[This Transcript is Unedited]
Hubert H. Humphrey Building
Room 705A
200 Independence Avenue, S.W.
Washington, D.C. 20201
Call to Order and Introductions, Review Agenda - Jeffrey S. Blair, Chair
Review of the Fourth Section of the Report
Continuation of Discussion From Previous Day Following Discussion of MOU
MR. BLAIR: Good morning. Welcome to the CPR Workgroup. Welcome to the National Committee on Vital and Health Statistics, the Workgroup on Computer-Based Patient Records Systems. Our focus today -- well, our focus today is going to be on reviewing the fourth draft of the report to the Secretary on uniform data standards for patient medical record information.
In particularly, since this is our fourth draft, the previous drafts, we have kind of concentrated on the earlier section. So, today we are going to be focusing on Section 4, which is on issues, observations, assumptions and recommendations and then later today on Section III, which is the overview. And if we have time, we will go back over other parts of the document.
I am with the Medical Records Institute. So, that kind of completes my introduction of myself at this point. What I would like to do is for each of our committee members to introduce themselves and then for the rest of the staff that is here to introduce themselves. If it is possible for each of you to get to a microphone for those that are listening on the Internet.
Simon
DR. COHN: This is Simon Cohn. I am the national director for health information policy for Kaiser Permanente. I am the chair of the Subcommittee on Standards and Security for the NCVHS and, obviously, a member of the workgroup.
MS. FYFFE: I am Kathleen Fyffe. I work for the Health Insurance Association of America. I am a member of the National Committee and part of the Workgroup on Computer-Based Patient Records.
DR. FITZMAURICE: I am Michael Fitzmaurice. I am senior science advisor for information Technology to the director of the Agency for Healthcare Research and Quality. I am one of two government liaisons to the National Committee on Vital and Health Statistics and co-lead staff to this Computer-Based Patient Record working group.
DR. SMITH: I am David Kent Smith. I am here representing Dr. Kolodner and the Veterans Administration. I am the chief clinical officer with the GCPR Framework Project.
MS. AMATAYAKUL: I am Margaret Amatayakul under contract with NCHS.
DR. YASNOFF: I am Bill Yasnoff. I am associate director for science in the Public Health Practice Program Office of the Centers for Disease Control and Prevention and I am staff to the committee.
MS. BEBEE: I am Suzie Bebee with the National Center for Health Statistics and staff to the committee.
MS. HUMPHREYS: I am Betsy Humphreys, associate director for library operations at the National Library of Medicine and staff to the committee.
MR. BLAIR: Do we have other folks that are in the audience that could come to a microphone and introduce themselves?
MS. FOULKES: I am Mary Foulkes from the FDA CBER.
MS. GUILFOY: Helene Guilfoy from In-Source Group, health care consultants.
MS. MIASETT: I am Jeanine Miasett(?) with Aspen(?) Publisher.
MR. BLAIR: Anyone else.
MS. WOLFORD: Hi. I am Heather Wolford from the College of American Pathologists.
MS. ALT: I am Vivian Alt(?) from the National Library of Medicine.
MR. BLAIR: Okay. The fourth draft, which you have copies of in front of you, was also distributed electronically to all committee members and staff members electronically on March 21st, so a number of folks have had the opportunity to read that over prior to our session here. Dr. Michael Fitzmaurice has done a fantastic job of carefully, thoughtfully going through the document and editing that --
MS. FYFFE: Excuse me, Jeff. May I interrupt? Kepa has just walked in the room. Perhaps we can have him introduce himself.
MR. BLAIR: Excellent.
We have another committee member, who has joined us, and we would like him to introduce himself.
DR. ZUBELDIA: I am Kepa Zubeldia with ENVOY Corporation.
MR. BLAIR: Thank you. Okay.
So, Margaret has an electronic version of that, also with some of the observations that I made also on these additions and we are in a position to go over all of them. In addition to that, Dr. Cohn has carefully read through the document and given it a great deal of thought and has observed that there may be some opportunities here for us to begin to maybe improve the way we have organized the recommendation section.
So, I am going to ask Dr. Cohn to articulate some of his thoughts in terms of what we might consider in terms of reorganization.
DR. COHN: Jeff, thank you very much. I actually just want to just make sort of a general comment about what I think is the overall intent of the day. Obviously, I think we have struggled mightily and you have my profound thanks for what I think is overall an excellent report. I think we have done a tremendous job in terms of developing the overall case for the need for acceleration of efforts around PMRI standards.
Obviously, today, the focus has to do with the recommendations. The one sort of point that I would make, I think, for everyone just to reflect on is that the important case we make, the most important part has to be recommendations and actionable recommendations or else our case, as interesting as it will be will be just another government document that has been produced.
So, it really speaks of, I think, an important focus for the day and we should not try to move through this too rapidly.
Now, to my view, the recommendations -- there are a couple of different issues and I would speak of almost an organization of how we proceed forward. As I have looked at the recommendations, I have some concerns that because of the structure we have imposed on the recommendations, in other words, having them based on focused area, that there is a tremendous amount of redundancy. And for those on the Internet, be aware that we are currently talking about recommendations, which is probably a little much for a report of this sort.
As one looks at the recommendations, there appears to be the same recommendation occurring in multiple different focus areas, which to me speaks of a need for us to consider a way to organize this, to streamline it. Now, that is, I think, the number one piece that we need to talk about. We may not need to come to complete closure on this because I think the organization is an iterative fit with the recommendations.
Jeff and I have talked and I think we need to come some agreement on what the organization of the recommendations ought to be or if there is a better methodology. Then we need to look at the recommendations.
To my view there are two questions on the recommendations. Question No. 1 is what about the current recommendations and then the other question is is what else. Hopefully, as we finish that off, then the question gets to be is does any -- does the current organization or any new organization we impose on it still fit.
So, this is sort of how I look at the activities of the day. I don't mean to take the -- the usurp Jeff's role at all, but, obviously, I have been mulling through these recommendations a lot, as I think the rest of the workgroup members have. I think we obviously owe it to ourselves and to the Secretary to do an exceptional job on these.
Now, having said that, I don't propose to tell you what I think is the perfect organizational structure. I would observe that a number of the areas, focus areas, that we have discussed, which include message format standards, medical terminology, data quality and the national health information infrastructure overlap to such an extent that it is almost impossible to disambiguate them. That is one of my more favorite words.
Indeed, if we think about the issues of interoperability and comparability, which themselves are very connected concepts, it is sort of like you can't fix one without the other without the other. So, there is a tremendous amount of overlap in all of this. The fact that there has been such an overlap in terms of just the concepts and the terms -- and be aware that, obviously, message format standards have terminologies in them. They use terminologies, et cetera, et cetera, that we need to potentially look at an alternative structure.
One possible structure, a potential way to clean this up, would be to look at the recommendations more around actions that need to be taken by various groups or types of actions that the government might take, upon which then there would be sub-bullets speaking of the specific actions. I just sort of throw this out as one option.
I know Dr. Yasnoff and I have had some chance to talk before and he has some other -- slightly other views, but I throw this out as one possible organizational structure. I would hope that all of you would improve upon it.
Certainly, as I looked through the recommendations, four themes stood out to me clearly. No. 1 is the government should play an active role in choosing and selecting or prioritizing health information standards and terminologies. I think that is a message that comes out clear with the number of action items related to that.
Another one is is the government should play a more active and facilitating roles with the SDOs and HISB. That is another theme that we see sort of replicated there. The government -- the next one, at least as I looked at it, is that the government should -- this one, obviously, I -- this one I haven't wordsmithed quite to the level of the others, but the key sense here is the government should begin to phase implementation as is appropriate and promote where it can't implement.
In other words, there is a whole lot of areas where things aren't quite ready for actual standards, but we need to be able to promote as possible and things that almost standard should be moved into the standards arena as quickly as possible.
Then there is a major government role in financing, both for research and development, sponsoring standards development, purchasing of right to use licenses, et cetera. Now, I think there are other recommendations that don't fit under those umbrellas, but if one looks at the recommendations, I think we are seeing a tremendous amount of overlap with at least those fundamental things.
I think Margaret is trying to write them down. Margaret, would you like to see my notes on this one? Would that be helpful?
MR. BLAIR: I was wondering, you said that you had a chance to discuss this with Bill Yasnoff and I was wondering what thoughts he had on reorganization? Incidentally, I discussed this with Simon so that you don't feel like we are just diverting into reorganization completely, is that we would have --
DR. COHN: Dr. McDonald has just arrived.
MR. BLAIR: Let me have you introduced in just a second here. Just a thought and since you are, Clem, that you might want to be aware of where we are. Simon has had a chance to go looking through this fourth draft and his thoughts were that we might consider on the recommendation section some reorganization and our thoughts were that we would kind of introduce some of these thoughts, discuss it for a little while early on so that we could kind of have a mind set.
We probably won't be able to agree this morning on exactly what that reorganization should be, but if we at least get some of the thinking process underway, then we would go through each of the recommendations and each of us would be able to begin to think in terms of whether one type of reorganization, a second or third or fourth, you know, whatever it might be or whether we should retain the imperfect organization that is here, in short. So --
DR. MC DONALD: Can I just make a comment on that?
MR. BLAIR: Let me kind of take it step by step here if I can.
First of all, Simon had indicated some of his thoughts and he was thinking that we might consider organizing it by who does what, like, you know, having a section where all the government actions and he discussed it with Bill Yasnoff and we were just about to solicit Bill's observations and thoughts about reorganization and then can we come to you? Is that okay?
Bill.
DR. YASNOFF: Thanks, Jeff.
Well, I certain agree with Simon's observation that there is a lot of redundance in the recommendations, but I also observed that there is a lot of interdependence of the recommendations, that in reality the Secretary could not take, you know, recommendation 1, 7 and 18 and just implement those. There are groups of recommendations that really must be implemented together and at the same time to make any sense. So, I think that that is something we need to account for.
The other thing is that -- Simon grouped these in terms of programmatic -- four programmatic areas and another way of looking at the organization is who is going to perform the activity. So, there are certain things that we are recommending to the Secretary that actually NCVHS do. And there are certain things we are recommending that the Secretary do within HHS and there are certain things that we are recommending to the Secretary that she do that really involve people and organizations outside HHS.
Again, I am not convinced that either of those ways of looking at things is the right way and I think there is probably some combination that will make the recommendations clearer.
My other observation, which I think is consistent with what Simon has seen in the document as it is much too long, many too many recommendations and I think our message is really much simpler and can be expressed more briefly than is in the document. I think it is in our interest to do it that way.
Then finally, I think that in the recommendation section, the various explanatory pieces of text in the recommendation section, I think, either should be in the introductory section or are redundant and should be removed. In other words, I see the recommendation section as here is what we recommend, 1, 2, 3, 4.
So, those are kind of my thoughts on that.
MR. BLAIR: Clem, could you introduce yourself? And then I think you have some comments.
DR. MC DONALD: Clem McDonald from Indiana University and Regenstrief Institute.
For one who sort of a major critic of this document, I think it has actually gotten pretty decent. So, I really worry about -- I mean, there are some specific things that I think we still need to talk about, but I worry about at this stage doing a major organization because everything will change with the reorganization and we will have a lot longer process.
I don't think we can just shuffle the paragraph.
MS. FYFFE: I have an observation.
This is Kathleen Fyffe.
Going back to the HIPAA law -- I am just going to reread here what it says briefly. "Shall report to the Secretary not later than four years after the date of enactment of HIPAA, recommendations and legislative proposals for such standards and electronic exchange." If I look at the table of contents, I don't see the words, "legislative proposals." Is that something --
MR. BLAIR: Is that not in our purpose statement?
MS. FYFFE: Well, do we have legislative proposals -- we don't.
MR. BLAIR: We don't, in the purpose?
MS. FYFFE: Margaret, do you want to make any comments here?
MS. AMATAYAKUL: We have identified that charge, but I think you are right, Kathleen. I don't think that any of the recommendations point to enacting new legislation.
MR. BLAIR: Although we do -- in the data security one, we do encourage the passage of federal legislation on privacy. I think that is the only reference to legislation. MS. FYFFE: Well, have we done what we are supposed to have done?
DR. COHN: Well, actually, I think I would argue with what Jeff just said. I think whenever we talk about financing, anything that has to do with financing, research and development, sponsoring standards development, et cetera, it by definition is legislative. That is budgetary. At least that is how I would interpret that.
MS. HUMPHREYS: Well, I think that as I recall some of the discussions that relate and that are reflected in the document, I thought that there was reflected here a general view that there were a number of things that the Secretary should do immediately but that given the state of development of clinical information systems in the country, a legislative proposal that we now should mandate standards for patient -- for medical record information was premature and that, in fact, the Secretary should be accelerating development of these standards and promoting their use in clinical information systems, but that a sort of mandated standard across the board use of these had to follow later.
So, I would have thought that if you had determined in your evaluation that it actually was possible to implement these immediately, then you might have proposed a legislative proposal that would say people have to establish standards and international standards. Absent that, I am not sure in the standards arena that you -- you could, of course, refer to something like at the time when it looks like these are -- you know, it is the right time, there should be some mandated standards, which might involve legislation.
MR. BLAIR: Kathleen, given Simon's and Betsy's response, do you feel as if, even though you don't see a lot of proposals for legislation, that the process that we have gone through, considered legislation in light of what we felt could be done at this time? Or do you not feel satisfied?
MS. FYFFE: I think that the workgroup has performed its role properly, but I think in terms of communicating that we really don't recommend legislative proposals or whatever our view is about legislative proposals ought to be very clearly reflected in the beginning of this report and, in fact, the words "legislative proposals" or "lack of legislative proposals" ought to be in the table of contents.
In my mind, that is important from a communication point of view because if I were a staff person on the Hill and I said, okay, what I am expecting are recommendations and legislative proposals, when I look at this, I am not sure that that is really what I am getting or that is what is what the Secretary is getting.
MR. BLAIR: Could I make an argument a little differently.
MS. FYFFE: Sure.
MR. BLAIR: It is my view that a report like this needs to state what the problem is and what needs to be done to address the problems and that if we wind organizing the documents procedurally in terms of winding up saying, well, here are regulations and here is legislation, I think we lose the ability to tie the recommendations and solutions to addressing the problems.
If in a particular recommendation, part of that recommendation is regulations and part of it might be legislative proposals, I would think that that would fit better in addressing a problem or issue than to organize the report and divide it up into what is regulation and what is legislation. That is my thought.
Did I convince you, Kathleen or not?
DR. COHN: Jeff, I think Bill and Betsy and I want to comment.
DR. YASNOFF: Jeff, I agree with you and I seem to recall that we had a discussion some number of meetings ago where we were talking about legislation, regulation, et cetera, and I thought, and my memory may not serve me correctly, but I thought that we decided that we were going to recommend what we thought needed to be done and let the Secretary figure out and the staff figure out how it should be done because it didn't seem like we should spend our time on the how but on the what.
I think that -- and I agree with that and I think we should concentrate on what we think needs to be done and in some cases, for example, privacy, we know that legislation needs to be proposed. Then we can be very specific, but rather than spend our time figuring out exactly how it should be done, I think we should concentrate on what.
I just want to say one other thing, one other comment on what Clem said and, Clem, certainly, I agree with you. I liked the recommendations a lot and Simon said that, I think, maybe before you walked in, but my concern is that saying the same recommendation five times I don't think is persuasive to the Secretary and I think that if we can organize them in a way that they communicate very, very clearly and are very concise, I think that that -- I am not sure how we should do that but I think that will enhance the chances of getting the recommendations actually implemented.
MS. HUMPHREYS: I actually think that without reorganizing the document, it would be fairly easy to address the issue of consideration given to potential legislative proposals in a specific upfront thing. I don't think your recommendation requires that we reorganize the document. I think it is just that, yes, we understood the charge. We did this, this, this. This is how we are proceeding with that charge.
We were able to identify that in the area of privacy, we definitely need legislation. These other areas it might be regulation or legislation and the timing is not necessarily right now for some legislation.
MR. BLAIR: Where would that be?
MS. HUMPHREYS: I think that right after -- either when you are talking the process you went through or in the introduction after you go through the charge, I mean, I am sure we can figure out a good way to put a paragraph or two like this up front. Because I agree with you that that was the charge. Where are the proposals? And that you should defer that or, I mean, sort of deflect that type of criticism.
MS. FYFFE: Betsy has articulated it very well. A paragraph or two in the introduction with a couple of sentences in the executive summary because some people will only read the executive summary.
MR. BLAIR: Kathleen, could you help us a little bit so -- that will also help us to be sharp and get exactly what you are addressing.
MS. HUMPHREYS: I had one other comment that relates back to your -- to Simon's original characterization of the four major themes. Although it isn't given as much worth, there is also a theme in here about support for R&D to determine exactly what is needed and how much in the standards area and how useful they are. I think that R&D doesn't fall neatly under the others. So, even if you don't say much, I think you need a separate header that is saying that R&D needs to be supported by the Department in this area.
DR. COHN: Actually, I want to follow-up -- I guess I have two comments. Really, this has to do -- follows Betsy's, which I think she said very well. The legislative piece, I agree, needs to be in the introduction. I think there also needs to be a small paragraph in the recommendations about it probably, but one would also observe that it is probably a little premature for us to shut off the legislative piece because part of the questions of the day is what other recommendations need to be here.
Until we have finished that discussion, it is probably premature to say, well, gee, there is going to be no legislative requirements.
DR. MC DONALD: I would still like to come back to what is our schedule and can we really do this. This is the kind of thing we should have done four months ago. We had this discussion. Is the organization right? Is the -- everyone said "yes." I thought there were way too many recommendations and said it and it wasn't attended to. Now, the question is this is going to be a major, major review again. You can't just slice and dice.
What is our schedule? Can we do it? If we can do it, we should do it. But I just want an understanding that we are all being -- cognizant of the fact --
MR. BLAIR: At this point, could up wind up because I think in recognition of both what Simon is suggesting and some of Bill's ideas and Clem's ideas here, I think that if we were to start to go through the recommendations now, we have in our mind the fact that we do have some issues of redundancy and that we should begin to look to see if there are better ways to reorganize it.
I think if we begin to go through the recommendations now that, first of all, we will be able to focus on specific recommendations. We will be able to think through as we go through these is it saying what we want to say? Is it addressing what we want to say? Is it sharp enough? Betsy has also contributed a number of thoughts that should be helpful to us when we get to the medical terminology piece in terms of sharpening these recommendations and I think, you know, later on in the afternoon we will wind up emerging with a modified organization or we will -- well, we will just see where it leads us.
So, at this point --
DR. MC DONALD: Can I still get a response to what is our schedule? When are we supposed to deliver this? What is the date that we are going to deliver this? Do we have time to --
MR. BLAIR: The date it is due to the Secretary is August. We have -- let me go through the dates here because even though that seems far away, the reality is that we only have one other work group meeting in June to be able to essentially fine tune the document before it gets final approval from the full NCVHS committee on I think it is June 21st.
So, I think that we are generally pleased that we are as far along as we are at this stage. On the other hand, we don't have all that much latitude at this point. I think that we really -- today is the day when we really need to pretty much come to consensus on the recommendations, feel satisfied with Section III, which was the overview, the introduction to that. Okay?
Then after that, Clem, in terms of schedules, there are going to be a number of thoughts in terms of -- especially when we get to the executive summary, which has not been written yet. We have been waiting to do the executive summary until after these other pieces are in place and we really want to make sure that that is, quote, a compelling preface to this document.
That has yet to be written and then the other piece is that in the time frame from middle April through May, we will be reviewing with interested parties within the Federal Government and subject matter experts that are in the private sector, thought leaders and medical informatics to try to see if we have overlooked anything or if there is something else that we could do to improve it. That will all be folded together into you might say the final draft, which our workgroup will review on the 1st and 2nd, in preparation for presenting it to the full committee on June 21st.
Does that answer your question?
DR. MC DONALD: Yes, but it makes me very worried because we really have two shifting foundations going on. We are going to reorganize it, which means everything will get rewritten and we are also going to get all this input and it is going to be happening at the same time.
MR. BLAIR: Well, Clem, could I just suggest this because I also worry about, you know, the time to reorganize and then to review the reorganizations and we lose something -- my thought on this, Clem, is to -- as we go through these recommendations and we do see, you know, areas of, you know, possible either ways to present it better, articulate it better, let's just think of that in the back of our mind.
If there is something we could do to improve the reorganization, you know, that is great. But any time you reorganize, sometimes you wind up creating new problems. So, I think we are going to just do it carefully. Is that okay?
DR. MC DONALD: Well, that is what I am kind -- yes, either that or we get more time.
MR. BLAIR: So, in short, we are not going to decide on a reorganization right now. What we are going to do is we have sort of had a discussion so that we can think about it so that as we go through each of these recommendations, you know, it is in the back of our mind in case somebody could come up with a suggestion that the rest of us agree to and that we could comfortably -- it doesn't have to be a total reorganization.
Maybe it is just, you know, some modifications. Is that reasonable?
DR. MC DONALD: That is more doable.
MR. BLAIR: Simon, do you feel comfortable with that?
DR. COHN: Yes. No, I think we all said this is a beginning discussion on a reorganization. Let's look at the recommendations, reflect on them, as well as try to clean them up and then let's see what organization fits best.
MS. FYFFE: I have a question or a comment.
Is Margaret going to help us through delivery of this document?
MR. BLAIR: Yes.
MS. FYFFE: I am not quite as pessimistic as you, Clem. I think that -- and as one who has prepared lots of documents, comments to federal regulations, getting input from everyone in the last minute, we always make it. I am very impressed with the quality of this paper, the amount of work this group has done and I am confident with Margaret's expert help that we can get this accomplished.
So, let's proceed.
DR. MC DONALD: You asked one other question -- one other question was are there other things that should be added. Is that still on the table?
MR. BLAIR: Yes. Actually, we really want to make sure that, you know, by the end of the day, we feel that all the recommendations we should have are in there. We feel reasonably good about how it is organized, that each recommendation is saying what we want to say. If there is additional work to be done we might be able to staff that to somebody to be able to sharpen it up or make it more precise.
DR. MC DONALD: I may have missed this but I would just like to --
MR. BLAIR: Oh, sure.
DR. MC DONALD: -- but I didn't read anything about patient identifiers or provider identifiers. I couldn't find that stuff. If we are really talking about the difficulty in moving data around, that is at least a third of it.
MR. BLAIR: The identifier piece was --
DR. MC DONALD: -- what position we want to take, but I don't think we have talked about it.
MR. BLAIR: Right. Way back when we were talking about what would be the focus areas, I think --
DR. MC DONALD: Let me rephrase it. We can do all this and make it perfect, but we are not going to achieve our goals.
MR. BLAIR: Fine.
DR. COHN: Can I comment on this? I mean, Clem, I think this is the appropriate discussion. Obviously, provider identifiers we know are coming down the pike. So, I don't think --
DR. MC DONALD: That is an issue that we should reinforce --
DR. COHN: Well, it should be out by the --
DR. MC DONALD: Probably reinforced in terms of --
DR. COHN: Okay. Well, I guess the point I would make is let's talk about the recommendations and the question is what else, what other sections are we missing. Let's at least at what we have to begin with and then let's bring up all this other --
DR. MC DONALD: I just used that as --
MR. BLAIR: As an example. And we have got to make sure that one way or another they are either covered in what we are doing or in previous HIPAA activities.
Margaret, can you start to take us through? And both Kepa and Clem came in a little bit later. You may know that Michael Fitzmaurice took the time to carefully go through and do some wonderful editing.
So, Margaret has a document here that includes a number of Michael's suggestions, so we get the benefit of making sure that they are included. We also had Stan Griffith also make some comments, but that was back on the third draft. So, we want to make sure that those are included as well.
So, there is a lot of integration that Margaret will have to go through. So, be patient if she is rumbling through a number of hard copy documents to make sure that all of the suggestions are included when we get to a particular recommendation.
DR. MC DONALD: I am looking at one that says March 22nd, Fourth Draft, revised by JMS. Is that the one we are looking at?
MR. BLAIR: Yes. And I went through and made some comments on it and she has -- Margaret has that all on her screen. So, that will be the basis. Okay? But you also should have a hard copy in front of you of the fourth draft before Michael made his comments because -- just as a little technical piece, you know, when you go through with the tracking changes piece, it is not perfect. Sometimes words are missing. So, you have the hard copy of the fourth draft, pristine and pure, to refer to in case you want to know what the original comment was.
DR. MC DONALD: We are going to basically assume that this is the one we are working on because I think it is a good one.
MR. BLAIR: Okay. Margaret, did you have any other comments before you start to take us through.
MS. AMATAYAKUL: I would just note that it appears that -- and hopefully this is true throughout the whole document -- the comments in red are Mike's, the comments in blue are Jeff's on the screen, but what you have got in front of you, I assume, if you printed out Mike's comments, that is basically this, except for a few little comments that Jeff may have made, which are in blue.
MR. BLAIR: And you also have the hard copy of the original to make sure you could go back to that.
DR. MC DONALD: Could make a suggestion on the next cycle, that we get the document that shows the changes and we don't make last minute changes? I mean, it just makes it almost mechanically impossible if we have to look at three different versions at once.
MR. BLAIR: Clem, it is awkward and every time that -- I acknowledge that. I just don't know -- I guess it is an art, Clem, is -- you know, you try to wind up making sure everybody's thoughts and comments and contributions are included. Sometimes it makes it a little awkward. How do we navigate that. You are right.
DR. MC DONALD: When we get a document, that is what we discuss. We read this and we study it and then it changes on the way in four days later. I don't think that is ideal. I don't think we should do it that way. I don't know how you can do it that way.
DR. FITZMAURICE: I have gone through Jeff's comments and I don't think -- his comments are basically "fine," "good," "let's keep it like this" or "let's let the group decide. So, he hasn't made any real --
MR. BLAIR: Right. No changes have been made. These are only comments.
DR. COHN: This is a mechanical issue. Perhaps the person dealing with the overhead could take it back in so we could see it. I can't see the bottom part here. It is too far back.
MS. AMATAYAKUL: Do you need the print bigger than this?
DR. MC DONALD: Yes, I think it would help. Maybe everyone else's eyes --
MS. HUMPHREYS: What is the amount of time we want to spend on Section III versus Section IV?
MR. BLAIR: We are going to focus on Section IV because that has gotten the least up until now and because Margaret and I really made major reorganizational changes to Section IV. We wanted to make -- and it wasn't so much that it should be the final organization as much as we wanted to move it along as fast as possible.
This way, at least, it is organized where you could critique it and improve it. Okay?
MS. HUMPHREYS: Okay. So, we are not starting with Section III.
MR. BLAIR: No. We are going to do Section IV and then we will go back and do Section III, towards the end of the day. From 3:00 to 5:00 we can do Section III.
DR. COHN: Why don't we start with the introduction and --
MR. BLAIR: To Section IV.
DR. COHN: Yes. Maybe we can start moving this thing.
Jeff, are you suggesting that we go through section by section here?
MR. BLAIR: Yes. And I was looking for Margaret to lead us, but did you have a comment on the first paragraph or two or something?
DR. COHN: I actually had an issue on No. 1, but I wasn't sure --
MR. BLAIR: I would like to start right at that beginning part, just in case there are any concerns there, the beginning part of Section IV.
MS. AMATAYAKUL: Are you ready?
MR. BLAIR: Yes.
MS. AMATAYAKUL: Okay. Section IV, Issues, Observations, Assumptions and Recommendations, Section A, Introduction. The National Committee on Vital and Health Statistics (NCVHS) has identified that limited interoperability between information systems, lack of comparability in healthcare data and issues associated with quality of healthcare data are major impediments to improving healthcare cost and quality and achieving administrative simplification.
MS. HUMPHREYS: Issues associated with health care quality is a pretty weak way in my view.
MR. BLAIR: Is that effect maybe --
MS. HUMPHREYS: It seems to me if you are saying that has identified that limited interoperability between information systems and lack of comparability in healthcare data, what is the point you are trying to make, that those two things impact the quality of care and, therefore, are major impediments to achieving administrative simplification and improving healthcare cost and quality.
DR. COHN: Betsy, are you suggesting we get rid of that issues associated with quality of healthcare data?
MS. HUMPHREYS: We love connecting this to quality of healthcare and I love that, but it seems to me that the third thing is the real point that the first two things impact; that is, the lack of interoperability and the lack of comparability --
MR. BLAIR: Could you suggest some wording for us that would strengthen that?
MS. HUMPHREYS: I can if everybody agrees that that is what they really meant. I didn't write the paragraph so -- is the point that the lack of interoperability and the lack of comparability effects healthcare quality and, therefore, we want to do something about it. Is that the intent?
DR. FITZMAURICE: I read it as three points, interoperability, lack of comparability and the quality of the data itself were impediments.
MS. HUMPHREYS: Okay. Well, then I think that would be fine if we just got rid of issues associated with and then it would be clearer to me. I didn't quite know what they meant.
MS. AMATAYAKUL: Then that sentence reads, "NCVHS has identified that limited interoperability between information systems, lack of comparability in healthcare data and quality of healthcare data --
MS. HUMPHREYS: Inadequate or poor or --
DR. FITZMAURICE: Inadequate, yes.
MS. AMATAYAKUL: And inadequate quality of healthcare data are major impediments.
Onward?
MR. BLAIR: Yes.
MS. AMATAYAKUL: Okay. No. 1, Sequencing and Prioritization of Recommendations. Recommendations for adoption of uniform data standards for PMRI and the electronic exchange of such information are presented by focus area. Generally, the sequence of the focus areas is indicative of the priority order in which the recommendations would have the greatest impact. The prioritization is based on three factors in combination.
(1) The maturity and thus availability for adoption of the standards within the categories. For example, message format standards in general are more mature and ready for adoption than standards for medical terminologies.
DR. COHN: Could I make a comment about the first paragraph?
I actually found this a little bit confusing because as I looked through the recommendations, I am not sure that I believed this, which is the sequence of the focus areas is indicative of the priority order, only because I saw recommendations sort of scattered throughout, which I actually thought were priority recommendations --
MS. HUMPHREYS: That whole sentence is a little confusing to start with, I think. Maybe it could just be eliminated.
DR. COHN: You mean, get rid of the sequence discussion period?
MR. BLAIR: Does everybody feel comfortable with eliminating that sentence?
DR. FITZMAURICE: You are going to lead into the whole section there and it is more of a case of do we have any priority order.
MS. HUMPHREYS: Maybe we should decide this after we have gone through the rest of it.
DR. COHN: Maybe that is true. I mean, one would like to think by the time we are done with these recommendations that there is some prioritization that would be obvious to the Secretary that if she -- you know, if she started with one and went through, that we would be sort of where we need to be.
MR. BLAIR: Margaret, did you have any thoughts that you had as to why you phrased things this way, before we go on?
MS. AMATAYAKUL: Well, we had talked at the last meeting. I think it was actually Barbara Starfield, perhaps, at the full meeting, that she asked about prioritization and was there a sequence associated with these and why did we put message format before terminology, et cetera. So, I was just trying to address her question there.
MR. BLAIR: Okay. Onward. We will revisit this after we have actually gone through them.
Incidentally, I would indicate that Margaret and I did attempt to try to sequence the recommendations in a consistent manner. We may have fallen short and some of it was difficult to do and maybe we still shouldn't say that, but I am just trying to say that there has been an attempt to at least sequence them in a logical manner. Those are different words then priorities. Okay?
DR. ZUBELDIA: Jeff, this is Kepa.
However, the sentence here is a little confusing because it says the sequence of the focus areas. It is not the sequence of the recommendations, but the sequence of the focus areas. After you read this and you are going to recommendations, it looks like Recommendation No. 1 is more important than Recommendation No. 19.
MR. BLAIR: Okay. After we review the recommendations, let's come back and see what we should say about the organization then. That gets back to Simon's thoughts on organization as well.
Okay. Margaret, onward.
MS. AMATAYAKUL: Okay.
MS. HUMPHREYS: Does this mean we can skip this whole section and come back to it?
MR. BLAIR: Yes.
DR. FITZMAURICE: Go to guiding principles. That is what I would recommend.
MS. AMATAYAKUL: Okay. No. 2, Guiding Principles. Consistent with other proposed standards under HIPAA Administrative Simplification, guiding principles for selection of PMRI standards are incorporated into the following recommendations. These guiding principles draw upon those already developed for use in the selection of standards for financial/administrative transactions and published in HIPAA NPRMs. Additional guiding principles specifically in reference to characteristics and attributes of PMRI terminologies and features and characteristics of data quality have been added.
MR. BLAIR: No comments?
DR. COHN: No, actually I have a comment. I am just struggling with what the comment is, though. I guess as I remember our last conversation, we thought that the guiding principles were important enough that they actually needed to be put in the body of the report. At least, that was my memory of the discussion.
This isn't the same thing as that. First of all, it is not indicated where the guiding principles are.
MR. BLAIR: I think they are Section III. We moved them up into Section III. I think that is right.
Margaret, is that correct?
MS. AMATAYAKUL: We have referenced the guiding principles by appendix name throughout the document elsewhere.
DR. COHN: Okay. So, it is not in the recommendations.
MS. HUMPHREYS: Is the issue here, though -- it says guiding principles for selection are incorporated, et cetera, and I know they are referenced throughout. I have seen them, but is the issue here that consistent with other proposed standards, et cetera, that the NCVHS has established guiding principles and then wants them to be applied? Because you don't actually say who created these and I guess that the working group has created them on behalf of the NCVHS, that you could say that -- or who created these? I mean, I guess it was the working group modifying the ones that had been created for the implementation of HIPAA, right?
So, I think that probably it is good to say that the committee established these -- has established these principles that are going to be, you know -- and, obviously, later on you are recommending that they be used in going forward.
MR. BLAIR: Any other comments?
Now, is Simon's comment still hanging here with respect to moving up the guiding principles from the appendix? What is the status of that? I don't know if that is satisfactory.
MS. AMATAYAKUL: Simon, was your intent to actually take those two pages and put them into the recommendation?
DR. COHN: Well, that is what I am mulling about because it is sort of a somewhat unwieldy piece and, yet, it is -- I mean, I guess, we need to reflect on that. I am not going to make a firm comment on that right now. I was just sort of struck that -- I mean, somehow there is sort of among other things one of the hearts of the recommendations, I think, and somehow stick them back in an area -- in your recommendations and not even reference where they are seems to me to be sort of understating them, but perhaps we need to come back to this and see if they need to be augmented.
DR. FITZMAURICE: You know, Simon, they could be put into a text box in one of the first several sections, kind of set aside, but in a text box so that they don't have to be in the mainstream of the flow, but can be referred to.
MR. BLAIR: Margaret, I know that you moved something up out of there, where you felt it would be a summary. I don't remember where it was. Maybe if you could point Simon to where that area was that he could determine whether or not that he feels it is satisfactory.
MS. AMATAYAKUL: We summarized the changes we made at the applicable recommendation. So, you know, the guiding principles were pretty much the same as they were published in other NPRMs, except for those that pertain specifically to interoperability and comparability and then we summarized those within the specific recommendation.
MS. HUMPHREYS: This discussion has led me to ask the following question. Guiding principles are for the selection of standards for PMRI. Right?
MR. BLAIR: That is correct.
MS. HUMPHREYS: So, they are not guiding principles for this document or for the sequencing of recommendations, which is kind of implied here in this introduction. They are actually guiding principles for selection of standards and it seems to me might, therefore, be referred to in the document where there is going to be a recommendation directly that the Secretary should task the NCVHS to select standards for PMRI and to select them according to these guiding principles, don't you think, rather than up here in this document? It doesn't quite flow because you are going to have other recommendations that don't actually relate to the selection of standards.
MS. AMATAYAKUL: I think that is actually what we have done.
MS. HUMPHREYS: Okay. So, then --
MR. BLAIR: So, we just alluded -- in the introduction we indicated that these guiding principles did exist, but then the detailed portions of them that applied to particular recommendations were elaborated on in the recommendation.
DR. FITZMAURICE: I think Betsy's point is that we need a rewrite to show that NCVHS adopted and modified the HIPAA guiding principles for selecting PMRI standards.
MS. HUMPHREYS: And I guess it seems to me that putting them under their own heading of guiding principles in the introduction seems to imply that these guiding principles are related to all the recommendations that follow and it seems to me they are specifically related to the recommendations that relate to the selection of standards, not to every other recommendation that is going to be in the report.
MR. BLAIR: What do you suggest we do? Should we change the heading on this or not have the section? What is it that you are suggesting?
MS. HUMPHREYS: I think it probably doesn't belong in the introduction unless you are referring specifically --
MS. AMATAYAKUL: Betsy, does the change up here help? What I have done is I have titled this "Guiding Principles for Selection of Standards" and then consistent with other proposed standards under HIPAA Administrative Simplification, NCVHS has adopted and modified guiding principles, Appendix C -- I should say "see Appendix C" -- for selection of PMRI standards and incorporate them into the following recommendations.
MS. HUMPHREYS: Sounds good.
DR. ZUBELDIA: But I would go further and move this entire guiding principles for selection of standards section under Area No. 2, which is message format standard recommendations.
MR. BLAIR: Yes, but it is not just the message. It also applies to medical terminologies and to data quality.
MS. HUMPHREYS: Yes. Well, I think that essentially if we converted the general recommendations with the overview and indented all the specific recommendations that remained under the general ones, then we would solve your problem.
DR. COHN: I think I probably agree but I am not quite sure what --
DR. FERRANS: The other question is are the guiding principles really -- are the guiding principles really incorporated into the recommendations or are they, you know, used to develop the recommendations?
MR. BLAIR: The guiding principles -- when you wind up having a recommendation, well, we are going to wind up hitting about several recommendations -- we are winding up saying that we are asking the Secretary to authorize the NCVHS to select and recommend specific standards or terminologies or data quality characteristics for adoption. In each of those we -- the criteria for that selection that is referred to would be the guiding principles that we are talking about here.
DR. FITZMAURICE: You know, Jeff, I want to follow-up on Kepa's suggestion of putting it in Section II, maybe even earlier in Section I. Since these were principles that guided our thinking, we could put them in a text box in Section I and explain where we found them, that we modified them and --
MR. BLAIR: -- clarify Section I.
DR. FITZMAURICE: Introduction.
MR. BLAIR: That is Section II.
DR. FITZMAURICE: Well, then I would go with Section II, wherever we first start talking about how do we formulate our thinking. We have got the charge. Given the charge, how do we formulate our thinking?
MS. AMATAYAKUL: May I ask for a clarification? Mike, are you talking about Section II, Introduction, Background and General Rationale?
DR. ZUBELDIA: Either that, which is 2B or under 2D, Process for Studying Issues and Making Recommendations.
DR. FITZMAURICE: There is reference to it in D.
DR. ZUBELDIA: And if you put it on as a text box in 2D, then you could dispense of this --
MR. BLAIR: Yes, but the only piece is that it wasn't part of our making our recommendations for this report. It would be part of the execution of the recommendations once the Secretary approves that.
DR. SMITH: But there were probably things that we considered in determining the maturity of the standards and how they would fit in with the existing systems to judge whether to make a -- we should adopt these now or we should wait until they mature. Probably influenced our thinking.
MR. BLAIR: Let me just get the feeling from the other members whether they would prefer to have it -- Michael is proposing that we move the references, you know, the general reference to the guiding principles, up into Section II, that Section II is the introduction section to the report. There is a subsection underneath there, which
-- Michael, could you reference the title on that?
DR. FITZMAURICE: It is Subsection D, the Process of Studying Issues and Making Recommendations.
MR. BLAIR: And he is suggesting that we put it there. Could we have some sense of whether or not most people feel like that is a better place for it or whether that should be in the recommendations section?
DR. COHN: I actually think it is a great idea. I don't care where it goes in the body of the report, but I think that sounds as good a place as any, but I think at the last meeting, we had decided that it needed to be in the body of the report. I mean, I think it is an important enough piece that it not get lost in the appendix.
So, I mean, I would almost defer to you and Margaret which section specifically it fits in, but I think the idea of the text box as opposed to trying to somehow put it in the body makes a lot of sense. I like that a lot. I think the others -- and where you put it is, I think, up to the --
MR. BLAIR: Let me make one comment if I may. I will defer to what the group decides on this.
It is my -- I think it is more appropriate to have it where it is. My reason on that is because although it may have -- we may have had some influence in the way we wound up developing the recommendations, the real application of those guiding principles would be if the Secretary approves these recommendations and allows the NCVHS to actually select standards.
So, that is my thinking as to why I think it goes where it is, but let's get a -- Simon, could you help and maybe just get a sense of the group as a whole as to where the preference is for its location?
DR. COHN: Are we voting?
MR. BLAIR: I think we can real quick, just to get a sense, is the majority -- which way?
DR. COHN: Okay. Who would like it somewhere in the body of the report?
DR. FITZMAURICE: Who is voting, by the way?
DR. COHN: The members of the committee.
MR. BLAIR: You know, is it just the members of the committee?
DR. FITZMAURICE: Let's get a sense of the members of the committee. That is really what it is.
MR. BLAIR: Okay.
The body of the report meaning where it is right now.
DR. COHN: No, no. The body of the report does not mean in the appendix.
MR. BLAIR: No, no, I meant -- I guess, maybe I was confused, but right now the reference is in the introduction to the recommendation stage. That is where I thought that -- that is what I am suggesting.
DR. COHN: That is fine.
MS. AMATAYAKUL: I got the sense that there was consensus you wanted to put it in a text box. I think the question was do you want to put it Section II or in Section IV.
MR. BLAIR: That is correct. My inclination is to put it in Section IV, which is the introduction to the recommendations. Michael is suggesting we put it in Section II, which is part of the introduction. Michael, is that correct?
DR. FITZMAURICE: That is correct, Jeff.
DR. MC DONALD: It wasn't designed to be part of the document and how it was written. No one is worried about how people stumble across it? You know, it fit in the paragraph --
MS. AMATAYAKUL: You might want to look at Appendix C in your copy just to kind of see what it looks like.
DR. FERRANS: I think that is why the text box makes sense because if it is not --
MR. BLAIR: I think the text box is a good idea.
DR. FERRANS: -- the perfect way to do it, put it in the body of the report.
MR. BLAIR: Should we try once again to get a feeling of the group as to whether it is in Section II or Section IV? Simon, could you help us?
DR. COHN: Sure.
DR. MC DONALD: Everybody agrees it should be moved out of the appendix?
DR. COHN: Yes.
MR. BLAIR: Yes.
DR. COHN: I guess it seems like sort of an odd use of time, but I mean do people care? Nobody cares.
MR. BLAIR: I care. I care which section it is.
MS. HUMPHREYS: Then if you care, let's put it where you want it to go.
MR. BLAIR: Well, you know, I just -- well, then let me ask the question specifically. Of the committee members, which of the committee members would like to see that in Section IV? And which in Section II?
DR. COHN: We got 1 to 1.
MS. FYFFE: And I am indifferent.
DR. COHN: I am indifferent.
MR. BLAIR: Margaret?
MS. AMATAYAKUL: Yes, Jeff.
MR. BLAIR: Tie-breaker. Which one do you --
MS. AMATAYAKUL: No, you have 2 to 1.
DR. ZUBELDIA: Jeff, could I ask for maybe a compromise that it goes in Section II and then in Section IV put a reference to these guiding principles every time you need to recommend the adoption of a standard, you say and this should be done using the guiding principles in Section II.
MR. BLAIR: Okay.
MS. AMATAYAKUL: Then that is easy to do because we have already referenced Appendix C. So, we just reference Section II.
MR. BLAIR: Okay. Onward.
MS. AMATAYAKUL: I am coming.
MR. BLAIR: I have a new assistant at home and she is working with a blind guy for the first time and she is very sensitive and we work out audible responses so that, you know, when there is silence, she tells me I am pulling up the e-mail or I am waiting for it to send.
MS. AMATAYAKUL: Okay. B. Recommendations. (1) General Recommendations. It was the consensus among testifiers to NCVHS on uniform data standards for patient medical record information, PMRI, that the ability of our healthcare delivery system to manage costs, improve productivity and enhance quality of care is severely constrained by the lack of comprehensive and consistently applied PMRI standards. While the industry has made strides, healthcare's decentralization often impedes its ability to reach consensus on standards and achieve agreement on their adoption.
To further realize the benefits of administrative simplification, the Department of Health and Human Services, HHS, needs to take a leadership role in accelerating the development and adoption of uniform data standards for PMRI and specifically address message format, medical terminology, data quality and other standards issues.
DR. FITZMAURICE: Could I make a suggestion on -- generally throughout the report that when we talk about a series of things such as costs, productivity and quality of care, that we move quality of care up to be the first one? It seems like taking the high road to people who may not -- their first concern may not be costs, but doing good for the patient.
DR. ZUBELDIA: May I suggest that we move privacy to the first one --
DR. FITZMAURICE: When it is in the series. It doesn't seem to be in this series.
MR. BLAIR: Is Jackie Adler here?
MS. ADLER: Yes, I am.
MR. BLAIR: Jackie, did we have a chance to distribute John Lumpkin's memo because it relates to Michael's suggestion right now and I think that John Lumpkin reviewed the report and he was positive about the report, but the area where he felt it could be strengthened is for it to have a little bit more focus on quality and from -- quality of care. Okay? If you could distribute -- I would very much support your recommendation, Michael.
Are there any other thoughts on that? Are there problems we create if we wind up resequencing?
DR. MC DONALD: I think quality must go first.
MS. AMATAYAKUL: I will search later for that and fix those later then.
Is everything okay otherwise with that?
DR. ZUBELDIA: At the end of that paragraph, you have adoption of uniform data standards for PMRI specifically address -- and then you have a list, message format, medical terminology, data quality and other issues. But then when you go through the recommendations, you have message formats, medical terminologies, data quality, accountability and integrity and then privacy, confidentiality and security and state laws.
If we ignore that privacy in that first symptoms, we are going to get --
DR. COHN: Kepa, are you saying we should get rid of the word "standards"?
DR. ZUBELDIA: No. I am saying that in that list of the last -- of the first sentence, at the end of the first paragraph, that list should also include privacy, confidentiality and security.
DR. MC DONALD: What line number are we talking about?
DR. ZUBELDIA: Last line of the first paragraph.
Page 27.
MS. AMATAYAKUL: Is that good?
DR. COHN: I think actually the only thing I would add to that is that I am not sure that the last word, where we say standards needs to be there. Actually, I think that it is other issues.
MS. AMATAYAKUL: Okay. All right. Recommendation No. 1. To move the healthcare delivery system into the information age, the Secretary of HHS should take a leadership role in supporting PMRI standards development and their implementation through: (a) encouraging government participation in healthcare informatics standards development organizations; (b) adopting an incremental approach to PMRI standards use within agencies for government business, for health plans that cover government employees and ultimately for all health plans receiving federal funds and (c) supporting research that promotes the development and implementation of PMRI standards (See specific recommendations referenced later) and explores their value for improving the quality and efficiency of health care.
MR. BLAIR: The "seeing specific recommendations referenced later" actually in a sense all three A, B and C are followed in the body with specific recommendations.
MS. HUMPHREYS: This, it seems to me, offers the immediate useful approach to consolidating the document, which is essentially to just organize the specific recommendations, perhaps shortening them under the general topics that are laid out in this front section. Then you don't have to say see the specific recommendations. In fact, you say the first one is encourage x and then you put something there for message standards if that is required and something there for terminologies and go on to the next, I mean, whatever you have.
MR. BLAIR: Would you reread A, B and C then? And let's think about Betsy's thought a little bit as you reread A, B and C.
MS. AMATAYAKUL: (a) is encouraging government participation in healthcare informatics standards development organizations; (b) adopting an incremental approach to PMRI standards use within agencies for government business, for health plans that cover government employees and ultimately for all health plans receiving federal funds and (c) supporting research that promotes the development and implementation of PMRI standards and explores their value for improving the quality and efficiency of health care.
MR. BLAIR: My thought is in reacting to that is that I think that we would be able to capture about 40 or 50 percent of our recommendations, maybe 60 percent, underneath those three categories.
MS. HUMPHREYS: And I think actually I would turn around and make Recommendation No. 2 -- I probably would make Recommendation No. 2, No. 1. No. 2 is the business about the Secretary authorizing the NCVHS to make specific recommendations and I actually think you should make that the first recommendation and then have these other activities, which will depend on what the NCVHS designates and selects or some of them will anyway, be the second recommendation.
MR. BLAIR: Now, let me just explain the reason why we put them in the way we did is that we wanted the first one to be that the Secretary assumes a leadership position and then the second thing we wanted was to authorize the NCVHS sort of as part of executing that leadership position --
MS. HUMPHREYS: Well, then, okay, then you could, in fact, put the second one as a first bullet under the incremental approach because the fact is you don't want people incrementally implementing standards when you haven't had the NCVHS designate the standards that should be adopted.
MR. BLAIR: Are you able somehow to keep a separate list to sort of keep track of this thought pattern?
MS. AMATAYAKUL: Yes.
DR. COHN: Betsy, I actually want to say your description of the organization begins to meet some of the needs that I was expressing. I mean, let's see if it plays, but it actually doesn't sound too bad.
MR. BLAIR: Okay. Did anybody else have any thoughts on Betsy's suggestion? If not, then let's go on to the --
DR. MC DONALD: I like it.
DR. COHN: I mean, it begins to make a global simplification, administrative simplification.
MR. BLAIR: Dr. Braithwaite.
DR. BRAITHWAITE: I don't know if this was discussed before because I have just come in recently, but it seems to me there is an overall organizational principle, too, about organizing the recommendations according to the target of the recommendations.
MS. HUMPHREYS: That has been discussed, Bill.
DR. BRAITHWAITE: Okay. Sorry.
MR. BLAIR: I am so glad you are here, Bill, because there is a piece that I want you to be aware of. We have, as you can see from the report, organized the recommendations according to the focus areas and we did so because many, many months ago you had made the suggestion that that might be a good way for us to organize.
MS. HUMPHREYS: It is all your fault, Bill.
DR. BRAITHWAITE: Well, I agree it is an excellent way to think about -- but in terms of the people who are reading them, it would make more sense for them to be --
MR. BLAIR: One of the things that was raised today -- you know, Simon had a chance to look through the document very carefully and observe that there are certain overlaps that are in our recommendations and that as we go through these recommendations, we should look to see whether there might be a modification or a better way to organize it.
So, what we are doing now as we begin to go through the recommendations we are beginning to consider, is there a better, more compelling way to organize them? We kind of have to do that a little bit carefully because, you know, there is probably no perfect way to do it to completely limit -- even new organizations may still have redundancies or overlaps. So, we are trying to just go through it carefully, but that is in the back of our minds. Does that help? Okay? We wanted you to be aware of that because it may change the organization you originally suggested.
DR. BRAITHWAITE: Well, about Recommendation No. 2, which brought up this thought on the first place for me, it seems to me that the NCVHS is already authorized to do everything that is here.
DR. COHN: Dr. Braithwaite actually steals my thunder on this one because I was actually going to reference the legislation and ask that question.
DR. BRAITHWAITE: You are recommending to the Secretary to do something that Congress has already done and that seemed a bit presumptuous.
DR. COHN: Let me ask you, shall we have Margaret read the section first?
DR. BRAITHWAITE: Yes. There might be a different angle to it that I am not --
DR. COHN: Well, no, I am asking -- I have the same question and I was going to --
DR. MC DONALD: Which one are we on?
DR. COHN: I think we are just moving into 2 and Dr. Braithwaite is already making comments on it.
MS. AMATAYAKUL: No. 2, we had talked about putting under 1(b), but the recommendation is Recommendation No. 2, to accelerate the adoption of PMRI standards, the Secretary of HHS should authorize the NCVHS to make specific recommendations for the selection and adoption of uniform data standards for PMRI. The process for this selection should include (a) utilizing the guiding principles for selection of PMRI standards. These include specific characteristics and features for message format, medical terminology and data quality (see Section II).
And (b) prioritizing specific content and functional areas. This would identify those areas where specific PMRI standards are most needed.
DR. COHN: Actually, can I start by making a comment and then I think Dr. Braithwaite will want to amplify it only because I was thinking about this, too.
As I looked at the HIPAA legislation -- and once again the question is is whether everything is authorized, but I agree with Dr. Braithwaite that there is a tremendous amount of what we are recommending here that is already authorized. I reference the Section 1173 standards to enable electronic exchange, where it says the Secretary shall adopt standards for transactions and data elements for such transactions to enable health information to be exchanged electronically that are appropriate for the financial and administrative transactions described in paragraph 2, which is the work that we have already done.
Then it says other financial and administrative transactions determined appropriate by the Secretary consistent with the goals of improving the operation of the health care system and reducing the administrative costs.
Now, as I read that, that isn't actually everything that we need to be asking the Secretary for but that is a big piece, at least as I interpret it and I would look to Dr. McDonald for further clarification. It seems to apply to really all the message format standards that we are talking about asking the authority of the Secretary for.
So, I guess, at least as I interpret the message format standards -- I guess the question I have for the workgroup, I mean, recognizing that I work in a big organization, too, and I am always careful to ask for things, partly -- No. 1 is because you sometimes get what you ask for, but, secondly, sometimes you never hear a response and then you don't know what to do.
One could imagine that something that we already have the authority to do, if we start actually specifically recommending -- asking for that authority again, we may never have a response and never know what to do as a result of it.
MR. BLAIR: Can I just -- because I thin there was a comment over here and then we wanted Bill Braithwaite's and then I had a comment as well and Betsy.
DR. FITZMAURICE: Let me suggest that we rewrite Recommendation 2 to recognize that NCVHS has this authority and the power and make the recommendation. Here is how we think NCVHS should do it; (a) utilize the guiding principles and prioritize the specific content and functional areas.
MR. BLAIR: Bill, you had a --
DR. BRAITHWAITE: No, I think that is an appropriate change, Michael, because it -- but I am not sure that we need to recommend to ourselves to do something that we are already in the process of doing.
MS. HUMPHREYS: I guess my feeling is that the community has had it beaten into their head that the HIPAA standards are for a certain set of data and if the NCVHS is going to proceed to make specific recommendations, then ask the Secretary to implement them, related to -- I think this document should reflect that.
DR. BRAITHWAITE: I agree and I think the recommendation should -- and Recommendation No. 2 should say something like that we recommend that the Secretary adopt under HIPAA the recommendations forthcoming from the NCVHS for standards for a PMRI.
MS. HUMPHREYS: That comes up later in some of these other recommendations, which is an organization problem.
DR. BRAITHWAITE: So, in fact, it may be a little redundant from what is later, but I think that is the point that the recommendation has to make.
The other point about, well, the Secretary should authorize NCVHS to do something that it is already doing doesn't make sense to me, but to recommend to the Secretary that she pay attention to the recommendations that are about to come forward for PMRI standards and, in fact, adopt them under HIPAA is something that people are not aware in general that she has the authority to do under HIPAA and it would point it out and make the Data Council and other parts of HHS aware that, in fact, there is more work to do under HIPAA with standards to deal with PMRI.
MR. BLAIR: Let me just kind of put in perspective a little bit why there was a separate recommendation like this Recommendation 2. Bill Yasnoff, I think, had given us some wise counsel that our mandate under HIPAA was not quite as specific as those for adopting -- making recommendations to adopt standards for financial and administrative transactions and identifiers and codes and data security and that he felt it would be appropriate for us to have a recommendation like this. I do think that the word modifications that both Michael and Bill have offered make that a little bit more precise.
So, I think that that makes sense, but I wanted to give that background because we did run that by John Lumpkin to make sure that he agreed with the fact that we don't go all the way to specifically adopting standards without asking for the Secretary to recognize that we can go forward.
DR. COHN: Well, I guess. I mean, do you mind if I jump in here because I am struggling. I think there are certain things that we -- that the Secretary may need additional authority to do, but I am sort of struck as I look at the actual message format standards that I think Dr. Lumpkin may be in error in his interpretation of the law in the sense that the Secretary doesn't already have the authority to do it, at least as I have reviewed the legislation.
Now, perhaps the one piece here that we may want to urge the Secretary in terms of a recommendation is to take a -- I mean, once again, we have a choice on this one, is to whether or not we urge the Secretary to take a wide interpretation of this section, which may be really what we need to say because depending on her interpretation, she could either say things are in or out or I do or I don't have the authority.
I don't know if you want to bring that to her attention, but that to my view would be the one question, at least in terms of message format standards.
MS. HUMPHREYS: I was going to say that the NCVHS has a mandate to recommendation activities the Secretary, which independent -- I mean, which their mandate was expanded in HIPAA. So, I would say that NCVHS is absolutely within its power to recommend anything it wants in this area. So, the heads up to the Secretary, we are going to recommend these to you and we want you to go ahead and implement them throughout the Department in these phases as represented later seems reasonable, but I think you can just say "hey," the next step is -- we have developed the principles. We are going to apply these. We are going to recommend you implement.
I don't think it is necessary to talk about interpretation. I mean, whether the Secretary -- the Secretary probably doesn't have yet the authority to mandate national standards in this area, but she certainly has the authority to implement them within HHS and she certainly has the authority to adopt them and she may even have the other, but that is down the pike. They are not ready to be adopted nationally.
MR. BLAIR: From all of the comments that I have heard so far, it sounds to me as if the wording that Bill was suggesting really could help resolve the issue. Does everyone feel comfortable with Bill's wording?
DR. COHN: Can we repeat it?
MS. AMATAYAKUL: I tried to capture this. Let me see if it works for you.
To accelerate the adoption of PMRI standards, the Secretary of HHS should adopt under HIPAA the recommendations developed by NCVHS for the selection and adoption of uniform data standards for PMRI. The process for this selection would include --
MR. BLAIR: Well, he had something about that it would be forthcoming. Bill, do you recall your words?
DR. BRAITHWAITE: No. Since we haven't -- the NCVHS hasn't made the recommendations yet --
MR. BLAIR: Right.
DR. COHN: And we are really not asking her for her permission around the guiding principles. We are more informing her.
MR. BLAIR: The words that you should hit on was to recognize that we would go forward and that these would be forthcoming. At least those are the ones I keyed on.
DR. MC DONALD: Can I make a suggestion that someone draft up something and we can come back to this?
MR. BLAIR: Bill, could you just work with Margaret?
DR. BRAITHWAITE: I would be happy to.
MR. BLAIR: Margaret, are you prepared to step us forward?
MS. AMATAYAKUL: All right. I am Recommendation No. 3 and Bill Braithwaite is going to give me something for No. 2. Okay.
To promote coordination of healthcare informatics standards, the Secretary of HHS should support strengthening the leadership role of and encourage continued government participation in the organizations having responsibility for coordination of standards, such as American National Standards Institute Healthcare Informatics Standards Board, ANSI HISB. To accomplish this, HHS at the departmental level should become a fully participating member of ANSI.
MS. HUMPHREYS: This seems to me to be a dead overlap with 1(a). These specific points could be mentioned under 1(a).
DR. MC DONALD: I would like to -- if HCFA or the government becomes the dominant force in this, that is not what we want. So, there are already members -- I mean, there are two or three people from the federal agencies, I think, on the ANSI HISB board. I am just a little worried about this whole thing where it is going to look like they are going to be deciding everything.
The other thing is there is a little bit of a emperor with no clothes here and I have said it before in that when it comes to coordinating, there is not the courage to push people together and maybe can't be in America on the ANSI HIPAA board and sometimes what it really does is dilute the effect of the market forces and slows adoption of the single standard.
So, I am not in favor of making -- well, making a special force that is supposed to make it get done faster because I don't think it will. That is, I think we would encourage -- the first sentence is good, encourage them participating in it in a vague sense. I don't think I would say they become -- at the departmental level because you have already got at least three, don't you --
DR. FITZMAURICE: Maybe a point of information, Clem. The last sentence, "To accomplish this, HHS at the departmental level should become a fully participating member of ANSI," that is not HISB. That is the ANSI organization, much as, I think, the Department of Defense or Veterans Affairs may be a member or the Department of Commerce may be a member.
DR. MC DONALD: That doesn't follow then --
DR. FITZMAURICE: You are right. They are two separate things. They are not --
MS. HUMPHREYS: It seems to me that whatever specifically we want to do or not say, it should be indented under 1(a)
DR. FITZMAURICE: I agree.
DR. MC DONALD: 1(a) is different. 1(a) is -- I am much more enthusiastic about it, saying get involved in the standards organizations, the ones that are doing the work, not in sort of an upper level organization.
MR. BLAIR: Let me just for clarification, okay, 1(a) refers to standard development organizations and that is those organizations that are directly developing the standards. Item 3 was talking about coordination and, Michael, you really helped craft Item 3. So, I defer to you on Item 3 in terms of how that was articulated.
DR. COHN: Can I make a comment after Mike is done?
MR. BLAIR: My only thought was, you know, in terms of what bucket it goes under --
DR. FITZMAURICE: No. 3, I envision that the government agencies as they have programs and missions that require standards coordination would be members of HISB. As they require specific standards, they would join standard developing organizations. But the Department as a whole must be a member of the national umbrella organization, ANSI.
DR. COHN: Okay. So, this is two recommendations and one -- do you think it could fit under 1(a)? I mean, to me the issue here is is that --
MS. HUMPHREYS: We could generalize A.
DR. FITZMAURICE: Certainly the last sentence could fit under 1(a).
DR. COHN: And actually the first part could actually be another bullet under 1(a) with some modifications.
DR. FITZMAURICE: I think probably, yes.
DR. COHN: Okay. I mean, my issue here is -- if we are talking about important recommendations for the Secretary to remember, I would hate to have Recommendation No. 3 one of the big three that she remembers because I think there are a lot of other very important recommendations we have here. Not that this is not an important aspect, but it is just not quite the same level.
DR. FITZMAURICE: Maybe A should have an overarching sentence with three components; participate in SDOs, participate in HISB, participate in ANSI.
MR. BLAIR: Is that okay?
DR. MC DONALD: I guess I would like to down tone the participation in HISB, because it has been done already. What are we telling people to do it for when it is done? Are you saying -- well, I have said what I said.
DR. FITZMAURICE: Some are participating. Some are not. It increases awareness of a place to go and it is complete.
DR. MC DONALD: Well, you are going to have more members from the government than you are going to have from the ones that are -- you are going to have a dominant government organization, which is not supposed to be.
DR. FITZMAURICE: What do you mean, HISB, ANSI or SDOs?
DR. MC DONALD: HISB.
DR. FITZMAURICE: But if they join SDOs, then they might dominate that, too.
DR. MC DONALD: But if you get 300, 500 members, 2,000 members in SDOs --
DR. FITZMAURICE: Anyway, I am just trying to complete. You join an SDO, coordinate through HISB. The Department should a member of the leading standards organization in the country.
MS. AMATAYAKUL: Question, to be a member of ANSI HISB, you have to be a member of ANSI. So, isn't that redundant?
DR. FITZMAURICE: The Department is not a member of HISB. The Department is not a member of ANSI.
MS. AMATAYAKUL: Therefore, it cannot be a member of ANSI HISB.
DR. FITZMAURICE: Right. It must be first of ANSI. So, it is not a member of HISB.
DR. MC DONALD: Well, there are a bunch of people go. I mean, they are not members?
DR. FITZMAURICE: The Agency for Healthcare Research and Quality is a member of both ANSI and HISB.
DR. MC DONALD: So is HCFA. So is -- I mean, how many memberships do you need?
DR. FITZMAURICE: We don't participate at all in the ANSI organization.
MS. HUMPHREYS: Who is we?
DR. FITZMAURICE: The Agency for Healthcare Research and Quality.
DR. MC DONALD: Margaret's question, how can you members of HISB if you are not members of ANSI?
DR. FITZMAURICE: By the rules, they cannot. The agencies cannot. You are supposed to be a member of ANSI to be a member of HISB.
MS. AMATAYAKUL: So, I guess my question is is it necessary to say ANSI HISB and ANSI?
DR. FITZMAURICE: I would have the Department become a member of ANSI, of the national organization, the Department be a member of ANSI. That is me talking. You know, here is the largest department of health in the world and here is the largest national standards body.
MS. AMATAYAKUL: So, really A is the overarching statement and then we have three sub-bullets. We have SDOs and we have coordination and then we have HHS being a member of ANSI. Okay. I will do that.
DR. ZUBELDIA: Michael, would the Department have other roles in ANSI, other than participating in HISB?
DR. FITZMAURICE: I don't know that the Department would then itself become a member of HISB, but in terms of
-- since healthcare standards are becoming a larger and larger force in the U.S. health industry, it ought to be a member of the large organization, that is, ANSI, in order to deal not only with national issues, but also with international issues.
I am looking upon that as a different role than an agency saying, you know, we need standards for immunization or something. Go to an SDO to do that. If you don't know where to go, go to HISB or ask an SDO if it is part of their mission.
DR. COHN: I think this is one we are going to need to sort of see back -- I mean, I am getting a little confused about. I mean I know that we are saying active participation in SDOs. I don't know if we are saying it needs to or if it needs to continue. We are certainly saying it needs to be a member of ANSI. I am a little confused myself about what we are saying about HISB. I think we are sort of saying that maybe it doesn't --
DR. FITZMAURICE: -- recognize the continued support.
DR. COHN: Maybe that is what we are sort of saying, recognizing continued support for its coordination activities.
DR. YASNOFF: It is past our break time. Can we take our break?
MR. BLAIR: Oh, it is break time. Okay. Sure. Now, could we be back -- I really would like to, you know, move these things in a timely manner. Do we all agree to be back in ten minutes or do we need more time? If somebody needs more time, then please say so now. Can we be back in ten minutes? Okay. Thank you.
[Brief recess.]
MR. BLAIR: According to my virtual timepiece -- and the giggles are because while I said everybody should be back in ten minutes, I failed to look at my watch to know when ten minutes was. So, by virtue of the virtual time police, it is now ten minutes.
And we are reconvening and we have gone through the first three items. I believe we are ready to go on to the message format section with Recommendation No. 4.
Margaret, are you prepared to take us through?
MS. AMATAYAKUL: Yes. I am coming to that. Okay.
Message Format Standards Recommendations: Considerable progress has been made to improve interoperability in PMRI systems through message format standards, several of which, such as HL7, DICOM, ASC X12N and NCPDP, enjoy wide market acceptance in their respective fields.
MR. BLAIR: Could I just do one thing here? Because we are talking about reorganization. Okay? And Bill already is working on something, ,which he will be presenting to us a little bit later in terms of a possible reorganization.
MS. AMATAYAKUL: Great.
MR. BLAIR: But before we actually go into the very first one, there are topics in this section. Could you just review those topics so that people have a feeling for the coverage and maybe the sequences underneath this section? Then we are going to go into one after the other.
MS. AMATAYAKUL: Okay. The first topic is accelerate development and adoption of message format standards. The second is to require implementation guides. The third is to require conformance testing. The fourth is to address gaps and inconsistencies.
Next is to coordinate data content; then promote semantic interoperability.
MR. BLAIR: Go back to our --
MS. AMATAYAKUL: Okay. All right.
Under "Accelerate Development and Adoption of Message Format Standards," users of current message format standards are still compensating for the lack of fully seamless unsupervised data exchange by having to expend costly and time consuming additional work to negotiate interface agreements between systems. To make applications work in their own environment, providers often must reprogram software to conform to their mix of information systems applications.
For every new information system application, codes and terms must be translated and mapped to other systems to interpret data content of the messages correctly. Finally, there are a number of new products on the market today that have not adopted applicable message format standards. Much work remains to develop all needed standards, raise the level of standards to achieve semantic interoperability and promote universal adoption. Testifiers indicated that government action was needed to help accelerate progress.
DR. COHN: Do you want to read the recommendation along with this one?
MS. AMATAYAKUL: Recommendation 4 is to accelerate the development and adoption of message format standards for PMRI, the Secretary of HHS should immediately task the NCVHS to study and recommend the most appropriate PMRI message format standards at they and the health industry mature.
MR. BLAIR: Now, you are reading -- you just read Michael's --
MS. AMATAYAKUL: Changes. Yes. They are okay?
MR. BLAIR: Yes.
DR. MC DONALD: I was just confused because this thing says it has got Michael's changes, but I don't actually see those words.
MS. AMATAYAKUL: You don't see the red?
DR. MC DONALD: Well, I don't see color because I have got a black --
MR. BLAIR: The hard copy you have in front of you does not have Michael's. The one she is displaying does.
DR. MC DONALD: Well, it says it does in the header.
MS. AMATAYAKUL: He sent two copies. He sent one that had comments in Section II and III and then he sent another one that had comment in Section IV.
DR. MC DONALD: I don't have that at all then.
DR. COHN: Let's read through this and is there --
DR. MC DONALD: This says it is his thing. This says it right on the top.
MS. AMATAYAKUL: That is because he did two of them.
MR. BLAIR: I think that what Margaret is displaying has --
MS. AMATAYAKUL: Everything. It has the original and it has Michael's track changes and Jeff's comments.
MR. BLAIR: Are you able to see -- my comments are also displayed?
MS. AMATAYAKUL: Yes, yes.
MR. BLAIR: Okay. Why don't you read them?
MS. AMATAYAKUL: Read your comments also?
MR. BLAIR: Yes. You know, with respect to Michael's. I don't know --
MS. AMATAYAKUL: I am coming. Okay. So, then we have NCVHS should and there are bullet points under there and then Jeff's comment is, "We have already spent 18 months studying PMRI standards. Let's let the group decide whether they want to say this."
MR. BLAIR: Now, the piece on that was the word "studying" because I thought we had previously had a discussion that -- and a number of folks on the workgroup felt as if we shouldn't use that particular word. That was my -- as a matter of fact, I was kind of paraphrasing what I think some folks on the group had said.
DR. FITZMAURICE: Here is what I don't
understand --
DR. COHN: Let her finish reading it, please.
MR. BLAIR: Oh, I am sorry. I didn't realize you hadn't gotten to the end.
MS. AMATAYAKUL: Okay. NCVHS should (a) identify the highest priority areas requiring interoperability; (b) apply guiding principles for selection of message format standards within the highest priority areas and (c) make recommendations for selection of PMRI message format standards to the Secretary of HHS.
DR. COHN: I wanted to start out with a comment and I know that others have -- Richard has a comment and I am sure that Bill Yasnoff also has a comment.
Now, first of all, I think my general comment -- I have actually two general comments. One is that this is grossly redundant with Recommendation 2 and ought to be someone included in the Recommendation 2 with whatever we do about that. Now, we have already identified that we need to rewrite Recommendation 2 around what the NCVHS should be doing and it is probably more of a notification than a recommendation.
The other piece has to do with the fact that while I think the first paragraph under this accelerate development section is actually very good, it probably -- if it hasn't been said in the introduction of the first four sections, probably ought to have been. So, it probably is a little redundant. Somehow it needs to be moved up there probably. And that is just an observation about that. That is my comments about this one.
I think, once again, it is a cluster with two.
Richard, you had a comment and then Bill and then Clem.
DR. FERRANS: You know, when we look at this thing, I agree with Jeff's, you know, comments up there of, you know, we have spent the past 18 months studying. The question is what do we really want to happen and I think the answer is that, you know, we want to use the guiding principles and make the recommendations but that is not a recommendation to the Secretary. That is what would -- I do believe that needs to be declarative. So, what are we asking the Secretary? And I think we would want to ask the Secretary is that the Secretary implement them if we recommend them.
You know, there was a discussion this morning as to what powers the Secretary has and given some of the discussion, this is within the scope, then, you know, the phrase that I came up with -- and this can go a little further than this part is that the Secretary should exercise her authority in implementing this or -- the real discussion is what are we really asking.
I think what we are really asking is, you know, here is our process. Here is the selection. We make some selections and give them to the Secretary and then there is some kind of adoption. I mean, it seems simple and I would ask, you know, Bill whether, indeed, that authority already exists and there has been some question to that as to whether, you know, with these PMRI standards we are in a study and make legislative proposals or whether, indeed, other parts of HIPAA that the authority to implement them already exists and whether that is what we are recommending.
You know, it has to be a consensus. And my final point is if that authority exists, what I said to Simon is there needs to be some reflection on that in the document and people have to be educated because people do not know that. People out there think that HIPAA right now covers, you know, administrative, which they think of as billing codes and that it covers security and privacy, that it does not cover what they consider to be clinical data standards.
If we are saying something otherwise, we need to clarify that and educate people on this document.
DR. COHN: Maybe we will exert some executive discretion and let Dr. Braithwaite respond and then Bill and then Clem.
DR. BRAITHWAITE: Well, that comment fits into what I was thinking about in terms of the requested redraft of Recommendation No. 2. The idea that came to mind was to -- because at the moment they are, I agree, redundant -- was to split them up and make Recommendation No. 2, in fact, a recommendation to the Secretary, something on the order of the Secretary of HHS should exercise her authority under HIPAA to adopt the PMRI interoperability standards that will be recommended by the NCVHS as a result of the process and some reference to the process of this --
MS. FYFFE: Before we go any further, I am a little confused. Can someone clarify what authority the Secretary has?
DR. BRAITHWAITE: I thought I had read the legislation.
MR. BLAIR: Bill was going to put that wording in with Margaret.
DR. BRAITHWAITE: The wording I just read is my first draft of what I am going to recommend to Margaret for -- and if you want a specific quote in there from the law, maybe we could do that, but I am not sure it is necessary.
MS. FYFFE: That is not exactly my -- please tell me -- can somebody clarify what the Secretary's authority is?
DR. BRAITHWAITE: Simon read the law a little earlier --
MS. FYFFE: I can read the law. I need an interpreter here.
DR. BRAITHWAITE: The interpretation is that the Secretary not only can adopt standards for the listed transactions, but also other standards can be adopted by the Secretary, as long as they improve the healthcare -- I forget the exact words, but improve it and/or lower the cost of efficiency --
MS. FYFFE: Okay.
DR. BRAITHWAITE: So, there are some specific words in there about the qualifications, but there interoperability standards for PMRI certainly meet those criteria.
MR. BLAIR: Limited to administrative and financial or does it also cover --
DR. BRAITHWAITE: It says administrative and financial and certainly --
DR. BRAITHWAITE: Is there a problem because it doesn't have the word "clinical" in there? Is that a limitation on us?
DR. BRAITHWAITE: I don't think so.
MS. FYFFE: I am going to go back and look at the definition of "administrative" and "financial."
DR. BRAITHWAITE: I don't think it is defined.
DR. COHN: The question I would ask -- I mean, I think the question we need to mull over is is that there may be things that are not covered under that and that we need to be asking for the Secretary to have additional authority for, but I think the view is is let's not ask for a recommendation where there is already the authority.
MS. HUMPHREYS: And it does seem that the way the additional instruction to NCVHS to make recommendations for PMRI is focused, you could easily interpret that anything that is a transaction, going between, is already covered but something that might be additional information that would be needed perhaps for internal quality control or whatever might be additional PMRI, where the legislation doesn't actually give authority because it is pretty focused on the transactions. But if you can say that the transaction improves efficiency and a better way to improve efficiency is to have specific, for example, medical terminology or coding or whatever in it, then it seems to me that it is covered.
DR. BRAITHWAITE: I am sure it is covered. Not only that, but any good lawyer would read this to say that if the law requires NCVHS to make recommendations to the Secretary for specific standards, that there is an assumption there that the Secretary has the authority to do something about those recommendations. Otherwise, it wouldn't be in the law.
MS. FYFFE: Thank you.
DR. FITZMAURICE: There is one way around that and that is simply to say -- make a recommendation that if the law -- if the Secretary does not already have the authority, the Secretary should seek the authority to expand into clinical.
MR. BLAIR: Let's stick with -- my inclination is to stick with Bill's word.
I think, Bill Yasnoff, you had --
DR. YASNOFF: I think my comment as well as the recommendation is redundant. And my comment is that the recommendation is totally redundant, that 4 and 4(c) are essentially already covered in 2 and 4(b), which is using the guiding principles, has already been stated in 2(a) and 4(a), which is prioritization is already stated in 2(b).
So, what we are doing is we are beginning to describe the process that NCVHS -- that we recommend that NCVHS use in developing future recommendations for the Secretary.
So, we have said it once. Now we have said it again and, in addition, in terms of using guiding principles -- and I don't know if we want to jump there or not, we also say that in Recommendation 16. So, we can either look at that now or later.
DR. MC DONALD: I guess I am going to be even more redundant, but I think that the paragraph above is actually misleading because it says we have got to do these things with message standards and two of the three reasons they are not working is, one, is because the vocabulary, which doesn't belong under this section. The other one is because some people haven't adopted them, which doesn't have anything to do with a change in the standards is going to help.
And I think the first paragraph is actually a little wrong because as one who was installing these things, it takes a week or so to figure out if there is any difference in the messaging. It takes three months to work about -- the doctor ID list is wrong and this list is wrong and the vocabulary is wrong.
So, I just think we should strike it. That is not -- this paragraph -- there is the vocabulary problem. There is the fact that everybody doesn't do everything.
MS. HUMPHREYS: It is well described elsewhere, the real problem.
MS. AMATAYAKUL: Can I get clarification, Clem? Did you say strike the entire paragraph?
DR. MC DONALD: Yes.
MS. AMATAYAKUL: Starting with "Users"
DR. MC DONALD: Yes.
MR. BLAIR: Is that in the preface before the recommendation?
MS. AMATAYAKUL: Yes.
MR. BLAIR: Could I come back to this point because Simon made it first and I think we are going to hit this as we go along? I think it may be very important also with respect to any reorganization we may have.
I think we may need to examine the introductory pieces of terms of what we really need there to help somebody understand the relevance of that recommendation, each recommendation. Maybe we sort of doing it now. We are deciding what we need to have and what we don't need to have and then we will go back and if we look at a reorganization, then we will wind up seeing whether those paragraphs are needed.
So, let me just strike my comment and we move forward.
DR. MC DONALD: The specific paragraph I don't think is appropriate for this recommendation.
DR. COHN: Oh, sure. I am hearing two consensus items. One is that we should strike the first paragraph and the second is is that the recommendation itself gets interwoven in 2. So, that is how I think this part is being resolved.
DR. FERRANS: But the third recommendation, which is mine, is that given some of the general discussion, that we do need to much earlier in the document explain what authority already exists.
MS. FYFFE: Clarify what authority --
MR. BLAIR: Now, I guess I need a point of clarification. We are striking the quote, first paragraph. Is that all of the introductory -- is there more than one paragraph or just one paragraph introducing?
MS. AMATAYAKUL: Just one.
MS. HUMPHREYS: It is the first paragraph under the heading of "Accelerate Development..."
MR. BLAIR: Is that the only paragraph?
MS. HUMPHREYS: Yes. There is just one --
MR. BLAIR: So, we are striking the entire introduction to it, right?
MS. HUMPHREYS: Yes, but we have gotten rid of the recommendation, too. So, it doesn't need an introduction.
MR. BLAIR: The recommendation is being folded into --
DR. COHN: Yes. And the only thing we have is actually a short paragraph introducing the whole section.
MR. BLAIR: Okay. It is going to be interesting how many of these introductory paragraphs, as we go along, we will be able to strike, but let's just go forward. Are we on to our next recommendation, our next topic?
DR. ZUBELDIA: Can I suggest something?
Where we strike this recommendation or we fold it into two, I would like to see it a little more direct, something like the Secretary should adopt under HIPAA the message format standards for PMRI recommended by NCVHS.
MS. AMATAYAKUL: Yes, I got it.
DR. ZUBELDIA: The Secretary should adopt under HIPAA the message format standards for PMRI recommended by NCVHS.
MR. BLAIR: Okay. Or to be recommended, right?
DR. MC DONALD: Let's not change it yet. Let's get it down.
MR. BLAIR: I think it is "to be."
DR. ZUBELDIA: Right there, Margaret, where you have the cursor --
MS. AMATAYAKUL: Yes, I got it. I struck it but I didn't. You raised it.
DR. COHN: Did you put in the 2 area?
MS. AMATAYAKUL: Yes.
Require implementation guides: Unlike HIPAA administrative simplification transaction standards, detailed implementation guides for the PMRI message format standards do not typically exist in a comprehensive and consistent format. This results in users having to create their own, non-standard guides. A single implementation guide for each standard would lower implementation costs, eliminate the need for components of many trading partner interface agreements and improve interoperability and data integrity.
The recommendation is: For those PMRI message format standards selected for adoption, standards development organizations should be encouraged, was the recommendation from Mike, will be required is the recommendation that was originally there, to develop standard implementation guides.
Jeff's comment is "I believe that implementation guides should be required. Let's let the workgroup decide."
DR. FITZMAURICE: The question I have is whom does the Secretary require to produce an implementation guide?
MR. BLAIR: Part of it, Michael -- and maybe we need to say this in this particular recommendation and we didn't do so -- is the thought was that when we go through the selection process, one of the criterias in the selection process is that an SDO would produce implementation guides.
DR. YASNOFF: Yes. When we make our recommendation to the Secretary that a standard be adopted, my assumption would be that we would forward the implementation guide and say the standard -- this is part of the standard, this implementation guide. So, if there is no implementation guide, then there is really no standard. Isn't that what we discussed?
DR. MC DONALD: I think there is a major wrong premise in this. All the standard groups have implementation guides, always have. There are two reasons why there are extra ones. One is the company doesn't want to do it that way. So, they make up their own. The second is -- but the criticism is they are not always specific enough. So, I don't think that this is going to get it by just saying you have got to have it -- I mean, you could say you have got to have an implementation guide and that won't cut anybody out.
MR. BLAIR: What should we say?
DR. MC DONALD: Well, I think you should say that the -- I don't know -- one of the things is that there should be only one. That should be it. People shouldn't get to make up their own.
DR. YASNOFF: So, aren't you essentially agreeing with me that when we recommend the standard that we should say this is the one and only implementation guide.
DR. MC DONALD: I guess I am more objecting to the leading paragraph that implies -- sometimes the guides aren't specific enough. So, there are problems in the implementation guides that exist.
DR. YASNOFF: So, what we should say is that NCVHS will recommend a single implementation guide with every standard.
DR. COHN: Is there a recommendation here or is this a point of information?
MS. HUMPHREYS: Yes, it is a point of information that when they recommend the standards, the standard is going to include a specific implementation guide.
DR. ZUBELDIA: I think that recommendation will be for the Secretary to adopt the implementation guide.
DR. FITZMAURICE: That will come when the standard is forwarded from NCVHS. We are kind of defining some operating rules for NCVHS in consideration of what standards to adopt.
DR. COHN: Is this part of -- I hate to lay more on 2, but is this, again, part of 2 then?
DR. FITZMAURICE: More like a text box. This is advice from NCVHS.
DR. COHN: Well, but 2 is really a -- words to NCVHS, I think, generally, with a couple --
MS. HUMPHREYS: You don't give advice to yourselves. Just say what you are going to do.
DR. COHN: That is right. See, the reason I am asking about this one is is if indeed we are going to do this, then 2 is becoming sort of what it is we are going to be doing. So, is there a recommendation to the Secretary here or is it more of a statement to the industry and the SDOs and to the Secretary that this is --
DR. MC DONALD: I think make a recommendation to the Secretary that the recommendation about the standards will include recommendations on implementation guides.
DR. FERRANS: In other words, we are requiring it. We are not asking the Secretary to require it.
MS. HUMPHREYS: This is part of the standard. We want you to adopt it.
DR. YASNOFF: Right. And what we are saying, this is part of our description of the process that we are going to be undertaking. So, we have described the process. So far we have said we are going to use the guiding principles. We are going to prioritize the content and functional areas, going to include a single implementation guide with our recommendation. So, these are all parts of the process that we are describing.
DR. FERRANS: And require conformance testing and the --
[Multiple discussions]
DR. YASNOFF: You are jumping ahead. That is the next thing.
MR. BLAIR: Does Margaret still need a little more time to capture this?
MS. AMATAYAKUL: No, I think I have got the essence of it.
MR. BLAIR: Okay. Then could I just ask, Margaret, you happen to have written this particular recommendation with these changes. Is there an issue that we haven't considered?
MS. AMATAYAKUL: No, I think this is great.
MR. BLAIR: Are we ready to go on to our next one?
DR. COHN: Dr. Braithwaite.
DR. BRAITHWAITE: I had one question and it may be been discussed earlier. Throughout this section, we are talking about message format standards. In fact, what we are adopting is an implementation specification, which includes message format stands, data content standards, data element conditions, lots of things besides the format of the message.
I am wondering if a different term would be more useful here, rather than implying that all we are suggesting is a standard for the format of the message.
DR. MC DONALD: I think everything you said is true, but I think it is still useful to focus on what comes out of the messaging because sometimes there will be variation allowed in x, y or z. There is no specific -- we are not going to specify how a history or a visit should be laid out in great detail.
I think that it is worth dividing it as to what those guys do and we will still have to something about the standards or vocabulary separately.
[Multiple discussions]
DR. COHN: I was actually going to make a comment here that when we first of all observed it so far, the only thing that exists in the section is the introductory paragraph to the section. Everything else is moved to some other place.
MR. BLAIR: When you say "2," what is 2?
DR. COHN: Message format standards recommendations. What I am saying is that the -- I am saying so far and Dr. McDonald wasn't here at the beginning, but I think the initial question we were asking -- well, no, was whether or not this organization supports the recommendations we need to make or whether some other format supports these recommendations better, one that sort of begins to blur the lines between message formats and medical terminologies and data quality.
I think Dr. Braithwaite was mentioning that. We have not reached a decision on it. What we were doing was mulling over that and then exploring the recommendation to see how things fit together. Now, I don't have a conclusion on this one yet, but so far one would observe that things are sort of beginning to fit together in different ways than we had expected.
DR. MC DONALD: What is happening is good but if we blur together everything, we are never going to get anything decided.
MS. HUMPHREYS: I am still anticipating that under Recommendation 2 there might very well be a header that refers to format standards and a header that refers to something else, a subcategorization the overall recommendation -- excuse me -- this overall statement that NCVHS is going to -- that the Secretary is going to adopt these standards that are forthcoming from -- recommendations forthcoming from the NCVHS.
DR. MC DONALD: Under conformance testing.
DR. COHN: Under conformance testing, yes. Are you okay?
MR. BLAIR: Yes. The additional question that I had for the group -- and, forgive me, the photographic memory is just not here -- do we have an introductory paragraph before this recommendation and, if so, is it one that we need to retain? Is there important information in it or can the recommendation be moved without the introductory paragraph?
DR. MC DONALD: Are we talking the very introductory paragraph?
MS. HUMPHREYS: No, the one that would require implementation guides.
MR. BLAIR: Implementation guides -- is there an introductory paragraph in front of that?
DR. MC DONALD: If there is, it is not right as it is now.
DR. YASNOFF: I think Clem was saying it should be removed or at least that --
MR. BLAIR: Part of my question is that -- and I think piggybacking a little on Simon's -- is whether we even need these introductory paragraphs?
MS. HUMPHREYS: I think in general we don't and if there is anything in them that should have been said before, we should move it up before.
MR. BLAIR: Right. So, is this a paragraph we feel that we -- if it is eliminated, everybody still could understand the recommendation?
MS. HUMPHREYS: Yes.
DR. YASNOFF: I think we covered this in the previous section that we haven't discussed.
DR. FITZMAURICE: I think we should go back and just make sure that we did talk about a single implementation guide. That doesn't strike a bell with me, but that is something that we easily do a check on.
DR. COHN: Let me just make sure that I understand the point we are making here, which I think Dr. McDonald is pointing out, is we are talking about a single implementation guide of enough specificity that --
MS. HUMPHREYS: People can actually implement it.
DR. COHN: -- that people can actually implement it. Is that the point --
MR. BLAIR: Not only that they can implement it, but that they could -- that it will facilitate interoperability when they do implement it.
DR. MC DONALD: But the problem with that is those words are all -- I don't think that is helpful because saying a --
DR. COHN: Well, it is a circular argument.
DR. MC DONALD: Yes. I think these things are specifiable. I mean, people are sending stuff this way. We are not -- then when you say "interoperability," which no one understands that word anyway -- everything is wonderful.
DR. COHN: And certainly the recommendations we have here are to facilitate interoperability and comparability. So, if we are sort of adding that --
MS. FYFFE: Can I make a comment? Does "interoperability" mean interfaces?
DR. COHN: No.
DR. MC DONALD: It literally means everything is perfect and you don't have to have people around.
MR. BLAIR: You don't need additional translations.
[Multiple discussions]
MS. FYFFE: Interface plus. In my -- a couple of decades ago when I was implementing systems, there was one word that would strike fear in my heart and that was the word "interface." The minute you said "interface," you knew you had a challenge on your hands.
DR. MC DONALD: Interoperable is a way to hide that fear.
DR. COHN: I think that is actually mentioned in the earlier parts of the document, as I remember from last night.
MR. BLAIR: Are we ready to move on to our next question?
MS. BEBEE: This is Suzie Bebee. I went back to the Section III and looked at implementation guides to improve interoperability and it doesn't have anything about a single implementation guide.
MS. AMATAYAKUL: I made a note.
MR. BLAIR: Thank you, Suzie.
Are we moving on to our next question now?
DR. MC DONALD: Why do we have to have her read it?
MR. BLAIR: Because it sure helps me a lot.
MS. AMATAYAKUL: Require Conformance Testing: A lack of conformance testing is a further impediment to the use of message format standards. Conformance testing performed by an independent organization assures that a standard has been implemented according to its implementation guidelines and performs its functions as intended.
The recommendation is to ensure that standards adopted for PMRI meet the requirements of interoperability, the health industry should adopt --
PARTICIPANT: You have got the word "adopt" twice.
MR. BLAIR: Maybe we have to go back to our original here.
DR. COHN: No, just take out the --
MS. AMATAYAKUL: Should adopt conference testing of PMRI standards by independent organizations.
DR. YASNOFF: First of all, for consistency in the introductory paragraph, instead of saying implementation guidelines, can we say implementation guide, so we people know we are talking about exactly the same thing?
MR. BLAIR: Once again, do we even need that introductory paragraph?
DR. MC DONALD: This one works, I think.
MR. BLAIR: This one we need.
DR. YASNOFF: It is only one sentence and then the other thing is no one can perform conformance testing of PMRI standards. You can only perform conformance testing of specific implementations of PMRI standards. It is, I think, an important difference.
[Multiple discussions]
That is separate from who should do it. It should be independent, but you are going to do conformance testing of specific implementation of --
MS. HUMPHREYS: Who are we recommending this to? And does that person -- I mean, what is supposed to happen here? The recommendations are going to the Secretary. The NCVHS is going to declare to the Secretary what they are going to do and what she should do about that.
Now, this sounds to me like a very true statement that somebody should do this conformance testing, but who is going to do and who is going to make them do it? What do you want the Secretary to do to ensure that this takes place?
DR. MC DONALD: I have a suggestion. What we also need is conformance tests. We don't have them and it is a very touchy subject. We need to make them. I would suggest that we fund NIST or we have actually listed a number of organizations, that we provide funding for the development of performance tests, the development to be done by an independent organization.
DR. YASNOFF: And then would the actual execution of the tests be done by someone else or by whoever develops them.
DR. MC DONALD: Sometimes they are portable and sometimes not. I don't know.
DR. YASNOFF: Betsy, in answer to your question, I think we are recommending that the Secretary essentially solicit and issue a contract with somebody to act as an independent agent to do this function and pay for it.
DR. ANDERSON: that the function would include the things that --
MS. HUMPHREYS: -- sounds like a good recommendation.
MR. BLAIR: Let me try to summarize and capture these things before we lose them. Okay? With Betsy's comments, she is saying we really have to have more specific actionable recommendations and that is that the Secretary fund a specific independent entity that will -- here is where we start adding Clem's comments and Bill's, that will wind up developing the conformance tests and executing the conformance tests.
DR. MC DONALD: We should take those one at a time. Because I want to build them and then we have to decide whether we encourage people to test them or we give them to hospitals to test them if we are buying them -- I mean, that is two separate issues, I think.
DR. FERRANS: Here is where I have a couple of problems with this. No. 1, if one person gets a contract, what are they going to charge? What is that going to do to the price of software? Vendors have to put it through this. And then what if there is a big backlog and people can't get their systems tested to say that it meets a certain conformance. No. 1 and No. 2.
In essence, what I read is that what we are trying to do is to tell the healthcare industry or the software industry that, you know, your systems will be regulated that they need to -- in order to claim that they meet the standard, they are actually going to have to meet the standard.
So, in some ways what we are saying is if you want to say that you meet the standard, we should require conformance testing to get the Good Housekeeping Seal essentially. But I am concerned about just one organization and whether that will impede progress.
DR. COHN: Well, I know that Kepa has a comment and I expect Dr. Braithwaite also probably has one and Kathleen after I am done.
This is an area where I think we need to look to what is happening. We have been going so far as saying, well, gee, these standards really -- at least the message format standards really aren't that different than what we are talking about with the financial standards.
So, the question is, well, gee, what is happening around the financial standards. So, the question is, well, gee, what is happening around conformance testing for the current, yet to be published HIPAA financial transaction standard and is that somehow applicable to what we are doing.
I don't have the answers, but those are sort of questions you would ask.
DR. ZUBELDIA: I think there are several parts. The test itself could be developed with government funds. The application of that test protocol or test parameters could be done by industry bodies, like it is being done with the administrative standards and it could be independent industry bodies that use that government-defined test protocol to test the compliance.
Then there is one more step, which is the accreditation or certification that you have passed the tests and whether that is required or not. And if that is required, who enforces the accreditation of the conformance testing. So, it gets pretty complicated, but I think that once the test is defined, then the industry could have an independent body or bodies that test using the government defined test.
MS. FYFFE: I think we are getting too far down into the weeds. Should we come back up to a little higher level and just say that there should be funding provided and work out the details outside of this paper? I just think the recommendations are a little bit too specific.
DR. MC DONALD: I agree with her. I think if we say that there should be funding for developing conformance testing, we get the conformance test developed, there will be forces that will work out and then we could do more later, make other recommendations later if they don't work out. Right now there aren't any. It is hard to do anything.
DR. BRAITHWAITE: Just as a reference from the administrative transactions, the specifications for conformance is the implementation guide and then the test is to take a transaction in whatever way is appropriate for whatever conformance testing organization comes forward is to test it against the implementation guide. That is the conformance test.
So, the development of the implementation guide produces already the conformance test specifications. Then on the administrative transaction side, private organizations are taking those specifications and conducting -- for a fee and not a large fee -- conformance tests for any organization that wants to send them a transaction for testing. I think that there should be no difference in this venue.
MR. BLAIR: If I could repeat the things that I am hearing, I think that there is some of this convergence on the fact that the statement should essentially say -- I want to make sure that you agree with what I am summarizing here, your thoughts -- that the statements should essentially say that we would be funding conformance testing, which includes the development of the conformance test and the implementation of the conformance test and not go into additional details of that.
However, it seems like Richard Ferrans expressed a concern, I thought, which was -- I almost thought was as to whether or not we should go down this path because you were concerned about the cost that would be imposed on users. So, Richard, are you okay with us going forward with --
DR. FERRANS: I very much like the approach of getting the funding and getting the testing. What I didn't want in the recommendation was, you know, let's pick someone to do the testing because at that point we run into all kinds of problems.
MS. HUMPHREYS: I have a question. Is the Department funding development of the conformance tests for the HIPAA transactions that have been collected or about to be? If the answer to that is "no," and we expect this to happen, then why do we need to fund it for these?
DR. COHN: Dr. McDonald.
DR. MC DONALD: It hasn't happened. There is resistance to it --
MS. HUMPHREYS: Well, unfortunately, the standards haven't been published yet.
DR. MC DONALD: No, no, I am sorry. I didn't mean about the administrative one, but in the clinical areas, there has been on ongoing kind of hesitation, backing away from -- it just isn't -- it isn't happening. It comes up at the standards meeting all the time and either -- well, someone will say, well, we don't trust them and if we could just get some of these things built as little software tools with some sample data and then pump it through and see what comes out, I think we would have a dramatic improvement in the interoperability.
MS. HUMPHREYS: I understand what you are saying about it not happening now with the clinical standards. But it seems to me that if we imagined this activity of the extension of HIPAA following on, then we -- the NCVHS recommends these standards. The Secretary implements them in a some phased way that she thinks makes sense, given the state of the industry or within the Department first or whatever.
It seems to me there will, in fact, be conformance testing for the HIPAA transactions and some of these are, in fact, going to be just extensions of the -- I mean, if we get conformance testing on the use of HL7 within the HIPAA environment, then we will have to have -- it can be extended to cover this other.
So, the fact that these haven't spontaneously come forward within clinical standards doesn't seem to me to mean that they won't come forward if this is the follow on to a preceding HIPAA process, which is going on.
MR. BLAIR: So, are you suggesting that we don't need this recommendation or are you suggesting there is not a problem with this? I don't understand what your conclusion is from what you said.
MS. HUMPHREYS: I think that we should not have a -- it doesn't seem to me to be reasonable for the NCVHS to recommend funding to the -- the Secretary fund conformance testing for clinical standards if it isn't recommended or they don't think it is likely to be needed for the other HIPAA standards. Because I think whatever happens with HIPAA will follow on and happen with these as well.
DR. MC DONALD: Just to clarify that the question was about paying for the development of the conformance tests, not to do the testing. That is still the same issue.
MS. HUMPHREYS: Well, I sort of agree with Bill's point that the definition of what the conformance test is is if you have a single specific implementation guide that you can put something out that meets it and if that is the approach that is going to be taken with HIPAA --
DR. MC DONALD: Too soft. Maybe because someone reads sit and goes, yeah, that is not the same as grinding it through and kicking things out.
DR. COHN: Can I make a comment and then I think Dr. Braithwaite and then Dr. Yasnoff?
We actually have a couple of choices here and I think we can actually even ask for expert secondary opinion on this one. One approach is, obviously, with the previous recommendation where we are talking about the development of implementation standards, that they be, among other things, of sufficient specificity to enable conformance testing. And then a comment that we believe if that happens the industry will take upon itself to do x, y and z. Now, that is one option we can do. The other case we could make is, well, gee, these standards are further behind than the financial transaction standards; therefore, we need additional assistance from the Secretary to accelerate what we are trying to do.
This is a type of acceleration that could occur. This is a way that the Secretary could accelerate things. Now, you are right. We can't make the case on the basis of, well, gee, this happened this way for administrative and now we are moving off into these other areas. I don't know that I have a strong feeling one way or another and at a minimum we need to do the first.
The question is whether we recommend the latter.
Dr. Braithwaite and Dr. Yasnoff.
DR. BRAITHWAITE: You took the words right out of my mouth, Simon.
MR. BLAIR: Bill Yasnoff.
DR. YASNOFF: I think there are two choices. One is -- and the way I have worded it is select and fund one or more independent organizations for conformance test development, execution and compliance certification.
That is one thing we could recommend. But the alternative is to recommend to the Secretary that she establish certification mechanisms for conformance tests and that would essentially say the Secretary could -- you know, anyone could develop a conformance test, submit it to the Secretary and the Secretary would say, yeah, this conformance test is okay. If you pass this test, then it is okay and maybe that is what we really want to recommend.
But I don't think even if the administrative transactions are not being conformance tested except through the implementation guide, I think there needs to -- I agree with Clem that there needs to be software around that says, okay, here I am going to submit a thousand transactions through the software and it is going to say "yes," these conform, "no," they don't conform and then I get a stamp of approval.
MS. HUMPHREYS: My understanding is that what Bill was saying was that there is already work afoot that organizations are, in fact, going to do exactly that with HIPAA transactions. They are going to develop their conformance test based on the specification but the idea is that you will run stuff through it. Right?
MR. BLAIR: I think Simon has a comment here and then I have a comment.
DR. COHN: I guess I am going to go back to what I was recommending before and try to see if we can get it up there a little bit, which is No. 1, that in the previous recommendation one of the requirements of --
MR. BLAIR: Selection.
DR. COHN: No, the implementation guide is -- it can include a single implementation guide that can be --
PARTICIPANT: The standard has to include an implementation guide.
DR. COHN: No, it can -- now it says that can be conformance tested.
[Multiple discussions]
No, I mean, I think we are talking about -- let's start with that. Okay. That is Step No. 1 is -- I think we are saying this of sufficient specificity --
DR. MC DONALD: I don't think we said that. I didn't hear that agreed to. You get into all kinds of theory if you do that.
DR. COHN: Are you saying that we should generate performance guides that can't be -- implementation guides that can't be conformance tested?
DR. MC DONALD: It is not a binary decision. Don't push me into a hole.
DR. COHN: Well, no, but what I am saying is is that I think that if we are talking about a standards guide, this becomes part of the specification of what an implementation guide should be is that it should be allowed -- that it should be of enough specificity do you know whether it is in or out.
DR. MC DONALD: Well, we are dealing with two things. We are kind of saying we want one anyway.
DR. COHN: That is right.
DR. MC DONALD: This is not going to help us with that. So, I would rather finish and come back to --
DR. COHN: Well, no, well, no. The only point I am making is is that we were just -- okay. Let me propose and then you can agree or disagree. Then I think the next recommendation has to do with because the industry is further back or whatever, these areas, an area -- a recommendation we have is the Secretary could accelerate activity in this stuff by funding development of software and other tools to enable application of the conformance testing.
DR. MC DONALD: We actually had two proposals from Bill. Maybe we should just focus on those, which I -- each of those -- I like one of them.
MR. BLAIR: And that was really where I was about to take us also. Is that okay? Okay.
One was certification and the one I think was funding of the process. Could you articulate the two different wordings?
DR. YASNOFF: The first one was the funding one, select and fund one or more independent organizations for conformance test, development, execution and compliance certification. That is one.
MS. AMATAYAKUL: Bill, can you read the last part of that again just a little slower?
DR. YASNOFF: Select and fund one or more independent organizations for conformance tests, development, execution and compliance certification. That is essentially saying the Secretary is going to have to pay for the whole thing, but it doesn't say there is just one organization. There could be many, one or more.
Then the second proposal -- and this is a choice we have to make -- is that the Secretary -- we recommend to the Secretary that she establish certification mechanisms for conformance tests. That is all.
MR. BLAIR: My reaction to that, Bill, is your first one, which is funding the development, execution and certification is stronger. It was what I would support. If we are just doing the certification mechanisms, I am afraid -- in the back of my mind is we want to accelerate this process. I think I would go for the stronger option and I guess I would ask the workgroup to, you know, determine which of these two alternatives they are inclined to support.
Simon, you had a comment or question beforehand?
DR. MC DONALD: It is an amendment to the first one.
MR. BLAIR: Okay.
DR. MC DONALD: We could take out "execution" because I am always -- I mean, it wouldn't be bad to leave some of this vague in even the compliance certification, but at least "execution" also has this very bad connotation.
MR. BLAIR: Okay. Generally, do people agree with that?
DR. GREBERMAN: I have a couple of questions, though. This is Mel.
I guess I see somewhat more flexibility in the second option, Bill. In the first one, unless I am misunderstanding it, I am seeing only -- there is one or more organizations that deal with the issue of compliance certification. But I can see some opportunities for a self certification based on established criteria, which the second one allows. The first one, at least the way I am reading it, I am not sure that is the case.
MS. HUMPHREYS: I like the notion of funding one or more organizations to develop the test, but I think that the way that the compliance is worked out, this is Richard's point. We don't necessarily want to have one or more where you have to go through it, where it could be possible that people could say here is my data. Here are the results of my test and I ran it through and I comply.
DR. MC DONALD: Then I would get rid of -- if Bill will accept, get rid of the compliance testing and then --
DR. YASNOFF: I am not recommending either of them.
DR. ZUBELDIA: Can I recommend against self-certification. This may sound weird, but if you have a programmer that is doing the programming for this, he will never or she will never admit that it doesn't meet the specifications.
DR. MC DONALD: We are not speaking for or against self-certification.
DR. ZUBELDIA: Self-certification will always pass. Nobody will admit that it doesn't meet the specs.
DR. GREBERMAN: Well, but I am not quite sure that is always the case because in terms of when we go in, we do have -- in FDA, we do very careful checks of the processes that they perform, et cetera, et cetera, and clearly there are ways I suspect, but -- I just want to allow some flexibility in this situation rather than prescribing right what should work in all situations.
MR. BLAIR: Can we go for the neutral ground that Clem has suggested and that is that we leave the certification ambiguous? Okay. We are just going to fund the development of certification tests.
DR. FITZMAURICE: Jeff, I have a question. This is Mike.
Probably we should have a sub component to this that recognizes that the GCPR may be doing quite a bit of this work in making sure that the standards they adopt will work within their system and the DOD system. So, maybe a work in conjunction, a learn from the GCPR project.
MR. BLAIR: That may happen but do we need to put it in the recommendation?
DR. MC DONALD: Well, I mean, what they are really saying is if you are going to have a governmental standard, which won't maybe have anything to do with -- I mean, I think it should work the other way. They should have to make -- we could get into real distorted situations. There are some very special situations in the military that wouldn't apply. If they are driving the whole standard thing, we are going to get it backwards.
DR. FERRANS: My view is something like that should be in the body of the report. If there is any mention, it shouldn't be in the recommendations. It should be noted in the body of the report.
I think that there are elements of both, just because they may get around to it first, but certainly --
MR. BLAIR: I think there are other recommendations where we really look to government projects to be able to get feedback on the effectiveness of the standards.
DR. FITZMAURICE: That is fine. I wanted to raise the fact so that it doesn't look like we are looking in one direction and there is something going on in a place where we are not looking.
DR. ZUBELDIA: How about funding a standard -- funding a reference implementation that can be used for conformance testing against it?
DR. YASNOFF: Can I try to capture this? Here is what I have. I am just trying to capture the sense of the group.
So, we are recommending to the Secretary that she select and fund one or more independent organizations for conformance test development and establish mechanisms for compliance certification and we are not saying what those mechanisms might be.
MR. BLAIR: I think that is excellent.
DR. COHN: What about enforcement?
[Multiple discussions]
MR. BLAIR: Are we able to step onto our next recommendation?
DR. MC DONALD: Could I briefly go -- just step back and -- I didn't realize that statement about conformance testing was in the -- in 5, and the only reason I worry about it is -- it ties very closely to OSI standards that aren't being used anymore. That is why I worry it is going to create interpretations that don't necessarily apply.
MR. BLAIR: Are you talking about the introduction paragraphs before the recommendation?
DR. MC DONALD: No, the previous one, that has a single --
DR. COHN: Let's take a look at 5 again.
DR. MC DONALD: With sufficient specificity for conformance testing. For example, that would maybe preclude having a standard where there weren't codes available, weren't yet defined or accepted. Because I just worry -- I think there is a very formal definition of that in the OSI stack of stuff, which will confuse this.
MR. BLAIR: What do you suggest we do?
DR. MC DONALD: I am suggesting we take out the sufficient for conformance testing, but sufficient -- you know, find some other way to fuzz that word.
DR. FITZMAURICE: Would you say compliance testing -- compliance with the standard?
DR. MC DONALD: Yes, that might be -- yes, compliance -- well, I don't know if we need it. A single and No. 1 implementation guide --
DR. YASNOFF: How about if you just say a single implementation guide that supports development of conformance testing?
MR. BLAIR: Supports the development of --
DR. YASNOFF: I have got 27 versions now.
MR. BLAIR: Are we ready to move on?
MS. AMATAYAKUL: Is it conformance testing or compliance testing? Because we use different --
DR. YASNOFF: Conformance is if you pass.
DR. FITZMAURICE: In Recommendation No. 6 are we talking about compliance certification or conformance certification?
DR. YASNOFF: I would argue you are doing conformance testing and if you pass, you are in compliance. Then what you want is to certify that you are in compliance.
MR. BLAIR: Could we capture that sentence specifically, that you are doing conformance testing and if you pass you comply?
DR. MC DONALD: That is not part of the recommendation.
MR. BLAIR: I think that is a clarification that will be useful to a reader.
MS. FYFFE: Excuse me. Who has the authority to say that someone legally complies?
DR. YASNOFF: We are recommending that the Secretary certify that you have complied.
MS. FYFFE: Do we want to go there?
MR. BLAIR: Maybe we should leave out complied? Let's just stick with the conformance -- you know, the conformance testing portion of it.
DR. YASNOFF: We just said that mechanisms need to be established to certify compliance -- I am sorry -- it is not the Secretary that would do the certification. So, the mechanism might be that you develop some software that is a conformance testing piece of software. You submit it to the Secretary and the Secretary says this software is okay if you can pass this test. Then you comply.
Maybe there would be some other way to do it.
DR. FERRANS: The question is what are you complying with. If the standards are to be adopted -- I mean, there is this notion out there, this concept that is being used that are you HIPAA compliant.
DR. ZUBELDIA: Can I address something really quick? On the administrative transactions, the way ENAC(?) is addressing that very same question is by saying that this one transaction that went through the compliance testing system is compliant with implementation guide because it can -- the fact that that one transaction is compliant doesn't imply that the next one will be. But that one transaction is compliant and that is about the scope of the testing.
DR. COHN: I think should get rid of that last part. It seems like we should get rid of the established mechanisms for compliance certification.
DR. FITZMAURICE: Yes, because the industry might just go ahead and do that. We are just helping with developing the test. We don't want to supplant the industry to do it.
MR. BLAIR: It seems like there is support for just saying we will help to develop --
DR. FITZMAURICE: We can encourage the establishment.
DR. COHN: There probably needs in a parentheses here just to make a comment that we believe if this happens, the industry will take care of this on its own.
DR. FERRANS: Well, if we put something vague enough that if where we want it to go and support it financially, then at least you weren't silent to it originally.
DR. MC DONALD: The hospitals would love this thing. I think we can still act later if something hasn't happened. This isn't our last shot.
DR. FERRANS: With support, you can at least say interpret that later to saying that that kind of support included --
DR. FITZMAURICE: But then the government support usually does mean funding. We could say encourage --
DR. FERRANS: Support the establishment of mechanisms is what I am saying.
DR. FITZMAURICE: Still support usually means funding in government talk. Encourage means other things.
MS. FYFFE: Oh, really.
MS. AMATAYAKUL: Is it "encourage" or "support"?
DR. FITZMAURICE: Encourage, which doesn't preclude support later on.
[Multiple discussions]
MR. BLAIR: This is the fifth time I have asked I guess if we are ready to move on. Are we ready to move on?
I think we need to finish this section. So, let's try to drive forward and at least be finished with the message format section before lunch. We have, I think, three more.
No. 7.
MS. AMATAYAKUL: The next area is Address Gaps and Inconsistencies. The development of message format standards should be guided principally by market forces and thus remain primarily in the private sector. Standard processes are by nature slow and the market is highly fragmented, making it difficult to address all market needs in a timely fashion. As a result, there are gaps and inconsistencies among the message format standards.
The recommendation is to identify and fill gaps and to address inconsistencies among message format standards the Secretary of HHS should: (a) Support enhanced participation by government representatives in ANSI-accredited standards development organizations to provide expert resources and to make federal program funds -- program needs and ideas known and (b) fund standards development activities that will accelerate solutions follow-up the gaps in the functional areas that will return the greatest benefit to government and private programs.
Jeff's note was "Let's let the workgroup decide."
DR. COHN: Can I make a comment? I think 7(a) is -- probably actually could be incorporated under 1(a), which is the encourage government participation in healthcare informatics standards development organizations. Now (b) is obviously a different issue and I -- we have so far a 1(c) that sort of says sort of funding research. I don't know where this fits or if it does.
MS. HUMPHREYS: I was trying to figure out what we were trying to get at here in the sense of did you actually want to strengthen the Department's hand in being able to knock heads together? Is that the goal of this set of recommendations?
DR. MC DONALD: Actually, I think it is a mixture from a couple of things. I think there was an intent to try to fund or to flow funding to some standard development activities to help accelerate things.
Then we struggle with how can we say that in a way that doesn't sound wrong. The problem with this gap business then is who decides where the gaps are. If the market can't decide, how the heck can some small august body decide?
DR. YASNOFF: That was my comment on this, Clem, that who is going to identify these gaps? The Secretary is not going to go around looking for gaps and inconsistencies. So, it seems to me if we want something done about this, that that is part of our description of the task that NCVHS is going to do and, in fact, we have two specific recommendations coming up later on that address gaps.
So, I think that this is part of the task we should assign ourselves, but also there is a recommendation later on in 13 that suggests that NLM be involved in this. So, what I suggested is that we assign ourselves the task of identifying gaps and inconsistencies with input and assistance from NLM. That goes this one and 13.
MS. HUMPHREYS: I think that the 13 is very specific to medical terminology and I don't think that anyone in NLM believes that we are going to be coordinating where the gaps and consistencies are in message format standards, which is where this was coming from.
DR. COHN: I was actually thinking of, based on what I am hearing is it sounds like this really actually is a high level recommendation upon which other things fit as sub-bullets potentially.
DR. MC DONALD: I would almost suggest getting rid of it.
DR. COHN: It without specifics doesn't make any sense. I am just saying that if there are other specifics later on that we can tag to this --
DR. MC DONALD: If we can find a way to fund standard development in a rational way, then we should find a place to put that in. To say the inconsistencies are going to go away as HIPAA decides that this group does this and this does this, you are not going to have the same amount of overlap. Then that force will also provide some opportunities.
I think we are going to find either it is somewhere else -- and the only one that is missing is this business about if -- there was this sentiment that we could make things go faster or -- if we could find a way to get some funding in an appropriate way to some of the standards organizations or --
DR. FERRANS: I guess one way to potentially address this -- and here is a bind that we could get into is that we have a standard that we want to recommend to the Secretary, but it is not perfect and this will happen a lot. Isn't there a way where we could say, you know, here is a standard that we are recommending for adoption under HIPAA and at the same time, here are some of the gaps and here is how we suggest that they be addressed and leave it at that. So, we leave it broad -- when we, you know, select the standard for adoption, there will be gaps and we will address them on an individual or come up with recommendations on an individual basis.
My other comment is that I very much agree with Simon about the funding issue, that that needs to go back to part of 1, 1(c), about supporting research. I really think that 1(c) needs to be sort of provides funds for and there needs to be three or four bullets and everything can follow that. That way, I think, most everything we can fit into one of those three points and --
DR. YASNOFF: How about this, if we, again, as part of what we are saying, we are going to continue to do is continue to make specific recommendations for addressing gaps and inconsistencies that are identified. In other words -- and that is what we are doing already. We have identified a couple of gaps. So, in our kind of statement of the work that we are going to do in NCVHS under HIPAA, we are going to be -- Madame Secretary, we are going to be sending you recommendations. We are going to use the guiding principles, prioritize, have a single implementation guide and we are going to continue to make recommendations to you about gaps and inconsistencies that we may identify.
What about that?
MR. BLAIR: Now, when you are saying that, are you harkening back as Richard was saying to the recommendation where we go through the selection process? Because I think it ties nicely --
DR. YASNOFF: Yes, I am.
MR. BLAIR: Are there any other comments?
DR. MC DONALD: I still come back to who is the key and who decides. You know, the benevolent dictator always works if you can just get the benevolent one. So, the beautiful thing about the market is that the whole forces self-correcting decide and if there is a gap, well, shoot, there are industries out there and there are groups to go to, why aren't they doing it. So that if we have to kind of deal with gaps, I think we are going to have a distorting effect on the process. I would deemphasize that.
MR. BLAIR: Well, then, is it possible because I think you make a very good point that the market is probably going to be able to identify new opportunities, new requirements faster than anybody could, you know, analyze them.
DR. MC DONALD: They could come up with money and time and --
MR. BLAIR: Right. There probably is to some degree a role. Maybe it is a minor role that when we go through the selection process, we will observe that there is a need for additional PMRI message format standards that maybe might even be underway, but an SDO might be having difficulty getting the subject matter experts in place to be able to move it forward fast enough and from that standpoint it is either a gap or something that needs additional support.
Would you at least feel comfortable -- that would be part in our recommendations when we are going through the selection process.
DR. MC DONALD: There was a discussion about the funding in terms of the research area. That is maybe a way to better handle it. But people will say we need a standard for hemoglobin. We have had very analogous things. We need a standard, a very, very specific standard, which are quite well accommodated than more general standards.
I worry about how we will identify gaps in a way that is not going to be political.
MR. BLAIR: Okay. Maybe my thought is that if we don't have this one as a separate recommendation on gaps, I am just trying to verify that if we --
DR. MC DONALD: We want a way to fund stuff. So, if we could find a way to put that on the funding side, we could talk about research and development and exploring.
MR. BLAIR: Well, that is one area, but I guess I was just trying to see if you would agree that when we go through the selection process -- one of the items and how we go through the selection process, there were two kind of pieces to that. One was the guiding principles and the other one was to identify the areas that were the most -- that had the highest requirements.
As we did that, if we find out that there are some that are out there that we really need some help with, where the SDOs for one reason or another had not been able to begin to address them, that we would, therefore, point that there is a gap here that needs support from SDOs.
Would you agree with that?
DR. MC DONALD: No.
DR. GREBERMAN: I would like to make a comment on that one. I would like to allow some flexibility so we had the opportunity to address -- identify and address gaps and I can see -- and it may be linked to certain areas, such as would they affect clinical quality. One key issue now clearly is the report -- IOM report on medical errors and if there are ways in which we could identify errors that could be reduced through identifying gaps and doing something about them, I can see that as an area we might to have a little more thinking on.
MS. HUMPHREYS: I think if there is some kind of general wording that covers the opportunity to do this, whether you ever decide to do it, it is good -- let's face it, some of the requirements and potentially some of the gaps might exist in areas where government agencies, whether federal, state or local, are the principal requirers of the thing, like public health things and then it might be very reasonable to say, well, there is a gap here and we are going to pay to fill it because it is actually more of in the interest of government to get it filled than maybe anybody else.
DR. FITZMAURICE: That was essentially my comment is that the government pays for maybe 40 percent of healthcare in some fashion and they have its own needs for standards and I would like to see us encourage the Secretary to use whatever tools that she has at her disposal and I would -- including funding standard developing activities, but it could also be conferences. It could be all kinds of collaborations, collaborate with an SDO, but to date there has not been, I think, any funding of standard developing organizations, kind of by design, not wanting to interfere with the private marketplace. But since the government is a good part of that marketplace, the government shouldn't be prohibited by a matter of philosophy from using all the tools at its disposal to accelerate standards development where it is going to improve quality or reduce costs.
DR. FERRANS: If we are going through the selection process, the whole selection process, we will bring out the gaps naturally. Anyone who is arguing against selection of a standard will say shouldn't select the standard because it is not mature. Why isn't it mature? Because here are the gaps.
And then at that point, there is flexibility. We say, okay, back to the SDO. Address these gaps and then bring it up for consideration again or, you know, let's get this government to address those gaps because they have to do specifically with public health or let's fund this. My point is we need to acknowledge that the gaps are going to exist and that there are a variety of strategies that that will be used to address them.
MR. BLAIR: Okay. We have Kepa and then we have Simon.
DR. ZUBELDIA: I think everybody agrees that the gaps need to be identified. They will be there. Something needs to be done about it. But I am a little confused about our recommendation to the Secretary in what we have there as the text. We will continue to identify the gaps. What are we recommending to the Secretary that she needs to do? And I think that is where maybe the funding is what we need to recommend, that she needs to provide the funding for NCVHS to identify gaps and fill the gaps.
But I think our recommendation needs to go beyond the fact that we will identify the gaps.
PARTICIPANT: When appropriate.
DR. COHN: Maybe I can -- it is actually, I think, very appropriate after Kepa's -- I am afraid of what Dr. McDonald is going to say after me -- as I look at the current discussion for recommendations, it actually sounds like it is actually part of 2, which is part of the process NCVHS will do, which is identifying gaps. I don't hear anything at this point that sounds actionable to anybody, other than us telling ourselves that is part of our process. We are going to identify gaps. If there needs to be specific recommendations around funding, we are going to write a letter to the Secretary, saying x, y and z needs to be funded.
Now, we may further on see specific recommendations. We haven't come up with one yet. So, we could say I guess at a high level make funds available but it is not very actionable at this point.
MR. BLAIR: Clem and then me.
DR. MC DONALD: I am recommending we support Simon's position, I guess, that we shouldn't do so much here. One example, I was at the End Stage Renal Disease Conference and we were talking about gaps. So, the guys who are now collecting the statistics have a specific format and it is just an arbitrary and a capricious format for the same data as collected in hospitals and labs all over the world, but it doesn't look that way.
They said they didn't want to mess with that. They wanted to have it just that way. Now, that is going to be defined as a gap, which is anti-standard in my mind. So, that is what we have to have a risk of this gap stuff. Whoever has a convenient area, they are going to call it a gap. So, if we call this -- if we want to have funding for opportunities, I would rather say that have assumed that anything anybody complains about is a genuine gap.
MR. BLAIR: I am going to give a stab at summarizing. If I come close, then maybe we could move forward. Okay?
With respect to this particular item, I think I am hearing that a large part of the identification of gaps and addressing them is going to be done in the private sector. But I think I am also hearing that both the government and the NCVHS can also play roles in identifying gaps, in addition to what the private sector could do. I am hearing from Simon that this item should be folded into some of the things the NCVHS is doing. I don't know exactly the one you are folding it into, but, you know, as we go through the consolidation, does that summarize how we could handle this particular item so we could go on to our next one?
DR. FITZMAURICE: This is address gaps and inconsistencies, not just identify them. So, providing funding is one of the options that the Secretary would have. One that people are reluctant to do, but one that the Secretary should have at hand and should encourage other agencies to fund standard developing operations where the benefits are great.
MS. HUMPHREYS: I think that is a lot stronger recommendation if you have a specific thing you want the Secretary to do, which you may have when we get to medical terminologies. But I would think that if you are dealing with what the NCVHS may recommend in the future, then they should be recommending what actions the Secretary should take when they have a specific case in mind.
It might very well involve funding and if we have to have the Secretary to act on this right now, then I think we should be probably a little bit more specific about where we think the funding should go.
DR. FITZMAURICE: But even without being specific, one could say that all of this is directing NCVHS to provide guidance to the Secretary when the time comes, I mean, the whole report.
MS. HUMPHREYS: Exactly.
DR. FITZMAURICE: On the other hand, if there are areas the Secretary is reluctant to consider funding even some of the HIPAA standards, for example, wanting the private sector to do it, this may be -- the committee may feel that the government has some responsibility, being such a large part of the healthcare, that it shouldn't hesitate to fund some of the standard developing operations. Will there be identifiers? Will there be code systems or something else?
DR. MC DONALD: I am for that.
MS. HUMPHREYS: I am for that, too, but I think that that doesn't make a general recommendation.
DR. FITZMAURICE: Well, but the general recommendation is to use all the tools at your disposal. Don't hesitate not to call a conference, not to fund the standard developing operations. Otherwise, we just identify gaps and when they come up, we will tell you what we want you to do each time.
MR. BLAIR: At this stage, I think that we probably can't go all the way because we may handle gaps in different ways in different situations. Sometimes the private sector may already be working on them. Sometimes they can't work on them or define them.
So, I think that that is a good way to handle it.
MS. HUMPHREYS: Now, next, you see, we talk about something -- a specific thing where there seems to be a gap and we would like the Secretary or you would like the Secretary to fill it.
DR. FITZMAURICE: The next recommendation is actually this,, filling the gap.
DR. COHN: Yes, but not by necessarily a standards development organization, but just filling the gap.
DR. ZUBELDIA: And maybe those two recommendations should be merged together and this one basically removed because there is really nothing that -- it is just a note for ourselves. What is it we are going to do? Maybe moving to Section III, take it out of this section and put it in Section III and give the example of filling the gap and how we want the Secretary's assistance.
DR. MC DONALD: And we would use just 8 and not 7?
MS. HUMPHREYS: Eight hasn't even been read out to the crowd.
DR. ZUBELDIA: Remove 7 and the subtitle completely and move this as to part of Section III -- I am sorry -- Section II.
MR. BLAIR: The introduction?
DR. COHN: Are you talking about the recommendation that has to do about what we are going to be doing?
DR. ZUBELDIA: What we are going to do.
MR. BLAIR: I am a little confused because the introduction is saying how we wound up coming this fair. It isn't recommendations of what we will do in the future. Are you sure you want to move it to Section II?
DR. COHN: It is that Recommendation 2 that we -- which is not probably a recommendation of 2, but is the holder place for all of the NCVHS activities.
MR. BLAIR: Thank you. I am sorry.
Does this complete our dealing with -- this was Recommendation No. 6, right.
MS. HUMPHREYS: No, it was 7.
MR. BLAIR: It was 7. So, now, it is about 12:16. We could either attempt to try to finish off the message format items before we go to lunch or is there a sense of urgency that we break for lunch right now?
DR. COHN: I think we should take a break. I think we need a break.
MR. BLAIR: You think people could be back at 1:00 really?
DR. MC DONALD: They never are.
MR. BLAIR: Then let's pick a time when we really can convene because otherwise, you know -- what time realistically can we start?
DR. MC DONALD: 1:00.
MR. BLAIR: Okay.
[Whereupon, at 12:20 p.m., the meeting was recessed, to reconvene at 1:15 p.m., the same afternoon, Thursday, March 30, 2000.]
MR. BLAIR: Let me reconvene our CPR Workgroup for those of you who are on the Internet. We still have a couple of folks on the committee and the staff that aren't quite here yet.
I have an issue that has been brought up that I need to bring to everyone's attention here. Okay? Susan BeBee has mentioned that it is apparent that we probably will be working late to be able to finish all of this work and she has discussed this with a few other folks, who are willing to work late. However, the consideration here is that if we do work late, some people need food.
Michael has indicated that, you know, if you all wish, he could arrange to have pizzas available to us. Is that correct, Michael?
DR. FITZMAURICE: I would find a way to get the pizza delivery person up here or at least to the front door.
MR. BLAIR: So, my question to the group is is this essentially what we would want to do? Is there a consensus that, yes, we should go ahead and do that so we could finish our tasks?
DR. FITZMAURICE: I think the incentive, of course, would be to try to get done -- get as much done as fast as we can and if we check at around 4:30 that we can get done by 6 o'clock, then we just push on to 6 o'clock and people can keep their dinner plans.
MR. BLAIR: I think that is okay in terms of ordering food, but, Bill Yasnoff, are you here?
DR. YASNOFF: Yes.
MR. BLAIR: Okay. Were there some folks that needed to, you know, make some home contacts or something to alert the homes that don't make dinner for us or something like that?
DR. YASNOFF: I don't know. I am here, you
know --
MR. BLAIR: In any event, we are going to be working until our break. I guess it is around 3:30 or 4:00 and I guess at that time we could finalize this.
DR. MC DONALD: I have one disadvantage and advantage. The big advantage is being here because I have to catch a flight. I can't just stay on until 8:00 p.m. like we did when we -- I have a 5:40 flight and there might be a later one.
MR. BLAIR: Let's just move forward as expeditiously as we can. We will be covering Section III as -- you know, the last part of the day.
DR. MC DONALD: It was until 8:00 -- it wasn't until 6:00.
MR. BLAIR: Well, you didn't realize as soon as you got off the phone, we continued working until 11:30 that night. You didn't know that? I mean, that is when all the work got done, Clem.
Margaret, can we start again?
MS. AMATAYAKUL: We are at Coordinate Data Content, which is the second to the last recommendation in message format standards.
That says there must also be coordination among message format standards developers on data content employed within message format standards. For example, ASC X12N and NCPDP transaction standards require a specific set of data elements and provide definitions for these data elements. When another standard is adopted for another purpose that also utilizes existing standard data elements, there must be information and assurance that existing standards will converge on a consistent naming and definitional process for the common data elements. A classic example is the inconsistency of health data in terms and definitions used to capture race and ethnicity.
The recommendation is to assure that data elements in all standards adopted under HIPAA Administrative Simplification are consistently named and defined, the Secretary of HHS should fund the development and maintenance of an open healthcare data registry, potentially based on the ISO 11179 standard for meta-data.
MR. BLAIR: Comments?
MS. HUMPHREYS: Sounds like a great recommendation to me. I don't know if you need the intro.
MR. BLAIR: Are we able to let go of the intro then?
DR. MC DONALD: Well, actually, yes, without it, it might be better because the issue really is whether the content is supposed to say the same thing. You know, one place it is talking about trucks and other places it is talking about people.
MR. BLAIR: Simon, do you have --
DR. COHN: I think I just took a -- I actually think it is overall a good recommendation. I am not sure if the goal of this is to have things consistently named or defined. I think that they need to be mappable and comparable. That is the point of a -- at least as I understand it, there is a meta-data registry. At least that is -- and maybe I am wrong about that. We need to figure out what the point of the meta-data registry is.
MR. BLAIR: It does include identification and definition.
MS. HUMPHREYS: I think consistently named and defined is excellent because it seems to me that it is not desirable to have there being in standard transactions in the healthcare arena, 16 things called provider with 16 different definitions. I mean, I think that if, in fact, we are going to have 16 different definitions, then we should have 16 different names.
MR. BLAIR: As a matter of fact, the ISO 11157 standard, that is part of the standard is that there be a -- it is a way to facilitate moving towards a common definition of each of the data elements.
DR. COHN: Well, but is that the point of what we are doing is to make sure everybody comes to the right naming? I thought the key to this was to know if my encounter definition is different than your encounter and, God knows, there are many different definitions of "encounter" and you are probably not going to get me to change my definition or naming, but at least we know what is the same and what is different, which is different than naming -- it is obviously the definition. It is the mappable relationship. It is are they comparable or not or whatever.
I am sorry that Bob Mayes isn't here to tell us what the point of this is, but I mean, I guess I would -- I will stop.
DR. YASNOFF: It is to have consistent definitions but then those definitions have to reference a consistent name. The reason you specifically want to mention the name -- at least one reason is so that you can, for example, communicate these things via XML, where you want your names to be unique and identified and associated with the definition.
I think the names are important.
MR. BLAIR: My thinking on this is that just the fact that we are referencing the ISO 11157 standard, that is going to include this. I think it is helpful to indicate the identification and definitions. I think that is for clarity, you know, so some -- a lot of people don't know what a meta-data registry is and that helps people know. But, you know, I don't feel -- if it is the consensus of the group that they don't want to have that in this phrase, then I sort of feel like it is covered anyway by saying ISO 11157.
DR. FITZMAURICE: What I wanted to say is that maybe assure is not the right word. I think the sense of a registry is that once you get it out in the open, people are going to make their own decisions. It is not an enforcement mechanism as it is a convergent mechanism. I think we want to know what is out there and over time it will converge. But the ultimate goal, I agree with Betsy and the others that it should be to have single names and single concepts that are associated with those names, but this registry isn't going to do it.
MS. HUMPHREYS: -- about moving toward that and that is why we are doing this. That is fine with me.
DR. YASNOFF: Do you want to say "enable" instead of to "assure"?
DR. FITZMAURICE: Enable would be better.
DR. MC DONALD: I mean, I think we are talking about a spectrum of things all at once. One end of the spectrum is what Simon is talking about, where we really don't have enough understanding to be able to fairly clearly say this is the same or we can get back and forth in some fashion or not.
The other extreme is it is a totally identical model, data model. The problems with just saying the names must be the same is that in some data models you use the same name for the name of the object everywhere. I mean, there is -- and then how you do the concatenation -- the other problem is that different standards will change their names at times to be -- develop internal consistency and does that lock them in -- this new name now is their old name. They can't change their names without tying to everyone else's names.
So, I think there are some challenges that we may not have explored. If we said something softer --
MS. HUMPHREYS: I think that is what everybody is saying. My feeling is you fast forward 25 years if we still have five different standards that have been declared national standards, all of which define the provider as a different entity, then that is not going to be a good thing. But I agree that we may have a lot of work to go from here to there.
DR. FITZMAURICE: Suppose we said something like to enable data elements in all standards adopted HIPAA Administrative Simplification to move toward consistency in names and definitions, the Secretary of HHS?
MS. HUMPHREYS: I think that is too long, but that is all right. I agree with the philosophy. Just start with the "to move."
MR. BLAIR: Simon, are you okay with that?
DR. COHN: Sure.
DR. MC DONALD: But there is one other piece -- there is another meta-data standard -- there are two of them, I think, that are moving fairly rapidly, but who is going to win, I don't know, and those are related to -- both of them are related to data warehousing. Microsoft has one and I think Oracle, another group, has one. So, I would not rush to this particular one unless it is compatible with the one that might end up being the one.
Then there is also Schema coming out of XML.
MS. HUMPHREYS: It says potentially, though.
MR. BLAIR: Actually, Clem, I don't think that that is contradictory to this because it might be complementary but not contradictory. The data registry that is being referred to here is with respect to health care information and the members right now that are working on it -- I mean, it is already underway and --
DR. MC DONALD: Well, HCFA has done some work already. Is that what you are talking about?
MR. BLAIR: Well, HCFA is the one that has funded this and is pulling it together. You know, the folks that are working on these conference calls and at the ANSI HISB meeting, it includes all of the SDOs, but in addition to the SDOs, it includes CDC, HCFA, DOD, VA. So, it already is a fairly substantial group of I think it is 10 to 12 different organizations that are going down the process of identifying the registration authorities and their fields and how to pull this together.
So, the fact that Microsoft might be also working on a meta-data registry of some form is probably complementary to this one, which is focused on healthcare data elements.
DR. ZUBELDIA: Jeff, I have a question. You have been mentioning 11157. In the recommendation itself, it says 11179.
MR. BLAIR: Oh, I misspoke? Thank you for the correction.
DR. YASNOFF: Jeff, do you want to say an open healthcare meta-data registry? It says "data" now and I can imagine a headline, "NCVHS Recommends Open Healthcare Data Registry."
DR. FITZMAURICE: You would add "meta-data registry"?
DR. YASNOFF: Meta-data registry.
DR. FITZMAURICE: They won't know what it is.
DR. YASNOFF: I understand but it is better that they don't understand than it be wrong.
MR. BLAIR: Thank you. That is good.
DR. YASNOFF: I also want to point out this is one of two recommendations that we have in here that address specific gaps; the one being a recommendation later on about developing a drug reference terminology.
MR. BLAIR: Are there other comments or questions on this particular recommendation or are we able to move forward?
DR. FITZMAURICE: Could we read it over just the way it is, so we can see what we wound up with?
MS. AMATAYAKUL: I just changed "assured" to "enabled," but I think it probably would be better to say something like to ensure consistent names and definitions or naming and definition of data elements and all standards under HIPAA Administrative Simplification, the Secretary of HHS should fund the development and maintenance of an open healthcare meta-data registry.
MS. HUMPHREYS: Just change that to ensure progress towards, then it will be fine. I think that incorporates the other comments.
DR. FITZMAURICE: Or at one point we had simply to move toward consistency in names and definitions, the Secretary should --
MS. HUMPHREYS: Oh, that is good, too.
MS. AMATAYAKUL: Say that again, Mike.
DR. FITZMAURICE: The shorter sentence says, "To move toward consistency in names and definitions, the Secretary of HHS should..."
DR. FERRANS: Since this is the to fund
category --
MS. HUMPHREYS: Might want to say data element names and definitions.
DR. FERRANS: Since this is in the to fund category, this could potentially fall under the to fund section if we are redoing -- this would be to fund an open healthcare meta-data registry because we had talked at the beginning at some point, whether it is Recommendation 1 or
2 --
MS. HUMPHREYS: My own view of that is that we should probably wait to see what we end up with because I am not sure that just because the Secretary is funding is to me the logical, functional way to organize the recommendation. But it might be.
[Multiple discussions]
Oh, data element names you want to insert -- insert data elements for names.
MS. AMATAYAKUL: Instead of data elements?
MS. HUMPHREYS: No, no, up in the first part. To ensure consistency in data element names.
DR. COHN: And definitions in all standards.
DR. ZUBELDIA: Should we say the Secretary should support the development, which includes funding, but it is more than just funding?
DR. COHN: Well, actually, I think "support" is less strong than funding. I think we should say "funding."
MR. BLAIR: When you are ready, let me know because I have a question for you?
MS. AMATAYAKUL: I am ready.
MR. BLAIR: The paragraphs that kind of describe the issue as a lead-in for each of these recommendations in our under the message format stuff, are there any that we have retained so far or have we agreed that we don't need each of them?
MS. HUMPHREYS: I don't think we have retained any of them.
MR. BLAIR: All right. Ready to move on.
MS. AMATAYAKUL: Would you rather I not read those and just read the recommendations?
DR. YASNOFF: Is that okay with you, Jeff?
MR. BLAIR: That is fine with me.
DR. YASNOFF: Let's just read the recommendations. That will speed us up.
MS. AMATAYAKUL: Okay. So, 9 is to promote coordination among message format standards and medical terminology developers to achieve true semantic interoperability and comparability of data the Secretary of HHS should sponsor conferences and workshops to promote harmonization between message format standards and medical terminology developers.
DR. MC DONALD: My thought on this is if your goal is perfect as described in your above thing, you want to get to the semantic interoperability and I don't -- I think what you really want to specify is that the message developers specify -- get that specific and let them work out how they get that specific. That is, in other words, instead of saying you guys work together, just say you specify what codes you are going to use in -- you can't say all the fields because -- that is the challenge. How do you say it because there are not always codes available?
MR. BLAIR: Could I add a -- oh, I am sorry. Were you finished?
DR. MC DONALD: I don't think the workshop issue is the issue. It is an issue of for given standards how do you get the codes -- which codes are you going to specify? You don't have to work with CPT-4 to say you are going to use CPT -- or you don't have to work with ICD-9 and say use ICD-9. You just say it. And there are some fields where you have to say one of those or the other, well, at least ICD-9.
MS. HUMPHREYS: I think there is also the other issue, though, Clem, because as I understand it, I think some people feel that for certain -- they would like to see greater collaboration because the existing vocabularies actually don't meet the needs and, you know, look, we have this data element over here and there is nothing over there that you are producing. But that is a different issue. It is sort of a follow-on to the first thing. If they haven't specified exactly what they want to use for each one, I don't know how they know that it isn't covered yet.
DR. MC DONALD: Some of the codes in message standards are message standards developers' business, you know, like the action codes, the control codes. There are lots of codes in X12. There is no general developer. You know, maybe two sets or three sets --
MS. HUMPHREYS: You know, Clem, I think there are at least some examples of message standards developers believing that that is the case, but if they had a little more collaboration with the terminology developers, they might realize that they could have referenced somebody else's vocabulary.
DR. COHN: There is a reason why this recommendation is at the end of the message format standards and the beginning of the medical terminology and I think it speaks to the overlap. I guess I am a -- I tend to think of this issue as an issue that overlaps the implementation guides and the specificity of the implementation guides. This is another piece of it that there is something which can be handled by better implementation guides, better medical terminologies and then better working between the two.
I talked here about promoting harmonization between information models that surround terminology and message format. Now, that is concepts that people would have to even figure out what that means. But we did mention harmonization earlier in the document. I don't know why exactly it isn't here.
MS. HUMPHREYS: I guess I am wondering, though, and I had the same thing when I looked at this -- maybe it is some of Clem's view, too -- is I was trying to figure out whether if the Secretary did this, would the results be what you wanted it to be because I have been -- it seems to me that I meet in a lot of rooms where the terminology developers and the format developers are there, but we haven't achieved this goal.
So, I don't know if we just put them in a room more times, we will.
DR. COHN: Is this a research agenda?
DR. MC DONALD: Some of it might be.
MR. BLAIR: Actually, Kepa, did you want to go first and then I will make a comment after?
Okay. I think we are all -- I think the intent of this was to make it a little bit easier -- Judy Osbolt's(?) group, where she tried to get the nursing developers together, I think, is an example. I think that Simon and Chris's work at the CPRI, where they attempted to get some convergence together, the national health information -- excuse me -- yes, national initiative for healthcare informatics. We worked for like nine months trying to see if we could wind up getting this done and we didn't have funding for that.
I think that all of these groups sometimes struggle to be able to get -- the subject matter experts from diverse groups that are not necessarily part of the organizations that each of them are affiliated with to get them together, this was to facilitate that, act as a catalyst and move things forward, and that is why the word, especially work sessions is in there even more than conferences, to be able to facilitate that work. So, that is the thinking that is behind this.
My thought is that after listening to the comments so far is I am not hearing anything that says that we need to change the wording on this.
DR. MC DONALD: Wait a minute and I will tell you something.
MR. BLAIR: Okay. Let Kepa go next and then to you, Clem. Okay?
DR. ZUBELDIA: I just wanted to point out on the issue of the codes, sometimes these codes intersect with codes by other industries. Transportation uses the codes for weight. In X12, you cannot change the definitions of those without calling it in with other industries. Sometimes we are stuck and we can't change the name and we can't change the definition. It is not an easy task.
DR. MC DONALD: Just a comment. I think we don't want to lose sight of the goals. What we really want to do is get the semantic interoperability. There is no doubt about that. We need to have something that comes out clear about that.
If we are specifying how to do it, what I hear is going to happen here, is we are going to have a new organization.
PARTICIPANT: No.
DR. MC DONALD: Let me finish. You have mentioned three new organizations when you talk about how this harmonization is going on. Right now there are consenting adults that have to work together and if you have a third organization that doesn't necessarily help that consenting adult working together process because now you have got a third set of players and it is funded by HCFA so they got that additional power and authority.
I think there is actually a disadvantage to that.
MR. BLAIR: I don't think that is what I was suggesting.
DR. MC DONALD: Well, it says that HHS should sponsor working sessions by whom? By this --
MR. BLAIR: Oh, it wasn't specifying because in many cases it could be HL7 getting together with the nursing informatics folks, you know, working on pieces like that. It could be ASC X12N and HL7 and some others getting together with drug knowledge groups, for example. So, it is open ended. It is just simply saying that funding would be available. Because sometimes it is difficult to get those groups together.
DR. MC DONALD: There is a lot of them not talking to each other. There is a lot of them together.
MR. BLAIR: Yes, they are and they are talking to each other.
DR. MC DONALD: Even from England they are coming over.
MR. BLAIR: Right. All this is saying is that to assist, the government would wind up selectively assisting those groups, especially -- there is one thing in terms of conferences but if you are going to meet for a week at a time, for example, to really break the back of some of these issues and you have to get the subject matter experts in from diverse groups to do it.
This is saying that funding would be available in order to facilitate those advancements.
DR. FERRANS: Jeff, I would just have to think also that if funding is given over a period of time also, I think that the next step being contingent upon some deliverable makes the funding very effective in terms of moving the process along in general.
MS. HUMPHREYS: Well, I think then that I would like to go back to -- if the consensus is with that this is a good thing to have someplace to promote the Secretary funding -- providing funding for these activities when they are appropriate, then I think working sessions is better than conferences.
MR. BLAIR: I agree.
DR. MC DONALD: Well, then could we say sponsor within the existing standards organizations domains, so we don't create a third group? We don't create this link -- these bridging groups end up being the third -- I mean, we don't get more standardization but we would end up with a new group that wants standardize.
DR. FERRANS: This is harmonization. So, are you saying that we should say that we should promote harmonization by, you know, giving the money to the groups that are going to be harmonizing, right?
MS. HUMPHREYS: -- medical terminology developers, right. So, it is referring to the existing players.
DR. MC DONALD: It doesn't say, though, who gets the funding. It says HHS is sponsoring.
MR. BLAIR: I don't think we should constrain that to say that terminology should get the funding or message format should get the funding. I think that should be open ended, depending on how these groups have been working together and how they pull it together. It could be a university that pulls together --
DR. FERRANS: What you don't want is a national harmonization organization that takes the money and then holds the purse strings to the other one.
MS. HUMPHREYS: But I don't find that at all the way it is currently worded.
DR. YASNOFF: But with reference to Clem's point, I think this should say that the Secretary should -- this should be part of what NCVHS is going to do. In other words, NCVHS should have funding that allows as part of this process working sessions to be convened.
DR. MC DONALD: I guess, the blunt part of it is, I think, the people who read it may not understand the problem at all.
DR. FITZMAURICE: That is why it should be NCVHS.
DR. MC DONALD: HIPAA is saying that, you know, there are these other constraints, these other realities. So, you get a third group that is going to be Pollyanna about this. They are not going to get a solution.
MR. BLAIR: Well, I would think that if funding is going to go forward that it is not going to be given to folks that don't have the support of the SDOs and the terminology developers to get together. I would think that the initiative is going to come out of those groups.
MS. HUMPHREYS: Or if we want to make this very specific, I mean, to address Clem's concern, you could be sponsoring working sessions among the developers of standards recommended by NCVHS or something like that, which would include the format standards and the vocabularies and it would not be bringing in third parties. I don't actually think it says that, Clem, but if we change the wording --
DR. MC DONALD: That would make me feel better.
DR. YASNOFF: So, what are you suggesting -- working suggestions among --
DR. MC DONALD: Among those formats -- the groups who have been --
DR. YASNOFF: But recommend is probably too strong because after we have recommended the standards is not when we need to have the meeting.
PARTICIPANT: Under consideration.
DR. YASNOFF: The existing standards developing, something like that, that is a little -- the idea is to put in the tool kit of NCVHS the ability to convene meetings to try to move the process forward. What you are saying is you don't want to create another organization. I don't think that is what this says. This says just as respectively we have done in these hearings, we have brought a lot of people together to talk about these things.
MR. BLAIR: Frankly, I don't feel comfortable limiting it because there are times when the CPRI has taken the initiative to pull this together. Sometimes you need a neutral body to be able to pull it together.
DR. MC DONALD: I think that is actually an example of why you don't want to do it. I will be blunt. We don't need three more organizations. We need to get to the place where people are working at it, not have a third party pulling three different ways.
There are five nursing standards. They need to get together with HL7 and X12. They need to get together with each other first so we don't get into these political kind of battles that will occur when there are groups that haven't ironed things out themselves.
MR. BLAIR: Let me put it this way. If they get together expeditiously to move things forward, I think everybody would say that is the best way to do it. But there are times when for political reasons these groups don't get together or have difficulty getting together or lack the funding to get together and this is giving the opportunity to be a catalyst and accelerators for those times when they are not getting together.
DR. MC DONALD: I have said my piece.
DR. YASNOFF: Clem, did you see what Margaret put in there?
MS. AMATAYAKUL: I had Secretary of HHS should sponsor working sessions as recommended by NCVHS to promote harmonization among message format standards and medical terminology development.
DR. MC DONALD: I like her words better, but --
PARTICIPANT: Is that okay?
DR. MC DONALD: It is not great, but I seem to be a Lone Ranger in this. So, I am not going to pursue it.
DR. COHN: I think the one question I would ask about all of this and what is -- not for right now, but for later on is this enough or does there need to be more things in this area, but it is probably a question for after we have dealt with medical terminologies.
MR. BLAIR: Any other comments on this or are we ready to move on?
Margaret.
MS. AMATAYAKUL: Okay. We are under "Medical Terminologies." Do you want me to read the introduction and the introduction to each section or just the recommendations?
MR. BLAIR: How does the group feel? Shall we go directly to recommendations or --
DR. YASNOFF: Read the recommendation only.
DR. COHN: Are we getting rid of all of these -- what are we doing with all the words?
MS. HUMPHREYS: Excuse me. I think that actually -- I just want to point out -- I don't want you to read it all, but I do want to point out that I think I am correct that in reading through the whole document, there actually were a couple of points in the introduction to this section that are very important that do not -- that are not stated as clearly elsewhere. I don't say they have to be here, but I think they have to be in the document.
DR. MC DONALD: I think these should be here.
MS. HUMPHREYS: Because the business here is that we want to -- here is where we are making -- or the report seems to be making the point that we want NCVHS and the Secretary to move ahead in the development of standard terminologies and we want that work to go ahead, but we don't want to simultaneously recommend that we immediately implement them as national standards because the community is not ready for them yet nor are the clinical information systems.
The distinction between, yes, we need concerted action to identify these standards and to develop them and to test them and to get them implemented where we can, but they are not ready yet to be mandated as national standards, is made in the first couple of paragraphs here and is not -- it is only -- if it is alluded to elsewhere, that is all it is and that is to me a very, very important point.
MR. BLAIR: Could I suggest then that we move that to -- within Section III, there is a subsection that begins to talk about medical terminologies and that we include it there? We move it there.
MS. HUMPHREYS: That is fine with me. It just has to be somewhere.
DR. MC DONALD: Has anyone suggested it needs to leave from where it is?
MR. BLAIR: I think that -- I think this is kind of awkward because Clem doesn't -- isn't privy to the discussions with Bill Braithwaite and Bill Yasnoff about this concept of how things might be reorganized.
DR. MC DONALD: Let me rephrase that. Let's worry about this content. We all agree that something might change where it is, but just by saying we weren't going to read it didn't mean it was going to go away.
DR. YASNOFF: No one is suggesting it is going to go away. We are just not going to read it.
MS. HUMPHREYS: And I have actually some suggestions for changes in the wording of it, but, as I say, I do not care where it goes. I think that it is very important to retain a very strong statement of the incremental strategy in this area and the fact that we can have federal action that doesn't involve immediately implementation or requiring national standards that no one is ready for.
DR. COHN: At the risk of -- I don't want to take more time arguing whether or not we should be talking about the wording than actually just reading the wording. I personally -- and, once again, I have had a chance to review what Betsy has done in terms of modifications to the introductory paragraphs. I actually would suggest let's just have her read it with the modifications. The question then is do we want to put it -- I mean, I don't care whether it is here or someplace else, but I think it is an important conceptualization that needs to be included.
I can't see how we can agree on it or not unless she reads it. Is that okay with everybody?
MS. HUMPHREYS: I was going to say while the development of message format standards at the functional level is fairly mature, the use of medical terminologies to achieve full semantic interoperability and data comparability needs more support. It is the area of medical terminology that can be most highly leveraged to achieve the next higher level of administrative simplification.
I would then -- I cut the next sentence and move on this way. Recognizing that medical terminologies need more developmental and testing before they can be widely implemented, the purpose of these recommendations is to accelerate the development, maintenance and use of clinically specific terminologies that provide a suitable basis for standardization, but not to impose premature national implementation of these terminologies as standards.
It still needs more editing. Then I went on from that -- this is the section "Accelerate Adoption and Use of Clinically Specific Terminologies" -- most medical terminologies today do not incorporate all the attributes that are necessary for clinicians to use them as standards for clinical information and then I said that is or i.e. clinical specificity, comparability, maintenance and usability. It is, therefore, appropriate to adopt an incremental strategy for expanding the use of medical terminologies in PMRI.
Then I went on to the list of the recommendations.
MR. BLAIR: I feel very comfortable with those. Is there --
DR. MC DONALD: The first paragraph as you have written it, I think we should just take it.
MS. HUMPHREYS: Okay.
MR. BLAIR: Can we go ahead and just incorporate that?
MS. HUMPHREYS: I can e-mail it at some point or give it to you on a disk.
We are now on Recommendation 10.
DR. MC DONALD: There is a second paragraph. The thing about ASTM standards just sort of stuck out as a non-sequitur.
MS. HUMPHREYS: I read the second paragraph. I eliminated that sentence.
Recommendation 10 as it stands has three parts and to promote development and adoption of PMRI medical terminology, the Secretary of HHS should -- and the first part of this was tasking the NCVHS to select these standards, but this is another one of these things where the NCVHS is, in essence, in this new format of the report just going to announce to the Secretary that they are going to be selecting these things according to these guidelines and forwarding them to her.
DR. YASNOFF: That goes back to No. 2.
DR. COHN: This becomes part of 2, right?
DR. YASNOFF: Right.
MS. HUMPHREYS: So, that leaves us with the other parts of this recommendation. I had inserted a new part, saying that the Secretary should ensure that all of the selected terminologies are incorporated into UMLS by the National Library of Medicine and are, therefore, available in a common, machine readable format.
We don't have to have this level of detail. Then I sometimes have to get into conversations with the developers of these terminologies, explaining to them why it is that I am going to call Bill Braithwaite down on their head if they don't give me their terminology to put in the UMLS.
So, the next one is "Support agencies within HHS that implement the selected medical terminologies for use in their projects involving PMRI. This support should make it possible for them to report to the private sector developers, vendors and users on the areas of effectiveness and areas needing further improvement." And it was worded "The agencies and projects..." -- I eliminated "and projects" -- should include or might include -- and the ones that were mentioned there were the National Cancer Institute, the Center for Disease Control and Prevention, the Agency for Healthcare Research and Quality and then it said the GCPR project. That seemed to be a little bit contrary to the beginning of this recommendation. So, I was going to say and the Indian Health Service as the HHS participant in the GCPR project.
I was wondering whether we didn't want to put FDA in here as well and I think we do and the Food and Drug Administration.
DR. KOLODNER: And HCFA. I mean, we are trying to include more of the agencies. So, I am not sure that specifying which elements of HHS --
MS. HUMPHREYS: Yes. I am not sure this is a good idea either, except that I do -- I think that we either mention more or fewer of them, but I do feel that if we are going to mention any of them, we don't want the FDA to be conspicuous by its absence.
MR. BLAIR: I think for the leaders that are reading this through, at least they understand the intent if we have the list.
DR. KOLODNER: I would also for the GCPR, do it without the hyphen and talk about it as the GCPR framework project.
MS. HUMPHREYS: Okay. So, the next part of this recommendation is -- I changed the wording to promote the use of PMRI standards in medical research funded by HHS.
MR. BLAIR: What word was there?
MS. HUMPHREYS: It was, "The Secretary should support the use...," but I think that seems to me a little bit less active. It is sort of like if somebody says they want to use the standards, yes, support them, instead of saying why are we supporting this project if you not using the standard. Why don't you use it?
Then I had altered the last one to establish a realistic time line for national implementation of terminologies for selected elements of PMRI, based on the experience of HHS agencies and grantees and the rate of national progress in installing PMRI information systems.
MR. BLAIR: There is an element there and this is one of the things where I didn't feel comfortable with -- if you recall John Lumpkin's letter, where he kind of urged that we take a viewpoint here that we are really helping patients, which brings us more to a private sector view.
I think that everything in that sentence is fine, but when we start sticking national in there, it makes it more of a government perspective than a patient care or provider perspective. So, I would encourage that -- and, Michael, I would like your reactions on this, too, because, you know, you had originally put the word "national" in there. With the comments that I just made, would you feel comfortable if we eliminated the word "national" from those sentences and, Betsy, do you feel that way as well?
MS. HUMPHREYS: My idea is that the initial part of these recommendations is saying, okay, NCVHS has done its job and selected the standards. Now, the Secretary will try to move this thing, accelerate, move it forward. So, the Secretary is going to require that these be used within the Department. She is going to require that these be -- or try to promote their use among grantees, at least, the people who receive funds from the agencies.
Then it seems to me that as with HIPAA, we get to the point where the Secretary says, okay, life has moved along enough in the field, let's make the same national standard. If it is a national standard, everyone has to implement it.
So, what I was just trying to put in here -- and I don't care what word we use -- is that there has to be the view after we see what happens with the standards recommended and after the Department has experience, good or bad, in attempting to implement them in its own systems and the grantees have experience and we look at what is happening in the field and how many people now have computer-based patient record systems as opposed to two years or whatever, then it seems to me the Secretary should, you know, develop a time line where we are going to have regulation, which is, okay, folks, we have gotten to the point where it is reasonable to impose these as national standards.
MR. BLAIR: I didn't feel uncomfortable with any of what you are saying. I just wanted the viewpoint to be with the idea that what the government actions are doing are in support of the private sector, as opposed that these are, quote, national standards, that some people may -- when they see the word "national," they may feel like the government is doing this.
MS. HUMPHREYS: Maybe there is a way to put this around to say that somehow that NCVHS will put that in their part, that as the government -- as the HHS agencies and other people implement these and experience is known and the NCVHS is monitoring what is happening in the field, then they will recommend a time frame for actual establishment of these as real standards that have to be used throughout the country. Maybe that is the way to do it.
DR. MC DONALD: I think that Lumpkin's concern is we need to put something under the issues earlier in the document to say that we are not saying doctors are bad people because they are not coding to an infinite degree their notes. That is how I read his thing. I think we need to have two more issues -- things as issue points, but that is not a discussion now.
This is nothing so terrible. It would be like saying you have to use ICD-9 for discharge diagnosis code. That is how I read it. Which ones are available and right and right. It is not saying that physicians have to dictate and turn everything they say into code. That is not how --
MS. HUMPHREYS: I had implemented this, establish a realistic time table for selected elements of PMRI and we can figure out how to say this. But I really was saying that we are going to have this experience. So, let's look at the experience and say, okay, things have moved along enough now. We can require this as a standard for this particular set of data, not necessarily that everything a physician writes has to be standardized.
DR. COHN: I actually think it is -- this is sounding very good. I want to thank you for your help with some of these conceptualizations. It certainly looks like that Item E is probably in that, somehow put into Area 2.
MR. BLAIR: What is Item E?
DR. COHN: The NCVHS will establish a realistic time line --
MR. BLAIR: Okay.
DR. COHN: And I think the idea of describing selected elements once again speaks to the incremental need to --
MS. HUMPHREYS: Yes, and I think that you could actually put it in and say the NCVHS is going to do this. It is going to recommend this stuff be put into these guidelines. Then there could be another one is the NCVHS is going to monitor the Secretary's progress in implementing these and the experience of the HHS agencies and anyone in the private sector who is doing this and then recommend a timetable.
DR. COHN: Now, the one question I have about this one and, Betsy -- if Dr. Braithwaite were here we would ask him also -- is does the Secretary have authority to -- I mean, for this particular part or is there additional authority needed --
MS. HUMPHREYS: I --
-- authority for financial and administrative transactions and the -- what is it -- the associated data elements. The question is when we get to this, I mean, is this something which needs more authority?
MS. HUMPHREYS: I think my feeling is that for the Secretary to promulgate national standards for this, my understanding would be that depending on what you are recommending and whether those data elements are actually part of any of the transactions that she has already got authority for, if they are, then she has got the authority. If they are not, if it is something beyond that at the time you want to recommend it, then she wouldn't have the authority, but it does seem to me that at the time the NCVHS laid out the timetable and whatever, then they could say, you know, here is our legislative proposal to give the Secretary authority to implement these standards if she didn't already have it. But I think it is all in the subjunctive mood until you --
MR. BLAIR: Could I back up a second because you just said what made -- something that made me feel nervous. Your phrase, "Secretary should promulgate national standards." I thought that the viewpoint we were taking was that the government would be reviewing standards that are developed in the private sector and recommending those that should be selected for adoption.
MS. HUMPHREYS: That is what I meant.
MR. BLAIR: Okay.
DR. GREBERMAN: I guess it hit me, Betsy, when you said the absence of the FDA was obvious. I wonder whether no comment had been made about HCFA because of all the really big kids on the block that would deal with these kinds of things, I think that would be important.
MS. HUMPHREYS: Yes.
DR. GREBERMAN: I guess I wanted to get a sense of -- I wasn't quite sure I got all the changes in the early part of this, which determined the selected standards from, I guess, paragraph A.
MS. HUMPHREYS: Basically, that related to the fact that we had agreed that there would be this recommendation -- well, we were as a place holder in this discussion. We have been referring to it as Recommendation 2, which would identify what the NCVHS was not actually recommending to the Secretary, but what the NCVHS was alerting the Secretary they were going to do and then they would recommend that she take the following actions with the standards that they had selected according to the guidelines, et cetera. That is why it comes out of here, I think, based on our previous conversations.
DR. GREBERMAN: One of my colleagues, Andrea O'Neal, had a question and I just want to ask it here. I think I know the answer, but I just want to confirm so that when I go back to her, I have the response.
She was asking the question since MEDRA(?) was being dealt with through a maintenance and ports services organization that is working towards ANSI accreditation but is not yet, would that cause any problems in terms of FDA's international activities? I think, no, because this is worded in terms of broad -- it is not just ANSI.
MS. HUMPHREYS: No, I think the biggest problem that -- I don't want to say it is a problem, but the biggest potential issue, it seems to me with MEDRA is that the way I would interpret the HIPAA regulations and this whole area, it seems to me that there is likely to be a certain amount of reaction in the community if a piece of HHS decides to mandate a standard, which has to be used by many health care organizations in this country and it didn't go through the HIPAA process, which is a conversation I have had with others at FDA.
Because a number of people in the health care industry have spoken to me directly saying wait a minute here, I at least thought if everything was going through a HIPAA-like process, I got to make my say, but if FDA turns around and mandates the use of MEDRA throughout the United States for certain activities that are taking place in my hospital and I didn't have my opportunity to register my view on those standards, then this could potentially be a problem for me.
So, I don't think this problem -- this issue in the community is real for a number of people in the community. They certainly have communicated it to me and I have talked about it to Andrea and others at FDA. I think it is a major problem for HHS, for NCVHS and for everybody else if we can't get, you know, the notion of the selection of MEDRA for any HHS-mandated activity, you know, if it becomes an actual standard or regulation somehow routed through the NCVHS to be brought in under the tent.
MR. BLAIR: Did you want to continue further, Betsy, or have you finished?
DR. KOLODNER: There was something on that third paragraph. It says, "NCVHS will monitor the experience of government and private sector use of medical terminologies and establish a realistic time frame for national implementation of terminologies and selected elements based on HHS agencies and grantees and the rate of national progress." I think this is an opportunity where although the Secretary doesn't fund the other healthcare agencies, that the experience of the other federal agencies is appropriate.
MS. HUMPHREYS: Very good.
DR. COHN: Okay.
DR. KOLODNER: So, we can just say federal agencies instead of HHS. Not other -- federal agencies covers HHS and others.
MS. HUMPHREYS: Okay. I didn't have any changes to the Recommendation No. 11. In the introductory paragraph, if it were retained, I would -- where it says -- it says, "The vast majority of data in clinical systems is not coded at a granular enough level and/or is not standardized sufficiently to provide comparability of data for clinical decision-making." Then the next sentence, "Few healthcare information systems today...," I would actually say are capable of supporting the practitioner in capturing clinically specific data. And I probably would say few U.S. healthcare information systems today because I think that at least in general practice in The Netherlands and in the U.K., they do capture a lot of clinically specific data. They have information systems to do it, too.
The Recommendation 11 -- since I am speaking, I will continue to speak here -- is just to accelerate the development and use of PMRI medical terminologies. The Secretary of HHS should fund research and demonstration projects in both the public and private sector to study and promote development of systems that make it faster and more economical to capture clinically specific information at the point of care in a manner that allows for derivatives of that data to be used for payment, public health, research and other purposes; (b) demonstrate the incremental value of improving cost, productivity and quality of care, but we know that quality of care is going to be first, by using medical terminology standards for data recording, practice guidelines, clinical performance measurement and intervention.
I thought those were probably reasonable the way they stand.
MR. BLAIR: By the silence, I am inferring that there is concurrence and that you could continue.
MS. AMATAYAKUL: Let me just ask a question, if I may. We have got some changes from Mike. Did you want to make those or do you want to leave them as they were originally?
MS. HUMPHREYS: I think his is probably better. I mean, it is just a more active way of saying it, isn't it?
MS. AMATAYAKUL: Jeff had a comment that he preferred the word "demonstrate" to "investigate."
MS. HUMPHREYS: All right. The next one is Address the Financial Barriers to the Use of Medical Terminologies.
DR. COHN: I guess I was confused because there were a bunch of things crossed out there. Are we accepting the other -- I mean, you got rid of the incremental value of improvements.
MS. AMATAYAKUL: That was Mike's suggested change.
DR. COHN: We need to decide whether we are in favor of that or not.
MS. HUMPHREYS: I kind of like it.
DR. COHN: Okay. So demonstrate the improvement in quality of care costs. Okay.
MS. HUMPHREYS: So, are we on 12 now?
MR. BLAIR: Yes. You are carrying the ball. We are following your lead.
MS. HUMPHREYS: Address the Financial Barriers to the Use of Medical Terminologies. I had reworded the introductory paragraph as follows: The expense of continual development, evolution and maintenance of medical terminologies that meet the characteristics and attributes for clinical specificity, comparability and usability is high. There is a need for a solution that covers the cost of maintaining robust medical terminologies and also facilitates their use by message format standards developers, vendors and creators and users of PMRI.
DR. YASNOFF: You got rid of the word "equitable"?
MS. HUMPHREYS: I didn't know what we were equating.
MS. AMATAYAKUL: Betsy, would you say the last part? I don't have your changes.
MS. HUMPHREYS: Oh, okay.
MR. BLAIR: Did you change the recommendation, too?
MS. HUMPHREYS: Yes. I am going to change the recommendation, too, but --
DR. COHN: So, the question is whether we say it is an equitable solution versus --
DR. YASNOFF: What is wrong with an equitable solution?
MS. HUMPHREYS: It can be equitable. That is fine with me.
MR. BLAIR: Could you just help me with the topic phrase for this one?
MS. HUMPHREYS: Was "Address the Financial Barriers to the Use of Medical Terminologies."
MR. BLAIR: Okay. Thank you.
And you are about to read the recommendation the way you have changed it?
DR. YASNOFF: She is submitting her papers to Margaret. Margaret is now looking them over very carefully. She is smiling. She is laughing.
MS. HUMPHREYS: Okay. Recommendation: To ensure that the medical terminologies selected by the NCVHS are available at minimal or no cost, the HHS should arrange for Federal Government support for basic maintenance and distribution of all selected terminologies, including those from the private sector.
DR. FERRANS: I am sorry. Could you say what HHS should do again?
MS. HUMPHREYS: Arrange for Federal Government support for basic maintenance and distribution of all selected terminologies, including those from the private sector.
Do you want to recommend that?
DR. FERRANS: What does arrange for support mean in government speak?
DR. COHN: I actually think what you are describing is good. I think we should probably -- you crossed "and evaluate financing alternatives." I think I might include that at the end.
MS. HUMPHREYS: Well, I felt that if we were arranging for Federal Government support --
MR. BLAIR: She is doing that.
MS. HUMPHREYS: -- for basic maintenance and distribution.
MR. BLAIR: She is being specific.
MS. HUMPHREYS: Or if you didn't want -- if you wanted to think that there were alternatives that didn't involve Federal Government support, that you wanted to -- you could say should arrange for funding for basic maintenance and distribution.
DR. FITZMAURICE: It would seem to me that what we want to do is make medical terminologies available at low cost and then what follows from that is what the government should do, whether it is buy a month and give them out for free, whether it is subsidize the maintenance and updating
-- there are a lot of different ways but the point is we want to have current terminologies available at low cost to users.
MS. HUMPHREYS: I was trying to word this in a way that didn't preclude -- that there were different approaches to how you would manage this but that I was assuming that all of them would involve some federal dollars.
DR. COHN: Actually, I take back what I said. I think I actually sort of agree with the way you have done this.
DR. FITZMAURICE: I am worried that it sounds a little anti-competitive and anti-entrepreneur. Somebody who anticipated the terminologies someday will have a value and invested their hard-earned money and now it comes time to reap the value and we are saying, no, we want to keep it low cost. Are we recommending that we subsidize those entrepreneurs to compensate them for what they have invested and maybe give them something extra for their entrepreneurship.
I am not sure how to operationalize what I think we want and that is make these available at low cost to encourage their widespread use.
DR. COHN: Maybe I can make a comment here. I am sort of -- the issue of terminologies and how we have approached them so far has been to create unregulated monopolies.
DR. FITZMAURICE: In some cases. I don't know that SNOMED is an unregulated monopoly.
DR. COHN: Well, we haven't done anything with SNOMED.
DR. FITZMAURICE: You are saying that some of the things --
DR. COHN: The current HIPAA approach is to say -- is to anoint but not create any sort of boundaries or whatever. I think this, at least, begins to apply some basic framework to begin to sort of structure and potentially control that a little bit.
Now, as I say this, it seems that within this, there is the opportunity to -- I am not sure reward, but to reimburse people for work that they are doing in the terminology effort.
So, I tend to think of this as beginning to provide a more regulated monopoly environment. I am not sure that I would want to go to the point where we have competition in the terminology market, where people have a choice of multiple different terminologies.
MS. HUMPHREYS: Well, you know, the thing is that what this is saying is that, you know, the NCVHS is going to go through a very appropriate process described and it is going to select these. And then I think there -- I think it would be beneficial for there to be a fairly direct recommendation that after the NCVHS has done that, then the Secretary ought to do something so that we know these things are going to be able to be maintained and available at low cost.
So, I like that better than bringing up funding alternatives. I mean, I don't know whether you want to say the Federal Government should fund, but I think you should say the Secretary has to do something.
DR. COHN: And I have retracted my comment about funding alternatives.
MR. BLAIR: Could I get back to one other piece here because we have sort of been mulling this over and I guess I feel like people feel generally comfortable with Betsy's suggestion. Mike wound up -- there is something about the phrasing that I think made you feel uncomfortable, Mike?
DR. FITZMAURICE: It was the implementation of it, Jeff. It was what do we do about some people who have established monopolies, some people who are investing in an area where there is no monopoly because it appears to have no value? What do we do to this continuum of fertile thought and anticipation of future value by conferring monopoly status on some and then saying but you can't hold on to the profits of that monopoly. They will say wait a minute, we are not a public utility. We invested our own money in this.
So, if you want to lower our costs of what we charge for this particular standard, you pay us x amount of dollars and we will lower our costs.
MS. HUMPHREYS: Well, maybe that is how it will be done. I mean, that would be federal support.
DR. FITZMAURICE: Then go back to the argument is that what we want to advocate? I agree with advocating at the high level. We want to make these available at a low cost. Now, how do you define what low cost is? Zero is the lowest possible cost, unless you pay somebody to take them. How do you work out the costs of maintenance and update and the risks that they took to get involved in this in the first place?
In some cases, maybe there is not a whole lot of risk because they have had a guaranteed monopoly.
MR. BLAIR: Are those questions that we need to resolve now as we make this recommendation?
DR. FITZMAURICE: No, because if I am the Secretary, I come back to NCVHS and say I accept this; don't recommend to me any standard that doesn't meet this criteria, that it can be made available at low cost. Then you find yourself in a bargaining position with the SDOs over the price.
MR. BLAIR: Maybe I was seeing the process a little differently.
DR. FITZMAURICE: Okay.
MR. BLAIR: I was seeing the process that we -- the criteria we would use to select standards would be based on the guiding principles, which is that the medical terminologies that would be selected have to have the characteristics that are identified there in terms that they are addressing areas where we need work, that they are clinically specific, that they are maintainable, that they have version control, all of the things that are in the guiding principles.
That would be criterias for the selection process and then if it turned out that one of the terminologies that we -- that met those criterias turned out to have licensing fees that were considered onerous or difficult, okay, then what Betsy has articulated kicks into place to say this is a vehicle to address that.
DR. FITZMAURICE: That does take away one of the avenues of holding costs down and that is to support a competing terminology, vocabulary coding system so that you have a second product you can buy if you don't want to afford the first product.
MS. HUMPHREYS: Yes, but I think that the problem with this, the reason why I would disagree with that statement is that if the real desire is to end up comparable health data, then you basically want to engage the community in a fair way in selecting what is a good basis and then you want to go with that and you want to maintain it and you want to give the resources so that that can be the standard.
The notion of -- and then five years later, let's have another standard when people have five years of health care data that are in the other one and we are then going to try to relate them, I don't think that is the way to move this forward.
I mean, you can have groups come forward to say here is an area that isn't covered and I want to cover it, but that is a different story.
DR. FITZMAURICE: So, you pick two or three but make sure that they are mappable.
DR. MC DONALD: The model that is being proposed is -- it is going to be a monopoly because if you want a standard, it would be like saying let's do message standards and do them 20 ways. I mean, it is the same exact problem. Now, what you are saying is you are worried the government says they can't set prices. Well, shoot, you know, guys go to medical school and invest a lot of time and they come out and they don't get very much anymore. I mean, some of them.
I mean, that is an old habit. So, that is nothing new or radical. If you are saying that everybody who makes an investment has to get -- I mean, I don't see how this thing constrains any of the options you want as long as we are assuming that we are not going to have 50 things doing the same thing because that is exactly what we -- this is an unusual situation.
MR. BLAIR: Bill Yasnoff, I think, is waiting to make a comment.
DR. YASNOFF: There are a couple of principles here. One is that I think -- I agree with Clem that the model here is we want to create a monopoly. We want one terminology and we don't want competing ones, just one.
MR. BLAIR: For a given subject.
DR. YASNOFF: But when you create a monopoly, then you have the problem of regulation. So, the model for that that we followed in other areas, for example, with the telephone system, the way AT&T was originally created is the people who were running AT&T went to the government and said give us a monopoly and then we volunteer to have our prices regulated. So, there is this tradeoff between regulating process and providing a monopoly.
But the principle that we are kind of dancing around here is that if people put in time and effort to develop these terminologies, they should somehow be reasonably compensated. I think that is the underlying principle, that -- and I hear underlying your concern is you are saying, well, if the government is going to provide support -- let's say the government -- let's pick on SNOMED. The government says SNOMED is the standard and we are going to pay you people at SNOMED $2.38 and then we are going to distribute it everywhere free.
The people at SNOMED said, well, wait a minute. We spent a lot more time and effort than $2.38. So, maybe what we need to do in our recommendation is assert this principle that people who put time and effort into the development of these standards should be reasonably compensated. That seems to be -- and if you include that in this, then I think that addresses the -- without getting into the specifics of saying, you know, we should have price regulation, we are worried about monopoly and so on, I think that might address --
MR. BLAIR: Simon was next.
DR. COHN: Actually, I think that you have said it very well what I was thinking.
DR. MC DONALD: The only thing about that, it is going to make the bargaining position much harder if -- you see, in some of these cases there are -- let's just make up some drug names, vendors -- and I don't -- I mean, I do know the names, but there is Drug Vendor A, who sells it and Drug Vendor B, who says they are giving it away.
Well, wouldn't that influence your choice in selections. If you wanted -- one of the goals is have it low cost, someone who has got a business model where the codes themselves can be given away and that comes out fine. I mean, I just worry we will handcuff the process a little bit if we set too many constraints on -- I mean, I don't see how anything in this thing says we couldn't do that or we are being nasty. It just says these are the goals and this is what we are recommending.
DR. YASNOFF: But I think Mike's point and, Mike, you can speak for yourself, as I am hearing it, you are saying if I am thinking about -- let's say I am an entrepreneur and I identify some gap in terminology and I say, wow --
MS. HUMPHREYS: If you are an entrepreneur, please stay out of the vocabulary development business. This is a terrible long term future for you.
DR. YASNOFF: Thank you. But let's say I am a misguided entrepreneur. So, I identify a gap in terminology and I say I am going to fill that gap with the expectation that someday this is going to pay off, then maybe I just should -- I should not have that expectation and I am, obviously, terribly misguided.
DR. FERRANS: Well, that is why they call it venture capital.
MR. BLAIR: I think Mike was waiting next.
DR. FITZMAURICE: Bill has put the finger on the second item. The first item is what do you do with the status quo, where we have monopolists and we have people who invested? I will agree that you could wind up with a system of rewards and penalties that you can make everyone at least as happy under the new regime as they are today.
The second thing I worry about is the pace of innovation and modernization. It wasn't until there was competition that we got away from dial phones and we got new switching devices.
MS. HUMPHREYS: You know, I am going to argue against your point in the case of vocabulary development. I think that the most consistently well-maintained vocabulary has been totally supported by the Federal Government for the last 40 years and that is the medical subject heading that is used in MedLine. I think most people would agree from a structural perspective, a content perspective and annual update perspective, it is not a clinical terminology but it has been, I think, the model and we -- it had a total source of support and it had a lot of users.
We are trying to generate the users here and I think we ought to provide the federal support to go with -- you know, to keep it updated after that --
MR. BLAIR: Let's give Richard a chance here and then I would like to comment.
DR. FERRANS: For the existing monopolies that we want to, you know, regulate, the question is does the committee want to come out with the, you know, minimal position, which is, say, we will reimburse you for your R&D and your ongoing maintenance cost. Without an analysis of doing that, I don't think we should be that specific because of what people can do with accounting and how long some of them have been around, that that might amount to a windfall. I mean, I don't think we should put that in the document. I think we should keep it at a much higher level and talk about making sure that the principle of making it available to people at a fair cost or at a low cost or no cost is observed and that we will work with them.
I think the carrot and the stick is is that if someone is anointed and they are willing to go by the guiding principles and have conformance statements and implementation guidelines, then they will get, you know, the -- they will get market share. They will get a hundred percent market share. I mean, I think that can be done.
MR. BLAIR: My inclination is to accept Betsy's wording without change and, Bill, you had offered the fact that we wind up saying reasonable costs. My inclination is that that enters an area where people start to argue about what is reasonable. I feel like it is just not necessary at this point to have that in the recommendations.
Michael, you would up indicating you felt that we should be competition in this area. You know, coming from the private sector and being with a vendor, I do think that there is a role for competition, but what we are talking about is turning these medical terminologies into standards and we don't want competing standards for a particular domain. We really want to be able to go through as far and equitable a selection process, which meets national needs and then wind up saying everyone should be using that particular terminology for that particular use in that particular medical domain and we could map to others or we could converge with others for different uses.
So, my inclination is to accept Betsy's wording as it is.
Michael, I think you are next and then I think --
DR. FITZMAURICE: I buy Betsy's argument about the mesh headings, which illustrates that I think standards are a public good and should be subject to public control if they are public good, should be provided in the private sector when the private sector can do it more efficiently.
You give up something with innovation when you put it into the control of a board. There may be -- if you leave it in the private sector, there will be gaps that it is just not profitable to cover. So, we have to find the right mix and the right balance.
MS. HUMPHREYS: I certainly wasn't trying to convey in this recommendation at all that the responsibility for the actual maintenance and the intellectual activity of updating would necessarily at all be moved from the private sector to the public sector if it is a private sector effort, just that there would be a basic level of support for that effort so that we wouldn't have to fool around with the pricing issue.
MR. BLAIR: I think Clem is next.
DR. MC DONALD: Well, just a clarification or maybe I am opening up a Pandora's box here, but one might imagine that these standards are required in the transmission, in the message and they are not necessarily required in the front end systems. If that is the case, then I don't think we have cut out competition in the sense of if someone makes a spectacular -- 20 times more granular coding system that maps beautifully into this other one, that they have lost those opportunities.
DR. FITZMAURICE: Which gets back to my statement about mapping. Somebody has got to make sure they map.
DR. COHN: I am just getting a little -- at this point we have talked so much about these, I am getting a little confused about what we are recommending. I think really specifically the question I had, I am looking up on the screen here and it says "available at low cost." Is it low or is it minimal or no? What did we -- I mean, I don't know which version we are dealing with right now. What adjective is it? Low cost?
DR. FITZMAURICE: Low cost is what it says now.
MS. HUMPHREYS: That should be selected by NCVHS.
DR. FERRANS: Did we also agree on support instead of funding? I am just curious. I don't remember whether we ever agreed on that.
MR. BLAIR: I think we hit on funding.
DR. FERRANS: I thought we agreed on funding is my point.
MS. HUMPHREYS: My word was support but, you know, it is really your recommendation, of course. I am trying to help the committee.
DR. YASNOFF: I would like to suggest one more addition to this and something about long term availability because my other concern is that whatever agreements are negotiated to create these monopolies, we have to ensure that these are available over the long term at low cost and that after some initial period, that then we are not -- essentially we have created a monopoly that is now out of control and we are out of luck.
So, I think it is the long term availability that we are concerned about.
DR. COHN: Yes. And just to remind everybody also, that this process, once something like this happens, this isn't set in stone forever. There is a process with HHS and NCVHS every year to sort of review what is going on and the Secretary can come up with other recommendations.
MR. BLAIR: Could we, just to try to get agreement here -- Betsy, could you reread exactly these two sentences I think that you have in your recommendations and see if we could agree and support those.
MS. HUMPHREYS: I have added in Bill's thing, I think. To ensure that the medical terminologies selected by the NCVHS are available for the long term at minimal or no cost -- do we want to say low cost?
PARTICIPANT: Low cost.
MR. BLAIR: Okay. Low cost.
DR. MC DONALD: That implies you shouldn't have one at zero cost, doesn't it?
MR. BLAIR: Yes. I would say minimum or no cost.
DR. FITZMAURICE: Minimum or zero.
MS. HUMPHREYS: I was taking the original phrasing from the document and then I noticed it had been changed up there.
MR. BLAIR: Can we say minimum or -- not minimum
-- minimal or no.
DR. COHN: Well, no, basically not -- let's argue about this one a little bit. I first of all don't know what minimal means. I, obviously, know what no cost means. But we could say no or low.
MR. BLAIR: Low is fine.
DR. COHN: Minimal just has very strange connotations to it.
MR. BLAIR: Fine. No or low cost.
Go ahead, Betsy. Onward.
MS. HUMPHREYS: The Secretary of HHS should arrange for Federal Government support for basic maintenance and distribution of all selected terminologies, including those from the private sector.
DR. YASNOFF: Then we kept the other language, right?
MS. HUMPHREYS: My feeling is that the candidates for financial support, et cetera, should be -- this is taken care of in the guidelines --
DR. YASNOFF: That is redundant.
MS. HUMPHREYS: To be referenced there and not here.
DR. YASNOFF: We should get rid of that. That way the entire recommendation now --
DR. FERRANS: I wanted to ask again about funding versus support, what the consensus was, what people want.
MR. BLAIR: How many people want support and how many people want funding? Let's hit support first. How many people prefer support?
MS. HUMPHREYS: My feeling is that it is -- since this thing says including those from the private sector, I mean, some of these things are actually or could conceivably already be developed within the Federal Government -- I mean, certainly that is the case of ICD-9, which is an administrative standard.
So, you know, I mean, support if you are -- I mean granted there would be federal funding for the ones inside but I -- I don't know. That is what I thought of when I used support instead of funding.
DR. FERRANS: I guess my rationale of what you are saying is completely accurate. My rationale is is by stipulating funding, I think that this will really again help accelerate and I want to make sure that the message is very clear that there are going to be dollars there.
DR. COHN: Can we say support and funding?
MR. BLAIR: Support or funding? And funding.
[Multiple discussions]
DR. YASNOFF: And Margaret, we agreed on no or low cost, I believe, is what we agreed on. So, the long term at no or low cost.
DR. KOLODNER: Betsy, was yours to ensure the medical terminology selected by NCVHS?
MS. HUMPHREYS: Yes. That is changing from what I originally had, based on all of our other changes.
DR. GREBERMAN: A small question. Wouldn't the support include funding? Maybe a wording might be government funding and other support.
MS. HUMPHREYS: Fine, to me.
Are you ready? Is Margaret ready?
MS. AMATAYAKUL: Could we take just a couple minute break? I mean, are you done with this particular recommendation?
DR. ZUBELDIA: Margaret, that last sentence that you have there candidates for financial support, all of that goes out, right?
MS. AMATAYAKUL: Yes.
DR. GREBERMAN: As we get ready to break, I would like to introduce one colleague of mine from the FDA, who will be joining us, Leyton Hansol(?). He is from our Office of Surveillance and Biometrics, which has a major role in many of the international harmonization efforts and he represents the FDA along with me and Chuck Ferfind(?) on the ANSI Healthcare Informatics Standards Board and will be having an increasingly important role in many of these standards activities. So, I am glad he is joining me on this group.
MS. HUMPHREYS: I have had many phone conversations with Leyton, but never seen you or I didn't know I had.
[Brief recess.]
MR. BLAIR: Betsy, do you want to take us to the recommendation.
MS. HUMPHREYS: Oh, yes. Okay. Our next area here is the rubric at the top, Jeff, is "Facilitate Convergence of Medical Terminologies." I changed the introductory sentences to the following: Most terminology developers and users believe that a combination of multiple medical terminologies will be needed to cover all requirements of PMRI. The terminologies selected as standards should form an interlocking set affording comprehensive coverage while avoiding duplication.
Recommendation 13 --
MS. AMATAYAKUL: Could I just ask a question?
MS. HUMPHREYS: Yes.
MS. AMATAYAKUL: I guess my question is are we still going to keep all of these little preface introductory things to the recommendations? Somehow or another I --
DR. COHN: Well, I think we should save them for the moment and then we can figure out what to do with them. Some of this stuff is very good.
MS. AMATAYAKUL: Some of it we can put in other places and I guess what I --
MS. HUMPHREYS: I just thought that was a more direct way of stating the thought and where the thought ends up is not of great concern to me.
MR. BLAIR: Margaret, I think that, you know, we already have a logical place for it in the overview where we discuss medical terminologies and the issues. If we put it there, then we could avoid redundancy because it will all be in one place.
MS. HUMPHREYS: All right. So, the recommendation here is to facilitate the convergence of medical terminologies and reduce gaps and overlaps. I wanted to convert this into a more direct thing.
The National Library of Medicine and the Agency for Healthcare Research and Quality -- Mike is out of the room, so I can assign this to him -- should convene the developers of medical terminologies selected by the -- the developers of the medical terminologies selected by the NCVHS to define the specific coverage of each vocabulary selected and to establish procedures and systems that will eliminate existing gaps and overlaps and prevent the creation of new ones.
MR. BLAIR: I don't know if prevent -- minimize?
MS. HUMPHREYS: You are being realistic here. The issue here is that I think that we have a real opportunity to achieve something like this once the selection has been made. I think it is a little difficult when everybody is jockeying for position and doesn't know if they are going to be at the table for them to give up any little bit of their coverage that might overlap someone else's. But once they are all an anointed group, I think we might have a rational approach to this that would move us forward and make sure that we are spending the effort on all the areas and not twice as much effort on one piece of it.
MR. BLAIR: Is there more to the recommendation than what you have read us?
MS. HUMPHREYS: That is where I was going to end it.
DR. COHN: Would you reread it again to see if, indeed, we have it up here?
MS. HUMPHREYS: Yes. To facilitate the convergence of medical terminologies and reduce gaps and overlaps, the National Library of Medicine and the Agency for Healthcare Research and Quality should convene the developers of the medical terminologies selected by the NCVHS to define the specific coverage of each vocabulary selected and to establish procedures and systems that will eliminate existing gaps and overlaps and minimize the creation of new ones.
MR. BLAIR: Comments?
MS. HUMPHREYS: You were out of the room, Mike, so I assigned you this responsibility.
DR. YASNOFF: It is assigned specifically to Mike Fitzmaurice.
Question, Betsy. How is this going to relate to NCVHS and if -- it seems like there should be some report to NCVHS or liaison or something. This activity seems disconnected from the whole NCVHS process. Should we address that?
MS. HUMPHREYS: Yes, I think you are right. That isn't what I intended. I have no objection. I mean, I think that there is actually an issue where if you ask a number of these excellent vocabulary developers, okay, define precisely the point at which you will stop developing and have no intention of developing, they actually can't tell you. So, I think the idea is to have them reach some agreement among themselves that they are not overlapping.
DR. YASNOFF: I can suggest that you could just insert after "Agency for Healthcare Research and Quality should convene," you could say "should, in cooperation with NCVHS, convene" and then it is clear that, you know, these activities are going to at least in theory be coordinated.
MR. BLAIR: All right. Any other comments?
DR. COHN: Well, actually, I think this is actually very good. I am just mulling about how it relates to a recommendation we had about semantic interoperability at the end of the last section where we basically talked about coordination between message format standards and medical terminology developers. I mean, they feel like they somehow relate. That was Recommendation 9.
MS. HUMPHREYS: I know that this is directly related to terminology but if you were -- after these standards were selected, if you wanted to generalize this recommendation and say this should happen and the next thing should happen, too, whether, you know, something similar should happen for the other coordination, maybe that would be a good idea. I don't necessarily volunteer NLM for the other one, but I will volunteer Mike.
DR. COHN: Okay. This appears to be consistent. I just couldn't tell whether these things felt like they were consistent or not. It is almost like we should do what you are describing first and then the next step after that is Recommendation 9.
DR. YASNOFF: Well, they would probably be in parallel.
MR. BLAIR: Maybe ideally, but actually, Simon, I thought this came from you, maybe it is you and Chris, but it was the idea that the message format standards and the medical terminologies, having those models fit together, I think you referred to that as vertical integration. Then what Betsy is articulating in this particular recommendation might be more like horizontal coordination. Both are needed and I think that both will probably be going on in parallel and then it will be a challenge for us to make both of them continue to work and have the compromises go on.
MS. HUMPHREYS: I guess what I would -- the only thing that I would say in response to Simon's comment is that I think formulating a recommendation in roughly the same form as this one for the other process, whoever you want to anoint as the convener, I think, might be good. And it would be more specific as to what was going on.
MR. BLAIR: Any other comments or concerns or suggestions?
Well, if I don't hear anything, I am going to wind up saying let's go forward.
MS. HUMPHREYS: All right. We now are at the convergence of drug code. Facilitate convergence of drug code and we have quite an introduction to this, which we probably don't want here, but my comment is that in reading the entire document, I felt that in the area of convergence of drug codes, there was not sufficient reference to an acknowledgement of what has been a fair amount of level of effort put in on this question in the HL7 vocabulary with the drug things. And I feel that somewhere -- not here in the recommendations, but in the document there shouldn't be -- there should be more mention to this existing activity. I mean, they have not been able to move this forward as much as they would like, but I don't --
MR. BLAIR: Could I address that? Because I have tended to sit in on most of the sessions.
There are issues and problems that have made it very difficult to move forward in that area and, so, noble attempts have been made and they are still struggling forward on it. But --
MS. HUMPHREYS: I think the recommendation is great.
MR. BLAIR: We found -- the reason that it was absent was because we found it difficult to reference that without winding up starting to get into the discussions of the problems and we didn't want to name names and we didn't want to -- so, it was not because we didn't want to recognize the progress that HL7 has had. It is because we really didn't want to get into -- it is not that we didn't want to recognize the progress, it was that we didn't want to articulate the nature of the problems that they have been facing.
MS. HUMPHREYS: Well, I can understand why you wouldn't want to do this and I would just say, though, that to one who didn't specifically know that rationale, because I didn't come into your phone call, although I probably should have, I think that to an outside person, it kind of looks like you have ignored an effort. So, I think you need to --
MR. BLAIR: Mention it in a positive way?
MS. HUMPHREYS: Yes. And just say there have been unresolved problems. That is kind of why you are recommending that the government get in there, I think, but somehow not act like you don't know it happened because I think that might also be offensive to people who have been trying hard.
MR. BLAIR: I think we can do that.
MS. HUMPHREYS: So, I didn't do much with your recommendation except I thought that rather than mentioning all of these candidate agencies, I mean, AHRQ and FDA, I thought maybe it would be more straightforward to phrase the recommendation this way. To promote the ability to share clinically-specific drug information to ensure patient safety, the Secretary of HHS should appoint an HHS agency to lead and coordinate the development of a drug reference terminology. This drug reference terminology should incorporate NDC codes, generic names, drug classes, et cetera.
DR. YASNOFF: I wanted to suggest a very small modification to this, that it is not just the development that needs to be coordinated, but also the ongoing maintenance.
MS. HUMPHREYS: Yes. Very good.
MR. BLAIR: Any other comments?
Okay. Is that the last -- okay.
MS. HUMPHREYS: Now we have -- we are down to "Map Vocabularies to Classifications." I have revised the introductory sentence, which probably goes somewhere else as follows: While medical vocabularies are evolving to support evidence-based medicine, there will continue to be a need for clinically specific data to be aggregated and mapped properly to classifications and code sets required for statistical and reimbursement purposes.
Then I go on this, to encourage toward more effective aggregation and mapping of data captured with medical terminologies to more general statistical classifications and reimbursement code sets, the Secretary of HHS should strengthen support for the National Library of Medicine -- thank you all for putting that in -- to extend and enhance the UMLS content and structure to improve the mapping capabilities between medical terminologies selected by the NCVHS and the code sets and classifications designated as HIPAA standards.
MR. BLAIR: Are you finished with the sentence? I don't want to interrupt you in the middle.
MS. HUMPHREYS: No, I am through.
MR. BLAIR: Could you clarify -- I am not sure that I really understand what you mean by aggregate. Are you saying that the data is aggregated before it is mapped or are you winding up saying NLM will aggregate each of the terminologies and then map the terminologies?
MS. HUMPHREYS: I am saying -- well, you know, we can get rid of this if you want. We were discussing this at NLM, this recommendation. And in fact, when you look at the issue of mapping from a very specific vocabulary in a patient record to a statistical classification, it is not at all a one-for-one mapping. It is often aggregation of different pieces of information in the clinical record in order to decide what of these higher level things and the idea is that you want to be able to put the -- generalize from the detailed information, which you can call it mapping if you like and if people understand that, but it is a much more sophisticated and difficult process than a simple map.
DR. COHN: Actually, Betsy, I like your idea very well. The one comment, though, I would make --
MS. HUMPHREYS: I don't think it is necessarily expressed clearly. We were having difficult figuring out how to say it.
DR. COHN: Yes, it is a one to many issue -- I think the only other point I would make about this is there is mapping and -- but there are connections. I am not sure the term is "mapping" -- not only between statistical and more granular technologies but between terminologies in more of a more horizontal frame also. If you select a terminology, you want to make sure that the more granular ones also fit together, which will require potentially some mapping at the edges.
MS. HUMPHREYS: Well, yes, that is true but -- and if you want to say that, that is fine with me. Actually, the mapping of the more granular ones to each other is a much simpler proposition and is generally handled not all that inadequately by the existing meta-thesaurus. It is when you have to say what is the clinically or statistically correct way of getting from this narrow set of data to the appropriate one of six candidate ICDs or whatever, that your real difficulty comes in and where, as we have said before, we have R&D to do on the best way to do this.
DR. COHN: I was going to just suggest we use the term "among and between" medical terminologies.
MS. HUMPHREYS: That is fine.
MR. BLAIR: Other comments? If not, I --
DR. YASNOFF: I know Betsy doesn't want to say this but do we want to say more strengthen support? Do we want to say something more direct like provide funding? That is what we are really saying. So, maybe we should just say it. Because I imagine the Secretary writing the director of NLM this letter saying I support even more strongly than before your efforts to do so, which just means that they are going to have to deprioritize another important program in an overall budget versus saying this is something that is a funding priority.
So, I agree with your point.
DR. ZUBELDIA: If we map this matter of speech, strength and support should be provide additional funding.
DR. YASNOFF: Good. Even better.
MR. BLAIR: We seem to have consensus on that.
Could I get back -- I am sorry. You tell me when I could add another thought.
DR. YASNOFF: No one else wants to talk, Jeff.
MR. BLAIR: If the concept of aggregation can be included within the concept of mapping --
MS. HUMPHREYS: You would rather just stick with mapping then?
MR. BLAIR: I would rather do it because we are going to have lay person readers reading this document and I am only concerned that some of them --
DR. COHN: Actually, I disagree. I think it actually needs to be aggregation.
MR. BLAIR: Well, let me tell you what I am a little concerned of and none of the people on this committee, I think, would interpret it this way, but people in public health tend to think of aggregating data for an entirely different reason and I think when they see that word, that is what they are going to think of unless it is explained. As long as aggregation can be included within mapping, I think we could save misunderstanding from lay person readers.
Did I convince you or not?
DR. YASNOFF: Jeff, I don't think we are going to be confused. I don't think the public health community is going to be confused anymore than they already are about vocabulary.
MR. BLAIR: Okay. My argument wasn't compelling. Then I yield.
DR. COHN: Jeff, did you want to bring up the other issues about content at this point?
MR. BLAIR: Ah, thank you for the reminder.
Helene Guilfoy, are you here?
MS. GUILFOY: Yes, I am, Jeff.
MR. BLAIR: Helene came up at the break and raised an issue which has periodically been raised and let me try to be concise in describing this. Okay? Way back when we were trying to say what is the scope of this report and we were dividing it into focus areas, the issue of the content of patient medical record information was one of the things we struggled with. At that particular time, we thought, well, content gets folded in under medical terminologies, maybe even to some degree under message format standards.
So, we did not include it. About a month or so ago, there was additional discussion of, gee, did we lose -- since we didn't have a heading for this, did we lose the opportunity to address this? And Helene has raised it again. Helene, would you articulate your concern and what you think we may have left out? Because I think now that we have finished the medical terminology piece, if this isn't covered somewhere in these first two sections, then I think we probably have to address it.
So, Helen.
MS. GUILFOY: Thanks, Jeff.
First, I would like to commend the workgroup on supporting low or no cost medical terminal terminology standards. As part of the user community, I would think that would be very advantageous to get us to use them.
What I have heard today is that there is a standard or there is a proposal to standardize the way we send and receive information and what we are going to call it once we send it and receive it, but I am not finding the content of what is going to be sent and received in any of the document.
Jeff just sort of stole all of my thunder, but I think that that is part and parcel of the problem with -- or the content of patient medical record information. When someone goes out to buy a computer-based patient record system, they have no way of discerning what they need to have a part of. So, each vendor has determined what that content would be.
I would suggest to you that that is part of the problem of medical errors. I was going back and looking at the beginning statements in the document, where it was talking about lack of uniform data standards resulted in a patient's death at one hospital because the information on allergy to an anesthetic was not in the hospital's standard format and was missed when preparing the patient for surgery. If the patient medical record information doesn't store that information, regardless of how it is called or what it is called, if it doesn't store the allergy, then the information is not going to be available to the clinician when they administer something.
I just think that -- I am disappointed that the workgroup has not confronted the issue of content. At the risk of backing off of my own statement, the minimum data sets that are out there from HCFA at least give us some guidelines in what the content is that we need to have in storing information.
I hesitate to use the word "minimum" because I think that puts a boundary and it is an artificial boundary around some information, but I think we need to address this in -- and I think we would be remiss if we didn't address it in defining patient medical record information.
DR. ZUBELDIA: Helene, one of the discussions we have had in the past is after this report goes to the Secretary, then NCVHS would have to look at defining the areas of the patient medical record by function that need to be automated and come up with a list equivalent to the list that we have seen for the administrative transactions where it said claims or equivalent encounter information. It didn't say 837 or NSF or UB92. It specified a function.
Once we have identified a function, then we can take a look at the standards and that is the point where the content will be identified. But I think at this point we are not there yet.
Does that make sense as a process to achieve what you want?
MS. GUILFOY: Well, I understand what you are saying, Kepa, but I don't -- I think if it is not in this document in the recommendations to the Secretary, then we have no guarantee that that is going to be the next step in the process. So, I guess if there was at least a place holder in this document, I would feel better that content was at some point going to be addressed, but I am concerned that we put all of the effort into message standards and we put a lot of effort into terminologies, both of which are required. I am not downplaying those. I just think that content is as much a requirement as those two.
MR. BLAIR: We have Clem and then Simon.
DR. MC DONALD: I think there is a mismatch in our vocabularies. I think if you take the message standards as total and you take the vocabulary as a total, you have all the content. Now, the question I want to ask you is are you saying that everyone, every patient should have a hemoglobin measured every visit?
MS. GUILFOY: No, absolutely not.
DR. MC DONALD: So, the content is going to depend on the patient. That is content. They got a hemoglobin. I think you are really saying what can I expect at least to be in there. That should come out of the medical professions not out of the technical standards activities. What should a diabetic have in their record? But these standards would permit that, would accommodate that with these two sets of things we are talking about.
MS. GUILFOY: I think in response, a diabetic should at a minimum have within their record age, height, weight, most recent blood value. You know, I mean, we can look at -- but we don't have to say that they have to have these in each and every time. That has nothing to do with
-- that is a specific medical determination.
DR. MC DONALD: When you mean content, what else are you talking about?
MS. GUILFOY: That is what I am talking about. What is the minimum that we need to have within a defined patient medical record information.
DR. MC DONALD: A patient medical record system should be able to accommodate anything, all of it. Mostly the commercial ones close to that so that they can accommodate whatever. The decisions about what must go in in a given disease is currently, I think, outside of our purview. I think that belongs to the professional societies in terms of their standards and all that and we just have to make sure that the standards will accept it when they decide that is what is needed.
MS. GUILFOY: I spoke to the committee back last October, I guess, all on the ASTM standard on content and structure of a patient record and I think there has been a lot of effort go into the creation of that standard. There is an additional part of that standard that is out there now, which is called the minimum information necessary for a patient record. I guess I would ask the committee again to take a look at that standard in determining what the content is and I would point again that ASTM standards are consensus-based standards.
I am not here purporting ASTM. I am here saying I am disappointed that there is not some effort here in content and if, as Kepa says, it is the intent once it goes to the Secretary and then comes back, that there would be a content committee at that point created. I guess I can live with that. I just would like to have a place holder that says that is going to happen.
MR. BLAIR: Simon and then Mel.
DR. COHN: And then I guess Margaret A was going to have a comment.
I guess we are all trying in some way to answer your question one way or another. I guess I used to think of data sets, which is sort of really where you are going towards and after much angst in that area, recognized that they were typically asituational in the sense that the data requirements for a newborn are different from the data requirements for a geriatric patient often or a diabetic or whatever.
As I began to look at the message format standards, I realized that there was the flexibility in a much more situational fashion to begin to specify that. So, to my view, while it doesn't exactly answer the same issue, in other words we are not describing the entire structure and content of the medical record, it begins to structure and define many of the most important elements, I think is my answer. Others may have other comments.
So, I guess my comment is that we are getting to it, just a slightly different direction, approach.
MR. BLAIR: Mel.
DR. GREBERMAN: I appreciate the points you are making. I think there is and there may be some wording here that I have missed, but there probably should be at least some reference in here that we are not dealing with that issue or at least, you know, have it as a place holder for later. I think it is important to recognize that as a piece of the whole puzzle. Clearly, I think we can point out what we have been doing in terms of the terminology and coding and message standards, support whatever the content is later on, as developed by the professional, by whatever mechanism is established later on.
So, I think it is at least important to -- it is valuable in recognizing that that is an area that needs to be -- that should be dealt with or is controversial or whatever and it is just outside the scope of what we are trying to deal with here. That at least shows it is an important area, even though we may not take it on totally.
MR. BLAIR: Let me bounce back here. I have been listening to this discussion and Helene mentioned the ASTM standard on content and structure. If I recall sometime back five or six years ago, Clem, I think you made a tremendous contribution to that particular document, but you seem to have a different view or perspective now, either that things have matured otherwise and --
DR. MC DONALD: No, what I contributed to was all the HL7 structure was -- I think these things -- I think there is a misunderstanding of the differences. I frankly do. It depends on what you define as your fields. If you define your field as potassium, then you start thinking of it one way. If you define your field as appointed to a meta-data dictionary, you think of it another way. We are still stuck with -- early data sets I think is the content issue and it is a prescriptive thing.
It is a thing that should be in the medical profession or the nursing procession not in -- not adjudicated at this level. We just need to have mechanisms that when people define -- no one would have ever said that triponin(?) was important for heart disease ten years, but now if you have a heart attack, that is what you use.
MR. BLAIR: Could I summarize? I think -- you tell me whether I am capturing this idea correctly. Is what you are saying that in terms of the scope of the NCVHS defining standards for patient medical record information, that we have identified those areas where we are able to review and select standards or terminologies, but that when it gets to the topic of content and structure of the record, especially when you go by specific clinical domains, that you are saying this really needs to be left to professional associations to take the lead in that. Is that correct?
DR. MC DONALD: Yes. What I am saying is is that if the data comes into a medical record from anywhere -- and the best I know, data doesn't just grow out into the record paper by itself. It comes from somewhere. There are mechanisms to send it. So, we have got mechanisms with codes and the messages to get it in there. How the physical structure of the record is probably going to be the vendor's choice. I mean, there will be internal structures --
MR. BLAIR: Physical structures --
DR. MC DONALD: But what must be in there, that is, what should be -- what variables or what pieces of information should be collected for a particular patient, for a particular circumstance, particular disease. That is going to be like a data set. And we don't know what truth is. Very often it is dynamic, but certain areas, there are recommendations out in the professional field that say diabetics should have these things measured, observed, recorded. Newborns should have these things recorded and those things, I think, are not in our purview. I think those are professional society purviews.
MR. BLAIR: Would it be appropriate for us to include that type of a statement of what you just said, like in the overview of standards?
DR. MC DONALD: I think so. Mel said the same thing sort of.
MR. BLAIR: Helene, does that address --
MS. HUMPHREYS: You want them to do the other thing.
MS. GUILFOY: I don't want to confuse it with medical protocols. I certainly don't -- that is nowhere what I want to say, which I think that is what you were alluding to when you were --
DR. MC DONALD: No. I am not talking about --
MS. GUILFOY: Oh, okay. I misunderstood when you were talking about cardiac patients that had -- I think what we need to address is the fact that there are -- for instance, this patient that died because the allergy to an anesthetic was not on the hospital standard format, well, who told the hospital to put the allergy in their patient medical record information?
DR. MC DONALD: Everybody. That is --
MS. GUILFOY: Clem, that is my point is that we all know that. We all say you need to have allergies in when you are collecting patient medical record information. But unless that is listed somewhere, unless that is standardized somewhere, unless that is in the list of data elements that you need to have, then there is not a guarantee that allergies always and forever are going to be included in every compilation of patient medical record information and if we don't have allergies, then we are cooked.
MR. BLAIR: Betsy, I think you were waiting to say something?
MS. HUMPHREYS: I actually -- there are two things that I think about this. One is that whereas I would certainly agree with the point on allergies, I feel that we don't have enough operational medical record information systems to actually know what should be in them and what should be stored and whether some of the stuff we are collecting and putting in them has any benefit in terms of quality or any other purpose. That is one thing I think.
But the other thing I think is that to me the piece of this that was going to move on to data content issues was, in fact -- and maybe this is a reasonable thing to infer that this is the next step -- when you talk about taking all of the message standards and saying we are going to have a uniform meta-data dictionary for all of these, then it seems to me you start to have a structure by which it would be possible for specialty societies or even groups of specialty societies or other groups to say, all right, we know that there are 10,000 data elements and Element No. 5050 -- you know, these are the 10 and you can tag them easily.
We do this in -- the subset of these that are defined as being essential for diabetes care, that are assigned for being essential for anyone admitted to a hospital, they are assigned for being whatever. So, you at least have a structure where these things can be registered in a way that everyone in the community has access to them, but I do feel that you need a procedure like this because I think that we have a lot of speculation about what is required for any given purpose and we don't necessarily have the data to show that it is really required or essential or that something else that nobody thinks is essential was actually the thing that we should never neglect to have in everyone's record.
MR. BLAIR: Could I suggest that Clem's statements with respect to the role vendors play in creating structure for patient medical records information and professional associations do in defining what the content might be and it will change over time, it would be different by domain and circumstance -- I would pretty much gather that Margaret is able to craft a paragraph to capture those ideas and include them in the overview of standards. Is that acceptable to everybody if she does that or, Clem, do you want to actually write the paragraph and submit it to Margaret?
DR. MC DONALD: We have a long history of me promising her things and not getting them to her.
MS. AMATAYAKUL: I will write it.
MR. BLAIR: Margaret will write it.
MR. BLAIR: Suzie.
MS. BEBEE: Actually in the introduction under 6, the last paragraph, it talks about what PMRI include --
MR. BLAIR: The introduction in Section IV, right?
MS. BEBEE: The introduction actually itself is --
MR. BLAIR: Section II?
MS. BEBEE: Right. Under No. 6 -- I am sorry -- under No. 5. How do standards for PMRIs fit within the HII and the last paragraph refers to PMRI and what it includes, which by the way does happen to say "allergy," but that might be where you want to embellish what you were talking about, Jeff.
DR. FERRANS: One other point is that with respect to allergies and whether we can deliver that information there, it is more of a -- I mean, I don't think it is so much of a problem of having a standard and requiring it. I think it is more of whether we have useful applications that have, you know, the intelligence to deliver that to the point of care. I don't think that we can regulate computerized patient record systems.
I think we are in the business of trying to provide the standards, you know, and financial encouragement and whatever else the government can do to try and make those things happen. But that is a problem for the vendor community and that is a problem for JACHO if it involves, you know, minimum things that hospitals should have. But I think from the, you know, data standardization and interoperability, I honestly don't think that interoperability is the root cause of that.
I think it is the lack of deployed applications that are causing that. And, you know, I agree with the clinical approach, too. We naturally assume that we know what the patient's diagnosis is so that we can create a data set when in many cases it is rule out something or a cluster of signs and symptoms and we don't know.
So, what should be the data set for, you know, a particular constellation of, you know, clinical problems that are on hand? We are never going to be able to define that.
Finally, if we start specifying what is in the record, then we are going to force people to use the applications to support that and we have got in this document that a lot of the user interfaces are not where they need to be right now. That is going to be a problem.
MR. BLAIR: There really appears to be consensus
-- what I am hearing is, you know -- Margaret, you could write a paragraph? I think that will take care of that.
DR. GREBERMAN: I think there is one issue I am not sure was clearly addressed and I think this may get to the root of at least what I thought one of your comments was, which is I think a valid one. You don't have to specify what has to be in the record for every given clinical condition or situation.
But I think one of the errors that has occurred is because if it is there, you are not quite sure where to find it. That has really been the root of some of the errors. So, I can see an issue of format that sort of clarifies where things go if they are there so at least you know where to look. I think, you know, that strikes me as a broader challenge. I am not quite sure that we have the time left in our structure to deal with that, but it certainly is an issue that I think needs to be at least recognized.
Maybe that can go into this general paragraph, too, because at least I think that is at the root of some of the errors you are talking about, not specifying that this hospital requires hemoglobin or blood glucose every third admission, but if it is going to be there, it is going to be in this sort of structure.
DR. KOLODNER: But I can't imagine on an electronic interface that you can start doing that. It just -- it boggles my mind because I may tailor different screens for different specialties -- I mean, I have no idea how these things are going to evolve and it just -- the fact that it is in the database --
MS. GUILFOY: I think that part of what we need to differentiate here is whether this is an electronic medical record, whether this is an electronic transmission of the information or whether this is just simply electronic storage of the information.
I think that is the distinction that I am pointing out is that unless it is stored, it can't be transmitted and it won't be received unless I have someplace to put it. So, that is my point is that unless we begin to define those pieces and parts that are critical to compiling patient medical record information, we can assume all we want that we are going to have the allergy contained in that record, but unless we say it somewhere, we have no guarantee that it is going to be there.
Now, Clem's point is well-taken that the vendors are all doing that. I am talking --
MR. BLAIR: Well, the vendors and the professional associations he said would be the ones that would be defining the content.
DR. MC DONALD: Well, the allergy one is a very specific record in the message structures saying all about all allergies.
MS. GUILFOY: But, again, Clem, you are talking about the transaction standard. I am talking about the record itself.
DR. MC DONALD: I am saying -- you are saying -- where does it start, the data? Does it start in the medical record?
MS. GUILFOY: I would hope it starts in the medical record before it goes anywhere.
DR. MC DONALD: I would assert it starts in the computer system that sent it to the medical records because the medical record knows nothing. It is a blank piece of paper. That is along the philosophical --
MR. BLAIR: Could I wind up moving us forward on this, please, because I do believe that we really have pretty much of a consensus that we do need to add a paragraph. We do need to mention the points that are made, specifically the fact of professional associations are addressing the content, the vendors are addressing the format and what is deliverable and that --
MS. GUILFOY: I think, Jeff, you also need to say that the standards developing organizations are addressing this information.
MR. BLAIR: Okay. And we could wind up, you know, indicating that that is also occurring.
DR. COHN: Without killing it -- I agree with you. We need to get off of this. Margaret has been very quietly raising her hand and I think is pointing to a recommendation that we had earlier on that I think she wants to point out and, hopefully, that will be the last piece.
MS. AMATAYAKUL: We had a discussion about this before and actually I think Kepa had, in the beginning of this discussion, a comment that related to this recommendation, which is up here. This is Recommendation No. 2(b) and it says, "Prioritizing specific content and functional areas, this would identify those areas where specific PMRI standards are most needed."
So, I guess my question is -- I mean, I interpreted this and I interpreted Kepa's comment earlier that we would, in fact, be looking at content in the future and that is the reason we put this recommendation in there.
MS. HUMPHREYS: So, I guess what you need to do is you need to reword the recommendation so people who are concerned about this issue can recognize that this is where their concern is being addressed because I skipped right over that, too.
DR. MC DONALD: I don't see that saying anything about what we just discussed nor should it be there unless we are going to become a medical practice organization.
MS. AMATAYAKUL: Recommendation 2(b).
DR. MC DONALD: I am reading Recommendation -- it says, "Prioritizing specific content and functional areas..." That is the areas of interest, in other words that the content was going to be a subject matter of our working.
MS. AMATAYAKUL: Content areas of interest.
DR. MC DONALD: Well, that is what the implication is. It is not a sentence.
MS. AMATAYAKUL: So, we need to either fix this, delete it.
DR. MC DONALD: Yes. Well, it is saying what we are going to do is prioritize the areas, if you look at the two sentences together, where standards are most needed. It doesn't say we are going to deal with content.
DR. KOLODNER: It doesn't say that it requires that it be there. It says that is where we are going to work next on the standards.
DR. ZUBELDIA: But I don't think we are going to work on the -- I think the standards organizations that will define the implementation guides are going to define the content that goes into the implementation guide.
DR. MC DONALD: Well, the word "content" is an almost -- it is a bucket. You can use it -- this thing, I think, we are talking about is what are we going to do, how are we going to prioritize. We use the word "content" and "areas" as synonyms and I don't think we are talking about content in the sense that Helene was talking about content in this recommendation.
MS. HUMPHREYS: And you remember that in the transaction -- and how there were two kinds of it because we discovered that even when we were developing this draft of the standard, people who were discussing it meant two different things.
I don't encourage you to use that word "content" without being a little bit more specific.
MR. BLAIR: Okay. I am not sure where to go from here because I am not sure that we have agreement on this. It sounds like --
MS. HUMPHREYS: I liked where you were before, which is that Helene has raised this area, which is not well-addressed in the document and that there should, in fact, be a statement up front that indicates who you all think is -- how you think this is going to be worked on, which it sounds to me like at least initially you think it is going to be a combination of vendors and organizations.
MR. BLAIR: Professional associations and standards organizations.
MS. HUMPHREYS: And I actually think that you might consider adding a little piece onto the data elements standards, meta-data directory, in terms of that would be a very nice community place to register what data elements people think are important for what purposes.
DR. MC DONALD: Well, that plus that you can't leave the vocabulary out because of the direction involved in a lot of these things.
MR. BLAIR: Let's leave it to Margaret to draft that and let's move on to our next recommendation.
DR. GREBERMAN: Can I just make one quick comment before we leave that, though, Jeff?
Besides the professional associations and vendors, there will be some select areas where the Federal Government will have a role and make some statements. For example, HCFA could say I want to see this --
MR. BLAIR: -- professional associations, vendors, standards organizations and the Federal Government.
DR. MC DONALD: But it is not going to be us.
DR. FERRANS: Quick question here on the data accountability, quality accountability and -- this is sort of an ordering question. Does anyone think that privacy, confidentiality and security should be moved up in the order?
DR. COHN: Let's talk about this one and then talk about the order.
MR. BLAIR: We already did move it up once and -- I think that the basic theme that we have, which is interoperability, comparability and quality, that those three --
DR. FERRANS: Those are the three and then this follows. Okay.
MR. BLAIR: Those are the three up front and then maybe -- okay?
Margaret, Recommendation 16.
DR. COHN: Suzie is making a --
MR. BLAIR: I am sorry.
MS. BEBEE: Jeff, you had mentioned four entities just then. I think we need to add the data content committees, just not the SDOs.
MR. BLAIR: Data content committees --
MS. HUMPHREYS: They may consider themselves --
MR. BLAIR: Margaret, add the data content committees.
Good. Thank you.
MS. AMATAYAKUL: We are on the section, "Data Quality, Accountability and Integrity." And we are --
DR. COHN: I guess the question is whether we are going to have somebody read the whole page that goes through before we get to the recommendations. I am somehow struck when I see a page of discussion prior to a recommendation. It makes me feel like there is something wrong.
MS. AMATAYAKUL: I thought we were going to incorporate that kind of content earlier in the document.
DR. COHN: Okay. So, do you read the recommendations?
MS. FOULKES: Before we get to the recommendation, can I suggest one addition to this list? One rationale for the whole activity from the point of view of FDA and CDC would be to facilitate, for example, voluntary adverse event reporting, which you may read that as part of the epidemiologic surveillance or other things in this list, but I think it might be helpful to specify that.
MS. HUMPHREYS: Which list are you looking at?
MS. FOULKES: I am reading under the first paragraph, data quality and accountability and integrity.
MR. BLAIR: Does everybody feel comfortable with that addition?
[Multiple discussions]
MS. FOULKES: In the same list where it is discussed as epidemiologic surveillance and public health indicators, I just think that these efforts are going to facilitate voluntary adverse reporting, which is already a burden on a lot of localities.
MR. BLAIR: Okay.
MS. AMATAYAKUL: Recommendation No. 16 is to promote quality, accountability and integrity of electronic PMRI. The NCVHS should utilize the data quality features and characteristics referenced in the guiding principles as part of the selection for -- as part of the criteria for selection of PMRI standards when recommending message format standards for adoption and the construction of conformance tests.
[Multiple discussions]
MR. BLAIR: Okay. Other than moving it up forward, is there any question on the wording?
PARTICIPANT: We have already said all that.
MR. BLAIR: Okay. Are we ready to go to 17?
MS. AMATAYAKUL: To provide incentives for using PMRI standards that incorporate data quality, accountability and integrity, all HHS agencies should require that health providers and plans use PMRI standards, which include data quality features and characteristics for all healthcare information that they report to HHS agencies.
MS. HUMPHREYS: Well, my thing on this is that this thing belongs somewhere else, too.
DR. YASNOFF: This is part of the incremental approach to implementing standards that we have also talked about earlier. Maybe we might be more specific in that incremental approach should be.
DR. FERRANS: This doesn't sound incremental to me, by my read. So, we are saying incremental on one end and on this end we are saying that -- well, everybody is going to be reporting.
DR. YASNOFF: Well, this is one of the increments that is close to the end of the incremental approach.
DR. FERRANS: Thank you for clarifying that.
MS. HUMPHREYS: I mean, essentially this is where we have implemented this as a national standard because there are very few players that don't have to send some data to HHS at one point.
DR. MC DONALD: Does that suggest we should just use the other one, which is less terrifying maybe?
DR. FERRANS: Yes, although we could call this a long term goal or -- I mean, I think it is a very appropriate long term goal.
MR. BLAIR: Well, could I speak up in defense of this because we had had some discussions on this and maybe it is not articulated in a way where we still have captured the thought that our committee had on this?
There was comment some time back that one of the reasons that we didn't have standards that really facilitated and promoted data quality, accountability and integrity was that the incentives were not in place by the end users of the information. So, the intent of this, at least as I understand it was to say here the Federal Government is one of the users as a payer at least and other -- using this information also for public health purposes, that as an incentive when we do the selection process, we --
excuse me -- not when we do the selection -- as an incentive, HCFA and other agencies would wind up expecting data to be presented in a manner with standards that have those characteristics and features for quality.
DR. COHN: 17 is --
MR. BLAIR: Am I on the wrong one?
DR. FERRANS: I thought we had talked about incentivizing people to report their data.
MR. BLAIR: Yes. Am in speaking on the wrong one?
DR. YASNOFF: Yes. There is a different recommendation about that, I think. But if I can remind the group of one -- what was originally Recommendation 1(b), it says the following: Adopting an incremental approach to PMRI standards use within agencies for government business, for health plans that cover government employees and ultimately for all health plans paid with federal funds. I think we could take this recommendation and fold it into that language as part of the incremental approach.
This is one other step in that same incremental approach and I think this also demonstrates the problem with presenting the recommendations in alignment with the work areas because now that we have moved these two, this area has no recommendations but, of course, really it does have recommendations. It is just that the recommendations cover multiple work areas.
DR. FERRANS: Jeff, as I recall, there were testifiers who said, you know, if you want people to adopt the higher quality PMRI standards or to do the reporting, using standards, if you somehow incentivized them, for example, gave them an extra 50 cents or a dollar or something like that on a bill, reimbursement, if they would report that data. I think that that was something that if one were to recommend, it would be something that -- recommend that -- but, I mean, that was a recommendation that testifiers had given but I don't remember that -- it sort of went to the point where we said we should have everyone report the data and there are no incentives. So, I see it the way that he said, which is it is part of the incremental approach.
MR. BLAIR: Simon has a comment.
DR. COHN: I guess I -- I am very confused about No. 17. Let me say this because I am looking at it under the data quality, accountability, integrity area. It doesn't to even fit there as best I can tell. At least as I read this, it is basically saying that HHS agencies will require all providers, using PMRI standards for all health care information that report to HHS agencies, which is very different than data quality, accountability and integrity, I think.
MS. HUMPHREYS: It is okay because we really think that 16 and 17 don't belong here and that the issues that are discussed under data quality and accountability and integrity, if not probably addressed up front, are going to be moved there. So, you don't have a problem.
DR. COHN: Great. Thank you for resolving my confusion.
DR. YASNOFF: Rich's problem is addressed in Recommendation 25(b), which says "Provide incentives for the use of healthcare information systems so the cost of these systems is shared by all who benefit. The full cost of implementing PMRI standards should be factored into reimbursement levels or payment schedules."
Did Rich disappear? Okay. Well, he must be happy then.
My point is that Rich's issue, which we did -- was heard in testimony, has not disappeared. It is just later on.
MR. BLAIR: Yes.
DR. COHN: So, I guess Recommendation 16 goes into 2.
DR. YASNOFF: 17 goes into 1(b).
MR. BLAIR: Into where?
DR. YASNOFF: 1(b).
DR. ZUBELDIA: So, this entire Section IV disappears.
DR. YASNOFF: Well, but we don't necessarily want to lose the verbiage, but that goes in the previous Roman numeral of the document, I think. Right?
MS. HUMPHREYS: Some Roman numeral.
DR. YASNOFF: Somewhere else in the document, not in the recommendation.
DR. MC DONALD: 18.
MS. AMATAYAKUL: 18 is under "Privacy, Confidentiality and Security."
DR. MC DONALD: There is 18, 19 and 20, all on the same subject, but I worry -- Bill's not here now -- about whether we should be making specific recommendations when there are currently regulations under comment, which if we get them in conflict, it is going to look -- rather than say that we support the regulations that will be forthcoming.
I don't know. That is just -- where did Betsy go? Who is our --
DR. COHN: I think Bill Yasnoff has his hand up and I will follow up after him.
DR. YASNOFF: My comment on this section is that there is another workgroup that is dealing with these issues and, therefore, whatever recommendations we send format to the full NCVHS, we certainly need to send a note saying these recommendations need to be coordinated with the people who are primarily dealing with these issues.
I have no problem sending it, but I don't think we have time to actually do the coordination. We have to leave that NCVHS.
DR. COHN: Maybe I can make a comment and then -- actually, we now have Dr. Braithwaite and Betsy here. They have other comments about privacy and security.
My own thought is is that -- I mean, we were asked by the NCVHS to consider privacy, confidentiality and security and have it referenced within this. Now, referencing within it rather -- versus making recommendations are two very different things. I think that we need to reference in it. I think it is a critically important area.
If, indeed, we have a recommendation that is unique and different and beyond for patient medical record information that is somehow not handled somewhere else, I think we need to do it, but I am not convinced as I look at the recommendations that there is anything that is mission critical that -- I guess that is just my opinion. I guess, with Dr. Braithwaite and Betsy, they have something to add.
MR. BLAIR: Are they both here now?
DR. COHN: Yes, they are now.
DR. MC DONALD: I had a specific question. We have three recommendations, which talk along some of the same lines as what is in the current under comment regulations or proposed regulations. What should we doing here or what shouldn't we be doing here when these still are under comment and they were stimulated in part by us?
MR. BLAIR: Could I just add one piece on this? It is because -- well, first of all, we originally had this in way back a year and a half ago, this section. It was removed and then John Lumpkin asked us to restore it because he felt that this was a very important area and that because we had figured that we would just simply make a reference to the fact that, well, this is a topic covered by the other subcommittee within the NCVHS.
So, may I simply ask that we listen to each of the recommendations here. If we don't feel they are appropriate or they need to be changed, let's do that, but let's not just say that this is not an area that should be in the report.
DR. MC DONALD: I am not saying that. I just really want to know what Bill's opinion was about how we had -- what care we had to take in terms of looking kind of silly or tangling our feet up underneath some other regulation in that process.
MR. BLAIR: Well, as we read through each one, I think, isn't Bill able to comment on whether or not that is in conflict --
DR. BRAITHWAITE: I am able to comment on anything. You know that.
In general, I think, the comments or recommendations from the NCVHS will not at this point affect the process of coming up with the privacy final rule. The comments have all been registered and that process is underway. But there are certain things that were recognized in the NPRM, which the Secretary can't do anything about, such as the recommendation that you have put forward that Congress deal with the problem of superseding state laws.
So, that recommendation certainly is independent of whatever the Secretary is doing. So, you could certainly add that as a recommendation to Congress.
MR. BLAIR: Well, the other piece is that, you know, our workgroup has a slightly different scope than the previous initiatives under the administrative simplification provisions. We are focused on PMRI. If that begins to raise some issues with respect to privacy and confidentiality that might not have been addressed within the previous initiatives, isn't it appropriate for us to make those recommendations?
DR. BRAITHWAITE: Certainly, if you come up with something that hasn't been said before.
MR. BLAIR: So, could we just step through these and decide whether or not we want to keep them or not or change them?
Margaret, can you --
MS. AMATAYAKUL: No. 18 is to ensure that standards for the confidentiality and security of PMRI are not violated in domestic and foreign business processes. The public and private sectors should incorporate strict provisions to protect confidentiality and integrity of data which they physically control, as well as the individually identifiable information they share with business partners. To do this, domestic healthcare organizations should reflect these requirements in their business partner contractual agreements.
MR. BLAIR: I think this is new.
DR. BRAITHWAITE: This is, in fact, a restatement of one of the proposals in the privacy NPRM.
MS. HUMPHREYS: But we don't know, in fact, what
-- where the burden of the comments come down. So, I guess it is okay for the NCVHS to say this is where they think it should come down. Right?
DR. BRAITHWAITE: Unless the NCVHS has already said something like this in their previous comments to the Secretary. I don't know. I don't remember.
DR. MC DONALD: Well, the only problem I have -- I have a problem with this one. It doesn't -- having read the NPRM and looked at the arguments and all of that, I am having trouble with the direction it is going. It is sort of saying --
DR. BRAITHWAITE: Who is it a recommendation to? It is directed at domestic health care organizations, I guess. I don't know if this is an appropriate vehicle for that recommendation.
DR. MC DONALD: And to get them into the contracts isn't the strongest way to avoid violation of it. I mean, there is --
DR. BRAITHWAITE: It is the way the Secretary approached it in her NPRM because that is the only authority she had.
DR. YASNOFF: I share the concern that this is kind of a recommendation to some people out there and I think it might be more useful in accomplishing the goal for us to recommend that the Secretary develop and publish model contract provisions about this, to say here, you know, we think you should do this and by the way, here are some provisions you could use to do it.
I think that might actually be more helpful.
DR. BRAITHWAITE: An alternative or additional recommendation in this direction would be a recommendation to Congress that they broaden the scope of the privacy law so that it would cover business organizations that get this kind of protected information.
MS. HUMPHREYS: Which privacy law?
DR. BRAITHWAITE: The one they haven't passed yet. The same one that we are going to tell them to pass to --
MS. HUMPHREYS: So, maybe the thing to do is to tell them pass the legislation and incorporate this into the legislation.
MR. BLAIR: Well, Simon was just observing that our next recommendation starts to deal with legislation. So, maybe if we just kept this one within the bounds of regulations and if we wound up -- Bill Yasnoff was winding up saying if we had a model contract, that may be -- a recommendation to develop a model contract.
DR. YASNOFF: Model contract provision.
MR. BLAIR: Comments on Bill's suggestion?
DR. FERRANS: Bill, is there any stuff for model contracts because I know there are model release of protected health information things or -- there were some model documents that were going to be put forth under the privacy -- under the NPRM.
DR. BRAITHWAITE: There were two model documents in the NPRM, but neither was a model contract.
DR. FERRANS: So, what we are doing is suggesting that that be an addition. Right?
DR. COHN: I actually think the only -- there is nothing recommendable here, except for something such as Bill is describing. I guess, the question is is do we feel strongly about this, that the recommendation -- the Secretary get model contracts.
DR. MC DONALD: The problem is we don't have the legislation yet.
DR. COHN: You mean the final rules.
DR. MC DONALD: Or the final rules. I wonder whether we need to do this one. We need to maybe work more on 19 to get some good legislation, which could also include model contracts instead of making this a stand-alone --
DR. YASNOFF: If you passed legislation, you could -- part of the legislation could include those provisions so then that validates the need for putting it in contract.
MS. HUMPHREYS: Or even the regulations that have to be established to implement the legislation could have that even if the legislation didn't.
MR. BLAIR: Given the difficulty that the legislative branch of the government is having coming to consensus, if the only recommendation that we have is that Congress should pass something. That, you know, may be a long time and --
DR. MC DONALD: Yes, but 18 just says be good, guys. We are not making recommendations to the Secretary. We don't have anything we can recommend.
MR. BLAIR: I thought we were still on 17. Aren't we on 17? It is the same one.
In terms of Bill's suggestion that we recommend that the Secretary create contract provisions, model contract provisions, are you saying, Clem, that we shouldn't do that?
DR. MC DONALD: Yes, I am, because what it is going to be -- on the basis of what? There are no laws about this. How could they construct this?
MR. BLAIR: I see.
DR. COHN: We have to find a rule that hasn't come out yet because we don't know what the --
MS. HUMPHREYS: I actually -- Recommendation 19 refers to legislation, which definitely has to be here in my opinion. I mean, I think that is a very good recommendation for the NCVHS to make. I agree with Jeff that it is not the recommendation that I have the greatest confidence will be implemented. Then the next recommendation, if you retain the next one, which is No. 20,, which is the Secretary of HHS should establish a center for healthcare privacy and do these various things, then you actually could add there, also produce model documents or whatever that would help people implement things.
I mean, you could fold that in as a specific under the center for healthcare privacy, which I think makes more sense because it seems like a very specific thing to have a separate recommendation.
DR. ZUBELDIA: Add model contracts to the list that is already No. 3.
DR. YASNOFF: Then it wouldn't be just restricted to model agreements in that particular area of Recommendation 18, but could be any agreements that might facilitate privacy, confidentiality and security.
MR. BLAIR: Clem, do you feel comfortable with that?
DR. MC DONALD: Yes. We are going to basically take the model -- we are going to get rid of 18 and we are going to add model contract language to 20.
MR. BLAIR: So, we are going to wind up with two, which is 19 and 20. Right?
DR. COHN: We haven't talked about 21, but at least 19 and 20.
DR. YASNOFF: We haven't talked about 19 either.
DR. COHN: Do you want to read 19?
DR. YASNOFF: Are we agreed that 18 goes into 20?
DR. COHN: Yes.
DR. MC DONALD: No. 18 goes away because there is no statement about --
MS. HUMPHREYS: The model contract language goes into it.
DR. YASNOFF: But 18 goes away and then we add model contracts. Good. 19.
MS. AMATAYAKUL: 19 is to ensure that all private health information in any medium used for any purpose and disclosed to any entity receives equal protection under law. Congress is urged to pass federal, preemptive privacy legislation and we had and Mike suggested cutting such legislation should provide standards that protect health information in all media and ensure the availability of health information for treatment, payment and healthcare operations.
MS. HUMPHREYS: I would agree that that could be cut.
DR. BRAITHWAITE: Yes. That second sentence refers to security more than privacy. Probably shouldn't be there.
DR. YASNOFF: Are we -- all our other recommendations are directed to the Secretary and if I remember the wording of the law, we are supposed to make recommendations to the Secretary for legislation. So, shouldn't this say we recommend that the Secretary urge Congress, although I know the Secretary is already doing that, but isn't that -- I mean, we can't really send something directly to Congress.
DR. FITZMAURICE: As I remember, I think it said report to the Secretary and make recommendations and legislative proposals. Maybe it is quibbling because the report does go to the Secretary and, so, who is going to take action but the Secretary's office?
DR. YASNOFF: I don't want to make a big deal out of it. I agree with --
DR. MC DONALD: Well, you will do some final words -- but I have two questions. When you say "preemptive," we really state preemptive, don't we? Do we have to say that?
MR. BLAIR: Preemption of state laws.
DR. MC DONALD: Is that implied by the same preemptive --
DR. FITZMAURICE: Maybe it is not implied strongly enough.
MS. HUMPHREYS: Federal privacy legislation that preempts state laws.
DR. MC DONALD: That is what we are -- I mean, is that what we -- that, I think, is what we mean by preemptive and, Bill, if preemptive is just sort of a code word for state preemptive, I don't care.
DR. FITZMAURICE: What has NCVHS recommended before in the letter to the Secretary? Do they recommend preemption of state laws?
DR. FERRANS: Well, the preemption means different things to different people because you can have the federal floor or federal ceiling or a single standard. That has been a huge point of contention with respect to privacy and if we are going to recommend something, we ought to be specific.
DR. MC DONALD: Well, either that or take the word "preemptive" out.
MS. HUMPHREYS: If the committee has already -- which they did -- make recommendations on privacy legislation, that this either has to line up exactly with what you recommended before or alternatively the full committee has to agree to recommend something different --
MR. BLAIR: Well, this gets a little murky and I wish Marjorie Greenberg were here. Apparently about three or four years ago, NCVHS did make a recommendation. At the time it wound up suggesting a floor. My understanding is that within the Committee on Privacy and Confidentiality, there was concern that the floor might not be adequate because if different states then wind up adding different requirements, then the interoperability and comparability can still wind up being affected.
So, there has been a change in view but I don't think there has been a new document that has been issued. Bill, do you have some insights into this? Bill Braithwaite?
DR. BRAITHWAITE: No. I know it is an issue. Different members of the committee feel differently about it.
MR. BLAIR: Yes. And I do know that one of the other thoughts was that if the floor is high enough, you know, then it would be very unlikely that a state would wind up adding additional requirements.
DR. FERRANS: Was there something about whether the Secretary could actually impose from a regulatory standpoint, whether the Secretary had the authority to establish a ceiling and floor?
DR. BRAITHWAITE: The Secretary specifically does not have the authority under HIPAA to preempt state law.
DR. FERRANS: Okay. That is my point.
DR. BRAITHWAITE: Where the state law is more stringent.
DR. MC DONALD: Perhaps to go with Betsy's suggestion that we should just do the research, line this up with the recommendations have been from our committee or what the current subcommittee wants and not guess about it now.
DR. ZUBELDIA: How can we incorporate our previous privacy recommendations by reference into the sentence?
MS. HUMPHREYS: I guess the issue is to be sure that the chairman and the full committee actually want that.
DR. COHN: The full committee will vote on this.
MS. HUMPHREYS: Because I would guess if I were a full committee member, you would want to get this all obviously lined up so that they can look at what they recommended before and what you are recommending here and make the decision. Otherwise, you have the same conversation again.
DR. ZUBELDIA: How can we say in a nice way to the Secretary please read our privacy recommendations?
DR. MC DONALD: No, no, we do that research and fix it or --
DR. ZUBELDIA: But instead of fixing it, just incorporate all of it here.
DR. MC DONALD: We don't have it right now. I just thought we could close on this by saying do that research and it will get put in in the way we said it.
DR. ZUBELDIA: What I am saying is I don't think we should try to put it again because there were a lot of recommendations in the previous privacy recommendation. There were a lot of them.
DR. MC DONALD: The one like this regulation?
DR. ZUBELDIA: Why pick on that one? I mean, we would have to include all of them and if we are going to include all of them, I don't think that is realistic. I think it would be easier to just recommend to the Secretary to go back to our previous recommendations on this subject and go over them again.
DR. BRAITHWAITE: Kepa, I think the reason to do this here is because NCVHS was asked to recommend to the Secretary proposed legislative language or to something to that effect. All of the other recommendations were recommendations that the Secretary should include in her privacy regulations. This is different because it is a pass-through to Congress to pass some legislation.
DR. FERRANS: Shouldn't this be something that the Subcommittee on Privacy and Confidentiality be doing?
MR. BLAIR: Yes. We had expected and hoped that that would have occurred by now and we will just have to be a little bit more emphatic in that we really need the review by that subcommittee.
DR. YASNOFF: This is an issue that was specifically commented on in John Lumpkin's e-mail and he says, "The issue of preemption of state privacy laws is urged." That is this recommendation. "I think that we have to be careful how we say that. Our earlier privacy document urges the adoption of for preemption. I believe that our concept of these standards should emphasize the increased flexibility that is possible when the standards are followed."
He says more. So that at least clarifies what -- confirms what Bill Braithwaite was just saying about the previous recommendations.
MR. BLAIR: Could we leave this to Margaret to do a new draft recommendation and we will have that reviewed by Kathleen Frawley and Bob Gelman to make sure that what we are proposing is consistent with the position from the Security Subcommittee?
DR. COHN: I guess I would be fine with that, as long as it is floor preemption. I mean, if we are going to recommend something else, let's have that discussion right now.
MR. BLAIR: Well, the only thing is that my understanding is that they have been reconsidering whether that would be their position. So, could we leave it to them to determine what the recommendation is?
DR. COHN: No. They is us. The subcommittee would not determine a whole new policy on its own. It can recommend a new policy to the new committee. I mean, certainly if you want to ask their input on it, I think that would be fine and we can bring it up to the full committee for discussion in June if they have a different feel on it. Because certainly the full committee has to do it, but we are not at a point where I think that the Privacy and Confidentiality Subcommittee can decide that they are going to put different wording in here for us.
MR. BLAIR: No, I wasn't --
DR. COHN: Am I misunderstanding?
MR. BLAIR: No, we are probably saying the same thing.
DR. COHN: Okay. Fine.
MS. HUMPHREYS: And I can easily understand why John would want the privacy in this because this is a report that is required by HIPAA. So, privacy is another issue. We want legislation and this is another opportunity for the NCVHS to underline that point. So, I think that he probably wants it in there and that makes sense.
MR. BLAIR: So, should I rephrase it that Margaret drafts maybe a paragraph and we get it reviewed by key members of the Subcommittee on Privacy and Confidentiality and then, of course, it will be reviewed by the full committee as well.
Does that cover what needs to be done on this?
DR. ZUBELDIA: Jeff, there is one more change. In the first sentence, to ensure that all private health information and that private health information is probably not defined anywhere. In HIPAA we have been addressing it as personally identifiable health information -- protected health information, rather than private.
MR. BLAIR: Thank you. Good catch.
DR. FERRANS: I was going to say that if we are going to be making recommendations for Congress to pass these things, it should -- perhaps it should also mention about employers since that was a specific area that HHS was not able to regulate and also the -- some of the on-line things that people are now becoming concerned about that the FTC is investigating.
I don't know whether we want to do that, but at least raise the issue because if not, it is sort of like, well, here is the NPRM, but then we want Congress to pass a law also and it is unclear why we want them to pass a law when regulations were just passed. If we want them to pass a stronger -- we should explain a little bit why.
DR. COHN: Let me think. I had a quick response to and I have lost it. I guess my concern here is that this is an area that was focused on by another subcommittee and we don't have the benefits of that, that day long hearing or any conclusions reached either from that hearing or other input.
I am struggling to figure out a way to get that in, recognizing our time frame.
DR. FERRANS: What I don't want is for the sort of confusion of, you know, if we just passed regulations, why are we asking Congress to pass a law. I am just saying it should be explained.
DR. COHN: Well, but, of course, we have repeatedly urged Congress to pass legislation because we have never believed it was going to be sufficient, the regulations.
MR. BLAIR: You know, I personally am very sympathetic with adding the employer piece but I sort of feel as if once again we really need to find what our boundaries are with negotiations with the Privacy Subcommittee. Maybe if Margaret just makes a note to see if that can be included, especially in the context from the fact that while we -- well, I don't even have to elaborate.
MS. HUMPHREYS: It seems to me that since this is an obvious interest of John's --
MR. BLAIR: Yes.
MS. HUMPHREYS: -- getting a response out of the other subcommittee -- I am not saying you are, but if you are, then you can turn that problem over to him.
MR. BLAIR: Is there other discussions on this point?
We are at 20. Is 20 the last one under privacy?
DR. COHN: No.
MS. HUMPHREYS: We have 21.
MR. BLAIR: Okay. My inclination is that for those who have talked about how we would deal with staying late, after we finish 21, I think we need to talk about whether we order food in and how we feel about staying late.
So, let's go on to 20 and 21.
MS. AMATAYAKUL: Twenty is to help the healthcare industry identify and correct vulnerabilities to breaches of confidentiality and respond appropriately to privacy and security incidents. The Secretary of HHS should establish a center for healthcare privacy. This center would develop privacy and security training, produce model documents, for example, contract provisions that would facilitate privacy, research causes of confidentiality violations and continually monitor violations of privacy legislation and regulation.
DR. MC DONALD: The model contract one, like the third in the list there, isn't it?
MS. AMATAYAKUL: Should we put it later in the --
DR. MC DONALD: Did you stick that in there? I thought --
MS. AMATAYAKUL: I just stuck it in there.
DR. ZUBELDIA: I would simplify that just to make it a list item without all the other stuff, just produce model contract provisions, no other --
DR. MC DONALD: That is what I was actually thinking.
DR. FERRANS: Maybe something small but do we want it sort of capitalized, Center for Healthcare Privacy, or is it just a center, so to speak? What are we asking for?
MR. BLAIR: You are asking a question?
DR. FERRANS: Yes.
MR. BLAIR: What is your preference?
MS. HUMPHREYS: Little "c" is better.
MR. BLAIR: Okay.
Bill Yasnoff, I think you are next.
DR. YASNOFF: I think for consistency we should call it establish a center for healthcare privacy and security. And the other thing I would suggest we add to the list at the end is issue periodic reports.
MR. BLAIR: Okay.
Michael Fitzmaurice, when he was editing the document, there were a number of times when, Michael, you altered "privacy" to "confidentiality." Does that come to bear in terms of the name of the center?
DR. FITZMAURICE: No, because the name of a center is the name of an organization. I modified privacy because I felt that you were referring not to individual's release of information, but to holding it in confidence when it is obtained by somebody else. But now it has become common to talk about a center for privacy. Privacy is used broadly in names of things, but still in an individual sense, this is
-- I would like to change "privacy" to "confidentiality" if it involves somebody other than the person about whom the information is.
MR. BLAIR: So, does everybody feel comfortable then with Bill Yasnoff's suggestion for the name of the center to privacy and security?
MS. AMATAYAKUL: Jeff, I did have a question about Mike's change from "privacy" to "confidentiality." I think the change probably reflects more accurately the term, but I actually did put privacy in there because of the lay people and lay people are concerned about privacy and they just don't see confidentiality as being the same thing.
So, that was the reason for the use of that term.
DR. COHN: Why don't we use both?
MR. BLAIR: Okay. Any other comments on Recommendation 20.
21.
MS. AMATAYAKUL: I am coming.
21. The Secretary of HHS should work with the Department of Commerce and Congress to promote adoption of policies, practices and standards for health information that are compatible with that directive.
MS. HUMPHREYS: Well, obviously, if we eliminate the introduction, we had better say the European Directive, et cetera, in the recommendation and I would favor that. But I must say that the notion of lining up Congress after the Department of Commerce doesn't seem like the right way to do this.
DR. COHN: I guess I am a -- this whole recommendation, it seems like it is coming sort of left field and I haven't seen -- maybe I missed something in earlier sections, but I am having trouble figuring out the case for this.
DR. MC DONALD: What about the Australian one? I mean, why is that our job to -- actually there is ongoing negotiations about it at higher levels.
DR. FERRANS: This sounds like we are agreeing to comply with the European Directive and I certainly don't know --
DR. MC DONALD: We don't know what it is.
DR. FERRANS: -- enough about the differences to be able to, other than they have a much higher standard and, whereas, that may be admirable that we raise the standard, on the other hand, it is a negotiation. The language should at least be watered down.
DR. YASNOFF: Did any of our testifiers, you know, come in here and ask us to do this?
DR. MC DONALD: I would be for killing it.
DR. FITZMAURICE: I think I remember that Peter Wegeman(?) mentioned the European Directive and maybe one or two other people, but I don't think there was a recommendation to work with Congress to --
DR. MC DONALD: -- pharmaceutical industry problem and I think there actually has been some negotiated agreements.
MR. BLAIR: I don't have a strong feeling about this, but the argument that I have heard about this being a concern, I just feel like I ought to articulate it and then if you still want to eliminate it, then that is fine. Apparently it affects our ability to -- apparently if the United States does not comply, apparently most other countries in the world are in the process of complying. It means that there is an unwillingness for European countries to transfer the health information of their citizens to the United States if their citizens are injured and to cooperate with us if we have our citizens in any of the complying countries because we are not part of the understanding, which means that it could affect the ability of healthcare for the people that travel.
So, that is the argument that I have heard for it.
DR. YASNOFF: Maybe if you want to keep this in any form, maybe it should be combined with 24(b), which is the Secretary of Commerce should monitor the activity of vendors abroad, take appropriate steps to correct anti-competitive activities that may be based on standards requirement with which U.S. vendors do not comply, such as the European Directive, if you want to put it in there.
DR. FITZMAURICE: -- dealing with the business aspects, but somebody ought to be watching out for the quality of care and the ability of patients to exchange information for their own care.
DR. MC DONALD: We are just making this up. This thing, the directive -- comes from the pharmaceutical --
DR. GREBERMAN: No, the Department has agreed to work closely with the European Community on issues related to this directive. John Fanning would be very helpful, but basically I think the European Directive on data protection -- we are dealing with very differently from all the other ones that you may have mentioned.
I think this may -- I can understand why somebody wanted it in here, but I think John could help maybe clarify whether this wording works.
DR. YASNOFF: But if we are already doing it, we don't need to recommend it.
DR. FERRANS: I also know that this is a much broader question than healthcare. This is an Internet question, I mean, with -- I mean, this is a question that has come up more broadly in the Internet about, you know, the data selling, you know, database marketing policies of U.S. companies and how they relate to having overseas operations and collecting data about -- from citizens that are originating in Europe.
I mean, this is a much broader issue than healthcare. I don't think we should walk into it myself.
MR. BLAIR: So, is the consensus that this gets deleted? Mike.
DR. FITZMAURICE: I want to support what Richard and Clem said. I have got a notice from BNA Healthcare Policy Report that I received today that says the U.S. Commerce Department Seeks Public Comment on U.S.-EU Privacy Pact. So, the Department of Commerce has this pretty well in hand, at least for the business aspect of it and they will probably have it out in an NPRM or at least in the Federal Register asking for public comment. So, it is being handled.
MR. BLAIR: Consensus that we delete it.
Well, if we are if are about to go to the next section then, what decisions do we need to make with respect to ordering dinner?
MS. AMATAYAKUL: Does this mean we can take a quick break?
MR. BLAIR: We could do that, too.
DR. FITZMAURICE: You know, it looks like we are close enough to being done.
MR. BLAIR: We have Section 3, after we do Section 4 today.
DR. ZUBELDIA: We haven't even started on that.
MR. BLAIR: We haven't started on Section 3, yet. Right.
DR. MC DONALD: If we hurry up and stay hungry --
DR. COHN: I think the question is what are we doing with that other section.
DR. FITZMAURICE: Maybe we can pass it around on the Internet and vote on word changes.
DR. MC DONALD: I would like to submit like two paragraphs of changes in the issues area, just to make sure --
DR. YASNOFF: I think we can deal with Section III in a totally different way. I don't think we need to have a big discussion about it.
MR. BLAIR: Fine.
DR. COHN: Plus, I think it is likely to require
-- I mean, what we have done today so far is going to require a major reformatting of the whole thing. So, I guess my view would be is that it needs to be reformatted. There probably needs to be a conference call to make sure that we are all at least sort of okay with it. Then we send it out for both internal -- government internal and subject matter experts.
DR. YASNOFF: I would suggest that we have a conference call on Section III after it has been reworked this time.
MR. BLAIR: Probably the conference call might be for Sections III and IV after we have redone IV as well.
DR. MC DONALD: The process -- if we could do -- no, no, no, no, I am talking about when we get to the conference call, if we made it a little different -- I am sort of just amazed and -- here are some suggested changes and it was so easy to work through and if we could instead of just talking about all the things we like or don't like, if we could submit suggested changes in writing and then just look at them, I think we wouldn't have to be up here until 8 o'clock at night on the conference call.
I know I am as bad as anyone doing it ahead of time, but if we could actually submit written suggestions about what should be changed, we could get this done a lot faster.
MR. BLAIR: That is fine. Does everybody feel comfortable with that procedure?
DR. COHN: What kind of turnaround would you need?
DR. MC DONALD: Well, if we got a document in a week, you know -- this thing is starting to shape up. It is not going to be thousands of pages of changes we are talking about.
MR. BLAIR: It takes a little longer than a week to turn this around.
DR. MC DONALD: No, no, no. I am saying a week after it got turned around. You wouldn't want to schedule a conference call in less than a week.
DR. COHN: After it is sent out.
DR. MC DONALD: And then you would probably want to -- I mean, the question is the written -- how we get them out. I guess we just do them back to you and you would e-mail them out.
DR. FITZMAURICE: Yes, we do have a version of where I have made corrections and Jeff has made comments on the corrections. It probably would be helpful to start there so you get a sense of at least two people
DR. MC DONALD: The first issue is we are going to get a clean copy. The question is whether all the suggestions will get incorporated.
MS. HUMPHREYS: I think that you would be better off figuring out how to respond to Clem's thing and circulate the process, which I agree it is helpful if everybody has got it in writing.
MR. BLAIR: Okay. So, we are going to wind up taking a five minute break, so that Margaret could --
DR. MC DONALD: No, no, no. No break.
MS. AMATAYAKUL: Margaret needs a break.
MR. BLAIR: Hold on one minute.
[Brief recess.]
MS. AMATAYAKUL: John Lumpkin made a comment about this in his note that I think we ought to consider and he says, "Issues of record retention linked and patient access to health information are not issues of PMRI."
MR. BLAIR: Well, if we are heading towards lifetime health records and states only retain the record for -- and some of them, what, three years, five years, seven years, others, 13 years. I mean, it is all over the place.
MS. HUMPHREYS: So, are you reading his recommendation that we -- I mean, are you reading John's comment that we should get rid of this altogether?
MS. AMATAYAKUL: Well, when I first read John's comment, that is what I wondered.
MR. BLAIR: But he was referring to record retention. My thought is that we would need to discuss this with John because I don't know if -- you know, I have difficulty understanding how record retention isn't very central.
The evolution of electronic patient records, especially we are talking about national health information infrastructure where, you know, we are heading more and more towards lifetime health records.
DR. YASNOFF: Since John is not here, can I suggest that if we agree on this, that we go on and, Jeff, you can discuss this with John and incorporate your discussion in the next draft.
DR. MC DONALD: Well, just to take John's position, I think he is right. I think if we get the standards right, we don't have to specify how long they keep it. It has nothing to do with interoperability. It is going to be a local decision and --
DR. YASNOFF: But what about electronic signatures for authentication, isn't that a PMRI issue?
DR. MC DONALD: Well, it is more pertinent.
DR. YASNOFF: He doesn't comment on that.
DR. COHN: Yes. You know, I am looking at the HIPAA legislation on the electronic signature and I am trying to figure out whether it actually covers it or not, where it says under "Electronic Signature," that there will be standards and the compliance with the standards adopted shall be deemed to satisfy federal and state statutory requirements for written signatures with respect to the transactions referred to in Subsection A1.
MS. HUMPHREYS: Yes. I actually thought that the electronic signature was the area -- I am sorry Bill is gone -- was the area where actually HIPAA did give the Secretary the right to preempt state law. I think it is the only one, but I think -- do you recall that, Mike?
DR. FITZMAURICE: Yes, it says that when the Secretary deems an electronic -- adopts an electronic signature, that will be deemed to be acceptable in all the states. That is one of the HIPAA transactions.
MS. HUMPHREYS: I mean, that was the one area where she was able to preempt state law.
MR. BLAIR: Okay. So, we need to strike then the retention piece is what you are saying?
MS. AMATAYAKUL: Bill Braithwaite at the Jahita(?) conference a couple of weeks ago, said that the final rule was likely not to have electronic signature in it.
DR. FITZMAURICE: There is a concern that the industry has not come up with a consensus standard for an electronic digital PKI, whatever you want to call it, signature. So, there is not an industry to be adopted for this.
DR. COHN: So, this is a recommendation to ourselves to push for a HIPAA notice of proposed rule on electronic signature? Is that what we are doing?
DR. YASNOFF: It sounds like it. But can I ask a question about the Secretary's authority? You said with respect to the HIPAA transactions --
DR. FITZMAURICE: That is the way I remember it.
DR. YASNOFF: What about other aspects of PMRI? Not everything is a HIPAA transaction.
DR. FITZMAURICE: I think it might be all of them, but I just don't know. I know that because I wasn't sure what the wording was.
DR. COHN: Let's check on that and the question is is if, indeed -- I think what we are talking about is extending the HIPAA piece, if necessary, unless it already handles that. So, that becomes probably part -- I mean, that one I would buy if there needs to have that --
DR. FITZMAURICE: It must be larger because none of the HIPAA transaction really do require a signature.
[Multiple discussions]
DR. ZUBELDIA: -- specified signatures for the HIPAA transactions.
DR. YASNOFF: But we should put in the part that we are recommending to ourselves that we need to get -- that we need to recommend, I guess, or do something to promote a consensus electronic signature standard. Right? That has to be in the list of things we are going to do.
MR. BLAIR: Can you clarify that a little bit? This statement, I have heard this before, is none of the HIPAA regulations require electronic signatures. But if we are dealing with patient medical record information, that has -- signatures are required.
MS. HUMPHREYS: Yes, but the thing is that -- Jeff, I believe that what we have here is that even though none of the HIPAA transactions require electronic signature, HIPAA itself separately says that the Secretary should pick a standard for electronic signature and it will preempt state law or state practice in this area, which is the only area that she is allowed to explicitly --
DR. ZUBELDIA: I think that the trick is that none of the named transactions require electronic signature, but since the Secretary is capable to adopt other transactions, other than the named ones, it is possible that the other transactions under HIPAA would require digital signature, in which case this is the digital signature standard that applies.
DR. KOLODNER: Right, but there is a government-wide effort to have a signal way that a citizen can identify themselves and, in essence, sign in dealing with the Federal Government, whether that is a -- the impression I got was it was trying to develop essentially a PKI way of verifying and would we want to have a separate way or would somebody if they have something want to use that way.
DR. ZUBELDIA: Let me address that a little bit. That is the ASIS(?) program within the government. The ASIS program is establishing digital certificates for authentication and there is a clear standard for digital certificates, XL509. That is how digital certificates are conveyed. However, there is no standard for digital signatures. Once you apply the signature on a document, it can be expressed in several different ways that are incompatible with each other. I think that is where we need to go, to a standard signature using the standard certificates.
MR. BLAIR: Let me interrupt things for one piece because I really feel like we should address one thing. We have been waiting until we went through everything before we wound up showing what Bill Yasnoff is coming up with for a suggested reorg. But Clem has to leave in ten minutes.
DR. MC DONALD: I don't need it. I saw it at lunch.
MR. BLAIR: You did? So, you feel generally comfortable with that?
DR. MC DONALD: The only thing I noticed in that
-- there are some other things I didn't like, but I liked the organization.
DR. YASNOFF: Yes. He didn't like the content. But we have gone through the content. So, the organization was okay.
DR. MC DONALD: Thank you.
DR. ZUBELDIA: I think that the recommendation as it is, I think it is perfect because it tells the Secretary that we want to have accreditation of PMRI and acceptance of electronic signatures. That could be used in the ASIS digital certificate or something else. It doesn't matter, but the electronic signature should be acceptable in all 50 states.
DR. MC DONALD: Just this further complicated thing, a lot of states do accept electronic signatures, but they have nothing to do with PKI or certificates. I don't know that we are going to get from -- I was just at an Internet 2 meeting yesterday -- that we are going to get an effective cross the world certificate process very soon. I mean, there is this -- so that the question is do we want to push for a procedural electronic signature that is okay and a lot of states do already accept or do we want to wait until we can really get the absolute, you know, enchilada?
MS. AMATAYAKUL: Yes, because this recommendation says electronic. It doesn't say digital.
DR. ZUBELDIA: But they security NPRM specifies that digital signature is the standard for electronic signature.
DR. MC DONALD: It does?
DR. FITZMAURICE: The proposed rule. Maybe not the final rule. It does, that the digital signature is the only one that meets the conditions.
DR. MC DONALD: Well, I mean, what will happen is all around the country, we will have to shut down all the things we are doing now if that becomes the preemptive standard.
DR. FITZMAURICE: Well, it doesn't mean that you can't have a digital signature. It means --
DR. MC DONALD: No, no. That is not -- that is there is a lot of accepted -- in the process usually there is a log and there is a transaction and there is a private password and you put it on it. So that all the soft med, all these signatures that are put on doctors' dictations are not based on a PKI level type of a signature.
DR. FITZMAURICE: And those are legally accepted in court?
DR. MC DONALD: Yes.
MR. BLAIR: And those are defined as electronic signatures?
DR. MC DONALD: Yes. In fact, the states are ahead -- I mean, really most of them have it now. There are not a whole lot that don't have it.
DR. FITZMAURICE: You are right. That could cause a monkey wrench to be tossed into the gears.
DR. ZUBELDIA: Clem, I am not sure those are legally acceptable in court.
DR. MC DONALD: I am sure they are. We have been through this with our legal people in our hospital. We have been through it -- they are absolutely acceptable. The issue that is required is that you have to have policies and procedures and trackability and all this other sort of stuff.
DR. COHN: What is wrong with the court recommendation?
DR. MC DONALD: I am not sure what it means, whether we are proposing -- are we proposing a digital signature or are we proposing electronic -- we are saying electronic --
DR. COHN: Do we need to specify? Is that a critical -- the question is a little vague. You are right. Is there any problem with it being a little vague?
DR. MC DONALD: I guess not.
DR. COHN: Are we precluding anything that we have talked about?
MS. HUMPHREYS: Now, the thing is that John's comment was that he didn't think that the standardization efforts that were within the scope of this really needed to address access for retention but he would have restricted this to the electronic signatures.
DR. MC DONALD: I would agree with that.
MR. BLAIR: Maybe I don't even need to speak to John. Do most people on the workgroup agree that patient access to healthcare information and retention should be stricken from what we are doing here for patient medical record information?
DR. MC DONALD: Yes, I think that will actually -- if we said that we had to have a four year retention, that may be slow down --
DR. ZUBELDIA: Clem, I don't think when we did this, I don't think that the retention time was what we had in minds, but that the ability to retain the medical record in electronic format be acceptable in all 50 states.
DR. KOLODNER: Enabling, not requiring.
DR. ZUBELDIA: Yes. Enabling the retention of the electronic medical record should be acceptable in all 50 states, which right now it is not and sometimes you have to just print it on paper to make it a legal document.
MS. HUMPHREYS: Okay. Then if that was clarified then maybe that would also address John's thing.
I do feel that the access to -- you know, that you have access to your records is something that is, in fact, covered in the privacy regulation and some form of that, I am sure, will survive if we get any type of a final privacy regulation. I mean, I don't know what form it will be, but something will survive.
MR. BLAIR: Okay. Do I hear then with Kepa's modified wording that we do concur then with --
DR. MC DONALD: I think we need to change -- a little bit of clarification to make it clear that that is what it is because I think John read it that other way, too.
DR. ZUBELDIA: Margaret just did.
DR. KOLODNER: The background information doesn't reflect that.
MS. AMATAYAKUL: I will fix the background, too.
MS. HUMPHREYS: You are going to strike "access"?
MS. AMATAYAKUL: That is my question.
MS. HUMPHREYS: I think that is reasonable to do that.
DR. MC DONALD: I think maybe -- PMRI is -- that is electronically, I think, and retain it in electronic form. I think what you really want to say, you don't have to have a hard -- Kepa, could you help with that to make it come out the way that you outlined?
DR. ZUBELDIA: Margaret is doing it.
DR. MC DONALD: Does it say what you want?
DR. ZUBELDIA: Enabling electronic retention of PMRI in all 50 states.
DR. MC DONALD: But that doesn't get you what you want because, sure, they don't say you can't keep it electronic. They are saying you must put it out as a paper. So, we need to get it so that instead of -- you don't -- it is not quite right.
MS. AMATAYAKUL: I think I have got the gist and I will work on it.
Twenty-three is to encourage diversity of expert representation in PMRI standards development and to explore methods of reducing barriers to participation. The Secretary of HHS should (a) fund outreach and demonstration projects to underrepresented user groups for participation in PMRI standards development.
MR. BLAIR: We need to go back to the original there. Did we lose the thought there?
MS. HUMPHREYS: No. I just wondered whether you wanted to fund participation of underrepresented user groups in PMRI standards.
MR. BLAIR: Is that the original -- did we have it phrased that way?
MS. HUMPHREYS: No.
MR. BLAIR: Could you go back to what the original one -- I think this is --
DR. YASNOFF: The original one just didn't have the word "user."
MS. HUMPHREYS: It was identical without the word "user."
DR. YASNOFF: So, it said, "Fund outreach and demonstration projects to underrepresented groups for participation." It didn't say "user" groups.
MR. BLAIR: Right.
MS. AMATAYAKUL: To me a user group is somebody -- is a group like XYZ vendor has and they all have their own user group.
MR. BLAIR: Right. And I didn't feel comfortable with "user" there. I thought it was much more understandable without the word "user."
DR. YASNOFF: Well, let's get rid of it.
DR. MC DONALD: Can we get to the -- we are up on 23. The word "diversity" has a certain connotation. What we really want is to encourage broad representation, isn't it?
DR. YASNOFF: Yes. What you are saying is what we want to title this is "Encourage Broader Participation in Standards Development." Right?
MS. HUMPHREYS: Yes. Broader participation is good.
DR. YASNOFF: Broader participation, not diversity.
DR. FITZMAURICE: I think by "broad" we mean broad in knowledge and also broad in industry representation, representation of the people who use PMRI.
DR. YASNOFF: "Diversity" is definitely a code word, which is not what we mean, I don't think, here. There is nothing wrong with it. It is just not what we mean.
DR. GREBERMAN: I guess I would like to get a little clarification on that "a" portion. Fund outreach and demonstration projects to underrepresented -- how do we determine who is underrepresented? I guess in one sense does that mean you just don't have to pay up your dues for long enough and we will pay your way to go? So that when the people who are actively supporting will say, well, why am I paying and they are not?
DR. MC DONALD: I have problems with some of this, too. We were trying to suggest -- I mean, there was a clear -- if we could reduce the travel issues or -- first the issue about letting them know about it. That is a no-brainer. And how do we really do that? Maybe we could just say broadly instead of an underrepresented group, do something that gets broadened.
MR. BLAIR: I think that to be honest with you if you take any particular standard development organization, some struggle with this issue to a greater extent and others to a lesser extent, where you have a meeting and you have individuals that are able to be represented by their organizations that either have the funds or are willing to allow the time for that subject matter expert or thought leader to be available on that standards community and if you wind up -- you wind up typically having the people represented either from large organizations or academic institutions and it is very difficult to wind up having representation from either small standards development groups or small terminology groups or private practice associations or smaller -- the groups that or individuals that don't necessarily have the funding or don't have the organizations and, yet, they may have some very important critical viewpoints that don't get expressed until much, much later, if at all and you hear them -- sometimes they testify to us because they testified because they already feel excluded from the process.
Many of them are in small group practices, solo practices and they feel like we are going to impose something on them because they haven't really been part of the standards development process. So, that is an example. But you wind up seeing it also when you wind up seeing -- and, thank goodness, you know, the government is becoming more active now in certain HL7 activities and the Centers for Disease Control is beginning to wind up saying, gee, we need immunization information, we need other information. But that isn't happening across the board.
So, I think that an SDO is able to wind up saying, gee, it would be really helpful if we can have this group, this group and this group present in our meetings. We need some help to be able to get their participation.
DR. COHN: I think we actually had talked this particular recommendation to death previously. So, I am fine with it, but I just think we ought to accept it and move on.
MS. AMATAYAKUL: (b) Encourage standards development organizations to make greater use of the Internet to solicit comments for the development of standards and implementation guides.
MS. HUMPHREYS: Sounds good.
MS. AMATAYAKUL: And (c) make existing government teleconferencing facilities available to standards development organizations to broaden participation in standards development.
MS. HUMPHREYS: Sounds good.
MS. AMATAYAKUL: Recommendation 24 is to promote the retention of open markets for U.S. healthcare information system vendors internationally. The U.S. must make sure that international standards for PMRI are compatible with U.S. interests. To do so (a) the Secretary of HHS should support U.S. Government and private sector participation in international standards development organizations and explore incentives or subsidies to U.S. organizations that serve as secretariat, provide technical assistance to assure that patient care information -- PMRI
-- may be exchanged under appropriate security safeguards with consistent meaning across countries.
DR. COHN: Did you want to do (b) or do you want me to kind of make a comment on this one?
Am I allowed to make a comment? Okay.
I feel like this one keeps coming back at me. And I am not quite sure -- I mean, it is not -- maybe my memory is faulty or whatever -- I thought we agreed that the -- we were talking about should encourage private sector participation. I didn't think we were going to start -- I mean, I read this as the U.S. Government paying for me to fly to an ISO meeting. I mean, that is basically what it looks like.
DR. YASNOFF: That is what it says.
DR. COHN: I guess I hadn't thought that any of us had agreed at this table that that is what we were doing. Did I miss something? I thought we had discussed this previously and we had been sort of saying "no."
DR. YASNOFF: That is what Clem said.
DR. COHN: I thought that we had agreed that, no, we weren't doing that, that we were in the favor of the government participating, that we were going to follow these things, that we were in favor of the private sector participating. But, yet, I keep seeing it coming up again and again and again.
MR. BLAIR: I thought we had cut back the wording so that it wound up indicating support of the secretariat, didn't it?
DR. COHN: No.
MS. AMATAYAKUL: No, it has got both in it.
DR. COHN: There is an "and."
DR. YASNOFF: Explore incentives and subsidies for U.S. organizations that serve as secretariat/provide technical assistance.
MR. BLAIR: Do you want to get rid of this one?
DR. COHN: I don't think we need to get rid of it. I just think it needs to be --
[Multiple discussions]
MS. HUMPHREYS: I think he was saying it is great for the Secretary to support government participation, but he doesn't want it saying that she is going to -- that the government is going to fund private sector participation in these standards -- I mean, just to go to meetings. So, I think we just get rid of private sector in that little first part.
DR. COHN: Yes. Truthfully, I mean, I would love to have my way paid, but it just feels very self-serving.
MR. BLAIR: So, you want to get rid of private sector so it says, "support U.S. Government participation" and then what about "explore incentives or subsidies to organizations that serve as secretariat/provide technical assistance. Is that okay?
DR. COHN: That is fine, yes.
DR. FITZMAURICE: That is disjointed. Maybe that should be the (b) and then what is below it is the (c). It sounds like they are two separate ideas.
DR. YASNOFF: They are.
MS. HUMPHREYS: So, the Secretary should definitely support U.S. Government participation in these things and the Secretary should explore ways of, you know, assisting private organizations who are going to -- or incentives or whatever it says.
DR. COHN: Is there some way to use a term like "encourage" private sector participation?
DR. YASNOFF: I guess I agree with Jeff that the sentence that Michael added -- I don't know if we really need that.
DR. ZUBELDIA: I think U.S. participation would cover both. I don't think that sentence adds much.
DR. FITZMAURICE: Okay. I added the government and private sector because I wasn't sure what was meant by participation. Now, you are saying, well, we could mean both. So, let's leave it there, which allows more flexibility.
MS. AMATAYAKUL: I am lost.
DR. YASNOFF: What we said in (a) before we should get rid of private -- encourage private sector.
MS. AMATAYAKUL: Get rid of that?
DR. YASNOFF: That is what we had said. Now, we can change that, but that is what we said. So, the way we left it, I believe, was, "The Secretary of HHS should support U.S. Government participation in international standards development organizations."
MS. AMATAYAKUL: I thought I heard somebody says and encourage --
DR. YASNOFF: And encourage private sector, yes.
DR. COHN: That was actually my suggestion.
DR. MC DONALD: I don't think we should be -- I mean, it is just an economic distortion. There are standards up the wazoo going on internationally, all over the place. I mean, that is how it works out. People sort things out.
DR. FITZMAURICE: Do you think there will be a coordination or monitoring?
DR. MC DONALD: No. Encourage almost sounds -- we have got a huge international business. People are really aware of all this stuff, but encourage is okay, but support -- why don't we do it with brick makers?
MR. BLAIR: So, you are accepting Simon's suggestion of encourage?
DR. MC DONALD: I think, again, it is not enough, but I don't think this whole thing is necessary. I don't mind it, but --
DR. ZUBELDIA: I don't know if it is very appropriate. I was in the meeting in Paris last week and there were four U.S. representatives, all private, and you cannot send 50 because it is a small meeting. It is an international meeting, but if you send 50, they will kick us out. They don't want us to overwhelm the meeting.
DR. COHN: So, you think we should discourage private --
MS. HUMPHREYS: If some want to encourage and some want to discourage, then the appropriate approach is to say nothing.
DR. YASNOFF: Right. Why don't we get rid of this one?
DR. ZUBELDIA: This came out of the testimony from Peter Wegeman.
DR. MC DONALD: That one is not as bad as (d). (d) gets even stronger.
DR. ZUBELDIA: Peter Wegeman testified about this very strongly. He wanted to have support.
DR. YASNOFF: Well, Peter wants us to pay for his trips to Paris.
MR. BLAIR: That, I think, is unfair and untrue and inaccurate and you keep repeating it.
DR. ZUBELDIA: You should see him smile. He is laughing.
MR. BLAIR: Oh, he is pulling my leg? I see. Okay.
DR. MC DONALD: Well, he has a special interest, let's say, anyway.
MR. BLAIR: Yes, but I think that he made a point, which was really quite valid and I think that --
DR. MC DONALD: Why is it valid?
MR. BLAIR: The point that is valid is --
DR. MC DONALD: The standards are all coming from here.
DR. COHN: Margaret has a comment, too.
DR. MC DONALD: I have to leave.
DR. COHN: I guess the question is is why aren't
-- it seems to me to be -- if there is a need and I have to look towards our government representatives for the Secretary to hear that the government participation in this is important, I think we need to say it. If there is no need, then I don't think we need to say it. Is there a need?
DR. FITZMAURICE: I would say at this point it is not on the Secretary's radar screen. The question is should it be on the radar screen.
DR. COHN: I think that it is -- I mean, whereas, I am not in favor of private sector payment, I think it is very reasonable. I mean, I would want my government representatives to be there watching out for our best interest, assuming that they can, of course, do that, but I presume that they can.
So, I would support having government -- the Secretary supporting government participation.
DR. YASNOFF: That is it.
DR. COHN: Yes.
MS. AMATAYAKUL: How about (b)?
DR. YASNOFF: No, we are saying no (b). Get rid of that.
DR. FITZMAURICE: That is really the job of the Department of Commerce.
MR. BLAIR: I don't even remember what (b) said.
DR. YASNOFF: What it said was -- we divided (a) into two parts and that was the part that said the government should encourage -- the Secretary should explore incentives or subsidies to organizations that serve as secretariat. That is pretty weak but --
MS. AMATAYAKUL: Actually, I think this was the part of the recommendation that we felt was where the funding was needed the most in the private sector.
DR. YASNOFF: Yes. And just not to take a position but to remind the group of the testimony we heard we heard was that every other country pays for the people to go. That doesn't mean we shouldn't, but --
DR. ZUBELDIA: The only representatives that are not paid for by the government is the U.S. representatives. Everybody else is a government representative, but it doesn't mean we are --
DR. YASNOFF: Everybody else might be wrong but --
DR. ZUBELDIA: It doesn't mean we are going to quit going. We are still going to go anyway.
MS. AMATAYAKUL: I think this was focused on the support for the secretariat, not for participants' travel.
DR. GREBERMAN: Well, to provide technical assistance sort of broadens it somewhat.
DR. COHN: Well, I guess sort of by definition what this is talking about is either ANSI or ASTM or HL7 or NCPDP or another standards organization, ANSI accredited standards organization being the secretariat because my understanding is that they are the only ones who can be a secretariat. Is that correct?
I am trying to remember whether I -- I don't think I heard any testimony that said that any of these organizations were under duress because of their attempts to be a secretariat.
MS. AMATAYAKUL: HL7 did. I think HL7 expressed concern.
DR. FITZMAURICE: And I know that ANSI has been under duress, not particularly because of being an executive secretary, but the organization in general has downsized, moved some of those people to Washington from the high rent district of New York.
DR. YASNOFF: Explore incentives and subsidies is pretty weak.
DR. ZUBELDIA: First of all, do we have agreement to move that security part?
DR. YASNOFF: I think we should remove it.
DR. ZUBELDIA: I mean, why center and security?
DR. YASNOFF: I don't think it adds anything.
DR. FITZMAURICE: I put it in there and the reason was is that you don't want to say that you are going to go around exchanging a lot of patient care data without saying you are also going to safeguard it. That was the reason I put it in there.
MR. BLAIR: I struggle with this because I am not exactly sure what is right. So, let me just kind of go back to what the intent is. Maybe the recommendation isn't properly crafted, but the intent is for us to protect -- "us" being the United States, to protect ourselves from, okay, I have to use very careful language here, the use of healthcare informatic standards in other portions of the world, which might be used as a vehicle for protecting their domestic marketplaces and they wind up using standards for ways to make it more difficult for American vendors to be able to compete in their domains.
If that is the issue, then it is critical that we have subject matter experts available in those international meetings so that we can't be -- so that we could properly represent American interests and American standards communities. So, if that is the issue and that is the problem, then, you know, that is what this was trying to get to. You know, maybe we need different recommendations here, but I do feel like that is a valid concern that we should be addressing.
DR. YASNOFF: Jeff, the third part of this recommendation asks the Secretary of Commerce to monitor that, but it occurs to me, if I were the Secretary and I got this recommendation, which now says the Secretary should explore incentives or subsidies to U.S. organizations that serve as secretariat, what I would do is I would send a note back to NCVHS and say why don't you explore this and send me a real recommendation to do something.
MR. BLAIR: Fine. That is not a good way of addressing the issue. What is a good way -- the thing is monitoring is good but if we only say "monitoring," then damage could occur and we wind up reporting, gee, we are in trouble here. If we don't wind up doing something -- at this stage we know that there is a risk and an exposure and I think we need to do something probative to be able to protect U.S. interests.
DR. YASNOFF: But we did say that the Secretary should support U.S. Government participation. Isn't that the role of the government participation?
MR. BLAIR: Yes, but my only concern is that there are some subject matter experts, like in medical terminology, for example, that may not be government employees.
DR. COHN: Well, I guess I haven't heard anyone -- and I am trying to think of any individual -- there has been certainly no individual that has testified that has been unable to attend meetings because of financial hardship on the international realm that I can think of that has specified it as a particular issue of duress.
MR. BLAIR: Well, then let me put it this way. We will wind up picking a specific example. How many places can Chris Shood(?) be at. There are so many things he is involved in. We need -- you know, he is funded by Mayo, but there are not that many other folks that have the funding and the support to be able -- we need more than just one person to do all these things and, you know, there are not that many organizations like Mayo and Kaiser that could afford to do this.
DR. COHN: Well, now, if I were Dr. McDonald, which I am obviously not, I would be speaking of the fact that the private sector seems to be handling this issue quite well, thank you. Now, I would look to others to make comments. I am not sure I quite feel that strongly, but are we, indeed, not being represented?
I am not sure I can make that case. Now, I can make the case that November in Tokyo was not a particularly nice place to be and, therefore, it is hard to get people there, but I don't know that that is a financial issue particularly.
DR. FITZMAURICE: I can speak to the financial issue, that I was not there. Travel expense, compared with the value to a specific agency.
DR. COHN: Well, that was the government.
DR. FITZMAURICE: Yes, that is government and not an unreasonable judgment to make, but, nevertheless, there was not representation.
MS. AMATAYAKUL: But that is covered in (a).
DR. COHN: We have already got that.
DR. YASNOFF: It seems to me that just as an observation that with respect to this private sector issue that there is not a consensus and there hasn't been a strong case made to the workgroup that this is a serious problem. So, I think we ought to leave it out.
MR. BLAIR: Let me accept that and we will roll on.
MS. AMATAYAKUL: The last one in this area is the Secretary of the Department of Commerce should monitor the activity of healthcare information system vendors abroad and take appropriate steps to correct anti-competitive activities that may be based on standards requirements with which U.S. vendors do not comply.
DR. ZUBELDIA: Margaret, wait a minute. You actually raised something that was not really what we were talking about. What gives out there is that the Secretary should provide incentives or subsidies to organizations that serve as secretariat or provide technical assistance. We were talking about subject matter experts.
I agree with you raising that because if somebody takes on the secretariat function, they take it on voluntarily. They know what they are getting into and if they don't have the funding for it, they should not have taken the secretariat function.
DR. COHN: So, you want to get rid of that also.
DR. ZUBELDIA: Yes. But that was not what we had been discussing.
MR. BLAIR: Was another thing removed that I --
DR. YASNOFF: We are back to the Secretary of Commerce.
MR. BLAIR: So, we did retain the fact that government support would be there and we would be doing monitoring. Is that correct?
DR. YASNOFF: Yes. So, everybody agrees with the Secretary of Commerce recommendation? Good. 25, last one.
MS. AMATAYAKUL: NHII. To promote the development of a national health information infrastructure, the Secretary of HHS should (a) provide leadership incentives for HHS and other federal departments to accelerate the development, implementation and evaluation of a national health information infrastructure, including demonstration projects, test beds and/or networks, such as the GCPR project, which I think is GCPR framework project.
DR. YASNOFF: What is leadership and incentives? Which code word is this? Does that mean money or not? What is the relationship of leadership and incentives to support and funding?
DR. COHN: Even more fundamentally, is this a -- are we all in favor of the Secretary should do something, but I guess the question is is the national health information infrastructure and the activities solely the province of HHS and other federal departments to do internally, which is really how I read this.
MR. BLAIR: We are taking the lead. I mean, you know, it is pretty hard for the private sector to take the lead.
DR. COHN: Oh, gosh, I actually thought it was sort of a cooperative activity myself, actually along the Internet model. But I guess the question is, I mean, is that what we are recommending that the government do this and that we -- it is hard for the Secretary of HHS to provide leadership and incentives for HHS and other federal departments. So, is the recommendation to Congress? I am confused.
DR. FITZMAURICE: You make a good point, Simon.
DR. COHN: Is this a funding request to Congress that --
MR. BLAIR: Could you reread the recommendation for me, please?
MS. AMATAYAKUL: The recommendation that has Mike's changes in it reads, "Provide leadership and incentives for HHS and other federal departments to accelerate the development, implementation and evaluation of a national health information infrastructure, including demonstration projects, test beds and/or networks, such as the GCPR framework project.
MR. BLAIR: What were the things that Mike added to that?
MS. AMATAYAKUL: The original statement was provide incentives to accelerate the development and implementation of the national health information infrastructure, including demonstration projects, test beds and/or networks, such as the GCPR project.
MR. BLAIR: I find it easier to understand with the way you just read it. Michael, what were you trying to add to it or --
DR. FITZMAURICE: What I was trying to add to it was that provide incentives is, oh, you want me to give money to somebody. No, we want you also to lead, as well as to give money and is this for HHS to do or work in collaboration with other federal departments, although I don't have the word "collaboration" there.
Then in looking at accelerating the development and implementation, I thought it also should be evaluated because the evaluation then tells you where further investment is fruitful.
DR. YASNOFF: What if we added in collaboration with other federal departments and the private sector?
DR. FITZMAURICE: Fine. That is even better.
DR. YASNOFF: That addresses your comments.
DR. COHN: Well, it does, except it is still confusing. I am still not sure what the sort of combination of incentive, HHS -- Secretary of HHS providing incentives for HHS still doesn't make any sense to me.
MR. BLAIR: Well, maybe we don't need incentives. We just need support.
DR. YASNOFF: Just call it funding. If that is what you want, call it what you want.
MR. BLAIR: All right.
DR. FITZMAURICE: Well, if we are going to say should provide funding for HHS in collaboration with other departments --
DR. YASNOFF: To work in collaboration with other federal departments and the private sector to accelerate the development, blah, blah, blah.
MR. BLAIR: Does everybody feel comfortable with that?
MS. AMATAYAKUL: (b) Investigate and provide incentives for the use of healthcare information systems so that the cost of these systems is shared by all who benefit from them. Specifically, the full costs of implementing PMRI standards should be factored into payments from both public and private sector third-party payers. In addition, users of secondary databases should support the costs of creating such databases.
DR. COHN: You know, this is like a really important recommendation and it is hidden as an afterthought in this. I don't know what it has to do with NHII, but I mean it certainly seems to be a really -- I mean, once again, I mean, I think this is like one of those few key pieces and I am -- I mean, it is sort of lost.
DR. ZUBELDIA: I would move this to the general recommendations at the very beginning of the report.
DR. YASNOFF: I agree with that, but I don't -- I am sorry, Michael, I don't like "investigate and." Investigate to me implies that there is some scandal that we are going to uncover or else there is some scientific study that needs to be done.
DR. FITZMAURICE: I am comfortable with it being dropped. The investigate was to figure out where to and how to do this.
DR. YASNOFF: I would say again that is just going to come back to us. The Secretary is going to say, oh, you want this -- well, NCVHS will investigate that for me. So, let's not say that. Let's just do it.
DR. FITZMAURICE: All right. That sounds good.
MS. AMATAYAKUL: I was confused by payments from both public and private sector payers. "From" didn't
seem --
DR. YASNOFF: Do you want to say payments by?
DR. COHN: You have your payment schedules.
MS. AMATAYAKUL: Originally, it was factored into reimbursement levels or payment schedules of.
DR. COHN: Which is where it should be. I think the old way was probably better.
DR. FITZMAURICE: Reimbursement implies that you are doing cost-based stuff. Payment says you are making a payment regardless of whether it is cost-based or not. It is in your fee schedule.
DR. YASNOFF: Well, I like keeping reimbursement levels because more people will understand what we are saying.
DR. FITZMAURICE: But then you don't get -- you are ignoring places like HMOs that --
DR. YASNOFF: No, no, no. I agree. I am not saying we should drop payment schedules, but the way it is worded up there, it was payment -- Margaret is changing it too fast.
MS. AMATAYAKUL: I am sorry.
DR. YASNOFF: That is okay. I liked it the way -- I liked it the way it was originally. Reimbursement levels or payment schedules because it seems -- that covers what you are saying.
DR. FITZMAURICE: But suppose it is not a reimbursement or a schedule. Suppose you are getting a member per month, suppose you are getting a flat sum to cover --
DR. YASNOFF: From reimbursements and/or payments. How is that?
DR. FITZMAURICE: Yes.
DR. YASNOFF: Basically we are saying if it costs something to use these standards, for the good of everyone, not -- and the benefits do not accrue to the individuals using them, we should pay for them.
DR. FITZMAURICE: Yes.
DR. YASNOFF: I think that is a very important recommendation. It should be up front.
DR. FITZMAURICE: The public good, the cost ought to be spread.
DR. YASNOFF: All right. Agreed.
MS. AMATAYAKUL: Support basic health informatics research on health data representation, data mining methods, work flow efficiency, change management and human-computer interfaces.
DR. YASNOFF: I am all in favor of that. I like it. I think that is really important, but I think the -- I am not sure that is where it belongs.
DR. FITZMAURICE: Maybe it goes back up in the research section.
DR. COHN: Do you want to show your overall --
DR. YASNOFF: Can you see that?
[Pause]
Is that good?
DR. FITZMAURICE: It could be a little bit larger. One font larger.
DR. YASNOFF: There you go. How is that?
DR. FITZMAURICE: That is much better.
DR. YASNOFF: What I had suggested was that if you look at how the recommendations fall, you can organize them into -- let me see how many there are -- about five areas. Let me just go through those. The first area is essentially what we assign ourselves. I tried to capture the way it was changed, but basically the Secretary should exercise her authority under HIPAA to adopt and require use of PMRI interoperability standards to be recommended by NCVHS. This incorporates --
MR. BLAIR: HIPAA interoperability standards or --
DR. YASNOFF: PMRI interoperability standards. So, that encompasses both the message format standards and the vocabulary standards.
MR. BLAIR: Well, then my thought is -- I tend to think of interoperability a little bit more skewed to message formats and, you know, I tend to think of comparability a little bit more with medical terminologies. Could we just simply say PMRI standards?
DR. YASNOFF: Sure.
MR. BLAIR: Thank you.
DR. YASNOFF: PMRI standards to be recommended by NCVHS. This covers Recommendations 2, 4, 4(c), 10(a) and 17 and that is in the original numbering. So, in developing recommendations, NCVHS will (a) use the guiding principles for selecting standards and that is referencing Recommendations 2(a), 4(b) and 16. Those are the places where we repeated that.
(b) Prioritize specific content and functional areas. That references 2(b) and 4(a). (c) Include a single implementation guide. That was Recommendation 5. (d) Continue to identify and make recommendations to support the means to fill gaps and inconsistencies that are identified.
We did have a big discussion about that. I am not sure I captured all that. That was the discussion we had around 7(d). But whatever it is we agreed to, I am saying it belongs in this section.
Then (e) sponsor conferences and workshops to promote harmonization. If we agreed to that, that was Recommendation 9 and that NLM should sponsor meetings on medical terminology in cooperation with us. That was No. 12 as revised by Betsy.
Then, finally, to establish an incremental approach and realistic time lines for implementation and that was Recommendation 1(b) and 10(c).
That is essentially the first category.
DR. COHN: And I guess just to help me conceptualize, I am sort of thinking as we look at the recommendations, this is almost sort of like a section called what we will do. And then the second piece gets to be what we need you as the Secretary to do.
DR. YASNOFF: That is right. This is essentially what we, NCVHS, are going to do and what we are saying is, Madame Secretary, here is what we are doing and when we send these to you, please adopt them.
MR. BLAIR: So, the first one is NCVHS is "we." Okay.
DR. YASNOFF: I am not sure exactly how we should say it but it is basically what we are going to do.
Then Section 2 is specific actions. We have two specific actions that we recommended. One was Recommendation 14, to designate an agency to create a reference terminology for drugs. And the second one was support development and maintenance of an open health care meta-data registry. That was Recommendation 8.
Those are the two specific things that we recommended. Then the third category is what HHS should do to support standards development. There are quite a few in here. The first one is arrange for government support for maintenance and distribution of selected terminologies. That was No. 12 as modified by Betsy.
The second one -- and these are not in any particular order, I am sorry -- include terminology standards in UMLS. That was the substitute No. 10(a) that Betsy provided.
The third one, participate in standards organizations. This has two parts. First, HHS should be a full member of ANSI and ANSI HISB. That was Recommendation 3. Second, support government representation in ANSI standards development organizations. That was No. 7(a). And U.S. participation in international standards development organizations. That was 24, but we just -- that we just worked on.
Then the fourth one under "HHS Actions" --
MR. BLAIR: The fourth or the third topic now?
DR. YASNOFF: This is now the fourth. The third one had those two parts.
MR. BLAIR: This is still a subset underneath --
DR. YASNOFF: Underneath "HHS Actions."
So, it is select and fund one or more independent organizations for conformance test development and encourage mechanisms for compliance certification. I think we changed that one, didn't we? I don't remember. But anyway that was No. 6, whatever is left of it.
The fifth one, support HHS agencies that implement standards for their use. That was 10(b).
Now I am on 6. Support NLM to extend and enhance UMLS for mapping. That was No. 15.
No. 7, promote the use of PMRI standards in HHS-funded medical research. That was No. 10(b). I am losing my count.
No. 8, encourage additional participation in the standards development process. This is from underrepresented groups. That was 23. We kept that one, right?
MR. BLAIR: Yes.
DR. YASNOFF: The next one is promote legislative initiatives that ensure consistency and access to PMRI. What did we do with that one?
MR. BLAIR: Are you still under the second major category?
DR. YASNOFF: This is the category of "HHS Actions."
DR. FITZMAURICE: I think we eliminated retention.
DR. ZUBELDIA: Would remove the access --
DR. YASNOFF: And retention, right?
DR. ZUBELDIA: No, we left the retention.
MR. BLAIR: Yes, but it was -- you said enable electronic retention, which was a different concept
than --
DR. YASNOFF: -- electronic retention of PMRI. Get rid of "access."
Promote legislative initiatives that enable electronic retention of PMRI. Did we keep the electronic signatures thing? And acceptance of electronic signatures. So, that is No. 22.
Then finally, that HHS should ask the Department of Commerce to monitor potential foreign anti-competitive activities, No. 24(b).
So, that is all things we want HHS to do. Then the next category is we want HHS to support some R&D activities. We want R&D to be funded on data capture, value of PMRI standards and basic informatics. That is Recommendations 11(a), 11(b) and 25(a) -- actually, it is not 25(a), is it? It is 25(c). Right? Sorry. 25(c).
Also research on convergence tools and medical terminologies and that would be through NLM. That was Recommendation 13.
MR. BLAIR: On the value of PMRI, I think that --
DR. YASNOFF: That was the incremental value at one point.
MR. BLAIR: Yes. I am assuming that you are leaving this to Margaret to be able to fill in the phrases.
DR. YASNOFF: Yes. These are -- right.
And then the final category, I put down as referrals and one was the NHII recommendations, which were 25(a) and (b).
DR. COHN: Actually, I have a problem with that. You might as well finish off.
DR. YASNOFF: Anyway, and we can reorganize those.
Then there were the privacy ones and I guess 18 is gone anyway. So, let me get rid of that.
DR. COHN: As I remember, we had talked about actually 25(b) being one of the really big ones.
DR. YASNOFF: That is right. I think we put 25(b) somewhere else.
DR. ZUBELDIA: We split (a) -- no, we split (b) into two or (a) into two.
DR. YASNOFF: Anyway, before we get into the details, I guess my question is do folks feel that this is a reasonable way to try to organize the recommendations, in other words, into here is what NCVHS is going to do. Here is what HHS is going to do. Here are the R&D activities we want and then I don't know about that final category.
DR. COHN: Okay. Let me just make a comment because I think generally I agree with you with some, obviously, modifications as we are talking. I guess I see No. 1 as -- what No. 1 is effectively is an internal set of things that we are committing to do, based on our evaluation.
Finishing with No. 1 being the first recommendation really to the Secretary, which is the Secretary exercise her authority to adopt and require use of the standards that we are recommending. That really occurs after we have gone through talking about all the things we are going to do (a) through (f).
DR. YASNOFF: Correct.
DR. COHN: I mean, that is sort of like the first major recommendation. Probably the -- I am just trying to think of ordering. I would wonder -- you have a title here -- I mean, you have that little area that says "Specific Actions the Secretary Should Take," which I think is reasonable, although I don't know that I would consider that to be No. 2 in terms of order.
Then you have 3, which is a litany of items around supporting standards development, which I think probably need to be subdivided a little bit.
DR. YASNOFF: I agree with you.
DR. COHN: I mean, something that has 12 items underneath it is probably a little much and maybe we may want to really differentiate those things, which are really standards versus things around terminology or something. There probably needs to be some -- this needs to be broken up a little bit.
R&D, I think, it is fine, though I personally would include 25(a). I don't know. Maybe Mike feels differently, but I consider that the development and implementation of the national health information infrastructure cannot be far from R&D. I think that is the "D" part of the "R."
DR. FITZMAURICE: Probably more R&D for us, more application maybe for the Department of Commerce.
DR. YASNOFF: So, we should put development of NHII, which is 25(a).
DR. COHN: That is right. And then (b) somehow gets moved somewhere as a major item.
DR. YASNOFF: What is (b)?
DR. COHN: (b) is the one that has to do with the costs being shared by all who benefit. That is clearly not a referral item.
DR. YASNOFF: No. We wanted to move that into kind of a major recommendation.
DR. ZUBELDIA: I think under what you have as No. 2, things for the Secretary to do.
DR. YASNOFF: Okay. So, this would be --
DR. COHN: It is such a big issue that it probably almost -- we need to think about whether it even deserves its own --
DR. ZUBELDIA: Its own bullet.
DR. COHN: I mean, one would wonder.
DR. YASNOFF: I think it deserves its own bullet. I like that idea. Why don't we call that Point No. 2 for now, just so we know it has its own bullet, which is that PMRI costs should be reimbursed. That is my shorthand for that.
DR. FITZMAURICE: Be shared by those who benefit.
DR. YASNOFF: Margaret has got it.
This is just my reimbursement and I am just noting it was 25(b).
Okay. Then I will get that out of the bottom. And then 19 and -- so, that leaves us with 19 and 20 to put somewhere. Those are actually actions for the Secretary. Right?
DR. COHN: That is right, but it is probably a separate header for the Secretary to do.
DR. YASNOFF: So, privacy initiatives for HHS, Secretary.
Okay. Then I think we still need to address this issue of dividing up a category, that big category, which has so many things, I can't show them to you all at once on the screen.
DR. COHN: Well, as I said, I guess I thought that probably since this mostly has either standards, promotion activities or probably some terminology activities, that maybe they are different enough that they can fit under different headings.
DR. FITZMAURICE: I think they are some of the stuff that HHS should do and some of the stuff that HHS should support and others doing it. That seems to me that breaks out. That is one crack at it.
DR. YASNOFF: So, you want me to try to rearrange this now or do you want to leave this to Margaret to divide.
MR. BLAIR: Just leave it to Margaret.
DR. COHN: Leave it in for Margaret and then perhaps we will have some time to talk about it at the final look at tomorrow after our hearings.
DR. YASNOFF: So, what I will say is we are going to subdivide this category of items. I will just make that like a --
MR. BLAIR: I would like to make one observation on this because I feel like this is kind of a thing that I maybe had hoped would come out of today is -- but I didn't realize that there would be somebody like you, Bill, that would be so efficient in reorganizing it.
One of the things that I have been concerned about was that I wasn't sure that this report was coming up with recommendations that were strong enough. When you have reorganized it, the perspective I have is this report has a lot of hard-hitting recommendations.
The reorganization, I think, breaks us away from the struggle of trying to -- well, it focuses on what we are doing and what we will be doing as opposed to the perfect tasks that the focus areas seem to imply, which we cannot resolve with one report.
So, I feel like this is a tremendous improvement. Thank you, Bill.
DR. YASNOFF: You are welcome.
I guess what I can try to do with this is I will print this and then we can distribute it tomorrow and look at it. How does that sound?
DR. COHN: That sounds great.
DR. YASNOFF: Then later I could e-mail it to Margaret.
DR. COHN: Giving her a piece of paper would be fine, too, probably.
DR. YASNOFF: If I can get into my e-mail, I will e-mail it.
MS. AMATAYAKUL: I have got everything you have got here.
DR. COHN: Now, I think for tomorrow, we will want to make sure everybody brings their calendars so that hopefully we can schedule a conference call. Is that a reasonable expectation at the end of the morning?
Does that make sense or do you want to try to -- I mean, I think we need a --
MS. AMATAYAKUL: There is somebody going to be here tomorrow morning that is not here today, right now.
DR. COHN: Kathleen Fyffe. Actually, unfortunately, we have already lost Dr. McDonald. Maybe we should do this over the Internet to try to schedule some time.
MR. BLAIR: What if we did it in pieces? What if we did our first cut with the people that are here tomorrow morning and then verify it over the Internet? How is that?
DR. COHN: Okay. You mean limit it to a couple of dates?
MR. BLAIR: Yes.
DR. COHN: That will be during that 12:00 to 1:00 slot that we will be looking at these things, if that is okay with everybody.
MS. AMATAYAKUL: Do you want me here tomorrow?
DR. YASNOFF: When are we going to do Section III also? We decided we were going to leave that and do it on a conference call, right?
DR. COHN: I think we have reserved 12:00 to 1:00 for whatever unfinished items there. I mean we could --
MS. AMATAYAKUL: I mean, I can be here. It is no problem. I just want to know what you want. Do you want me to do something for tomorrow? What do you want me to do?
DR. COHN: I think the items we are going to be looking at tomorrow was one last look at the organization after we have slept on it and see if we can improve that because that will be very important for you.
Then the other item is to schedule realistic times for the conference call, recognizing that we really do want to get this out to everybody and we want to get it out to external reviewers and to the government for review in a timely fashion.
MR. BLAIR: Could you consider this. There is a lot of reorganization that Margaret is going to go through and if there is an hour where we could go through that overview section, that Section III, so that at least she has a little bit of that under her belt and not waiting -- is that all right?
DR. COHN: That is fine. And I would be happy to -- if things go shorter tomorrow morning, we can start right then. I mean, I think we have until 1:00. We have reserved some time for that discussion.
DR. ZUBELDIA: We are meeting at 9:00.
MR. BLAIR: I thought it was 8:30.
MS. AMATAYAKUL: Tell me again what you want me to do.
DR. ZUBELDIA: Oh, just get it all done by tomorrow.
MR. BLAIR: Maybe if you are able to digest the new organization as much as possible so that we could look that over and then the other piece is that we would be spending maybe an hour on the overview section, Section III.
MS. AMATAYAKUL: Okay. So, I have got everything Bill has in my computer. So, I can't print it out, but he is going to print it out. I will be whenever you want me to be here. Just tell me when you want me to be here.
DR. COHN: Be here by 11:00.
MS. AMATAYAKUL: 11:00. Okay.
DR. COHN: I mean, we will likely not get started until 12:00 but in case we have time --
MS. AMATAYAKUL: Sure.
MR. BLAIR: Is this yours, Simon?
DR. COHN: Yes.
DR. YASNOFF: You want me to try to get this printed out and distributed in the morning? I will see what I can do.
MS. AMATAYAKUL: I can send it -- I can do e-mail. I could send it to Jackie if you want.
DR. YASNOFF: I have got a computer here that I can print it.
MR. BLAIR: What an outstanding day. Thank you, everybody.
Meeting adjourned.
[Whereupon, at 5:35 p.m., the meeting was recessed, to reconvene the following morning, 9:00 a.m., Friday, March 31, 2000.]
DR. COHN: From our last discussion, it appears that a hearing will need to be scheduled in the September/October time frame to deal with possible changes to the standards and all of this. So, I think we had talked previously about a date. We will send off an e-mail to all of the subcommittee members to look at dates in that time frame.
I know some of you have been holding two days right after the full committee hearing in September, but I have heard from enough of the individual members of the subcommittee, that I think we need to look at that and probably have it later so it isn't a full week of meetings.
So, we will be querying everybody about that. I think beyond that, once again, I think we have just witnessed a historic activity and we want to thank the MOU signatories for their hard work.
Now, beyond that, I think really what we are talking about now is trying to deal with the recommendations. I know, Jeff, do you want to make some comments about this or lead us through --
MS. FYFFE: May I interrupt just before we get started?
Are we also going to talk about other issues beyond what the handouts include, because there are some --
DR. COHN: Let's talk about that now. By "other issues," you mean issues related to the overall HIPAA
regs --
MS. FYFFE: Correct.
DR. COHN: Please. I think this is the time before we move into the workgroup issues.
MS. FYFFE: This is something that I brought up I believe last August and I would like to raise the issue again. It is the issue of the eventual adoption by the Secretary of ICD-10 codes. And I am bringing this up because at last week's National Conference of the Workgroup for Electronic Data Interchange there was some discussion of this and WEDI is also working on a white paper or an issue paper about how ICD-10 codes will affect providers and payers. In fact, I believe there is a workgroup that is co-chaired by someone from the American Hospital Association and someone from the Blue Cross-Blue Shield Association.
I think that we should seriously consider having a presentation or testimony from someone at WEDI about this topic before the end of this calendar year. I was also wondering if anyone knew in general time frames when these ICD-10 codes would be considered for adoption. In other words, when would they supersede the ICD-9 codes?
DR. COHN: Let me begin to answer part of your question and then maybe Marjorie would like to make a comment.
First of all, I do appreciate your comments about WEDI. We had actually based at our last NCVHS meeting, we had identified that for the June meeting of the NCVHS that we were going to have a panel on ICD-10. It may be appropriate based on that to invite a WEDI representative also potentially to that or to the subsequent session.
Now, my understanding of the process for ICD-10 acceptance is essentially the HIPAA process, that it -- you know, that there needs to be hearings by the NCVHS. There needs to be a recommendation, that there needs to be a notice of proposed rule created. There needs to be comments from the public and then a decision by the Secretary.
So, in reality that question is really as much in your hands as it is in anyone's, for good or bad.
Marjorie, I think, needs to also comment on that, if you would like to comment?
MS. GREENBERG: Sure. The ICD-10 -- clinical modification of ICD-10, which I assume is what you are talking about.
MS. FYFFE: Correct, yes.
MS. GREENBERG: -- is in the process of being finalized but is actually probably won't be finalized, including results of the pilot testing until the end of the summer. So, we had actually wondered whether June was the correct time or exactly -- I mean, I think you have to look at ICD-10 CM in the context of -- in the broad context of code sets as well. That was part of what I think the subcommittee needs to discuss, whether we want to have a hearing on the whole overall issue of medical code sets, which is diagnoses, procedures, et cetera, I mean, putting aside all the other code sets, which I think you would probably want to separate that from, but -- or a specific hearing about ICD-10 CM.
I mean, one of the things that would be very helpful certainly to NCHS and to the Department, I think, would be to hear from the industry as to what types of tools, et cetera, they feel they would need to make a transition, to ease the transition or to facilitate really the transition to ICD-10 CM. I mean, I realize that there are issues across the whole spectrum as to about the implementation.
I have asked the codes and classification team, which pretty much hasn't been meeting regularly since they reviewed all the comments after the transactions, NPRM and code set NPRM, and that, of course, took quite awhile in preparing all the information for the preamble, et cetera, the final rule, but they haven't really been meeting. I have the chairs to convene to start thinking in terms of what kind of process they see going on and what type of schedule. I think realistically this is -- you know, obviously, this is going to be subject to the HIPAA process and it is -- you know, so, it is going to be probably a lot longer than some people would like and sooner than others maybe would wish, but it is certainly not something that would, you know, happen quickly and would be subject to the whole process of rulemaking.
But I think, you know, once the classification is finalized and we have the results of the pretest or the pilot test and have incorporated those findings, it would be premature to actually even propose a date for it to be implemented.
In the past, we have -- really before HIPAA, we had told the industry that they would have two years from the time it was announced before it would -- you know, that it was going to be implemented until it was implemented. That was, you know, without HIPAA and, obviously, that adds some time in relationship to an NPRM, et cetera. But we also -- you know, we have constituencies who are eager for us to roll it out as well.
So, I think any assistance that this subcommittee can give and particularly in gathering information from the industry about, you know, what they feel they would need to make -- you know, for the transition, would be very helpful. I am not quite sure about the timing on that.
DR. COHN: Well, it sounds like by your description that we have probably -- even though we have been intending to have that in the June time frame, that it is probably really an issue for the September NCVHS meeting.
MS. GREENBERG: Probably.
MS. FYFFE: When you say a panel discussion, would this be at the full committee level?
DR. COHN: Well, my thought was to kick the discussion off with a full committee panel, but I would be open to -- I mean, if we as a subcommittee feel that this is one of the few issues that we need to be handling this year, I would be, obviously, happy to arrange time during one of our sessions.
So far we have -- as I remember, I think we have security and PKI as an issue that is on our plate. Obviously, the whole implementation of HIPAA. Beyond that, I think things had been unsettled.
MS. FYFFE: I think there is value in a panel presentation in front of the full committee. So, I guess what you are saying is it is a question of whether it would be more beneficial in June or in the fall.
DR. COHN: Well, if things aren't ready in June, I think we had better do it in the fall.
MS. GREENBERG: Well, it depends on what you want the panel to discuss. If you want to hear about the issues about what the industry feels it will need -- I don't know when this paper, this white paper, what its time frame is in relationship to the whole range of medical code sets of diagnoses and procedures or you want it specifically on ICD -- the transition from ICD-9 CM to ICD-10 CM. It partly has to do with just what you want to focus on, who you want to hear from.
DR. COHN: I guess I would look to -- Kepa, you actually need to make a comment before I start trying to answer this question.
DR. ZUBELDIA: Yes. I am curious to know whether this testing of the ICD-10 includes DRGs or it is just the diagnosis codes because I think with other DRGs there are not very many people that would be able to use it. That has to be a group that works with ICD-10. There has to be --
MS. GREENBERG: Certainly. I mean it is not going to be -- it would be implemented in the context of its uses and, obviously, all of -- you know.
DR. ZUBELDIA: And that will be ready by the end of the summer?
MS. GREENBERG: The new DRGs by the end of the summer, no.
DR. ZUBELDIA: ICD-10-based DRGs have to be new. They have to be based on the ICD-10 instead of the ICD-9.
MS. GREENBERG: Well, I think that -- yes, I mean, obviously, they can't start doing that until they have a final product that has been through its testing, et cetera. I mean, I think it might be helpful if you wanted to pose several questions, which then the chairs, the co-chairs of the coding and classification team could address with their committee.
Karen, what do you think? Does that seem reasonable?
MS. TRUDEL: Yes.
MS. GREENBERG: And then, as I said, they are planning to convene in the next week or two, I think, I think the week after next. So, if you want to identify some information you would like back from them or some questions you want to pose to them, that will then be discussed in the infrastructure team and the health data standards committee. But they meet weekly, so --
DR. COHN: My memory is that Pat Brooks is in charge of DRGs from HCFA, isn't she?
MS. GREENBERG: Well, she is in charge of procedure coding and she --
DR. COHN: Oh, I am sorry. I thought she did DRGs also. I guess I am confused then.
MS. GREENBERG: Someone from HCFA would have to -- I mean, she certainly has input. I mean, she is involved with that process.
DR. COHN: Okay. Well, I mean, we could actually ask the person doing DRGs to comment on how ICD-10 -- how they see ICD-10 working with DRGs. I mean, I think Kepa is probably asking the questions that is asked probably frequently in the industry because as important as ICD is, DRGs are really important.
MS. GREENBERG: Well, they are, obviously, related.
DR. COHN: Yes, exactly.
But now I guess before we finish this topic, I mean, what is the interest or the desires of the subcommittee? I don't see this as all being handled in one hearing. To my view, the idea was let's introduce the area. It certainly is inappropriate for us to start talking about ICD-10 until the work has been done with the testing and evaluation. I mean, I think it becomes a useless conversation without data and we need to have a data-driven discussion as opposed to a discussion that is mostly involved with heat and uncertainty and fear of the unknown.
So, I think that there is -- you know, we need to time this appropriately. I guess my thought -- and I once again looked at the subcommittee for guidance -- I had thought that the initial focus, rather than on the general issue of code sets, would probably be better served by a discussion around ICD diagnoses, but I could also -- I men, nothing has been scheduled or done yet. So, if you think that it would be better to have a general discussion on code set changes, I would be happy to also arrange something like that.
DR. ZUBELDIA: Simon, I think a discussion on code set transitions will be important because we are going to be facing the transition of the CPT-4 to CPT-5 relatively soon and there are some HCFA exchanges and --
MS. GREENBERG: 10 PCS.
DR. ZUBELDIA: It is a whole set of codes that will be changing and how to address that industry-wide because it affects not only the HIPAA transactions, but also paper transactions, the whole industry. I think that is important.
MS. GREENBERG: You could do that in June without having, you know, the final details on every code system. I think 10 PCS is still -- is also in a testing phase. I think they are further along. I am not quite sure what their end date is, but I mean sort of a more generic discussion of, as Kepa was saying, of the whole issue of transition in code sets and even, you know, which ones -- do they have to be paired? Can they be done separately? You know, I mean, that is the same question that came up about the transactions, I guess, can -- you know, ideally everything happens on one day, but that doesn't -- that isn't the real world. But what would be -- you know, what is people's preference? What would be especially problematic, I mean, in, you know, relationship to the many uses of the code sets?
MS. FYFFE: It might make sense to have a more general panel discussion in June so that some issues or questions can be raised that should be under consideration for then more detailed hearings or presentations later in the year or even the beginning of next year, depending upon the timing of the pilots or work being done out in the field.
DR. COHN: Other comments or questions?
I see Rich in the back. Please introduce yourself.
MR. LANDEN: Thank you. Rich Landen and I am wearing Blue Cross-Blue Shield Association hat while I am speaking this time.
I want to echo the concern that my organization has specifically about ICD-10. As you all well know, it has got clinical aspects -- transition from 9 to 10 has clinical aspects. It has also got major health care administration, specifically claims administration impacts and on the claim administration processing impact, we already know that for our member plans, this is going to be a big ticket item; I mean, major orders of magnitude here.
Every claim that is filed in the country has a diagnosis code, one or more diagnosis codes. As Medicare knows, DRGs are a major impact. Many of the private business arrangements in health care piggyback on DRGs. So, Medicare DRG changes also impacts the private sector or the private sector component of claims payment.
So, my constituency already knows enough that it is a big ticket item. Major reprogramming of core information systems will be required. Not an easy process, very complex process. What we have not heard yet is the advantages that the industry will get from the transition from 9 to 10.
So, I think that is an important part of the message that has to be addressed during this process.
My second comment is that while ICD-9 transitioning from 9 to 10 CM is a big deal unto itself, it is also one of a number of issues that HIPAA leaves very fuzzy in terms of transitioning code sets in general. So, I do endorse the idea of the committee looking into how under HIPAA we transition across all code sets, but I still think that the ICD-9 to 10 CM is still an order of magnitude that it warrants its own hearings.
DR. COHN: Thank you.
I would like to finish this topic up so we can get back to the CPR Workgroup. I think what we are hearing is is that the subcommittee considers the code sets as removed beyond the CPR Workgroup activities, which has obviously been our primary focus now for awhile, is an important area that we want to address this year.
I think my only concern is I -- and I would just look to some of the people around the room who may want to make a couple of comments -- has to do with the timing of getting into this before the publication of the final regulations for the transactions. I am only concerned as I think about it, that there may be some confusion or perceived confusion related to final transactions. We are going to get new code sets and people get confused about the discussions -- I mean, the actual implementation of the final regs versus this issue of, well, gee, we are just beginning to have very preliminary discussions about transitions to code sets.
So, I think that we just have to think about how to what I describe as timeness in a way that decreases the amount of confusion.
MS. GREENBERG: Well, and, frankly, that is really why the team has not, you know, been actively addressing this because they felt it was premature until the final regulation was published. I think that that could be an issue for June. I can only say that from the point of view of the exec sec and planning for the June meeting, where, of course, we will have this CPR -- we will have the symposium, et cetera. We will have the CPR report, just for starters. But we do need guidance pretty soon if you want to have some type of panel at the June meeting. It might be preferable as been discussed.
Certainly, I would say that would not be probably the appropriate time to have a panel or hearing specifically on ICD-10 CM. But, you know, whether you want something more generic and -- you raised a good point about the timing may not be the best in that we are pointing towards the June 30 -- this is like ten days before what we hope will be the publication of the final rules.
DR. COHN: I guess what I would say is is if you give me discretion in terms of exactly how we time this, but recognizing I think what I have heard from you and Kepa and I think everyone around the room, that we all think that this is an important issue, both the issue of code set transitions in general and ICD-10 diagnosis in particular because that is, of course, of such major importance to the whole industry and that we should wade into it at the appropriate time this year.
MS. FYFFE: Okay. Thank you.
DR. COHN: With that, are we able to move into the -- sort of a review of what we did yesterday and subsequent updates?
Jeff, would you like to lead us through the discussion?
MR. BLAIR: Thank you.
Let me just very briefly give some recognition which I really think is due. We had an outstanding day yesterday. Margaret, are you here?
MS. AMATAYAKUL: I am here, Jeff.
MR. BLAIR: Great. Thank you.
Margaret, during these last several weeks, really did an outstanding job in pulling together the report in such a manner that it made it possible for people to review, in particular, that Section IV and recommendations and be able to see opportunities for really improving it, which we never had before.
That was a major effort to be able to pull together ideas during a lot of these other sessions. So, one of the results that came after that was that Michael Fitzmaurice went through the document very carefully and thoughtfully went through and improving wording.
Simon reviewed the document and began to observe that especially in that Section IV on the recommendations that there were some opportunities to significantly improve the report if we wound up reorganizing it in a better way and shared that view with Bill Yasnoff, who then really dug in and created a framework for us in terms of a new organization, which I think by and large yesterday we felt very excited about the impact of reorganizing it in that fashion.
Now, Bill has indicated that he now has an update for us in terms of the reorganization. Simon, did you have any other thoughts? My thought would be that if Bill could review the new format for us.
DR. COHN: I agree with you. I think it is critically important that we agree on the structure so that the next version can be completed.
MR. BLAIR: Bill, could you take us through that?
DR. YASNOFF: Sure. I guess, Margaret, you have got this up on the screen if we want to make changes to it, but also everyone has a copy of it. It is marked "Draft Three" with today's date. You also should have a copy that has essentially no header on the top, which is exactly what we talked about yesterday afternoon.
Actually, during this morning's meeting, I was working on further reorganizing it based on the comments from yesterday afternoon. So, it is now in six major sections. Let me just go through them. Let me just outline what topics are in each section and then we can go through them in detail.
The six sections are first recommending the Secretary continue to exercise her authority under HIPAA to adopt and require use of PMRI standards to be recommended by NCVHS. This is essentially the same -- this section has not been changed since yesterday, although I did change the wording to include, "The Secretary should continue to..." acknowledging that this is already going on.
So, our recommendation to the Secretary is not to do this but to continue to do this.
The second one was -- the second area consists purely of Recommendation 25(b), which everyone felt was very, very important and this was the issue that there needs to be some recognition that the use of PMRI standards, that the benefits and costs do not distribute themselves equitably necessarily and that the use of these standards is a public good and, therefore -- but on the other hand it imposes a potential burden on providers and others. So that the costs for using those standards should somehow be reimbursed or paid for. That was Recommendation 25(b).
If we can confine our discussion at the moment to just the organization, then we can have some further discussions about exactly what the recommendation should say.
The document you have is not intended to fully reflect the full recommendations. That is why I put the numbers with them. So, that is the second area. Everyone thought that was very important and should be close to the front.
The third category, which is that big category I have now split into two parts -- the third category involves things that HHS should fund, various activities in support of standards that should be funded and we will go through those in a minute.
The fourth category involves specific actions in support of standards development that HHS should take. The fifth category are specific HHS actions to address gaps that we have identified.
The final area are items with respect to privacy and security. So, those are kind of the six areas that I have defined. I think, although I have not gone back and double checked this, I believe that these areas incorporate all the recommendations that we have made. But, again, it needs to be double checked.
DR. COHN: Shall we just stop now and see --
DR. YASNOFF: Yes.
DR. COHN: -- any wordsmithing issues here. The question is is this a reasonable organizational --
DR. YASNOFF: That is the question.
DR. COHN: -- structure, sort of recognizing that the words are probably not right and we would all argue about them for the next three hours, does this make sense?
DR. YASNOFF: There may be -- it might be worthwhile for me to explain what is in each section, but if people have comments now on just the overall categories, that would be great.
MR. BLAIR: Is there a general feeling that Bill needs to explain those things? You have got copies of it and, you know, unless somebody specifically says that you would like Bill to review item by item, maybe you could just comment on the general organization.
DR. COHN: Dr. Braithwaite, do you have a comment? You were in and out of the meeting yesterday.
DR. BRAITHWAITE: This organization certainly deals with the problem that I had with the previous organization. It makes it very clear who the recommendations are directed at and what categories they include. So, I am very pleased with it.
MS. FYFFE: I think this is more effective -- a more effective organization and I appreciate it.
I guess I am still on the hook for getting something to you all for the executive summary and for the introduction about the legislative proposals. Okay? I apologize for not drafting anything last night, as you did.
DR. YASNOFF: I did it during the meeting today. You were busy.
MS. FYFFE: Oh, okay.
DR. COHN: Do we want to talk about each section individually -- Jeff, how would you find the time to be best used in terms of drafting the next version? Do you want to talk about these individually or --
MR. BLAIR: At this stage, how about this thought, kind of collaboratively here, my feeling is that this outline is sufficient for Margaret to begin to reorganize the document. We had a lot of discussion. There are a lot of loose ends where there were introductory issues to each of the recommendations and they have to be folded into probably Section III.
My thinking at this stage is that we don't really have time to go through the details of Section III. It is not organized. It is going to be changing. I think we went through the individual issues. I think it would be my inclination that this, just to give people an opportunity if there is a particular issue that you feel we didn't get a chance to cover yesterday, you know, this would be an opportunity for us to discuss it now, maybe in the next 10 or 15 minutes, before we go ahead and commence on drafting a new document during the next couple of weeks.
The only other piece I would say after that would be maybe to schedule for when we would have the draft ready and the review ready and the calendar dates ready. Is that reasonable?
DR. YASNOFF: That sounds fine.
MR. BLAIR: Okay. So, let's give people an opportunity if they have any concerns that they felt were not fully vetted yesterday.
DR. COHN: I think Bill is going to make a comment.
DR. YASNOFF: Unfortunately, of course, Clem is not here, but I think he began to bring up yesterday the issue of the patient identifier as a concern of his that was not in these recommendations. And of course, I would not in my wildest dreams presume to speak for Clem, but he did bring that up and so I thought I would remind the group and perhaps someone can follow up with Clem on that.
MR. BLAIR: Let me do that. This issue had been raised in some previous meetings. At one point we had this mentioned in the recommendations. At that particular time, the workgroup decided it was not appropriate for us to include those in the recommendations, but Clem may be raising the point from a different perspective. So, I will follow up and find out if it needs to be reintroduced.
DR. COHN: Mike.
DR. FITZMAURICE: I might suggest that while HIPAA is taking care of the identifiers, we might reiterate, at least in the text, the importance of the identifiers as mentioned by the testifiers. That would provide even added emphasis to the need to get the HIPAA identifiers out in a timely fashion.
DR. COHN: Are there other comments?
MS. GREENBERG: I know I wasn't here for -- I certainly wasn't here yesterday and I apologize for that. I wasn't able to be here but I have been not here continuously. I was -- so, I am not quite sure where the discussion went after the last time I heard it mentioned.
I mean, I know I heard the group talk about it, I think, at the last meeting, prior to the February -- the previous workgroup meeting and there was recognition that it couldn't be solved, obviously, by this group and that it shouldn't -- it shouldn't dominate the report as well. Though as Mike just said -- I mean, I think the presence or absence of identifiers, all of the identifiers, offer both advantages and challenges.
The presence of them offers certain advantages that were discussed by many and are inherent in HIPAA, but
-- and the lack of them also presents some challenges, which probably can be met, but, you know, create some additional issues when you are talking about a longitudinal record and you are talking about all the things you are talking about in this PMRI.
I was a little -- certainly, the privacy issue is discussed and addressed in the report. I was a little surprised to see zero mention, at least I didn't see it, of the unique patient identifier. Is there any mention in the report?
MR. BLAIR: At one point we had them in the recommendations. Then we wound up moving them to, if I recall, a discussion -- Margaret, you may be able to help me on this -- where we were indicating the things that were within the scope of what we were going to cover, indicating that patient identifiers was, you know, being covered by the HIPAA financial administrative transactions, the other pieces of the HIPAA legislation and, therefore, we weren't going to separately address it in this.
But, Margaret, do we still have a phrase --
DR. COHN: No.
MR. BLAIR: Okay. It is not there anymore?
MS. AMATAYAKUL: No. We took it out.
MR. BLAIR: We took it out in one of the previous meetings.
DR. COHN: I think Mike is making a very good point that there ought to be a paragraph with a heading that talks about the issue of identifiers. I mean, one would have to observe that Congress has already passed a unique patient identifier for individuals. So, it is hard to call upon them to re-pass this.
I think the observation needs to be made that they -- no, they passed a piece of legislation that called for it and basically they put it in an appropriations bill the fact that one couldn't do anything on it. So, I think that one needs, I think, to reiterate within the body of the text the importance of identifiers to all of this.
I guess my own general feeling is is that I don't think I would waste the -- I don't think it should be in as a recommendation, at least at this point, unless I hear otherwise because I think it would overshadow everything else.
MR. BLAIR: I need a little help because I am trying to -- I am afraid that I do not recall when this issue came up in the workgroup previously what was the rationale that the workgroup for why they wanted it removed. Does anybody recall that discussion and could help.
DR. FITZMAURICE: I think to the best of my recollection it was because we thought we would have identifiers by now. By the time the report got out, we thought we would have identifiers.
DR. COHN: I think we are talking about all the identifiers together and I think probably reiterating within the body the importance of identifiers, well maintained identifiers -- and there is still a risk about well-maintained part -- is probably appropriate and how we wordsmith in the body -- I guess, Jeff, I mean, I am sort of looking at everybody. I mean, do people want to have a recommendation about unique patient identifier?
I think I may be the one who spoke out against that as sort of a -- it didn't seem to make much point at this point.
MS. GREENBERG: The only question I have is whether the lack of a unique patient identifier requires other kind of work or standards to compensate for that and more of additional research needs to be done on master patient indexes or whatever because that, I think, is, you know -- if that is the case, not mentioning it is sort of a gap.
DR. YASNOFF: I think, again, and I don't presume to speak for Clem, but Clem's point was what we are supposed to be doing is looking at the role of standards and facilitating the exchange, not just the exchange of information, but the full semantic exchange of information and he was pointing out that if you don't know who the patient is, that is a serious problem in exchanging information. It is really hard to argue with that.
So, maybe we can take the approach that Marjorie is suggesting, to say that from our perspective in exchanging patient medical record information, having a unique patient identifier would greatly facilitate that, but in the absence of that, it will mean additional standards are needed and additional costs will be incurred and I think that is important under the -- I mean, HIPAA is supposed to be administrative simplification, not additional complications.
We should point that there is a price to be paid and that is a policy decision that has to be made. But I think that is a legitimate observation we can make.
DR. FITZMAURICE: I was going to say pretty much what Bill said, but him saying that kept me out of trouble.
DR. COHN: I was going to make a suggestion here because maybe there is a piece, not a bulleted one through six recommendations here, but maybe there is a piece under R&D that without -- I mean, what we are sort of saying is that, gee, there needs to be some way to uniquely identify the individual. If we are not going to have a unique identifier, then there needs to either be some R&D or some efforts around coming to sort of universal agreement on how we are going to go about best identifying people most efficiently. I don't know if that is -- I think that may be an R&D activity.
DR. YASNOFF: There is certainly no agreed upon procedure or set of procedures that you can use in the absence of an identifier to figure out who people are. There are numerous approaches and I think R&D in that area would be very beneficial.
MR. BLAIR: I do recall one of the things that was said with respect to when it was removed from the -- because we did have it as a recommendation and it was some individuals who wound up pointing out that the Vice President has indicated we would not go forward on this. Congress has indicated that we should not pursue this issue until privacy legislation is passed and that they felt it was inopportune for us to have it as a recommendation.
However, you know, at least to me, it certainly seems as if what Marjorie suggested and the issues that have been raised here, that we certainly could include that like in Section III in the discussion of the issues to indicate that this is a situation. It has consequences and even though we are not raising the issue again as a recommendation, in the face of Congress winding up saying cease and desist, that we have duly noted it as an issue.
DR. KOLODNER: One of the things that I think needs to be pointed out is that people feel that they have privacy by not having a single identifier, it is that privacy is terribly compromised now. So, there are mechanisms for linking up data very effectively to compromise privacy so that -- I think the sense that if we had a single identifier we would compromise privacy, in fact, there are circumstances under which it would enhance privacy.
DR. COHN: Okay. I am hearing two things. I don't think we have come to closure on either of them. I think we are talking about (a) -- and, Rob, I apologize for blanking there for a second, but one is that there needs to be something in the body of the text referencing identifiers. But let's not turn this into another paper on personal identifiers. We have already, I think, done things like that previously.
The question, though, that I don't have an answer for -- and I am hearing, I think, some consensus on that, that there needs to be some identifiers --
MR. BLAIR: Separate from patient identifiers.
DR. COHN: Just the issue of identifiers.
MR. BLAIR: Yes. Okay.
DR. COHN: With a special reference to the fact that patient identifiers is obviously a very important one. I think the question I have is is there a place in recommendations to talk about some action that the Secretary needs to do. I have been proposing that maybe it be in the R&D area unless it is somewhere better that might help in the absence of a unique patient identifier, that there are other actions that need to be taken. I am sort of finding myself convinced that there ought to be something there.
Now, I didn't hear -- I sort of said that and we went off into a different topic, but is that something that we want to add, say, under the R&D area as something that the Secretary ought to come up with or is it a different type of recommendation or should it even be there?
DR. YASNOFF: I think putting it under R&D makes sense and we can say the Secretary should fund R&D in mechanisms for accurately identifying patient medical record information. We don't have to be specific and we can say that this actually even if there is a unique patient identifier, there still is a problem when the identifier is lost or compromised and so on.
So, I think that really captures the spirit of Clem's point that a key part of exchanging PMRI is knowing who it belongs to.
DR. FITZMAURICE: One might also relate it to patient safety, that if you don't know to whom the appropriate tests are pertaining to, then if decisions are made without that information -- and that might have an impact on patient safety, it might be useful to research the impact of mis-identification on patient safety because there is no unique identifier.
That is a good thought.
MS. FYFFE: The IOM study on medical errors.
DR. KOLODNER: One other thing if we are going to be talking about funding, unless somebody is aware that the definitive studies have been done, if we are going to fund the impacts of how you would link data if there is an identifier, we ought to also talk about how you de-identify data securely so that you can implement techniques that would be trusted by individuals and groups for use in public health or surveillance or other kinds of activities that we know would be needed for the population data as well.
DR. COHN: Let's make sure that we are agreeing with that last comment before we -- are we in agreement that that ought to be part of research and development agenda?
Okay. We have about 18 minutes left.
Any other final comments about all of this? I mean, is there anything else we are missing? I know Jeff will go through the time line between now and June. Go ahead.
MR. BLAIR: Actually, I am going to ask for Margaret's help a little bit with this. I think she has got the best handle right now on the time schedule for when we are able to come up with the updated version and get that distributed and the opportunities for us to have a conference call and the opportunities for us to be able to distribute this to other groups.
Bill Braithwaite, ,one of the pieces in this discussion might be a time for when either this could be distributed to other interested parties within the Federal Government or I think the words you used at one point was whether this should be presented.
So, maybe you could also suggest what the right form should be for that piece of it. But let me let Margaret go through the time lines first and you can be thinking about how we can share this information and get feedback from interested parties within the Federal Government.
MS. AMATAYAKUL: Okay. We think that we should be able to finalize the next draft with all the structural changes and everything by April 17, which is a Monday, and get that out to the workgroup. We would ask for comments back by Tuesday, April 25th. Then depending on the number of comments that we receive and their nature, we might need a conference call. So, it was suggested that we schedule a tentative call.
We were looking at like Monday, May 1st.
DR. COHN: Maybe we ought to say it a little stronger than that. We will schedule the conference call for Monday, May 1st. If we are lucky, we can cancel.
MS. AMATAYAKUL: By May 1st if we have a conference call and you are comfortable with the changes, we would send it to selected external reviewers. If a conference call isn't necessary, we would be able to send the draft out to external reviewers a bit earlier, the week before.
I think we suggested that Friday, May 12th, would be the day we would need comments back from any external reviewers. We would spend the next week processing those comments and generating a final draft for the June 1 and 2 CPR Workgroup meeting here in Washington.
The following week we would process any revisions from that meeting and be ready to send a final draft to NCVHS for NCVHS distribution on June 9, if that works for Marjorie okay.
MR. BLAIR: Comments, thoughts about that schedule?
DR. YASNOFF: Is there any chance we could do the conference call on May 2nd, rather than May 1st?
DR. COHN: I am actually fine with that. Is there -- I look to Margaret and Jeff to see if -- as long as that gives them enough time.
MS. GREENBERG: When are you talking about sending it to external reviewers?
MR. BLAIR: After the conference call or maybe the conference call may not be necessary. If it is not deemed to be necessary, then we could send it to them a week before.
DR. COHN: The only reason we are going to have a conference call is if there are major issues that need to be resolved. My preference would be for us not to have it.
Shall we schedule a time? About 10 o'clock in the morning California time, which is 1 o'clock Eastern time.
MS. GREENBERG: Although you can expect the workgroup to turn around comments in a week, I would think external reviewers would need a minimum of two weeks. Otherwise, it doesn't seem like you are serious.
MS. AMATAYAKUL: From May 2nd to May 12th is nine days.
MS. FYFFE: Can we give them to the middle of the following week, which would be Wednesday May 17?
MS. GREENBERG: What we are working towards is that the committee members would receive it what -- the meeting is the 20th. So --
DR. YASNOFF: Can I suggest that whoever the outside reviewers are going to be, that before they receive it, they all be contacted and so they expect it and are informed of when the comments need to be back so that they can plan it.
I think then you can get better, much better response and much more thorough review if you let them -- I mean we can tell them now that this is going to be coming.
MS. FYFFE: To expect it and to set aside some blocks of time.
MR. BLAIR: Is that schedule then appear to be --
DR. COHN: Is that going to work, I guess -- I am sort of looking at the schedule and --
MS. AMATAYAKUL: Oh, there was also -- you wanted a schedule for government agency review.
MR. BLAIR: Yes, I was waiting -- if this general time line is okay, then I would probably ask Bill if within that time frame from May the 2nd to May the 17th, Bill, were you still thinking in terms of having us do a presentation to a group of government representatives or should we distribute it for comment? What do you feel is the best mechanism and is that time from May the 2nd to the 17th reasonable for presentation and follow-up?
DR. BRAITHWAITE: I think the timetable is reasonable particularly if we notify people ahead of time. I would think sending it out to the members of the Data Council's Health Data Standards Committee with your other selected external reviews, you know, include that in the group of external reviewers, would give them a chance to get some input.
The Data Council is probably the right target for the final recommendations going to the Secretary. A presentation to the Data Council would be appropriate when it is done. I don't think you need to present it to the HDSC. Enough of the members of the HDSC have participated in the process at one point or another to be able to educate their peers, the Health Data Standards Committee of the Data Council.
DR. COHN: Actually, Bill, I agree with your comments about that. I was a little concerned that we would be presenting -- right now we don't need to be presenting and getting verbal feedback. We are at a point now where we need to be getting written feedback related to the draft. I appreciate your view on that.
MR. BLAIR: That gives us all the feedback that we need then.
Are there any other comments or questions or concerns with respect to the overall schedule and the activities that we have between now and the June 1st and 2nd next CPR Workgroup meeting?
That CPR Workgroup meeting, we would wind up not only having, you know, this next draft, but actually we will probably have two drafts that we would go through because by that time we would have a draft that would include, you know, some feedback from the external reviewers and government agencies.
DR. COHN: Which one would have that?
MR. BLAIR: June.
DR. COHN: June had better have all that. I mean, that is the whole point.
I also want to ask the subcommittee's forbearance. I think we will use significant executive discretion in terms of if there are ways to get this out to the reviewers faster because I am a little concerned as I look at these time frames. If it turns out that there are just a couple of issues that are contentious for the subcommittee, we may choose to send it out either with a notation that there is contention and asking for specific reviewer content or, you know, the various options that we are seeing or whatever, to get further comment, we may choose to deal with it that way.
As I said, there are multiple issues. We will get it altogether, but I think we just need to be very focused on getting this out in a timely fashion so that it can be adequately reviewed and also Margaret and Jeff have time to take the comments, put it together in a way that we can review it on the 1st and 2nd.
So, does anyone have any objection with that approach?
Bill?
DR. YASNOFF: No. I think that is good. So, the agenda for the 1st and 2nd would be we would potentially have two full days or a day and a half exclusively to work on this final draft?
DR. COHN: Yes. There will be a minimum of a day and my feeling is --
MR. BLAIR: It is June 1st and 2nd.
DR. COHN: -- that this needs -- this is the priority for the 1st and 2nd. As you have noticed, we have shared this up until now.
MR. BLAIR: Actually, the way we have phrased it is what you would be reviewing on June the 1st and 2nd would be what we would consider to be the final draft. Okay? And that is June 1st and 2nd and those would be any changes that the workgroup would make prior to it being presented to the full committee later in June and that would be for final approval of the report before it would go to the Secretary.
MS. GREENBERG: Essentially it is the same members. The subcommittee would bless it as well, I guess. It officially needs to go through the subcommittee.
DR. COHN: Yes, exactly. One would hope that we would be able to bless it when we are all done.
Questions, comments? Dr. Yasnoff.
DR. YASNOFF: Just one question. Once it is approved by NCVHS, how does it go to the Secretary? Just dropped off at her desk or digital signature?
DR. COHN: I think Dr. Lumpkin, as chair of the committee, will arrange the appropriate way of communicating it to her.
MS. GREENBERG: Typically, though, there is a letter from the committee and, in fact, you are probably going to want to have a draft of what -- I mean, that would speed things up because if you had a draft of what you wanted in the transmittal letter, but -- at the June meeting, but in any event it is then sent to the Secretary
-- would be sent, I think, to the Secretary and the co-chairs of the Data Council. That is generally the way recommendations go to the Department.
DR. COHN: Well, considering that we also need to vote on the transmittal letter, we had better have a copy of that for the NCVHS maybe.
MS. GREENBERG: I was just thinking --
DR. COHN: You are right. I mean, we -- agreed.
MS. GREENBERG: You can defer to the executive subcommittee or the chair or whatever, but it seems simpler -- I mean, I think it would speed things up if you have a letter. It can always be modified, based on discussion.
DR. YASNOFF: Simon?
DR. COHN: Yes.
DR. YASNOFF: After the letter is transmitting, assuming probably it will take the Secretary a minute or two to respond, perhaps a long time to respond, what is the plan for the workgroup? Obviously, if the Secretary responds, we will act in accordance with that response. But prior to when the Secretary responds, are we going to continue to meet and work on these things or are we going to just wait for the Secretary's response?
DR. COHN: I actually am going to be talking with probably all of the members of the workgroup and this will probably be a topic for the June meeting also. I think my hope was is that we could basically have -- turn this back again into a full subcommittee and that this is just one of the activities of the subcommittee was my -- was at least the thought that I would be bandying to people. But there has certainly been no decision made on that because this work doesn't go away based on our recommendations. It is just the question of is do we have a separate activity or is it part of an overall activity. I think we need to discuss that. You can all think about that between now and June.
MS. GREENBERG: We certainly wouldn't want to lose the excellent support of the people who are staff. Although the members are all the same, we actually have somewhat different staff.
DR. COHN: Yes. I think for the staff it is an issue, but I think I would encourage the staff to recognize that the work doesn't go away and the issues don't go away. It is just a question of whether it is the actual workgroup or the subcommittee or the full subcommittee itself that is dealing with these issues.
DR. YASNOFF: So, to state my question another way or to confirm your answer, I should keep the meetings after that on my calendar.
DR. COHN: Yes. Just to remind you, specifically, as we have looked at the recommendations related to message format standards, that is fully -- that is something that we need to be doing as an ongoing and probably accelerated basis in relationship to this area. That is clearly sort of next steps happening in July, September, October and beyond.
MS. GREENBERG: This would be facilitated by having the letter so it would be ready to go, unless, you know, you have to go back to revisions. But, hopefully, that won't happen with all the input.
Actually, I mean, it seems to make sense to me that when you send it out for external review, it should also be available to all of the committee members. It would seem to include them in that. So, if there are some who really haven't been involved, although it was discussed at the last meeting.
But the other thing is that probably one thing that might, you know, focus departmental response would be to make a presentation to the Data Council possibly as soon as the July Data Council meeting, July or August. But anyway, I mean, that is where a -- I think it is a reasonable thing to do when you issue a major report to the Department to present it to the Data Council.
I assume the Data Council will be asked -- members will be asked to comment on it anyway. That is typically what happens. So, an opportunity for a presentation and questions and answers or something might be good.
DR. COHN: Okay. Other comments? We have two minutes before 1 o'clock.
I mean, I think we have talked about next steps. Jeff, thank you very much.
MR. BLAIR: Thank you.
DR. COHN: Good job moving this forward. Marjorie, also.
We will be adjourned until our June meeting, our May 31st meeting. Obviously, you have all written down the conference call time, which we will send out information by e-mail about also.
Thank you very much. The meeting is adjourned.
[Whereupon, at 1:00 p.m., the meeting was concluded.]