Hubert H. Humphrey Building
Room 705A
200
Independence Avenue, SW
Washington, DC 20201
Call to Order and Introductions
Discuss June Letter to Secretary
DR. COHN: Why don't we get started. If we could have everyone be seated. This is a meeting of the Workgroup on Computer-based Patient Records of the National Committee for Vital and Health Statistics. It will be going on for approximately the next two hours, plus or minus a couple of minutes.
Our agenda for this meeting includes discussing the revised work plan, which is now under version 7.0, which Jeff will read off. I think we learned a lot from the last set of hearings that we had, and I think that is being incorporated now and have changed the work plan.
Then we want to spend the rest of the time talking about upcoming hearings planned for March and May. So that's really the agenda. Is there anything else anyone has that they want to have added to the agenda? Rob, anything else?
Okay, with that, Jeff, do you want to review or at least give them the introduction of version 7.0 of the work plan?
MR. BLAIR: By now I hope that most of you are fairly familiar with the workplan. Obviously it's version 7 now. We had two or three conference calls since our December hearings, where we attempted to understand and assimilate the feedback that we had received from the December 8-9 hearings.
I just wanted to help you, for those of you that may be just glancing at the workplan for the first time, to understand how some of those thoughts have been folded in and updated to the workplan. If you recall in the conference calls that we had following those hearings, we had pretty decided that we wanted to include into the introduction to our final recommendations, definitions of uniform data standards, patient medical record information, the electronic exchange of such information.
We wanted to be able to make sure those final recommendations included short- and long-term reflections. A number of the things that we had heard both in the hearings and afterwards, you will find that those notations are included in the introduction of the workplan here. There was no point in making a separate section on that, but you'll find those comments included there.
The other things that we wanted to do was we had revised the number of focus areas, so that you'll see that instead of having four high priority focus areas, we now have six high priority focus areas. That's an assimilation again, of the feedback that we got, the critiques that we got from December 8-9.
The other thing that the hearings and the conference calls led to was the fact that we needed to do what we might call an interim report to the secretary on what our workgroup is doing. If you notice, we have like the supporting activities after the six focus areas. You will see that that reflects that by June of this year we will wind up having -- and I forget the exact phrase that we used, I think Simon is suggesting that we call it an interim report, which might be a better phrase for that. We'll be addressing that shortly.
Finally, you wind up having a new time frame at the end. That's the area where I have the greatest concern at this point, because we are now at the point where in order to flesh the focus areas where we know we have concerns, we need the time to be able to get hearings and do studies on each of those focus areas, to understand them well enough that we could have recommendations of some substance.
As you can see, the calendar for this year starts to get a little bit short. We'll come back to that a little bit later. I do want to make sure that have time to really talk through that calendar, and probably go through maybe some revisions or enhancements to that calendar to make sure that we can actually get all of this work effort in.
I think you wanted to talk about the six areas of focus?
DR. COHN: Yes. I think the introduction to really the calendar has to do with making sure we have the focus areas right. I think that is sort of a first step. Then we can begin to look at how some of this calendars out, and then hopefully after that, begin to talk about really the substance of what we see as hearings over the next couple of months.
Now I think Jeff has commented that we're obviously talking -- we just threw into this workplan, the issue of an interim report to the secretary, planned for around June. Just more of a touch bases, this is what we are working on, this is what we think are pertinent issues.
The other piece of course is that throughout this, and I think Jeff commented on this, we were both looking at long-term directions, as well as some near-term pieces that are practical, that we can recommend to the secretary. So as you move through each of the focus areas, we are trying to mix the long-term direction that we think we ought to be proposing to the federal government and to the secretary, along with are there some quick hits that can be recommended?
Now with that, let's move on to identification of major areas of focus within the workplan, which is III. I think the six areas we identified, and I'll sort of go through them one by one, to make sure that we're all okay with them at this point is number one has to do with identify and recommend message format standards that contain patient medical record information.
This area of focus would include recommendations from our initial -- I guess I should ask Jeff on this one -- from our hearings.
MR. BLAIR: Is there a typo there?
DR. COHN: This is area of focus would include the recommendations from our initial hearings, that we evaluate the need for coordination of these message format standards, and also include document formatting standards, as a particular example.
MR. BLAIR: By initial hearings, that was meant the December 8-9 meeting. Let me change that.
DR. COHN: Any comments about the first focus area? That's pretty much unchanged, with the addition of the fact that we see that we also need specifically to look at the issue of document formatting standards, and the work going in that area.
Major area two has to do with standards in medical terminology.
MR. MAYES: I have one question. We have found certainly in the work with HIPAA to this point that there are sort of two ways of looking at these standards. There are kind of the technical, actual messaging format or transaction format. Then there are the content issues. They tend to be of interest to quite different groups, and we have had some confusion, at least initially in the HIPAA standards so far, over how to coordinate those two different ways of looking at it.
Do we want to make more clear whether we are talking about such things as XML or HL7? I'm just throwing these various technical types of standards out, as versus working with particular content area experts or organizations to work on issues of content standards?
MR. BLAIR: The feeling I have on that, HL7 right now is looking at XML as a modified syntax for message format communications. I think that that aspect of XML probably will -- as a matter of fact, in Michael Fitzmaurice's first draft of the questions that we asked, he seemed to have included that piece in. The other area where XML tends to get folded in is XML is a syntax that would be used within the document formatting standards as well.
Now the third area, if I capture all pieces of your comment is in terms of the content area. We don't have an explicit focus area for content, however, it was mentioned when Ralph Korpman started to discuss the information infrastructure issues. Information models was referenced there, and of course HL7 is looking at the reference information model as a tool or vehicle to generate version 3 of their message formats.
I don't have a strong feeling as to whether we include information models or content issues within the message format area, or whether we include it in the information infrastructure area, or whether we break that out as a separate topic.
MR. MAYES: I guess what you have described, and in fact what is going on as we move towards the object oriented technologies. The XML syntax of course only works when you've got the tag sets defined in a standard fashion. So I guess my own feeling is that they are no longer separable. Maybe we ought to make that clear, that it's very difficult to talk about pure messaging formats as divorced from what is being carried in those messages. And the newer technologies that seem to be coming to the fore, make it actually undesirable to do that.
MR. BLAIR: Should we add another phrase to how we've articulated that?
MR. MAYES: I don't think in this paper, but I think as we go forward, we probably, as we have hearings, and as we produce the questions for the panelists and such, that we should somehow make it known that we are not going to be creating necessarily artificial issues or separations between these two.
DR. COHN: I think that this is a thought that needs to be brought up when we start talking about the questions for the March hearing. I think we are all in agreement that syntax and semantics are beginning to merge a little bit in these things. So we just need to make sure that we're exploring both as is appropriate.
MS. FYFFE: I'm appreciative of you bringing up that point, because in the many hours of the ADMINSIM(?) stuff, you've got the messaging formats, which some people call the electronic envelope, and then you have the data that goes in the envelope. It is never easy to really completely separate those. So it's a lesson we have learned, I think.
MR. MAYES: The transaction message formats are actually based on a view of the world of transactions. As we move into this area, it becomes even less easy to separate those things. It's something to keep in mind as we move forward.
DR. COHN: Should we go on to item two? Item two really is focused on standards for health care terminology related to patient medical record information. It includes such things as data element definitions, data models, and code sets.
MS. HUMPHREYS: Excuse me, wasn't the data element definition just what Bob was talking about?
DR. COHN: Yes.
MS. HUMPHREYS: So you're going to have to put all three of them together, if you put any of them together. We had a big issue with people who also didn't understand when we were talking about content. Even the content people didn't understand. We had two groups of content people in the room. There were those who want to define the data elements, and they didn't know that the other half of the room was actually talking about the coding sets or terminology that would go in the data elements.
So we have a three partite division between people, and I don't think it's useful to divide them into two, and it's not useful to divide them into three either. But there really are three groups, and they often are not talking to each other, even within the two content groups.
It actually was quite a discussion between those of us who are working on drafting the NPRM, where we had to come up with the initial statement, there are two things that we mean when we say data content. One is the data elements, and one is some of the coding sets that go in the data elements. This was quite a discussion issue among the people who were drafting the NPRM.
MR. BLAIR: Are you suggesting that we modify our phrasing here?
MS. HUMPHREYS: No, I'm just suggesting to Bob that in some sense we already have two things in number two, and you, I guess, were really advocating putting three things in number one. That's okay.
MR. MAYES: I'm happy enough with the language here. But I think we need to be aware that these are becoming so intertwined. In fact, one of the problems that we face is the fact that historically they have tended to be of interest to very separate groups who have had a particular focus. One of the things we are going to have to do is somehow try and figure out how can we bridge that and bring them together.
MR. BLAIR: Could I just make one phrase here? Because I think I'm hearing something, and if I could articulate this back, and if we kind of agreement with this statement, it might help. Right now we have these defined as area of focus. In some ways they are perspectives. One of the things that is an attribute of an area of focus or a perspective is that they are not necessarily mutually exclusive. There are not sharp boundaries.
I think that it's beneficial for us to look at each of these without a sharp boundary, because of the fact that every one of these issues winds up having things that influence them, or considerations, which does overflow those boundaries. We can't look at them in isolation. Is that a fair statement that most people would agree with?
[Several people answer affirmatively.]
DR. COHN: I was just going to add on to that, that if we are talking about comparable patient medical record information. I think what we are all saying is it's all of these pieces that need to be looked at. It isn't just one or the other that will do. So clearly, there are focus areas.
Obviously, as part of that we include such things as coordination and maintenance of vocabularies, and other issues related to the actual maintenance and upkeep of health care terminologies. There was one area that was identified specifically which has to do with coordination of drug knowledge basis as a possible area that we needed to look a little further at.
MS. GREENBERG: A question here on content. I shudder to use the word, but is the workgroup thinking about actually recommending some kind of a core data set for medical records, or that there be a common data set, which could also be greatly expanded, but that there be some common core? Not that you would recommend what the core was. I don't think you were going to do that, but what is your thinking on this? Just recommending the vocabulary that would be used? Where are you on that?
MR. BLAIR: At least my thought is that we have identified areas of focus, because we have gotten some indication along the lines that there are problems or gaps or issues that maybe the private sector is struggling with. As we begin to understand those areas of focus, in this case the second one, which winds up including such things as data definitions and data models, and possibly core data sets.
If in the hearings they wind up indicating that if the private sector or government agencies don't feel they are making satisfactory progress, and they feel as if we ought to make recommendations to Congress or Donna Shalala that additional action needs to be taken, to serve as a catalyst or enable that, then we would listen to that and consider that. But I don't think we have preconceived ideas at this stage.
MS. GREENBERG: These are areas of focus that will be addressed in hearings, and were addressed in the first hearing, and continue to be addressed, depending upon how those hearings come out. Is that the level of detail or direction that your recommendations --
MR. BLAIR: One other thing just in your comment here. We have only had one hearing, which was in December. The purpose of that hearing was to give us guidance on whether our initial four focus areas were the right ones. We modified that into these six in response to what the areas of focus should be.
DR. FERRANS: Actually, that brings up a very interesting issue, because I understand what you are saying, however, the language as it is currently written is identify and recommend standards for medical terminology. So therefore, the natural output of what the group would be doing at the end of the day would be to have some recommended terminology standards. I think we're saying that that's not what we want to do. So we either need to remove that.
DR. COHN: The legislation talks about uniform data standards for patient medical record information, and the electronic exchange of such standards. What we're beginning to see is that that means many different things to many different people. Obviously, one of the points of today is to make sure that we are able to get something done over the next year. So as we review all of these things, I think we'll come back and reflect on some of these issues.
MR. BLAIR: Could I respond? I think that's a very perceptive observation. That is a flaw in the phrasing here. We could work on the wording of this, but maybe it should have been identify and make recommends concerning standards. Thank you for that correction.
DR. COHN: The third focus area has to do with identifying and recommending ways to address the business case issues regarding the development and implementation of uniform data standards for patient medical record information. The area of focus would include such things as the cost burden of vendors, SDOs, code set developers, and users to participate in the standards development process. I think many other areas also.
DR. FERRANS: I think if we could also try and add in here just as a suggestion, issues regarding return on investment. I think it was clear from the hearing that we had, that we needed to develop some return on investment. Especially if we are going to be identifying the cost burden, we need to identify the return on investment.
I'm sure it's our intention to do so, and we had discussed it. I just think that perhaps we should make it explicit. When we talked about the business case, I think a lot of us said we really would like to make more explicit the data that says that if we do these things, there can be these savings in the long-term, or there can be these improved outcomes, and that we should put those in as part of the business case.
MR. BLAIR: When we say return on investment, and by the way, the reason I had left that out, and maybe we should put that back in, I left it out because when the discussion was before, people were thinking of the return on investment for a computer-based patient record. Over time we began to realize we were more focused on uniform data standards for patient medical record information. There still may be a return on investment for vendors to develop and implement standards. Am I on target with what you are thinking of?
DR. FERRANS: I think so. In fact, I was speaking to some people recently who were talking about the cost per interface of using proprietary interface engines and that. If you standard along a particular code set or messaging format, or whatever, that you can sort of obviate those costs after a one time up front cost perhaps. And that's one of the things you can say, well, this is one of the justifications for it.
MR. BLAIR: Let me just try to capture this thought, and you tell me whether I've articulated it correctly for an update to the workplan, which is to modify the area of focus on business cases to include a return on investment on the development and implementation of various standards. I think you have even expanded it to the ability to interoperate. Is that correct?
DR. FERRANS: Yes.
DR. KOLODNER: I think one of the things as you phrased that, or as we look at that, it may not be the return on investment for any one vendor, or insurers, or the medical record vendors, but it's really for the whole health care industry. That the savings are seen, and ultimately those dollars are paid one way or another by the people purchasing health care.
So I think that there may be some trade offs, and there may be some areas where it won't be a positive return on investment for a subsegment, and yet overall, at least for HHS, for HCFA, for the consumer, that it lead to more efficiency.
MR. BLAIR: So we need to look at the return on investment for the industry as a whole, as opposed to an individual user? Is that your point?
DR. KOLODNER: Yes.
DR. FERRANS: Some of the business case issues also had to do with improved outcomes I thought, and that the savings came through improved outcomes. I didn't know whether we wanted to put outcomes as -- I don't know how difficult that is to tackle also.
MR. MAYES: I quite support everybody's view on the issue of return on investment, however, I see a big problem here. Return on investment for what? You've got six different focus areas. You could do a return on investment model for any of not only these six areas, but the little subareas, since we are not talking about a CPR in a totality, we are talking about specific standards.
The talk of a global return on investment I think would be a very difficult calculation in the real sense, in the business plan sense, to really make. I don't argue at all that there is return, but to present it that way, we would have to go back and look. I think this goes back to what we were talking about just earlier -- look to the structure of what is it that we're actually trying to achieve?
Well, we're trying to achieve the common exchange of information, but we almost have to start from that point, and then filter down into the specific steps, and somehow qualify that. It would be the return on investment for meeting the charge within the legislation versus the others ways you could make the case. There is a return for going to standard vocabularies, for instance, even if you don't do anything.
MS. FYFFE: Depending on who you talk to, you can always come up with a return on investment. It might be negative. There are different time frames for looking at an ROI. Is there a return on investment for the Department of Defense?
MR. MAYES: For what? Return on what investment?
MS. FYFFE: I know. It's difficult to define. But I think I start this up early on, because I am concerned about the 20 percent of hospitals in this country that run in the red. They are not going to close because they are in the red. They have to provide health care for people. I am very concerned, and I will go on record that any recommendation we come up with consider those types of institutions.
It's a simple matter of you have someone up in Vermont, who is a Medicare patient, who goes to Florida for the winter. Are they going to be able to communicate necessary medical information about that particular Medicare patient? I'm sort of getting off track.
DR. COHN: I would also comment, because we have been through this area before. We have all had this discussion before. The reality is that we modified this to say that we were not going to develop the business case, but we were going to address the issue.
MS. FRAWLEY: That was the start of that discussion last June.
MR. MAYES: I'm just commenting on including the term "return on investment." I'm not so sure that's what we -- we don't have it in there, and I don't think I'd put it in.
DR. LUMPKIN: I would agree with leaving that out. This is just a semantical discussion, but I have been educated that it's all about semantics. So having learned that lesson, I would say that given the hierarchy as I understand it, a business case is much broader, and a return of investment is just one component of that. I don't think we want to focus in on that piece. We want to focus in on the business case.
MR. BLAIR: When you said leaving "it" out, I wasn't sure what you were referring to. What is "it?"
MR. MAYES: The ROI. It's part of the development of the business case within the context. Therefore, it need not be specifically addressed, because I think it gets us off into a direction and trying to present what we are trying to say about computerized patient records.
DR. COHN: There are some other hands up. Let's see if we can wrap this particular piece up pretty quickly. Mike?
DR. FITZMAURICE: I think I tend to think the way John does. ROI to me says what's the return on investment on one particular project. I think our minds are in what's the return to society from investing in standards? We have to understand the business case, because we're not doing this alone as part of the government. We want to know what are the incentives there for business that we can encourage and help with. They only carry us so far. What should the government to get us further for the benefit of society? Of which part of that is a private benefit. Part of it is a public benefit.
DR. COHN: Any final comments on this? I guess what I'm hearing from people is that one of the questions that we need to ask as we get into business case probably bears on their views on ROI. That's probably how we ought to address that particular case.
MS. FYFFE: You might call it cost-benefit analysis, but return on investment means that you're going to make a particular investment, and hope you have a positive return.
DR. COHN: Okay, so we capture that as a question.
MR. BLAIR: The struggle that I have on this is a little similar to what Bob Mayes just indicated. I don't deny that it's important to look at things in terms of a return on investment. I just felt that within our resources and our time, and I think Simon said the same thing, for us to try to do a business case for return on investment would be beyond what we have the resources to do on a small piece, let alone a big piece.
But I thought that the issue was important here, so what I thought was if we could focus as Kathleen said, on those areas where we know there are problem areas, where there are difficulties in justifying a business case. One of the things that we had in the hearings on the 8th and the 9th was an individual who said that it's difficult for small standards development organization to send people to the standards meetings.
So I thought that was a specific thing that we could look at, to say can the government facilitate or help these things if we want to promote standards? I thought if we looked for other specific things, where we know there are business case cost/benefit problems, that that would be our focus.
Now I'm not sure that what I just said captures the concern that Kathleen has, or that some of the rest of you have. Kathleen, does it or not?
MS. FYFFE: I understand you, Jeff. I don't know any way to articulate this any better.
DR. COHN: Kathleen, can I sort of try to sum it up a little bit, because I think that what you are describing is one small piece of it. It's just one of many aspects of it. It may be one of the near-term things that we can make recommendations, but it's certainly a much bigger issue than that, and we just sort of need to asking people as we go along, these are the issues of cost/benefit. What are the issue to you? Why do you need comparable patient medical record information.
Probably the generic type of questions that we asked at the first set of hearings, we probably need to continue to ask almost everyone else that comes before us as one of the questions. So I think the answer is probably yes to it all. So I think you have done the right thing, but I think there are other areas that we need to explore as we begin to come up with questions.
Is everybody okay with that in terms of trying to move on to the next item? Everybody is going yes. Good.
I am actually going to jump to number five here for just a second, just because I think it makes a little more sense, and then go back to number four, if that's okay with you Jeff. Number five has to do with the issue of data quality. It says basically identify and recommend standards for data quality related to medical record information. This area of focus would include: data quality issues; beginning with initial capture or recording of data; the communication of data; the translation and coding of data; the coding or presentation of data; et cetera. These standards are intended to enable accountability for quality.
I think all of us at our first set of hearings saw that there was a fundamental issue. You can't have comparable patient medical record information no matter what you do, if you don't have good data quality. So we added that to the list. That was a new one from the last face-to-face meeting.
Do people have comments or questions about that?
MR. MAYES: It is of course covered in et cetera, but transformation of data I think is also an area that we might want to explicitly say.
DR. COHN: You want to add transformation.
MS. FRAWLEY: What's that?
MR. BLAIR: Could you put it in the context of where we would put it?
MR. MAYES: There is just this long list in terms of beginning with the initial capture, recording, the communication, the translation, and transformation.
MS. FRAWLEY: Bob, can you just define for us what you mean transformation of data, to make sure we're all on the same page here?
MR. MAYES: Oftentimes data is aggregated to various levels and then moved on. So decisions are often made on aggregate data, and not necessarily on atomic pieces of data. It's important to understand as this data travels through -- a good example is the HEDIS data for looking at quality of care in managed care.
Those are aggregate data that in fact are reported to NCQA as aggregate data. What we have found in HCFA when we have done our audits of the Medicare HEDIS is that there are real issues about the fact that people are aggregating and transforming that data differently. So you don't know really whether or not you are comparing apples to apples, and apples to oranges. That's just one example.
MS. FYFFE: Rules of aggregation, rules of normalizing data. You've got to know what they are.
MR. MAYES: Well, that's what I mean. It's an area of data quality that sometimes is kind of like these others, that has not been explicitly looked at in terms of the standards type of issue.
MR. BLAIR: The example that you gave, in my mind gets a little bit more to performance measurement. I would have no problem. Would you suggest, or are you suggesting that the name of this focus area be data quality and performance measurement?
MR. MAYES: No, no. Let me pick another example. One of the issues that we see in laboratory reporting is that -- and this is addressed for instance in the LOINC codes -- is this issue that different labs use different machinery, which have different reference levels. So what is normal in one lab, you can't just take the actual moles per millimeter type of thing and assume that it means the same thing. You have to have more understanding of the element than just the value and the name of the element.
How do you translate? For instance, this will be an issue with the GCPR project. If DOD is using different reference levels for their labs in the VA, somehow you have to transform that, because when it comes across, you've got to put it within the context of the receiver of that. So that's just another example. I don't want to get into great detail. I just thought transformation might be a word for that.
DR. KOLODNER: I guess in looking at this, the thing that troubles me is talking about standards for data quality. What I'm not hearing is standards about data quality. It's standards about other things that impact on the data quality. It's really standards of data management, standards of data manipulation and aggregation that impact on the data quality. To say standards for data quality, I wouldn't know quite what those are.
MR. BLAIR: Should we alter the name of the focus group?
DR. KOLODNER: Yes, but we know that the intent is to look at improving data quality or standardizing data quality. But the standards themselves are not data quality standards, they are standards having to do with the manipulation and management.
DR. COHN: The capture and all these other pieces.
MR. BLAIR: And in fact in a lot of cases here there are not even standards. So could it be that these are issues that affect data quality?
MR. MAYES: Well, but, Jeff, there is a real interest in this. I mean HL7 for instance has just put together over the last year, a new special interest group on exactly this issue.
MR. BLAIR: Accountability, quality, and performance.
MR. MAYES: Gary Dickinson, as you know, has been interested in this for a long time. So I think we are beginning to recognize that this is a legitimate area of interest within a standards-based approach. But it is, along with what Rob Kolodner was just saying, tends to be saying can we come up with standards for the management in the exchange of data that will address quality issues.
DR. COHN: Which special group was this?
MR. MAYES: This was the -- I always refer to it as the accountability sig.
MR. BLAIR: Accountability, quality, and performance measurement.
MR. MAYES: Yes.
DR. COHN: Let's wordsmith it with these understandings, which I think help clarify this a great deal, because we are certainly not the workgroup on quality, nor do we intend to be.
MR. MAYES: It's a very legitimate area.
DR. LUMPKIN: Maybe I'm a little bit confused about this discussion, because when I read that section, I took away something else. It harkens back to my first rotation in internal medicine. I took somebody's word for a lab result, and the senior resident said, you assumed?
Part of this system is the fact that we are essentially are having data that is clinical information that is generated, recorded, transmitted, and then interpreted. Is it of high enough quality that sound clinical judgments can be made solely based upon that data?
That is different than QA data. That is really talking about does this mean exactly what it says? There may not be standards necessary there, but I think we need to address that particular issue if in fact we are going to make our business case.
MR. MAYES: You are absolutely right, John, but the issue is that in today's world it is no longer simply a two point movement of data. It's not just the data creator and the data receiver. There is usually a chain involved now, and it's getting increasingly complex.
What we're talking about here is you may know who it is that you got the information from directly. But do you actually know where they got the information? If they are not the actual -- for instance, if it's a lab test or something, what is lacking now is any kind of formal discussion or description or whether you want to call them standards or not, with how do you understand where this data came from to make that final judgment, is it worthwhile data or not.
DR. LUMPKIN: That's really meaningful to me, because sometimes I can't read my own writing. So I kind of have to guess. So I know that there are a lot of translation errors. You don't want to make clinical judgments based upon bad data, because then you have bad outcomes.
DR. COHN: I think some of what you are describing is actually handled in four also, when we talk about accountability and data integrity. I guess part of the question I have now is I think we are pretty much handled with five. As I looked at number four, and this is referencing the conference call that we had actually thought personally that the issues of accountability and data integrity really fell underneath this issue of quality, but I would be happy to put it wherever it makes the most sense.
MR. MAYES: Four and five to my mind, are very closely linked.
DR. COHN: The one thing that four has at this point, and I should read it -- it says identify and recommend standards necessary to support the health care information infrastructure. This area of focus would include: recommendations on guidelines or standards for accountability; data integrity; including accuracy; consistency; continuity; completeness; context, and comparability; and information models.
MS. FRAWLEY: I have a few comments on that. On our last couple of conference calls when we were discussing this, what we were talking about were standards for the health care information infrastructure, piggy-backing on the work that Don's workgroup has been doing, kind of wedding some of that. And then next part of it in my mind was what we were discussing as a completely different issue.
So number four is actually two different things, the way I was looking at it. We wanted to take some of the work that was being done on the workgroup that Don has been chaired on the health information infrastructure, so we wouldn't be duplicating efforts, because that was our concern on two conference calls ago, that we might be reworking a lot of stuff.
Then the rest of those elements I saw coming in as part of six.
DR. COHN: Five or six?
MS. FRAWLEY: It doesn't make any difference to me. I just remember in the discussion -- I can't remember which conference call we were in, but I feel comfortable with it in five. But in my mind they are separate pieces.
MR. MAYES: Well, infrastructure implies that's the sort of building blocks that you would then address these other issues with.
DR. COHN: The only part that actually isn't included is really the information model issue.
MR. MAYES: But that becomes critical when you want to trace all this data quality stuff. You have to have information on how it is structured.
MS. FRAWLEY: Don's group has been working on an information model, haven't you?
DR. DETMER: Well, I don't know that we would say that we've got on. I think we're clearly going to catalogue what's going on around the world, and try to relate to some of that, and build a matrix. But candidly, it's not like anybody has got a monopoly on this business. It's mostly as you say, just two groups doing the same thing. We're all too busy to do that.
MR. BLAIR: I think that I wasn't sure how to handle it. I'm sure that I did it the right way. What I did was I stripped out the reference to our work on a national health care information infrastructure. You don't find those words anymore in the workplan, because I figured that seemed in the other subcommittee.
Now what I tried to do, and I don't feel like we have to keep it this way, let me offer a modification, because I think Simon is looking at the information infrastructure area, and noticing how many overlaps there are with data quality. Is that correct, Simon?
DR. COHN: Correct.
MR. BLAIR: We might consider combining those two focus areas into one focus area. If we did so, I think it is useful to still have the words "information infrastructure." If we called it something like data quality and information infrastructure, which is kind of more on like a local basis, like within a hospital or an information system on a local basis as opposed to a national health care information infrastructure.
Then took that information modeling piece, so that we don't lose that out of there, and consider under the medical terminology and under the message format standards, there is modeling being done in both of those areas. Just make sure that we cover modeling in both the message format focus area, and also the modeling that relates to medical terminology.
Does that address your thoughts? Or is that a good solution or not?
DR. COHN: That certainly would address my needs. Does everyone understand what we are describing?
DR. FITZMAURICE: I would propose it a little differently. I would take the last half of four, and put that into data quality, because I think it's largely data quality. I would leave a health care information infrastructure focus area. Under that I would have us look at what new technologies are coming down the road, what technologies already exist.
If Congress has solved some of the security problems, is there a need for patient medical record information standards so that it fits that particular security solution? Is there is a commerce solution that these data may have to fit into if they are going to be part of claims or part of quality measurement accumulations?
New presentation formats, new operating systems, high speed transmission of the data, more broad band width available, does that have any implication for patient medical record information standards? If no, then it's a very small section. If some, then it's a medium section. If it's a lot, then it's probably more than we can handle, but we need to address it I think.
DR. COHN: Other comments? John?
DR. LUMPKIN: I guess I'm okay with that. I just have a conceptual problem. That is that we seem to be walking backwards. I thought maybe today we needed to have a little discussion about the mission statement. Because the function of computerized patient records is to enhance quality of care. The test of whether or not the computerized patient record is meeting that is not whether or not it's consistent with the national information infrastructure or the messaging standards. It's whether or not it enhances the quality of care.
So we need to make sure that we put it in the right order, because it may be that it's better for patient care to do it this way, and maybe I'm overemphasizing for effect. But there may be some structures that make it cludgy to use in a clinical setting. In which case, we may need to reconsider our transactional standards, rather than trying to have a cludgy clinical interface that is consistent with our transaction standards.
So it's just a matter of emphasis. I'm okay with that language, but I just think we need to throughout the document and our approach, make sure that we're always focusing on what the goal here is, which is to enhance the quality of care, and efficiency of delivering those clinical services.
MR. MAYES: And access too.
MR. BLAIR: Well, I'm kind of prompted by John's comments in the sense that what's our focus, what are we really trying to do? I think that this reflects testimony from Ralph Korpman of Health Data Sciences. I thought there was a lot of real good value to his comments on that.
But when you wind up saying we should stay focused, I go right back to the phrase uniform data standards for patient medical record information. That's our focus, and the electronic exchange of that. I almost feel as if the attributes of the focus area, health care information infrastructure, is more towards a computer patient record than it is uniform standards for patient medical record information.
If that is true, if you agree in part that that is true, then it tends to make me more support Simon's suggestion that we roll those attributes into data quality. Make it data quality and information infrastructure. I guess I'm rolling back to the idea. And just make sure that the information modeling is included in the message formatting, and in the medical terminology areas.
DR. FERRANS: I would agree about putting it back on quality, because I agree, uniform data standards is not an ends, it's a means to an end. I think we should make that explicit somehow.
MR. BLAIR: Mike Fitzmaurice I think suggested an alternative there, that I didn't want to override.
DR. FITZMAURICE: My alternative was to put the quality in with quality. Leave a holding place for the health care information infrastructure, and look at does it have any implications for the standards for patient medical information or its electronic transmission. In other words, let us be tied with the health information infrastructure working group, and let's not ignore whatever implications there are for these standards.
I fully agree with John. I think all of us do, that the focus is on the quality of care to the patient. That's primary. Next is the efficiency of that care. If there are any implications for access in the standards, we want to consider those too.
DR. COHN: I think what I'm hearing is a consensus at this point. Let me just briefly see if I can articulate it, and then we can try to move on. What I'm hearing is that virtually everything in number four, which has to do with infrastructure, goes into the quality area, with the exception of information model, which probably gets reflected back more in message formats, and gets asked to the format standard developers and others.
That the issue, however, be kept and sort of deferred for the moment pending the results of the white paper coming out of the work group on the national health information infrastructure, and I think a re-evaluation in a number of months. Is that what I'm sort of hearing from people?
MR. BLAIR: That's a good solution. The small modification to that is that some of the information modeling will also probably be reflected in medical terminology as well.
DR. COHN: Agreed. Thank you. Okay, yes, Mel?
DR. GREBERMAN: I agree it's important to show the link to the value for clinical care, but I would also not lose sight in that general statement of the value for public health also. That would include a variety of the kinds of applications of the agencies sitting around this table, as well as state organizations, et cetera. But I think it's important to note both.
DR. DETMER: That fits into the thinking at the HII level, because actually what we are contemplating are three sets of computer-based health records. One that is really sort of patient-focused, one that is population-focused, and one that is personally-focused. So what this group chooses to carve out is obvious its business, it seems to me, but I think ultimately we have those kinds of records, and they will be scalable, and to some extent interactive. At least that's the vision that I certainly would like to see roll out eventually.
Now there is so much work to be done just on the patient one, the care system one, that far be it from me to dissuade the group to just focus on that. That's a gigantic chunk of work the way it is.
DR. GREBERMAN: I agree with that Don, but I think that since the focus is on the computer-based patient records, as an example, we at the FDA would rely heavily on information that derives from them, looking at some of the other issues too.
DR. DETMER: I see it as a worthy debate. The point is there is plenty of work to go around.
DR. LUMPKIN: I'm basically relying upon at least not health systems development, but those that we have developed are public health systems around maternal and child health. Our experience shows that if you make the system work at the point of delivery, you are going to have all the information you need for public health, management, and other purposes, if it works for them to deliver enhanced care.
So I think that's a good point. I just have a fundamental belief that everything I need in my health agency will come out of a record that is developed for the purpose of enhancing care.
DR. COHN: A final comment on this one.
MR. MAYES: That's true, John, but I think that one could argue that there are probably institutions that deliver top quality care using paper. That unfortunately, does not meet the needs very easily of for instance public health or some regulatory agency, because it's the exchange. It's the second part of the charge there, the exchange.
I think actually that we may be -- I really would like to believe that the people that drafted this language, maybe you can inform us, Bill Braithwaite if that's the case. We're so forward looking, that they purposely did not use the words "computer-based patient record," because the fact is that once we fall into this semantic trap. A record means many things to many people. We just heard from Don, they are talking about three different types of records.
So maybe this language here allows us to explore the more fundamental issues. I mean in a way, the record is simply the model, the context in which we turn the data into information for our particular need at that particular time, or for that particular purpose.
So maybe if we don't fall into discussing a particular need, but try to say well, what are the fundamental issues that have to be addressed regardless of whether your need is direct patient care, public health, payment regulation or whatever.
DR. COHN: John, do you have a comment about that?
DR. LUMPKIN: If I could just make one additional comment. I think again, I basically agree, but we need to work it through. For instance, you can go to most records in emergency departments, and you will not find adequate information to do accurate E coding. But I would argue that the information that you would need about the etiology of the injury is important for the care exchange, but basically because of the cludgy nature of our system of record keeping, it is not captured. So that's my fundamental approach there.
MR. MAYES: If there is no care delivered, there is not health care system.
DR. COHN: And there's nothing to code. Any final comment on this? Obviously, we're reflecting on the good work being done by the workgroup on national health information infrastructure, and I think as we look at that, we'll be incorporating various views into some of the work ongoing.
MS. GREENBERG: I don't want to prolong this. I agree, when I read this number five, all the things that I was kind of thinking of were actually up here in number four, so putting them together. In your last sentence here in five -- because we've been talking about two things. We're talking about the quality of the data, but we've also been talking about the data or the purpose is to improve the quality of care. Of course you can't improve the quality of care with bad data quality. In any event, these are two different things.
So here you have these standards are intended to enable accountability for quality, you mean quality of care?
DR. COHN: Yes.
MS. GREENBERG: Maybe you want to say that. You've been talking about data quality there.
MR. BLAIR: Intended to enable accountability for quality of care.
DR. COHN: Let's move on to six, and then we can hopefully move into what it is we're supposed to do over the next couple of months.
DR. FITZMAURICE: I've got a question, because on five, if we are recommending standards for data quality, it is only then that you can have accountability for the quality of the data. We're not talking about quality of care standards, we're talking about data quality standards.
MS. GREENBERG: I wasn't sure what you were talking about there. We were talking so much about quality of care, that I wondered if you were trying to get that in here somewhere.
DR. COHN: No, I don't think that was what was meant there.
MS. GREENBERG: All right, so the quality of the data then. I think you've got to say the quality of what.
MR. BLAIR: Well, it could be different. What I was thinking of was that if you have quality data, you could begin to hold the institutions and the providers accountable for care. You could begin to measure them meaningfully. So I was thinking of accountability for the quality of care.
DR. FITZMAURICE: I'd rather leave that to the users, as a personal preference, and just say better quality data can -- can it help you do your functions better? All right, we want better quality data, and not tell them how to do their functions. Not tell them how to deliver care better, tell them how to make the quality of the data better. Then if the data enables them to deliver better quality of care, then that's their step and their judgment.
Our charge is to develop better standards for patient medical information. Now why do we want better patient information?
MR. BLAIR: For a lot of reasons, and this is only one, is what you're saying?
DR. FITZMAURICE: Yes. I'm saying let's not prescribe how they are going to deliver better quality of care.
MR. BLAIR: Remove accountability.
MS. GREENBERG: But then do you want to say the quality of data.
MR. BLAIR: Pardon?
MS. GREENBERG: If you just leave this word "quality" hanging, you're not talking about quality of care, you are talking about the quality of the data.
DR. COHN: I think we get rid of that whole sentence.
Number six is identify the inconsistencies and contradictions among state laws that discourage or prevent equation(?), storage, or communication of patient medical record information in a consistent manner nationwide. Inconsistencies include laws for record retention, document authentication, access to records, et cetera. This area of focus includes suggestions from our initial hearing that we consider recommending national legislation that will preempt such inconsistent state laws.
So comments? That's number six in the final issue. Kathleen?
MS. FRAWLEY: When we first started the workgroup, and we started talking about this issue, one of my concerns was that this could be like a morass that we would just never get out of, which is why we had originally come up with four areas of focus. I understand the concerns from the hearings, because these are big issues.
I will just caution everyone that AHIMA has done a lot of work in this area already, and we developed model legislative language for creation, authentication, and retention, and spent several years studying this issue. We'll be happy to hand that work over to this workgroup.
We are now starting a new work project on trying to define what the legal medical record is in a computer-based patient record system, because our members have no clue anymore when they are subpoenaed, what they should be introducing in court. That again, will probably be about a year project.
I just am worried about this, because this is one of the ones again, that we would wind up spending an awful lot of time on, and not getting very far. So I will offer whatever we can take from AHIMA to the workgroup, but I just still go back to my initial concern when the workgroup was first formed that we could spend an awful lot of time just in this area alone.
MR. MAYES: Kathleen, maybe that's all we need to do. The charge is simply to make recommendations. So if there has been significant work of high quality that reflects these things, maybe that would the sum of the recommendation was that this has been identified by a variety of groups in the public/private sector, and here is what they have come up with, and we think it's good stuff. You ought to pay attention to it from a legislative perspective.
MS. FRAWLEY: There is so much other important stuff that we need to do. To me, some of this other stuff is much higher priority.
DR. FERRANS: There will be some pieces that perhaps I can help provide too. We had a meeting of the Southern Governors Association Medical Technology Task Force two weeks ago in Atlanta. One of the things that we are going to be looking at are the differences in state laws regarding several different issues.
This is coming up, because the governors want to take a position on some of the legislation that is coming up for privacy and confidentiality. They are very interested, and really that's a lot of what is driving them to look at these, because they think there is going to be federal preemption essentially.
So the next part was, has a lot of this work already been done in terms of look at those issues specifically with regard to security, and then privacy and confidentiality?
MS. FYFFE: I have just hit the wall. This meeting goes until six?
DR. COHN: Right.
MS. FYFFE: Are we committed in finishing this work plan by six o'clock this evening, so that we don't have to discuss it again? I'll stay to 6:15 p.m. or 6:30 p.m. if I can get that commitment. I apologize for being rude, but can we get that commitment, please?
DR. COHN: Jeff?
MR. BLAIR: I don't know how to answer that question. I really want to move this forward as fast as possible. I don't know what compromises the group will agree to in terms of what could be deferred or handled in conference calls. What is it in particular that you are looking for commitment on? I don't quite understand.
MS. FYFFE: Well, we're on page 3, and we've got pages 4 and 5. We really need to bring closure to this work plan. What do you think, Simon?
DR. COHN: I actually think that the key issue in the work plan is number one, agreement on the focus areas and proceed on forward. And then really from my interest at this point, there is a question of proposals for what we are going to do for the next two sets of hearings. That's really how I had intended to move on. I hadn't expected we would go line by line for the next three pages.
MR. BLAIR: Actually, I had a little bit different view, I'm afraid. That is, I am slightly less concerned with refinement of the focus areas. I think if we basically have those down, we are going to be able to cover them one way or another. My concern at this stage is that we are already down to nine or ten months left, to be able to explore these areas. The time tables are where I really feel like we need to spend time. I don't think we have time today to do that anymore. That was what I had really hoped to be able to spend our focus on.
I think what we are left with now is I will probably have to craft by date, how these issues might be laid out for the rest of the year, and work this out in conference calls and try to get that moving within the next 30 days by conference call. Because we no longer have time during this year to do as much investigation and hearings on these issues as I think would have been necessary.
But I do think that for us to stay on focus at this point, I could at least do that separately, and the rest of the time we could wind up where Michael has contributed some questions on the hearings for March. I think that we might consider focusing on those.
DR. COHN: Are we talking about the same thing, Kathleen? If we now move into the issue of what are we going to do in terms of over the next year, in terms of substantive hearings, would that meet your needs?
MS. FYFFE: Yes, I want you all to give me an assignment to call up somebody to get them in here for a hearing. That's basically what I want. Please honor my wishes.
DR. COHN: Let's begin to talk about the first two hearings, and then we'll move on from that, time permitting, for hearings later on in the year. I think we are actually down to the point where we are looking at the overall activities, and timings of hearings and of this.
DR. LUMPKIN: Not wanting to prolong the preliminary discussion, my concern about this document and our approach is that in many ways we are speaking to ourselves or a small group of people. My concern is if we go into a hearing without clearly delineating what it is that we're trying to do, can we not only help define this, but also become advocates and evangelize on this particular message about its importance?
So I think we don't necessarily need to do it here today, but we need to have a document that speaks to those who are on the fringe, who are interested in the issue, who are opinion makers, who may want to come in and say this is what I would like to see the system do, because we have tried to put it in and we haven't. These are obstacles. These are what would make me decide to commit our organizations resources to it.
I think we also need to hear that. I'm concerned that the document is a little bit too much into our internal language, and not enough in the broader term. I just think we need to work on that piece, but not necessarily as a committee.
DR. COHN: I guess what I'm proposing is that we spend the next 45 minutes or so, knowing that we all want to get out of here at six o'clock, talking about some of what we think needs to happen at the first hearings of this year, as well as talking about how we need to spend our time potentially later on to make sure that we cover the areas to our satisfaction.
Now we have talked about the focus areas. We know we're not going to cover all focus areas in the same depth. There is no such thing as comprehensive and complete in all of this. It's a question of what recommendations need to be made to move things forward in all areas, as we move, knowing that really do have until August 2000 to complete recommendations and get them to the secretary. They may actually be the first of ongoing, year-by-year recommendations, depending on what we discover as we move along.
This has been an area that has been worked on for many years now, and I don't know that we are going to solve all problems even in one year, despite the best minds. But if we can make forward progress in each area, I think we should be delighted and satisfied. Is that a reasonable way to describe it?
MS. FYFFE: Sure.
DR. COHN: Now I think what Jeff had indicated in the work plan, and I think what we are proposing is that in the initial March hearings we begin to look into the whole issue of message format standards. Jeff, help me with this one a little bit. I think we were talking about one day of message format standards, talking to some of the standards development organizations on their views of what they think needs to be happening. Talking to them both about longer-term and near-term recommendations.
Some of the areas that I thought we had thought that we needed to investigate and understand a little better included: such technologies as XML, and its applicability; this whole issue of the overall format standards, which you had identified; the issue of the reference information model from HL7 and other information models that may have bearing on comparable patient medical record information. And asking them for their good advice and insight.
MR. MAYES: I think it's important though that when we talk to them and send them the questions, that we make them aware of the time frame. Because when you talk about near-term, the recommendations don't even go forward until the end of 2000. In this kind of a world, I think if you were to say at the end of the year 2000, what would you see would be the recommendations? Because there are going to be significant changes.
Just for instance if you take HL7, right now they are still in the world of their version 2.3, but by 2000, they are not going to be in that world. So if they were thinking you were talking about recommendations for tomorrow, they might talk about 2.3. They won't even bring that up if we are talking about 2000. So the near-term is very relative.
MR. BLAIR: Simon, that is correct on the message formats. We figured we'd have one day on the message format standards, and one day on data quality. Actually, the reason that we picked them out of sequence was because there are things going on outside of the NCVHS committee addressing issues of medical terminology, and we wanted to give them a little bit of time to pull their thoughts together.
So we thought we would defer the beginning of hearings on medical terminology until May, even though we recognize medical terminology will probably have to have several sessions, because it is a major, complex area.
DR. COHN: Let's talk about terminology in just a second, but going back to the format standards piece, are people comfortable with that as a starting place for the March meeting, and all that?
[Several members answer affirmatively.]
DR. COHN: Now one of the questions I have in my mind after this discussion and how much we are putting into these various areas, do people think that there is time in a second day to begin to talk about issues of data quality, or should we plan on devoting -- or is it something that we really should intend to devote all of the March session to the format standards?
DR. FITZMAURICE: I guess I'm a little puzzled, because if we ask them, what do you need comparable patient medical record information for, as I think you asked earlier in the day, what do you use it for? What do you exchange in these messages, then it would be a natural set of questions to ask them what standards do you currently use? What do you like about them? What do you not like about them? What could be done better?
Then to ask them, does the quality of the data that gets transmitted influence what you do with it at the end? Then that leads us into data quality. I can see that virtually for every witness who transfers data and uses a message format, to tell us then if it gets to the other end and it's no good, gee, we shouldn't have shipped it.
So I see not so much as a link, as we have these great people here, let's ask them more than one question, on more than one subject.
DR. FERRANS: Thinking sort of along what Mike is talking about, even though we have these six focus areas, there is a lot of crossover. I agree, I would be very interested to hear what some of the business issues would be regarding implementing the AA standard messaging format. And we're going to have some of the right people to ask, maybe not all of them, but we're going to have some of the right people to ask. It's not just going to be about picking this standard.
Especially putting that in relation to where they are going to be, because I agree, particularly in messaging standards, it's going to be a whole different ball game, where people are at that point, going to be migrating towards a whole different ball game. It will a help if we lay out what it's going to be like.
MR. MAYES: I would like to make sure that when we do ask them the questions -- in some ways it's like an analogy of we're in a world where there are a bunch of scribes, all working with their feathered quills, copying things over and over. You can ask them, how could you do this more efficiently? We might say, we'd like better ink, or better feathered quills.
What we are also trying to figure out is how do we invent a printing press. In other words, how do we actually utilize the information management, information technology to enable business process re-engineering? It's only how can you do what you are doing better the way you are doing it now, it's what areas could you potentially see? The kind of people that come and talk to us here are the kinds of people who think, I think, more forward looking.
What kinds of technologies do you see on the horizon, or would you like to see that would address some fundamental business issues? Not necessarily make it more efficient the way you're actually doing it, but would actually free up to do things.
John always brings up these ER examples, and how if we had this or if we had that technology it would be wonderful in the ER. That is really I think, in addition to what Mike was saying, what are you doing now, and does it work for you, I think that's what you are getting at. We want not only a sort of today's view of the world, but do you see some potential there for really making fundamental changes in the way health care is delivered in terms of its quality, accessibility, and all the other issues.
MS. FYFFE: For the hearings in March, which are March 29 and 30? Is that correct? The Monday and Tuesday.
DR. COHN: Yes.
MS. FYFFE: What organizations are we talking about inviting?
DR. COHN: Mike, I think you have a list, don't you?
DR. FITZMAURICE: What was your question again?
DR. COHN: Who we were thinking about inviting for the 29th and 30th?
DR. FITZMAURICE: I had a proposal that was based upon our discussion at the two telephone conference calls, the messaging standards people, i.e., X-12, HL7, NCPEP, and of a working group of CORBA MED people, IEEE, document formatting standards people, for example ASTM, Claudia Tessier(?), a representative from HL7 CONA, which has been renamed PMA.
MR. MAYES: PRA, patient record architecture.
DR. FITZMAURICE: Thank you. Data Medic, which would talk about ENM formats. Michael Kahn(?), I think he was with Data Medic, I'm not sure. Then a group of people talking about legal barriers in federal, state, and industry. Another category, new technologies, object oriented technologies. Harold Sobrick(?) at 3M was suggested. I guess he also is with CORBA MED(?). XML, Rachel Socolophski(?), HL7, and ASTM she's affiliated with.
Somebody doing data acquisition or collection. Then I have another category, scanning and optical character recognition. I guess this is under data acquisition, scanning and optical character recognition, voice recognition, somebody from Leonard(?) and Hosby(?), Dragon IBM systems, someone who develops or uses computer pick lists. I have something here that doesn't make sense to me, patient entry in waiting room versus physician entry versus nurse/clerk entry. I think that sounds like a research project.
MR. MAYES: Who is providing the data.
MS. FYFFE: So that's a list of about 15 or 20 folks or organizations.
DR. FITZMAURICE: It goes on a little bit further. There is also data quality, Kathy Coltin.
MR. BLAIR: Could I add just one thing? We didn't feel as if we could cover message format standards in one day. We felt that we didn't want to try to do it all at once, because what we may learn out of this first day, we may want to follow-up and refine questions for hearings that might be in May or June or September.
DR. FERRANS: Not all of the people on this list sounded like they had to do with message formats. Some of the data entry types I think, that started getting into other issues. I guess one other question for Kathleen also was about getting in users or hospitals or whatever. I was curious if we were going to do some of that? People who were using some of these standards, and have problems.
I think from some of the users we'll get some of the practical experience about the difficulty of trying to implement poorly defined standards for example, with all the different flavors of standards, and some of the issues there, or on some of the hidden costs or hidden gains in doing these.
DR. COHN: I agree with you. We certainly need a bunch of users.
DR. LUMPKIN: One of the things that struck me about the initial HIPAA hearings is that there were a number of hearings where we heard from the same folks on a different issue. I was just wondering, in looking at the areas that we have, if we could perhaps frame three or four, and invite people in for a longer session, whereby we would kind of walk through some of these pieces as was suggested, in a different format that we have traditionally done. Come in, everybody speaks for 15 minutes, and maybe we'll have five minutes for questions.
Maybe schedule them in for a longer period of time, and try to walk through a couple of these issues as they impact looking at it more longitudinally. And maybe with an alternative structure, we might be able to get closer to what we want to get out.
MR. MAYES: I think that's a good point, John, because if you go to for instance -- and Jeff, you'll relate to this -- the ANSI HSBI(?) meetings right now, one of the things we have seen out of the HIPAA legislation is a greatly increased interest in collaboration among for instance the SDOs. It would be very interesting to sort of look at the areas that they are beginning to collaborate.
For instance, I was at a CORBA MED meeting two weeks ago. X12 was there, because X12 is very interested in moving into the object world with their standards. So by looking at some of these proposed collaborations or actual collaborations that are going on, CONA didn't start out in HL7, it migrated to HL7. That actually, I think, a lot of that activity is being driven in part by business use cases and things like that.
That might be a way of saying, why are you coalescing together around these areas? What is it about this or that that makes you want to work collaboratively with three or four organizations, versus focusing just on your own particular area of specialties? So that goes along the lines of what I think you were suggesting.
DR. GREBERMAN: I wanted to suggest the idea of bringing in some of the users in the clinical area. For example in the area of voice recognition, I know people at Hopkins have had extensive experience in evaluating some systems. I think it would be useful to have that counterpoint.
I guess in terms of the user community in a broad perspective, clearly the clinical users of some of the systems in the future. Also, that would be a good opportunity to bring in some of the specific needs of some of the agencies, again sitting around the table, in terms of what their needs are.
So we could have that discussion between these organizations that are developing message standards, et cetera, and some of the thoughts as to how the current things don't meet the needs and/or do, and see what might be next steps.
MR. BLAIR: We have been running so quickly, that we haven't had a chance to do feedback or anything, so this is very dynamic. My thoughts are that in terms of message format standards, given what we heard from our hearings on December 8 and 9, plus the other concerns that I have heard about message format areas is that there are four primary concerns that we have heard.
Number one is coordination among the SDOs, and whether or not the government needs to encourage or facilitate that. Number two are the emerging areas of document format standards, and again, whether or not there is a role for the government to play in that. The third area is information models. The fourth area is emerging syntax like XML or object oriented syntaxes for carrying message format standards.
Those are the four areas that I thought should be our primary focus as we drive down the message format area. Now Michael, you have a few other things on there, and I just sort of may not understand that there are things related uniquely to health care. For example, scanning and voice recognition, those technologies of course would be applied to health, but I'm not aware that there is a requirement for health-specific message format standards that are necessary for scanning --
DR. FITZMAURICE: Nor am I.
DR. FERRANS: It actually falls under five, under initial capture or recording of data.
DR. COHN: I think before we go on to solutions, we better figure out how people perceive this.
MR. BLAIR: If we are going to have hearings on message format standards, then I don't understand why those are there. So maybe there is something I don't know about.
DR. FITZMAURICE: This is what I picked up from our brainstorming session. I probably have added some of my own in here. It's not meant that these would be all of the things discussed at one hearing, or that they need to be in any hearing. But I am short of ideas. I'm short of whom to invite to the next hearing. So it's my way of putting this in front of you saying, all right, let's have some decisions made, and then let's have some suggestions on people to call.
DR. COHN: I guess I have a couple of comments listening to people. First of all, I think that Jeff's areas of focus are probably very appropriate areas in terms of some areas that we ought to be looking at. So I agree with you about that Jeff.
I also heard from John, and I sort of liked the idea that we should try to rather than doing these areas sequentially, we should try to see how many of the areas we can handle for a group at one sitting. We definitely ought to make sure we get some quality questions in to whoever comes on any of these issues.
We may also decide that there are some other areas here. Maybe business case issues become an area that we once again ask people as they come through testifying on some of these other things, because if we don't do it that way, we're never going to get it done anyway. So we need to think about it in a slightly different way.
Now having said that, Mike, you're obviously asking who in the heck we should be inviting.
DR. FITZMAURICE: Whom should we invite? What questions should we ask them.
DR. COHN: Yes, and obviously we need a combination. We don't just need people who are developing standards, but we clearly need a mix of developers of standards, users of standards, vendors trying to implement standards, so that we can understand the various dimensions of the implementation and use and opportunities.
Do you agree with that, Mike?
DR. FITZMAURICE: Yes.
DR. COHN: Kathleen?
MS. FYFFE: I think for practical purposes we need to know who we need to invite, and get the word out to them, with a general letter saying we're going to need information from you in these general areas, and we will follow-up with a more specific set of questions in a couple of weeks.
What I get concerned about is getting on people's calendars, and really identifying who we need. I really hope that we can make some phone calls this week or next week, and invite folks to these hearings, which are just next month, so that we don't get caught not being able to get certain groups.
DR. COHN: Well, Kathleen, just to focus things, I think that we probably can come up with many of the names in standard development organizations that represent the four focus areas that we're talking about. I think the place that it would be of help for us to just think about for a minute might be the business community, the user community, others that are outside of what we think of standard developers.
As well as if we do want to in any way touch on specifically this issue of quality, are there other people in addition we should be inviting that might be able to address it during some panel? So Kathleen, you're good on business users. Do you have some thoughts?
MS. FYFFE: I want to hear from some hospitals. Forgive me, not the American Hospital Association. I want to hear from some actual hospitals themselves, as well as some practice management system vendors, because often in physicians' offices it is the vendors that are essential in figuring out whether they are going to be able to do any of this.
MR. BLAIR: Let me just add here, I do think we need ambulatory vendors. Practice management systems, for the most part, deal with applications of scheduling and reimbursement issues. We're trying to focus on uniform data standards for patient medical record information. So you probably want to go after the ambulatory vendors that are dealing with electronic health records, as opposed to practice management.
MS. FYFFE: Well, that's actually one of the symptoms of the challenge here. Because you have a lot of medical practices out there that only have scheduling and appointment and claims submission. They don't have anything else. That is one reason I want to hear from that segment. There are a heck of a lot of them out there.
We obviously need to hear from ambulatory, but I'm also interested in hearing from those organizations that aren't anywhere near what the ambulatory guys are doing, because they are part of this equation as well.
DR. FERRANS: We could just hand out invitations at HIMS.
MS. FYFFE: HIMS?
DR. FERRANS: The big IT -- there is a large health care IT conference. I was sort of joking, because all the vendors are going to be sort of lined up there. We could probably find them very easily there. But that's certainly not going to meet our time frame.
DR. COHN: I don't think we want all vendors. We want a representation of vendors, with multiple different interests.
MS. FYFFE: If you start with the end in mind, and we want to get this thing implemented into all hospitals, and hopefully physicians' offices, you have to hear from those folks. They are the ones that are at ground zero. So we have to find out from supposedly a business case point of view, where they are now, and what it's going to take for them to implement our recommendations.
MR. BLAIR: My only thought in making the comment was that we want to -- I thought that it would be most productive to hear from the vendors that have attempted to deal with these issues, which would be those folks that are attempting to build some form of an electronic health record, because they've struggled, and they're having problems with lack of standards, they are having problems communicating.
The practice management folks, if they are dealing with applications of scheduling or electronic claims, a lot of those folks really don't have experience yet in dealing with standards for patient medical record information.
DR. COHN: Jeff, actually I'm going to agree with Kathleen on this one, only because I think at our last hearing in December we heard relatively extensively from the group that you just described. I think it's important that we cast our net a little wider to hear from many of the other vendors. I can think of four or five who fit the description that you just gave.
So that's not to say we don't need some of the others, but I think we need to figure out -- I just need to find out from people who aren't doing things.
MS. FYFFE: Right, we shouldn't preach to the choir here. We have to hear from the other folks who may not even know anything about this.
DR. FERRANS: I would love to hear from the CIO of a medium-sized community hospital, that is out in the suburbs. It would really be considered a large hospital. It's not academic.
MS. FYFFE: I would also like to hear from the CF or the CIO of a large inner city hospital that is in the red. We don't have to look far.
DR. COHN: I guess the other question I would bring up for this March hearing is whether or not some people that are dealing either with performance measurement, quality, or other end users of data, since obviously one of the clients of all of this -- I'm talking about comparable patient medical record information.
Vendors are people that need to be dealing in this area. Hospitals need to be dealing. There are probably people dealing with utilization, quality assessment, outcomes research, others that may -- we need to be careful obviously in identifying who that might be, but it becomes a different group that we might want to talk to.
DR. FERRANS: The person I was actually thinking of in that regard would be the sort of regional CIO for a large hospital chain that is sort of doing data warehousing. They are getting feeds from maybe 20 or 50 hospitals, and then having to look at the quality metrics for the purposes of managed care and whatever kind of quality metrics.
MS. FYFFE: That's an excellent suggestion.
DR. COHN: I think obviously Mike would love to have names also.
MS. FRAWLEY: I was going to say that Kathleen and I can come up with lots of names. I've already got a list of people that I think about. I guess what I'm still struggling with is how we're going to handle these two days. We were talking about the message format one day, and then data quality the next day.
I agree with John's point that trying to get people to react to more than one issue could be very, very helpful. I have no problem coming up with a list of names of users, vendors, different groups. I agree with Kathleen, we don't want to just hear from the same group. We would like to have some fresh faces to the table. But I still struggling with how we are going to work out the 29th and the 30th. How many people are we going to invite? It could get very overwhelming also.
DR. COHN: We've done that before.
DR. GREBERMAN: Just two comments. One, I did want to follow-on some of Kathleen's comments. I agree, understanding why we to be able to get some of the nontraditional faces around the table showing up. But I think it is also very useful to work with the trade associations, and I'll include the American Hospital Association, and some of the other vendor trade associations. I have found them often helpful in identifying those people. It helps get the word out afterwards.
MS. FYFFE: Yes, I take full responsibility for my comment about the AHA, by the way. But I want to qualify that. I want to hear from somebody who is out in the trenches.
DR. GREBERMAN: I don't think it is mutually exclusive in finding somebody in the trenches, as well as dealing with those other organizations. At least based on my experience, it has worked out.
MS. FYFFE: If the AHA can help us find some folks in the trenches, that's the person that ought to be sitting at the table, not someone who is one or two steps removed, who is on the staff of the AHA, because they are not out there doing it.
DR. GREBERMAN: In terms of structure of the meetings, if we look like we're having a variety of topics, more than would run for two days, we might want to consider parallel sessions, with the opportunity for crossover, as one way of dealing with that.
DR. COHN: Yikes. You mean dividing us up into two different groups? I don't think so. I don't think we have enough manpower, staff.
Let's try this one on for size. Obviously, we're talking about hearings, we're talking about perhaps a few fewer people per session, with the chance to have a little more interactive discussions during each of the sessions. We're probably talking about going into the afternoon of the second day. Rather than having the whole afternoon for us to talk, probably just an hour or two towards the very end of the day on the second day for us to begin to put things together.
Probably starting out with more structured information about some of the areas I think Jeff had identified around messaging format. We'll look at the opportunities and issues around them to see if there is something there that we need to be further investigating.
Then beginning to move into the vendors, and other users, and as we go into the second day, beginning to also pull some of the quality people in, and other secondary users of data. People like the data warehouse CIO from a large hospital or otherwise to begin to talk about some of the other issues.
Does that begin to paint a day and a half or two days? John?
DR. LUMPKIN: Again, depending on how we do it, I just wonder if there might be some benefit, and it's an issue that came up in the privacy committee, which was there may be some benefit to having a more cross-sectional panel discuss some of the issues, where you can get interplay between the groups that we talked about bringing. They are going to be talking to each other, and I think we might get a different interchange if we have some of the quality users talking in the some panel with some of the format folks, with some of the ones. And maybe have one panel with the vendors.
DR. COHN: Other thoughts or comments? Clearly, there are going to need to be some conference calls in the very near future to come to final agreement on the questions and additional speakers.
Kathleen?
MS. FRAWLEY: I'm just concerned in terms of time. My concern is just there are only five committee members on this workgroup. Four of are here, so that's good, but I'm just concerned that we just can't keep having conference calls. I am more than happy -- I will not be back in my office physically until Monday -- but I would be more than happy to send Mike a list of people that fit into all the groups we just talked about, and jot off a bunch of questions.
My concern is that we just don't have time to fit any conference calls in. I'm just starting to get concerned, because I keep looking at this work plan. I just don't see how we are going to get this all done, because there are just so few of us, and meanwhile in the Subcommittee on Privacy and Confidentiality we just agreed to do another day and a half somewhere. I don't know when. We haven't even gone to the Subcommittee on Standards and Security, and figured out what we are going to be doing there.
It's the same group of us around the table. So we just are trotting from one meeting to another. So I just don't want to be the wet blanket, but I'm just turned that it's ten to six, and that we really need to make some commitments today, because the idea of trying to schedule another conference call, by the time everybody gets their calendars cleared and we get an e-mail message out, and we set up another call, we have lost another week or two.
MS. FYFFE: Now I support what Kathleen has said, but in addition, the other folks here who are not members of the subcommittee, who are from HHS and HCFA, who have been tremendously helpful to us. I greatly appreciate that, and we know you have limited time as well. So we need to contain our ambitions here.
Can we just start by saying over two days of hearings, perhaps we should have a maximum of 12 organizations invited? I don't see how we could have a discussion of really more than 15 organizations or 15 people at most over two days. That's a heck of a lot.
DR. FERRANS: What did we have last time? How many speakers did we have?
MR. BLAIR: We had about 23-24.
DR. FERRANS: And that was over?
MS. FYFFE: Two days.
MR. BLAIR: A day and a half.
MS. FYFFE: That was information overload for us.
DR. FERRANS: I agree. I think that there were some people, and I think there were some other comments about that, that we wished they could have stayed for a half a day. I think it would be helpful to certainly get the number under 23; maybe 12 or 15, and have them in for a little longer.
MS. FYFFE: You would have to give me a really good reason that it would have to be more than 15.
MR. MEYER: As an observer, I would like to add additional weight to John's recommendation. It makes sense to me to embody a select panel of six to eight people, and spend the day with them on a series of topics, and get their perspective on the whole issue of data capture, data quality, warehouse content, information exchange, and go through the whole litany with this panel that represents several perspectives.
Before, as you pointed out, the panel has been focused on a given area. You have basically got repetitive information from six or eight people -- little changes here and there, and that's okay -- but much the same information. Then you have limited yourself in your ability to interact with those folks.
I think John has a lot of merit to his recommendation. And to get that interaction, where a privacy advocate or a small hospital CIO might say, well, that's sounds good to you as a vendor, but I never see it in my environment. Here is why.
DR. COHN: More thoughts?
DR. LUMPKIN: I'm not sure about a full day. We might do a half day with a panel of six to eight. I think that would be good.
DR. COHN: Okay.
MR. BLAIR: This maybe only reflects the area that I have here, and it may not be appropriate for the committee as a whole, and I haven't discussed this with anybody yet. What I was envisioning was if we had four panels during the day, one panel would focus on the coordination issue, another would focus on the information modeling, another would focus on syntax, another one would focus on data formats. That's one day.
I don't expect that we will resolve all issues. I don't think we can complete in one day. My thought is that we'd get enough information on that day that the remaining issues would be addressed in a follow-on session either in May or June or whenever. But for a panel, which could basically go for an hour and a half.
If you want to just take X amount, there is diversity of issues on how it could be used, and what it could be used for, and how fast it could be used, and where it is appropriate. My feeling is that we might have four different viewpoint or perspectives represented on XML.
Please don't confuse the fact that if there is a representative from HL7 on XML, that that's redundant with the representatives we had in the past. They would be different people, with different backgrounds. These would be the folks that happened to be with HL7 or ASTM, but they would be different people that we would be seeing. They would be XML focused, expertise people.
By the same token, if we had a representative from a vendor, and that vendor happened to be HBOC, it wouldn't be Dan Russler(?) a second time, that kind of gave us an overview in our past piece. In this case in terms of the message format pieces, it might be whoever -- it may be Chuck himself or someone else that is especially concerned about the areas of coordination for example.
So in any event, I thought that that would try to give us the diversity. It would give us the focus. It would give us an opportunity in a day to drill down to a core set of issues, which we could follow-up in a subsequent hearing day.
DR. COHN: Other comments?
DR. FERRANS: Just to play devil's advocate. Those groups are sort of focused on the standards, and from an engineering perspective. Perhaps trying to bring in the end users in that paradigm, I'm not sure where they would fit in, or how would we put them in? Would we put in a different panel?
MR. BLAIR: I was thinking of including the end users and the vendors and representatives of SDO in the particular panel on the particular topic. We could do it different ways, but certainly there are users that are pioneers and leaders, that have struggled to implement these systems, that are having problems with the implementation.
There are vendors that are trying to wind up pulling this stuff together, that have very different viewpoints on whether these things are appropriate or not. So I would think that if there was a panel on XML for example, there would be some users, some vendors, and some SDO representative, and we would particularly look for diversity.
DR. FERRANS: And the panels again were syntax -- what were the four panels again?
MR. BLAIR: One would be the issue of message format syntaxes. Syntaxes would include both XML and object orientation. The other one that I thought might be appropriate might be on information models. A third area that has been raised to us as a concern has been coordination among the SDO organizations and message formats, and document formats. That's an emerging area.
DR. COHN: Nothing like trying to make decisions at 6:00 p.m. Do people have opinions one way or another about this? My sense is that we need to do sort of a mix and match of some things. I think that Jeff probably is right, that there are certain issues that maybe we can focus in on and have relatively focused discussion. But I would like to also provide for some more heterogeneous discussions with larger groups.
Comments, views? We can do it however people want to do it.
DR. GREBERMAN: I think it makes sense to have some of the diversity, heterogeneity in this. I guess one other area of heterogeneity I wasn't quite sure whether I got that in context of Jeff's comments. For example, people can deal with alpha-numeric information data, image data. Then there will be some other graphical representations, and a variety of other things. Probably the same people will think of voice obviously. I think the diversity has to include the people/organizations that can deal with the diversity types of data.
DR. LUMPKIN: I guess my comment is less on the way that the pie is sliced, as much as the format of the hearings. I just think that after doing this for two years, that having too many speakers and too short a time to really have give and take, I don't think has been useful. It was easier before when we had to just, okay, yes, we do like 837. That was fairly easy.
When we're dealing with more difficult subjects, I think we need to give ourselves a leeway to get a little bit more in depth. Four panels in a day I just don't think will allow us to do that. It may be that we may want to spend half a day on two of the panels' worth of stuff. Coordination of the SDOs is an important issue, but perhaps dealing with that in the abstract may not be as important as trying to deal with it in the context of either the syntax or the messaging standards.
So if we can think of some way that we can consolidate some as a diversity group, and try to dig in a little bit deeper and better understand, and not have as much stuff thrown at us, there may be a way to do both.
DR. FERRANS: If we could knock out actually the coordination of the SDOs panel by perhaps asking the question ahead of time, or having one of the SDOs perhaps come up with some laundry list of where they are coordinating.
Then maybe one of the questions could be sort of along the lines of how we directed the original. Where are there problems with coordinations of SDO, and how can the government encourage? Then it would just be in the context of the other panels that we have. So perhaps it's not a panel dedicated unto itself. That might knock out one panel.
MR. BLAIR: I think that's a constructive idea.
DR. LUMPKIN: Then if you've got three panels, that's a day and a half.
DR. COHN: Okay, I think we have come to some agreement on how we're actually going to do this. I think what we will need is people to come up -- I think we have an early draft of possible questions. I think we need to revise that over the next couple of days, or by the end of the hearings. People on the subcommittee will hopefully have a revised version that then they can further comment on over a couple of days by e-mail, along with coming up with additional people that we think need to be at these sets of hearings.
Now let me just talk for a second --
MS. FYFFE: Can we just do some time lines? When we are going to get the list of people from Mike and the questions?
DR. COHN: Hopefully, Mike and I will have another draft done with some questions by the end of the NCVHS meeting. When do we need to get back names and comments on questions?
DR. FITZMAURICE: I'm going to out all next week, and then back for the duration. So I can probably get something if we work together on questions, by Friday. Well, I'm on jury duty tomorrow. But hopefully, nobody will commit a crime, and they'll say go home as soon as I get there. But there is Thursday. I can think while we are having other discussions as well.
Is the questions that is critical? I think we have settled on the three areas that Jeff has proposed, is that right? Have we decided quality questions about data in with the testifiers, and not have a separate session and the next day on quality?
DR. COHN: Yes, and try to interweave them, as well as maybe additional people as part of the actual panels.
DR. FITZMAURICE: All right. We'll aim for having something like three panels on day one, rather than four panels on day one? Or is three too many?
DR. COHN: Two panels on day one, and maybe one panel on day two.
MS. FRAWLEY: What we're basically talking about is about five people. That would be a total of 15 witnesses.
MR. BLAIR: I was hearing two different things here. I thought I heard three panels on day one.
DR. COHN: No, two panels on day one.
DR. FITZMAURICE: We're talking about roughly five witnesses at each panel.
MR. BLAIR: The only thing that I have a concern about is an individual that might have XML expertise, may not be an individual that has information modeling expertise, or data formatting? I do think we can roll in the coordination of standards as a question within all of those, so we can eliminate that one.
So basically what you are saying is like we would have a panel in the morning on XML, and a panel in the afternoon on information modeling? Is that what you are saying?
MS. FRAWLEY: No. I guess what I'm hearing -- that's why I just want to make sure we get this put to bed tonight. So we would have a panel in the morning, a panel in the afternoon, and a panel the second day. The five people on that panel can talk to us about X number of issues, which is data quality, which is about syntax, which is about modeling, which is about business case. I mean the whole soup to nuts.
MR. BLAIR: I just don't think that you are likely to find -- the information modeling and the XML tend to be leading edge areas. You don't necessarily find somebody that can talk very informatively about both. There would be different people.
MS. FRAWLEY: I don't know how we resolve that, but the point is that I think my big concern is that I just don't want to spend a lot of time hearing from the SDOs talking about different kinds of things. I think the sentiment is that we want to get lots of different perspectives and some diversity.
When we started some of the original HIPAA hearings, if somebody didn't know something or didn't have a comment on that, they passed. So they get their time to talk about their area of expertise. If they don't have any comments on the other issues, fine. Somebody else may sit on the panel, have nothing to say about A, but have comments on B, C, and D. That will be valuable.
I just don't want to see us locked into a box where we listen for three hours on XML, because I know I would have a gun to my head, and I probably wouldn't come back for the remainder of the hearings. I guess what I'm hearing is 15 witnesses. Because you had to think like today. We had five witnesses today, and we did three and a half hours. That worked fine in terms of the amount of time. I felt like we got what we needed to know. There was some we need to follow-up on.
I think that five in the morning, five in the afternoon, five the next day, and we pick the best 15 we can come up. If we need stuff submitted for the record in writing, people can send stuff.
DR. COHN: Kathleen, just to further state it. I think what you are talking about also is that we ask a set of questions to everybody, with a paragraph saying, we know that you are expert in all of these areas. Feel free to not comment on areas that you feel you don't have expertise.
MS. FRAWLEY: We did that for one of the hearings. I remember we worked with Bill on that. We had a laundry list of questions. I remember saying to people if you didn't have a particular area of expertise here fine, you could just pass the gauntlet on that one. Because I think the main thing is that people will do a better job for us if we let them know up front what the questions are.
We gave everybody who came today questions, and said this is what your little contribution -- this is what we want to hear, so we didn't have people meandering all over the place. I guess what I'm trying to get a sense of Mike, if we get stuff to you by February 15, does that work, if you are out all next week?
DR. FITZMAURICE: Yes.
MS. FRAWLEY: That's six weeks out.
DR. FITZMAURICE: That's the day I come back. I can put stuff together and turn it around to you very quickly.
DR. COHN: Let me talk for just a second about the May meeting, and what I think we're thinking about for that one, knowing that we'll obviously have to have a conference call or two at some point to discuss that further. Our intended focus for the May meeting is actually likely to be medical terminology or health care terminologies. Even though I know that Jeff is very anxious about that area, I think we all should be somewhat anxious, because it is a big area.
The good news is that between now and that session there are likely to be five days of national meetings occurring around health care terminologies that we hopefully will be able to leverage. So we need to think of this as sort of the capping of a number of national meetings that will be occurring, one of which hopefully this group will help co-sponsor.
The idea being that it isn't just the two days that we're going to depend on, but we'll have a whole bunch of other information, as well as discussions by the affected parties occurring there, that will hopefully come up with some recommendations that will of some value to us.
Now I will just warn everyone right now that meeting is actually scheduled for May 17-18. That date may slip a couple of days later, as into the later part of the week potentially. We will obviously query people. Hopefully, we'll know over the next couple of days about that.
MS. FRAWLEY: Why are we changing the dates? We've kind of committed to those.
DR. COHN: The reason has to do with the fact that one of the major meetings that we're depending on, that date itself may be slipping to the 17th. Those dates may actually be the 17th, 18th, and 19th for the national terminology conference.
MS. FRAWLEY: Who is putting on the national terminology conference?
DR. COHN: The CPRI.
DR. FITZMAURICE: This is in May?
MS. FRAWLEY: That's not in May.
DR. COHN: It's in April, but it's potentially slipping.
MS. FRAWLEY: I don't know how it slipped, because I'm on the executive committee, and I haven't heard any slip. I don't want to be a wet blanket here --
DR. COHN: We'll give you a phone number to call.
MS. FRAWLEY: I left my office last night, and this is the first I'm hearing of this.
MR. BLAIR: He sent out the notice yesterday.
DR. COHN: I just want to alert people that there may be a slippage. I'm not stating that there will definitely be a slippage. I just want to alert people that it might end up slipping a couple of days.
MR. BLAIR: Could I just add one other thought on that? Kathleen, I very much agree that the format for today's meeting worked extremely well. When I think of medical terminologies, I think the format would work well where we have folks who have expertise in medical terminology and a diversity, and we could have that a half a day or even a whole day, and that would work every well.
In terms of your suggestion that we have the extensions with respect to message format. I have a little bit more difficulty, because things are a little bit more fragmented. They are not as -- we'll do the best we can to get individuals that at least have some cross knowledge. I think it's going to be a little bit more difficult to do with message formats, but I do agree that it can be done with the medical terminology.
MS. FRAWLEY: The only reason I'm just concerned is because I can't make the hearing in March. I'm just worried if we try and talk about slipping dates in May, because you only have five members, including the staff. My only concern is when we start talking about slipping dates, people's calendars start filling up. I bolded those dates out so that nothing else gets onto my calendar. This is the first I'm hearing that the CPRI conference is slipping.
DR. COHN: Yes, and you're on the executive committee.
MS. FRAWLEY: I knew nothing about it. I'm glad I'm here.
DR. LUMPKIN: Point of order. You actually have six members.
MS. FRAWLEY: Oh, good.
DR. LUMPKIN: I'm officially a member.
DR. COHN: I think before any changes are made, Jeff and I will individually query the members, and hopefully we'll have this determined and settled by the end the NCVHS meetings over the next two days.
MS. FRAWLEY: I agree, there is no point in us doing these hearings, because we were predicating that on the conference being held in April. So I mean there is no point in having it. My only concern is we're going to start running into Memorial Day weekend, and the beginning of June is CPRI -- we'll be on a roller skate, trying to figure out when we can get the next meeting here set up.
The other thing, in terms of the terminologies piece also in May -- that's the only thing we're going to do in May then, as far as that hearing? Those two days?
MR. BLAIR: I could easily see that that could be a full two days. That wouldn't be the end of it. I imagine that there are going to be some real serious issues, and we may have some follow-up hearings in June or September or October.
DR. LUMPKIN: As long as we can do it on our own terms.
MS. FRAWLEY: The only reason I'm concerned is because our time line is tight in terms of our work plan. I think you did a really great job in terms of putting out the time line. My concern is that once you hit June/July, then we're up to September. The next thing you know, it will be the end of the year.
So I'm just concerned in terms of resources, how we approach this. So like I said, the May thing definitely in terms of the terminologies is a big issue. I guess the other thing I'm just concerned about is that before the summer we've got a good handle on most of our focus areas.
DR. COHN: Well, Kathleen, let me just ask, because we haven't talked about the remainder of the year. Certainly one option is to put a hold on the day before the June NCVHS meeting, to have hearings.
MS. FRAWLEY: I was going to say, if you don't grab it, I will.
DR. COHN: Yes, I know. That's why I'm sitting here looking at you.
MR. BLAIR: Two days, one for confidentiality and --
MS. FRAWLEY: Yes. The problem that we all have is we're trying to tack meetings on to other meetings. So I don't have any problem with that. My concern is that if we don't get a handle around our six focus areas by June, that we're never going to be able to get through this whole work plan. I hate to keep pushing it, but I just want to make sure that we are maximizing our time.
MR. BLAIR: As a committee, and I think Kathleen has said this, and maybe you're saying it now, I would hope that at this point we agree on the six focus areas, and our next step is to make sure we schedule those hearings and lay them out for the rest of the year. I would make a draft or straw person of trying to lay them out for the rest of the year. Get that out as quickly as possible by e-mail. Have you all critique whether you feel like that's in a realistic balance of times and schedules. Is that inconsistent with what you are saying?
MS. FRAWLEY: No, that's great. I just want to make sure that we don't spend a lot of time talking about the plan, as much as how to activate all of it. So I feel like we're making some progress. We've got a good game plan for March. I don't know what we're doing for May.
MR. BLAIR: Let me ask you one thing, because I think this really gets to it. Simon, in terms of a time table for the rest of this year, I had a couple of assumptions, and you folks tell me whether these are reasonable assumptions. Do we have five minutes just to focus on the time frames?
Folks, could you glance at the time frames, please, in the work plan, which is the last section. I'm not sure these assumptions are correct, but my feeling was that for each focus area we would time by the end of this year to come up with a draft of our recommendations for each focus area, so that we would have the first half of the year 2000 to integrate all of those individual recommendations for the individual focus areas into a final document that goes to the secretary of the Department of Health and Human Services and Congress.
I left virtually six months for those final recommendations to be done. Maybe I would ask both Michael Fitzmaurice and Bill Braithwaite in particular, because I have never gone through this process within the Department of Health and Human Services. Do we need to leave that much time? Is that realistic for something like this?
DR. FITZMAURICE: It's probably realistic that it will take that amount of time, regardless of when we turn it in. But if it's not so controversial -- we're not talking here about implementing a HIPAA-style. We're talking about here are the issues we think are important. He's what we think the government can do about it. It probably isn't going to take that much time. It probably won't take but three months.
MR. BLAIR: Well, if it only takes three months, instead of six -- is Bill Braithwaite here too?
DR. BRAITHWAITE: I'm here, yes.
MR. BLAIR: Do you concur with Michael's judgment?
DR. BRAITHWAITE: I do.
MR. BLAIR: Then that gives us a little bit more breathing room to lay things out during this year.
MS. FRAWLEY: Jeff, when we were doing the privacy recommendations to the secretary, that was a three month process in terms of what we did. So using that model, the subcommittee worked on it. The drafting was done, and then we were reacting to the document, and we brought it forward to the full committee and finished it up. That was about three months.
So I think the important thing is we are going to need some time in that first quarter of 2000, because let's just say on a wild guess that Congress passes the legislation on privacy and confidentiality. My concern is we're going to need some time in that first quarter of 2000, that if there has been any legislative or regulatory activity, we may have to kind of go back and do some more work in terms of some issues.
Or maybe all the sudden -- in terms of terminologies or code sets, something happens in the industry. So I guess what I see the first three months of 2000, is kind of going back and looking at our six focus areas, and making sure we've got all the information that we need. Because if we haven't talked to somebody in a year, it was March 1999 that they came to talk to us. We need some time there to make sure we've got it all pulled together, and then probably April, May, June is when the report would be written and shipped off to the secretary.
At least that's kind of my though process. I just still think this is very, very ambitious. I just worry about the resources, because even with all the people sitting around this table, I still feel like it's very daunting.
MS. FYFFE: It's not only the resources. You have certain windows of opportunity to do something. Once that window is closed, we have lost it. So we have to be very careful about laying out the remaining months, and it's going to move by very quickly.
MR. BLAIR: When you take a look at that time frame, I did it in three sections, information gathering, analysis, and recommendations. I just sort of did blocks of time. The reason I had analysis is because in some cases I thought we may have to commission some form of a study, obviously it couldn't be a big one, or some type of analysis of some form. In some of the focus areas that may be necessary; in others it won't be.
Maybe in the areas of the business case area, we might look to analysis more. Or maybe in the difference of the states, where the recommendations that you would be providing us, Kathleen, with respect to what AHIMA has done, that may be a little bit more of a study than it is a hearing, just understanding what those issues are.
Do you feel like it's appropriate for us to keep that time in there? It's almost like reserving some time. Are there any thoughts on that?
MS. FRAWLEY: I think it's important to leave the time in there. One of the things that we have to keep in mind too is financial resources. I know Marjorie is going to probably speak to that issue. I'm just concerned about the fact that we have limited resources in terms of hearings, travel, and any kind of study work. So a lot of this we are going to have to do staff and members. It may have to be like some work done between meetings, and not necessarily face-to-face or a hearing format.
So I just make that comment. I know Marjorie is like jumping up and down over there wanting to say something.
MS. GREENBERG: I think we do have to think in terms of how we want to use what resources we're going to need. I was just asking Bill, did they say who was going to write the report? We have had mixed experiences using outside people. Sometimes it takes going through a few before you get someone who is really able to capture what you want.
The sooner we know, particularly if you are going to want particular studies or contract out particular pieces, the sooner we know, the better, so we can start planning for that. I, myself, was thinking during that discussion about -- and I don't know where exactly you ended up, and it's not fair for me to ask, since I had to leave the room -- on how many people you are going to have, and about the March hearing.
As I was looking at some of these people, I was thinking you don't want them to keep coming back. We want to maximize the time with them. It seems like they could address a number of different issues. So even from the point of view of using resources well, and using your resources well, which is what I keep hearing from Kathleen, understandably, I think to try to maximize the time when those people come in would be good for a number of reasons, both content, and even efficiency.
One thing I'm a little unclear about, but from the point of view of how wide do you need to spread the net, at least from the point of view of hearings is just how the group is that you need to hear from in order to feel comfortable with whatever recommendations you are going to make.
In the case of the initial HIPAA standards, I think it was a little clearer who would be impacted. It was more specific. So I don't know whether the committee would be criticized if it went in depth with a smaller number of people, which I think would be very beneficial as we were talking about it versus a wider net with a broader array of people.
I personally don't have a good feeling for that in this area, but it's something to think about, because again, these are somewhat different recommendations. They aren't necessarily to go into regulations that will then be issued, but nonetheless it's essential to have that balance between hearings and some real key experts, but making sure that you've at least touched the bases.
Just the bottom line is we don't yet have new contractual funds, but we have a request in for them, and we're quite optimistic we will get them. So I think if you can think in terms of if you want it, but it always takes longer than you think -- identifying the person to do it, getting the contract negotiated, even though it would have to be through like a task order or a professional services contract. Already we're too late to do some kind of open solicitation, but that's not what you are looking for anyway. You're looking for kind of specific expertise in areas. But it always takes longer than you think.
MR. BLAIR: Did you hear her say that we've got a budget of $10 million?
MS. FRAWLEY: No, I can tell you it's not even close. I almost fell out of my chair at the last executive committee meeting when I realized how paultry it is.
DR. BRAITHWAITE: I just wanted to emphasize what Marjorie said. In our experience in trying to contract out work for the standards work, we had great ambitions, but it was clear that you could get absolutely nothing out of a contract before six months was gone, and sometimes longer. So you have a three month period set aside for analysis, and if you are expecting that to be done under contract, you better plan for it nine months before you actually need it.
MS. GREENBERG: Words to the wise. But we will work with you. Obviously, this is a major responsibility of the committee. I think we can support it adequately, but the more you focus in, maybe after the March meeting. I do think it's very important, there is always also the trade off during meetings between taking testimony and yet having time to talk as a workgroup or a subcommittee, but that latter is so important. I know you can do some of that in conference calls, but do try to leave time for that.
DR. COHN: Okay, I think we're done. Any final comments?
MR. BLAIR: There were a couple of items that we had on our agenda that unless there are any other comments on it -- one was the fact that we had scheduled that initial letter on the work plan for June 30th. I think, Michael, you indicated that you would probably do a first draft of that maybe in the May time frame. Is that correct?
DR. FITZMAURICE: We're talking about the letter to the secretary?
MR. BLAIR: Yes.
DR. FITZMAURICE: I can do it in any time frame that you want, but we need to be a little more focused on the content.
MR. BLAIR: Right. I think we deferred it, because we felt we had to have a good, solid agreement on the work plan in order for you to have the basis for that letter.
DR. FITZMAURICE: Kathleen Fyffe I think also volunteered that she had great expertise in this, so I would be willing to let her carve it up and rewrite it as she would like.
MS. FYFFE: Yes.
MS. FRAWLEY: I still think that we shouldn't spend a lot of energy sending a letter to the secretary unless we have some really valuable stuff. I'm still not sure that June is going to be the right time to send the letter to the secretary.
DR. FITZMAURICE: That's what is in my mind.
MS. FRAWLEY: I just think in terms of the March hearing and May, I'm still not sure what we would write to the secretary in June other than the fact that we've had three meetings, and I'm not sure we need to tell her that. I just throw that out in terms of making sure we have kind of closed the agenda.
DR. COHN: Why don't we consider that to be an ongoing issue that we'll re-evaluate, without looking at the focus areas again and again. We can decide.
DR. BRAITHWAITE: I would only add that if you have a recommendation to the secretary, or you think you're going to, which requires the secretary to set up some process or do something, or take some action on the basis of your recommendations, that too takes 9-12 months to activate. So if you want to send a letter in June, then you might get something back from that in early 2000. So if you wait for another three months, then you have to tack that on to the end.
MR. BLAIR: My understanding of that letter was, Bill, I thought that you had asked us to consider preparing that letter, just basically state what our plan was for the next 18 months. If you don't feel that that's necessary, then I don't see any reason to do it.
DR. BRAITHWAITE: We can talk further about that.
DR. LUMPKIN: We may want to see what we hear from the hearings in March and May. Having listened to the time frame that Bill was discussing, there is another factor, which is we ought to probably do it in June. The druthers would be to have the current secretary respond, and let us not forget that January 15, 2001, there will be a new secretary. So the longer we wait with that time frame, the more likely we are going to get caught up in transition issues. At which time, things that normally move slow, stop.
MS. FRAWLEY: Our report has to be before Congress by August 2000.
DR. LUMPKIN: So I'm a year off.
DR. COHN: Just to finish, because we really do need to finish, I think we will hold the issue of a letter to the secretary. We will discuss it. Hopefully, we will have something that we can begin to communicate, along with perhaps some recommendations in the June time frame. But we will continually re-evaluate that as we move down with more hearings, and discussing what it is we're hearing and understanding.
So with that, I think it's time for us to finish the meeting. I want to thank everyone. I know it's been sort of a tough meeting. Obviously, we have some e-mail and other discussions in the meantime, but the next hearings are in March.
DR. FITZMAURICE: Simon, did we agree that members will send to me, questions and suggested people by February 15th?
DR. COHN: Yes. What I heard as the next steps is that you and I will try to draft another version of the questions. Send them out to everybody by Friday. They will come back with additional questions, and additional people for testimony.
Thank you, everyone.
[Whereupon, the meeting was adjourned at 6:35 p.m.]