Hubert H. Humphrey Building
200 Independence Avenue,
S.W.
Room 505-A
Washington, D.C.
MR. BLAIR: Well, let me go ahead and convene because it is almost 10 to 4:00.
In terms of the CPR work group that Simon and I co-chair, we have been having a plethora of conference calls during the last several months as we have been tried to drive forward on the work plan to be able to wind up starting to get that implemented and starting to get feedback on the appropriateness of what we have crafted for that work plan and the priorities of that work plan.
During the next hour and a half or -- excuse me -- during the next, I guess, hour and 40 minutes we will be covering four topics. One of them is going to be what our preparations are for the hearings that we will be holding December the 8th and 9th here in Washington, D.C. And Michael Fitzmaurice really has taken the lead on that. So, he will be describing what we have done in terms of the invitation letter, the witnesses that we have selected and some of the names and we are going to be soliciting, you know, some additional things.
Please keep in mind that the 8th and 9th are hearings to get feedback on the appropriateness of our work plan for the next year and a half and that these are the beginning of hearings that will go on for the next year and a half. It is feedback on the work plan. There will be a lot of specific issues that we will focus in on during the next year and a half with a lot of other witnesses.
So, we are looking kind of for general comments on the work plan on the 8th and the 9th. Now, the other topics are that it has come up in a number of the conversations that there are some questions about some people, including ourselves, sometimes getting a little confused on our focus because of our name being the CPR work group. So, there is going to be a little of discussion as to whether or not we should modify to reflect the fact that we are focused on data standards for CPRs. So, we will talk about that after Michael is finished.
The third area is it has been mentioned that many folks on the committee are still, although you received copies of the inventory of clinical information standards, many of you may not have had a chance to look at that. So, we thought we would help you a little bit, give you a little bit of education, discuss, show you some of the strengths and the weaknesses of that document as a resource for us to build upon.
So, that will be the third topic that we will go through and then the fourth topic will be a little bit of a discussion to help us focus on what we are ultimately heading for, which is the recommendations to Congress related to unified data standards for patient medical record information and the electronic exchange of that information.
Before I turn to Michael to tell us a little bit about the preparations for the 8th and the 9th, Simon, did you have any other comments or questions before we do that?
DR. COHN: No.
MR. BLAIR: Okay. Michael, could you give us an update on where we stand with respect to the invitations that will go out for the December 8th and 9th hearings?
DR. FITZMAURICE: Jeff, yes, I can.
In front of you, you have two documents. One document is the December 8th and 9th hearings plan. The other document is the invited hearing participants and the status of it.
I will run through the hearing plans first. This is a result of several conference calls with small groups, with e-mail passing among the whole group and so the plan has been vetted. Let me give you the results that we have. The plan has four different components: the structural choices for the hearings, the topic areas for discussion, the questions for the testifiers and the groups of organizations and suggested testifiers from those organizations.
First, the structure choices, we decided to have linear panel testimony with questions at the end of four speakers. So, speaker 1, speaker 2, speaker 3, speaker 4 and questions. Each speaker will have about ten minutes to talk, addressing the questions that we supply, plus additional questions that they prepare for themselves.
Secondly --
DR. COHN: Excuse me. Did you want to pass out the remaining copies to the audience?
DR. FITZMAURICE: There are some remaining copies. Is there anyone who doesn't have a copy?
DR. COHN: Sorry to interrupt there.
DR. FITZMAURICE: That is all right.
On the structure choices, sequence of testimony, testifier groupings, we will probably group by testifier category, such as medical vendor, SDO, but we will also be sensitive to who has the time and when can they testify.
Type of questions, a mix with more general questions than specific questions, more open than closed-ended questions. Timing of the testimony. I think I have gone through that, four people testify for ten minutes and then respond to questions for 35 to 50 minutes.
We expect to have six panels of four people. So, that is 24 people. The first day we will have two panels in the morning and two panels in the afternoon. The second day, two panels in the morning and then the CPR work group or whatever we will be called. We will have a summary discussion and talk about our future directions in the afternoon.
The topic areas read almost like the letter of invitations. So, as you read through the topic areas, you will be reading what you would receive if you were invited to speak. I will draw your attention to the four focus areas of interest for the report on the second page. The four areas of focus, which comes from Jeff Blair's work plan, are guidelines and standards for administrative and clinical messages and guidelines and standards for patient clinical information. This is the content, the data element definitions, models and code sets.
Third, ways to enhance the coordination and maintenance of both administrative and clinically specific code sets and, finally, ways to address the business case issues for these standards. The specific questions that we have decided to ask of the testifiers are -- and I am shortening this a little bit in the interest of time -- we ask them to give you a name, title, describe your organization and then address the following questions:
No. 1, how do you interpret the congressional instruction? There was no polite way to say how would you like to have the instruction interpreted. But Congress gave us a broad mandate. So, we wanted to get some focus from the private sector.
Secondly --
MR. BLAIR: Michael, at that point, that phrase, the key phrase there, which is also in that letter, you may want to repeat. What we are really asking them to focus in on is that phrase that the NCVH is to study and make recommendations on unified data standards for patient medical record information and the electronic exchange of that information.
DR. FITZMAURICE: That is a very good point. Jeff reminds me that the major reason we are doing this is that Congress gave us a mandated report to do that is due in August of the year 2000. Congress charged NCVHS to, and I quote, study the issues related to the adoption of uniform data standards for patient medical record information and the electronic exchange of such information and then after we study it, report to the Secretary not later than four years after the date of enactment of HIPPA -- that would be August of the year 2000 -- recommendations and legislative proposals for such standards and electronic exchange. That is found in HIPPA, Section 263.
All right. So, now I will go on with the questions. How do you interpret the congressional instruction? I neglected to tell you what the congressional instruction was. Now we know.
Secondly, what factors or issues are preventing or delaying the development and widespread implementation of uniform standards for patient medical record information and electronic transmission. Explain.
The third question is: Is the private sector able to address these problems satisfactorily? In your opinion, what is the role of government for assisting the private sector in the guidance development, coordination and implementation of standards?
How might the government help to improve the standards processes?
Fourth question, we want the testifiers to address is in three parts. It is: Which standards related to patient medical record information and its electronic transmission would (a) add the most value for improving the quality and efficiency of health care for the nation and why? (b) Which standards would be the most important to the business or goals of your organization? Why?
And the third component is what is the business case for more rapid standards development and implementation? That is really kind of the focus of all of this. We probably agree very much on a common vision and we want the business case for more rapid standards development and implementation.
The fifth question is: Do you agree with our emphasis on the four focused areas listed above and explain. Then we move to -- having gone through structure, topic areas and questions, the final category is groups and suggested testifiers. That occupies about three full pages. So, I won't go through each entry, but we looked at vendors of hospital systems, vendors of ambulatory systems, the pioneering users, the consultants who assist people with purchase decisions and implementation, purchasers and consumer groups, standard developing organizations, professional associations, managed care organizations/insurance companies/health plans, care management organizations, quality and accreditation organizations and government.
So, I now turn your attention to the invited hearing participants. It has been a very short time, but as I call people up and invite them to testify or I invite them -- I say that the organization is in a category that the committee work group has decided it wants to hear testimony from, are you or someone in your organization the best one to give us testimony and here are the four or the five questions that we would like you to address.
Out of 17 people that I called, 16 said "yes" and the 17th one said, "no," I am going to be out of the office and everybody who knows anything about this is going to be out of the office on December the 8th and December the 9th. So, we have got tentative acceptances from 16 people and more to contact.
As I look through the people who have said -- who are on the list compared with the people who could be on the list, we probably need more representation certainly from insurance companies and I have got a line on some insurance company people, but I need your help in identifying perhaps specific people and their phone numbers, Aetna, Prudential, United Health Care, HIAA and so forth.
Care management organizations, such as Lilly, PCS, Merck-Medco and others, I can use suggestions there. And the purchasers/consumers, the representatives of such organizations, such as the Pacific Business Group on Health or the Washington Business Group on Health, AARP, MedStat, I have a call into, and we are planning to ask them about which large manufacturer might be a good testifier to say here is why we need this useful clinical information, why there should be standards for it.
As I call these people and asked them to testify, I am also asking them their opinion about what should be said and who should say it, not only from their organization but from some of the organizations that appears to be pretty thin.
I would now like to open it up for discussion and get your opinion on where you think we might fill out the list of testifiers more, where you think we are thin. If you think we are too thick, whom should I tactfully disinvite, so that we get a good representation at our first hearing. Remember that the point of the first hearings is to gain an understanding, a grounding for ourselves in what benefits the private sector, particularly the business case, for more rapid standards development and uniform implementation in the United States.
Any comments or questions?
DR. MC DONALD: Some of the things, I didn't count -- I counted more denials that you said here or are they not -- or not yet accepted. Are they all accepted now?
DR. FITZMAURICE: They are not all accepted. This is not -- what I passed out to you is as up to date as of like 12:30 this morning, but there is some voice mail messages that I received back. A lot of this has taken place over voice mail. You call someone up and leave a message. They call back and say, yes, I am pretty sure I can do it. I will check my travel budget or my travel budget is not a problem. So if I have "accepted" there, they have said, yes, they will come and, yes, they will be there.
If I don't have "accepted" like on the number -- the first one on the upper left hand side, I have "LVM," which meant I left a message on November the 6th. So, I have not heard back from that person.
Yes, Richard.
DR. FERRANS: I wanted to -- Richard Ferrans -- I wanted to see about whether we would have adequate representation both from the SDOs and also from the vendors with respect to issues regarding vocabularies. I think in our previous meeting, we had identified that this was going to be one of the more vexing problems that we are going to have to face, number one.
Number two, at least myself personally, the business case issues there, I think, are not clear to me, the business case for why this needs to move forward. I mean, I am certain it does to need to move forward. I don't want to -- but sort of how does one construct the business case for it so that we can communicate it?
So, I just wanted to make the point of do we have the SDOs that are going to be coming? Are they going to address that? And also among the vendors, whether we had any vendors that do any work in that arena?
DR. FITZMAURICE: I would hope most of the vendors do the work in the arena of business cases. In the area of vocabulary, we have several vendors who work specifically with vocabulary but it is so difficult sometimes to form the business case and, yet, the reason that HIPPA was passed is because there was a business case, certainly a business case for administrative data standards. So, now, following the same line of HIPPA, we are looking for a way of expressing the business case.
MR. BLAIR: Michael, let me also help address the question a little bit and that is the need to wind up getting feedback, expert feedback on our work plan in the sense that it would appropriately be addressing medical vocabularies. That was very much in our minds when we came up with the list.
Now, you don't necessarily just see the response to that concern only when you look at vendors because there are representatives of providers, large academic medical institutions. As a matter of fact, I could name off several of the names that are on the list between Dan Rustler(?) and Jim Samino(?) and Ken Swafkman(?) for SNOMED(?) and others and there are several more. And they have either played a role in a professional association as a vendor or as a provider as thought leaders in the areas of medical vocabulary.
So, yes, we tried very hard to try to make sure we got some of that input. The second thing is that in terms of business cases -- and we talked about that also -- in this case, it is the question of does a vendor or professional association see a business case value to send their employee to a standards development organization to create a standard.
Are you with me? Okay? So, it is not the business case for a CPR. It is not the business case for a product. It is the business case for that institution to send its people to help create a standard. With the names that we have there, we did try to solicit individuals that address that, but maybe what you are telling us that maybe wording that we have in the letter isn't clear on that point. Is that part of your message?
DR. FERRANS: Yes. I think what it says, what is the business case for more rapid standards development and implementation. I would sort of look at that on a more -- I would interpret that more globally if I were reading it as someone who was invited. You know, what is the --
MR. BLAIR: Do you have suggested wording that would make it a little bit more sharp or more focused or does anyone else?
DR. COHN: I guess I will jump in here. I guess as I look at this, I am actually wondering if in some ways the issue of rapid standards development and implementation may be almost what I would describe as a red herring in the sense that that is really -- the other pieces are probably more important in the sense of what is the value of the standards and what is the -- what are the business cases around them?
One of the ways that that could all play out is more rapid standards development and implementation, but somehow when we put that there as the final question, it draws all of our attention to it. So, you may want to actually consider it even potentially removing that aspect there.
DR. FITZMAURICE: I might suggest that one could say that there is a strong business case for standards and they are valuable and we have all we need and we have them today. But I suspect that it is not the case. So, we probably need to focus on why are standards valuable. Are there additional standards that are valuable, valuable enough that you would people to an SDO meeting to help develop them and is there a case for a rapid development or is the market doing just fine?
DR. COHN: Yes. Actually and maybe the issue is that we see more rapid -- maybe it is additional standards development and implementation, not to wordsmith too much. Maybe that is -- is that what you are asking or are you talking about more rapid standards development?
DR. FITZMAURICE: Well, I guess it is -- the speed of standards development has always been described as slow. Is there a case for more rapid standards development or is there not and is there a case for additional standards? I guess I think in terms of what is the business job to be done. What is your business doing that it requires standards? And do you need the ones we have only you need them harmonized? Do you need them more uniform or do you need new and different standards?
As we start voice transcription, as we have signals and all of that gets pushed into the electronic patient record, do we need additional standards to handle that information? I don't know. Someone may raise that as a business case issue.
MS. HUMPHREYS: This doesn't seem all that unclear to me when I read A, B and C in light of the -- you know, the top of the thing of four, which standards related to patient medical records and then it would --
DR. FITZMAURICE: Are there other suggested comments on improving the -- the person who would go out in the letter of invitation, improving the questions and then, of course, I am also going to ask you for names and telephone numbers of testifiers that you would want to suggest.
MS. HUMPHREYS: Bill and I were kibitzing over here about whether we want a Blue Cross-Blue Shield and he was suggesting maybe from New Jersey, where they have done a lot of work already.
DR. FITZMAURICE: Good idea.
DR. MC DONALD: The problem that I am having is that the organization of the letter and the organization of the list of people, they are not grouped in any way that I can tell who you are counting as what. That may get to the point about whether those -- you know, you have got something for vocabulary, for clinical information -- maybe not even -- but you had like three major categories and I don't know how these line up.
Is there going to be another day or is this the whole shooting match?
DR. FITZMAURICE: This is the plan for the hearing. This isn't the letter yet that will go out, but you can look under topic areas to see that that is the guts of the letter that will go out.
DR. MC DONALD: I am kind of looking at the list of people.
MR. BRAITHWAITE: This is the first hearing. There will be more.
DR. MC DONALD: Can you just describe kind of how you thought you would group the testimony and then we could more easily --
DR. FITZMAURICE: We haven't grouped --
DR. MC DONALD: You have vendors. You have --
MR. BRAITHWAITE: Dr. McDonald, actually they are listed here as to how they are sort of grouped.
DR. MC DONALD: This list of the actual invitees who accepted isn't related?
MR. BRAITHWAITE: Well, they are, but this is alphabetical order groups of people.
DR. MC DONALD: So, you would present them like this, though? You would them grouped --
DR. FITZMAURICE: Yes. Those are how the other panels will be made up. Maybe some of those groups would be confined, depending upon how many people will be testifying.
DR. GREBERMAN: I would suggest one group -- I think it crosses a couple of the borders dealing with the professional associations, the SDOs, as well as industry. Somebody from the DICOM(?) group would be, I think, a good idea to contact.
PARTICIPANT: Yes, that is listed up at the top here. They don't have a name.
DR. FITZMAURICE: The name that would come to mind is certainly Dean Bitgood(?). Now, there was one thought on the SDOs and that later on in subsequent hearings, we might want to hear from the SDOs individually to find out what standard they are working on. Are they meeting some of the gaps and some of the needs that are developed early on?
So, our thinking was that for the SDOs, we might invite just one for the first hearing to get our grounding and the best name that we came up with was Peter Weckerman(?), who is the chair of HISB.
In the course of preparing for the report to Congress, report to the Secretary, mandated by Congress, we do need to hear from the SDOs. I am just -- at the very beginning, we need to know what is so important about standards. Why are they to be pulled together? And then after we learn that, we may pull the standard developing organizations in to say do you know this, are you responding to this? How could you respond faster to their needs?
MR. BLAIR: Please keep in mind -- let me remind that group that we will be having hearings on these topic areas for the whole year of next year. What the purpose of the 8th and 9th is is to get feedback from some industry experts and thought leaders as to whether our focus areas and the other questions are on target because basically that is the essence of our work plan for the next year.
We will have many hearings where we will have many more representatives of SDOs, of insurance companies and the others. It is just to get feedback on the work plan.
DR. COHN: I actually have a question for Kathleen Fyffe just because I -- as I looked at this, one of my big concerns is that we appropriate business input and what the business values might -- you know, are in all of this to help direct and I wonder if you have any thoughts about either other insurance companies or other people in the health care industry that might flesh some of this out.
MS. FYFFE: I have a lot of thoughts on the business case and as I came in today, I got a little bit sidetracked on my thinking, but my concern is whether or not in the end the standards that we recommend are actually implemented. Okay? I mean, we can come up with very elegant ideas and so on and so forth, but if the physicians in their offices or in their clinical practices or the hospitals don't feel that there is a compelling reason other than the law -- and I hope this never becomes mandated in law -- to do it, they are not going to do it. It takes money. So, we need to get some input about what the -- you know, what the different constituencies see as the important factors in determining whether or not they are going to implement these standards.
I know in some of our conference calls we talked about some of the vendors who have -- currently have software in thousands of physicians' offices and clinics and really we ought to get some input from those vendors to see how their software might be modified or if they are even looking in this area at all. That is part of what I think I have been articulating in the past.
So, we have to hear from users, meaning the providers, and we have to hear from their software vendors that they are using right now. When I say providers, I mean both institutional and non-institutional and then both institutional and non-institutional software vendors.
MS. SERCKS: Mr. Chairman, may I make a comment here from the audience? I am Kathryn Sercks for the Association of American Physicians and Surgeons and I would like to second what you are saying. The area that you are going to have the most resistance is from the folks in private practice because there is going to be an expense and seen only because of the law.
Therefore, I would like to offer a suggestion for the hearings, which would be Dr. Jane Orient(?), who is the executive director of the Association of American Physicians and Surgeons, which is essentially a physician organization across all specialties, but mostly people who are in private practice and to see -- to get some feedback on what it might take to drag some of them kicking and screaming into the technology age.
MR. BLAIR: Keep in mind that there is nothing for people to react to yet because it will be a year from now as we go through hearings and we begin to hear folks say where they feel standards are needed, where they feel standards are not needed, what type of standards are needed, whether it is medical vocabularies, whether it is standards for data sets, whether it is standards for message format standards and what the characteristics are there. So, it is going to be a year from now before we get to the point where we even know whether or not there will be any standards that we will be recommending and, if so, what they are before we can wind up offering to folks, saying here are the ones we are considering now. Do you feel a concern about this?
So, I think your concern is valid, but I feel like we are a year away from even knowing whether or not there is going to be clinical standards that we are going to recommend.
MS. HUMPHREYS: The other issue, of course, would be whether this group would, in fact, whether it was likely that this group or other associations would, in fact, be -- have an opinion in essence in favor of particular standardized data that would be beneficial to them and, you know, that they, in fact, would like to find and that, of course, would be appropriate input at this time.
DR. LUMPKIN: I think that one of the areas that we need to, perhaps, address is, you know, we say what is the business case for doing this. That is only part of the analysis. The other part of the analysis is that we turn on investment. You can make a strong business case, but if the costs are so high going into it, it doesn't matter if it seems to make sense. It is just can you afford that. And given the current environment of many practicing physicians, who are outside some organized entities, it certainly is a very unfriendly environment and not one which one is considering a capital investment.
So, our -- one of the issues that we need to address and I can think of, perhaps, a good person to speak to this. I had a conversation with Gary Mecklenberg, who is the CEO at Northwestern University Hospital, which is one of the largest academic institutions in Chicago. And he doesn't basically doesn't believe that there is a -- he would like to go computerized patient records. He doesn't believe that it is feasible now.
MS. FYFFE: Feasible in what --
DR. LUMPKIN: They have looked --
MS. FYFFE: Economically feasible?
DR. LUMPKIN: Well, what I am getting to is that there are issues related to barriers that exist and the question is will standards make it more accessible? Will standards make it more believable that it will work if you are not as much concerned about costs? Will standards make a larger entity, such as a multi-specialty group, which has much more capital, believe that the cost benefit breakpoint has been reached.
If we, in fact, do standards and the standards don't lower the costs for implementation, then I don't think we will have solved the problem. So, I think that is the piece that we may need to try to address somehow, some way in our hearing process. But if we listen to many of the same old folks about what we need to do in order to get there, it doesn't address that piece of the puzzle. I don't know if the first hearing is the place to do it, but definitely we need to do that.
MR. MAYES: I just want to make a point, John, because you are bringing up exactly the issue around the name, which was we call ourselves the Computer-Based Patient Record Work Group. However, nowhere in the law does it talk about computer-based patient health records. The charge to the committee is to study the issues related to the adoption of uniform data standards for patient medical record information and electronic exchange of such information.
That is not a charge to talk about how one would implement or develop a computer-based patient record. So, I think you are kind of making a leap, which some of us had a concern over our name, which you are making a leap here from uniform data standards and electronic exchange of those data to the implementation or recommendation of standards for the implementation of the computer-based health records.
MR. BLAIR: Our discussions were that we really should consider making our name more appropriate to our actual mission and this is a problem getting this first letter out because I am afraid that some of the witnesses are going to misunderstand this, too; whereas, if the name of our work group were CPR Data Standards Work Group or some variation of that, that it begins to sharpen the focus of what the issue is we are focusing on.
We are focusing on data standards for CPR, not to justify the CPR.
DR. COHN: Well, actually I would speak to what John was describing as an important perspective to have at the group because I think whatever we are doing doesn't lessen barriers to increased access and input of data and collection and all of that stuff, we are somehow missing the boat. I think that that was what you were talking about I think in many ways. Though I guess I am a little confused only because I thought Northwest University had asked you to put in a system in their ambulatory environment.
So, this would be very interesting to have them reflect potentially on some of theses.
MS. FYFFE: My curiosity is particularly piqued by your comment, John, because I had always thought that the big university teaching hospitals had beaucoup money to spend on such systems. And it was the B flat community hospitals out there that weren't going to be able to, you know, get on the northbound train, but if what you are saying is that -- well, and I know you are not speaking for all university teaching hospitals, but we have got -- I mean, that is very interesting.
DR. LUMPKIN: Well, let me clarify.
MS. FYFFE: Okay.
DR. LUMPKIN: I didn't say the issue was money.
MS. FYFFE: Okay.
DR. LUMPKIN: Northwestern is not hurting. I think that there is a perception at the CEO level, which may be different than what we may hear from people who are at the implementation level because I had the same impression that many other people did, that they do have it. I think they may have it in a certain portion of their clinical practice, but it has not been institutionalized and I think that is the issue.
So, I am just suggesting that we may want to think about some non-traditional people to testify, who would give us a different perspective and he may know nothing about the details of the computerized patient records, but maybe give us the CEO's perspective on why they haven't institutionalized it within their operation.
MR. BLAIR: And that is the name that you are suggesting maybe, Michael?
DR. LUMPKIN: Well, there may be some better names, but, yes, that was just an example somebody ran into.
DR. COHN: And, Mike, you have captured that name?
DR. FITZMAURICE: Gary Meckler, CEO at --
PARTICIPANT: Mecklenberg.
DR. MC DONALD: I think we have a big problem with this pronoun "it." You used "it" a couple of times in this electronic medical record. I will bet any money what he is talking about all physicians putting everything directly into the terminal and I think most people agree that that is not necessarily going to be tomorrow because that hospital does have laboratory data, radiology data, all the other parts, and they don't -- it was the one system that Paul Tanglia(?) was working on was in two clinics, where they were typing everything in.
If we are going to say that the only thing that the medical record is the one where all physicians are tied on to it, of course, we are not there. Why do we have a session on that? I mean, if we are going to talk about medical records, a lot of stuff going in and a lot of people are using it, then they are everywhere. There was a thing in one of those throwaway magazines listing each company's sales of medical records systems. And I think there were 800 or 600 of them, only about a third of them installed, but that is probably not the purchasee's problems, you know. So, if you take those 3,000 -- there are only a certain number of big hospitals and I think actually the academic ones are, I think, more often poorer than the private ones because they more often take -- so, I don't know how they are generally rich.
DR. COHN: I want to actually defer this particular conversation because the good news is that we have actually specified the questions. So, if our questions are wrong, we need to review them. But I think what we want to do is we want to take these diverse points of view and ask them our key questions, which is about issues around patient medical record standards, as opposed to CPR standards.
DR. MC DONALD: Okay. But if you start out saying we don't know what the "it" is, we are going to get some very confused testimony and I think we ought to be clear what we are talking about because everybody -- it is a huge spectrum of what we are talking about in this "it."
MR. BLAIR: How can we refine that, Clem? What do you suggest?
DR. MC DONALD: I really like Bill's point that what we are talking about is exactly what it says in the law. It is almost as short as the title.
[Multiple discussions.]
You said it. I mean, you took the words out of the law and it wasn't much longer than what we are making up as a title for this.
DR. LUMPKIN: But Bob is always talking about uniform standards.
DR. MC DONALD: What were the exact words?
MR. MAYES: Well, Clem, it is here. It is right at the bottom. Study issues related to the adoption of uniform data standards for patient medical record information, the electronic exchange of such information.
DR. MC DONALD: I didn't want to make it sound like it wasn't one of the brethren on CPR stuff. I just think that I sort of agree with Clem is that, you know, when you start throwing out CPR, computer-based patient record, you are going to get a lot of people who think of it as the "it" and who think like, well, are we going to be mandated that every, you know, private physician have this electronic medical record system in place in their office that is, you know, the one uniform implementation around the world. And I don't think that that is our goal, you know, or what we are planning on doing.
I mean, there are many things that you can do around data standards that don't assume uniform implantations at the local level.
MR. BLAIR: Well, do we resolve that in terms of modifying the letter or do we resolve that by modifying the name of our work group or do we need to do both?
MR. GARVIE: If you resolve the name issue, it will take care of the letter.
MR. BLAIR: Okay. Well, what thoughts do folks have, what suggestions do they have as to what we ought to modify the work group name to?
DR. FERRANS: Jeff, what about data standards for patient medical record information work group, sort of plagiarize the actual text?
MR. BLAIR: Yes. Are there other comments on or thoughts about that?
DR. MC DONALD: Well, if you could get the word "exchange" into that, you have got the whole content because there are two pieces, information and how to exchange it.
DR. FERRANS: Standards and exchange or --
MS. FYFFE: I have a question.
DR. MC DONALD: We need a DOD guy here. One with a good --
MS. FYFFE: What do we mean by adoption of uniform data standards?
MR. BLAIR: That, I think, is what our job is this next year, to study that and determine what that should be.
MS. FYFFE: Okay. We also -- is part of the law, it says legislative proposals for such standards and electronic exchange. Do we endeavor to come up with a comprehensive and exhaustive list of what the data in the medical record is going to be?
MR. BLAIR: I don't think we know yet. I think we are going to wind up having a lot of hearings and --
MS. FYFFE: No, I know we don't know what it is yet, but do we endeavor to do that?
DR. FITZMAURICE: I think that is just a moving target.
MS. HUMPHREYS: I guess the question is whether when you are through studying this and listening to everybody, you figure that if that were standardized in some way, shape or form, it would really help and then it might be a task, but if it didn't look like it was, based on what everybody said, you wouldn't do it, right?
DR. FERRANS: But in some ways it is a coverage question in terms of if there were certain standards identified, this would take care of 90 percent of it. We don't know.
MS. FYFFE: But to be really simple about this, would we come up with a legislative proposal that might -- do we have any practicing docs in here? Okay -- that is going to tell you in your respective clinics and institutions what exactly needs to be in the medical record, down to the data level?
MR. BLAIR: Kathleen, the way I am envisioning it and this may not turn out this way --
MS. FYFFE: Well, because this is what you guys did with the insurance industry with the claims.
MR. BLAIR: Let me try to answer the question. What I am envisioning is much more likely out of this is that a fair amount of the answers we are going to get is that the private sector doesn't need help in many of these areas, but there are some areas where the private sector is struggling to be able to pull together standards.
One of them is very likely to be medical vocabularies and they are working on medical vocabularies but right now the organizations that are working on it need some encouragement. This is -- I am jumping ahead, okay, and it may not turn out this way, but I think we are probably more likely to wind up being asked to facilitate or assist in coordination or maintenance of the efforts that are already out there -- don't take them over, don't subsume them, but help them to move a little bit quicker to come up with convergent medical terminologies or cross walks with terminologies or something because that is a key element that is an impediment to everyone moving forward.
And in a lot of ways, I think that it is going to turn out to be the vendors that are winding up saying we can't move -- we don't have the money to do this by ourselves or we haven't -- or it is taking too long to do it by ourselves and the vendors in many cases are the ones that are also in the SDOs. They also represent their customers that are the providers.
I am trying to jump ahead just to answer your question because I think that the view that you have that we are going to wind up having this laundry list of standards that every organization is going to have to adhere to, I don't think that is going to -- I don't envision that that is where this next year will wind up leading us, but I don't know yet.
DR. COHN: I was actually going to ask the question, Kathleen, what do you think? Where do you want to see this end up?
MS. FYFFE: I don't know. I think we are still defining what our role is.
DR. COHN: Okay. And I think this brings us back to the fact that the first question that we are asking this group is a very good one, which is what would they like to see us do.
Dr. Lumpkin.
DR. LUMPKIN: I was struck by something that Kathleen was saying. Maybe we should do a little bit of honing down. Clem says there is a whole bunch of stuff in the medical record. And I think there are different classes of stuff in the medical record. There is demographic stuff and we have already dealt with that with the various X.12 transaction standards, of taking care of and automated that piece of the medical record.
There are laboratory results, which are part of the medical record and we have an XL7 standard for that. And as we start to hone down, we may actually clarify what we are talking about automating. And I don't think that is rocket science. I don't think that that is something that hasn't been done, but if we were to ask people not about the patient medical record but about the part of which there is still some issues with, it may frame the discussion in a more focused way.
MR. BRAITHWAITE: For example, is there a need to express in a standard way the problem list, so that it can be exchanged from one system to another. I would submit that there is that need. It hasn't been done. It ought to be done.
DR. LUMPKIN: So, a list of what needs to be done I suspect would be more comprehensible and shorter. I mean, it may not be short, but it certainly would be shorter than just saying what is out there now. Or it may be that we need to adopt a standard like DICOM or something for certain pieces. Those may need official sanction.
MS. HUMPHREYS: The issue then is -- it is an interesting one because if you say what do you want standardized -- where do you think standards are needed where there aren't them now, then you can't ask that questions very sensibly of people who have no idea about the existing standards and the existing exchange of data and the fact that there are lab things and DICOM exists and -- are you following me?
And a lot of the people that are on this list could answer some questions very well about what they need and what they think would be useful, but they do not have a clue whether down in the bowels of the organization or that there is really a perfectly good standard and they just need to buy a system that actually implements that standard, you know, like DICOM or whatever.
DR. MC DONALD: -- isn't actually an ANSI approved standard for sending problem lists. It just doesn't have a standard code set, which to highlight Jeff's -- and HL7 has had that for two years.
MS. HUMPHREYS: It sounds like a catch 22 to me.
DR. MC DONALD: I think we do come back to the codes or the vocabulary.
DR. LUMPKIN: Well, then if what we are really talking about is code sets and vocabulary -- and I am just saying is -- then it seems like that should be where we are to focus, more so than -- I am just posing -- we need to get down to the part we need to address.
MR. MAYES: I mean, XML, for instance, I mean there are some interesting new technologies coming down the road that we might begin -- that offer some potential where hithertofore, there hasn't been very much, I mean, in terms of putting some structure around what we are currently treating as blobs of free text and things like that.
So, we may -- I mean, terminologies and codes are one thing, but there are some other areas where there might be --
DR. KOLODNER: As we are talking about this -- and honing down on code sets and vocabularies certainly is near and dear to our hearts, at least in terms of our GCPR activities because that is, you know, a lot of where we were focusing because at least to us for exchanging the information for purposes of the shared population that we serve, that seemed to us to have been an area that still needs development.
But as I think about and look at the charge from the law, one of the things is we have been talking about it from the point of view of maybe the provider or maybe, you know, having to submit a bill and making sure that it is standard, but we haven't been talking about it from the point of view of the person receiving the care and if -- you know, if we want to say, well, what is the whole purpose of this? Is it to support the health care system or is it to help people and then as a byproduct collect some information about health status and other things, it may, again, help us to kind of reframe where we want to start and, you know, what we -- well, who we want to have involved in some of this.
DR. FITZMAURICE: So, Rob, if I understand what you are saying, you are talking about health status measures. You are saying what is currently in the patient medical record may not be all that should be collected to benefit the care of the patient.
Now, a lot of the things that we are talking about, I think, we are going to hear from the people or we are not going to hear from the people. That is one of the reasons we are having the hearing is to kind of put some weights -- we are in a crowd of believers and sometimes it is only a matter of do you believe it is going to happen in five years, ten years or 50 years, but to get a business sense of, as John put it, what is the return on equity for investing today versus waiting for the market to settle and investing sometime tomorrow? What is the role for advancing faster versus advancing at the current market speed?
We are hoping a lot of people to give us that sense.
DR. KOLODNER: But, again, when you say, you know, what is the advantage? The advantage to whom? The advantage to the person receiving the care is I want to make sure that wherever I go, they know about the -- but if I am a solo practitioner, that may not be my primary focus.
DR. LUMPKIN: See, I would disagree. If you ask people what they want to know about their care, they want to know can they have access. If they see a clinician, will that clinician help them stay healthy? If they get sick, will that clinician help them get better?
If they have a chronic illness, will it help them live with that illness and how they handle dramatic change? And the concern is not does that physician know about me, but does that physician remember about me and doesn't give me penicillin when I am allergic to penicillin.
Is the care that I am getting the highest quality of care? In other words, can my physician manage all that medical knowledge to give me up-to-date care? And that is dependent upon the ability of the system getting that information up front. So, for the patient, I would argue that it is not the exchangeability, but it is the ability of putting knowledge management tools in the hands of the provider. For the provider, I think, it is very similar.
MR. MAYES: Well, but there is one other dimension to that, John, and that is this provider the one I want to see or do I want to see the one in the next block. Certainly, just to give you a perspective from HCFA, we are under a great deal of not only pressure but congressional mandate to start providing comparative data on the quality of services available to and provided to Medicare beneficiaries.
So, you know, that is an example of where -- I think that goes to -- that is a whole different point of view of users, not a provider. We are trying to let -- have the beneficiary be able to look at see and has to have comparable data. You know, hospital mortality was an --
MR. BLAIR: Could I interrupt this for a second because the work plan goes into all of these areas with a whole set of hearings that will be laid out. There are expansions of these four areas and of three other areas that are lower priority. So, our discussion is beginning to get under the surface to more details, to more perspective, all of which will come out of these general topic areas.
I guess I can't see, so I don't know whether or not I am pushing things too assertively. So, let me just ask the group here. Can we get agreement that the letter is our first start for general feedback on the four general directions that we will be going forth with with this next year? Can we get agreement on that?
MR. MAYES: Jeff, did we decide to change the name of the work group?
MR. BLAIR: I think that is the next topic is -- okay. Yes.
So, is the letter just generally okay to get feedback on the direction of our work plan with those four focus areas. If I don't hear a negative --
DR. FERRANS: Actually, I had -- I think someone mentioned something about return on investment. Did we want to make that an additional question beyond the --
MR. BLAIR: The thing is I think -- we have the question in there that that is a focus area and that that is an area that we are going to want to get more information during this next year. We will be able to do a lot better on getting that once we have gathered enough information to know what types of things we might recommend. Then somebody could react to wind up saying, well, that has got a good business case for us or that doesn't. But as of this stage now, we really don't know where this hearing and a year of hearings is going to lead us in terms of what standards or infrastructure will recommend.
DR. COHN: Jeff, if actually I can interject for just a second, actually, I think it is already included. The question about what is most important to the business or goals of your organization is effectively asking the question of ROI in business case. I mean, it is really -- already envelopes that. So, I think it doesn't specifically mention ROI. We may in future hearings want to drill down to that, but I think that the intent of this was to really look at, you know, those issues, at least for a first glance. So, I think we okay there.
Now, I see everybody looking very carefully at this and I see Dr. McDonald has furrowed brows here. Maybe we should ask him to comment.
DR. MC DONALD: No, no. I was trying to -- one through four items on the top of page 2, those seem reasonable. Are we asking to get agreement on that or on the question?
MR. BLAIR: We are asking to get agreement that those are the four major areas of focus from which our work plan for this next year will flow. Now, that work plan actually -- we have stipulated several iterations of the work plan. There is expansions of those four focus areas into an array of hearings to flesh out issues in those, which we can still continue to modify.
We just want to get validations from this group that, oh, well, we overlooked another focus area or that we should put more attention on focus area No. 1 or No. 4 or whatever. So, that is what we are looking for.
DR. COHN: Dr. McDonald, we have already agreed that we are potentially working on these four focus areas.
DR. MC DONALD: That is Item 1 through 4 before the questions.
DR. COHN: Before the questions. What we are asking today is are we asking for the first set of hearings these five questions and are these the right questions to start out asking at our first hearing, recognizing as Jeff has commented quite eloquently we are trying to do is to just evaluate these four focus areas and identify anything else that we should we may have missed.
So, we should look very carefully at the four questions. I was actually also going to comment I don't want to lose this, that Dr. Kolodner, I think, identified that we needed to make sure to hear a patient perspective. And I think that we need to somehow make sure that he may have some suggestions off line of groups if we haven't included them appropriately to present a patient perspective also.
MR. BRAITHWAITE: If I may interpret Clem's question, I think when Question 5 says do you agree with the above four items, it is a bit confusing because people would first look to the first four questions as if that was what you were asking agreement about.
MR. BLAIR: And maybe we even ought to be more explicit to say do you agree with the four focus areas and reference them a little bit more directly as the primary focus for our hearings for this next year.
DR. MC DONALD: I have got to ask one more question. Ass these questions are phrased as thought we are starting, you know, in the year zero in terms of standards. You know, what standards do you think we should invent, what standards -- we should ask them what they are using while you are at it.
DR. LUMPKIN: I think -- or that you would recommend.
DR. FITZMAURICE: Well, I mean, remember they have got only ten minutes.
DR. MC DONALD: Yes, I know, but you are starting out, you know, what factors are preventing going to development and why is it implementation, you know, from standards, which could be read to read why aren't we doing any standards. And I don't think that is accurate.
I mean, certainly it is -- there is as many clinical messages going around as there are standard billing messages or more right now.
MS. HUMPHREYS: Maybe it is the issue of -- you are assuming this level of sophistication in the sense that everyone there is going to understand that the standards that we have all been talking about ad nauseam for the last three years are not patient record standards, but they are something else.
I am not necessarily certain that everyone will come into the room understanding necessarily your distinction. I mean, there will be the Climishente(?), who will understand this perfectly, but I think maybe that is what Clem -- a piece of what Clem is getting at if you just sort of say, well, what standards are needed. We really don't want people to tell us again that, you know, they use CPT and ICD-9 because we know they have to and we know they are recommending -- you know, I mean -- so, is there a way to sort of maybe change the wording a little so people are above that level right in the questions that you are asking them and they just don't have to understand that when you say patient record information, we don't mean all that stuff we have been talking about all along.
DR. FITZMAURICE: Is it worthwhile to consider describing HIPPA's mandate, administrative standards, and then say this is something different. This is not administrative. This is clinical. That is a suggestion.
MR. BLAIR: Uniform clinical standards?
DR. FITZMAURICE: Yes. The uniform standards for clinical data.
MR. BLAIR: Well, I think we would need to stay right to the words; uniform data standards for patient medical record information.
MS. HUMPHREYS: Maybe just introducing a letter saying, you know, HIPPA has several things. We have been focusing on these administrative standards. There is this other piece and now we are moving beyond that, you know, in terms of these recommendations. And, of course, that is really said here, but I am just thinking that there may be some people who would come into the room, don't live and breathe all this stuff all day and night and you want some of those people to come and tell you what they think that might not quite get it.
DR. COHN: Very good.
I actually have a question for Dr. McDonald because I am not sure whether -- I may be a little confused but I thought I heard you saying something, but I am not longer sure. Were you earlier referencing the fact that people are using administrative standards a lot or where you referencing the fact that people are doing a tremendous amount of clinical standards already and we should ask them for the baseline of what they are using.
DR. MC DONALD: Well, yes, and I think -- Clem, to you, Simon -- we are getting real formal here in this --
PARTICIPANT: But not to the rest of us. I would understand that.
[Laughter.]
DR. MC DONALD: Really, I think we could get some sense of things. NCPDP is in 90 percent of the community privacy, that is clinical data. So, if we are talking to the vendors to get an idea of where they are having problems, it might not be bad to say, you know, what clinical message standards are you using and what problems could -- you know, are you having that could be solved and the vocabularies will be tougher because we don't want to go back over ICD-9 and CD-4, which we know they are using. But maybe get something out of them, too, you know.
Are you exploring, you know -- but so we get something more -- and then maybe that would also kind of cast the issues, you know -- but I think if we asked them and -- the vendors will know. They will know what they are using. They will know the issues and they may say, well, our problem is we are using it differently. So, we have got to get some -- our problem is it doesn't do the job. Our problem -- I don't know what they will say, but -- or their problem is there are no codes that are standards. So, it doesn't help us enough.
But I am afraid if we just ask -- say, what is preventing using it, you are going to get a lot of people thinking, well, gee, it can't be the standards we are using because we are using those. It begs the question is that we are starting in the very beginning of time.
MR. BLAIR: Is there generally agreement that we ought to ask a question saying what clinical standards are you using or what --
DR. MC DONALD: And what problems are you having with them --
MR. BLAIR: Are there any objections to adding that question.
DR. FITZMAURICE: I guess I just see that is a five minute discussion right there for each speaker.
DR. LUMPKIN: Well, it may be a five minute discussion. My suggestion would be is that we would add in there that some of you may already be using that and those that are -- what standards are you using? What would you recommend? Please submit to that to the committee in writing in addition to your testimony. So that way, you know, we can hear what they have to say and then get some written testimony that will allow us to start building an information base.
MR. BLAIR: Is there general support for that?
MR. BRAITHWAITE: It would actually fit as an introduction to Question No. 2 actually.
MR. BLAIR: Is there any other modifications to the questions?
DR. GREBERMAN: The issues related to the electronic exchange of such information relate to some of the activities, I would think some of the other subcommittees and particularly, I have in mind is standards and security and privacy and confidentiality, clearly the issue of privacy, et cetera, is a very important one related to transmission of electronic data and this one is increasingly becoming important to the international community, including the things we discussed at the Data Council, the European privacy directive, will issues like that get into this or will we have an opportunity to consider things like that in terms of this broader purview?
MR. BLAIR: We did have a focus area related to data security in our work proceedings up until this point. We decided that since we have another community within NCVHS that is focusing on that, that with the limited time we have -- we have one year of hearings -- that we would focus on the four that we selected as high priority, but coordinate what we are doing with the privacy and data security committee.
Now, I am not sure that that is necessarily the right decision, but we did make that decision, what, back in September?
DR. MC DONALD: There has been at least six or eight days of hearings on that already, too.
MS. HUMPHREYS: I think that Mel's point or Mel brings up a good issue and that is given you have had these other hearings and you have this other group, maybe, in fact, you want to say other than security and privacy. I mean, do you want everyone to come in and spend all their time talking about security and privacy?
MR. BLAIR: I would rather leave it open ended and see what they tell us.
DR. LUMPKIN: And I think that maybe we need to be very careful in or presentations to comment that this work of this work group is based upon an assumption of support and implementation of the committee's position on privacy and confidentiality and security. State that up front because I think there is a potential for people to misunderstand and if they don't see the words there in every single issue paper, then they think we don't care about it.
MR. BLAIR: Are there any other suggestions for modifications or changes or enhancements to the questions?
If not, then could we go on to consideration of a name change for the work group?
DR. COHN: Jeff, I just had a question about the process by which we get this Question 2 straightened around and to our satisfaction. Mike, are you going to try to do something --
DR. MC DONALD: It is an extra question is what I thought --
DR. COHN: I think what we saw -- I guess that is -- I guess we aren't straightened around what is going on here. I had thought -- what I had heard was the suggestion that the beginning of Question 2, almost --
DR. FITZMAURICE: I guess what I heard was that it be a question to be answered in writing, but not specifically to be addressed in their discussion, unless they wanted to bring it to their discussion. Maybe I am wrong.
PARTICIPANT: That is what I heard, too.
MR. BLAIR: Clem, is that correct?
DR. MC DONALD: What John said sounded great. It is all recorded.
DR. FITZMAURICE: But it is going to be two or three weeks before we get the transcript back.
DR. MC DONALD: Could you say it again.
DR. FITZMAURICE: It will sound nice in February.
PARTICIPANT: We can get it on the Internet tomorrow.
DR. MC DONALD: What I said before.
MR. BLAIR: All right. In the interest of time, I think I heard one suggestion that we consider modifying the work group to -- if I can paraphrase you a little bit, so that it is maybe not quite so long, what, patient medical record information data standards work group or -- that is already pretty long.
DR. LUMPKIN: Jeff, I could -- I think we have a little bit of a political issue, which I don't know quite how to address in that I know that when the original name of the committee for the work group was adopted that Don felt fairly strongly that it include the computerized patient record as part of its name.
MR. BLAIR: Could we retain that by saying CPR data standards or data standards for CPR work group?
DR. LUMPKIN: I would suggest just because he is out of the country and I would hate to change it and then have him come back because that is always disconcerting -- that we would call -- in our communications we would just refer to it as the hearing on standards for whatever that word --
MR. BLAIR: Patient medical record information?
DR. LUMPKIN: The uniform standards for patient medical record information. All of the CPRWG --
MR. MAYES: Do we even have to refer to the work group in the -- this is a hearing of the Subcommittee on Standards and Security related to these issues, the issues of data.
MR. BLAIR: And that is how we get around it until we can address the issue.
Does everybody agree with that?
That is a wonderful solution. Okay. Now, separately from that in terms -- that is a solution for the letter.
PARTICIPANT: Never give out our true name.
MR. BLAIR: That is a solution for the letter. Now, since we are meeting here --
DR. FITZMAURICE: There is a problem and that is if we are now the Subcommittee on Standards and -- I forget what it is -- Security, and we say in the letter we are leaving the work on privacy, confidentiality and security to the subcommittee, that then becomes us. I guess we just say we are covering it somewhere else.
MR. BLAIR: Well, we are addressing the topic of security for patient medical record information.
DR. LUMPKIN: Since I am the only swing member between the two groups and I plan to be there anyway, it doesn't really matter.
MR. BLAIR: Okay. Let me try to be an opportunist here. Okay? I think we have solved the problem of avoiding the name in the letter. Do we have a consensus that we would want to change the name with Don Detmer's approval to CPR data standards work group?
PARTICIPANT: Is there an exchange?
MR. BLAIR: Is there any strong or medium or partial objection to that?
DR. FITZMAURICE: I am partial to what Clem said. It is not only data standards but also the exchange and that gets us into additional functions if --
MR. BLAIR: How do you get that into a title without making it rather long?
PARTICIPANT: You can't avoid it.
DR. COHN: I would actually suggest that we defer this discussion until after we have had the hearings, recognizing at this point there is no time urgency to this particular resolution. It may be that after someone sleeps on it, they will come up with the exact right name.
MR. BLAIR: Is there general agreement to defer?
Okay. Let me go on to the next topic. Is there someone who could help me pass this out? There is this and there is this. The next topic is to give you a little bit of a brief education on the strengths and weaknesses, the value and lack of value of an information resource we have to do the work of our work group, which is the inventory, the profiles of clinical information standards.
What is being passed out to you are two documents. One is a three-page document, which gives a list of the profiles that we have -- and you all, by the way, have copies of this. This was given out in June. And I realize that you stayed up nights and weekends just reading through this document, which is why we thought that we would maybe shortcut a little bit of your understanding by just reviewing some of these things that may help you a little. Okay?
The three-page document is the table of contents for the three different sections. The first section is message format standards. Now, please, understand that it was difficult to make a lot of these things mutually exclusive. While we tried to focus on clinical information standards, in many cases you can't have a sharp dividing line and it blurs over into administrative and clinical but we pretty much tried to stay away from the financial information standards, which were covered by the NPRMs that we got through during this last year, the X12 and the NCPDP, the ICD and the CPT codes. Okay?
So, we are trying to focus on the clinical to the degree that we can. The second section we wound up calling it, I think, patient clinical information or patient medical record information and essentially it was to try to focus in on the data elements, data definitions and data models and we allowed the developers of these data elements, data definitions, data models, to identify whether or not they felt that their standards or code sets or data sets belonged in that section or the third section.
The third section is a list, which we call code sets. Some folks felt as if what they really had to offer was a vocabulary or a nomenclature and, of course, we didn't go through the attempt to come up with strict definitions. We allowed the developers to define what section they wanted to be represented in. Some of them shifted during the process of this thing.
Now, that -- there is like, I think, 78 or 79 profiles. We know that that is not a hundred of the universe out there, but it is more than we -- you know, a reference source has made available to us at this point. So, it gives us a lot to go on and there was a tremendous amount of cooperation among these organizations that volunteered to put work in. And if you have a chance to go through this document, you will wind up seeing that there was a lot of work to make the information relevant, to make it informative, to make it as complete as possible and to make it readable.
There was a process that we went through to do that. The other document gives you a feeling for the process. It is dated January 9th of this year and it includes the templates that each SDO and data and code set developer used to respond to the inventory. There are three different templates. There is one template that the message format standards developers used.
There is another one for the second set and the third for the code because, frankly, the questions would not -- the questions had to vary. They varied within a framework, though. The framework was that we wanted a general description of the standard. We also wanted to know the degree of readiness of the standard.
We wanted to know what degree of market acceptance there might be. And there are many different ways to measure market acceptance. That is why there are as many questions as there are under each of these sections.
We wanted to know the degree of clinical specificity because clinical specificity is critical to interoperability. Clinical specificity is essential for meaningful outcomes research and performance research. Clinical specificity is essential for decision support. It is essential for a lot of things that we know we want to achieve with the standards. Okay?
The relationship with other standards, if we have a code set and that code set already has agreement to be imbedded within a message format standard, those are the types of information we wanted to know. We wanted to know if that particular code set had good working relationships with other domain-specific code sets.
One example of that happens to be SNOMED, which has microglossary relationships with several of the domain specific code sets. That is useful information to us. Okay?
Another piece is -- and it is the last piece to the degree that they can answer the question -- is identifiable costs. Okay? Now, as you start to look at the templates, you will wind up seeing that the questions are questions that some SDOs and developers can answer and others can't. So, with the ANSI Health Care Informatics Standards Board, we spent over three months developing these templates to try to do it in a manner that the SDOs and the code set developers and the data set developers considered fair, which gave them an opportunity to strengths, which didn't embarrass them, with the understanding that was going to be many of them that had certain strengths and certain weaknesses and where they had weaknesses, the way they handled it for the most part was they didn't respond to certain questions or they gave a shorter list to certain questions; whereas, those that had strengths in certain areas wound up not only elaborating on their strengths to certain questions, but in many cases they would add an appendix. We had some SDOs that wound up actually giving tables and matrices to show the extent of their data elements and their data sets because they were very proud of it and they really wanted to make sure that, you know, the folks that were going to wind up using this had an appreciation for the richness and the specificity of what they had to offer in their standard.
Now, let's talk about some of the limitations. The first limitation we have already mentioned, which is that even though there is -- and I forget the number, 78 or 79 profiles, each profile, by the way, varies -- the average is, I think, 8 or 9 pages that they took to fill out the three-page template. Okay? Some of them are as much as 15 or 17. Some of them are short and they are only four or five pages.
So, we know that we don't have the complete universe. For example, we would have had to have come up with a different template to have gotten responses from those organizations that are developing standards for object-oriented services; C-COW(?), Andover Working Group, CoriMed(?), those -- okay?
We don't have templates for object-oriented services standards. Okay. We don't have responses from international organizations, other than the National Health Service in England, which was the Read Codes. That is the only -- well, actually we do have a couple of others. World Health Organization responded with a physician's code set.
Many of the standards that we tend to think of as standards that are U.S. developed standards are really international. Health Level 7, I don't remember the number of countries, but I think it -- is it seven, eight, nine, ten? Does any -- Clem, do you know?
DR. MC DONALD: It is at least seven.
MR. BLAIR: Seven different languages that -- countries. Okay? Take SNOMED, SNOMED has been translated into 13 different languages. It is called SNOMED International. Okay?
So, DICOM is accepted internationally. So, a number of these standards, although they were developed in the U.S. are international, but we know there are many standards developed by CED(?), Committee on European Denormalization in Europe that did not respond. And there are others. Besides the definition of a standard is not fixed, where as you begin to look through this document -- I will pick the code set section, for example.
Most of the 30 some odd respondents that we have, I think, most folks would wind up saying that is a valid code set. To some degree, we are liberal. We tried to be liberal. Frankly, we tried to do down no one. There was one organization where we did wind up indicating that they had submitted some profiles that just simply were inappropriate.
Some of them, for example, like in the code set section, we were liberal enough to wind up saying if they defined a standard that is a guideline for nomenclature, we accepted that. Okay? That is related to that issue, code sets and vocabularies.
And there are some other examples as you go through where we felt the relationship was pertinent. Okay? Others, where it was too difficult and too far away and I think that there was a total of seven that we rejected as just simply not being relevant to the section that it was in.
Other limitations, when you get to code sets, the certain areas of code sets that we know are very critical for the future, getting down to clinical specificity. There are certain code sets that are very strong in this area. How do you wind up coming up with a template that begins to give them an opportunity to display their strengths without crafting a template that 90 percent of the code sets can't respond to. So, we tried to do a middle ground and a middle ground of cost falls a little bit short of some of the strengths of a convergent medical terminology, a concept relationship code set that is very strong there.
On the other hand, we wound up, you know, recognizing that the domain specific code sets are also important. So, maybe that is the reason we wound up with 30 and not 5 or 10 that responded. Okay?
The other thing is that while there was work in the process that we set up, all of these profiles were submitted. They were reviewed. Critiques were sent back to the authors of the code sets for either clarification, more information, improvement in the clarity of the writing, maybe the fact that they didn't quite answer a question quite well and they responded very appropriately.
So, from a standpoint of being informative, relevant and readable, we did okay. Okay? But the piece -- let's see if I am losing my train of thought -- the piece that is the limitation is that there was not content critique of what they offered us. By that I mean that there is not an analysis. We didn't go down through all the message format standards and wind up saying that we are rating one as more appropriate than another or the data sets or the code sets. Okay?
So, an analysis of the strengths and weaknesses of individual code sets has not been made. This is what the standards development organizations and the developers submitted to us without critical critique of their content. That may be something that as a group we may wish to follow up on this information in terms of a further analysis or we may not feel the need to. That is an open question of follow-up work that we need to do. Do we need to wind up ranking these or not?
Some of the witnesses, the hearings that we are going to have will help us to answer the question of whether we even need to go into that. For example, one of the questions that in -- the question that Michael reviewed with us was does the private sector need help in these standards areas. The private sector may give us the word back that they don't need any help in developing clinical message format standards and they don't need any help in developing data sets and data definitions. They are doing fine. They might like to work faster, but they are doing just fine in that and that the only area of focus where the government can provide assistance or catalyst or a forum might be the code set area. Okay?
So, the hearings will give some of the answers to that. I think I have kind of given you -- by the way, is there somebody that, you know -- let me pass this around so folks can kind of flip through and I don't know who to hand it to and I don't know who is interested.
DR. COHN: I thought we had already received copies of that.
MR. BLAIR: You already did. I just didn't know whether there might be an individual here that maybe is new to the committee or new to the group and hadn't seen the binder or somebody in the audience. So, anyway.
DR. FITZMAURICE: Jeff, I will take it because I know somebody who wants it.
MR. BLAIR: Okay.
Questions, comments?
DR. MC DONALD: Well, I guess it does suggest two things. You said what you didn't do is analyze them. So, that would beg that question of whether out of the hearings we should get some analysis, which also then goes back to the same questions. Do we ask them which ones they think are important and which ones they are using and which ones are working for them.
Just listening to all of these numbers, it looks like there is a lot of stuff here, but in real life there is not as much as it looks like in the list. I won't make that --
MS. HUMPHREYS: Well, one of the things that if we wanted to ask people to submit in writing as we said, what they were using now, maybe actually giving them the list as an attachment to the letter saying, you know, these are some of the ones that were submitted by whoever and maybe it would be easier for them to check off or that would prompt them thinking what do they mean? Well, I guess this stuff is what they mean or whatever.
Then if they wanted to check of CPT again, that would be all right because it would just be a checkoff on the list and we could move on.
MR. BLAIR: Please understand when you start to reference CPT, there was another inventory that was submitted to the committee a year ago covering the financial administrative standards. So, there is a certain degree of coverage there for ASC, X12N standards and NCP that are not reflected in this inventory.
MS. HUMPHREYS: Yes, that would make sense, yes.
DR. COHN: Though I would actually comment on the basis that there are people out there that think both ICD-9 and CPT are actually clinical vocabularies and we had better be aware of that. I know people who use ICD in their clinical information systems as one of their main diagnostic inputs. So, having said that, we should probably be aware of that.
DR. FITZMAURICE: Let me ask a clarifying question. Do you want sent out in the letter these three pages that list the clinical data standards and have them returned with checks beside the numbers or circle the number -- the patient number beside the standard that they use? Is that useful information?
DR. MC DONALD: I think it would be useful information but I think you have to do more front-ending than that. You know, just say check -- I mean, you would probably have to have a header on each page and these are message standards. These are model standards. These are codes. The issue about ICD-9 and CPT, you are right, you know, they are not listed here, but they obviously, are things that people would think are clinical standards in most contexts.
DR. FITZMAURICE: I would suggest that this might be construed as a survey because it is going to be more than nine people and would have to go through OMB clearance and might have to go through the Paperwork Reduction Act and --
MR. BLAIR: What if when they come to give us the hearings, if we hand them the list when they are here for the hearings?
DR. FITZMAURICE: If they should pick up it up off the table and take it off themselves voluntarily and turn it in, who are we to deny them the opportunity to do that, Jeff?
DR. COHN: How about this as a suggestion? How about if we send it as an appendix saying these are some of the standards that we are aware of. You may want to reference them in any comments you make in answering this question.
DR. FITZMAURICE: That is good. For your information, we have attached a list of what we think are clinical data standards that currently exist.
DR. COHN: As an extension, though not complete list.
DR. KOLODNER: If we are going to do that, we may want to list ones that we didn't list as clinical standards that they may be thinking of as clinical standards.
DR. COHN: Such as?
MS. HUMPHREYS: CPT is on the list and so is ICD-9 and so is ICD-10. So, I think we really don't have a problem.
PARTICIPANT: It was in both inventories. It is another example of things that fall in more than one category.
DR. MC DONALD: Yes. I think that would provide a lot of crystallization to what are mean standards because people often get flipped over the idea that standards for care, even though you -- which is another thing.
DR. COHN: I think on the basis of this discussion, Jeff, it makes me want to go back and re-review the clinical inventory, at least page through it once again. I know as I reflect upon these standards, I think that there probably needs to be some critiquing and some analysis done. Though, I find myself sort -- just sort of sitting here for just a second sort of going, gee, if what we are trying to do is to reference standards for the year 2000, for example, I would probably want to know a lot more about HL7 Version 3.0 than I want to know about Version 2.3, for example, and things like that.
DR. MC DONALD: I thought we were trying to get a -- we can't make the judgment as a committee as to what should be what is right and what is perfect and what is used. But what we get a sense of, what does the industry think? And, you know, we can always talk about futures, but you have got to pay a lot of attention to, you know, what is today, not what they might do sometime in the future.
So, I don't think -- everyone of them, there is another generation coming and those people are already expert, but, you know, you are going to hear from some industries that we are doing this. That is what we are doing. If we hear a consistent story, it will make it a lot easier to make recommendations in the various domains.
MR. BLAIR: Any other comments on -- sorry.
John.
DR. LUMPKIN: I am looking at this list of stuff and I am saying what is missing.
DR. FITZMAURICE: You want me to tell you some of the things that are missing?
DR. LUMPKIN: Sure.
DR. FITZMAURICE: National drug codes are missing.
DR. LUMPKIN: No, no. Actually that is not my question. It is a little bit higher level question.
DR. FITZMAURICE: Oh, I am sorry.
DR. LUMPKIN: If all these standards were it, wouldn't it seem that there would be some movement in the industry to settle on something? But there is a piece missing. And I don't know if it is a piece of technology or if it is a standard to get us from -- into a workable system. That is just a question -- I don't know. It may be a question that we may want to ask not necessarily as part of the written questions but when we get our panels there, we may want to ask them, you know --
MR. BLAIR: You know what may be missing is kind of a model to put all this together. How does it fit together?
DR. MC DONALD: I bet it is we are not really missing -- we are not missing anything in intent, but there are dimensions and there are many -- more than one of some. You know, it is too many of some. There are -- there is this and that, but I think that you really have all the pieces, not to do the huge yet, make positions happily tapping in front of screens, but to move all the data around that is in computers right now. We have most of the pieces and if you talk to the industry, they will tell you what they are doing. I don't think there is too much confusion in the industry.
The vocabulary has got two sets of problems. One of them is there are still some areas that may not be covered. I am not sure that is true. And there hasn't bee a clear -- there is more than one choice in some cases. I am sure there are areas that aren't covered. But there are some very nice covering sets, some of these very nice covering -- Reed has a very nice covering set and there are some things that you could probably jostle to make something come loose in those domains.
DR. FERRANS: I do appreciate the comment and what was said about, well, what is missing because, obviously, there are all these standards yet. It is not a seamless thing to exchange clinical information and to, you know, take all the various pieces that really constitute a profile of what is going on with the patient either at a particular instance or longitudinally, even in a summary, and be able to do that so that it can be done sort of meaningfully.
I mean, there is not a standard for that --
DR. MC DONALD: I disagree with you. What is not being done now is physicians don't code everything and they don't say everything and there is no one who is recording functional status, but that is not a technical standards problem as much as just a lot of problems.
Now, that may be another code you want, you know, which ones are the functional status codes, systems you are going to use.
DR. LUMPKIN: Well, I don't think we have time, you know, but I think that, you know, is it the interface that is the problem? Is it some piece that leads us to not having -- I mean, because docs shouldn't have to code. It is one thing to ask them to code. It is another way to write in a structured way.
You know, one of the questions we may want to ask them is how much of -- how much would you be willing to write or to encode in a structured way in order to get this functionality; i.e., writing, you know, which side is first. That is the first thing you write in your diagnosis. The second thing is the body system. The third part is the actual disease process.
But, you know, we can't discuss that tonight, but it is an idea we may want to just sort of put in the back of our minds.
MR. BLAIR: John, I think that if we were to assume that we are going to have physicians writing codes and dictating codes and having to know codes, that really we are not going to make too much progress. I think what is needed is that we have physicians work in a natural way, either with natural speech or with selections through systems, which don't delay them and that the software be able to translate that into appropriate code sets, which are consistent and interchangeable.
So, in a lot of cases, to be honest with you, we are really directing this at vendors that are struggling to make systems that will do that work and we are looking at some leading edged providers and academicians, academic medical centers -- individuals in medical informatics from academic medical centers, who have been struggling with these things to try to create systems that will not burden physicians.
They are the ones that have been struggling with these issues and I think what we need to find is do they need help or are they doing just fine, thank you.
DR. COHN: Well, I actually think to be the devil's advocate for just a second, I think the other piece of this question is does all of that really matter. Some day that probably is important and the question is is all data important or is some really more important than the other. And I think that is the other piece of this whole thing, that we -- this is once again something we need to hear from the community about.
DR. MC DONALD: I agree a hundred percent. I just don't know -- if we don't phrase the questions in a way, we are going to be all over the map. They are not going to get those answers.
DR. COHN: Okay.
DR. MC DONALD: Because we are really -- the docs in our hospital think they have got a medical record. They don't want to enter anything. They are happy as heck to be able to read the discharge summaries, look at lab results and all that kind of stuff, but it is all computerized. So that this idea of -- this is a leap of having -- you have been there and when there -- there are still things that a lot of people regard as medical records that used to be in a paper, except what they wrote, and now it is in the computer and they are happy with it.
So, if we are talking about the physician on line, someone getting it in, it is a little different story than exchanging data around -- all around the place, which we are doing today.
DR. COHN: And I think we had better hear from industry and the public what it is they want to help us figure out what it is we should be doing here.
Now, I don't know what time it is, but I think we are getting pretty late.
MR. BLAIR: Michael, the one area we didn't cover was that last area of recommendations, thoughts on that, but I think we will have other opportunities to discuss that.
DR. FITZMAURICE: I think you are right, Jeff, and we will be better informed after the hearings.
DR. COHN: I was actually going to comment that we -- reminding everyone that we are having people coming in to talk for a day and a half, but the agreement was is that we would spend the afternoon of the second day figuring out where we were, maybe beginning to come back to some of these questions that we have been mulling over this afternoon, with some additional knowledge to help us figure out what it is we should be doing.
So, I would strongly urge people not to plan to leave at 1 o'clock or 1:30, you know, that sort of thing. I mean, figure that you will be there for most of the afternoon while we really look at the work plan, reflect on it in relationship to the questions we have begun to ask today.
Okay? Jeff, do you have any final comments?
MR. BLAIR: No. Thank you, Simon.
Any final questions or concerns?
DR. GREBERMAN: I will raise the question non-related to what we are meeting here. I lost my cell phone since getting here today. If anybody sees a cell phone lying around, please --
MR. BLAIR: Whoever has the inventory, you are more than welcome to keep it. Please return it to me tomorrow.
DR. FITZMAURICE: Jeff, you wanted it back?
MR. BLAIR: That is my copy.
DR. FITZMAURICE: Oh, all right. I will get it back to you right now.
[Whereupon, at 5:30 p.m., the meeting was adjourned.]