Room 505A
Hubert H. Humphrey Building
200
Independence Avenue, S.W.
Washington, D.C. 20201
Opening Remarks and Introductions
Review/approve Work Plan Section I-III
Update from G-CPR Project Team
Simon Cohn
Jeffrey Blair
Don Detmer
Kathleen Fyffe
Michael
Fitzmaurice
Robert Mayes
William Braithwaite
James Garvie
Mel Greberman
Rob Kolodner
James Scanlon
Richard
Ferrans
John Lumpkin
Hellene Gilfoy
DR. COHN: Okay, why don’t we get started here in just a second, so if everyone could get seated. We’ll start with introductions.
I want to welcome everyone to the second meeting of the Work Group on Computer-Based Patient Records. I think what we will do is start out with introductions, first around the table and then everyone else who is in the room, and then we will begin to talk about the agenda and how we intend to get things done in a reasonable time frame after that.
So with that, my name is Simon Cohn, I am the co-chair of the Work Group.
MR. BLAIR: Jeff Blair, I am the other co-chair of the Work Group.
MR. SCANLON: I am Jim Scanlon from HHS. I am staff to the full committee.
DR. KOLODNER: Rob Kolodner from the Department of Veteran’s Affairs, one of the staff to the committee.
DR. FERRANS: Richard Ferrans from the LSU Medical Center and the VA in New Orleans. Also staff to the committee.
MR. GARVIE: Jim Garvie with the Indian Health Service, also staff to the committee.
DR. BRAITHWAITE: Bill Braithwaite of CDC and ASPE, also staff to the committee.
MR. MAYES: Bob Mayes, Health Care Financing Administration, co-meet staff to the committee/work group.
MS. FYFFE: Kathleen Fyffe, member of the committee. I am with the Health Insurance Association of America.
DR. LUMPKIN: John Lumpkin, Illinois Department of Public Health, and I think I am visiting or something.
DR. COHN: I guess ex officio member of the committee. Isn’t that how that works?
DR. LUMPKIN: Member of the committee.
DR. COHN: Others in the audience, please.
[Audience introductions are made.]
I guess based on the discussion this morning first of all we should comment that we do have a bare quorum for this work group so we are thankful for that. I also want to thank the staff support for joining us for the session here. It seems sort of a big table.
Also in reference to this morning, does anyone not have a copy of the draft Work Plan? And Mel, did you introduce --
DR. GREBERMAN: I am Mel Greberman from FDA Center for [unintelligible].
DR. COHN: Okay, thank you. Okay, there is agenda or copy of the Work Plan. Is there anyone in the audience who does not have a copy of the work plan? Okay, I think we have copies to distribute. If you want to take one. And I apologize, we do not have copies of the agenda that I know of.
Let me just review the agenda for the moment so that we sort of know the playing field and know how we are going to progress. Sort of the objective today is first of all, to review and approve with whatever changes we need to make, the Work Plan. And to do that we are going to first of all discuss Sections I through III, hopefully coming to resolution on those pieces, which we have seen before at previous meetings.
At that point we will, I will not say quite break(?), but we will at that point have a discussion and presentation on the current status of G-CPR, with the topic being how potentially can we work together and begin to leverage all of our activities to get things done? And then we will proceed with that discussion as we move into talking about Sections IV through VI of the Work Plan.
As soon as we are done with that we are really going to start moving down a couple levels of granularity and talk about really what it is we need to do over the next two, four, six months, specifically around hearings, panels, other information gathering, research activities or otherwise, to begin to make some progress in this area. And then as we need we will continue the discussion along tomorrow morning, recognizing I think we have already decided we will need to have some session tomorrow morning which will probably include whatever we do not get done today and integration into the overall subcommittee Work Plan so we can sort of figure out how our work relates to the overall subcommittee charge and make sure we get things working reasonably for the next six to eight months.
Now, having said all that, is there anything else that we need to cover that we are not discussing here?
[No response.]
Okay, well, with that I think we should get into looking at the Work Plan. Now, I would just sort of comment that recognizing the length of time we had to review this, this is not an exercise in word smithing. I am also expecting that most of you will have seen this. We are not going to sit down and read it for you out loud. But we are going to try to pull out substantive issues to discuss, so if there are other areas that you have noticed, please speak up.
[Question about dates on draft Work Plan.]
I think that all of these are the same whether it says September 9, September 14 or 11, we believe all of these to be the same, since it was actually all sent out at the end of August to all work group members.
Let’s just ask first of all, just generally going from I to II to III, are there any comments about bulleted item number 1 which is just the introduction, lists out the provisions in the HIPAA legislation related to what we are trying to do.
DR. FITZMAURICE: Simon, I would like just to comment, I thought it was very straightforward and brief, just what it should be. It does not charge us to do more than Congress charges us to do.
DR. COHN: Okay. Item Number 2, I guess I am hearing that there is no significant comment on #1. I do not think there really should be. It is really per the legislation.
Bullet Number 2 has to do with the vision of computer-based patient records which we had identified at the last meeting that we needed to have an articulation of what we perceived to be our vision, which is Item A. It is drawn from the IOM report and we should just all look it over.
And then we will spend a little more time talking about Item B which I think is really more of substance and really more what we are really going to need to begin to talk about and get into.
Okay, are there any comments about Item A, which is the vision as currently stated?
[No response.]
Good.
DR. FERRANS: Simon, I do have a comment regarding this. Although this, I agree with the definition that is stated in the vision of computer-based patient records, I think part of the, how we can sort of take this vision and look at the mandate as far as --
DR. COHN: A little louder.
DR. FERRANS: I think the part that is missing here is the interoperability part, and I think that whereas many computerized patient record systems perhaps will meet these criteria within a particular organization, within a particular group, they may not be able to exchange clinical information, and that is the shortcoming, the dilemma that we are trying to examine. And so that sort of builds in to be about comparable information.
DR. COHN: Okay, well, let’s take a look. Actually, I think you may be right that it perhaps needs to be referenced in A. But maybe that begins to fit into this Item B which is called Requirements for Comparable Patient Medical Record Information. And I do not know whether it is requirements for or a value proposition about. I think it is some sort of combination.
But the, this is really the discussion which has to do with issues of, I mean, what sort of use cases, what is it that we need to do around comparable patient medical record information? Recognizing that this work group, even though it is called the CPR Work Group, I think as we are seeing our charge at this point -- and I am looking at everybody to see, make sure, maybe see if we do all see our charge the same way -- we see sort of in our vision of CPR, but sort of the way we are going to get there is with slow, steady steps related to comparable patient medical record information and requirements about that. Kathleen?
MS. FYFFE: Could you explain what you mean by comparable, and maybe expand this with some comments, because I am not sure what comparable patient medical record information means. What are we comparing?
DR. COHN: Well, do you want to give a try to answer that to begin with?
MS. FYFFE: Well, are we talking about various lab systems, comparing one against another? Or, are we talking about comparing lab systems to radiology systems? Or, are we talking about both of those dimensions? Or, is it something else? I am just trying to get a grasp on what you mean by this because I do not, I mean, this really leaves a lot open to interpretation.
DR. COHN: Bob?
MR. MAYES: I can give you some thoughts on this -- Bob Mayes -- on how I look at it, and I think there might be some others that have similar opinions. What we are looking at here basically is the idea of, let me back up, if you do not need to share information you do not need a standard, because any way you decide to do it is a standard if you are the only person using a particular piece of information. The more broadly that one needs to be able to share information and to have others act upon that information in a consistent way or in a way consistent with why, with the reason you are sharing that information, the more useful a standard becomes.
So, in my reading of this, comparable information has to do more with the types of information that are needed by more than one organization or individual to provide services. Comparable is probably not the way, not the exact term I would use but in other words, I need to give you information to provide services so that you can provide services that are in line with what is needed by a particular individual’s health care or group, and so we need to have comparable data, comparable information. If I send you this information in such a way that you can either not interpret it at all or that you would interpret it differently based on how I sent it to you, then we have a problem here. Then we are not really solving a business problem which is to share information so that we can reach a common goal. That is sort of the way I look at the way of comparable.
MR. BLAIR: Kathleen, why don’t I kind of give you a little bit of a history of how the word evolved when Simon and I were pulling together the Work Plan a little bit.
We did not have a Section II at first on, I guess it was Version V or IV, and Simon was pointing out that we needed to wind up articulating a little bit better to bridge between the phrase in the law, uniform data standards for patient medical record information, and what many of us began to look at those words and wind up saying, gee whiz, when I think of patient medical record information I tend to think of a computer-based patient record system.
So, as we were, you know, having the discussion and trying to grope around for clarification to make sure that we all had the same vision and drum to march to, we began to think of the idea of not only comparable medical record information but the requirements for medical record information that were uniform and standardized. And we evolved to one thought which was, do we need to have the same understanding of how specific or granular that information needs to be to be comparable? And we came to the conclusion that that was only one dimension of interoperability or comparability.
And so the thrust of this is to wind up maybe raising the issue a little bit of having some hearings before we start to go into the rest of the activities to get a feeling of how deep do we have to go during the next I guess it is about 18 months as we gather information to make our recommendations? How deep, how specific do we need to go to make information comparable?
And, Simon and I did not attempt to come up with our own answer for that. We just put this here kind of as a place holder to try to see if maybe one of the supporting activities which we are going to get to a little bit later might be able to start to address this problem a little more.
Simon, I do not know if I confused things or helped clarify things with that answer. Do you want to --
DR. COHN: No, I think you, I think we are all sort of agreeing that this is an area we need to know a little more on. Mike?
DR. FITZMAURICE: As I looked at it I had some thoughts. One thought is that, one way to look at it is the requirements for uniformity of patient medical record information. Why do we want uniformity? Because we compare things. And then there is a companion to that and that would be the requirements for the exchange of medical record information. And so it seems to me that we need information about both things, both what is the uniformity or how do we achieve uniformity of patient medical record information? And, how do we exchange that information? So, maybe B has two components or maybe there is a B and a C, one focuses on uniformity and so it probably gets into vocabulary and meanings. The other gets into how do we exchange it from one place to another place?
MR. BLAIR: Could I suggest this, if I might, see if you feel like this is okay. I want to get out of sequence a little bit here. We might want to come back to this thought of comparability or uniformity after we have looked at the items in Section III which are the activities because in a sense when Simon looked through those activity areas he wound up basically saying, well, what is our criteria to know how deep we need to go? And then we could come back and revisit that thought. What do you think of that, Simon? Does that make sense.
DR. COHN: It sounds fine to me. Other comments about this one before we -- yes?
MR. MAYES: I do not think comparability and uniformity are synonymous though.
DR. COHN: I am sitting here playing with that, too, and certainly exchange is a reason that you would have comparability or uniformity as opposed to being a separate issue, one of the reasons you would bother to have some uniformity. So I think it fits in that context.
But, having said that, what is your difference between uniformity and comparability?
MR. MAYES: Well, I think uniformity implies a singleness of implementation, if you will, I mean, a sort of, if something is uniform it is the same.
Something can be comparable without being the same. I mean, you can map between comparable information. It does not have to be, it does not have to be implemented in identical ways. I mean, I can use the codes, 123, and you can use the codes, NFU, as long as we understand that those are both, those are used in the same context to mean the same thing. They are comparable. However, they are not uniform.
And the only reason I bring that up is that we face the struggle as we try to put together the implementation guides for some very uniform standards under HIPAA in the transactions and those have proven to be a tremendous struggle. And we are talking there about very finite, very small in the scheme of things, sets of data. And to try to come up with a uniform computer-based health record might be seen as being a little overly ambitious.
DR. LUMPKIN: So, in other words, the three of you in the public health service in uniform are really not uniform but comparable since you are in whites and they are not.
[Laughter.]
PARTICIPANT: Maybe they are just contrastable.
DR. KOLODNER: I think Bob brought up this point that we are dealing with something that is very complex. And one way that we tend to deal with complexity is we try and put in rigid systems to define and control. And I think that there are other approaches, and we can look at the Web. There is an example where there are complex things that the best way to provide a way of sharing and communication is actually to keep it real simple and very basic and let the complexity kind of evolve and grow out of it.
So that what I think we are looking for is what one person talked to me about, a shared meaning. That we need to have that ability to understand the same things as we are looking at it. Sometimes we are having two different sodiums with two different methodologies and they are not exactly comparable, but we at least understand those meanings and how to use them in some sense. And that may be much more of what we are trying to do. It goes to the issue of how deep do we try and structure things, for example, which I am real hesitant if we start going too --
MR. MAYES: To maybe put it in linguistic terms, I mean, I sort of see uniformity as this intractable issue versus comparability which is more semantic, an issue of semantic management.
DR. COHN: I guess, to remind you, I think the real question here is where is the value? And I think the value proposition is what needs to drive us. This is an area unlike the other parts of HIPAA where it is not, we do not say things and they happen. We have to sell them in addition to agreeing upon them.
MR. MAYES: Which means that you have to get the largest constituency possible.
DR. COHN: Yes, I mean, there has to be clear value as opposed to rightness.
MR. MAYES: That’s right. Although God is on our side.
MS. FYFFE: So you are talking about the common denominator, is that --
MR. MAYES: No, I think in some respects it is a, I mean, to get back to what Rob was talking about about shared meaning, I mean, I think there is a nice phrase that the Australians have used in discussion of some of their efforts about justifiable prejudices at the implementation level. The deeper we go there are reasons why people implement things or syntaxes are different within different context.
And yet, there is a great deal of value that can still be added to a discussion if you raise the level of abstraction up. I mean, even if we were to only come to conclusions at the meaning level, at the definition level, about what we think a particular term or concept means, there is great value in that activity. It does not have to be driven all the way down into saying, you know, you shall always use this particular representation in every system. And so the issue is at what level of abstraction do we still retain some meaningfulness in the activity and yet can we gain the greatest consensus?
DR. FERRANS: Simon, I would just add to that that, you know, I think part of what Rob was trying to talk about about meaning was that if we can, if this can be approached from the standpoint of data, that the data or the clinical information will retain its meaning independent of the system upon which it resides, because I think that is one of the current dilemmas. So it is separating out that meaning and sort of making it absolute.
And what do we need in terms of whatever standards, and I agree with Mike that it has to, that this will involve some exchange standards and perhaps some other types of standards. There may be reference standards. There may be data model standards. And certainly this is going to be a collection of them.
I think, and the other comment is about the selling point. I think it is important for us to articulate, as you had mentioned before, the business case or what is the value of being able to have this meaning and this ability to exchange information and this ability to compare and even contrast clinical information? And I think that there are a variety of sources in the literature that have pieces of it and a lot of experts who know a lot of this, but it needs to be stated in a coherent manner.
DR. FITZMAURICE: Let me tell you what the value is in this for me, and what I mean by uniformity. If you doctors are taking care of me and things aren’t looking so good you might say, gee, it looks like he’s going south. You might say, oh, I think he is getting rather crumbly. You might say, oh, it doesn’t look good to me. I want you all to mean the same thing.
Now, if you are talking to each other face to face, you can convey that meaning in a lot of different words. If one of you is on the West Coast and the other is on the East Coast, I want you to be able to convey the same meaning about me by the exchange of information through a computer-based patient record. So what I mean is, uniformity of meaning, that you are describing me the same way so it gives you information on which to take action.
Now, if we are talking about different ways of doing sodium, then put in a baseline and deviations from the baseline and give me statistical significance. Give it some meaning so that in a computer-based patient record you can look at it and you can say, yep, he is rather crumbly. Yep, he is going south. Yep, it looks like things are sour here.
That is what adds value to me, is that you are communicating the same information about me that leads to good action.
DR. FERRANS: And perhaps that also means the portability part of HIPAA also is is information portable? Because currently in electronic format I do not believe that it is as a generality. So, if my employer changes managed care plans on me and that information is stored electronically what happens? Do I have to start over from scratch and is the value of that information lost because it cannot be compared, it cannot be exchanged in a proper fashion?
DR. COHN: Other, Rob --
MS. FYFFE: Yes, I am a bit frustrated because, let me paint a negative picture here. The law does not require that anybody do this so we have to be very persuasive to the hospitals and the physicians’ offices and clinics in this country that there is some benefit they are going to get out of doing this. It has to be more than an academic exercise. And, to make matters worse, there is less money now than there was before for data processing budgets and so forth.
So, I am really struggling to figure out the best way to try to come up with a persuasive argument in, you know, getting a hospital or a clinic or physician’s office to adopt this. And that is part of the business case but we really have to, you know, we have to come up with very, very persuasive arguments and reasons to have the health industry move in this direction and I, you know, unless we do that I think that our efforts are not going to be well spent.
DR. COHN: Thank you. Rob.
DR. KOLODNER: I agree with you. I think that the case needs to be made as a business case to the people who are going to have to initially pay for it. I think that a lot of what we have been doing is staying at a level of looking at one point at the insurers and another point at the providers, and I think we may be the advocates who have to talk about the patients. And that we are all going to be patients as well, but that it is in your interest as an individual to have your medical information at a level of detail where it is not just a series of diagnoses because, frankly the diagnoses are wrong because the medical knowledge is incomplete and what has been diagnosed as pneumonia or something else before Legionnaires disease was known was wrong, but the description, the clinical information at a more atomic level has meaning and retains meaning even as the diagnoses and the classifications change.
From a business point of view I think we can, in fact, make a good case to those who pay the bills that if I can get the information on you when you transfer into my plan and I have a continuity of that information, I can cut my costs in taking care of you. I can give you better care. And I think we are going to have to make both cases.
But the one to me that matters most is that from the individual’s point of view it is better for them. They get better care. They have continuity. As medical knowledge changes they can benefit from it. And that one of the problems is that in the classification or the coding, which is a very high level, we have already lost all sorts of detail and I do not benefit from that as medical knowledge changes. So, I think somehow I would like to see us capture something about that value.
DR. COHN: I do want to comment that without trying to solve this problem I think we are going to be able to get into the issue. And I think what we, I mean, be aware that it is not or, or, or. It is more and, and and and and. Because, I mean, I think we are all in agreement we need to make a persuasive business case and part of the business case may be the patient case, part of it may be the dollar case, part of it may be interoperability cases, I mean, but we need to begin to look at them and sort of come up with out of all of that where do we start and how does one proceed? Because we do not, you know, walk in tomorrow and proclaim that crumbly and sour are really the issues that we need to dwell on, I don’t think. And that is, you know, I think what begins to become the first part of work, to really get this a little tighter than we have it now.
Richard, it looks like you were going to say something.
DR. FERRANS: Well, I was also going to add that from the broad sort of policy perspective and from, and regarding the dollar standpoint, while I was driving home and listening, I guess it was to NPR last night and they were talking about the fact that health cost, health care spending was, they had predicted was going to go up significantly and that effectively the managed care portion of trying to contain costs had reached somewhat of a peak. And I think a lot of, there is a lot of agreement that the long-term savings is in outcomes, in improving outcomes. And there is an important business case to be made with regards to these records in terms of being able to measure outcomes, the use of decision support systems, and I know Clem is not here, but some of his work with regards to that and how it can change behavior and get people to focus on prevention behavior. I think we can, there is a case that can be built that this will assist in moving towards that outcomes-type scenario that we want.
DR. COHN: Other comments? Yes, Jim.
MR. GARVIE: I just have one question, Kathleen. Which aspect did you refer to as not being required by the law? Just so I better understand.
MS. FYFFE: Um . . .
DR. COHN: The whole section.
MS. FYFFE: Yes, all of it.
MR. GARVIE: This entire work group subject area?
MS. FYFFE: Well, the requirement of the law, as I understand it, is to give a report to Congress, okay, but there is, nowhere does it say you have to do it. It is not like the other part of administrative simplification where it has to be implemented.
DR. FITZMAURICE: What do you mean -- implementation is not enforced?
DR. COHN: It is not even required.
MS. FYFFE: Well, it is not even laid out.
PARTICIPANT: This is just recommendation.
MS. FYFFE: It is quite voluntary is what I am saying. And, okay, let me play the devil’s advocate. If I am a hospital administrator and I am spending 6 percent of my budget on data processing and related information technology, if somebody comes to me and says, okay, you have to spend 8 percent, I am going to say, oh, yeah? You know, why? I hate to be that crass about it.
DR. COHN: Agreed.
MR. MAYES: Yes, we need to be clear that the law actually requires you to make a recommendation, legislative recommendation and that is all. It does not even talk, I mean, it does not -- but I think that there are, I want to bring up two points. One, in today’s world I doubt you could find, you would search hard and long to find an individual provider that deals with no other provider. So, in a business sense you have to communicate information if you are in the health care business. So, I think that to look at it as just internally what do I do with my system is just too narrow. No one would look at it in the businesses that way.
I think actually that there are existing, you know, without having to suppose that this would make things better, there is a very good example of how this approach has already been quite successful and that is in retail pharmacy. The fact that you can go in, the fellow from Justice was just talking to me after the last panel and said, gee, you know, I was just in Michigan at my kid’s college. We had to go to a pharmacy and I handed him my GW card. Right away they knew what my deductible was, they knew what my other, they knew the other drugs that had been prescribed. And that is all based on the fact that there is comparability in information.
So people, there are some real implementations that can be used to demonstrate the sort of real-life benefits, the real-time benefits of these types of what we are talking about here within the health care sector.
DR. DETMER: I would hope that as we do make progress with HIPAA you start getting some sense of momentum to this. I am not saying we would ripple(?) but we certainly would hope so. We are finally for the first time starting to get into a little of the habit of exchanging, off of uniformity and standards approaches, so, you know, I agree that as far as the law is concerned right now that is true, but I like to think as these things move forward there will be some momentum to see it keep happening.
MR. MAYES: And I would actually like to follow up just a little bit on what Don just said. One of the real benefits for those of us who have now been dealing with this HIPAA stuff for the last two or three years, is a tremendous surge in collaboration and cooperation across SDOs and other organizations that are interested in this, that they have really gone very much farther than they were two years ago in terms of understanding that even though my specific interest might be this one piece of the health care information world, I really cannot achieve anything meaningful unless I collaborate more broadly.
So, I would look at this and, in fact, people that I talk to about the HIPAA legislation and this requirement under HIPAA, see this as just a furtherance, as a way of building upon what has already taken place within the more restrictive standards that we, in fact, published. Because a lot of people said, gee, you know, this is a pretty good process. I mean, so far, we have gotten this far and no one has actively tried to kill it off and that, to me, represents a real plus. I mean, to get this far and this many NPRMs on the national level without people writing Congressmen day after day saying, you know, this is crazy, has been a real plus. So, I think we need to look at this as a possibility to build upon that kind of enthusiasm and greater collaboration that has taken place.
DR. COHN: Now, I am actually going to suggest that we, I mean, not that we stop this conversation but that we hold it, because I think we will come back to it as we move along. The reason I let the conversation go this long on this issue is because I am pretty convinced that this is really our first work item, and I think the fact that we are in here chewing on it already and do not have the answer, we better be a lot clearer about this as we begin to wander into the substantive issues of, you know, the actual work products that we are trying to come out with.
So, we made some notes. We will come back and reflect on that as we begin to talk about what needs to happen over the next while. But, clearly, the amount of energy, it is a clear statement that this needs to be handled and addressed early on. Is everybody okay with that? Okay.
Now, let’s take a look at 3 for a second which is, I think as we have identified what the -- I am trying to think about how to put this together with what we just talked about -- I think this is our sense at the last meeting and sort of a little further refined, of sort of the areas that as we develop the value and understand the business propositions a little better, that we will be focusing in likely on these areas, especially the first four items, at least this is per the last meeting. Do people have comments about these? Are these short enough that you would like me to read them off as we go?
MR. BLAIR: For those in the audience --
DR. COHN: Do you want me to read them?
MR. BLAIR: No, but for those in the audience who might not have been at the June meeting, in the June meeting the Work Group worked on a charter and a scope and out of that work came essentially what you see in Section III here, which are these items. The first four items were the ones we felt were the high priority items.
DR. COHN: Let me just read through them very quickly just to make sure that we are all, and for those people on the Internet to understand what we are talking about.
We prioritized four areas of focus as our primary interest, recognizing, of course, that this may all be modified as we begin to identify value propositions and business cases and all of this.
But, first is to identify and recommend guidelines and standards for administrative and clinical messages.
The second is identify and recommend guidelines and standards for patient clinical information, as in data element definitions, data models and code sets.
The third has to do with identify and recommend ways to enhance coordination and maintenance of these code sets, recognizing increased computerization and increased specificity of these code sets.
And the fourth has to do with the business case pieces that I think were, I think we probably have just spent the last half and hour discussing, or at least beginning to get to, and those are really the four that everyone at the last meeting felt were really sort of the domain areas that we needed to be involved in, at least asking questions about.
I mean, where is the value in these areas? What is the current feeling as one looks at this now?
MR. MAYES: Just a point of clarification. Within those four, I do, we did not put a priority within the four. The four were priority but just because they are listed one through four on this --
DR. COHN: Yes, we just spent the last while talking about business cases so business cases are number 1 for today.
DR. FITZMAURICE: Simon, is there a place for content? Is that in Number 1?
DR. COHN: Content is actually Number 2 which is standards for patient data, element definitions, data models and code sets, to my definition is sort of, at least what I would describe as content, unless others feel differently. That has sort of been my definition of content.
Comments about these?
[No response.]
Let me just make a couple of comments about items 5, 6 and 7 which are there because they were identified as being of second priority.
Five is identify and recommend ways to address data issues related to CPR processes, functions and services including decision support and enabling technologies.
Number 6 is track issues related to data security. And that is actually interesting that, I was thinking today as we were talking about the NPRM on security, it is probably going to be more than just tracking issues because, for example, the digital signature piece which is part of the NPRM only talks about digital signature in the context of these transactions that have been approved by HIPAA. They need to be thought about as we move into the CPR and clinical data environment to see about their applicability. Because it actually is likely that the digital signature will have much more applicability and order(?) entry(?) in other clinical information areas than it may signing off an 837 transaction. That would be my thought, anyway.
So, we may want to review that and look at that as we move into that. And then obviously the final one has to do with issues around CPR storage. Bob?
MR. MAYES: I would like to make just one comment and it is not really word smithing and I do not want to change the words but I think we need to keep it in mind, the terminology we are using in this document is very data base-centric. This is the data base view of the world. And that is because most of us currently live in a data base view of the world.
There are technologies, specifically XML is one that is really coming along very rapidly, that present a different way of structuring information. There still, data is still a useful term but it is not going to be structured in the kind of formal structure, you know, it is the sort of, we have always had this in the last number of years, structured data entry versus natural language processing kind of debate. XML takes us through to look at it from a much more intermediate point of view than those two and so as we do our work I just want to be sure that we do not constrain ourselves necessarily to a data base-centric view of information exchange and realize that technologies may move us forward and open up new opportunities.
Certainly the work, for instance, in transcription standards that are being proposed is going to look, I think, very heavily at that technology which is a somewhat different view of the world. I do not want to --
DR. LUMPKIN: I actually had a question -- I am not sure whether it is a comment or a question -- on Number 3, which is the term, clinically specific code set. What does that mean? I am trying to think of a code set for clinical information. Most of the code sets I think of convert clinical information into something else.
DR. COHN: Well, I think probably SNOMED might be a clinically --
MR. BLAIR: The ones I think of, for example -- there might be some argument on this -- there has been a tendency to think of ICD and CPT codes as code sets that are used for reimbursement purposes but clinicians do not have a lot of confidence in them for clinical specificity for a diagnosis and for procedures. Whereas, there is a greater level of confidence in code sets that are architected as well as more specific like DSM, like SNOMED, like LOINC, where you not only have an architecture that is more stable over time, it is not a classification system, it is something where you can begin to go down in terms of granularity to a greater degree, and when you wind up seeing those codes as a clinician you tend to have a higher degree of confidence. Does that answer --
DR. LUMPKIN: It does, but I think, and I think I will leave that there but we are really talking about structured ways of writing clinical information which is, to my mind a code set is a transformation of that information. And we are talking about training clinicians on how to write information in a way that others can read it and understand it the way that they wrote it.
But I think I understand this term and the way we use it. I am just wondering if code set is the right word. Perhaps that is discussion for a different day and different time.
DR. COHN: Maybe terminology may be a term we might want to use, but, Rob --
DR. KOLODNER: Yes, I think that was the point, that it is terminology or terminology models or kinds of structured ways where that makes sense and where it does not constrain the advancement of our knowledge.
DR. FERRANS: Yes, and I think that brings in Bob’s point, for example, with document-type definitions, that that is one of the ways, that that is not really a code set but allows people to represent information, just as an example.
I had two other points that I thought we might discuss on this, and one because a business case has to be made and because certainly industry is important here, do we want to discuss or solicit comment from industry as to, given some of the things we are looking at, about migration issues? Because I think it is not just necessarily that people who are going to have to pay for this but also people are going to have to develop to this, and people are going to have to take their systems and modify what would then be legacy systems to be able to reach this. And that may affect some of the issues. I think that comments in those areas would be very helpful.
The other thing that I do not see, and I know that this is somewhat abstract, and I do not mean to be expansionist in what we are trying to do, but if one does recommend these things then one can end up with what amounts to a distributed system of patient records. And then where is the quote/unquote, longitudinal, patient record here? You know, do we have bits and pieces everywhere of clinical information and how does this all relate to each other in the various sources in which they reside? Is that something that we want to discuss? I think we can propose a solution but it sort of grows out of this in some ways.
MR. BLAIR: As we were evolving this we did intend to, we did wind up expanding the scope somewhat. You remember we started with the idea of uniform data standards for patient medical record information and the electronic exchange of that information. And if we stuck strictly to that then we would not have Item 3 in there, for example, which is the maintenance piece. But we felt that that was such an important issue that we all seemed to agree to expand it somewhat to that issue, and we also felt that we needed to at least have the same vision of computer-based patient records because that was at the back of our minds as we were thinking of the uniform data for patient medical record information. And, you know, as a group we may decide to expand it further into how do you transition from legacy systems to computer-based patient record systems. But that would be another step of expansion.
DR. KOLODNER: The migration I think can be subsumed under Number 4, the implementation and some of the implementation aspects. I would, other that saying that we want to be able to draw upon all of the information for an individual, in other words the life line medical record, I would be real careful about getting into the particular instantiations of whether we do it by having a data base where everything is together or whether we do it because the network is there. I think that is going to change over time as technology and society evolves. But at least state what the goal is and what we are trying to achieve. I think we do need to make sure that that is clear in here, and it may not be fleshed out well enough yet.
DR. COHN: Mel, your comment.
DR. GREBERMAN: Yes, I would like to get some clarification on Number 2, especially since I was not at the first meeting. In terms of the, since this was the content section and we have items such as data element definitions related to patient clinical information, did we mean to include as elements for consideration those that are not just used for direct patient care but, for example, for submission to some of the agencies around this table? FDA is one example for adverse event reporting, clinical trial information, HCFA for other purposes and then how do -- I see later on a list of participating organizations. We do have some of the federal agencies listed, but it was not clear to me that this statement for patient clinical information included other uses of clinically-related information that might not just be used for patient care purposes.
MR. BLAIR: It was intended to be broad enough to include research and public health, clinical research and public health research as well as for direct patient care.
DR. GREBERMAN: Thank you.
DR. COHN: I think that I would concur with Bob in terms of his comments about your comment, which is that this issue of migration I think firmly fits under the whole business case issue or something that has to be thought about in terms of business cases. Because if you cannot migrate to something, no matter how good it may sound there is not much of a business case for it.
And similarly, I think that other piece, which is the overall structure of the medical record, is, I think, a subsequent project, at least at this moment.
But, with that are we effectively, I mean, let me make a comment about work plans. I have never done a work plan where I have actually executed it completely. There is always something that happens after the first or second meeting and I think the reality is that we are going to structure whatever we do so that as we get additional information we will go back and say, well, based on the work plan and the information we have, what are we really going to do next? And this thing is going to be a living document.
So, even though it may go to the subcommittee or even up to NCVHS, the full committee, I do not think we are going to be tied to it completely. So, I think we need to use this as a way of getting started with the recognition that if things do not quite work out or do not make a lot of sense, we will sort of change them, I am sure, over the next three to six months.
But, having said that, is everybody okay with where we are with this piece so far?
[No response.]
Okay, well, with that, Rob, we have finished with Number 3. You are on for G-CPR update.
DR. KOLODNER: Okay. And, fortunately, I have a couple of colleagues here at the table also who can, maybe you can give more up to date things. When last we met we had put out an RFP to identify a vendor to work with us on a key aspect of the G-CPR and we have subsequently selected a vendor, that being the LT(?) PRC. And we are in the process of negotiating with them the particular task order and the details and the time line.
MR. BLAIR: Can you tell us what those initials stand for? Many of us are not familiar with that organization.
PARTICIPANT: Ling Temco [unintelligible] a big steel company years ago.
MS. FYFFE: PRC is a planning research corporation? Yes, they are around, they are in northern Virginia, I think. They are systems people.
DR. KOLODNER: Yes, one of those with three initials, several around. Basically they responded, as did some others, and we compared those responses and chose the one that we felt was on target best with what we were thinking. I think that over the last nine months that we have had the G-CPR formed we, and this is where my colleagues can correct me if they disagree, we have really clarified that there are two major efforts for this particular project that have become clear.
One is the effort that we are doing with the vendor, and that is the creation, sometimes I describe it as we are commissioning a new utility company. It is a utility company that is providing linkage, the routing and the translation of the clinical information starting with the four partners. And so part of that is that they have to have communications protocols and standards and security and we have to have policies in terms of what information goes and how people are authenticated.
And then we have what we are calling use cases or we called trigger(?) events, now talking about use cases. That is, here is a circumstance, here is a scenario, and based on that, what information does that provider or that researcher want to obtain from the other organizations, the other partners. So, if it is, VA, DOD and Indian Health Service, for example, have a reference laboratory network that we agree upon and that in Baltimore VA laboratory is going to do those reference labs and in San Francisco it is going to be a DOD lab, that when that sample is drawn there is certain information that is sent over to the entity that is doing the test, and certain information that comes back.
Or, it may be that an active service person shows up at LSU in the emergency room and based on coming into the emergency room, what is that set of clinical information that we want to have at the fingertips of the provider? And, as you may recall, our focus is not only on individual but on public health, that is aggregate data as well as individual. So we might look at cohorts as we attempted to do with the Gulf War veterans, that being one of the stimulations for the directive by the President to VA and DOD to develop this lifeline medical record.
So, one thing, one activity is getting this utility company going that not only routes, like a long distance company, it does not really control the wires. Right now we are talking about using the Internet, Web-enabled. I am not sure how that is going to evolve, but right now that is what we are talking about. But there is also a translation and that is that they apply a lexicon and do the translation of the terms.
But, rather than including the data models and data representation in as part of the RFP, we made a conscious decision to have that be a parallel activity of the partnership, that we believe that the identification and, in many cases, the creation of the models that we need -- and right now I think we are reasonably comfortable that we need an information model and that we need a terminology model and that there may some other things, some knowledge models that need to be there -- that that effort has to be done out in the open in a participatory style with standard development organizations or other kinds of entities where we may start by pushing things forward and doing the 80 percent or the 85 percent or whatever. In fact, many of us believe that if we stayed with the clinical and away from the business complexities -- but talk about taking care of an individual and providing care -- that we actually are very compatible with lots of settings and that it may be it will be even 90 or 95 percent the same in terms of the models that we need. But whatever it is that we get started and move forward on a time table that is rather fast for us. Our leaders are saying, get something going and get it going yesterday.
But that ultimately that will be turned over to an open process that we then participate in and commit to adopt when, as it reaches, say if it were an information model, for example, a valid information model, or if it is a terminology model that we would participate in whatever process there is for maintaining and involving that terminology model.
So, that is different than how we described it back in January and how I may have described it a couple of times that I have had the opportunity to present it, because we really did not have it separated into those two activities. But there is, the idea is that the vendor will commit to use those open standards as they evolve, although probably in the first instance, for the first iteration they will have to provide something, both in terms of mediation services and in terms of a lexicon or models that they will start with. But that the idea is that we expect that the other models will be incorporated.
DR. FITZMAURICE: Rob, as I understand what you are saying, you are building the architecture with the help of a contractor, and you are going to have a set of specifications for exactly how to exchange certain quantities of information that are brought about by trigger events. It may be here is the information that a doctor needs to order a lab test, here is the information that he needs to get it back.
Do I also hear you say that you are going to build a reference laboratory, not on paper, but a real laboratory that will communicate this information through existing open standards, such as HL-7 standards, with a specific implementation so that you will show us that it works here and that because it works here in this real, live place, it then can work at Triple or it can work at other places. It can work in New Orleans. But that you are building the architecture and then you are going to build the real life prototype and then you are going to have that prototype be duplicated in other places?
DR. KOLODNER: You said it much faster and much clearer than I did. Thank you. Yes, in fact, the first year deliverable is the design and demonstration in the laboratory. Then after that the next phase is to actually have it in a couple of our different sites and to actually move information around between those.
DR. FITZMAURICE: Now, I guess I see what the work of our Work Group is is that we are doing the architecture building, that that is kind of our vision, and what our output is is issue development, analysis and recommendations. Somebody ought to do this, somebody ought to do this, somebody ought to do this. And we might even identify the somebodies.
You already have maybe made a choice and one of our recommendations might be, somebody ought to do it better or there ought to be one or two ways of doing it, not 25 ways of doing a particular organization’s standard.
And then we might get into areas that you, because you are picking a place and you are starting, you do not plan to get there for maybe three or five years, but we have to get a report out of here in two years.
DR. KOLODNER: And is expect that the interaction, I think this goes to, or really the discussion of what is the interaction between G-CPR and this committee, which is really what we were seeking, there are, we will end up in some areas being a real test for, oh, that is the theory, but can you do it?
And we will, I am sure, run into barriers and challenges that were not anticipated, some of which we will have to come back and say, you know, we thought we could go this way but this piece is missing. Right now, for example, I would not be surprised if we say, yes, there is a good place for an information model, but there is no good place yet for a terminology model in terms of an open process and an organization that is going to maintain it.
And that that then is something that this committee get input from industry and from standards development organizations and others to say, well, okay, how can we approach that? How can we do that?
Or the linkage with world-wide efforts, so I see it as something where in some cases we are coming to you having identified some issues that need further work and in some cases we will be trying out some of the things that you think need to be done, and there will be that interaction.
DR. COHN: I guess I would also hope, recognizing the time frames we are talking about, that one would like to also have, where there are, answers that, you know, we have identified them, you should look at them very carefully. And, if you have identified them, we probably ought to look at them very carefully because I think the country would very much like to have answers, not just a lot more process. Anyway, Jeff, you had a comment? MR. BLAIR: That is okay. You covered it.
DR. FERRANS: I wanted to add to Rob’s comment and to say that I think what is particularly useful about this project is that since technology is fairly scalable, if we were all to buy the same computerized patient record systems and exchange information that would not necessarily be such a big deal. What we are talking about doing is having a framework where different systems can exchange information. And I think that is one of the goals that ultimately we want to try and, this committee is trying to see, you know, what data standards, what code sets, what exchange standards will support that.
So this is a, we developed a conceptual model and issued an RFP and now we are having, and now a systems integrator is going to be building the software that will accomplish this. And the other part, as Rob has spoken to, we, ourselves, have an internal process where we are trying to achieve certain, agree upon certain standards that are in existence to try and facilitate this happening. And because of the size and importance of especially, you know, the VA and the DOD, but certainly all of us put together, picking something has impact. We want to do that carefully. And that is why we have been working with HL-7 and with CPRI and other organizations.
I think there is certainly a commitment to open the standards, a commitment to try and have an open process. And also a commitment to, whenever we can to have these things reside in the public domain. We think that that is another very important issue.
DR. KOLODNER: Actually I guess the last few months we sometimes shift from public domain to public use so that it is not something that can be taken and changed constantly. You want something that has some protection to it. But that is not something where there is a large fee, necessarily. You want as low a barrier as possible because you really want everybody to buy into it.
MR. BLAIR: Could I get something clarified? Michael used the word, architecture, and I am not sure who it was who just spoke a moment ago who used the word framework. And previously when G-CPR has been presented to us the word framework has been used. Are you thinking of them as being synonymous or is there a difference?
DR. FERRANS: This is always a trick IT question. I think in the context of what he was saying I think that they are synonymous.
DR. KOLODNER: Mike, you are agreeing?
DR. FITZMAURICE: Oh, I agree, but can I take this opportunity to ask you another question?
DR. KOLODNER: Sure, go ahead, if Jeff is satisfied with the answer.
MR. BLAIR: Yes.
DR. FITZMAURICE: Let’s suppose that there were a commercial laboratory system out there that you could buy that provided the information back and forth and by paying another fee, you could buy its architecture, that is, its data definitions, the way it communicates and make it openly available. Or you could insist that it be an HL-7 and that you buy that particular implementation of it and make it open? Would you do that as opposed to inventing your own architecture slash framework, your own definitions and then saying, here is the VA/DOD/New Orleans/Indian Health Service architecture for laboratories.
DR. KOLODNER: I think the more that is already there, the better and that, for example, our discussions with HL-7 are such because the rim model seems to, in fact, be what we are looking for in an information model. We need to resolve it or harmonize it with some of the DOD models and some of the other things.
But there is an interesting model that could serve as a model for what we are trying to do, and that is that if you look at the VISA network, the VISA organization is not the important thing. People do not know much about it, where it is or anything else. It is the network that counts. And G-CPR succeeds if G-CPR, in fact, is in the background and gets overtaken by something else and the network and the standards and the other things are prominent. And that is what we focus on in a very open fashion.
The idea of the Web, of how do you get something started and let it evolve rather than thinking that we know
all the answers up front is a much more attractive strategy for approaching it. And so we are trying to make the right steps and listen carefully and talk with people, and if we make a mistake hopefully catch it early enough to back up and to go forward.
And I think if you look at how we talked about G-CPR in January versus how we are talking about it now, there are a number of distinct and important changes, but that the only reason that right now we stay with four partners is because we need to move forward. But it really needs a very broad buy-in so we have to meet lots of different needs.
DR. COHN: Well, I guess I may have to take back my comment about process but I think this is perhaps a slightly different type of process than I was referencing. And certainly I think it is a recognition that the process of improvement of whatever is as important as whatever one has in hand. Is that an apt statement?
DR. KOLODNER: Yes.
MR. MAYES: I have a question. There is a Quality Interagency Coordination Council, QICC. This came out of the President’s Commission’s Report on health care quality and patient rights. That particular council has representatives from all the federal agencies that have to do with health care, including DOD and VA. And, in fact, one of the subcommittees on that is an information systems which is being co-chaired by a DOD person.
My question is, you know, we are having some meetings, in fact this Friday, of that group and have you been able to get your G-CPR Project on the radar screen of the representatives to that group? There should really be a great deal of coordination between this group, the NCVHS, between a major federal project in health care such as G-CPR and certainly this transagency, transdepartmental federal group tasked with coming up with approaches to increasing quality of health care in this particular instance through technology, through information technology things.
And so, I am not, I am just curious as to whether or not, you are obviously aware of it because you are nodding your head saying, yes. But I was just wondering whether you have been able to get to that person. Because, frankly, when I saw their first agenda, the issues that they were originally thinking about were to my mind not the most fundamental issues, those that both this committee as well as your project have now been talking about. I think we have been able to move the agenda somewhat more towards these types of issues, but I would hope that, I am just curious.
DR. KOLODNER: VA and DOD are the lead for the information systems and the deputy under secretary asked me to serve as a contact with Mr. Reardon’s office. So we are taking the first step.
DR. COHN: And I guess we need to flag that as a group that potentially needs to come and talk.
MR. SCANLON: Well, I think they might be part of a presentation tomorrow. That is the follow-up group to the President’s Commission on --
MR. MAYES: Oh, that is correct.
MR. SCANLON: -- so I think we will hear about it tomorrow.
DR. FERRANS: I did want to reiterate one of Rob’s comments and that is that with respect to this activity that, you know, thou shalt not reinvent the wheel. And we take that very seriously.
There has been a tremendous amount of very fine work done by the SDO community, and I think as the committee will hear when we get testimony from them, there is a tremendous amount of frustration of, you know, we cannot get everybody on board. And we hear people say, you know, if a couple of big players came along and adopted them that might get it going, and, you know, how that activity, G-CPR, will help impact that and how, you know, the activity and the recommendations of this committee will help, you know, move that process forward. Because there is a lot of work to be leveraged.
DR. COHN: Okay, one last comment and then we will move on.
MR. SCANLON: To achieve this sort of flexible and moving forward kind of a vision, what is the government structure for, the government G-CPR groups or is it sort of, is it kind of amorphous at this point?
MR. GARVIE: It is not so amorphous that it cannot be described. There is a governing board which is made up of four members, one from each of the organizations and the governing board essentially sets strategic direction.
Then there is an Executive committee which is, Jim, I expect charged with carrying out the board’s wishes. It includes two representatives from each of the organizations.
And then we have a committee structure, a work group structure, if you will, to address such things as functional -- we have a clinical oversight group, for example, that Dr. Ferrans here chairs that then has subgroups that focus on some of the specific aspects of the work that Dr. Kolodner was describing and so on.
We have an acquisitions finance work group. We have a legal work group, that bringing the four organizations together as one is quite an interesting challenge. It may take making the state of Louisiana part of the Federal Government in order to -- but anyway, we are working through this.
[Laughter.]
In a nutshell that is the basics of the organization. We can certainly provide a more formal presentation on the G-CPR organization and where we stand, you know, where we are headed, if you like.
DR. COHN: Okay, thank you. I want to move the conversation a long a little bit, recognizing that [unintelligible] has a commitment(?) not to be here until 6:30 p.m. and I think everyone else has.
I think we are beginning to get some ideas, once again, of cross, of interactions and interrelationships. I do want to, I think, in light of that talk about this Item IV back in the Work Plan where we have a description of activities and some steps.
Now, I need some help from the group. We have, I know Kathleen is, you have 40 minutes, is that correct?
MS. FYFFE: My ride leaves at 5:30 p.m.
DR. COHN: Your ride leaves at 5:30 p.m., and you are sort of the end of our quorum. Well, let me tell you what I want to suggest. Let us focus this discussion on things that we think we need to do over the next four to six months and defer to a later discussion items that need to be potentially started later. And then we can sort of swing around, I mean there are a couple of items here that at least according to the Work Plan if we want to do them, we really should begin to get started.
And I think we should use that to help guide us and then we can go back and loop back and look at this issue of value and if we were to do something in the next term, what should we be doing. Okay?
So, I think based on a good numberings session, we really need to talk about, we certainly need to take about Number 1 and probably begin to talk about Number 2 potentially. But let’s talk about those two items and what we are talking about as things that potentially we may be able to make some progress on, at least in the near term. Jeff, are you okay with that?
MR. BLAIR: Yes.
DR. COHN: Okay, Item Number 1 has to do with this identify and recommend guidelines and standards for administrative and clinical messages. And the suggestion is first of all that we may want to hear some testimony from SDOs and users, we probably should be underlining users, and that there is also a need to analyze the guidelines and standards. But, obviously to analyze that you need to agree on the scope and criteria to evaluate those standards, which is no small task and then you need to basically, I mean, basically you need to do the analysis at that point.
It certainly occurs to me as we are talking about, potentially, this is, I mean, something we are just talking about in many ways, that we are talking about, geez, that there are some good standards out there, and potentially it is an area that we need to begin to journey into in one way or another to begin to get an idea of that, to begin to identify sort of the scope and criteria to evaluate the standards. Thoughts? Suggestions? Bob?
MR. MAYES: I just had a question. This is a scope question. Do you anticipate that the committee is going to send forward to Congress recommendations for specific standards? In other words, you know, we think that HL-7 should be the Messaging format for clinical information. Or, do you see these recommendations being abstracted up a level?
DR. COHN: Okay, let me give my comment and then I will let others jump in. I want to hear from users, the public, the health care community, and if there is a strong -- and obviously the government -- and in those areas where there is strong support I would like to send up the recommendation that these things be standards. Now, that is not a uniform statement. There are areas where I think we will be able to come to some consensus agreement with clear direction on. There are going to be other areas where we are going to say, geez, that one needs work. Anyway, that is my opinion of what we need to be doing. Jeff, what is your thought?
MR. BLAIR: My thought is that this first work item is one that I think we probably would choose to be expeditious about. I think that there are other areas where Congress and the national really need our direction.
Item Number 1 is something where the marketplace is pretty much answering much of the question on this. When we did the inventory of standards we basically had 16 clinical information message format standards. The marketplace is very rapidly beginning to accommodate them. I think that in terms of an analysis of those we might take a look at that in terms of the degree to which the options still fall short of complete plug and play or interoperability and whether or not there is any role for the government in terms of being a catalyst to assist. And there are still going to be certain areas where HL-7, DICOM(?), IEEE, NCPDP, the basic message format standard developers still have some messages to develop for like Home Health or for the progress on immunization or, you know, some others.
But my thought is that other than validating -- I think that is what Simon wanted to do -- because it appeared as if when we went through this exercise with X-12 it seemed like pretty much the obvious answer for us and, in fact, we did finally wind up recommending that. But there was a lot of comment that came through and I think maybe the reason why we have been able to be so, or the reason we have not had a lot of controversy with the comments on the NPRMs is because we listened to the field quite a bit first before we made that recommendation. So, we made the recommendations in a way that maybe confirmed what the market was telling us.
So, from that standpoint I agree with Simon that we should do some hearings with respect to message format standards, but I think that they might be maybe one or two sessions listening to users and providers and vendors and SDOs. And I think that, you know, we should really spend our time on the other areas where I think the nation needs our guidance like with, especially with Item 2 and even more so with Item 3. I think Item 3 is going to be --
[Technical difficulty with taping; text lost.]
MR. MAYES: -- wasn’t focused on Item 1. It was all together of the report. And I would caution us to draw too close an analogy with this work to that under the standards that were required under HIPAA. Those, they had the law already identified, very standard transactions. It was, I mean, the question was coming up with the message but, you know, claims exist and --
[Technical difficulty with taping; text lost.]
-- those variations. I think we are in much greyer, much more nebulous areas. I do not think that the medical record or the computer-based health record is that well defined. But I just use Messaging as an example. I mean, I was curious as to whether or not the report would be specific, whether code sets, messages, vocabularies or what.
DR. COHN: Okay. Don?
DR. DETMER: I guess I have a view sort of like -- what I would really like to see us do is, if you have a situation, if you really do know that you are dealing with an a, and, or the article and somebody just needs to say, that is what it is, I would like to see us say it so that we do not sit there and screw around forever just on that point.
So, I guess from my own point of view I think we need to stay nimble on the thing. And the thing that I think right now I do not see out there -- the comment came up earlier about unfortunately we still do not have a way to know when that last drop, when you were in chemistry and you were titrating something, that it turned red. And then everybody said, it’s red. You know, we really, we just are not quite at that.
Now, we are doing a little of that, I think, with some of these first sets of standards. We are sort of doing that. Now, the issue is, do we then start getting people to say, oh, okay, Well, this is the chemistry lab. We come in and we will titrate these things. I mean, we have not even been in a habit of titration.
And I guess, part of what I guess I am trying to say in a somewhat metaphorical way, I guess, is I think we need to stay flexible as we see this, but try to stay in a conversation with a very complex environment out there. It is not only just the U.S. environment, to some extent it is a global environment, too.
But I would like to see us be that voice where at least if we say it we know a certain number of people will, in fact, look at it in listen. Not necessarily agree but pay attention to it, you know, to some degree.
I still, I guess, am somewhat cynical(?) about being able to just sort of run it, as we said. I think it is too big an animal. On the other hand, if it starts getting into a little bit of a habit, of a rhythm of something, then it is possible that the thing, you could maybe start getting more and more precise and have it actually stick. I do not know.
DR. COHN: Well, I think you are right. I think we do need to be nimble. I guess I see this as a balancing act and I do not think that we need to devote, I think that there are some things that we can take as wins and we should try to take them as wins. And I do not think we should spend all our time on just the most difficult problems we can imagine. I have done that enough in research in my life. We all know how to do that one.
And it is really a question of balancing because we are really looking for value and that drives us sort of back to this earlier issue of, of course, the value. And letting the value help drive us as well as what works. And it is beginning to sound like that we may have some people around the table that can begin to speak for things that work. And those become very powerful combinations, especially early on.
Now, I guess the question I have at this point is, is, I mean, do we want to talk, I mean, we have talked some about levels that we are going to go to, and I think I am hearing, I do not hear big complaints about on an opportunistic basis trying to go to the most exacting level that we can, when it makes sense and when it is driven by value and the business case and all of that, but knowing that we will not do that on every single issue.
And I think we have identified that there needs to be some work around SDOs. I think my co-chair thinks it is probably a little boring because a lot of people already use these things but I think there is probably value to further validate and identify what needs to be happening there, as well as, we identify that there are issues that are not immediately apparent.
I guess, I mean, do we want to talk about Number 2 or do we want to stay on Number 1 for a while at this point?
MR. BLAIR: The section that we are in, by the way, if you would look at Section IV and it begins to elaborate a little bit on what we might look at for Items 1 through 7, and then you can also see how they get laid out on the time frame. This is just a first shot, just to kind of get, to let you have a feel for how we might balance off these things. So, it is to promote discussion.
DR. COHN: Yes, and I guess the question I have for you is, we have, basically 25 minutes left, and do we want to continue on and talk briefly about 2 or 3 or do we want to run back and talk about this issue and the value proposition and dwell on that a little more? Yes, Mike.
DR. FITZMAURICE: I would like to see us focus on what kind of information do we need and where are we going to get it? And when should we have our first set of hearings? What kinds of questions shall we ask them so that we get some buy-in as to our starting place? Did we start in the right spot? Are we heading in the right direction? So that subsequent hearings can be more focused.
But I think the first set of hearings have to be kind of wide open, here is what Congress told us to do so we have a short presentation, five to ten minutes, on here is what we think Congress told us to do, what do you see in this scope that would be helpful to you? Where would you guide us? And then have people around the table tell us where we should go.
DR. COHN: I think that on the basis of, what I will do is some executive privilege here and agree with you and let’s focus in --
DR. FITZMAURICE: I will agree with that.
DR. COHN: Let’s talk about a first hearing panel or whatever, because if we do not we probably are not going to have another chance, recognizing, and we have begun to talk about some value issues and business issues. We have talked about Item I. Clearly there is stuff there that is a first hearing.
MR. MAYES: And I would hope that we can tie this directly in to whatever comes out of the discussion tomorrow on the national health information infrastructure. I think that if, in fact, that is accepted and moved forward as a recommendation from this committee, that that would, in fact, provide a further overarching framework for this work.
DR. COHN: Okay, I agree. I guess I would further, I mean, yes, and let’s talk if we are going to do a set of hearings. I guess my thought is that we are beginning, we need to talk about it but I am thinking that there may be enough things that we have talked about that there really may be a two-day set of hearings that we need to hold, either later on this year or, I mean, if we can figure out the right date, or at the very latest, early January.
And that, I am going to state just sort of as a general suggestion about our process that, if we hold two-day hearings, let’s reserve the last half day to review where we are, to review what we have learned, to identify what we need to be doing next, recognizing at least for the first while we are likely to get a lot of ah hahs, and it is going to require some, you know, changes in planning. I do not know that it makes a whole lot of sense to do three or four, try to plan three or four hearings in a row right this second. But that we try to structure at least this next one and probably all of them that way so we do not leave it to staff to try to put things together as we go. Does that sound like a good process?
[No response.]
Now, I think the things that I am hearing from everybody, and let me just try to restate some of them, is that there is a whole issue about are we at the right spot? And that is certainly a, you know, do we understand the charge right, do you agree with it, are we at the right starting point as far as the public, the health care environment, health care users, SDOs, others, are we in the right spot?
There is a whole issue around business value and where is the business value in all of this. There is a, I think some validation and discussion that also needs to occur around what SDOs are doing in this area. I mean, is that, am I hearing other things. I mean, obviously I am trying to pull things out of my notes and my computer screen is pretty small here. Yes, Mike.
DR. FITZMAURICE: I guess the people I would like to hear from to get a sense of are we heading down the right track, I would like to hear from the vendors who have to go out there and sell stuff that would incorporate these kinds of standards. I would then like to hear some of the users who buy these systems that work or do not work depending upon how they exchange information and do or do not exchange information with other kinds of systems. I would want to hear from some people on the cutting edge, the Beth Israels the Reagan Streets, LDSs, to find out what would add value so that other places could get some of the functionality that they have. And I would like to hear from some medical people to tell us, yes, but we have to exchange the concepts that we need to know about to take care of patients. And that would give me a good, full plate to start off with, but I probably missed something on that.
MR. BLAIR: Did you overlook SDOs?
DR. FITZMAURICE: They will do whatever people will send experts to the table to work on. And they will take their cues from what we have here. They will produce what the marketplace wants. But I want to hear from people who are buying and selling in the marketplace and then we can tell the SDOs what we think they should be doing, and if they can gather the right kinds of experts, they will do it.
DR. FERRANS: I would also like to hear from the SDOs not just, and the G-CPR experience has also taught me this about the SDOs, is that one of the issues that SDOs have is an adoption of their standard. The downside to that is, then, the maintenance issues and who is going to pay for it, and this is the government. And I think that perhaps a, an exchange about those issues will be very useful because that is an unintentional consequence of progress. And they are very keen about it. Ed Hammond just talked about that and it especially goes with Number 3 about the terminology issues. That is one of the fundamental issues regarding that.
DR. COHN: Do you want to hear about that from first hearing?
DR. FERRANS: Just when, when we hear from SDOs that they also address, in the context of addressing the maintenance issues.
MR. BLAIR: Help me to stay focused on this thing because you mentioned the maintenance issues. Are you saying that on the first one or two sessions we should go to that one, which was Item 3? I thought we were going to be focusing on Item, on the first activity area which is the message formats. So, did I get lost here?
MR. MAYES: Jeff, this is Bob. I actually do not, my impression was that the first set of hearing were not going to focus on any of these in particular. That one of the purposes was to sort of distribute this document basically. I mean, that is what I would propose, is that we decide on who we are going to invite to this, give them this document or something that Simon has been busily typing on since we have been talking, and say, you know, here is what we are sort of thinking about. Here is the approach we are taking. Here are the four priority areas or the seven areas. Now, in your world view, you the vendor, you the user, you the whatever, are we moving along on an activity that has some value to you or are we just off in left field here talking to ourselves?
And then based on that, I think that is what Simon was talking about the last half day, based on that feedback maybe we should sit back in the second half of the second day and sort of say, well, we got validated or, boy, do we have some work to do here. We have heard completely different stories.
MR. BLAIR: Okay, Simon, that was your thought?
DR. COHN: Yes, I actually thought that we could actually even begin to move a little bit into some of the SDO pieces based on time. But I think that is a scheduling issue and how much we really can do in a day and a half.
DR. FERRANS: I do think that if we do do that, that that sort of gets into the business case issue since each particular group will come and say, well, I either validate or you are way off base based on the business case for my particular perspective.
So then the question really is, is the first activity centered around business case issues? And one way to think about that is that as we have talked about accomplishing the activities to agree on the scope and criteria to evaluate standards, some of the criteria are going to come from the business case issues. Perhaps that is an appropriate place to start.
MS. GILFOY: Yes, this is Hellene Gilfoy from Catholic Health Initiatives, and I think this is just to speak to support what Mike had said, although I was standing up here before Mike said it, so I had the idea first, Mike. And that was specifically on 3A, looking to identify the coordination of both administrative and clinically significant code sets or clinically specified code sets. A speaks to gathering information from academic medical institutions and then goes on to say code set developers, et cetera, et cetera.
I would suggest that there is a very large segment of the institutional health care community which is the community hospital. And to speak to what Kathleen said earlier, we are the ones who are going to be heavily impacted by determining whether or not we buy a computer-based patient record. And we are the people that you have to sell this thing to. I have to go back and be able to sell this to the people at my organization to say, hey, this is the best thing. But if you do not get our input and you simply get the academic medical center input, there is going to be a dearth of information in there.
MS. FYFFE: Let me just add one thing to what Helene has said. To the extent that you can get the commitment from the community-based hospitals versus the academic medical centers the overall cost is going to come down, because the developers of this will develop it and resell it many, many times and it will, more people will have access to it, or more organizations will have access to it.
MR. SCANLON: You know, Simon, in terms of IA, sort of identifying it as [unintelligible] do we believe that we have much of this information, or will have it, in the inventory of clinical standards --
MR. BLAIR: We do have them, yes. We do have them. As a matter of fact, it is especially well done. And, the stuff that was submitted from the SDOs was especially well done. They gave us eight to twelve pages apiece on each of their individual standards that they have been developing. So it is well documented. It is comparable. So, you know, we have quite a -- this is the area where we have a running start. A lot of the other areas are much more ambiguous. So, but the SDOs have done a very good job in giving us information here.
DR. COHN: I guess the only question I would have about this first hearing as I am looking at it is I am sort of enchanted somehow with also getting from people sort of views of what works and what does not in their view, just because that also helps augment this issue around, especially around the standards. People are aware that some of them are in more common use than others and that is not something that, at least to my understanding, is well documented from a vendor or user view in the criteria, in the inventory. Is that correct, Jeff?
MR. BLAIR: I did not quite -- could you --
DR. COHN: Oh, I was just commenting that I think that in the inventory it was reported by SDOs about use data, but we did not have independent verification of that from users.
MR. BLAIR: That is correct and that is where we have good information from the SDOs, but we wanted to validate the perceptions that you might get from those profiles that are in the inventory, we wanted to validate that from users, academic medical institutions and others to make sure that that was leading us down the right track.
DR. COHN: Okay, so if we have time we can begin to ask those sorts of questions.
Now, I am going to actually look at Bill for a second and do you think that we have enough structure upon which to build a set of hearings at this point?
DR. BRAITHWAITE: Well, I think we have a general subject matter for the hearings and a general idea of what kinds of questions to start to draft to ask the witnesses to address. And as we have done for past hearings we can get the various staff people working on your Work Group to come up with a draft set of questions and then circulate it two or three times by e-mail as people refine it and get it down to something that makes sense while we collect suggestions for names for people to invite to address those questions. And then put the whole package together and build an agenda which we would then pass around again. So that is probably the next step.
MR. BLAIR: One of the other things that I might add here so that we do not attempt to reinvent the wheel here is that since we do have a pretty good body of knowledge to start with that the SDOs have given us, I think it would be helpful if the committee has not had a chance, to read through that material. If we do read through it then we will be able to start at a much higher level as we begin to ask questions and look for insights and see where the gaps are and see where lack of interoperability might still exist or lack of market acceptance might still exist.
We can start at a much higher level than if we fail to take advantage of the information that has already been provided to us.
DR. COHN: Okay. Don?
DR. DETMER: Yes, just to stir the pot, I think Bob Mayes talked about the quality study. The Institute of Medicine is heading into another round of activities on quality and the challenge that they, at least I think they are going to put to themselves in that is not to look at just quality for quality’s sake studies or to use the conversation, I guess, that I have been hearing here, is that, well, we just do not want to reinvent the wheel.
Well, if you can come up with a heck of a lot better wheel it is not that bad to invent. I think the issue is, in my view, is that I see a country that access to care is going the wrong direction, costs are looking like they are really going to go up and that quality already is very uneven. The only new player on the scene in my way that could reinvent health care, in my mind could reinvent health care is information technology.
And you clearly are seeing a guide to consumerism with people starting to use the Net. There is some capital investment moving into that area to figure out how that will happen. But the point, I guess I am getting at is, is that I hope as we focus on this we do not so much focus on just what a vendor is wanting to try to sell to somebody this year or next year, because from what I have seen, a lot of the big vendors are frankly not that creative. I mean, they are trying to meet a market that will buy right now. Now that is not to say they are wrong. They are staying in business. I totally understand them. If I were working for them I would be doing the same thing. I want to sell something.
So I think at the one hand I do not want us to make incremental movement, but I do think our country has a real challenge here and if we really look at essentially, well, essentially the challenge that the 91 Committee talked about as well, let’s don’t look at the computer-based patient record as simply a paper record or some variant of that put on a computer and digitized.
I am not hearing us say that but I just come back to how can we keep pressure on this to be creative to societal need, in a sense and really leverage this technology for what it can do. And if you look at the Web just as a phenomenon candidly within the last week, this is becoming increasingly a source for our culture and it is going to play out in health care, too.
MR. MAYES: And also just to broaden the discussion just a bit and I would suggest we look into this, we are not the only country that is doing this. There are a number of countries that have actually moved further along than we have in exactly this arena. And much of this is a sociopolitical process more so than a technical process. There are technical issues but we have certainly found even with the previous HIPAA stuff that it is the sociopolitical issues that are the challenges.
And I would hope that maybe we could have the opportunity, if at all possible, depending on the timing, that we might be able to get some representatives, for instance Australia is actually very close to us in the way their health system is structured. They have a national health information model. They have a national health data dictionary. They have adopted HL-7, are in the process, as a national clinical Messaging standard. So, to get perhaps some of these other countries, and the new ISO committee, I think, would serve as a possibility to find some people, to get some other experiences of groups that are attempting to do from the sociopolitical aspect what it is we are attempting to do here, might be quite useful.
DR. COHN: Yes, I agree. I actually do remember that Australia is single-payer which I think does help.
MR. MAYES: No, they actually, well, but they have, no they have private insurance.
DR. COHN: Oh, do they have private insurance? Okay.
MR. MAYES: The percentages are different but the overall structure is similar.
DR. COHN: I am going to run down one or two more comments and then we will wrap up. Mike, do you have -- this, hopefully, is not on a new item.
DR. FITZMAURICE: No, I had identified vendors, users, cutting edge developers, medical and someone else suggested SDOs, but Don raised a point, I am not sure that we have the people there who can say, here is how IT can drive quality. Don, or anybody else, do you have some suggestions on who might be good representatives at a hearing to say, here is how IT can drive quality?
DR. DETMER: Well clearly, I think you mentioned the LD group. I mean, I do think that is how they are trying to run their plays. There is one. I do not know that they are really focused on this both as population at the same time, in other words making sure that there is an interplay between numerator quality and excellence and denominator quality and excellence. I mean, that is how you are ultimately going to get really return on investment in health care. I do not think they are, but now maybe Brent James would say, you’re missing something, but that is a piece of it.
PARTICIPANT: I could throw out a group, the peer review organizations, state peer Medicare, state peer review organizations. They are, that is their business now is quality improvement and they are basing it on moving more and more toward leveraging IT.
DR. FERRANS: I was thinking actually of Brent James also and he has been advising us on our state wide disease management initiative. This is a subject he speaks to very eloquently.
DR. COHN: Last comment and then I want to do a little wrapping up.
DR. BRAITHWAITE: Certainly from the literature we have seen that attempts to lower the costs has not changed or has decreased the quality of health care, but attempts to use IT to increase the quality of health care has uniformly decreased the cost, and we ought to take advantage of that knowledge.
DR. COHN: Now, I want to wrap this up. It is 5:27 p.m., at least according to my computer. Now, we are still going to meet at 8:00 tomorrow morning and what we are going to do is to review the idea of a hearing. I want everybody to bring your calendars along because if we can get down to one or two dates for the actual hearings that will actually move us that much further along. And I think that really what we are looking for is probably some time in December, if we have to, early January, something like that is realistically what we are looking at.
But we will review what we are talking about. We will talk overall, then we will transition into a meeting of the subcommittee and discuss among other things what we really want to do with the Work Plan now, whether we want to just keep it as a subcommittee document or take it up to the full Work Group, as well as begin to talk about the overall issue of Work Group hearings, subcommittee hearings and how they all interrelate. At 8:00 a.m. tomorrow. Right? Eight o’clock in the morning. Okay, well, thank you all very much. I appreciate your help and we want to thank the staff. Thank you all.
[Whereupon the meeting was adjourned at 5:30 p.m. on September 15, 1998.]
Sept. 16. (Discussion Continued from Sept. 15)
MR. BLAIR: Simon and I were talking about what we might be covering this morning, and our thoughts were that there still needed to be a little bit more discussion, a little bit more questions, with respect to the value proposition and the business issues, kind of like the global issues, and I might indicate that, you know, our thoughts during the next 30 or 40 minutes of time would be that we could get a little bit greater understanding of how we all might feel about the issues that we have to address in terms of the business issues, comparable value, and global issues.
Then what we wanted to try to do before the meeting was out was focus on the first couple of days or day and a half of meetings for the workgroup where we would have witnesses, and we were thinking in the timeframe of the first or second week in December. So we were checking dates and all, and we were also thinking that we would probably have in those hearings additional testimony on the issues that we would be discussing this morning, the global issues, and if possible - we do not know, depending on how the group feels - maybe see if we could begin to address any of the seven issues during that time.
Simon, did you want to - are you there?
DR. COHN: Well, I am sitting; I am just trying to think of where to go with this. I think we stated pretty well where we are from yesterday.
MR. BLAIR: Maybe while you are thinking, I think that there are - we went through very quickly yesterday afternoon, and I am not sure that everyone had to time to express concerns or ask questions with respect to the work plan overall.
DR. COHN: Jeff, well, let’s go back and talk a little bit about what we need to do over the next half an hour to make sure that we meet our needs. I think we decided at the last meeting that we were really going to go and defer full discussion of the work plan until after we - as a last part of that session of the hearings and/or at November if we have time, and I really think we need to focus this session on being clear about any issues that we need regarding the hearing. We need to come up with, I guess, first and second choices around dates, and why don’t we try to keep the discussion limited somewhat to that, and then if we have time we can talk more about the overall issues of the work plan. I just think in 20 minutes to half an hour we are not going to have a chance to in any way have any full discussion around the other items we did not get to. Is that okay with you?
MR. BLAIR: Well, let’s see if it is okay with the group. Is that okay? Hello?
DR. FITZMAURICE: That sounds good. I guess one of the things that I would like is to further out Simon’s discussion about dates for a hearing, the suggestions for the kinds of people, suggestions for questions. I will put that together, and I will send it around to the group, expecting people to add to it, but just to get a start on it, if it is all right with you.
MR. BLAIR: All right. Could I just do one little thing in terms of kind of making some closure on this? I think that Simon feels - and since I cannot see the expressions on your faces, maybe you have been nodding all along. I gather that the feeling is that the work plan is something that is going to be a living document that is going to be revised as we go along, but I gather that the general consensus is that it is enough for us to begin to work with and start to have hearings. Is that correct?
PARTICIPANT: I agree with that.
PARTICIPANT: Yes, that is correct.
MR. BLAIR: All right, fine. Good.
DR. COHN: Well, so, Mike, you have identified that you were going to take responsibility for trying to put together questions and -
DR. FITZMAURICE: Questions and lists of people to invite. Lists of people to invite, questions, and we also aim for some dates.
DR. COHN: Great. All right. Does it make sense for us to talk a little bit about possible dates that might work? First of all, is everybody okay with a December set of hearings?
MS. FYFFE: Yes, I think so. What are the other - when does NCVHS meet?
MS. GREENBERG: November 12 and 13.
MS. FYFFE: Where is the winter AMA meeting, John?
DR. LUMPKIN: I think it is in Maui.
[Laughter.]
MR. BLAIR: Simon and I had talked about December - was it December 8 and 9 or December 9 and 10?
DR. COHN: Well, I think we are looking at that week, and I forget if you had full availability on that week? How does that work for -
MS. FYFFE: I have some flexibility that week.
PARTICIPANT: Me too.
DR. COHN: All right, I see everybody is nodding their heads, and Dr. Lumpkin is pulling out his calendar.
MS. GREENBERG: December 8 is a Tuesday.
DR. COHN: Right.
PARTICIPANT: Where would we be having this?
DR. COHN: I think it would be in Washington.
MR. BLAIR: Lynnette told us that it would not snow before December 15 in Washington. So we are okay.
DR. FITZMAURICE: So we are aiming for the 8th and 9th.
MS. GREENBERG: Or maybe the 9th and 10th.
MR. BLAIR: What is your preference?
PARTICIPANT: The Data Council has standards on the 9th. The HHS Data Council.
PARTICIPANT: On Thursday?
PARTICIPANT: On Wednesday, the 9th, in the afternoon.
MS. GREENBERG: From 1:00 to 3:00.
PARTICIPANT: Well, it does not necessarily rule it out.
MR. BLAIR: I guess what I am going to suggest is that we look at that week. Since we have two members not in attendance of the workgroup, we should try to see if one or the other of those particular couple of days, you know, either enables them to be here with us or not.
DR. FITZMAURICE: All right, we will aim for the 8th and the 9th, we will check it out with the other two members, and it may go to the 9th and the 10th. Is that agreeable?
PARTICIPANT: Yes.
DR. BRAITHWAITE: And the plan is to have two days, a day and a half of hearings and a half a day of workgroup discussion.
MR. BLAIR: Now, when you are saying a day and a half, I am assuming you are thinking full first day and half day the second day. Is that what you are thinking?
DR. BRAITHWAITE: Correct, yes, and the afternoon the second day would be workgroup discussion and summarization of what we have heard.
DR. COHN: And review of the work plan in light of that discussion and any learnings we may have had on the basis of that.
DR. FITZMAURICE: Now, is two hours enough on that afternoon? Do you want three hours?
DR. COHN: The second afternoon?
DR. FITZMAURICE: The second afternoon.
DR. COHN: I think we are going to need three hours.
MS. FYFFE: Yes, I think we might even need a working lunch.
MR. BLAIR: Did I get lost? I thought you said a day and a half, full day the first day and until noon on the second.
DR. COHN: A day and a half of hearings, but the -
MR. BLAIR: I am thinking about people who want to get back to the West Coast.
DR. COHN: Oh, so like 3 o'clock on the second day is what you are saying.
MR. BLAIR: Ah.
MS. GREENBERG: We are talking the 8th and 9th or the 9th and 10th?
DR. FITZMAURICE: The 8th and 9th, but it could be the 9th and 10th, depending on those two members who are not here.
MR. BLAIR: Those three days, somewhere in those three days.
DR. FITZMAURICE: And as we poll some of the other folks that are not here, maybe that will be the tie-breaker.
MS. GREENBERG: Dan is actually here.
DR. COHN: Well, Dan actually is not a member of this workgroup, though. Kathleen Frawley and Clem McDonald are the other two members.
Let me just ask - just bring up two other issues or two other questions for the workgroup, since we have a couple of minutes, and then we will come back. Actually, probably it will be three issues.
The first issue is that my sense at this point is that the plan that we have is something that I guess needs to be - since we are effectively the same as the subcommittee, I think we are approving it as a draft document, noting that there are going to be further revisions. I think we should share it with the full committee, but in no way should it be voted on. I mean, it does not have enough certainty to it.
MR. BLAIR: What if we labeled it a working document so that that kind of implies that it is something that gets revised over time?
MS. FYFFE: Yes, or put an edition date on it. Really. I mean, put as of, what, September 16, and then it will stay with that edition date until we make a change to it.
MR. BLAIR: Is that a different term than a version? Does it matter?
MS. FYFFE: It is probably the same as version.
DR. LUMPKIN: Actually, to be truthful, I think that an executive summary of this work plan would really be what we should send to the committee. If you look at the other work plans, they tend to be much slimmer and trimmer.
MS. GREENBERG: That is a good idea.
MR. BLAIR: Provide an executive summary. We could pull that together.
DR. COHN: Yes, probably for November we can pull that together.
DR. LUMPKIN: Right, and I think that is what we would want to have the committee approve, rather than a more detailed plan that we are going to use to accomplish the task. An executive summary, you are figuring, is one page; it is two or three paragraphs?
MS. GREENBERG: Well, two pages.
DR. COHN: All right, so we will have that distributed prior to the November meeting, and hopefully that will be up for full committee review in November. Well, that is good. That is issue number one.
Issue number two is recognizing that when we are talking about hearings in December, what might we want to do in November? Is there a reason for the workgroup to meet? Is there a reason to sponsor a panel or otherwise at the NCVHS meeting? Actually, I should look at Marjorie to see what is your view of the agenda for that meeting in November?
MS. GREENBERG: It is still fluid. It will definitely be a two-day meeting, because it is the 12th and 13th, and the 11th is Veteran's Day.
DR. LUMPKIN: Which for you non-government employees, Veteran's Day is a holiday.
MS. GREENBERG: Well, the building will be closed. On the other hand, we probably will try to arrange working sessions, breakout sessions, although, as you know, there is a lot of overlap of these various groups. So depending upon need - is the Privacy and Confidentiality Subcommittee planning to - I know their next topic was supposed to be pharmaceutical -
MS. FYFFE: I am not certain. We needed to check with the members who were absent in order to determine when our next meeting would be.
DR. FITZMAURICE: I would suggest that we do have a workgroup meeting in November when the NCVHS meets, that we talk about the hearings, approve the list of people to be invited, approve and modify the questions to be asked. Bill has also suggested, and I think it is a good idea, that we have read the clinical inventory standards beforehand and be prepared to discuss it at that time. So I do think we have enough for a good meeting.
DR. COHN: Now logistically I would like that, too. Does this fit timewise? I have not gone through some of this stuff. Marjorie or Lynnette, could you give us some guidance a little bit here, timewise? Michael was suggesting that we take advantage of the time on November 12 and 13 to review the questions that we would be giving to the witnesses and to refine how we would be conducting the December meetings, if it is going to be the 8th, 9th, or 10th. Is that too late for us? How long of a lead time is it?
MS. GREENBERG: Well, we need to put something in the Federal Register at least a month in advance, but that we can do with just very general description. Typically, Judy or Bill - in some of the hearings that we have had for standards and security, we certainly kind of line people up at least a month ahead of time. Actually, we have had in the past tried to put the questions in with the Federal Register notice, also, now that I think of it. I know we have done that. So other people would send in comments, testimony, if they wanted to. So I guess, given that this is the middle of September, it would be better to have finalized the questions, I think, prior to 12 and 13.
MS. FYFFE: Yes, and these are going to be hearings and not a roundtable discussion.
DR. COHN: Well, I think we have some ability to do both.
MS. FYFFE: I mean, not to take shortcuts here, but sometimes a roundtable discussion is very productive. You do not necessarily have to have a hearing.
DR. COHN: Well, I suspect that we will want to potentially mix and match. I guess what I am going to propose, based on what I am hearing about timing is that we try prior to the November meeting to have most of the questions, and I think the chairs will work with staff to come up with relatively advanced draft that we can distribute prior to that meeting to potential speakers as well as potential roundtable participants, with the idea being that potentially we can review it. If there are additional questions that we come up with, then we can send those out as additional questions after the November NCVHS meeting.
Is everyone okay with that?
MR. BLAIR: Well, just to lock back into Michael's suggestion and Marjorie's comments then, I think everybody agrees with what you said to be done prior to that November meeting, but Marjorie, is the November meeting too late for refinements of the questions, for example?
MS. GREENBERG: No.
MR. BLAIR: So we can still wind up doing that in the November meeting.
DR. COHN: Well, we can send it out less formally, the short questions.
MS. FYFFE: Let me ask this. If we put the questions in the Federal Register, is there any type of required timeframe in advance of a meeting in December for posting the questions in the Federal Register?
MS. GREENBERG: I mean, the questions would be with the Federal Register notice of the meeting, which is supposed to be at least a month.
DR. BRAITHWAITE: I thought, Marjorie, that the legal requirement is only for two weeks ahead of it.
MS. GREENBERG: For the Federal Register?
MS. FYFFE: All right, so we could review our questions in the November meeting, and then shortly after that put the Federal Register notice up.
DR. BRAITHWAITE: I think she was saying the Federal Register notice goes out before.
MS. GREENBERG: Jackie? I thought we aimed for having the Federal Register notices in a month in advance.
PARTICIPANT: The Federal Register notice has to be printed at least 15 working days prior to the meeting.
MS. GREENBERG: Fifteen working days? So that is three weeks.
MS. FYFFE: One thing we could do to help out our potential testifiers would be to have the Federal Register notice saying that the meeting is announced and say please check the Web page for the questions.
MS. GREENBERG: I was thinking the same thing. Put the questions on the Web site and refer to that in your notice.
MS. FYFFE: Yes, so you could put the Federal Register notice out 30 days in advance and say, you know, watch the Web page.
MR. BLAIR: And I would think we could also wind up having an outline of the topics or questions and then maybe refining them in the November meeting, which I think is what Michael was - was that the thrust of your suggestion, Michael?
DR. FITZMAURICE: Yes, I think that will work out.
DR. COHN: I think we have the process together then to move us through. It sounds like we can really talk about the questions in November.
DR. FITZMAURICE: We should also talk about them today, too.
DR. COHN: Yes, or we will be two hours to review that. Now, having said that, my sense is that there is not much more for this workgroup to discuss. I mean, I guess what I am hearing are two things that we need to be doing in November. One is reviewing the questions and then some discussion around the clinical inventory, which hopefully everyone will have reviewed by that time, but just as a high level discussion.
DR. FITZMAURICE: And also review the witnesses, as well. Also review the witnesses.
DR. COHN: Well, we are talking about the focus of the meeting, yes.
Yes, Kathleen?
MS. FYFFE: Do we have the clinical inventory already? Am I supposed to have it? I mean, I have lots of material from NCVHS, and sometimes - you know, it is all in the retrieval. I have to figure out what I should be looking at.
MR. BLAIR: The inventory, the binders were distributed in the June NCVHS meeting.
MS. FYFFE: Oh, yes. That was that. All right.
MR. BLAIR: It weighs 40 to 50 pounds.
MS. FYFFE: That is right, all right, thank you. So that is the document that we need to -
MS. GREENBERG: It is the one you are using for your -
MR. BLAIR: It comes with a little clip in the back about speed-reading classes.
MS. FYFFE: Evelyn Wood, yes.
DR. COHN: But based on this discussion, I am actually not going to suggest that we not sponsor any sort of a panel for a larger discussion for the formal full NCVHS meeting in November. It seems out of sync.
MS. GREENBERG: Yes, we might think in terms of the February 2 and 3 meeting.
DR. COHN: That might be an option.
MR. BLAIR: One other piece here, at least in my mind - maybe, Simon, you had a sharper vision on this - my thoughts were that if we have a day and a half or a day and three-quarters in December that we could have that first morning divided into maybe two panels or something like that where we could have one panel, you know, asking those and another panel users or whatever they might be, but that the morning might be dedicated to, for example, this topic of getting a better understanding of the value of comparable data and the business case issues. Are you with me? Simon, are you?
DR. COHN: I guess I was whispering on the side.
MR. BLAIR: Well, why don’t you make sure - I want to make sure that we are in sync on what we would be doing.
DR. COHN: Let's start from the top again, Jeff.
MR. BLAIR: All right, my thought here was how are we going to lay out that - are we going to focus on one issue, two issues, or three issues? My thought was that during the morning there would be time enough for at least two different panels where we could focus on the comparable issues and the business value type issues, and in the afternoon we might be able to pick one of the first four priorities. I do not think it necessarily has to be item number one, but it might be. It could be two or three or four. Then the morning of the second day, we might be able to pick another, and I would just like people's thoughts on that.
DR. FITZMAURICE: Now as I understand hearings, there is probably room enough for two sets in the morning and two sets in the afternoon.
MR. BLAIR: That is what I would think.
DR. FITZMAURICE: All right, and you are suggesting that we focus, first of all, on the charge to us from Congress and what is entailed in that charge? That is where you get into the comparability and you had said something else.
MR. BLAIR: Right. In my mind, when I am beginning to think of these, I am not thinking that the issue of the business case and comparability issues would be completely resolved in just the December meeting. I think, you know, there may be a January or February meeting, as well, where - all I am really trying to say is that I think we have to think of doing at least some parallel scheduling rather than completely sequential, because just to cover those four priority issues we have an awful lot of things to learn, but I do not know whether my thoughts, you know - Simon, how do you feel about that?
DR. COHN: Well, I guess I am - I have not completely thought through what we will be doing in December yet, and I agree with you, Jeff, that this whole issue of value and really letting the public and the wider groups speak as to where they see the value, are we in the right spot, have we started in the right spot, where there may be value in that, is I think the highest priority that needs to occur in December. Now I do think at the same time that we can begin to address some other areas, and I guess as I began to look at other items that we might be able to ask questions about - and once again, I do not in my own mind know whether I am talking about hearings or these sorts of roundtables or sorts of a combination of the two, and it may be that we mix and match depending on who is there, only because I think that in some cases you get more information from these roundtables than you do from having people just up testifying, sometimes as quickly as possible.
But there was an item here that sort of caught my eye which had to do about - especially in relationship to number one - around the standards and guidelines, having to do with the criteria to evaluate or agree on scope and criteria to evaluate those standards, and it might be a very reasonable time and a very reasonable way to begin to get into especially item one to begin to ask people, you know, if we are going to do further analysis and recommend potentially some of these, what sort of criteria should we be using to identify what we should be recommending, and I think that would be a very reasonable way to begin to move into that.
Is that a further refinement of what you are thinking, Jeff?
MR. BLAIR: I think that is absolutely right on target, because that sets us up; once the criteria are established, we then can apply those criteria to deciding how we want to analyze the information that we already have.
DR. FITZMAURICE: I am sorry; what are the criteria for again? The purpose of the criteria is to -
MR. BLAIR: Well, let me explain a little bit here. We already have the inventory, so there is a lot of information in there that kind of gives us a jumpstart on item number one. Now the question is - but the issue is that it is a compilation of data that were submitted by the SDOs; they have not been validated, and even though the SDOs really did a very good job in making it readable, informative, and relevant, nevertheless, in terms of what we are going to do with that information, if we are going to analyze them to be able to come to a conclusion, I think we have to agree on what we are driving towards. What are going to be the criteria?
Is it going to be a criteria of market acceptance? Is it going to be a criteria for interoperability? If it is going to be a criteria for interoperability, then what is going to be our criteria within that? You know, what is going to be the measure of interoperability? Is it going to be something in terms of whether these standards coordinate with each other or not? What are going to be the criteria of analysis that we will go for?
DR. FITZMAURICEC: Yes, and the purpose of the criteria is to guide us in making our recommendations and our legislative proposals to Congress?
MR. BLAIR: Yes.
DR. FITZMAURICE: All right.
DR. COHN: Well, as well as just - one is to do our work.
MR. BLAIR: Richard, you had a comment, and then John.
MR. FERRANS: We had a conference recently about vocabularies, and the output of the conference was actually a set of criteria that we should use, and I think that that exercise will be very useful and that there is some good work that has already been done from experts that we can bring here.
I think the other point I wanted to make, if we are going to have these hearings, and I was thinking last night about the business case for computer-based patient records. I think that there would be those who might argue that perhaps, you know, we should allow the market to allow this to develop rather than having either a regulation or legislation, and I think in addition to the business case of why standards are needed, I think that there should be some consideration to discussion of why regulatory or legislative effort is needed, because I personally feel that there should be some of this effort, but I think that the case has to be made explicitly of perhaps with specific examples as to why there has been a failure to rally around standards and why the standards cannot propel forward or why with some standards that are very mature that they are already in place. I just hope we have an opportunity to hear from some of the different viewpoints, the SDOs and other people, on that matter.
MR. BLAIR: You might notice that on each of those focus areas it kind of folds right along the lines you are suggesting, because there is a phase of information gathering that is followed by a phase of analysis of the information on each of those areas, and then it is followed by a third area which is, after the analysis, what kind of recommendations do we bring forth, and it parallels exactly what you said as to whether the recommendations should be funding or catalyst or legislative action or just leave it to the private sector, or what?
DR. LUMPKIN: I think we need to perhaps think through our methodology a little bit more. As I am sitting here listening to what we want to try to do, I am not sure that hearings are necessarily the best vehicle to get all the information that we want to get. For instance, on the criteria, a lot of the information that we want to get does not require an interactive environment, like a hearing is. We may want to solicit input from some of the SDOs, some of the associations, on what the criteria should be, and then based upon that have a hearing where you can do something more interactive. We may want to look at beginning to go into the December and the subsequent hearings as far as getting more input first and then using that to focus what we want to get out of the hearings.
DR. COHN: I mentioned, you know, hold that as a discussion for the December afternoon, because I think you are bringing up some very good points, which really has - I was going to bring up this issue of how are we going to work over the next year and a half and decided that it was probably not the time to begin that discussion, both because of time and because I think we are going to get a much better sense in December when we have a full half-day to discuss it. So I think that that is a topic that we fully need to bring up and explore exhaustively in December, if that is all right.
DR. LUMPKIN: The fact is if we have two hours, exhaustively is not -
DR. COHN: Well, it could be three or four hours.
DR. LUMPKIN: That will not be exhaustive.
DR. COHN: Is that all right with everyone?
MR. BLAIR: Could you repeat exactly what the -
DR. COHN: Well, the comment was that we really needed to look at how we were going to work to get the work done and the process. John was positing that in certain cases we needed to be very targeted in soliciting information and then using that to base hearings upon rather than getting the information from the hearings, and while I really disagree, I think we need to talk about that in the context of the book items.
MR. BLAIR: So you were saying that this would be something which would be part of the November meeting that we would -
DR. COHN: No, I am seeing it more as the December afternoon where we are spending it talking about the work plan.
MR. BLAIR: Oh, all right, how would we proceed? Can I make a suggestion on that, and that is that I think that that is going to wind up having different answers based on the different areas of focus.
Everybody is shaking their head.
PARTICIPANT: In agreement.
[Laughter.]
DR. COHN: Now, what I would like to - let me be a little - not transparent, but what I want to do is to finish this meeting, because I think we need to reconvene as a subcommittee for the next 15 minutes. Are there any final issues related to the Workgroup for Computer-based Patient Records?
Yes?
DR. FITZMAURICE: What witnesses would you like to invite?
MR. BLAIR: How could you pick the witnesses before we know what topics we are going to cover?
DR. FITZMAURICE: Well, I would suggest that the vendor community and the user community would be two sets of witnesses you would want, regardless of the topics, but those are suggestions for your consideration. I would not like to be here Friday and not know the kinds of witnesses you want and how to start approaching them, how to start framing the questions according to the topics that are selected. So I think we still have some work to do.
DR. BLAIR: Well, my thought on this was that, at least when I started going through those areas of focus, I started coming out with different witness lists, depending on what we were focused on, which was why I was trying to in this meeting right now get at least a preliminary target of what are the issues we are going to cover in December and then from there I think we would very readily wind up seeing what the breadth and depth of the witness list would be.
DR. FITZMAURICE: That sounds fine to me, as long as I have some guidance as to whom you would like to invite and what the topics are before we close the meeting.
MR. BLAIR: Well, then could I make this rough suggestion - and really, I do not care if we change this, but I think we have to have some target that we are driving after. Simon, if we focus on the comparable issues and the business value issues during - and I might even give it more than just the first morning - why don't we say right up through maybe through the first half of the afternoon of the first day, and that should be plenty of time, and then just arbitrarily - I am just making a stab here, and then starting on the second half of the afternoon of the first day, which would be like 3 o'clock - from 3 o'clock of the morning of the second day, we focus on area of focus number one, which is the message format standards people critiquing those, and then that leaves us the afternoon of the second day for pulling this stuff together and deciding on other things.
Reactions? Does that seem like a workable first start?
DR. FITZMAURICE: I might suggest that we consider also the content, because content is important for HIPAA, as well as for the report, and if we could get some input into content, we may want to involve some of the content committees like the NUBC and the NUCC. It might serve a dual purpose.
MR. BLAIR: All right.
DR. COHN: I feel a little frustrated, because I do not know how we are going to come to a conclusion on this particular topic in the next five minutes.
Kathleen?
MS. FYFFE: My initial reaction, Mike, is that I do not think that although we eventually do have to talk to the content committees, I do not think that it is necessary to do that by this December. I think that can wait until the spring or summer.
DR. LUMPKIN: For procedure, I would like to suggest that perhaps Simon and Jeff can have a paragraph 13 conversation.
[Laughter.]
Along with staff, and then develop that list and then email it to the rest of the members of the committee for comment and that is how we can kind of pull it, because really, I think, in past areas it has been a little bit difficult to try to pull together exactly all the pieces in a larger group.
DR. COHN: Yes, and we can certainly use the questions. It may be that we get experts in various - vendors and whatever - and we ask them all a whole slew of questions, which has happened certainly previously, also. So it may be that the questions all get handled, but they do not happen quite in the same time order as you are suggesting.
MR. BLAIR: I think that the sense I get from Michael is that if we do do that, you know, between Simon and I and some of the other folks in the smaller-knit group, that we get both the questions out to everyone as quickly as possible and the witness list out as quickly as possible so that they can be added to or we could catch the things we are overlooking. Is that what you are driving at, Michael?
DR. FITZMAURICE: You captured it very succinctly, Jeff, yes.
DR. COHN: Dr. Braithwaite?
DR. BRAITHWAITE: There was a question earlier about whether this hearing we are proposing for December should be a hearing of the working group or a hearing of the subcommittee.
MR. BLAIR: Working group.
DR. COHN: With that, I would like to adjourn the workgroup meeting and defer to John to reconvene as the subcommittee.
DR. LUMPKIN: And given the timeframes, I would like to propose a methodology, since we do have a meeting coming up in November. What I would like to suggest is that if we can find room on the agenda for the November meeting, we would do a presentation on the immunization registry EDI issues. I think that is pretty easy to determine the issues. I think we have the folks. We can get HL-7. I think there have been vendors who have been involved with CDC, and perhaps one of the states, to do a panel, and I think that would be an informative.
I suspect it may be informative for the whole committee, so we will discuss whether or not we do that as the subcommittee or the full committee, and then at November we discuss the issue in a little bit more depth of the maintenance issue of the standards, which I think we need to schedule a hearing sometime in the winter.
DR. COHN: All right. Yes, I think that is a great idea. I guess the other question is what is the current status of the claims attachment standard which we were following on?
MS. GREENBERG: Is anyone from HCFA - well, yes, Karen Trudel is. I spoke to Steve Barr[?] a few weeks ago, but you may have more current information about the current status of the claims attachment standard?
DR. COHN: I guess while she is coming up to the table, I am going to suggest that we actually have a meeting of the subcommittee and get these agenda items out and approve them for November.
MS. GREENBERG: What are you suggesting?
DR. COHN: A meeting of the subcommittee where we then go through some of these issues, in November, also.
MS. GREENBERG: In November, all right. What, about two hours? Because we have a lot of the same members. So we will have certain -
MS. TRUDEL: The proof concept on the attachment has not picked up again, because we are waiting for the fiscal year to begin. The group is still looking through various issues and starting to work on actually drafting a proposed rule, some of which can be done in advance, and what advance work we can do we will.
MS. GREENBERG: Is there sort of a tentative timeline of possibly putting out an NPRM in February? Is that correct?
MS. TRUDEL: I am not sure. I am going to have to check on this.
DR. LUMPKIN: Has there been discussion of whether or not to do the NPRM or an NOI? Again, we have had a little bit of concern on the committee about publishing a rule with an untested standard, and I am just wondering if - I know we have some requirements under HIPAA, but on the other hand, putting something out that is not quite right yet may not be the best. Has there been any discussion or consideration?
MS. TRUDEL: There has been some discussion. We are proceeding right now as if it will be a Notice of Proposed Rulemaking, but we would be interested in having your input on that.
DR. BRAITHWAITE: John, the concept of putting out the NPRM and then refining it over the one or two or three years after that, or 10 years or 20 years after that, is where we are going, because none of these standards is expected to be static. Every year some aspect of these standards must be modified to keep up with the changes in business needs, in any case, and since it is going to take a couple of years to implement even the first aspects of this particular standard, since it does not exist yet, we felt it would be better to put out an NPRM, get people started on the implementation of the small fraction of claims attachments that the standard, the first standard, will cover, and then every year it will be modified and more claims attachments will be gradually added to that standard in an evolutionary manner.
DR. LUMPKIN: Do we have a liaison to that working group?
MS. GREENBERG: Clem McDonald. He was expected today. I do not know -
DR. LUMPKIN: All right. So we will have to track him down to get a feel for -
MS. GREENBERG: I mean, immunization, I cannot speak for that stuff very well. Kathy is here. I think it would be of interest to the Subcommittee on Populations. So probably it would be something at the full committee.
DR. LUMPKIN: That is what I was thinking.
MR. BLAIR: Could I just add one little tiny thing here, and I guess I am really speaking - you know, my thought is that Simon and I probably could get a conference call together like maybe next week sometime. We have not even picked a date. We have not talked about this yet. But my thought was that since we are moving kind of quickly in terms of trying to set the date for December and what would be in it, what would be the topics and questions and all of that stuff, are there other folks that would be interested in participating in that conference call so that we do not -
MS. FYFFE: I would be interested in Thursday or Friday of next week. The first three days I am tied up all day in other meetings.
MR. BLAIR: Michael?
DR. FITZMAURICE: Any time.
MR. BLAIR: Any time? Bill?
DR. BRAITHWAITE: Yes, early next week is okay for me. Later in the week is possible, but I would have to do it from the road someplace.
MR. BLAIR: Do you have a day which is better for you? Simon, do you have a date?
DR. COHN: Well, I guess my sense would be to probably schedule this off-line. We do not need to take the committee's time to go through all of this.
MS. GREENBERG: Mike, you work with Jackie or -
DR. FITZMAURICE: All right.
MS. GREENBERG: This will be to talk about the questions and the witness list?
MR. COHN: Yes, throw our ideas together and who is going to do what.
DR. LUMPKIN: Okay, I think we have a plan, and we have five minutes before the full meeting. So I think we also need to adjourn. Thank you.
[Whereupon, at 8:57 a.m., the meeting was concluded.]