Hubert H. Humphrey Building
Room 705A
200 Independence Avenue, SW
Washington, DC 20201
Speaker - Betsy Humphreys, NLM
Briefing Letter to the Secretary
Set up January-February Meeting
MR. BLAIR: This is the second day of our September hearings here for the CPR Work Group. Again, for the benefit of those that are listening in on the Internet, this is the National Committee on Vital and Health Statistics, the CPR Work Group. Our focus is on studying uniform data standards for patient medical record information, and the exchange of that information.
We are in the information gathering stage, and we are having testimony and hearings during most of this year. This is a continuation of that process. The person that will be testifying to us will Betsy Humphreys of the National Library of Medicine.
So before we go into Betsy's testimony, let me just go around the table and let each person on the Work Group and the NCVHS staff each introduce themselves.
[Introductions were made.]
MR. BLAIR: Betsy, we are very happy to have you. Why don't you go ahead and begin your testimony if you are ready.
MS. HUMPRHEYS: I'm speaking today here in part because I was unable to attend the meeting in May when your hearings on terminology developers.
[Brief technical difficulties with the microphone.]
Anyway, as I started to say, I'm speaking today on NLM's perspective on clinical terminology development, in part because I was unable to attend the May hearing when terminology developers were presenting. And then it was thought well, find you can review all the testimony that was made, and I did read every single word. Then I'll comment on some of the same issues or some of the issues that were discussed there, plus bring the Working Group up-to-date on some particular projects that NLM has been pushing forward itself.
This is quite an intimate group here, so you probably all know this, but for those who might wonder out on the Internet why the National Library of Medicine has a perspective on clinical terminology, it relates to basically about 40 years of work in automated terminology development, starting with the development of our own medical subject headings, which went into regular use 1960, and I think probably has the distinction of being the first major thesaurus that was actually created for use in automated retrieval systems.
Then we launched our Unified Medical Language System, which I will discuss a little bit more in a minute, in 1986. We ran, in conjunction with the Agency for Health Care Policy and Research, a large scale vocabulary test in 1996-97, where we were attempting to get some metrics on the extent to which existing vocabularies covered the terminology that people wanted to control in patient records and other types of clinical systems. And then I have been involved with the HIPAA code sets and classifications team as co-chair since 1996.
Just to quickly review, the Unified Medical Language System project has a principal focus of building machine-readable knowledge sources that can be used by a variety of software to overcome two major problems that affect information retrieval, which is where we started with this issue, information retrieval.
The two issues are basically the disparities in language used by different users, and in different types of information systems. We, of course, are concerned not only with patient record systems, but also with the medical literature, factual databanks, and so forth. And the other problem being difficulties in figuring which of many information sources is relevant to any particular question.
So in pursuit of that goal, we built multi-purpose tools or what you might call intellectual middleware for system developers. And the largest of these is the meta-thesaurus, which I describe briefly. It essentially incorporates a large number of different biomedical terminologies. The specialist lexicon and lexical programs that deal with the syntactic aspects of language and variation, and a semantic network.
The meta-thesaurus is most relevant to what we are addressing today. The 1999 version of the UMLS meta-thesaurus has about 627,000 concepts, 1.1 million terms. In this context the singular and plural of anything are the same term. So for example eye and eyes would equate to one term. And 1.3 million strings or individual concept names, and in that case we are saying that eye would be one, and eyes would be a different string.
These come from -- depending on how you are counting, because we have translations in foreign languages of a number of these vocabularies -- somewhere around 50 different source vocabularies, including all of the HIPAA code sets except the NDC.
The UMLS knowledge sources are updated and distributed annually. They are free under a license agreement with the National Library of Medicine. But you need separate license agreements with vocabulary developers if you are going to make production uses of some of the individual vocabularies.
So what you could say in the area of licensing vocabularies is that the UMLS does not compound the problem at all, but it doesn't solve it either. You still have to negotiate for example, a separate license with CAP for the use of SNOMED if you are going to use it in a routine way. And you have to negotiate a license with the AMA for example, if you are going to use CPT.
The relationship of the UMLS to HIPAA is that it does provide a uniform distribution mechanism for all of the standard codes with the exception of the NDC. That is, you can get a version of each where the bioformats and the logical structure of the files and whatever have been converted into a consistent pattern. And if there is any relationship between them, those have been noted.
It also provides a uniform distribution mechanism for essentially all of the major candidates for patient record vocabularies. So you therefore have all of these systems available to you in the same database structured.
So therefore, you can see that you can regard the meta-thesaurus as a vehicle for building and maintaining maps between the standard HIPAA codes, and the more specific patient record. And the meta-thesaurus is also one mechanism for distributing information about which vocabularies are valid for which particular specific segments of transactions.
The UMLS project has had a major impact I think on the field since it started in 1986, by essentially I think really increasing the level of sophistication, interest, and expertise in vocabulary matters. It is not, I think, accidental that at least three of the people who testified before you the last time spent major -- have and some still are spending a major effort on the UMLS project: Jim Cimino, Stan Huff, Mark Tuttle, and the list goes on.
I think that the other thing which is interesting is I think a lot of the focus on the specific requirements or desiderata for well formed vocabularies grew out of the UMLS project, because as we attempted to map all the existing candidates, none of which qualified -- I have to say MESH(?) was the closest when we started, and when new versions, for example the new SNOMED and the new REED came along, they had made great strides in that direction.
I think a lot of these things like concept orientation, context free identifiers, explicit separation of hierarchical coding from unique identification and so forth, a lot of the interest and understanding of the importance of these issues basically grew out of people's experience with UMLS, or at least that was one of the precipitating factors. And we of course, benefitted from having all of these great people contributing to the project.
So the large scale vocabulary test that I mentioned before -- and these next three slides that I'm going to show you are directly out of a presentation that I gave at the 1997 CPRI terminology conference, which Chris Chute mentioned, and you have heard about it from Simon too. In his testimony, he was referring back to this.
I was reporting out the results of the large scale vocabulary test at that time. There is masses of data, and it's all been published, and I'm not going to summarize it for you here. But essentially what I said at the time that the punchline was that the existing vocabulary systems have most of the terminology needed to describe patient conditions. The combination of existing systems is better than any single system. And that the test was organization and technically very successful. This was a distributed test where everyone was using the same set of tools over the Internet and contributing data. So those were the conclusions.
Then I went on to say, what are the implications of these conclusions? Well, the implications are that the bulk of vocabulary creation patient conditions has been done. And that to some extent the structure or model of the patient record determines the range of vocabulary needed. You have all have heard this from people many times before.
The obvious example is that if in fact you structure a patient record with a separate section or data element for mothers' history, then you do not need a vocabulary term that says mother has a history of breast cancer, because in fact you can just put breast cancer in the section of the family history, rather than having a different term for it. So that's the obvious thing.
There are many cases where what the decision about the structuring of the patient record will require one system to want a different set of fully specified or combined terms than another will need for that reason.
I then went on to say -- many people at the same meeting were saying this. I might have said it first, because I appeared relative early on the program. But at any rate, basically what I felt were the major implications of our results were that we needed a workable strategy for eliminating unnecessary duplication of effort between vocabulary developers for supporting the ongoing maintenance enhancement of key complementary systems.
And for establishing a closed feedback loop between clinical system builders and vocabulary developers, so that we would in fact have the terminology that matched the data element lay outs and the model of the patient record that was being put into various systems. So as I say, it was not surprising.
I think I'm going to do in some sense what Chris did in his testimony in May and say, okay, what happened in this area since 1997. Chris felt, and I agree with him, that there has been quite a lot of work toward more collaboration and arrangements and agreements and projects that should tend toward helping to eliminate duplication of effort. So I think we have seen some positive steps.
He mentioned agreements between LOINC and SNOMED. There have also been agreements between CDC and LOINC in terms of actually expanding LOINC to meet CDC requirements. We have the agreement between the CAP SNOMED and the National Health Service to eventually in essence merge SNOMED and REED.
Judy Ozbolt and others spoke about efforts in the nursing community to try to get better harmonization among the different systems. Judy's meeting was held. She mentioned it was going to be at the May hearing. Although I have not seen the report yet -- I think it's in the draft stage -- I think that they do have some useful plans for moving ahead.
I would say that a question in all of this of course is something we knew about in 1997, but that in 1999 emerged as something that has to be dealt with by a lot of people who are involved in clinical systems, which is the MEDRA(?). I think that's another one where over time, it might be valuable to get some collaboration going.
A related theme in the collaboration area that also was mentioned by Chris Chute and came out pretty heavily at the 1997 meeting was that it really would be very useful from the point of view of developers and users if there was a good mapping between SNOMED and CPT on the one hand for procedures, and ICD-9-CM for diagnoses on the other.
The system developers made the comment that given that people have to report out using these systems, they are not going to be too interested in capturing data two ways. So if there was a good mapping that would at least be semi-automated or automatically assisted, that you could capture data at greater detail using SNOMED for example, and then know that it could be reliably mapped out to what you had to report and build with, that this could be very beneficial in terms of moving along the adoption of detailed terminology.
And so that seemed right up NLM's alley in terms of mapping. So shortly after that meeting we formally invited the AMA, the CAP, and the NCHS to collaborate with us on creating such a map. There were a lot of issues associated with this in terms of intellectual property and things that had to be worked out. So it was I would say roughly a year later when we were all on the same page and agreed to go ahead.
And we began work and have done some preliminary work --
MR. BLAIR: Betsy, I may have lost track here. At what time was this? What year are you referring to now?
MS. HUMPRHEYS: Thanks, Jeff. We proposed this collaboration in November 1997, right after the first meeting. I think that we sort of all agreed and that we were ready, and that we definitely were going to go ahead and do it probably around the following summer or early fall.
Then we got underway, and had some meetings, and developed some preliminary drafts and tests and so forth, but not something that the participants think is far enough along to share with the broader community. The general plan is to come up with a proposed draft format with some examples circulated to see if people think it makes sense to them. Potentially revise this draft based on comments. And then actually do a test of a fairly large section to see if it works.
And then once we have the mapping, actually make it available for testing to see if people can use it. It's a little bit more complicated than that, because I think we have decided that in order for such a thing to work, you not only need the basic data mapping, but you also need a set of decision rules. When you are mapping from specific terminology to more general, there may be more than one appropriate code, depending on other information that is in the record. So you a decision rule to say, well, yes I used this code, but if it's a woman and she is pregnant, then I use a different one; this kind of thing.
So it's a non-trivial problem to figure out how you lay out the mapping. I should probably say that we have been approaching it from the point of view, using a document that was generated by the National Health Service on mapping. The latest version of that document I think is dated maybe January 1999. I'm not sure about that. But it's a very good explication of the issues and the approaches to mapping, and we sort of started from that point.
At any rate, this thing has been relatively stalled over the summer due to other competing priorities like the development of CPT-5, SNOMED-RT, and negotiations with the National Health Service and so forth. So there hasn't been any action lately, and I would not be able to estimate when we would have a draft format to circulate to the community, but we're going to see if we can revive or refocus attention on the project.
In the area of coming up with mechanisms to support ongoing maintenance, what NLM has done in this area is arrange a collaboration with the Veterans Administration and the Department of Defense to put in place as sort of test case that will be available to the NCVHS to monitor, and will also help us I think work out some of the -- well, it will give us a model that we can work on to basically fund the basic expansion, development, and distribution of LOINC for the next three years.
This was chosen as a test case, because it is about to be named as a HIPAA standard in the claims attachment standard. It is a chosen target coding system for a major project within the GCPR project. CDC is very actively engaged in its expansion and use of it in projects related to public health. And it, we think, gives us an opportunity to develop a model of what we think an open update process and efficient electronic distribution and maintenance of updates will be.
So this contract is probably being signed in Indiana as we speak or something. I think it left our contracts office late yesterday. So we will be getting underway with this with an initial meeting.
One of the initial things we're going to be talking about is the issue of defining in essence a standard format for people to use when they submit requests for changes and additions, so that the processing on the receipt end is as efficient as possible. We're also going to be going through the issue of what will be the elements of the open process that allows people to participate and know what's going on, and why decisions are made and so forth in the development of it.
So we will be probably convening an initial meeting with the funding parties. I think what we will probably do is come up with initial proposals or initial approaches to these things. And then also have those subject to comments from the community as to whether they think they're appropriate.
So the other thing I would say here for the benefit of the federal agencies, in addition to providing basic funding for the maintenance, distribution, and development of the enhanced procedures for distribution, LOINC today is freely available on the Web. But there are a number of issues that relate to sort of codifying procedures and also identifying specifically and distributing change sets, so that you can not only get a new version, but you can get a labeled set of exactly what is different between this version and that version. I think this will help us bring those issues along as well.
So that's what the basic funding is for. The contract is written in such a way that if federal agencies would like also to have the Reagan Street Institute specifically assist them in mapping some internal terminology to LOINC as a way of moving forward, they actually can use this contract vehicle. There is some additional ceiling in there for that purpose.
In that same regard I should probably mention NLM awarded a new contract for meta-thesaurus backend system development and support to Lexical Technology, or whatever the company is now. I think it was Lexical when we signed the contract with them.
And that contract also has additional ceiling in it if other federal agencies want to use -- that was done primarily because I was asked probably a dozen times during the course of the last contract by three or different federal agencies if they could award a task or work under that contract, and the answer was always no, because the contract ceiling was just what we needed to get our own work done. So we awarded that one differently this time.
So then we go to what I do believe is very critical here, and that is what happened in the area of establishing tight feedback loops between system builders and vocabulary developers since 1997. I think that we have now some relatively tight feedback loop examples. The LOINC is definitely one. That is, the expansion of LOINC is driven by people who are trying to implement LOINC in specific systems.
MEDRA is also has a pricing mechanism where if you pay for core services, then you can also submit requests for additional terminology. Those are processed quite quickly.
And the NCI, which is not in the same category, actually within the National Cancer Institute they have a thesaurus development group, and they have a number of system developers. They have quite a tight feedback loop, but that's really more analogy to what the National Library of Medicine has had since 1960, with the medical subject headings.
It is definitely true that if you have a very close relationship between the vocabulary developer and the people who are implementing them in systems, you end up with a better product on both sides.
I think that SNOMED I would regard as a looser example. This certainly has been a major impact in terms of vocabulary development of the joint agreement between the Kaiser, which of course is building systems or putting them together, and SNOMED in the sense that I think that certainly Keith Campbell, who is not your average clinical system builder, influenced the development of RT and the notion of the reference terminology dramatically.
But I think in some sense that's a special case, because it is almost a joint vocabulary development agreement, rather than the other. I think SNOMED is, in terms of seeking input and doing the beta test of RT, was definitely trying to get into a feedback loop with the system developers.
One has to say that if we want to establish tight feedback loops between system builders and vocabulary developers, which I think is highly desirable, and indeed necessary if we are going to really see the use of controlled vocabulary in systems, then the development of major new versions really complicates this process, because if you are midst of totally redesigning your system, and it isn't quite there yet, and you have major things, it's very difficult to maintain.
It's more difficult. I think you have to manage it very carefully to continue to have some sort of a feedback loop during that period. And I think that actually the National Health Service can provide the cautionary tale of what happens when you don't. Because when they introduced Version 3 of the REED system, which I considered to be really a well designed system, and a good system, it was so far ahead of the people who were using and had implemented REED.2, that it is still not too heavily used.
And I think that this is not a specific criticism of the National Health Service, because I think that anyone else who would have done it would probably have done something similar. And it is difficult when you are doing a total rewrite and expansion to also be dealing with a gradual bringing along of your existing community. It's a tough thing to manage well, but I think it is important to manage it.
Those are the points that I had slides on. I was very interested in, as I always am, in the notion -- I do think that we have a very key issue here with coming up with a workable model for supporting the development and maintenance of terminologies so that they are truly available at relatively low cost to everyone who might want to use them.
I think that in looking at the LOINC model, it is to me, quite justifiable when you have incredibly wide use and need both for controlled terminology and the creation of data within the government in large enterprises like the VA and the DOD, and a tremendous need to obtain standard data for public health purposes throughout the -- and of course in the Indian Health Service as well -- in terms of the care of people.
But you have a tremendous need to be able to obtain good, standard data throughout the Department of Health and Human Services not only for public health, but obviously for monitoring and insuring that the Medicare population is receiving good care, and so forth.
So it does, to me, seem perfectly reasonable for the government to consider that this is a reasonable approach. So we'll see how the model with LOINC works. And there may be other models for doing this. I know some people in this room are working on other approaches that might have the same effect.
But I do think that it is essentially absolutely in the federal government's interest to see more comparable data. And I think that it will be up to this Working Group and then the full committee to recommend how we could best help that along. I know that's part of your agenda.
That's what I had to say.
MR. BLAIR: Thank you, Betsy.
Committee members and staff, are there questions?
DR. COHN: Jeff, do you mind if I start? Betsy, thank you very much for a very enlightening overview, as well as conceptualization of I think two days of relatively intense hearings that we had in May.
MS. HUMPRHEYS: I decided I wouldn't comment on every point made.
DR. COHN: Well, thank you.
As I listened to you, I am struck that the committee is obviously concerned about sort of the relatively few things that must happen to insure success in moving forward with uniform clinical data standards, and the success in the future of the country in terms of being able to improve the efficiency and effectiveness of the health care system. I think most of us believe that if we get better clinical data, we will be able to understand better what's going on and improve the efficiency and effectiveness.
Now as I'm listening to you, I'm wondering if you have used -- to me, the mapping seems to be one of the critical few things that needs to occur in the relatively near-term to help insure the success of everything else happening.
MS. HUMPRHEYS: Yes, I would agree with you, Simon. I think that the mapping issue is also somewhat complicated by the movement to major new versions. We were dealing with this with the NCHS. There are real problems in terms of current understanding in some disease areas in ICD-9-CM. They are known problems. They are solved in ICD-10-CM, or a number of them are solved. That is, these conceptual higher level classes.
There are areas, oncology is one of them I think, where the overall organization ICD-9-CM is sort of at odds with the way people view the world today. And ICD-10-CM has gone quite a long way to correct these. So it is actually easier to map from a current -- it's much easier to map to current versions of the world, even if they are dividing the world in different ways, and even if they are for different purposes, than it is to map a version of the world which is pretty much 1990s view of world, to one that is pretty much 1970 view of the world.
We face this all the time in building the UMLS. You get into these areas where you are looking at the medical subject headings, and the way it breaks down something or SNOMED currently, and those are the two systems we deal with and REED, those are the three that are most currently maintained. Then you try to map this to ICD-9-CM, and sometimes it just is very difficult, but it's easier to map them to ICD-10.
So I think that we need to come up with a format, we need to come up with the agreement. Then we've got the big issue of if we are going to sit down and do this systematically, which version on all sides of this question is worth that amount of time and effort, because it will be. It's very worthwhile work, and it can be done, but I think that in some sense that cools enthusiasm for immediate action on this activity by the vocabulary developers.
DR. COHN: Just a follow-up comment probably question. I do understand that we are in the midst of a transition. Unfortunately, we've been in the midst of a transition for the last couple of years.
MS. HUMPRHEYS: Absolutely. So at one point we just have to do it. I agree with you.
DR. COHN: At least we're in the midst of a transition for the next 15 years as we increasingly computerize, computers become very, very cheap, as we figure out all the technical barriers.
MS. HUMPRHEYS: I think that the issue too is that it seems to me irrespective of what we do, we have a sufficient body of data that we will continue to find useful, that does include the current version of CPT and ICD-9-CM, that it's probably worthwhile doing it just so that we can make effective use of the data that we have, because obviously those are the two where we have some level of comparability, whether we can argue how useful it is under certain circumstances, but it's what we have. So I think we are going to have to deal with it.
MR. BLAIR: Incidently, have we had any other committee members join us that should introduce themselves?
DR. COHN: No.
MR. BLAIR: Okay, Stan?
DR. GRIFFITH: By the way, thank you very much. That was a very thorough presentation. You made it clear that no one code set is going to satisfy all our needs; your experience with the UMLS. And I thought you also made it real clear that although the UMLS does not compound licensing problems associated with the different code sets, it doesn't resolve it either.
I'd be really interested in your very specific views on possible solutions for dealing with that licensing problem. And in particular, I would interested in your views of whether or not the federal government could play a role in promoting a solution.
MS. HUMPRHEYS: I actually will not surprise people who have been listening to me on this topic for a while by saying that I think that the federal government should play a role here. That's my view. I think that it will be, for the federal government, less expensive to provide some level of up front subsidy for the vocabularies that are identified as being important for government projects.
I do feel that the subsidy does not have to be -- LOINC is a very easy case because of a number of factors. And it is of course a very justifiable case in part because of its very likely designation as a HIPAA standard. But I don't believe that you want to designate a mandatory requirement to use very detailed clinical vocabularies in patient records any time soon.
So I think we will not be able to have that same argument, it is a standard, when we go into patient data and so forth. The reason why I don't think we'll be able to do it any time soon is that we really have to have a controlled vocabulary in operation in more real clinical systems, and figure out what the problems and the issues and everything are before it would make any sense in my view, for the federal government to say, okay, everybody you're all mandated. You have to collect all of this using controlled terminology. We don't know where it pays off. We don't know too much about it.
I think that I agree with Mark Tuttle's statement that we all believe that it's going to be important for comparable data at some level. We don't know yet exactly where you're going to have to use it get what pay off.
So it seems to me, however, that we could still easily justify federal subsidy or up front payment, or some level of support for terminology development, even if we weren't going to turn around tomorrow afternoon and say this is the national standard. Everybody has to use this in their problem list.
We could justify it based on the internal needs here in the department. It could justify it based on the collection of detailed data for public health purposes, the GCPR project, and so forth. So I would encourage us to move ahead with that if we can figure out a good way to do it, and obviously get some budget to support it.
MR. BLAIR: Dr. Kolodner, you had a question.
DR. KOLODNER: Betsy, thank you for the presentation. I think also reminding us of some of the historical recommendations and the progress made is very important. In fact, your last comment I think also brings us to the point where we have a multiple role for this Work Group.
We are now working on models that we are going to explore and build, and how to resolve some of that with MEDRA, that also by implication should then help resolve it with some of the other vocabularies.
That's what we have kind of put together so far, but we would be very interested in any additional advice, guidance as to how to make sure that that investment by these agencies -- obviously, you are involved in some, or at least I hope you are. How will you further do this so that some of what we are talking about in the letter to the secretary -- in fact, we are hoping to provide a little gentle guidance to all of us and make sure at least what we are doing is consistent with that direction that we are seeing.
MS. HUMPRHEYS: As you know, I think that the GCPR effort is terrific. And it is terrific not only because it will obviously be very useful to the agencies involved, but I think that it does definitely give an opportunity for decisions to be made that affect a lot of government agencies. And for these things to be tested and used, and you will obviously have an influence as you select what vocabularies you are going to use. You will have an influence on vendors who want to do business with you, and on the field.
I think that's great, because I think we need to -- Keith made the point in his remarks, and it is a point that many of us have made over the years, you want to pick something that is a good starting place. But more important than the good starting place is the procedure for maintenance and ongoing development.
It seems to me that what the GCPR project can help us do is say okay, here is a good starting place. And here is the investment that we are willing to make to assist and help insure that there is a good update trajectory. And so I think this can be very helpful.
I think that when I say multiple vocabularies too, Stan, it's essentially because some of these things really fit together like pieces. And some of them are different cuts on the same problem. When you are dealing with the pieces, it is much easiest. You can obviously literally say this is going to be my vocabulary for drugs.
And then you can say, okay, we won't use the AXIS(?) or the section of another vocabulary there because we think this is the one. And you don't run into problem doing that obviously, or at least there is no sort of obviously theoretical/technical problem to do it I mean. And the same thing would be true with devices, for example.
By the way, I didn't mention that there really is also -- I could have used as another example of more intense work since 1997, the FDA's work with ACRI(?) and other international partners to come up with sort of a new and unified device nomenclature system. I think that's a very good effort as well.
Then you have the cut on the same problem. We know that we really do think, and Chris emphasized this point that essentially one of the truths that was recognized by all participants at the first terminology conference is that we basically need a continuum. The fact that we have detailed patient data does not mean that we never need to aggregate this into classifications such as ICD or whatever.
It is just that the one won't serve the other purpose and vice versa, so we have to relate them. I think that obviously more recently, I guess it was probably coming out of that meeting as well, or at the same time or a little bit before it, the notion that you need to be able to have an underlying reference terminology, but you may have different approaches in terms of what you show to clinicians in different areas that is familiar terminology to them, and can be in fact translated into something which is more uniform across the enterprise.
So that is in essence, a different cut on the same problem. It is obviously a much greater coordination effort to insure that we can get on the one hand, from the detailed to the classification properly each time. And also that we can get from the entry vocabulary or the 15 of them. And when that reference thing gets dropped into the record, all of those 15 actually meant the same thing.
And I think, however, that it is a very good model, because deciding that you are going to mandate everyone speak the same language is probably not -- it's nothing that we've ever been in the business to try to do. Obviously, the meta-thesaurus is kind of designed to give you the underpinning so that you can give people their own terminology.
I'm meeting with Steve Brown the middle of next week, and we'll also have Frank Hartell(?) into that meeting, some people from LTI, because we have some issues specifically related to update cycles, integration of UMLS as a provider of source terminology and so forth. And as you know, I have been quite interested in having the VA be a model in this area for a number of years, and now I think we're actually all in a position where it can happen.
MR. BLAIR: Dr. Cohn?
DR. COHN: Actually, I have a question. I really focused on it from Dr. Kolodner. First of all, reminding you that probably in October we need an update from GCPR on what is going on.
At the risk of perhaps beating a horse that I've already been whipping a little bit during this session, just recognizing that you are taking an approach to clinical data and leverage it, clinical standards potentially of one sort or another. What is your strategy for deriving the administrative data from all this? Do you see the same risks that I'm bringing up, or is your timeline different?
DR. KOLODNER: Since a number of us from GCPR activities are here, I think Stan Griffith has been actually one of the people who is leading the charge on making sure that we have administrative data or administrative uses that are part of it. So that has come up early in the discussion.
Stan, I don't know if you have more updated information as to whether we have done that yet, or whether we're biting off the first piece which still stays clinical. Stan, maybe some of your discussions?
DR. GRIFFITH: I think we're still biting off the first piece primarily, although I'm a bit confused sometimes to be quite frank, when people talk about administrative data. My understanding of what you mean by that -- and I need to make sure I understand what you mean by that -- is that, and this actually leads to the question I wanted to ask anyhow, that we are collecting clinical data at the point of encounter.
From that clinical data we are deriving data that we can then use in much more generalized fashion. When you say administrative to a clinician, that doesn't include public health. That doesn't include a lot of other things, and I don't think you mean that. I think what you mean is that we derive a subset of data that can be used for population studies, for population health care, for organizational decisions and management, for quality improvement, and yes, for billing and for cost accounting and other things. Is that what you mean by administrative data?
DR. COHN: No, I was actually thinking more of the Balanced Budget Amendment of 1997, and the requirements to submit data to HCFA and other organizations to help insure that reimbursement occurs in a timely and reasonable fashion. Probably I'm just using a euphemism when I really mean ICD-9 and CPT-4, at least for the moment, recognizing that they are tightly tied to the whole reimbursement revenue realization part of the world.
So that's really what I was specifically referencing, rather than data that we might use internally for administration of my organization.
DR. GRIFFITH: Or externally for epidemiology, public health. You're not talking about just aggregated information that we use for of aggregated data for decisions. You're not talking about that. You are talking about pure administrative.
DR. COHN: I guess I'm using the right term then.
DR. GRIFFITH: I just want to make sure we are using the same language, because I get very confused sometimes. In that instance, and I guess my response would be we are really focusing on clinical data right now. We are clearly focusing on clinical uses for that data, although I think I made the argument, as Rob well knows, that we have to do more with it later on.
I wonder if I could ask a question tied into that? It was sort of my next question. Jeff Rose testified yesterday that in fact most of the information that we are going to be gathering -- much of it, if not most of it -- is going to come from clinical encounters. So it's going to be clinicians putting information down about specific services. For clinicians I use the term broadly by the way, not just doctors. I'm talking about everybody who delivers a health care service to a patient.
So most of our systems are encounter-driven, and many, if not most are going to be clinical-type encounters, although there will be some administrative encounters. And Jeff made a fairly articulate I thought, statement that our information systems should be driven from clinical vocabularies. And then administrative data, including billing and things like that be derived from that. Rather than the other way around, which was is in some cases --
MS. HUMPRHEYS: It doesn't work. It's impossible.
DR. GRIFFITH: I'd be really interested in your view on that statement. Do you agree with it? Do you disagree with it?
MS. HUMPRHEYS: I definitely agree with it. I think that Jim Cimino was making this point too at the earlier hearing and other, if we are going to improve the quality of health care both in terms of alerts, reminders, monitoring care as it is given, so that we can prevent stupid mistakes, and notice when events occur, whether they are mistakes or not just because of patient variation or whatever, then we are going to have to have more detailed data.
If you are going to collect the detailed data, then who wants to have a separate intellectual process to aggregate the data or categorize it in some way if we, as the NCVHS had put in its recommendations to the department related to coding and classification, agreeing with us that the first HIPAA standards had to be what they were, but that really what we needed to go toward was something that more interlocking between what needed to be captured at a detailed level. And then being able to automatically map to something at a higher level. Yes, I'm in total agreement with that.
DR. GRIFFITH: Then my follow-up question would be, because I think that's sort of the focus as I understand it of the Work Group, what role might the federal government play in promoting that kind of an evolution that in fact this has to be driven by clinical vocabularies, and that aggregrated clinical questions and administrative questions then get derived from that?
MS. HUMPRHEYS: Well, I think that basically the issue is that -- and Mark talked about this in his statements in May -- we have to figure out how much of this is both necessary and affordable. And I think that we are going to find this out by sort of incrementally moving toward it.
MR. BLAIR: By 'this' do you mean the development of clinical vocabularies?
MS. HUMPRHEYS: I don't mean the development of clinical vocabularies. I mean at what level are we imposing a requirement that everything has to be -- well, not everything, but that we are attempting to use controlled vocabulary in every possible data element in a record. In theory, I'm in favor of that, but I think that we have yet to determine where is the biggest payoff in terms of quality of care, usability of the system.
So I think that what we are going to have to do, or what should be done in the GCPR and other projects is to identify where the apparent value of that is the highest, and then gradually implement that level of control. And we all obviously need to -- there needs to be a lot of development, because I'm quite certain that we can get to the point where doing this is relatively efficient.
I am a great believer in the marriage -- and this is an area for research and development -- but I think we're very close to the point where this is going to be valuable research and development. I think one of the things we need to do is to marry up the use of voice data entry with reference terminologies, and essentially allow the person's spoken English to be the entry, and to code it properly. Not just that we can translate the words and put the words in properly, which of course is the first step, and we may not be there 100 percent.
But I think there is a lot of progress there. I think that what we could then do is say once we can recognize what the person is saying, then we could also say, yes, that's what Joe calls it, but really what we want stored in the record is not only what he calls it, maybe even his actual words saying we'll store with, but in fact some coded representation.
So I think that we're going to have to get much smarter about how we make it very efficient to get coded data. As we get more efficient, then it will be reasonable to require more controlled data.
DR. COHN: Betsy, I hope you don't mind if I interrupt. I fundamentally agree with everything you have said, and I think Stan is next to you smiling and nodding, because he actually made that recommendation yesterday during his testimony.
Just to also, however, put a little here and now back into the discussion, I'm just reminded in our discussions I had mentioned earlier that we're in the midst of a transition. I said that we'll go out and we can all guess around the room how far we are off in that transition. But the recognition, then beginning our discussion around clinically useful terminologies, LOINC, et cetera, et cetera, really become usable because we have computerized those aspects of clinical data.
It is very hard to use any of these more granular terminologies if you are still based in a paper-based paradigm. That's another piece of the transition. A lot of the world out there is currently in a paper-based world where coders have all they can do to figure out the right code in 5,000 terms, or in 10,000 ICD terms or whatever. And there is still a significant amount of error in even that process as we heard yesterday from one of our quality colleagues, who said that he was even having trouble getting the relatively common diagnosis CHF well captured off of a coding system.
So we need to be aware that we need to be moving in the right direction. We need to make sure that we're moving there. We also need to make sure that we're also not abandoning the many people in our society who still haven't made the jump to computers. I think that's why sometimes I reference the concept of administrative, recognizing that in a world where you don't have a good CIS or a good computer-based patient record, you are stuck with that.
MS. HUMPRHEYS: That's exactly why that I would say that a very good thing that can be helped along by GCPR and whatever is for there to be good encouragement and support for the maintenance and development of clinical terminologies that meet the needs of emerging systems. But I feel that that's kind of independent of us ever getting to a point, or shall we say it's independent of the timing of getting to the point where we would say, okay, now instead of reporting an ICD-9-CM code for certain things, we want you to report something at a much more detailed level.
Because we will have to have the majority of the people in the systems where this is reasonable for them to do before we can have a national standard. That's why I feel that we should not have this logic in mind that the government can provide support for a national standard, but can't provide support for the maintenance of clinical terminology, which they need themselves for large systems. And if they do that, then they will hasten the day that we will get to the point where we can have a national standard.
It would be insane to say okay, standard. Everyone has to use this detailed clinical terminology in the records they submit to XYZ government agency tomorrow afternoon. This is impractical.
DR. FERRANS: Betsy, your comments are always very welcome and thought provoking. When you were talking about the speech recognition, I was reminded, and I like to say that I don't see us reducing our nation's physicians to people using pick lists and constructing sentences through three or four windows. I actually saw that you all have some research efforts in natural language processes, and I would love to hear where that is in relation to vocabularies.
The other thing I was going to mention to you is you brought up the question of what comes first, the chicken or the egg in terms of national standards. It's been interesting, there has been discussion among witnesses, and also I think among some panel members about one way to get people to use structured vocabularies is to incentivize them to do that through a different reimbursement structure.
Now this sounds like a great idea. Then I was struck listening to you, and I say the last time that I checked the prices of using some of these systems, it was prohibitive. When I talk to the vendors and they go, well, it's the licensing fees for the vocabulary.
So I think if you really do the economic analysis, I don't think the government would reimburse even to incentivize people enough given the current pricing schemes for the systems, plus the vocabularies, and you do need both.
MS. HUMPRHEYS: I guess my feeling is that -- Mark Tuttle was the one who was proposing this idea. I think he had a very good point. I think that probably both would be a good idea. That is, some level of up front support for the vocabulary development so that they can be distributed at lower costs, but still be maintained in a useful way. And also encouragement for people to use them by some mechanism such as you described.
DR. FERRANS: And I think that the combination of those two would be very powerful, but how about a third piece? And here's the other idea I wanted to float to you. What if there was a requirement that people participated in a maintenance process if they were going to be reimbursed for this. Is that something that would be feasible?
In other words, as they develop new terms or find problems in the vocabulary, that there would be a process for which they could submit that? And that somehow by having more people doing that, that would accelerate the further development of the vocabulary. Do you see that as something even --
MS. HUMPRHEYS: Well, I think one of the things that we are going to be doing with this LOINC project is essentially we are going to be looking at trying to come up with procedures and requirements that are on so that the input that people provide about needed changes is higher quality, so it can be handled more easily.
Also, trying to provide tools to the people who are attempting to determine whether there already is something in LOINC that is identical to their need. So that you don't get so many inquiries about we need a code for X, and then somebody comes back and says, yes, there it is. It's code number 52. In fact, it was the first one we put into the system five years ago or something. So there's that.
But if you don't have an efficient mechanism for submitting the requests, getting organized in such a way that you get enough information that you can act on the request without an hour phone call to the person who sent it in. And then some efficient mechanism of handling it, then you are not likely to want to encourage input, because you can't deal with it when it comes.
I think that's something that everybody is very interesting in now, and there are various models being developed, because of course the ideal thing would be that people are trying to use the terminology. They identify a real, legitimate hole that belongs in this terminology and not in somebody else's. That's the first thing, where you say there are no drugs in this terminology. I will submit all my drugs this way, when they really should go to someplace else. There are obvious issues like that.
Some of them are a little more subtle, but you still end up requesting things that are totally outside the scope or the purview or the structure of a particular vocabulary. So you have to educate people. And you have to give them tools that make it difficult for them to send you incomplete information, or not to find something that is already in there.
In fact, I actually say that the large scale vocabulary test, the tools that were used for that really can be a basis, and I think people are looking at them for this work. We, of course, ended up with 41,000 things submitted to us in that vocabulary.
My colleagues spent a lot of time in designing those tools so that the probability that somebody would submit something when it was already was minimized, because we were going to have to review all of this stuff, and we wanted -- or they were supposed to submit and say whether it was there or not. We wanted them to be right as close to 100 percent of the time. When they told us it wasn't there, we didn't want it to be just a function of the fact that they couldn't find it for some odd reason.
So you have to have tools to support this maintenance process. If you don't have good tools, then the person who is responsible for the vocabulary is overwhelmed with noise. Things that don't need to be added, but people can't find them for whatever reason. So you get this. You want to minimize that. That's an area that some of the funds that are being provided to the LOINC group is to kind of work through those issues.
And again, I feel that that may be a very useful model that can adopted. I know other terminology developers are concerned about the same issues. So we will certainly be -- I certainly will be encouraging the LOINC folks to get in the room with the other people who are working to see if they can take advantage of each other's insights on this.
MR. BLAIR: Before we go on to Dr. Kolodner's question, you had kind of a three part question. The first part of it was you wanted to know from Betsy what was the research activity in natural language support. So I wanted to make sure that wasn't lost.
MS. HUMPRHEYS: I think that I am not the best person to speak about the full range of this. I'll send the references. There is actually good material on NLM's Website that describes this in fair detail. I can tell you that we have people who are doing research, and they use the UMLS knowledge sources in their research to attempt to basically understand the meaning of medical text, but they are focused not so much on clinical text as they are on published text in terms of the potential for automated indexing of the text.
So they are essentially using the UMLS knowledge sources, primarily the meta-thesaurus -- well, all three, the semantic network, and the lexicon, and the Lexical tools, and then additional, more experimental programs to essentially determine what is the sense of paragraphs and sentences by determining what the semantic types are, and determining what is the meaning of the sentence.
This work has been very, very influential in the development of the UMLS knowledge sources, because in this case we have a fairly sophisticated group of researchers in-house who are attempting to use the UMLS knowledge as natural language processing. So we basically make enhancements to the Lexical programs, to the semantic network, to the lexicon, and to the characteristics of the meta-thesaurus to support them.
A specific example, by the way, is we now have tagging, what we call the suppressible synonym tag in the meta-thesaurus to basically allow people who are doing language processing work to ignore or delete or not use the more esoteric abbreviations and strange illformed names that are often alternative names in these systems.
So basically you can sort of say, well, get rid of all the stuff that isn't real language, and let me use the synonyms in the meta-thesaurus that are really language. Now these synonyms are very important. If you put that abbreviation in your clinical data, you don't want us to throw it out of the meta-thesaurus. You want to get from that to other information in the meta-thesaurus. So we have to have them. But they wreck havoc obviously when you try to process text which may have similarly illformed things in it that, but they don't mean the same thing.
So drug numbers and various and sundry things that can cause problems. So that's something that they said this is a big problem. We said, well, if it's a problem for you, it's a problem for everybody. So now actually if you want to use the UMLS and natural language process, and you can get rid of some of this stuff that would actually be useful for clinical data, but not for text processing.
MR. BLAIR: Dr. Kolodner.
DR. KOLODNER: One of the things, Betsy, that you were mentioning is the need to do things incrementally. And certainly as complex as this is, I think none of us know about how to go about doing it; but maybe the next little step in front of us. So the idea of requiring people to do something as opposed to attracting them to do it I think is probably the pathway that I would encourage us to explore within our agencies or in our regulations as much as possible.
You raised the issue of the role of the federal government to front end some of the investment, and that's one that we talked about periodically for a number of years now. I think you have been one of the champions on that. And it's something that I hope this committee can make some recommendations that actually although they will go to Sec. Shalala, in fact may be something that will have to be dealt with more at the Data Council or across the agency setting.
Because the problem often is that no one agency either has the scope to make the investment, or can justify within it's potential benefit, the gain, and yet the effort at coordination across agencies, as opposed to saying it is in the interest of the federal government total. And assigning that responsibility and the appropriate hopefully funding.
MS. HUMPRHEYS: You know, it's very interesting. This model is so familiar on the library side of the house that that's maybe why it just seems obvious to me to do this. The Library of Congress and the National Library of Medicine maintain subject headings. These subject headings are used by catalogers around the world. When they are cataloguing something that we haven't catalogued, so they can't just copy our record, they use these.
So what are they paying for this? Well, they aren't paying anything if they're on-line. Otherwise, they've got a book which costs in our case $40 a year for the updated version, and the price is set by NTIS or GPO, not by us. It just sort of is like this is the standard. We all benefit. NLM benefits. If we want to use somebody else's record, if they get there first and we want to take their record and avoid our own work, we want them to use the standard.
I really feel that in some sense the way to view this is that the long-term benefit to the government operations themselves, and certainly to everyone else that we're theoretically running the government for is great. And the up front investment will be so tiny.
In the meantime, we have long delays of people making decisions because they don't know how to set the license fees, and they don't know this, and they've got to recover their costs, and somebody else is saying that's too much for me. I'm not going to have controlled vocabulary there, because I can't afford it. It seems like there is a quick, easy solution. It isn't even that expensive.
DR. KOLODNER: Maybe that's one of the important items that will result in our report ultimately, because I think that it has to be -- if we believe that that's the vital step, and I think we have an opportunity to make that case and describe the important effects and implications.
MR. BLAIR: Are there any other questions?
DR. COHN: Can I just make a comment? Betsy, I really want to thank you for coming and briefing the committee. I have known you for years, but I find every time we have a discussion like this, that there are sort of new thoughts and new conceptualizations that come up.
One of the things that we sort of touched on in many different ways is one of the work efforts of the overall National Committee which has to do with overall framework. I don't think we're going to handle the overall framework as part of our recommendations to the secretary within the timeframe, but certainly there will be pieces -- mapping, how to begin to put terminology together, which will, I think, certainly be parts of our recommendations.
MS. HUMPRHEYS: The other thing too is that's one of the reasons why NLM was interested in doing the mapping, and to some extent supporting it. Again, it seems that if people are trying to recover the cost of what they are doing, and they don't have a good model, and they don't have users. People are standing around, and we're saying there must be a map. This is not a trivial thing to do. It requires direct input by the people who most clearly understand the system.
Yet you are asking them to do -- I don't think it's reasonable to think they can do it out of the goodness of their heart, when they have a very difficult cost model already. So that piece seemed like, fine, we could do it. I think that in some sense I still think we can. And from my perspective mapping between vocabularies, that's one of the main functions of the UMLS activities. So that works.
It is difficult of course, when people have very major projects, because you only have so many resources to go around. It's not like for this mapping effort -- basically you need the experts in the system. So if the experts in the system are building the new version or whatever, it's not like you can hire somebody else to be the expert. There are only a limited number of them. I mean there are more than one, but many of them are heavily engaged at the moment. So it is something that can be done, but it's very understandable that people say, well, we can't get at it right this moment.
MR. BLAIR: I have saved my question for last. And you had mentioned early on that things had become a little bit more, I don't know if you used the word 'confused' or a little bit more difficult to pin down because of the work that is being done on the next version of CPT and CPT-5. And SNOMED-RT is being developed, and then beyond that the work with the NHS with the clinical terms, that alliance.
DR. COHN: And ICD-10.
MR. BLAIR: And ICD-10. In short, you kind of indicated that that creates a lot of open questions. Bringing that back to our struggle on this committee to try to see what appropriate-wise recommendations we could synthesize from all of the testifiers we have heard from, you could just talk about, maybe even speculate a little bit as to where that is leading, and what again the role of the constructive government should be to try to help the process move forward in a proper manner?
MS. HUMPRHEYS: Well, people develop new versions for a variety of reasons. Usually they are because they feel that there is some major shortcoming of the current version which incremental enhancement will not take care of. And so if they are right, as opposed to just inventing work for themselves, which I don't think is the case probably in any of the cases, then we just have to live through it, and manage it in some way.
I think that what is in some sense very attractive about LOINC is there it is. You can look at it right today. They spent a lot of time coming up with their model. Whenever they get a new type of thing, they spend a lot of time coming up with a model for the new type of thing, and then it goes forward.
So you can look at it on any given day, and you can say it needs more of these. But it is there as a structure, and it seems to be a current, good structure. So if you provide support to that, you know what you are getting. You are getting the expansion of this thing that you can look at and kick the tires on and whatever, moving forward.
I think obviously, if you are thinking about things like CPT-5, until you see CPT-5, or the new work, or at least have a more specific idea of what the trajectory is, I do think, because I asked this question yesterday -- not yesterday, but I specifically asked Ken Spackman about what their model was for bringing current users with them as they went forward.
He sent me what I thought was a good answer to the question about how they are working right now on exactly how they are going to deliver change sets over time, and they are also interested in this notion of really coming up with a specified change set, so that people can move along. I think that that maybe is a good thing to focus on. That is, okay, can we come up with maybe even something that would be a common approach that would be used by different vocabularies about what is the appropriate change set model.
You are not telling them how to run their terminology so much as saying but when you make a change, you have to be able to specify the change and deliver that information to people. And I think that in some sense a focus on -- and this is also something that I feel we can sort of try to push with, at least get one model on the table with LOINC.
Everyone is interested in this question. It seems to me that if you, as a system developer, didn't necessarily know all the content changes or whatever, or even the structural changes, but you knew that this is how they were going to tell you about those changes over time, maybe that would give us something helpful to move forward. You obviously don't want us to turn around and say, no, please don't make a major improvement to the system. We can't stand it.
MR. BLAIR: Let me just refine my question a little bit. Let me put it this way, because I'm really seeking your guidance and your advice on these things; your interpretation a little bit. Think of it in terms of each of those terminologies are coming out with new versions. Here is a direction. We know what the directions are for each of them. So let's wind up saying the question in mind that I would ask you is do you feel each of them is well directed to meet the needs of the markets they are serving? That would be my question.
MS. HUMPRHEYS: To continue to use ICD-9-CM, it seems doesn't make sense, and is not going to help us in terms of comparability of data with the rest of the world, where comparability at some level with the rest of the world becomes more important every minute, rather than less. So I think that to me we should move to ICD-10-CM.
I guess my feeling is that with the case of SNOMED, I think that my view is that we should get into some sort of model where -- SNOMED is a great system. I can't imagine a solution now in the immediate future, or a large scale project that doesn't include it. I think that getting in essence more people to understand and to potentially even have some input into the direction that it's going to go with merging with REED, I think it would be great to have some real users and some people who hardly use the system, helping to support, and also contributing to the thinking about how that merger should take place in a way that's going to be most beneficial.
But that's not a national standard, so it would be more I think recommending that in some sense that the federal government get into this process and provide some level of support, and be involved.
On the case of CPT-5 I can tell you that technically I am a liaison in this effort with the National Library of Medicine. They have wanted me to participate, and I have missed every single meeting that they have, some of them overlapping with every other thing I was doing including HIPAA and this, that, and the other thing.
So I have to tell you that although in my office there is a stack of documents of CPT-5, I have not studied those documents. I certainly have heard them describe the motivation for their effort, and what they are trying to do, and the areas they are trying to move in. And to me, it's certainly sounds like we're moving in somewhat of a good direction.
I have nothing negative to say about it. It's just that I haven't studied it, so I don't want to say anything. Maybe Simon knows more about it than I do.
DR. COHN: Obviously, as with any effort -- and actually, I do know some about it. As you know, I am involved in this process. I think the interesting question from that would be whether or not there is actually a version --
MS. HUMPRHEYS: And evolution.
DR. COHN: Incremental improvements.
MS. HUMPRHEYS: It's interesting, as I was saying in terms of this whole thing, there is an up and a down side to both approaches. There is certainly an upside to gradual enhancement. Of course if you feel that the basic structure has some major problem with it, then obviously you could say well, the gradual enhancement isn't going to be good enough, so it is not an argument with all the positives on one side of it by any means.
DR. COHN: I actually had another question to ask you know. On the global issues of terminologies may be a tough question to handle, but there is an issue of the fact that it requires a work group discussing those issues. Some of them are issues that are beyond the scope of the work group.
MS. HUMPRHEYS: My feeling is that when we did an assessment of the mapping requirements legislation, the coding classification specification essentially stated that none of the existing code sets really had fully specified really good approach to identifying changes.
It seems to me that we are now in the position, and it is actually part of the statement of work as it relates to the LOINC project, and it also is something that I know that SNOMED is very interested in, talking about for a long time of doing a better of serving the medical source. It's just notable that there is one, and it's an attempt in that direction.
MR. BLAIR: Let's take about a 15 minute break.
Thank you very much, Betsy.
[Brief recess.]
Agenda Item: Briefing Letter to the Secretary
MR. BLAIR: Are they any other Work Group members with us that I didn't name? That's everyone, Jim Garvie and Richard.
Why don't we do this. We would like to see if we could end no later than 12:30 p.m., and we might be able to end before that. We have a copy now of the draft letter, the progress letter to the secretary. If you haven't had a chance to read through it, I would like to spend maybe the next 30 minutes making final corrections on these, and from 11:30 a.m. to 12:00 p.m. settle in on the version for the staff, and our dates and our availabilities for late January or early February for the Work Group meeting that would work on our first draft of the recommendations. We are also going to have to work on that in December as well.
And also for us to have some time in that 30 minute timeframe to discuss a little bit more what we plan to have for hearings for October, because that's going to have to be a pretty busy day and a half. And we have only got a month to prepare for that. We've got a lot to cover. That's pretty much our last shot at gathering information.
So Michael --
DR. COHN: Jeff, can I break in for a second to make a comment from our earlier discussions on terminology. I just wanted to indicate to the audience, as well as to the Work Group that I do actively participate in the CPT-5 process, so as a general rule I sort recuse myself from the discussions or any decision-making in relationship to that. Those are all voluntary activities.
MR. BLAIR: Now we're kind of a small group, and I think it's a little bit informal. Do you need time to glance through the updated letter and then discuss it, or should we go ahead and start paragraph by paragraph with Michael?
DR. FITZMAURICE: Jeff, I would suggest we take two minutes just to look through it and make sure that the changes were made that you wanted made. I do notice one already, that is, I need to go through the attachments, and wherever I see PMRI, replace it with patient medical record information, or get a list up with patient medical record information.
Can we take two minutes?
MR. BLAIR: Sure.
[Whereupon, the committee takes the time to read the draft letter.]
MR. BLAIR: Michael, I think we've given everyone enough time to glance through the letter. Maybe you could take us through paragraph by paragraph.
DR. FITZMAURICE: Let's begin. Dear Secretary Shalala, first paragraph:
"On behalf of the National Committee on Vital and Health Statistics (NCVHS) I am pleased to inform you of our progress on the next report we are preparing for you as mandated by the Health Insurance Portability and Accountability Act (HIPAA) of 1996."
"HIPAA directs the NCVHS to study the issues related to the adoption of uniform data standards for patient medical record information, and the electronic exchange of such information, and to report to you not later than four years after the date of enactment of the Health Insurance Portability and Accountability Act of 1996, the recommendations and the legislative proposals for such standards and electronic exchange. This is in HIPAA Section 263. The Computer-based Patient Record Work Group within NCVHS's Subcommittee on Standards and Security has the responsibility for studying the issues and preparing the committee's report by August 21, 2000."
Those are the first two paragraphs. They are very much straightforward from the original letter with some minor modifications we made yesterday. Are there any suggested changes to the first two paragraphs? No? It meets with your approval.
The third paragraph is:
"This report will be important to you and the nation because it will make recommendations about standards that will significantly improve the efficiency and effectiveness of the health system for the delivery of high quality care. This reflects the first of ten guiding principles for selection patient medical record information standards (Attachment 1). The principles are based on the guiding principles for selecting standards for HIPAA."
That's the third paragraph. I have one suggestion. I think it originally came from an email from Marjorie Greenberg where she suggested starting the paragraph with, we believe this report will be important to you, reflecting the feeling of the committee. Does that meet with approval? I see heads nodding.
DR. FERRANS: By the way, should it be the health care system instead of the health system?
DR. FITZMAURICE: That is care delivery itself plus the management and quality functions should all be part of the health care system.
DR. FERRANS: We use the term 'health system' synonymously with health care?
MR. BLAIR: I think we do make the distinction. I know that in the information infrastructure, the National Health Information Infrastructure group that is also part of NCVHS the distinction is that if you just use health system or health infrastructure, that's broader than health care. Health care is the provision of care.
DR. FERRANS: Well, then health system would be appropriate.
DR. FITZMAURICE: Any other suggestions on the third paragraph? All right, it's accepted. Let's move on to the fourth paragraph, which contains the bullets regarding the six focus areas:
"This report will address the following focus areas as they relate to patient medical record information (Attachment 2):
DR. COHN: I only bring this up, and I don't know what the desires of the Work Group are with this. Sometimes people refer to medical terminology in the broader sense, which means health care terminology. I think there is not a lot of difference in the way to describe it. I don't have a strong feeling one way or another. But I think there are certain terminologies that are not necessarily medical terminologies.
DR. FERRANS: Health care is the more appropriate term with all the nursing codes and all sorts of other things.
MR. BLAIR: I have no problem moving from medical to health care or health, but should we be consistent and go to health terminologies instead of health care terminologies. Is that what you were saying, Simon?
DR. COHN: I don't that I've heard of health terminologies. I know I've heard health care terminologies.
DR. FERRANS: I think for PMRI, I think it does have to more with health care.
DR. COHN: Actually it's referencing patient medical record information, so maybe we ought to just leave it at medical terminology based on the legislation.
MR. BLAIR: I do think that it should be terminologies, plural, not singular.
DR. FITZMAURICE: And since we are talking about the six focus areas, whatever changes we make here, Jeff, I will make in the titles of the six focus areas in the attachment.
Are there any other suggested comments on the fourth paragraph with the bullets? Let's move on. The next paragraph is a short one:
"To gather information for this report, so far we have heard from blank testifiers during five hearings over a total of nine days in 1998-99. We plan for additional hearings during the next few months."
Now if I might suggest striking out 'over a total of nine days' just to reduce the amount of detail. Is the secretary interested in nine days? I think she would be interested in how many testifiers we've had. The number of hearings, what do you think?
DR. COHN: I actually disagree on that. If Kathleen Frawley were here, I think she would also disagree. I think you want the secretary to recognize that we are spending a considerable amount of time on these issues.
DR. FITZMAURICE: That's reasonable.
DR. COHN: I think that the letter is now short enough that I think we're at risk for losing her, since it's only a page and a half long.
DR. FITZMAURICE: Any other thoughts on that?
MS. BURKE-BEBEE: I agree with that too. The only suggestion I have though --
DR. FITZMAURICE: You agree with Simon, or you agree with me?
MS. BURKE-BEBEE: I agree with Simon. I also suggest to say in gathering information for this report we have heard from, because I think the second sentence tells the additional so far that we intend.
DR. FITZMAURICE: There is head nodding. So it reads:
"In gathering information for this report, so far we have heard from blank testifiers during five hearings over a total of nine days in 1998-99. We plan for additional hearings during the next few months."
Next paragraph, if there are no other comments. The next paragraph is moderately long:
"So far testimony has shown some areas of significant accomplishments by both the private and public sectors. However, the witnesses believed that we need both additional areas to be covered by standards, and more widespread adoption of existing standards. First and foremost, this would improve individual patient care and dramatically reduce adverse events. These advances in standards are essential for solving many of the health care system problems including clinical efficacy, effectiveness, performance measurement, and research. The witnesses also believed the government should find ways to play a constructive role to advance progress. The committee is currently developing recommendations on how best to proceed."
DR. FERRANS: I think on that sentence after the first and foremost, I think it needs to be second, because it says the advances. The other thing is --
DR. FITZMAURICE: Excuse me, you would put second in front of these advances?
DR. FERRANS: Yes. And the other problem with that sentence is that these standards are essential for solving the health care system problems, including efficiency -- efficiency is not a problem, nor is research. So we need to reconstruct that somehow.
DR. FITZMAURICE: Addressing challenges.
DR. FERRANS: They are not problems.
DR. COHN: I'm still not sure that research is a challenge, nor is performance measurement.
DR. FERRANS: Improving the health care system in areas such as, and I think we're there.
DR. FITZMAURICE: Second, these advances in standards are essential for --
DR. FERRANS: Improving the health care system in areas such as.
DR. FITZMAURICE: Improving the health care system --
DR. FERRANS: I prefer addressing the health care needs in areas such as. I like that better.
DR. FITZMAURICE: For addressing health care needs in the areas of. Let me see if I've got it. Second, these advances in standards are essential for addressing health care system needs and then in areas such as. But is that to be dropped and be care system needs including?
DR. GRIFFITH: Clinical efficiency, performance measurement, research.
DR. FITZMAURICE: If we describe them as areas, it makes them broader. If we describe it specifically without the word 'areas' in there, that implies that those are specific needs.
Health care system needs in areas such as clinical efficacy, effectiveness, performance measurement, and research.
MR. BLAIR: What happened to improving quality of care?
DR. FITZMAURICE: First and foremost, improve individual patient care, and dramatically reduce adverse events.
MR. BLAIR: When we get through with this section, I would like to back.
DR. GREBERMAN: Jeff, it sort of stands out there early, the issue of adverse events. Clearly, that sentence really stands out there the way it says it in terms of individual patient care and dramatically reducing adverse events. I'm wondering why it's that way when the sentence after that would include some of these issues. What I'm wondering is in reading this letter, and we could dramatically reduce adverse events, why is that pinpointed there? And then how could this help us do that? I don't see any of that in this letter. That didn't hit me in any of the other issues that were raised.
DR. FITZMAURICE: I would guess it's because we heard from witnesses, and quite a few witnesses said one of the low hanging fruits is reducing adverse events, errors in medicine. We heard it again yesterday, and I think that's what the committee grabbed on.
DR. GREBERMAN: I can appreciate the use of the word, but I'm wondering in terms of the letter, is there something that ought to tie it to how? And then you just pointed out some things.
DR. FERRANS: I would say that if the focus on the first and foremost is not on reducing adverse. It is on improving patient care. And I think that that comes from two sources. Number one, from every witness that we heard, like loud and clear. And number two, I think also the chair made some comments earlier on in the process when he said this is about health care. I heard him say that very clearly. I think he wanted to focus on that.
But I think the problem with the way the sentence is constructed is that it sounds like we are telling the secretary first and foremost that we could reduce adverse events. I think that's an unintentional consequence of the sentence.
DR. FITZMAURICE: So it speaks to suggestion of the deleting 'and dramatically reduce adverse events,' or rewording it.
MR. BLAIR: Could we look at this kind of in combination if I may? I agree with your points, and I sort of feel like the point I'm about to make may pull these things together. On that first sentence, the first phrasing of that winds up saying that significant progress has been made, but it doesn't say related to standards for patient medical record information. You don't know what the progress is until you get to the end of the sentence.
My thought is that if you moved up the reference to standards for patient care up to the first part of the sentence, you then can take the last part of the sentence, and have it focused on the need for additional improvements for patient care and adverse drug reactions. Does that work? Does that tie the stuff together, or is that confusing to you?
DR. FITZMAURICE: I guess for me it would make sense to put after so far testimony has shown some areas of significant accomplishment in the standards arena.
MR. BLAIR: In standards for patient medical record information. That's what we are focusing on here, or related to standards for patient medical record information.
DR. FITZMAURICE: That works.
MR. BLAIR: Okay, now you don't have to repeat that at the end of the sentence. And how would the rest of the sentence read?
DR. FITZMAURICE: Let me read the paragraph as I understand it:
"So far testimony has shown areas of significant accomplishment in standards for patient medical record information by both the private and public sectors. However, the witnesses believe that we need both additional areas to be covered by standards, and more widespread adoption of existing standards."
MS. BURKE-BEBEE: Can I say something there? Instead of both, say growth on two issues, then colon or something, and then those are the two issues; something along that line.
DR. FITZMAURICE: You mean put a (1) in front of additional areas to be covered, and (2) more widespread adoption?
DR. FERRANS: I might have put in both, but now I am wondering whether it is redundant.
DR. FITZMAURICE: If I don't read it right, it sounds awkward.
MR. BLAIR: If right after the word 'however' you said, however, in order to improve patient care we need to expand the use of existing standards.
DR. FITZMAURICE: There is more than just patient care improvement that the witnesses believe in. And we do make that point in the next sentence. Maybe that would work out. So let me read that again. "However, the witnesses believe we need" and the question is do we need both in there or not? "However, the witnesses believe that we need additional areas to be covered by standards, and more widespread adoption of existing standards." We could italicize the 'and' and drop the 'both.'
"However, the witnesses believe that we need additional areas to be covered by standards, and more widespread adoption of existing standards. First and foremost, this would include individual patient care," and I think we proposed dropping out the remainder of that sentence, which is "and to dramatically reduce adverse events."
DR. GRIFFITH: Mike, I agree with dropping the rest, but something everybody has done here which I agree with is they have dropped 'individual.' So I would drop it. That's too limiting.
DR. GREBERMAN: One possibility though in terms of the adverse events, if it was really a strong focus, it could be built into the next sentence with that string.
DR. COHN: Let me make a couple of comments. I'm all in favor of wordsmithing. I think first of all, the point of this first sentence was that we're moving away from the health care system into the actual individual effect of this, which I think is a fundamental issue. Everything else we have here is sort of at this high level research, performance measurement. Things that only sort of indirectly touch the patient.
The two points we've made in the first sentence were improvements of individual patient care, something that people would directly see as improvement. And another piece of that which we wordsmithed or could potentially even take away, but something that's of concern to individual patients which is adverse events. We can remove the adverse events, but I would just have you recognize that that was really meant to be moving from the individual, then up to the population.
DR. FERRANS: I would agree with you on the individual patient care, because God knows that every IT vendor claims to improve patient care, and it is too high level. As far as the reduction of adverse events, that certainly could be put in the health care system, or an alternative one would be if you end that sentence to improve individual patient care, and then say, for example, standards would enable decision support systems, the widespread adoption of decision support systems or something like that. Just say for example, something about decision support systems.
If you wanted to tie it to individual patient care, I would put it in a follow-up sentence. Otherwise, if you wanted to tie it to the system, then I agree with Mel that we should put it in with clinical efficiency, effectiveness.
DR. FITZMAURICE: There is another way to make it broader, and that is to put in comma for example by reducing errors in medicine, of which adverse events may be one.
DR. FERRANS: I think adverse events is a stronger term. It implies morbidity and mortality.
DR. COHN: I think Margaret had a comment.
MS. AMATAYAKUL: [Remarks off mike.]
DR. COHN: I like that. Do you have it written down?
DR. FITZMAURICE: Say that one again, Margaret.
MS. AMATAYAKUL: First and foremost, this would improve direct patient care such as by fostering efficient support systems to reduce adverse events.
MS. BURKE-BEBEE: Such as by fostering decision support systems to reduce adverse events.
DR. GRIFFITH: I like it. It's more positive. The other one is going to be a red flag. And direct patient care I think is better than individual patient care.
DR. FITZMAURICE: Do you like improve direct patient care, or do you like improve patient care directly? Let me read it starting with the second sentence. "However, the witnesses believe we need additional areas to be covered by standards, and more widespread adoption of existing standards. First and foremost, this would improve direct patient care such as by fostering decision support systems to reduce adverse events."
DR. FERRANS: You know, we keep saying that sentence is awkward, and I think I have a solution. In the middle of it where it says, 'more widespread adoption,' it should be as well as. Now we're wordsmithing this.
MR. BLAIR: No, that's good. That helps. As well as more widespread adoption.
DR. FITZMAURICE: "However, the witnesses believed that we need additional areas to be covered by standards, as well as more widespread adoption of existing standards. First and foremost, this would improve direct patient care such as by fostering decision support systems to reduce adverse events. Second, these advances in standards are essentially for addressing health care system needs in areas such as clinical efficiency, effectiveness, performance measurement, and research. Witnesses also believed that the government should find ways to play a constructive role to advance progress."
DR. COHN: I have a suggestion other than 'should find ways.' The government can play a constructive role. And that goes on to the next sentence that says, the committee is currently developing recommendations.
DR. FITZMAURICE: It reads: "The witnesses also believed the government can play a constructive role to advance progress."
DR. GRIFFITH: Mike, in the previous sentence, a suggestion. One of our testified used a term that I liked, adding to that list, organizational management. I thought that was really nice, because they were talking about reorganizing organizations, managing organizations. That was just a suggestion in that list of four things, efficiency, effectiveness, performance measurement, organization management, and research. It's just a suggestion.
DR. COHN: Can I speak against that? I think efficiency and effectiveness probably get close, and then the list gets too long. It's not a bad idea, but it's just that I don't think we gain by adding -- putting a long list together.
DR. GRIFFITH: I'll tell you and then I'll stop. The reason I'm suggesting it is I'm reading this as a provider. And listening to what Gary said, and how they are going to take it, a red flag would be reducing errors. They are going to see it as a punitive system coming down. Most of these appear to be focused on the provider, rather than the organizations that are preventing them from delivering the quality of care they want.
I was trying to put something in there that would give something if a provider read it, that they wouldn't see this as Big Brother coming down saying, you're doing bad. You're not efficient. You're seeing as many patients as you should. You're not doing the paps in your patients that you should.
There is nothing in there that I see that says we've got to address our organization of our care so that our providers can do a good job. That's where it's coming from. Now that term may not be right, and we may choose -- it's long enough anyhow. But as a provider looking at that, I was going to try to put something in there.
DR. FERRANS: My sense is we would need a different term. I understand the concept. It is sort of a concept I hadn't really heard before, so I think it would stand out in the letter.
DR. GRIFFITH: We don't have to decide it now. It's just something to stick in the back of your mind. If you can come up with stuff that will diffuse that a little bit, it might be good.
DR. FITZMAURICE: All right, I think we are satisfied with that paragraph, but let me check and make sure that we are. Yes, we are. The next paragraph:
"Although it was not included within the scope of this work effort, many testifiers stressed the importance of legislation to protect the privacy and confidentiality of health care information."
Now we have health care as one word, and above there we talk about health care system, and we use health care as two words. We should be consistent.
MR. BLAIR: I go for two words.
DR. FITZMAURICE: Everybody is very neutral, so it seems to carry the day. It's two words at this point. Do we want to use the tense although it was not included? Do we want to say although it is not included? Let it as although it was not included? Because we are in the past, talking about the testifiers.
MR. BLAIR: Margaret had a question. I wasn't thinking it was going to be reflected in the letter, but maybe it should be so. Margaret, go ahead.
MS. AMATAYAKUL: Yesterday as I was listening to the testimony, it seemed that nearly everybody raised the issue of unique patient identifier. I know it's highly controversial, and I know sending it forward or doing anything with respect to that, that has been removed. But it was really stated quite often yesterday. I don't know whether it would be appropriate to add to the issue of legislation for privacy.
Maybe something to the effect that and there following attention placed on unique patient identifier systems.
DR. FITZMAURICE: That struck the same kind of bell that one of my earlier comments struck. But not because it's not a good idea, and not because they didn't mention it, and not because it isn't considered an essential step for moving forward, but because it is being handled politically elsewhere at this time at the vice president's level and the Congress has said, don't move forward. So we can't tell the secretary to do something the Congress has said we won't let you spend any money on final implementation of personal identifier.
DR. FERRANS: I would agree with you, but for different reasons and say that the bulk of the testimony, there was mention of it in portions. I would go as much as say throughout. But I did not hear people saying that this is a burning issue. Like we can't do this without the universal patient identifier. I did hear people say loud and clear we need privacy. That was a more burning one.
That's why I would include this in the letter, and not the patient identifier, although certainly the political dimension also.
DR. FITZMAURICE: That's part of what Margaret said. I think I remember the first couple of hearings people emphasizing that, that an identifier was needed to pull together the records of patients treated in different sites. But I'm arguing against myself, but I'm saying I think it's an important point. I don't want to detract from the letter and from our job at this point. But those are my thoughts. How about yours?
MR. BLAIR: My thoughts are to not include it in the letter. I guess there are three reasons. Number one was the first one that you articulated. Number two is that I think that yesterday's comment about the patient identifier was not consistent -- well, let's put it this way. Most of the testimony we have heard did not make an emphasis on the unique identifier.
There were a couple of references to it before, but they were mixed, because among the testimony that I remember hearing is that we could go forward without a unique identifier, because there are master person indices. It would slow us up.
DR. FITZMAURICE: We could leave that last sentence as the last sentence. The last sentence is, "The NCVHS looks forward to delivering a cogent report on time with the recommendations and legislative proposals." My preference on that one would be to stop it on time. The charge at the beginning of the letter already says what it should contain.
DR. FERRANS: Half of the letter is centered on what it is, why it's important. Then there are six areas, which all we've done is listed the area. And then it basically says we need more standards, more widespread adoption, and that this would help everyone. Just comment on that.
DR. FITZMAURICE: If we are in agreement at this point, I will make the revisions in the letter and send them around to the Work Group and staff early next week. If you have any comments, please send them in.
DR. COHN: Can you help us here with what will happen in terms of the timeframe?
DR. FITZMAURICE: You will have it before next month.
Agenda Item: Discussion of January-February Meeting
MR. BLAIR: Any other comments on the letter to the secretary?
Let's move on to the next agenda item. I hope you as many as you brought your calendars as possible. We are going to need to schedule a day and a half of deliberations with respect to our recommendations for either the last half of January or the -- I said the first half of February, but the critical thing is that we have this meeting in time for us to be able to present to the full committee at the end of February. I think it's February 23 and 24 when the full committee meets, for them to give reactions to at least our first draft, our initial draft.
We will still end up having input from other interested parties with the Department of Health and Human Services. We will be updating it a number of times. The next time that the full committee meets is going to be June. We will have to have their approval. So we want them to at least see as much as possible by then, before the 23-24th timeframe so that they can critique it.
[Brief technical difficulties, some text lost.]
MR. BLAIR: So if we miss being able to have something for them to give us feedback on, then the first time they would see is June, where we are asking for an approval. That may make it more difficult for us to get approval. So we're trying to see if we can get as much done as possible to review with them.
DR. FERRANS: Are they going to have a problem with things that maybe they didn't see earlier, but that we added later?
MR. BLAIR: Well, maybe this would be helpful. We have a draft which was handed out yesterday with timelines. Let me kind of step you through that. I mean it's not perfect, but we could revise it if we have to. And we are starting to drive forward. And to be honest with you, I do wish we would have more time in many areas to do more, but we have scheduled for the full NCVHS meeting later this month that we would be reviewing with them the progress letter, and attempting to get their approval and authority for us to go forward to send that to the secretary.
And this is going to be the next subject after we try to get some tentative dates in mind, that today we are going to try to make sure we have as much scheduled and included for the October hearings. That's still information gathering hearings. And you could wind up seeing there are a bunch of topics there, not only users, but ontology, a glimpse at international standards, the business case issues, more data quality testifiers.
So there is quite a bit that we want to make sure that we include in there. And with Betsy Humphrey's testimony, I would like to get an update from Judy Ozbolt on the nursing code set development, coordination among those. And that would be the end of our at least formally scheduled information gathering sessions. And after that, I think that I will probably attempt to work together with Margaret to try to summarize before the end of October, the issues, and at least maybe a framework for the recommendations.
Let me step back. By the end of October maybe we could get the issues out electronically. By the end of November we could get a framework out to all of you so that when we meet in December we would totally dedicate ourselves to beginning to develop the first draft of the recommendations.
We felt that this was more than could be done in a day. And that's the reason that we start working on that. We continue to exchange that and update that electronically the rest of December and January until we get to meet again for a day and a half. At which point we refine it some more so that we have as much progress as possible on those recommendations to review with the full committee at the end of February.
We will probably get new critiques and viewpoints the committee will give us, and we will have to then revise and update those recommendations in March. In March we would probably be able to update that. And then begin to send it to other interested parties within the Department of Health and Human Services for their input. Probably update it again in May, and then review the final with the full committee in June. Now that's the way we have it laid out. If you feel we need to modify that plan.
DR. FERRANS: I would only express my concern that sounds like we are going to take two days in December. I would just recall that Clem was very expressive about that last night too, that we need less testimony and more deliberations. Sort of we need to get on with the deliberations.
DR. COHN: Recognizing that Jeff has gone through the activities between now and then, unfortunately, we don't have a quorum of the Work Group or the subcommittee, so we really can't even agree that that is indeed the right work plan. Everyone who looks at the work plan recognizes that at a minimum we need January, December, something like that.
Some of that will depend on how good the work being done by Margaret is based on the work that Jeff and Mike have done and myself also in trying to capture all of the issues as we have gone along. And the value of the testimony. Certainly, I would speak myself against us not having users testify in October, because we really have not heard adequately the user point of view, and they are above and beyond the key group that we could hear from right now, understanding what's real and what's doable in the way of recommendations. But probably there are ways to meet all of these needs.
DR. FERRANS: As I was looking down the list I was thinking are there any places were we could get written testimony. I think it's going to be important for our process, just trying to squeeze as much deliberations into the limited time we have is the objective, not necessarily at the expense of limiting testimony, just changing the format.
MR. BLAIR: The only thought that I would have, I would love to be able to move it up and give them more time. But the thing is that if we don't have some type of a structure or framework, if we don't know what the issues are that we are addressing recommendations for, it's hard to go right into the recommendations. I think we have to do some consensus building as we go through this.
I would love to be able to move faster. I was struggling. I was having difficulty seeing how we could get the issues, review and have everyone come to some degree of consensus on what the issues are, and then from that have enough time to then wind up crafting well, what kind of recommendations would we have to review in December where we could be efficient in going through those recommendations, where we have some degree of consensus development. Does that make sense?
DR. FERRANS: Yes, it does. And in some ways -- I'm sure this is just me thinking this, but one of the things I was thinking is that it would even just helpful in the session if we had a little bit of time at the October hearings where we just had a frank and honest discussion about where we were at to see where are some of the issues where there is a tremendous amount of agreement, because building that framework is very easy; whereas other things where people are fairly polarized.
That may help guide use in our December deliberations. I don't know if that's an appropriate --
MR. BLAIR: What about if we did something like if we had one or two or three hours maybe on the second day, where we could try to get convergence on the issues. And then from that, if we get some degree of convergence on that, that would help us toward saying what would be the recommendations to address those issues?
DR. COHN: Could I make a comment? I think that all this depends on staff support. Unfortunately, Michael Fitzmaurice is not here to be able to nod what he can do between now and October. Margaret A., who is another part of our support and help --
MS. AMATAYAKUL: I just should mention I won't be under contract until October 1 anyway.
DR. COHN: Oh, okay. I think that this is part of -- I think that these are pieces that we need to put into the project plan. Certainly if we can't agree on what the issues are, and if we can't somehow synthesize the hearings and what we have heard in the testifiers into the key issues, we certainly can't identify what sort of agreement we have on recommendations.
I think being a public body, we really have to rely a lot on what we have heard. And we certainly had a lot of very good expert testimony. So I think that as much as we might like to move the process up, I think we need to probably talk to Mike off-line, and identify what the process that can actually be met in terms of all of this stuff.
I shared in the discussion one of the things that you have identified is that we need to have some time to talk in October. I am, however, I'm not saying frustrating, but my concern is that we are going to have this discussion again in about 10 days at our meeting with the NCVHS. So actually I'm wondering whether we might just take a couple -- maybe defer other parts of this discussion, only because we need to have it again, where we have enough of the committee that they can say yes or no to the process that we are developing and recommending.
I guess I would ask that maybe we might just take a second and talk about another issue that I know Jeff had laid out, which is are there things that we are missing for October in terms of hearings or hearing from people or otherwise that we need to make sure we capture, recognizing that other than for specific focused issues, that may be the last time that we really take public testimony on these issues.
Mel, are you raising your hand?
DR. GREBERMAN: Well, the one area that hit me as Betsy was talking earlier is one we talked about a couple of months ago, but never really followed through, and that is the issue of the discussions now going on within the United States and also internationally regarding the medical device terminology standards. That's getting into a really growing area that I think we should consider in these discussions.
And also, these discussions may have an impact on the way that proceeds in the future. So I think it would be useful from a multiple perspective. I'm not sure, if you would like to pursue that I'll give whoever would want to make the phone call, the proper name and phone number, and I'll brief that person so you could decide whether you it makes sense at this time or not.
MR. BLAIR: Help us a little bit on this, because we did have testimony during the terminology hearings in May from IEEE that develops a medical device terminology standard. So we heard from a developer. Is it that you feel like we need to hear from the user?
DR. GREBERMAN: No, what I'm saying is the government has got a very active activity that is underway that relates in some ways to these other activities, but by far not completely. It really is working government to government in may. But ECRI has been involved in that one also with us.
MR. BLAIR: Okay, we heard from them too. If you have someone that you feel we should hear from, can you give it to Michael or myself.
DR. GREBERMAN: What I can do is have Mike talk to them. Mike obviously knows far more detail of what has been said at some of these hearings than I may. And so I think it would be useful to have Mike talk to them and make that final decision. My own gut feeling is it would be very helpful from a variety of perspectives.
MR. BLAIR: Any other things that have been left out that needs to be included?
MS. AMATAYAKUL: Earlier today you commented that perhaps an update on the GCPR project would be useful for October.
MR. BLAIR: Okay, update on GCPR project. We had also mentioned -- that's not listed there -- an update from Judy Ozbolt. She had pulled together an effort to try to coordinate the nursing code standard, nursing terminologies.
DR. COHN: That might be one where we could have in person to brief us on what's happened, or if she wants to submit to us a progress report in the issues that she is still facing, that would be actually be another reasonable way to get that information. I think I would defer to you and Mike in terms of the scheduling on that.
MR. BLAIR: Now we do have a commitment now from First Data Bank to testify. That's the drug knowledge base area. That's a somewhat controversial area right now. So we really want to hear from them. We already heard from Multum, a drug knowledge base vendor that had a particular viewpoint.
Other areas?
DR. COHN: I am hearing pretty strongly that we need to somehow get some things together that we can begin to at least look at the high level issues, if at all possible.
DR. COHN: One of the other areas that I would like to ask for your help on any ideas, from the very beginning we had business case issues among our focus areas. And there have been comments about business case issues during the testimony that we received in March and May and June, and even a little bit yesterday.
We have had difficulty trying to specifically focus on a questionnaire for business cases, or identify an individual that really felt that they could explicitly speak to this issue. If any of you have any ideas as to how we could get more information on business case issues from the narrow standpoint of the business case to develop the standards, or the broader issue of the business case for electronic health records, computer-based patient records, that would be helpful.
DR. COHN: I actually wanted this to remind ourselves that we actually did hear, I think a very compelling set of business arguments from Dr. Jessee yesterday, which I thought were very enlightening and very helpful.
DR. FERRANS: The only thing I would say, and undoubtedly it was compelling, we often hear from those who build rather than buy. And I think the literature clearly shows that probably the best implementations are those of people who have invested and built. I would love to hear from the CIO of a big private system like Alina(?) or someone else who says I have to buy from H. Buck, Cerner(?), SMS, or build myself. Here are the issues I would look at.
Here is the real return on investment that I have to show the CEO to justify these purchases. Talk about the cost prohibitiveness of systems, and talk about the long implementation cycles. I think like with Pax(?) there are "return on investment" models that have been developed, and people question whether they are always realized.
It would be interesting to hear the sort of middle of the road view. We were talking about the Olympians yesterday. We hear from the Olympians a lot here; people who have just been extraordinarily successful in implementing systems.
MR. BLAIR: You have prompted another thought on that. We have been struggling with trying to have many of those users here today. Michael called a number of hospitals to try to get the CIOs and others to do that, testify. They seem to fade away. I think we should still try to do that.
But one of the thoughts is I think that CHIM did a survey of I think business case issues where they took a survey of users. We hadn't thought about that. That might be helpful. Margaret, do you know anything about that in greater detail?
MS. AMATAYAKUL: Are you talking about the one they did a couple of years ago on valuing CPRs?
MR. BLAIR: Yes. Does that have useful information or not? What do you think?
MS. AMATAYAKUL: Well, actually that was CPRI that surveyed CHIM.
MR. BLAIR: Okay, then you do know more about this.
MS. AMATAYAKUL: I have a copy of the report that I could give you. Maybe we could just pass it around and see whether it's useful and needs to be updated.
MR. BLAIR: Is that something even you could testify on? Or would you feel like just presenting the material for us to read would be sufficient?
MS. AMATAYAKUL: Let's just present the material first and see.
MR. BLAIR: But, Richard, definitely we're going to try again in October to get end users, CIOs, and folks that maybe manage -- we were especially trying to go after small hospitals, or folks that pull together ambulatory settings, to try to get away from the very large institutions. We've heard from most of the larger institutions.
DR. FERRANS: That would be great too.
MR. BLAIR: So, we'll try again.
MS. BURKE-BEBEE: Mike has decided to hand that over to me. He is going to work with me to go through contacting these people.
MR. BLAIR: Wonderful. While we are here, are there clinics or small hospitals that you could give those names to Suzie, or even individuals you know within health care institutions that she can contact.
MS. BURKE-BEBEE: I'm a registered nurse by the way, 17 years, so I might be able to have an open door to get in to some of these places that you might know that I could contact.
DR. COHN: I would comment that I think we have done a very good job of hearing very well thought out presentations and bits of information from many of the associations. UMGMA has done a good job, AHA, others have come prepared with an ability to represent many of their memberships. So it may be a question of whether it's CHIM or CHIME, it may be an opportunity to talk to them if we want to hear from CIOs; CHIME from the CIOs.
We may want to talk to Kathleen Fyffe, who I know we've explored before, but may be able to help us identify some other associations that may represent some of the viewpoints that we're seeking.
I know Margaret A. has a comment.
MS. AMATAYAKUL: What about the Clinic Club? Somebody from the Clinic Club I think would be good, because the Clinic Club is sort of an elite group of CIOs from the major clinics. I think there are like 29 in the group. And there is Mayo, Scripps, St. Mary's, Carl Clinic, Cleveland Clinic, Eisinger(?). That would represent more of the people who are out there buying products too.
MR. BLAIR: Any other areas where it would be helpful for us to get additional information in October?
DR. FERRANS: I know that there is a group here in town that is a consulting firm called the Advisory Board Company. I know that they have had some recent health care CIO roundtables. I know them, and I could certainly find out if they knew of someone who might fit the profile, so to speak. They might be very useful.
MR. BLAIR: Suzan, maybe you could tell all of us your phone number or your email address so that if during this next week people come up with additional thoughts or ideas, they can get the information to you.
MS. BURKE-BEBEE: My email address is on the roster.
I have a question, Jeff. You were referring back to this business case. Is there any further development from this testimony that I will be trying to get together that would be important to help develop the business case that you were referring to?
MR. BLAIR: I don't think that we were going to develop a business case. We just wanted to understand the business case issues. And now I think there are two things. This is not easy. There were just references in a lot of the testimony that we had here and there where people talked about business case issues. There were a couple of presentations that really went after it. I guess it was back in March I think.
Margaret, as you are going through that, I don't know whether you are about to ferret some of that out.
MS. AMATAYAKUL: I'll try.
MR. BLAIR: When we get on the phone, I'll try to pin down those that I recall, or Simon can where we remember that they were richer with information about business cases than others.
DR. COHN: I guess I'm presuming that Margaret will be reviewing the testimony, which I think should include all of that information. So I guess I'm presuming that as part of that she will be divvying up what is appropriate for the business case, what's medical terminology, ferreting out all the issues into the buckets that we need.
MR. BLAIR: Speaking about that, since we're trying to move forward on this, as you can tell in the conversation that we have had here, we would love to be able to try to pull together an initial set of issues by the end of October. Can you help us with that? Are you going to be able to do that?
MS. AMATAYAKUL: As long as I get a contract by October.
DR. GREBERMAN: Is there anybody who was involved with the preparation of the IOM report that might shed some useful discussion on the business case issue? It's worth thinking about potential people.
MR. BLAIR: Which IOM report? There are several IOM reports.
DR. GREBERMAN: I'm looking at the one here, "The Computer-based Patient Record: An Essential Technology for Health Care." I haven't read that report.
DR. COHN: Dr. Collin, I'm sure would be happy to come out and brief us.
DR. GREBERMAN: I suspect so.
MR. BLAIR: Now Margaret were both at that study for the 18 months. And Margaret, was, I think, extremely instrumental in the development of the book, if I recall.
MS. AMATAYAKUL: Well, I feel like I have the book practically memorized. I'm not sure I guess that -- I think there were elements, but that part is back from the late eighties, early nineties. Although it was revised to be still current on issues, I think there are more current issues that some of these other groups would probably address better.
MR. BLAIR: Okay, let me interrupt. Simon has to leave in three minutes. Simon, could you just tell us before you leave what dates in that last week of January or first week in February, when are you not available?
DR. COHN: I think I'm available completely the last week of January, and the first two days of the first week of February.
MR. BLAIR: The last week of January, and the first two days. Is that the 1st and the 2nd of February.
DR. COHN: Actually, it's the 31st and 1st.
MR. BLAIR: You are open those times. Maybe the easiest way to do it is would you all email me the dates when you are not available during the last two weeks in January and the first two weeks in February. Tell me when you are not available. From there I'll try to pull together several options that we could get out.
Would you mind doing that, if you don't mind, Monday or Tuesday, and I could then get with Jackie, and Jackie will get it out to the broader group?
Simon, is that is okay with you?
DR. COHN: Yes, except that you're asking the wrong group. That's my only complaint here. The first group that you need to be asking is the Work Group about their availability. They should be the ones to determine what the dates are, with the staff support being also available. You are basically in a situation where you are asking a couple of Work Group plus basically the support what their availability is.
You can certainly send out an email to everyone asking them. I don't have any issue about that. You might as easily just ask everybody to bring their calendars with them to the next session, which will be in a week.
MR. BLAIR: Okay, I'll do that too.
DR. COHN: It's just a question of what's really important right now is to make sure that the Work Group is actually in attendance as we sit here and go through the recommendations. They are going to be really the key group that we need to make sure are here.
MR. BLAIR: Richard Ferrans and I have some of the same genes, and we have this sense of urgency.
It sounds like Simon is right. I think the time is for us to adjourn. Send me whatever emails you have with when you are not available, and at least that will all help.
Thank you, everyone.
[Whereupon, the meeting was adjourned at 12:20 p.m.]