[This Transcript is Unedited]

DEPARTMENT OF HEALTH AND HUMAN SERVICES

NATIONAL COMMITTEE ON VITAL AND HEALTH STATISTICS

SUBCOMMITTEE ON STANDARDS AND SECURITY

November 19, 2002

Hubert H. Humphrey Building
200 Independence Avenue, SW
Washington, D.C.

Proceedings by:
CASET Associates, Ltd.
10201 Lee Highway
Fairfax, Virginia 22030
(703) 352-0091

P R O C E E D I N G S [3:15 p.m.]

DR. COHN: Ok, we understand that we have one of our consultants whose working with us on PMRI on the phone is that correct?

MR. BLAIR: That is correct. Walter is here.

DR. SAJANSKI: Hi, can you all hear me?

DR. COHN: I wanted to make sure we could hear you. Ok. Anyway those of you who were involved in the previous session know that I have not changed my name. I'm still Simon Cohn, I am Chair of the Subcommittee on Standards and Security, as opposed to the Acting Chair of the NCVHS today.

I want to thank you all for joining us and we probably ought to have, since we have a couple of new people at least sitting in and hopefully new members, at least introduce the Committee members who are sitting around the table briefly, and then I'll just talk about the agenda today. Actually Judith do you want to just start?

MS. BEREK: I'm Judith Berek from Centers for Medicare and Medicaid Services, I'm the liaison.

MR. HUNGATE: I'm Bob Hungate.

DR. FITZMAURICE: Mike Fitzmaurice.

DR. MCDONALD: Clem McDonald from Indiana University and Regenstrief Institute.

MR. LOCALIO: I'm Russell Localio from the University of Pennsylvania School of Medicine.

MS. GREENBERG: Marjorie Greenberg, NCHS, CDC, and Executive Secretary to the Committee.

MS. TRUDEL: Karen Trudel, Centers for Medicare and Medicaid Service, staff to the Subcommittee.

MS. PICKETT: Donna Pickett, National Center for Health Statistics, staff to the Subcommittee.

DR. HUFF: Stan Huff, Intermountain Health Care and the University of Utah in Salt Lake City, and a new member of the Committee.

DR. STEINDEL: Steve Steindel, Centers for Disease Control and Prevention, staff to the Subcommittee.

MR. BLAIR: Jeff Blair, VP, Medical Records Institute, member of the Committee.

MR. HOUSTON: John Houston, UPMC Health Systems, new member.

MS. BEBEE: Suzie Bebee, NCHS, staff to the Subcommittee.

DR. COHN: Ok, now the agenda today. We're going to start out, actually Jeff you're going to take the lead on a review of the draft of scope and criteria for selection of PMRI terminologies. And for the new members we're obviously in the midst of looking at the whole issue of patient medical record information terminology, the clinical terminologies. Then with remaining time we will take a quick reflection on our discussions around ICD and I think it's really more about what we identify as a next steps feeling that there was not a tremendous amount of correction, and then I will talk a little bit about the December hearings. And maybe if we have a chance even talk about the January hearings, but we may not have much time for that, that may be more of a December hearing issue. With that Jeff would you like to take the floor?

MR. BLAIR: Thank you Simon. There are several new folks, and of course the folks on the internet may need some perspective, so let me give you the context within which we will address the subject of PMRI terminologies.

HIPAA directive indicated that the NCVHS should study issues related to the adoption of uniform data standards for patient medical record information and the electronic exchange of that information, and make a report to the Secretary four years after the legislation was passed. The NCVHS did that in July and August 2000, it was about a 60 page report, it was called the Report to the Secretary on PMRI Standards. That Report gave an outline of the framework that the Committee would be using to proceed forward, you might think of it as a vision and a strategy, so it had the framework, it had the guiding principles of the selection of PMRI standards, and it also had ten recommendations to HHS, not only related to the selection of standards but also initiatives to be able to encourage the acceleration of standards development and promote early adoption of PMRI standards.

That framework, those recommendations and the guiding principles were then drawn upon in our recommendation of PMRI message format standards which we made on February 27th of this year and we're now proceeding with this second phase, the recommendation of specific PMRI standards also continuing to draw upon the base report, the framework, guiding principles and recommendations from the base report of July/August 2000.

In August of this year we began with the process of exploring PMRI terminologies and this is a complex issue so we're spending more time up front trying to understand and agree what our scope should be and then within the scope trying to understand what the criteria for selection of PMRI terminology should be. We had hearings on August 28th where we heard from a number of testifiers. We met again October the 10th I believe it was and we discussed our interpretations and our understandings of that, and we had sort of a preliminary summary of what we had heard on August the 8th.

And in that period of time we were also fortunate enough to be able to contract with Dr. Walter Sajanski, who is on the speaker phone, and Walter is a consultant who is going to help us throughout the process of this next year as we go through the selection of PMRI terminologies.

Just briefly let me indicate to you that the steps we've set out is that today Walter will be discussing the first draft of the scope and criteria for selection of PMRI terminologies. The second draft will include the comments and suggestions from today's discussion, and Walter will present that to us on December the 10th and 11th. And then based on those comments and changes, he will produce a third draft, which we hope will have pretty much consensus by December the 20th.

If we're able to keep to that schedule, we could then take that criteria for selection, fold it into a survey document, which because of the restrictions of HHS, a number of different restrictions, that's something as we will need the Committee itself to be able to distribute that survey, and we will distribute that survey by the 10th to terminology developers. We expect to get the results five weeks later and then I would turn that back to Walter for validation, evaluation, analysis, and Walter will then give us the results of the information we've been able to gather from terminology developers by March 25th I think it is.

Then in May we should be able to hear from vendors and users of terminologies to see how they feel about the different vocabularies and terminologies that are available and then during the summer we will wind up, if we still need any additional information, Walter will be able to validate or check that with any industry experts for additional information that we may need to resolve. This is all intended to leave for complete for a target deadline for us of September 15th when we hope to be able to make our recommendations on PMRI terminologies.

Now I said this all from the standpoint of us recommending which terminologies will be selected. That is our stated goal, our stated purpose. This is an area which is very complex and which may lead us in areas where we don't exactly anticipate. And if that happens there is the understanding that if the right thing to do is to go down some different paths, we are not closing things off to that, but we do believe that this work plan which I've just outlined would at least be able to move us forward, help us to gather information, and if that information does lead to different paths then we can do the right thing and decide whether or not we need to modify the work plan.

At this point, I can't see if you raise your hands or if you nod your heads, is there anyone on the Subcommittee who has not received the first draft that Walter Sajanski has developed? Is there anyone who hasn't had a chance to look at that? I thought I would hear somebody, I'm assume that that's the case. Ok, I'm assuming that if you have received it you've at least had a chance to glance through it. Steve Steindel has had a chance not only to glance through it but to make a number of very perceptive and insightful comments on it, so could I ask Walter if you could take, Walter do you feel comfortable in sort of stepping us through the recommendations in maybe 15 or 20 minutes and then after you've done that we could maybe give Steve Steindel a chance, Steve do you feel ok with this or do you want to do it a different way? To add his comments and questions and then we could continue the discussion until, Simon do we have 45 minutes for this?

DR. COHN: No. You have about 35 minutes total, and I think that probably Walter ought to step through this relatively rapidly because I think the assumption is that most people have read it or if they haven't, a quick step through will be appropriate, and then those of us who have comments, and he needs to hear our comments.

MR. BLAIR: Ok. Then Walter maybe if you could step us through in no more than 15 minutes, 10 minutes if you can, then that will leave time for questions and comments.

DR. SAJANSKI: Sure, I think I can do that and very quickly, too. Let me start off by just giving a little of standing on the background pursuant to the previous meeting that determined to some extent the approach documented in this report. And that was that the initial approach that had been decided upon at least as a straw man approach would put that most closely associated with the testimony of Jim Campbell, and that is the basis for which the general architecture described in this document was based. And obviously that's not a final word on that topic but as indicated it's the initial word on that topic if you will. So that's just a little bit of background.

Let me just walk through really quickly and give section by section if you will and speak a little bit about each one. We'll just start with section two and the requirement. Again this was discussed in the previous meeting on this on the 10th and 11th I believe, the need for requirements and the role of more specific requirements guiding the recommendations of the Subcommittee. And this is something that I personally feel is important and I think that the Subcommittee felt was important at the end of those discussions and that's why that is included here. And it essentially, this section talks about, gives examples of requirements that can be used to help determine what the recommendations would be used to help measure or any recommendations. Again, the goals that the Subcommittee decides on for the recommendations and the rationale again is that in the absence of such more specific expressions of the requirements, it may not be clear what the recommendations mean or what if they were to be adopted or followed what that would result in, what benefit there would be to that and so forth. And conversely if they were not to be followed what there would be lost. So in order to kind of help guide the recommendations, it gives them more muscle to whatever recommendations ultimately come out. I think more specific requirements are important. That's all I'll say about that section.

Since the proposed approach again is an architecture if you will based largely on the ideas of Jim Campbell, touching on some ideas of some of the other testifiers, and he, as I go through this I'm going to address a little bit some of Steve Steindel's comments and that may help to clarify things a little bit and save us some time later as Steve discusses those as well.

So first of all the notion of the proposed approach of the core terminology, layer two terminology and then layer three terminology, this doesn't necessarily, first of all it doesn't say that there's an existing terminology that can and should be the core terminology. The statement here is that again, based on the testimony, that there's merit to having eventually a single tightly integrated and cohesively maintained core terminology that may end up being the amalgamation of several existing terminologies, terminology models that exist today, but in the end the result will be a single core terminology.

So that's the first point that I want to make about the core terminology. Now, I listed here the four specific features of that core terminology that I think are important to achieving the goal that again, based on what I understand of the forecast proceeded by the Subcommittee and the documents that have proceeded by the Subcommittee related to PMRI standards, I see those four features as important and I think consistent with the goals that were expressed in the previous documents.

Again, I won't go through these in detail, but they have to do with comprehensiveness and availability, and certain technical features that are deemed important for standard terminology to really achieve the benefits of the terminology, which is interoperability and comparability in data analysis, all the reasons you want to have a standard in the first place.

And then some logistical and practical considerations about how the terminology will be maintained, how open it will be, how available it will be and so forth. Again, I think those are important requirements in addition to the technical requirements if the real objectives of a standard terminology are to be achieved. And I think some of that also came out in the testimony, but again that's subject to discussion.

About halfway through my time, we're on to layer two terminologies. These are distinct from the core in that they state, aren't necessarily comprehensive with respect to the domain of clinical patient care. They don't necessary prescribe to all the technical criteria that are important to data analysis, comparability, interoperability, etc. And at the same time they are incredibly being used because no terminology prescribes to all those technical criteria today and no terminology is comprehensive today and people have honestly felt the need to use some terminology, so they're in use today and they will probably continue to be in use and there's an important role for those terminologies, so it's important for any architecture that's trying to standardize terminologies in a practical sense to accommodate existing terminologies.

The layer three terminologies likewise are in use and are very, very important. And they're mentioned for administrative, financial, epidemiological, and regulatory functions, and they include the HIPAA mandated transaction codes. And again, these are different from the layer two terminologies in the sense that they're not specifically, they're not designed for capturing clinically specific information and for supporting clinical care process and the documentation of the clinical care process, yet they need to again, be accommodated and accounted for any architecture that's standardizing patient medical record information. So the way that both the layer two and the layer three terminologies are accommodating it in an architecture based on a single core terminology is through support for mapping and that is a very important point.

And the purpose of identifying layer two and layer three terminology is so that as the core terminology is created and maintained, that mapping to the layer two and layer three terminologies are taken into consideration to some extent, that those mapping to those other important terminologies is an important part of that. The diagram very generally and simplistically shows that.

Then the last piece of the document talks more about the standard core terminology and starting with why this approach at this point was preferred to some of the other approaches that were discussed, that came out in the testimony. I won't go through all that right now.

The next section, I want to make a very important point about the next section, building blocks to the core terminology. This is not, at this point is not endorsing any particular building block for the core terminology at all. It's not necessarily even saying that in the short run the core terminology needs to be any one of these terminologies or any particular tightly knit combination. It's just making the statement that there are some terminologies that are probably better candidates for the core terminologies based on the features of the core terminologies that were listed earlier than others. Some are better choices for that than others and this is a sample list of ones that may be under consideration.

The next point, again in the section that I want to make an important point about the desired technical features. This document, in this document I'm not endorsing or making a statement about any particular technical features that should be in the criteria at this point. I'm listing some that are candidates that may be deemed important that are candidates for important criteria but these, any one of these deemed not necessarily be in that final set of criteria, and this is very much subject to the discussion we may have today and during early December as to what are the features, what are the technical requirements that are important.

So this addresses Steve's comments a little bit, where he has stated that he's not sure that description logic is necessary and I agree with that, it's not necessarily necessary, nor are formal concept definitions, but whether or not they are necessary I think should be determined by the requirement the Subcommittee decides or the goal, for the goal of having a standard terminology in the first place. And if those goals can be met without description logic and the technical criteria for terminology, then that's perfectly fine. But that process of analysis needs to take place.

Kind of wrapping up here. Relationship to message standards and information models. The only points I'm making here are that terminology is not enough for certain important PMRI standardization goals and I give some examples of why I think that's true, and I think when a testifier made this point as well. However I don't think it's necessarily important in the short run to have a holistic integrated model where terminology models and messaging standards and patient medial record models and so forth are all integrated, I don't know that that's feasible in the short run. And I don't know that it's necessary to achieve perhaps some of the more important goals of PMRI standards. But again, that's something that needs to be discussed in the Subcommittee and that needs to be resolved. I'm just raising this issue here so it's on the table.

And then lastly the other practical considerations such as reiteration of more detail of some of the non- technical, non-content related issues that may be important to achieving PMRI standardization therefore may be the subject of the recommendations as well, may be an important part of the recommendations made by the Subcommittee. But again, that is something that their discussion whether it's desirable to include that in the recommendations.

That's basically it.

MR. BLAIR: Thank you very much Walter. Very much appreciate your work. I think you did an outstanding job of pulling together the thoughts that had been expressed both in August 28th as well as in October by the Subcommittee. I think this is very helpful.

One of the things I'd just like to mention just to I think help us keep focused in terms of what we can accomplish today. I'd like to have you recall when we did our PMRI message format standards, we listened, we wound up getting information from the Standard Development organizations and then we listened to the health care information software vendors that use the message format standards, as well as other users, and the guidance that they gave us significantly modified where we went with our recommendations.

And while the criteria for selection that we had for message format standards was beyond what we generally found in the marketplace, the recognition of market acceptance was very, very important. And that was reflected in our recommendations along with a set of recommendations that would serve as a catalyst for HHS to help accelerate the development of standards that did come closer to the criteria for selection. In this case it was HL7 version 3, that we wound up indicating, well I'm not going to go through the details of it, but several different recommendations to accelerate and support the development of HL7 version 3.

I'm mentioning that because this first draft, second draft and third draft, our focus really is what are the requirements, what do we really want for criteria for selection for the purpose of information gathering. It won't be until next summer before we gather information both from the terminology developers and the vendors and the users before we really make our determinations of what kind of recommendations we will be having.

So with that, Steve you had a number of other points and questions and concerns.

DR. STEINDEL: Yes, thank you Jeff. One of the problems with using markup, it tends to get well circulated because people can read it, but I appreciate the chance to, I'd also like to make a note that those of you who have looked at the markup comments, it's one of the dangers as Simon pointed out, reading stuff on the plane, it's worse trying to type on a plane, especially when it's trying to land at National.

But that in mind, a couple of overall comments as I was reading the draft. And I found that Walter's draft in general I thought was excellent. It covered a lot of good points and a lot of detail. There were some nuances in it that I think will cause some problems, especially as the government is moving forward with some of its processes and I'd like those addressed as the NCVHS process moves forward.

One area, these are just some overall comments I made, and these are subtle. If the Committee agrees I'm sure Walter can modify the draft just by changing a sentence or a word. It opens new areas such as one, SDO oversight of the core terminology. And that, an anti-process for terminology and an informational model. These three things were not considered in our original scope and those of us who have been in the terminology world for a long time realize all three of them are politically charged. I think if we delve on those and look into those we'll delay the process. It mixes a discussion of single and multiple core terminology and it's unclear in what the final model should look like.

At this point in time as I mentioned later on, and I did a lot of wordsmithing, the government is looking at a set of core terminologies. Our initial analysis of this, and what came out in a lot of the testimony on August 28th, is we do not see one size fitting all, and Walter even makes that point later on, and he just made it in the discussion. But I would like the wording of the document to reflect from the beginning that we're looking at the core being a set of inter-related terminologies, it's not necessarily going to be one terminology, and even Jim Campbell's proposal mixed three vastly different terminologies in what he proposed as the core.

And then in his model when he talked about layer two and layer three, I like Keith Campbell's definition, when you say something it should be URU. Understandable, reproducible and universal I believe is the third one. But I couldn't put good definitions on what terminologies could I put in the core, could I put in layer two and could I put in layer three. I saw a mix, and I could see myself shifting things around. I think the core should be strictly clinical terminology and I was looking at the way layer three was designed, I started looking at it as HIPAA code sets. But then I started looking at some HIPAA code sets might be falling in layer two and some in layer two might actually have clinical information in it and could fall into the core, so I had problems in defining what terminologies should go into those different layers. I like the idea of the layered model and specific terminology falling into the layers, but I think we need to be fairly precise as to what terminology should go in there.

In his section three, most of my wordsmithing in section three was just revolved what I just mentioned. I think we should be in that explicit in that section that we're not looking at a terminology but a set of terminologies for the core.

And I had no problem at all with his four criteria for core terminology, except making it plural. And then my comments I've already made on differentiating between those, the rationale for core terminologies, I really didn't have any problems with. I did have a couple of comments. One of his comments was that without a good inter-related core terminology we'd have difficulty in retrieving information and I know we're going to have difficulty in retrieving information. We're even going to have difficulty retrieving information if you have a single core terminology. Bob Dolan had a very good presentation at AIMIA(?) this year that showed us the step on how to do this very difficult task.

He talked about the issue that it might be harder to coordinate the SDO's than it would the terminology. And I think NCHIS was making better progress right now with coordinating the SDO's and I'm wondering if we might actually achieve better progress than in coordinating the terminologies.

The building blocks, again, Walter noted the comments there. I think a lot of us felt that the phrase referring to the NLM SNOMED discussions did not really have a place in this document and should be removed. As a matter of fact Betsy's not here because she's in the middle of those negotiations.

And Walter mentioned the question about description logic, that was the only one of those that I really had a little bit of a difficulty with and that's just because there really isn't a good consensus of the utility of description logic at this point.

And then the information model. The requirement for an information model in this case, you have a very clear information model for messaging. The rim is moving forward in that, it's about to be balloted as a standard, we'll see how it survives that ballot but that's not a purpose of this discussion, but we really don't have a good information model for clinical information, which is different than messaging that information. And I think if we started going off in that direction, we would delay this process.

I really think those are my most significant comments. There's a couple of others that are in the document. Thank you, Jeff.

MR. BLAIR: Walter, are you able to capture these comments audibly?

DR. SAJANSKI: I'm sorry Jeff I missed that.

MR. BLAIR: I'm wondering if you're able to capture --

DR. SAJANSKI: I guess that's a no. I heard Steve's comments clearly.

MR. BLAIR: Ok, you did, because we hear you very clearly and as long as you can then I'm just going to turn it over to everyone to say their comments, so that you can just capture as many of these things as possible, then you can come up with your second draft which you will be presenting to us on December the 10th. Oh, by the way, if anyone doesn't feel like they have the opportunity to fully describe their comments here, Walter will accept comments and suggestions up through what, next Monday?

DR. SAJANSKI: Right, in fact, I would prefer for those of you who have the time to jot down your comments, even the way Steve has in the document itself, that's the absolute best way to get your comments to me, there will be no potential for misinterpretation or for me missing anything you've expressed. So I'll certainly be documenting what people say today but it would also be helpful and maximally accurate for you to send me written comments as well.

MR. BLAIR: Ok, and on the 10th and 11th, we should have a lot more time to be able to go through this, your second draft. Are there comments?

DR. COHN: Yes, I'll talk I guess then maybe Clem has just a couple comments on this. I really thought that it was overall a very good document and like Steve obviously I have a number of questions, but Walter obviously we will send you a red-line version with comments. I guess I want to bring up and just sort of ask which have to do with scope, and it seems to me, I think if the conceptualization, it's going to be architecture will conceptually model, and I'm not sure which we're talking about here, I think they're probably the same, I find it very useful in terms of helping me think about the terminologies and putting together, and that's obviously what I always seek at this point when I'm talking about conceptual models or architectures. And so the level threes are, for the sake of having a better conversation, is really the HIPAA standards, which obviously includes things like NDC which are not listed in level three but really should be there. And then level one is this sort of an idea of a well integrated non-redundant tightly coupled set of terminologies that span some sets of domains, and obviously one of the key questions is how many domains are we talking about. And I find myself sort of surprised for example when you hypothesized that a medical devices might be a level two code where I went well geez, that seems to me like a pretty tightly important piece to the health care domain. So it just caused me to put some thinking into this one.

Probably more importantly though, and the one piece that I just want to see what other people think about, is that you seem to spend a fair amount of time specifying and discussing support and other for the level two codes. And to me the issue is you've got level three and level one and then you've got everything else. And I'm actually wondering both in terms of the word that we do as well as the surveys that we may send out, I mean we could come up literally with thousands of various terminologies that exist up there. Some local, some supported by specialty societies, some handled, you can go on and on and on.

And it seems to me that the value, and listen, I throw this out because I don't know the answer, but I'm wondering that maybe the value that we may bring to the level two codes may be more specifying the characteristics, the need for the mapping and all of this stuff rather than getting involved with them much more than just giving a couple of examples. And once again, this speaks of in terms of the amount of work that we're going to have to do. Because certainly trying to identify every level two code that might be in existence or even providing funding for them becomes a much bigger job than the other pieces that we had talked about. So that was the issue of scope.

DR. SAJANSKI: May I respond to your comments? Are you done?

DR. COHN: Sure, I am done.

DR. SAJANSKI: I agree with you about the difficulty of distinguishing between the core and the layer two and I think that's going to be, that issue surrounding that is going to be one of the most important and balancing parts of the recommendations, but I also, I do think it's also one of the most important for the following reason. That advocating on that point if you will by saying either we're not going to say anything about the layer two terminologies and anyone can have a layer two terminology or be a layer two terminology, may create problems in that those terminologies will either continue to be used and continue to be independent of the core terminology which is the thing that we're really putting for that, we have them for the standards, so that there will be no real consideration for the mapping between those, any layer two terminology and the core, which I think will make adoption and recognition of the core more difficult, so that's one extreme.

The other extreme is that the distinction between the core and the layer two will, there will be no distinction so that a large set of layer two terminology may be considered part of the core and the core itself will bequeath a large number of topical layer two terminologies, which again will not really move us much past where we are today in terms of having a terminology standard that betters of course the ultimate goals of interoperability, comparability, and so forth. So somewhere we need to think about and negotiate that so the extremes, I think, carefully in moving ahead and gather as much information about that as possible.

DR. COHN: Clem, would you like to make a comment?

DR. MCDONALD: Yes, I guess it's like coming back to a city that you haven't been at for ten years, it looks real different. That's actually my reaction to this paper. I think it's a very nicely written paper, it's a very nice conceptual piece. But it doesn't resemble what I thought I heard at the last two meetings, and it doesn't resemble what I thought the task was, which was to set criteria for picking vocabularies, was what was actually the label on this. I guess probably I'm prejudiced also because I was thinking it would look something like the same process we went through on the messages, where you've had lists and bullets and ratings and that. This is really, this is sort of penning a model of a beautiful future, which I think that by itself is good, but I'm still a little off balance as to whether this is what we set out to do two months ago.

I didn't hear any consensus that the Campbell model was the outcome of the meeting in my ears at all, and anyone else, I'm seeing other people nod agreement that they didn't hear any --

MR. BLAIR: We actually did wind up at the end of the meeting, we did kind of go around and there was at the end --

DR. MCDONALD: I think I was at that meeting, and I heard the end, and I didn't hear it that way.

MS. GREENBERG: I didn't really either.

DR. COHN: No, I think this was the second day of the last set of hearings. We're you there? It was here, and I'm trying to think if you were actually there or not. You know Clem, I guess I would say that we, I guess I heard that there was not necessarily consensus but that we were trying it on for size. To see if this would help us and the question is if you've got a better way of doing something that helps us rationalize and make sense of the world of terminologies --

DR. MCDONALD: I heard it come out that there's a lot of despaired views, I heard people talking about whether we should have, just pick a couple or we're going to make a coherent one or we'd have one single one, there were two or three different I thought, there was definitely the spokesman for having one single terminology and everything would map to it. I just didn't come away what that set of--

MR. BLAIR: Let me piece back on this because maybe the concern you have, at least as I listen to you, my thought is that we're not as divergent from your thoughts as you might have thought, in the sense that the exercise we're going through right now isn't so much for saying what weight we will put on these criteria come June, July, and August, or even whether we'll keep all of these criteria by that time. By that time we will wind up getting information from the terminology developers --

DR. MCDONALD: Let me distinguish the two different issues. Again, I think this is a beautiful conceptual piece. I didn't, I wouldn't sign my name as having heard this at that meeting. That's all, and I know there's a couple others. The second thing is, there are some parts in here that says criteria, but it's like two paragraphs. That's what I thought we were building.

MR. BLAIR: The criteria right now is sort of a tool. It's a tool for helping us zero in on what should be the questions that we should ask the terminology developers during the first quarter of this next year to gather information. So if we start from the basis of what is the criteria we might use to select the terminologies and develop questions based on those criteria, then at least we hope to be able to get information that's useful to us when we get to the June, July, August period when we're actually deciding how we'll wind up choosing.

DR. MCDONALD: It just doesn't look anything like the document you had last year for the message centers. It doesn't look like a criteria document.

MR. BLAIR: Well we actually won't be pulling together the criteria document until after these first three drafts. We're going to use these first three drafts to pull together the questionnaire.

DR. MCDONALD: Well this is titled Scope and Initial Criteria for the Selection of PMRI Terminologies, so that's why I thought that's what this was supposed to be.

MR. BLAIR: But it's only the first draft and the second draft would go through on December the 10th, the third draft we would receive by December the 20th, and it would be the third draft we would use to develop the questionnaire.

DR. SAJANSKI: Can I make a point here Clem? You're absolutely right that the initial first draft doesn't contain a lot of details about the criteria. The logic there is that because this model is a little bit different or perhaps quite different than what was done with messaging standards, that it was important to make some decisions and reach some consensus about high level models and for detailed criteria, for example, for each of the three layers, were listed because if a three layer model isn't the right model, than it would be a waste of time to go through and assign criteria to each of the layers. So that's why that information isn't there at the level of detail that you may have been expecting.

Another clarification, I'd like to just, just from my memory about the last meeting. The second day of the last Subcommittee meeting I believe we read a written statement from you Clem because you, I think you were not available to attend that session and that's probably why you don't recall hearing --

DR. MCDONALD: So I haven't lost my mind.

DR. SAJANSKI: The third point I want to make is part of a general direction is that this underlies in my opinion, this underlies the importance for thinking at least a little bit more about the requirements of the standardization activity for terminology, because it may be that the requirements in this area are such that selecting, deciding on a set of criteria and selecting a set of terminologies to be in the standard, that that process will not result in, will not meet the ultimate requirements that we all have in the back of our minds or at a high level regarding really progress with respect to data comparability, and interoperability and so forth.

I'm not saying that's necessarily the case but I think it's important to consider whether that may be the case and if not, consider how a group of terminologies that are loosely coupled and selected according to criteria would meet the goals of interoperability and comparability and so forth.

DR. HUFF: I'd like to make a few comments. I've had a chance to review this. Again, I would just echo the comments made by others that this is a well written document. Whether it continues in this exact form or goes forward, there's some issues that I just wanted to just get on the table and make it part of the discussion.

In terms of the criteria, one of the things, and this comes out could be included in a couple places, but this is specifically in section 2.1 about the intermediate level requirements. I think it's important to assert that all hierarchies are created for a purpose and once, I think what that means in terms of these requirements are, this has to be the core terminology has to be structured in a way that people can make new relationships that suit a particular purpose. That's my assertion.

I think for purposes of discussion it means that that's an issue that somehow we need to address as people decide whether that's an important characteristic or not. So it's not important that I assert it but I think it's important that it gets discussed and people have an opportunity in future sessions to say whether they think that's important or not as well.

I would second everybody's comments in saying that the document seemed to be of two minds. It talked about a single terminology and I think it should be clear from the start, this is especially in section three, that what we're really talking about is a core terminology that was created from more than one source, if that's what you really intend. And I think it is by what's said later in the document.

Another point that I would make and this is in section 3.1, bullet three, that talks about that core terminology should be developed and maintained, be open to efficient process. The next sentence, at the same time the specific work of creating and maintaining the core terminology should be undertaken by professional experts who can maintain the desired technical properties of the terminology while expanding its domain coverage, etc. I think there's an alternative there again that should be discussed and that is the alternative approach is to have very strong tools, distribute the work and have a very strong central editorial process.

And that's different than thinking that you have everybody in one building and everything comes into that, into one large workgroup that tries to do all of the work. So I think there are viable alternatives to having sort of a single one shop where all this stuff comes and I think there are other ways to attain the goals of the integrated terminology that don't necessarily mean that it's one big tent with everybody inside there.

I would underscore in bullet four in that same section, I think we really have to get input from people about how, about IP encumbrances if you will. What I mean by that is that it's one thing to talk about economically and legally feasible, I think those things actually pale in comparison if this core terminology is encumbered even with the width of intellectual property, that means I can't make useful deliberative products from it. That just shouldn't be, and again, that's just my opinion, but I think we want the opinion of those who would use this terminology.

I think the last thing is, not the last, the second to the last thing, this is in section, this is a comment in section 4.4 and that is, and this is where it's talking about information models, reference information models, etc. And I don't know that I would change anything that's stated there but I would just voice an opinion that to comprehensively link the terminology to reference information models and do it globally is very difficult and will take years to do. However, there are some linkages that are more important than others and in fact we could get huge benefits from making those simple linkages. So I mean if we just say things like we're going to use for representing lab data, this is our reference model and we're going to use link codes for the observation ID's in that, we get huge benefit from that. And if you said in medication orders, we're going to use this model for medication orders, than it could be more or less the HL7 rim we set in, and in this slot we're going to use RX NORM drug codes, that would be huge benefit to people and you would get huge benefits where there are high volumes of messages and where the content of those messages is very clinically important. To be comprehensive is truly difficult. To get huge benefit I think there's some things we could do, and so I wouldn't dismiss it out of hand.

The final thing is in, my final comment is in section 4.5, and that is practical considerations. And the thing that came to my mind in terms of practical considerations are sort of three separable issues about this core terminology. What content is in there, that goes back to those building block terminologies, what's in there. Second is, what's its structure? Is it structured like SNOMED RT? Is it structured like the UMLS Metathesaurus? Is it structured in some other way? And the third thing is, who is the organization? Where does it live?

And with the organization part it can really be broken down into two parts with two sub parts. I mean is it a private organization? Would this core terminology live in a private organization or in a government organization? And within those two options, does it live as a new, it could be an entirely new private organization or it could be some existing private organization. If it's a government organization you have the two options, should this core terminology be supported by some entirely new government division that's purpose is this core terminology? Or for instance should it have a home at the National Library of Medicine, at CDC, at CMS, some other existing government agency that has experience in terminology? And I think those are all separable. You could choose SNOMED content and SNOMED structure and still have the home of it be a government agency.

That's the part that I really wanted to emphasize is that choosing particular content or particular structure shouldn't dictate the choice of where its permanent home is. And those, I think we should go through the options and actually talk about the ones that we think are viable and then get input from those who provide testimony about what their feelings are on those issues. Those are my thoughts.

DR. STEINDEL: If you don't mind, Betsey sent some comments, you can be at the meeting, I'm not looking at the time, very early this morning, do you mind --

DR. COHN: Steve, your going to do it in about two minutes because we have to move to the next items.

DR. STEINDEL: It's very quick, it's very short. This is from Betsey and I'm going to just quote. "From my perspective I would think that the outcome of the process should be to identify a non-overlapping set of core terminologies that taken together cover the waterfront of interest. All members of this core set should be present in the UMLS Metathesaurus, probably with an added attribute indicating that they are part of the U.S. core clinical subset. The Metathesaurus can then be the vehicle for constructing and distributing the mappings between the core clinical set and other vocabularies of interest including the HIPAA code sets." And that's really all that I needed to read.

MR. BLAIR: Ok, let me close then by simply indicating that please, everyone, I think Walter indicated that it would be most helpful if he gets your comments, even if you have articulated them here today, in a written form where he could reference them accurately and make sure he doesn't miss anything as he begins to pull them into the next draft.

May I ask, and this has been a practice our Subcommittee has maintained for the last several years, as you send that to Walter would you please copy the rest of the members of the Subcommittee and staff so that each of us has an understanding of where the comments are being directed, and it will also give the rest of the Subcommittee members the opportunity to comment to Walter on an on-going basis?

DR. COHN: Jeff, thank you.

DR. MCDONALD: Just the process, I'm a little worried about this. We've got a very large document, well written document, but I worry about how do we, it's not edits that I'd like to see, I'd like to see it be able to represent some of these concepts such as Stan mentioned and Betsey mentioned, there's a lot of overhang in the document that's not needed to be able to put out these bulleted points. I mean it really takes a very strong position, it may be deeper than some of these other points, some of the other opportunities for like Betsey just described, or Stan described, and how do we give those things enough presence in this otherwise deep strong document that has a very strong position in one direction?

MR. BLAIR: Well, I think that we can. When I was listening to both your comments and Stan's comments, the feeling I was having is that there's a set of criteria, and I keep thinking of the criteria in terms of how we can turn these into a question to the terminology developers to gather information. There's a set of criteria which indicates the purpose and the intent of their terminology. There's a set of criteria in terms of the attributes and domain coverage. And then there's a set of characteristics like especially those that Stan indicated in terms of you might call them business issues where they house, how is it done, getting onto maybe cost of royalties or all those other things. So I would think that all these things could be turned into questions to --

DR. MCDONALD: No, I agree, what I'm looking for is the possibility is if we could thin this down and make it start as a thinner document.

DR. COHN: As a bulleted work piece?

DR. MCDONALD: Well maybe not that thin, so that it's more neutral and we can add these other things in more easily. And I see Steve is nodding, I don't know if that means he thinks I'm funny or whether he things that’s a good idea.

DR. STEINDEL: Nicely put. I agree Clem.

MR. BLAIR: I think the only reason that this was presented the way it was is so that as we start to think of criteria for terminologies we at least come to agreement among ourselves that the criteria for what, for lack of a better phrase, might be considered core terminologies might be significantly different than the criteria we decide to pick, for lack of a better phrase, at level two.

DR. COHN: Yes, I think certainly a lot of the thickness of this document is examples and discussions and whatever, so I would think it would be easy to tighten it down a little bit, one that could be built back up again. Obviously we will talk about this more in December, we're looking for everybody to send in their red-line versions to Walter. Walter, thank you very much, we appreciate it.

Now, let's move on to a couple of other issues. The next issue is trying to figure out what in the heck we're going to do with ICD-10 based on that conversation. And I think I have perhaps a draft proposal to make as well as a timeline that I was mulling about and then we'll talk a little about the December hearings and all of this.

Now, first of all I think we're in a bit of a, I wouldn't say a stew, but given that two of the experts on the Subcommittee that know a lot about terminologies are currently recusing themselves it makes, this is a difficult area to move forward in to with a tremendous amount of expertise, but clearly what we heard during the discussions --

DR. HUFF: When we get done we can recuse and just cancel each other.

DR. COHN: That might work. I don't know, we could arm wrestle or something. But I think we heard in many ways a confirmation of I think our scope, which is obviously in terms of diagnoses focusing on moving from ICD-9-CM to 10 and trying to understand the costs and the benefits. And geez, if the costs are way out of line in terms of what are the benefits, if we can identify that, are there ways to do this in a way where we achieve many of the benefits and decrease the cost significantly. Maybe I'm being simplistic but I sort of see that as sort of the work that we sort of need to do around ICD-9-CM.

Now in terms of procedures I'm hearing sort of at a minimum we need to be looking at similar issues around moving from vol. 3, once again, the scope is institutional, we decided that we were not going to go off and deal with the whole single procedure coding issue, which I sort of heard pretty strongly. But in the sense of institutional procedures, that we were really looking at a minimum moving from ICD-9-CM vol. 3 to ICD-10-PCS with a similar sort of question about what sort of benefits, what sort of costs, and then are there ways by doing things a little different that we could get things further.

Now the one piece I don't, and I heard something and I don't know quite what to do about it because people were mentioning this phrase about ready to go, the X procedure or classification was ready to go. And I certainly would agree with CMS that I think we do believe that ICD-10-PCS is ready to go. I don't know if there's anything else ready to go. I mean I just don't have that knowledge at this point.

And then the question is, is do we ask the consultant as part of their scope of work to have them independently, and once again this is not something that any of us would, I mean this is a full political issue, but is there anything else that's ready to go, should that be evaluated, be it other international code sets or anything else. And I don't know if that's something we even want to put in the scope. I will leave that as a question because we could spend the next hour and half talking about that.

Now what I think we need to do is we need to come up with a plan, obviously get an independent contractor to do whatever work we decide needs to be done, and I'm looking at people such as Ed Sondik and Marjorie as well as Bill Yasnoff to help with sort of getting increased clarity about all of this. I guess my hope would be, and regardless of what this other question is, what scope we decide, that we would try to have this work done in time where it could be presented at our May hearing.

Now I think we're also asking for others in the industry, recognizing that we are doing a piece of work that we know others will be looking at the same issues perhaps with different eyes, that if they have other cost benefit evaluations that they've done, what we should do at our May hearing is both hear from our own results but also invite if there are others, if other work has been done in this area we should also hear at that point, with the idea being that we would in June come forward, present our results as well as reference any other work that we think is good or otherwise critique it to the full Committee for a recommendation.

Now, does the timeline sound ok? Is this about what people thought we were supposed to be doing? We'll bury the scope issue on procedures for a second, but does that make some sense in terms of a timeframe as well as plan?

DR. MCDONALD: It makes some sense.

DR. COHN: Some sense.

DR. MCDONALD: I thing that makes good sense is if there's private work has been done, because we actually said that at a previous Committee, that they could present it, too.

DR. COHN: So at the May hearing.

MS. GREENBERG: And hopefully the intent would be for the contractor to talk with some of these organizations so it shouldn't, obviously not to be doing this in a vacuum, particularly the ones who identify that they have done some work, the benefit from that, and there's no point in totally reinventing the wheel. I would hope that we would have a contract in place and have some preliminary, not results but, we would interact with the contractor, the December meeting might be too soon, but certainly, let's see when is the next meeting after that? In January, again in February, so that we don't want something to come forward in May that wasn't what you wanted.

DR. COHN: Marjorie does the timeframe that we're describing overall? I think it's reasonable, we don't want to spend forever on this one and yet we obviously want to, we need some data.

MS. GREENBERG: I think, my understanding that the Department can move along with this work as it sees fit but it will not obviously issue anything prior to these results. There's no reason why you can't get started working on things that the different agencies would like to move forward with. But I would certainly hope that the Committee could come to some closure on this at the June meeting, which will be a full year after the original letter recommending an NPRM was brought forward. If this May schedule will allow for that, fine. But my concern is that, actually I'd rather hear from these other people who are doing cost benefit studies or who have information to share, I'd rather hear from them before May. Because I think May is a little late, it would certainly be late in the process for the contractor and to only have that leave probably less than a month before the June meeting.

And as I said, I think, you could talk about this for the next ten years and I think it would be good to get some commitment that the Committee is going to make some recommendation in June. I would say let's try to hear from these other people sooner rather than later.

DR. COHN: Steve and then Jeff.

DR. STEINDEL: Simon just as a practical comment reacting to Marjorie, if we are going to move on this type of schedule I think we need a draft scope of work to finalize at the December meeting, which is just three weeks away.

MS. GREENBERG: Well, we have a scope of work, draft, no, we don't?

MS. PICKETT: We've been working on questions as part of the process but we still need to have some additional information to include in that.

DR. STEINDEL: So we could award the contract by the first, around the first of the year.

MS. GREENBERG: We'll have, we'll probably send something out to you before the December meeting, I think we definitely have to reach closure on the scope at the December meeting.

DR. COHN: Jeff and then Robert.

MR. BLAIR: Early this morning when I was listening to a number of the comments, they kind of drove me to a number of observations so I'm going to ask Marjorie if these types of things can be folded in to the statement of work for the "cost benefit study." I guess it was Carole Bickford who was indicating that other things other than straight costs might need to be included. I'm throwing this out as ideas just to know if they're feasible, but patient safety is a major issue. And if ICD-10-CM and ICD-10-PCS will facilitate better patient safety than if we have the ability within the scope, our budget, our timeframe to be able to get some indication of whether or not that it can make a difference, I think that that's a factor that if we can include would be good.

The other piece I probably feel more strongly about. The one that I feel strongly about is that when we do whatever comparison we do, that we break it into at least three sections, not two, not a well you stay with ICD-9-CM versus you make a transfer to the ICD-10's. If you make a transfer to the ICD-10's and you put in the implementation costs, you just about bury the equitable measurement. I think if you divide it into three things, where you say what's the cost of staying where we are for the next five to ten years, what is the cost? What is the benefit or impairment of benefits if we stay where we are and project that?

The other piece is the transition costs separate, what does it take to do the transfer in two years, three years, four years, five years, the transfer costs. And then the third thing, independent of the transition costs, is once you're at ICD-10, what is the cost benefits from that point on, independent of the transfer costs. If we can see those three elements independently, we could wind up coming up with a much more wise evaluation than if we bundle the implementation, or rather the transition costs with one alternative or the other.

DR. COHN: Jeff, thank you. Bob?

MR. HUNGATE: Jeff has said a lot of what I was thinking about. Also it seems to me that there is a time that you're going to make a change and is it really a matter of whether or is a matter of when that we're talking about here. You do have to move to the next world some time. When these are broken they're broken. And it seems to me that it gets more expensive if you wait. And I don't know how that gets expressed in the cost analysis. The opportunity.

DR. COHN: Clem and then Steve again.

DR. MCDONALD: I'm going to sound like a broken record. The problem is we shouldn't be using these codes with structure in them, that's why it's so hard to change each time and I just like to get on the table. Where we really should be making a change is something where you get out of these structured codes and then we won't have this shift ever again, there's other ways to do it that are easy, so that's one thought.

The second thing is I'm just worried about if we go to an expert who's good, and there's some places we know, they really know how to do cost benefits, if we make some very complicated set of prior division, I had trouble following what that meant, and I'm not sure that the contractor would follow what that meant, dividing it in three pieces. I think you really want to get a fair balance, cost benefit assessment.

The third thing is, and this is a sneaky bad thing. I was challenged at the break about why I was taking certain positions, and I think I know why but I don't want to give that all right now in public, but it would be really interesting to know if we could get a side discussion about what really is the difference between, I don't want to bring PCT into this strongly, but why is it that it's got, there is, it's different, for doctors or non-doctors actually because there's, doing procedures in a hospital and how big are those differences that they need differences and how would we come to a future world where we wouldn't be having such subtle things make a need for difference. And how much does it really cost to use the alternative, what's the real prices. Some of those things which are what the obstacle is maybe to the alternative. And that isn't an alternative to the thing but just to understand, maybe it really just is different, the facility costs, the room, the operating room, that's what we're talking about, but the codes don't look like we're talking about that on either side. They both look like we're talking about procedures. And if we could really understand, the world understand what these subtleties are instead of feeling like we're maybe being hoodwinked, we could make decisions easier.

DR. STEINDEL: I'm really, in a sense I'm going to echo what Clem is saying. If we are going to open up a study and call it a cost benefit analysis, an impact analysis, I don't think we should take off the table the idea of a single procedure coding system. We need to bring that into it. This is what Clem is talking about --

DR. MCDONALD: Not full borne, just sort of just to understand the picture.

DR. STEINDEL: Understand what the processes, this is what Barbara was talking about, this is what we're told the rest of the world is on, this is a stand that the NCVHS has taken, and if we're paying for a study, and anything that we implement, we even heard this from CMS, it's not going to happen tomorrow, it's at least four or five years down the road before the process is put into place. So we have to live with vol. 3 of ICD-9 for the next few years, and we've got to put things out of place on the book shelf for that period of time, and if we're going to have a report in May I think the report ought to look at that subject in a little more detail, so we have some idea of what the cost of that will be and what the problems of that will be.

DR. MCDONALD: I confess, I wasn't going that far.

DR. STEINDEL: I know you weren't.

DR. MCDONALD: I was just trying to say so we get a perspective such that if those things we'd understand it, it just seems so confusing and insensible.

DR. COHN: Karen, do you want to comment?

MS. TRUDEL: I'm really just kind of reacting off the top of my head, but I honestly do not believe that with any amounts of money that we have available to us, we can do that comprehensive a study by May. Of all of those different factors and all of those different moving parts, I simply do not believe it.

MS. BEREK: Can I just add, for us to get something done four or five years from now, we have to start now, so you can't have a study that drags into that process if what we're going to do is put forward a rule and do a study that's going to influence the putting forward of that rule, or the contents of it as it becomes a rule, and then turn that rule into something that is programmable and operational.

So for something to happen four or five years from now, we have to be in the process now, and I would love to be able to say to you that it is true that we have a more flexible system, but we don't. So I really think that we need to what we can done by May, in order to keep this train moving, and if we can do a whole big broad study by May, I don't care what kind of study we do, I just want to keep on the timeline. I'm being perfectly honest with you, in terms of the interest of CMS, more information is better. We're not saying do a narrow study because we don't care what the bigger picture is. But what we're saying to us is that we are in a position now where we need this process to begin, to move so we can begin to change our system.

DR. COHN: One that's sort of observant, I'm certainly the last thing I want to do is get involved in a single procedure coding system discussion because we could be here until 11:00 tonight. But indeed there has been a lot of work done on that. There's a GAO study that looked at it, there was obviously NCVHS ten years ago, I don't know that we necessarily get a long way by trying to replicate all that work. So I think maybe by doing a slightly narrower focus we might actually be able to do something that might help the country. So I think it's once again, divide and conquer, and maybe not perfection but maybe a couple of steps forward, these are sort of my mantra on a very good day. Ed?

DR. SONDIK: I would think given the time, I think time is a critical factor here, because I'm not sure we're going to find a contractor who can put everything together. I mean actually I think that's impossible with this because from what I heard the objectives were really not all that clear for people were talking about different types of benefits, different aspects of costs and so forth. So I think what's feasible is to put together a clearer picture of the issues, to put together some quantitative information on the magnitude of the different options, of the change, what a change would actually mean with some sense of the magnitude of that, which didn't come up today.

And I think outline as part of that a variety of different costs, a variety of different benefits, some of these other dimensions would come into it, which I think could then be a basis for decision making. And I think the point that came up about when is important, because I think that is part of the decisions, actually when to do this, so staying with the current systems if you will for the next decade is an option, I'm not saying it’s a good option, but it's an option, and that can be characterized or staying with them for the next five years, has some implications as well. So I think the person putting it together can give a, can be able to put together a presentation of all of this that would enable the Committee to get a pretty good handle on it.

DR. COHN: Ok, I think we're sort of all reaching agreement on what we should try to do. Now I'm going to be deputizing a number of the staff to work with me and I'll see who else I can get from the Subcommittee to sort of look at some of the pre-versions with the idea that we'll bring back a project proposal in December for us to take a look at, and hopefully we'll be able to get started after that if everyone's ok with that plan.

Now, I'm trying to think what else, surely there was something else on that but I'm quite frankly blanking on, I'm sure it will come to us over the next day, maybe over wine this evening we'll be able to debrief a little further.

Now, let's talk for a minute about the December meeting, which obviously now has a new item which will be discussion of that scope of work, and hopefully coming to final agreement on that. Currently the plan is that this is the time for the yearly DSMO reports, and I'm sure this involves not just the chair but all the DSMO's to sort of talk about sort of recommendations for the year as well as potentially some thought about where we've, what's happened over the last year. And I guess my hope would be is they might have some views about code sets, since that's an issue for them I think as well as for us. I don't know whether they will or not but obviously we'll be hearing from them.

Now, the next piece of work for December I think is something that's been on the agenda now for a while, which is looking at ways to improve the HIPAA process. And once again I don't think there's answers here but I think that there has been work both at the federal government, there was a commission that was looking at improving administrative burden and all of this, as well as I know WETE and others have maybe not answers but at least some thoughts about ways that maybe this whole thing could work a little better and if the DSMO's are here also it may be a time for a larger conversation.

The third piece is obviously, hopefully by that time we will have some view from the ASCA database of potentially some of the learnings from that information that might help us figure out what it is we need to publish in the way of best practices, and maybe after that meeting we can actually begin to do some work in that.

There is obviously the issue of the PMRI scope and criteria discussions. There are a whole bunch of other issues that are sorting of hanging out and I don't know whether we'll be hearing from then in December or not. I mean one of them is the issue that we had heard, there are certain issues that we had earlier in the year about the HCPCS National Panel and coordination between the level two HCPCS and level one HCPCS and we were supposed to be receiving a report back from the National Panel, with I think some of their thoughts about all of these things, and have not heard back from. If there's time on the agenda and they're ready we could certainly hear from them at that point.

There is also the whole issue of DMS-4 and how that's going to work under the new world of HIPAA, which we know, my understanding there was supposed to be attorneys talking and I know that we have not heard a report back from them about that at this point.

Now the other thing that will happen in December is I think we'll be sitting down and doing some planning for the January session and I think as you know January we have scoped out at least some time to talk about the issues of alternative health care. I don't know whether Kepa will be taking the lead working on that or whether one of our new members might be enjoined to help with that discussion but we can talk about that one. We've also, and I think there's Richard Mayhem, Richard thank you for coming.

Obviously we've asked Richard who's from the National Center for Complementary and Alternative Medicine, which is part of NIH as I understand, to sort of assist us with putting together both, hopefully providing us with some background, helping us put together some information either before or at the meeting, helping us with putting together panels just because quite frankly I think the Subcommittee is not that familiar with the whole area, and I think it includes such basic questions as the nature of these groups, what are their needs in relationships to code sets, are they billing things electronically, do they need to bill these electronically. Once again, sort of fundamental questions, and they help us we begin to think about the issues of alternative and complementary health care in relationship to the HIPAA electronic transactions.

And we're hoping that we'll be able to have a slightly more formal conversation, because I'm already running over ten minutes already on this one, but I think those are the scope of things that we're hoping that you may be able to help us with, and we obviously want to thank you for being involved and being willing to come.

So that's sort of the plan for December. Do people have comments? Are we missing anything big? I'm not hearing any comments, anyway that's really about it. Now the upcoming meeting dates as you know for the December meetings are December 10th and 11th, and then for the year, and then next year we have three sets of hearings already scheduled, January 29 and 30, March 25 and 26, and May 21 and 22. And obviously those are separate from the full Committee meetings.

Those who are new to all of this will observe that this is one of the hardest working Committee's that I think the federal government has, and this is a very hard working Subcommittee because as you see we're trying to deal with a lot of activities all at once. Well, with that we will continue the discussions and we will adjourn this meeting. My understanding is is that the next meeting, which is the NHII Workgroup, which is being chaired by Jeff Blair will be starting momentarily.

DR. SAJANSKI: Can I ask a few questions?

MR. BLAIR: Walter, that only have a little bit time on our NHII thing. So please ask your questions and we'll try to respond to them as quickly as we can.

DR. SAJANSKI: Basically one question, if the transcripts to the meeting that was just held is available and I could get my hands on it, there's no need for those of you who made comments to redo those comments in written form for me, I don't want to create busy work for anyone. Is that transcript available to me?

MS. GREENBERG: Generally the transcripts are available in ten working days after the meeting, so it certainly when it's available we will definitely, we will post it on the web-site for that matter, but we would also be happy to make it available to you. But that would be ten working days is going to be --

DR. SAJANSKI: Yes, that's not enough time.

MS. GREENBERG: Not enough time for you I don't think.

DR. SAJANSKI: Unfortunately, I would like to do that before we send me written versions of their comments. And the only other thing is we didn't really discuss this very much in the meat of our conversation, but if there are those of you who have other requirements that you'd like to articulate either at the intermediate level or use cases, specific use cases along the lines of things in the documents, those would be very welcome and would be very helpful as we move forward. That's all I have to say.

MR. BLAIR: Thank you Walter.

[Whereupon, at 4:43 p.m., the meeting was adjourned.]