part of the budget process, the secretary is proposing -- obviously we'll have to agree -- but the secretary is proposing an initiative on improving information for decision-making. There are three themes in this area, but it brings together I think the folks around the table; a lot of the ideas the committee has talked about in terms of data policy and health information policy and privacy and so on.

Again, the three themes relate to: (1) bringing together a number of activities to close critical data gaps; (2) to promote the building of the next generation of health information systems, and I'll tell you what this involves specifically; (3) not just developing information, but actually improving on the ways that we deliver the information, useful, timely, and accessible information to decision-makers and other customers for decision-making and for public health action.

The initiative as conceptualized would include what the agencies in HHS would be developing in this area. As you know, we have a wide array of agencies interested in the health information technology and statistical area. But it would also include some cross-cutting kinds of approaches where coordinated and perhaps unified approaches could be taken across HHS, or at least across several agencies, and working with partnerships in the public health and research communities as well.

Let me briefly describe each of these three theme areas, at least at that level, and invite the committee's participation as we move along. I think all of you know that some of our major data gaps in the statistical area in health deal with populations and subgroups, race/ethnicity populations, but also special populations. Individuals with disabilities and so on.

In fact, our Healthy People 2010 framework for the health of the nation now includes more or less a standard template or framework for special populations including race/ethnicity populations that would apply to virtually all of the objectives. So one aspect of the initiative would involve a number of agency activities and cross-cutting activities to try to address some of those gaps in various health information about populations, as well as some national and state level data resources as well.

The second area that the department has been looking in the area of serious gaps in information is the whole area of the health care system, the provider information, information on plans, and so on. I think people are concluding that while many of our surveys serve very well in being able to monitor and describe the health system, we are clearly reaching the point now where we think the ability to describe and monitor those developments is falling behind in changes; rapid changes in the health system itself.

So that even the old taxonomies of what's a provider, what's plan and so on don't make as much sense any more. The Department has been working on trying to identify what some of the needs are on the health system, and try to plan to meet some of those. That would be a part of the initiative as well.

Third, you heard Dr. Eisenberg yesterday talking about the quality improvement and quality measurement. So a third area of the gaps that need to be addressed would include outcomes, effectiveness, and quality of information. And finally, any initiative should always include a research and methodological development obviously. So we would try to direct some attention to resources in the area of improving our methodology, evaluating methodology, and tools for data collection.

The second major theme deals with building the next generation of health information systems. And some of these are very familiar ideas to the committee. This would deal with the area of trying to provide and obtain support for standards, activities, not just the HIPAA standards, but other standards as well for security issues. How might HHS approach in a more coordinated fashion how we would deal with security issues, obviously in the context of the HIPAA data standards as well.

Trying to improve the participation of the public health and research communities in the data standards development areas. The industry is fairly well represented, as all of you know, but it's fairly difficult to keep the public health flag and the research flag flying in the discussions. We would aim here to provide some convening role and some support to help with that area. And then in general, evaluation and dissemination of information dealing with EDI and the health care system.

Finally, the third theme deals with really the endpoint of all of this, delivering information to the folks who need it, customers, consumers, decision-makers, and the public health community. Here we would try to pull together some proposed investments that would try to make some of the data that is collected and is available easier to access, easier to use. And we would take the point of view of the user of information.

This is largely statistical information that we are talking about here. It would also support some training and technical assistance in these areas. It would help with building some expertise within HHS on analytic methods and translating data in useful information. And it would focus on some improved analytic methods, the counterpart to the improved data collection methods and tools.

There are several cross-cutting areas as well, as part of the initiative. These would be focused again on bringing the HHS community together on perhaps policy research on the privacy and confidentiality area; disseminating information and evaluating it. Again as I said, sort of an work in a virtual data warehouse for sort of unified user oriented director or access to statistical and research information. And potentially a small demonstration project that would involve support for a small number of states to pull together integrated information systems at that level.

And then finally, there would be the continuing work with the industry to provide health system data. This would the counterpart to the data gap area I identified earlier. This would be really HHS efforts to work with the various associations, the hospital association, the AMA, and others to see what data they have that we might use to see where we might pursue common and mutual efforts.

So let me stop there. Those are some of the updates on the population-based data area.

Do you have anything, John?

Agenda Item: Update from the Department, Privacy Component - John Fanning, ASPE

MR. FANNING: Two items. First, to update the committee about our progress on confidentiality regulations. As you know, the Health Insurance Portability and Accountability Act directed the Secretary to prepare recommendations on how to protect confidential. The Secretary proposed in September 1997 the Congress should pass a national law to protect health record confidentiality.

Congress has not taken any action on that. HIPAA says that if Congress doesn't take action on protection of information in the electronic and financial transactions in the claims system by August 20, 1999, that is one ago, the Secretary was then obliged to publish regulations covering that class of information by February 20. We are working very hard on a notice of proposed rulemaking to establish just such a regulation.

The official word is that we will get it out in the fall. The practical hope, and I think it's a realistic one is that we will get it out by about a month from now. I just call this to the attention of the committee, so the committee can plan its review of it. We are obliged to consult with the committee, and we'll value especially the views of the committee on that topic.

Are there any questions about that or related matters? Dr. Braithwaite will speak a little bit later about some related matters.

One other item which has been of interest in the past is the command of the Congress to OMB to modify the grants management circular A10 governing how federal grantees use their money, and how they conduct themselves. Congress directed OMB to amend that circular to require that anyone who gets federal grant money, and the results of whole research is used in federal policymaking be obliged to make the underlying data available to the public as if were federal information subject to the Freedom of Information Act.

The view of this Department is that it's highly desirable that such information be made available, but that it does seem the Freedom of Information Act intersecting with this circular is probably not the best way to do it. OMB published a proposal of how they were going to do that. There were elaborate comments from this Department.

They did publish a revision which improved their prior proposal in two particular ways that we thought were desirable. One, they redefined data so as not to include information that wouldn't be available on the Freedom of Information Act anyway. The practice effect of this would be most particularly from the privacy standpoint that the raw information would not have to come to the federal government for evaluation of its disclosability.

The second thing that we thought that they improved it with was in narrowing the definition of what federal policy action triggered the available of this information, and it is fairly narrowly defined to cover essentially rulemaking under the Administrative Procedure Act, Notice and Comment Rulemaking.

The Department and a large part of the scientific community commented in addition on the new proposal, and we rather expect that the next event will be the publication of a formal amendment to that circular by OMB.

That's all I have, Mr. Chairman.

DR. LUMPKIN: Thank you.

Agenda Item: Update from the Department, Data Standards Component - Dr. William Braithwaite, ASPE

DR. BRAITHWAITE: Well, good morning. Many of you heard Karen Trudel yesterday giving a detailed account of where we are with the HIPAA standards process, as you well know, because you have participated in the comments on the NPRMs. We published four NPRMs last year, notices of proposed rulemaking. And those four rules are very close now to coming out in final form.

The transaction and code set rule and the employer identifier rule are in the review and clearance process, which is sort of the last stage before they get published. And the security and national provider identifier rules will be going into that clearance process in the next couple of weeks, and should lead to all four of those rules being published in final form by the end of this year.

As a caveat of course, the clearance process, as you all know by now is fraught with uncertainty. So this is not something you can put in the bank, but it's our best effort to get things out by the end of the year.

Just to remind you, the provider identifier rule is one of two rules, that is it and the plan identifier rule, whenever it comes out, which is likely to have a delayed effective date. The provider identifier rule is something we are hoping to publish by the end of this year, but its effective date will not be earlier than July 2000, basically because we need to build a system to provide identifiers to providers when they apply for that, and that takes a little time.

We don't want to start the two year implementation time clock until we've got the capability of actually assigning the identifiers that people apply for. So you should expect a delayed effective date on the national provider identifier rule when that comes out.

In addition to those four final rules, we have three more notices of proposed rulemaking in the hopper, again either in or very close to the review and clearance process: a proposed rule for the claims attachment transaction; a proposed rule for plan identifier; and a proposed rule as John said, for health information privacy.

So we have seven rules going through the process, or about to go into the process for publication by the end of the year. We are very busy, as you can imagine.

Any questions? Thank you.

DR. LUMPKIN: Any questions on the departmental report? Well, thank you very much.

Obviously, the three NPRMs that are coming out will mean that we, as discussed earlier, will need to be able to figure out a way to those between our November meeting and February meeting, assuming that something happens between then.

Dan?

Agenda Item: Discussion of 21st Century Vision Project and CNSTAT Workshop - Dr. Friedman

DR. FRIEDMAN: Thank you, John. I'm going to spend a few minutes providing you with information about the current status of the Work Group on Developing a 21st Century Vision for Health Statistics, and where we are as the 21st century rapidly is approaching.

The work group has been active for 18 months, and it has included Barbara Starfield, Paul Newacheck, David Takeuchi, and I, along with a really active involvement and support from Gerry Hendershot and Marjorie Greenberg and Ed Hunter and Lisa Bradman(?) from NCHS.

The work group activities include four major components. First of all, commissioned papers. Five papers have been commissioned:

"Selected National Health Data Systems: A Background Paper for Planning the Future of Health Statistics in the United States," by Jennifer Zelmer(?) and her colleagues at Canadian Institute for Health Information.
"A National Health Statistics to Health Information Systems: A Model for the 21st Century," by Charlyn Black(?) and Nora LaRusse(?) of the Center for Health Policy and Evaluation at the University of Manitoba.
"Numbers We Need, Health Statistics and Health Policy," by Rick Cronick(?) at the University of California-San Diego.
"Health Statistics Needs for Children," by Lorraine Clearman at the University of Alabama at Birmingham.
"Characteristics of a Robust and Useful Health Statistics System," by Dan Melmick.

I'm pleased to let you know that we have received drafts in varying stages of draft-ness from four of the authors. The draft for the final paper is not due actually until mid-January. So we are in the process of reviewing those preliminary drafts. We have already had a couple of conference calls with the authors on the drafts. We have another couple of conference calls scheduled for this week.

Parts of those papers have already been presented. Jennifer Zelmer presented parts of hers at a June meeting of the National Association of Public Health Statistics and Information System. Charlyn Black presented parts of hers at a CDC meeting last week. And both have really been very well received, and have been really instrumental in stimulating conceptual conversation about where we are in health statistics in this country.

A second component to the process has been a series of a couple of discussion groups and a working session of the discussion groups focused on future health statistics needs and health information needs in the 21st century. Those were held in March and May, and included roughly 30-40 participants from a whole variety of sectors -- academia, federal agencies, states, and private, as well as non-profit. And a two day working session in March which focused on definition of and criteria for health statistics.

Draft summaries of those sessions have been completed, and I think are just about ready for being put up on the NCVHS website. They have been reviewed by all participants in the meeting. Personally, I think the discussions have been very helpful. On the one hand, they did not -- it's not as if they illuminated any brand new issues. And at the same time, they did serve to put on the table a whole variety of issues that we really need to keep track of, that we need to be aware of as we think about where we should be in 10-15 years.

And again, we had really good participation in the sessions, both from NCVHS, as well as from a variety of different folks. Barbara was at I think all of them. Jim Scanlon was there. Marjorie was there. Ed Sondik was there. Kathy attended one of them, et cetera, et cetera. So it was good participation and good discussion.

The third component of work group activities has been or will be the Committee on National Statistics Workshop, which is scheduled for early November. All committee members either have been or will be invited to that. The draft agenda for that is included in your agenda book.

Developing that agenda has been a iterative process, I think overall a pretty successful process with the Committee on National Statistics. Four of the five papers that we commissioned are going to be presented there. Dorothy Rice is going to be giving the keynote address, which I'm very much looking forward to.

And there are going to be sessions there on: health status and determinants of health; organization, delivery, and financing of health services; data policy and technology environment; changing roles and responsibilities the health statistics system; and finally, developing an agenda for health statistics in the 21st century.

There are around roughly 100 invited participants, which again represent I think a pretty good range. One hundred people is fairly limited, particularly when you essentially parse out us on this committee, the Committee on National Statistics members, the presenters, et cetera, et cetera. You are left with a smaller group than the ideal world one would want, but that group includes good representation from universities, state government, local government, federal agencies, and private industry.

The fourth part of the process, and one that we feel is especially important and we're really just beginning to emphasize now is a much more public process, and one where we are going to try to be soliciting input essentially beyond the Beltway, and two types of input. First of all, input in real, local cities and towns where people live who are end users of health statistics data.

To that end we are thinking of having three or four local meetings, one pilot local meeting perhaps in October in Harrisburg, Pennsylvania if we can manage that. And then three later meeting, which would probably be in communities that have participated in the turning point process, which John Lumpkin suggested, and I think is a really good suggestion.

Those meetings are going to focus again, on end user health information and health statistics needs. What do folks need now? What are they going to be needing in 5, 10, 15 years. And try to move beyond the relatively narrow circle of people we have been talking to.

Second, we've also been talking about having three regional hearings, again, to move out of Washington, but to get more state and regional level input on health information needs, and on drafting the health statistics vision. We see the process at this point as being essentially an iterative process, where following the committee meeting, following some of the local meetings, we are going to go back and draft some of the guts of a vision, and then take it back to this committee, take it back to regional meetings and get continued input on it.

There are a couple of products which we have been discussing, one of which is a vision report that would focus on principles, components, and second, hopefully an edited volume as well that would include the commission papers, and perhaps some parts of the CNSTAT workshop, as well as pieces of a vision report.

So that's where we are. I really invite comments from Barbara and Paul and Marjorie especially, who have been instrumental in the process.

DR. LUMPKIN: Paul, anything? Questions? I would certainly like to encourage all of the members of the committee -- we are having a shortened meeting in November with the intent that as many as possible can attend the workshop. This also is a component part of our NHII vision, and fits within that complex. Our intent of course is to have that vision, at least the next iteration of our description of it ready for our June meeting associated with the 50th anniversary activities.

So that certainly will be worthwhile. I know that there are some of the subcommittees that are also going to be having hearings during that time. So for those of you who are doing that, we would invite you to come when you can.

MS. GREENBERG: I think it would be helpful if any committee members' suggestions, particularly about the regional hearings, that the committee would sponsor. People are just beginning to think about developing those, and it possibly could be in conjunction with some of the goals of the NHII work group as well.

DR. LUMPKIN: I'm nodding vigorous, for those who are listening. I do think that thinking of this within the NHII context, and bringing those two together, it is really essential.

Agenda Item: Reports from Subcommittees and Workgroups, Action Items

DR. LUMPKIN: Well, thank you. We are a little bit ahead of schedule. So we are going to proceed on some of our action items. The first action item is the draft process. We have another iteration based on comments we received yesterday. I would like to pass this out and then kind of walk people through the changes.

The changes are essentially under 5 and 6, for those of you would like take a second to read those. Meanwhile, I will read them out loud for our audience out there.

Number 5, instead of the complicated section there, the new wording would be:

"When there is an advanced notice at a full committee meeting that an issue will require response prior to the next meeting, the committee will agree during the meeting on the procedure that will be used for developing the response." That dramatically simplifies that one.

Item 6, "If an individual member or staff person identifies an issue in between meetings that might benefit from committee input prior to the next committee meeting, that person will inform the NCVHS chair. The chair will consult with the executive secretary and the executive staff director, and at his or her direction with the executive subcommittee to determine whether a committee response is feasible, and cannot be deferred to the next full committee meeting."

"If a timely response is considered desirable, the committee will request a specific subcommittee or the executive subcommittee to take responsibility for developing the committee response. Members the full committee will be given a minimum of two weeks to review and comment on documents, and provide input to the response. Procedures followed then will be as follows:"

"If this process results in a specific recommendation by the subcommittee to the full committee, that recommendation must be deliberated by a quorum of the subcommittee members in a conference call that permits participation by the public. Approval must be by a majority of subcommittee members participating in the call. Notice to the public about the conference will be provided through a Federal Register notice if time permits, or be posted in the NCVHS website."

"After receipt of the recommendation from the subcommittee a conference call be convened of the full committee, again with an opportunity for public input as above. A quorum of the NCVHS membership must participate in the conference call. The first order of business will be a vote on whether to proceed with the recommendation to the department. A decision to proceed will require an affirmative vote of two-thirds of the membership. Vote on this motion may be by proxy if a member is not able to participate in the call."

"If it is agreed to proceed, approval by the full committee of any recommendations, comments, or other documents for transmittal to the Department will be majority of the members participating in the conference call."

What this change does is it recognizes that there are really two issues. Should we proceed between the meeting? And that requires a super majority. Once the decision has been made to proceed, then we would just take a majority of members to take the vote. And also it provides that should members who cannot participate object to the fact that we are proceeding, they can do so by proxy, as well as members who cannot participate, but may want to approve it.

So that would allow us to in fact reach the super majority if we so determine that's appropriate for the committee. And if not, then we would obviously take no action at the recommendation that are further on there, which was that individual members can then give their individual opinion to the secretary if they so choose.

That's the proposal. Questions?

MR. GELLMAN: This seems to be focused on making recommendations to the Department. It says the first order of business will be a vote on whether to proceed with a recommendation to the Department.

DR. LUMPKIN: Correct.

MR. GELLMAN: What if the committee wants to do something else? For example, one of the issues that came up before was comment on the OMB regulations on A10. So I just wonder if this isn't too narrowly focused. I don't know if that was a slip or that was intended or what. You also find the same language with number 3. It talks about when a matter in the Department may require committee response. That may not be inconsistent with the rest. That may just be an additional thing.

MS. GREENBERG: That's a fair point. I think in general the committee mandate is to make recommendations to the Department. Sometimes the committee comments on documents that the Department is also reviewing, and then the comments usually could go directly say in that example to OMB and would also go to the Department. Perhaps this is somewhat limiting in the way it's written. It could just say make recommendations.

DR. LUMPKIN: Wherever it says 'recommendations to the Department,' we'll say recommendations.

MR. GELLMAN: What if the committee wants to take actions that aren't recommendations? The committee could make a decision about something.

DR. LUMPKIN: Recommendation or action? Proceed with a recommendation, position, or action. So that will substituted throughout. Wherever it says 'recommendation to the Department,' it will be recommendation, position, or action.

MR. GELLMAN: I have a couple of other ones here. It says a quorum of the NCVHS membership must participate in the conference call. That's a sort of unclear what 'participate' means. If you have a two hour conference at which members were present, but not at the beginning, at the end, not in the middle, but just by the end of the call you happen to have had a quorum, but at no time during the course of the call you had a quorum present, you met the standard here, but you never met the quorum requirement. Is this loose wording?

DR. LUMPKIN: No, I think it would be consistent with Robert's Rules, which is what we tend to deal with the non-question issues. There would need to be a quorum to start. At any point, a member may call for a quorum. So that the intent would be that there is a quorum at that point, and a quorum when the vote is taken.

MR. GELLMAN: I'm worried that what you said is not what this thing says. I'm not sure I want to rewrite a whole set of parliamentary quorum rules, but I'm also not sure I want to change the policy that otherwise applies.

DR. LUMPKIN: A majority of quorum? In the last sentence.

MR. GELLMAN: By a majority of the members participating in the conference call, a quorum being present. I'm also going to make a suggestion that we expressly provide in the rules that all votes in a conference call be done by roll call, so that will demonstrate whether you have a quorum.

DR. LUMPKIN: A quorum being present, and by roll call vote. Let me read that last sentence. "If it is agreed to proceed, approval by the full committee of any recommendation, position or action will be by a majority vote of members participating in the conference call, by roll call vote, and a quorum being present."

Any other questions? Paul?

DR. NEWACHECK: Just one minor point. The bullet listed there on the top of the first page, they are described as principles, but they are really just phrases, and they need to be filled out a little bit to make them clear as to what they mean. For example, opportunity for public input. If you could say adequate opportunity for public input, just to fill them out a little bit.

DR. LUMPKIN: Well, in the desire not to see this document again, would be it acceptable to have poor English, rather than try to refine it?

Can I get a motion?

DR. STARFIELD: I move acceptance.

DR. LUMPKIN: It's been moved. Is there a second?

MS. COLTIN: Second.

DR. LUMPKIN: Further discussion? All those in favor signify by saying aye. Those opposed by nay. Abstentions?

[Whereupon, the motion is unanimously approved.]

The motion carries. Thank you.

Okay, the letter to the Secretary.

DR. COHN: Jeff, would you like me to handle this?

MR. BLAIR: Actually, in our meeting yesterday it was our subcommittee work group, and I think the letter is now at the stage where it was done by the subcommittee. So I think it's appropriate that Simon take the lead at this point and introduce it to the full committee.

Simon, do you agree?

DR. COHN: Yes, if that's okay with you Jeff. I think you all have the letter in front of you. We have actually done a little bit more wordsmithing even since this final version, and I just want to point out to you the wordsmithing that we've done, as well as the wordsmithing based on your input yesterday.

The first three paragraphs are unchanged from our discussion yesterday. As you remember, there were really no comments that any of you had on any issues related to it.

Based on your feedback for the need for a focus area on privacy, confidentiality, and security, we had added that where it says, "This report will address the following seven focus areas as they relate to patient medical record information." The final bullet, which we actually further modified now reads, "protection of privacy, confidentiality, and security." And we have stricken electronic patient medical record information, since in the top area it's very common for patient medical record information. So that's one change that we made from yesterday.

We have also on the second page, and I will just read this paragraph, since it also relates to privacy and confidentiality, which is the second paragraph on the second page.

"Many testifiers stressed the importance of legislation to protect the privacy and confidentiality of health care information. The committee recommendations will address these issues, as well as security requirements with respect to patient record information." That was once again, based on the input.

There is a typo. The final sentence in the letter, was not intended to be there. Where is says in "developing recommendations and legislative proposals," and that should be stricken.

One other change we made in keeping with the comments that the change be made on the first page of our letter is in Attachment 2. The final bullet now reads, "Protection of privacy, confidentiality, and security." And we have now stricken the, 'of electronic patient medical record information,' for the same reasons. That's once again in Attachment 2.

The document is otherwise unchanged from our reading yesterday. Comments, questions?

DR. LUMPKIN: It's been moved by Simon and seconded by Jeff. Are there questions on the motion? All those in favor say aye. Opposed say nay. Abstentions?

[Whereupon, the letter was unanimously approved by the committee.]

Anything else on this? Great.

The next item for action, Lisa, Medicaid managed care.

DR. IEZZONI: Okay, this is the report that just won't go away. This is again, the Medicaid managed care report that we presented to you yesterday. Our subcommittee did go through it yesterday afternoon, and made a very few minor kind of more typo and clarifying types of corrections that I won't go through, because they didn't change the meaning at all.

The only thing that we will hopefully add, which will be a single paragraph of more substance to make the following point. And that is that before managed care came into Medicaid, Medicaid agencies were collecting tons of data on patients. They were collecting enrollment information as people were getting into and eligible for Medicaid, and they were collecting claims for Medicaid services.

So what happened when Medicaid managed care came into being was that the types of data that were now collected were very different from what was under the initial Medicaid, and in fact they were less, and made Medicaid agencies be put in the position of not necessarily being able to monitor or oversee the care that they were giving to Medicaid beneficiaries, to insure that it was of good quality. There being adequate statutory language permitting those kind of data to be collected.

So what our report is hopefully going to do is not to propose additional data collection. In fact, what we are proposing is less data collection than was under the old Medicaid rules. What our report is hopefully trying to focus on is making data gathering more rational. And in fact at several points we suggest that they collect less data, because the case just has not been made for collecting all the information that some of the states have been proposing to collect.

So we are going to try to craft a paragraph that will be at the beginning of the report, because we feel that that historical context has been somewhat lost in the iterations, and that people may really not understand that what we're hoping to do is less than what was done before under old Medicaid rules.

Let me also say that we are concerned about privacy and confidentiality, and in fact went back to look at the original questions that we asked all of the people who testified in front of us during those many meetings in Washington, in Arizona, in Massachusetts. And there was an explicit question to them about whether they had privacy or confidentiality concerns.

So, at this point, hope that the full committee will recommend that the report be approved and forwarded to the Secretary. I think there needs to be a motion.

DR. MC DONALD: Just a clarification. You said you still have a paragraph to add which isn't there?

DR. IEZZONI: That's right. Let me amend what I just suggested. That the subcommittee would have your agreement that we would craft a paragraph that would put this into historical context.

DR. LUMPKIN: So the motion is to adopt the report with the inclusion of a paragraph that would embody your initial statement.

DR. IEZZONI: Right, putting it into historical context.

DR. LUMPKIN: Is there a second?

DR. MOR: I'll second that motion.

DR. LUMPKIN: It's been moved and seconded. Is there a discussion on that?

MS. FRAWLEY: There was a discussion this morning on this report in the Subcommittee on Privacy and Confidentiality. We were concerned that the report still did not adequately address privacy and confidentiality concerns. Our subcommittee is making the recommendation that a section be added to the report specifically on privacy and confidentiality. And that I would be working with the contractor to assume that responsibility on behalf of the Subcommittee on Privacy and Confidentiality, to make sure that that is reflected in this report.

DR. IEZZONI: I need to ask Marjorie for clarification at this point, because my understanding is that the subcontract has expired.

MS. GREENBERG: Yes, we are not in a position to ask for any additional work from the contractor.

DR. STARFIELD: I have a clarification that also. I mean basically this is our report, not the subcontractor's report. So there is nothing that prevents us from adding a paragraph, right?

MS. GREENBERG: Oh, no, it's just that there would have be another method for Kathy to work with the contractor. But we don't really have access to the contractor anymore. No, it's absolutely your report. Anything can be added, subtracted.

DR. MC DONALD: That complicates the motion substantially, doesn't it? We have a paragraph with a small paragraph missing, and something else which no one has seen.

DR. LUMPKIN: Actually, it seems that there is agreement that there needs to be some beefing up. The committee is suggesting that be done with an introductory paragraph embodying what Lisa suggested. The subcommittee on privacy is suggesting that it may require more than that, and they are offering to help in the process of rewriting it.

DR. IEZZONI: The introductory paragraph will not touch specifically on privacy and confidentiality. Again, it is to put our recommendations in the historical context of the large amount of data that were gathered previously on Medicaid.

DR. NEWACHECK: Kathleen, can you outline what would be in the section or paragraph on privacy that's not in the report now?

MS. FRAWLEY: Just really to put it in context in terms of this data collection; that patients' privacy needs to be respected, and that obviously there need to be procedures in place for confidentiality and security of health information. It would be based on some of the work that the committee has done before in its report to the Secretary.

DR. NEWACHECK: That seems not unreasonable. On the other hand, there is in our recommendation section right now, there are separate references to the need to protect privacy and confidentiality. But you still feel that is inadequate at this point?

MS. FRAWLEY: That was the discussion of the subcommittee this morning.

MR. GELLMAN: I don't want to restate everything I said yesterday, but adding a paragraph to this report that says we're all concerned about privacy as far as I'm concerned, doesn't accomplish anything. These are fundamental questions of how you collect data, how you use data. I think this committee was very ill served by its contractor. I think this report totally ignored alternative ways of collecting it.

I appreciate that the rules have changed. One of the advantages of managed care is that less data flows to the government. That's a benefit. If we're going to change that and go back to an old system, maybe things need to be reviewed I think to a certain extent. You may complain that the subcommittee's work is being judged by a shifting standard. I think that's a good thing. I think we're taking a harder look at privacy than we have before. What was done before isn't good enough any more, and that alternatives have to be looked at.

I think that the position that is reflected in this report is that collection and data use and data sharing is a good thing, period. And that there is no consideration given, and there is no balancing of privacy interests. I'm not saying privacy interests win all the fights. They have to be considered. They were not considered. Alternatives to using identifiable data were not explored here.

And I don't think there is anything that can be done easily or quickly by adding a paragraph or a section or whatever that is going to cure the fundamental problem here, that the concerns about privacy were not built into this problem when it was looked at, and some of the alternatives that are available that would accomplish or potentially would accomplish the objectives here, which are perfectly legitimate, as far as I'm concerned, would accomplish those objectives without impinging on privacy interests were not even considered or explored in the slightest, and that's my objection here.

MS. WARD: I think we have two investigations and two reports. Again, the paragraph that the committee was wanting to add without having it written is putting at a right angle, at least as said verbally. And it's the putting it into context it has nothing to do with.

I think that's what is really critical here. I think there is a continuum of how you want to address what Medicaid does about its data collection. We came at it from the middle of that continuum. I think the confidentiality and privacy committee, for very legitimate reasons, is asking us to look at it from an entirely different set of questions.

I think that's a different issue and a different report. I don't think you keep going back and redoing, trying to produce a different report. A report that is different than what the original goals and objectives are. Maybe now that we have passed down this road as a committee, we are looking at more and more issues. But I don't think we can keep -- I think it's a different issue and a different investigation.

I think it would take different questions. I think it would take different testifiers. I think that's my comment.

DR. LUMPKIN: Further comment?

DR. MC DONALD: We have a motion on the floor which was seconded, and we have another proposed amendment I guess, but that's how it is stated. I would like to know where we stand on a procedural vote, and what are supposed to do next?

DR. LUMPKIN: Well, the functions of Robert's Rules and rules of procedure are really to get the business of the committee moving. I think we have to be careful that we don't get caught, because usually one would need a motion to refer back to committee or some other action. But I think we need to have some agreement on what we want to do, and then we can go back into the procedural mode within that context.

DR. COHN: I'll make a comment. I also share Kathleen's concern that this document doesn't feel finished. I think there certainly needs to be a paragraph such as Lisa you have identified, though without seeing it in writing, it's hard for me to vote without a report where we are sort of adding things that we sort of conceptually hear for the first time.

I think that there is another meeting occurring in a month, and I think it's a much better document than the last we saw it. I think fundamentally it needs the paragraph you describe. I think it needs a section or something in the recommendations that have to do with privacy and confidentiality.

And I think we should try to get that done in the next month, with the idea that then we could look at it altogether and give final approval to it. I guess that would be my judgment or opinion on the process at this moment, recognizing that we're not waiting 6-8 months before our next meeting.

DR. STARFIELD: Can I just ask a suggestion. Is it possible to look at a paragraph say after lunch?

DR. LUMPKIN: I think the difficulty -- and this is kind of my take on this, and I know that the Committee on Populations has worked very hard on this report, and spent a lot of time and effort. But what I'm coming to recognize is that we as a committee have a fairly clear position on the issue of privacy. And it was clarified in a letter that we sent to the Secretary.

And we sometimes think about our documents, well, we've taken that position, now let's talk about the issues that we really want to talk about. But people from the outside I think look at our documents as a whole. They don't look at them in the context of what we have done before.

What I am hearing from the privacy committee is an offer which I think is one that we need to look at within the context of this report, but also in future work. I have this sort of discussion I was in and resulted in a request for them to pay closer attention to what we are doing on NHII.

We need to think about privacy in the beginning. What we tend to do is think about the key issues. I'm not saying we're opposed to privacy, but we are assuming that we have already taken a strong position, and we don't need to include that. In this particular report what the suggestion would be is to allow the privacy committee to add in those things that we have already decided, we've already had hearings. It's not new issues. It's really prior positions of the committee, and using that to sort of add to the report. I think that that's probably a reasonable thing to do.

DR. IEZZONI: I have no objections to that. The proposal of the privacy subcommittee was to work with the subcontractor to do that. And the subcontractor is not available to us. So it would require the privacy committee to have the time available frankly to write it themselves, without the assistance of Sara Rosenbaum and her group.

DR. LUMPKIN: And I think the committee chair said that's fine. So if it's agreeable, we can postpone consideration of this. I think that it's fair for the privacy committee to look at that, and at our next meeting also allow the originating committee to review what they have done to make sure it's consistent with what they have heard at the hearings. And then we will have a document that will be a merger of the work of the privacy committee and the Committee on Populations.

DR. ZUBELDIA: In the process of adding the privacy information about previous positions, could the privacy committee make an explicit reference to the recommendations to the Secretary so it's all included explicitly as part of this, as background information?

DR. LUMPKIN: I think that will be piece of our -- the committee may decide at some point, they may make reference to our prior document. They may decide that it should be attached as an appendix. I think that really kind of depends on how the writing goes. I don't think they should take that as a recommendation.

DR. IEZZONI: One final comment, and I'm going to say something which everybody has to understand I don't know anything about law. There is statutory authority for collecting information under Medicaid managed care. It's explicitly outlined in the report. So the only thing that I would request is that the privacy subcommittee, if you are making recommendations that go explicitly contrary to that statutory authority, that you highlight, so our report doesn't have this situation of proposing something that is contrary to what is currently law, and without making a -- clearly identifying those situations, and stating what our rationale is for doing so.

DR. LUMPKIN: Now in this context I think it also would be helpful if the paragraph that was suggested, if the population committee could prepare that. Because I think that's important to delineate that, that process of how you started and where you got there. Because that, as you suggested, isn't really talking about privacy. It's really simplification.

DR. IEZZONI: It's just the context of historically what happened before.

MS. GREENBERG: I'm sort of reluctant to say this, because I know there is really basically a month between now and the November meeting. I really think since although we don't like people to read just our executive summaries. We like them to read the whole report. That if it's coming back, I really think it's go to include the executive summary, because that's what you want to highlight.

DR. IEZZONI: We simply didn't have time to do it. I got staff to agree yesterday that the executive summary will be a verbatim listing of text from the report. And so it won't have any different words in it than what appear already in the report. We're going to need to talk to Carolyn about this. She was also going to be drafting that contextual paragraph.

DR. MC DONALD: I would just like to maybe highlight more of the paragraph that you keep describing as just being an historical -- in a good way. It really does say that we have gotten rid of some silly things. It really is a very powerful part of it, of what you have done, and it didn't come across as clearly reading through it as what you just said.

DR. IEZZONI: No. Can I just ask, do we have a breakout session scheduled at the November 3 meeting? We don't. So there is really not going to be any time for the subcommittee to look at this. So we have already planned what we want to do at the February breakout session, and I would hate to carry this over until February.

DR. NEWACHECK: Can we do it by e-mail?

DR. LUMPKIN: My assumption will be is that the changes -- it's really going to be a review by the committee to make sure that the changes that were made, don't change the intent and the content. I suspect that would not be a long discussion, and could be done by e-mail.

DR. IEZZONI: I guess my question is when will the privacy committee have their revisions ready to send to our subcommittee?

MS. FRAWLEY: I need a few days to write a paragraph.

DR. IEZZONI: Oh, a few days, that's great. Okay.

MS. GREENBERG: So I was going to suggest we actually agree to a timetable. It's micromanaging, but because I know how this works. I think you'll provide your paragraph to the subcommittee, and the subcommittee will provide its paragraph to the full committee, so that really everybody has had an opportunity to see whatever additions there are prior to the meeting.

DR. LUMPKIN: So two weeks for the other pieces, the two pieces?

DR. IEZZONI: I think what we will try to do is mail the full report to everybody two weeks prior to the November 3 meeting, not sending it out with the book, but sending it out two weeks prior to the meeting. And maybe with an e-mail, Marjorie, saying that it has been sent out. So if people don't receive it, that they should notify us, given what happened this time with trying to get agenda books to people.

Because one of the frustrations is that we have tried to have amply time for comment. And we want to make sure that that is respected.

DR. STARFIELD: I don't have any objection to that. But it's really hard to get a report two weeks before a meeting and read the whole thing. So if it comes, it should be clearly identified what is different.

DR. IEZZONI: I think that that's absolutely right. We have gone through the report, and should really only at this point be trying to look at what's been changed.

MS. GREENBERG: If it's going to be mailed two weeks before, then the interchange between the two committees has to have taken place prior to that.

MS. FRAWLEY: I was going to say, I will be out of town for the next week.

DR. IEZZONI: So will I.

MS. FRAWLEY: So I can have my comments back to Lisa probably by the 13th.

DR. IEZZONI: I will be out of town next week.

DR. LUMPKIN: So if we look for the exchange to occur somewhere two weeks out. That still gives us adequate time.

DR. COHN: I just wanted to sort of re-emphasize a point that I think Barbara was making, which is that I think at this point we have all reviewed what is a relatively long and relatively complex document. I am expecting that as this version gets refined, there will also be little changes that occur here or there or whatever. So all of these wordprocessors have an edit function in them. So we want to clearly identify for everyone any changes, any additional text, anything that is happening, so we don't have to go through comparing this document with the old, or necessarily have to review the entire document again.

DR. IEZZONI: It is not the plan of our subcommittee to make any other revisions.

DR. LUMPKIN: But any revisions that are made will be so indicated.

DR. IEZZONI: They will be paragraphs, and hopefully we'll have to figure out some way in printing it to put a bar across the margin or whatever.

MS. GREENBERG: Well, we can reference if it's literally one paragraph here and one paragraph in a cover note.

DR. LUMPKIN: Okay, we have plan. If it's agreeable with the committee, we will consider the motion to adopt withdrawn, and we will then take the plan that we have agreed upon, which won't require a vote, because we will take a vote at the next meeting.

DR. STARFIELD: Do we have to do another motion?

DR. LUMPKIN: If you are agreeable to doing that.

I think that's all for action items. We now have one item, which is a briefing on the revision of the standard certificates of live births, which the people giving that, we have asked them to try to come early.

MS. GREENBERG: Actually, Dr. Potrzebowski is here.

DR. LUMPKIN: That's only one of the three.

MS. GREENBERG: We still have need reports from the subcommittees and the work groups.

DR. LUMPKIN: Oh, sorry.

MS. GREENBERG: The ones that haven't reported.

DR. LUMPKIN: Yes, are there additional reports that the committees would like to make?

DR. IEZZONI: I would like to make one. Because I really want to enlist Kathleen and Simon's help in the initiative our subcommittee will be undertaking, and I want to make a formal invitation to you to do that. Again, this is the Subcommittee on Populations.

We are tentatively planning, although we're going to firm that up at our October 28-29 meeting to spend the next nine months or so looking at how to capture information about how live their daily lives. Functional status is a phrase that is often used to describe this, but it really has to do with the health and well being of the population.

This information could be used for many different purposes. It was first targeted in the core data elements project that a number of you are very familiar with, where we basically a placeholder for functional status information, because we didn't know how to do it. At this point what we are going to try to do is spend the next year trying to figure out how to fill that placeholder, or whether we should even try to fill. Whether there are feasibility and other problems with doing it. Whether it is something that our health system should consider further.

We believe in confronting this, that it's going to present considerable issues both for the standards of data transactions, because we really envision this being part of the fabric of the health information infrastructure, and not special data collections, such as surveys.

But it also will have very significant implications for privacy and confidentiality, because some of the information will be of a highly sensitive nature. And we are specifically intending at this point, to hear from advocacy groups for people with disabilities, and people representing vulnerable populations to see how they feel about collecting this information that could be used for their benefit in the sense of monitoring and improving health systems for addressing clinical needs, but could also be stigmatizing and could also be deleterious to them, especially given the fragmentation of our health care system and the 45 million uninsured.

So there are a lot of issues that I think we would very much benefit from on the participation of the privacy and the standards subcommittees. So we just would like to make a formal invitation at this point to have you participate with us. What we would like to know is how would be the best way to facilitate that.

We do have four meeting dates planned, one for the end of October, as I just mentioned, October 28-29, again in January, again in April, and again in July. So we can at least give you the meeting dates, but Simon and Kathleen, you need to let me know exactly what procedures you would like to undertake to participate. It could be that some of these meetings would be jointly convened by the various subcommittees.

DR. LUMPKIN: Now let me just clarify, it's my understanding that what you are talking about is a high level presentation on this. It's not the intent to go down to the point of actually indicating code sets or so on, but trying to describe the code sets that may be required?

DR. IEZZONI: That's true. As I said to the subcommittee, my vision of what might come out at the end of this is recommendations for exactly what kind of further study would be needed. Because I think that this is going to be a very complicated issue. We might find at the end of the year that it's not ready for prime time in any way at all.

There is a code set that is used internationally, and that's the ICIDH. We may -- I don't anticipate that this will be the case -- we may feel that we hear from the field enough interest in the ICIDH that it may come that we might recommend that to be used in specific settings. I don't anticipate that that in fact be the level of detail at this point in time.

Especially for pediatrics, because again, as Paul and Barbara have eloquently stated, the state of instrumentation about measuring how people live their daily lives if they are tiny infants or children is at a much less developed state than it is even for adults, where it's also similarly kind of only half-baked.

DR. COHN: Well, first of all Lisa, thank you very much for the invitation. I think I speak for the subcommittee. I think we will try to participate as much as possible. I do have a suggestion just in terms of committee process. At least in some ways on the Medicaid report that we had, which is that I think when a subcommittee goes off to do an active that is in-depth and rigorous, trying to keep the rest of the committee up-to-date on what's going on is always an area that is difficult, but not doing it is fraught with hazard.

So I think that we need to figure out a way in either the February or upcoming meetings to maybe create a way to communicate to the full committee some of the thinkings and learnings from this activity. So it's just something that Kathleen Frawley or myself is exposed to, but we all have a chance to see and comment on where the thinking is going.

DR. IEZZONI: I noticed Marjorie squirming a little bit, Simon, because in fact during the Medicaid managed care report all the agendas of all of our meetings were sent to everybody. All of the minutes of all our meetings were sent to everybody. And I guess the question is, what procedures in addition to informing everybody about all of the agendas -- exactly who is going to be speaking, which is what has happened all along. You will see in your books here everybody's meeting agendas and who came to talk to them, and the minutes. What procedures in addition to that would be helpful?

DR. LUMPKIN: I think what I take from Simon's point, listening to that, is that at the full committee meetings we may want to just have a summary discussion in February, and again in June that would allow the full committee to at least get some idea of what you are thinking about based upon what you are hearing.

DR. IEZZONI: I think that that's fine. I hope, however, that there will be more involvement. I think merely giving a five minute presentation does not satisfy my hope, especially on the privacy side for involvement.

DR. LUMPKIN: I don't think that's a substitute for more direct involvement either through a liaison membership. But I think that there may be some benefit of more than five minutes; maybe a half an hour kind of here is what we are hearing. Here are the kinds of issues that we are trying to tackle.

I think that's true for perhaps some of the work of the other subcommittees. Because what we end up doing is that when the work group on patient and medical records and electronic transmission thereof, when they issue their report sometime next spring, and we're going to have to get it to the Secretary by August, there are some people on this committee who will not have seen really much or anything.

So it really begs the issue not just for what you are doing, but for the other subcommittees to think about a process of trying to bring the committee up to speed. We did a better job of that when we were working on the HIPAA standards, and we did have some updates. I think we just need to go back to doing that. So that's kind of like on me for scheduling the agendas. We'll try to do that better.

DR. FRIEDMAN: John, this is a related point, not on the Medicaid managed care report, but on the process for reviewing and vetting committee documents, which is at some point hopefully in the not far future, we will be developing our vision report. One issue that at least I've been repressing as far down as I could, but bubbling up in my active conscious right now is we talked about this as a joint process for NCVHS, NCH, and the Data Council.

And specifically the issue that we're going to have to deal with is, is this going to be a joint report of all three of us, et cetera, et cetera, and what's the vetting process that we will need to go through? That's not something that we have explicitly addressed. The vetting process is not something that we have explicitly addressed really in any way other than sort of acknowledging that this is a joint project, and this will be a joint report.

DR. COHN: First of all, I feel funny, because Lisa, it's still your report. I will comment to you that Jeff and I and the Subcommittee on Standards and Security have been talking about the same sort of issues and related to the report on patient medical record information. We actually are in our section going to talk about how we see getting input. Not necessarily co-sponsoring, but we think that important reports that come out of this group need to be vetted and discussed in other venues, such as you are discussing. And we have a process that may be of some help to you.

Lisa, are you done?

DR. IEZZONI: Oh, I'm done.

DR. COHN: Should I ask Jeff to talk a little bit about the process then?

DR. LUMPKIN: I think we'll probably --

DR. COHN: After lunch?

DR. LUMPKIN: Yes, because we're pushing on the lunch hour. Perhaps we will do that as part of your report. I think this begs a number of issues, and certainly that which we'll have to discuss in the Executive Committee. It gets to we come together for two days, and we try to spend as much time in the subcommittees meeting, that we have reduced the amount of time that we spend in the full committee. That makes it a little bit difficult.

So we're just going to have to go back to that old struggle of committee time versus subcommittee time at the meetings. But we need not do that right now.

Anything else, Lisa?

DR. IEZZONI: No, I'm fine.

DR. LUMPKIN: Well, I'd like to thank you, because I think you are, in raising these issues the way you are, you are raising important issues for the committee as a whole and how we do our business. This is a very busy committee. I think all of the members kind of feel that, and we're trying to maximize our time at the same time. Recognize that we individually, as parts of the committee, have responsibility for all of the work of the committee, because it will come to us all, and to try to figure out how to do that is going to be challenging.

So why don't we think about that over lunch, and maybe we'll have a solution when we come back. I doubt it.

The work group on the NHII will be having lunch together back here, much as we did yesterday. We are reconvening at one o'clock.

[Whereupon, the meeting was recessed for lunch at 11:55 a.m., to reconvene at 1:00 p.m.]

A F T E R N O O N S E S S I O N (1:08 p.m.)

DR. LUMPKIN: We have with us Mary Anne Freedman, Director of the Division of Vital Statistics at NCHS. And something I didn't realize is that Mary Anne is originally from Vermont. See, you know someone forever, and you learn something new every day.

Trish Potrzebowski is Director of the Division of Health Statistics in Pennsylvania. And Dorothy Harshbarger is state registrar from the Alabama Center for Health Statistics. I think I'm going to see your boss tomorrow, since ASTHO, which is the Association of State and Territory Health Officials has its meeting in Savannah, Georgia.

Agenda Item: Briefing on Revision of U.S. Standard Certificates of Live Birth and Death for 2002 - Mary Anne Freedman, NCHS

MS. FREEDMAN: Thank you very much, Dr. Lumpkin.

I'm Mary Anne Freedman, as Dr. Lumpkin said, from the National Center for Health Statistics. With me, my colleagues are Trish Potrzebowski, who in addition to being from the Pennsylvania Department of Health, also was the chair of the panel to evaluate the standard certificates for this round of revision. Dorothy served on the panel as the chair of the subgroup that addressed the issues related to the birth certificate.

We are here to tell you first of all a little bit about the process we have gone through over the course of the past two years, and then to talk a little about the new certificates.

Just let me begin by reminding you of a couple things about the national vital statistics system. First of all, it is state-based. There are no federal laws requiring the registration of births and deaths in the United States. We do at NCHS, have a legal mandate to collect vital statistics data from the vital records that are registered in state health department. When I use the term 'states' I'm using it as a bit of shorthand. There are actually 57 official registration areas within the United States, but we'll call them states for the sake of brevity.

To insure uniformity in national vital statistics NCHS periodically issues recommended standards that take the form of model laws, standard definitions, reporting forms, et cetera. The states adopt these form voluntarily. The standard certificates are models used by the states in designing their own data collection instruments, their birth certificates and death certificates.

The federal has been issuing model standard certificates for many years. The first standard certificate of death was issued by the Census Bureau in 1900. Since then the death certificate and ensuing birth and fetal death records have been revised periodically, generally on approximately a ten year cycle.

The revision that is being used currently in the United States was implemented in 1989, and these are the documents that we going through a process to evaluate and revise over the past two years. The revision process is a cooperative effort of states and NCHS, and generally we accomplish it through the work of an expert panel that we appoint at NCHS.

The panel for the current revision consisted of 24 members. As I said, it was chaired by Trish. I think that Jackie handed out a list of members, or it's included in your agenda book. Just let me run over the types of people that we had on the committee. We had state vital registrars and directors of statistics, organizations that had a stake in the process, and some independent researchers.

Types of organizations that are represented on the panel were: the American Medical Association, ACOG, the American Academy of Pediatrics, the College of Nurse Midwives, the maternal and child health project directors, the American Health Information and Management Association, the National Funeral Directors Association, the National Association of Medical Examiners, and the College of American Pathologists.

The panel's charge was first of all, to review the current certificates to evaluate the existing data in terms of its utility and quality for both statistical purposes and legal purposes for which vital records are put to.

Secondly, to identify unmet data needs, which the standard certificates would be an appropriate data collection mechanism, looking out 10-15 years into the future.

And finally, to recommend the content, format, and item definitions for the new standard certificates. We did this with the eye to the fact that the certificates are really no longer just paper documents, but really a standard data set, with emphasis on electronic data collection.

In undertaking this charge, the panel set several goals. First of all, to educate data users and providers about the vital registration system in the United States, and to suggest alternate data sources when vital statistics might not be the most appropriate source.

Secondly, to recognize that data needs differ at different levels of government. More detailed data may be needed at the state level than at the national level. And the needs at the local level may be different from those at either the state or national, because the intended uses of the data are different.

Finally, the panel thought it was important to identify at least the major users for each data item, and also in those instances where we decided not to recommend an item for inclusion, to give specific reasons for that.

The group worked through four subgroups which addressed the content of the birth certificate, the death certificate, and the fetal death report. And a fourth group that looked at standards and designs, and looked at not only the design of the paper document, but also electronic systems.

There was an oversight committee called the parent group, which was charged with reviewing the subcommittee recommendations and making final recommendations to NCHS. This group consisted of 11 state registrars and statisticians, and essentially represented the programs that will have to implement these recommendations.

Just a note about the type of input the panel got for its work. NCHS surveyed approximately 1,600 organizations and individuals to get suggestions and recommendations for the revised certificate. The panel also took personal testimony, both written testimony and oral presentations from organizations and experts. We did also put together two small expert medical groups of people who were not on the panel, but who came to provide us with advice on specific issues related to the medical items on the birth and death records.

Last April the panel completed its work after 15 months, and has submitted its recommendations to NCHS. What I would like to do right now is to stop, and to turn this over to Trish, who is going to talk about some of the items that are common to all certificates, and also talk about the fetal death record and death.

DR. POTRZEBOWSKI: Thanks, Mary Anne.

I also want to thank you with the opportunity to provide you with information on the revised standard certificates as developed by the panel. The major recurring theme through all of our efforts was to improve data quality for vital statistics data.

The panel developed three criteria for the revision process, and each of the criterion needed to be met in order to include an item on the new certificate. The three criteria were, first data were needed for legal research or statistical purposes, or for public health programs. The second criterion was that the data must be collectible with reasonable completeness and accuracy. The third criterion was that the vital statistics system needed to be the best data source. That is, if the information could be better obtained elsewhere, it should probably not be included as part of the standard certificate.

For the first time this time with this revision the panel is recommending further testing take place for selected items, as well as the development of a detailed implementation plan. This is something new. Previously, panels would recommend that an item be on the certificates, and they would just be put on without further testing.

We have also focused more broadly on the entire data collection process, not just on the data collection instruments. For the first time, in the revision process we essentially designed an electronic data set, not just a piece of paper. This provides many opportunities for expanded instructions, health screens, a number of techniques to improve data quality.

For example, we have developed worksheets for both the birth certificate, and the fetal death report. While we still needed to design paper forms, which you have in your packets, we were not as constrained by page sized limits as in the past. We also developed a complete package, as I mentioned before, including both worksheets and instructions, not just the certificates themselves.

A number of recommendations were made by the panel that also addressed improvement to the state vital records system, such as training and education of data providers, quality assurance efforts, public relations, automation, as well as resources needed, and evaluation of the revision process, and suggestions for the next revision of the model vital statistics law.

The first thing I'm going to be doing today is reviewing the three items that affect all the certificates, race, Hispanic origin, and education. These items have been standardized across the certificates. Race and Hispanic origin have been redesigned to conform to the revised OMB guidelines, and all three items are modeled after the 2000 census questions.

The first revised item on all certificates as race. As per the revised OMB guidelines, the new certificates will allow respondents to report more than one race. These certificates will contain the instructions 'check one or more races.' This of course will present new challenges for both data collection and data analysis. Please note that the race question on the certificate differs slightly from the OMB guidelines by adding an 'other specified' category. This is consistent, however, with the plans for the 2000 census.

Hispanic origin is the second revised item on all certificate types. This item also conforms to the OMB guidelines. You will note that this question is asked before the race question on each certificate.

Education is the third revised item on all certificates types. Again, this item adds additional categories to distinguish among various levels of education after high school, as does the 2000 census. It also collapses education below the completion of high school into two categories, grade 1-8, and grades 9-12.

Next I will review briefly the changes to the death certificate. I think you all have in your packet, copies of each of the forms. You will see now that the death certificate is now a multiple document. I don't know if you can read that slide, but basically that's just showing you that have instructions on the top for the certifier, the physician, and then you have the certificate itself on the second page, and the third page consists of instructions for the funeral director.

For the most part, the existing items on the new death certificate did not change. However, the panel added three new items to the certificate to address public health concerns, and those three items are tobacco use, pregnancy, and traffic status.

The first new item on the death certificate is tobacco use. The tobacco use item was added because this was a major public health issue and better measures are needed. Currently, tobacco use is not well reported as a contributing cause of death. This question, which will serve as a prompt to help eliminate underreporting will be treated as if tobacco use was an entry in part two of the cause of death section.

The question format is based on existing questions in two other states. Utah and Oregon already have this item on their death certificate. They have been quite successful in substantially reducing underreporting of tobacco use.

The second new item on the death certificate is the pregnancy item. Maternal mortality, while much reduced in the past century, is still an important public health issues. Studies have indicated that a separate question on pregnancy improves the quality and completeness of data collected on maternal death. This question will help with the ICD-10 coding, and is supported by ACOG, CDC, and the World Health Organization.

The third new item on the death certificate is traffic status. Again, this question will facilitate ICD-10 coding, which places greater emphasis on traffic status information than does ICD-9.

The next form that I'm going to go over is the report of fetal death. In appearance, the new fetal death report form closely resembles the proposed birth certificate, with an addition of a cause of death section. In fact, many of the items on the fetal death report are the same or similar as those found on the birth certificate. This is to insure consistency between the two data files.

However, in several important areas the revised fetal death report differs from that of the birth certificate, and also from the previous version of the fetal death report. For example, both the new fetal death and the new birth certificate include the item risk factors in this pregnancy. Some of the risk factors such as hypertension, are the same on both the birth and the fetal death list, but there are other items such as motor vehicle accidents, acute drug effect, and prior incision of uterine wall, which are risk factors more specific to fetal death, and are included only on the fetal death certificate.

In addition, previous adverse pregnancy outcome is a separate item on the fetal death report, which permits the reporting of six different adverse outcomes such as previous neonatal death, and previous delivery with a congenital anomaly.

Another item common to both the revised fetal death report and the birth certificate is infections present and/or treated during this pregnancy. However, in the fetal death report there are additional infections that are added, in addition to the ones that are already on the birth certificate. Those are more relevant to the assessment of fetal death, such as listeria and toxoplasmosis.

The most significant change though from the 1989 revision of the fetal death report is the section related to the cause of fetal death. For decades the fetal cause of death was collected using a format virtually identical to that found on the death certificate. But unfortunately, substantial numbers of fetal death reports were registered with very inadequate descriptions of the cause of the fetal death.

So in order to address this issue, a new format was developed which combines check boxes of some of the major causes of fetal death, along with additional space to specify the detail about the cause of death. The one that was just up was for the initiating cause. Then the second one, which is very similar, is for other significant conditions.

So these check boxes provide guidance about the information which is desired, while the specified lines allow the certifiers the flexibility to describe the cause of death. There are some other new items that were also added to the cause of death section, and you can see those on the actual death certificate. They are included to help with the investigation of the cause of fetal death. They include questions about autopsy, pathology, and the physiologic characteristics of delivery.

Now as I mentioned before, standardized worksheets for the mother and hospital staff were also developed which will include clear, unambiguous questions, definitions, instructions, and information on the preferred sources of data, and where in the records that information is most likely to be found. These worksheets we hope, will assist with the data collection process.

In conclusion, you can see that the focus of the revisions to both the death and the fetal death certificates are to improve the quality of the data being collected, and especially to further clarify and improve the cause of death entries.

Next, Dorothy Harshbarger, who chaired the birth certificate subgroup, will describe the changes to the new certificates of live birth.

MS. HARSHBARGER: Thank you. We made a lot of different changes to the birth. The panel made a lot of recommendations for those. And so we are going to go through a number of those today. And for completeness, we have essentially included all of the slides here, so that you have the information.

A number of items did stay the same. This is a list of some of those. We stay the same. There are a couple wearing some minor changes, such as the time of birth. We're now asking for a 24 hour clock. And in birth weight we are asking for grams. They are really just minor things on those items.

We did delete some items from the old certificate. We decided that since we are moving into the electronic age we don't need the signatures as much anymore. We are recommending that they no longer be collected as signatures.

We found that the alcohol question, the way it was worded in the past, we got very poor data from that, so we dropped that question.

A number of items remain on the certificate, but they have been modified to some degree. These are really modified very slightly. For example on the first one, the place where the birth occurred. We are adding a box asking if it's a home delivery, was it planned to be at home. Those kinds of little things that help us get some more specific information.

In the pregnancy history we just changed some of the wording to help clarify the question. We really didn't make a great number of changes on any of these questions.

Obstetric estimate, we changed the wording there to revise from the clinical estimate. So again, hopefully just get some better information.

Some of the other items we modified a little bit more. The tobacco use question, it was decided it really wasn't that useful the way it stood. So California had done some studies, and had tested out a number of different questions. The question that we are proposing, the new question, both of them are shown here. But the new question, we are looking for the change in smoking over the pregnancy, and are basing this on some of the studies that were done in California.

The weight gain during pregnancy, again, that item was not useful as it stood. We didn't have enough information to really make use of just the pounds gains. So in order to be able to use the question, we are proposing the additional items as a height, prepregnancy weight.

The other thing we found is the mother is often asked the weight question. That is not the best source of the information, so we are proposing that the information be taken from the prenatal charts.

On the month the pregnancy prenatal care began, this is another one that has had much discussion over the years as to what does this really mean? So in order to hopefully get better information, we are also proposing a change here. That is that we collect month, day, and year that prenatal care began, and that we get this information from the prenatal care record.

For Apgar score, we dropped the one minute Apgar score, which some of the physicians on the panel thought was not as useful. It was determined that we should keep the five minute Apgar score. And then to get more additional information on really the progress of the infant, if the score is less than six at five minutes, then we would want the score again at 10 minutes, because the physicians felt that this was a better indicator of some of the problems that the infant might have.

In order to look at our medical items, and if you are familiar with the birth certificate, we kind of call those check box items, because they have so many check boxes at the bottom, and they were revised that way in the past. We decided we needed to do something a little bit different.

As Mary Anne indicated before, we set up a special panel to make some recommendations to us. The panel came up with the recommendations for the birth subgroup to look at. They consisted of people from the American College of Obstetrics and Gynecology, and the American Academy of Pediatrics.

The criteria that were considered when you look at the medical items were, were the data needed for research purposes, statistical purposes, or for a public health purpose? Were the data collectible? Could we get them through the birth certificate? And would the data be available when the record was completed? Some things you can get, but it's not available at the time this is completed.

And is this the best source to get them? And if the data were available from another source, then it was likely that we would collect them through that source. So those were all considered by the panels that made recommendations back to the group.

We also set up some focus groups. Once we came up with some possible questions, as I said, they were different from what we had in the past. In Alabama and New York City we pulled in some staff from hospitals. What you will find is that people in the hospitals that complete these are generally clerical staff, and generally not well trained. They are usually the lowest clerk.

We wanted to get some reactions from them as to some of the proposals. We were surprised. The results were favorable, but we also learned that we needed to help them. We needed worksheets. We needed to provide information back to them so that they could see what to extract from the record, and we made a recommendation to have worksheets.

We also had a group that made a mini test of some of the proposed questions. Our representative from the American Health Management Association worked with someone from the National Center. They went out to a hospital and tried some wording of the questions. Again, we learned a lot. We found out we do need to do a lot more testing. We found we do need some rewording of the questions, and so we made a lot of recommendations in this vein.

Well, the categories that were modified were quite a few. The risk factors for this pregnancy. While we deleted some items from the old certificate, we also added some items here. One of the ones that we expanded was the diabetes for the prepregnancy, and then the gestational diabetes. That was one that we had been asked from the public health community to do some work with.

Another one of interest is pregnancy resulted from infertility treatment, which is a new question on there. Again, a lot of interest, and we seem to be getting a lot of outcomes from those that we can look at. So hence that question was added.

Another one that was modified was obstetric procedures. There were substantial changes here. We took off a lot of the questions that were there, and put some information with procedures on timing of delivery, and on fetal presentation. Again, some of these indicate the importance of worksheets with definitions so that the clerk who is extracting this can get the correct information.

The method of delivery, we expanded that question quite a bit. The fetal presentation was new. Previously that was in the complication section. It was moved to this section, because it really relates to the delivery. This question is continued on the next slide. Again, all of these are available from the delivery record, and we felt that they could be obtained quite easily.

These questions were also reworded quite a bit, hopefully to improve the information that we do get, particularly on the cesarian sections.

Abnormal conditions of the newborn. This was changed considerably also from the previous records, and this one we worded to get some information about the newborn and some of the treatment that was involved. It could be some indications of some of the problems with the newborn.

The congenital anomalies. On this one we have proposed a much condensed version of the question. Much of this we are not sure is evident at birth. The intent here was to try to get those that are evident at birth. And also that this question serve as what we'll call an alerter to those states that have birth defect programs. It's not meant to be the definitive source. It's just meant to be an alerter so that the states can do some follow-up to get the information into their birth defects registry.

New items, the characteristics of labor and delivery replaces what we used to call complications of labor and delivery before. In this case what we are trying to do here is look for some actions and conditions that would be present during the labor and delivery.

The chronology of labor and delivery. This is one that the group recommended to include to get better information on such things as the length of labor, the length of stay in the hospital prior to delivery, the interval between rupture of membranes and delivery. And all of these are available from the delivery log, so that they can be obtained.

Infections presented or treated during this pregnancy. These are specific infections that we felt were important to look at during the pregnancy, whether they were present during the pregnancy. I will mention that one, we normally asked about HIV is not up there. That's not up there for a specific reason, and that is that many states have a problem with confidentiality related to this one.

I will also note at this point that states do have the option -- while this is the standard recommendation, states do have the option to put questions on that they want to put on. For those states who wish to, they can the question on HIV. But I did want to point out that we made a definite decision not to include that one.

Questions on maternal morbidity were added also again for significant indications of maternal problems that may warrant some further follow-up.

Other items that were added relate to some different areas. The question on source of payment is on a number of state certificates now. It is on Alabama's for example. We have found this question very useful in looking at the Medicaid program, and making some evaluations between the persons who are on Medicaid and other programs. Also it's somewhat of a source of looking at socioeconomic status if we can get some of this information.

Another new item was the Social Security number requested for this child. And also the Social Security numbers for the mother and father. These are questions that are on most state certificates now. We have added them to the standard just for completeness here.

Was the prenatal record available for completion of the birth certificate? This was added as an attempt to make sure that that was available. To see if available, and determine the source of some of the information we are getting.

Did the mother get WIC? A very important question for public health and the public health arena.

Other new items that we are proposing, if available for both the facility and the national provider identifier, and also the mother's medical record number, the newborn's medical record number. These are important for follow-back and linkage to other data sets.

The question on is infant living at time of report, this is also useful for the states to search for infant deaths and linking back for infant deaths.

And is the infant being breast fed is a very important question our maternal and child health area. This is one that we did a lot of rounds on how to ask the question and ended up with this version, but we recommend that a version be on there if this version doesn't prove to be the appropriate version in the testing.

And I will emphasize again that we also made a lot of recommendation for a complete package of worksheets that are thoroughly tested. Separate worksheets for the parents and the hospital staff, with complete definitions on the worksheets. The testing of the items is extremely important to make sure that the questions can be answered by the hospital staff in the way we intended.

Then the other area is that there is be appropriate standards for the collection of these items when states collect them through the electronic birth certificates, which are already available.

So with that, I'll turn it back to Mary Anne.

Well, we think the panel has done an excellent job in giving us a product that we can work with. So the question for us at NCHS is where to do from here. Our goal is to implement the new certificates in January 2003. In order to get there, I know that seems like it's a long way off, but there are a lot of things that need to be done in the interim.

We have to first of all work with the states to get buy in from all of the states. And the implementation plan that we have mentioned is an important part of that. We have just in the past two or three days let a contract to field test the parts of the certificates and the worksheets that you have heard mentioned. And that will include also an iterative process of making modifications as necessary.

We have got another contract that we have let this summer with George van Amburg, who is a former member of your committee to develop the data specifications for the new data sets.

And once the field tests, the modifications, et cetera are complete, Dr. Sondik will send the certificates through the Department for clearance. The revised certificates then would be released to the states by the Secretary, as has been the practice in the past.

Our goal is to have the final products, including the certificates, the worksheets, the definitions, file specifications, requirements for electronic registration systems, et cetera out to the states by the year 2000, which will give them two years to take the necessary steps to implement it in 2003.

The other important component of that of course is we're going to have to have funding in place to help partially cover state efforts in implementation.

So that's where we are in this right now. We would be very pleased to answer any questions, and thank you very much for the opportunity to talk to you.

DR. STARFIELD: I have two questions. One of them has to do with the contract that you mentioned. There is a far amount of literature recently about the importance of community context. I can't see here -- it's not obvious to me how you are going to get that by zip code or block or whatever it is.

The other is the specific bacterial vaginosis. There is a lot of thinking about that being related to low birth weight. I guess the current thinking is that it's not, but I don't know that the issue has died yet. You're not getting that on the birth certificate.

MS. HARSHBARGER: I can't speak specifically to that. I'm not a medical person. As I said, the items were recommended back to us by a panel who looked a variety of things. Primarily what we ended up with were the items that they recommended. We didn't make a great deal of changes to those items. So they did not recommend that one back to us. I can't answer why, but we can find out and let you know, but I can't specifically tell you.

I can also answer your other question. I didn't go into this in a great deal of detail. We do have the mother's residence on there. One of the new fields we added specifically was the zip code. So we do have all of that on there. The states do code to a great detail in the states themselves, many times to using geographic information systems to get to a lot of small level data.

DR. LUMPKIN: Other questions?

DR. ZUBELDIA: I have kind of a difficult question. On the fields that you haven't changed, some of them show updates with two digits for the year. You are probably going to have to change that to four digits.

MS. HARSHBARGER: Oh, absolutely. That's an oversight on our part.

DR. ZUBELDIA: It looks like in the characteristics under labor and delivery, method of delivery, you have some redundancy. One of the characteristics of labor and delivery shows non-vertex presentation. And method of delivery shows fetal presentation, cephalic, breech, or other. Could that lead to inconsistencies?

MS. HARSHBARGER: It could. I noticed that myself as I was going through some of these in preparing the presentation. As I said, I can't speak to specifically why the medical group recommended specific things in specific questions. But we can go back and ask them, and make sure that we are very clear on those, and get that clarification for you.

DR. ZUBELDIA: I would remove the question about external cephalic version, successful and failed down to where it says fetal presentation. Maybe, I don't know, if it's cephalic, there is no sense in asking the other question.

MS. FYFFE: In block 43 you talk about infection --

DR. LUMPKIN: Which one?

MS. FYFFE: The live births, the draft. Infections present and/or treated during this pregnancy. You have several check off boxes, and then you say none of the above. Do you want to have a blank there for fill ins there, or you just don't want that at all?

MS. HARSHBARGER: No, we made a specific recommendation not to do a blank for other, specify in most of these cases, because as I said, many times it's a clerk in a hospital who is extracting the information. So it would be difficult for someone like that to do the extractions. If states do decide they need other infections, then they can add the questions as they choose.

DR. POTRZEBOWSKI: Can I just add in answer to the question on the vaginosis, and also on this question, remember that states can add or modify these. We have actually had the question on vaginosis, and I think that there will be one to states who may add those items. Then of course that can be our test for the next revision, just as the smoking was with Oregon and Utah adding the question. It was very helpful to us, because there were several other different smoking questions, but we found that those two states, the way they asked the question worked the best.

So we really do not discourage states from adding their own questions. We encourage it, because then it helps us with the next edition.

MR. GELLMAN: I haven't noticed on your materials that you included a Web address. Is all this information up on the Web somewhere?

MS. FREEDMAN: I don't believe we put the drafts up there yet.

MR. GELLMAN: Is there a reason why not?

MS. FREEDMAN: Because they are still in draft.

MR. GELLMAN: Lots of things are in draft and still on the Web. You are circulating them to us. You are circulating them to people in the states. Don't you think they ought to be available to the public at large that might be interested in this?

MS. FREEDMAN: At this point we expect that over the course of the next three or four months there may be some revisions depending on the outcome of the field tests. They have not gong through the clearance process, and they are clearly drafts, so we just haven't put them up yet.

MR. GELLMAN: You described the process that you went through in terms of consultation. I didn't hear any patient advocacy or privacy advocacy groups. Did I miss it?

MS. FREEDMAN: I think that they were on our -- I'm sure that they were on our original mailing list when we did our first round of inquiry. I can't tell you what the response rate was from them offhand. We did also put notices in many of the scientific journals.

MR. GELLMAN: Well, that's fine. It seems to me that what you've got here is something that has a direct effect on just about everybody, and that you need to do outreach to find people that are concerned about these issues with other points of view other than the professional medical people that have obviously a perfectly legitimate and key interest in all of this.

I think you need to go out. I think you need to learn the lesson that HCFA learned with the OASIS thing, because what you have here could blow up in your face at any time, because you've got a lot of information that you want to collect, a lot of new information that you want to collect. Some of this information falls in the public domain.

Is the information you are proposing to collect on whether a mother has gonorrhea or syphilis going to become public?

MS. FREEDMAN: No, that is generally protected under state law.

MR. GELLMAN: But there is plenty of other information on here that does become public.

MS. FREEDMAN: I don't think there is any information on here that becomes public that hasn't been public for the past 20 years.

MR. GELLMAN: Well, that's fine, but standards for privacy are changing, and information that used to become public people now object to. Congress is taking steps in a variety ways, as have the states, to try and stop the use of Social Security numbers in various ways. And this is furthering that. It's something that needs to be looked at. It's something that needs to be brought to public attention.

MS. FREEDMAN: I believe the Social Security numbers are on the record because they are required by law to be collected on birth certificates.

MR. GELLMAN: I understand that. Are they required by law to be made public, however?

MS. FREEDMAN: No.

DR. POTRZEBOWSKI: Actually, if you will notice, I think it is most obvious on the birth certificate. You see a line right below certifier, only about a quarter of the way down. And below that is a label that says information for administrative use. Then a couple of lines below that is information for medical and health purposes only. I believe in about two-thirds of the states no birth and death certificate information is public information. It's all confidential, protected by state law.

And in the remaining about one-third of the states where they do have open records, including California -- I can't think of any others. California comes to mind. But I would say about only a third of the states. In those states the information below that line is not public information.

MR. GELLMAN: I still think that the collection of more information use needs to be examined, not just by the people that are using it, or the people that want to use it. This is a matter of significant public interest and concern in a way today that has not been the case before. I'm not kidding when I tell that you face the possibility of being inundated at some point by somebody if you don't go out and collect views and educate people about this, and discuss some of these issues.

It's very simple for someone to get on the Internet and send out a message and start screaming about this. Then you guys will find yourself at the wrong end of 250,000 complaints, congressional complaints, inquiries, and all kinds of things. You need to look at that community. You need to find them. You need to go out and wave this in their face, and try and get them interested, otherwise it's going to happen at the end of the process, and you will be extremely unhappy about the result at that point.

DR. POTRZEBOWSKI: I agree with you, and I think this is a message for the states. Because remember, all NCHS has done is develop the model. It's really up to each state now to adopt that model, adapt it to their own use, and to go through a similar kind of process that NCHS has done, but at this point probably bring in the public in each state in terms of what their input should before this is adopted in each state.

MR. GELLMAN: Well, I think that's perfectly fine, but that doesn't absolve you of your responsibility to inform the public.

DR. POTRZEBOWSKI: I am a state person.

MR. GELLMAN: I don't know where you are from, but for NCHS to do this exact same thing at this level. You are proposing this. You can't just propose and say it's up to the states to decide all of that. There is a public interest and concern about all of this. I think this is very important that this be done.

MS. FREEDMAN: I agree with you. I also think it's important that you and the public understand that NCHS does not get the identifiable data from these records.

MR. GELLMAN: I understand, and that's all fine. But I think there needs to be a lot more discussion about this, and about what happens to all of the data elements. Who gets them. What are the terms. What are the protections for the data, how it's being used, and all of those sorts of things.

There are a lot of privacy issues surrounding birth certificates particularly, and the way that they are used and abused. And when you are expanding the amount of information that comes in, it only makes all of the problems worse.

And I really think this is something that ought to be on the agenda on this committee, and we ought to come back to it again in a couple of months and see if something has been done in terms of doing it, and if not, do it ourselves.

DR. COHN: I'm going to ask a much more mundane question. It just had to do with a clarification. I was looking at your draft form, and in many places you have a description called 'none of the above.' As I was looking at this, I was confused about if 'none of the above' means none, or it just means something else, but not one of those listed. In other words --

DR. POTRZEBOWSKI: It could be either none, or none on that list.

DR. COHN: So in other words if you were filling this out, then you would sit there and wonder about if you really had none, whether or not you should leave that space blank, that question blank, or whether you should none meaning that it's another one.

DR. POTRZEBOWSKI: Maybe that's something we need to test. Maybe that's something that we need to talk about when we do the testing.

DR. MC DONALD: I was on a committee in Indianapolis, Indiana for a while about birth certificates. I don't think it's correct, as inferred, that the professional society is the one that is most hungry for this data. In fact, there was significant resistance to additional questions in part because the data is often very difficult to get at the time of birth. You are asking things that really require going back to the office in some fashion, or maybe many office charts, depending on who is delivering the baby.

So that was just one issue. I think that these things generally derive from strong public health risks related to mortality and what not. There is nothing bad about that. ACOG are good soldiers; they go along with it. But individual physicians aren't always excited about it.

The other thing I was just curious about, I thought maybe it's partly the result that -- I see that things are numbered, 20 or 50 or something like that. Many of the boxes that have one number on it have many questions inside of them. Is that a way to make the doctors think they don't have to answer as many questions? So are the numbers just sort of an accident of history, or do they have any real meaning?

MS. FREEDMAN: They are somewhat an accident of history, but they are to make it easier for us to find things on the document. The doctors will never overestimate or underestimate the new amount of information we are asking.

MS. HARSHBARGER: And in actual fact, when the worksheets are done, the clerks may not follow this order anyway. They will follow the order that is most convenient for them.

DR. MC DONALD: From the point of view, what I was really worried about, if you are really going to use this data and collect it and manage it, you would like some label on each of these. You would like to make sure there is something when you mix them all up, you still know what they were.

DR. POTRZEBOWSKI: And they will be different in each state.

MS. FREEDMAN: Bear in mind that right now 99 percent of our births -- actually 90 percent of our births are collected through electronic registration processes so that the actual paper document is something that for most records, is never created.

DR. MC DONALD: Underneath this there are some code numbers?

MS. FREEDMAN: Oh, yes.

MR. SCANLON: My question had to do with once the final certificate is issued, what's the nature of the action that each state has to take. Is it literally enactment of a law or a regulation?

MS. HARSHBARGER: It varies from state to state. Some states can take our data items to their board of health, some it's regulation. I doubt if it's specifically law, although law protects the information, what we call the legal information, which is the person identifiers, the name, et cetera, the medical information. The medical information is usually protected by law in many states. But it does vary. It's a long process. There are lots of things you have to do in the states to implement.

DR. LUMPKIN: Let me just add, in Illinois I think we may have to go to the court, because we have a court decision that impacts the birth certificate and what information the father can see versus the mother in filling out the application; Herps(?) v O'Malley and Lumpkin.

MR. SCANLON: Just a follow-up. In terms of a national standard, states can obviously adapt the model. Are they encouraged to do so in a manner that allows you to aggregate back to the national standard?

MS. HARSHBARGER: Absolutely, yes. That's part of the reasons for having standards, the standard data set, and the standard codes. We do provide now back to the National Center, as many of you know, items in standard code that we code for, and send a standard data set back to the National Center so that they can aggregate. That's the reason that we developed the standard certificate to start with, so it can all be put together for national data.

DR. LUMPKIN: And they send us money in exchange. And if it's not in a standardized format, then we don't get the money.

I have a series of questions. The first is in reference to electronic birth certificates, electronic death certificates. Have you considered establishing an HL7 standard?

MS. FREEDMAN: We have actually been talking about that. Part of what we are wondering is whether we should go out and establish a specific standard for birth and death certificates, or whether there is one of the medical standards that we can fall under, whose umbrella we can fall under. But, yes, and certainly we will be compatible with HL7 at the very least.

DR. LUMPKIN: Because we have had testimony before the committee about the establishment of an HL7 standard for an immunization record, which has facilitated transfer from state-to-state. That certainly has been, I think, an advantage. And particularly since we started -- as I'm sitting here and contemplating the budget implications, at least for Illinois, of changing the birth records, and therefore having to modify our EBC system and our EDC system we are just in the process of implementing, it's quite significant.

But to the extend that we can move into an environment where we can use electronic data interchange, the cost of these kind of changes then becomes significantly less as the time goes on, so it's something to consider.

The second is on the death certificate, you used the term 'accident' a couple of times, traffic accident. I harken back to my days in injury prevention, and I shudder every time I see that word.

DR. POTRZEBOWSKI: We did too, but this is an ICD-10 terminology that we apparently have to use as a World Health Organization signatory. That's what we have been told.

DR. LUMPKIN: Now you have to code to that, but the data collection form doesn't have to use that term.

MS. HARSHBARGER: We also talked about it from the standpoint of the coroner or medical examiner who is not familiar with the term 'unintentional injury' may not know exactly what we mean. And we can collect it using the term, but when we publish we can use the other terms.

DR. POTRZEBOWSKI: We never use the term even in our statistical publications. We know not to do that. We only use unintentional injuries, but this is apparently legal terminology that the coroners and medical examiners understand.

DR. LUMPKIN: Well, we need to educate them.

I notice in the fetal death record and the birth record that there is not an option for maternal death. If, as you said earlier, that's underreported, wouldn't that be an important place to try to capture that data?

MS. HARSHBARGER: We talked about that. That was one that was considered by our group, and since most states link all of their death -- well, many do all women in pregnancy age, the 15-44 group, link them back to birth records to see if they do have any birth records. Certainly if the death certificate indicates any sort of pregnancy, and there is a question on the death certificate about that, we link them back. So we decided we didn't specifically need the question on the birth certificate.

DR. LUMPKIN: On the birth certificate for complications I noticed that injury is not included in that. Injury is certainly a cause for premature labor. That's the stage in which women are most suspectable to abuse by spouses and significant others. It seems like that may be an important item to capture.

MS. HARSHBARGER: We didn't talk about injuries specifically. We talked a lot about social items, abuse being one of them, other social items. What we found is it's very difficult to get at those kinds of questions, and get that kind of information with one or two questions to the mother. You almost need a series or a follow-up.

Also we're proposing a worksheet that you hand to the mother for her to complete. We thought it would be difficult to have one question on there or something on there to get at a number of those social questions. we did discuss it. We had a lot of people that wanted that, particularly researchers from outside wanted that. We just couldn't come up with a really good way to get that.

There are some other systems, one of which is the PRAMS, the Pregnancies Assistant Monitoring System from CDC that a number of states have. Those kinds of questions are in that survey. It is a survey of mothers who recently had births. You can get at a number of those questions through that survey. So we felt it was not something we could put on the birth certificate.

DR. POTRZEBOWSKI: But if you can figure out how to do it in Illinois, and you can get good data from it, then it would be helpful for the next revision.

DR. LUMPKIN: Just toss that right back on me. Okay.

The last one is records for pregnancy termination is not in the batch. Are there plans to revise those?

MS. FREEDMAN: At this point you will notice there is also no marriage and divorce revision process here, because the vital statistics system does not include it. At the national level we are not collecting abortion data presently, so no, we did not. Now they were recently revised by the Centers for Disease Control and the Division of Reproductive Health about three or four years ago when they modified the list of termination procedures.

DR. POTRZEBOWSKI: I think they added medical procedures.

DR. LUMPKIN: Well, thank you very much. This has been a very interesting interchange. We wish you luck in the process, and please keep us informed as it goes along.

The next item on the agenda is the report from the Subcommittee on Standards and Security.

Agenda Item: Reports from Subcommittees and Workgroups

DR. COHN: Well, I think I will let Jeff Blair start by talking about the work plan for the CPR work group, and then I will add on after he is finished by talking about the other activities of the subcommittee.

MR. BLAIR: Thank you, Simon. You had invited me just before lunch to talk about some of the things that we were doing to at least attempt to coordinate with other groups, and get linked together. And just let me preface my comments on this that -- Lisa, are you here?

DR. IEZZONI: I am here.

MR. BLAIR: Okay. These may or may not be useful, and these are some of the things that we do to try to lay out our work plan, coordinate with other folks. You will recognize them as basic project management things, and even so, you still struggle to try to meet the dates, to get everybody together, to get everything coordinated. I'm not representing this in any way, shape, manner, or form as a perfect way to do it. I'm just going to fold those comments in with my report, and if they have value good, or if you have questions, let me know.

In terms of our update on our work plan and the dates that we have for completing our report, the work plan basically was the CPR work group work plan. As part of that we had our areas of focus for what would be in the report. They included the things that we all know and love like message format standards and medical terminologies, and areas such as data quality and accountability.

But the focus, and this is one of the things that may be of relevance, the focus areas also included where it was important, coordination with the Subcommittee on National Health Information Infrastructure. And we actively participate in that, so we wind up attempting to make sure that we will not lose those ideas, and make sure that they are included in our report as appropriate.

And even with the fact that we have gone for months with that in there, the coordination with data security. It was in at one time. It went out. It's come back in again. So that's another way that it is reflected in the work plan.

The other piece is after developing some degree of consensus on what our focus areas are, we then wound up laying that out so that we could wind up meeting our primary objective. I'm going to run through those real quick, because there are a few folks here from our work group, who were not here yesterday when we were going over it in our subcommittee activities. So some of the dates may be relevant. You might want to break out your calendars just in case.

The objective we have is to have our report to the Secretary of course by August of next year. In order to do that and coordinate with the full committee, we wind up listing two major milestones. One of course is the final approval, which has to be in June. So we have to be ready for the June meeting of the full NCVHS committee. And we only have one other shot before then to review things with the full committee, and get ideas so that we could modify or change the report, and that is the full committee meeting which is at the end of February.

If you keep those in mind, then you could wind up seeing how we built our plan to try to make sure that we were in sync to coordinate with all of the other groups. We have one more set of hearings in October, which is October 14-15. We are trying very hard to get the diversity of input possible in this last opportunity.

And then in order to meet these dates, we want to try to pull together all of our ideas into the major issues, the things we have learned by the end of October. If we get the issues identified by the end of October, then by the end of November, which is just before the December 9-10, and this is the next date for all of those that wish to attend our next CPR work group, December 9-10 is the next meeting.

We feel that by the end of November we at least have to have a framework for the recommendations, if not something to assist in that meeting to make it expeditious, so that we are not all over the place with the recommendations. Something so that we make good use of our time in that two day session.

Now what we're working towards with those recommendations is to have a first draft of the recommendations available for the full committee by the end of February. In order to do that it became very clear to us that the December 9-10 is not enough time for us to build consensus within our work group, and also have it approved by the subcommittee, the Standard and Security Subcommittee for the full committee.

So as a result, we have also scheduled another work group meeting for January 31 and February 1, and we figure that between those times we will probably be pretty active with e-mail and exchanging updates. But we are really hoping that that will give us enough time to have a first draft of the recommendations, and at least an outline or as much of the report as possible, so that the full committee can give us their critiques at the end of February.

We figure that in March we will probably be updating and rewriting the report and the recommendations based on the feedback we get from the full committee. And then taking it to other interested parties within the Department of Health and Human Services, which is likely to include at least the Data Council and probably other agencies within the Department of Health and Human Services, and of course anyone else that we identify at that point.

Those further sources of feedback will probably be occurring in April, maybe a little bit in May, and then we would need to fold those all back in for the final report for approval by the full NCVHS in June. Then we probably will still have hopefully at that stage only minor changes that we would be making so that could go to the Secretary.

Let me just ask, Simon, is that what you were looking for in terms of my report, or did I leave something out?

DR. COHN: I think that's fine. Actually, I think it was trying to specifically address Dan's view about how to get input into the process. We have been thinking in our work plan of after an initial reading by the committee, sending it out for further comment, and then bringing it back and folding it in. So that's our solution to I think the issue that you brought up earlier of how to fold all these other comments in, and get other buy in and input in, in the process.

MR. BLAIR: It is still imperfect. Simon?

DR. COHN: I don't have any other comments about that, except that I guess we only ask for any input from the committee knowing that some of you have been very involved with the process. Some of you have no idea what's going on with these hearings -- and I don't mean to say, but I don't think that many of you are reading through the entire manuscripts of any of the hearings that we are having.

But from all of you what we ask is does this sound like a reasonable work plan to meet the time requirements that we have? If anyone has any suggestions for either a part that we are missing or something else that we should be doing, I think we've seen that these complex reports are difficult to go through the committee, and we're certainly hoping within two meetings that we can make it through.

DR. LUMPKIN: I think the only thing I would add to that is to the extent that you have something ready, to send it out to the committee members, the full committee when it's ready, rather than waiting for the meeting books. Sometimes when you get the book, even if it's a week or two before the meeting, your ability to absorb it isn't the same as if you get it some other time, and you can spend a little bit of time on the document.

MS. GREENBERG: Really, in fairness to the Subcommittee on Populations, we did have their report, and in the future we'll make it available, a report like that. I think we erred in waiting to send out with the agenda books, and I apologize.

DR. COHN: Let me just make a comment then about the overall activities of the subcommittee, of course of which the work group is one part. We actually have another full page of work items, 12 point, single spaced, that we're also going to do at the same time. So it's a fairly active set of work going on.

As you know, the subcommittee is advising the full committee on issues related to implementation and the whole issue of yearly reports that we are required to send to the Congress related to implementation. One of the current work items is to identify and develop a baseline set of metrics, recognizing it's likely that by January, February, March of next year the final rules will be known, implement will be beginning. We wanted to be able to identify what the baseline and current environment is.

So we are working on that along with Dr. Braithwaite, Karen Trudel, and hopefully we'll have some metrics to discuss by the February time frame.

Recognizing that we are also part of the process of updating these standards, and trying to identify how implementation is going, we are looking towards at least one set of hearings in the spring, and it may be two. We are not quite sure what the issues are going to be at this point, but there will be obviously implementation issues around both transaction standards, code sets, as well as the identifier issues that are coming up at that point.

And then we will also begin to hear about any suggestions or proposals for either changes to the standards or new administrative transaction standards that may come to fore. So that would be I think a spring into fall activity for next year.

We are also gearing up in probably the nearer term having to do with preparing a letter for the committee in terms of responding to a projected NPRM on claims attachments. This may be along with the privacy NPRM that I know Kathleen Frawley is going to comment on. It's the first chance we have to use this new process that we just approved in how to handle things between meetings.

Marjorie, do you have a comment?

MS. GREENBERG: Actually, the process is for when we identify something -- when you all identify something between meetings.

DR. COHN: Well, actually that's one of the processes. There are two processes. One is for when you identify things between meetings. The other process is when you know about them, and they are just going to be handled between meetings.

MS. GREENBERG: Right. That process then is decided upon at the meeting.

DR. COHN: That's right.

DR. LUMPKIN: So we appreciate your work group coming forward with a proposal for that process, or your subcommittee.

DR. COHN: I think in November I think probably both Kathleen and I will have to come forward with our recommendations on what the processes should, whether it's the same or different. I think that will be a November discussion on the agenda.

Finally, actually at the meeting yesterday, which is common that we had an update of something I think the whole committee ought to know about, which is the memorandum of understandings that are being developed by the Data Content Committee. As we know, it's one thing to make standards and have initial standards. The ability of these standards to be useful to the American people really has to do with the ability to update and approve those standards.

I think what we have seen, and actually we don't have the full draft of this is a plan between the various data content committees which includes HL7, X12, the National Uniform Claims Committee, the National Uniform Billing Committee, and ADA, NCPDP on how they will be dealing with requests for change and improvements to their standards. So we'll be keeping close track of that, but we think that's a very important piece of the puzzle, trying to put this together. So we'll be update the committee as that moves forward.

Any questions or comments?

DR. LUMPKIN: Thank you. Privacy?

MS. FRAWLEY: We did spend some time this morning talking about the proposed notice of rulemaking for the regulations on confidentiality of health information. It appears likely that we will have to work outside of the committee meeting in order to have our comments drafted, approved by the full committee, and submitted to the Department.

According to John Fanning from ASPE it is likely that we could see a notice of proposed rulemaking at the end of October. We might at our November 3 meeting be able to discuss the notice of proposed rulemaking. However, it is also possible that November 3 could come and go, and the notice not be published yet. So we're in one of those situations where we know that we're going to have to submit comments. It will just be a matter of trying to work through the process.

What we discussed at the subcommittee this morning was that our subcommittee would review the NPRM. And then we would hold conference calls to discuss our recommendations and drafting our comments. And then what our anticipation would be is that we would probably send it on to the full committee under the process that we approved this morning for their review and comment, and then a conference call to approve it.

So it looks likely that this something that we will be doing by the committee process committee meeting, and just so that people are aware of that, so we know that that's coming.

MS. GREENBERG: And we'll work with you obviously on that to see at least the final conference call by the subcommittee in which you are developing your recommendations or agree on your recommendations to the full committee. Then we would want to have some lead time so that we could schedule that and allow public input.

MS. FRAWLEY: This is going to be a very tight time period, because this is a 60 day comment period. So that's the only thing. Surely we'll do that, we'll work our schedule out. But in order for us to get this through the subcommittee, route it on to the full committee, get full committee approval and be able to get the comments out, it's going to be very tight in terms of the timeframe that we're going to be working on. Anyway, just so people are aware of the fact that you will expect that coming.

We also had a briefing from John Fanning on the European Union directive, and also on some international privacy activities, and also some national privacy activities. We had a number of good briefings from him on a couple of different topics.

We did spend some time on our work plan, looking at our work plan. The committee is deciding its next area of activity is going to be use the Internet for health data. So what we are looking at is probably holding a hearing. What we will be doing is polling the subcommittee members after this meeting as far as dates. But hopefully looking to see if we could build something around our February meeting date.

What we would be looking at is to invite companies that are currently using the Internet to really understand their practices and what their privacy policies are, and try to really see if we can flush out some of the problems and some of the issues. We recognize the fact that that may necessitate a meeting at another date on this, but we do have a long work plan, but we felt that that was the next issue we want to tackle.

That's really it.

DR. LUMPKIN: Any questions?

MS. GREENBERG: So you're thinking in terms of having a subcommittee on either side of the February meeting?

MS. FRAWLEY: Yes.

DR. LUMPKIN: Did I miss any subcommittees or work groups? Quality.

MS. COLTIN: We met yesterday to try to rationalize our work plan in view of the ambitious work plan of the Subcommittee on Populations on the area of functional status, and trying to figure out where we could best make a contribution. And where we came down on that is that we would take a look at working jointly with the Work Group on the National Health Information Infrastructure to see whether in fact there is a quality view in your terminology, that could be created, that would represent the types of information that are needed to assess and improve quality.

And that we would arrive at what those data elements might be, or those pieces of information through a process of taking testimony from those who have developed quality measures, and looking at what kinds of problems they have run up against in trying to use existing data sources to create measures, and where they have had to turn to medical records, or to surveys to try to deal with the absence of necessary information through administrative or electronic record databases.

So that is the approach that we are going to try to take. We're going to focus in on a few key categories of data that are felt to be most important in trying to construct a picture of quality, or trying to identify high risk patients for intervention who might most benefit from quality improvement interventions and so forth.

And doing that by, as I said, holding some hearings or meeting where we will take testimony from creators and users of performance measures. The first such hearing is the evening of November 3. So it's following our meeting on November 3, for those who are staying over for the CNSTAT workshop, that evening from 5:00-8:30 p.m.

We are tagging on to a meeting of the NCQA Committee on Performance Measurement, because there will be a lot of people particularly from California and other parts of the country in town, and we won't have to fly them out. And try to meet with them and get input from that group. Then we'll be planning other similar types of opportunities to do that, usually around full committee meetings, so that we don't have to set up separate meetings.

DR. STARFIELD: Where will that be held, Kathy?

MS. COLTIN: That will be held at the Wyndam City Center Hotel.

MS. GREENBERG: Have we confirmed that? Okay, good.

MR. BLAIR: An area of at least a little bit of overlap. I'm sure that you are going into this in much greater depth and specificity than we were able to, but one of our focus areas in the CPR work group was data quality and accountability and data integrity. And we have testimony that you may be interested in from MEDSTAT, JCAHO, NCQA in October. I believe we have asked AMAP to come, and we have a questionnaire that we developed for data quality.

Also HL7 has an accountability, quality and integrity technical committee, actually special interest group. They are going to be testifying this October. So we are more than happy to share that information with you since you are inviting -- they may not be the same folks, but representatives from the same organizations. We would be more than happy to get that information to you before they come so that you may find some of their answers and testimony of value beforehand.

MS. COLTIN: Thank you.

DR. LUMPKIN: Other questions, comments?

[Question off mike.]

DR. LUMPKIN: No. The question is whether or not we have a work group report from the NHII. Well, I guess can. This is a little bit difficult, because we are trying to build some conceptual model. But basically what we are working is we are looking at the NHII, which is best described as being the sum total of the information technology standards, applications, systems, values, and laws that support all facets of individual health, health care, and public health.

And we envision taking the next step from the previous document we have to try to describe what it is that the NHII will do, and how it's put together. One piece would be, although we would not spend a lot of time on it, is a national data model. And there has been a lot of work done on this in other countries, and a very graphic model that exists in Australia, which we had a presentation on before this committee in the past.

The second piece to add on to that is really how this model will be used. We are having some difficulty with terminology. We have played around with terms such as view, information organized folder, portfolio, but it essentially connotes a conceptual approach to health information. One view is what we call the patient, personal, or consumer view. I'm using terms because we haven't settled upon the term.

This is the information that an individual needs to make their health choices, and ought to be their own personal information. Part of this would be a meta database, which would be available to that individual, which would tell where all their health records are, and which would be under their control.

So when they see a provider, they may authorize that provider to have access to some, but not all of their information. And once they give that authorization, then that provider of health care would then have access to that information. But the holder of where that data is located, which providers have which records, much as it is right now, but right now people tend to keep that in their head. They say well last year I saw Dr. So and So, and then they sign a release form.

This would include information that may come in from other views such as health hazards in their community, as well as information from their provider that they think is pertinent for their own information.

Then there is a caregiver view, provider view. Again, the terminology isn't set. This is information that is required in the therapeutic or preventive health encounter. It would include information from the personal view, which would authorized by the patient. And it would include information that the provider may generate separately due to those encounters such as laboratory results.

Information that is in the caregiver view that is a dynamic thing. For instance, the patient may show up and may not choose at an initial visit to give authorization to have access to certain records related to substance abuse or to a psychiatric history. At that some point in that ongoing encounter with the provider it becomes clear that that information is of importance, and the patient may say, yes, you may have access to it or not. But if you do, then in that view that information then becomes available.

Data about the community would also come into there. Lead levels in homes, that sort of thing. Nitrate levels in water. Those would be information that would appear in the caregiver view, although not necessarily generated by that provider.

The third view is a population/community view, again, those two terms that we're kind of using. This is a view that would look at the community's health. Some of this view may be built based upon aggregated data off of clinical encounters. Others may be generated by surveys in the community, such as the behavior risk factor survey that may be based upon environmental measures of what's going on in the community, positive poverty figures, and so forth.

So we are conceptually trying to think of not only just what the technology is that would be in a national health information infrastructure, but how it would be used, and what the different approaches are to looking at the data.

The final issue that we are debating the issue of whether or not there needs to be a fourth view, or whether that should be considered to be part of the other views, so a fourth or a fifth. The fourth view is the administrative view. That would be a view that would provide information to the personal view for instance on coverage. So when the person is making health or health care decisions, they can know what coverage they have, and this is frequently a problem.

It would provide information to the provider view for instance on a vaccine for children program. It would keep track of the amount of biological that they have in stock, and would order it from the state if they are participating in that program.

And in the population view it would look at issues related to how the systems are running. We're not clear whether or not that is a separate view or a function that may be included in the other views.

The fifth one which sort of fits in that category would be the quality view. And we are again discussing whether that will be a piece of the other three views, or a separate one in itself.

So when I suggested that I didn't want to make a report, it was because we are still in some of the important conceptual stages. A lot of this discussion will be occurring on the list serve. We're going to try to put together a full day face-to-face meeting in December, and are inviting and have encouraged -- although Richard is part of the committee -- again, active participation early on by the privacy committee, so that as we begin to talk about these different views of where it may or may not threaten privacy and so are taken into consideration.

That's a brief rundown. Any questions?

Next meeting.

Agenda Item: Future Meeting Agendas - Dr. Lumpkin

MS. GREENBERG: Well, everyone knows that our next meeting is November 3 of the full committee. I believe we'll be meeting at the Holiday Inn in Georgetown. We were not able to get access to a meeting room in this building.

Also the CNSTAT workshop is being held at the Holiday Inn in Georgetown.

DR. IEZZONI: There is not a Metro extension to that.

MS. GREENBERG: I know there's not a Metro, which is unfortunate. It's next to their building, and they had already selected that. Obviously we will be reimbursed for taxis, but I realize the Metro is more convenient. If we were selecting the room on our own, we would have taken that into account, but it seemed to make sense for people who were going to be at both meetings to stay at the same place.

The Wyndam I think is more Metro accessible, but of course not from Georgetown.

For the things I have down here, going back a little bit with John, and I ask for any input now or after the meeting when you get back, send me an e-mail. What we have planned for the November 3 meeting is we will not have any breakout sessions. Obviously, there isn't time.

But what we will be talking about is we'll have our usual updates. Part of this is dependent upon whether NPRMs that have been released by then. The one briefing we were going to have was a briefing on summary health measures that we were going to have at this meeting, but we didn't have time for. So that's something on our list.

Also, someone who will be at the CNSTAT workshop, Michael Wolfson, who has written on this and is very knowledgeable, I thought we get him to come in a day early to provide that.

The executive subcommittee is having a conference call on Wednesday, October 13 from 10:00 a.m. to 12:00 p.m. At that time the executive subcommittee will be planning both the November agenda, as well as looking towards the February and June agendas, which also will include planning for the 50th anniversary symposium that's being held in conjunction with the June meeting. It's going to be the afternoon of the 20th and early evening/late afternoon reception at the National Academy of Sciences.

So I also had two issues that we have talked about being addressed, rolled out, what have you at the symposium are the work of the NHII work group, and the 21st century vision project, which in fact are trying to coordinate in any event. Any ideas you have on that on how the 50th anniversary symposium, what should be covered in that, please get that information to either me or John. We'll have that for those of you who wouldn't be participating in the conference call.

As you know, there is an evening meeting of the Quality of Care Work Group. If there is somebody who is not on the work group, but is staying over either for CNSTAT or otherwise and wants to attend that meeting, let us know. There might be one or more of you who fit into that category.

And as for action items, we will be bringing back the Medicaid managed care report.

DR. STARFIELD: Marjorie, can I ask you to confirm the executive subcommittee meeting? I have the afternoon of the 13th? It is from 10:00 a.m. to 12:00 p.m. on the 13th?

MS. GREENBERG: Yes. I think we sent out an e-mail to that effect. We talked about a few possible dates on our conference call.

DR. STARFIELD: That's much better for me. I'm glad.

MS. GREENBERG: Okay, good. And although we're unlikely I think to have actual comments to review on the claims attachment NPRM or privacy NPRM, at a minimum action items at the November meeting will be agreeing on the process for developing those comments.

Anything else for the November meeting that anyone knows about?

Just some heads up on the rest, the February and June meetings. I think at the February we'll provide an opportunity to really report on the CNSTAT workshop and discuss the continuing role of the National Committee in advising NCHS. I guess obviously the committee is advising the Department in these areas, but that was something that was kind of put on the back burner until after the workshop.

And comments probably at the February meeting I would think we need to approve comments from the plan ID NPRM, but that's something to be looking towards. There will be annual report HIPAA to Congress again. And that's about what I have at this point.

So I think this is an opportunity which I will turn it back over to John, but if there are items or issues you want discussed by the full committee in the next six months, it would be good to get those on the table so we could start planning for.

DR. LUMPKIN: In February we want a briefing on the work group on computer-based medical records.

MS. GREENBERG: I actually have in my notes you wanted to make a briefing in November. But is it actually February?

DR. COHN: Actually, it's a first reading of the report. So the first draft is a little more than a briefing.

DR. LUMPKIN: And then I would like perhaps at the June meeting if we could have a little bit more in-depth progress report on function status. You will have conducted some hearings. Just sharing so that the people who are not on the population subcommittee can just have a feel for what you think has been coming out of the hearings.

DR. IEZZONI: By February we will have held two hearings. So I think that you ought to hear from us in February.

DR. LUMPKIN: Okay. I said June, but February is fine.

MR. SCANLON: For the November meeting, the Data Council's working group on race and ethnicity data might have their draft set of recommendations and data strategy, if the committee has time. That's a one day meeting. At any rate, we could a copy at that point of the draft.

MS. GREENBERG: Actually, I should mention too that the executive subcommittee is having a half day meeting here in the Humphrey Building on December 7 from 1:00-5:30 p.m. One of the main objectives of this meeting is to do sort of longer term strategy and budgetary planning for the committee.

So for example I know the population subcommittee was discussing this morning the possibility of having at least one of their hearings outside of the Washington area. Obviously the chairs of the subcommittees are on the executive subcommittee, so they will bring that information to bear. But hopefully, we will really be able to do some projecting certainly through the calendar year 2000 and possibly beyond.

MR. GELLMAN: Is there a calendar on the website that has all the subcommittee meetings? Is that routinely available?

MS. GREENBERG: All the ones that are scheduled should be up there. If some of them aren't, we'll make sure they are. Agendas as they become available, but certain the dates should be up there.

MR. SCANLON: Related to the point about planning projects, we would expect to get the financial support for the committee, as we did last year. But if any of the subcommittee or work groups envision a project of a larger nature, a separate workshop, or contract worker, anything of that nature, please let Marjorie, John, or I know so that we can begin planning in the fiscal 2000 budget as well.

DR. LUMPKIN: Having now exhausted our agenda and ourselves, we will now stand adjourned. Thank you.

[Whereupon, the meeting was adjourned at 2:50 p.m.]

DEPARTMENT OF HEALTH AND HUMAN SERVICES

NATIONAL COMMITTEE ON VITAL AND HEALTH STATISTICS

Tuesday, September 28, 1999

Proceedings By: CASET Associates, Ltd. 10201 Lee Highway, Suite 160 Fairfax, VA 22030 (703) 352-0091

PARTICIPANTS:

TABLE OF CONTENTS

P R O C E E D I N G S (10:20 a.m.)

A F T E R N O O N S E S S I O N (1:08 p.m.)

Proceedings By:
CASET Associates, Ltd.
10201 Lee Highway, Suite 160
Fairfax, VA 22030
(703) 352-0091