Room 505A
Hubert H. Humphrey Building
200
Independence Avenue, S.W.
Washington, D.C. 20201
Consideration of Vision Document and 1997-1998 Annual Report - Dr. Detmer
Report on CPRI Terminology Conference - Dr. Christopher Chute
Reports from Subcommittees and Work Groups
Workshop on Implications of HIPAA for Public Health and Health Services Research
Healthy People 2010: Overview, Data Issues, and Eliminating Disparities - Deborah Maiese, et al
Plans Regarding Hearings on the Unique Individual Identifier - Dr. Lumpkin
Agenda Item: Consideration of Vision Document and 1998 Annual Report.
DR. DETMER: I would like to call us to order and recognize Vince Mor who was not with us yesterday. It is good to have you with us. Is there anyone in the audience that wasn't here yesterday who would like to introduce themselves?
[Introductions made off microphone.]
DR. DETMER: By the way, before I get underway further, I just want to report that I will be sending the e mail along to George Van Amburg, saying how much we enjoyed the dinner in his honor last night. It was wonderful, and that we will try actually to catch him in the room for one of those as well, if we can. In any event, it was nice getting together with folks.
Our first item today is Tab F and G. The history on this is a little circuitous, at this point talking about the vision document. Let me make a couple of introductory comments.
We had been working on a draft that actually had had two pieces put together. The first piece actually was sort of what we saw as committee objectives for national health and health services, to then guide what kind of a
health information policy we thought the government might wish to pursue, and then the actual recommendations on a health dimension for the national information infrastructure, which is in your book, the first part.
At the executive committee meeting, a decision was made to split those, and actually try to put a document together just relating to the national information infrastructure.
Then we will need to decide, really, what we want to do about that, as well as what we might want to do further relating to objectives for national health and health services.
The data council is under the direction, as we said yesterday, of Peggy Hamberg and Jon Eisenberg. Both of them are really quite interested in taking more strategic views as it relates to, I think, the data council and the department. I think they are reflecting actually the Secretary's interest in that regard.
So, this document that you have before you, I think, however we come out on it, the data council will be clearly interested in what we have to say.
With that, if there are questions about my introductory comments, fine, we can entertain those, or we can get on into the substance of the draft.
DR. HARDING: Pardon me, Don, was there a question on the floor?
DR. DETMER: The item before us is what we wish to do with this draft document on the national information infrastructure. I think that is the first item before us.
Then the second item is what we may or may not wish to do relative to continuing to do some work on the second item.
DR. STARFIELD: What do you mean?
DR. DETMER: I think that the data council would like to get something relating to how it should look at this issue.
The question, of course, before the full committee is whether this is what you have in mind to want to forward to them.
So, I think that what is open before us is essentially what do we want to do with this. Do we want to amend it? Do we want to move it forward? Do we want to start over? What, in fact, is the committee's pleasure?
DR. STARFIELD: I really like it. I don't have any suggestions. I want to move that we accept it and send it forward.
DR. LUMPKIN: Second.
DR. DETMER: There is a motion on the floor, and it has been seconded, that the document as it is drafted, move forward. Is that your motion? Is there discussion.
DR. FRIEDMAN: Don, I really like the document as well. Having said that, there are a couple of relatively minor points that I thought might be worthwhile to add.
DR. DETMER: Good.
DR. FRIEDMAN: One, under population-based data, I think it may be worth putting in a sentence or two about the potential implications of HIPAA for population-based data and the potential for creation of essentially population-based encounter data sets over time, health histories and so forth.
A second related point is under the computer-based health records, the potential for the integration of direct service delivery computer-based health records with population-based health records.
DR. DETMER: Okay, would you be willing to draft such a sentence?
DR. FRIEDMAN: Sure.
DR. DETMER: Okay, great. Other comments, questions?
MR. GELLMAN: There have been a couple of drafts of this document. I think this is much improved over earlier drafts.
I still think it suffers from the same problem as the earlier drafts, and that is that it doesn't have a clear purpose.
It says at the beginning that the idea is to develop a comprehensive view of health information policy in order to use federal resources more effectively. How does this document do this?
It seems to list every major health issue related to the health information infrastructure and basically says that we should do more of everything.
There is no sense of priorities. There is no list of tasks. There is no ranking of issues by importance. There are no specific assignments to anybody. There is no road map in here for the future.
It is a wish list. It is like saying we should feed the hungry. It is nice political rhetoric, but it doesn't accomplish anything.
At the end of the document there is a vague request to the Congress, to the President, to HHS and to other agencies, "to assess where, in their respective domains, greater effort and expenditure are needed."
This is not exactly a helpful recommendation and I wonder which intern in the Speaker's office is going to draft a letter in response to this vague request.
The document ends by suggesting that a White House overseer might be needed in these matters. It seems to me that that is an insult to the Secretary and to the whole department, and it echoes a common request from every special interest group in D.C., that they want more visibility for their issues and they want a White House staffer dedicated to their responsibilities.
Then following that is some other unclear policy document that, as far as I can see, also has no purpose, although it doesn't have any content yet. So, I will reserve judgement. I intend to vote no on this document.
DR. DETMER: Okay, would you be willing or interested in trying to submit language to improve it?
MR. GELLMAN: I don't see a point to it. It has been unclear from the first draft what we were trying to accomplish with this document.
DR. DETMER: It is beyond clarification; is that what you are saying, or the ability to clarify it?
MR. GELLMAN: Right. It has got all kinds of very nice language. I can pick any sentence in there and I might well agree with it. But I don't know why we are saying it or what this thing is supposed to do.
DR. DETMER: Other comments or questions?
MR. MOR: I am a little uncomfortable responding. It is not that I agree, but my first question reading this was, is this like a vision statement and how are we behind it. All this stuff is great, so --
DR. DETMER: I think that is basically it.
MR. MOR: A vision statement.
DR. DETMER: Right, and if it isn't doing that, then obviously it needs either more work or to be ducked. I think that is really what we are --
MR. MOR: Is it a call that a vision should be developed?
DR. DETMER: It is a question of what we want it to be. That is why it is on our table. It is not like we have decided. We are here to discuss this.
MR. MOR: I like a lot of the features here. I think that Bob is right; it does not have a purpose. If we are saying exhortations, that an interagency over-arching federal or national scope or vision for health data infrastructure be a task, that the data council and this committee and others get involved with, I think we should be explicit about saying, that is what we recommend. We recommend that this be a real initiative, in that sense.
DR. DETMER: I think that is very useful. I mean, clearly, we have an array of options here. One is to sharpen the language, obviously not do such a thing, or add language and move forward.
I guess, do you have a suggestion to make on what you would prefer to do?
MR. MOR: It seems to me, then, that the section from the NCVHS role and recommendations for the Federal Government actually could be sharpened and made fairly concise and say, given these considerations, we recommend that the data council, the Secretary, and so on and so forth, initiate a process to develop a detailed vision of what the health infrastructure should be. This is just kind of a snippet.
DR. DETMER: No question about that.
MS. FRAWLEY: Following up on Vincent's point, I think on the first paragraph on page one of the document, the second sentence is says, after working for almost two years on specific HIPAA policy mandates, the committee now wishes to help the department develop a comprehensive view of health information policy in order to use federal resources more effectively to realize the potential of the nation's health and information systems.
I think that could be sharpened and be kind of the lead off, that that is the purpose of this document, and that we have outlined --
MR. MOR: And that that should then be echoed in the sets of recommendations at the end. That is a clearer statement of purpose.
MR. BLAIR: I think it was a couple of years ago, the Council on Competitiveness that is out of the Vice President's office, if I recall, pulled together a document, the need for a health care information infrastructure.
Often those were the words and phrases, and I don't remember the details of it, but I thought it kind of set forth a vision. Was that document what we were assuming the basic vision would be or did we look at that?
DR. DETMER: Is that the one that had -- I thought that was really a document more focused on the NII rather than the HII, if it is the one that at least I am aware of.
If so, I am not sure that we did --
MR. BLAIR: No, I think there was one on the health care information infrastructure about two years ago. The reason I am saying it is that I was asked to contribute portions to the standards section within the document, and tomorrow I could just get the number and copy and send copies to people.
MR. SCANLON: There is a White House information infrastructure task force and there is an associated council on competitiveness.
There was sort of a road map kind of a document, I think, that included a little bit somewhat on health.
There was another paper that was done for the White House task force that Mike Fitzmaurice pulled together, that actually went quite deeply into the health information component of this. That was included at least as a reference.
I actually have a copy of that other road map report. I can pull it out.
DR. DETMER: All right, good. It sounds like we should take a look at that and also see what we missed in that. That is useful. These are all very useful comments.
MR. SCANLON: Just one other comment. In all of these documents that we have been talking about, the idea of the NII and the HII, it is not viewed as a federal activity. It is viewed as a national activity.
In fact, the private sector has a much greater part here in terms of a lot of what will be required. My only fear here is that we are focusing more on the federal side, what federal agencies should do. That may be appropriate, to the extent that it looks more like a federal activity.
Maybe we could use some words that would indicate that this is a full partnership effort and there are things that Microsoft does better than the Federal Government and should continue to do it, and there are other things that the Federal Government does, including the privacy framework and so forth.
DR. DETMER: Without getting into Microsoft, it sounds like what I am hearing is a need for continued work on this.
Unless there are other content points, it sounds to me like what might be useful is for us to take these comments under consideration.
There are some people listed interested in the HII effort. So, I will follow up with those players. There is no immediate rush on this at all.
What we will do is, I think, continue to work on it and then come back at our next meeting, if that is acceptable.
DR. STARFIELD: Why don't I withdraw the motion.
DR. DETMER: Okay, is that okay with the second? I don't remember who seconded.
DR. LUMPKIN: Yes.
DR. STARFIELD: Would it be more useful maybe to focus the document on what the national committee sees itself doing and have a section on where we might take it, but make it a vision statement for us rather than a vision statement for the Federal Government.
DR. DETMER: That is fine, except that I do think that the data council would like to get our thoughts on what they should do.
We don't need to do that. Clearly, I think it would be very important for us to look on what we, ourselves, want to do.
Again, I think that speaks to Bob Gellman's comment about the lack of clarity, where it is going. I don't know. Would you rather have it just limited to ourselves?
MR. MOR: No, I think actually if the data council is the right vehicle to charge, to be charged by us, or recommended by us to be charged with the goal of providing leadership in a national effort, not just a federal effort, the articulation of such a vision in substantial detail, negotiating with the private sector or providing some kind of integrated force as, I think, the HIPAA example -- which I think is nice -- has been done, a lot of that has gone on in the last two years.
There has been a nice, I believe, reasonable partnership that has come out of some of these hearings that have actually occurred through this committee.
What we are just basically saying is let's extend that. Let's not just focus on HIPAA. I think that is a reasonable thing to say.
DR. DETMER: All right, is there more discussion on this today? I think the other question, again, just asking for some direction, should we just hold this whole discussion on objectives for national health and health services until we have completed the other document, or what is your pleasure on that?
DR. COHN: This is the next document?
DR. DETMER: Yes, this is just the very skeleton. Again, the concept here is there are a variety of -- quite a variety actually of -- government documents that have spoken to quality of care, equity, access, privacy, administrative simplification and so forth.
The question was, do those documents, again, in total, essentially give the framework for a national health and health services kind of vision that we could pull together if we chose to do so, again, to help guide some of our thinking in terms of our deliberations.
I think specifically this may relate, Dan, to the work that the national centers are trying to get some help on.
Again, what kind of a -- your data systems ought to relate to what you are trying to accomplish at some level, and what kind of a vision does one have relative to that.
Again, this is also very diffuse kind of -- it could be a very diffuse kind of activity. The question is whether we want to get into it and how much.
There is no comment, to my knowledge, from the data council relative to this kind of exercise. Is that fair?
MR. SCANLON: I think so.
DR. DETMER: We have clearly no compunction to do one thing or another on this.
MS. GREENBERG: Just for those who haven't been involved, I guess, in the earlier parts of the process, the impetus for some of this was in a few earlier versions of the infrastructure paper that were reviewed by the executive subcommittee.
There was some need to have a vision that would guide information policy, as it says here, or why are we doing all of this, or what type of a health care system, health objectives for the nation, are we trying to promote by doing this, by supporting all of these activities.
Now that the other document has evolved, that feeling may not be as strong, that feeling that it was needed.
This is kind of a segue to the next topic, although I am not trying to shut off conversation on this one, but this first document or these two documents or some combination were seen as documents that would be kind of the forward to the annual report, the 1997-1998 annual report of the committee.
I think the real issue is whether there is discomfort going forward with the first document without some of the types of issues that are dealt with in the second document, which they seemed to be earlier, or whether, in fact, people are quite comfortable with the first document with its revisions, et cetera, standing alone and the committee not really addressing kind of the overall vision that these information sources and structures are supposed to address. I don't know if that clarified things at all.
DR. STARFIELD: I guess one of the reasons that I am having difficulty with us is because of the statement that it is arguable that a composite vision could be constructed out of these elements.
That lays it out, as you know, we are going to test whether, in fact, this is useful or not. I don't think is intended. That is why I am having trouble dealing with it.
DR. DETMER: Obviously, we are not even near the point of, I think, reaching closure on the NII piece, as far as that goes.
My sense is we can clearly do an annual report without this, as you are saying.
MS. GREENBERG: That is, I guess, my bottom line question. Is there discomfort going forward maybe with this first document, the data council and the annual report, et cetera, as a stand-alone document without articulating some of the issues in the second document.
DR. DETMER: I think the context of it was essentially an information infrastructure is not an end in itself. It is a means by which actually other ends can be accomplished.
There are elements to it that, by its very nature, then allow you to create and reach other ends that you otherwise couldn't have thought about doing.
The point is, it itself is more of a means to accomplishing things than an end. The question was, what ends are we actually trying to accomplish, and does this committee actually have the time and the energy and the interest, if it considers it appropriate, to try to create such a concept, drawing on basically prior government documents, and so forth, the recent quality commission and so forth, that has spoken and the consumer bill of rights, and there are just a variety of those things.
When we are talking about advising the government on vital statistics and such, are those documents such that, if we pulled them together, they would be a framework under which we wanted to do our work.
I think that is really the question, but it is not a simple undertaking to do that, and to do it well.
MR. MOR: I am not convinced there is a need real soon.
DR. DETMER: I saw another head nodding earlier. Maybe what we could do is table that for a moment and then come back to it if it looks like there is interest in the executive committee. Then we will bring it back to the full committee. Is that fair enough?
Why don't we go on, then, and look at the next one which is tab G, which is the annual report.
There typically is an annual report. 1997-1998 looks like two years to me, rather than an annual report. In any event, the issue is that there typically is a report. Maybe you would like to make some comments on sort of how that has been done in the past and kind of what at least you are envisioning, and then we can open it up.
MS. GREENBERG: Okay. The committee actually has had annual reports going back to 1949, which is a little teaser for you all to be thinking about observing, in some appropriate way, our 50th anniversary, which we did discuss at the honorary dinner for George last night. We were in kind of a celebratory observing mood.
In any event, with the new charter of the committee, it was not specifically chartered to do an overall annual report, as it had in the past, although we do report to the department as an advisory committee, and of course continue to do that.
In the legislation, the HIPAA legislation, the committee was given the responsibility to report annually on the implementation of HIPAA and its many requirements, and we did do that.
However, in doing the latter, we also noted that there were many activities of the committee that didn't, although they in some ways dove tailed with HIPAA, they couldn't be fully covered or even partially covered in that HIPAA report.
So, the executive subcommittee decided that it probably was a good idea to have an annual report for the committee that pulled together all the significant work of the committee.
By the time this was decided, it was, I think, at the November meeting and it was a little late in the process. So, it was agreed that there should be a 1997-1998 report.
Also, although previous annual reports had, it was also agreed or recommended that the report would not present information by subcommittee, as the last 10 or more annual reports did, but that it would be more of a theme type of document.
In the past, also, we didn't have the internet. We didn't have a web site. So, we always used the annual report to publish, in a sense, all the reports of the subcommittees.
At the last executive subcommittee, I think it was agreed that that would not be necessary, that they could be referenced, and that the web site could be referenced, because they are all up on the web site, and just the high points of what the committee's recommendations were, the process, could be covered. That would make it a leaner report as well.
Also, at the executive subcommittee, it was reflected on the fact that by the time it came out, it would be in 1999, and that being the 50th anniversary of the committee, that it might highlight -- really just highlight -- some aspects of the 50-year history, most of which has been covered up to 1995 or something, in the 45-year history which Susan Kanaan, our reporter and writer, prepared for the 45th anniversary symposium. Susan will be working on the annual report, so that was sort of a natural, too.
There will be a preface by Dr. Detmer and possibly the preface could just very quickly or very broad brush pick up this theme of, you know, the infrastructure, and all of what we are doing is for an end, obviously.
That could be where you could actually put it and not make it a stand-alone document. The preface is usually pretty much what the chair feels he or she wants to say about the work of the committee and where it is going.
We thought that the infrastructure document would be kind of like a forward to the report. In any event, it would be included in the annual report.
The contents, again, were going to be by themes, which are suggested in the middle paragraph.
We would have a draft for everyone to review at the November national committee meeting. Probably it would be finalized through the executive subcommittee, but everyone would get drafts to review and everyone would certainly sign off on it.
MR. BLAIR: Since it is the 50th anniversary and you are going through sort of a reflection on the history and evolution of the committee, HIPAA has significantly expanded the role of the committee, in my mind, in two dimensions.
One is clearly in terms of health care information standards. Secondly, I think the implications are in terms of the health care information infrastructure.
Has there been any discussion or consideration of modifying the name of the committee to reflect -- it sounds like there has been -- its broader responsibility?
DR. DETMER: Yes, I will comment. Yes, the executive committee has talked about that matter. I think the basic conclusion was that if you start getting into that kind of a thing, you would have to do it through Congress, and you could wind up with something very different than what you went in trying to accomplish.
MR. BLAIR: I see.
DR. DETMER: I think the question is, the mandate that we have got obviously does have a lot of history behind it.
I think it is a very fair question. Clearly, people on the committee have raised this, in addition to yourself. Candidly, people on the Hill have also raised the issue.
I am not aware of conversations actually in the department seriously talking about it, although it has been knocked around a bit.
I do sense that the celebration, the 45th celebration event, sort of spent everyone to the point that mounting another major event for the 50th has gotten a rather flat look.
My guess is that whatever we mostly would choose to do -- we mainly were talking last night about trying to maybe get a picture of all of us together up on the eighth floor with the capitol in the background.
MS. GREENBERG: We used to do that every year.
DR. DETMER: Do something of that nature and then have our report. I do think it is interesting, Jeff, the point that you raised about the committee's charge, and its sort of current role, I think, is kind of different in a minor way relative to the responsibility, clearly, of I think standards that end up being across the whole country, not just essentially on the government side.
I think that is relevant and clearly we can raise that in this report. But I don't know; this is kind of a free and open discussion relative to that report.
DR. COHN: I first of all don't want to go to the discussion of changing the name of the committee. I really actually wanted to talk more about the report.
I am actually struck that this is the 50th annual report, and that the concept needs to be actually modified that this is not the annual report for 1997 and 1998, but it is really a 50th anniversary report, which also includes reports in 1997 and 1998.
DR. DETMER: This bumps up against that 45th thing. They really did, indeed, go back through all of that.
It is the 50th year. I guess the question is -- it is our business. The committee can decide to do something.
DR. COHN: I guess I am raising the issue whether this is a biannual report or whether this is the 50th. I do recognize that there probably was a very extensive 45th anniversary annual report that maybe just needs to be updated in some ways for the 50th.
I am also very well aware that we have a very aggressive work plan that we are all involved with, at this point.
MS. GREENBERG: Actually, until the executive subcommittee meeting on May 21, this was strictly a biannual report, to replace two annual reports, although given the time that it would be coming out in 1999, there seemed to be some value that some of the members saw, in maybe kind of tying it in with the committee's history.
I think actually these expanded areas really built on a whole history but have obviously really expanded also the scope of the committee.
I think the desire was, then, or the intent was to then go back to an annual report, so there would be an annual report for 1999.
DR. DETMER: One question, of course, as she said, before we had a web site, it was really pretty tough to necessarily know what the committee had necessarily been up to and done.
I think our web site really changes the complexion of this, and I think it is literally the reason we haven't put out a paper report each year, as far as I am concerned.
I think that is also a question that we have got; do we want to save the trees. I think the general sense is, we ought to have some hard copy document every couple of years.
Lisa, you have been on the committee a long time. What are your recommendations?
DR. IEZZONI: I remember how hard folks work around the 45th. I also remember that it was fun. There was a two-day conference that was enjoyable.
I think that if Susan is willing to work on it, that you have a way of doing it that has always resulted in a nice report, and I think we should get them to go ahead and get a draft to us, and look at the details.
MS. GREENBERG: I can tell you that the Carr-White library at the University of Virginia has every annual report and is wondering what happened after 1995.
DR. IEZZONI: There are people who actually keep these.
DR. LUMPKIN: It is always difficult, in the present, to give appropriate perspective to the past, and particularly when you are looking toward the future.
I say that because somewhere around 1926, someone got it into their brain to do a history of the Illinois department of public health and history of public health from the time that the area was first colonized by the first native peoples.
That is an incredibly important historical document. I am sure they didn't think it was as important as we do today.
I think it is very important for us as a committee to put down our thoughts of where we were and where we have been in that 50 years, not because it may be important five years from now, but it may be important 10 or 15 or 25 years from now. I would encourage us to do it.
DR. IEZZONI: John, Susan wrote a very nice history of the 45 years. I guess the question is, should that be simply updated.
DR. DETMER: That is what it sounds to me like.
DR. IEZZONI: Word processing is our friend.
MS. GREENBERG: Not a separate report, not like a reissue.
DR. DETMER: No, but it should be referenced.
MS. GREENBERG: Absolutely, and Susan is the perfect person to do it. Do you want to come to the table, Susan?
MS. KANAAN: It just occurs to me that if you are interested in some reflections, one of the things that I certainly enjoyed most in writing and preparing the 45-year history, and that I think made it a more interesting document, was the interviews that I did with past chairs, such as Carr-White, and other observers of the committee.
I don't know whether you want to go into anything like that, or even select one person or two. I just throw that out as an idea, as a way of reflecting on where the committee is and looking back a little bit.
DR. STARFIELD: There has been only one chair since 1995. Maybe just bring it up to date with Judy.
DR. DETMER: Yes, Judy and myself.
MS. GREENBERG: Of course, Judy was very involved with the preparation of the 45th.
MR. MOR: Let me propose an alternate concept for the document, and one that goes forward, in John's poetic language.
That is, since the 45th anniversary, the charge to the committee has changed dramatically with HIPAA. It changed the whole variety of things the committee has sort of been doing.
We are now grappling with reorganization to look at continuity with the past, but with a broader vision of what the future would be.
I think it does make sense to think about a document, whether it is for the 50th anniversary -- I don't care about the technical stuff -- that is actually framed in that way, going forward, taking some from the past and going forward, as opposed to merely an expression of continuity.
I agree with you, that it is probably not a good idea to go up to Congress and ask for a redefinition. It is like opening up the Constitutional Convention. Forget it.
MS. FYFFE: I disagree with the reluctance to change the name. I unfortunately read the table of contents of the Federal Register every day.
DR. DETMER: I would get out of that habit.
MS. FYFFE: It is unavoidable. Cyclically, I see public laws enacted that name all sorts of things, post offices, buildings, airports.
I don't accept the idea that it is difficult, so let's not do it. I think in the long run the name needs to be changed.
If someone needs some help in the long-run preparation for that, I would be happy to help. I think we are doing the committee a disservice by continuing with a name that doesn't describe what we do.
Maybe after the 50th anniversary, we could change the name and put it out on the horizon there.
DR. DETMER: We have got kind of two issues on the floor right now. Let's try to split them for the moment.
It sounds like that we should actually, rather than maybe cast this -- unless you want to have two documents -- it sounds to me like what we are talking about is trying to bring, for the 50th year, an update, up to the current, since it happens to be the 50th year next year.
MS. GREENBERG: Or that could be done in 1999, of course.
DR. DETMER: I agree. Do you want a biannual report or do you want to try to bring this up to the 50th?
It seems to me that I doubt that we are going to have as dramatic a shift between 1998 and 1999 as we have had between the last five years, on where our mission is. I think that is the case.
I see some argument, since it does happen to be the 50th, and again, with the list of things on our plate, that if we were going to try to cast this in the sense of history, it might be smarter to just really re-look at this plan and then have a five-year update for the 50th kind of thing, including obviously what we have been doing for the last couple of years. Is that problematic for you? That is what I am hearing from the group.
MS. GREENBERG: I am only one voice here, one who for years wanted the history done, and was thrilled when we were able to have it done. The history and how this all ties in is kind of important for me.
Personally, I think there is value in having a report that does kind of highlight what the committee has done in the last two years.
You can look at web sites, but nothing pulls it together other than a report.
DR. DETMER: Why couldn't that be in the context of the last five years, bringing it up to the 50th?
MS. GREENBERG: You could just mention the things in the -- we have a 1995 report. We have a 45th history and then we have a 1995 annual report.
For 1996, 1997, 1998, it is really sort of three years, and the committee, its new charter happened in the beginning of 1996.
Actually, we never had a 1996 report. I mean, I suppose this could be bringing it up to date from the last annual report and the 45th anniversary.
DR. DETMER: That is what I was saying.
DR. LUMPKIN: I would propose a two-stage approach, which would be the first stage would be to write about those things that occurred that normally would go into this biannual report.
The second phase would be to add the missing stuff that would make it a five-year update. So, we would publish the biannual report by the end of this year, and then next year we would do the 50th.
MS. GREENBERG: So, it would be a second document.
DR. LUMPKIN: A second document which would encapsulate the first one.
DR. DETMER: I guess that is one suggestion.
DR. COHN: I guess I am going to suggest another possibility. I guess I am just concerned about what is described as the fire power of the staff.
It seems to me, at least from my view, that what we need is one report in 1999 that includes what John was describing, which is really covered within the 50th annual report.
If it takes a couple of extra months to do or if it takes an extra six months to do and it comes out in June of 1999, that probably isn't a bad thing.
I think it is important -- I have, like John, a sense of history and we should not forget that. We should do some things to mark this occasion.
I was also going to comment that this probably, while I don't want to really put this on as an agenda item, we do need at some point to talk about if we do want to do anything beyond this, to mark the 50th anniversary.
MS. GREENBERG: I would suggest that we should do some kind of modest reception in connection with the June meeting.
DR. DETMER: Apparently it consists -- from what I heard by government policy -- of liquids only, and non-alcoholic liquids.
DR. STARFIELD: I want to support the two-stage process. For the archives we need an annual report. I think it is a year too early to do the 50th report, because we have just been through our other acute shock in changing our focus, at least temporarily. We need a year for that.
DR. DETMER: Does that sound okay, folks? Let's come back with a draft for the report and then we will re-look at what we do on the 50th. Fair enough?
MS. GREENBERG: And really not deal with --
DR. DETMER: We will think about it. I guess that is how we will proceed. If you have comments or thoughts on what should be in or out of that -- did you want to comment?
MR. STRIEMER: A very minor comment. I see words like highlight activities and I don't see words like accomplishments.
I tend to like that word. I don't know how others feel, but I would suggest focusing on that.
DR. DETMER: I don't think that is minor. I think that is very important.
MS. GREENBERG: I think we focus on process as well, and maybe focus less on process.
DR. DETMER: Let's talk a moment. We did also glaze around a little bit on the name. Let's engage that a little bit.
The executive committee had, as I said, talked through that somewhat. Obviously we are in on this as a full committee, and I think it is a good question. It is a legitimate thing to talk about since we are in this set of issues.
MR. SCANLON: Actually, the executive committee did look at changing the name, or at least using sort of a parenthetical or a by-line to the committee.
When HHS refers to this committee, we typically say it is the advisory committee for national health data, privacy and health information policy.
When we tried to actually get that subtitle in the chartering, we ran into some legal issues. They are very strict, for good reason -- there have been law suits, as you know, about federal advisory committees -- that we strictly stick to the name that is in the book and not assume that we have other authorities or other names. We were told not to use the by-line.
DR. DETMER: That still leaves the question whether we want to obviously pursue a change or not.
DR. LUMPKIN: My inclination would be to not change. I am a little bit concerned; there are a lot of issues going on at the federal level having to do with privacy and confidentiality and other issues.
To provide a vehicle for other issues that may get tied into it, I just don't think the timing is right. I can see that it makes sense, but maybe in a year or two when things have settled down, the proposed rules become final rules and we have some clear direction where we are going.
MS. FRAWLEY: We discussed this at the executive subcommittee meeting in November. The points that I raised are that when Congress re-chartered the committee and expanded the membership of the committee to 18 members, it could have so chosen at the time to change the name of the committee.
Congress did not choose to do so. My feeling is that at this point we have a new charter; we have an expanded membership.
At this point I agree with John. I don't think it is prudent to decide that you want to go back up and request the authority from the Congress to change the name, the charter, the membership.
MS. FYFFE: No, I am not talking about the charter.
MS. FRAWLEY: I understand that but the problem that you have is that when you open up that process, you could wind up with no committee, b, a very different committee.
I think those are the realities that you need to be aware of. So, based on that discussion, at the November executive subcommittee meeting, the decision was to not move forward at that time.
MS. FYFFE: Okay, if those kinds of risks exist, then I don't think we should pursue it.
DR. DETMER: All right, are people comfortable with that for the moment?
MS. GREENBERG: I would just say that once Dan Friedman and the subcommittee on population has really carried forward this vision for health statistics for the 21st Century, the name may seem less inappropriate than it does now.
DR. DETMER: That is great. I think I would like to see us then move on to our next item. Dr. Chris Chute is here. If you will please come on up, he is going to report to us on the CPRI terminology conference. It is nice to have you back.
Agenda Item: Report on CPRI Terminology Conference.
DR. CHUTE: Thank you, Mr. Chairman.
DR. DETMER: We have had Dr. Chute before us in the past. He is a professor at Mayo and we are glad to have you back.
DR. CHUTE: Thank you very much. I am here to report, as many of you know, on the CPRI-hosted terminology conference.
It involved not just the CPRI of course, but a large cast of planners and a partial list, I think, of the planning task force should be mentioned.
You will recognize a lot of people in the room, a lot of people on the committee.
More pertinent, this was not just the work of individuals, but the work of organizations. The sponsors and planners for this included, I think, a spectrum of payers, providers, of organized medicine and organized health care, that provided an appropriate cross section of interested parties with respect to the terminology problem as we understand it.
Again, I think you will notice many organizations with which you are familiar.
I want to recognize my co-chair, the good Dr. Simon Cohn, who was masterful in his helping me make this thing happen.
The nidus or purpose of that particular terminology conference grew out of a prior summit that had happened about one year previously -- people are smiling; it must have been mentioned -- the national information health summit in November of 1996.
Three items were emphasized as priorities for health care as we move forward. Specifically, patient identifiers, confidentiality, and terminology, all were given more or less co-equal status in terms of what we should do about them.
One of the conclusions of that study, of that conference, with respect to terminology -- there were several of them, but I won't bore you with them all.
With respect to terminology, it was to convene a national conference to carry this particular topic or interest further. It is indeed that subsequent follow-up conference about which I am reporting today.
The intentions of our get-together were to bring together providers, practitioners, users, vendors and developers.
I think you would agree, not only from the planning personnel, but from the sponsoring organizations, that we were reasonably successful in bringing large numbers of them to the table.
I apologize further for the item in your handout which appears, evidently, to have been a wrong version of the draft, complete with strike outs and edit bars and all kinds of things. My fault. Forgive me, Marjorie.
MS. FRAWLEY: I thought you were trying to emphasize that it was a draft.
DR. CHUTE: Yes, it was definitely a draft. It was trying to be a cleaner draft.
The goals of the meeting were to understand, fundamentally to listen. Being a card-carrying academic, of course, I love to lecture. But the purpose of this particular meeting was to listen to the membership and the constituency that were presented and invited, to have industry define terminology requirements, to agree upon a framework for progress -- always a trivial undertaking -- to prioritize those requirements, and to provide knowledgeable input into national deliberations, of which, of course, this forum is one, if not the premier.
We used as a starting point, for what we were to talk about in that terminology, a document that had grown out of a joint working group comprised of the CPRI working group on terminology and the ANSI health information standards board subcommittee on terminology.
They provided a nidus around which a white paper was written, that provided, among other things, ideal criteria for terminology development and harmonization in the clinical context, highlighting excruciating details on characteristics, structure, maintenance, administrative management.
There was a conclusion at the end that there be an adaptation or philosophy of interlocking terminologies, as opposed to a monolithic refit of everything we think of in clinical medicine and its implementation.
The notion of starting from scratch with yet another terminology that would replace everything we had done was, to put it mildly, rejected.
This was for many excellent reasons: feasibility, practicality and, frankly, need, since it was thought that we could achieve our goals with the principles of interlocking cooperative terminology.
This begs what the heck is a clinical terminology anyhow, and I see that we have a little truncation.
I panicked. I went to Kinko's about 45 minutes ago, so these have been copied but not read. We have panderized terms and their synonyms which record patient findings, circumstances, events, interventions, with sufficient detail to support clinical care, decision support, outcomes research, quality improvement and can be efficiently mapped to broader classifications for administrative regulatory oversight and fiscal requirements.
We felt that an everybody-must-love-it kind of definition actually functionally captured what we meant, in that it fundamentally gets at the notion of patient descriptions while, at the same time, embracing the broader categorical uses of terminologies and classifications and that we clearly saw those along a continuum.
That continuum was very explicit. The recognition was that, while hinted at in the framework document, frankly as a footnote, it was expanded as a primary theme in the context of the conference, that this historical tension between detailed nomenclatures and excruciatingly refined descriptions of patient events was, in fact, not in conflict with the goals, needs and requirements of broader level classifications.
Rather, they exist, both importantly and perhaps independently, but nevertheless in a relationship along a continuum where more explicit classifications could be summarized for more detailed patient representations.
The key is not to think of them as systems that need to be mapped or somehow wired together, but as they co-evolve, can be coordinated along a continuum so that there is a natural incorporation of higher level concepts in the more detailed representation and that, if you will, there is semantic resolution; there are notions of meaning and detail and concepts that are coordinated.
The format involved keynotes from these two persons. I don't know if you are familiar with them, Don Detmer and Bill Braithwaite.
They were both gracious enough to provide outstanding keynotes, which set the session not only of where we are but a very pragmatic statement of what is needed and where we need to go.
This was followed, of course, by sessions. Whenever you speak in front of a committee, it is always good manners to paraphrase the chair. But the good Dr. Detmer presented what he articulated as founding principles, not only of the nation, but as they were articulated by Jefferson, that the merits of health care are quite important to the social fabric of a nation and to its development and evolution.
I won't go on in that vein. He can do it so much better. He did, however, get quite specific in terms of his personal view of desiderata surrounding terminologies.
That is, that they be fundamentally public domain, accessible at minimal cost, periodically reviewed and revised so they are highly dynamic.
They can be cross walked, which essentially implies the notion of mapping or continuum. International consultation should be sought and the variation between and among local implementations can be accommodated within these larger terminologies. We have you on tape.
In addition, Bill Braithwaite, of course, spoke of the HIPAA legislation, something quite familiar to this committee.
Betsy Humphries presented the results from a large-scale vocabulary test which was conducted by the National Library of Medicine and the Agency for Health Care Policy and Research.
Robert Mays addressed the interests of HCFA in the context of outcome studies, of quality evaluations, fraud and abuse detections and other applications, if you will, wherein detailed patient information would be required, and it is information that they feel they do not presently have.
Simon Cohn reviewed in detail the principles that had been generated within the framework of his BCPRI joint working document.
Panels proceeded to describe in a thematic way, what were the common needs and requirements among health care organizations represented by the VA, Kaiser, and the good Bob Mays stepped in as chair to describe them in the context of HCFA's requirements.
In terms of primary care, with representatives from family medicine, nursing, health and rehabilitation professionals as well as -- I neglected to add -- general internal medicine, specialty care which was represented almost as a sampling, by no means exhaustively, by ophthalmology, ob/gyn, the dental association, and psychiatry.
Psychiatry is somewhat interesting in that they have invested enormous energies -- as many of you know -- over the past 40 years in highly detailed patient classifications and descriptions, which were quite apt to this conference.
We were pleased to have the editor of the DSM provide those comments.
Additionally, there was a panel on software developers, hailing from CERNER, Columbia, Medicalogic and Oceana.
The final panels we had to present perspectives were roles for clinical data from the National Uniform Billing Council, the Nursing Data Center, the Illinois Department of Health -- John, have you heard of them -- the NCQA.
Then there were terminology developers, representing AMA, NCHS -- Marjorie -- LOINK, nursing, Snomed, and the NHS clinical codes, as they are fondly known these days, formerly known as the Reed codes, which is essentially the United Kingdom initiative for clinical patient description.
That is what we did. What did we find out? Surprise; the recognition of the importance of terminology. This is sort of a set-up on that one.
A need for integrative solutions was solicited broadly. We didn't even have to fish for that one. This seemed to be a consensus of the industry representation that we didn't even have to remind them of.
There was recognition of the need to create and adopt good practices for terminology development. Industry in particular decried the absence of delivery standards, representation standards, development standards, maintenance standards, in the dreaded terminology morass, where they confront, in the context of their vendor application and sales, the nightmare of trying to coordinate terminologies that are presented in an ad hoc fashion without any consistency or discipline in their representation and their engineering.
Similarly, other conclusions included the fact that terminology should be encouraged to begin design and maintenance changes, which will enable the efficient and non-redundant cross mapping and linkage.
It is not merely the instantiation of a terminology within a vendor product, but what the heck do you do with it when you are confronted with a maintenance update problem over time, and with the need, which is ever present, of using clinical information within a clinical environment for a broader spectrum of secondary purposes; the cross walking problem essentially, and the importance of a need for industry standard mapping for administrative and clinical terminologies, which is more or less a specific -- Marjorie, I will mail you this slide set; you don't have to take too many notes.
This is a special case of this mapping, in a sense. Administrative data representations have rule sets and requirements unique unto themselves which need to be formally captured in the context of the logic and mechanisms that would engage that mapping.
There was a further recognition -- and this was cribbed more or less from the framework conclusions -- that an entity serving the public interest would be a boon to the coordination of these interlocking technologies.
It was not stated that it could not happen without such things -- this is America. It was certainly recognized that it would be easier to have a designated, benign serving-the-public-interest player providing that role.
There was, furthermore, something of a consensus achieved at the last; that fair recovery of development and ongoing maintenance costs were not so awful bad.
There had been a quasi-militant view among many at the beginning of the conference and prior to this, that terminologies must be free; sort of waving banners, Free Terminology.
The recognition that many of the real costs as they are borne in the private sector or as they are borne in non-profit organizations, can only be sustainable if there is a fair -- and an emphasis on fair -- nominal cost for their distribution, maintenance and application.
This slide is in black and white. For those of you who have seen this slide before, this was my grand schematic of how terminologies integrate with what I thought was a clever use of color. Suffice it to say, use your imagination.
We have stove pipes of clinical classification as they are applied in the medical industry, be they Snomed or CPT or ICD or pick your favorite classification.
They evolved for common purposes. The graph, the way it originally appeared on my lap top, had all these different stove pipes beginning with a red hue, implying that they shared the common humanity of the patient and that descriptions that occurred at the detailed level were all comparable across the baseline, if you will, of these terminologies.
Nevertheless, as they evolved toward their specific application, they would -- and it was quite visually clear -- assume a different colored hue, so that you ended up with a rainbow pattern of specialization, of differentiation, throughout the universe of terminologies; yet they arose from a clinical base which was fundamentally patients.
The clunky arrows represent historical patterns to map at these higher differentiated layers, between and among terminologies.
That is a dicey process, because those cells have differentiated and they are no longer sharing embryonic roots.
If you take a clinical notion and descend to its atomic representation in the context of the patient, then you can have more or less plug board base mappings between and among terminologies at the level of their common roots.
It is very hard to understand in black and white. I swear to you, it was self evident in color.
This addresses the notion of stove pipes and their classifications, that mapping can occur at the root level premise.
That is not to say that we cannot have coexisting higher level expedient mappings among these terminologies, but it is not necessarily the way that one would go.
Another recognition out of the conference was the operational role of terminologies and their distinguishing features.
That is, you can look at it either operationally or functionally, separating the universe into entry terms, reference terms and administrative terms, is one way to think about it or, analogously into specific nomenclatures, a base atomic representation and then aggregating classifications that can exist cooperatively, independently or in a common reference frame.
Diagrammatically, what does that look like? A lot of the graphics have disappeared, but that is all right. Entry terminologies are where health care providers interface with the notion of classifying patient information.
Historically, there have been two ways to do this. Clinicians write down what the heck they want and poor people elsewhere in the institution try to interpret what they meant, and then code it.
That is a viable model for many purposes, but it is recognized that if there is a more clinically relevant and friendly entry level terminology, that that can be mapped as an explicit process to underlying reference terminologies.
These would form, if you will, that baseline, that atomic red space that you never saw in the stove pipe patterns.
These, in turn -- and this is where data bases and clinical repositories and warehouses and what not would be premised.
These, in turn, can be converted on demand, or by methodologic process, to applications and needs in administrative aggregation of quality measurements, administrative measurements, cost allocations, the usual suspects that require an aggregation of the information for a specific purpose in a specific way.
This implies that clinical terminologies really function everywhere, if we think about it for more than a few minutes -- virtually every aspect of what we do in the information intensive environment of health care today.
It also implies that it would be neat if they could therefore be linked to common underlying servers which share this reference terminology model, and that the functional role of their access to this server -- the application that is using that server -- would determine the appearance and flavor of the terminology as delivered.
It is recognized that one size does not fit all, but a common interlocking terminology suite, which is integrated by a reference concept, can accommodate that model. Let me show you that diagrammatically.
Think for a moment of -- again, we have lost graphics, but the principles are clear -- of indications for orders as a clinical instance, a problem list, a reason for a visit, billing diagnosis, outcomes capturing.
Those are all classification problems in their simplest context that would do well, in any clinical analytic model, to share a terminologic reference point among them.
It is not reasonable that the terminology that they use appear identical each and every time, which is why we have the notion of a common terminology server to which an object agent -- which can be a human being; human beings are perfectly capable objects -- that can inference the server information or the reference information for the specific application.
More elegantly, we could make computer science notions of an agent, a corporate agent, a common interchange agent, that would negotiate the application's specific needs with a view of the terminology model that was relevant to the need at hand.
This extends, somewhat, in a specific way, what we were thinking of at the conference. The point of the conference was, assume that we had a perfect vocabulary; make that assumption.
That is still not sufficient because people have to use them. They have to use them rapidly; they have to use them practically; they have to use them reliably and they have to use them easily.
So, it begs this notion of human navigation and presumably a computer interface. That is where these notions of application and dependent accesses to a common server arose.
The action item that came out, beyond the need to communicate and publish -- and we have a web site, as you know, that is referenced in your handout as a footnote on the first page, I believe -- wherein every slide, every power point presentation, every session summary is included on that web site -- those of you who don't have the handout, it is www.cpri.org/terminology.
The action item that was preeminent, of course, was what do we do with all this. It is fine to have a group of people get together and reason out purposes and needs and requirements, but where do we go from there, beyond sputtering about it in various forums.
One of the action items -- and as I say the preeminent action item -- was the need -- and this was planned prior to the conference, as we understand it -- for a follow-on conference to revise and update the consensus that we achieved at the first one. It will be roughly 18 months or if things change.
Establish a mechanism for interlocking development along that continuum. It is one thing to describe it would be a good idea, but how do you do that, anyhow?
Define a coordination process. Recommend the dreaded entities serving the public interest.
That is presently planned for late January in the D.C. metro area. We thought about having it in a lovely warm area, but on the other hand, we wanted people from this community to have convenient access.
From Minnesota, actually, D.C. is warm. So, it is all relative. That is the summary as I understand it. Dr. Cohn, do you want to make an explicit addition?
DR. COHN: No, I think you have done a very good job of providing the summary view of the conference. I do want to commend you.
I think the summary was excellent. I think it will provide -- the conference itself and the work that went into it provide very important beginnings for the work group on computer-based patient records, and I really think all the terminology and data work that we are going to be doing over the next year or two, and so I really commend you for that.
DR. DETMER: I thought also that it was a very good conference. I was pleased actually that the committee related to the activity.
I think it was a good thing because it is so central to some of our charges, as you pointed out. I have one question, and others may as well, Chris. It was an excellent review.
What conversation went on relative to the entity, government, non-government? Was this something that the CPRI saw itself uniquely suited to do? What conversation occurred, or what do you anticipate is likely to move forward in that regard?
DR. CHUTE: That is a very central question. I will be quite frank. The detail of the discussion that occurred at the conference merely threw out candidates, and was not in any way close to resolution, recommendation.
The candidates -- I don't think it is necessarily a secret -- included NCHS, included the National Library of Medicine, included CPRI, and included others which escape me.
There was no clear clamoring on the part of any of those organizations to seek the job. The recognition was that it had to be universally regarded as neutral on these issues, and that describes, of course, precious few organizations on the planet.
MR. BLAIR: Chris knows that whenever I am at a meeting, I always wind up adding a different aspect and then asking him for his guidance, because he has thought about these things much more than I have. Let me do it again.
I think, in your presentation to the committee, you really helped many folks who are not familiar with the concept of a reference terminology, to try to put together something that terminologies can converge to, with integrity that can be updated over time.
Your presentation, I think, did great value in educating the committee on that piece.
There are two more things that I know you are familiar with, and we have had an introduction to from other folks who have given presentations.
I want to mention those, and then really ask you what your thoughts are on how we pull all of this together.
Simplistically, I would wind up indicating that the reference terminology might be a way to integrate terminologies, let's say, horizontally.
At the same time, we have some excellent work being done within the HL-7 vocabulary sig. They are pressing to improve interoperability by identifying data elements and code sets within fields.
I think of that as trying to move forward to interoperability and clinical specificity, but sort of integrate things vertically.
I think some of these phrases I may have even stolen from you, so I claim no credit for the intellectual leadership in this.
Both of them are needed. Then, beyond the horizontal integration and the vertical integration that is needed for terminology and vocabularies, there is also the fact that we have to live with who knows how long a period of time when we will have to have multiple terminologies and code sets for multiple uses, multiple perspectives.
Therefore, we need mappings, which Betsy Humphries has described to us the projects she is envisioning to be able to provide those mappings.
It seems to me as if all of those three things are required. So, now I want to ask for your guidance and wisdom and thoughts, because I don't think we can really work together on one of those three dimensions. I think somehow we have to work forward with a perspective on at least three, and maybe you know of a fourth or a fifth that we need to consider as well. What is your guidance and advice on how we should move forward in this multi-faceted environment?
DR. CHUTE: Well, as you might expect, Jeff, I certainly agree with you on your articulation of the multiple axes upon which we have to think about terminologic harmonization.
I would add -- and I don't think it is a pedantic addition -- the jargon of semantic normalization. By that, I simply mean agreeing on what we mean within instances of term expression, across terminologies. That is a fairly non-trivial one.
It cannot really be brokered in the absence of an underlying reference frame or reference terminology model.
The how you get there is not going to happen in the absence of happy cooperation among the independent terminology developers.
I think this is actually beginning to be achieved. I was somewhat despairing three or four years ago, but am quite sanguine at present, that our ability to -- persuade is too strong a term -- but to demonstrate the utility of having consistent usage of semantic models and meaning and root forms across terminologies is beginning to be appreciated across many organizations, although we lack at the moment a home for this coordinating process.
This makes it terribly difficult because many people are competing, more or less, to be that home.
I think the HL-7 project, which as you may know, I have recently become part of myself, I have great respect for that effort.
It is a more narrow and focused effort with a very specific goal, which is to populate table entries in message exchange transactions with consistent contents.
I think they would agree that it is, for the present, little more than that. However, in the domain of pharmaceuticals and drug dosing and pharmacy messages, that is non-trivial enough.
It is a huge task and one that I think they have appropriately circumscribed for the time being. Nevertheless, it is an instance of precisely what you describe. It is an instance of a cooperative, collaborative effort that represents where we need to go and how we need to go there.
It is by no means an exhaustive model that would subsume the entire process.
MR. MOR: At the risk of asking a question that might take forever to answer -- and if it is, just tell me it is unanswerable -- the stuff at the bottom, the interchanges of these languages, it would be really helpful if I had an example of how you think of intermingling these various terminology, other than this table structure that you just described HL-7 to be in the process of.
DR. CHUTE: Let me give you a concrete example. ICD has, as a rubric, ascending colon cancer, which if you think about it for a few minutes, actually contains a lot of constituent parts and pieces.
One would want to define an appropriate level of reference frame. One can get very pedantic about this. One can start quibbling about, well, gosh, is colon cancer a discrete entity and we are glad to declare that an atom, or are we going to break that one apart into neoplasia as it occurs in the colon.
Well, you start bumping into contingencies because what is the ascending colon. Is that a piece of the colon, or is ascending modifying the underlying aspect of that anatomic structure?
There are two tasks that are needed. One is defining -- and ultimately this would be a subjective, arbitrary process and everybody agrees about this -- what the level of resolution of those atomic elements are.
Once they are instantiated, you will be able to take more complex concepts and break them down, more or less, into their reference representations.
You could then go back and say, ah-hah, the ICD rubric for ascending colon cancer is really a composite of this, this and this.
We label it whatever the code is, 153.X, I don't know, and it is convenient to use it that way and there are legitimate and useful purposes for using it that way. It can also be seen as this more specific reference representation.
MR. MOR: And all the associated procedures that one would do would have their corollary sets of classifications.
DR. CHUTE: I would argue that ICD-X-PCS is already moving in this direction, more or less.
DR. COHN: I actually wanted to move up a level in the discussion, because I think it is exquisitely granular in the discussion.
I just wanted to reflect for a moment, actually, about the conference, and I think reemphasize a key point that came out of it now. It has been almost a year since the conference and I think we tend to forget some of the thoughts that I think are really ground-breaking in retrospect, that really brought home, I think, to the developers and others in the community certain key points.
I was reminded about this yesterday when we were talking about the work group for computer-based patient records.
There has historically been a view of administrative terminology, administrative classifications and administrative terminologies.
I don't think it has been very clear to the world that they really needed to be joined, and that there needed to be a continuum and have them be mapped.
Whether or not they are mapped to a reference terminology or whether they are mapped just very well and very cleanly mapped, I think, is always the question, but I think it became very apparent to everyone at the conference, and I think it has become generally clear to everyone since then that this is really a continuum.
The way that we are going to get good administrative data is by having good clinical terminologies, and by very efficient mapping that does a very good job of moving that up and providing many uses.
I think that was really the sort of ah-hah that at a very fundamental level came out of that conference. I think those of us who were at the subcommittee on security and standards on Monday heard a presentation from Betsy Humphries, who was also at the conference.
She began to talk about issues of how she was really going to begin to try to do some beginning mapping efforts.
I think once again it is something that became a very clear high priority out of that conference. I think we really need to be thankful for that vision which, once again, will be very helpful to the committee as it proceeds.
DR. DETMER: Chris, do you have a comment on that?
DR. CHUTE: I agree.
DR. DETMER: I thank you very much for coming back and giving us a nice summary. As you can tell, it is a topic of obviously a lot of interest to the committee, and we will look forward to staying in touch as this continues to move forward. It is never done.
All right, I would like, before we break for lunch, we have a few minutes and I asked John Lumpkin if his group did have a language to come back to us for. I thought we could cover that item before we broke for lunch. Then, when we came back from lunch, we would pick up on the rest of his subcommittee's report and the other work groups, and then we will go on from there. John, if you will proceed.
Agenda Item: Reports from Subcommittees.
DR. LUMPKIN: On the document which was response -- it is entitled HCFA 0149-P -- there was an issue that came up in regard to methodology for the data content committees.
On page 4 of the document that is being handed out with that reference number at the top -- I will give you a second to get it.
On page 4 of that document, in the heading under new and revised standards, the second point on that, which is at the bottom of the page, the committee, in discussing the issues, which were the option one which listed nine elements of what would be the criteria for accepting a data content maintenance committee, we first of all, reread the NPRM, which Kathleen helped us with after about a half hour of discussion.
We realized that we were far exceeding the scope of what we were trying to answer. We realized that the language said that the comments regarding the approach outline and recommendations for data maintenance committees for each of the X12 transaction standards identified in this role was much narrower than the whole issue of data content committees.
That coincided well with the intent of the committee, because we had wanted to conduct hearings on that issue, of how committees that would be maintaining content, data content including coding committees, would be recognized by HHS to continue to do that work.
So, having honed down on that, we came up with the language that you see under number 4. The NCVHS believes that HHS should specify and establish guidelines in the final rules for the operation of data maintenance and content committees.
We believe that such committees, if not ANSI accredited, should operate in accordance with four principles.
These four principles are:
Because there are several specific issues to be resolved concerning the operation of data maintenance committees, the NCVHS intends to hold hearings to advise HHS on future rules that may be appropriate.
The rest of the language is essentially what you saw yesterday.
DR. DETMER: Your group brought that to us for the full committee to approve?
DR. LUMPKIN: That is correct.
DR. DETMER: Is that a motion?
DR. LUMPKIN: That is a motion.
DR. DETMER: Is there a second?
DR. STARFIELD: Second.
DR. DETMER: Is there discussion on this? Hearing none, all in favor say aye.
[Voices heard in the affirmative.]
DR. DETMER: Opposed? Abstentions?
[No response heard.]
DR. DETMER: So moved. Do you have other items?
DR. LUMPKIN: We also have a revised charge. I don't know if this requires any action by the full committee.
DR. DETMER: Accepting it.
DR. LUMPKIN: The only difference from the charge you may have seen earlier is that the original charge for the committee under four had stated computer based medical record systems.
We inserted the language from the act itself, which talked about uniform data standards for patient medical information and electronic exchanges of information, including computer based medical records, because we thought the original language was broader than just that.
DR. DETMER: I actually think it would be good to have this approved by the committee.
DR. LUMPKIN: Then I so move.
DR. DETMER: Is there a second?
DR. STARFIELD: Second.
DR. DETMER: Any discussion?
DR. IEZZONI: I haven't had a chance to read this in detail, so it might be in here and I just didn't notice it.
Our subcommittee on populations feels strongly that HIPAA has implications for population-based data as well.
I would like to see some language in here about working with our subcommittee, or at least being aware and thinking about issues having to do with generation of population-based data around the HIPAA standards.
DR. LUMPKIN: I think that would probably fit --
DR. IEZZONI: As I say, I just got this.
DR. LUMPKIN: I think that issue of how we relate health care transaction data and standards to population issues of the committee is broader than the specific charge. I would see adding a sentence along the lines of what you said into the introductory paragraph.
DR. IEZZONI: Yes, that is very appropriate.
DR. LUMPKIN: So, if the committee would agree, we will work out an additional sentence that will say that.
DR. DETMER: I am glad you raised that because I think you are exactly right. I think we will have this interface issue to deal with.
Do you accept that as well, then, to the motion?
Other discussion items? Hearing none, all in favor of this motion with this amendment, say aye.
[Voices heard in the affirmative.]
DR. DETMER: Opposed? Abstentions?
[No response heard.]
DR. DETMER: Thank you.
MS. GREENBERG: The other documents didn't change?
DR. LUMPKIN: The other documents did not change. We had the work group charts. Is that ready to go to the full committee?
DR. COHN: Yes. Did you want to talk about the work group charge?
DR. LUMPKIN: Yes.
DR. COHN: It has actually been handed out, I think, to everybody.
MR. BLAIR: Forgive me. I don't know that I am in the right context here. The phrase that you just read, John, and Iris was trying to catch me up on that, it was with respect to the phrase, uniform -- if I can remember it, uniform data standards for patient medical record information and electronic exchange of such information.
Just help me understand here, because it is hard for me to visualize that within the context of the whole thing.
I am not sure whether -- in the law, it had issues related to uniform data standards. Do we kind of capture that notion in what prefaces that phrase?
I felt it was important that we didn't lose the breadth of that phrase, issues related to.
DR. LUMPKIN: Let me perhaps read the introductory to it, because it is at that point.
Based upon consultation and analysis, make recommendations to the full committee on the implementation of the provision related to health data standards outlined in PL104-191, with special attention to the standards relating to.
Then we say uniform data standards for patient medical record information. You can't have standards or issues related to.
DR. DETMER: Does that answer your question?
MR. BLAIR: I think so.
DR. DETMER: Simon, do you want to go through, then --
DR. COHN: Why don't I go through the charge. I apologize; I think it is just being passed out right now, so Lisa should get it here in just a second.
There are actually two documents. One is an action document which is actually about a three-quarter-page charge.
Then if we have a moment, we can talk about a draft which has to do with focus, scope and deliverables. The key point here is that the action item is the charge.
I don't know whether I should read it or we should just have everybody --
DR. DETMER: I see Jeff nodding. If you want to work your way through it, it would be great.
DR. COHN: The charge itself actually starts out by quoting the pertinent section of public law 104-191, which requires that the NCVHS -- and we have talked about this before -- study the issues related to the adoption of uniform data standards for patient medical record information and the electronic exchange of such information, and then shall report to the Secretary no later than four years after the date of the enactment of HIPAA, recommendations and legislative proposals for such standards and electronic exchange.
Meeting these requirements will be a primary focus for this work group. Specifically, the work group will, one, develop and initiate a work plan to ensure that the committee is able to respond appropriately and in a timely fashion to the legislative requirements;
Two, identify opportunities and issues for subcommittee and full committee attention;
Three, through a variety of mechanisms, provide outreach, liaison and consultation with, and serve as a public forum, for the public, consumer groups, the health industry, SDOs, the research community, state and local governments and other interested parties; and
Four, based upon public hearings, consultation and analysis, develop recommendations to the department and legislative proposals for subcommittee and full committee consideration on issues related to the adoption of uniform data standards for patient medical record information and related information and the electronic exchange of such information.
This has been reviewed by the work group and approved by the subcommittee, and comes to the full committee for your consideration.
DR. LUMPKIN: Second.
DR. DETMER: All right, that has been moved and seconded. Is there discussion on this charge?
MR. MOR: In addition to the typo -- I assume it is initiate, not initiative in item number one -- item number two, I don't really know what item number two means. I don't think you need an item number two.
If I read this correctly, I look at item number four and it basically says you want to hold public hearings, you want to hold consultations and analysis and then develop recommendations, and that is really the charge, as I read it here. The rest of the stuff, I am not quite sure. A work plan is not a charge. It is just a process. I am sorry to be a pain in the butt.
DR. DETMER: No, that is why we bring it up to the committee.
MR. MOR: Item four has public hearings, consultations, analysis and then recommendations, and it is all in relation to the act.
Item three and item two have no qualifiers whatsoever. It is just like hold a big party. It doesn't say about what.
I have been through this enough times that this is always a tough one. You rewrite it and rewrite.
MR. MOR: At least you don't need two.
DR. COHN: I would certainly be happy to take out two. I think that to go further, I think begins to compromise the activities of the committee, but I would consider, from the amendment, taking out two.
MR. BLAIR: I would concur and accept that we don't need two. Could you reread three for me so that I could reflect a little more clearly?
DR. COHN: Three is, through a variety of mechanisms, provide outreach, liaison and consultation with, and serve as a forum for the public, consumer groups, the health industry, SDOs, the research community and state and local governments and other interested parties.
DR. DETMER: I think what Vince is saying is about what.
MR. MOR: Yes, about what.
MR. BLAIR: Assuming that it is in reference to computer-based records.
DR. DETMER: It doesn't say so, is what you are saying.
MR. MOR: It doesn't say so and, in some sense, it is redundant to the clause, consultation and analysis.
MS. FYFFE: Vince, we can tell that you are fresh today. We were doing this late in the evening last night.
DR. STARFIELD: Can I just sharpen that? As someone who is thinking about whether it would be useful to join this work group, that document doesn't help.
DR. COHN: This is why we bring it up to the full committee.
DR. DETMER: Do other members of the group have comments?
DR. COHN: I guess my own feeling is that I am never quite sure whether charges do help you decide whether you are going to become a member of a work group.
DR. DETMER: This is a tough group today anyway.
DR. COHN: What is it that you are looking for that would help, if this doesn't help.
DR. STARFIELD: I guess I sort of want to know how much of the work is conceptual and how much is technical. You know, specifically, what is --
DR. COHN: Is that in a charge, though?
DR. DETMER: Everyone is comfortable or at least willing to drop two; is that correct?
DR. COHN: That is correct.
DR. DETMER: Marjorie, weigh in.
MS. GREENBERG: I don't have any problem with dropping it, but I think the point of two was that in this area you will be raising issues to the subcommittee and then to the full committee that the work group will not be really independent of the subcommittee.
As I understand it, one could be a member of this work group and not a member of the subcommittee. Actually, you would probably not be bringing things to the full committee. You would be bringing things to your subcommittee.
DR. DETMER: So, the question would be, you either drop the whole thing or you drop the full committee.
MS. GREENBERG: You can drop the whole thing.
MR. MOR: Don't we someplace else have definitions of what work groups are, so if this is a work group it is going to meet all the functions of the work group, so you don't need to actually do that.
DR. DETMER: That also was the topic of some conversation. Certainly it is a question that has not been solved.
There is a motion on the floor with a second, to accept this with the change of removing item two. Is there further discussion?
MS. GREENBERG: Did we need to add to item three?
DR. DETMER: That is a separate motion. Hearing no further discussion, all in favor say aye.
[Voices heard in the affirmative.]
DR. DETMER: Opposed? Abstentions?
[No response heard.]
DR. DETMER: Now, do you want to add regarding computer based records or something to item three, or not?
DR. COHN: Isn't that implied by the title of the committee?
DR. DETMER: I think it is, personally.
DR. COHN: That is why I actually quoted the pertinent legislation in the beginning part of it.
DR. DETMER: Okay, so I think we are set; right? Okay, then why don't we break for lunch and then we will give you time to read the draft, so we can pick it up after lunch, at 1:00.
DR. COHN: I want to be very clear that the draft is not an action document. It is a discussion document.
DR. DETMER: That sounds fine, and then we will go ahead with the rest of the agenda. Lunch.
[Whereupon, at 12:00 noon, the meeting was recessed, to reconvene at 1:00 p.m., that same day.]
DR. DETMER: All right; it is 1:00 o'clock. So, we will resume.
DR. COHN: Really, what I wanted to do was take a couple of minutes and really introducing the committee to the work group on computer based patient records.
I think now we have read the charge. Barbara has commented that she didn't know exactly whether it made her interested or not.
I think I wanted to just talk for a minute or two about the work group and kind of walk through a document which we call proposed focus, scope and deliverables.
It is not a vision. I will talk about some of the issues around vision. It is recognizing that this is maybe actually part of a work plan.
If first of all wanted to comment that I want to thank the people who decided to become members of the work group.
Obviously, the membership is not closed, but so far we have -- the membership is open to anyone who is a member of the committee.
So far, Jeff Blair and I are obviously co-chairs. Kathleen Frawley is a member, Clem McDonald, Kathleen Fyffe. John Lumpkin is an ex officio member. Vince Mor has offered to take the lead in an area around post-acute care. I forget the right word for that, but whatever that term is.
We want to thank you all and obviously continue to invite membership in the work group.
You have seen the charge. We will talk about focus, scope and deliverables.
I do want to comment -- and once again, this is my own vision of how the work group needs to approach the whole issue.
If one looks at the legislation as well as what really needs to be done, you begin to really talk about a data driven vision of what needs to happen.
The focus of the work group is not really around, does the CPR have decision support and does that make it a CPR or not. That is not really the focus, at least initially, of the discussion.
The discussion really has to do with the issues around uniform data standards for patient medical record information, and the electronic exchange of such information.
Within that there is a wide variety of, I think you used the word use cases, but a wide variety of options, of how the work group might take that and apply it literally.
For example, it could mean the type of data in messaging standards, as in between a CPR and a lab system or otherwise, and just that amount of data. That is certainly one option that we have to explore.
It can also apply to the issue of bench marking data, which is a more generalized issue of uniformity of data within patient medical record systems and clinical data, period. It obviously speaks of us having to address a wider solution.
Then, of course, there is the issue of collaborative health care. A patient is seen, for example, in Kaiser Permanente and then goes and gets specialty care in some other place. How does that information get transmitted back and forth in a way that is useful, meaningful, and helpful to our patients and the public.
Finally there is the issue that I think about relatively frequently, being in a managed care organization and being a provider of health care, in the sense that our patients are mobile.
A member can be a member of the public; a patient may be a member of Kaiser Permanente Health Plan; maybe another year they are part of Harvard Pilgrim, or even within the same community, but they have moved providers or moved HMOs.
How are we going to move that data so the patient has a longitudinal health record and continuity of care, which is once again an even much broader issue.
The work group, as one of its tasks, really needs to decide the scope. I would suggest to you that this is a relatively wide scope that we need to identify and decide where our initial focuses are going to be.
That is really, I think, a point that has to do with the development of a common vision which is, I think, the third paragraph here, where it says that it is understood that an early task of the work group will be to adopt and articulate a common vision of the value and use of uniform data standards for patient medical records, information and the CPR.
Of course, it is also understood that we will make use and leverage all the HIPAA standards wherever possible. No one is interested in reinventing the wheel, and that is an understandable principle.
Having said all that, we believe at this point -- and this is based on Jeff's initial work plan, having been revised by the work group in sessions over the past couple of days -- is that the primary focus of the work group will be to develop recommendations and legislative proposals in a couple of areas, basically one, two and three on the back page.
The first has to do with guidelines and standards for administrative and clinical messages that contain patient record information and their formats.
Two is the guidelines and standards for patient clinical information. By that we mean data element definitions, data models and code sets, including their specification, two, recommendations to enhance the coordination and maintenance of both administrative and clinically specific code sets, so they can support the demands of the computer environments that requires continuous availability, greater interoperability, more timely updates and greater clinical specificity, and then of course, Jeff's notation that these are, of course, core data dictionary issues.
Now, the third item, which is actually something that Kathleen Fyffe has generously offered to take the lead on, has to do with developing a business case regarding the implementation of uniform data standards for patient medical record information.
Now, those are really the high priority issues for the work group. In addition to that, we think that the work group needs to further investigate data issues related to CPR processes, functions and services, including issues around decision support, and enabling technologies that improve data exchange and interoperability.
Then, of course, we need to track the issues around data security in relationship to the CPR and standards for data storage, i.e., principles regarding the permanence of media.
Now, this document is really meant not to be either approved or disapproved, but rather, discussed by the committee, if we could have any comments or input.
We see this as providing a central piece to an overall development of a work plan that I think Jeff and I are planning on taking back and working into an overall work plan and bringing back to the committee in September. So, comments or questions.
DR. STARFIELD: I have a question.
DR. COHN: Does this help you any more understand what we are talking about?
DR. STARFIELD: I think so, and I want to ask a question about it. It says, first bullet under two says, their specifications. What is their? The way it reads, it refers to guidelines and standards, but I don't think that is what it means.
DR. COHN: No, I am actually referring to clinical information, data elements, definition of data models.
DR. STARFIELD: That is what is in the computerized patient model; that is what it means.
DR. COHN: Wider than the computer-based patient record. I mean, look at the legislation. It talks about uniform data standards for patient medical record information, which may or may not be in a computer-based patient medical record.
It could be in a lab system, a registry, decision support system elsewhere.
DR. STARFIELD: Their includes all those things?
DR. COHN: You have heard my vision of this. I think the work group is part of why a vision needs to be well articulated.
I think it is a relatively expansive -- if you have data, it doesn't just have to be in the CPR, but maybe just part of a CPR.
MR. BLAIR: Simon and I have very close views. Sometimes we come at this from slightly different perspectives, so we articulate things slightly differently. What I am about to say really is consistent with what Simon has said, but let me just give a slightly different perspective.
I think we are less focused on saying that our work group is going to articulate standards. In some cases, maybe we will articulate them either by endorsing them or encouraging them or promoting them.
I think we are more focused on understanding the evolution of standards and other related issues, to facilitate interoperability, the exchange of data, the processing of data, the greater clinical specificity of data.
The health care information infrastructure and patient record systems can then bring us the benefits that they promise. Does that help?
DR. STARFIELD: Yes, it does.
DR. DETMER: Other questions or reactions at the moment? All right, we may be obviously sending you additional reactions and we will be interested in hearing back from you. John, does your group have other items?
DR. LUMPKIN: We think that is enough.
DR. DETMER: That surely is enough, I think. Dr. Iezzoni?
DR. IEZZONI: Unfortunately, we don't have a new charge to float in front of the whole committee at this point.
That will be drafted within the next week, and then we will circulate that to members of our newly-reconstituted subcommittee.
Marjorie, do we know exactly who those people are at this point? Do we have a fixed list? Has the sign-up list gone around?
MS. GREENBERG: Just the people who have signed up on the subcommittee on populations who are here or were here, are you, Elizabeth Ward, Kathy Coltin, Hortensia Morrow, Stan Friedman, Barbara Starfield and Vince Mor.
Paul Newacheck, I think I can confidently say, will also be participating, since he participated in both the work group on population-based data and the subcommittee.
DR. HARDING: I haven't had a chance to sign up yet. Could you pass that around?
MS. GREENBERG: Yes, sure. What I intend to do also is summarize what we have, and send it out to all of you, including those of you who work here now or only part of the time and try to see what we have at the end. It is a fair number of people.
DR. IEZZONI: Yes, we are excited and pleased. Let me just say that I think our subcommittee, probably more than any of the other reconstituted subcommittees, has a different focus, or additional focus compared to what the original subcommittee did, by the simple addition of Kathy Coltin's work group on quality.
That adds a whole new piece and dimension. I think that Barbara and Dan and George and Paul's work group on population-specific issues folds beautifully into the charge of newly-reconstituted subcommittee.
I think that transition will be quite easy. How we are going to work around and make sure that we are productive in the quality area is something that we are still going to have to work on a little bit.
Just an update on our activities, we have completed our hearings from outside people on Medicaid managed care.
We had a wonderful series of testimony that we heard in Boston in mid-April, where we heard all the way from patient advocates to safety net providers, to people representing the state medicaid officers, to researchers in Boston.
It was a good way to end and I want to thank Carolyn Rimes and other subcommittee staff for putting that together.
We also have GW, we are continuing to work on their subcontract on the legal contractual language around data reporting for Medicaid managed care.
They are about to start conducting a survey of nine states for us. So, we expect that we will have that report by maybe late summer or so.
On July 14 and 15 we will be holding a series of hearings about health data issues for the insular territories, the American Virgin Islands, and Puerto Rico.
Subcommittee staff has done a masterful job of putting that together, and yesterday they taught us about protocol, about how to respectfully address these people, some of whom are very high level members of their health departments, in various islands out in the Pacific.
We are looking forward to those two days and to making recommendations to the Secretary about how that could be improved.
DR. LUMPKIN: That protocol also applies to me.
DR. IEZZONI: Oh, dear, you are absolutely right. Do we call you Your Honor or minister? Very good point, John; sorry.
Anyway, we are being instructed, because we are so informal here.
We also heard some very interesting commentary yesterday from Census, from OMB and from NCHS about the implementation now of the OMB Directive 15 guidelines about the reporting of race and ethnicity.
It is fascinating to hear what Census is doing and thinking about. You might have seen the article in The New York times on Sunday, about how there are 63 different racial categories if you group things certain ways and over 200 if you do it a different way.
This is an issue that our subcommittee will be continuing to track, what the implications are for longitudinal perspectives about the health of the public, based on how you aggregate people by race and ethnicity.
We are probably going to be, as our next year's activity, initiating an exploration of the continuum of care with a focus on post acute care -- Barbara didn't hear me say that.
The point is that under the balanced budget act, as I mentioned the last time we were together, HCFA is mandated to implement new prospective payment systems for home care, for rehabilitation care, and for long-term care.
The private sector is increasingly being asked to pay for care in those settings, and data are being gathered in totally different ways in those settings about people, in ways that is going to make it hard to look longitudinally at how patients do across settings of care.
So, we are only beginning. Vince will be a lead person in doing this. We are only beginning to formulate how we are going to go about doing this, but we will.
Dan and Barbara and probably Paul are going to be taking a lead, and do we have an agenda item on talking about the workshop coming up? I won't go into depth on that now. Oh, that is a different workshop.
There is a workshop that Ed Sondik is hoping to hold at some date early next winter. Maybe I should ask Dan, because I think it is important, to just give us a very brief summary of what that is entailing and what Ed Sondik has asked us to do.
DR .FRIEDMAN: A couple of different times in the past several committee meetings, Ed Sondik has mentioned to us his desire to have the committee participate with NCHS in both developing a vision of health statistics for essentially the next 10 to 15 years, as well as the role that NCHS would play in that vision.
He had initially thought of it in terms of -- and we had initially thought of it in terms of a couple of discrete workshops that would be conducted jointly with the Committee on National Statistics.
As our discussions continued between Barbara and myself and Paul and Marjorie and Jerry Hendershott and Ed Sondik and Ed Hunter, et cetera, it became increasingly clear that we really needed to move the focus off the workshops in and of themselves as essentially ends of themselves, and more into a process of trying to develop a vision of health statistics, as well as the role of NCHS in that vision, and more of a road map for NCHS.
So, what we have been discussing, and what we are going to really start implementing in the next few weeks, is a process that includes a couple of -- several very, very small facilitated focus groups that are aimed at defining health statistics, its purposes, roles and boundaries, defining criteria for evaluating the current status of health statistics, and how we can evaluate progress in the next 10 to 15 years.
We have discussed commissioning a series of papers that would focus on a review, or one would focus on essentially a review or reviews.
There have been a variety of different reports written in the past decade or so with recommendations to NCHS and to HHS more generally, relating to health statistics.
It would be helpful to put those papers together, to look at the recommendations side by side, to try to make sense of them in a more general sense, as well as to assess what progress has been made on those recommendations. So, that would be one paper.
Other papers could focus on what could we learn about health statistics needs from recent policy discussions, such as health care reform and children's health insurance program.
Other papers could focus on what could we learn from health statistics systems that have been robust over time, such as vitals, which has been around for 150 in a centralized way in some of the states, communicable diseases which has been around for 120 years, HIS, which has been around for a substantially shorter period of time, but which is also a very stable system.
Also, what can we learn from health statistics systems of other countries. The results of the workshops, of the focus groups, and the commissioned papers would feed into at least one, and possibly two workshops that would be organized by the Committee on National Statistics.
The first workshop would focus on that first vision, the 21st Century vision of health statistics, and would really try to define key issues that will need to be addressed in roughly 10 to 15 years, and key information needs, as well as gaps in the existing systems.
If there were a second workshop, it would really focus much, much more specifically on the implications of the first workshop for NCHS, and really how NCHS could implement the first workshop's recommendations.
Ed Sondik spoke to us yesterday and he is committed to moving forward on this. He seems eager to move forward.
He would like to have the first workshop in January of 1999. I am, by nature, I think, much less optimistic about time frames than Ed, because I hate to miss deadlines.
I am a little bit more pessimistic about the January deadline, given our desire to commission the papers before then and have the papers done and have the focus groups, et cetera, et cetera.
Hopefully, all that would be done. The papers and the focus groups would all be done by late 1998 and we could schedule the workshop for some time in the early months of 1999.
DR. IEZZONI: Dan is going to be thinking about a process by which we can productively give Dr. Sondik the advice that he had hoped that the national committee would be able to give him, about the direction of NCHS over time, not just this one initiative. That will be on the radar screen of our subcommittee.
Finally, the issue that I mentioned this morning in response to Dr. Lumpkin, the Honorable Dr. Lumpkin, about the fact that HIPAA and the standardization issues have a lot of impact on our ability to look at health of populations.
We want to try to make sure that to the extent that issues arise that we think you all need to be aware of, or that we want to hear from you, we will try to continue to make sure that that interface occurs.
Dr. DETMER: Questions or comments?
MR. MOR: One addition. The issue of the continuum of care is really the point at which there is an interface between the health and the service use kinds of statistics and kinds of data.
Particularly for the population that is the highest consumer of those kinds of services, as Medicare moves toward managed care, we see less and less and less of that data, because their consumption statistics about them become invisible.
I think that is an issue that we are going to have to grapple with as a committee.
DR. IEZZONI: I think Kathy and the quality work group will be very much on top of those kinds of issues. So, we are going to have to -- unfortunately, Kathy could not be at this morning's meeting. So, we are going to have to really figure out how to integrate that perspective.
DR. DETMER: I think it is a key issue. Just a comment, that the executive committee -- obviously, we have a new structure now -- is going to have to work to make sure that we try to keep these things as coordinated as we can. I think we are committed to that.
DR. LUMPKIN: I think similar to your suggestion about adding something to our work plan, our charge, I think when you look at your charge, I would also encourage you to look at the implications of HIPAA.
DR. IEZZONI: We do actually have that in our current work plan and we will have that in our future work plan.
DR. LUMPKIN: Right. I think that is wonderful, because a lot of what we try to do in health departments is limited by the accessibility of data, which may change.
DR. DETMER: Thank you very much. Kathleen.
MS. FRAWLEY: The subcommittee on privacy and confidentiality met this morning. The first thing I would like to do is acknowledge the contributions of three new staff members to the committee.
Wendy Liffers is on detail from the National Institutes of Health to ASPI, and also Lois Schoen and John Burkel from HCFA.
We are very appreciative of the fact that we had three new staff join us at the subcommittee this morning.
We do have two action items for consideration by the full committee, and there are documents, hopefully at your place.
We will give everyone plenty of time to review the documents. We will walk you through them. We will talk to you about them, before we ask you to vote on those items.
The subcommittee did hold round table discussions last January regarding issues, regarding the issue of what is identifiable or non-identifiable data, and a second round table on the issue regarding registries, and what constitutes a registry.
So, the recommendation of the subcommittee was to draft a letter for consideration by the full committee, to be forwarded to the Secretary, outlining some of our findings and recommendations from those two round table discussions.
Under tab K, you have the original draft of our letter that was in the briefing book, and the subcommittee did review that this morning and make recommendations to that document.
So, what I would just like to lay out for you is what the recommendations are and then ask for your consideration.
Basically, our letter just outlines really the focus of the two full-day public meetings to gather the information on those particular issues.
What I want to specifically go over are the specific recommendations on the identifiability of health information and then, secondarily, the recommendations regarding registries.
As far as identifiability of health information, one of our major comments to the Secretary is that distinguishing between identifiable and non-identifiable information is at the heart of every current legislative proposal for health privacy, including the HHS recommendations. Then we have a series of bullets.
The distinction between identifiable and non-identifiable data has become much harder to make. Whether something is non-identifiable depends in large measure on what other information is known or knowable.
For example, it is not difficult to identify someone from their health data, or from data such as zip code or date of birth associated with their health data.
The next point is that the amount of personally identifiable information available from public or commercial sources has grown significantly in recent years.
The growth has been fueled by cheaper computer power, the internet, and the commercial sale of personal information.
The next point is health and statistical agencies have always been, and continue to be, aware of the potential for identification of individuals from publicly released information, including public use data tapes.
The explosion of individually identifiable data from other sources means that these agencies must constantly reexamine their policies and practices to guard against inadvertent identification.
The next point is that everyone who collects and uses health data must also pay attention to, and continue to evaluate, that data once believed to be non-identifiable may no longer retain that status.
In particular, institutional review boards should be alerted to this issue.
Our next point. From a legislative perspective, more substantive definitions to distinguish between identifiable and non-identifiable data and procedural mechanisms are needed to protect individuals against identification.
The next point is that mechanisms that may be appropriate include the use of contracts or other legal restrictions designed to expressly prevent those who receive data from manipulating it to identify individuals.
The goal is to continue to support socially beneficial uses of data without impinging on the privacy interests of individuals.
As far as confidentiality considerations for health registries, we have another series of comments to the Secretary.
Basically, many health and medical registries exist. There is no common definition of a registry. They serve numerous purposes, exhibit considerable diversity and operate under different structures.
Then there is a series of points. First, there is a law establishing registries at the federal and state levels, but no comprehensive regulatory or policy structure can be found that addresses or defines a registry.
The committee strongly supports the work of registries for research, public health and related purposes.
Our next point is, any health privacy legislation will affect the flow of health records into and out of registries.
None of the legislative proposals for privacy to date, including the HHS recommendations, expressly address registries.
Our next point is that the National Committee of Vital and Health Statistics believes that it is important that health data be provided only to registries that conduct research, public health and related activities.
Legislation should not undermine the flow of health information into and out of such registries. Registries should be brought under any new legislative framework, so that data subjects can be assured that information entering a registry will be fairly treated, and so that record keepers can be assured that cooperating with registries is permissible.
Our next point is that clearer rules for registries may contribute to more effective research and public health activities, by permitting data from other countries to be shared with registries in the United States.
Our final point there is, solutions to the issues of registries may include a statutory definition or an administrative process for identifying appropriate registries.
That really summarizes the points that came out of our round table discussions in January. So, the subcommittee has approved this letter and is forwarding this letter for approval at the full committee this afternoon, so that it can then be transferred to the Secretary.
DR. DETMER: Is that a motion?
MS. FRAWLEY: Yes.
DR. DETMER: Is there a second?
DR. STARFIELD: Second.
DR. DETMER: It has been moved and seconded. Is there discussion to this item?
DR. STARFIELD: There are some very specific recommendations that I think the Secretary could act on it from it, particularly in the second part, the registry part.
The first part just really identifies, and doesn't say that the committee is going to deal with those problems, and I suppose we are, so perhaps it is worth saying that. Are we?
DR. DETMER: I am sorry; I didn't catch your point.
DR. STARFIELD: In the first part, the identifiable problems, it identifies the problem but it doesn't say that we are going to deal with them; we are going to solve them. I suppose we are, so we should say that.
DR. DETMER: You mean the committee will?
DR. STARFIELD: Yes. I mean, we have identified a whole series of problems. What do we expect the Secretary to do with them.
DR. FRAWLEY: The problem that we have is the fact that there is no substantive definition to really distinguish between identifiable and non-identifiable data, and that is the problem.
DR. STARFIELD: Who is going to make the definition, if not us?
DR. DETMER: That is a good point. I guess the question is -- two ways you might want to relate to this. One is to put it in your work plan, to think about whether your group would want to take that on as an issue.
Essentially what this does do is express what the committee has heard and what they think, in the first cut, ought to come from that.
I think you do raise a good question. What else might we appropriately wish to do about this and that is not in there. Is that basically what you are saying?
MR. MOR: I actually think that Barbara's point was that the second piece on registries, there were actually, we believe that, that these are proactive statements that the Secretary should do something.
There is not a corollary step of proactive statements that we would do. We have made recommendations in the first section on identifiability, one of which might be, based on what Kathleen just said, that somebody has got to sit down and work out the issue of what is identifiable and not identifiable in such a format and manner that it is flexible enough to work over time, and also be able to issue legal contracts and restrictions, to examine the viability of those, because that is what is suggested here.
There may be other things that aren't even there. You have the seeds of recommendations, but they are not made explicit.
MS. FRAWLEY: Then what I would recommend is that, based on that discussion -- because this is important in terms of time constraints, and I think the committee needs to be sensitive to this.
What I would like to recommend, then, is that we take some of the points under identifiability of health information -- particularly the last three bullets that talk about the responsibilities of those who collect data, to continually evaluate the likelihood that data once believed to be non-identifiable may, in fact, be identifiable; that IRBs need to be aware of that.
From a legislative perspective, there need to be more specific definitions and mechanisms. What I would recommend then is that we would rephrase those into, this is what the committee believes is important, and lay those three out, similar to the format that we followed under the second series under confidentiality considerations for health registries.
I think that would solve the problem. If people feel comfortable with giving us the liberty to make those changes, so that we can then be able to get the letter on to Don for transmittal to the Secretary, because I would hate to let this go any longer. It has been almost six months.
DR. DETMER: Does that meet your needs?
DR. STARFIELD: Yes. I think we have to make it clear, what we want the Secretary to do.
DR. DETMER: Okay, consider that done.
MS. FRAWLEY: I am doing it right now and Wendy Liffers, our staff person, is also taking notes.
DR. HARDING: I think Barbara is making a good point. I think it shows the kind of concern that the subcommittee had, in that this is a moving target continually, and it is hard to draw a bead and pull the trigger on this.
It is always getting better and better technology and so forth, and it is really -- you pointed out the weakness, that it is hard to really get a good shot at it because of that.
DR. FRIEDMAN: I had one specific editorial comment and then one slightly somewhat more general comment.
In the first bullet under identifiability of health information, I would think that that second sentence, the for example, you may want to specify that a little bit more.
It is not difficult to identify a person from their health data, maybe from their health data alone, or maybe add some kind of a geographical modifier there.
Now, at least to me it implies that, given somebody's health data, regardless of where they are, that one could identify them. Maybe adding a geographical modifier.
Under the health registries, I am somewhat concerned about the lack of distinction between legally mandated registries and essentially private registries, which seem to me like two very different entities with two very different implications for legislation as well.
MS. FRAWLEY: I guess what I am confused about there is that the point is that there are mandatory registries. It is in our first bullet.
We did discuss this morning at the subcommittee meeting that the problem that we have is that there are mandatory registries that are mandated by federal and state laws. There are also voluntary registries.
So, what would you recommend? Like I said, we have to spend the time this afternoon and bring closure to this. This is not something that we can keep circulating back out.
If it means taking a few minutes to offer constructive verbiage, it is really at this point -- I don't think the subcommittee has the time to be able to take this back one more time.
If there is something you can suggest now, I specifically asked Don Detmer that we would have the latitude as a full committee, because we have two documents that need to be acted on.
I mean, I need to know, for your first point, what you would need to know in your for example. It is not difficult to identify a person from their health data or from data such as zip code or date of birth associated with their health data.
That is what I am trying to figure out, is what is the recommendation there.
DR. FRIEDMAN: Personally, I would think of something like, it is possible to identify a person from their health data alone within whatever, a specified geographic area, something like that.
DR. DETMER: It may be possible.
MS. FRAWLEY: From the health data, given zip code and date of birth?
DR. FRIEDMAN: Yes, something like that would even be better, Barbara.
MS. FRAWLEY: I just have to make sure that staff has got it. For example, it may be possible to identify a person from their health data, or given their zip code and date or birth.
DR. FRIEDMAN: Yes, period.
MS. FRAWLEY: On the registry consideration, if we add a sentence under the first header, where it says many health and medical registries exist. There is no common definition of a registry. They serve numerous purposes, exhibit considerable diversity and operate under different structures.
They may be voluntary or mandatory. Then the first bullet goes into --
DR. STARFIELD: May I make a suggestion that under the first bullet, we say but no comprehensive regulatory policy structure can be found that addresses or defines the universe of registries.
MS. GREENBERG: You may want to make that into two sentences, that there are laws establishing registries at the federal and state level, with a semi-colon. There are other registries that are voluntary.
DR. HARDING: Are there laws mandating it, I think is preferable to mandatory, or establishing.
MS. GREENBERG: And then say in the second sentence, regulatory or policy structure --
DR. DETMER: As she said, the universe of them.
MS. FRAWLEY: Okay, the recommendation that we have for the bullet under confidentiality considerations for health registries is, there are laws mandating registries at the federal and state levels, period.
No comprehensive regulatory or policy structure can be found that addresses or defines the universe of registries.
MS. GREENBERG: You didn't want to have a phrase that other registries are voluntary and operate in the private sector or something, that we are not just talking about mandated registries.
DR. STARFIELD: I suppose at the very least we could say they operate under different aegises, both public and private.
MS. FRAWLEY: Other comments? That many health and medical registries exist; there is no common definition of a registry; they serve numerous purposes, exhibit considerable diversity and operate under different aegises.
Bullet. There are laws mandating registries --
DR. STARFIELD: Both public and private.
MS. FRAWLEY: There is a different between public and private and voluntary and mandatory. We have to be clear on what our point is. So, what is your pleasure?
DR. COHN: Public and private is the main issue, isn't it?
MS. FRAWLEY: No, it was voluntary and mandatory.
DR. FRIEDMAN: I am not comfortable with the word mandatory. I mean, it is legally mandated. That is different than mandatory.
MR. MOR: It is.
DR. DETMER: It is. It is mandated.
MS. FRAWLEY: We discussed that this morning. That was our discussion at the subcommittee meeting, the fact that we have voluntary registries and mandatory registries.
With the mandatory registries, it is very clear because there are federal or state statutes or regulations that prescribe a process that the registry has to follow.
The problem that we have is that we have people who are setting up registries that are not under any particular jurisdiction.
Like, if you just decide to open up a registry in your basement next week, then the question is what rights does the individual whose information you are collecting have.
That was the discussion with the voluntary and the mandatory. That is the point that we were trying to get across in our first three sentences, before we got into the bullets.
DR. FRIEDMAN: I must say, my only confusion relates to, is the mandatory referring to the existence of the registry or the individual's being recorded in the registry.
MS. FRAWLEY: The existence of the registry.
DR. FRIEDMAN: My impression was, up to now, that we were talking about the nature of the individuals being recorded in the registry. I thought that was what the mandatory meant.
DR. STARFIELD: Why don't we say mandated or voluntary.
MS. FRAWLEY: So, where would you like that to go?
DR. STARFIELD: Under separate aegises, public and private, mandated and voluntary.
DR. DETMER: Okay?
MS. FRAWLEY: That is fine with me. I just wanted to make sure that we got all the comments.
DR. DETMER: Any other issues on this? Does the original motion then include this restructuring?
MS. FRAWLEY: So moved.
DR. DETMER: All in favor say aye.
[Voices heard in the affirmative.]
DR. DETMER: Opposed? Abstention?
[Response heard in abstention.]
DR. DETMER: One abstention.
MS. FRAWLEY: Thank you. The next document that the subcommittee was asked to review and approve was the follow up information that was requested by the House Ways and Means Committee, subcommittee on health, as a result of a hearing held on health information privacy that was held on March 24, 1998.
There was a series of questions that were forwarded to Don Detmer on behalf of the National Committee on Vital and Health Statistics, that was to elicit additional information regarding the hearing.
What staff has put together, and the subcommittee reviewed this morning, and made changes to, and has forwarded to the full committee for approval, is a series of questions and answers.
For those people who have not seen the document before, let me explain that the bold is the actual question posited by the member of Congress.
Therefore, it is not something that can be edited or changed in a debate. That is the specific question that Don Detmer was asked.
As you can see from some of the questions, it wasn't clear after two paragraphs what they were asking him. So, we made the best choice that we could, based on what we thought they were asking Don, was to put together this entire document.
What we tried to do was make sure, in responding to the subcommittee's questions, is to make sure that we referenced the health insurance portability and accountability act and, where appropriate, referenced the subcommittees recommendations which came forward to the full committee as a report, on our particular recommendations on privacy and confidentiality, and also incorporated the recommendations of the Secretary which were made to Congress on September 11, 1997.
So, to walk you through the document, which I think is the easiest way to do it, in the first question, the basic question --
DR. STARFIELD: Can I just ask a question? Have we seen a previous draft of this?
MS. FRAWLEY: No. The first question, Congressman Thomas was trying to find out, in essence, whether there should be a time line in which we move to electronic records, and then to kind of address individually identified records.
So, the first part of the answer that you see before you is that it lays out the requirements of the health insurance portability and accountability act, with a specific reference.
Then it lays out the specific recommendations of the Secretary, pursuant to the requirements of HIPAA. Then you will see an actual quote from the Secretary's recommendations.
DR. DETMER: In that sense, Barbara, you have seen this language before. These responses do not go beyond what the committee has already done. You have not seen them put together in this format in response to these questions.
MS. FRAWLEY: The next part of the response lays out a summary of the hearings that were held by the committee, and specifically references testimony that was received at the hearings.
Again, you will see that in quotes. Again, it summarizes some of the recommendations of the committee. The last part of our answer there just indicates that we have not addressed incentives or disincentives for keeping electronic records, and that we have established a new work group on computer-based patient records that may address this issue in the future.
We thought that was important in our response to the subcommittee.
The second question really lays out the whole issue of audit trails, and the response there is that we did provide recommendations of adoption of security standards in a letter to the Secretary dated September 9, 1997.
In laying out our principles and recommendations, we stated -- and you have the specific recommendation -- that organizations should develop audit trails and mechanisms to review the access to information systems, to identify authorized users who misuse their privileges and perform unauthorized actions, and detect attempts by intruders to access systems.
Then we have a series of questions by another Congressman. The first has to do with research currently being done by managed care companies with reference to informed consent of individuals. We indicated that the committee does not have information on this area.
The second question relates to the EU directive, and again, we respond that we are aware of the EU directive; that the United States does not have a comprehensive legal stream of data protection, nor an official United States privacy protection, as the sole responsibility of our nation on a government-wide basis.
Obviously, we have a number of separate state and federal laws, but no privacy law generally applicable to all.
The next question, again, is on the EU directive and just some of the activities that are now ongoing within the Commerce Department, the State Department, and the Department of Health and Human Services.
Then the last question was, in our view at this point, do we currently meet the specifics of that directive. We just indicated that we believe the United States does not currently meet all the criteria of the EU directive.
We have next a series of questions on preemption. Our response there, if you remember, as a subcommittee we brought forward to the full committee the fact that preemption of state laws was the most difficult conflict, that when identified at hearings we held, it did not yield a clear answer.
In our recommendations to the Secretary that are dated June 27, 1997, the next four paragraphs are specifically from our report on the issue of preemption.
The next question talks about the need for a standard, a federal standard, in this area. Again, we outlined the fact that the committee, in its recommendations to the Secretary, made a number of principal findings.
Again, the next two paragraphs that are on pages four and five are from the committee's recommendations to the Secretary.
The next question talks about discrimination, including insurance, and some concerns there.
In our response is that the relationship between privacy as defined by principles of fair information practices, discrimination was an issue that was raised a number of times during the NCVHS hearings last year, and that there have been concerns regarding protecting health information to prevent the discriminatory use of information both inside and outside the health care setting.
We do note that there are several current Congressional bills addressing the possible discriminatory use of genetic information.
We then go on to say that discrimination based on health status remains a major point and concern. While the committee has not focused its full attention on discrimination, legislative responses are appropriate.
It is not clear, however, that the general privacy concerns and discrimination concerns should be, or must be, addressed together in the same piece of legislation.
An already complex health privacy bill is not the best place to sort out responses to equally complex discrimination problems.
The committee suggested in its recommendations to the Secretary, again dated June 27, 1997, that privacy and discrimination issues deserved separate legislative treatment.
The problems of discrimination are important, but not enough work has been done to explore the content of anti-discrimination legislation.
We urged the Secretary to propose legislation expanding the anti-discrimination provisions of HIPAA to cover all aspects of discrimination based on health status and condition.
We went back to a series of questions again on the issues regarding preemption and the concept of what areas should be left to regulation versus statute, and whether there was a need for state preemption, and the whole issue of a safety valve provision.
Again, what we chose to do in our response there was, again, reference our recommendations to the Secretary, and then the Secretary's recommendations to Congress, to respond to that inquiry.
The following question has to do with the whole issue of the electronic exchange and the whole idea of some of the issues associated with that.
We chose in our response to go back to the health insurance portability and accountability act, and specify the requirements of the Secretary to adopt standards for electronic data transactions, but not mandate that providers exchange information electronically.
While issues regarding cost of maintaining and providing information electronically have been raised in these hearings, the committee has not addressed this issue.
Then we go back to a series of questions by Congressman Thomas again. The first was a number of statutes that he referenced and wanted to know if we had done any in-depth examination of those particular statutes.
Our response there was that we had not examined the privacy act or any other laws in depth in developing our recommendations.
A follow-up question was the whole issue of how we deal with balance. Again, it is a follow-up to the response that we had crafted to question nine, again recognizing what our recommendations to the Secretary, and the Secretary's recommendations to Congress were.
Then, the final series of questions have to do with the issue of, once there has been a disclosure, what type of enforcement and sanctions would the committee recommend.
Again, we indicated, based on our recommendations from the committee and the Secretary, we have in quotes the substantive language from that.
This document was approved by the subcommittee this morning. I really have to congratulate Wendy Liffers, who left our meeting at 10:00 o'clock and went back and made all these changes, which was not easy to do, given our discussion. She did an excellent job.
We are moving approval of the response that has been approved by the subcommittee to the full committee, so that Don Detmer can respond, as requested by Congressman Thomas, based on the hearing that he testified at on March 24.
DR. LUMPKIN: Second.
Dr. DETMER: Okay, it has been seconded. It is open for discussion.
DR. LUMPKIN: It looks fine. It is consistent with the previous position.
MR. SCANLON: One editorial point, on question five, again, on the European Directive. It is hard to be definitive about whether the United States does or doesn't comply. There are a lot of different ways to comply with the directive, including contracts.
I guess I would feel a little more comfortable if we were a little more -- I guess that question five answer, I guess, the United States may not.
DR. DETMER: All right; ready for a vote?
MS. GREENBERG: One thing, and it may be decided to ignore it and I am just trying to read along with you here.
In this question on page 5, question 8, where he is really asking if you want to comment, it seems to me, to some kind of community rating, it would seem to be appropriate to say that that is not within the purview of the committee, or that that is not an issue that the committee has addressed. It really isn't. You just ignore it in the current answer, but that seems to really be what he is asking.
DR. DETMER: Actually, that is a good point. It turns out that when I actually testified, I made that comment, that the committee itself had, in fact, not gotten into that. That is already on the record, but you don't know that.
MS. GREENBERG: No.
DR. DETMER: I don't care. We could repeat it here, if we want, but actually, I have already -- I sort of did that the day of the testimony.
DR. LUMPKIN: What we have here is a round-about way of saying no, we don't want to comment on it.
DR. DETMER: I don't care. Would you rather see us add something to it or just leave it? John, I am hearing you say just let it go. Other questions or comments?
Hearing none, all in favor say aye.
[Voices heard in the affirmative.]
DR. DETMER: Opposed?
[One voice heard in the negative.]
DR. DETMER: One no. Abstentions?
[No response heard.]
DR. DETMER: No abstentions.
MS. FRAWLEY: Those were the two action items. So, thank you for allowing us to bring closure to those items.
Just to follow up on our 1998 work plan, the subcommittee will be holding -- at this point the proposal is either a hearing or a round table to elicit information on confidentiality and privacy issues related to pharmacy benefit management and use of prescription information.
That was the next item on our work plan. So, we did talk briefly this morning about moving forward with staff on scheduling that activity.
On unique health identifiers for individuals, we did review the list of proposed questions for the hearings to be held, and discussed the need for some additional questions.
I did not have a chance to let John Lumpkin know, but the subcommittee did vote to co-sponsor the hearings of the subcommittee on standards and security on unique health identifier.
We did make a series of recommendations to staff, and Wendy Liffers will communicate those to Judy Ball, on some additional questions that we thought were appropriate under the general questions to elicit some further dialogue with the industry and with the public on alternatives that individuals might want to propose in terms of the whole issue of unique identifier.
We also looked at some of the questions on confidentiality, privacy and approved uses, and made some recommendations there.
We are also going to be moving forward on the issue of the relationship between confidentiality of health information and health care anti-fraud activities.
As the next activity, Kathleen Fyffe has agreed to assume the lead role in coordinating that activity, and that will be for later this year.
Then we spent some time looking at our existing work plan. Just for the full committee's benefit, the outstanding issues that we have on our work plan is health privacy in employment, certificates of confidentiality, provider confidentiality, off-shore exportation of clinical data for transcription, data mining, and use of information for marketing.
So, we decided, based on that list, that the next issue, after we finish the issues on pharmacy benefit management and prescription information, then fraud and confidentiality of health information, that we would move on to health privacy in employment, that we felt it was the next most pressing issue.
We probably will not see that activity occur until early 1999. Based on our discussion this morning, Elizabeth Ward has expressed some interest in potentially coordinating that activity.
We agreed as a subcommittee that we would flesh that out further and focus our agenda accordingly.
We did spend some time just doing an update on some of the Congressional activity. There are five bills now pending in Congress, with a sixth to be introduced next week, in the whole area of confidentiality of individually identifiable health information.
So, we did spend a few moments just reviewing the bills that are out there and just talking about some of the hearings that have been held recently that Don, Richard and I have had the opportunity to testify at.
That really summarizes our -- it was a very full and action-packed two hours.
DR. DETMER: Any questions or comments? John, do you want to comment about just the idea of -- okay.
I need some help. Our Healthy People 2010 group aren't all here yet. I guess the question I have got, the other item we have is the workshop on implications, that piece. I don't know who is, in fact, going to --
MS. GREENBERG: I think I am.
DR. DETMER: Are you? Do you want to do that? Why don't you do that.
Agenda Item: Workshop on Implications of HIPAA for Public Health and Health Services Research.
MS. GREENBERG: This relates to tab J in your agenda book, which is the summary of a planning meeting that we held at the end of January at the National Center for Health Statistics.
It was for a workshop on the implications of HIPAA on public health and health services research. The National Centers for Health Statistics, the Centers for Disease Control and Prevention, are planning to go ahead and hold this workshop on November 2-3, 1998 in Washington, D.C.
I think that I just want to very briefly tell you a little bit about it. We have had the committee's support, in particular through the participation of Dan Friedman, which I hope will continue, and we would like to also have some additional participation in the meeting by the committee, and also welcome any suggestions that you would like to give us as we very intensively now plan the workshop itself.
Basically, the planning meeting agreed, the people at the planning meeting, that HIPAA has tremendous potential implications for public health and health services research, and I think that theme has resonated just in the last hour or so, as we just heard the subcommittee charges and responsibilities and inter-relationships.
Back a number of months ago, I think it was early fall, the national center and Dr. Sondik, who is the senior advisor to the Secretary on health statistics and, thus, sits on the data council, and the CDC administrator both recommended to the data council that, because of these implications, the department should establish a process to allow broad input into the maintenance and revision of these standards.
This, of course, is part of what we talked about in the context of responding to the NPRMs in the subcommittee on standards and security.
In order to allow -- there are two pieces of this. One is allowing broad input and making sure there is a process for that. I think the department has been quite receptive to that, and the data council, that was generally agreed.
Also, then, these communities have to be in a position to give that input. In many cases, they haven't necessarily been prevented from participating in the process. They just have not seen it as particularly relevant to their activities or have not really had a way to work together to try to represent some of their common interests.
This is what we really wanted to do in holding this workshop and beginning to really establish a process for this.
There are several objectives for the workshop. One is just -- one objective of the planning meeting -- was just to inform individuals about HIPAA and particularly groups representing public health and health services research, and particularly at the state and local level.
So, there is also an educational component to this workshop. We really are considerably more ambitious than that, in that we want to work with these groups -- and this is something that we have actually started prior to the workshop itself.
We have asked the groups to work on, and we will be working with them through our contractor as well, to begin to identify what data needs of public health and health services research might be met through these administrative and financial standards, as well as, of course, ultimately the computer-based patient record.
The focus is primarily on claim/encounter records, enrollment records and claims attachments, probably the transactions that would be the most relevant to their needs.
Of course, there are a number of other types of needs for information that can't be met necessarily through any of these transactions, but some of the standards might carry over as well.
So, we would like to begin a process for developing consensus on some of the high priority data elements and data needs.
Then really consider how the public health community and the health services research communities should be represented in these organizations.
Basically the data content organizations or those organizations that are developing the standards, should they have membership, develop their own group, a variety of different mechanisms. We really haven't pre-determined what would be the best mechanisms and we would probably have some type of a white paper prepared on that, throwing out different options, prior to the workshop.
Then, talk about what type of infrastructure would need to be created to inform these representatives. Any way you look at it, there is just going to be a handful of representatives, probably, going to these standards groups, going to these data maintenance groups.
We are going to have to have some process that can bring forward the proposals and look at how they can be coordinated, and then represent them and inform those representatives, so that the representatives can come forward not with just something that maybe New York or Illinois or some particular program needs, but that a variety of different programs have agreed are high priorities.
The feeling that this will definitely strengthen the hand and the voice let's say, strengthen the voice of public health and health services research in this whole standards development process.
So, this is ambitious but we have gotten a lot of really positive response from the organizations that participated in the meeting, if you look at the second page or the third page -- I am not quite sure what it is -- of the executive summary.
At the bottom of the second page, it lists the organizations that participated. Many of them were representing state based public health, epidemiology, labs, including -- we also had county and local health offices represented, and Medicaid, which we see as a very important partner in this activity as well.
Specifically, I wanted to let you know about this -- I know I have mentioned this before, but it is becoming really a reality now with having set the dates and the place.
I also would welcome your recommendations on other organizations that should participate. This is basically going to be an invitational workshop, so that we will have people representing organizations and the idea is to sort of partly train the trainer as well, that these organizations then will be taking this back to their membership using their own news letters, their membership, et cetera, to advance this.
So, it is really a network of organizations that we are talking about trying to start talking to each other more than maybe they currently are, and particularly around the area of health data standards.
We also, each of the -- we expect representatives from each of these groups, and others, as I said, we would welcome your input.
We had one representative, basically, from each of these groups at the planning meeting. We would probably like to have two or three, at least, at the actual workshop.
So, we really are looking for a few additional representatives from the national committee as well. As I said, Dan is already on board. Elizabeth has expressed a real interest in this to me.
You don't have to necessarily volunteer now, but I would like to have at least three, I would say, representatives from the committee, if possible.
Also, you know, your input is what you think would be most useful about this, ways we can improve what we are planning to do.
If there are a few of you who would like to be involved in the planning and reacting to it, even though you might not be able to come to the workshop, we would welcome that also. It is really a very open process and one that I think has a lot of potential to feed back into many of the things that the committee is doing.
DR. STARFIELD: Could you mention it again, the dates?
MS. GREENBERG: November 2 and 3. That is a Monday and a Tuesday. I believe the national committee is meeting later in the month. I will have to look at my calendar.
DR. DETMER: Comments and questions while we are checking the dates?
MR. MOR: I can give you a list of additional organizations that might be of interest.
MS. GREENBERG: Great. You could e mail that to me. That would be wonderful. The committee is meeting on the 12th and 13th of November. The following week is APHA.
DR. DETMER: How many people do you anticipate?
MS. GREENBERG: Sort of our goal is to have about 75. It may get a little bigger than that, but we certainly want to keep it under 100. There are going to be break-out sessions and it is really kind of a working meeting.
As I said, the education function will have to be beyond the meeting, and that is part of the plan.
We are going to commission several papers which actually, in some ways, may dovetail with some of the work being done on the vision for health statistics, looking at the uses of administrative data in public health or health services research, and looking at different ways for this process to be organized.
If you have any suggestions on white paper topics, those have not been completely finalized either. Jane Harmon is here from NCHS who has been very involved with our internal team. I wonder if you have anything to add on this.
[No response heard.]
DR. DETMER: It sounds like this will be very worthwhile, ultimately, back to us, too. It would be good to have obviously as much participation as we can. Okay, so you really want additional organizations, committee members, ideas for white papers, show up and come back.
MS. GREENBERG: Right, and if you are really interested but don't think you will be able to attend the meeting, but would kind of like to be kept abreast, we will keep that list and e mail stuff to you.
DR. FRIEDMAN: The only thing I would add -- and I know Marjorie and I have had some discussions about it -- is that in addition to the claims and transactions standards, I think it is also going to be very important for that workshop to focus on the implications of the possible uses of identifiers.
I think that is something that at least in public health is receiving much less attention, and both practically as well as politically, I think it has tremendous implications for our surveillance systems.
MS. GREENBERG: The confidentiality and privacy issues did come up, too, at the planning meeting. Obviously we are going to have to weave that in as well.
DR. IEZZONI: Will code sets also be an issue? I think for health services researchers, especially, the opportunity to rationalize coding is going to be a major thing.
In looking at the list, Marjorie, it looks great. Health services research is represented here, but not a preponderance of the public health folks.
I will look at my calendar. I feel that the health services research community really needs to be a little bit beefed up in terms of its representation here.
MS. GREENBERG: Right. We had a little bit of trouble.
DR. IEZZONI: Yes, you have AHSR and you have Judy Ball from AHCPR, but there is --
MS. GREENBERG: Absolutely. The Association for Health Services Research has agreed to help us identify additional people.
Plus, I have been working with the Agency for Health Care Policy and Research. There is a possibility of their co-sponsoring but, if not that, at least certainly helping us identify people and involve that community. I agree with you.
DR. IEZZONI: If we had break out sessions, some of the health services researchers may not feel that they resonate as well with the public health community.
MS. GREENBERG: If you would be willing to let us bounce ideas off you on that, that would be great.
MS. HAMMOND: One thing that I would say is recruiting people from the private sector health services research, for the major health care organizations, as they expand beyond the staff model HMO, they are going to be bound to HIPAA standards the same way. We really have almost no involvement by that group.
DR. IEZZONI: Sheila Leatherman would be a good person to talk to about that, also Jeannette Bolls, also from Minneapolis.
MR. MOR: You could talk to the CEO of Algorithmics, the company that is owned by Aetna/US Health Care.
They are astounding. They have spectacular data systems and they use them all the time.
DR. IEZZONI: We can talk about that at the AHSR meeting next week in Washington. It might be a place where you can find private sector folks. They are going to be there in droves.
Kathy and I are actually doing a session with Jeannette Bolls from Minnesota on using administrative data to measure quality of care. You might be able to find some folks there.
DR. STARFIELD: Irene Peterson has taken over from Sheila Leatherman at United HealthCare. She is heard of the research unit.
DR. IEZZONI: Yes, she is also doing a session at AHSR on administrative data.
MS. GREENBERG: Our scouts will be there. Also, send me e mails.
DR. DETMER: Richard Klein is here. I don't see Deborah or Olivia. We are a few minutes early. How do you have your part organized? Is it one, two, and you are three?
Our break is not scheduled until after this. Do you want to do a five-minute break now? Before we break, I want to really thank staff as well as the committee members for just a tremendous amount of work that is obviously going on.
I think it is just really impressive. Let's take a five-minute break.
[Brief recess.]
DR. DETMER: I would like to call us back to order. We are really pleased to have Deborah Maiese and Olivia Carter-Pokras, and Richard Klein with us. They are going to talk about Healthy People 2010, and are going to give us an overview of it, as I understand, and what some of the data issues might be for us, as well as you folks. Are you going to start, Debbie?
Agenda Item: Healthy People 2010: Overview. Data Issues and Eliminating Disparities.
MS. MAIESE: Thank you, Don. If to all of you Healthy People 2010 sounds like some distant event, it actually is much closer at hand.
I hope that all of you have gotten this little handy book mark that really shows that we are aiming for the release of Healthy People 2010 in January of 2000.
We really are but 18 months away from this release. In part, this release date has a lot to do with Presidential politics.
We hope to be out and officially released with this agenda for our nation's health improvement before the Iowa Caucus and the New Hampshire primary. That is why the race is on.
In fact, the other significant event on this little calendar is that we will be going out for consultation this fall with a complete set of draft objectives.
The timing of this presentation today and hopefully this will whet all of your appetites to go up on the web.
The back of this book mark shows you the web address of Healthy People 2010 development. It also is linked to the longer Healthy People 2000 web site. Both of those web sites remain a work in progress.
Let me share with you what I believe is probably one of the biggest successes of Healthy People 2000. Jackie has gone out to get a copy of an article that I did with the National Center for Health Statistics on data issues and challenges in Healthy People 2000.
It has to do with the fact that when we started the objectives for this decade, about a third of them lacked baseline data.
In essence, 91 of the 300 objectives in Healthy People 2000 had no measures. We are now down to 11 of those objectives having no baseline data.
Over these eight years we have, in essence, driven the development of new data systems.
In school health programs and practices, the school health objectives in Healthy People have helped CDC to support a collection on school health practices and programs.
In the Office of Disease Prevention and Health Promotion, we were able to secure one percent evaluation monies to do a provider survey, asking clinicians, nurse practitioners, physicians assistants and doctors, about the extent to which they inquire, assess and counsel on smoking, diet and exercises, things that don't appear in the insurance and reimbursement forms.
It is, once again, the objectives that have driven the data development. We hope that in Healthy People 2010, to again be a data development agenda.
One of the things, as I go into a couple of slides, we will talk about the data development potential of Healthy People 2010.
The presentation that I am about to give is under tab I in your briefing books. It starts out with an article that I co-authored with Earl Fox, on laying the foundation for Healthy People 2010.
This describes some of the consultations that began in 1996, with us going to our national voluntary membership organizations as well as to states, and asking questions about, is Healthy People too large or too small. Do we have too many objectives or too few. Should we reorganize Healthy People from a disease and intervention-specific focus to a life stage focus.
That stakeholder's report is up on our web, and those two items continue to be the subject of debate, even today going on, at the Institute of Medicine.
Last year, we went up on the web and took public comments on our draft framework for Healthy People 2010. You will see in my slide that we seem to be coming around on consensus about the vision statement, about the goal statement.
Now what we are trying to do is figure out how to best package Healthy People 2010, to communicate what this agenda is all about.
I want to quickly go through a few slides and then that way, once we get through with all the panelists, you can ask us questions.
I usually put up a slide of the globe, to remind everyone that Healthy People is the United States contribution to the World Health Organization's call for health for all.
In Geneva in May, the nations of the world passed a resolution calling for us to renew our commitment to health for all. So, Healthy People 2010 will be our contribution to the WHO effort in the next millennium.
This is the time frame in a little more detail. Let me elaborate on the fact that Secretary Shalala designated a Secretary's council on national health promotion and disease prevention objectives for the year 2010.
That group met April 30 of this year. They meet on an annual basis. Their work is supported by a departmental steering committee that is representative of all optives in the department. These two groups really guide the policy of this initiative.
In addition, they have set forward the framework and the schematic that I will show you in a moment.
This fall, the consultation will begin by us posting the draft objectives on the internet. We will be publishing documents. We will be happy to make sure members of this committee get their own copies.
There will be five regional meetings. I will show you a map with the dates of those regional meetings, as well as our annual consortium meeting here in Washington before the American Public Health Association, November 12 and 13.
Each of those regional meetings, as well as the consortium meeting, will be a formal hearing, and we would invite each of you to participate, particularly to help us make sure that we are shaping the data development, the surveillance and infrastructure objectives of Healthy People 2010 in a way that is useful to you.
This is a broader framework than us here at the national level. We want to make sure that this is useful in states, in localities, for healthy community and healthy city initiatives. We want to make sure that this is useful as a teaching tool overall.
We are expecting that the public comment period will close on or about December 15, and then work groups in the department, in consultation with others, will be using that input to finalize a set of objectives that will go to clearance about next summer.
Then, in the year 2000, we are planning on releasing a three-volume set. The first volume will be focused on people and settings, in essence, the policy document.
The second document will be the objectives themselves, the scientific references, the objectives with their target. It will be the nitty gritty of this three-volume set.
Then the third is the data volume that will, in essence, show the dimensions under which each of these objectives will be tracked, and I will let Olivia and Richard get into the dimensions of how things will be tracked.
This is what our web site looks like when you open up under web.health.govhealthypeople.
Listed under there is our 2010 development guide that describes in some more detail what I am trying to share with you in this short time today.
The stakeholder's report gets into that dimension I was just describing. Are there too many or are there too few objectives.
The public comment site is really useful, I think even now. It reflects all of the 700 comments that we got on the framework last fall.
It is key word searchable, so you can look up diabetes or you can look at who commented from Illinois, John, or you can just ask and search on any dimension to see what comments we received last fall.
I would encourage people who are beginning to use these objectives to do their own 2010 development, to look at what the public has said to us.
For the first time, I think, in Healthy People development, we have actually heard from the general public. About 62 percent of the 700 comments came from people who did not list an official organization affiliation.
Let me talk about the two types of objectives in Healthy People 2010. We are proposing to label those that have no baseline as development objectives.
We will not set a year 2010 target until such time as we have measured this particular indicator. One of the things we want to be very explicit -- in fact, last week at the data council meeting it is my understanding that Ed Sondik distributed an initial draft of these developmental objectives.
They number about 200 at this point in time, a rather awesome responsibility and data agenda to fulfill, particularly to fulfill by the mid-decade review in the year 2005.
We are setting a high hurdle for ourselves, saying that these developmental objectives should be measured by the year 2004, so that in 2005 we can set a 2010 target.
The other objectives will be the measurable ones where we have current baseline data from which we can bench mark a 2010 target.
These are the criteria that were published in our 2010 development guide. They seem to have served us well thus far in this development process.
I think a couple of important criteria are that they drive action, they are measurable, they are scientific based, and that they are understandable, useful and relevant.
Of course, we continue to maintain our prevention orientation at the same time we are expanding this agenda to include emergency medicine and long-term care.
We are starting a series of audio conferences with the states. The first one happened April 27. The next one is next Wednesday, June 24, with Dr. Satcher and Ed Sondik, focusing on data development with the states, talking about how to get started for 2010.
In fact, we are proposing to the states that we use public health week in the year 2000 to release state plans on the heels of our national document as well.
Then the next in this series of audio conferences is making the community connection, to really encourage the states to support healthy community and city initiatives at the local level.
This talks about our Healthy People consortium meeting, which I think I have adequately described as a key note address on November 12, with morning break outs, the lead agencies in work groups to talk about the draft objectives that have been proposed, with the afternoon focused on public testimony.
These are the regional meetings. They are in your notebook. Let me make sure that the date in Philadelphia is October 5 and 6.
That meeting date, and all of these meeting dates are tentative. They are a work in progress. We will be in Chicago November 5 and 6, Seattle December 2 and 3, Sacramental the 9th and 10th of December, and New Orleans on October 20 and 21.
Again, these meetings will be a half day of sort of facilitated discussions and a full day of hearings on the draft objectives.
If you watch our web site, you will be able to get more information and we hope to enable you to be able to register on line.
One of the building blocks for 2010 is to expand the audience of Healthy People beyond the public health community.
The Robert Wood Johnson Foundation has funded the Partnership for Prevention, to form a business advisory council for Healthy People 2010.
We are really excited about expanding our reach and looking at the extent to which we can make these objectives useful to employers, not only for work site health promotion, but for community health promotions as well.
This schematic was drawn for us at the April 30 Secretary's council meeting by Dr. Richmond in the meeting, focusing on our vision statement which resonated with people last fall, of healthy people in healthy communities.
Health for all recognizes that connection to the WHO initiative. The two over-riding goals -- and I will let Olivia get into the eliminating disparities and the implications of that -- for one target fits all for 2010, no differential targets. We are going to be audacious in our initiative.
We have added the years to the first goal of Healthy People, quality of life years, not just healthy life years.
What we heard in the public comments is that people didn't quite understand what we meant by healthy life. They thought quality of life years was really important.
Then we organized the chapters into these three categories of promote healthy behaviors, and promote now safe communities is a new adjective we have added, to prevent and reduce diseases and disorders.
So, let me yield the microphone to Olivia, to say let us make sure that the 2010 objectives that we develop are based on good science, sound data, and would guide sound policies. Thank you.
MS. CARTER-POKRAS: This has been a long drawn-out I guess opportunity within the Department of Health and Human Services to finally do something about these racial and ethnic disparities in health.
We feel very good about the fact that a proposed goal for Healthy People 2010 is eliminating disparities, which strengthens the goal for Healthy People 2010 of reducing disparities.
This is something we have heard quite loud and clear from our constituency groups, everywhere from public comments during the public comment period on the proposed framework for Healthy People 2010, to the progress reviews that we have had over the past few years on Healthy People objectives, as well as other forums.
So, we are feeling quite good that we are at this point. But it also means that we are having to grapple with some tough issues that we never had to grapple with before.
They are bringing to light, for instance, how we actually set our targets for the year 2010, what our data sources are going to be, how we are going to present the data.
I am going to present some of this data, and Richard is then going to carry that out.
A renewed and vigorous commitment to address these health disparities goals in Healthy People 2010 is obviously needed, if we want to improve upon the experience of this decade, and actually close the gaps between racial and ethnic groups in health and health care access.
While we know that the health of the general population has improved, we still see some major racial and ethnic disparities still remain.
Approximately half the year 2000 objectives either are proceeding in the wrong direction -- 19 percent -- or lacking sufficient data to determine progress, which is 30 percent, with such problems being greater for the minority objectives than for the rest of the population.
For some groups, including Hispanics and Asian and Pacific Islanders, looking beyond the aggregate data may be actually indicated, in order to unmask health disparities for specific subpopulations.
Our next overhead briefly describes some of our problems that we have had in monitoring and addressing health problems for racial and ethnic minorities, due to persistent data issues and challenges.
Often the issue is one of no national data for racial and ethnic minority groups, and/or subgroups or, when the national data do exist, it is insufficient or of poor quality. They are unreliable, for instance.
Lack of good national data, though, does not necessarily mean the lack of a national health disparity, and here is another issue as far as the presentation of the data.
In the current Healthy People 2000 documents we focused on those subpopulations for which there were the greatest disparities.
Oftentimes we heard from the subgroups who wanted to know where they fit into the scheme of things. They wanted to know whether, indeed, they had this problem. In some cases we didn't have the data. We couldn't answer them with that question.
The usual reasons given for this lack are the small numbers of some of the groups or subgroups and the lack of resources for the kind of data collection that is needed.
Now the problem is, no data, no objectives, or subobjectives. When there are no objectives or subobjectives, there is little, if any, policy and programmatic attention at the national level to a number of health problems of real concern.
An interesting report was published by Dr. Moon Chen, in which he reviewed NIH funding. He actually found that it seemed to be very much related to whether or not there was a Healthy People 2000 objective in that area.
If they didn't have an objective for a particular health problem, it was unlikely that money would be directed in that area.
It is important to see that this is not just a paper exercise. This is actually used by national and state agencies to help set funding priorities. We have seen that consistently in our reports from the states.
Without such attention, as we know, the gaps between these groups remain or actually increase. For example, we have data from Puerto Rico about health insurance coverage which indicates that more than half of all Puerto Ricans -- a vast disparity from the total population -- lack health insurance.
Not only do our national estimates exclude U.S. insular areas, of which are going to hear more at the national committee hearings on July 14 and 15, but Healthy People 2000 objectives also exclude these geographic areas.
Now, of course, these areas are encouraged to develop their own objectives for the year 2000. That may mean that they are going to be excluded from this prioritization and the funding decisions that are being made at the national level.
Related to this issue of no reported data to identify and monitor health data by race and ethnicity is the issue of explaining away all such disparities on the basis of socioeconomic status, and replacing race/ethnicity variables with those related to SES, like income, education, occupation.
Now, we know that SES contributes to the vulnerability of groups, such as racial and ethnic minorities. However, the Office of Minority Health, in its review of the literature, has found that it cannot fully explain their poor health status, or the significant differences in health care and health care services that they often experience in comparison with non-minorities.
This committee, the National Committee on Vital and Health Statistics, has certainly taken a lead, and taken a closer look at the research that can be conducted, and the data needs for that research, to look at these other reasons.
The HHS policy that was issued by Secretary Shalala last October to include data on race/ethnicity in all HHS-funded or sponsored data collection and reporting systems is a tremendous step in the right direction.
Data collection at regional and local levels, where minority populations reside, and the use of these data when national data are poor or unavailable, should also be considered.
Here is another place where Healthy People 2000 perhaps has not been able to address some health problem areas of concern, because the data were not there at the national level to support the objectives.
This is part of the beauty of these developmental objectives, is to kind of push to make sure that the data are there.
Another data challenge is that of identifying and addressing health disparities for racial and ethnic subgroups that may be masked when data are aggregated.
One example is the percentage of Asian-American births that occur among teenage mothers in the United States. This overhead focuses on those mothers born in the United States.
The overall rate for Asian-Pacific Islanders is 12.9 percent, but it varies from 3 percent for Chinese mothers to 19 percent for Filipino mothers.
This demonstrates the need to not only collect racial and ethnic data using the federal minimum standards, but also by subgroups whenever possible.
Current plans are to present baseline and monitoring data for each population-specific objective -- in other words, not counting number of hospital beds or whatever when we are talking about people -- for Healthy People 2010, following the minimum standards for racial and ethnic data -- OMB directive 15 and its successor.
Richard is going to be explaining a little bit more about some of the transition problems with that. Along with the new HHS inclusion policies for racial and ethnic data, this should encourage the collection, analysis and presentation of baseline and monitoring data for each population-specific objective, not just those that are tailored to racial and ethnic minorities, as in Healthy People 2000.
OMH recommends that when data are missing, that there be a no data indicator. So, we are hoping that that will come out finally in our decisions for presentation.
Now, how do we target policy, attention and resources to Americans with the greatest negative disparity in order to achieve improved health for all?
With the race and ethnicity health disparities initiative that was announced on February 21 by President Clinton, the President has embraced the elimination, rather than the reduction, of health disparities of six health focus areas: infant mortality, cancer screening and management, diabetes, HIV and AIDS, and adult and child immunization.
The argument against applying the elimination of disparities goal to all health focus areas in Healthy People 2010, beyond the six included in this initiative, is that in many instances the gaps are too wide, and their elimination is unrealistic for 2010.
The Office of Minority Health's response to that is, well, if not by 2010, when are we planning to do this. We certainly need to start somewhere.
We have certainly heard that call very loudly from the constituency groups.
So, the Surgeon General has just sent around, to the priority area work groups, the following recommendations and guidelines to develop their year 2010 targets. This is where we are at right now.
For those objectives that can reasonably influenced in the short term by interventions in public health or improvements in access to health services, a single target for the year 2010 should be set, that is an improvement for all segments of the population; in other words, a better than the best target.
This would include life style objectives, such as those relating to diet and physical activity, modifiable risk factors such as those relating to smoking and blood pressure, and access to services such as prenatal care and mammography.
For those health status and outcome objectives that can be directly influenced in the short term by changes in behavior, such as homicides, suicides, alcohol-related motor vehicle fatalities, one target should be set for 2010 that, again, is an improvement for all segments of the population.
Then, for health status outcome objectives that are contained in this racial and ethnic disparities initiative, again, one target is an improvement for all segments of the population.
Now, the one that differs from this is the health status outcome objectives that are unlikely to achieve an equal health outcome in the next decade, regardless of the level of health investment, such as those based on risk factors that occur early in life, such as occupation exposure and resultant lung cancer, or those with a significant genetic component.
The target should represent an improvement for a substantial proportion of the population. So, there are four categories, for three of which is a single target that will be an improvement for all segments of the population. This is the one exception where there will be an improvement for a substantial proportion of the population.
Now, all of this is open to public comment in the fall. It may be that people don't like this approach and they have objections to it, and I certainly encourage you and your colleagues to participate.
This is not just a data issue. This is really a health policy issue. How do we really want to sort of drive the movement that needs to be driven to eliminate these health disparities.
Now, the target for this fourth category, this one where it is an improvement for a substantial proportion of the population, is going to be considered a minimum acceptable level for all populations.
In other words, we expect those who have already met or exceeded that level to continue to improve on that level.
There will be acknowledgement for these people in the presentation of the information.
I would like to show you how this would play out. First, how it looks in Healthy People 2000.
I picked infant mortality. For this, I have a one-pager that I passed out for you, if it is easier to take a look at it.
The shortened version is what we see in Healthy People 2000. It shows that there is an overall target for the total United States population of seven per 1,000 live births for the year 2000.
We have three different targets for the subgroups. For blacks, the target is 11, not 7. For American Indians it is 8.5, not 7, and it is 8 for Puerto Ricans.
What we are saying is that, for 2010, we expect only one number there for that 2000 target, for all subgroups.
We are also saying that, instead of just presenting the information for the groups with the greatest disparity, we are going to present it for at least the minimum categories that are suggested by OMB directive 15 and its revision.
These are, again, for the population-specific objectives, the ones pertaining to people. So, we will be able to actually see what is happening across the board and we will be able to hopefully shed light on the fact that we are missing data for many of these subgroups of the population. So, we can do something about it.
If we can take a look at the next one, the other side of this, you can see what it would look like if we had information for all the groups.
As we take a look at this, we see that there are three groups for which they have already achieved the year 2000 target of seven per 1,000 for their baseline year; Japanese, Filipino and Native Hawaiians. They already achieved the target.
In this case, this is infant mortality. So, this is one of the six health focus areas for the racial and ethnic health disparities initiative. Therefore, there will be a single target that will be an improvement for all.
What is not clear at this point is whether that target will be better than 6.2 for the Chinese or better than 7.3 for all Pacific Islanders.
Now, for other mortality objectives for which we know that these are chronic diseases and, for instance, the lung cancer, the approach will be a target set that represents an improvement for a substantial proportion of the population.
One approach which was considered and dropped was to continue to use a target that some groups may have already achieved, as was the case for the infant mortality objective for Healthy People 2000.
An advantage for that approach was that it drew attention particularly to those who were furthest away from the target.
The disadvantage is that the groups which have already achieved the target may find it difficult to improve upon, or maintain, that advantage, perhaps even feeling discouraged from doing so, which is why we ended up with the approach which we have right now.
It is important to note that the department is grappling with issues, as I said before, which were not addressed during the development of Healthy People 2000.
The decision to present data for all racial and ethnic groups as well as the proposed goal of eliminating disparities, has brought to light new issues regarding the setting of targets.
A similar discussion is occurring at the Institute of Medicine this week, regarding the selection of leading health indicators for Healthy People 2010, which may or may not be a subset of the Healthy People 2010 objectives.
Following up on the conclusions of an internal working group, IOM is considering some measure of health disparities.
One approach which has been considered is selecting from the Healthy People 2000 objectives, for which there was at least a 25 percent or greater disparity.
Another approach is to present baseline and monitoring data for all leading health indicators by race and ethnicity. Obviously this is one which would be very consistent with the approach we are taking for the other approaches to 2010.
The third approach is actually a measure of income disparities, or some overall global measure of health disparities.
International comparison studies have found extremely strong correlations -- correlation coefficients of more than .8 -- between the income disparity for a particular country and its life expectancy.
We strongly encourage you and your colleagues to participate in the public comment period, since we know that closing the gaps will require conscious and deliberate efforts.
We need to do more than we have done before, because obviously it is not working. In some cases, like life expectancy and infant mortality, in the last decade we have seen some of the gaps actually have grown larger.
We do see that there are opportunities to eliminate disparities. We have achieved it for mammography. The rate of mammography use among black women is now equal or greater than it is for white women, and that has happened in a very short period of time.
So, we have hope, and we feel that revising how we approach Healthy People is going to certainly move us in the right direction. Thanks.
MR. KLEIN: Olivia made an interesting point. She said something was a policy issue and not a data issue, and this is something that we come in contact with very frequently in Healthy People, and we have many interesting discussions with our colleagues downtown and tell them this is a policy issue, not a data issue.
For example, like setting a target. If you want to do some kind of regression analysis or set some kind of algorithm, that is a statistical issue.
A policy issue is, should all groups be the same; should they be better. So, it is a very interesting interplay between the data end of it, which is kind of the pure statistical end, and the policy end.
At some point they meet and become very difficult to distinguish.
In some sense, these two people have covered a lot of the data issues, but more from the policy perspective. Some of the issues that we have that Olivia was alluding to in presentation -- you all might be familiar with this publication -- this has been our annual report of the Healthy People objectives as they exist right now.
It is a fairly good size. When we start thinking about, for 2010, having possibly twice as many objectives as we have right now, and breaking out numerous demographic categories, breaking out race, ethnic, age, socioeconomic status, possibly disability status, we could be looking at a very large document.
I think we are having to re-think the way that we present data. I think we are thinking much more electronically, and that a lot more of this will be available on the internet, and you will be able to pull out what you are interested in. If you are interested in a particular demographic subgroup, you can pull that out.
I think the idea of a single book and looking at these things linearly is probably going to pass us by in the next decade.
Some of the issues that we have grappled with that you all might be interested in would be the number of measures in an objective.
From our perspective at NCHS, a national objective, in order to know if you are going up or down, we should limit it to a single measure.
If you look at some of the measures that were in Healthy People 2000, or some of the ones that are proposed for 2010, there can be multiple measures in the same objective.
Some can be going up, some can be going down. So, we have a category that we end up calling mixed progress, which I don't think really does anybody a lot of good.
We have been advocating for a single measure to an objective, and to discourage creative numbering schemes that allow people to use A, B and C.
That have one objective. They call it hepatitis, but it has about 10, hepatitis A, B, C, they have them all in there.
So, we have kind of been moving those toward separating those into particular objectives that we can determine very easily, is it going up, is it going down, has it reached the target, et cetera.
Another thing that we were strong on this time is to not have what we call duplicate objectives. In Healthy People 2000, if an objective was of interest to more than one group -- like smoking or overweight is probably the biggest example -- it is in four different areas.
It is crucial for heart disease, for diabetes, for physical activity, for nutrition. It is in all of those areas.
It presented us with kind of a numbering nightmare. Even though it is important there -- we have two different numbers.
We have the number of objectives that are progressing that are not duplicating, and then how many duplicates? Does overweight count four times if it is going down or does it count one time? It is in there with four distinct numbers.
We have sort of come to an agreement to just use a single unique number. It certainly can be referenced in the other areas, but there is just one overweight objective, and it is just in there one time.
Other issues that we are dealing with that certainly were mentioned by both folks are these developmental objectives.
There are several hundred of those in the current document. If anybody takes a look at those, you will see that these present a much more serious data collection problem, in my opinion, than we had in Healthy People 2000.
These are very lofty -- some of these are just like hoping somebody will collect these data.
In Healthy People 2000, a great majority of the objectives that Debbie mentioned, the 91 without baselines, were planned for the National Health Interview Survey, or they required a kind of concentrated survey like the primary care provider survey, that they could be picked up. I think we have a much more daunting challenge this time.
I also personally -- this isn't speaking for NCHS -- I don't think it is necessarily bad that we put objectives in that we can't measure.
I think we need to decide what is important and what should be measured, and that hopefully this will drive that kind of action, to some extent.
Some of the other issues we are dealing with are going to be basic comparability and consistency issues. I am sure you all are familiar with a number of major changes that we have coming up in the next few years that are going to wreak havoc with our trends, if we set targets.
We have the change to ICD-X in 1999 that is going to cause some discontinuity in the mortality. We have a change in the standard population being used for age adjustment.
Has anybody presented that here? We all know that. We are going to the year 2000 and it is going to be radically different rates, obviously.
It also will affect the racial comparisons, to some extent. Since we are using an older population, we are going to be narrowing the racial gap. Who says statistics can't make a difference in public health?
MS. CARTER-POKRAS: I should point out, the eliminating disparities goal was discussed before that decision was made, so those statistics are not necessarily linked.
MR. KLEIN: I am going to show an overhead. I am sure you all are familiar with this also. The current OMB categories are the American Indian, Asian or Pacific Islander, either white and black and Hispanic separately, or non-Hispanic black, non-Hispanic white, and Hispanic.
The fairly subtle change that is happening with OMB 15 that is scheduled to go into effect for all agencies by the year 2003, is the breaking out of Native Hawaiians and other Pacific Islanders from the Asian group.
That is a fairly straightforward issue for us statistically. I think what is much more complicated, with the OMB 15, is the provision where somebody will be allowed to check more than one race, and nobody knows how they are dealing with that right now.
We will all be coping with that over the next few years, and that certainly could cause some changes in these trends that we are trying to monitor for a 10-year period in Healthy People.
Healthy People is kind of assuming a comparability over time that really, you know, doesn't always exist for the different data systems.
I am also in Tab I in your book, following Debbie's talk. I want to say a little bit about something Olivia mentioned, these leading health indicators.
IOM's meeting right now -- I was over there this morning -- discussing this leading health indicators. We produced a little talk for Dr. Sondik to give over there this morning.
In the office, we refer to Healthy People as the blue brick. It is about this big. Those of you who have seen it, the original Healthy People, we use it for weight lifting.
Dr. Sondik's speech writer called the leading health indicators a chip off the old brick. The idea is that there is no way that you can summarize the 300 or possibly 500 or 600 Healthy People objectives into any kind of summary list.
The best we have been able to do is 150 are going up and 100 are going down and 50 are mixed.
So, the idea is to create a set of a few, maybe a very few, up to a dozen or 20, or whatever, things that could be considered as leading health indicators, using as a kind of model the leading economic models, where we can summarize in single numbers, or in several numbers, the economic condition of the country.
This is being considered right now. Right now they are looking at the criteria for measures, and that is in your book.
I won't go over those. Those are pretty obvious, but we are talking about, are they interpretable. Are they applicable to the population; are the data available; can you track them at various levels.
I think the things that we are the most interested in, as far as those go, are, first of all, regular availability.
I think the committee talked that they had to be available regularly, but I think what we are really talking about is annually.
As far as most federal data systems, there are what I call either annually or whenever you get the money. There are very few systems that are regular, regularly funded but periodic.
I think the youth risk behavior survey is every other year, but I think if we are going to consider something as leading health indicators, we need to be able to produce regular data on those.
We also have to be able to produce those data below the national level, at least at the state level, in order for them to be important, to be used as a report card, to be able to compare areas, ideally below the state level, but at least at the state level.
We also would have to be able to break out at least the standard OMB race/ethnic groups, and possibly even some greater demographic detail.
I think most important, the thing that possibly gets considered less, is that if something is selected for a leading health indicator, let alone a Healthy People objective, there has to be assured adequate funding and resources to collect the data, if it is not part of a regularly-funded data system.
We have to say, if it is a leading health indicator, we are committed to collect that.
Of course, at this point, all those are kind of unclear. I think we are working now with the data council and trying to come up with a data development plan over the next decade. What do we need to collect? Who is going to pay for this?
Many of the data we have collected at NCHS for Healthy People are used by any number of public health service agencies, and there hasn't been a clear stream for funding these on a consistent basis. This is something we are all dealing with.
The three models that the Institute of Medicine is considering -- this group that did this was a public health service group, and they fed three models over to IOM that they are going to be looking at.
One is a health status model, and it is based on the figure 2-1 and 2-2 in your book, which is what is called health status indicators that were developed as part of Healthy People 2000 by a committee called 22.1.
They were designed to be able to give a group of indicators that could be measured at at least the county level to provide this kind of report card.
That was the 18 that are in your first figure. The second figure has several more that were also recommended by the committee, but that the data weren't available at that time -- this was about eight or nine years ago -- to be measured below the national level.
They said, if you could get the data, these would be good to add. They are things like cigarette smoking, mammogram, and that type of thing.
Since that time, a great number of those are available through the behavioral risk factor survey. So, the health status model includes both of those.
There was a health disparities model that was proposed that took the Healthy People objectives that showed the greatest disparity -- there are about 30 or 40 objectives, homicides, and things like that, that showed the greatest subgroup disparity. Those would be the leading health indicators.
The third model is something called summary measures/leading contributors approach. It took some summary measures of health that I want to talk a little bit more about, like years of potential life lost, life expectancy, that type of thing, and matched those against something called leading contributors.
In other words, instead of causes of death like heart disease, cancer, these would be the smoking, obesity, sedentary activity, violence, substance abuse, that type of thing, the thing that was called, in the McGinnish, Fahey article in JAMA a few years ago, the actual causes of health. That was the third model.
Dr. Sondik said this morning that he thought that all these were interesting, but he didn't like any of them. He is looking for something that I think is going to be a real challenge for us, and they haven't even solved this in that economic sphere.
If you look at the leading contributors approach, where you have smoking, substance abuse, overweight and that kind of thing, you have some global outcomes, like the years of potential life lost.
What is the actual connection? How tight an analytic connection can we make? If we make an X percent change in one of those risk factors, what is the change in the outcome?
These are things that they haven't gotten too good at in economics, to know if the unemployment rate changes a tenth of a percent there is going to be this type of an effect.
I think we are really looking at trying to have a much tighter set of analysis. We kind of put these things out on faith; that if we make these changes, this effect will happen, without really being able to quantify that. That is also a challenge for us.
The last thing I will speak about are these summary measures, which is something that we are getting deeper involved in at NCHS.
In Healthy People, the first goal of Healthy People was to increase the years of healthy life. We did develop a measure, bringing in some experts in the field in NCHS, called years of healthy life.
It is one of a family of measures that combines mortality and morbidity. I am sure a lot of you are familiar with these. There are the QALYs and DALYs and HALYs and some of them want to call them MOLYs, quality adjusted life years, disability adjusted life years.
All of these take a survival, a mortality experience, and apply some factor of health to it, some zero-to-one factor, and come up with a healthy life expectancy, or a disability-free life expectancy.
We have had this measure for a number of years. It hasn't gotten a lot of publicity. It hasn't gotten a lot of use yet. I think people aren't real clear what to do with it.
It is the kind of thing that you can summarize in a single number the health of the population.
We are trying to expand that. We have a conference that is going to be coming up in September. We are bringing in some international experts.
There is a lot of work that has been done in Europe and Australia and Canada on these measures, and we are looking for possibly two or three measures that we can use over a decade. We will track all of them and see what they tell us.
I think the issue we have with these is the same issue that I just mentioned, Dr. Sondik's issue about what does a change in years of healthy life mean.
It went down two tenths. What does that mean? You would have to do the disaggregation and the understanding, but these are things that we are really interested in and have a lot of possibilities. We plan to do quite a lot of research on that in the next decade. Thank you.
DR. DETMER: Very good; thank you. Let's open for discussion.
DR. STARFIELD: My reaction is wow. This is really impressive. It must be exciting, too. A couple of things.
As you know, the WHO has taken as its thing for the next century equity. When they talk about equity, they mainly talk about socioeconomic issues in equity.
In the year 2000 objectives, if I counted correctly, there are about 10 times more objectives for minority and ethnicity than there are for socioeconomic status, if I counted correctly, something on that order of magnitude.
I wondered really whether you were going to frame the issues for this one so at least people would have uppermost in their minds, if not uppermost at least in their minds, that they have to think about this.
Really, for the great mass of things, the greatest disparities are, in fact, in socioeconomic.
It is sort of even moreso if we take to heart what you said about money following objectives. If we think that one area has the greatest disparity, and the greatest disparities are socioeconomic ones, we ought to have at least the possibility of having objectives in that area.
Even moreso, you know, increasingly a policy is being made on the basis of socioeconomic disparity; say, for example, the state CHP program, which is clearly directed at low income kids.
If we are going to think about how we are going to measure the impact of that program, which we must do, we want to think about reducing disparities in health between those kids and other kids.
So, if there is anything, I think I would sort of suggest and be really willing to work with you on is to try to, if not frame every objective that way, at least framing it so that everyone can think of every objective in that way.
MS. MAIESE: Good; thanks for that comment. We do have a work group that has been focusing on SES and, in fact, has suggested that we look not only at the cut point of above or below poverty, but at some income gradient.
Of course, even that gets into an issue of standardizing those income gradients when, in fact, a food stamp program and the nutrition objectives want to cut the point at 130 percent of poverty versus a health insurance program which might want to link at 185 percent or 200 percent of poverty.
One of the things we are able to grapple with in Monday's Healthy People steering committee is the extent to which we are going to provide some more guidance about SES.
We will certainly take your comment from this meeting back to the steering committee on Monday and encourage everyone.
They have begun to look and certainly, I think again, it presents another data challenge, of the extent to which we are competent about having the income linked with some of these health indicators as well. Push us, and we are pushing ourselves, too.
DR. STARFIELD: In terms of your comments, Richard, about how do you know how much a difference one thing makes, like a difference in a risk factor, I am sure you know about this Lancet article which started us thinking on how you might go about that, because I think it did quantify it.
MR. KLEIN: I think there is a lot of new kind of exciting work on it, but it is pretty much in its beginning stages.
People have been thinking about this for a long time. I think what Dr. Sondik wants is a tighter analytic correlation.
A lot of the work that has been done -- all work like that has to make a lot of assumptions. You get the outcome -- you get different outcomes based on different assumptions.
MR. SCANLON: Let me turn to this issue of leading health indicators versus concurrent versus lagging, I guess.
In the economic sphere, there are three times. Leading literally means in advance of the business cycle, while concurrent means what we typically refer to here in health.
Are you literally thinking of leading indicators in this framework or are you thinking of sort of what has just happened?
MR. KLEIN: I think obviously, in their measurement, they are going to be more concurrent or past. They are going to be past data.
However, there is considerable interest in them having some kind of forecast capability which is sort of connected to the point that was just made on these connections between cause and effect.
Obviously, in order for them to really be useful, they would have to have some kind of a forecast capability.
MR. SCANLON: Just some predictive value.
MR. KLEIN: Some predictive value.
MR. SCANLON: Some regression relationship or whatever.
MS. MAIESE: We have actually contracted with Clem Bezel at the Institute for Alternative Futures, to help put some scenarios and what are sort of the enablers and what are the barriers to achieving these two audacious goals for 2010.
The extent to which we can quantify some of those and make those forecasting and predictive, in addition to this leading health indicator set -- I mean, there are many different components of this.
MR. KLEIN: I can tell you, this name didn't come easily. Mike McGinnis is chairing this committee for us, from the National Academy of Sciences.
WE spent weeks -- we started out with sentinel indicators. People said, no, sentinel is the canary in the mine, you know. Sentinel could be like, when we look over mortality lists, we are looking for a measles death; we are looking for a polio death; we want to see something that shows up that you don't expect to see.
A sentinel indicator could be something that is really rare that kind of tips you off.
What they meant was the important list, but we really had trouble with the name. As you can see, even leading has this kind of other connotation of future. They really don't mean that.
Obviously, it would be the most recent available data. But one of the proposals for doing it would be a monthly type of report or a semi-annual report or a quarterly report.
If you had quarterly data -- which we don't have a whole lot of -- the other was a monthly-type report where it would be a disease of the month or an issue of the month type thing, to try to get it more publicized.
The Secretary wants something that will go in a box of USA Today down in the corner there that says, you know, today the leading health indicators -- something that you could catch the public. That is one of the things they are looking for.
MR. MOR: As a follow-up to that, and in light of your interest in actually using these data, or using these objectives to pull the data along, it is very easy -- not very easy, but it would be perfectly possible to restructure the health data collection, or particularly vital statistics and lots of other things, to have them available monthly.
It is concurrent; it is ongoing. It is just the question of restructuring relationships between the states and some federal or national services, to make data available.
Hospital discharge abstracts, nursing home discharges, lots of other things are also available, literally on a weekly basis or monthly basis as well. You have got to get these bills out or you are not going to get paid.
It is not beyond the pale of possibility of thinking about these as literally the leading indicators or in the same framework as the economics.
You may not be totally satisfied with the content, but with the will, it would be possible to restructure the data receipt and timeliness to make those things available.
MR. KLEIN: Yes, I think the timeliness is a big issue. The fact is, for many of these outcomes, they just don't change that much.
We are talking often about chronic conditions. What are you going to see in a change in cancer mortality in a month.
However, some of the other things could really be -- many things are streaming on line. We are doing vital statistics every six months now because it is electronic.
Also, the HANES survey now is going to be keyed in right in the trailers and theoretically the data will be available on this kind of basis.
The problem with anything below like vital statistics, once you get into survey data is, you are just going to be having small numbers feeding in and they are not going to be nationally representative.
I think we really have to think about this idea of what kind of change are we expecting to see, and what does a change mean from month to month.
We could get into the kind of thing where we are showing something that is not meaningful.
DR. FRIEDMAN: I think that presenting as much of the data as possible by subgroup is going to be really a terrific addition.
I think part of that can be using the documents as a means for pointing out the complexity of the impact, and the relationship between the complexity of race, as we think about it in this country, and health status and health outcomes.
I would hope that even if it is only on an example basis, that we really take that even beyond the more readily available subgroups, to also include -- again, even if it is only on a sample basis, even if it is only for a very limited set of indicators -- place of birth, which would have for Asians and Hispanics, has a huge impact on outcomes and health status, as well as subgroups for blacks.
Again, there are huge differences between African Americans, for example, and Jamaican Americans, Haitians, et cetera, et cetera.
MS. CARTER-POKRAS: We actually have been pushing this for quite some time at the Office of Minority Health.
We found the Healthy People 2000 review documents to be even more helpful in explaining what is happening in a particular health problem area than our regular report to Congress, Health United States.
It is much more comprehensive as far as the health problems that are addressed in there and the way the data are presented. So, we are happy we are moving in that direction.
I should have pointed out, earlier Dr. Starfield made some excellent comments. Guidelines have gone out to the priority area work groups. It is not just race/ethnicity, but also some indicators of socioeconomic status.
The problem is that we do not have a standard, as we do for race/ethnicity. We don't collect education, say, or income or poverty on every single one of our data systems in exactly the same manner.
That makes it a bit more difficult. The mortality objectives, we may only be limited to education, or something like that.
DR. LUMPKIN: I would just caution us to be careful about being seduced by the ability to have data on smaller chunks in a year.
Infant mortality is a good example. The smaller the rate of infant mortality, the more unstable those rates get.
In Illinois our difference in rates, a few infant deaths, whether or not we get cases reported from Indiana on time can dramatically change our infant mortality rate at the level we are at.
Much of the survey data is not designed to be monthly data. The behavioral risk factor survey, if you get it monthly, you are only going to get it across a subset of the state.
It is not necessarily going to be a reliable set. So, I think it is desirable, but many of the things we measure aren't stable across years.
The immunization survey is another example. We went from the 10th lowest state the first year of the survey. The second year we were the ninth highest state and then the third year we were the eighth lowest state.
I know our immunization activities haven't changed that much. We just have to be hesitant and make sure that we are reporting real stuff when we start looking at the summary data.
MR. KLEIN: A number of outcomes are seasonal in nature. Typically the economic cycles are, too, and they seasonally adjust, and we have done that also.
It would be nice to have some of these problems to work with.
DR. DETMER: I think the quality commission will flag, like you are, what metrics and what markers can we find that really will help us look at achievable benefits we are not achieving.
I think that is kind of the challenge. If you can find that, it seems to me we really ought to reward plans and such for impacting on the health status of those regions.
You need to have it adjusted for the populations in those regions. Until we get to that kind of thing, clearly we can throw 20 percent of our GDP but not necessarily gain 20 percent of health out of that.
I think that this is really very relevant work you are doing. Probably the group knows this, but the Institute of Medicine has focused, in their last strategic exercise, on a set of priorities.
One of them that they are going to be looking at is this health of the poorest 20 percent. They just took it as a number.
It will be kind of interesting to see sort of what plays out of that, because I think that would also relate to what you folks are doing. I don't know if that has come up in your meeting or not.
DR. STARFIELD: Compared to what?
DR. DETMER: That is just the statement. They are going to go off and decide what that means. It whetted her appetite.
The question I have got is, do you have any sense of how far it might be -- you continue to grapple with this -- but how far it might be before we might get some of these kinds of metrics, at what frequency and so forth, that we really could reliably tie to incentive structures for the delivery system?
I mean, you have got one set of things out here. Unless it kind of fits also into the public health and delivery system, you don't leverage probably what you ought to be leveraging.
MS. MAIESE: As many of you may know, the NCQA did adopt the set of clinical preventive service targets that are in Healthy People 2000.
In fact, when they had released their initial measure for diabetic eye exam, it was every other year. Because our mid-course correction added an objective for annual dilated eye exams for diabetics, there was an example of NCQA changing their measure to match the Healthy People measure.
The targets have been the same. In fact, last week I was asked whether or not NCQA would then change their targets to bench mark with Healthy People 2010 which, of course, would be something, once we have settled these targets and released them, would be a venue for us to pursue.
So, to some extent, there is parallelism between the HEDIS data set on clinical preventive service measures and Healthy People.
One would help that as we experiment with this new set for Medicaid and, likewise, introduce new measures in Healthy People 2010, that again that could become a way to dovetail at least with the managed care industry, the measures of quality as well. That is only one slice, I think, of a much broader --
DR. DETMER: I invite you to try to keep this committee at times focused on that dialogue. I think all these things are so complicated and so interesting that we can get caught up and stay very busy, but lose a little sight, maybe, of the real objective, which is health, in all of that.
MS. MAIESE: One other thing that is just new in Healthy People 2010, you will see a new set of health communication objectives, public health infrastructure objectives, population-based capacity objectives, that we haven't had in Healthy People 2000.
Again, many of those are developmental, being put on the agenda so that we will have a better sense of the public health capacity to do health improvement as well.
Please let us know the extent to which some of those new measures are useful as well, and become markers for the public health community.
DR. STARFIELD: To help us, could you summarize for us -- I don't mean now but at some point -- the different criteria for deciding on the socioeconomic classes.
You mentioned that there are several. What are the relative frequency -- I don't mean now.
MS. CARTER-POKRAS: Actually, there was a memo that was sent out from Dr. Diane Wagner -- Rich's little niche of the National Center for Health Statistics -- that helps with the monitoring for Healthy People, out to the priority area work groups, giving them some guidance as to the minimum set for reporting categories that we were hoping to see in this initial draft.
Of course, that still has to be revised and we are developing further guidance regarding the socioeconomic status presentation.
One of the suggestions, because we did look -- several of the priority area work groups have already tackled this, even before they were asked to do so.
One of the concerns we had is, when we took a look at it, they tended to report poverty or not poverty, for instance.
We said, at a minimum, at least three income categories, not just two. So, we were giving them some initial guidance like that.
MR. KLEIN: So, a near poverty was added, like 100 to 199.
MS. CARTER-POKRAS: Right, but then again that runs into the problem that Debbie was mentioning, that depending on which health objective that we are talking about, it may be those three categories may have to change, because they relate directly to eligibility for certain services, or relate directly to that health status objective.
DR. STARFIELD: If you have got that summarized, I would like to see that.
MR. KLEIN: The one thing we did do, or that we are doing for Healthy People 2010 is we are getting away from straight income categories that we had here. We had under $10,000, under $15,000. That is not meaningful to track over a decade.
At least we will go to the inflation index, poverty level, so we can have some kind of measure. That is something that we have decided on.
There were a few in here, I would like to mention. They were almost all income level.
MS. CARTER-POKRAS: The work groups were also encouraged, besides race, ethnicity and socioeconomic status, they were also encouraged to look at age, gender and disability.
MS. MAIESE: We will provide the committee with that guidance.
DR. DETMER: Great. Anything else?
Well, thank you. We wish you all the best and we will want to stay in touch.
MS. MAIESE: We look forward to your comments, individually and collectively this fall, and encourage you all to participate in all these consultation activities.
DR. DETMER: It sounds great. I have got my book mark.
All right, we had a break before. So, I think we could just move on and finish up, if that is fine with folks. We are slightly before 4:00 and we had tabled an issue until 4:00, but I think we can bring that up at this point.
I think that is really the last issue, is to get back to the discussion on the unique individual identifier and a motion that Mr. Gellman brought forward yesterday. That is at least one item. I don't know if there is anything else that we had left on that or not, but that is certainly on our plate.
I think that is the last of it, unless John, you or Kathleen have more to add as well?
Agenda Item: Plans Regarding Hearings on the Unique Individual Identifier.
DR. STARFIELD: Can I just ask a question? What about the questions about the hearings? Do you want to get back on the questions?
DR. DETMER: All right, do you want to do that first?
DR. LUMPKIN: I am not sure we need to do that in the meeting. I think you can send it to myself or Kathleen. We are going to have to be reaching an agreement between the two committees on the question list.
DR. DETMER: Okay, so on that item what we will do is look over those questions and, if you have comments, get them to either John or Kathleen.
DR. LUMPKIN: Or both.
DR. DETMER: Or both, because that will then be firmed up and it will go out in time for the Chicago session.
MS. GREENBERG: One other thing. We typically, at each meeting, talk about agenda items for the next meeting. We have some items that we have been carrying over.
If any of you have any thoughts on this, send e mail to either Don or me.
DR. DETMER: Let's go ahead and pick up this item we have.
MS. GREENBERG: I was going to say it doesn't have to be on the agenda today.
DR. DETMER: I don't mind doing it. I mean, I think that is a good idea, and if there are any questions about dates and so forth, housekeeping things. So, let's come back to that.
I don't know if the easiest way -- maybe you want to just reread your motion and then we will go from there, if you have it.
MR. GELLMAN: Move that all NCVHS committee and subcommittee documents that address the subject of the unique patient identifier or that relate to any committee or subcommittee activities about the unique patient identifier be exempt from the secrecy rules for documents in the committee's ground rules for dealing with the media and other external organizations -- paragraphs 1, 2 and 3 from the document section -- and that these documents be made available to the public at the same time they are circulated to members of the committee or any of its subcommittees.
DR. DETMER: Okay, is there a second to that motion?
DR. HARDING: Second.
DR. DETMER: So, it is on the table.
DR. LUMPKIN: I just have a question. Paragraph 1, I think, refers to internal HHS documents that are shared with the committee. Two and three, I think, refer to our own documents. Was your intent to cover the internal HHS documents?
MR. GELLMAN: Yes.
DR. LUMPKIN: In that case, I would like to move to divide the question, and that we would cover paragraph 1, which are the internal HHS documents, separate from our own committee documents.
DR. DETMER: Okay, is that a friendly amendment that you are making to this, that you would like, and see if they accept that, or do we need to sort that out and vote this down? I am not a parliamentarian. Does anybody know the rules?
MR. GELLMAN: I have no objection to voting on the paragraphs separately, if that is what you would like.
DR. LUMPKIN: I just think there are two issues. One is HHS documents, which is not ours, and the other two are our documents.
DR. DETMER: If you don't object and you don't object, we will split that and we will talk about the first item first.
DR. LUMPKIN: I would like to speak in opposition. I think one of the unique experiences that we have had as a committee is the fact that we have been included, in a number of ways, to much of the internal HHS operations.
That, in many ways, fits our category of special government employees. My guess is that if we were to vote this up and approve it, that we would find that HHS would probably no longer share those documents with us, because they are pre-decisional documents which are not to be discussed outside the department.
I think we should not vote this -- I think we should vote against this.
DR. DETMER: Other discussion on the point that is on the table right now?
MR. SCANLON: I think that is true. We, in essence, need the authority of the Secretary for any pre-decisional documents that we share with you. You are special government employees when you act in your capacity as advisory committee members here.
I doubt, to be honest, that the Secretary would be willing to share much of this pre-decisional material -- in fact, it is often shared with you before she sees it, or before the leadership of the department sees it.
You often see it when it is in a working group. I just think that would severely -- it would certainly curtail the flow of that kind of document to you.
I just don't think the Secretary could have these issues sort of decided for her before she even gets a chance to see them.
DR. DETMER: Do you want to comment?
MR. GELLMAN: I just want to make some general comments about this. I think that the policy that we adopted last September -- over my objection, I might point out -- is pointless; it is unclear; it is inconsistent with current law; and it is stupid.
One of the pieces of evidence that it is stupid is this motion, which gives you a choice of either continuing to stick to a policy that you have agreed to, and conducting the hearings under an aura of secrecy, which is the headline, or simply doing away with the policy.
I haven't seen any documents that I have gotten from here that are the least bit sensitive, that could not be made public without any harm.
That includes any HHS documents, none of which come to mind off-hand, although there may be some.
I think on this issue particularly, of such great importance, broad public interest, that we need to bend over backwards to make sure that the public knows as much as possible about what we are doing and what we are thinking about.
The fact that a document is a pre-decisional document does not mean that it is exempt from exposure under the Freedom of Information Act. It depends on lots of other criteria.
Just characterizing HHS documents as pre-decisional simply doesn't make any difference. You have to go well beyond that and get much more detailed before you can make a legal conclusion about whether the document is exempt.
I think we should operate these hearings under the maximum amount of sunshine and under the greatest possible public disclosure of anything we are doing and anything we are thinking about, and that is the reason for the motion.
DR. DETMER: More comments relative to the first item that is before us? Do you want to take a vote on that?
DR. HARDING: You know, I have mixed feelings. I certainly don't want to go against policy of HHS and so forth, and don't have any desire to stir that up.
This issue kind of is the mother of all privacy issues; the big one, that will be something that people will look back on for the next 50 years, just like Social Security numbers have been used and dealt with.
I think trying our best to have sunshine -- the word Bob used -- on this is extremely important. I don't know that we can be completely open, but certainly doing all we can and making any modification to talk about the privacy of the privacy issues with as much openness as possible would certainly be beneficial, I think, as this develops.
I think this will be -- and it is just a prediction; I don't know -- but I think this will be something where we will have all kinds of groups especially concerned about it, from all different spectrums of the political spectrum. We need to do our best to be open.
I would like to hear what is it that we wouldn't want to be telling or talking about. I follow the rules, and I will follow the rules, but what is it that would happen about a privacy issue that is so private that we shouldn't talk about it, in the early stages.
It is not executive session, so to speak. Go ahead; others wanted to talk.
DR. LUMPKIN: It is not an issue of what can't be talked about. It is an issue of our relationship with the agency that we advise.
Whether or not a document is releasable isn't our choice; it is the Secretary's choice. Whether or not there is a determination that it meets the Freedom of Information Act, is not our decision.
It is the Secretary's decision, if it is the Secretary's document. If we are seen as a committee which is given documents which the Secretary has made a decision -- right or wrong -- and there is due process that is available under the Freedom of Information Act and we say, well, we don't agree with the Secretary; we are just going to release it ourselves, then, in fact, the Secretary and her agency will not share those documents.
We will not become a close advisory committee. We will not see the drafts, as we saw, as the privacy committee saw, of the document that went to the Secretary for a decision and on which we based many of our own positions. We will not see many of those documents.
If I were the Secretary and I was in that position and I felt that issues that I personally hadn't had a chance to approve were being leaked to the press by one of our agency committees, that committee would be cut off.
I don't think that is the role we want to play. I think our own documents are different.
MR. GELLMAN: Can I respond to that? I don't want to see us making deliberations and decisions on the basis of documents that aren't public.
If it means that we can't see the documents, that is fine with me. It is simply going to be another piece of procedural evidence that the decisions and deliberations and hearings conducted by this committee are unfair.
MS. GREENBERG: Again, to some degree, we may have a semantic issue. As I told you earlier in the week, Betsy Humphries told me they were the only real issues anyway.
Let me give you an example of what I would see the scope of this covering.
We have implementation teams. We have some people who are working on this area, as well as on all the other areas.
They -- one or more of them -- might draft something. The members of the committee, or at least a few members of the committee, have actually been the liaison to those implementation teams.
They review this document at the same time that the other members of the team do. Then it goes up to the infrastructure team.
What this individual -- well-meaning, but in any event, individual -- may have drafted may have absolutely no support, as it turns out, in the other members of the team. It just may not reflect anything that policy is being made on because it is rejected as something they don't want to put forward through the process.
If you are talking about documents that the committee has access to, you are including documents at that level, which I don't know whether that sheds light or it adds smoke to the issue.
They go well beyond being pre-decisional. They are just kind of floaters, developmental, and haven't got anybody's imprimatur, let alone the Secretary's.
On the other hand, as special government employees and as partners with the department in the HIPAA area, I think they have felt there has been some benefit.
Frankly, we haven't done this as much in the past, but I think everyone has said this has been of real value in the HIPAA process.
There has been some benefit in getting it, whether it is John or whoever it is. It is probably not all the members; it is a few members who are particularly liaising with those implementation teams, to get their input into it. There are e mail exchanges, et cetera.
I don't know whether -- I am not sure whether those documents would qualify under the Freedom of Information Act or not. I realize that it is a complex matter.
On the other hand, generally you don't -- something that might possibly qualify usually isn't the standard for just making things available.
I think you have to look at is this really going to be beneficial. Is it really going to add more sunshine or is it going to add less sunshine.
If a document goes out and it has a life of its own, the fact that it never made it past the first level supervisor or the second level supervisor gets lost. I mean, it is out there floating around.
I think just forgetting about secrecy versus openness, I think we have to look at what is of value. It may be at a higher level than the level I just described, but that is the level at which committee members have access.
MR. GELLMAN: Can I respond to that? That is the usual bureaucratic defense of secrecy. God forbid if anyone should find out what we are doing or what we are thinking about.
The things we are talking about do not involve classified information. They do not involve details of personal lives. They do not involve trade secrets.
This is purely a public policy issue and choice. There is nothing particular sensitive about it. It is not like we are dealing here with a department where all the documents are really kept secret.
Documents leak out of here all the time, just like every other government agency. We are not dealing with stuff that is some highly protected secret that people are going to be fired for releasing.
As a matter of fact, any document we are likely to see is going to be available from other sources without any trouble by any good reporter or anyone who has got a source in the department, without any problems.
Why don't we just accept the reality of this and operate under sunshine, so that our hearings and our activities in this area can't be questioned.
DR. DETMER: Other comments or questions?
DR. STARFIELD: Can I just ask one question?
DR. DETMER: Sure.
DR. STARFIELD: What kind of information would be helpful? We are having public hearings. The hearings will be public. What kind of information do you think would be helpful to people?
MR. GELLMAN: Any documents that are being circulated within the committee, or given to the committee, that relate to this subject ought to be made public.
They have a bearing on this issue and it all ought to be public, whether it is a department document or a committee document.
I don't know what those documents might be but I don't see any reason, I don't see any justification for any degree of secrecy in this area.
MS. FYFFE: I am really torn over this issue because, in theory I agree with you all. In practice -- and I am a highly pragmatic person. I think it would be troublesome for the operations of the committee and the government, HHS.
DR. HARDING: I agree exactly with what you said. The only problem that I see -- not the only problem, one of the problems that I see is the perception of this being such a critical issue, and what are they hiding; that concern.
Nothing? Well, then why is it all that way? Because of administrative issues? It is explainable, but the perception will be difficult, of the people who are already very anxious and suspicious, that something is being pulled off here somehow.
Immigration, Aryan Nation, all those people extrapolate that a unique patient identifier will be used for things far beyond what Bob was talking about yesterday, I think.
They are watching with that suspicion. Just to open it up may not solve that problem of their suspicion, unfortunately, but I think it would be a better product in the end, even though it would be more of a hassle in the meantime, and it would be a hassle because of the leaks and so forth.
MR. SCANLON: Well, I agree with Richard. That is why there is a need for this committee to play a central role as open public process. That is why we are asking the committee to hold hearings.
Where possible, there would be documents in advance for everyone who attends the hearings or is aware of the hearings to respond to.
As a practical matter -- I am certain I speak for the leadership of the department -- you simply would not begin to see -- you simply would not begin to see -- as a very practical matter.
Federal agencies -- I think this is a recognized authority on the part of federal agencies. You have to have a certain amount of time to develop something for your internal matters before you can even present it to a decision maker for any sort of a reading.
The idea that you would share such material, no matter how you might characterize the options or the impact, before the next decision maker has even had a chance to see it, I think the practical effect -- whatever the theoretical effect -- the practical effect is that you simply won't see much of this until it is ready for everyone to see.
That is a way to proceed. The committee could decide that anything it has prepared is a public document as well.
Certainly from the point of view of government documents, pre-decisional material, I think the practical impact would be what I suggested.
DR. DETMER: I think we have clearly gotten this on the table.
MS. FRAWLEY: I just want to remind everyone, because we tend to lose focus, I have just appointed myself to bring the folks back.
The motion that is before this committee right now is whether or not we want to recommend that pre-decisional material that we have no authority over be made available to the public.
We keep mixing up our discussion about wanting to make sure the public is well informed. The point is the motion is about pre-decisional document.
We can go then on a second motion or a third motion to talk about other issues. The issue before us now is pre-decisional documents.
So, we can talk about hearings. We can talk about being open and inclusive, sunshine, rain, thunder storms, whatever. The bottom line is the motion is on pre-decisional documents. So, I move the question.
MS. GREENBERG: Pre-decisional documents provided by the department.
MS. FRAWLEY: Correct.
DR. DETMER: So, the question has been moved. The way it was stated is that they would become available, the way the motion is set up. So, if you voted yes, it would be that all pre-decisional documents would become available.
DR. HARDING: I thought it was the request that they be made available.
MR. GELLMAN: No, the motion is that these documents would be made available to the public at the same time we get them.
DR. DETMER: All in favor of the motion say yes.
[One voice heard in the affirmative.]
DR. DETMER: Against it say no.
[Voices heard in the negative.]
DR. DETMER: Abstentions?
[One voice heard in abstention.]
DR. DETMER: Okay, it is defeated. Now we talk about the second part, which would be the committee-generated documents.
MR. GELLMAN: Yes.
DR. DETMER: That is open for discussion.
DR. LUMPKIN: I think that there is some foundation for the request. My concern is that -- I am concerned that I as a committee member may develop a document, or Simon may develop a document, for a work group, or a subcommittee.
In that document, Simon pulls a Bulworth and it gets released to the public, and it reflects upon the whole committee.
I think that I would be comfortable with a process whereby, if it came to a work group and it was approved by the work group to go to the full committee, that on this issue we would release it, and that we would charge the executive committee to come up with a procedure for that.
I am just uncomfortable with giving the imprimatur of the NCVHS to a document that really has gone under no scrutiny and no review.
DR. DETMER: Other comments? Did you have your hand up, Simon?
DR. COHN: I was, first of all, impressed that John had thrown the word Bulworth into the vocabulary. It has now entered our terminology.
I think, like John, I think I am wrestling with this issue. Certainly an early document, I think, should not necessarily be up for comment. Yet, I do think we should bend over backward in this area to provide everything we have for public view.
I am just trying to decide whether, if something is past the subcommittee approval, generally are we feeling good enough about that document to expose it for public decision?
That is really the only question I have. I would think probably the answer is yes.
MR. GELLMAN: Can I respond to that?
DR. DETMER: Sure.
MR. GELLMAN: That is all very nice, but you either operate under openness or you don't. If you have a policy that only things that have been approved by the subcommittee are available, it is a subterfuge.
It is very easy to just have documents and pass them around and just not bring them up for approval, and just everybody gets to see them and you avoid the rule. This is what agency does all the time. You write a set of openness rules and they look for loopholes and they find ways to hide documents.
This is just creating that kind of loophole. So, nothing will ever become available unless it has already been voted on. Once it has been voted on, it is already public, so it doesn't really make any difference. This distinction makes no difference.
DR. DETMER: Bob, I guess I have one question. What keeps any member of the committee, then, throwing anything out and saying it is a committee document.
MR. GELLMAN: No one has the right to say something is a committee document. There is nothing in this motion about that.
If I circulate a document with my name on it, it has got my name on it. There is nothing to stop you from saying, this is Gellman's document. We haven't seen it; we haven't approved it; we haven't voted on it. That is absolutely perfectly legitimate.
MS. FYFFE: I hope I am not confused here. Is what you are suggesting that, if you have a document that is in draft form for discussion purposes, to be considered by a subcommittee or work group; that at that point it be made available to the public?
DR. DETMER: Bob is saying that any document that is under discussion by the committee or a subcommittee or a work group would be publicly available. I think that is what you are arguing in your motion, aren't you?
MR. GELLMAN: I am just looking at the text.
MR. BLAIR: Bob, would you read the text of two and three again for me?
MR. GELLMAN: Yes. I move that all NCVHS committee and subcommittee documents that address the subject of the unique patient identifier, or that relate to any committee or subcommittee activities about the unique patient identifier, be exempt from the secrecy rules for documents in the committee's ground rules, and that these documents be made available to the public at the same time they are circulated to members of the committee or any of its subcommittee.
MS. GREENBERG: I can hear again -- do you want to hear, again, what those guidelines are?
MS. FYFFE: Yes.
MS. GREENBERG: This is now number two, because number one was departmental documents. All committee or subcommittee documents that have not been approved by the full committee and transmitted to the department should not be shared or discussed with anyone who is not a member of the committee or staff to the committee.
This includes documents being prepared by a contractor.
Requests for pre-decisional NCVHS documents should be referred to the executive secretary. That is two.
Three is, a good rule of thumb is that a departmental or committee document can be freely shared and discussed as soon as it appears on the HHS data council or NCVHS home page.
Requesters should be referred, to the extent possible, to these web sites for documents.
MS. FYFFE: I don't necessarily see the harm in allowing a document that I have been asked to prepare -- let's say Simon gives me an assignment.
I write a memo on that assignment to the computerized patient record work group. If I put a stamp on it that says, tentative and preliminary, for discussion purposes only, I don't particularly see the harm in that type of thing being released.
DR. DETMER: His motion is actually unique identifier issue. I mean, it is not even all of our work.
MR. GELLMAN: It is very narrowly focused. I am only talking about patient identifiers. Other subjects may be the subject of another motion.
DR. DETMER: You are talking about something for a unique identifier document, is what we are talking about.
DR. LUMPKIN: I think we may be dealing with a fine point. If there is a document that is being prepared for a subcommittee on the unique identifier, does that document show up on the committee's web page?
If the document shows up on the committee's web page, then it appears to have the approval of the committee, whether you put draft on it or not.
That is different than allowing committee members, on this particular issue, to circulate over their own name these same documents which, under our rules, would not be allowed.
On this particular issue, I guess I wouldn't have a problem with it. If you were preparing a document or so on, and you gave it to someone, which is different than us putting it on our web page, sending it out as a mailing to the committee --
MS. FYFFE: Guess what? E mails to each other. That is an example, are the e mails that we send to one another.
DR. LUMPKIN: If I happen to send an e mail and I thought it was in that context, e mails I have a problem with.
MS. GREENBERG: How else would you make it available if not on the web site? What are you thinking about?
If this passed, wouldn't the logical thing be -- just a point of question -- to put these documents all on the web site?
MR. GELLMAN: Which documents?
MS. GREENBERG: The ones you would want to be exempt from this.
MR. GELLMAN: Of course. That would probably be a legal requirement under FOIA.
DR. LUMPKIN: Can I hear the motion again? I think I have an amendment.
MR. GELLMAN: I move that all NCVHS committee and subcommittee documents that address the subject of the unique patient identifier, or that relate to any committee or subcommittee activities about the unique patient identifier be exempt from the secrecy rules for documents contained in the committee's ground rules -- skip the cross reference -- and that these documents be made available to the public at the same time they are circulated to members of the committee or any of its subcommittees.
DR. LUMPKIN: First of all, I object to the word secrecy. That is not the function of these rules. So, I would have trouble voting for that motion, even if I agreed with most of the principles.
Second, I believe that if we do release documents, those documents should have been at least approved by one of the bodies of this committee, be it a work group or a subcommittee. I guess I will vote against this.
MR. BLAIR: Do you think we could modify the word secrecy? Do you think you could accommodate what John has said. It seems that it is reaching awful close to what your statement says.
MR. GELLMAN: No, I don't think so. I think what John said is the current rule. It has got to be approved first.
MR. BLAIR: He went all the way down to a work group level.
DR. LUMPKIN: Our rules say they have to be transmitted to the Secretary before they are released. I would step back, before it gets to the full committee, after it has had some review by somebody, which would be a work group or a subcommittee.
MR. GELLMAN: I appreciate that, but I don't agree. Documents are public or they are not. I think all the documents in this area, whatever level, should be public.
MR. BLAIR: Could you clarify for me whether our subcommittees or work group level deliberations -- like for example on Monday when the subcommittee on data standards, which also included within that a subgroup on CPR, was that all transmitted over the internet?
MS. GREENBERG: Yes.
MR. BLAIR: So, it is all public now?
MS. GREENBERG: Meetings are. All of the meetings are.
MR. BLAIR: All the meetings are public?
MS. GREENBERG: Yes.
MR. BLAIR: Literally, during that time, we virtually are reading the documents out loud, because I am here, sometimes.
I feel like that is going an awful long way toward addressing your concern. If I may, I would like to use the word confidentiality rather than secrecy, because I think it is more appropriate.
DR. HARDING: Just a point of information. If somebody walked in and said, due to the Freedom of Information Act, I would like to see the memo that was written by Kathleen, can they get that? Can they only get things that are documents of the HHS?
What is the level at which somebody could walk in and say, I would like to see it, under the Freedom of Information Act? Does anybody see it?
MR. SCANLON: Well, the Freedom of Information Act is treated individually. In the case of a committee member writing to another committee member?
MR. GELLMAN: If the document is within the possession of the agency, possession or control is the general standard used under the Freedom of Information Act.
If I send you a document, Richard, it can't be obtained under the Freedom of Information Act, unless I send a copy to Jim.
In that case, he has got a copy of it. It can be requested and it would likely be disclosed. It would, of course, depend on the contents of it. It would depend.
MR. SCANLON: Each of these is evaluated as a separate request and it would depend on the circumstances.
DR. COHN: I have a point of information also. That has to do with what we mean by document, in the context of all of this. I am just trying, in my own mind, to make a clear distinction between what is a document versus what is an e mail.
Is the intent of this is that every e mail sent in relationship to this gets posted to our web site and becomes a public document? Am I missing the point here?
MR. GELLMAN: No, I think it is a very nice question and I would address it to whoever wrote this policy in the first place, which doesn't say, if I send you an e mail and you pass it along to your assistant or to somebody else to get a comment, have you violated the committee's rules?
It depends on whether e mail is a document. I didn't write this policy. I don't know what a document is.
DR. COHN: I don't think I can make a decision. I can't vote on this one today. I think there are some important issues that are being brought up. I would like a chance to see physically the rules that this is pertaining to and think about it a little bit more.
I guess I am proposing that we table this until the next meeting of the committee.
DR. DETMER: It is a privileged motion. Jeff, did you want to comment on that?
MR. BLAIR: Actually, I wanted to offer a friendly amendment to it. I am trying to synthesize a little bit what I am hearing John Lumpkin saying, as well as -- Bob, I think you are bringing forth to us concerns that exist in the public from certain special interest groups that have very high sensitivity on this subject area.
They are real and it would probably help this committee if we could avoid some of the fear and anxiety that some of these groups may have on this subject.
How far can we go to reasonably address their concerns? In some cases, I think there are things we could do to do it.
I don't think we could go to the point where we could defend ourselves against paranoia. So, what could we reasonably do to go the extra mile to try to be as open as possible.
If you would allow a friendly amendment on this, to indicate that documents that have been approved two levels down, as John Lumpkin was saying -- in other words, if a work group has voted to approve -- that is two levels out.
There is the full committee, the subcommittee and then there is the work groups. If a work group has approved a document, that document approved by a work group could be made available to the public, I probably could accept that.
I don't know -- I would hope that maybe you would feel comfortable with that?
DR. DETMER: Unfortunately, right now we have a motion to table.
MR. GELLMAN: Can I just respond? I appreciate it. It is still inconsistent with the spirit and purpose of my proposal.
DR. LUMPKIN: I think we should vote on the motion to table.
DR. DETMER: There is a motion before us to table this matter. Is there further discussion?
DR. HARDING: Point of information. What does that mean, then, if we tabled it? It would be taken off the table at the next meeting of the full committee?
DR. DETMER: That would require a motion to bring it back at a time specific. Right now it would be tabled, period.
DR. LUMPKIN: No, the motion was to postpone -- it was postponed definitely to the next meeting, and that documents would be prepared that would give us more background.
DR. DETMER: I missed that. You said the next meeting?
MS. FYFFE: Yes.
DR. DETMER: I am sorry; I am glad you asked.
MS. FYFFE: With information being provided to us so that we can better understand.
DR. DETMER: About policies and procedures that relate to this.
DR. LUMPKIN: If the motion to postpone indefinitely would pass, I would certainly urge the executive committee to review it and come back with the background material and proposal.
DR. COHN: Do you want to amend that, that the executive committee actually be charged to look at this and report back at the next meeting on this?
MR. GELLMAN: Gosh, I don't know. I guess I should look at you for that one.
DR. LUMPKIN: I think the executive committee knows that this is an important issue. Without this motion, certainly the executive committee, I would hope, would take it up and, when we bring this motion up, perhaps have an alternative.
DR. COHN: I don't think that requires a separate motion.
DR. STARFIELD: What are we looking for? What other kind of information are we looking for, that would help us deal with it?
DR. DETMER: What are you wanting us to do?
MR. GELLMAN: I guess I would like to see in front of me the actual rules, the proposal for the modification. I would actually personally like to see a legal review of what the ramifications are, for example, what does the document really mean.
Things like this make it impossible for me to vote on this. I was actually hoping to have it reviewed also by my own legal staff, actually.
MS. GREENBERG: A point of information. I believe that under the Freedom of Information Act, e mails are considered documents.
We have been told, don't put anything in an e mail that you wouldn't have released.
DR. DETMER: That is the kind of thing that you would like to know about; is that what you are saying?
DR. COHN: Yes, and if there were some other proposals, that would be great.
DR. HARDING: Can he let his legal counsel look at that?
DR. DETMER: That is an interesting question. We don't have anything yet.
MS. GREENBERG: What is the legal counsel going to look at?
DR. HARDING: It seems that is against the policy. It gets boggling.
MR. GELLMAN: I want to support Simon's right to have an attorney.
DR. HARDING: In fact, Bob is available. [Laughter.]
DR. DETMER: What is in front of us?
MS. FRAWLEY: What is in front of us is a motion to table. The executive committee has been directed to prepare information to present to the full committee at the meeting in September on the issue as to what constitutes a document, the implications of FOIA requests for documents prepared by the subcommittee or full committee, and that that should be brought before the committee at its September meeting. That is the motion that we have, in essence, before us.
DR. DETMER: Okay, more discussion before we consider that? I think one of the key things, obviously, that is worth pointing out is that we are talking about a hearing in July, which clearly, I think, ought to be a matter on the table and understood, before we vote.
DR. STARFIELD: May I speak against tabling it? I just hate to be distracted and run around in circles where I don't really see any outcome that is going to be helpful to us. I am going to vote against tabling it.
DR. DETMER: Any other discussion?
Okay, all in favor of tabling, raise your hand?
[Five hands raised in favor.]
DR. DETMER: Five, tabling. Opposed?
[Three hands raised in opposition.]
DR. DETMER: Abstentions?
[One hand raised in abstention.]
DR. DETMER: The results?
MS. GREENBERG: Five to table, three not to table, and one abstention.
DR. DETMER: So, it is tabled. Then I guess the executive committee will take this up and get back.
MR. GELLMAN: Mr. Chairman, may I have a minute for a statement? I think it is perfectly clear, from what has gone on in the last two days, that these hearings are quite important and there is broad public interest and there is likely to be a lot of public attention to what we do, much moreso than anything we have ever dealt with.
There are lots of affected individuals and interest groups that go far beyond the ordinary organizations we hear from routinely.
One question that is going to come up -- and I don't expect it to be resolved immediately -- how many hearings do we have to hold to accommodate public demand and to hear from an adequate selection of points of view.
I have given the staff a list of 40 names of people and organizations who may be interested in the privacy implications.
DR. DETMER: Do you mean four or 40?
MR. GELLMAN: Forty. It is not a complete list, but it is a good start. Certainly not all of these groups will want to be heard. Some of them may be combined. There are going to be some common views.
I think it ought to be an open question, how many hearings we need to hold. I don't have an answer to that and we have to wait and see on that.
I want to put the committee on notice -- and I think I have already done that -- that the conduct of these hearings -- the conduct of the hearings -- is likely to be an issue in the future.
I may ask for more hearings, if necessary, and I will certainly resist any rush to judgement. I want to make it clear, however, that that is what we have already decided, to rush ahead with the hearings in an aura of secrecy, and if the hearings end prematurely as well, then it will simply provide more evidence of a hasty and potentially unfair process, and I expect that these procedural points that we have debated these last two days and refused to deal with, are going to become major issues. Thank you.
DR. DETMER: Does anyone else wish to make a comment? Do we have any other items pertaining to the unique identifier?
DR. STARFIELD: I have one. I have a lot of concern that we have 44 questions for those hearings and most of them are directed at the industry.
It is my intent to talk to John about that, but I hope that we can pare down questions and make them more publicly relevant and industry relevant at this stage.
DR. DETMER: Other comments?
Okay, we have a couple of quick items here. Are there agenda items, other agenda items?
MS. GREENBERG: One thought. This is a single decision, not a global one. What about putting all the questions that are being considered up on the web site and ask for welcome comments and other questions that might be considered, the groups that are being considered and ask for input for that?
Again, our web site may not be a household web site. I don't see any objection to that and certainly, right now, otherwise, we are not going to really discuss this.
This has been tabled until after the first hearing. Would that be of benefit, do you think?
MR. GELLMAN: I think it is a lovely thought and it violates the existing rule. I don't object to it, but I am just telling you, that is what the existing rule says. You can't do it.
It is all right with me if you do it anyway, but I am telling you that it violates the rule. If you want to establish a precedent to violate the rule, that is okay with me. Do it.
DR. DETMER: Is that a motion?
MS. GREENBERG: I can't make a motion.
DR. DETMER: Someone else could, if they chose to.
MS. GREENBERG: The requests for pre-decisional documents should be referred to the executive secretary. You can refer this to me and I can say yes.
DR. DETMER: Does anyone want to move referring that to our secretary?
DR. COHN: So move.
MR. BLAIR: Second.
DR. DETMER: It has been moved and seconded that this be forwarded to our executive secretary to make a decision.
MR. GELLMAN: Point of order. Is there a quorum present?
MS. GREENBERG: There isn't, now that John has gone.
DR. DETMER: All right, we will have to do a poll vote or we can't consider the question. Do you want to send it out by e mail? We will send the poll out by e mail on the question.
MS. GREENBERG: The question being whether releasing or putting these documents on the web site should be referred to me.
DR. STARFIELD: The questions.
MS. GREENBERG: Even proposed -- well, the white paper yes, when it is available. We were going to do that anyway. Ideas of groups and panels that are being planned for the first hearing.
DR. DETMER: It is your decision if it passes the group. Are there other agenda items that we want to have in our next meeting that people already know about, a distant, early warning.
MS. GREENBERG: I can just tell you what has been laid out. A major thing which had been deferred from this meeting, at the last meeting we had a panel on the quality of data, or looking at the quality of care, and then we were going to actually have a panel on data issues related to measuring quality of care.
We deferred that for the new work group to get started. I guess, depending on how much work that work group has accomplished in the next month and a half -- which may be a little difficult -- we could either have that at the September meeting -- we would need the work group to help us put that together.
I guess that can be discussed at the executive subcommittee meeting, but if people have thoughts about whether we need to have -- whether we should be having something for the full committee in September on this issue on quality of care and data issues related to quality of care.
Another one is, we deferred a report to the full committee on ICD-10-CM and ICD-10-PCS, because the comment period will just be ending and the results and the pilot test wouldn't be ready by this meeting. We deferred that to the September meeting.
I have something down here about public education, but I am not quite sure what. I think it is a concern of the executive subcommittee, but we had felt that there haven't really been sufficient resources to expand in that area.
Another thing that I think would be very helpful input to the executive subcommittee in its meeting in July -- because one of the main purposes will be to plan the September meeting and maybe even some preliminary planning for the November meeting -- would be thinking about how you would feel -- particularly the chairs of the subcommittees will be at that meeting, the executive subcommittee meetings, but the chairs of the work groups won't necessarily be there; in a few cases they might be because of their membership.
How you would like to see the full committee meetings structured, in light of these new groups and the overlapping membership in these groups.
I know John and I have briefly talked about, maybe only a day and a half for full committee deliberations, so that you could have more time for these different groups to be meeting and people who want to participate to do so.
That would reduce the number of presentations we would have before the full committee. It would probably have to cut back the full committee really more to just getting reports from the work groups and subcommittees, et cetera.
DR. FRIEDMAN: Marjorie, at some point, I would like to hear a presentation on the surveillance and data systems objectives for the Healthy People 2010. I think that really cuts across the full committee.
DR. COHN: Marjorie I was just going to, I think, remind you that we had asked, after you looked at the membership of the new subcommittee and work groups, to propose a way of -- how they should meet in a way that there is minimal overlap, so people could attend these.
That may help us figure out some of the ways that it ought to happen.
MS. GREENBERG: What I will do is, we will send out what I have signed up here for everybody. Then, as I said, add and subtract.
It is a pretty quick turn around, I think. Probably the only person that we won't ask to commit is our new member.
I think it would be a little premature when he hasn't even attended a meeting, to force him to commit. We have never done that with anyone. He may want to.
MS. FYFFE: Send him an e mail right away.
DR. DETMER: Relative to that, I wonder, in fact, whether -- I think clearly some of us use e mail a lot more than others do.
MS. GREENBERG: I was going to send it on e mail.
DR. DETMER: I think it would be really useful if either e mail, fax, we could get feedback back.
We may even have to go to conference call mentality periodically, too, on some of these things when we go as far as we do between meetings and have, as this meeting showed, very complex levels of new considerations coming to us.
I just don't know that we are going to be able to put more time on the subcommittees and cut down the full committee and get the work done.
MS. FYFFE: I agree. If we can increase our effectiveness by having interim conference calls, I would encourage us to do that. Half my life is conference calls right now. I can add a few more.
DR. DETMER: I don't know how the rest of you see it. It just worries me. I don't want to see us not do a decent job in what we are trying to do.
MS. GREENBERG: I do think one issue is, if conference calls become almost a substitute for subcommittee or work group meetings, we are going to have to have some accommodation for the public to be able to participate.
That can be done under a FACA, but they have to usually let you know so that you can get the right number of lines or something, and there is a maximum number of lines.
I would not want to see the committee operating less in sunshine because they are not meeting.
DR. DETMER: We can maybe consider that when we re-look at where we are on this other issue. Any other issues? I don't think the calendar issues, I don't think you need to run through them. Do you have questions about any?
MS. GREENBERG: No, but I think we should start identifying -- not now, but maybe through e mail or something -- identifying dates for 1999.
MS. ARAKI: I think the next meeting is when David is going to -- I think we can actually start polling. He actually said he is going to join the subcommittee on populations.
MS. GREENBERG: Good. If we know that, that is fine.
DR. DETMER: Okay, is there a motion to adjourn?
DR. STARFIELD: So move.
MS. FYFFE: Second.
DR. DETMER: Okay, all in favor, say aye?
[Voices heard in the affirmative.]
DR. DETMER: Thank you. Thanks very much to staff. There was a lot of work and they really responded wonderfully.
[Whereupon, at 4:37 p.m., the meeting was adjourned.]